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CONTENTS MARKET Vol.11 No.3 DECEMBER 1-15, 2015 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bengaluru Neelam M Kachhap DESIGN National Art Director Bivash Barua Asst. Art Director Pravin Temble Senior Graphic Designer Rushikesh Konka Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Harit Mohanty - West & East

JAN AUSHADHI

HINDERED BYHURDLES The Government was supposed to launch a policy for the ‘Jan Aushadhi Scheme’in September 15.However, it has been delayed due to implementation challenges. Key industry stakeholders express their views on the delay and share measures to overcome the challenges that beset the policy launch | P40 P51: POST EVENT NovaLead Pharma completes global phase I/II clinical trial for Galnobax

CPhI INDIA P52: INSIGHTS

PRODUCTION General Manager B R Tipnis

Improving quality, cost and efficiency

Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar

ROADMAP FOR SUSTAINABLE GROWTH

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SHAPING THE GROWTH AGENDA

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IS IT TIME FOR ‘ONE PHARMA’?

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IN SEARCH OF AN EFFECTIVE HEALTH SYSTEM

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ENSURING SUSTAINABLE DEVELOPMENT

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WHY UCPMP NEEDS TO BE STATUTORY

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EXPERTS ADDRESS IMPACT OF M&A IN PHARMA

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INDIA PHARMA 2016 TO BE HELD FROM JANUARY 7-9, 2016

P LIFE

Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Arun J Ajanta Sengupta Nirav Mistry

Manager Bhadresh Valia

P-MEC INDIA

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2016: Onward and Upward, India!

P56: Pharma manufacturing – P58: At ‘CRO’ssroads P61: PRE EVENT CPhI India to be held in Mumbai from Dec 1-3, 2015

BOSCH, KLENZAIDS JV MARKS COMING TOGETHER OF GERMAN QUALITY SYSTEMS AND INDIAN VALUE ENGINEERING

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SKILLING FOR SUSTAINABLE GROWTH

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TALENT ACQUISITION– A CRITICAL SUCCESS FACTOR

Express Pharma® Reg. No.MH/MR/SOUTH-77/2013-15, RNI Regn. No.MAHENG/2005/21398. Printed for the proprietors, The Indian Express (P) Ltd. by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright © 2015. The Indian Express (P) Ltd. All rights reserved throughout the world.

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EDITOR’S NOTE

Sifting the trends into 2016

I

f the latest edition of the Antal Global Snapshot (AGS) on annual global hiring and firing trends is any indicator, hiring in India’s pharmaceutical industry is picking up and set to firm up in the next quarter. Across the globe too, the survey says less firms are laying off and more are hiring. In India, pharma firms surveyed in September put the sector's hiring at 62 per cent, which is predicted to increase marginally to 64 per cent in this quarter.

But pharma firms in India also had a high firing level (32 per cent), set to increase to 37 per cent this quarter, the highest among all sectors, according to the AGS. Antal International India's Managing Director Joseph Devasia clarifies that most shedding is due to performance issues with individual candidates, and should not be taken as an indicator of the sector's financial health. In fact, hiring within India's pharma sector is set to remain buoyant into the next year, but without much increase in head count. Sales and marketing profiles will continue to see high levels of recruitment, followed by compliance roles in the quality control and regulatory affairs division, the latter most obviously in response to the constant pressure to meet increased regulatory scrutiny and raised benchmarks on pharma manufacturing and pharmacovigilance. These are also the profiles where senior experienced talent is scarce.

The AGS is more or less in line with the rationale that M&As like the Sun Pharma-Ranbaxy deal caused an exodus from the latter over the past year.

Industry insiders say that while this was a painful period for Ranbaxy employees, good talent was poached and snapped up by competition.

M&As between global and Indian pharma companies are fraught with another layer of

Can we translate political rhetoric into a healthcare infrastrucuture that will last?

complexity: that of a cultural disconnect which unless rectified, can lead to disaster. As HayGroup's Global Managing Director, Life Sciences Ian Wilcox puts it, global pharma companies need to find people who are “Indian at heart, with global technical operations skills” to execute this manufacturing transformation to global compliance. The acquiring company cannot hope to achieve seamless integration unless the senior management of the acquired company are taken on board and are part of all decision making initiatives.

The message about “total accountability” has to filter down the line to every level of the company.

The company will thus have to hire for skills and aptitude as well as attitude if they are to match the right people to the right profiles.

Investment in the pharma, lifescience and healthcare sectors promises to stay steady if not increase. 2016 will see global biopharma companies as well as technology solution providers go even more aggressive in emerging markets, while Indian pharma companies do the reverse: strive to build market share in matured markets; particularly in the US, EU and Japan. The December 1-15 issue, our 21st anniversary special as well as the CPhI-PMec India special, has thought leaders sifting the trends.

2016 could also see health moving further up the political agenda. Several initiatives driven by the Centre, like the Jan Aushadhi Scheme, the Swacchh Bharat Abhiyan, Digital India, etc impact the health delivery mechanism directly or indirectly and political parties could leverage these as poll issues to whip up voter angst. But, can we translate political rhetoric into a healthcare infrastructure that will last? Only time will tell.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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MARKET INSIGHT

Roadmap for sustainable growth

DR AJIT DANGI, President and CEO, Danssen Consulting

Dr Ajit Dangi, President and Chief Executive Officer, Danssen Consulting, outlines measures needed to ensure the Indian pharma industry’s continuous and accelerated growth IN THE recent past we have been bombarded with catch phrases like, Swachh Bharat Abhiyan, Digital India, Make in India, Universal Health coverage etc. However, the ground reality is a little different from these rhetorics. A recent article in the globally acclaimed medical journal The Lancet lambasts Modi Government for ignoring India’s health sector and has warned that India is on the verge of collapse under the weight of its own ill health. While the criticism seems too harsh, it is time to wake up and face the realities.

A fundamental problem is the lack of investment in healthcare, with just about one per cent of GDP being allocated to healthcare by the government. As long as this is not significantly enhanced, the healthcare challenge will continue to haunt us.

While we are still battling the menace of infectious diseases like malaria, TB, HIV AIDS etc., we have to face an increasing threat from NCDs which have reached alarming proportions due to lifestyle changes. This will have significant impact on not only public health but also on the economy. With a burgeoning population, and around 70 per cent of them living in rural areas, the problem is compounded.

There are three As of healthcare viz. availability, affordability and access. The Indian pharma industry has effectively contributed to the first two by being the third largest producer of quality medicines at affordable prices. The industry, how-

24 EXPRESS PHARMA December 1-15, 2015

With over 10,000 pharma manufacturing companies, the market has become intensely competitive, fragmented and cluttered with ‘me-too’ products, with even the top company having only six to seven per cent market share ever, needs to partner with government to improve access which is abysmally low at less than 40 per cent. This will happen only when health infrastructure like diagnostic facilities, physicians, hospitals, retail chemists etc. is substantially improved. The pharma industry, being an integral part of healthcare, will have to focus on following four areas for sustainable and profitable growth. ◗ Innovation: While we are proud of being called the ‘Pharmacy of the World’, our contribution to the global pharma sales, which is about $ one trillion, is less than two per cent.

Why does this happen? Well, it is because we have focused on reverse engineering to produce generics which is a ‘high volume and low margin business’. Our competitive advantage has always been low costs. Whether it is manufacturing, R&D or clinical trials, our costs have been 30 to 40 per cent lower than those in the developed countries.

However, now we have move up the value chain from cost arbitrage to intellectual arbitrage as cost advantage is seldom sus-

tainable in the long run. While drug discovery domain requires deep pockets and global marketing muscle, we can always graduate towards biosimilars, NDDS and complex generics as a first step towards innovation. But, to succeed in this area, we need an ecosystem which fosters innovation such as intellectual property protection, pragmatic pricing policies and collaboration with academic institutions to get a continuous stream of intellectual capital with appropriate skill set. ◗ Quality: The recent crackdown by US FDA on our pharma majors for non-compliance is a worrisome develop-

ment. While consistently producing standard quality drugs is not rocket science, it needs strict adherence to standard operating procedures (SOPs), data integrity as well as continuous and rigorous training of personnel involved in drug manufacturing and quality assurance.

The drug manufacturing costs are continuously increasing due to automation required to reduce human error, introduction of newer technologies such as Process Analytical Technology (PAT), high inspection fees by the US FDA for inspecting manufacturing facilities and approval of Abbreviated New Drug Application (ANDAs), Drug Master Files (DMFs) etc.

However, the cost of non-conformance is much higher and the erring company also suffers from reputational damage.

Quality, therefore, must be on the top of every pharma CEO’s agenda. ◗ Pricing strategies: The recent incident of Turing Pharma, a US-based company coming under fire for raising the price of Drug Daraprim used for toxoplasmosis, from $13.50 to $750 a pill has put pharma pricing

back in focus, even in free market economies like the US. Blaming the high cost of drugs and lack of price control has become a popular subject in the US Presidential election campaign. Hillary Clinton, a presidential candidate has claimed that she will fight ‘price gouging’ by pharma companies and has emphasised on the need for price regulation, which has earned her good ratings in the electoral campaign. Another presidential candidate, Bernie Sanders received a huge applause from the audience for naming ‘drug companies as the enemy he is proud of.’ Pharma companies have to explore innovative pricing strategies, particularly for expensive lifesaving drugs as well as those required for chronic diseases. In this context, Project Sambhav of MSD India for their anti-HCV drug is worth emulating. Sambhav involves educating the patient and the family about HCV transmission and prevention. It also helps manage the therapy cost by subsidising the cost of treatment. Similarly, pricing their anti-diabetic drug Januvia in India at one-fifth of its price in the US is a case in point. Sovaldi is granting voluntary license to many Indian generic companies for Sofosbuvir, a drug costing $85,000 for complete therapy in the US. It is already a blockbuster and worth replicating. In other industries, it is common for vendors to promote their product through equipment lease, soft loan, supplier finance credit etc. Time has now come

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to adapt such models, especially for expensive lifesaving drugs and those used for chronic diseases. ◗Productivity: Sales force productivity through conventional doctor detailing is increasingly becoming an area of low RoI in a large country like India which has over nine lakh doctors and over 30,000 hospitals. Industry has to find newer ways like use of social media and digital marketing to help hospitals manage their drug costs by using principles of pharmacoeconomics and efficient inventory management. Similarly, co-marketing, contract sales force and geographic expansion in rural areas etc. need to be actively explored.

With over 10,000 pharma manufacturing companies,

tivity and help focus on one’s key strength and make the industry robust and agile. The

pharma industry is a jewel in the crown of India’s fast growing economy. Its suc-

I S S U E

cess and sustainability depends on the aforementioned strategic factors.

Pharma companies have to explore innovative pricing strategies, particularly for expensive lifesaving drugs as well as those required for chronic diseases the market has become intensely competitive, fragmented and cluttered with ‘me-too’ products, with even the top company having only six to seven per cent market share. Consolidation of the industry through mergers and acquisitions is overdue and will improve scale of economies, improve produc-

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December 1-15, 2015

MARKET

Shaping the growth agenda Dr RB Smarta, Managing Director, Interlink, talks about the changing scenario in the pharma sector , the growth trends and the issues that need to be tackled to ensure sustainable progress

DR RB SMARTA, Managing Director, Interlink Consultancy

TODAY AND in the near future, the world is likely to face volatility, uncertainty, ambiguity and complexity (VUCA) along with ‘black swans’ (unpredictability). VUCA is a managerial acronym for the current situation in world. VUCA world expresses the systemic failures and behavioural failures, leading to organisational failure. The VUCA world is driven by digitisation, sustenance and rise of the developing world. This situation can be translated to various industries such as pharma, automation, nutrition etc.

Today, the pharma industry on one hand needs to be prepared to face the unexpected future and on the other hand it should accept the challenge to go beyond research and tailormake solutions for total care of the patients.

dustry towards innovation where ‘Big Pharma’ has decided to spend huge money equivalent to a small country’s GDP to work on blockbuster medicines.

On one hand we can see that big pharma companies cannot come out of this traditional mind set, while on the other hand small biotech companies, along with academicians, are

Future concerns Apart from the VUCA world, the industry is also faced with various other issues that may affect its growth.

FUTURE CONCERNS Ageing

Medical Nutrition

Issues & Concerns

Behavioral Justice

■ Ageing population in developing countries The number of ageing population in the world is increasing and they are looking at lifestyle diseases. This ageing population is the active healthcare seeker today.

26 EXPRESS PHARMA December 1-15, 2015

Generic P redisposition

R &D

Innovation & technology

■ Generic revolution The pharma industry is at the crossroads today, of generic revolution, with the patents going off the cliff. The demographics differ from country to country and we can see that emerging markets have come to the forefront to provide growth drivers.

Modern Medicines

Generic Revolution

working on innovative solutions and bringing new hope for the industry. It has been observed that the last five to six years have been years of add on medicines!

■ Behavioural justice ■ Modern medicines The modern medicines industry is facing criticality and constraints as the younger generation wants to be more fit and healthy by balancing nutrition.

As a solution, the pharma industry needs to attain a higher level of competition, limitation, collaboration and consolidation.

■ Genetic predisposition/ damage Genetic predisposition along with consciousness about health

has led to predisposition profiling. Integration of genomics and gene therapy methods with pharma products would increase market size for pharma products and services. These personalised or customised medicines would compel the industry to move towards faster improvisation and innovation on new therapies.

a demarcation in the society in terms of high and low class. In spite of this demarcation, the pharma industry is focusing its R&D on lifestyle diseases. The pharma industry needs to shift its focus to R&D on antibiotics in order to sustain itself in the coming years.

■ Research and development

Diagnosis, micro surgeries, emerging role of traditional medicines are pushing the in-

In developing countries there is

■ Innovation and technology

Today’s patient is more aware of his health and the services offered by healthcare providers to him/her. The patient is no longer helpless and wants value/justice for the money he is spending on healthcare facilities.

■ Medical nutrition Industries within the health and life science sectors are moving towards one another leading to new avenues like the medical nutrition sector. Convergence of these industries plays a crucial

ANNIVERSARY

MARKET role of shaping new markets for pharma products. This birth of medical nutrition has shown the pharma industry a dual path of relying on product and service.

S P E C I A L

and biopharma. As well as, these various factors make India a lucrative market for investment in pharma and biopharma. This can happen provided we manage sustainable growth.

Growth of biopharma Many of the pharma companies have hastened their efforts to strengthen their presence in the emerging markets by means of R&D investment, licensing deals, acqui-

I S S U E

sitions or other partnerships.

However, with global markets facing dynamic demographic and disease trends, changing market demands, and evolving regulatory requirements, it has

Can sustainability be achieved?

In order to achieve sustainability, we need to focus on approaches that address innovation and capability building, drive leadership and define market tailored and defective business strategies for each market segment.

The industry has seen growth over a period of years.

But now the growth is declining due to lower prices of generics which have led to reduced value, no new blockbuster drugs, demographics and no real R&D in the developed countries.

As a result, we need to look out of the domain markets viz. the emerging markets for survival and sustainable growth.

Emerging markets The pharma industry is mainly driven by emerging markets, as according to certain industry estimates the total expenditure on healthcare in these emerging markets is expected to grow upto $499 billion by 2020. The scientific and technological advances together with sociodemographic changes along with increasing demand of medicines and trade will revive pharma’s fortune in another 10 years and deliver dramatic improvements in patient care.

Unleashing the potential of India India, today has a great talent pool of skilled workforce, with over 8.5 million qualified scientists, around 35,000 students graduating from medical and pharmacy colleges, low set-up costs, contract research and manufacturing, genetically diverse patient pool, low treatment costs as compared to developed nations, recent growth friendly government policies etc. All these factors can add to the potential of India as an emerging market for pharma

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December 1-15, 2015

MARKET

GROWTH OF BIOPHARMA Focus on core and drive it to leadership

been hard for manufacturers to devise the strategies needed for success in each of these areas.

Apart from this, the rise in issues such as patent cliff/patent expiry majority of the pharma companies are looking at diversifying into biopharma industry by developing biosimilars and getting into joint ventures with the manufacturing companies.

The major lobbying areas in the biotechnology industry in India are research and development, support activities, marketing, innovation and new drug discovery etc.

It has been observed that opportunities in the biopharma sector are quite huge and growing rapidly. Pharma and health biotech are some of the fastest growing segments in India. Biopharma accounts for around 64 per cent of India’s biotech industry. It is currently valued at

flammatory) generating sales of more than $10 billion a year.

Sustainable growth model

Innovation and capability building

Defining market tailored and effective business strategies

around $2-3 billion and is growing at a CAGR of ~20 per cent.

Vaccines and biosimilars constitute the largest component of the Indian biopharma market.

The growth in biopharma market can be mainly attributed to the exports as the domestic market is far less as compared to the exports market.

The biopharma sector has

the potential to become mainstream in the near future. The efficacy and safety of biopharma products, combined with their ability to address previously untreatable conditions, allows companies to grasp higher prices for innovative drugs. Biopharma products have redefined the concept of blockbuster drugs, with drugs such as Humira (anti-in-

A multi-pronged approach for sustainable growth In today’s times, it is important for pharma companies to adopt a multi-pronged approach to address diversity, lifestyle and behavioural issues such as doing

justice to the emotions of patients, demographic dividend of emerging markets, biotech innovations and utilisation of stem cells. This multi-pronged approach for effective healthcare is necessary to come up with innovative solutions for sustaining the pharma industry in the coming years.

Should the pharma industry avoid the trap of uncertainty and, in this new world, consistently improve and innovate new solutions through this multi-pronged approach?

References 1.Pharma Emerging Markets 2.0, Strategy&, Booz and Company 2.Development of Biopharmaceuticals Industry in India, Dr. Bhaswat S. Chakraborty, Sr. VP & Chair, R&D Core Committee, Cadila Pharmaceuticals Ltd. 3.Unlocking Pharma Growth

Is it time for ‘One Pharma’?

Dr Gopakumar G Nair, Chief Executive Officer, Gopakumar Nair Associates, elaborates about the scope for coming together as ‘One Industry,’ on a common forum

DR GOPAKUMAR G NAIR, Chief Executive Officer, Gopakumar Nair Associates,

IN AN invitation for the Annual Day of a leading pharma industry association, the president of the association had mentioned the scope for coming together as ‘One Industry.’ If the current trend and evolving ambience (except for couple of hawks) is taken into account, one could qualify this for a possible outcome of ‘One Pharma’ in India.

The reasons for this are as follows : ◗ Health and Innovation are common to the emerging Indian pharma sector. Indian generic pharma industry has recognised the need for innovation to move up the value chain. Many Indian pharma honchos are on the verge of breakthrough in NCEs.

on all pharma companies.

More voluntary licensing is happening in the market place (which should have commenced much early). In this field also, there is a silver lining for coming together, more than before. ◗ The challenges faced by Indian as well as MNC pharma companies are increasingly being realised as common to both.

This gives added incentive to join hands and work together to make a ‘One Pharma’ forum for Indian pharma industry, compared to anytime before in the past.

It is hoped that this will also help the national image of pharma industry in coming years.

28 EXPRESS PHARMA December 1-15, 2015

Japan has all along been a drug discovery location. However, Japanese companies needed global MNC support to take the molecules forward for commercialisation. Earlier, Ranbaxy and Dr Reddy’s Laboratories had been let down in similar collaborations. However, Indian pharma has gained better knowledge and experience to negotiate and work together, foreseeing failure scenarios and planning and incorporating corrective measures in contracts. It is, therefore, a good time to reduce the disputes and plan for working together with ‘enhanced efficacy.’ ◗ Indian and global companies are teaming up for ethical mar-

keting (as per news reports).

‘Uniform Code of Pharmaceutical Marketing Practices’ is an ideal forum to test the waters of co-operation and collaboration.

The nauseating scenario at the global level which exploits the patient population, calls for such a uniform code. India needs to move to adopt global practices in all fields to eliminate malpractices and to encourage good practices. ◗ Even though India has been fighting the wrong interpretations of ‘counterfeits’, wherein the definitions included ‘generics’ and similar sounding brands, India cannot ignore the wrongdoers who try to pass off spurious and substandard ille-

gally manufactured medicines, labelling them as those of reputed manufacturers. There is a common threat and challenge to be faced and resolved in this field as well. ◗ The patent disputes are tapering off. In the post-2005 emerging product patent scenario, there were many infringement suits, majority on perceived threats of infringers, filed against Indian generic competitors. These suits have been dragging on and have now reached some conclusion or are under mediation and negotiations. Currently, more suits are emerging between Indian pharma companies. Soon, the futility of such litigations will dawn/are dawning

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I S S U E

In search of an effective health system Ranjana Smetacek, Director General, Organisation of Pharmaceutical Producers of India speaks about the need for innovation in order to improve healthcare access in India

RANJANA SMETACEK, Director General, Organisation of Pharmaceutical Producers of India

INDIA IS the fifth fastest growing economy in the world and poised to become the third largest by 2040. A growing educated middle-class, rising income levels and increase in life expectancy are all indicators of a developing country. Unfortunately, rising affluence has also led to an increase in chronic and lifestyle-related diseases. The emergence of non-communicable diseases now poses a big challenge to the healthcare system. A news report in India has cited Richard Horton, Editor-inchief of The Lancet to say, “Failing to combat non communicable diseases like diabetes and heart disease and reduce maternal and child health will cost India’s health system and social care ‘enormously making India collapse.’” Horton also said “the (Indian) government cannot protect the sovereignty of its nation, cannot ensure sustainability unless it has a healthy population.”

For India to realise her dream of health for all, we need an effective healthcare system.

Access to healthcare extends beyond the cost of medicine, to the proximity, quality and functionality of the infrastructure that supports that access. More than affordability, the barrier to access is the inability to pay out-ofpocket and the lack of insurance cover. According to Horton, “The main issue is the lack of investment in the public health system and the growth of an unregulated private sector. And

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this imbalance between the unregulated private sector and the quality of care in many cases is appalling compared with the public system that is struggling to meet the demands of the rising population.”

We must accord priority status to healthcare and this will be best demonstrated by increasing budget allocation. Noted economist and Nobel Laureate, Amartya Sen pointed out that India spends 1.2 per cent of GDP on public healthcare which has now been reduced to one per cent, while China spends three per cent. India is wanting high growth rates like China but overlooking that China has improved public services dramatically. It has pretty much guaranteed healthcare for all. At one per cent of

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GDP, public spending on healthcare in India is among the lowest in the world.

Our draft National Health Policy has proposed an increase in public spending on healthcare, from the current one per cent to at least 2.5 per cent. A new study on Healthcare Financing, released at OPPI’s fourth Healthcare Access Summit, elaborates on the need for a well-designed composite and hybrid model of Universal Health Assurance that is efficient and affordable. Here, public insurance programmes can be supplemented by a private insurance system, to establish an affordable, quality healthcare system. This would also encourage international investment in Indian healthcare.

Healthy India, innovative India

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develop and innovate in India if we are to truly become a ‘Pharmacy of the World.’ The plan for a new IPR Policy presents a positive step toward building the architecture of an IP regime that has the potential to support a number of economic and socio-cultural benefits. A robust IPR framework provides the country an excellent opportunity to further stimulate the biopharmaceutical industry creating thousands of new high value jobs, while paving the way for newer avenues of foreign direct investment.

India has signalled its intention to become a significant player in the innovative medicines sector and develop the necessary environment to support biomedical investment, technology transfer, and growth.

The creation of a healthy India requires balancing the need for innovation with the necessity for more affordable medicines, within a robust environment. Pro-innovation policies must go hand-in-hand for the benefit of our patients. We will need to make,

30 EXPRESS PHARMA December 1-15, 2015

The ‘Make in India’ campaign lays emphasis on life sciences as a strategic sector. Such aspirations are also aligned with Prime Minister Modi’s goals of bringing growth to India through research, innovation, and manufacturing. “Intellectual Property (IP) not only attracts innovative medicines to a market, but it can also impact whether that nation’s scientists and physicians will play a role in global drug development, and if drugs will be developed for locally endemic conditions,” according to Scientific American Worldview: A Global Biotechnology Perspective.

During the past year, the government has taken some laudable steps, such as liberalising FDI in brownfield and greenfield pharmaceutical projects, developing a National Health Policy draft and stating their intention to encourage R&D and implement IPR regulations in letter and in spirit.

In the recently released Ease of Doing Business ranking by the World Bank, India still lags at 130 among the 189 countries covered. We must continue to strive for an ecosystem of transparency and predictability in our business environment. India has all the knowledge, technologies and interventions required for providing quality healthcare to her people, for both disease prevention and treatment. The research-based pharma industry continues to bring the fruits of years of research, for the benefit of Indian patients. We look forward to a tomorrow that will see a ‘Healthy India and an Innovative India’.

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Ensuring sustainable development Dr Arun Garg, General Secretary – IPGA, Prof & Dean, School of Medical & Allied Sciences, KR Mangalam University, Gurgaon speaks on SDGs for pharma THE AWARENESS of sustainability as a main issue of pharma companies’ performance has considerably grown over the last year in healthcare. Sustainability is “development that meets the needs of the present without compromising the ability of future generations to meet their own needs.” It has four fundamental pillars: environmental protection, economic growth, social equity and healthcare promotion.

This so-called “triple bottom line” has become the frame of reference for further discussions about sustainability. Especially the sustainability approach of pharma companies often aims at ensuring a balance of their economic, ecological, social and healthcare ranges of responsibility.

The adoption of the sustainable development goals (SDGs) gives governments and those involved in the health community a chance to embrace a vision as fundamental as the Declaration of Human Rights when it was adopted by the UN General Assembly in 1948. There is a sustainable development priority, but there is rocket science: tackling the cycle of poverty and poor health is complex and something no single appendage of society can do alone. It involves more than reducing the price of medicine. It requires partnership along the entire health value chain – from researching neglected diseases and training personnel, to reorienting policy choices and the allocation of resources at global, national and local levels. The experience of the Novartis Foundation for Sustainable Development (NFSD) shows that, even if drugs are given for free (as in the case of the anti-leprosy multi-drug therapy by Novartis), effective use cannot be guaranteed without considerable additional efforts in social marketing, product advocacy and securing patients’ acceptance and compliance –

DR ARUN GARG, General Secretary – IPGA, Prof & Dean, School of Medical & Allied Sciences, KR Mangalam University

together with the vital contribution of NGOs. To suggest that access to medicines is just a matter of high prices and patents is to oversimplify.

The Jan Aushadi Scheme is not fulfilling the objectives of providing cheap medicines to the citizens of India, as the scheme is restricted to only some places in Delhi and also in India. As per my opinion, the Government of India should have strengthened the already existing public health care system by improving the health care at primary health care, district hospitals and other government hospitals in big cities where free drugs are dispensed to patients.

Recently, Indian Pharmacy Graduates' Association has organised the 30th Annual Conference in Delhi on the theme 'Role of Pharmacist in Digital Era', where several speakers gave their views on online pharmacy and digitalisation of pharmacy services.

In my opinion, online pharmacy can benefit the quality use of drugs in patients by providing information online. On the other hand, it needs to be regulated strictly as per our Drug & Cosmetic Act, which means strengthening of FDA system in India, as has been witnessed in Maharashtra from the past few years.

Dr GN Singh, DCG(I) has called on the pharma industry to take advantage of the opportunities being created by the Government through the ‘Make in India’ scheme , by investing in making medical devices indigenously.

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Why UCPMP needs to be statutory Dr Milind Antani, Legal and Tax Counseling Worldwide & Anay Shukla, Member, Pharma and Life Science team, Nishith Desai Associates opine that a statutory code is required to shift the focus from a ‘HCP-prescription’ driven industry to a ‘patient-impact’ driven industry IN THE pharmaceutical and medical device business, no one can overemphasise the importance of promoting drugs and medical devices before healthcare practitioners (HCPs). The whitepaper called ‘prescription’ with Rx is revered like no God is. All pharma and medical device companies hope that their product appears on as many prescription papers as possible by HCP because it works like a ‘purchase order’ in pure business sense. Once a product is prescribed by a HCP, its sale is a mere formality. So it won’t come as surprise to anybody that pharma and medical device companies would leave no stone unturned to promote their products before HCPs. Pharmacy in India does not have a comprehensive code that governs interactions of the pharma and medical device industry with HCPs like many developed jurisdictions have. It has, however, a code that seeks to regulate the promotion of drugs and medical devices before HCPs. The code is called Uniform Code of Pharmaceutical Marketing Practices (UCPMP) and has been published by the Department of Pharmaceuticals (DOP). Because of the origin of the code, it is sometimes informally referred to as DOP Code as well.

The UCPMP has been published for voluntary adoption and compliance so far. However, a closer look at its provisions make it clear that its vol-

32 EXPRESS PHARMA December 1-15, 2015

The pharma industry and medical device industry will move from a ‘HCP-prescription’ industry to ‘patient-impact’ driven industry. When there will be little scope of influencing the judgment of HCP, the industry will focus on bringing better quality and affordable drugs to the market untary nature is a hogwash. It is as mandatory as any other guideline which does not have a statutory backing would be.

Unfortunately, as mandatory as it may be, it is just teeth that possibly cannot bite. It does not have any penal provision which would act as a deterrent to a company. Not to forget, the UCPMP is based on the principle of self-regulation. The penalties prescribed under it, while insignificant, are supposed to be imposed by the industry association. Nothing speaks more of the success of self-regulation than the fact that since the publication of UCPMP, not even a single pharma or medical device company has been officially reprimanded by an industry association for violation of UCPMP. The UCPMP prohibits sponsorship of hospitality and travel of HCPs for attendance of conferences and workshops in capacity of delegates. However, since UCPMP does not have a statutory backing, it is openly flouted. The UCPMP also prohibits pharma and medical device companies from providing gifts to HCPs.

However, HCPs do accept gift under various disguise. The short point is that the UCPMP has not succeeded well as not all companies have complied with. There are many companies who strictly abide by UCPMP and have developed policies around that.

It is expected that the government will sooner or later introduce a statutory code that mandates the same things as are mandated by the UCPMP, but with a penal consequence attached to it. So, is that good or bad for the pharma and medical device industry?

We believe that it will be very good for the industry for the fol-

lowing reasons. The pharma industry and medical device industry will move from a ‘HCPprescription’ industry to ‘patient-impact’ driven industry.

When there will be little scope of influencing the judgment of HCP, the industry will focus on bringing better quality and affordable drugs to the market.

The playing field will level and all serious players will stand to benefit. Not to forget the easing off on burden on the pocket of the common Indian who today is ignorantly paying for the promotional activities of pharma and medical companies.

Like any medical pill, the UCPMP has its side-effects as well. Genuine training efforts of companies, especially those in medical devices sector, are being hindered because of the restriction on sponsorship of travel and hospitality. Keeping HCPs abreast with developing science and technology is in the interest of public at large.

However, very few HCPs are willing to spend money from their own pocket to attend training sessions in India and abroad. Consequently, advanced medical device compa-

DR MILIND ANTANI, Nishith Desai Associates, Legal and Tax Counseling Worldwide

ANAY SHUKLA, Member, Pharma and Life Science team, Nishith Desai Associates

nies are unable to sell their products in India. This happens to be the single biggest grouse of the medical devices companies with UCPMP but they are helpless. When UCPMP because statutory, medical device companies will be able to approach the court of law to strike down such a restriction on the ground of excessive restriction on their right to carry out business. It is likely that the court may take a sympathetic view on the grounds of public interest.

A statutory code will also ensure transparency and accountability in the administration code. The decisions given will be bound by principles of natural justice and fair trial.

All decisions will be published. The aggrieved party will have an avenue to approach the court of law if due process is not followed. By relying on precedents, the industry will be able to see future path very clearly.

Today, under the current form of UCPMP, there seems to be no future path. All roads lead to the shady past which weighs heavily on at least the new generation of pharma and medical devices companies who are global, or aspire to be global, and who would rather invest in quality of their product than over a HCP.

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GROWTH TRACKER

IPM clocks ` 8601 crores in October 2015 Eight therapies have outgrown the IPM growth THE INDIAN Pharma Market (IPM) clocked ` 8601 crores in October 2015. It has grown at 21.8 per cent in the same month.

Amongst the top 10, Pfizer grew by 25.4 per cent followed by GSK at 23.9 per cent and Abbott at 23.6 per cent. 22 corporates have crossed the growth of IPM for

October 2015 amongst top 50.

Amongst the top 50 corporates, Bharat Serums has the highest growth of 62.7 per cent followed by AstraZeneca at 57 per cent and Wockhardt at 50.4 per cent. 45 corporates have shown growths of more than 10 per cent amongst the top 50.

Amongst the 11-20 ranked corporates, Glenmark has the highest growth of 43.6 per cent followed by Micro at 33.6 per cent and Alembic at 31.4 per cent. Amongst the 21-30 ranked

corporates, Wockhardt has the highest growth at 50.4 per cent followed by MSD at 40.1 per cent and Unichem at 26.6 per cent.

Amongst the 31-40 ranked corporates, Bharat Serums was at 62.7 per cent, AstraZeneca has the highest growth at 57 per cent and JBCPL at 43.7 per cent.

Amongst the 41-50 ranked corporates, Troikaa has the highest growth at 37 per cent followed

by Hetero at 30.6 per cent and Win-Medicare at 18.9 per cent.

Amongst the 51-60 ranked cor-

porates, Boehringer Ingelheim grew at 69.6 per cent followed by Centaur at 37.2 per cent and Corona at 33.4 per cent.

Amongst the 61-70 ranked corporates, Fresenius Kabi grew at 66.8 per cent followed by RPG by 37.9 per cent followed by Geno at 23.6 per cent.

MSD has entered the ` 1,000crore club, Bharat Serums entered the ` 500 crore club, Hegde & Hegde in ` 300-crore club, Geno Pharma in ` 200crore club, Veritaz in ` 100-crore

club on MAT basis.

Ind-Swift and Shreya who had declined for years are staging a strong revival on growth as well as six months trends look positive. 100-plus ranked companies like Alarsin and Vanguard are showing a strong positive upswing on monthly basis.

For the month of October 2015, amongst the top 10, Abbott HC grew by 27.6 per cent followed by Pfizer at 25.4 per cent and GSK at 23.9 per cent. 23 companies have crossed the

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growth of IPM for the month of October 2015 amongst top 50.

Zuventus grows by 27.4 per cent, Novo by 22.8 per cent, Alkem by 20.6 per cent and MSD by 53 per cent. Indian companies have grown at 21.4 per cent versus 23.5 per cent for MNCs in October 2015. Amongst the top 50 in MNCs, AstraZeneca grew at 57 per cent, MSD grew by 40.1 per cent followed by and Pfizer at 25.4 per cent. Under the NonNLEM category Indian companies grew at 22.6 per cent whereas MNCs grew at 24.1 per cent.

The DPCO containing molecules market grew at 15.4 per cent whereas the non-DPCO market grew by 22.9 per cent and Non -Sch Para 19 Market at 20.9 per cent resulting in an overall growth of 21.8 per cent.

NLEM and Non - NLEM category showed unit growth at 13.4 per cent and 11.7 per cent respectively. The Non-Sch Para 19 market grew at 16 per cent from units perspective.

From therapy perspective, eight therapies have outgrown the IPM growth. The respiratory market grew at 21.8 per cent, the gastrointestinal market grew at 22.4 per cent, pain and analgesics market grew at 21.1 per cent whereas anti-infectives grew at 22.1 per cent. The antidiabetic market grew at 29.8 per cent and cardiac at 21.1 per cent in chronic business. The derma market grew by 23.2 per cent and urology market at 19.5 per cent.

From regional perspective, 14 regions have outgrown the IPM growth. Haryana market grew

34 EXPRESS PHARMA December 1-15, 2015

With Bonus Units at Full Value Val in Crs CORPORATE

Rank MAT

MAT Oct-15 MTH

IPM

Oct-15

Val (Cr)

MS%

GR%

Val (Cr)

MS%

GR%

94495

100.00

14.7

8601

100.00

21.8

Sun + Ranbaxy

1

1

8379

8.87

15.5

729

8.47

17.6

Abbott + Abbott HC + Novo

2

2

5923

6.27

15.7

522

6.07

23.6

Cipla

3

3

4685

4.96

15.5

426

4.95

21.0

Zydus + Biochem

4

4

3970

4.20

12.4

357

4.15

22.1

Mankind

5

6

3310

3.50

13.7

308

3.58

21.8

Lupin

6

8

3273

3.46

18.9

289

3.36

22.2

Alkem + Cachet + Indchemie

7

5

3266

3.46

10.9

315

3.67

20.0

Glaxo

8

7

3135

3.32

5.4

300

3.48

23.9

Pfizer

9

9

2858

3.02

18.6

256

2.97

25.4

Macleods

10

10

2736

2.90

18.2

249

2.90

23.0

Intas

11

11

2627

2.78

24.0

243

2.82

27.7

Emcure + Zuventus

12

13

2513

2.66

10.9

222

2.58

17.8

Sanofi India

13

15

2367

2.51

18.3

202

2.34

16.5

Aristo

14

12

2345

2.48

16.7

231

2.69

27.5

Glenmark

15

14

2231

2.36

26.8

217

2.52

43.6

Torrent

16

16

2225

2.35

24.5

188

2.19

19.8

Dr. Reddys

17

17

2166

2.29

16.4

186

2.16

21.0

USV

18

19

1866

1.97

19.5

160

1.87

15.0

Micro + Bal

19

18

1790

1.89

10.7

171

1.98

33.6

Alembic

20

20

1285

1.36

16.0

125

1.45

31.4

Wockhardt

21

22

1253

1.33

27.1

123

1.43

50.4

Novartis

22

23

1237

1.31

7.8

119

1.38

19.1

the highest at 34.9 per cent followed by South AP market at 33 per cent and North AP market at 32.3 per cent. No regions had negative growth in October 2015.

Amoxycillin + Clavulanic acid market grew at 17.8 per cent whereas Glimepiride + Metformin grows at 20.9 per cent at number two. The markets of paracetamol grew at 46.2 per cent, atorvastatin 15.5 per cent, probiotic microbes at 27.6 per cent, cefixime 22.3 per cent, pantoprazole 20.6 per cent, montelukast + levocetrizine at 23.7 per cent, glimepiride + metformin + pioglitazone at 24.3 per cent,Vvitamin-D at 29.5 per cent, hydroquinone + mometasone + tretinoin at -4.4 per cent, voglibose + metformin + glimepiride at 51.8 per cent, rosuvastatin at

28.1 per cent, protein supplements at 17.7 per cent, Azithromycin at 18.4 per cent, calcium carbonate + Vit D3 market at 28.2 per cent.

Mixtard leads the pack with ` 35 crores followed Monocef at ` 33 crores, Corex at ` 32 crores for October 2015. Few brands who have gained ranks include meronem (+167), rotarix (+95), trajenta (+46), betnovate c (+45), cardace (+41), betnesol (+40), betnovate n (+38), rantac (+36), mucaine (+32), panderm plus rhoclone (+29), omez (+28), spasmoproxyvon plus, ascoril plus(+23), deriphyllin (+22), januvia, mifegest kit (+20), istamet (+18), calpol (+17), magnex (+15), jalra , dolo, vertin(+14), pantop (+13), telma (+12), janumet, shelcal (+11), sinarest (+4), amongst

top 100 brands over october 2014. Few brands that have moved up ranks fastest into top 300 brands for the month of october 2015 are brilinta, lonopin, dexona, mero, meronem, glizid M, bevon amongst others. 300th biggest brand is Bifilac from Tablets India.

A total of 223 brands and 421 SKUs were launched in October 2015. Top new brands for October 2015 were Zitamet Plus, Ixarola, Jardiance. Biggest new launch by an MNC were Jardiance, Dulcosoft, Optive Fusion.

About PharmaTrac PharmaTrac is a the secondary sales data audit conducted by AIOCD Pharmasofttech AWACS, a pharmaceutical market research company formed by All

Indian Origin Chemists & Distributors (AIOCD ) in a joint venture with Trikaal Mediinfotech.

AWACS (Advanced Working, Action & Correction System) reflects the underlying philosophy behind AIOCD AWACS’ research tools to reduce time to information by 50 per cent or more and to significantly improve on accuracy of information.

Terminologies used MAT – Moving Annual Total MTH – Month Val (Cr) – Value in Crores MS per cent – Market Share in Percentage GR per cent – Growth in percentage.

For more information, visit http://www.aiocdawacs.com/

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Experts address impact of M&Ain pharma Also, deliberate on promoting API manufacturing in pharma IN ORDER to provide greater clarity on the policy governing M&A/FDI in the pharmaceutical sector, while striking a balance between larger public health concerns and strengthening domestic capacities, the Knowledge Partnership Programme (KPP) supported by Government of UK’s Department for International Development (DFID) and implemented by IPE Global, recently hosted a half-day workshop in New Delhi.

The workshop, which registered the participation of stakeholders from the government, industry associations, research bodies, donor agencies, pharma companies, deliberated on the findings from two studies; one on API manufacturing in India and the second study on the imapct of M&A in the pharma industry.

DFID played a catalytic role in commissioning these studies, under the KPP to IMS Health. Such studies not only influence the Indian pharma industry but consequently also impact more than 200 countries where Indian products are exported.

Considering India is largely dependent on import from a single source for basic chemicals, intermediates and APIs for many commonly used medicines, experts at the workshop felt the need to focus on the manufacturing of APIs in India. This would avoid the price and supply risks associated with such situation and ensure assured and sustained availability of these basic inputs to formulation sector and is also

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consistent with the avowed objective of the Government of India’s ‘Make in India’ initiative. Also, the Ministry of Chemicals and Fertilizers, Government of India has declared 2015 – as the ‘Year of Active Pharmaceutical Ingredients (APIs)’ to initiate reforms and make India self-sufficient in bulk drugs.

The API study recommendations resonate with the high-level Katoch Committee recommendations released in September 2015 constituted

by Government of India to study and identify the APIs of critical importance and to work out a package of interventions/concessions required to build domestic production capabilities and to examine the cost implications.

The workshop also addressed the fact that Mergers and Acquisitions (M&A) not

only act as a source of capital, productivity and innovation but can potentially jeopardise the capability of the Indian pharma industry in relation to ‘access to medicines’, which is one of the major goals of the health system. The top 1.25 per cent companies (approximately 250 companies) con-

trol 70 per cent of the overall market. The Indian domestic pharma players enjoy certain advantages which attract M&A in the country: lower cost of operations, research and development and capital expenditure, proven track record in bulk drug and formulation patents, strong do-

mestic support in production and so on. The opening of the pharma sector for FDI has directed lots of capital and interest into the sector from a foreign investment point of view.

However, it has been noted that more than 90 per cent of FDIs are currently for brownfield projects which has already led to the loss of local production of many important

drugs. Say for example, the brownfield investment between April 2012-13 was $989 million compared to $87.3 million for greenfield investments.

The workshop deliberated upon the overall the current status of M&A in Indian pharma. The recommendations were offered in four broad areas: pricing, production and availability, R&D and social consequences.

The discussions highlighted the need for the industry to work in tandem with the government to ensure commercial viability is maintained on innovator drugs and for policymakers to promote competition in selected molecules where competition is lower and public health priority is higher.

EP News Bureau-Mumbai

JP Nadda lays foundation stone for advanced research centre in Ghaziabad VK Singh proposes Ghaziabad as the next pharma hub to the Health Minister Usha Sharma Ghaziabad UNION HEALTH Minister Jagat Prakash Nadda recently laid the foundation stone to build an advanced research centre at Indian Pharmacopoeia Commission (IPC) in Ghaziabad. The estimated investment for building the centre, which is likely to be ready in one year, is approximately ` 60 crores.

Other key dignitaries present at the ceremony were, Dr Jagdish Prasad, Director General of Health Services. Ministry of Health and Family Welfare; VK Singh, Union Minister

36 EXPRESS PHARMA December 1-15, 2015

The estimated investment to build the advanced research centre at Indian Pharmacopoeia Commission (IPC) in Ghaziabad, which is likely to be ready in one year, is approximately ` 60 crores of State for External Affairs; Dr Nityanand and Dr B Suresh, Vice Chancellor, JSS University, Mysore and President, Pharmacy Council of India, New Delhi.

Nadda said that the new facility will go a long way in improving the quality of Indian drugs. He also mentioned that

the Centre has made provision of ` 1750 crores to improve the drug regulatory mechanism.

During the ceremony, the Union Minister also said that India excels in the field of pharmaceuticals and is exporting good quality medicines at cheaper rates to Africa and several other countries where

it is in competition against European and US-based companies.

He further said that the Centre is going to ease the conditions of patent law which will help drug manufacturing units in getting their formulations patented without hassles. He also interacted with the repre-

sentatives of the pharma industry on the occasion.

Dr GN Singh, DCG(I), welcomed the guests and shared brief history of IPC. He also informed that WHO Geneva has recognised the laboratory in IPC, Ghaziabad as a regional centre for drugs and vaccine monitoring pharmacovigilance programme of India. He also mentioned that since October 2, 2015, this (Ghaziabad) laboratory has become functional 24X7. Singh said that there is a need for a state-of-the-art institute, for which space is available at the existing campus.

Singh said that a proposal will be soon submitted to the

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government.

In his speech, Dr Jagdish Prasad, also asked the DCG(I) to prepare standard guidelines for Ayurveda, Siddha and Unani as well.

After the ceremony, VK Singh requested Nadda to consider making Ghaziabad a pharma hub since it is going to become a smart city and provide subsidies for making it a success. He also requested the IPC authorities/scientists to develop standards which should become an ideal for the global pharma industry.

Nadda, while speaking about TRIPS, said, “We will continue our association with the African countries and lowcost quality medicines.” He also stressed upon the fact that in the next three to four years, many top selling drugs will go off-patent and that the Indian pharma industry should take this as an opportunity to file for patents. He also said that this is the right time to consolidate India’s position in the global healthcare arena.

He said, “We should maintain efficacy and produce quality medicines and more than that we need to build and imbibe trust of the importing countries.”

Answering VK Singh’s proposal of making Ghaziabad a pharma hub, Nadda said that Ghaziabad is going to become a national centre for pharmacovigilance and a research centre. He said, “We both should take this forward to the respective ministries, as it requires the involvement of various ministries.”

Under the PM’s Digital India Programme, SUGAM, a portal for online licensing system was inaugurated by the health minister to ease procedures for upcoming pharma units. Reportedly, the objective of the portal is to build a transparent system and incorporate global benchmarks and practices. With the help of this portal, applicants will be able to apply online, track and receive the approval online.

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VK Singh also mentioned that the research lab should be constructed using state-of-theart technology with provisions

for rainwater harvesting, solar energy and effluent treatment plant as Ghaziabad is included in the initial list of 13 cities of

Uttar Pradesh shortlisted under the Centre's smart city scheme.

Indian Pharmacopeia 2014

I S S U E

Addendum 2016 was also released, besides two more books at the event. u.sharma@expressindia.com

EVENT BRIEF

ANNIVERSARY S P E C I A L

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DECEMBER 2015 - APRIL 2016 1

CPhI India

7

National Conference on Drug Discovery & Therapy

7

India Pharma 2016

28

Asia Pharma Expo 2016

CPHI INDIA

NATIONAL CONFERENCE ON DRUG DISCOVERY & THERAPY Date: January 7-8, 2016 Venue: Department of Biochemistry and Biotechnology, Annamalai University Summary: Department of Biochemistry and Biotechnology, Annamalai University will organise National Conference on Drug Discovery & Therapy (DDT-2016). The conference will provide an excellent forum for sharing research results and interaction/ discussion for the

38 EXPRESS PHARMA December 1-15, 2015

PHARMA Pro&Pack Expo 2016

from 28 countries along with 8,500 square metres of floor space and 9,000 trade professionals visited the show.

Date: December 1 – 3, 2015 Venue: Bombay Convention and Exhibition Centre, Mumbai Summary: Key decision makers in the pharma industry from 92 countries, including India, China, the US, the UK, France and Italy will participate. Visitors will be able meet all major suppliers of pharma ingredients, outsourcing, equipment and biosolutions in one location. PMEC, ICSE and BioPh will be co-located with CPhI event.

Contact details UBM India Times Square Unit No. 1-2, 5th Floor, ‘B’ Wing, Andheri Kurla Road, Marol, Andheri (East) Mumbai – 400 059 Tel: +91 22 61727272 Fax: +91 22 61727273

27

Contact details Email: mail@AsiaPharma.org Website: www.AsiaPharma.org

PHARMA PRO&PACK EXPO 2016

scientists and students working in the area of drug discovery research.

Contact details Dr N Rajendra Prasad, Assistant Professor, Dept of Biochemistry & Biotechnology,Annamalai University, Annamalainagar 608 002 Tamil Nadu Tel: + 91 4144 – 238343 Fax: +91 4144 – 239141 Mob: + 91 9842305384 Email: drprasadnr@ gmail.com

INDIA PHARMA 2016 Date: January 7-9, 2016 Venue: Bangalore International Exhibition Centre, Bengaluru

Summary: Department of Pharmaceuticals, Ministry of Chemicals and Fertilisers, Government of India with FICCI will provide a platform to global investment community to connect with stakeholders in the pharmaceutical sector in India, central and state governments, leading business leaders and top executives from the industry, academics and experts from the world.

The event will cover the whole process of pharma manufacturing, from various kind of manufacturing/processing machineries to lab equipment, analytical instruments, APIs and other total solutions.

Contact details BK Nayak,

Senior Assistant Director, FICCIT/ F: 080 22861949 Mob: 91 9945790735 Email:nayak.bk@ficci.com

ASIA PHARMA EXPO 2016 Date: January 28 to 30, 2016 Venue: Dhaka, Bangladesh Summary: Asia Pharma Expo 2016 (APE 2016), the 8th international exhibition on complete pharma manufacturing technologies, will be beneficial to all participants from local business associates to international machinery manufacturers and API / bulk active manufacturers. through participation at the exhibition. During APE 2015, 492 exhibiting companies

Date: April 27-29, 2016 Venue: Mumbai Exhibition Centre, Mumbai Summary: IPMMA and GPE Expo will organise PHARMA Pro&Pack Expo 2016. The exhibitors profile include: machineries and equipment: Pharma processing M/c (tablet, capsule, injectable, ointment, dry syrup powder) packaging machineries lab and biotech instruments, glassware, packaging materials, lab-wares and consumable, clean room and environment control products and services, utilities equipment and services, project consultants and turn key contractors.

Contact details PHARMA Pro&Pack Expo 2016 / Mumbai GPE Expo Global, 402-403, Abhijyot Square B/h Divya Bhaskar, SG Highway Ahmedabad 380 051 T: +91-79-40008233 / 40008253 E: mail@PharmaProPack.com W: www.PharmaProPack.com

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India Pharma 2016 to be held from January 7-9,2016 India Pharma 2016 will cover all the sectors of the pharma industry INDIA PHARMA 2016, an international exhibition and conference on pharmaceutical industry, is a joint initiative of Department of Pharmaceuticals, Government of India and Federation of Indian Chambers of Commerce & Industry (FICCI). The conference, to be held in Bangalore International Exhibition Centre, Bengaluru, from January 7-9, 2016, will provide a common platform to all the participants to get an opportunity in order to enhance their brand value by displaying their product and the capabilities among the conference delegates and business visitors provided by the event.

India Pharma 2016 will cover all the sectors of the pharma industry starting from finished formulations, APIs, Bio-pharma, fine chemicals and intermediates, natural extracts, excipients and many more. Latest pharma machinery, plants, laboratory equipment, analytical instrument and cleanroom equipment will be displayed. Visitors will have direct access to highly targeted senior pharma executives, buyers, procurement managers, contract manufacturers. They can also meet managers and business development managers who are looking for new supplies, building strategic partnerships or entering into new ventures.

CEOs, technocrats and scientists from drug manufacturing companies, decision makers, pharmacists, engineers, R&D professionals, biotechnology specialists, doctors, policy makers, diplomats and foreign commercial corporations, regulatory officers, petc are likely to visit the conference.

EP News Bureau-Mumbai

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MANAGEMENT

JAN AUSHADHI

HINDERED BYHURDLES The Government was supposed to launch a policy for the ‘Jan Aushadhi Scheme’ in September 15.

However, it has been delayed due to implementation challenges.

Key industry stakeholders express their views on the delay and share measures to overcome the challenges that beset the policy launch

BY USHA SHARMA

40 EXPRESS PHARMA December 1-15, 2015

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Involvement of pharma SMEs, as part of their CSR activities, could help in revival of the scheme

J

an Aushadhi scheme (JAS) was launched with the aim of making generic (unbranded) medicines that are equivalent therapeutically to the more costly branded medicines available to the public . Similar efforts were taken by the Rajasthan Medical Services Corporation for procurement and distribution of medicines at reasonable prices in Rajasthan. They have around 50 stores in the state, known as 'Life Line Drug Stores' for making medicines

available at affordable prices.

Under JAS so far, out of the 182 stores that have been opened, only 111 stores are operational in various parts of the country. The drawback of the earlier scheme was lack of quality medicines, shortage and unavailability of critical medicines most of the time etc.

The scheme has potential, however, it requires proper execution and dedication by those involved in its implementation.

I feel that involvement of small and medium scale

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â– SURESH PAREEK, Managing Director, Ideal Cures

pharma manufacturers, as part of their CSR activities, could help in revival of the scheme. Involvement of the pharma industry will serve dual purpose. Since SMEs are already in production of pharma medicines they will have the necessary quality certifications. This will ensure quality of medicines and achieve added trust of patients. Another advantage is that direct involvement of pharma SMEs will ensure timely availability of medi-

cines for distribution and sale.

Once trust is established with the patients on the quality of medicines, the scheme will automatically pick up and more and more doctors will also prescribe generic versions of the medicine. Awareness of masses about availability of good quality affordable medicines should also be encouraged. Television and print media, social networking websites etc. can help spread such awareness.

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December 1-15, 2015

MANAGEMENT

Responsible healthcare has to become the norm in India and patients must be guaranteed quality medicine

W

e welcome the Indian government’s effort to breathe new life into the somewhat stagnant Jan Aushadhi initiative. It is a big challenge to ensure consistent supply of quality medicines, in well-stocked outlets, evenly distributed across the country.

A professional approach is required and, among other things, this would entail: a motivated leader heading the initiative; appropriate focus on supply chain, logistics and warehousing; and aware-

■ RANJANA SMETACEK, Director General, (OPPI)

ness building efforts to change existing perceptions. The pharma industry will cooperate to support the government’s efforts in this area.

In a recent assessment of the Indian economy, the Organization for Economic Co-operation and Development (OECD) identified India’s poor health outcomes as one of our major developmental challenges. Today, we have among the highest disease burdens in the world.

Responsible healthcare has to

Jan Aushadhi stores could augment stateoperated schemes for availability of generic medicines

become the norm in India and patients must be guaranteed quality medicine. OPPI’s recent Fourth Healthcare Access Summit, also showcased the successful bulk procurement mechanisms used by the Tamil Nadu Medical Services Corporation, which guarantees access to quality medicines at affordable costs. The proposed Jan Aushadhi stores could augment such state-operated schemes to ensure the availability of generic medicines to those in need.

Over dependence on support from state government for these schemes would be unproductive

T

he state government typically spends around 10 per cent of its annual budget on healthcare. It runs hospitals and allopathic dispensaries. In addition, the state health department also runs mobile dispensaries, school health scheme, centralised accident and trauma services (CATS) and its AYUSH department administers ayurveda, unani and homoeopathic dispensaries and hospitals. The department is also responsible for executing several public health programmes. At the national level, Government of India spends a measly four per cent of its budget on health.

Given that, a state spending 10 per cent looks healthier, but it still leaves a lot to be desired.

India's burgeoning population, large clusters of slums, the healthcare system remains overwhelmed. In many hospitals, we will observe the lack of

42 EXPRESS PHARMA December 1-15, 2015

resources, overcrowding and lack of cleanliness. Poor political will, bureaucratic apathy and inertia have contributed to the sorry state of affairs. Many of the rural healthcare facilities are dysfunctional and a burden on the state exchequer because of the gross underutilisation. State governments are already laden with such several plights so over dependence on support from state government for these schemes would be unproductive.

Poor supply chain management With shorter product life cycles and changing market demands, companies are forced to embark on a lean journey. It is important to note that the supply strategies in a lean environment support the operations strategy. The challenge is always to find not just a lean concept, but a working lean solution.

order to facilitate their use, it is recommended that the physicians need to be reassured and educated about the drug regulatory authority approval system of generic medicines with regard to their bio equivalence, quality, efficacy and safety.

State governments launching free supply of drugs ■ BHAVIN MUKUND MEHTA, Director, Kilitch Drugs India

Non-prescription of generic medicines by the doctors The majority of the physicians from private medical centres has negative perceptions about safety, quality and the efficacy of generic medicines. These negative perceptions could be the cause of the limited use of generic medicines in the private medical centres. Therefore, in

State government distributes free medicines for all diseases, including cancer, at state-run health facilities, for instance Odisha Chief Minister declared that his government would distribute quality essential medicines through its procurement agency Odisha State Medical Corporation. Tertiary-level medicines for cancer and heart diseases will be part of the free drugs in government hospitals.

The Chief Minister directed the district collectors to personally supervise the initiative for its successful execution.

Lack of awareness among the public Education plays an important role in spreading awareness regarding health, wellness and sanitation. Educating woman in particular is extremely important, as an educated woman can take care of hygiene and sanitary issues of her family.

Lack of education and awareness has resulted in epidemic of HIV/AIDS which has become one of the greatest social challenges. The Government has mapped out a number of remedial measures for its prevention and treatment, but its outreach and effect has been limited. India needs to spend more on educational and awareness campaigns.

UK spends an estimated two million pounds on its no-smoking campaigns, whereas India spends a dismal amount on such campaigns, which play an important role in health education.

MANAGEMENT

Supply chain management from source needs to be improved

T

he prime reason for lack of success with the earlier JAS was due to the limited number of exclusive retail outlets of Jan Aushadhi.

This can be rectified by ensuring that Jan Aushadhi generic products are available in all retail shops in India. AIOCD has already offered its support to DOP for stocking Jan Aushadhi generic products. This, along

â– SV VEERRAMANI, President, IDMA

Lack of success with the earlier JAS was due to the limited number of exclusive retail outlets of Jan Aushadhi with, increased awareness amongst the public, about availability of Jan Aushadhi generics in the retail stores can increase access. Supply chain management from source also need to be improved in order to ensure that the right products are available in the right places as per market requirements.

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ANNIVERSARY S P E C I A L

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MANAGEMENT

Jan Aushadhi seems to be failing probably under the influence of vested interests

W

hile a large number of well meaning schemes has been initiated with high degree of nationalistic posture and in public interest by the Modi Government, it is unfortunate that not much has changed in the coterie culture in the capital. The middlemen continue to have a field day and the benefits are still delayed in reaching the needy. In most initiatives, the real stakeholders are not taken on board, leading to serious planning and implementation lapses. JAS is no exception. While JAS providing low cost medicines to public is laudable, people due to vested interests, don’t want the scheme to be a success. ◗ First and foremost, the decision of the government to only rely on public sector undertakings to make the drugs available for Jan Aushadhi makes the scheme a deceased programme to start with. The

deceased state of public health undertakings automatically and contagiously contaminates the otherwise healthy potential of this scheme. The government should have invited WHO/GMP (or higher qualified) certified generic manufacturing pharma companies to participate in the programme. This would have given a wide range, including lifesaving and critical care medicines, in the Jan Aushadhi bracket. ◗ Most patients approaching the Jan Aushadhi shops do not receive pharmacist support for generic options, as well as generic options themselves, as against the costly branded medicines they are prescribed.

This leads to poor supply chain management issues since it has only poor supply chain available to them. To improve the scenario, one needs to increase the supply, both in range, depth and options. As

■ DR GOPAKUMAR G NAIR, Chief Executive Officer, Gopakumar Nair Associates

it stands today, the JAS is built on poor supply chain, with not much to manage. ◗ There are no generic prescriptions being prescribed by the doctors directed towards JAS as the medical professionals do not know what is available under the scheme which are at faraway places and are very few in number. The

medical professionals cannot be blamed for this. The ‘What, Where’ data and dissemination is missing. The medical professionals or their associates or councils are not in the loop.

Presently, the octogenarian patients and the downtrodden are running from one Jan Aushadhi store to another with branded prescriptions from consultants and specialists, seeking generic options. They often return disappointed after ‘chasing a mirage or will-o’the-wisp’. This is the primary reason for failure of Jan Aushadhi. While there is a need and while there are needy, Jan Aushadhi seems to be failing probably under the influence of vested interests.

Consequently, the government is reported to have opened 175 Jan Aushadhi stores across 16 states out of which almost 81 are reported to be non-functional. Among

the remaining, more than 50 per cent are deficient in stocks. ◗ State government launching free supply of drugs is not an option for two reasons. Anything free is considered to be cheap and unwelcome, especially for treatment of near and dear ones. Secondly, anything launched and distributed free would land with the greedy rather than the needy. ◗ There is no lack of awareness among the public as far as the scheme is considered.

However, the public do not know how, where and which way to go to avail the benefits of cheaper generic options through JAS with nobody to guide on the right generic options for the branded products which is often not available in the public sector undertakings, shopping cart or catalogues. u.sharma@expressindia.com

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UPDATES

FDAapproves Gilead Sciences’HIVdrug cocktail Genvoya is not recommended for patients with severe kidney problems GILEAD SCIENCES said the US Food and Drug Administration had approved its HIV drug cocktail, Genvoya, to treat patients aged 12 and above. Genvoya, a combination tablet approved as a complete regimen, is designed to treat previously untreated patients weighing at least 35 kilograms (77 pounds), the

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FDA said. The drug also aims to treat adults whose HIV-1 infection is currently suppressed due to antiretroviral therapy. HIV-1 is the most common and pathogenic strain of the virus.

Genvoya is not recommended for patients with severe kidney problems, the FDA said.

The treatment carries a boxed warning, which flags potentially fatal risks such as buildup of lactic acid in the blood and severe liver problems. The label also states that Genvoya is not approved to treat patients with chronic hepatitis B virus infection.

Genvoya - developed from Stribild, an older version of the four drug cocktail was also given positive recommendation from European health regulators in September.

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RESEARCH

Blood stem cell self-renewal dependent on surroundings Blood formation: bone marrow and blood stem cells work in close harmony STEM CELLS have two important capabilities, they can develop into a wide range of cell types and simultaneously renew themselves, creating fresh stem cells. Using a model of the blood forming (haematopoietic) system, researchers at the Technical University of Munich (TUM) have now been able to precisely determine, which signalling pathways play an essential role in the self-renewal of blood stem cells.

A particularly decisive role in this process is the interactive communication with surrounding tissue cells in the bone marrow.Our blood is generated by blood-forming (haematopoietic) stem cells (HSCs) in the bone marrow. In conjunction with bone marrow tissue cells, these HSCs form a microenvironment known as a niche. As long as the body is healthy, the HSCs remain in 'standby' mode. But if an accident leads to substantial blood loss, for instance, or the defence against a pathogen requires more blood cells in the course of an infection, the stem cells are activated.In response, the entire blood cell formation system switches from standby into a state of alert. The activated stem cells generate new blood cells of every type to counteract the blood loss or combat the pathogen. At the same time, self-renewal keeps the stem cell pool replenished. This switch is accompanied by a complex communication process between the stem cells and tissue cells – an area that had not previously been examined in any depth. “In our study, we set out to establish which tissue

46 EXPRESS PHARMA December 1-15, 2015

signals are important to stem cell maintenance and functionality, and which HSC signals influence the microenvironment,” explains Prof. Robert Oostendorp from TUM’s university hospital, Klinikum rechts der Isar, where he works at the III. Medizinische Klinik led by Prof Christian Peschel.

Together with team members Dr Rouzanna Istvánffy and Dr Baiba Vilne, Oostendorp used mixed cultures of tissue and stem cells to investigate how the two cell types interact. To unravel the complex signalling pathway map, the scientists used their own findings from the analysis of factors regulated up or down in the interplay between tissue and stem cells, linking them with the signalling pathways described in existing literature. They then consolidated this information within a bioinformatics

computer model. To achieve this, the researchers collaborated with a group led by Prof Hans-Werner Mewes, TUM’s Professor of Genome-Oriented Bioinformatics. Finally, the team conducted extensive cell experiments to confirm the computer-generated signalling pathway model.“The outcome was very interesting indeed: the entire system operates in a feedback loop,” reveals Oostendorp. Summing up the results, he continues: “In alert mode, the stem cells first influence the behaviour of the tissue cells – which, in turn, impact on the stem cells, triggering the selfrenewal step.”The team’s findings paint a clear picture. In alert mode, the stem cells emit signalling substances, which in turn induce tissue cells to release the connective tissue growth factor (CTGF) messenger. This is essential to

US FDA approves Baxalta’s drug for rare bleeding disorder

maintain the stem cells through self-renewal. In the absence of CTGF, the stem cells age and cannot replenish.

“Our findings could prove significant in treating leukemia. In this condition, the stem cells are hyperactive and their division is unchecked,” describes Oostendorp.

“Leukemic blood cells are in a constant state of alert, so we would expect a similar interplay with the tissue cells.” To date, however, the focus here has been limited to stem cells as the actual source of the defect. “Given what we know now about feedback loops, it would be important to integrate the surrounding cells in therapeutic approaches too, since they exert a strong influence on stem cell division,” the scientist confirms.

THE US Food and Drug Administration (US FDA) has approved Baxalta's drug for use in patients with a type of rare bleeding disorder. The drug, Adynovate, was approved to control and reduce the frequency of bleeding episodes in patients with Hemophilia A, the agency said.

Data from a late-stage study, which tested 137 patients, showed that Adynovate was effective in reducing and controlling bleeding episodes, compared with Advate. Baxalta, which also owns Advate, said the drug is the world's most prescribed hemophilia treatment.

Hemophilia is a rare bleeding disorder in which the blood fails to clot normally. Seven out of 10 people have severe form of the disorder, according to the National Institutes of Health.

Patients with the disorder experience repeated episodes of serious bleeding, primarily in the joints, which can be severely damaged. Baxalta, spun off from Baxter International earlier this year, developed Adynovate in partnership with Nektar Therapeutics.

EP News Bureau-Mumbai

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US FDAapproves J&J drug for advanced multiple myeloma Darzalex, given as an infusion, is a monoclonal antibody that works by helping the immune system attack cancer cells US REGULATORS have approved an experimental treatment from Johnson & Johnson (J&J) that may offer hope to multiple myeloma patients who have run out of other options against the blood cancer.

The US Food and Drug Administration (US FDA) said it had approved Darzalex (daratumumab) for patients who had already undergone at least three prior standard treatments for the cancer, which affects infection-fighting plasma cells that reside in the bone marrow.

Darzalex, given as an infusion, is a monoclonal antibody that works by helping the immune system attack cancer cells. J&J licensed worldwide rights to the medicine from Danish biotech company Genmab A/S. In one 106-patient study, tumours shrank or were no longer detectable in 29 per cent of patients taking Darzalex, and the benefit lasted for an average of 7.4 months. In a second trial, involving 42 patients, 36 per cent of patients taking the J&J/Genmab drug saw a partial or complete reduction in tumours. Researchers said it is the first antibody drug to demonstrate effectiveness against myeloma without having to be combined with other medicines.

The most common side effects of the treatment included fatigue, nausea, back pain, fever and cough. An estimated 26,850 Americans are expected to be diagnosed with multiple myeloma in 2015. All patients eventually become resistant to existing therapies, which include Takeda's Velcade and Celgene's Revlimid, as well as newer drugs Kyprolis from Amgen and Celgene's Pomalyst.

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RESEARCH

Alcoholism drug can ‘wake up’ dormant HIVto be killed: Study The drug, branded as Antabuse but also sold as a generic called disulfiram, was given to 30 HIV positive patients in America and Australia SCIENTISTS SEEKING a cure for the AIDS virus have made an unexpected discovery with a drug designed to combat alcoholism which they say could be a critical part of a strategy to 'wake up' and then kill dormant HIV hiding in the body. The drug, branded as Antabuse but also sold as a generic called disulfiram, was given to 30 HIV positive patients in America and Australia who were already taking antiretroviral therapy (ART) AIDS drugs.

At the highest given dose, there was evidence that 'dormant HIV was activated', the researchers said in a study published in The Lancet HIV journal, and with no adverse effects.

Julian Elliott of the department of infectious diseases at The Alfred in Melbourne, Australia, who worked with Lewin, said waking up the virus was only the first step to eliminating it.

"The next step is to get these cells to die," he said. HIV latency,

where the virus remains dormant in the body in people taking ART, is one of the biggest hurdles to achieving a cure for the viral infection that causes AIDS. HIV/AIDS has killed some 34 million people since the 1980s, according to the United Nations HIV program UNAIDS.

HIV can be held in check by ART, and by the end of 2014 an estimated 36.9 million people around the world were living with the virus. Some two million people a year are newly infected.

Scientists say finding ways of "waking up" the virus in these dormant cells and then destroy-

ing them is a key cure strategy, but researchers have so far been unable to find the exact effective combination of drugs. Sharon Lewin, a University of Melbourne professor who led the work, said that while scientists have made headway? into activating latent HIV, one of the main concerns is the toxicity of the drugs trailed. With disulfiram, however, this did not appear to present a problem, she said.

"This trial clearly demonstrates that disulfiram is not toxic and is safe to use, and could quite possibly be the game changer we need," she said.

"The dosage of disulfiram we used provided more of a tickle than a kick to the virus, but this could be enough. Even though the drug was only given for three days, we saw a clear increase in (the) virus in (the) plasma, which was very encouraging."

Reuters

Panel recommends Merck & Co continue cholesterol drug study The committee reviewed safety and efficacy data from the large study, including a futility analysis MERCK & CO said an independent data monitoring committee recommended that the drugmaker continue a study of its experimental cholesterol drug, anacetrapib. The recommendation comes a month after Eli Lilly & Co stopped testing a

48 EXPRESS PHARMA December 1-15, 2015

similar cholesterol drug, belonging to a class of drugs called CETP inhibitors.

Merck said that the committee reviewed safety and efficacy data from the large study, including a futility analysis. A futility analysis is done to gauge if a

study is likely to succeed or fail.

Merck is now the only major drugmaker still aggressively developing a CETP inhibitor, drugs aimed at raising HDL, or 'good cholesterol' levels in the blood and cutting levels of LDL, or 'bad cholesterol.' Lilly stopped test-

ing the drug for cholesterol due to low likelihood of it meeting the main goal of the study. In 2006, Pfizer also scrapped a study on a similar drug, after the treatment was linked to higher death rates.

Reuters

Nexvet canine osteoarthritis drug meets main goal in study NEXVET BIOPHARMA drug for canine osteoarthritis showed promise in a study.

Dogs enrolled in the study experienced relief from pain at four weeks when compared with placebo, the company said, adding that the results would form the basis for a regulatory application with the US Food and Drug Administration.

Analysts said the results came in as a pleasant surprise, especially after interim results in March indicated the possible expansion of the size of the trial. The standard of care for canine pain is currently dominated by NSAIDs, or nonsteroidal anti-inflammatory drugs, which can cause kidney toxicity and gastrointestinal disturbances, said Mark Heffernan, Chief Executive Officer, Nexvet.

Nexvet's drug, NV-01, is the first monoclonal antibody in development for canine pain.

The drug is administered through an injection once a month, while anti-inflammatory drugs need to be administered daily. Canine pain treatment, with a market size of about $400-600 million, is a huge opportunity for Nexvet, Piper Jaffrey & Co analysts wrote in a note. NV-01, could generate revenue of about $35 million in 2020 and $70 million in 2025, analysts said. Nexvet is also running an additional trial with 150 dogs, with different dosing regimens.

Reuters

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Alnylam,The Medicines cholesterol drug effective for 6 mths The drug, called ALN-PCSsc, cut LDL by more than 50 per cent in the 69-subject study AN EXPERIMENTAL cholesterol fighter being developed

by Alnylam Pharmaceuticals and The Medicines Co slashed levels of bad LDL cholesterol and remained effective for six months, according to data from a small, early stage study. The drug, called ALN-PCSsc, cut LDL by more than 50 per cent in the 69-subject study presented at the American Heart Association scientific meeting in Orlando.

No significant drug-related side effects were reported in the small ongoing trial.

If approved, ALN-PCSsc would compete with Amgen's Repatha and Praluent from Regeneron Pharmaceuticals and Sanofi, potent injectable biotech drugs that won approval this year and belong to a new class of treatments called PCSK9 inhibitors.

PCSK9 is a protein that prevents LDL being removed from the blood. ALN-PCSsc also targets PCSK9 but via a different mechanism called RNA interference, or RNAi. While Repatha and Praluent block PCSK9 from doing its job in the blood, Alnylam's drug prevents production of PCSK9 at the source in the liver. Doses of 300 milligrams, 500 mg and 800 mg led to sustained reduction of PCSK9 of 80 pct or greater. At Six months, the effect began to wane with LDL down by 47 per cent.

Lower LDL is associated with reducing heart attacks and death. Huge ongoing trials will determine if the new PCSK9 drugs have that affect, as widely used statins such as Lipitor do. Alnylam and Medicines Co envision twice a year injections of their drug, likening it to a flu shot, which could enhance patient compliance.

Reuters

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RESEARCH

Portola reversal agent for Xarelto succeeds in late stage trial Portola's andexanet alfa reversed the anticoagulant effect of the new drugs, known as factor Xa inhibitors, within minutes of being administered A DRUG developed by Portola Pharmaceuticals to rapidly reverse the effect of new blood thinning agents in cases of major bleeding or other emergencies proved highly effective in a late stage study, according to data presented that should help make the case for its approval.

Portola's andexanet alfa reversed the anticoagulant effect of the new drugs, known as factor Xa inhibitors, within minutes of being administered, with no reported serious side effects, researchers said.

The factor Xa drugs, Xarelto (rivaroxaban) and Eliquis (apixaban) were approved as effec-

tive and safer alternatives to the decades-old drug warfarin to prevent blood clots and strokes.

But there is no approved antidote should the effect of the drugs need to be stopped in a hurry, if for example, emergency surgery is required. The final stage of Portola's Phase III programme tested the reversal drug against placebo in 39 healthy volunteers aged 50 to 68 who were given Xarelto.

Andexanet alfa significantly reduced anti-Factor Xa activity by 97 per cent compared with placebo, with reversal persisting for one to two hours after completion of its infusion, which was

deemed highly statistically significant. The Portola drug "was able to almost immediately, almost completely reverse the affect of the drug," said Dr Mark Crowther, the study leader who presented the data at the American Heart Association's scientific meeting in Orlando. Similarly effective data on andexanet alfa's ability to reverse Eliquis previously had been presented.

Results of both also were reported in the New England Journal of Medicine.

Portola said it plans to file for US approval before the end of this year. While major bleeding episodes are more rare with the

new medicines than with warfarin, they still occur. And patients taking them also could seriously injure themselves in falls, car accidents or other incidents of trauma that cause extensive bleeding, researchers said.

"Having knowledge that there is an effective reversal agent will increase provider comfort in using these drugs for sure," said Crowther, a professor at McMaster University in Hamilton, Ontario.

A reversal agent for Boehringer Ingelheim's anticoagulant Pradaxa recently won US approval.

Reuters

be something about this medication that has a very early impact."

GILEAD SCIENCES said the US Food and Drug Administration (US FDA) has approved the expanded use of its blockbuster hepatitis C drug, Harvoni. The drug can now be used to treat patients with subtypes of chronic hepatitis C virus (HCV) and patients who are co-infected with Human Immunodeficiency Virus (HIV), Gilead said.

The once-daily pill, used in combination with antiviral ribavirin, was also approved to be used for 12 weeks as an alternate therapy to Harvoni alone, which is used for 24 weeks to treat patients with cirrhosis. Results from the study showed that about 93 per cent of the patients with subtypes of the virus and 96 per cent of patients co-infected with HIV showed a sustained response to the virus within 12 weeks of treatment.

Sustained viral response is the term for a successful hepatitis C treatment outcome. It means that hepatitis-C virus is undetectable for 12 or more weeks after the end of treatment. Gilead's blockbuster Harvoni was first approved by the FDA in October 2014. The drug had sales of about $3.3 billion in the latest quarter ended Sept 30.

Hepatitis C, estimated to infect about 3.2 million Americans, is a viral disease that causes inflammation of the liver that can lead to liver failure.

Patients with HCV and HIV co-infection represent about 30 per cent of the total HIV-infected population in the US, Gilead says.

Reuters

Reuters

Lilly diabetes drug cuts heart failure death, hospitalisation: Study The new data showed Jardiance, known chemically as empagliflozin, reduced the combined risk of hospitalisation for heart failure or death from heart failure ELI LILLY'S new diabetes drug Jardiance significantly cuts the risk of heart-related death and hospitalisation for heart failure in patients with type II diabetes who are at high risk for serious heart problems, according to data from a large study presented.

The three-year trial of more than 7,000 patients caused a sensation in September, when Lilly and Jardiance partner Boehringer Ingelheim released preliminary data showing the drug cut deaths by 32 per cent.

50 EXPRESS PHARMA December 1-15, 2015

Earlier, similar studies of other types of diabetes medicines were undertaken to prove they did not cause heart problems, and a neutral outcome was considered reassuring.

The new data showed Jardiance, known chemically as empagliflozin, reduced the combined risk of hospitalisation for heart failure or death from heart failure by 39 per cent, compared with a placebo when added to standard treatments. The benefits were seen in those who had heart failure

at the start of the study and those who did not. Heart failure, a progressive condition in which the heart becomes unable to pump enough blood, is a leading cause of hospitalisations and death.

Nearly half the patients in the study were on insulin, an indication that their diabetes was at an advanced stage. The benefits of Jardiance appeared almost immediately, Inzucchi said. "The event curves begin to diverge almost on day one," he said. "There seems to

US FDA approves Gilead's hepatitis C drug for expanded use

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RESEARCH

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POST EVENT

NovaLead Pharma completes global phase I /II clinical trial for Galnobax NOVALEAD PHARMA announced a potential breakthrough in the treatment of diabetic foot ulcers (DFU). The recently concluded global Phase I/II clinical trial of its repositioned investigational drug, Galnobax successfully met both primary and secondary end points for efficacy and safety.

In this trial, Galnobax demonstrated significant benefit over placebo in terms of ability to close hard to heal DFUs in much shorter time, making it potentially the first small molecule drug for DFU. In addition the trial reported no side effects of any significance. The data supports anticipated mechanism of action of Galnobax that it triggers the intrinsic wound healing processes impaired in diabetics.

In comparison to the published data of existing therapies like growth factors and skin grafts, Galnobax trial data is considerably superior in terms its wound closing ability as well as the time to heal. That it is self-administrable, Galnobax is likely to save expenses for the patients and also ensure better compliance.

This innovation is noteworthy because Galnobax is a generic drug originally indicated for a cardiac condition, repositioned by NovaLead for DFU in a gel form for topical use. Galnobax is discovered through NovaLead’s proprietary technology platform which enables systematic approach for finding novel therapeutic indications for known drug molecules. Using this platform NovaLead has generated a robust pipeline of which Galnobax is the first candidate in human trial.

EP News Bureau-Mumbai

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CPhI INDIA 2015 SPECIAL INSIGHT

2016 : Onward and Upward, India!

Nick Mitchell, Managing Director, Phenomenex India, opines that the pharma and biotech industry within India, need to develop a series of short-term goals and targets to accelerate progress

2

015 marks the midpoint of the second decade of the 21st century. A good time for reflection and critical analysis of what has been accomplished, and what has yet to be done.

Prime Minister Narendra Modi summarises one of our toughest moments, on July 27th this year, “India mourns the loss of a great scientist, a wonderful President and above all an inspiring individual. RIP Dr APJ Abdul Kalam". And in his death we should recall some of his incredibly forward-looking works, written and published before we even crossed into the new millennium, challenging all of us to think about India – 2020.

In the early 1990’s, Kalam offered India a SWOT (Strengths, Weaknesses, Opportunities, and Threats) analysis for the nation and a strategic vision looking over 20 years into the future.

One example was recognising India’s incredible agriculture production potential, but identifying the weaknesses such as cold storage solutions, lack of roadways, and rapid transportation from rural areas to the heavily populated metros across

52 EXPRESS PHARMA December 1-15, 2015

the country.

In the pharmaceutical and biotech industry within India, now might be an opportune time to develop a series of goals and targets that we can work toward over the next five years, the decade which will take us to 2025, or perhaps as far out as 2030. For those of you responsible for goal-setting within your organisations, we all know that mid and long-term goals can be very challenging to set and might only be achieved with a strong focus on clearly defined short-term goals.

A recent meeting in September of a number of UNmember nations in New York, brought government leaders together for an exercise to develop a series of global goals, across number of categories.

The meeting concluded with the finalisation of seventeen global goals. These goals have short-term metrics, and will drive the stakeholder nations to achieve the objectives.

If world leaders can come together and develop a set of goals with such tremendous scope, then surely we in the Indian pharma, biotech and life

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sciences space can take inspiration and challenge ourselves to do something similar in our niche arena, wouldn’t NICK MITCHELL Managing Director, Phenomenex India

you agree?

To further the parallel of this analysis, let’s go back to 1990 and review the progress made on one of the UN’s Millennium Development Goals.

In 1990, the percentage of the global population below the poverty line was 36 per cent.

The goal was to reduce this number by 50 per cent by 2015.

By 2010 (five years early), the percentage was decreased by half (18 per cent), and by 2015 this number has reached 12 per cent (http://www.bbc.com/ news/business-32082968). It’s interesting to note that the establishment of the original goal was coincidentally incredibly close to India’s economic liberalisation which officially began in 1991.

Let’s consider India’s pharma market development over the same time frame. Although the industry began as early as the 1950’s and 1960’s, there was incredible momentum created during the economic liberalisation of the early 1990’s. This development, coupled with India’s unique position on intellectual property considerations during this same time period, fuelled the rapid growth of the active pharmaceutical ingredient (API) and generic drug manu-

India is an emerging market, and emerging markets are very cost conscious To subscribe: bpd.subscription@expressindia.com

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CPhI INDIA 2015 SPECIAL

Source: http://www.globalgoals.org/. facturing within the country.

Transitioning to a world class research and development nation within the fields of pharma and biotech pharma requires a conscientious decision on all stakeholders. It requires a commitment from the academic institutions to develop educational models that are focused on delivering the latest content, and delivered by leading academics publishing research in the most reputable journals worldwide. It requires a commitment from industry to invest in the latest analytical technology platforms to perform their testing protocols, and the leaders of these organisations must recognise that the increase in expense of these platforms is a long-term investment to increase the quality of testing results across the entire spectrum. And ultimately, an increased risk tolerance has to be accepted by those that develop the financial models to support these development objectives.

54 EXPRESS PHARMA December 1-15, 2015

The short-term impetus to moving in this direction is very clear, it is re-establishing India’s place at the front of generic pharma manufacturing market; head to head with our immediate rival, China. As a nation we must regain the trust of the international community, specifically the regulated markets of the West, by agreeing to accept this initiative and not falter on 100 per cent compliance. The mid to long-term position will be to effectively move into the rapidly developing bioequivalents and biosimilars market.

The Make in India initiative is establishing a communication platform to bring industry stakeholders together in early January 2016 (http://makeinindia.com/sector/ pharmaceuticals/). If the homework is done now, this meeting could act as a catalyst for the change that the industry must undergo. With this fo-

rum as a backdrop, there needs to be a coordination between policy makers and players across the value chain for meaningful change to take place.

The suggestion of a plan for migration further up the value chain with a fifteen year timeline between 2015 and 2030 is more than reasonable. It will afford ample time to drive all stakeholders to comply. It also offers the opportunity for those organisations that are already serving the Western markets to re-affirm their position, as well as offer their support to those companies which are currently struggling. Finally, it would permit a timeline toward a zero tolerance initiative that the Indian pharma community must accept as they integrate into

the global community and recognise a single global standard.

India is an emerging market, and emerging markets are very cost conscious. However, low cost products are not the panacea to all of the dilemmas we are facing within our sector today. On the contrary, the commitment to significant investments are required across the sector to increase the level of quality as well as to confirm the quality of the processes and their final products that the Indian pharma and biopharma companies are manufacturing.

A final thought to borrow from another vertical in India that has done very well over the last two decades, namely business process outsourcing and IT consulting. In this space, there have been incredibly strong training programmes for the graduates of India’s

strongest engineering schools.

Companies like Infosys, Wipro, and Tech Mahindra to name a few, have training programmes that can last anywhere from four to six weeks, six months, or even a full year. These programmes take the brightest of students and put them through rigorous sets of protocols, where deviance cannot be accepted, else dismissal is the end game. Ironically enough in visiting a few of these institutions over my years of living in India, I have never heard of “jugaad IT innovation”. There cannot be cutting corners, there is a compliance to “off’s” and “on’s” (“0’s and 1’s”). And it is this compliance, and the respect of this compliance that has turned this industry into a multi-billion dollar one across India. I think our pharma and biopharma companies can learn a lot from the companies in a high technology industry right next door to ours’.

Over the last month of 2015, take the time to consider, how

CPhI INDIA 2015 SPECIAL

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I S S U E

Transitioning to a world class research and development nation within the fields of pharma and biotech pharma requires a conscientious decision on all stakeholders will I do my part to take my organisation to the pinnacle of success globally? Phenomenex India is so interested in supporting our clients globally that strive to reach new heights. Our products and services are recognised by the US-FDA, the European Pharmacopeia, and are in hundreds of validated methods around the world. We manufacture all our products under the strictest of ISO guidelines, and we are always deeply committed to reach positive resolutions to all of your chromatographic challenges. We take this opportunity to wish you a strong finish to 2015, and best wishes for a fantastic 2016, during which we will celebrate our official “Five Years in India� at the end of April 2016.

We look forward to you sharing in our celebrations. And lastly, thank you to all of our customers that have worked closely with us toward advancing the frontiers of separation science, here in India and across the globe. We sincerely appreciate your support and we look forward to working more closely with you in 2016 and the years ahead.

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INSIGHT

Pharma manufacturing – Improving quality,cost and efficiency Dr K Anand Kumar, Dy Managing Director, Indian Immunologicals speaks on the aspects that need focus to improve pharma manufacturing standards INDIA IS a leading country engaged in production of cost effective and quality generic drugs. Many countries, in developed and developing world, are dependent on India for their generic drug requirement. One of the main advantages which India currently enjoys is the exceptional cost competitiveness.

Same is true in the field of vaccines, Indian manufacturers are able to manufacture quality vaccines at a lower cost. In the last decade, several Indian manufacturers have been prequalified by WHO for supply of vaccines to UNICEF, Pan American Health Organization (PAHO) other international agencies engaged in public health and immunisation.

Growing global demand for quality drugs that are competitively priced has resulted in big opportunity for Indian pharma manufacturers who have manufacturing capability to produce quality products meeting international standards. Large and successful Indian enterprises focus on supplying drug products primarily to the US markets. In the recent past, some Indian manufacturers have suffered setbacks due to issues related to non-conformance to cGMP and data integrity. This has brought focus to practices adapted by Indian manufacturers and resulted in lingering doubt in the mind of international community about quality of Indian drugs. This situation was the result of poor implementation of quality systems in true spirit by some of the companies despite having a robust regulatory guidelines. This has led to increased vigil by USFDA and Indian regulators and situation

56 EXPRESS PHARMA December 1-15, 2015

need to be redeemed at the earliest in order to stay competitive. China, our most fierce competitor is a good example in this regard.

Good manufacturing practices is an essential cornerstone of pharma manufacturing in order to maintain consistent quality of drug products. There are several GMP guidelines national (Schedule M) and international (US FDA, WHO, PIC/s, PDA) covering almost all the aspects of manufacturing right from the facility, raw materials, equipment, manpower, process, quality testing and final product.

These guidelines are a live document and are subject to change with time, hence GMP is always termed as current good manufacturing practices (cGMP).

GMP comes at a cost; apart from investment in building a modern facility, maintenance of the facility on a consistent basis requires substantial expenditure, and includes periodical calibration of instruments and validation of equipment and facility.

Most significant of all is manpower which needs to be qualified and regularly trained, not only in core technical skills but also in cGMP and regulatory aspects. Skilled and conscientious manpower is vital in ushering a GMP culture. A sizeable portion of expenditure of all successful enterprises need to be earmarked for acquiring, training and retaining manpower.

There are some aspects to be looked into with an objective to bridge the gap between increasing expectations and present state of affairs.

A significant share of capital is used in construction of the fa-

GMP is essential in pharma manufacturing to maintain consistent quality of drug products

cility. A no-frills manufacturing facility with a simple design and a focus on proper layout for men and material movement as well as process requirement is the basic criteria. We also need to focus on energy efficient construction, which is the need of hour. A large clean room facility requires enormous energy to run and maintain. Let us look at three major components: heating ventilation and air conditioning (HVAC), process and utility equipment and lighting; HVAC consumes approximately 60 per cent of total electricity, lighting accounts for approximately 10 per cent and balance is used by equipment. Hence, it is a must to assess the facility layout design with this perspective, selecting the right clean room grade for a particular activity/operation, apart from selection of energy efficient equipment.

Worldover, pharma industry has understood the significance of energy efficiency built in the design and operating system. In an increasingly competitive

world, to deliver consistent quality and be cost-effective for sustainability of the business, Indian manufacturers cannot ignore this critical aspect of facility design. Moreover, to meet increasingly stringent guidelines and deliver consistently good product quality at a lower production cost, one needs to be mindful of selecting energy efficient technology and practices. A multiproduct facility, where some of the support services viz. cleaning and sterilisation, media and solution preparation is common between different products can also reduce installation and operating cost without compromising quality of operation and product/s.

Another critical aspect is water, pharma manufacturers consistently require large quantity of high quality water for manufacturing. Water is a scarce resource and it is the biggest challenge that the industry is going to face in the coming years. Water is used for different purposes in pharma manufacturing operations viz. cleaning and rinsing, media and buffer preparation and formulation apart from running utility services. Quality of water is paramount for all these activities and does have a direct impact on the quality of the product. Design of a water system is a critical aspect as it has high energy need like a WFI generation and distribution system that needs to be maintained at 800 C with continuous recirculation at a flow rate where biofilms are not formed inside the loop over a period of time. Input quality of water is a crucial factor to be considered while designing a water purifica-

DR K ANAND KUMAR, Dy Managing Director, Indian Immunologicals & Director, Pristine Biologicals (NZ)

tion system. While modern purification technology can efficiently address organic and chemical impurity, elimination of microbial contamination require greater effort in terms of design and operation. Like electricity, water is required 24x7 and its availability is of great concern, hence design of process, equipment and facility should also be vetted against the quantity of water requirement. In order to reduce consumption of water, manufacturers of biologicals and vaccines are exploring the possibility of single use multi-product facility, where need of water for cleaning during process changeover is obliterated.

Consistent product quality demands a robust manufacturing process which delivers drug substance or drug product batch after batch within the requisite quality specification. Robustness of a process is not only evaluated by quality of the end product but also by the consistency of the process parameters, defined as critical process attributes established during product development and verified during process validation studies. Quality by design (QbD) is a scientific, risk-based approach for product development which helps in complete understanding of critical process parameters and its impact on product quality and performance. From the perspective of a manufacturer engaged in production of biologicals and vaccines for several years, one can simply state that biological manufacturing processes are infinitely more complex than synthetic chemical processes.

There are numerous variables in bacterial fermentation and viral

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culture which need to be continuously monitored and controlled to deliver a good quality antigen.

Biological processes are more challenging to control and difficult to reproduce with the same result, batch after batch. Hence, there is a need for exhaustive study of all possible process variables of a manufacturing process during development and the importance of a complete and robust process validation study can’t be understated. It is key to maintain consistent quality. It is mandatory as a part of regulatory compliance to document all out of specification (OOS) results, deviations and changes in the annual product quality review (APQR). This enables the manufacturer to assess, analyse and evaluate the process for its robustness and helps in giving a fillip to consistent quality improvement.

A quality assurance system is the framework under which all manufacturing activities are carried out, right from the receipt of raw materials to dispatch of the finished product. Quality assurance is responsible for overseeing the end-to-end manufacturing process including testing, procurement and dispatch. The role and responsibility of quality assurance is well defined in several guidelines pertaining to pharma products. Validation of process, analytical methods and equipment, audits, in-process quality checks, documentation and batch release is some of the key functions. It is pertinent to point out that documentation is also a very critical component of quality assurance which needs to be clear, correct and reliable.

Quality assurance is a most vital element to ensure and assure product quality and its role is ever evolving. Nowadays, pharma companies engaged in research and development (R&D) have a dedicated quality assurance team for supervision which is responsible for evaluating the product and process from a very early stage. This brings efficiency, removes bottlenecks and considerably reduces the time from lab to market. The team engaged in assuring product quality should

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have varied skills and experience which not only includes sound knowledge of basic science, emerging technology and regulatory guidelines but also possess good analytical abilities and problem solving skills.

With increasing awareness about environment, any responsible pharma manufacturing

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company needs to assess its products, processes and practices from the perspective of safety to environment which also include people, both operators and customers. In the field of biological manufacturing, processes are evaluated on the basis of risks to operator and environment and classified accord-

ingly, thereby enabling the manufacturer to design and build a safe facility. Manufacturing processes and practices also need to be designed and adapted with the safety of people, product and environment in mind.

How we treat our solid and liquid waste in an energy efficient manner is as important as the

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manufacturing process.

A sustainable business is one which adapts to change in its environment with speed. Indian pharma manufacturers also need to accept, evolve and adapt to global regulatory demands and customer needs. The cornerstone of such change is efficiency.

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CPhI INDIA 2015 SPECIAL

INSIGHT

At ‘CRO’ssroads

NILESH NAYAK,, Global Head – Business Development, VerGo Pharma Research

Nilesh Nayak, Global Head – Business Development,VerGo Pharma Research, says CROs can no longer sustain only on the service model and need to have a relook at their strategies

CONTRACT RESEARCH Organisations’ (CROs) have always been the back stage boys in the Indian pharmaceutical industry. The silent operators have been away from the limelight but their contribution to the growth of the industry can never be underestimated. Being majorly privately owned, the total size and reach of this integral part of the pharma world is very difficult to estimate. But going by the number of new units and service providers mushrooming in the country we have all the reasons to believe that this sector is doing well and has reached the critical mass from where it can and will jump and leap frog into the next orbit of growth. The regulatory clogs and business uncertainties in the growing economies of the world have made the growth story a bit difficult for these companies. It’s an industry which is easy to enter but to grow and to sustain is a different ball game all together. Too many service providers in the same area juggling for limited space have forced the companies to rethink their strategies. It’s time for these innovation focused companies to reinvent themselves and have a closer look on the road ahead. They are at crossroads of growth and sustainability and it’s a tough decision to make.

CRO: Explaining the term The abbreviation CRO is used for both 'Clinical Research Or-

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ganisation' and ‘Contract Research Organisation.’ The former includes only the clinical research companies which can be subdivided into two categories: ◗ Clinical research organisations offering phase I to phase IV clinical trials ◗ Bioequivalence centres offering BA/BE studies For the sake of this article, we will be focusing on only the latter, ‘Contract Research Organisations’ which includes product development and custom organic synthesis companies assisting the big pharma innovator and global generic companies in formulation development, chemistry processes and other areas like stability studies and scale ups.

The Contract Manufacturing Organisations (CMOs) have been kept out of the gamut of discussion here.

CRO business in India Historically, India was always considered as a powerhouse for chemistry-based research. Our expertise in reverse engineering for synthesis of active pharmaceutical ingredients, process optimisation for bringing down the cost of synthesis, solvent recovery, synthesis of different salts and later different isomers gave India an unprecedented identity as a partner for chemistry research. As the companies started getting a foothold in the API market, the focus slowly started to move towards the next step in the value chain — formula-

tions. Within no time the formulations market started growing and along with it, India’s expertise in the formulation research also started to take shape. The earlier patent regime giving Indian producers the liberty of not aligning towards product patents and only respecting process patents made us experts in process research and we found innovative ways for circumventing patents and bringing the latest products out in Indian markets. This helped the collective innovative thinking in the country to grow and our scientists became experts in generic product development, thereby gaining a grip on the generic industry.

The outsourcing or contract research industry is an off

shoot of this development and many scientists with global development expertise started becoming technocrats and set up small chemistry and formulation development laboratories to service the global pharma industry. Indian CROs became extended arms for global generic companies and were seen as a reliable and cheaper source of development compared to in-house development in the bigger pharma companies. More and more companies started outsourcing their chemistry and formulation requirements to India and the market which was not existent till the late 90’s now suddenly became very attractive.

The main factors which drew the global companies for outsourcing to India were: ◗ Scientific acumen and understanding ◗ Low cost for research ◗ IP understanding ◗ Respect for confidentiality ◗ Documentation skills because of language proficiency ◗ Professional approach and adherence to regulatory requirements What started as a trickle in the 90’s with only a few companies providing these services soon became a steady flow of new companies entering this arena because of less entry barrier in form of investments needed and a big gap between outsourcing needs (demand) of pharma companies and the capacity of CROs (supply) to meet these needs.

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CRO business model: Evolving with time The CROs operated in multiple business models and the most common amongst those were: ◗ FTE-based model: Full Time Equivalent or FTE as its popularly called was one of the first models chosen by sponsor companies outsourcing their chemistry programmes to Indian CROs. This was a simple risk free model wherein the sponsor pays the CRO a fixed amount of money for a fixed amount of period depending on the number of scientists they engage for the project. This was very popular with the innovator and drug discovery companies who used to engage a fixed amount

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Typically a contract research company offers the following services: Product Development

Organic Synthesis

Preformulation studies

Medicinal chemistry

Formulation development

Salt and polymorph studies

Analytical development and validation

Intermediates and API’s

Stability studies

Impurity synthesis and Characterisation

Scale up and tech transfer

API process optimisation

Dossier compilation

Analytical development and validation

Clinical supplies

Clinical supplies

of scientists for their research work and CRO was paid a fixed amount of money per scientist engaged. In some cases there was a success-based incentive for the CRO in case of positive outcome to the research work. This model was similar to the working of the

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BPOs but because of the knowledge quotient involved the industry was also referred to as the KPO (Knowledge Process Outsourcing) Industry. The FTE model was generally favored for long-term engagements between the sponsor and CROs and rela-

tionships spread across multiple projects and assignments. ◗ Fee for service model: The FTE model was not suitable for the outsourcing of smaller projects particularly in the areas of formulation development wherein the projects were distributed by the sponsor across multiple CROs and the sponsors didn’t want to get tied up to one CRO for all their projects. The fee for service model worked on milestonebased payments to the CRO which were pre decided and time bound. Various factors like API availability / CMO availability / bio study failure etc throws the project out of time lines and both the sponsor and CRO are adversely affected with the CROs cash

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flows getting affected and the sponsors’ projects getting stuck and not moving ahead.

The risks associated with the fee for service model are high and there is practically nothing that both the sponsor and CRO can do to mitigate the risks. The carrot and stick approach in form of success fees and penalties respectively are not known to have any positive outcome on the timelines and project deliverables. ◗ Co-development / Outlicensing model: As the CROs began to mature and started having a surplus cash flow they started investing in their own in house developments. The strategy was simple. Select products that would be attractive to generic

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sellers and with minimum players in market, develop the products till proof of concept (positive stability and pilot biostudy) and then scout for partners for investing in the manufacturing of the exhibit batches and pivotal biostudy which make up for substantial part of the development cost.

The CROs can aim for better revenues in this model as they share the risk of development with the sponsor and can offer more definite timelines thereby improving their time to market for the products.

The co-development model is becoming very common even in custom chemistry synthesis areas.

Bottlenecks for growth As the CRO industry pro-

gressed from one business model to another, the more competent and ambitious one’s graduated to different levels of services and entered into the next areas in the value chain by offering manufacturing services and sometimes also offering complete dossiers with market authorisations.

The investments of the CRO have increased considerably with now private investors and venture capitalists entering into the fray. The mom-and-pop shops have metamorphosed into professionally run corporate houses with management coming from the bigger generic and innovator companies. Most of the CROs are still privatelyowned and stand alone businesses making them vulnera-

The stage is set for the industry to try something new to grow and sustain the business in future. CRO’s can no longer sustain only on the service model

ble to changing market dynamics. The slowdown in the EU markets and stiff price wars in the US generic industry had an adverse effect on the CRO’s with flow of projects slowing down and sponsors negotiating heavily on pricing of the projects. The increase in competition and smaller players entering the fray further worsened things and many of the CRO’s are fighting for survival.

The stage is set for the industry to try something new to grow and sustain the business in future. CROs can no longer sustain only on the service model and need to have a relook at their strategies. With the flow of projects not guaranteed and limited investment possibilities in own projects the CROs are at crossroads

and need to take a decision of whether to remain independent and continue to provide services or to align themselves with their sponsors by providing the sponsors a stake in the company and becoming their integral part. This will provide the sponsor better control over the CRO and they could get their projects prioritised and for the CRO there will be better sustainability with a bigger sponsor acting as their guardian angel. The BA/BE industry had seen this kind of alignment happening in the past and it’s a model which has worked for them. Whether the contract research companies will also take this plunge and join hands with bigger companies is an inevitability waiting to happen?

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CPhI INDIA 2015 SPECIAL

ANNIVERSARY S P E C I A L

I S S U E

PRE EVENT

CPhI India to be held in Mumbai from Dec 1-3,2015 The event will be co-located with P-Mec India CPHI INDIA and its co-located events are the largest and most comprehensive pharmaceutical industry events in South Asia.

CPhI India will be held along with P-MEC, which will take place at Bombay Convention and Exhibition Centre, Mumbai, from December 1-3, 2015.

Visitors will be able to meet with key decision makers in the pharma industry from 92 countries, including India, China, the US, the UK, France, Italy.

Technical seminars will be held during the event. CPhI India Pharma Awards will be given out to recognise and appreciate the contribution and efforts of the Indian pharma industry.

Exhibitor profile includes, active pharma ingredients, alkaloids, amino acids, antibiotics, antibodies, antimicrobial preservatives, antioxidants, biocatalysts, biotechnology, capsules/ encapsulation, chemical synthesis/ analysis, chira intermediates, coating agents, colour and dispersions, custom manufacturing, cytokines, emulsifying/solubilising agents, enzymes, excipients and drug formulation, fine chemicals, flavours and perfumes, glidants, herbal teas, hormones and synthetic substances, immunochemistry, intermediates, medicinal plants, microencapsulation, ointments bases, peptides, phospholipids, plant/animal extracts, prostaglandins, publisher, purification and separation techniques, regulatory affairs, sera and vaccines, solvents, stiffening agents, stiffening bases, suppository bases, suspending/viscosity, increasing agents, sweetening agents, synthetic organic chemistry, tablet binders, tablet disintegrants, tablet fillerbinders, tablet lubricants, tissue culture medias, wetting/solubilising agents.

EP News Bureau-Mumbai

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INSIGHT

In the pharma fast lane Abhishek Bardhan, Director, Business Development, M+W Group, writes about the opportunities for the pharmaceutical industry in India to compete on a global stage INDIA HAS blazed a trail in developing home grown manufacturing centres and the biopharma sector is no exception.

Prime Minister Narendra Modi flew the flag earlier his year at the Hannover Messe, the world’s largest industry and technology trade fair. The massive presence of Indian companies at the show heralded India as a country that established markets could do business with; insisting that he was committed to introducing a ‘predictable’ business environment in his country. It would seem that the promises made in his pre-election ‘Make in India’ campaign to promote the country as an investment destination and manufacturing centre is beginning to pay off — in a big way.

His goal is to market India as an industrial hub for foreign players eager to take advantage of the country’s large workforce, raw materials and infrastructure.

This is especially relevant for new technology industries led by pharmaceutical companies including some of the world’s biggest players — and importantly with Indian businesses is the vanguard of manufacturers positioned to develop not just home markets but also creating a global footprint.

Opportunities for pharma sector The opportunities for win/win in best practice and cost control for players in the pharma industry are substantial, especially in India. International businesses have been on the receiving end

62 EXPRESS PHARMA December 1-15, 2015

Top 10 Publicly Listed pharmaceutical companies in India by Market Capitalisation as of July 2015. http://listz.in/top-10-pharma-companies-in-india.html Company

1

Sun Pharmaceutical

2

Lupin Ltd

3

Dr. Reddy's Laboratories

4

Cipla

5

Aurobindo Pharma

6

Cadila Healthcare

7

Glenmark Pharmaceuticals

8

GlaxoSmithKline Pharmaceuticals Ltd

9

Divis Laboratories

10

Torrent Pharmaceuticals

of the Indian pharma industry is attracting several companies that are finding it viable to increase their operations in the country. In terms of value, exports of Indian pharma products increased at a CAGR of 26.1 per cent to touch $ 10.1 billion during FY06-13.

But, there are some issues that are putting the brakes on an otherwise impressive growth of the indigenous manufacturing base. Currently, the Indian pharma industry is highly fragmented with about 24,000 players (33 per cent in the organised sector). The top ten companies make up for more than a third of the market.

Already major manufacturers based in the sub-continent have flexed their muscles with a flurry of M&A activity, with clearance to enter North America. The US market alone ac-

enues as a precious resource.

Partnership key to BRIC economies

Rank

of a full on assault by the Indian government and an army of financial advisors and business strategists who had placed emerging markets — and India in particular — on the radar for serious investors, due to its impressive growth, strong democracy and developing standards as well as its high numbers of skilled staff. What’s more, India itself is fast tracking its presence on the global pharmaceutical manufacturing scene by deploying smart strategies.

According to figures cited by the Indian government, last year globally, the Indian pharma industry is ranked third largest in volume terms and tenth largest in value terms. The sector is highly knowledge-based and its steady growth is positively affecting the Indian economy. In addition to the relatively low cost-base, the organised nature

ABHISHEK BARDHAN, Director, Business Development, M+W Group

counted for nearly 30 per cent of India’s medicine exports of $15 billion in the fiscal year through March 2014.

Europe’s reputation for quality and precision finished products, and German engineering excellence in particular, is still the order of the day with emerging markets keen to learn from years of experience. In 2012, Europe’s pharma trade surplus was estimated at €80 billion.

The advantage that India has over other emerging markets is a plethora of highly skilled engineers and technology graduates providing a ready-made low cost labour market. They cover the most sophisticated of manufacturing processes from R&D to world-leading production regimes. This is in sharp contrast with Europe where the skills gap for engineers has placed a premium on such av-

Times are changing, however, with emerging markets gaining a foothold. For many BRIC economies, the question is how they manage to compete on a world stage with the developed regions such as Europe. The answer is simple — through partnerships. Indian pharma manufacturers are leveraging the expertise and brand strength of European engineering organisations to build GMP and cleanroom facilities that provide the necessary environments for manufacturing of pharma that meet stringent FDA and WHO regulations across the globe.

The strength of the pharma market in India is gaining traction and growing with investments continuing to pour in, largely through mergers and acquisitions. With many Indian drug companies investing outside of India as well, confidence in the market is growing from both sides. The benefits for European engineering organisations to partner with Indian pharma manufacturers lies largely in the cost benefits. Due to availability of skilled labour, India has the ability to deliver cost efficient programmes.

Pharma manufacturing projects can cost between 30 and 40 per cent of manufacturing projects in the US, a significant reduction in costs leaving cash left over for investment or future projects.

One of the main reasons why In-

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Indian pharma manufacturers are leveraging the expertise and brand strength of European engineering organisations to build GMP and cleanroom facilities that provide the necessary environments for manufacturing of pharma that meet stringent FDA and WHO regulations dia’s pharma market has catapulted to become a significant player is the amount of government support it has received. With the implementation of ‘PharmaVision 2020’ the Indian government is aiming at making India a global leader in end-to-end drug manufacture.

Leading clean room technology solutions provider M+W Products’ work with global clients is regarded by many industry insiders as the ‘go-to resource’ for innovation and leveraging competitive edge. One of the key challenges according to Bardhan is the lack of readily available advanced technology products for facilities, which are needed in order for India to deliver its pharma manufacturing at global standards. European engineering and products both have strong reputations of technology and engineering excellence, which pharma companies in India are cottoning on to in terms of the benefits of partnering with such organisations. There is an incredible amount of research and development already taking place in the Americas and across Europe. Rather than follow the same route yet remain 50 to 100 years behind many organisations, businesses are realising that a combined approach to building up the Indian pharma manufacturing industry is ideal. Furthermore, these partnerships help Indian pharma companies deliver global levels of safety and quality while adhering to the - FDA and GMP standards which are essential for their products to be acceptable globally.

Delivering solutions for Indian customers The latest technological innovations related to cleanrooms show that development is still being pursued 50 years after the first cleanroom was developed, al-

though much of the innovation deals with improved equipment for individuals working within a cleanroom environment. Michael Rodd, M+W Products Chief Sales Officer has together with Abhishek been a driving force in delivering solutions for Indian customers. He cites, for example, when considering clothes, everyone working in cleanrooms has to change frequently.

This costs time and money. This has led to many asking the question: what if the clothing could remain clean throughout the entire process?

Photodynamic disinfection A potential solution being worked on is called ‘photodynamic disinfection’.

With no negative impacts on the human body, photodynamic disinfection is a way to develop a highly disinfectant affect that destroys microorganisms in minutes. In order to achieve this, a suitable lighting technology is required which assures that light can penetrate into difficult areas of clothing such as folds or seams. This innovation is especially of interest for the food industry and medical facilities as well as cleanrooms.

Hygienic furniture Over the past year, the design and manufacturing of hygienic furniture has evolved to meet specific cleanroom requirements. There has also been a clear shift in the way laboratory users want their cleanrooms to be designed, not only to meet current needs, but to future proof them for years to come This has taken two distinct routes: the first is a generic module approach that is flexible; the second is tighter involving furniture being placed in precise

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Bosch, Klenzaids JV marks coming together of German quality systems and Indian value engineering The joint venture between Bosch Packaging Technology and Klenzaids Contamination Controls, where the former will acquire a 49 per cent share in the latter, will complete a year this December. Viveka Roychowdhury gets an update on the integration process and a sense of the rationale behind the JV from Dr Andreas Mattern, Project manager - post merger integration of Klenzaids and Hamish Shahani, Managing Director, Klenzaids

DR ANDREAS MATTERN, Project manager post merger integration of Klenzaids Bosch already has a presence in India, so what was the rationale for the JV? Speed was an important criterion for the joint venture.

The Indian pharmaceutical market is growing at a very fast pace. The portfolios of Bosch and Klenzaids complement each other ideally.

This enables us to service customers’ needs for costeffective filling lines from a single source. By combining Klenzaid’s strengths in cleanroom equipment, peripherals and sterilising tunnels with Bosch’s innovative filling technology – such as the FLC 3005 vial filler series, which was developed in India — we are able to cater to the requirements of this socalled emerging market.

On a larger scale, we see high potential for joint projects and opportunities in further emerging markets, which goes

64 EXPRESS PHARMA December 1-15, 2015

After the contract signing in 2014 (from left): Andreas Mattern, Project Manager - post merger integration of Klenzaids, Matthias Müller, Senior Vice President Engineering, Bosch Packaging Technology, Hamish C Shahani, Managing Director, Klenzaids, Hariharsubramanian Krishnamurthy, Director Finance, Klenzaids

well with our focus on Africa as a further growth market.

Both Klenzaids and Bosch already have good references here. By strengthening our offer for cleanroom equipment, turnkey solutions

and containment options, the joint venture will bring us a number of interesting new opportunities.

While the Bosch plant in Verna, Goa will continue to mainly focus on the

confectionery and food equipment, Klenzaids brings another important asset into the joint venture, they already have a manufacturing set-up and a supply chain, which is tailored to the requirements of

the pharma industry.

One year after the JV was announced, what is the progress on the integration front? What were the learnings from integrating a fam-

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One of the main challenges is to improve pharma quality standards and the accessibility of medicines for the general public ily-driven Indian company into the Bosch group?

We are extremely happy with the progress. The teams are connecting well, as they are driven by similar company cultures that emphasise a ‘customer first’ and quality mindset.

Bosch associates value the depth of knowledge and experience of their new Indian counterparts and the quality of the equipment they produce. This has generated trust and a lot of interest for joint projects, which is essential for the fast integration. On the other side, the Klenzaids colleagues also see the benefits of building a more scalable organisation, which is on the fast track to turning from a regional champion with some international outreach to a truly global player.

First successes prove that this is the reality, and not just theoretical planning. The first filling lines with licensed Bosch technology have been sold, and customer feedback on the partnership has been very positive.

They see that we are now able to provide them the ‘best of both worlds.’

What is essential for a good integration? From our point of view it’s fast decisions, an open and honest communication, as well as being open for change on both sides. Bosch and Klenzaids had already worked together on joint projects in the past, so we knew each other quite well.

This meant that from day one, we started with a common idea, and a high amount of mutual trust.

Is Bosch looking at other JVs in India? If so, at what kind of companies, services, products would be added to the Bosch Group? Any timeline to these fresh JVs? Our current set-up perfectly matches our business needs and we are not actively looking for other partners in India. Of course, Bosch is always open to interesting opportunities.

What would you list as the top cleanroom challenges facing the industry. What are the current trends in India (from a machine manufacturer’s perspective) and how is the JV best positioned to meet these challenges and fulfill customer expectations?

One of the main challenges is to improve pharma quality standards and the accessibility of medicines for the general public at the same time.

This is not only a challenge for the pharma industry but for the politics and the entire society, with numerous initiatives under way. With the joint venture, we have decades of global experience and offer high quality and safety features to India, while keeping the equipment on an affordable level for an emerging health system.

As far as projects and their timelines are concerned, it is not only about time to market. It is also about ‘time to money.’ By combining our turnkey project experience, the local service team can significantly speed up overall projects from equipment delivery through to full installation and validation cycles.

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HAMISH SHAHANI, Managing Director, Klenzaids Klenzaids already has a good legacy in India, and to global clients. What then is the rationale for the JV? We wanted to create a true centre of competence in the region for a comprehensive one-stop-solution to remain ahead of competition. In my view, Klenzaids should be positioned as a strong player in the international regulatory compliant market place. And the joint venture with Bosch would fast-track this goal. We also add value to the current Bosch portfolio with existing Klenzaids products going hand in hand and create unparalleled bandwidth in the scope of possible supplies which is unique in the market to our mind.

What are the ‘cultural changes’ necessary over the past one year? Given these learnings, what would be your advice to other Indian

promoters looking at such JVs? Bosch is arguably one of the most professional and ethnically managed companies in the world. At the same time, Klenzaids has always been professionally managed as a family-owned company. This has made operations smooth and seamless. Nevertheless, it’s very interesting to see the coming together of German quality systems and Indian value engineering. Culturally, one has to move to the means and methods that will ensure higher quality assurance. My advice to Indian promoters would be to take time and chose their partners and positions well. They should focus on becoming completely professional about every single aspect of the business and its execution.

Would there be a rise in prices of the equipment post the JV? Given that India is a price sensitive market, what is the strategy to sell given these constraints?

My advice to Indian promoters would be to take time and chose their partners and positions well.

They should focus on becoming completely professional about every single aspect of the business and its execution We are not seeking price increases. Of course, depending on requirements, we offer various solutions at different prices. Additionally, Klenzaids is now moving into high-volume production in a conscious attempt to rationalise costs.

The strategy has evolved based on existing and trending market realities and is fully cognizant of client needs and imperatives.

What would you list as the top three cleanroom challenges facing the industry. What are

the current trends in India (from a machine manufacturer’s perspective) and how is the JV best positioned to meet these challenges and fulfill customer expectations?

I would rank the top three challenges like this: First, the increasing reliance on cRABS and isolator technology as the primary barrier, relegating the cleanroom into a true ‘background.’ Second, Manufacturing Execution System (MES), other initiatives such as industry 4.0, and the

like, which promise to change many things as we currently know them – including intelligent buildings. Third, ‘overall safety’ not just regarding the prefab suites themselves but every aspect and attribute of the system. I believe we have a lot to do to ensure compliance with the global standards. The joint venture is sensitive to these industry initiatives and is truly placing their best engineering talents to pursue this course.

pharma products and the relatively smaller share of revenues they have historically accounted for in big pharma companies have led to industry-wide challenges in the supply chain. Complexity, cost and service levels are far from small-molecule best practices, even considering the additional complexity of coldchain requirements.

New classes of molecules, from drug conjugates to the cell and gene therapies arriving in the next five years, will each require its own novel manufacturing, supply and quality-assurance approaches. Today, many companies that are insourcing these products in the

late clinical or early commercialisation phase are struggling to set up the novel technologies and processes required to produce them.

Cleanrooms are not your everyday purchase. They have a very specific purpose to control and remove contamination.

In today’s technologically advanced world, the key now is in attempting to future proof the cleanroom. As we all know, technologies are advancing at such a fast pace that keeping up is becoming impossible.

This is why innovators like M+W Products are looking to the future and how we can make the products used, as op-

posed to the infrastructure, as future proof as possible. For example, many vendors are making products and controls that will be key to enhancing flexibility and sustainability in cleanroom facilities, and many of these systems are getting so complex and subtle in terms of how they will react to the building and its technologies.

By concentrating efforts on the equipment and controls, we are able to continue innovating, and more importantly, improve efficiencies and saving costs.

M+W Products’ experience in India is demonstrating that European/ Indian partnerships are proving beneficial to both sides.’

viveka.r@expressindia.com

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In the pharma... locations. Whichever route is chosen, the finish is becoming just as important as the function. There is increasingly a focus on achieving a ‘showroom’ finish in cleanrooms. This could be down to demands for the best quality working environment.

Also, the viewing windows enable laboratories and cleanrooms to clearly demonstrate to visitors that they are committed to quality and control.

Is biopharma the next big thing for manufacturers?

According to a report by consulting firm McKinsey & Company ‘Rapid growth in biopharma: Challenges and

66 EXPRESS PHARMA December 1-15, 2015

opportunities,’ as the number of products rises and new process technologies such as continuous manufacturing are introduced, the complexity of biopharma operations and the biopharma supply chain will increase. Evidence indicates that current production programmes are already stretching the industry, with several players failing to deliver to the market. This challenge will only increase as sites move from the current ‘one line, one product’ setup toward nimble and flexible multiple-product operations and are required to manage both current and future technologies under one roof.

The high premium on bio-

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‘Our products are innovative, high quality, safe and energy efficient’ Gandhi Automations is one of the most sought after manufacturers of clean room high speed doors for the pharma industry. Samir Gandhi, Director, Gandhi Automations, reveals different aspects of their products in discussion with Sachin Jagdale

What are the different types of products you manufacture?

We design, manufacture, supply, install and maintain highly sophisticated industrial and commercial doors and loading bay equipment. The doors meet various objectives like temperature control, dust ingress, noise control, maintain hygienic conditions etc. At the same time it allows seamless traffic of forklifts, pallet trucks etc. All our products are manufactured by European and American technology that conform to very high standards of safety. Our dock levelers also adhere to the most advanced concept. The prefabricated solutions for quick construction of loading bays allows a cut by 60 per cent of the construction time of pits and dramatically reduces the need of man labour.

Our product range includes high speed industrial doors, high speed clean room doors, sectional overhead doors, dock leveler, dock shelters, rolling shutters, fire rated rolling shutters, fire sliding doors, swing doors, aircraft hangar doors and shipyard doors, swing gates, sliding gates, retractable gates

and boom barriers.

Which are your pharma specific products? Besides pharma, which other industries do you cater to?

We manufacture clean room high speed doors especially for the pharma industry. In this industry, clean room doors play a crucial role in the manufacturing of pharma products which require the environment to be free from microbial and particulate contamination and protected from moisture– controlled environment.

These industries make high demands with respect to hygiene, sealing, operating reliability, fitting and a trouble free after-sales service. Our clean room high speed doors satisfy all these requirements and work in strictly regulated operating conditions.

Apart from pharma, we cater to logistics, warehousing, cold chain, food, safety, commercial, residential, etc.

Basically our products are high in demand in industries which require safety and quick open and close applications at the entry and exit points where controlled environment needs to be maintained. This helps in

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Apart from pharma, we cater to logistics, warehousing, cold chain, food, safety, commercial, residential, etc. Basically our products are high in demand in industries which require safety and quick open and close applications at the entry and exit points where controlled environment needs to be maintained not only maintaining the hygiene but also the temperature within the area and lower energy consumption thus reducing the costs substantially.

Apart from doors, we also manufacture loading bay equipment for efficiently loading and unloading of goods and maintain quality of the goods during loading till they reach to the consumers.

We also manufacture aircraft hangar doors for aviation industry, shipyard doors for ports, gates and boom barriers for residential and commercial establishments.

Briefly describe these products. ● High speed industrial doors: Gandhi Automations develops prime range of high speed automatic doors used for fast access for internal and external areas of

68 EXPRESS PHARMA December 1-15, 2015

buildings.

Prime high speed doors are designed and manufactured with German collaboration using innovative and creative engineering technology for frequent use in high traffic areas with opening speeds up to 3 m/s. The high opening speed reduces time taken in movement of material thus accelerating the logistics process. A wide range of prime high speed doors are available for various operations, including areas with special requirements for temperature control, hygiene, pharma, storage and handling of frozen foods, ATEX explosion proof areas, deep freezer, warehouse, loading bays and on conveyor systems. Prime reset features a special innovative self-repairing system. ● Loading bay equipment:

Gandhi Automations offers complete logistics solution by providing dock levelers, dock shelters, scissor lifts, sectional overhead doors, high speed doors and dock houses. The dock equipment conforms to the highest safety standards like EN 1398 for dock levelers and EN 1570 for scissor lifts in addition to the CE mark on the products. ◆ Dock levelers Dock levelers are the most essential part of the material handling system. It improves safety, security and fast loading and unloading of goods at the warehouses, loading dock by compensating the difference in heights between the loading bay and the vehicle.

It’s the most convenient way of loading and unloading goods. Dock levelers offered

by Gandhi Automations are manufactured conforming to

EN 1398 standards and using the advanced robotic welding technology to create a precision engineered product. A single push button activates the dock leveler into operation.

gap between the building and the vehicle in such a way that when the sectional overhead door opens, goods and personnel are protected against the harsh weather conditions outside.

◆ Dock shelters

◆ Sectional overhead doors

Dock shelters cut off the inside environment from the outside. It is not only useful to the human working conditions, but also for avoiding useless wastes, therefore resulting in energy saving, ecological safeguard, protection of perishable goods and greater working efficiency. Gandhi Automations offers a complete range of dock shelters available for every kind of use and environment from the outside cold conditions or the chilled ones from outside heat and also from rain, wind, snow and dust. Dock shelters seal the

Porto sectional overhead doors are ideal for all industrial and logistics needs. The design and different solutions offered ensure the door to be aesthetically pleasing and perfectly suited to any architectural environment — from modern and traditional industrial buildings to fine commercial buildings. Porto doors are built to ensure the highest ease and flexibility of use which, in turn ensures a quick, hassle free and accurate replacement of old shutters. Depending on the structure of the building and the requirement, a choice

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can be made from a standard lift, vertical lift, horizontal lift, low headroom or inclined lift. The range consists of a wide series of track systems, panel options and safety features. Special glazed doors provide excellent lighting and vision into the building where required.

doors are designed for tough environments with extremely large openings. The sliding aircraft hangar doors are recommended where no headroom is available and side clearances permitted, whereas hoist up doors obviates the need for heavy foundation under the door for bottom tracks.

◆ Scissor lift tables

3.Industrial sliding doors: Motorised heavy industrial sliding doors are excellent for large openings and are custom built to meet the requirements of our customers. They are ideal for industrial applications, both as external and internal doors where maximum door opening is required. The doors are designed for tough everyday operation, extremely sturdy, resistant to impact and effectively corrosionprotected.

Gandhi Automations offers lift tables that enhance the loading and unloading operations and conforms to EN 1570.

1.Rolling shutters: Gandhi rolling shutters — Classic, are ideal for situations where side room is at a premium and security is required. Our rolling shutters require very little headroom above the structural opening. They combine strength with elegance along with durability and are designed for both external and internal applications. Gandhi rolling shutters are fabricated of interlocked galvalume, galvanised insulated and non-insulated, stainless steel, patented aluminum or polycarbonate profiles and patented bright steel bar rolling grills. Each of our rolling shutters is solidly constructed to promote trouble-free operation and long life.

The rolling shutters can also be designed as per client’s specifications or conforming to IS 6248.

All our rolling shutters are automated using robust drive technology with manual override in case of power failure and is compact, noiseless and reliable with low decibel level.

Gandhi rolling shutters fit openings to a maximum width of 30,000 mm and height of 40,000 mm with an endless array of options to satisfy both aesthetic considerations as well as working requirement.

2.Aircraft hangar doors and shipyard doors: Aircraft hangar doors — Hoist-up and sliding offer remarkable advantages for versatility to be suitable for aircrafts in different sizes. Optimum reliability and operational safety are important design principles. The hangar

4.Commercial doors: ◗ Sliding doors Automatic sliding doors are solutions devised to meet the modern requirements of interior design. They smartly enhance the look of commercial areas and work environments. These are ideal for office buildings, shopping malls, apartments, hotels, restaurants, conferences and others. Gandhi offers a complete range of automatic systems for sliding pedestrian doors (single leaf, double leaf, telescopic) curved doors. ◗ Swing doors

Gandhi Automations offers automation for swing doors that have very distinctive features.

While being elegant they also comply with European regulations and are sturdy to be used for heavy duty application. ◗ Garage doors

Garage doors open vertically, they slide upwards, then along the ceiling, through the guides provided, making them ideal when space is at a premium or when the garage door opens directly onto the pavement. Garage doors help in sound proofing and have a heat insulation coefficient, due to their insulated panels, which ensures insulation rating from heat/cold

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and contribute to saving energy.

not surprising that entrance automation and loading bay industry is rapidly growing.

The market that has been tapped till now is only the tip of the iceberg. With a ready made market available, this could be one product category which could witness double digit growth rates over the next decade.

5.Fire rated shutters and doors ◗ Fire rated rolling shutters Fire rolling shutters are rated physical barriers that protect wall openings from spread of fire. They provide automatic closing in the event of fire detection. Fire rated rolling shutters provide up to four hours protection against fire. The operating system can be directly wired for activation by fire alarm systems or smoke detectors. ◗ Fire rated sliding doors

Fire sliding doors are ideal for wall openings where headroom is limited and frames can butt up to a ceiling or fix directly to overhead lintels. The counterweight on the door is linked to the fuse and closes the door only when the fuse breaks at a temperature of 74°c. The sliding door remains in a ‘normally open’ position and goes to a complete closing in case of fire. Available in single and double leaf options.

8. Gates: Gandhi designed and fabricated gates are not only aesthetically pleasing, but sturdy and perfectly aligned.

The pre-tensioning of the gate leaf construction reduces the risk of bending.

The leaf design is available in standard form or custom made to suit the client’s requirements.

Electromechanically driven steel gates are robust and suitable to be installed at any industrial, commercial or residential premises. The automated gates ensure longterm reliability and superbly blends in with the style of the buildings. We offer different types of gates like: conventional sliding gates,

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High speed door

telescopic sliding gates, cantilever sliding gates, retractable gates and swing gates.

9.Boom barriers: The soft edges, rounded corners and high performance boom barriers offered by Gandhi Automations are suitable for any type of installation environment. The wide range of lengths and accessories available ensures that all installation requirements are met. All models are equipped with a provision of manual operation in the event of power failure and battery back-up facility in selected models. Wide range of models suit various applications like car parking sites, condominiums, toll collection and industrial entrance. The models are available for boom length up to 8.4 m. They can be opened up to 16.8 m, which can be covered with two barriers operating as master/slave.

The boom barriers can be manually released in case of power failure. Battery backup facility is available in

select models.

Tell us about your infrastructure?

Our company is headquartered in Mumbai.

We have state-of-the-art manufacturing and warehouse facility of 300,000 sq ft in Bhiwandi. With offices in 23 major cities of India and a strong team of more than 500 people, we have a strong national presence and international footprint.

What is your total market share in India?

We are the leaders in entrance automation and loading bay segment with a market share of more 70 per cent in India i.e. three out of every four entrance automation or loading bay equipment have been sold and installed by us. Our products are innovative, high-quality, safe and energy efficient. Our passion and commitment to quality propels us to continuously thrive to do better for our customers by exceeding their requirements and

expectations. Gandhi Automations is committed to provide excellent customer service by prompt response to customer queries. Our customer care team is available to our customers 24*7.

How will you describe Gandhi Automations growth prospects in India?

The market for our industry has been growing at a steady pace over the past couple of years in India. Entrance automation and loading bays have become a common sight in several types of industries nowadays. Rapid industrialisation and the steady growth of the commercial realty sector have been behind this growth. The thrust being given to the manufacturing sector is what has brought this product category into sharp focus. With several Special Economic Zones (SEZs), National Manufacturing Investment Zones (NMIZs) being announced, apart from the various industrial corridors that have been proposed, it is

Which marketing strategies have you adopted that have led to the success of your products in India?

Our strategy is not to appoint dealers for marketing and selling our products. All our contacts with the clients are done directly by our staff themselves. We believe that a dealer will never be able to service a client with the same passion as we do. In this industry, the model of appointing dealers to service a client is an absolutely unsuccessful one which ultimately results in the client being unhappy.

What are the key strategic moves that have engineered the success of the company?

We constantly strive to grow. Our strategy is to focus on some of our key areas of operation. It is all about offering technologically advanced products to our customers. We understand the needs of our clients and offer them the best products along with high levels of service. We are having 3,00,000 sq ft of manufacturing and warehouse facility at Bhiwandi where we carry out our manufacturing process.

Apart from catering to the Indian market, we have also been exporting our products to the US, Far East, the Middle East, Europe and Africa. sachin.jagdale@expressindia.com

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I N T E R V I E W

‘We target new upcoming markets’ Mack Pharmatech is globally known for its quality stability chambers. Kiran Badgujar, Managing Director, Mack Pharmatech, reveals more to Sachin Jagdale

Which equipment will be displayed at P-Mec India 2015? What are their features?

We have a wide range of products and in P-MEC India 2015, we are going to display walk in stability chamber.

The equipment has the following technical features: ◗ CE approved ◗ PLC based control system (make: Allen Bradley) ◗ 21 CFR Software ◗ HMI (LED Touch Screen Display) ◗ Stand by refrigeration system ◗ Stand by humidity system ◗ Imported Hygroflex sensor ◗ 8+8 Scanner ◗ Password protected door access system ◗ Heavy duty Rack & Trays ◗ SMS mobile alert system ◗ Hooter system ◗ Full view glass door ◗ GMP model Will you be launching any new products at the exhibition?

We are going to launch updated 21 CFR software in this exhibition and below are their additional advantages/details: ◗ Browser-based technology ◗ Free of cost software with equipment without any extra costing ◗ Unlimited equipment connectivity in

With a strong new business visibility and our ability to expand existing relationships, we remain confident that we will continue to drive growth

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single software ◗ Unlimited user creation and as per their designation provision of resources ◗ Automatically calculate MKT ◗ Data generated on PDF format ◗ Open door with reason master ◗ Input / Output status of major components ◗ Automatic back up facility ◗ Secured audit train ( user, equipment, alarm, SMS & events )

High quality of our products with latest technology and prompt after sales service differentiates us from the competitors With many of your competitors displaying their products in the same event, how are you going to differentiate your products from your counterparts?

High quality of our products with latest technology and prompt after sales service differentiates us from the competitors and this is how, we are growing faster than our competitors.

How will you describe your experience with previous editions of P Mec? What are your expectations from this year's event?

P-Mec exhibition is number one hub to get top to user level crowd in overall pharma industry, so every year, it is a main plan for promoting and

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interacting existing as well as new clients in the market.

This year, we are expecting foreign clients as well as distributors to promote our products.

What is Mack Pharmatech's market growth over the last two years in India? What percentage of your revenue comes from the international markets?

In FY 2013-14, we have achieved 20 per cent hike as compared to FY 2012-13, whereas, in 2014-15, we grew up to 35 per cent and up to the end of third quarter, we reached 40 per cent.

Right from the beginning, there was a double digit growth to our sales Y-O-Y. This indicates the confidence of the buyer in our products and no doubt the aggressive approach by our marketing team. We have an all India marketing network covered by our own team of marketing people as well as the agents, who represent us in various parts of the country.

We have already crossed the borders by supplying our machines to Europe, Ukraine, Africa and other parts of Asia and a total of 25 per cent revenue comes from the international market. We are targeting new upcoming markets in the Middle East and South Asia as well and is expecting 50 per cent revenue in the years to come.

What are your business plans for the next five years?

With a strong new business visibility and our ability to expand existing relationships, we remain confident that we will continue to drive growth, achieve our strategic corporate objectives, and emerge stronger in our journey towards global leadership. sachin.jagdale@expressindia.com

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‘We mainly focus to reduce the energy consumption’ Contec Airflow, offering its service to the Indian pharma sector for over 17 years, is a known name for completing and handling over the project as per the technical requirements and within timeline.

Mukesh Sehgal, Managing Director, Contec Airflow, talks about the company’s business strategies to Usha Sharma

Contec Airflow is involved in offering large centralised air conditioning and cleanroom projects. Tell us more about the company’s ongoing business activities.

Our main focus have been on the HVAC (heating, ventilating, and air conditioning) projects especially cleanroom applications. In cleanroom also, the major focus segment is pharmaceuticals, however, there have been a large number of requirements from thermal/ hydro power plants, dairy plants, logistics warehousing, cold storage, textile (spinning, quench, take up areas), digital printing etc. As production machines are getting more sophisticated, HVAC requirements is becoming necessary.

Contec has been serving the Indian pharma industry since the last 17 years. What changes did you see?

Clients have become very knowledgeable which in turn

highly regulated one.

Which regulatory requirements do you adhere to?

We follow ISO 14644-1, 2, 3, and 4 guidelines for all our HVAC system designs and its validation. As far as process layout it is the prerogative of the client.

makes them very demanding.

Their main focus is on compliance to the WHP cGMP / US FDA guideline.

Everyone wants the best of the facilities.

The pharma industry is a

Contec is specialised in turnkey air handling system. Tell us more about it Our main focus is on the design and build jobs. We focus on the industrial applications which provide design challenges in the system. Not that we don’t do routine jobs like hotels, offices, shopping malls etc. but these applications does not provide the required challenges/ excitement at the time of commissioning. We are working on design for hydro power plants which are 300 ft below the ground in a tunnel. We are implementing projects requiring humidity as high as 90 per cent RH and as low as 10 per cent RH and temperature ranging from

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+40° C to -30° C. Class of cleanliness from pure ventilation system to class 100 applications, from oral solid dosages to class B/A sterile areas.

Why clean room needs to have air conditioning?

In a cleanroom application, HEPA filters are part of the air filtration sequence. These filters are nonwashable and throw away type. If the area is not air conditioned then we will have to have 100 per cent fresh air system. If it is 100 per cent fresh air system, then HEPA filters will get choked in about three to six months of time. This will increase the operating cost.

As the temperature increases, the disturbed state of motion (entropy) of the air increases. If the area is not air conditioned, the movement of dust particles is higher as compared to the air conditioned area. This higher energy levels or disturbed state of motion makes it difficult to maintain the class of cleanliness.

Tell us about the regulatory requirements in maintaining the air conditioning temperature?

The temperature to be maintained in purely guided by the process requirements and dress codes of the operators.

How critical it becomes in the pharma industry if the humidity is not maintained and And how adverse will it be?

Maintaining humidity is very critical.

If the humidity is not maintained, quality of products suffers. This can have serious impact on shelf life, fungal/bacterial growth and end performance of product. Humidity levels are purely guided by hygroscopic nature of the product and it is very important and critical to maintain humidity as per product requirements.

Which are your major products and how does it work?

Our company’s main thrust area is projects and to complete a project, major equipment used are ◗ Air handling unit ◗ Pre fabricated ducts ◗ Terminal HEPA filters ◗ Chillers ◗ Cleanroom partitions ◗ Paintings and floorings

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◗ Building management system ◗ Cleanroom equipment (Pass boxes, laminar airflow, dispensing booth, air shower etc.)

Some of the products are manufactured by us and the other products are made in our associates factory as per our specifications.

How many projects have been commissioned in the pharma sector?

In the industry on the whole, I’m not sure about the number of projects getting executed. We normally execute between 15-20 pharma projects in a calendar year.

Where do you see the Indian pharma industry in next two years and how it will help to accelerate company's growth?

With regulatory authorities getting stricter, latest guidelines getting very comprehensive, manufacturers have to upgrade their existing facility. Therefore, the growth of pharma industry is phenomenal and the opportunities are immense. It is not about taking projects, it is about completing and handling over the project as per the technical requirements and within the timeline.

Whom do you consider as a major client and why?

Intas pharmaceuticals, ITC and ONGC petrochemical additives [OPAL] are some of the major clients for whom we are executing projects.

Right now they are major clients because they give us large size projects on a continuous basis i.e. one after the other.

Tell us about the company's future plans.

The company wants to focus on energy efficient design i.e as per green building codes and guidelines.

Major operating cost in any pharma plant is power cost. With our design and calculation, we mainly focus to reduce the energy consumption. We have various equipment and design to achieve this goal. We are planning to have in-house manufacturing for cleanroom partition, cleanroom equipments and upgrade / update the existing facility for AHU and filters.

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u.sharma@expressindia.com

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CASE STUDY

MUPS specialist Acino trusts in Romaco Innojet Kai Koch, Engineering Manager, Romaco Innojet, in this case study highlights how Romaco Innojet machines, with its air flow bed technology, have enhanced production at Acino Pharma’s Liesberg facility ACINO, THE Swiss pharmaceutical producer, has trusted in Romaco Innojet technologies to make its MUPS tablets ever since 2004. Five processing machines in the VENTILUS series are currently used to coat micropellets at Acino’s Liesberg facility.

There is a steadily growing demand worldwide for innovative oral release forms.

The backdrop is breathtaking, about 20 miles south of Basel, surrounded by the mountains of the Swiss Jura, is the site of Acino Pharma’s Liesberg production facility.

The Acino Group, headquartered in Aesch, is specialised in the development and production of complex galenic formulations. The manufacture of pharmaceutical solids with delayed API release is one of the Liesberg plant’s core competencies. Around 1.5 billion tablets and capsules currently leave the factory every year.

“In spite of this, our capacities here are not yet exhausted and our international target markets are growing at exponential rates. That’s why we’re planning to double our volumes in the medium term,” explains Christophe Dohr, Pharmaceutical Production Head Liesberg, Acino Pharma.

Acino Pharma presently employs some 110 staff in Liesberg, with production in

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Acino production VENTILUS

KAI KOCH, Engineering Manager, Romaco Innojet

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The Acino Group, headquartered in Aesch, is specialised in the development and production of complex galenic formulations three shifts, five days a week. The majority of the output is destined for licensees both in Switzerland and worldwide. Acino’s portfolio at the Liesberg

the sustained-release coating of the micropellets. All of these criteria help improve patient compliance.

The demand for MUPS formulations has risen steadily in the last few years for these diverse reasons. In particular, tablets are a dosage form to which most patients are already accustomed. Acino was among the first to recognise this trend and position itself accordingly. Today, more than 90 per cent of all pellet batches are pressed into MUPS tablets.

“Acino specialised in the manufacture of MUPS tablets over a decade ago. The highly complex production process has been continuously improved ever since and we’re now in a comfortable situation where we can deliver premium quality at attractive unit costs,” Dohr emphasises.

Two-stage coating process

Romaco Innojet Rotojet

site comprises oral drugs for treating cardiovascular disorders and Parkinson’s disease as well as various narcotic substances. So-called MUPS tablets form the mainstay of its business.

MUPS and their many advantages Multiple unit pellet systems, or MUPS for short, are a dosage form consisting of coated API pellets, which are mixed with microcrystalline cellulose and pressed into tablets. Their main characteristic is the controlled release of the active ingredient, which is achieved by applying a functional coating to the pellets. The medication is absorbed in the intestine once the tablets have dissolved in the stomach. Since the tiny pellets pass through the digestive cavity rapidly and unhindered, MUPS tablets do not necessarily have to be taken on an empty stomach. They can also be halved without losing their therapeutic efficacy. Cutting the tablets in two does not damage

Before being pressed into tablets, the pellets undergo a two-stage coating process in which their weight is more than doubled. Neutral pellets made from glucose are used as starter particles. In the first step, the active pharma ingredients are applied one layer at a time, followed by the sustained-release coating. This process takes several days, during which the diameter of the pellets increases from approximately 300 µm to 1000 µm (micrometres). The micro format gives a good idea of the complexity involved.

Since 2004, Acino has trusted in the air flow bed technology originally developed and internationally patented by Dr h.c. Herbert Hüttlin to build up these pellets. Five Romaco Innojet production machines in the VENTILUS series are installed at Acino’s Liesberg facility together with a pilot system of the same type, which is used for research and development. The containers of the production scale machines have a capacity of 800 litres and are designed to handle batches weighing up to about 600 kg.

Despite its sheer physical size the technology saves valuable space on the production floor. “The air flow bed unites all the processes which are necessary to build up API pellets and granulates in

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Acino has an in-house test laboratory in Liesberg with air flow bed systems for laboratory and pilot trials.

Many customers take advantage of this opportunity to test their formulations during the development phase

Acino Liesberg site

one system,” confirms Michael Tewelde, Team Expert Granulation, Acino Pharma. “Alternative technologies would need a much bigger footprint, not to mention the additional storage capacity.”

over down between ten and fifteen percent, saving further time and money.

Air flow bed technology The process air used for the air flow bed is controlled by the special booster – an ingenious container bottom consisting of overlapping circular plates. The homogeneous flow conditions which are created in this way result in a spiral, orbital product flow. The process air causes the pellets to hover, so that gentle intermixing is guaranteed and particle collisions or friction are avoided. The speed of the pellets and the distance travelled are clearly defined. The evaporation rate can therefore be calculated precisely and the dose rate adapted to match. The coating material is sprayed into the product from below by a central bottom spray nozzle. This nozzle is designed with a rotating spray head which prevents the annular spraying gap from

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Acino’s Liesberg lab

Acino MUPS sample

becoming blocked. The gap has an adjustable width, enabling the droplet size to be varied. In addition, the spray angle can be set exactly by means of the spraying and support air and there is virtually no measurable spray loss.

The pellets pass through the liquid film regularly. Be-

fore the next coating is applied, they must be sufficiently dry for the product not to be over-wetted. The spray rate can be adjusted to rule out unwanted agglomeration due to the carrier dissolving.

“The Ventilus technology lets us regulate moisture extraction absolutely accurately;

that way, the pellets are built up homogeneously with only a very small standard deviation,” Tewelde continues.

“They’re spot on in terms of quality and process efficiency.” Owing to the selective application of the suspension, Acino’s consumption of raw materials and coating is more-

Acino has an in-house test laboratory in Liesberg with air flow bed systems for laboratory and pilot trials. Many customers take advantage of this opportunity to test their formulations during the development phase. Scale-ups from pilot to production are a regular event there on a VENTILUS V 200. Video cameras which show the product movement directly on a screen are installed in all Innojet systems to permit the coating processes to be monitored. The operator can thus keep a close watch on the batch process at all times and intervene immediately if necessary. And for interested customers, it’s a unique chance to see the MUPS coating technology live in action.

P-MEC INDIA 2015 SPECIAL

INSIGHT

Innovations in cleanrooms and environmental monitoring Dr Tim Sandle, Head, Microbiology at Bio Products Laboratory and visiting tutor at the Department of Microbiology, University of Manchester, UK discusses some innovations relating to cleanroom and clean device operations, together with personnel control and environmental monitoring

PHARMACEUTICAL manufacturers of both sterile and non-sterile products, and medical devices, are required to demonstrate that manufacturing processes and procedures minimise any potential contamination to the product from the manufacturing environment. Contamination can arise from a number of sources: water, air, surfaces and personnel, each of which poses a potential risk to product.

These risks of contamination are avoided by putting environmental controls in place (through correct grade of airsupply, satisfactory cleaning and disinfection practices and

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❑ Ideally, a mock-up of the cleanroom should be constructed. This is particularly important for testing the process, product and personnel workflow. In terms of understanding contamination control it is essential to understand what objects are passed from one class of cleanroom to another.

so on). Where controls cannot off-set every contamination risk, and also as a means to demonstrate the level of control, environmental monitoring programmes are devised and put into action(1).

The primary protection from contamination is through well-constructed and maintained cleanrooms. This is supported by trained personnel, following strict gowning protocols, and cleaning and disinfection(2). Once environmental control has been accomplished, verification is undertaken through environmental monitoring (for both particulates and viable microorganisms).

Modular cleanrooms and bespoke design

Cleanrooms Cleanrooms and clean air devices are typically classified according to their use (the main activity within each room or zone) and confirmed by the cleanliness of the air by the measurement of particles. The primary objective of cleanrooms in pharmaceutical processing is to minimise and control microbial and particulate contamination. There are many sources of contamination. There are four principles applying to control of airborne microorganisms in cleanrooms. These are(3): ❑ Filtration (through the use of HEPA filters). The air entering a cleanroom from outside is filtered to exclude dust, and the air inside is constantly recirculated through HEPA (High Efficiency Particulate Air) filters (alternative filter are ultra-low penetration air (ULPA) filters). This is controlled through a HVAC (Heating, Ventilation and Air Conditioning) system. ❑ Dilution (to ensure that particles generated in cleanrooms, in addition to those which pass the filters, are carried away by diluting the area with new “clean” air). ❑ Directional Air Flow (to ensure that air blows away from critical zones, as particles and microorganisms can-

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not “swim upstream” against a directional air flow). This is achieved through pressure differentials. ❑ Air Movement (rapid air movement is important for as long as particles and microorganisms stay suspended in the air they are not really a problem, for it is only when they settle out that they become an actual cause of contamination).

Innovations with cleanrooms There have been several advancements or changes in approach relating to cleanrooms.

These include the use of modular cleanrooms and studies in energy efficiency, designed to make cleanrooms cost effective whilst still maintaining contamination control principles.

Cleanroom design Modern approaches to cleanroom design is aimed at ensuring that the cleanroom is designed at optimising contamination control. It is important to dedicate time in designing cleanrooms and the equipment located in clean-

rooms for, if there is a design fault in one part, this will affect the items of equipment and if there is a fault in conception stage this will be expensive and time consuming to rectify.

For cleanroom design, modern approaches utilise Computer Aided Engineering software for the design process, such as Building Information Modelling (BIM) software.

Such software covers geometry, spatial relationships, light analysis, geographic information, quantities and properties of building components (for example manufacturers’ details)(4). Systems, assemblies and sequences can be shown in a relative scale with the entire facility or group of facilities.

When designing modern cleanrooms, the following approach should be adopted: ❑ The type and function of the cleanroom should be established. This should include the required cleanroom grades or classes and how cleanrooms of different grades will interact (including requirements for air-locks and pressure cascades).

❑ The most important aspect is drawing up the process flow.

Here the cleanroom management, together with engineers and quality assurance personnel, should map the path that equipment, product and operators will take in the cleanroom. ❑ Established quality risk management tools like HACCP (hazard analysis and critical control points) or FMEA (failure modes and effects analysis) can be used for this purpose. Areas which pose a contamination control risk should be noted and attempts should be made to design these risk areas out (the principles of quality by design). Other considerations can also be included at this stage, including whether there is adequate clearance under door frames for equipment to pass through. ❑ In the design, there should be sufficient space for equipment and connections. ❑ The cleanroom should be constructed from a material which is compatible with different cleaning and disinfection solutions.

Modular cleanroom are cleanrooms that are assembled from prefabricated modules.

This process of cleanroom construction differs from standard (or 'common') cleanrooms in that: ❑ Common cleanrooms are assembled at the construction site from many elements ❑ For modular cleanrooms a significant part of assembling works is done at the factory that produces modules. Only assembling of complete modules remains for the customer’s site.

Common cleanrooms are tailor made cleanrooms. Their design follows specific layouts that are drawn by the technologist from understanding specific processes. Whereas modular cleanrooms are often designed to fit into existing spaces. With modular cleanrooms other restrictions can appear. This is because the cleanroom construction process is separated into two parts, which are executed in two different places: the modules manufacturer and the customer’s site. This can present certain difficulties in terms of transport and later assembly (5).

Antimicrobial coatings Some types of equipment and surfaces can be manufactured with antimicrobial coatings.

One example is the incorporation of silver or copper which are effective against a range of micro-organisms. An advantage of silver ions, for example,

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is that although they have antimicrobial properties, silver is rarely toxic against human cells. Examples of the application of silver include implements like forceps. Also in relation to surfaces, the incorporation of wipeable surfaces onto equipment allows for the easier cleaning and disinfection. Some of these innovations include polythene covered computer keyboards.

Energy efficiency Cleanroom technologies are not only directed towards contamination control. The energy efficiency of cleanrooms is currently of great importance for companies who wish to save costs and to reduce the

amount of carbon generated.

To address this International Standard ISO 14001, which describes environmental management and practices and EN 16001, a European energy standard, are becoming increasingly used (both standards are likely to be amalgamated into international energy standard ISO 5001). Despite the appeal of controlling energy consumption, care must be taken when adopting such standards in relation to contamination control for actions to alter the operation of HVAC (heating ventilation and air conditioning) parameters can have an impact upon the level of non-viable particles and viable counts. Therefore microbiolo-

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gists should always be involved in any energy saving projects.

Barrier technology The use of barrier technology protects critical cleanroom operations. Within many cleanrooms unidirectional airflow (UDAF) units are found. A UDAF is classified as a minienvironment; an alternative term is ‘separative devices’ (separative devices range from open to closed systems and include isolators and Rapid Access Barrier Systems (RABS)). These are localised environments created by an enclosure to isolate a product or process from the surrounding environment.

The advantages in using a minienvironment include the

following: ❑ Minienvironments may create better contamination control and process integration. ❑ Minienvironments may maintain better contamination control by better control of pressure difference or through the use of unidirectional airflows. ❑ Minienvironments may potentially reduce energy costs.

Of these types of micro-environments, the most widely used for contamination control in relation to aseptically filled products are isolators.

Isolators intended for aseptic processing are required to be operated under positive pressure and are subjected to decontamination process be-

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fore start of the batch processing. Modern isolators more often use vapourised hydrogen peroxide, although alternatives are available including peracetic acid or chlorine diox(6). ide These methods can also be deployed for the decontamination of cleanrooms.

The key principles for isolator use are (7): ❑ The air exchange between the isolator and with the surrounding environment must occur only through a microbial retentive filter such as HEPA or /Ultra Low Penetration Air (ULPA). ❑ The positive pressure aseptic processing isolator must be decontaminated in a repro-

We from Optima Pharma are convinced: A demanding customer should never have to settle for mediocre solutions and - above all - not when it comes to safety and hygiene.

This is why we plan, develop and design filling lines that keep all the options open – regardless where your machine will produce.

p-mec India | December 1–3, 2015 | Mumbai | India Hall 6 | Booth # E 28

OPTIMA pharma GmbH 74523 Schwaebisch Hall | Germany | www.optima-pharma.com OPTIMA India Packaging Machines Pvt. Ltd. Unit 110, 1st Floor, Brigade Rubix | Plot No. 20, HMT Main Road Bangalore - 560 013 | India | +91-80- 29724090 | www.optima-ind.com

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ducible and quantifiable manner to ensure the sterility assurance level of 10-6. This is assessed through the use of biological indicators of a suitable population, species and resistance. For vapour phase hydrogen peroxide systems, geobacillus stearothermophilus is normally used. ❑ Entire activity / handling of materials inside an isolator shall be achieved remotely; any part of human body cannot enter the isolator. ❑ Asepsis shall be maintained for each unit operation and for material transfers. Any material entering the isolator must either be decontaminated inside the isolator or shall be sterilised and taken inside via a rapid transfer port.

Disposable sterile plastic technology A major advance with cleanroom technology is with singleuse sterile disposable technologies. Such technologies have reduced risks by allowing organisations to move away from equipment which needs to be sterilised (such as stainless steel vessels). It also negates the need to use consumables that are recycled or which present a risk with their transfer into cleanrooms, to disposable and single-use sterile items. The advantages of this technology is that it eliminates the need for cleaning, eliminates the need for the pharma company to perform in-house sterilisation, reduces the use of chemicals, reduces storage requirements, reduces process downtime and increases process flexibility, and avoids cross contamination. Single-use items are typically sterilised using gamma rays (electromagnetic irradiation), which kill microorganisms by destroying cellular nucleic acid(8).

Aseptic connectors A variant on single use technology is the aseptic connector.

Innovations in aseptic connec-

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tion technology have led to the development of single use connector systems. These are based on the so-termed alphabeta principle which allows the connection to be performed in an environment this does not require unidirectional airflow or other capital equipment to maintain sterility.

Disposable holding devices Plastic technology has also led to an array of sterile plastic holding devices. An example is with disposable mixing systems. These can be connected to capsule membrane filters and a hold bag. These interconnected disposable systems have a considerable advantage in that they are gamma sterilised and ready to use.

Garments Given that people are one of the primary sources of microbial contamination in cleanrooms (through shedding of skin flakes, many of which contain microorganisms), attention has been paid to gowning.

While behaviours and techniques for gowning can be addressed through training and procedures, aspects of the

gown design require attention.

Manufacturing gowns using continuous strong fibres of pure high-density materials, like polyethylene, fabrics can be constructed that are low linting and free of inherent contaminants that could represent a risk in critical environments. Cleanroom managers are more often requesting certification for gowns to show that they are low in particulates. For gowns that are relaundered, stipulating the maximum number of times that a gown can be washed and irradiated is important.

Polymeric flooring A risk to cleanrooms arises from personnel transferring contamination into the area via footwear or through equipment transfer (such as trolley wheels). One way to minimise contamination is to use special mats which are designed to remove dirt, particles and micro-organisms. Where such mats are used they have traditionally been sticky-mats. Although these are fairly effective, more efficient contamination control can be achieved from polymeric flooring.

Polymeric flooring is an especially designed ‘plastic’ which works through electromagnetic forces causing particles to be attracted from surfaces like footwear, and retained on the surface of the mat. This mechanism ensures that any contamination residing on the mat is not passed back onto the personnel who walk across it.

Monitoring technologies The most significant advancement with microbiological monitoring methods has been the advent of Real Time LaserInduced Fluorescence Systems. These instruments continuously monitor both inert particulates and viable microorganisms in real time.

They are very sensitive, where the limit of detection can be down to 1 microbial cell. It provides both total particulate and viable counts.

The instruments are based on optical spectroscopy. This is an analytical tool that measures the interactions between light and the material being studied. These instruments work by elastic light scattering.

This measures two things (9): Particle counts: where the size of a scattering particle, as it passes through a light beam, is comparable to a certain wavelength of light. The intensity of the scattering is dependent upon the size of the particle. Such systems will detect and quantify particles within a 0.5 to 20 um range.

Microbial counts: a 405 nm laser that intersects the particle beam, so that as a particle passes through the inelastic scattering measures the intrinsic fluorescence of the particle, from the metabolites (such as NADH and riboflavin) inside microorganisms.

There is a growing trend within the pharma industry towards the use of Process Analytical Technology (PAT). The goal of process analytical technologies (PAT) are to improve consistency of product quality, provide "right first time" manufacturing (to reduce costs and reduce cycle time), reduce the regulatory delays associated with changes in manufacturing, and improve the safety of chemical processes. PAT could also be used to reduce the endof-line laboratory testing. The ‘real time’ counters fit well with this paradigm.

With more classical environmental monitoring methods (the use of agar plates), it is now commonplace to be able to track the use of the media through barcoding. Scanning bar codes allows the information about the plate, such as the media batch number and expiry time, to be transferred to a Laboratory Information Management System (LIMS).

To ensure that the sample is not at risk to adventitious contamination, several types of Petri dishes now come equipped with lockable lids.

Environmental control Arguably the most important aspect of environmental control in a cleanroom is the control of airborne particulates as

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this is a direct indicator of cleanroom contamination. Particles in the air are measured through particle counters. The most efficient means of monitoring particles is by linking particle counters to a facility monitoring system (FMS). It is consist of discrete particle counters, each with individual pumps, and the data is sent using wireless ethernet to a central data capture system. Modern particle counters have the advantage that they meet the more rigorous demands of the new international standard for particle counter calibration (ISO 21501). In the event of a

counter breakdown a spare counter can quickly replace the malfunctioning counter due to ‘plug-and-play’ features and the particle counting software will record the serial number for audit purposes.

This feature is important for aseptic filling where continuous particle counting is a GMP requirement.

REFERENCES 1. Sandle, T. and Saghee, M.R. (2013). ‘Cleanroom certification and ongoing compliance’. In: Sandle, T. and Saghee, M.R. Cleanroom Management in Pharmaceuticals and Health-

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care, Euromed Communications: Passfield, UK, pp169-184 2. Sandle, T. (2012a). ‘Application of Disinfectants and Detergents in the Pharmaceutical Sector’. In Sandle, T. (2012). The CDC Handbook: A Guide to Cleaning and Disinfecting Cleanrooms, Grosvenor House Publishing: Surrey, UK, pp168197 3. Halls, N. (2004): ‘Effects and causes of contamination in sterile manufacturing’ in Halls, N. (ed.): Microbiological Contamination Control in Pharmaceutical Cleanrooms, CRC Press, Boca Raton, pp1-22 4. Sandle, T. (2013). Application

of Quality Risk Management to cleanroom design, Clean Air and Containment Review, 13, pp24-25 5. Sandle, T. (2014) Modern Approaches to Pharma Cleanroom Design, Controlled Environments, 17 (1): 8-10 6. Mau, T., Hartmann, V., Burmeister, J., Langguth, P. and Häusler, H. (2004) Development of a sterilizing in-place application for a production machine using Vaporized Hydrogen Peroxide, PDA J Pharm Sci Technol.

58(3):130-46 7. Midcalf, B, Neiger, J. and Sandle, T. (2013). ‘Fundamentals of pharmaceutical isolators’. In: Sandle, T. and Saghee, M.R.

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(Eds.) Cleanroom Management in Pharmaceuticals and Healthcare, Euromed Communications: Passfield, UK, pp185-226 8. Sandle, T. and Saghee, M.R. (2012). “Application of Sterilization by Gamma Radiation for Single-Use Disposable Technologies in the Biopharmaceutical Sector”, Pharmaceutical Technology, Supplement: Bioprocessing and Pharmaceutical Manufacturing, May 2012, S20-S27 9. Sandle, T. (2012b). Real-time counting of airborne particles and microorganisms: a new technological wave?, Clean Air and Containment Review, Issue 9, pp4-6

NEWS

Werum ITSolutions and Sarla Technologies sign MoU Partnership will help in delivering MES projects in India

WERUM IT Solutions, a leading supplier of manufacturing execution systems (MES) and manufacturing IT solutions for the pharmaceutical and biopharmaceutical industries and Sarla Technologies jointly announced a memorandum of understanding to partner for delivering MES projects in India.

Sarla Technologies will become an official partner for Werum’s PAS-X MES throughout India providing project control and Werum’s PAS-X MES enables pharmaceutical facilities to run manufacturing processes completely paperless at the highest level and to be compliant with international GMP guidelines and

Sarla Technologies will become an official partner for Werum’s PAS-X MES throughout India providing project control and Werum’s PAS-X MES enables pharma facilities to run manufacturing processes completely paperless at the highest level FDA regulations. The requirements of the pharma industry are directly addressed by Werum’s out-of-the-box solution without any need for expensive and time-consuming customisation. Based on stan-

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dard functionality and best practice content, pharma manufacturers will be able to have the number one global MES solution up and running in a very short.

“We are pleased that Sarla

Technologies will join us as a partner to expand our presence in India and to leverage their great experience and track record in the Indian pharma industry and also in automation and process con-

trol for projects requiring complete integration with machines and equipment,” says Lars Hornung, Senior Director Global Sales, Werum IT Solutions.

Anil Mehta, Chief Executive Officer, Sarla Technologies adds, “Our partnership with Werum enables multinationals and leading local pharma companies in India to gain full advantage of MES. PAS-X and Werum’s expertise along with Sarla’s Level 2 integration and automation know-how will tremendously help them to increase productivity and meet global regulatory requirements.”

EP News Bureau-Mumbai

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PROFILE

The UEC: Leaders in pharma packaging machinery manufacturing since 1963 THE UNITED Engineering Company (UEC) with the brand name 'UNITED' is known for being the pioneer and commander in packaging machinery manufacturing in India.

UEC, which was started in 1963 by GD Roy, from the beginning, attained a high reputation in providing machines and services of highest standards with utmost care. With the founder's innovative ideas and unmatched leadership qualities, UEC crossed various boundaries in different fields of work.

Initiating the business with solutions for parenterals (ampoules and vials), UEC has diversified its business into the bottle packaging sector and has also mastered in providing machines for automatic tablet coating. UEC also provides customised solutions for its customers.

With a vision to provide the best pharmaceutical manufacturing technology, UEC has also ventured into different industries such as distilleries, cosmetics, foods and beverage, paints, chemicals, home care, office and student stationery and others.

The company has also expanded its footprints abroad in a large way. Today, 'UNITED' machines are exported to more than 21 countries across the globe namely the US, Canada, Bolivia, Nigeria, Kenya, United Arab Emirates, Iran, Sri Lanka, Bangladesh, Malaysia, Indonesia, Vietnam, Korea and others.

UEC puts in a lot of effort for their research and development and strives to provide the best and optimised solution to its customers. By virtue of dedication and continuous hard work of their

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R&D team, 'UNITED' machines provide technically advanced solution for its customers.

Presently, UEC is having its head office at Kolkata. It has three manufacturing units in West Bengal, covering an area of over 10000 sq ft. UEC is having another office at Mumbai along with a service station.

The United Engineering Company has been honoured by the prestigious ‘Innovator’s Award’ from the Indian Pharmaceutical Congress for their innovation and development.

Today, at UEC, machines are equipped with the latest technology. For its customers,

UNITED machines are cost effective but are guaranteed with the highest quality, optimum production and ensured unconditional service.

UEC is equally focused on being a corporate citizen. It has never shirked the responsibility of the society and has always been an active participant in numerous social events which help in uplifting the quality of living of the deprived.

With almost every pharma formulation manufacturer being an 'UNITED' machine user coupled with over 50 years experience, UEC commits in becoming better than the best in the near future.

Founder: GD Roy (R)

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P-MEC INDIA 2015 SPECIAL

NEOMACHINE MFG.CO.: Aleader in automatic coating technology Kolkata-based Neomachine MFG CO was started in 1973 with an objective of manufacturing all types of pharmaceutical machinery.

For a decade, the company catered to the requirements of the Indian pharma companies in injectable, liquid, tablet, capsule and ointment sections machinery.

'While catering to this market segment, Neomachine happened to come across a Kolkatabased pharma producer, who were facing problems in film coating of tablets. Until then, the tablets were being coated in conventional pans, which were not only causing health hazards to the coating personnel, but was also a time consuming process. Inspired by this opportunity, Neomachine started the process of developing an auto-

matic coating machine in the right earnest. After, two years of research and development, the first 'Neocota Automatic Coating System' was manufactured in 1984.

During the last three decades, Neomachine manufactured and marketed over 550 machines, out of which 100 machines were exported to the countries like the US, Australia, China, Jordan, Yemen, the UAE, Uganda, Kenya, Sudan, Cyprus, Saudi Arabia, Austria, Brazil, Bangladesh, etc.

Neomachine, a professionally managed organisation now has two manufacturing units in Kolkata, which are equipped with state-of-the-art equipment like fabrication, machining, assembling, finishing and other related jobs.

The company has been

Anup Maitra, Managing Director, Neomachine

strictly following all the quality control guidelines during manufacturing. The bought-out items are inspected at the manufacturers' works periodically.

The company has dedicated team of engineers for providing erection and commissioning and prompt after-sales service

to the clients.

The in-house R&D facility is abreast of the latest technology upgradation and the latest developments in 'coating technology'. This helps in continuous improvement of the product.

Neomachine also provides DQ/IQ/OQ/PQ qualifications for automatic coating system and are in the process of getting CE Certification.

Over the years, the company has gained vast experiences in manufacturing ‘automatic coating system’ by interacting with various Indian and multinational pharma and confectionery units based in India.

Products like Cadbury India’s fast-moving product ‘Gems’ and Parke Davis’ ‘Chicklets’ are coated in the systems manufactured by Neomachine.

The company also impart aque-

ous and non-aqueous film coating and sugar coating technology to clients, who need the same expertise.

Neomachine also supplies Hepa Filter for filtration of incoming drying air and mobile bed wet scrubber for purification of exhaust air, for these companies that need these items.

Neomachine, being a singleproduct company, manufacturing various models of Neocota.

The automatic coating machine, gained vast experience in coating technology since the last two decades. Neocota is designed to comply with current US FDA and other international legislation as well as anticipated trends. The improved and flexible design enables Neocota to perform in national and overseas environment without any system modification.

PHARMA LIFE

DR SHRI THANEDAR

THE SPUNKY ENTREPRENEUR From a small town boy in India to US millionaire, Dr Shri Thanedar’s journey to success is a saga of grit and gumption which would continue to inspire entrepreneurs in the times to come

BY SACHIN JAGDALE “Listen to the mustnt’s, child, Listen to the don’ts Listen to the shouldn’ts The impossibles, the won’ts Listen to the never haves Anything can happen, child, Anything can be”

T

hese lines by Shel Silverstein, American poet, singer-songwriter may have inspired Dr Shri Thanedar, CEO, Avomeen Analytical Services, as he embarked on his educational and entrepreneurial journey to the

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US, from a small village in Belgaum in Karnataka, India. His life is a reflection of a journey that is filled with emotions, tragedies, struggles, celebrations and success. Today, Thanedar is one of the most sought-after analytical service providers in the US pharma and chemical industry.

Back to the beginning Like many young ambitious students, Thanedar too dreamt of pursuing his education in the US. However, unfortunately he was denied the

visa four times as he did not have the requisite bank balance and enough property to convince the US consulate that he will return to India after completing his education.

Thankfully, after a lot of trials and tribulations, he somehow got the visa in 1979 and started pursuing his PhD in polymer chemistry at the University of Akron.

Thanedar’s life in the US was tougher than his experiments in the chemistry lab. In the initial days, he did not even have a place to reside. So he

used to conduct experiments throughout the day in the laboratory and sleep there itself (going against the set protocols). He recalls an incident when after performing experiments till late in the night,

was unable to wake up early the next morning and unfortunately his professor saw him sleeping in the seminar room.

He had to literally run with his sleeping bag from there.

Overcoming all the difficul-

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place she did not have an efficient customer service. So, he decided to improve customer service and tried to deliver work as fast as possible. While speaking about how he managed to generate more revenue at Chemir, Thanedar elaborates, “The problem with Craver was that her focus was infrared spectroscopy. I decided that Chemir was not going to concentrate on just one technology. We had to encompass the entire spectrum of the available technological facilities. Therefore, I expanded on technologies like nuclear magnetic resonance spectroscopy, liquid chromatography, mass spectroscopy, TGA, DSC and a lot of other technologies as well, so that we can solve a wide variety of problems. As our customer service vertical improved, the company also started growing faster. From a revenue of $150,000 in 1990 it gradually grew to $4 million in 2000. In 2000, I bought another company called Industrial Testing Laboratories, located in St Louis Missouri, the same town as Chemir. At that time, this company was not faring too well, I merged it with Chemir.”

AWARDS CONFERRED TO THANEDAR ✦ Ernst and Young "Enterprenuer of the year", 1999 ✦ Outstanding Teaching Assistant, 1981, University of Akron ✦ "Overseas Business Person of the Year", Government of India, 2000 ✦ "Inc 5000 Fastest Growing Company", Inc. Magazine, 2015 ✦ "Outstanding Entrepreneur" White House,Washington DC, 2001 ✦ "Fast 50 Growth Companies" Regional Chamber of Commerce, St. Louis Missouri, 2000, 2001, 2002, 2003, 2004, 2005

ties, in 1982, Thanedar got his PhD and after that he pursued two years of post doctoral research at the University of Michigan. From 1984 to 1990, he worked as a scientist in a chemical company called

Petrolite.

Being an entrepreneur His entrepreneurial journey began after his stint with Petrolite. He informs, “In 1990, I decided to start my own busi-

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ness, and in the same year, in October, I purchased a company called Chemir for $75000 from Dr Clara Craver. It was a small enterprise and had only three employees. The revenue generated was only $150,000.

Interestingly, I had purchased the company at a loan of $50000 from a bank and Dr Craver also offered me a loan of $25000. On my credit card, I had $3000 which I used as working capital. Thus, technically speaking, I did not start

a business then, I acquired a business,” explains Thanedar.

Chemir was a service company which primarily were into non-pharma activities.

The pharma work was hardly 10 per cent. If anything went wrong with any product, Chemir used to conduct chemical testing and discerned the problem.

Charting out Craver’s business model, Thanedar observed that although she had a sound technology system in

The ‘fix it’ guy The company was earning substantial profits and in 2003, its revenue was around $8 million. When Thanedar did a revenue analysis, he was surprised to find that revenue worth $1 million came from pharma testing and the rest came from the chemical sector. Interestingly, this was despite the fact that Thanedar had never marketed the services to the pharma industry.

At this time, he never realised that he had become famous in the chemical industry as a man ‘to go to’ whenever any company would fall short of resources and expertise.

Pharma industry too was not an exception. In fact, there were quite a few instances where tricky chemical problems faced by pharma companies have been resolved by Thanedar.

An instance that deserves a mention is that of an aspirin manufacturer who encoun-

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tered a problem where aspirin tablets started showing small black specks. Customers were unable to find out what went wrong despite having in-house lab. These black specks were tiny in dimension and could be seen only under a microscope.

They came to Chemir and inquired whether the company could identify the problem and suggest a solution to eliminate the contamination. Thanedar explains how he resolved the problem. “We used a sophisticated technique called infrared spectroscopy that has microscope attached to it. We obtained a chemical finger printing of that black particulate material. With proper analysis we inferred out that the contamination was chemically equivalent to rubber. Not only this, we also identified that there were a large rubber gaskets used at the manufacturing plant, some of which were degraded and were the source of that black contamination.”

He narrates one more episode where a contact lens solution provider noticed that a batch of his eye drops started causing eye irritation. “The company told us to do reverse engineering of good product and bad product and find out what is causing eye irritation.

We solved this as well. In fact, we did a lot of similar work.

There are not many companies like us which can do investigational work for the pharma industry. Most of the pharma companies had routine labs.”

Thanedar’s erstwhile home in Belgaum

Birth of Azopharma Looking at the prospects offered by pharma business, in 2003, Thanedar split Chemir in two companies. While one remained Chemir, the other became Chemir Pharma Services which later became Azopharma. However, getting into the pharma business was not a cakewalk. .

He informs, “In the case of Azopharma I decided to grow through both acquisitions and organic routes. There were

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Thanedar’s current home in the US

several small pharma companies that had innovative ideas and scientists but were lacking resources to reach up to the final product. This was where Azopharma’s role started. When these pharma companies began approaching me I understood that I could only conduct analytical stud-

ies for them, not studies like animal studies, as I was unable to analyse blood. So, I needed a full service lab to take the molecule from early discovery stage to clinical trials.” With the pharma business growing faster than Chemir, Thanedar approached the Bank of America. Now, he was heading

an extremely successful company, Chemir, a testimony of his business acumen. “I knew that in order to grow my pharma business, I needed to have a lot of investments in place. I needed to buy several equipment as well as acquire smaller companies,” he explained. He managed to get a

loan of $24 million for the period of 2003 to 2008.

Thanedar bought six different companies and merged them with Azopharma. Eventually, Azopharma’s revenue grew from $1 million in 2003 to $55 million in 2008. Azopharma was considered as one of the leading laboratories in the US that take part in drug development. So, till early 2008 everything was going well.

Thanedar was doing very well professionally. He decided to take some time off for nurturing his hobbies as well and dedicating more time towards them. He wrote his first book in Marathi called ‘Hee Shrichi Icchha’, which narrated the tale of his struggles. This book became so popular that the former US President Bill Clinton even requested Thanedar for an English translation so that American youth could get inspired by it. In addition, Thanedar started receiving invitations from different colleges in India and the US to give lectures on entrepreneurship. In the mean time, he started taking more interest in Marathi culture. He used to organise shows of Marathi theater and films in the US. Leading Maharashtrian personalities from different arenas in India frequented his residence in St. Louis. However, somehow Thanedar felt that he could not give much time to Azopharma and he decided to sell it.

“In February 2008, I wanted to sell my pharma company and focus on Chemir.

So I hired a company from Chicago called William Blair who could act as middleman in selling the company. William Blair then started marketing Azopharma to Private Equities (PE) and other strategic pharma companies. They sent out information to 200 odd companies of which 65 had showed interest in purchasing Azopharma. And out of these 65, approximately 21 companies had sent letter of intent to

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purchase Azopharma. They offered approximately in the range of $70 and $90 million.

Even India-based major pharma company was one of the potential buyers,” informs Thanedar.

Thanedar's investment bank suggested him to go back to potential buyers and ask them for their best offers. So out of 21, six buyers responded with a revised proposal that valued from $90 to $132 million. The highest offer came from Boston based PE firm.

They offered $132 million.

Thanedar signed their letter of intent in August 2008.

across the US in a year.

Thanedar informs, “We have some clients in India and Europe but 95 per cent of the clients are in the US. Now Avomeen’s work is a combination of both Chemir and Azopharma. Currently, I also have less loan. So, even if recession comes, I will not get affected like before. My source of funding is my own assets, profits generated out of Avomeen, and minimum bank loans.”

Mentoring young talent

Testing times However, he was unaware that tough times were lying in wait for him. Within two weeks the American economy started going down. Stock market started sliding. Eventually, the highest bidder was unable to arrange the money and withdrew its offer. Yet, accustomed to adversities and struggles in his initial days in the US, Thanedar remained undaunted and decided to face up to the tough times.

He says, “I assured myself that I will run the company again. I will wait for the recession to get over and then will try to sell the company again.”

Though Thanedar’s resolve was strong, the situation appeared grim. Revenues of companies in the US were going down but Azopharma’s revenue was falling much faster.

Azopharma lost almost 60 per cent revenue over a one and half year period. Azopharma suffered to a great extent because of the strategies. He explains, “All the customers of Azopharma were small innovative biotech startup companies that were funded by either venture funding or owned by PE. These companies were involved in early stage drug development. During such recession venture funding dries up because nobody wants to invest in such an economy. Fur-

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ther, early drug development is a long and expensive process.

Companies stopped investing in early stage drugs which was Azopharma’s speciality. Thus, if one wants quick money then one wants to invest in late stage drug development in such a period.”

Azopharma started losing its customers as the focus shifted to late stage development instead of early stage drug development. In addition, it was difficult to predict when the recession will end and the economy would become healthy. Thanedar assumed that most recessions last for months or a year. So he decided to retain his employees. Azopharma had around 400 employees and Chemir had around 80 employees. In 2008, Chemir’s revenue was around $12 million.

However, Thanedar’s optimism was marred by the harsh reality. With time, he had to let go off Azopharma’s CEO. He owed the bank a sum of $24 million. These banks had the rights to acquire assets of such business and sell them to recover their loans.

Bank of America intimated Thanedar to repay his loans. “I

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requested them to have patience and promised to create value again. But, the bank wanted to sell off my assets, which I refused. I did not want my employees to lose their jobs. Bank saw that Chemir was doing well. I had some real estate that was faring well. However, I could not stop the bank anymore and in April 2010 they took all my assets, Azopharma, Chemir etc. So within months, my net worth of hundreds of millions of dollars came to nothing,” narrates emotional Thanedar.

Never say die attitude Though he lost most of his fortune, Thanedar still had some money left with him. However, the risk of the bank taking away even that money was constantly haunting him. Yet, Thanedar was not ready to throw in the towel. He came up with a stronger plan this time.

Thanedar says, “For threefour months I was unsure whether I had the zeal to fight.

But I decided to start another innings and in December 2010, I decided to start a new company, known as Avomeen Analytical Services. I actually acquired assets of a company in

Michigan that had gone out of business.”

It is said that fortune favours the brave. This proved true in Thanedar’s case. In March 2011, the bank found a buyer for Chemir for $23 million. It sold Azopharma for $2 million. They also sold other real estates and recovered a sum of $30 million. It is noteworthy that even in the grim situation, Thanedar’s personal assets remained untouched. This helped him to start Avomeen. “Today, Avomeen is more than a $10 million company with more than 50 employees. I purchased a 25,000 sq ft facility and established it into a modern laboratory. Now my business is growing three times compared to what Chemir used to be. I am thankful that my company is faring well again. I am back again mentoring people. I am writing my second book where my fall and rise will be narrated,” says Thanedar. Thanedar's goal for Avomeen is to increase its revenue to around $100 million in the next three to five years. The company currently serves approximately 300 clients spread

Thanedar strongly feels that it is his duty to encourage young entrepreneurs in their struggles to live up to their own highest ideas. According to him, youth should leave the mindset of doing mundane jobs. They should take risks.

However, these risks should not be blind in nature, they should be calculated risks.

Starting a business requires lot of preparations and ideas.

They should hire efficient resources. Thanedar is not just a role model for young entrepreneurs but he also epitomises Indian talent and potential which will continue to inspire many budding entrepreneurs in India and across the world.

An inspiring persona “The battle of life is, in most cases, fought uphill, and to win it without a struggle were perhaps to win it without honour. If there were no difficulties there would be no success; if there were nothing to struggle for, there would be nothing to be achieved” — Samuel Smiles, Scottish author These words exemplify Thanedar's life and success.

His journey from a small place in Belgaum to a palatial home in the US is a result of strong determination, great resolve, unceasing hardwork, tremendous self belief and perseverance. sachin.jagdale@expressindia,com

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Skilling for sustainable growth Ranjit Madan, CEO, LSSDC, emphasises on the need for skilling workforce in the life sciences vertical to propel its growth

THE LINE dividing ‘demographic dividend’ and ‘demographic debacle’ is thin. Much has been touted about India’s ability to reap the former, endowed as it fortunately is with a young population with an average age below 30, almost 10 years lower than the average age of most other nations. However, this dividend is contingent upon India’s ability to skill its youthful population. The task is challenging. At this point, with under five per cent of its workforce classified as skilled, India finds itself at the bottom of the table in comparison to other nations. Countries like China, Germany, Japan, Australia, the UK, the US, Canada, South Korea boast of between 50 to 97 per cent of their total workforce being skilled.

Skilled work force percentage Somewhere the country has missed a trick in regard to skilling its youth. As PM Modi aptly put it, ‘the best time was around 68 years ago......the next best time is now!’

As the country and its youth look to a new era, replete with ‘Make in India’ and other such energetic campaigns which promise much hope, the challenge of rapidly skilling the workforce remains, debatably, the most challenging task. Life sciences sector, comprising pharma, biotech and clinical research, is no exception. That the sector is a shining beacon, and possibly the only sector which can take pride for already being

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Minister of Skills and Entrepreneurship, Rajiv Pratap Rudy at fifth GB meeting of LSSSDC Key stakeholders and general body members of LSSSDC

in the ‘Made in India’ zone, despite shortage of skilled workforce, speaks volumes. Organisations in life sciences, export to around 200 countries. One in every three tablets sold around the world is ‘Made in India’; one in every three vaccines given to children around the world is ‘Made in India’. No surprise then that India is now called a ‘Pharmacy of the world’. A proud achievement!

The sector needs to press on towards higher value added drugs, with much greater emphasis on innovation. Scaling the ‘Innovate in India’ summit, puts yet greater emphasis on skilling the youth, given that the sector is growing at almost 16 per cent per year. There are myriad issues like inadequate skilling in-

Skilled work force percentage

RANJIT MADAN, Chief Executive Officer, Life Sciences Sector Skill Development Council (LSSSDC)

frastructure, insufficient pool of trainers, inadequate funds (life sciences require expensive equipment to skill youth) and many more. Most importantly, and as is the case in most other sectors, there is the key issue of disconnect between the supply side (schools, colleges and training institutions i.e. academia) and demand (employers i.e. industry). Basically, since Independence, the country has been churning out students with degrees and diplomas, with inadequate attention to the requirement of the industry. A paradigm shift is needed to move from a ‘supply stipulated’ to a ‘demand determined’ model.

Life Sciences Sector Skill Development Council (LSSSDC), under the able guidance of newly formed Ministry of Skills, CII; Chairmanship of Satish Reddy (Chairman, Dr Reddy’s Lab) and its governing body ( which has practically each active association on its governing council), aims to bring about precisely this kind of shift.

With support of associations and its members, and key stakeholders, the council has developed standards (known as ‘occupation standards’) for about 60 key job roles, which account for almost 90 per cent of the job volume of the sector — currently put at eight lakhs. Of these, the four most important have been validated by the industry and are now classified as ‘National Occupation Standards or NOS’.

With industry support, curriculums and content have been developed for these four, and

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training partners are being accredited to impart skilling in major clusters. With ‘Master Trainers’, nominated by the industry, a pool of certified trainers is being created, which currently totals over 120.

Since the job role of medical sales representative (MSR) accounts for almost a quarter of the total job volume of the sector, special emphasis is being given to this. Leveraging government’s incentive programme (Pradhan Mantri Kaushal Vikas Yojana or PMKVY), over 40 training partners in 16 states will be skilling almost 5000 students, as MSRs in the current quarter. Those certified are expected to get meaningful employment in the industry as MSRs. There are also plans to assess currently

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standards set for a further over 50 job roles are expected to be validated by the industry. A veritable buffet of job roles would then be available for interested

training partners, to impart skilling in a cross section of job roles, across levels and functional areas. Some of these, such as research associate product

development, research associate process development, scientist clinical research development and bio process engineer will catalyse innovation. Successful

Content manual developed with industry input e.g for skilling MSRs

employed MSRs, under ‘Recognition of Prior Learning (RPL)’.

To facilitate this, LSSSDC is engaged in having e-content available on a mobile app. This will enable MSRs who, after assessment, are found weak in certain areas, focusing specifically on those (at a time of their choosing) using the mobile app. Resultant up-skilling of MSRs through this would raise productivity of sales force and benefit the industry. Interestingly, LSSSDC recently conducted a Pilot RPL, involving 500 MSRs from 10 of the largest Indian and MNC pharma companies. Pass per cent was found to be 59 per cent.

Over the next few months,

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skilling of youth in such job roles will be key to the sector’s success in repositioning itself as one that has successfully transitioned beyond ‘Make in India’!

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INSIGHT

Talent acquisition– Acritical success factor

PRASHANT NAGRE, CEO – Fermenta Biotech)

Prashant Nagre, Chief Executive Officer, Fermenta Biotech, talks about the importance and need for talent acquisition within pharma companies “NOTHING WE do is more important than hiring and developing people. At the end of the day, you bet on people not on strategies — Larry Bossidy THESE LINES sum up the vision for a sound talent acquisition programme. Talent acquisition has become a very strategic and critical function in most of the pharma companies. The process of identifying and attracting a talent within the pharma industry has turned out to be a key objective for the success of any business. Talent acquisition specialists are integral to business and long-term resource planning meeting.

A sound talent acquisition strategy has a direct and profound impact on an organisation’s business strategy. In today’s scenario, pharma companies are faced with multiple issues of varying magnitude such as a growing need for enabling innovation, an unending list of expanding priorities and to top it up an ‘achieve more with less’ economic climate.

New tools for talent acquistion Today’s workplace is changing dramatically. To keep pace with the same we need newer tools for talent acquisition. The past decade has witnessed a need for a great deal of change in HR practices. If the organisation’s current process of talent acquisition does not modify or keep pace with these changes, companies will be at a high risk of not only losing qualified candidates but also land up in a situation where growth and performance will be highly compromised. It is

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undeniable that alignment to business goals should be kept on priority rather than just filling up vacancies. One does feel, especially in the pharma domain, that despite a growing pool of available talent, finding the key talent that matches the organisational requirements remains a challenge even for the most seasoned HR managers.

Social media: a hiring tool It is evident that many of us are spending more time than ever on various social networking platforms, and many of the growing pharma companies, including ours, are learning to capitalise on this trend. This was initiated by consciously joining online conversations to reach potential hires via a plethora of options in the social network arena. Today’s recruiters are connected with top talent through social media and one gets to profile a prospective candidate rather accurately using this powerful tool. LinkedIn, Facebook, Twitter and lately even Instagram have helped HR professionals understand the candidate in a better and cost effective manner.

A strategic planning approach in an organisation involves creating an organisational talent requirement road map.

This approach is also relevent in the pharma industry which is driven by innovation as the talent requirement will change depend on a long range plan.

Product pipeline, manufacturing plan, supply chain requirements, marketing and sales force budgets, patient service etc., are a few amongst a number of detailed plans which the talent acquisition manager needs to carefully study and understand along with various department heads.

The job requirement is just a small bit of the total overall strategy; what matters most is creation of a multilevel talent requirement charter. For e.g, a company who would be launching an OTC product portfolio in two years’ time would need a dedicated business development candidate from day one; however the sales head and dedicated logistic team may be required in the later phase at a time of execution. A talent acquisition specialist has to include these things in his plan.

Segmentation of workforce Elements of talent acquistion To understand talent acquisition one must take a holistic view of its key elements viz. strategic planning, segmentation of workforce, employment branding and candidate relationship management. One must individually understand that each element needs to be carefully studied and understood prior to implementing it in an overall talent acquisition protocol.

Segmentation of work force is an equally important element.

The standard performance bell curve though used extensively may not be a very useful tool for a talent acquisition specialist. Segmentation of workforce involves classifying them in one of the three major segments viz. top performers, high potentials and finally employees in critical positions. All these put together comprise the ‘vital few’ mentioned in the Pareto Principle.

Employer branding We all are aware that employer branding is the process of promoting a company, or an organisation, as the employer of choice to a desired target group, one which a company needs and wants to recruit and retain. With more and more competition entering it is one of the most valuable elements for talent acquisition. Here is where the PR and HR function of an organisation must work in sync to depict a robust attractive face of the organisation.

In the pharma context, it is important to showcase the innovation awards (to cater to the R&D lot) or even a case study on a successful new product launch.

The aim is to create the perfect benchmark firm for all to work in. It involves being talked amongst the targeted group. It creates a positive aura which is a major attraction factor for a number of potential candidates.

Trust, mutual respect and employee friendly atmosphere etc., are some of the key factors which coupled with good performance and work ethics are definitely a turn on! Employment branding has the potential to increase the quality of employees and it has in it what one needs to inspire them to become more productive. Moreover it also can open numerous new opportunities to the company in the marketplace.

Candidate relationship management As a model for managing a company’s impressions and interactions with potential and future hires, Candidate relationship management scores very

high amongst the various elements in talent acquisition strategy. The ability to identify a technology which can organise, automate and synchronise the holistic approach towards attraction communication and management of talent is today’s HRs most valuable tool! With growing complexity in pharma and biotech fields it is becoming a need of the hour to rely on technology to manage candidate relationship more effectively.

Today’s talent management professional has a plethora of options when it comes to solutions for candidate relationship management. It makes it easy for visitors to one’s website to send job postings to friends, with links to all the job details and maybe even a resume form! One can set up special emails or newsletters to targeted groups, this works well when there is a specific group having focused skill set interest e.g. a group of downstream specialists in fermentation technologists or a brand managers managing pediatric endocrinology as a therapy.

Many organisations have initiated online chat to give candidates an opportunity to communicate directly with recruiters, hiring managers or employees.

One needs to understand that in today’s competitive scenario with a perceived scarcity of right talent (especially in the pharma industry), it is necessary to ensure that targeted candidates listen to the organisational message. It is high time the industry adopted a novel approach that focuses less on just ‘filling positions’ quickly and more on meeting organisations goals and objectives.

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Therapeutic biologicals: Challenges and opportunities Prof Kiran Kalia, Director and Dr Viral Shah,Assistant Professor, Department of Pharmaceuticals, National Institute of Pharmaceutical Education and Research, in this article, highlight the potential of therapeutics for more efficient and patient-centric treatment against varied diseased conditions COMPREHENSIVE UNDERSTANDING of the pathophysiology of various diseases and precise knowledge of molecular and genetic basis has changed the landscape of management of diseases. Until late 20th century, therapeutic basis relied on the use of drugs that had been developed through empirical approaches with no detailed understanding of the molecular mechanisms involved in the pathologic condition. This approach changed at the end of the 20th century, due to the intensification of interest in the clinical management of diseases, new treatment modalities and potential impact of personalised medicine. A wave of scientific advances and new technologies dramatically changed the discovery mode of new drugs.

Greater knowledge of the genetic and molecular level of diseases has allowed researchers to invade new targets for therapy and successfully predict how certain biopharma will affect specific sub populations of patients. The breakthrough innovation of therapeutic biologics to address largely unmet medical needs in varied disease conditions including cancer, diabetes, haemophilia, and immunological impairment made bio-industry as one of the strategic emerging industries (SEI) [1].

In contrast to small molecular weight drugs, the biologicals as defined in Section 351 of the Public Health Service (PHS) Act are “virus, therapeutic serum,

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toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, applicable to the prevention, treatment, or cure of a disease or condition of human beings.” FDA regulations and policies have established that biological products include bloodderived products, vaccines, in vivo diagnostic allergenic products, immunoglobulin products, products containing cells or microorganisms, and other protein products. [2] The categories of therapeutic biological products regulated

by Centre for Drug Evaluation and Research (CDER) includes ◗ Monoclonal antibodies for in vivo use. ◗ Plant, animal, human, or microorganisms derived therapeutic proteins recombinant

versions of these products. ◗ Immunomodulators (non-vaccine and non-allergenic products intended to treat disease by inhibiting or down-regulating a pre-existing, pathological immune response). ◗ Monoclonal antibodies, cytokines, and growth factors intended to mobilise, stimulate, decrease or otherwise alter the production of haematopoietic cells in vivo. [3] As per the US Food and Drug Administration (FDA), biologicals, represent the cutting-edge of biomedical research and latest scientific discoveries translated into novel therapies. They provide new treatment options for patients and eventually serve as the most effective therapeutics for a variety of medical illnesses and conditions where

other treatments are either not available or are most challenging and costly [4]. It is estimated that by 2016, 48 per cent of the top 100 best-selling drugs would consist of biological medicines .[5] The human genome inside every human body consists of about 25,000 genes, each responsible for a specific protein including various enzymes, hormones, antibodies and other proteins needed to make the body function.[6] The defective and missing genes in the body will not have the proteins for proper functioning and may have many proteins that cause disease. Amalgamation of biotechnology with modern tools of computer technology used to harness scientific progress have helped biopharma scientists to analyse the

KIRAN KALIA, Director, NIPER

DR VIRAL SHAH, Assistant Professor, Department of Pharmaceuticals, NIPER

massive amount of data quickly, determining which genes or proteins are defective and which proteins are being used for treatments across a range of therapeutic areas thereby pushing the frontiers of science.

Currently biologics represent the 30 per cent of licensed products and are the world’s best-selling pharma as depicted in Table 1. The biologics have fewer adverse effects compared to small molecules due to their high affinity for targets. [7] The improved manufacturing efficiency, increasing access to biologicals and reducing costs is the need of the hour. Most importantly, with FDA outlining its latest guidance for the future of biological medicines, patient safety must be the primary focus of all stakeholders [8]. In the

TABLE 1: TOP SELLING DRUGS IN 2013: 7 OF THE TOP 10 WERE BIOLOGICS Product Humira

International Nonproprietary names INN adalimumab

Company AbbVie/Eisai

Global Sales 2013 ($) 11.0

Enbrel

etenercept

Amgen/Pfizer/Takeda

8.8

Remicade

infliximab

J&J/ Merck & Co

8.4

Advair

fluticasone

GSK

8.25

Lantus

Insuline glargine

Sanofi

7.6

Rituxan/MabThera

rituximab

Roche/BiogenIdec

7.5

Avastin

bevacizumab

Roche

6.8

Herceptin

trastuzumab

Roche

6.6

Crestor

rosuvastatin

AstraZeneca

6.0

Abilify

aripiprazole

BMS/Otsuka

5.5 Source: First Word and Fierce Pharma, March 2014

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future, biological therapies are likely to be used more selectively based on personalised benefit/ risk assessment, determined through reliable biomarkers and tissue signatures.

Biologics

Small molecules

Manufactured in a living system such as a microorganism, plant or animal cells.

Manufacturing process is chemical synthesis, combining specific chemical ingredients in an ordered process

Key challenges of therapeutic biologics industry

Complex to manufacture and have comparatively higher GMP requirements

Well-defined chemical structures

Basic difference between therapeutic biological and small drug molecules is depicted in Table 2.

Developing novel biologics is the complex process and requires a thorough understanding of disease state, immune system, target site of immunomodulation and the biologic itself. Due to the complexity in its therapeutic structure biologicals poses several challenges in its development as summarised below:

Difficult to characterise

Finished drug can usually be analyzed to determine all its components.

Multisite manufacture – the hidden challenge of comparability Logistical hurdles are associated with limited time factor available for transporting harvested patient donor cells to the manufacturing site and their return to the clinical site for administration to the patient. In many cases, product developers are bound to use contract manufacturers where the environmental requirements are usually compliant with GMP. These raised difficulties in manufacturing continuity desired during later phases of development [9] and makes the transition to commercial-scale production of autologous cell therapies, prohibitively expensive or even infeasible. [10] ◗ Pharmacokinetic studies of therapeutic biological Pharmacokinetic studies are routinely carried out for small therapeutic molecules, whereas for biologics experimental analysis to predetermines underlying mechanisms for clearance and bio-distribution or identify factors that regulate absorption, distribution, metabolism, and excretion (ADME) cannot be determined thoroughly.[11] New technologies to deliver therapeutic biologics using needle-free devices, a for-

TABLE 2: DIFFERENCE BETWEEN BIOLOGICS AND SMALL MOLECULAR WEIGHT THERAPEUTICS

TABLE 3: ADME-RELATED CONSIDERATIONS FOR BIOLOGICS Key contributing factors Physical/chemical properties

Size, shape, charge, stability, heterogeneity in isoforms.

Absorption mechanism

Route of administration, formulation, injection site, subject characteristics, target-dependent mechanisms, physical/chemical properties

Distribution patterns

Size, shape, charge, target binding, target-dependent mechanisms, route of administration, formulation

Elimination pathways

Proteolysis, target-mediated clearance, nonspecific endocytosis and formation of immune-complexes followed by complement- or Fc receptor-mediated clearance, protection from catabolism via FcRn mechanism

Nonlinear kinetics

Saturable target mediated clearance, immunogenicity.

Subject characteristics

Body weight, age, sex, disease status, prior exposure to biologics, concomitant medications

Species difference in PK profiles

Target binding affinity, FcRn/IgG interactions, immunogenicity, contribution of lymphatic absorption, off-target effects

mulation with nanoparticles, intranasal and ocular delivery and novel therapeutic approaches such as stem cell therapy and individualised medicine are continually emerging. These advances limit the in vivo disposition assessment of biologics. Recently, unusual PK profiles of mAbs have been reported for many mAbs. [12,13] The mechanistic-based ADME studies are often required to understand possible causes for such unusual PK profiles. Despite of the great clinical and commercial success for some biologic drugs, the rate of clinical success is still a matter of ambiguity. [14] Recently, significant research efforts have been focused on understanding the correlation between PK, especially drug concentrations at the target site, and pharmacodynamics (PD) to improve clinical trial outcomes. [15] Three key questions should addressed to select a drug candidate for clinical trials: (1) What is the probability of the compound to reach the target organ(s) at a therapeutic concentration (2)

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Would the compound bind to the target(s) in vivo and result in required biological activity?

(3) Would the compound exert the functional modulation of the target? In-depth investigations of ADME properties and relationship between ADME profiles and pharmacological effects (e.g., biomarker activity) in preclinical and clinical studies would accurately answer above-mentioned questions.

Consideration of other factor for ADME studies of biologics like species difference in target-binding properties and host immune response to a biologic should also be given equal weightage. It is a well established fact that antidrug–antibody mediated clearance for therapeutic biologics is species-dependent.[16] The prediction of ADME profiles of therapeutic biologics in humans may not be relevant based on common animals eg. rodents and dogs. The transgenic animals that express human targets or receptors are useful for the qualitative assessment of potential clearance mechanisms.

◗ Analytical assay development techniques Structure similarity between therapeutic biologics and endogenous proteins along with the hydrophilic nature of biologics limits its qualitative and quantitative analytical estimation which is to be followed after extraction and purification of these drugs from in vivo samples.[17] The detection limit of analytical instruments makes the direct measurement of therapeutic proteins in biologic matrices a challenging task. Enzymatic digestion required before qualitative and quantitative analysis of these proteins in vivo samples, limits intact recovery of therapeutic biologics during sample treatment. Interference of endogenous proteins preset in in vivo samples is also a major concern during quantitative estimation of biologics. However, conventional analytical approaches for pharmacokinetic studies of biologics like ligand binding assays, such as the enzyme-linked immunosorbent assay (ELISA) include high specificity and sensitivity, ease of sample handling, and low

cost.[18,19] But developing high quality and specific reagents for ELISA methods to quantify therapeutic biologics and antidrug antibodies (ADAs) could be a time-consuming and labour-intensive process. Common imaging technologies are used in in vivo drug bio-distribution studies such as optical imaging with luminescence and fluorescence molecular probes, radiotracer-based single photon emission computed tomography (SPECT) and positron emission tomography (PET) imaging, magnetic resonance imaging (MRI), ultrasound imaging, and X-ray imaging. [20,21] In contrast to the conventional cut-and-count approach or whole-body autoradiography with radiolabeled biologics, imaging studies can be conducted in live animals, which provides the advantage of obtaining real-time dynamics on the biodistribution. [22] ◗ Suitable drug delivery systems With only a few exceptions, almost majority of therapeutic biologics are administered by parenteral routes, which usually

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lacks patient compliance. New drug delivery systems are need to be explored to increase targetspecific delivery, improve safety and convenience for patients, and support for individualised medication. Since biologicals tend to denaturise in harsh gastric environment conditions and also undergo enzymatic degradation so the current need is to develop a efficient dosage form for the oral delivery of such biologicals with high therapeutic efficiency. Some examples of novel strategies investigated for delivery of biologics include polymeric micro-structured arrays for potential delivery of proteins ,[23] needle-free injection devices for SC injection, [24] and nanoparticulate systems. [25] ◗ Pharmacovigilance of biologics Pharmacovigilance is basically checkpoint studies for determining drug’s performance, particularly adverse reactions, after it has been released in market. A variety of natural sources—human, animal or microorganisms are used for obtaining biological so a robust and vigilant traceability system should be in place to facilitate accurate surveillance of marketed therapeutic bilogics. [26]

Regulatory concern The regulatory guidelines for biologics address the manufacturing process and quality aspects, the pre-market regulatory requirements for quality, preclinical and clinical studies and postmarket regulatory requirements for similar biologics.[27] The competent authorities, Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT) are involved in the approval process for biologics and lay down the regulatory pathway for a similar biologic claiming to be similar to an already authorised reference biologic. The Review Committee on Genetic Manipulation (RCGM) functions in the Department of Biotechnology (DBT), Ministry of Science and Technology, Government of

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TABLE 4

APPROVAL PROCESS FOR SMALL MOLECULE GENERICS, NEW BIOLOGIC AGENTS, AND BIOSIMILARS Small molecule generic

New biological agent

Biosimilar

Quality

Individual quality Assessment Comparison Individual quality assessment with reference product

Individual quality assessment comprehensive comparison with reference product

Preclinical

No data required

Full pre-clinical programme

Abbreviatedpre-clinical programme (tolerance, PK/PD)

Clinical

Bioequivalence study

Phase I Phase II Phase III in all Phase I PK/PD study Phase III study in one sensitive, indications Risk Management Plan representative indication Risk Management Plan Source: Mellstedt, Clinicalconsiderationsfor biosimilarantibodies, EJC, Vol.11 (3); 1–11, Dec2013.

India. In the context of similar biologics, Genetic Engineering Appraisal Committee (GEAC) is placed under the Ministry of Environment and Forests (MoEF) as statutory body for review and approval of activities involving large-scale use of genetically engineered organisms and products thereof in research and development, industrial production, environmental release and field applications. CDSCO, responsible for the approval of new drugs, headed by the Drug Controller General (India) DCG(I) is the apex regulatory body under Ministry of Health & Family Welfare (MoHFW), Government of India is also responsible for grant of import/export license, clinical trial approval and permission for marketing and manufacturing of similar biologics. State Food and Drug Administration (FDA) works with CDSCO in each state and is responsible for issuance of license to manufacture similar biologics in India. Stringent regulatory guidelines as depicted in Table 4 at early stage of developments of new therapeutic biologics creates a hurdle in the growth and development of biologic industry .[28,29]

Manufacturing complexities Most biologics are very complex molecules and are difficult to be fully characterised by existing science. For this reason, they often are characterised by their manufacturing processes. The manufacturing processes are likewise very sensitive and complex. Temperature fluctuations or other factors can impact the

final product and affect their efficacy. Changes in the manufacturing process or facility may require clinical studies to demonstrate safety, purity and potency.[30] Batch to batch variability, time length for creating cell lines are some other factors that are needed to be addressed.

Drug–drug interactions With the increase in the number of approved therapeutic biologics, potential drug–drug interactions (DDI) between concurrently administered drugs (small molecule–biologic drugs or biologic–biologics drugs) have become a major concern. The importance of therapeutic protein–drug interactions and guidance that recommends how and when to evaluate such interactions have been published recently by FDA. [31,32] However, preclinical tools and in vitro test systems for assessing drug interaction potential of therapeutic proteins are limited. Thus, DDI assessment is often evaluated as a part of clinical trials.

Blood–brain barrier (BBB) transport BBB transport for small molecules has been extensively studied which has not been fully explored for biologics. Knowledge of the mechanism of BBB transport for biologics will benefit the safety assessment and the drug discovery for central nervous system (CNS) indications for therapeutic biologics. [33]

Placental transport of therapeutic biologics Placental transport of biologic drugs is not studied exten-

sively, because of the common belief that the placental transport is minimal for biologics.

Whereas, the placental transport of immunoglobulins has been recognised for more than 50 years .[34,35] A specific FcRnmediated binding of IgG at the maternal surface of the placenta has been proposed as the first step in the transport mechanism by which IgG is transferred from the mother to the foetus. [36,37] The challenge of drug concentration measurements for foetal tissues limits placental transport studies.

Cost factor The cost for development, validation, and implementation of these new technologies is significant. Thus cost also serve as a major limiting factor in the growth of bio industry.

Opportunities and growth potential of therapeutic biologics industry ◗ Value to patients Therapeutic biologics are leading towards a paradigm shift by significant unmet medical needs for many critical diseases. From recombinant human insulin to interferons to monoclonal antibodies (mAb), biologics have saved patients’ lives and improved quality of life for patients suffering from diabetes, infectious diseases, haemophilia, and cancer. ◗ Value to industry Tremendous and noteworthy growth is observed in the global market for therapeutic biological. Bio industries are expected to be a key growth driver in upcoming decade for the global

pharma industry. ◗ Value to the economy Therapeutic biologics, along with other biotech products in the fields of agriculture and energy, constitute the broader bioindustry that is expected to grow fastest annually. [38] With the right enabling policies, the broader bio-industry could become one of worlds pillar industries by 2020. The bio-industry if explored correctly will help India to transform from a labourintensive economy to a knowledge-intensive economy and contribute to the sustainability of future economic growth. ◗ Biosimilars The introduction of many biologic therapies to the market has revolutionised the area of therapeutics. However, the patents protecting their manufacture are about to lapse, and follow-on generic products, known as biosimilars, are about to flood the pharma market. The ‘biosimilars’ are different from the generic products of conventional drugs concerning efficacy, safety, and immunogenicity.

Biosimilars have attracted great attention with the hope that they will allow wide-spread availability of currently expensive biologic products.[39] Given their structural complexity, multifaceted manufacturing process, and, as a result, challenges for predicting impact of the manufacturing process changes on immunogenicity, biosimilars are not generic alternatives per se and are not interchangeable.[40] Thus, unique regulatory pathways are re-

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quired for biosimilars. PK and immunogenicity assessments, together with efficacy and toxicology studies, are key components in the development of biosimilars. ◗ Personalised medicines The age of ‘personalised medicine’ is predicated to administer the right medicine to the right patient in the right dose at the right time.[41] The cost-centric overshadow the practice of patient-centric medicine, there is a potential negative impact on both patient safety and clinical effectiveness. The future of biological medicines will be bright if patients, physicians, biotechnology companies, and other stakeholders work together to ensure patient safety, which is the foremost priority of the biosimilar policy discussion, likely because of the common belief that the placental transport is minimal for biologics. However, placental transport of immunoglobulins has been recognised for more than 50 years.[34,35] A specific FcRnmediated binding of IgG at the maternal surface of the placenta has been proposed as the first step in the transport mechanism by which IgG is transferred from the mother to the foetus. [36,37] The role of the second placental barrier, the foetal capillary endothelium, is not yet clear. The challenge of drug concentration measurements for foetal tissues limits placental transport studies.

Additional research is required to understand fully the mechanism of placental transfer of various biological modalities and its implications for the safety assessment of therapeutic biologics.

References 1. Lee YS, Tee YC & Kim DW. Endogenous versus exogenous development:a comparative study of biotechnology industry cluster policies in South Korea and Singapore. Environment and Planning C: Government and Policy 27, 612-631 (2009).

2. Nelson AL, Dhimolea E,

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Reichert JM. Development trends for human monoclonal antibody therapeutics. Nat. Rev. Drug Discov. 2010;9:767–774.

3. Verdine GL, Hilinski GJ. Stapled peptides for intracellular drug targets. Methods Enzymol.

2012;503:3–33.

4. Gillies SD, Lan Y, Brunkhorst B, Wong WK, Li Y, Lo KM. Bifunctional cytokine fusion proteins for gene therapy and antibody-targeted treatment of cancer. Cancer Immunol, immunother: CII. 2002;51:449–460.

5. Chow SC, Ju C. Assessing biosimilarity and interchangeability of biosimilar products under the Biologics Price Competition and Innovation Act. Generics and Biosimilars Initiative Journal (GaBI Journal). 2013;2(1).

6. Vugmeyster Y, Szklut P, Wensel D, Ross J, Xu X, Awwad M, et al.

Complex pharmacokinetics of a humanized antibody against human amyloid beta peptide, antiabeta Ab2, in nonclinical species.

Pharm Res. 2011;28:1696–1706.

7. Vugmeyster Y, Xu X, Theil FP, Khawli L, leach MW. Pharmacokinetics and toxicology of therapeutic proteins: advances and challenges. World J Biol Chem.

2012;3:73–92.

8. Keizer RJ, Huitema ADR, Schellens JHM, Beijnen JH. Clinical pharmacokinetics of the rapeutic monoclonal antibodies.

Clin Pharmacokinet.

2010;49:493–507.

9. Wu S, Lourette NM, Tolic N, Zhao R, Robinson EW, Tolmachev AV, et al. An integrated top-down and bottom-up strategy for broadly characterizing protein isoforms and modifications. J Proteome Res. 2009;8:1347–1357.

10. Chirino AJ, Mire-Sluis A. Characterizing biological products and assessing comparability following manufacturing changes. Nat Biotechnol.

2004;22:1383–1391.

11. Lin JH. Pharmacokinetics of biotech drugs: peptides, proteins and monoclonal antibodies. Curr Drug Metabol. 2009;10:661–691.

12. Wang W, Lu P, Fang Y, Hamuro L, Pittman T, Carr B, et al. Monoclonal antibodies with identical Fc sequences can bind to FcRn differentially with pharma-

cokinetic consequences. Drug Metabol Dispos: Biol Fate Chem.

2011;39:1469–1477.

13. Yeung YA, Leabman MK, Marvin JS, Qiu J, Adams CW, Lien S, et al. Engineering human IgG1 affinity to human neonatal Fc receptor: impact of affinity improvement on pharmacokinetics in primates. J Immunol.

2009;182:7663–7671.

14. Herbertson RA, Tebbutt NC, Lee FT, MacFarlane DJ, Chappell B, Micallef N, et al. Phase I biodistribution and pharmacokinetic study of Lewis Y-targeting immunoconjugate CMD-193 in patients with advanced epithelial cancers. Clin Cancer Res. 2009;15:6709–6715.

15. Lee JI, Zhang L, Men AY, Kenna LA, Huang SM. CYP-mediated therapeutic protein–drug interactions: clinical findings, proposed mechanisms and regulatory implications. Clin Pharmacokinet. 2010;49:295–310.

16. Girish S, Martin SW, Peterson MC, Zhang LK, Zhao H, Balthasar J, et al. AAPS workshop report: strategies to address therapeutic protein–drug interactions during clinical development.

AAPS J. 2011;13:405–416.

17. Roman J, Qiu J, Dornadula G, Hamuro L, Bakhtiar R, Verch T. Application of miniaturized immunoassays to discovery pharmacokinetic bioanalysis. J Pharmacol Toxicol Methods.

2011;63:227–235.

18. Ezan E, Dubois M, Becher F. Bioanalysis of recombinant proteins and antibodies by mass spectrometry. Analyst.

2009;134:825–834.

19. Li F, Fast D, Michael S. Absolute quantitation of protein therapeutics in biological matrices by enzymatic digestion and LC-MS. Bioanalysis.

2011;3:2459–2480.

20. Khalil MM, Tremoleda JL, Bayomy TB, Gsell W. Molecular SPECT imaging: an overview. International J Mol Imaging.

2011;24;43-52.

21. Von Schulthess GK, Schlemmer HP. A look ahead: PET/MR versus PET/CT. Eur J Nucl Med Mol Imaging. 2009;36(Suppl 1):S3–S9.

22. Vugmeyster Y, DeFranco D,

Szklut P, Wang Q, Xu X. Biodistribution of [125I]-labeled therapeutic proteins: application in protein drug development beyond oncology. J Pharm Sci. 2010;99:1028–1045.

23. Park J-H, Davis S, Yoon Y-K, Prausnitz MR, Allen MG (eds).

Micromachined biodegradable microstructures. Proc IEEE Microelectromechanical Systems Conference. 2003; 371–4.

24. Wang MM, Defranco D, Wright K, Quazi S, SpencerPierce J, et al. Decreased exposure of Peptide X in Zn formulation after subcutaneous dosing and in vitro metabolism in skin. AAPS J. 2011;13(S1):M1086.

25. Shi J, Votruba AR, Farokhzad OC, Langer R. Nanotechnology in drug delivery and tissue engineering: from discovery to applications. Nano Lett.

2010;10:3223–3230.

26. World Health Organization [homepage on the Internet]. Pharmacovigilance. [cited 2013 Mar 4]. Available from: http://www.who.int/medicines/ar eas/quality_safety/safety_efficacy/pharmvigi/en 27. Van der Laan JW, Brightwell J, McAnulty P, Ratky J, Stark C. Regulatory acceptability of the minipig in the development of pharmaceuticals, chemicals and other products. J Pharmacol Toxicol Methods. 2010;62:184–195.

28. Minghetti P, Rocco P, Cilurzo F, Del Vecchio L, Locatelli F. The regulatory framework of biosimilars in the European Union. Drug Discov Today. 2012;17:63–70.

29.GaBI Online – Generics and Biosimilars Initiative. FDA’s public hearing on biosimilars draft guidances [www.gabionline.net].

Mol, Belgium: Pro Pharma Communications International; [cited 2013 Mar 4]. Available from: www.gabionline.net/Biosimilars/General/FDA-s-public-hearing-on-biosimilars-draft-guidances 30.Wittrup KD, Thurber GM, Schmidt MM, Rhoden JJ. Practical theoretic guidance for the design of tumor-targeting agents.

Methods Enzymol.

2012;503:255–268 31. Ponce R, Abad L, Amaravadi L, Gelzleichter T, Gore E, Green J,

et al. Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies. Regulatory Toxicol Pharmacol: RTP. 2009;54:164–182 32. De Groot AS, McMurry J, Moise L. Prediction of immunogenicity: in silico paradigms, ex vivo and in vivo correlates. Curr Opin Pharmacol.

2008;8:620–626.

33. Pardridge WM, Boado RJ. Reengineering biopharmaceuticals for targeted delivery across the blood–brain barrier. Methods Enzymol. 2012;503:269–292.

34. Pardridge WM. Biologic TNFalpha-inhibitors that cross the human blood–brain barrier. Bioeng Bugs. 2010;1:231–234.

35. Kane SV, Acquah LA. Placental transport of immunoglobulins: a clinical review for gastroenterologists who prescribe therapeutic monoclonal antibodies to women during conception and pregnancy.

Am J Gastroenterol.

2009;104:228–233.

36. Chaparro M, Gisbert JP. Transplacental transfer of immunosuppressants and biologics used for the treatment of inflammatory bowel disease. Curr Pharm Biotechnol.

2011;12:765–773.

37. Pentsuk N, Van der Laan JW. An interspecies comparison of placental antibody transfer: new insights into developmental toxicity testing of monoclonal antibodies. Birth Defects Res Part B, Dev Reprod Toxicol.

2009;86:328–344.

38. Declerck PJ, Simoens S. A European perspective on the market accessibility of biosimilars.

Biosimilars. 2012;2:33-40.

39. Declerck PJ. Biologicals and biosimilars: a review of the science and its implications. Generics and Biosimilars Initiative Journal (GaBI Journal). 2012;1(1):13-6.

40. Dranitsaris G, Amir E, Dorward K. Biosimilars of biological drug therapies: regulatory, clinical and commercial considerations. Drugs. 2011;71:1527–1536.

41. Class JN, Langis L. A patientcentered paradigm for the biosimilars market. Generics and Biosimilars Initiative Journal (GaBI Journal). 2012;1(1):17-21.

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ANNIVERSARY S P E C I A L

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VENDOR NEWS

Recipharm signs agreement with Daewoong Secures €25 million contract for Erdosteine API RECIPHARM HAS signed an agreement with Daewoong, a leading Korean-based pharmaceutical company with a strong presence in respiratory therapeutics, for a 10 year extension of its existing contract, through to 2025, for the manufacture and supply of Erdosteine API. The finished Erdosteine product is manufactured by Daewoong Pharmaceutical at its Korean facilities.

Under the terms of the new agreement, Daewoong will annually purchase minimum API quantities of Erdosteine worth a total of about €25 million from Edmond Pharma, a Recipharm Group company. In return, Daewoong has secured exclu-

Daewoong has secured exclusive rights in Korea and Thailand to sell both the original product and to register and market all the new formulations, based on Erdosteine, which are currently under development at Edmond Pharma sive rights in Korea and Thailand to sell both the original product and to register and market all the new formulations, based on Erdosteine, which are currently under development at Edmond Pharma.

The first licensing agreement between Edmond Pharma and Daewoong Pharmaceutical was signed in 1994.

As a consequence, Daewoong became Recipharm’s exclusive partner in Korea and from 2008 for Thailand as well. The product has been sold under the name ERDOS in the Korean market ever since 1997.

Erdosteine is indicated for the treatment of acute and chronic respiratory diseases.

Its pharmacological profile is

characterised by a unique multifactorial activity: mucomodulatory, anti-bacterial, anti-inflammatory and antioxidant. The molecule is marketed in over 40 countries and currently, 75 per cent of Erdosteine sold worldwide is supplied by Edmond Pharma.

Erdosteine is available in capsule, sachet, suspension and dispersible tablet formula-

tions. The chemical synthesis of API to the manufacture of capsules and dispersible tablets is performed in Recipharm’s Paderno Dugnano facility, located just outside of Milan.

Pierfrancesco Manzo, Sales and Business Development Director, Erdosteine said, “Daewoong Pharmaceutical is our first customer for the purchase of our Erdosteine API. We are therefore delighted to have secured this substantial extension of our contract with the company and believe strongly that this sets the basis for significant new growth of Erdosteine in Korea.”

EP News Bureau-Mumbai

Merck set to complete Sigma-Aldrich acquisition European Commission approves sale of divestment business to Honeywell MERCK ANNOUNCED that following the final approval of the European Commission it is set to complete its $17 billion (€13.1 billion) acquisition of Sigma-Aldrich.

The European Commission had granted conditional approval to the acquisition of Sigma-Aldrich on June 15, 2015, subject to the divestment of certain SigmaAldrich assets. On October 20, 2015, Merck announced an agreement to sell parts of Sigma-Aldrich’s solvents and inorganics business to Honeywell. Now that the European

Commission has approved that transaction, all necessary closing requirements have been fulfilled for Merck to complete the acquisition of Sigma-Aldrich. The formal completion date is scheduled for November 18, with the delisting of Sigma-Aldrich’s stock from NASDAQ taking effect following completion.

Karl-Ludwig Kley, Chief Executive Officer and Chairman, Merck said, “We’ve reached the home stretch and are set to complete the largest acquisition in our almost 350-year history. With this acquisition,

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With this acquisition, Merck will become a leading player in the $130 billion life science industry with almost 20,000 people, 300,000 products Merck will become a leading player in the $130 billion life science industry with almost 20,000 people, 300,000 products and thousands of patents coming together to help our

customers tackle the toughest problems in life science with innovative solutions.”

Merck and Sigma-Aldrich announced on September 22, 2014 that they had entered

into a definitive agreement under which Merck would acquire all outstanding shares of Sigma-Aldrich for $140 per share in cash. The final approval of the European Commission follows the approval of the acquisition by SigmaAldrich’s shareholders at a special meeting held on December 5, 2014 and the satisfaction of other customary conditions, including antitrust clearance in the US, China, Japan and several other countries.

EP News Bureau-Mumbai

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Alfa Laval’s membrane filtration equipment comes with built-in advantages Equipment ensures that the best possible solution is available for each particular application MEMBRANE FILTRATION systems are often less expensive than many other alternative technologies. Especially the Alfa Laval PP spiral membranes that are more compact, thus a larger filtration area gives a better performance and the possibility to produce a wider product range. These membranes give sustainable benefits like reduction of water and chemical use as well as

longer service life, meaning less maintenance and less downtime.

Membrane filtration is a clean technology. The separation process is carried out solely on the basis of molecular size, making the use of additives unnecessary. This results in an end product of top quality, and makes it easier to comply with the many stringent requirements from both consumers

and public authorities. The Alfa Laval PP spiral membranes are even more hygienic than conventional membranes as they withstand high numbers of Cleaning-in-Place (CIP) cycles, hot cleaning temperatures and high pH levels.

Membrane filtration can be used for products with a wide range of different viscosities, including high-viscosity products that can be difficult to process.

Alfa Laval membrane filtration equipment is designed on a modular basis that gives a high degree of flexibility. The design of a system can be customised to meet any process needs and is it easy to expand if production requirements increase.

The efficiency of membrane filtration systems depends heavily on the reliable, uninterrupted application of consistent pressure. Hygienic high-pres-

sure pumps make the feed stream flow across the surface of the membrane and through its microscopic pores at a consistent rate, boosting both reliability and efficiency. You benefit from efficient logistics, from all the components dovetailing perfectly, and the advantages of purchasing the full spectrum of sanitary equipment and fittings from one single expert source.

EP News Bureau-Mumbai

Bespak,Aesica unveil new single source supply chain solution for drug delivery device The new business model has been brought to the market following Consort Medical’s acquisition of Aesica BESPAK, A leading drug delivery device design, development and manufacturing company and Aesica, a global pharmaceutical contract development and manufacturing organisation (CDMO), have unveiled the industry’s first single source supply chain solution for drug delivery products incorporating formulation development, device design and development, drug and device manufacture, fill/finish and secondary packaging. This new business model has been brought to the market following Consort Medical’s acquisition of Aesica. Consort Medical has combined and integrated Aesica’s drug formulation, manufacturing and packaging capabilities with Bespak’s

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Consort Medical has combined and integrated Aesica’s drug formulation, manufacturing and packaging capabilities with Bespak’s market leading drug delivery device, design and manufacturing services market leading drug delivery device, design, development and manufacturing services.

This has created a global single source drug and device contract manufacturing partner for pharma customers. The full

range of services that the Group now provides includes inhalation, nasal, ocular, Buccal, and transdermal drug delivery device concept generation, design, development, and manufacture at pilot through to high volume

commercial scale, as well as API and formulation development and manufacture and finished dose fill/finish. Bespak and Aesica have strong synergies and similarities across quality control, regulatory compliance and reliable manufacturing. This includes QP release and ISO certified Quality Management Systems, cGMP compliance and operating to FDA and MHRA standards of approval. Furthermore, both companies comply with environmental and health and safety standards. Aesica provides secure facilities that handle up to schedule II controlled substances, together with a high containment suite capable of manufacturing products in the

SafeBridge category III potency level.

Both brands provide pilot up to volume manufacturing – operating at scales from low volume pilot manufacture to very high volume automated production operations and from grams to full scale manufacture of drugs. In addition, continuous improvement tools underpin each company’s operations.

Moreover, Bespak and Aesica offer complex solutions and capabilities ranging from better than 6-sigma manufacturing operations at Bespak through to semi continuous processing, high capacity and high potent drug manufacturing at Aesica.

EP News Bureau-Mumbai

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S P E C I A L

I S S U E

PDP’s 20 years experience dedicated to clinical research and lifescience logistics Receives Global BS EN ISO 9001:2008 accreditation to ensure that clients receive the highest levels of service through business practices and operational procedures PDP IS a global specialist courier with over 20 years’ experience dedicated to clinical research and lifescience logistics, cold chain management and pharmaceutical distribution. The global services include export of IMP, clinical trial materials and kits, transport of diagnostic and research specimens, and cold-chain management.

PDP has achieved Global BS EN ISO 9001:2008 accreditation to ensure that clients receive the very highest levels of service through our business practices and operational procedures.

PDP employees around the

PDP employees around the globe are trained in the principles of GDP and the operations teams around the world work within and adhere to defined internal and clientspecific operating procedures globe are trained in the principles of Good Distribution Practice (GDP) and the operations teams around the world work

within and adhere to defined internal and client-specific operating procedures. The core proposition is simple, regard-

less of value, to deliver your shipment. They are at the right place, at the right time and at the right temperature.

PDP understands that the challenges of daily import and export demands trust and reliability. The company has the experience, capability and best practice procedures in place to respond to and fulfil the requirements every minute of every day.

PDP values and, above all, respects building trust with customers and can demonstrate a proven ability to respond to the specific requirements of clinical trial,

lifescience and healthcare logistics on a global scale. It has has successfully built and continues to expand the expertise driven and demanded by our customers in their key markets, geographies and industries.

Industry specialisation inlcudes central laboratory logistics (outbound supplies & inbound specimens), medical and drug R&D, comparator drug & managed access programmes, cord blood, stem cell and biobanking, public health service and healthcare agencies and pharma / biopharma.

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Waters ionKey/MS System receives R&D Magazine R&D 100 Award Novel approach is to enhance the sensitivity of bioanalytical, biomarker validation, pharmacokinetic and food research LC/MS analyses WATERS CORPORATION announced that Waters ionKey/MS System has received an R&D Magazine R&D 100 Award as one of the 100 most technologically innovative products to be introduced over the past year.

Intended for use with Waters ACQUITY UPLC MClass System and a range of Waters mass spectrometers, including the Xevo TQ-S , Xevo G2-XS and the Synapt

G2-Si, the Waters ionKey/MS System physically integrates a UPLC separation into the mass spectrometer producing up to a 40x improvement in sensitivity, enabling scientists to achieve unparalleled separation and detection of compounds. The ionKey/MS System’s iKey Microfluidic Separation Device, which is about the size of a smart phone, contains the fluidic connections, electronics, ESI

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interface, column heater, eCord Intelligent Chip Technology and the 1.7 micron UPLC grade particles packed inside a 150 micron I.D. channel to perform hundreds upon hundreds of UPLC separations reproducibly and reliably without a degradation in performance.

For quantifying extremely low abundant analytes, researchers often turn to microscale LC techniques em-

ploying microfluidics because of their ability to optimise ionisation efficiency and improve MS sampling. Merck scientists beta-testing the ionKey/MS System reported that the method they developed achieved an overall 20-fold increase in sensitivity (0.5 picomoles vs. 11 picomoles) for endogenous levels of GLP-1 in human plasma, a faster run time (nine minutes vs. 35 minutes), increased specificity

and resolution over a more traditional LC-MS/MS method.

Since the R&D 100 award competition began, Waters has won nine R&D 100 awards, most recently for its CORTECS 1.6 micron analytical columns, Oasis 96-Well (micro) Elution Extraction Plate, XTERRA Columns, ACQUITY UPLC System and the ACQUITY UPC2 System.

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Merck Millipore introduces enhancements to its EMPROVE programme The enhancements also help drug product manufacturers meet their own internal quality guidelines as well as those recently published by the European Commission MERCK MILLIPORE has introduced enhancements to its industry-leading EMPROVE portfolio of pharmaceutical raw materials. The expanded documentation and regulatory information facilitates drug product manufacturers’ risk assessment workflows and supplier qualification. The enhancements also help drug product manufacturers meet their own internal quality guidelines as well as those recently published by the European Commission. This was the first regulatory body to formalise risk assessment requirements for pharma excipients, despite the practice being common in industry.

The EMPROVE portfolio

includes approximately 400 raw and starting materials used in the manufacture of drug products and includes excipients, process chemicals and active pharma ingredients.

The newest enhancements enable the selection of raw and starting materials best suited for applications, based on their risk assessment. The essential products target moderate risk level applications, expert products are specified for higher risk applications where low microbiological and endotoxin levels are critical. API products provide the quality and regulatory documentation required for active pharma ingredients.

GMP requirements are fulfilled, as all products are produced in Europe, according to the ICH Q7 guideline.

In addition to the currently-available material qualification dossier (formerly referred to as the basic dossier) drug manufacturers can obtain two new dossiers for regulatory information.

These new dossiers help streamline and accelerate the costly and time consuming information collection and risk assessment process. The quality management dossier is structured according to the new EU guideline 2015/C 95/02 and supports risk assessment and supplier qualification for excipients.

With greater detail on raw

Corbion Purac in agreement with MSL The transaction includes the sales and delivery of lactic acid and lactic acid-based derivatives in India CORBION PURAC and Malladi Specialties Limited (MSL) have recently signed an acquisition agreement. The transaction includes the sales and delivery of lactic acid and lactic acid-based derivatives in India. No production facilities will be acquired.

Production will remain with Malladi Drugs and Pharmaceuticals Limited (MDPL), also part of the Malladi Group, which will produce derivatives on behalf of Corbion Purac. MDPL is one of India’s leading pharma manufacturing company with a global presence. This transaction al-

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lows for a local production base through the partnership, while maintaining control on quality supplied to our customers. Corbion Purac has acquired the lactic acid business for an undisclosed amount.

MSL is a leading manufacturer in India of lactic acid and lactic acid-based derivatives such as calcium lactate, sodium lactate and buffered lactic acid and supplies the pharmaceutical, home and personal care, chemical and food industries in India. MSL is a Malladi Group Company, one of India's leading

pharmaceutical companies.

Frank Goovaerts, Regional Vice President, Corbion Purac Asia Pacific said, “For over 80 years Corbion Purac has been an established name and superior service provider in the food and pharmaceutical industry with lactic acid and its derivatives.

MSL has a very strong customer base and distribution network in India. This acquisition will enable Corbion to grow its distribution network and customer service in India even further.”

EP News Bureau-Mumbai

material properties, the new operational excellence dossier helps drug manufacturers design more consistent and predictable processes and quality. This dossier includes elemental impurity profiles that address the ICH Q3D guideline requirements published in December 2014.

Drug manufacturers have an option to use the new online EMPROVE Suite Web site. This platform provides product information and dossiers for the entire EMPROVE portfolio and enables direct, 24/7 access to the comprehensive regulatory information.

EP News Bureau-Mumbai

Thermo Fisher Scientific receives IVDD CE Mark THERMO FISHER Scientific, a leader in serving science, has received the in vitro diagnostics device (IVDD) CE mark for its Thermo Scientific Prelude MD HPLC, Endura MD mass spectrometer and ClinQuan MD software. Available for general in vitro diagnostic use in Europe, clinical laboratories now have access to a high performance liquid chromatograph, mass spectrometer and LC-MS software designed and manufactured for in vitro diagnostic use in analysing patient samples as components of laboratory-developed tests.

"We're strongly committed to bringing the advantages of LCMS to the clinical market," said Bradley Hart, Strategic Director, life sciences mass spectrometry, clinical markets, Thermo Fisher.

EP News Bureau-Mumbai

Aesica launches new brand identity FOLLOWING ITS recent acquisition by Consort Medical, Aesica Pharmaceuticals, the global pharmaceutical contract development and manufacturing organisation (CDMO), has launched its new brand identity. This reflects the new alignment and consolidation of the full Consort Medical group.

The combination of Aesica and Bespak enables Consort Medical to provide customers with a single source for drug and device development, formulation,

manufacturing and packaging. The group’s unrivalled global offering comprises advanced delivery technologies, formulation development and manufacturing solutions for drugs. The new logo and branding will be adopted across all Consort Medical businesses, creating a consistent identity for all group companies. The official launch to the market has been planned to coincide with CPhI 2015.

EP News Bureau-Mumbai

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Mr. Zoru Bhathena's Division – PERICLAVE, backed by 65 years of family experience in manufacturing sterilizer and laundry equipments, is an ISO 9001 : 2008 and CE certified company. For last 17 years Zoru Bhathena pioneered in successfully introducing new technologies for CSSD / TSSU and Laundry equipments which was never seen and heard of in the country. Periclave consistently produces superior quality products meeting high level national and international standards for Pharmaceutical environment. Big or small, Periclave offers a complete spectrum of CSSD / TSSU, Laundry and kitchen solutions to modern Pharmaceuticals. At Periclave, we have a team of over 100 personnels to give our customers 100% satisfaction both pre sale and post sale. All our products are energy efficient, reliable and overall we are an eco-friendly company.

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South India Regional Office Tel: 044-22335533 Fax: 044-22335544 Mobile: 09841020440 Email: siro@periclave.com

West India Regional Office: Tel: 022-28673130 Fax: 022-28673140 Mobile: 09821385258 Email: wiro@periclave.com

East India Regional Office: Tel: 033-30071701 / 40448716 Mobile: 09831543224 Email: eiro@periclave.com

North India Regional Office Mobile: 09870085258 Email: niro@periclave.com

Heavy Duty Kitchen Equipments Cooking Range / Bulk Cookers / Hot Food Trolleys.

G Sterilizing Sinks / Chapati Plate Cum Puffer / Food Distribution Trolleys.

G Bulk

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PHARMINTECH TURNKEY SOLUTIONS PVT. LTD. CLEANROOM PARTITIONS & DOORS PPGI / PCGI modular panels/ Flush Metal Doors Walk able / Non- Walk able False Ceiling

HVAC SERVICES Sterile OSD

VALIDATION SERVICES Particle Count Test

R & D Labs Bio-Tech

HEPA Filter Integrity Test

Velocity Measurement Test RH Mapping

CLEAN ROOM EQUIPMENTS

Pass Boxes

Laminar Air Flow Units

Bio Safety Cabinets

Sampling/Dispensing Booths

108, Swastik Regalia, Off Ghodbunder Road, waghbil, Thane West-400615 @

sales@pharmintech.net

www.pharmintech.net

Air Showers

Garment Storage Cabinets

Mobile Trolley

022-2597 1641 / 42 +91 - 992 032 4980 / + 91 - 809 777 9747

ER k c ORT EXP Roll Pa : N T o. !! AT ! File N !

W !!

NE NG F Type AKI M BRE allats D A USD

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Reduce energy cost and raw material rejection with 100% fresh air cooling solutions

HMX-PCU-F

Reduce energy costs Indirect evaporative cooling Most energy efficient way of pre-cooling air for air-conditioned areas Works as a standalone unit or in conjunction with an existing system

HMX-FAAC

Reduce raw material rejections Combination of indirect evaporative cooling and DX/CW coils Maintains desired RH and temperature inside a raw material warehouse in all weather conditions Suitable for both 100% fresh air application as well as return air application

Reduction in TR load on existing air-conditioning system

(Business Unit: HMX) T: +91-20-3088 1100 E: ambiator@hmx.co.in W: www.hmx.co.in, www.ategroup.com

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June 2015

A.T.E. ENTERPRISES PRIVATE LIMITED

CIN: U51503MH2001PTC132921

An installed base of over 21 million CFM cooling more than 4.2 million square feet...and still counting!

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2

Designers, Engineers & Manufacturers of Machinery & Filteration Equipments for:

es Decad ies. ustr Over d In to ice of serv ing Stronger Grow t & Integrity us with Tr

Pharmaceuticals, Packaging, Chemicals, Food, Beverages, Distilleries, Breweries, Paints, Food, Oils & Consumers

MAJOR PRODUCTS MANUFACTURED AT UNIPACK Linear Vial/Bottle Washing Machines Sizes: vials 2ml to 100 ml & Bottles 15 ml to 500 ml Scramblers/Unscramblers Sizes:24” dia, 36” dia. 48” dia 60” dia Hydraulic Loading Platforms Inspection Tables Loading and unloading Conveyors Liquid Filling, Rubber Stoppering & aluminium Cap sealing Machines for Vials Powder Filling, Rubber Stoppering & aluminium Cap sealing Machines for Vials

Sterlity Testing Units in S.S. Sizes: Single Place, Three Place & Six Place Plate and Frame Type Filter press in SS Size: 20 cm X 20 cm, 40 cm X 40 cm, 60 cm X 60 cm, 100 cm X 100 cm Zero hold up/Sparkler Filter press Size : 600 LPH to 15500 LPH Sterile Pressure and Storage Vessels Size : 10 ltrs to 500 ltrs Membrabe Filter Holders (Size: 293 mm, 142mm, 90mm) Inline Filter Holders (Size:47mm, 25mm, 13mm) Basket/Bag/Catridges Filters

We Supply different sizes of Filter Sheets and Filter Modules of Major International Brands

Our Achievements: Over 2500 installations of our major products manufactured in-house are supplied to all Leading Companies in India & Multinationals abroad

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SADE SP440

100% WEIGHT SORTING

C Ph Jo H I, in al P u l 5 -M s St EC a an I t d nd M ia 2

ALL TABLETS | ALL CAPSULES | ALL SIZES

WEIGHT SORTING FOR THE PHARMACEUTICAL INDUSTRY The SADE SP440 is a versatile and effective weight sorter for use in pharmaceutical production, quality control and R&D departments for the 100% weight sorting and recovery of failed batches of tablets, capsules and softgels.

SADE SP440 KEY BENEFITS

• Sorts tablets, softgels & capsules • Sorts different shapes & sizes • No change parts between product batches • Consistent & high accuracy, +/- 1mg • Quick and easy clean down • 24-hour operation • Statistical reporting

Contact us today for more information.

Email: info@ptepl.com

• Material certification & validation documentation • Installation & operator training by our experienced Customer Support Engineers

Our weight sorters are used by customers in India amongst others: AUROBINDO - DR. REDDY’S - MYLAN LABS - JOHNSON & JOHNSON PIRAMAL - RANBAXY - SANDOZ

Process Technology and Electronics Pvt. Ltd. R. O . : 5 Malkauns, N.P. | Thakkar Road | Vile-Parle (E) | Mumbai - 400 057 | India T +91-22-6505 5819 F +91-22-2613-4269 E info@ptelectronics.in www.ptepl.com

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AVAILABLE DIRECTLY FROM THE MANUFACTURER AT HIGHLY COMPETITIVE PRICES < Ortho / Para Anisic Acid < Ortho / Para Cyano Phenol < 2 – Ethoxy Benzoic Acid < 1 / 6 – Hydroxy – 2 – Napthoic Acid < 3 / 4 / 5 – Methyl Salicylic Acid & Ester < 3 / 4 / 5 – Chloro Salicylic Acid < 3 / 4 / 5 – Amino Salicylic Acid < 6 – Methoxy – Naphthaldehyde < All types of Paraben & Mixtures thereof.

AN ISO 9001 : 2008 & 14001: 2004 COMPANY OUR PRODUCTS ARE STAR K-KOSHER & HALAL CERTIFIED

3A, Barodawala Mansion, 81, Dr. A.B. Road, Worli, Mumbai-400018.

Tel : +91-22- 43625500 Fax : +91-22-24974886 E-Mail : gujorg@gujaratorganics.com Web : www.gujaratorganics.com

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OSMOMETER 3250

Milk Cryoscopes Available

127, Bussa Udyog Bhavan, Tokershi Jivraj Road,Sewri, Mumbai - 400015. India

Tel: +91-22-24166630 Fax: +91-22-2662776 E-mail: support@rosalina.in Web: www.rosalina.in 142 December 1-15, 2015

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â&#x20AC;˘ â&#x20AC;˘ â&#x20AC;˘ â&#x20AC;˘ â&#x20AC;˘

Made from Hydroxy Propyl Methyl Cellulose (100% plant origin) Satisfy the vegetarian, religious and cultural requirements Ideal for moisture sensitive, hygroscopic and liquid formulations Capsules are chemically stable even at low humidity levels Low moisture content and hence cross linking is avoided

Corporate Office: # 102, SHRESHTA BHUMI, #87, K.R.ROAD, BANGALORE-560004 Phone: 080-26671571/73/81 Mr.Jhaveri(9967055937)(West)

Mr.Tandon(8288841337) (North)

Mr.Kevin (9500114237))(South)

Mr.Siddesh(9342508861) (Corp.) Mr. Prasanna (9480812409) (Corp.) Ms.Parimala(8095990324)(Coordinator)

Email: info@naturalcapsules.com

Mr.Ramesh(8121175801) (Central)

Mr.Tomar(9327916181) (Gujarat)

Website: www.naturalcapsules.com

Visit us at CPHI INDIA on 1st - 3rd DECEMBER 2015, IP 82-83, Bombay Exhibition and Convention Centre, Mumbai

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Two great brands come together under Charles River to provide an even stronger testing solution for our customers.

Microbial Detection & Identification

Charles River Laboratories India Private Limited Bangalore (Regd. Office): Phone: 080 25588175 / 76 / 77. Email: blroffice@crl.com Ahmedabad: Phone: 079 40194730. Email: ahdoffice@crl.com Hyderabad: Phone: 040 27179998. Email: hydoffice@crl.com Mumbai: Phone: 022 27810061. Email: bbyoffice@crl.com Mumbai - Accugenix Facility: Phone: 022 41270504 / 05 / 08. Email: CRLIaccugenix@crl.com

www.criverindia.com

ABS

Pharma Equipments

Manufacturers Of: Pharma, Cosmetic, Food Process & Allied Equipments Semi Drie

r

Gelatin

Melter

Mixer

ixer

Multi mill

ry M

ta ane

Pl

Fluid Bed Dryer Octagonal Blender

Vibro Sifter

ABS Pharma Equipments Gala No. 22/B, Star Industrial Estate, NaikPada, Waliv, Vasai (East), Dist. Thane - 401208 Maharashtra (India)Email: anupnath326@gmail.com / anupnath326@rediffmail.com Please Contact :

146 December 1-15, 2015

Mr. Anup K. Nath Cell: 9890204833

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R

STERILIZING & DEPYROGENATION TUNNELS.

SUITABLE FOR AMPOULES / VIALS ENTRY LEVEL TO CFR - 21 COMPLIANCE MODELS From An team of technocrats with experience of 30 years to their credit.

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Advertise in

Business Avenues Please Contact: ■ Mumbai, Ahmedabad: Rajesh Bhatkal 09821313017 ■ Delhi: Ambuj Kumar 09999070900 ■ Chennai: Arun J 91-9940058412 ■ Bangalore: Khaja Ali 09741100008 ■ Hyderabad: Mujahid 09849039936 ■ Kolkata: Ajanta 09831182580 156 December 1-15, 2015

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Solutions for Poorly Water-Soluble APIs and Pharmaceutical Mixing

The NETZSCH range of VITA mills and mixers offer solutions to all of your pharmaceutical mixing and milling needs. n in pplicatio uct or a st centers. d ro p r u Test yo -of-art te ur state one of o more! to learn 55 w o n -64 Call 00) 676 Tel: 1-(8

Homogenizer housing designed for high flow and reduced cavitation Bi-directional tool-less sidewall scrapers (no loose parts) Rotor-stator systems with foreign body protection

Ideal for development to commercialization Particle size reduction 50-500 nm range possible Easy to clean Repeatable results, batch after batch

DELTAVITA速 15-300 Agitator Bead Mill

NEW

KAPPAVITA HM Homogenizing Mixer

Can be used independently or in conjuction with other NETZSCH mills and mixers Powder suction and magnetic drive available Capable of heating and cooling

Mid-pressure homogenizer powered by compressed air Efficient dispersing of particle agglomerates and aggregates Creation of emulsions Capable of particle delamination and cell disruption GAMMAVITA AB 200 Premix/Preparation Vessel

OMEGALab Economic Dispersionizer

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www.netzsch.com/gd

NETZSCH Technologies India Pvt Ltd No. A-30, SSIO Complex, Vanagaram Road, Athipet Chennai 600058 Tel.: +91 44 26536821-26 Email.: info.gd@netzsch.com

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PHARMA ALLY

ANNIVERSARY S P E C I A L

I S S U E

PROFILE

Chempharm: On a growth track Chempharm, a clean room equipment and turnkey solution provider, has been consistently growing since its inception three decades ago to become a leading player in its field

MILESTONES 1985 - Started with HEPA manufacturing and testing as per FED 209 Std using DOP and particle counters 1990 - Implemented its first clean room project without HVAC for Ranbaxy Toansa under the guidance of H&G (now Jacobs) 1995 - Implemented its first OT clean room for AIIMS in Delhi 2000- Implemented a clean room with HVAC for a FDAapproved facility Stericon in Bengaluru for eye drops

CHEMPHARM Industries India is one of the oldest and most experienced clean room equipment and turnkey solution provider in India. The company started its operations in 1985 under the aegis of Anil Sapra and Rajnish Garg, both chemical engineers from Chandigarh. Garg also has a post-graduation degree with specialisation in filtration/ membranes while Anil Sapra is an MBA in Marketing. “Our engineering back ground and Garg's specialisation in filtration helped us to enter into clean room technology and filteration systems,” informs Anil Sapra, Director, Chempharm Industries India

The growth trajectory They gained initial experience in filteration systems by de-

veloping some filters in-house with the help of media suppliers like H&V Company. Experience in clean room technology was gained by carrying out validations with the help of equipment suppliers of particle counter and aerosol photometers. The learnings in HEPA filters manufacturing and validations gave them confidence and stood them in good stead in the years to come. The first clean room they implemented was for Ranbaxy API projects in Toansa way back in the 90s with the support of a renowned consultant M/s H&G (now Jacobs). Today, they have enormous experience in all types of clean rooms for critical applications like vaccines, formulations, in FDA approved facilities etc.

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Till date, they have implemented over 500 clean room projects in India and countries like Bangladesh, Nepal, Sri Lanka, Egypt, Zambia, Nigeria, Ethiopia, Kenya, Sudan and Niger. They also boast of a strong manufacturing base and large experienced team. F) Last but not the least consistency in the business from last 30 years

Next gen leaders The company has been growing from strength to strength in the three decades of its existence. Now, the next generation of leaders, Rohan Garg, (Graduate engineer from the US) and Sahil Sapra (MBA and CFA from Canada) are expected to lead the company to further glory. Currently, both are in the process of gaining

invaluable experience in manufacturing, marketing and finance.

Future plans “Chempharm has always had firm belief in India's capability and competency in engineering manufacturing. We are entering into more advanced manufacturing by acquiring the know-how from some critical containment equipment manufacturers overseas. All these equipment like isolators, mist showers etc will be manufactured in India and shall be exported to Europe and other developed countries,” informs Anil Sapra. He further informs that they are in discussion with a European firm to form a JV though he didn't divulge further details.

2010 - Implemented its first EPC project with civil + modular clean room + HVAC + BSL 3 labs for a vaccine manufacturing unit at VBRI Hyderabad 2010 - Implemented EPC for a bio pharma unit in North India with civil, modular, HVAC, BMS, water treatment plant, fire fighting system and all electricals (symbiotic labs) 2013 - Expanded the manufacturing base to multifold with state-of-the-art machines like laser,Tturret, 3D pipe bending, CNC presses, powder coating, paint booth, MIG and TIG etc to become the most advanced manufacturing in India for containments and panel manufacturing 2014 - Expanded their base South and West Africa

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PHARMA ALLY

Cleanroom industry in India – On the path to progress Ravi Thakur, Director, Pharmintech Turnkey Solutions, talks about the rapid progress in India’s cleanroom industry IN TODAY’S world, the cleanroom industry is one of the major industries growing at lightning speed.

Pharmintech Turnkey Solutions believes that the cleanroom industry has grown rapidly in India and in the other developing countries.

Has you ever thought of the number of research done on understanding the market position of this industry?

According to some latest research, it is seen that India and other African countries will be the largest buyers or consumer hubs in the upcoming years in relation to pharma products, food products, healthcare sector, semiconductor industry etc.

Indian research statistics say that the Indian cleanroom industry has seen considerable growth during the past two to three decades with more than 4000 pharma, R&D, food companies. India holds a huge share in the cleanroom market globally.

I remember an expert saying, “Investing in Indian cleanroom industry in the 21 st century generates high and instantaneous economic growth.”

If we talk about cleanroom contracting or cleanroom equipment manufacturers in India, they offer turnkey contracts to establish a competitive advantage and attract more new business. We be-

176 EXPRESS PHARMA December 1-15, 2015

lieve that offering turnkey contracts delivers high performance and flexible completion and solutions of work.

The cleanroom industry is developing rapidly with the invention of new products, services and machineries, some industries offer turnkey cleanroom contracts to the product manufacturing companies for their plants, labs

etc. and hold superior position in the market than other contractors and manufacturers.

Turnkey contractors do everything needed for the projects. Hence, project management consultants need not search for various contractors for a particular work. This, in turn, saves their overall project time.

The primary benefit of turnkey contracting is that the facility can be utilised as soon as the project is completed. As far as I have seen, turnkey projects allow other industries to share technologies, know-how and a great way to earn economic returns from the advantages and provide the skill to power and control the services.

Though the expectations are good from this industry in India, there is a need to update the technology to achieve benefits in the turnkey contracting.

We, Pharmintech, are experienced in offering cleanroom and HVAC turnkey projects, manufacturing cleanroom equipment and thereby offering a concept of 'one vendor satisfaction' to our clients.

Turnkey services provided by us include cleanroom partitions and doors, HVAC, cleanroom equipment, and validation.

We deliver defect-free and flawless range of products, widely demanded in various pharma cosmetic, biotechnology and food industries across the globe.

Assisted by a futuristic infrastructural and a diligent team of executives, we are capable of becoming one of the noticeable choices of their clients within a short span of time. We have achieved a stature in this competitive market.

Our main target of the company is customer satisfaction through awareness of customer needs and quality control. Our products and services are constantly upgraded. Our cross-sector obligations go far beyond the scope of our business, sustainable development, and environmental protection, social and civic policies.

PHARMA ALLY

ANNIVERSARY S P E C I A L

I S S U E

Paan Pharmatech Engineers: World-class quality PAAN PHARMATECH Engineers is primarily engaged in manufacturing and supplying various pharma processing plants and machinery. Since its inception, the company has been supplying quality machines in a number of pharma industries around the world.

Its repertoire of clients is spread across the country and the globe speaks favourable about its quality products.

This has been made possible because of its world-class infrastructure as well as efficient and qualified team of workers.

Furthermore, its associations with the leading names of the industry enables it to grow rapidly. All its products are available at competitive and conservative prices.

Assured quality The company's uncompromising attitude towards quality, standards and designs have enabled it to achieve large clientele. The foolproof system of quality checking and meas-

urements at every stage of production guarantees the expected quality, shape, standard and specifications and above all customers’ satisfaction through concept feasibility planning and design, implementation, installation and commissioning, training and documentations.

skilled and qualified team of experts who have adequate experience in the pharma industry and understand its specific requirements. Its team of mechanical engineer, technocrats, researchers, marketing experts and others, is trained to carry out the actual manufacturing process.

Infrastructural facilities

Name of the directors

The company is equipped with technologically advance infrastructure's facility. The facility boasts of technically advanced and automatic machineries that manufacture products par excellence. Also, to cater to the increasing demands of its customers, the company increases production capacity at regular intervals.

Apart from it, the company also specialises in offering customised products as per the requirements and specifications of its clients.

◗ SD Botre ◗ Dr Neha S Botre

Team of experts The organisation is backed by

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Experience and specialisation PAAN has been a leader in manufacturing machines for pharma, chemical and food processing for two decades.

Over that time, the company has helped various industries for their challenging process and packaging requirements.

Research and development PAAN continously develops new equipment with dedication to high techniques to meet

the challenges of today's most demanding applications, fulfilling cGMP and FDA regulations, and in close cooperation with the customers.

PAAN constantly strives to constantly improve and ensure superior processing, increased reliability and reduced maintenance. Latest workshop techniques are available to the design staff. There is a fullfledged library attached to the R&D sections where all the references and various standards are available.

Customer satisfaction Rendering superior grade products and services and thereby satisfying its customers has always been the company’s foremost business objective. The company devotes time and energy for fulfilling varied demands and orders of its clientele from across the country and the globe. Its technology advanced manufacturing unit enables the company to manufacture

and supply designs as per the exact requirements.

Product range Owing to quality and technological advancements, the company caters to diverse requirements of the pharma and chemical industry.

Comprehensive range of products ◗ Fluidised bed dryer: Model FBD 1 kg to 300 kg ◗ Fluidised bed pellet coater: Model PC 1 kg -120 kg (Wurster design) ◗ Fluidised bed granule processor: Model FBGP 1 Kg to FBGP 300 kg ◗ Fluidised bed bowl tipper: Model FBDT 60 kg to 300 kg

R&D to production scale ◗ Multi mill ◗ Cone mill ◗ Jet mill

R&D to production scale ◗ High shear homogenisers ◗ Trial models are available

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PRODUCTS

Optima Pharma to showcase INOVASV125 at P-MEC India OPTIMA PHARMA will present its multi-use INOVA SV125 at P-Mec India. The product can process pre-filled syringes, vials and cartridges.

Filling systems include peristaltic pumps, rotatory piston pumps and time-pressure systems, or a combination of dosing systems for high flexibility.

The machine can be configured for ten heads to reach an output of up to 18,000 units per hour. The space requirements are compact for this output and only slightly longer than that of the machine model for five line heads. The INOVA SV125 can be further expanded and connected to manual, semi-automatic or

Optima Inova SV125: One machine for three types of containers as well as filling systems: INOVA SV125

fully automatic functions upstream processing including debagging and robotic handling. The SV125 can be equipped with 100 per cent InProcess Control (IPC). It can be delivered with vacuum technology and be designed for all and containment systems such as isolators.

As a 'Turnkey Provider', Optima Pharma places all the latest developments in filling, closing and process technology at customer disposal for all pharma, biotech and diagnostic systems. A part of the portfolio, containment systems for sterile processing, isolators and pharma freezedrying are also included. The

spectrum ranges from machines for finest laboratory measurements to fully automated turnkey solutions, as these are more and more requested by the customers.

Optima Pharma will exhibit its products at P-MEC India at Hall 6, Stand-No. E28.

Contact details Felix Henning Public Relations OPTIMA packaging group GmbH Steinbeisweg 2074523 Schwäbisch Hall Germany email: Felix.Henning@optimager.com Phone: +49 (791) 5061464 Fax: +49 (791) 5061480

Sanner to introduce Atmo Guard System at CPhI India AT CPHI India, Sanner, a manufacturer of high-quality plastic packaging, will introduce its Atmo Guard System.

This comprehensive service is offered to all customers purchasing a desiccant plastic packaging from Sanner, and ensures a safe, timely and cost-efficient market launch of new pharmaceutical and healthcare products.

The Sanner Atmo Guard System relies on real, product-specific data and takes all relevant factors into account,

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thus delivering reliable measuring results backed by safe, tried and tested processes. As true primary packaging experts, Sanner has an extensive know-how regarding moisture input. The holistic approach of the Atmo Guard System makes sure that all steps and aspects are incorporated in the process â&#x20AC;&#x201C; be it for drop-in, integrated or individual desiccant packaging solutions.

Sanner engineers put their focus on the ideal interaction

of product, desiccant and packaging. By taking into account the right parameters, they define the most economic packaging solution.

Sanner will exhibit its products at CPhI India, booth V87.

Contact details Annette Crowther T +49 6221 58609-18 F +49 6221 58609-11 sanner@commha.de www.communicationharmonists.de

ANNIVERSARY

PHARMA ALLY

S P E C I A L

I S S U E

Testo automates temperature and humidity monitoring in cold chain TESTO, A measurement technology manufacturer, offers cold chain management professionals an efficient solution for automatic monitoring and documentation of temperatures and humidity values in all refrigerated rooms and across the cold chain. The innovative monitoring system testo Saveris 2 saves staff from reading out and documenting the individual measurement data, simplifying the assurance of high product quality.

In order to guarantee the quality and shelf-life, and to comply with legal hygiene standards, perishable products such as food and pharma products need to be stored and processed under constantly perfect climatic conditions.

Thanks to the cloud-based application, the Wi-Fi data logger system- testo Saveris 2 allows to keep the temperature and humidity values in all refrigerated rooms and displays under control everywhere and at all times, without any ongoing work procedures. Once the system is installed, it monitors and documents the ambient temperatures fully independently. The measurement data are directly transmitted to the online data store, the Testo Cloud, by wireless LAN, where they can be called up, managed and analysed online by the user via smartphone, tablet or PC absolutely anywhere and anytime. This uninterrupted and exact documentation allows the stringent HACCP standards to be adhered to.

Another important advantage of the system is that if an upper or lower temperature or humidity limit is exceeded, the

user is immediately provided with an alarm by e-mail, or optionally by SMS. The system can be easily and quickly installed. For the use of the cloud, customers can choose between the free basic or the more comprehensive advanced functionality, depending on their requirements.

This new Wi-Fi data logger system, Testo Saveris 2, has replaced time-consuming manual data monitoring and documentation.

Testo also offers a solution for reliable cold chain monitoring during transport. With the new data loggers testo 184, every step of the cold chain can be monitored. The loggers travel on the user's behalf in freight and loading rooms, monitoring temperatures during the transport of sensitive goods on rail, in air or on the road. At the destination, it can

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be seen at a glance whether the configured limit values have been adhered to. In order to obtain detailed information, it is sufficient to connect the logger to a PC and a PDF report is immediately generated with all the relevant data.

These loggers are pre-configured and operated with just a 'Start' and a 'Stop' button.

No measurement experts are required for their operation. A simple logistic operator can also manage the start and stop of a measurement cycle.

Furthermore, it requires no software download, no installation for accessing the data.

The sender of the package is geographically somewhere different than the receiver of the

package. In such cases, any USB cable needs to be plugged to the computer and the data can be accessed. A PDF/A report with the transport data is created immediately on connection of the testo 184 data logger to the USB interface of a computer. All testo 184 data loggers can be read out on site also with an NFC-capable Android smartphone.

Use and throw version of these loggers further eliminate the trouble of sending the logger back to the sender, especially during exports.

Testo also offers a special data logger for dry ice applications — testo 184 T4. Dry ice (80 ° C) is used for transport especially in the pharma industry, for example when transporting blood plasma, organs, virus, scientific material, etc. testo 184 T4 logger housings are made out of a special ABS polymer that can survive in such low temperatures. The extremely cold conditions are also very harsh for the batteries. Nevertheless testo 184 T4 batteries can hold for 100 days at -80 °C. testo 184 data loggers are compliant to the most important standards for the transport of pharmaceuticals and food products, namely, GxP (GMP, GLP & GDP), 21 CFR Part 11, HACCP and EN 12830.

Contact details Testo India Plot No. 23, Sind Society,Baner Road, Aundh, Pune – 411007, Maharashtra, India Phone: +91 20 6560 0203EMail: info@testoindia.com Fax: +91 20 25850080 www.testo.in

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Romaco's innovative solutions to be displayed at P-Mec 2015 ROMACO WILL showcase its innovative solutions for aseptic filling, tableting, granulation and coating of pharmaceutical products based on Macofar, Kilian and Innojet technologies at the upcoming Mumbai trade fair. The exhibits on show will demonstrate Romaco’s extensive expertise when it comes to processing pharma liquids, powders and granulates.

logical checking, particle presence checking and nitrogen flushing before and after filling the bottles can be supplied as options. The 100 per cent torque control provides optimal process control in case of eye drops. The Macofar LVI 6 can be flexibly configured and is available with weight control on request.

Romaco Kilian S 370 Prime: Tableting solution for mid-sized batches

Romaco Macofar MicroMaxX 18: Aseptic microdosing The Macofar MicroMaxX 18 microdosing machine continues the engineering specialist’s decades-long tradition of solutions for aseptic microdosing.

It is equally suitable for processing both pharma powders and sterile liquids and meets all the requirements for downstream freeze-drying. The Macofar MicroMaxX 18 features a dual dosing disc which allows multiple dosing into the same vial; alternatively, the product can be filled in two separate process steps. Thanks to the new weight control system, all vials can now be weighed individually for the first time. The Macofar MicroMaxX 18 is the fastest in the market today with 100 per cent weight control, with an output of 12,000 vials an hour. It can be equipped with various containment systems owing to its modular concept. Sterile external access to all components is assured via glove ports.

Romaco Macofar LVI 6: Handling system for sterile ophthalmic liquids The newest generation of Ro-

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while the space efficient design means no external electrical cabinet is needed. The machine is controlled via the integrated HMI touch panel and Vicon visualisation software, so that operation is very straightforward. The Romaco Kilian S 370 Prime can be equipped with an automatic tablet tester and a trending function on request.

solutely reliably at high speed.

What’s more, all product and format changes can be completed quickly and easily.

Clean: The optimised hygienic

The Romaco Kilian S 370

Romaco Kilian KTP 720X: Double-sided rotary press for high speed production

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maco’s Macofar LVI 6 was specifically developed for handling sterile ophthalmic medications. This double indexing machine achieves a maximum output of 150 glass or plastic bottles per minute. The monobloc design of the aseptic rotary filler unites the three main operations, namely liquid filling as well as the application of the dropper and screw cap.

This compact machine is moreover ideal for use with an open RABS (Restricted Access Barrier System). A special recirculation system can be integrated in the product tank for filling suspensions. Microbio-

Prime is designed for fully automatic production of midsized batches and compresses up to 300,000 tablets an hour.

It offers excellent value for money and the low initial capital investment is a convincing argument for pharma manufacturers all over the world.

This compact press combines several highlights such as GAMP compliant automation, an integrated lifting system to speed up die table exchanges and patented, wear-free brake magnets. Retooling and cleaning times are reduced to a minimum because easy access is possible to all components

Cool, fast and clean — these are the hallmarks of the Romaco Kilian KTP 720X tablet press for mono and bilayer formats.

Cool: The special compression rollers, bolts and bearings reduce mechanical friction, enabling the temperature in the process area to be maintained at a constant level below 30°C. The press is consequently ideal for processing temperature sensitive medications such as Ibuprofen or Metformin.

Fast: This double-sided rotary press compresses up to 1,020,000 tablets an hour ab-

design improves product quality and makes the process more reliable. The hermetic separation of the compaction area and the machine compartment means no product gets into the service area. The patented punch bellows protect the tablets from contamination with lubricants. The ingenious press design simultaneously restricts cleaning to a minimum. The Romaco Kilian KTP 720X is very simple to operate thanks to the new generation of HMI panels featuring zoom and swipe navigation.

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Romaco Kilian STYL’ONE Evolution: Tableting robot for R&D applications The STYL’ONE Evolution single-stroke tablet press provides an effective demonstration of Romaco’s laboratory expertise. The STYL’ONE is predestined for formulating mono-layer, multilayer or core tablets (tab in tab) in a broad array of R&D applications as well as for producing very small batch sizes. It is equipped with a gravity or paddle force fill shoe and is capable of compressing up to five layers with three different components. The production process on any standard rotary press can be simulated precisely using ANALIS, the intelligent PAT software. The user selects the machine model, tablet thickness and compression force for this purpose. ANALIS then automatically determines the optimal compression parameters for the machine. Only a tiny quantity of powder is needed for ultra-precise test batches with up to 1,200 tablets per hour.

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Apart from developing new formulations, the Romaco Kilian STYL’ONE Evolution can also be utilised in a targeted way to make manufacturing processes more efficient or troubleshoot errors.

Romaco Innojet VENTILUS V 2.5: Lab-scale granulation and coating The internationally patented technology of the Romaco Innojet VENTILUS V 2.5 is based on the air flow bed method originally developed

by Dr hc Herbert Hüttlin. This laboratory-scale machine processes particles from 10 µm to 30 mm in diameter, such as

powders, granulates, pellets, tablets, capsules and numerous other free-flowing bulk materials. A proven allrounder, it is the perfect granulation and coating system for pharmaceutical, chemical and food products. The enhanced processing efficiency permits up to 25 per cent shorter batch times. The homogeneous flow conditions inside the cylindrical product container enable extremely gentle intermixing of the batch. The process air is controlled by the ORBITER booster, an ingenious container bottom consisting of overlapping circular plates. Together with the ROTOJET, the cen-

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tral bottom spray nozzle, the booster forms an innovative functional unit that meets all the requirements for linear scale-ups. The air flow bed technology ensures accurate control of the product movement and equally precise application of the spray liquids. The resulting formulations achieve the required release profile with between 10 and 15 per cent less spray liquid.

The products will be displayed at P-MEC in Mumbai Hall 6, Stand D32.

Company contact Susanne Silva Market Communications Romaco Group Am Heegwald 1176227 Karlsruhe Germany P: +49 (0)721 4804 0 F: +49 (0)721 4804 225 E: susanne.silva@romaco.com

MeasureTest Instruments launches Lighthouse USA Model 3350 LIGHTHOUSE USA Model 3350 is the only particle counter in the world that measures down to 0.3 Micron @ 100 Lpm Flow Rate. If one studies the specifications of most particle counters with 100 lpm flow rate, one fact clearly stands out. The smallest particle size they can measure is only 0.5 microns, not 0.3 microns. Their counting efficiency for their most sensitive threshold of 0.5 microns is 50 per cent. In other words, compared to a theoretically perfect counter, they are only counting half the parti-

cles of 0.5 micron size.

Counting efficiency is an expression of the probability that a particle counter will sense and count a particle passing through its sample volume. This probability is a function of size up to a certain critical size above which all particles are normally sensed and counted. Unlike others, Lighthouse model 3350’s most sensitive threshold for 100 lpm flow rate is 0.3 microns.

Lighthouse counting efficiency for 0.3 microns is 50 per cent and for 0.5 microns it is 100 per cent. Because other

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manufacturers cannot achieve this sensitivity, they have to offer 75 lpm counters instead of 100 lpm flow rate.

Coming to laser life, Lighthouse sensors have the industry’s longest laser diode life of 20+ years MTTF-based on continuous 24/7 operation. So maintenance costs will be very low. An attractive feature of the Lighthouse portable counters is selective printing – one can print just two channels say 0.5 and 5 microns out of the six channels if desired.

Sampling can be done in terms of time or volume.

Company contact Jyoti Gangwani MeasureTest Instruments 94, Atlanta

Nariman Point Mumbai 400 021 Phone: 022-2202 7982 email: sheesh@mtnl.net.in

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Mack Universal’s partner International Washing Technologies launches W200 cGMP Part Washer MACK UNIVERSAL, established by Manoj Chaudhari in 2012, caters to the Indian pharmaceutical industry’s needs and wants by providing them the best the world can offer in the area of pharma and lab equipment. The company has tie-ups in various countries.

International Washing Technologies (IWT), an Italian organisation, and specialist in washing, cleaning, drying (both COP & CIP) and decontamination, is one of Mack Universal's esteemed partners.

IWT has recently launched their state-of-the-art 'W200 cGMP Part Washer' a pharmaceutical grade washer especially for the pharma companies which are looking for ‘smaller’ COP low pressure washers/machines due to lack of space. It will address footprint constraints and reduce the running and maintenance costs.

Design key points of W200 ◗ Compact and modular design: Limited space required in highly costly areas. Fits easily into existing or new washing area ◗ Two chamber sizes different solutions according to the space and parts to process. The most suitable washing chamber size according to the needs.

W200 is fully compliant with cGMP, ASME-BPE, FDA and GAMP5. It meets the latest regulatory and quality standards. ◗ E-Cabinet always on board (in

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front). Enhance the all-in one space saver compact setupEasiness of installation and maintenance. ◗ PLC with embedded multicolour touch screen HMI Automation and diagnostic function, reliable - repeatable - fail safe. Easy to use and cycle real time information (and alarms) displayed. ◗ Quality of construction:Entirely made of AISI316 S/s and FDA approved polymers. Non proprietary high quality compo-

nents (Gemu, Hilge, Festo, SMC)

Key features of W200 ◗ Rotating arms and quick lock ● Water supplied simultaneously to both arms and quick lock ● Limited piping and valves lead to simple system easy to maintain, ● Qualify and manufacture ◗ Interchangeable loading baskets via quick lock ● Allow to process a wide variety of parts from different

process lines

● Guarantee of perfect rinsing

● Product contact and non con-

of the load ● Validated procedure, reduces the frequency of the QA tests ◗ W200’s Locked configuration limited to the price list options ● Limited options according to the market needs without overfeaturing. Simple engineering, lean production means manufacturing cost reduction ● Price effectiveLimited investment for a great improvement od the cleaning proceduresEvery company can afford it! ● cGMP documentation packageQualification protocols and procedures for easy of qualification. Everything is duly documented for straight forward inspections/audits W200 is available in 2 variants: W200-040 and W200-080.

W200 is a new cleaning solution ideal for customers looking for safety of operation and production, reliable and robust of equipment, efficient cleaning performance, easiness of use Validated cleaning process, cGMP, FDA and GAMP5 compliant, compact and performing solution.

Contact details Mack Universal B-48, Malegaon MIDC, Sinnar, Dist - Nasik, Pin - 422 113, Maharashtra, INDIA. Mobile No.: +91 93206 68848 Telefax : +91 (2551) 230877 E-mail : sales@mackuniversal.com | info@mackuniversal.com | manoj@mackuniversal.com

tact parts can easily be cleaned ◗ Drying facility (with HEPA filtered hot air) ● Cleaned parts/tools/items can immediately be re-used ● Short downtime of the equipment for cleaning operation ◗ Steam or electrical heating ● Flexibility of use according to the sources of energy available (however steam heating is more performing leading to shorter cycles) ◗ Up to two water connections ● Wash and rinse can be performed with different water quality (RO/PW) ● Optimisation of the water usage focused on running cost savings ◗ Up to two detergent dosing systems with flow meter ● Allow to use the right chemical for any cleaning task ● Improve the efficiency of the cleaning process ◗ Hinged glass doors (single or double/interlocking) ● Manually operated doors lead compact design and easy of service ● Glass doors permit to observe the process in progress with no light ◗ Active door sealing by inflatable gaskets ● Guarantee of tightness of the chamber ● Allow real barrier separation between loading/unloading areas ◗ Final rinse water conductivity control

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Kitten Enterprises’Hd 680 and Hd 650 DEI-Vrotary sealers KITTEN ENTERPRISES' Hd 680 and Hd 650 DEI-V rotary sealers series are the high performance devices of the HAWO generation easy product line. The purist and medical practice-suited design, the high quality and robust materials and observance of the highest safety guidelines, make the generation easy equipment the perfect companion for daily hygiene in the medical practice. The sealing process of the Hd 680 De-v And Hd 680 Dei-v is validatable.

HD 650 D-DE

HD 680 DE

Ink test Pro

Seal check strip

Hd 680 DE/DE-V/DEI-V Rotary sealers for the automatic sealing of pouches and reels in medical and dental practices. ◗ Reproducible sealing process ◗ Hd 680 DE-V/DEI-V: validatable process in accordance with ISO 11607-2 ◗ Hd 680 DEI-V: interface connection for external process and for batch documentation systems

Hd 650 D/DE The basic rotary sealers for the automatic sealing of pouches and reels in medical and dental practices. ◗ Reproducible sealing process ◗ High sealing speed (10 m/min)

VALIDATION (ONLY HD 680 DE-V AND HD 680 DEI-V) ISO 11607-2 and the German DIN 58953-7 series of standards explicitly require validated packaging processes.

Therefore Hd 680 DE-V/DEI-V rotary sealers fulfil all necessary requirements for process

validation in accordance to ISO 11607-2 as well as the therefrom resulting specifications of the World Forum for Hospital Sterile Supply (WFHSS) detailed in the ‘Guideline for the Validation of the Sealing Process’.

Functionality Quickly graspable functions and thought through solutions make perfect operation possible. Due to the patented hawoflex sealing technology of Hd 680 DE-V/DEI-V, the devices conform to every material, even HDPE (Tyvek). In addition, the devices can be fastened to the wall with a special mounting to save place.

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Ergonomics Work processes in the preparation of instruments should be as simple and comfortable as possible. That's why the unit is aligned for the ideal utilisation of the work area. The high quality material guarantees high durability and makes cleaning truly simple. Maintenance is reduced to a minimum; worn parts are easily replaceable.

Services Regular maintenance can extend the life of the product.

Hence the company offers maintenance (ServiSeal), calibration (CaliSeal) and validation service in accordance with

ISO 11607-2 for sealers with validatable process (ValiSeal) as well as a seal seam strength test in accordance with EN 868-5:2009 just from one source.

For routine monitoring of the sealing seams, HAWO offers testing systems for the routine testing of the sealing seams as well as for the monitoring of the quality properties during validation and revalidiation.

HAWO Seal Check: The Seal Check med (paper/film pouches and reels) and Seal Check HDPE (Tyvek/film pouches and reels) make deviations visible on the indicator area of the Seal Check.

HAWO InkTest: The standardised dye penetration test for testing the seal integrity in accordance with ISO 11607-1, Annex B (ASTM F1929), is distinguished by its simple handling and provides objective results. For this purpose, a special test ink is given with a pipette into the pouch or reel.

Defects (e.g. channels) become immediately visible.

Contact details Kitten Enterprises W- 407, TTC Ind Area, Rabale , Navi Mumbai : 400701 T : +91 22 2764 9249 E : kittenmailer@gmail.com W: www.kitten.co.in

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IKAlaunches A10 basic batch mill THE NEW A 10 basic batch mill from IKA offers a lot of extras for increased safety and ease of use. The mill operates only when the cover is closed and can only be opened when at a standstill. A quick-stop function further increases safety for the operator.

A membrane keyboard makes operation easy, while the digital timer, the counter showing the grinding time and the error code display are additional user-

friendly features. The mill is unique in allowing users to reduce the capacity of the grinding chamber for small sample sizes.

The redesigned batch mill with integrated cooling water connections grinds hard and brittle, as well as soft and fibrous materials – all up to a volume of 50 ml. Samples become brittle in the grinding chamber, which means that tough, oily and aqueous samples can be processed.

The A 10 basic can be operated in intermittent mode.

The cover is easy to open and close with the bayonet lock, while cutters and knives can be replaced in just a few simple steps. The A 10.1 stainless steel cutter is included in delivery. The mill can be used in virtually any industry, especially in food, cosmetics and chemicals, as well as in agriculture and pharma.

Contact details Sonja Steiert Project Manager – Sales & Marketing IKA India 814/475, Survey No.129/1 Mysore Road Kengeri-560060 Bangalore Karnataka Phone: +91 (080) 26253 960 Fax: +91 (080) 26253 901 E-mail: sonja.steiert@ika.in

Gandhi Rolling Shutters - Quality Engineered GANDHI AUTOMATIONS, manufacturer of rolling shutters is certified to ISO 9001 2008 quality management system. This has resulted in the implementation of continuous improvement in personnel training, production, inspection, equipment calibration, machinery maintenance, logistics and customer relations. The product engineering team uses the latest software combined with technologically advanced machinery to offer to the customer a well-engineered product.

Over years of meticulously working on the design, fabrication and installation, Gandhi Automations has developed technical expertise in manufacturing various kinds of automated rolling shutters. The research and development team with its extensive know-how and experience are able to produce specific types of rolling shutters unique to certain sites and client requirements. A consistent quality product has thus become the hallmark of

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rolling shutters are fabricated of interlocking galvanised insulated and non insulated, stainless steel, patented aluminum or polycarbonate profiles and patented MS rolling grills.

Each of the rolling shutters have been designed as per clients' specifications conforming to IS 6248 and solidly constructed to promote trouble-free operation and long life.

Gandhi Rolling Shutters fit openings to a maximum width of 30,000 mm and height of 40,000 mm with an endless array of options to satisfy both aesthetic considerations as well as working requirement.

Gandhi Automations' manufacturing process right through installation to after sales service.

Gandhi rolling shutters are

ideal for situations where side room is at a premium and security is required. Our rolling shutters require very little headroom above the struc-

tural opening. They combine strength with elegance along with durability and are designed for both external and internal applications. Gandhi

Contact details Gandhi Automations Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064 Off: +91 22 66720200 / 66720300(200 lines) Fax: +91 22 66720201 Email: sales@geapl.co.in Website: www.geapl.co.in

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Process control through real-time particle size analysis Dr Michael Caves, India Business Development Manager, Malvern Instruments, in this article looks at how milling can be automated using realtime particle size measurement, and examines the potential benefits

TRADITIONALLY, pharmaceutical mills have been operated manually with reference to off-line particle size measurement. However, with the goal of greater manufacturing efficiency now at the top of the agenda, this practice is beginning to change. The FDAâ&#x20AC;&#x2122;s PAT initiative invites the industry to use innovative technology and better control strategies to develop processes that are more reliable and efficient â&#x20AC;&#x201D; the goal being reduced risk and lower production costs. For milling, the technology available to achieve these goals is commercially proven and reduces the barriers to uptake. The specific example considered is spiral jet milling, a technology widely used in the pharma industry, but the approach is equally applicable to almost all milling processes.

makes process optimisation more difficult. Figure 1 illustrates how a spiral jet mill works. Feed is accelerated into the flat cylindrical milling chamber using pressurised air. Air is also fed tangentially into the chamber at

very high velocity via a number of injection nozzles around the circumference. The circulating air picks up the feed, promoting particle particle collisions, especially at the outer edges of the chamber where particle concen-

tration is at its highest. At the vortex finder, in the centre of the chamber, air exits, carrying with it particles of a certain size. This size is determined by the drag and the centrifugal forces acting on individual particles. Centrifu-

Spiral jet milling Easy to clean, and with no moving parts, spiral jet mills deliver fine materials with a narrow particle size distribution. They are highly suitable for temperature-sensitive materials and enable milling in an inert atmosphere for materials that are susceptible to oxidation. However, the principle of operation is relatively complex because such mills combine comminution and classification. Potentially this

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gal forces throw larger particles back out to the edges of the chamber while finer particles are entrained in the exiting air stream. At the design stage, particle size cut off can be controlled by varying a number of factors: the geometry of the milling chamber; the distance of the vortex finder from the base; the diameter of the vortex finder; and the number, diameter, and angle of the air nozzles. However, once the mill is installed there are far fewer variables that can be used to control performance. Within the manufacturing environment particle size typically is controlled by varying milling and injector pressure and/or material feed rate. Optimising these parameters within the constraint of meeting the particle size specification is the key to efficient milling.

Why real-time particle size analysis?

Batch or campaigned processing is extremely common in the pharma industry, and many mills are operated manually, in this way, with reference to offline analysis. When faced with a new batch of material, a typical approach is to establish conditions that produce the required particle size distribution by milling small samples and then fix operating parameters.

Where a process is controlled using off-line analysis, the information on which to base operating decisions is relatively limited.

There may be a considerable delay between taking a sample and the return of results, and, during routine operation, pragmatism may dictate that samples are taken only once or at most twice per hour.

When establishing conditions for a new batch, delays make iteration towards a successful conclusion a lengthy process. And on an ongoing basis the lack of information makes it difficult to efficiently change operating parameters during a run. This explains why the decision is often taken simply to fix operating conditions once an inspecification sample has been

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Batch or campaigned processing is extremely common in the pharma industry, and many mills are operated manually, in this way, with reference to off-line analysis produced. The problem with a fixed process is that product quality then depends on the consistency of the feed. Where batches of material are being processed this should, arguably, be a reasonable assumption, but this may not always be the case.

For instance, the sample used to set the operating conditions may not be representative of the bulk, or segregation may occur during processing. Furthermore, with this approach every new batch is a new, time and material consuming, optimisation problem. Product quality and yield are often low. In contrast, using a continuous, realtime particle size analyser to monitor the milled product greatly increases the amount of information available for control.

It is possible to confirm that the

specification is met all of the time, and also to instantly observe the effect of any operational changes made. In addition, the data such analysers produce can be used to automate control.

So, for example, in the case of spiral jet milling, it becomes possible to automatically vary feed rate to maintain the particle size specification.

Automated milling solutions Example data from a fully automated milling solution is shown in Figure 2. The top dark blue line shows the feeder output, the light blue line shows Dv90 (particle size below which 90 per cent of the volume of particles exists), and the orange line Dv50. The set point for the system is defined in terms of a

Dv50 and shown in green. At the start of this period of operation the mill is running in steady state at a set point of three microns. The measured Dv50 is within +/- 0.3um of the set point. When the set point is changed to four microns the system quickly increases the feed rate until the particle size distribution reaches the new target. In the next part of the trial the set point is returned to three microns and in the last part raised once more to six microns. Each new set point is reached extremely quickly, with the fast response of the PID control loop bringing the Dv50 to within 10 per cent of set point in ~10 sec (in each case, as quickly as the dynamics of the system will allow). At each set point the mill runs ex-

tremely steadily and produces a very consistent product. The mill is under extremely tight control and runs at optimum efficiency.

Conclusion Automating mill operation optimises process efficiency, an increasingly important goal in pharma manufacture. It ensures consistently high product quality and maximum mill throughput, simultaneously minimising the requirement for manual analysis for control purposes and for QC, and moving operation closer to the goal of realtime release. The feed rate to a spiral jet mill is automatically varied on the basis of the particle size data to give very tight process control. The success of the solution is evident from trial data, which shows rapid transition between different set points, the speed of change limited only by the fundamental dynamics of the system. Automating control in this way results in an integrated, highly efficient solution for micronisation and milling applications that is beneficial at both pilot and commercial scale.

MEET TODAY’S STANDARDS WITH TOMORROW’S TECHNOLOGY From comprehensive reporting to reliable, redundant operation, TSI measurement solutions provide the confidence you need to certify a cleanroom, monitor a process, or track down a root cause. TSI offers a suite of products that ensure you get the perfect measurement– every time, all the time.

TSI particle counting solutions include: + Handheld, Portable and Remote Particle Counters + Real-Time Viable Particle Counter + Facility Monitoring Systems Understand more at tsi.com/lifescience

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