Express Pharma June 16-30, 2013

VOL .8 NO.16 PAGES 86

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Market Value-added OTCs on the radar Management DPCO 2013: A fair move or a misstep?

Research Playing by protocol 16-30 JUNE, 2013, `40

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V O L 8 . N O . 1 6 J UNE 1 6 - 3 0 , 2 0 1 3

CONTENTS

Chairman of the Board Viveck Goenka

MANAGEMENT

Editor Viveka Roychowdhury*

DPCO 2013: A fair move or

BUREAUS

a misstep?

Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das

PAGE 28

Nutraceuticals – on the move…

PAGE 32

Whistleblower Protection in India – Delay in

Bangalore Neelam M Kachhap

framing legal enactment will harm the

Delhi Shalini Gupta

public interes

PAGE 35

MARKETING

RESEARCH

Deputy General Manager Harit Mohanty

Playing by protocol

Senior Manager Rajesh Bhatkal

PAGE 37

Novartis receives positive opinion from

PRODUCTION

CHMP for Lucentis

General Manager B R Tipnis

Stem cell study could aid quest to combat

Manager Bhadresh Valia

range of diseases

PAGE 40

PAGE 41

Celgene’s Revlimid wins FDA lymphoma

Asst. Manager - Scheduling & Coordination Arvind Mane

approval

PAGE 42

Deputy Art Director Surajit Patro

PHARMA ALLY

Chief Designer Pravin Temble

‘Companies are able to benefit without

Senior Graphic Designer Rushikesh Konka

the need to make a significant

Photo Editor Sandeep Patil

investment’

PAGE 44

Layout Rakesh Sharma

Intertek to organise seminar on Managing

C I R C U L AT I O N

Process & Powder Safety

PAGE 45

Circulation Team Mohan Varadkar

Bilcare secures Abbott’s exports

Express Pharma Reg. No.MH/MR/SOUTH-77/2013-15 RNI Regn. No.MAHENG/2005/21398 Printed for the proprietors,The Indian Express Limited 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.

PHARMA LIFE

Copyright @ 2011 The Indian Express Ltd. All rights reserved throughout the world. Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

June 16-30, 2013

The power of choice

PAGE 46

PAGE 78

USP announces new acting COO

PAGE 80

MARKET The import tax anomalies faced by MD manufacturers, are ‘tariff barriers’ erected against domestic companies

PAGE 17

DoP calls for comments on soft loan scheme for mid-sized pharma cos Cipla expands collaboration with MEDA in allergic rhinitis segment Quest Life Sciences to tap US market

PAGE 20

PAGE 21

PAGE 22

Dr Reddy’s and Fujifilm call off JV for generic drugs in Japan

PAGE 23

www.expresspharmaonline.com

EXPRESS PHARMA

9

EDITOR’S NOTE Learnings from the Ranbaxy saga

RANBAXY'S PEERS IN INDIA NOW HAVE TO WORK HARDER IF THEY WANT TO REMAIN AMONG THE GLOBAL GENERIC TOP GUNS. THE INDUSTRY WOULD DO WELL TO EXPECT AND PREPARE FOR MORE FREQUENT AND STRINGENT INSPECTIONS

10 EXPRESS PHARMA

Dinesh Thakur's expose on Ranbaxy is not the first in the history of the pharmaceutical industry nor will it be the last. Probably the most infamous case in the pharma industry's list of whistle-blowers is Peter Buxtun's struggle to end the Tuskegee trial in 1972.

After numerous internal attempts to stop the trial failed, he went to the media and the resulting public and political outcry finally had the desired result.

Buxtun's testimony against his then employer, (the United States Public Health Service, no less) and subsequent investigations led to a major reform of clinical study protocols, with an emphasis on protection of participants and concepts such as informed consent. In fact, clinical trial protocols continue to evolve to this day: check out our story in this issue: Playing by protocol, page 37.

Reviewing some of the more prominent examples, we see a similar pattern. In 1996, Dr David Franklin's disclosures on how Parke Davis (now owned by Pfizer) illegally promoted an epilepsy drug, Neurontin, for unapproved uses while withholding evidence that it was not effective for these conditions, eventually led to the establishment of higher standards.

And more recently, in November 2004, Dr David Graham, a veteran drug safety researcher at the US FDA, blew the whistle on the increased risk of cardiovascular problems associated with Merck's antiinflammatory blockbuster, Vioxx. After first attempting to discredit Graham, the US FDA had to ultimately mandate large warning labels on the drug's packaging.

After Vioxx, the US FDA has reportedly reviewed and upgraded its evaluation of drug safety standards.

The Ranbaxy saga seems to have already set in motion a review at India's national regulator of drug safety standards, the Central Drugs Standard Control Organization and various Ministries associated with the industry. The Drug Controller General of India (DCGI) is due to submit a preliminary report on the implications of Ranbaxy's guilty plea within a month's time. The Commerce Ministry has issued a strong statement alleging 'vested interests' are out to malign the image of India's generics industry, in a bid to move

www.expresspharmaonline.com

in on what has so far been India's acknowledged forte.

In contrast to the Commerce Ministry's damage control stance, the Health Ministry seems to have decided to be more circumspect. It is keenly waiting for the DCGI's report so that they can take action on the quality aspect if necessary.

Threatened by a backlash from the medical community Ranbaxy issued a statement assuring consumers of the safety of their products.

Simultaneously, stung by the allegations that Daiichi Sankyo was misled during the buyout process, Ranbaxy's original promoters, the Singh brothers, refuted all charges alleging that the current owners were 'trying to desperately shift the blame ‌ away from itself'.

This war of words looks set to continue but what's clear is that Ranbaxy's peers in India now have to work harder if they want to remain among the global generic top guns. They will face tougher scrutiny, never mind that import alerts are part of any exporter's business risks. The news that another major player from India, Wockhardt, was issued an import alert just days after Ranbaxy's settlement merely added to this perception.

Beyond the corridors of India's FDA Bhavan, this episode is hopefully a loud wake up call for other generic companies. Many industry leaders source from players in the unorganised sector, often referred to as the soft underbelly of the Indian pharma, and it is quite possible that while there are many ethical SMEs, there will also be those who crimp corners on cGMP. The US FDA is better placed today to conduct more in-depth and surprise inspections on Indian drug manufacturing sites, with two offices in India and more staff on the ground. So the industry would do well to expect and prepare for more frequent and stringent inspections. The message for the industry would seem to be: 'Document what you do' and its corollary, 'Do what you document.'

Viveka Roychowdhury viveka.r@expressindia.com

June 16-30, 2013

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MARKET

W H AT ’ S INSIDE

THE BUSINESS OF PHARMACEUTICALS

DoP calls for comments on soft loan scheme for mid-sized pharma cos PG 20 Cipla expands collaboration with Meda in allergic rhinitis segment PG 21 Quest Life Sciences to tap US market PG 22 Dr Reddy’s and Fujifilm call off JV for generic drugs in Japan PG 23 M&A activity increases significantly in value terms PG 24 SCDM Asia Conference receives overwhelming response PG 26

MANAGEMENT 28 RESEARCH 37 PHARMA ALLY 44 PHARMA LIFE 78 June 16-30, 2013

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I

India currently ranks 11th in the world for over the counter (OTC) drugs. The market is poised to grow to the ninth position within five years.

The Indian OTC drug market is around `12,000 crores and is growing at 12 to 14 per cent annually. Success stories of brands like Otrivin (nasal spray format), Crocin Advance (fast acting Optizorb Technology), Volini (nano and duo technology), Disprin (fast dissolving aspirin) has made a mark within the market in the form of consumer recognition, trials and acceptance. Hitesh Gajaria, Partner, KPMG says sales of OTC medicines in India are predicated to increase from ` 141.3 billion ($3.03 billion) in 2011 to `267.8 billion ($6.23 billion) in 2016.

Adding value Presently, the market has 70,000 OTC brands which are competing with each other and is a burden for the customer’s wallet in India. It is imperative that companies focus on differentiating their products which is demanding to add value to an existing product which may involve launching it in more palatable flavours for example products like ENO, more patient compliant dosage forms like Crocin drops for paediatric patients), and more effective medication such as Iodex gel for better permeability.

As Gajaria, points out, “The objective of any valueadd exercise should be to meet the consumer needs that can be of varied kinds, from quick and long lasting relief to psychosomatic relief.”

With changing market dynamics and consumer demands, market players are compelled to take a leap

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SUSAN JOSI Managing Partner, Sorento Healthcare

in the profitable OTC drugs business.

Susan Josi, Managing Partner, Sorento Healthcare feels, “As the competition started to intensify, it soon became clear to marketers that they need to add value to their products in order to get consumer attention and stand strong amongst the clutter. Pharma companies have always been competent in the area of novel formulation technology. Till date they were leveraging this competence in Rx brands and so with the new opportunity in OTC, they are leveraging the same competence in this space. Hence, the marketers have started investing in R&D to offer OTC products with a value-add to gain a competitive advantage, as well as to provide a best fit for consumers’ needs.”

Dr Manu Chaudhary, Director- Research, VMRC, and JMD, Venus Remedies emphasises, 'Value addition is to remain competitive and alive in established brands and that makes companies reinvent the existing product to offer something new to the customers. Over the years, OTC industry has shown a significant growth due to the rising consumer confidence in such products which is reflected in the expansion of its market.”

Josi reveals, “There are more than 80 therapeutic categories of OTC drugs available in the Indian market for categories like acne and weight control products.

There are about 400 brands playing in the market, of which 76 per cent brands are promoted through doctors but enjoy a deemed OTC sale (repeat buy by consumers) while rest 24 per cent brands are frank OTC brands and they are advertised directly to consumers. These 24 per cent brands contribute 35 per cent to the total sales of the Indian OTC market.”

She continues, “With www.expresspharmaonline.com

DR MANU CHAUDHARY, Director- Research, VMRC, and JMD, Venus Remedies

As the competition started to intensify, it soon became clear to the marketers that they need to ‘value-add’ their products in order to get consumer attention and stand strong amongst the clutter

Value addition is to remain competitive and alive in established brands and that makes companies reinvent the existing product to offer something new to customer

tightening price regulations and shrinking R&D pipelines, pharma companies started exploring newer avenues to grow. Additionally, emerging markets like India are in a phase where consumers are becoming increasingly cautious of lifestyle ailments and are also seeking convenient and suitable solutions for same.”

Kedar Rajadnye, President and Chief Operating Officer, Consumer Products Division - Piramal Healthcare predicts, “In the future we will find that more and more pharma companies will enter this space with their existing products along with new areas with line extensions or new brands.”

Spelling out this opportunity, Josi says, “There are huge untapped opportunities which exists for non-advertised brands to switch to OTC promotion and achieve higher sales turnover.”

Many pharma companies are exploring the OTC market by finding niches, targeting specific demographic segments as well as offering newer formats. Companies are also exploring the Rx-toOTC switch strategy to widen the consumer base of their established Rx brands.

Globally successful brands like Gaviscon, Mucinex are being test marketed and are likely to be rolled out nationwide soon, according to Josi.

Companies like Ranbaxy, GSK, Johnson & Johnson

have wide OTC portfolios and are investing significantly in building their brands, mentions Gajaria.

Rajadnye explain why pharma companies have started adding value to their OTC products and says, “For most of the pharma companies, OTC space is an usual growth lever.

However, unlike pharma industry, where the customer can be the doctor himself, for OTC the customer is the consumer. With increase in sources of knowledge, the awareness level among consumers has gone up significantly and consumers have become more demanding.

Therefore, it becomes all the more important for pharma companies to create differentiators to help them gain higher market share.”

Joshi avers, “Almost all companies who are longstanding players in the OTC segment are seriously investing in innovation. So you have GSK, Ranbaxy, J&J, Dabur, Piramal, Emami among many others are launching value added products. Value added OTCs is a comparatively newer trend.

With increased competition and parity products in the same space, companies are forced to think of value adds as differentiators and also at times to command a premium. This also arises from the need to fulfil consumer latent needs like convenience (onthe-go formats), speed of June 16-30, 2013

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action (technology), organoleptic properties (taste, smell, feel).”

New trends OTC segment has been there since ages but majority of the Indian pharma companies are primarily focused on bulk drug manufacturing.

Besides this, OTC products demand creative marketing techniques and a lot of branding to reap the benefit of entering into this particular segment.

Chaudhary informs, “Ranbaxy was the first Indian pharma company who broke the ice with four OTC products: Revital, Garlic Pearls, Pepfiz and Gesdyp. There is a huge potential and untapped space in the OTC segment for domestic players. Brand building, and proper positioning of the OTC product is the key to success in this market, which has traditionally been the strength of FMCG companies. Customer needs value for money and quick solution to his problems; therefore, the response is exciting. It is increasing with the rise in paying capacity of the customer.”

THE INDIAN OTC DRUG MARKET IS AROUND ` 12,000 CRORES AND IS GROWING AT 12 TO 14 PER CENT ANNUALLY.SUCCESS STORIES OF BRANDS LIKE OTRIVIN (NASAL SPRAY FORMAT), CROCIN ADVANCE (FAST ACTING OPTIZORB TECHNOLOGY), VOLINI (NANO AND DUO TECHNOLOGY),DISPRIN (FAST DISSOLVING ASPIRIN) HAS MADE A MARK WITHIN THE MARKET IN THE FORM OF CONSUMER RECOGNITION,TRIALS AND ACCEPTANCE

positive response from the consumers.”

Gajaria feels, “The OTC segment has a tremendous growth potential. Both innovator and generic companies are increasing focus on the OTC segment. Innovator companies introduce an OTC drug, to extend the life of their product which is nearing patent expiry or has

Extending horizons With market players sparing no efforts to add value to their existing OTC products, how far will this trend create a sustainable business environment?

Expressing his opinion, Rajadnye stresses, “This definitely is a new trend in the industry and will stay. There are definitely some companies who have products that can be taken into the OTC space. However, the business of OTC is very different as compared to the pharma business and therefore they will have to evaluate this market thoroughly before they get into this space. This market has a huge competition (as you will be competing with virtually all the players from telecom, automobiles to FMCGs for the consumer mind space amongst the media clutter), lower success ratio, requires excellent customised distribution infrastructure and high financial commitments.

All those who have been able to create value by product differentiation, meet their unmet needs and are able to create brand registration in the already cluttered media that are hitting the consumers, will see a June 16-30, 2013

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already witnessed high competition. Generic producing pharma companies are also lured towards this segment owing to the increased acceptability it fetches when marketed as an OTC product as opposed to a prescription drug.”

Since this trend is here to stay, several pharma players are devising strategies to leverage the opportunities available at the moment.

Enlightening on the recent move taken by Venus Remedies, Chaudhary highlights, “We have introduced our first OTC product ‘EZENUS’, a stress reliever in the domestic market. It is a herbal sugar free candy for stress reduction with strong blood purifying, antioxidant, hepato-protective and immune boosting activity.

Herbal OTC is a growing segment with many companies working on different lifestyle needs. Market will soon be flooded with more OTC products but strict controls on medicine systems will restrict irrational entry of allopathic medicines in this segment.”

Which are the areas

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which could see such products? “On-the-go formats which are convenient for consumers on the go. Cough and cold and antacids preparations could be offered in unit dose sachet packs for on-thego convenience. (eg.

Gaviscon has sachet packs globally). Eye care is another flourishing area which could benefit from technology innovations offering liquigels with cooling effect to treat dry eye syndrome,” suggests Josi.

HITESH GAJARIA

KEDAR RAJADNYE

Partner, KPMG

President and COO, Consumer Products Division, Piramal Healthcare

Miles to go

Innovator companies introduce an OTC drug, to extend the life of their product which is nearing patent expiry or has already witnessed high competition

This definitely is new trend in the industry and will stay. There are definitely some companies which have products that can be taken into the OTC space

government initiatives and the corporate sector; the segment offers immense potential,” feels Gajaria.

With the market players striving to be one up on their peers, it is ultimately the consumer who stands to benefit

as each brand endeavours to position itself to fit a new need; sometimes even before the consumer recognises his own need! Thus all signs predict smooth sailing for the OTC market.

Chaudhary predicts, “There are many therapeutic segments which need new technologies especially stress management, depression, pain management segment, allergies, cough syrups, skin ailments and so on.”

“There is a tremendous opportunity and scope for innovation in the field of sports medicine and general fitness. Neutraceuticals in general offer a huge opportunity for companies. With consumers taking healthcare more seriously and the large importance being given to preventive healthcare via

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u.sharma@expressindia.com

June 16-30, 2013

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The import tax anomalies faced by MD manufacturers, are ‘tariff barriers’ erected against domestic companies UK-based Smith and Nephew group, a global leader in orthopaedic segment recently announced the acquisition of Sushrut-Adler, a home grown medical devices (MD) company catering to the trauma segment.

Ajay Pitre, Managing Director, Sushrut-Adler group shares his thoughts on the challenges facing the Indian medical device industry in an interview with Shalini Gupta

at a faster pace to meet what could today be considered latent or unmet needs.

However, this can happen only when the challenges of

INTERVIEW

How do you see Sushrut’s acquisition by Smith and Nephew?

This is a unique agreement for the Indian orthopaedic industry wherein two companies with complementary businesses– Sushrut-Adler with its leadership position in trauma and Smith & Nephew’ with an established position in the Indian orthopaedic reconstruction and sports medicine market have come together to build a sustainable Indian business, as well as develop mid-tier trauma offerings for other emerging regions. From a purely Sushrut-Adler perspective, it gives us access to the broader global network and resources of Smith & Nephew. The entire management team, including myself, will become part of Smith & Nephew once the agreement is complete.

Even as medical device imports continue to account for 60-70 per cent of the market, several innovative players such as Perfint, Trivitron and Forus have made a dent.

How do you see the Indian medtech landscape?

The acceptance of medical devices in India is driven by a growing awareness in both the medical community and patients who want to recover fast and get back to work.

There is a strong likelihood of demand for more effective medical technology growing June 16-30, 2013

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availability and affordability are suitably resolved. Hence, I do believe the question is not whether this will happen, but rather how much and how soon. Recognising this trend, West-based multinational device companies have established a presence in the Indian market recognising an emerging high growth opportunity here after having experienced a degree of saturation in their traditional high price realisation markets in Europe and the US. It is also heartening to note some Indian companies are actually investing into meaningful innovation, addressing the needs of India for cost effective healthcare.

This is imperative considering that the high cost models of healthcare have now proven to be unsustainable for even the most affluent countries.

These efforts need to be supported. India with its capabilities in engineering and innovation acknowledged worldwide, I believe, is an ideal location for creation of such meaningful solutions. If we get our act together, in a consorted effort by all stakeholders and an enabling policy created by a holistic approach, we can lead the way in demonstrating via successful models, delivery of cost effective healthcare (a crying global need) over a couple of decades of committed efforts.

What challenges remain for medical device manufacturers in the country?

The nature of challenges faced by the Indian medical device industry varies and differs depending on the progress that individual sections of the industry have made. Companies that have been progressive and forward looking have been facing severe challenges of innova-

THE EXPECTED NEW LEGISLATION MUST BE FOLLOWED BY ACTIONS THAT TAKE INTO ACCOUNT THE FACT THAT THE REGULATORY AGENCY NEEDS TO SET UP SUITABLE AND CAPABLE INFRASTRUCTURE AND STAFFING WITH THE QUALIFICATIONS, SKILLS AND CAPABILITIES APPROPRIATE TO REGULATE DEVICES THAT ARE PRIMARILY ENGINEERING PRODUCTS USED IN CRITICAL HEALTH RELATED APPLICATIONS 18

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tion and the high costs associated with R&D, testing, validation and regulatory approvals, especially in an environment of relatively low price realisations. With a long development cycle, the need to ensure safety at the outset and efficacy in a statistically significant manner over the long term, the ability to invest and ride the relatively longer lead time is critical.

Additionally, it has to be noted that medical devices have a much shorter life cycle, as well as far smaller volumes when compared to the traditional engineering industries.

In India, where cost is an overriding consideration, companies find it difficult to make a business case considering that the end price realisations with a substantial lead time make it difficult to attract investments. However, paradoxically, Indian companies realise that their progress is going to be best achieved with innovation as its key driver.

It is due to this reason that the Government should directly financially support deserving companies based in India in the device industry to develop products, and even more importantly to develop capabilities. How should this be done? Companies that have demonstrated capabilities to design, develop, test and validate devices with an understanding of safety requirements and clinical considerations should be shortlisted and financially supported to enable them to create high quality infrastructure and further enhance internal skills that will enable them to take further steps in the journey of developing clinically safe and effective devices without straining their financials to breaking point.

The setting up of crucial knowledge-based facilities focused on testing and validation of devices is another critical area where Governmentdriven actions will go a long way in supporting the emergence of a strong medical device sector. These capabilities when developed can also support the regulators in correct implementation of regulations as well as industry to meet the regulations.

What changes need to be made in the tax, tariff and import duty structure, in order to incentivise the domestic medical device manufacturing industry?

Even before discussing incentives, we should first www.expresspharmaonline.com

create a level playing field in terms of import tariffs and taxes. Currently, the import tax anomalies (import of inputs taxed higher than import of finished products) faced by medical device manufacturers, actually are ‘tariff barriers’ erected against domestic companies. Even in the recently introduced corrections (raw materials to manufacture orthopaedic implants, cardiac stents) to enable domestic companies to import raw material at rates that only equal the tariff imposed on import of finished products, the administrative conditions imposed on the domestic manufacturer are such that it leaves you wondering whether it is more cost efficient to pay the import tariff. The import of finished goods at this Nil to low tariff, however, is unconditional and without any additional administrative compliance requirements. Needless to mention, if the government realises the need to attract investment in medical technology industry for creating capabilities within the country, it would need to be suitably incentivised.

While a lax regulatory structure helps entrepreneurs and innovators, it can be a barrier when it comes to the approval of products in competitive marketplaces. Your comments.

It is my personal view that there is no place for a lax regulatory structure when it comes to products as critical as medical devices that directly influence patients’ health and well-being. The prevalence of inadequate devices, an inevitable consequence of inadequate regulation, imposes incalculable costs on not just the health system but on society at large.

From an industry perspective, a correctly constructed, appropriately staged and transparently implemented regulation is actually an enabler for progress. In the long-term quality always results in lowering of costs – and even if that were not to be, it is an imperative in this industry. Needless to mention, that the regulations have to result into meeting and continually enhancing quality objectives while retaining clarity rather than mandating processes. Regulation should also be supportive to innovation.

How is the funding(VC/PE) environment in the sector?

The VC / PE route for funding is typically capital that gets raised and deployed from the developed markets of the west. However, I personally notice that the biggest step in their learning curve is to understand the difference in the realities of our market and theirs -i.e. where they have developed their understanding and thereby established business models. Those who can achieve this realistic local understanding and thereby suitably calibrate their expectations in terms of business models, returns and most importantly time horizons. I am sure, will have success stories to share going forward.

At the moment, however, I would not be surprised if several struggle to justify investments in this industry, due to the differences in the models they are used to seeing vis-àvis the realities of our market.

CK Prahlad has expounded the concept of 'Fortune at the bottom of the Pyramid'.

However, it will need some innovative thinking to understand and relate this to the medical technology industry.

Having said this, I strongly believe, that these models will need to be created here and can certainly not be replicated from the developed world for obvious reasons.

New guidelines on applying drug rules to medical devices were introduced in 2012, and an updated Bill will be presented to the Parliament bringing all medical devices sold in India under (CLAA) under the CDSCO. What are your expectations form the bill?

As is generally well known now, both the regulators and the industry were overtaken by events that moved rather abruptly (in 2006) wherein the need to regulate with immediate effect was forced on the government and unfortunately the government chose to notify selected 'Medical Devices' as 'Drugs' as an expedient route. This was a fundamental mistake – a fact not only evident by studying the global understanding on this subject but also a realisation by our regulators as of date. Hence, the regulators have needed to take stop gap steps to correct in the meanwhile, while pursuing the root objective of separately defining medical devices and building a suitable and correct regulation for the industry. Now that nearly June 16-30, 2013

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six years have passed since the announcement of regulation, it is an appropriate time to take stock of what has been achieved and what more needs to be done.

Factually speaking, the implementation of regulation has thus far been restricted to reviewing of documentation and certifications of 'imported' products. Regulation of the domestic industry continues to be conspicuous by its absence (of implementation) at large. However, the lack of clarity on the implementation of the regulation, the application of the inappropriate drug law and the non-uniformity of understanding of the industry at the Central and State regulator levels has led to some rather piquant situations.

Responsible domestic device companies who have voluntarily approached the regulatory authority are subjected to intrusive inspections and insistence on complying with inappropriate and unsuitable requirements by state level regulators whereas a large section of the domestic device industry who prefer to operate 'below the radar', continue to sell unregulated products with impunity.

On a positive note, our regulatory agency, at the senior most levels, has demonstrated excellent understanding and commitment to the course that needs to be set.

The industry has been involved collaborating with the regulators to share their knowledge. The regulators have initiated these consultations by setting up of joint action groups to frame regulation that is suitable to medical devices and replace the drug rules that are not applicable or appropriate to the device industry.

However, a lot more needs to be done. Long awaited fundamental legislative actions need to be hastened. This is in the form of defining ‘Medical Devices’ separately from ‘Drugs’ in the Act. The expected new legislation must be followed by actions that take into account the fact that the regulatory agency needs to set up suitable and capable infrastructure and staffing with the qualifications, skills and capabilities appropriate to regulate devices that are primarily engineering products used in critical health related applications. Extensive recruitment and internal training are no doubt necessary by the regulatory authorities to create an organisation that can suitably June 16-30, 2013

regulate the industry in an appropriate manner with the objective of creating a vibrant domestic industry that can hold its head high on the world stage and earn recognition for quality and innovation.

What is your vision for Sushrut and for the Indian medical devices sector in the

next few years?

It is a generally accepted in the world of medical devices today that innovation and new solutions emerge from the developed western world. However, the sustainability of their high cost device development model is questionable given the emerging financial pressures on healthcare costs. Further with

85 per cent of the world’s market in the less affluent developing economies, the situation is ripe for innovative device companies from countries such as India to develop solutions suited to them both from the point of view of clinical needs(that may be different), and cost effectiveness, a criteria that western world innovation has always found

hard to meet. At SushrutAdler, we see this unique combination of circumstances as a significant opportunity to bring to these markets, innovation, new techniques and technologies that respect the fundamental principles of medical device safety and effectiveness while being costeffective at the same time. shalini.g@expressindia.com

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www.expresspharmaonline.com

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COMPANY WATCH DoP calls for comments on soft loan scheme for mid-sized pharma cos With a corpus fund of ` 500 crores, the Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) aims to coax them to upgrade to WHO-GMP norms Usha Sharma – Mumbai epartment of Pharmaceuticals (DoP) has requested comments on the latest version of the Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) designed for encouraging mediumsized pharma companies to upgrade to WHO-GMP standards by providing soft loans.

As per the new time bound soft loan scheme, eligible pharma medium-sized enterprises (Mes) will be provided a soft loan of upto `2 crores per unit at a concessional rate of interest of five per cent per annum through Small Industries Development Bank of India (SIDBI) or any other financial institution, duly authorised by SIDBI. With a corpus fund of `500 crore, it is possible to extend the benefit to around 250 MEs in the 12th Plan period and around 400 MEs in the 13th Plan period out of the revolving fund generated through repayment of loans including interest earnings on the soft loan deposits, as per a detailed project report on the PTUAS. Pradeep Yadav, Joint Secretary, DoP, while speaking to Express Pharma, said, “This will be like any other soft loan provided by the Government of India but it has been specifically designed for medium-sized pharma companies. We have asked all concerned people related to the pharma industry to share their views and comments. We would like to share the draft report with the Planning Commission, Government of India for review before the end of this month.”

He further said, “It is expected that the Planning Commission will take a minimum of three to four months to review the report and we

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hope to launch this scheme before the end of this year.”

SIDBI will be borrowing the corpus amount from the Government of India without any interest and will be returning the loan amount after a period of 10 years in five equal annual installments.

As per the set criteria by DoP, companies with a turnover of `5 crores to `10 crores will be eligible for the loan and need to repay the amount within five years of the disbursement procedure completion period.

Yadav emphasised the need for this loan scheme for medium-sized pharma companies and said, “Developing countries generally follow World Health Organization (WHO) GMP norms. Any export of drugs from India to such countries must adhere to these regulations and it is economically not feasible for medium-sized

will be beneficial to the pharma companies.”

Jaishankar added, “WHO GMP is going to be mandatory for the approval process as manufacturing facilities should have WHO GMP compliance. The Government has identified the equipment and is ready to fund it under the soft loan scheme. Also, there needs to be a clause that the companies should avail this loan only when the companies are making profit in the last five-year period.”

As per information provided by the office of Deputy Director General (Chemical &Petro Chemical), dated 21.9.2011, on the basis of reports received from State Drug Controllers (SDCs), there were 752 MEs units functioning in India. Out of these, 153 MEs have got WHO-GMP certification from the office of Central Drug Standard and Control Organization (CDSCO) and

ELIGIBLE PHARMA MEDIUM-SIZED ENTERPRISES WILL BE PROVIDED A SOFT LOAN OF UPTO `2 CRORES PER UNIT AT A CONCESSIONAL ROI OF FIVE PER CENT PER ANNUM THROUGH SIDBI companies (to upgrade to these norms). It (the soft loan facility) will not be an extra burden to them but will provide better quality of drugs and encourage them to explore more export-oriented markets for better growth.

This will also help them to meet with the efficacy requirements.”

Sharing some of his initial views on SIDBI’s proposed role, TS Jaishankar, Chairman, Confederation of Indian Pharmaceutical Industry (SME) pointed out, “Most pharma companies do not deal with SIDBI directly and in the past many other industries were not happy with their process. So, it will be better if the Government considers any nationalised bank as the eligible one for the process, which www.expresspharmaonline.com

State Licensing Authority. It is further projected that around 50 units may graduate from SSI pharmaceutical units to MEs during the 12th and 13th Five Year Plan (FYP) period.

Timeline to the PTUAS The proposal has been in the discussion stage for a long period of time. It was during the 11th Plan period, that the DoP had submitted a scheme to the Planning Commission for providing financial assistance to pharma SMEs for technology upgradation to Schedule ‘M’ Standards as laid down under the Drugs & Cosmetics Rules, 1945.

The Planning Commission had accorded ‘in principle’ approval to this Scheme on

5.12.2007 and after various consultations this proposed scheme was tweaked/merged with the existing Credit Linked Capital Subsidy Scheme (CLCSS) of M/o MSME as per decision of Empowered Finance Committee (EFC) in a meeting held on 02.03.2009.

However, WHO-GMP and other international GMP compliance was found to be not practicable under the CLCSS Scheme as maximum loan available under this Scheme is `1 crore per unit while the minimum financial requirement was reportedly `2 crores per unit, as per a detailed project report on the PTUAS scheme.

DoP then proposed a new PTUAS to assist pharma MEs, which were not covered by the CLCSS Scheme of MSME. The new scheme provides soft loans at an interest rate of five per cent per annum for making these units WHOGMP compliant.

The DoP circulated this modified PTUAS scheme on 15.6.2010 for comments to SIDBI, MSME, Ministry of Health & Family Welfare. This modified version was also circulated to the Planning Commission on 16.6.2010 for getting the ‘in principle’ approval.

The Planning Commission on 11.1.2012 advised the DoP that instead of the subsidy route, SIDBI could be approached directly by medium sized pharma units for a soft loan.

SIDBI submitted their comments on the Scheme on 10.12.2012 and proposed an `500 crores interest free Corpus Fund to be kept with them for disbursement of loan to 250 MEs at the rate of `2 crores per unit. These comments from SIDBI were submitted by the DoP to Planning Commission on 8.1.2013, The modified Scheme is the version finally being presented to industry for its comments prior to getting the final nod from the Planning Commission. u.sharma@expressindia.com June 16-30, 2013

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Cipla expands collaboration with Meda in allergic rhinitis segment Will build further on the existing collaboration by granting global commercialisation rights to Meda for Dymista

allergic rhinitis (SAR) in patients 12 years of age and older who require treatment with both azelastine

hydrochloride and fluticasone proprionate for symptomatic relief.

EP News Bureau – Mumbai

ipla is in collaboration with Meda in the field of allergic rhinitis.

Cipla and Meda will build further on the existing collaboration by granting global commercialisation rights to Meda for Dymista, excluding some markets for which Cipla will take the commercial lead.

With the same agreement, both companies will collaborate on follow-up compounds for Dymista, capitalising on intellectual property retained by both partners.

Commenting on the extended agreement, Subhanu Saxena, Global Chief Executive Officer, Cipla said, “We are pleased

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BOTH COMPANIES WILL COLLABORATE ON FOLLOW-UP COMPOUNDS FOR DYMISTA, CAPITALISING ON INTELLECTUAL PROPERTY RETAINED BY BOTH PARTNERS. THIS AGREEMENT IS PART OF A BROADER RELATIONSHIP BETWEEN THE TWO COMPANIES IN THE FIELD OF ALLERGIC RHINITIS

to announce the new agreement with Meda, who is our strategic partner in the area of Allergic Rhinitis.

Dymista nasal spray approved by US FDA, is a new patented product for the treatment of seasonal June 16-30, 2013

www.expresspharmaonline.com

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Quest Life Sciences to tap US market To register 10-15 products in the US market, expand its formulation facility in Chennai Usha Sharma – Mumbai hennai-based contract research company, Quest Life Sciences, plans to tap the US market.

The `9-crore company will be registering 10-15 new products in the pain management, gastrointestinal and CNS therapeutic segments in the US market by 2014 with an investment `35 crores. The company also plans to expand its formulation facility at

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Gummidipoondi, Chennai after the registration process.

TS Jaishankar, Managing Director, Quest Life Sciences said, “Presently in the international sphere, we have our business presence in rest-ofthe-World countries and to expand this, now we are targetting to explore the US market.”

“After the registration process in the US market, we plan to invest in our existing manufacturing unit at Gummidipoondi in Chennai.

With the help of this facility, we will be manufacturing products for the US market,”

added Jaishankar.

Quest Life Sciences conducts late phase trials involving multiple centres across India. It offers a complete range of ICH GCP compliant services for phase I to IV clinical trials and delivers cost effective, timely research solutions. The company offers a full range of clinical trial services, having extensive experience in conducting PK/PD (Pharmacokinetic-pharmacodynamic) studies. It has employed 65 scientists at its research centre and plans to increase head count at the facility to 200 (including office

staff) after the expansion.

With a current turnover of `9 crores, it is targeting to touch `12-15 crores in 2013-14 and ` 100 crores by 2017.

Commenting on the future roadmap of his company, Jaishankar said, “We provide end-to-end business solutions and work with many domestic, as well as multinational pharma companies. We have received queries from various companies and are in discussions. We are not interested in selling our company at any cost, however, are looking at forming strategic alliances.” u.sharma@expressindia.com

Zydus pioneers India’s first NCE, introduces Lipaglyn Will launch it in the Indian market by the end of third quarter

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he Zydus Group announced a breakthrough in its research efforts with Lipaglyn (Saroglitazar), a novel drug targetted at bridging an unmet healthcare need for treating diabetic dyslipidemia or hypertriglyceridemia in type II diabetes, not controlled by statins alone.

The drug has been approved for launch in India by the Drug Controller General of India (DCGI). With a novel action that offers lipid and glucose lowering effects in one molecule, Lipaglyn is reportedly the first Glitazar to be approved anywhere in the world. The company plans to launch it in the Indian market by the end of third quarter and intends to introduce it in the developed market in the next three to five years. “Lipaglyn provides patients suffering from diabetic dyslipidemia the option of a once-daily oral therapy that has a beneficial effect on both lipid parameters as well as glyceamic control,” said Pankaj R Patel, Chairman and Managing Director, Zydus Cadila. "It has always been our dream to take a molecule right from the concept stage up to its launch. Today, we have realised this dream. It is an important breakthrough and I would like to dedicate this to all the Indian research scientists in the field of drug discovery,” Patel added.

Diabetic dyslipidemia is a condition where a person is diabetic and has elevated levels of the total cholesterol, the ‘bad’ low-density lipoprotein (LDL) cholesterol and the triglycerides and a decrease in the ‘good’ high-density

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lipoprotein (HDL) cholesterol concentration in the blood. optimal LDL cholesterol levels for adults with diabetes are less than 100 mg/dL, optimal HDL cholesterol levels are equal to or greater than 40 mg/dL, and desirable triglycerides levels are less than 150 mg/dL. Lipaglyn, a non-thiazolidinedione, is the first therapy to be approved for this condition.

Discovered by the Zydus Research Centre, the dedicated new chemical entities (NCE) research arm of the Zydus group, Lipaglyn is a best-inclass innovation, designed to have a unique cellular mechanism of action following an extensive structure-activity relationship study initiated in the year 2000. Lipaglyn has a predominant affinity to PPAR alpha isoform and moderate affinity to PPAR gamma isoform of PPAR nuclear receptor subfamily. The molecule has shown beneficial effects on lipids and glycemic control without side effects. This molecule underwent extensive pre-clinical characterisation and the IND was submitted in the year 2004.

As a part of the clinical development programme, extensive phase-I, phase-II and phase-III clinical trials were conducted to evaluate the phamacokinetics, pharmacodynamics, efficacy and safety of Lipaglyn. The new drug application for Lipaglyn was based on a comprehensive clinical development programme spanning eight years.

Results from the first phase III programme with Pioglitazone as a comparator www.expresspharmaonline.com

drug in diabetes patients showed that the 4 mg dose of Lipaglyn led to a reduction of triglycerides and LDL (bad) cholesterol, and an increase in HDL (good) cholesterol as well as a reduction in Fasting Plasma Glucose and glycosylated haemoglobin (HbA1c), thereby confirming its beneficial effects of both lipid and glycemic control in diabetic patients. In the second phase III study, Lipaglyn was studied in diabetic dyslipidemic patients insufficiently controlled with statin therapy. The results from this study confirmed that Lipaglyn had a pronounced beneficial effect on both the lipid and glycemic parameters in these subjects.

In both the studies, Lipaglyn was well tolerated

and had a better safety profile than the comparators.

Importantly Lipaglyn has a non-renal route of elimination, and did not show adverse events like edema, weight gain, myopathies or derangement of liver and/or kidney functions, thus making it safe and efficacious. Lipaglyn is recommended for once daily administration as 4 mg tablets.

Zydus will offer a dedicated Lipaglyn support programme to patients and caregivers. The programme is expected to provide important support and information regarding access, adherence, education and thereby help patients to start and appropriately manage their disease and therapy over time.

EP News Bureau – Mumbai

Sun Pharma announces US FDA approval for generic depo-testosterone injection Is indicated for replacement therapy in males for conditions associated with symptoms of deficiency or absence of endogenous testosterone un Pharmaceutical Industries has received final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for generic version of depotestosterone injection, testosterone cypionate injection USP, 100 mg/ml and 200mg/ml.

This generic testosterone cypionate injection USP, 100 mg/mL and 200mg/mL is

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therapeutically equivalent to depo-testosterone injection of Pfizer and is indicated for replacement therapy in males for conditions associated with symptoms of deficiency or absence of endogenous testosterone. As per April2013, IMS MAT, the product had annual revenues of approximately $130 million in the US. EP News Bureau – Mumbai June 16-30, 2013

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Dr Reddy’s and Fujifilm call off JV for generic drugs in Japan Fujifilm realigns its longterm growth strategy for the pharma business

Products Division said, ”In the long-term we will be focussing more on priority fields such as new drugs in cancer field,

more value-added super generics, and bio-related business by using our core technologies: analysis technolo-

gies, original nanotechnology, and high reliability and high quality manufacturing technologies. Meanwhile, we

will continue future collaboration with Dr Reddy’s in other fields.”

EP News Bureau – Mumbai

r Reddy's Laboratories (‘Dr Reddy's’ hereinafter) and Fujifilm Corporation (Fujifilm hereinafter) have decided to terminate the Memorandum of Understanding (MoU) to enter into an exclusive partnership in the generic drugs business for the Japanese market and to establish a joint venture (JV) in Japan.

Based on the MoU signed on July 28, 2011, the two companies had conducted detailed studies on the establishment of a JV for developing and manufacturing generic drugs in Japan. However, as Fujifilm realigns its longterm growth strategy for the pharma business, both companies have led to a mutual agreement to terminate the MoU. The two companies will continue to explore partnership/alliance opportunities in other pharma businesses such as active pharmaceutical ingredient (API) development and manufacturing, contract research and development and manufacturing, and the development and marketing of super-generics.

Sarabjit Kour Nangra, Vice President Research, Pharma, Angel Broking said, “Given that the JV does not contribute, this will not change our estimates and hence maintain our buy recommendation on the stock with a target price of `2535.”

Commenting on the development, GV Prasad, Chairman and Chief Executive Officer, Dr Reddy's said, "Unfortunately, we will not be able to partner with Fujifilm specifically for generic formulations business in Japan. However, I want to reinforce our commitment towards a planned entry into Japan to bring affordable and innovative drugs to more patients worldwide."

Takatoshi Ishikawa, Director Corporate Vice President and General Manager of Pharmaceutical

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June 16-30, 2013

www.expresspharmaonline.com

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M|A|R|K|E|T DEAL TRACKER

M&A activity increases significantly in value terms with a focus on core therapy areas Indian pharma sector witnesses no deals during May 2013 Figure: M&A (including private equity) trend analysis

Source:

Top M&A deals (May 2013) Rank

Date

Target

Acquirer

Deal value ($m)

1

05/27/13

Bausch & Lomb Incorporated (US)

Valeant Pharmaceuticals International, Inc. (CA)

8700

2

05/20/13

Warner Chilcott Plc (US)

Actavis, Inc. (US)

8500

3

05/28/13

Omthera Pharmaceuticals, Inc. (US) AstraZeneca PLC (GB)

443

4

05/22/13

DOC Generici s.r.l. (IT)

Charterhouse Capital Partners LLP (GB)

425.19

5

05/29/13

Okairos AG (IT)

GlaxoSmithKline plc (GB)

322.6

6

05/08/13

Inviragen, Inc. (US)

Takeda Pharmaceutical Company Limited (JP)

245

7

05/01/13

Intrexon Corporation (US)

Randal J. Kirk; Third Security, LLC; Undisclosed Investors

150

8

05/02/13

Symphogen A/S (DK)

Novo A/S; Pensionskassernes Administration A/S; Danica Pension

54.06

9

05/15/13

Tokai Pharmaceuticals, Inc. (US)

Apple Tree Partners; Novartis Venture Funds; Undisclosed Investors

35.5

10

05/13/13

Dyax Corp. (US)

RA Capital Management, LLC; Venrock; Federated Investors, Inc.; Undisclosed Investors

30

Source:

Figure: Venture financing trend analysis

&A activity in the pharmaceutical sector witnessed significant increase in value terms with a focus on expanding complementary product pipelines in core therapy areas. The pharma sector recorded M&A deals worth $19 billion during May 2013, an increase of seven times over the previous six months’ average of $2.7 billion.

In line with the above trend, Actavis agreed to acquire Warner Chilcott, a US-based specialty therapeutics company, for approximately $8.5 billion. This acquisition augments Actavis’ specialty brands business in core areas of women’s health and urology and also adds gastroenterology and dermatology therapeutic categories along with marketing infrastructure.

This transaction will enhance the value of each company's portfolio and provide a substantial foundation to support the successful launch of new products over the next several years, particularly in women’s health, including Minastrin 24 Fe; Esmya; metronidazole vaginal gel 1.5 per cent; the progestin-only contraceptive patch and other complementary products under development.

In another key deal, UK-based AstraZeneca agreed to acquire Omthera Pharmaceuticals, a US-based specialty pharma company for approximately $443 million. This transaction complements AstraZeneca’s existing portfolio in cardiovascular and metabolic disease, one of its core therapy areas.

With this acquisition, AstraZeneca will gain access to Epanova, a novel omega-3 free fatty acid composition being developed for dyslipidemia treatment.

In another high value deal, Canada-based Valeant Pharmaceuticals agreed to acquire Bausch + Lomb, a USbased eye health company, for $8.7 billion. The transaction will significantly strengthen Valeant’s capabilities in ophthalmic pharmaceuticals, contact lenses and lens care products, and ophthalmic surgical devices and instruments.

M&A activity in the pharma sector decreased in volume and increased in value terms, when compared to the average of previous six months (Nov 2012 – Apr 2013).

According to Datamonitor’s Medtrack database, the pharma sector recorded 22 M&A transactions in May 2013, against the previous six months’ average of 34.5 transactions. In value terms, the sector recorded deals worth $19 billion against the previous six months’ average of $2.7 billion.

The Indian pharma sector witnessed no deals during May 2013, against the average of one deal over the previous six months.

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Venture Funding Companies in the pharma sector raised $202.4 million during May 2013, against the previous six months’ average of $298.1 million. In terms of volume, the sector recorded 10 venture funded deals, when compared to the previous six months’ average of 23.6 transactions.

Notes and definitions

Source:

Top venture financing deals (May 2013) Rank

Date

Target

Investors

Deal value ($m)

1

05/09/13

Trevena, Inc. (US)

Forest Laboratories Holdings, Ltd.; Alta Partners; HealthCare Ventures LLC; Yasuda Enterprise Development Co., Ltd.; New Enterprise Associates, Inc.; Polaris Venture Partners

60

2

05/29/13

Ophthotech Corp. (US)

Novo A/S; Clarus Ventures, LLC; SV Life Sciences; HBM Healthcare Investments Ltd

50

3

05/20/13

eFFECTOR Therapeutics, Inc. (US)

U.S. Venture Partners; Abingworth Management Limited; Novartis Venture Funds; SR Onep; Astellas Venture Management LLC; Osage University Partners; Mission Bay Capital, LLC

45

4

05/08/13

Lumena Pharmaceuticals, Inc. (US)

Pappas Ventures; RiverVest Venture Partners; Alta Partners

23

5

05/28/13

Trino Therapeutics (IE)

Fountain Healthcare Partners; Enterprise Ireland; Growcorp Group Limited; Wellcome Trust

11.6

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Definitions: 1. Deal value trend is based on transactions where associate values have been disclosed.2. Trend analysis excludes rumored and terminated deals.3. Value and volume analysis excludes private equity exits.

For more information, visit at www.medtrack.com

Source:

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Medtrack is a comprehensive, fully integrated, global biomedical database providing information on companies, products, patents, deals, venture financing, and epidemiology. It is a live database, constantly updated with news, milestones, trial information, etc. Medtrack’s unmatched coverage is supported by a user-friendly, highly dynamic set of decision support tools and analytics. Inhouse analysts and researchers add key insights and conclusions to provide you with the primary and secondary information you need. Key uses of the database include competitive intelligence, target identification, screen potential licensing and investment opportunities, patent assessments, product due diligence, royalty valuations, and developmental benchmarking.

www.expresspharmaonline.com

June 16-30, 2013

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EVENT BRIEF Innopack Pharma Conference Date: June 27-28, 2013 Venue: Mumbai Summary: InnoPack India 2013 focuses on innovation in pharma packaging for compliance and safety. A contentbased conference with high level keynotes, exciting learning formats and unparalleled networking sessions covering a host of topics like, innovations in patient compliance packaging, packaging materials and drug delivery devices, effective anti-counterfeiting measures and packaging regulatory compliance, will be held.

InnoPack India 2013 will gather a host of packaging experts including Laura Bix, Associate Professor, School of Packaging - Michigan State University, Robert Winter, Director Materials Management, Pfizer, Gautama Buddha, Senior Director Packaging Development, Dr Reddy's Laboratories,

June 16-30, 2013

Santanu Chowdhury, Associate Director Packaging Development, Ranbaxy, Prashant Kane, Senior General Manager Packaging Development, Sun Pharma Advanced Research Centre and others who all are at the centre stage of developing innovative packaging for pharma globally.

Contact details: Tel: (022) 61727001 Email: Conferencesindia@ubm.com Website url: http://www.innopackindia.com/?utm_campaign=M EDIAPARTNER&utm_medium=EVENTLISTING&utm_so urce=EXPRESSPHARMA

Seminar on Managing Process & Powder Safety Date: June 28, 2013 Venue: The Lalit, Mumbai Summary: Intertek India has put together a one day training programme whose objective is to make the partici-

pants aware of the inherent risks involved during chemical/pharmaceutical manufacturing and taking action on them. This seminar is aimed at technicians, chemists, chemical engineers, plant managers and safety specialists who wish to understand the various hazards posed by static electricity, dust explosions, runaway reactions and how to investigate processes and unit operations for thermal hazards. In order to do this successfully, it is necessary to fully understand the thermal data and the means by which it can be acquired.

This seminar advocates a structured approach supported by theory and case studies focusing on the role that laboratory thermal data has in an overall risk minimisation strategy.

This course will introduce you to the theory of static electricity and its hazards in day-to-day operations. It will then elaborate on how powders should be safely handled with specific emphasis on drying and milling operations. Next the course will focus on ther-

www.expresspharmaonline.com

modynamics of a chemical reaction, identifying and preventing runaway situations and managing the risks involved therein. The medium of instruction will be through films, presentations, case studies and problem solving exercises.

Contact details: Munmun Dey Kundu Intertek India ‘F’ Wing, 2nd Floor, Tex Centre, Chandivali Farm Road, Andheri (E) Mumbai – 400 072 Tel: 022 - 42450204 or Mob: 09930554776 munmun.deykundu@intertek. com

Seminar on 'Widening the Horizons for Practicing Pharmacists in Industries and Hospitals'

Summary: PSG College of Pharmacy will organise a national level seminar on 'Widening the Horizons for Practising Pharmacists in Industries and Hospitals'. The seminar will be co-sponsored

by Department of Science and Technology (DST), New Delhi and The Tamilnadu Dr MGR Medical University, Chennai. The seminar will highlight the concept of practising pharmacist services in community and the opportunities/role for pharmacist in the healthcare industry.

Contact details: Tel: 0422-4345841 Email:principalsgcp@gmail.com Website: www.psgpharma.ac.in

4th Annual Pharma Supply Chain Summit Date: July 11-12, 2013

Date: July 5-6, 2013 Venue: Mumbai Venue: PSG College of Pharmacy, Peelamedu, Coimbatore-641004, Tamil Nadu

Summary: Now in its 4th year, CPhI’s Annual Pharma Supply Chain Summit would be focus-

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ing on practical case studies and open discussions on important topics like Government Policies - GST Act, extensive use of IT for visibility and automation of supply chain, optimising international logistics and the critical debate on 3PL for effective outsourcing of supply chain. The topics will be discussed in innovative networking formats like speed geeking, i3 centre, clash of the titans and the end of the conference by a relaxing cocktail reception.

Contact details: Tel: (022) 61727001 Email: Conferences-

india@ubm.com Website url: http://www.pharmasupplychainindia.com?utm _campaign=MEDIAPARTNER&utm_medium=EVENTL ISTING&utm_source=EXPRE SSPHARMA

Pharmac India 2013

material exhibition going to be held in Hyderabad, Hitex. It has successfully brought together manufacturers and buyers on a common platform and contributed substantially towards the growth of the industry. Pharmac India 2013 is jointly organised by Orbit Exhibitions and IDMA (GSB) and actively supported by BDMA and CIPI.

Date: September 5-7, 2013 Venue: Hitex, Hyderabad Summary: Pharmac India 2013 is 4th International pharma machinery, equipment, bulk drugs, API and

Contact details: Varsha Surve Manager - Exhibitions Orbitz Exhibitions 101, Navyug Industrial Estate, TJ Road, Siwree (W) Mumbai - 400015

Mob: 9322037955 Email: info@pharmacindia.com

CPhI India Date: December 3-5, 2013 Venue: Bombay Exhibition Centre, Mumbai Summary: Reflecting the continued growth in the API, generics, fine chemicals and bio-pharmaceuticals industries on the Indian sub-continent, CPhI India and related pharma services events saw an increase in visitors and exhibitors. CPhI

India will bring pharma professionals from all over the world to Mumbai and facilitates initiating and closing business deals. Take this opportunity to showcase your products and services while enhancing your brand at South Asia’s leading pharma industry event.

Contact details: Chaitali Patil UBM India Times Square Unit No 1 and 2, B Wing, 5th Floor, Andheri Kurla Road, Marol,Andheri (East) Mumbai - 400 059 T +91 22 61727162 F +91 22 61727273 E chaitali.patil@ubm.com

POST EVENT SCDM Asia Conference receives overwhelming response Event held for the first time in India sees more than 150 participants from seven countries

Management, St Jude Medical inaugurated the conference and delivered the welcome speech. Paula

Brown Stafford, President, Clinical Development, Quintiles and VK Raman, Head of Global, BPO

Services, TCS, gave the key note address.

The conference focused upon 'The Changing

Usha Sharma – Mumbai ociety for Clinical Data Management (SCDM) recently concluded the SCDM Asia Conference in Mumbai. The two-day conference from May 31 to June 1, 2013, was the first one to be held in India and outside the US. More than 150 participants from seven countries took part in the conference and were represented by 50 companies. The theme of the conference was ‘The Changing Landscape of Clinical Data Management (CDM): Transformational Trends and Technological Innovations.’

Jennifer Duggan, Director, Clinical Data

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EXPRESS PHARMA

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June 16-30, 2013

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Landscape of CDM: Transformational Trends and Technological Innovations', and represented the who's who of the CDM industry in India, as well as countries such as China, Japan, Australia, the US, the UK and Sweden as well. Risk-based monitoring, project management methodologies, Transcelerate, CPI, CTTI, Lean Six Sigma in CDM, outsourcing, Big Data, semantic interoperability and personalised medicine, were some of the highlights of the meeting.

In her keynote speech, Stafford presented the trends in the information management from 20102015, with real world therapeutic evaluation. She highlighted the three data-driven innovations like risk assessment, data surveillance and dynamic monitoring with real time challenges.

Raman stressed on the changing landscape of CDM transformation trends and technological innovations.

He pointed out the trend of decreasing approvals on the global front with the soaring costs. He also shared his views on the importance of social media and suggested an effective partnership, not only between pharma companies but also with the regulators.

On the second day, Baljit Samra, Country Manager, Parexel India delivered the keynote at the conference.

The evolving role of the CDM leader in Asia, retention challenges, the need for competency development and the role that SCDM could play through its professional certification programme, the growing recognition of India as a destination for high quality and communication as a key skill were some of the important take home messages. The conference touched upon important subjects ranging from talent pool in the CDM industry to innovative metrics, advancements in data collection to system integration, risk management and outsourcing challenges.

Some of the prominent names addressing the gathering included Jonathan Andrus, Vice Chair, SCDM and Sr VP, Operations, BioClinica, Conference CoChairs Dr Nimita Limaye from TCS and Dr Suresh Bowalekar – Biostatistics, India and Terilynn Koster – Vice President, Global Data Management, inVentiv June 16-30, 2013

Health Clinical. The overwhelming response that this conference received and its success has set the ball rolling for SCDM to participate and organise more such conferences outside of the US. Revealing more details on the success of the event Andrus said, “After the success of SCDM Mumbai con-

ference, we are contemplating conducting more such events in Asia. This was the first time we have conducted the event in India and there are plans to have similar conferences in Bangalore; as well as Singapore.”

He also revealed the key reasons behind conducting the conference in India, “We strongly felt the urge to have

an event in India because financially it is not viable to train in the US. I am very happy and as a company we are planning to do a technology partnership for the 2014 event. I strongly feel that research-based companies should come together for a joint partnership which we did not have this year.”

Raman further said, “I

believe industry fora like these help professionals update their knowledge, renew their contacts and contribute to the furtherance of the domain. I enjoyed being in the midst of learned colleagues from the bio pharma industry and was happy to share my perspective.” u.sharma@expressindia.com

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Headquarters: Glatt Ingenieurtechnik GmbH Nordstrasse 12, 99427 Weimar / Germany phone: +49 -3643 -47-0 fax: +49 -3643 -47-1271 eMail: info@glatt-weimar.de Indian Office: Glatt (India) Pharma Engineering Pvt. Ltd. 13 Ground Floor Palam Marg, Vasant Vihar New Delhi - 110057 / India phone: +91 -11 - 460 529 60 / 61 / 62 fax: +91 -11 - 460 529 64 eMail: info@glatt-india.com

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W H AT ’ S INSIDE

MANAGEMENT INSIGHT FOR MANAGING PHARMA

Nutraceuticals – on the move… PG 32 Whistleblower Protection in India – Delay in framing legal enactment will harm the public interest PG 35

RESEARCH 37 PHARMA ALLY 44 PHARMA LIFE 78 28

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June 16-30, 2013

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‘Drug price controls aren’t the only solution’ KIRAN MAZUMDAR SHAW Chairman and Managing Director, Biocon

Any move that makes healthcare affordable for patients is welcome, but drug price controls aren’t the only solution. The Government can’t expect the industry to bear the full burden of making medicines affordable, while abdicating its responsibility towards public health. The Government should speedily come out with a policy for universal healthcare coverage (UHC) to

address the needs of the poor. The pharma industry is a highly regulated one and drugs account for only 15 per cent of total healthcare costs, which means that there are other costs which also need to be regulated.

Apart from drug price control, the Government needs to also address other more serious issues like the sale of spurious and sub-standard drugs in the country. The price ceiling formula should have been based on a weighted average of prices and not a simple average as has been done. The simple, average formula fails to create a level playing field between integrated companies with end-to-end infrastructure and others that are virtual companies with hardly any overhead costs. The Government, in fact, needs to incentivise investment in manufacturing and R&D.

‘Adverse impact of DPCO will be significant on OPPI member companies’ TAPAN RAY Director General, Organisation of Pharmaceutical Producers Of India (OPPI) Immediate adverse impact of DPCO 2013, on both sales and margins, will be quite significant to OPPI member companies. However, a change from cost-based to market-based pricing methodology is expected to have transparency and be directionally more prudent for the pharma industry on a longer term perspective.

‘The paradigm shift from cost-based pricing to market-based pricing has been long overdue’ DAARA B PATEL Secretary-General, Indian Drug Manufacturers Association India’s search for a universal formula to fix prices of essential drugs appears to have been addressed with the new pharma policy and the DPCO 2013 endorsing market-based pricing method as the panacea to this perennial problem of balancing public need and industry’s survival and growth. The various drug policies, all these years, were broadly based on the principle of putting a ceiling on prices of the most popular drugs on a 'lowest common denominator' basis. The Government finally realised that keeping prices under strict control and artificially very low will neither benefit the patients, nor the industry. The National Pharma Pricing Policy (NPPP) 2012 envisaged three key principles — essentiality of drugs, control only on formulations and market-based pricing.

The paradigm shift from costbased pricing to market-based pricing has been long overdue, as it has been stunting the industry’s growth and forcing manufacturers to discontinue production of some controlled

THE GOVERNMENT FINALLY REALISED THAT KEEPING PRICES UNDER STRICT CONTROL AND ARTIFICIALLY VERY LOW WILL NEITHER BENEFIT THE PATIENTS, NOR THE INDUSTRY June 16-30, 2013

drugs since they were proving highly unviable. Today, the Indian economy is largely market-driven, with prices determined by market conditions and market forces.

The Department of Pharmaceuticals has now notified the DPCO 2013 and recommended that a simple average of all the products in a therapeutic category with at least one per cent market share is to be considered based on IMS data. It would not be out of place to mention here that manufacturers are not in agreement with the prices arrived at through IMS data and hence National Pharmaceutical Pricing Authority (NPPA) has asked manufacturers to provide information on prices (all inclusive) of the products.

The DPCO 2013 does not provide any distinction for formulations under the National List of Essential Medicines (NLEM), which are both in hard gelatin and soft gelatin capsules, although separate norms existed in the DPCO 1995. Similarly SR, CR, once-a-day tablets etc. also have the same dosages as ordinary products, but are distinctly more beneficial therapeutically and hence need to be priced as well as marketed differently; which the new DPCO seems to have overlooked. The pharma industry needs to be provided some returns to invest in Novel Drug Delivery Systems (NDDS), newer and better therapies and drugs; otherwise patients will not benefit as they will not have access to the same. The prices revised by the Government have to be implemented within 45 days of notification. This is draconian and an almost impossible situation, it involves recalling lakhs of retail packs from over 600,000

retailers and thousands of stockists from all over the country and repacking them with the revised price labels. It is unfair and illogical to hold the manufacturer responsible for ensuring that all retail packs with chemists all over the country are returned. This also will lead to shortages in the market for many weeks and months, not to mention heavy losses to manufacturers in carrying out this herculean exercise and then having to repack /relabel each pack.

How the issue of excise calculation all over again would be worked out

will need to be seen once this exercise begins.

On the whole, the DPCO 2013 appears to be fairly well balanced with availability and affordability being taken care of by ensuring that there is control on essential medicines, at the same time allowing market forces to ensure that prices are affordable. It is a very rational attempt at achieving a fine balance between reasonable prices, uninterrupted availability, administrative feasibility, future growth and investment.

'A win-win policy for all stakeholders' AMEESH MASUREKAR Director, AIOCD Pharmasofttech AWACS DPCO 2013 is truly a win-win move for the patient, pharma industry and the Government. Indian pharma industry generates approximately `70,000 crore turnover with a 15 per cent gross margin which by any means is not profiteering. However cheaper/affordable medicines are a requirement in all societies for all times to come. What NLEM 2012 and DPCO 2013 have done is that they have carved out key medications in each and every therapy to cover all the common illnesses. An adequate list of medicines has been brought under price control to ensure that the less fortunates have access to medicines for every illness. The ball is now in the doctors' court – how they choose economical alternatives for patients who cannot afford to pay more. Even in these medicines, ensuring market-based pricing instead of cost-based policy will in turn ensures that top quality players stay interested in the market and do not discontinue/withdraw the brands – like what happened to 40 per cent of the medicines in the 1995 DPCO list. Thus the twin aim of making medicines affordable and available can be achieved with DPCO 2013. The aim of the Government (or even the most ardent of patient groups) was never to punish any pharma company or kill the profitability of the industry. After all, it gives great export earning plus employment to lakhs of people employed in pharma companies as well as engaged in the pharma trade, not to mention the significant excise and corporate profit tax that it generates. The policy will pinch, but most companies will be able to overcome that and the sector will remain viable and vibrant.

To summarise about this policy, it gives patients quality medicines at affordable prices while allowing the survival and growth of the pharma sector. Truly a win-win policy for all stakeholders.

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‘DPCO 2013 will equally affect domestic as well multinational pharma companies’ AMIT BACKLIWAL Managing Director, IMS Health — South Asia

The DPCO 2013 aims to put in place a regulatory framework for pricing of drugs so as to ensure availability of 'essential medicines' at reasonable prices to end consumers. Based on their extensive databases, deep insights and knowledge of the pharma market, an expert team from IMS Health has deep dived into this issue and found:

Impact at company level Both local companies and MNCs stand to lose almost equal quantum of sales on account of DPCO 2013 implementation. However as expected, MNCs will be hit relatively harder as compared to local companies on account of their premium priced portfolio. While at an overall level, local companies would lose ~1.6 per cent of their current revenue, MNCs are likely to see ~3.7 per cent erosion in their sales.

Companies Most Impacted By DPCO 2013 MAT Value

Value of NLEM Portfolio

Contribution of NLEM Portfolio

72762

13033

18%

Revised Value of NLEM Portfolio

Value Erosion

Value Erosion % on Total TO

11437

1597

2.2%

% TOTAL MARKET

%

GLAXOSMITHKLINE

3021

837

28%

671

167

5.5%

ABBOTT

5122

1189

23%

1035

154

3.0%

RANBAXY

3015

753

25%

620

133

4.4%

PFIZER

2351

462

20%

344

118

5.0%

ZYDUS CADILA

2887

749

26%

652

96

3.3%

NOVARTIS INTL.

1223

373

31%

277

96

7.9%

CIPLA

3589

854

24%

762

92

2.6%

WIN MEDICARE

346

156

45%

92

65

18.7%

ALEMBIC

1215

297

24%

240

57

4.7%

SANOFI

2077

314

15%

263

51

2.4%

SUN

3174

363

11%

317

46

1.4%

WOCKHARDT

1252

237

19%

195

42

3.3%

DR REDDYS LABS

1504

296

20%

256

37

2.5%

Source IMS Health, Total Sales Audit March 2013 MAT Value

Revised Value Post

DPCO 2013 Implementation

Rs Cr

Rs Cr

Rs Cr

%

72762

71166

1597

2.2

ACUTE

51807

50654

1153

2.2

CHRONIC

20955

20511

444

2.1

TOTAL MARKET

Value Erosion

Source IMS Health, Total Sales Audit March 2013

Impact Of DPCO 2013 On Therapies Revised Value Post DPCO 2013 Implementation

MAT Value

Value Erosion

Rs Cr

Rs Cr

Rs Cr

%

Impact at therapy level

Total Market

72762

71166

1597

2.2

The impact of DPCO 2013 implementation on acute and chronic therapies is almost identical. Both segments are likely to witness a drop in annual revenue of ~2.1 to 2.2 per cent. However, patients on chronic therapies who are currently using those packs listed under NLEM 2011 and which are currently above ceiling price, will benefit more in the long term.

Anti-infectives

11892

11420

472

4.0

Cardiac

8505

8246

259

3.0

Gastro Intestinal

7613

7476

137

1.8

Neuro / CNS

4322

4206

117

2.7

Dermatology

4012

3907

106

2.6

Gynaecology

4073

3985

89

2.2

Pain / Analgesics

5936

5855

81

1.4

Vaccines

1387

1309

78

5.6

Hormones

1285

1214

71

5.5

Anti Diabetic

5000

4942

59

1.2

Respiratory

5711

5680

31

0.5

Blood Related

771

743

28

3.7

Source IMS Health, Total Sales Audit March 2013

Impact Of DPCO 2013 On Formulations Listed Under NLEM 2011 MAT Value

Revised Value Post DPCO 2013 Implementation

Value Erosion

Rs Cr

Rs Cr

Rs Cr

%

Total Market

72762

71166

1597

2.2%

Amoxicillin Trihydrate + Clavulinic Acid Potassium Salt Tablets 625mg

638

540

98

15%

Atorvastatin Tablets 10 mg

365

310

54

15%

Ciprofloxacin Hydrochloride Tablets 500 mg

231

179

52

22%

Omeprazole Capsules 20 mg

213

166

47

22%

Azithromycin Tablets 500mg

301

255

46

15%

Povidone Iodine Ointment 5%

106

66

40

38%

Premix Insulin 30:70 injection Injection 40IU/ml-SR/CR/XR

361

324

37

10%

Povidone Iodine Solution 5%

84

50

34

41%

Levothyroxine Tablets 50µg

82

51

31

37%

Hepatitis B Vaccine Injection

69

39

29

43%

Tetanus Toxoid Injection

79

50

28

36%

Folic Acid Tablets 5 mg

101

72

28

28%

Source IMS Health, Total Sales Audit March 2013

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June 16-30, 2013

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‘Longer-term growth prospects’ the policy’s key positive is the shift that it brings in from a cost-based approach to a market-based mechanism, which according to many market players is expected to bring in greater transparency.

‘This pricing policy would help on affordability issue’ SUJAY SHETTY Leader Pharma Life sciences, PwC India The impact on the pharma industry revenues will be limited for around 12-18

months, post which the product portfolio will evolve to overcome the dip in the revenue. For consumers this pricing policy would help to some extent with the issue of affordability. Overall this is a solution which the industry and Government can live with as opposed to the alternative price control formulas based on cost of production etc.

SUBRATA RAY Senior Vice President, Co-head— Corporate Sector Ratings, ICRA ICRA expects that the latest proposed market-based pricing mechanism for the Indian pharma industry would impact near term earnings of pharma companies with relatively higher dependence on the Indian market. With the NLEM estimated to cover almost 20 per cent of the `728 billion domestic formulation business, an expected price cut of 15-20 per cent will erode the market by three to four per cent. Its impact on earnings will be higher as much of this will directly eat into the relatively higher margin India business.

Companies with higher dependence on the Indian market (Indian arm of MNCs, mid-size pharma companies), premium-pricing strategies and greater share of acute therapy segments (70 per cent of NLEM) will be impacted the most.

Conversely, the impact of the new policy would not be substantial on companies that have a sizeable share of earnings from regulated markets, especially US generics.

Companies are likely to review their portfolios over the medium-to-longer term but in the near-term cost rationalisation measures like scaling down promotional/marketing budgets, consolidating field force etc. appear to be more achievable goals. Unlike earlier, price revisions, in line with change in WPI or otherwise for drugs that are not under NLEM, may become a common phenomenon now. The policy has also tightened the norms, for pricing drugs that involve any changes; especially combination therapies (involving even a single molecule from NLEM) will fall under price control. Besides benefitting the consumers,

June 16-30, 2013

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'It would be too early to call this policy a boon or bane'

'Government should also focus on affordability and access'

DHEERAJ AGGARWAL

SUBHANU SAXENA

CFO, Venus Remedies

Chief Executive Officer, Cipla

The NELM policy is adopted to strike a balance between the growing pharma industry of the nation and offer accessibility and availability of reasonably priced medicines to the consumers, particularly the poorer masses. The regulation of medicines' prices is based on the prices of the formulations only. This ensures specific pricing control of the required medicines which are prescribed by doctors, and is in the interest of the consumers. Research products (patented) are kept outside this scheme; therefore there would not be much impact on Venus and other pharma companies, which are driven by research products. Besides this, as the policy is applicable only to the domestic sales, export driven pharma companies also fall out of this scheme, thereby keeping the impact on margins to almost negligible.

Certain products of Venus Remedies fall under the NLEM 2011.

However, pricing of these products are already low as compared to the market leaders, therefore the impact of the policy on the company would be minimum. We are sure that a part of the impact, if any, can be passed on to the API suppliers.

Moreover, as the Ministry of Health and Family Welfare, Government of India has not fixed and announced the ceiling price for the NLEM 2011, it would be too early to call this policy a boon or bane for the Indian pharma industry and its players.

Whilst the move to market-based pricing is positive, the Government must focus on the real issue which is affordability and access for all medicines in India. We already have the lowest prices in the world for generics.

Since the Government has already constituted a committee to regulate patented medicines, the government must quickly put in place a mechanism to address the more important point — affordability of patented/monopoly products. This could be either by way of reference pricing or compulsory licensing in return for reasonable royalties. The Government should join hands with the industry to put health of the nation as a top policy priority. This means that the Government must immediately overhaul the current new drug approval mechanism and make it more pragmatic and relevant to India's health needs.

This will also restore the confidence of all stakeholders. Industry is willing to invest in innovation and manufacturing to improve patients' lives if the government provides the support and incentives to do so. Together we can build a pharma industry that is the envy of the world.

To conclude, post DPCO 2013, patients may spend less on medicines as the new policy underlines affordability of medines. On other hand, it is likely to hit the bottom lines of both domestic and MNC pharma companies and could even harm industry. Companies with sizable revenues from the US market will not feel the pinch as much. In the long run, government needs to find a better compromise between price and access to medicines.

(With inputs from Shalini Gupta), u.sharma@expressindia.com

INSIGHT

Nutraceuticals– on the move…

Suhas Wadwalkar, Vice President — Corporate Affairs, Premier Nutraceuticals, focuses on the fresh and emerging segment of evidence-based nutraceuticals now being referred as ‘Third Generation Nutraceuticals’ utraceutical segment in India is on the up rise. Success could be definite but not easy. A foray into this segment needs thorough understanding of the healthcare industry segmentation, the nuances between the wellness and illness orientation, the converging economic and demographic trends, changing laws and rules impacting the industry, scientific work happening at the world stage, the paradigm shift in the attitude of healthcare professionals towards nutraceuticals, threats and concerns pertaining to drug segment and the unfolding advantages of being in the nutra segment.

An in-depth analysis of these factors will be the basis to strategise the way forward

N

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to enter into this burgeoning market. I have written an article which gives a brief insight touching the broader aspects of this industry segment in the present context.

Evidence-based nutraceuticals are now being referred as ‘Third Generation Nutraceuticals’ which is different from the current and conventional market of `8500 crore comprising mostly of vitamin, minerals, hematinic and calcium and protein preparations. The focus is on scientifically studied, clinically supported and standardised new ingredients derived from food, plants and from animal resources. The attempt in this article is to see how we can expand the market space and not just share the existing market. www.expresspharmaonline.com

Nutraceutical market scenario The `80,000 crore Indian healthcare prescription market has been traditionally dominated by pharmacological products. The reason being that the industry mainly relied on the prescription

support of healthcare professionals who need to be convinced about the science behind each product which was amply found in the pharmaceutical products.

Nutraceuticals lagged behind due to lack of adequate scientific data and standardisation.

However, in the recent past several developments in the industry have catapulted the nutraceutical segment as the ‘sunrise segment’ drawing attention from prominent players in the industry. ● The global nutraceutical market is around `7 lakh crore (mostly in consumer health care) ● The Indian nutraceutical prescription market is estimated to be `8500 crore but growing rapidly with new products and new players entering the market segment in life style related, chronic diseases and women’s’ health. ● Market volumes are curJune 16-30, 2013

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rently dominated with vitamins, minerals, hematinic, calcium andcombinations, protein supplements and antioxidants. Rapid growth in the segment is perceived with the advent of new age nutraceuticals.

Nutraceuticals vs.

Pharmaceuticals

THE ` 80,000 CRORE INDIAN HEALTHCARE PRESCRIPTION MARKET HAS BEEN TRADITIONALLY DOMINATED BY PHARMACOLOGICAL PRODUCTS.THE REASON BEING THAT THE INDUSTRY MAINLY RELIED ON THE PRESCRIPTION SUPPORT OF HEALTHCARE PROFESSIONALS WHO NEED TO BE CONVINCED ABOUT THE SCIENCE BEHIND EACH PRODUCT WHICH WAS AMPLY FOUND IN THE PHARMACEUTICAL PRODUCTS

This has facilitated the smooth growth of this sunrise industry by addressing the issues under one roof with clarity and transparency.

The growth drivers Today the opportunities are plenty. There are empty spaces in the market, industry is getting flooded with

Although both nutraceuticals as well as pharmaceuticals are integral parts of the Indian healthcare industry and both are prescribed by the doctors, there is an inherent difference between these two segments which need to be captured by a marketing manager for positioning ● In general, drugs are chemicals which are invented and tested and nutraceuticals are the natural entities that are discovered and developed. ● Drugs need to establish their safety whereas in nutraceuticals the safety is well established by its wide and long term use in different geographical population groups and what needs to be established is its comparative efficacy through standardisation of dosage. ● Drugs are mainly focused on treatment and illness whereas nutraceuticals are primarily into prevention and support ensuring wellness. However, now with the advent of newly developed ingredients like nutraceutcal antibacterial-Hibiscus safdarifa or nutraceutical anti-diabetic like Chromium dinico systeinate, a change is noticed in the perception of this product segment and the treatment factor is also featuring in this segment. ● Supported by robust scientific study, clinical trial data and standardisation, now the nutraceuticals can also make health claims like drugs after the regulatory approval following the evaluation of these claims by the said authority.

Regulatory support for nutraceuticals The Food Safety and Standards Act, 2006 consolidates eight laws governing the food sector and establishes the Food Safety and Standards Authority of India (FSSAI) to regulate the sector and other allied categories.

June 16-30, 2013

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newer and more advanced nutraceutical entities from world over, the ethical market is openly welcoming new entrants, competition is not yet intense and multiple growth drivers are in place.

Hence, in all probability, there could not be a better timing to aggressively enter this market segment in India than now. ● Nutraceuticals enjoy support of 70 per cent specialists. One out of four prescriptions carry a nutraceutical product – ORG IMS ● Booming research and development activities, robust scientific back-up and clinical trial and validation of new nutraceutical entities paving way for a major growth in the segment especially in developing countries. ● While the new drug pipe line is drying the nutraceutical ingredients are pouring from world over ● Changing demographics and increasing life span creating more demand for supportive products in age related disorders ● Sedentary lifestyle pushing up demand for life style related preventive & supportive healthcare products ● Increasing disposable incomes and growth in aspirations to lead of better quality of life also positively impacting the demand for nutraceutical entities proven to add value to a healthy life style ● Governmental control over the pharmaceutical drugs but new regulatory regime under FSSAI streamlining the entry of nutraceuticals helping the segment to ensure a sustainable growth

Leading global suppliers of nutraceutical ingredients The global activity in standardising nutraceutical ingredients is being passionately promoted by some of the most reputed healthcare companies of international standards. Their massive and well developed infrastructure for scientific research and development is rolling out innovative ingredients addressing the crucial healthcare needs of patients’ world over.

Most of the very large nutraceutical ingredient companies operate globally, such

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as BASF, ADM, Cargill, Lonza, Tate and Lyle, DSM, Danesco, Lane Labs, PL Thomas, DuPont, Evonik, Danone, Dow Chemicals, Cognis, Bactolac, Gnosis, Naturex, Pharmachem Labs, Fruitarom, Helios Corp, Innovactive, Interhealth, Albion, and many more offering a wide range of standardized & branded nutraceuticals.

Some of these companies also have their agents in India.

Some fertile categories and promising ingredients Following list of categories and the multiple ingredients addressing vital needs of each category reveals not just the goodness of nutraceutical products but the richness with which they are getting projected across the world.

The consistent value addition by the originators adds to the existing confidence in the products pertaining to their efficacy and safety. ●

Bone health While Calcium supplementation dominates the treatment course other emerging ingredients like

Collagen Type I from plant and animal sources, short chain fructooligosaccharides (scFOS), Natural vitamin K2, known as menaquinone-7 (MK-7), synthetic derivative of the isoflavone genistein, Galactooligosaccharides (GOS) & also Inulin have been proven to slow down resorption and enhance calcium absorption and retention in the bones. ● Joint health Nutraceutical ingredients have made a promising entry into this ever growing segment. Glucosamine helps produce glycosaminoglycans (GAGs), which are present in joint cartilage, Chondroitin sulfate is also a GAG found in the cartilage, Hyaluronic Acid HA is uniquely a non-sulfated GAG, Type II collagen in various forms, Omega-3s, particularly eicosapentaenoic acid (EPA) and also botanicals like curcumin has drawn much attention for its anti-inflamwww.expresspharmaonline.com

THERE IS A GREAT SCOPE TO DEVELOP THE NEW GENERATION EVIDENCE BASED NUTRACEUTICAL PRODUCTS WHICH IS POSSIBLE DUE TO THE SUDDEN SURGE IN THE GENERATION OF A MASSIVE RESEARCH DATA TAKING PLACE ON A GLOBAL PLATFORM matory actions in cartilage.

Cognitive health Many nutrients have been linked to positive cognitive benefits—an encouragement considering the vast number of disorders affecting memory, learning, mood and behaviour.

Phosphatidylserine (PS) is the most consistently effective brain nutrient and very well tolerated even by children. Other brain nutrients like Glycerophosphocholine (GPC), citicoline a precursor to phosphatidylcholine (PC), myo-ionositol, Acetyl-L-carnitine (ALC) and S-adenosyl-Lmethionine SAM-e are significantly used here. On the botanical side one finds Ginkgo biloba extract (GBE) and Bacopa extract, while patented mineral elements like Magnesium L-threonate have made a mark in this category. ● Heart health Research is helping to boost the use of heart-healthy nutraceuticals.

CoQ10, Tocotrienols, polymethoxylated flavones (PMFs), policosanol, Beta-glucans and chitin-glucans, marine sources like Krill oil and plant sources like walnuts and flaxseeds, are some of the popular nutraceuticals used in this category. Vit K2-7 known for its bone health benefits finds a prominent place in heart health due to its anti-atherosclerosis properties. ● Diabetes control Type II diabetes is a manageable disease with lifestyle changes and supplementation. Research proves again and again the benefits of botanicals, vitamins, minerals and many others in the fight against diabetes.

The richness of nutraceuticals can be clearly felt in this category. There are well established nutra products which can be classified as insulin modulators, carb blockers and calorie burners.

This category is flooded with proprietary blends such as Insinase, Diabetinol, InSea, Etc. ●

●

Ocular health Lutein and Zeaxanthin, the main macular pigments, limit macular degeneration and are linked to reduced incidence of cataract. Antiinflammatory omega-3s DHA and EPA positively impact glaucoma and dry eye, improving tear production and maintaining corneal epithelial integrity. Flavonoidrich herbal products—black currants, bilberry, pine bark extract and curcumin, for example—address inflammatory and oxidative factors in eye health. ● Digestive health With digestive systems struggling to keep up with modern diets and lifestyles, probiotics—the beneficial bacteria that work to preserve certain areas of the gastrointestinal (GI) tract—are gaining traction in the nutrition and health markets. As with all rising stars in this niche, regulatory, technology and marketing challenges will require continued attention. ● Women’s health Rediscovering the importance of certain dietary components in maintaining women’s health has led to the rapid growth of women’s health ingredients. The established safety of natural ingredients in important phases of pregnancy and lactation gives a special impetus to this category.

The way forward There is a great scope now to develop the new generation evidence based nutraceutical products with unique features and differentiating benefits. This is possible due to the sudden surge in the generation of a massive research data taking place on a global platform. Now is the time to optimise the available resources, encash the booming opportunities, leverage the new regulatory regime to the company’s advantage and grab the initiative and get the first mover advantage in the currently low competitive environment in this market segment.

June 16-30, 2013

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LEGAL EAGLE Whistleblower Protection in India – Delay in framing legal enactment will harm the public interest There is no specific and concrete legal framework to ensure protection of the whistleblowers in India.

Rajdutt Shekhar Singh, Principal Associate, Singh and Associates gives an insight about the protection which needs to be provided to the whistleblowers he Law Commission of India way back in 2001 recommended in its 179th report to formulate a specific legislation titled ‘The Public Interest Disclosure (Protection of Informers) Bill, 2002’ to encourage disclosure of information regarding corruption or maladministration by public servants and to provide protection to informers. Now even after a gap of more than ten years, there is no specific and concrete legal framework to ensure protection of the whistleblowers in India. In the recent times, the voices have been raised in favour of a strong piece of legislation to combat dishonest, illegal, corrupt practices prevailed in the government machinery as well as in the private sector.

The recent Ranbaxy episode has whistled an alert that vigilance and par-

T

NOW EVEN AFTER A GAP OF MORE THAN TEN YEARS, THERE IS NO SPECIFIC AND CONCRETE LEGAL FRAMEWORK TO ENSURE PROTECTION OF THE WHISTLEBLOWERS IN INDIA ticipation of the people associated with the companies/organisations is required in form of June 16-30, 2013

whistleblowers to surface the activities which are not only against the core principles of the companies but also against the law of the land. In other jurisdictions such as the US, the UK etc. action can be initiated against private companies by invoking the whistleblower provisions of their enactments which allow private citizens to bring actions against wrongdoings of such companies and also provide protection to such whistleblowers.

In order to address issues related to public interest disclosure and protection to whistleblowers in India, a bill called Public Interest Disclosure and Protection to Persons Making the Disclosures Bill, 2010 was introduced by the Indian Government in 2010.

On December 27, 2011, the Lok Sabha passed the bill by renaming it as the ‘Whistle Blowers Protection Bill, 2011’ [Bill 2011], which interalia provides for adequate safeguards against victimisation of the person making disclosure on any allegation of corruption or wilful misuse of power or wilful misuse of discretion against any public servant. www.expresspharmaonline.com

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As far as protection to the whistleblowers is concerned, the Bill 2011provides that if the Competent Authority is of the opinion that either the complainant or public servant or the witnesses, etc. need protection, the Competent Authority is empowered to issue appropriate directions to the concerned Government authorities (including police) which shall take necessary steps, through its agencies, to protect such complainant or public servant or persons concerned.

There are still a number of issues which require attention of the legislators such as the Bill 2011 does not address the protection to be provided to whistleblowers in the private sector and it does not include the definition of victimisation. Further, competent authorities under the Bill are very limited and right of appeal is not provided to the complainant in case he/she is not satisfied by any order of the competent authority. Appeal provisions have been provided only relating to imposition of penalty. There is no provision relating to reward to the whistleblowers. Actions on anonymous complaints have not been included in the ambit of the Bill.

In order to protect the informers/whistleblowers in absence of any concrete legislation on whistleblower protection, Indian judiciary has from time to time directed the Indian Government to formulate suitable guidelines/regulations to protect the whistleblowers. In this regard, the Supreme Court while hearing a writ petition regarding the murder of Satendra Dubey, who exposed corruption in NHRI, directed the government to form a suitable machinery for acting on complains from whistleblowers until a suitable legislation is enacted. In compliance of the directions issued by the Apex Court, the Government of India issued a Resolution No. 89, dated 21 April, 20041 authorising the Central Vigilance Commission as the designated agency to receive written complaints from whistleblowers. The said Resolution also provides for the protection to the whistle-blowers from harassment, and keeping the identity of whistle blowers concealed.

In a similar manner, following the directions of

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Punjab and Haryana High Court, the Haryana Government issued a notification on September 6, 2011 (amended vide notification on 19.09.2012) with respect to a policy for providing security to Whistleblower/right to information activists/complainants and witnesses in serious cases. Recently, the Maharashtra Government has also placed its policy for the protection and safety of whistleblowers before the Bombay High Court.

The pharmaceutical industry is also not an exception and this sector also requires participation of the general public to expose misconduct, irregularities, breach of rules and regulations prevailing in this sector. In the last several years, the Government has felt that spurious or fake drugs is a sensitive issue affecting not only the health of the citizens but also the reputation of the country’s pharma trade interests and therefore it was realised that people’s participation is significant to fight against the elements engaged in such illicit trade of spurious drugs. As an initiative, the Drugs and Cosmetics Act, 1940 was amended in 2008 whereby stringent penalties for manufacture of spurious and adulterated drugs were introduced. Certain offences relating to spurious and adulterated drugs were made cognizable and nonbailable. The amount of penalty was also increased from `10,000 to `10 lakh or three times value of the drugs confiscated, whichever is more.

Further, in order to encourage people’s participation, Ministry of Health and Family Affairs devised a reward scheme for whistleblowers in the fight against the menace of spurious or fake drugs, cosmetics and medical devices2.

This reward scheme provides rewards to the informers who provide specific information to the designated authorities leading to the seizures of spurious, adulterated, misbranded and not of standard quality drugs, cosmetics and medical devices. As per this reward scheme, reward is to be given only when there is a confirmation of the seizure of spurious, adulterated and misbranded drugs, cosmetics and medical devices by www.expresspharmaonline.com

THE PHARMACEUTICAL INDUSTRY IS ALSO NOT AN EXCEPTION AND THIS SECTOR ALSO REQUIRES PARTICIPATION OF THE GENERAL PUBLIC TO EXPOSE MISCONDUCT, IRREGULARITIES, BREACH OF RULES AND REGULATIONS PREVAILING IN THIS SECTOR the designated officers of the Central Drugs Standard Control organisation [CDSCO]. There is a provision that the reward of maximum of up to 20 per cent of the total cost of consignments seized is to be payable to the informer which should not in any case exceed `25 lakh in each case.

The scheme also incorporate provisions related to protection of the whistleblowers by keeping secret the identity of the whistle blower / informer and it is the responsibility of the concerned officials to keep the details of the whistle blower / informer secret.

Unfortunately, this reward scheme has not brought any significant impact. Various complaints have been received since its inception, however, these complaints were found to be fictitious3. DCGI has noticed that problem is that a whistleblower is required to file an FIR for CDSCO to take any action4. Further, it lacks provisions ensuring protection of the whistleblowers.

Similar reward schemes have also been initiated by other government departments such as reward scheme introduced by Directorate General of Central Excise Intelligence under which Government of India grants rewards to informers who provide specific information leading to seizure of goods, currency, bullion or leads to detection of duty evasion including wrong declaration of quantity, description, value etc.

The maximum amount of reward to the informers can be as high as 20 per cent of the duty evasion detected plus 20 per cent of the fine/penalty realised5.

Conclusion The Resolutions made by the Government of India, Notifications issued by the State governments and directions passed by the

Indian judiciary on “as and when required basis” with respect to the protection of whistleblowers may be termed as a temporary relief, however, it cannot in any manner be equated to an effective mechanism required to provide protection to the whistleblowers.

The reward schemes introduced by the government have not been succeeded in attracting the participation of general public since these schemes do not comprehensively cover the provisions related to protection of whistleblowers and these issues can be addressed only by way of introducing a strong Whistleblower Protection Act. The proposed Whistleblower legislation should include corporate whistleblowers.

India has emerged as one of the most preferred destinations for export of drugs and various Indian pharma companies have US Food and Drug Administration (USFDA), MHRA (UK), TGA (Australia), MCC (South Africa), Health Canada etc. approved plants, for generic drugs manufacture.

Therefore, the Drugs Authorities are required to be more diligent towards Indian pharma manufacturers engaged in export of drugs and the reward scheme introduced by Ministry of Health and Family Welfare should be reassessed to make it more effective.

References 1. http://cvc.nic.in/whistleblow.pdf 2. http://www.cdsco.nic.in/ Whistle%20Blowe%20(3).pdf 3. http://www.thehindu.com/business/Industry/fake-drugs-whistleblower-plan-draws-a-blank/article4403904.ece 4. http://articles.economictimes. indiatimes.com/2012-0909/news/33713590_1_spuriousdrugs-cosmetics-and-medical-devicesfake-drugs 5.http://www.dgcei.nic.in/a/information.asp June 16-30, 2013

RESEARCH

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EXPERTISE FOR DRUG DEVELOPMENT

Novartis receives positive opinion from CHMP for Lucentis PG 40 Stem cell study could aid quest to combat range of diseases PG 41 Celgene’s Revlimid wins FDA lymphoma approval PG 42

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rotocol design’ is a regular phenomenon across different industries. However, as far as the clinical trial industry is concerned, it’s an activity of laying down a procedure/steps that would have an impact on the life and death of the patients/participants. Hence, it is no wonder that clinical trial protocol is one of the most scrutinised aspects of any clinical trial by Ethics Committees (ECs).

Developing and maintaining a protocol might be a bitter pill to swallow for the clinical trial operators, but for the patient, it gives an assurance that they are the part of a genuine initiative and every effort is undertaken to safeguard/minimise risk to their lives.

DR RAHUL PANDIT

AYAN NEOGI

AROHEE KETKAR

Senior Consultant, Intensive Care, Fortis Hospital, Mumbai

Business Development, Karmic Lifesciences

Senior Project Manager, Clinical Operations, SIRO Clinpharm

For a clinical trial protocol a physician shall act in the patient's best interest when providing medical care

The ECs in their SOPs have mandated monthly, quarterly and yearly project updates submission from the site team to the ECs. The sites have been following this diligently

Inadequate justification for usage of placebo groups and inadequate rescue criteria can become red flags in getting clinical trial protocol approved

Development, Karmic Lifesciences informs that as per Schedule Y Rules in India for conduct of clinical studies on human population, the amended version of year 2005 in Appendix X clearly states the required contents of any Protocol of a proposed study. He says, “Any EC will thoroughly review these contents and will raise concerns in case discrepancies are noted or if the aspects are not appropriately detailed.”

Besides the points highlighted by Pandit and Neogi, according to experts, the ECs should also review some specialised areas of research which require additional safeguards. Dr Arun Bhatt, President Clininvent Research, provides some specific details.

He says, “Research involving children, vulnerable subjects and those with diminished autonomy should get additional protection. The EC has to review the trial protocol; suitability of the investigators; as well as facilities, methods and material to be used in obtaining and documenting informed consent of the trial subjects.”

Red flags

and also if the previous trial results required as per the Schedule Y requirements are not mentioned or not available, the protocol can be rejected.”

Giving the doctor's perspective, Pandit says, “Lack of patient safety is the major factor and it is followed by objective/hypothesis based on non-scientific data, clear harm shown in animal experiments/experimental studies, lack of provision / consent to accept or withdraw and adaptive methodology based on the prefixed notion leading to a change in protocol during the study.”

According to Arohee Ketkar, Senior Project Manager, Clinical Operations, SIRO Clinpharm, “Inadequate justification for usage of placebo groups and inadequate rescue criteria can become red flags in getting clinical trial protocol approved.”

Though the purpose of the trial is to discover a remedy to any disease, sometimes the trial itself is so risky to a patient's life that EC would not allow it to take place. Moreover, the clinical trial's future also

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Must haves Basic requirements for any clinical trial protocol are more or less same and as expected, patient’s safety is the top priority. “The health of my patient will be the first consideration,” states Dr Rahul Pandit, Senior Consultant, Intensive Care, Fortis Hospital, Mumbai. He adds, “The ECs all around the world act as per the 'World Medical Association Declaration of HelsinkiEthical Principles of Medical Research involving Human Subjects.' For a clinical trial protocol, a physician shall act in the patient's best interest when providing medical care. Design and performance of clinical research must be clearly published in a protocol and submitted for review. A preceding assessment of risk involved to patients must be undertaken. A detailed patient information sheet and right to participate or not to participate.”

Ayan Neogi, Business

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www.expresspharmaonline.com

There are instances when ECs would take an objection to the amendments made in the protocol.

Any misplay with the requirements that are mentioned in the protocol would invite the ire of ECs who regularly keep a vigil on it.

Neogi says that ECs can take an objection to the protocol if the study design is not appropriately mentioned in the protocol, highlighting the number of patient visits, the number of blood draws for safety and efficacy assessment, the amount of blood draw etc. He informs that an objection can also be taken if the management of serious adverse events are not appropriately highlighted and mentioned in the protocol, or if the subject compensation to trial related injury and other reimbursements like travel etc. are not highlighted appropriately.

He adds, “If use and duration of the product under investigation and comparator/placebo is not justified appropriately, if the study rationale and the further need of conduct of the proposed trial/study is not mentioned and explained

June 16-30, 2013

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DR ARUN BHATT

ARUN NANIVADEKAR

President, Clininvent Research

Independent medical research consultant

Research involving children, vulnerable subjects and those with diminished autonomy should get the additional protection

Various adaptive designs are under discussion, but their feasibility, statistical and clinical validity, and acceptability to regulatory agencies are not yet fully resolved

depends on the eligibility of the investigator. “If an EC feels that the investigator is not competent to conduct the trial, it can reject protocol,” informs Bhatt.

discussion, but their feasibility, statistical and clinical validity, as well as acceptability to regulatory agencies are not yet fully resolved. However, on a positive note he says, “Progress is likely to take place case by case to begin with, and then pick up speed as all parties develop confidence about them. Novel statistical methods for using historical data on placebo so as to avoid the use of placebo control again are also under discussion. Proposals for embedding phase 3 trials in routine practice have also been made.”

Latest trends Over the last few years, the use adaptive design methods for clinical research and development based on periodically accumulated data have found many takers in the industry.

It allows great level of flexibility and efficiency.

Adaptive designs vary based on the adaptations applied.

An adaptive design is crucial for a clinical trial as it allows for modifications as and when needed.

Pandit provides details about the latest trends in adaptive clinical trials. He says, “By definition it means changing the key parameters during the trial based on the data from current or external studies. The commonest trend is to change the sample size at interim analysis.

The second most common adaptation is to change the hypothesis or objective, for e.g., switching between a non-inferiority trial to superiority trial. The other adaptations are to change the end point or drop or add new arms in the study. All of these lead to an increase in the Type I error which is rejecting a 'null hypothesis' when it is in fact true.”

According to Arun Nanivadekar, an independent medical research consultant, various adaptive designs are under June 16-30, 2013

Loopholes in the protocols In India, clinical trials are always associated with controversies. The Indian Supreme Court's recent outburst over the alleged deaths during clinical trials in the country has added strength to the voices of opponents of clinical trials. Can these deaths be attributed to the protocols that clinical trial operators might not have followed properly? Or do these deaths indicate that ECs have not been able to plug the loopholes in such protocols?

Amid the controversy, Neogi puts his weight behind ECs. He asserts, “ECs consist of people from different backgrounds. As per the Schedule Y requirements in India, for review of each protocol, the quorum of an EC should be at least five members with the following representations: basic medical scientists www.expresspharmaonline.com

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(preferably one pharmacologist), clinicians, legal expert, social scientist/representative of non-governmental voluntary agency/philosopher/ethicist/theologian or a similar person and a lay person from the community.”

Neogi adds, “The idea behind having all these roles in place is to validate the protocol from all angles so that no loopholes are left.

Cases are evident where ECs and scientific review committees at the sites have time and again asked for clarification or have rejected protocols wherein they thought that there is no sci-

entific rationale to conduct and support the study or wherein they thought that the subject’s safety and wellbeing is at risk. The ECs in their Standard Operating Procedures (SOPs) have mandated monthly, quarterly and yearly project updates submission from the site team to the ECs. The sites have been following this diligently.”

However, contrary to Neogi's views, Pandit opines, “The new trial protocols, adaptive methodology and innovative trial designs have increased the loopholes and it is a constant challenge to plug

them. The whole concept of independent ECs needs to be reviewed.”

Bhatt is in favour of ECs. While justifying his stand, he opines, “In India, the clinical trial protocol is reviewed by the Drug Controller General of India's (DCGI) office, New Drug Advisory Committee and other bodies like Indian Council of Medical Research (ICMR). If these bodies do not see any loopholes in clinical trial protocols and approve them, one can not hold an EC alone responsible for any issues in them.”

India is already a favourite destination to per-

form clinical trials.

However, certain practices during these trials have also raised a question mark over their credibility. Though there is a lot of hype around deaths during these trials, the fact is that India's share in the global clinical trial market is hardly around two per cent. In future, the clinical trial market in India would continue to grow and in order to avoid further catastrophes, clinical trial protocols that are already in place would have to be more stringent and more vigilantly monitored

by ECs. sachin.jagdale@expressindia.com

UPDATES Novartis receives positive opinion from CHMP for Lucentis Lucentis recommended for approval in EU to treat patients with visual impairment due to choroidal neovascularization secondary to pathologic myopia ovartis has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for Lucentis (ranibizumab) to treat patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (myopic CNV). CNV is the most common visionthreatening complication of high myopia [1].

Myopic CNV usually affects patients younger than 50 years old so any associated vision loss can have not only a significant impact on their quality of life but also on their productivity and to society [2]. In patients with untreated myopic CNV the long-term prognosis is poor with approximately 90 per cent of affected patients developing severe vision loss after five years [3].

Tim Wright, Global Head of Development, Novartis Pharmaceuticals said, “Lucentis has already transformed the management of wet AMD, and we are hopeful that if Lucentis receives approval in a fourth major ocular indication that patients with myopic CNV will benefit from this medi-

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cine. Currently, all we hope to do for these patients is to stabilise vision and prevent further vision loss, so a treatment with the longterm safety profile of Lucentis that actually improves and maintains vision with just a few injections would be of great benefit."

The submission was supported by data from the Novartis-sponsored clinical trial, Radiance, that showed Lucentis provides superior improvement in visual acuity compared with the current licensed standard of care, Visudyne (verteporfin PDT), in patients with myopic CNV. These new data showed around 40 per cent of Lucentis treated patients compared with 15 per cent of Visudyne treated patients gained 15 or more letters of visual acuity at month three[4]. Mean visual acuity gains of approximately 14 letters at one year were demonstrated with Lucentis; this was with a median of 2.0 injections.

In this pivotal phase III study, patients were randomised to one of three treatment arms: Lucentis treatment based on visual acuity stability (group 1) or disease activity (group 2); or Visudyne treatment (group 3). Subjects randomised to Visudyne could be given Lucentis after three months based on persistent disease www.expresspharmaonline.com

MYOPIC CNV USUALLY AFFECTS PATIENTS YOUNGER THAN 50 YEARS OLD SO ANY ASSOCIATED VISION LOSS CAN HAVE NOT ONLY A SIGNIFICANT IMPACT ON THEIR QUALITY OF LIFE BUT ALSO ON THEIR PRODUCTIVITY AND TO SOCIETY activity.

The primary endpoint was Lucentis superiority to Visudyne based on the mean visual acuity change from baseline to month three. Patients were followed for twelve months.

Both the Lucentis treatment groups were statistically superior (p<0.00001) to the Visudyne treatment group. Mean letter gains at month three from baseline in the two Lucentis groups (groups 1 and 2) were 12.1 and 12.5 letters, respectively, compared to a 1.4 letter gain in the Visudyne treatment arm (group 3). At twelve months, the mean letter gains from baseline were 13.8 (group 1), 14.4 (group 2) and 9.3 (group 3).

The safety profile of Lucentis was consistent with that observed in other studies as well as real-world experience and no new ocular/non-ocular safety risks were identified. The most

common adverse events occurring in more than 10 per cent of patients, at 12 months, were conjunctival haemorrhage (ocular) and nasopharyngitis (nonocular).

EP News Bureau-Mumbai References 1. Neelam K et al. Choroidal neovascularization in pathological myopia. Prog Retin Eye Res 2012;31:495525. 2. Rose K et al.

Quality of life in myopia.

Br J Ophthalmol 2000;84: 1031-1034.

3. Yoshida T et al. Myopic choroidal neovascularization: a 10-year follow-up.

Ophthalmology 2003;110:1297-1305.

4. Wolf S et al.

Ranibizumab vs verteporfin PDT for choroidal neovascularization secondary to pathologic myopia: a Phase III study.

Asia Pacific Academy of Ophthalmology 2013.

June 16-30, 2013

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Stem cell study could aid quest to combat range of diseases To better understand and develop treatments for diseases such as multiple sclerosis, Parkinson’s disease and muscular degeneration cientists have taken a vital step forward in understanding how cells from skin tissue can be reprogrammed to become stem cells. New research could pave the way to generate these stem cells efficiently to better understand and develop treatments for diseases such as multiple sclerosis, Parkinson’s disease

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has not been clear how adult cells ‘forget’ their specialised roles to be reprogrammed by scientists.

Experts say that current methods of iPSCs production are time consuming and costly. It takes around four weeks to make human stem cells and even then the process does not always work. Researchers say that

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and muscular degeneration.

The study of how these cells known as induced pluripotent stem cells (iPSCs) were reprogrammed was led by the University of Edinburgh and is published in the journal Nature.

Scientists found that the process by which iPSCs are created is not simply a reversal of how skin cells are generated in normal human development. Researchers made the discovery by tracking the change of skin cells during the reprogramming process. All cells in the human body begin life as a mass of cells, with the capacity to change into any specialised cell, such as skin or muscle cell.

By returning adult cells to this original state and recreating the cell type needed for treatment scientists hope to find ways of tackling diseases such as MS, in which cells become faulty and need to be replaced.

Scientists have been able to create stem cells in this way since 2006 but, until now, it June 16-30, 2013

their new insight will enable them to streamline the stem cell production process. The finding may also shed light on how to create different cell types like muscle or brain cells that can be used to improve our understanding of diseases and treatment.

Dr Keisuke Kaji of the Medical Research Council Centre for Regenerative Medicine at the University of Edinburgh, said, “As exciting as this technology is, we still know very little about how cell reprogramming actually works. Using a new technique, we have improved our understanding of the process. Our work marks an exciting step towards ensuring that induced pluripotent stem cells technology will meet its full potential.”

The study was funded by the European Research Council, the Medical Research Council, the Anne Rowling Regenerative Neurology Clinic and the Darwin Trust of Edinburgh.

EP News Bureau-Mumbai

Environmental Conditions Affordable Ideal for ASAP

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Celgene’s Revlimid wins FDA lymphoma approval To add another revenue source for the $4 billiona-year medicine

elgene Corp said that its flagship blood cancer drug, Revlimid, was approved by US health regulators to treat mantle cell lymphoma, adding another revenue source for the $4 billion-a-year medicine.

The US Food and Drug Administration approved Revlimid to treat mantle cell lymphoma (MCL) a type of non-Hodgkin's lymphoma that has relapsed or progressed following two prior treatment regimens, one of which must include Takeda Pharmaceutical Co's Velcade.

"There remains a tremendous unmet need for patients with previously treated mantle cell lymphoma," said Dr Andre Goy, Chairman and Director and Chief of Lymphoma, John Theurer Cancer Centre in Hackensack, New Jersey. Revlimid, which will be the first

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oral treatment for MCL, is already approved to treat multiple myeloma and the blood disorder myelodysplastic syndromes. The medicine had sales of $1 billion in the first quarter for the US biotechnology company.

Despite the unmet need cited by doctors, analysts predicted only a modest revenue boost for Revlimid from the new indication. Cowen and Co analyst Eric Schmidt forecast additional annual sales of about $100 million to $200 million from the additional approval, saying it was not likely to provide a boost to Celgene's shares.

MCL accounts for about six to seven per cent of total non-Hodgkin's lymphoma cases, or about 11,000 cases, the company said.

Reuters

Double dose of Tamiflu proves no better in severe flu Researchers found no difference in virus levels or clinical outcomes between the treatment groups atients with severe flu had no benefits from a double dose of Roche's drug Tamiflu, despite calls by some experts for the use of higher doses in the most serious cases. That verdict from the first randomised clinical trial to study the issue has implications for global guidelines on stockpiling drugs for a potential flu pandemic, researchers said.

“Our findings do not support routine use of double doses to treat severe flu infections, which could help to conserve drug stocks in the event of a pandemic,” said Jeremy Farrar, Director of the South East Asia Infectious Disease Clinical Research Network.

Flu experts are on alert for a potential pandemic, with concerns centered on the new H7N9 strain of bird flu that has killed 36 people in China.

So far H7N9 has not been able to spread easily from person to person and cases of the disease are receding, although experts are concerned that H7N9 may be able to develop resistance to Tamiflu rapidly.

Previous studies have shown that early treatment with Tamiflu, known generically as oseltamivir, helps speed recovery in seasonal and pandemic flu. It also improves survival in patients hospitalised by the virus, leading some health authorities to recommend double doses in

bad cases. Results of the latest Tamiflu study were published in the British Medical Journal, following a study of 326 patients with severe flu infection in Indonesia, Singapore, Thailand and Vietnam who were given either a standard dose or double dose of the drug for five days.

The researchers found no difference in virus levels or clinical outcomes between the treatment groups. The study, which took place between April 2007 and February 2010, was funded by the Wellcome Trust, US National Institute of Allergy and Infectious Diseases, and the Singapore National Medical Research Council.

Reuters

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GSK’s breast cancer drug Tykerb fails in gastric cancer study It did not improve survival rates for patients with gastric cancer compared to the use of chemotherapy alone laxoSmithKline said that its breast cancer drug lapatinib in combination with chemotherapy did not improve survival rates for patients with gastric cancer

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compared to the use of chemotherapy alone.

Lapatinib, which is marketed as Tykerb mainly in the US and as Tyverb mainly in Europe, is approved for

the treatment of breast cancer and some other solid tumors. The British company said the drug did not meet the primary end point of improving overall survival rates for patients with HER2-positive advanced gastric cancer, including esophageal, in a late-stage global trial.

Reuters June 16-30, 2013

W H AT ’ S INSIDE

Intertek to organise seminar on Managing Process & Powder Safety PG 45 Bilcare secures Abbott’s export PG 46 Thermo Fisher Scientific releases new small benchtop centrifuge PG 48 Cost effective ways to test powder flowability PG 49 Building a greener world for today and tomorrow PG 50 RF ValProbe—Wireless Validation System PG 51

PHARMA ALLY ‘Companies are able to benefit without the need to make a significant investment’ Since its launch in mid-2011, Office 365 is one of Microsoft’s fastest growing businesses globally.

Ram Kumar Pichai, General Manager - Microsoft Office Division talks about the service, its USP and its importance in the pharma industry Explain the advantages of Microsoft 365 and its uses in the pharma sector?

Office 365 is an enterprise class software that has exchange for mail, SharePoint for collaboration and document management, Lync for instant messaging and PC to PC calling coupled with Office applications. This entire portfolio is available on cloud as a service so that customers of any size, from SOHO to large enterprises, can avail it. For health organisations of all sizes, Office 365 can help transform complex, time consuming operations into efficient, collaborative, information-driven processes in the cloud.

Connect the healthcare ecosystem: With the rich collaboration capabilities of Lync online and SharePoint online, stakeholders throughout the continuum of care can share sensitive data securely using the organisation’s existing unified communications tools.

With exchange online, users can access and manage work schedules, email messages, contacts, and calendars on nearly any device.

Powerful web-based tools simplify online deployments for the IT department.

Microsoft runs Office 365 on a global network of data centres, with guaranteed 99.9 per cent uptime, georedundancy, and built-in disaster recovery to help provide the robust security and reliability that your data requires.

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Address compliance requirements: Microsoft products and services, alongwith the Microsoft security development lifecycle (SDL), can help organisations address compliance

INTERVIEW

requirements.

Microsoft Office 365 supports the following where applicable and/or possible: ● I n t e r n a t i o n a l Organisation for Standardisation (ISO) 27001 ● EU Safe Harbor ● EU Model Clauses ● Data Processing Agreement Reduce operational costs and complexity: In today’s budget-conscious climate, streamlined IT operations in the cloud gives you more time to focus on improving the quality of medical services. For care providers, Microsoft and partner solutions help connect disparate systems, processes, and data sources with a single user interface for accessing multiple clinical and informational systems. Automating daily functions and extending work-flows help to minimise human error, as well as keep information moving, supporting timely decisionmaking and action.

In the recent past, it has been seen that pharma companies are focussing more on spending and hiring medical representatives. How will your service give an extra mileage to the pharma companies in this regard?

Microsoft Windows 8 can provide the devices and experiences users love, while delivering enterprisegrade solutions. Microsoft Flexible Workstyle offerings help extend securityenhanced, controlled access to information and applications from virtually anywhere while simplifying application and resource management.

Empower users and increase productivity www.expresspharmaonline.com

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Allow virtually anywhere connectivity: Provide health professionals, patients and medical representatives with security-enhanced, hassle-free access to the data, applications, people, and social networking tools that they need to provide and access care virtually anywhere, any time, and on a variety of devices. ● Provide a personalised experience: Improve productivity by providing healthcare professionals, patients and medical representatives with personalised experiences that anticipate their needs, remember their preferences, and adapt to their unique work styles so that they can deliver quality care where and when it is needed.

Address the needs of your ICT department ● Enhance security and control: With centralised desktop and mobile device management— and a common identity infrastructure—it can help mitigate security and privacy risks by consistently enforcing compliance with industry regulations and organisational policies. ● Simplify application and resource management: A single view across envi-

ronments, desktops, and devices—and across the applications and services deployed on them— can enable you to more pro-actively and efficiently secure, plan, deploy, and manage your entire ICT infrastructure.

Common, familiar tools to deploy, configure, monitor, and report across different environments simplify the management of a complex system and help you keep it up to date.

What special features does Microsoft 365 provide to pharma companies?

The three key features that Microsoft Office 365 provides the pharma companies are: addressing compliance requirements, reducing operational costs and complexity as well as connecting to the healthcare ecosystem.

How will these features help pharma companies to cut cost and add more margin to the firms’ top line and bottom line?

Accessing productivity solutions in the cloud is a win-win situation for any pharma company. Firstly, they are able to take advantage of industry leading IT tools which can make a tangible difference to individual and collective performance and boost the bottom line.

And secondly, they can be sourced with very little upfront investment in infrastructure, helping to preserve vital IT budgets. With Office 365, the software is supported by a Microsoft data centre, alleviating the pressure on firms to invest large sums in on-premise hardware. As well as reducing capital expenditure, it also means companies can reduce their management bills, and free up IT workers to focus on other areas where value can be added.

The use of hosted productivity solutions also has security benefits, in the June 16-30, 2013

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sense that the product vendor assumes responsibility for servers and other critical hardware. Benefitting from economies of scale, the provider is able to invest more on security than individual companies would be able to do alone. This means companies are able to benefit from unprecedented levels of security, without the need to make a significant investment out of their own budget.

For example, Lupin, one of the fastest growing pharma companies globally, recently deployed Microsoft Office 365 to simplify employee communication, gain business insights and share experiences across its offices in four continents. By

moving to Office 365, Lupin reduced costs in a number of ways including personnel, hardware, facilities, and deployment expenses. From initial project ROI estimates, this could work out to as much as 40 per cent over a three year time period.

Presently, how many pharma companies have already implemented this into their system and what type of responses have you received from them?

Since its launch in mid2011, Office 365 is one of Microsoft’s fastest growing businesses globally. After only 18 months, one in five of Microsoft’s enterprise customers worldwide use the paid service, up from one in seven a year ago. The

number of small and medium-sized businesses using Office 365 around the world has also grown by over 150 per cent in the last 12 months.

How many products have you introduced for the Indian pharma sector and what are the responses so far?

Indian customers are adopting Office 365 four times faster than its predecessor BPOS. Clearly there is a strong appetite in the market across all sectors, including the pharma sector, to get powerful productivity and collaboration tools.

What are your future plans for the Indian market?

Microsoft recently

announced the general availability of the next-generation Office 365 for businesses in India. Office 365 works across multiple devices, is social and integrates seamlessly with the cloud.

It unlocks newer productivity scenarios and provides organisations with the desired IT control and management.

Simultaneously, Microsoft also made available business SKUs of Office 2013 for on premise users. It also includes updated Microsoft Lync Online, Exchange Online, SharePoint Online and the all new Yammer.

Office 365 can be installed on up to five devices for a single user under the Office 365 licensing. u.sharma@expressindia.com

PRE EVENT Intertek to organise seminar on Managing Process & Powder Safety Seminar to be held in Mumbai on June 28, 2013 ntertek India will organise a one-day seminar on Managing Process & Powder Safety on June 28, 2013 at The Lalit Mumbai.

The objective is to make the participants aware of the inherent risks involved during chemical/pharmaceutical manufacturing and taking action on them. The seminar is aimed at techni-

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cians, chemists, chemical engineers, plant managers and safety specialists who wish to understand the various hazards posed by static electricity, dust explosions, runaway reactions and how to investigate processes and unit operations for thermal hazards.

In order to do this successfully, it is necessary to fully understand the thermal data and the means by

which it can be acquired.

This seminar advocates a structured approach supported by theory and case studies focusing on the role that laboratory thermal data has in an overall risk minimisation strategy.

The seminar will introduce to the theory of static electricity and its hazards in day-to-day operations. It will elaborate on how powders should be safely han-

dled with specific emphasis on drying and milling operations. It will also focus on thermodynamics of a chemical reaction, identifying and preventing runaway situations and managing the risks involved therein.

The medium of instruction will be through films, presentations, case studies and problem solving exercises.

EP News Bureau-Mumbai

VENDOR NEWS Romaco sales up 16.7 per cent in FY 2012 Incoming orders in FY 2012 totalled 106.3 million euros omaco Group, a leading global supplier of processing and packaging equipment, generated sales of 109.0 million euros during the 2012 fiscal year – an increase of 16.7 per cent compared to the previous year and up by 24.4 per cent since 2010.

Incoming orders in FY 2012 totalled 106.3 million euros.

The company also report-

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ed 19.4 per cent higher sales of machines and plant in the last FY while the Romaco Group’s Customer Service and Aftermarket business rose by 9.4 per cent. “The growth trajectory is continuing on a steep upward curve,” explained Paulo Alexandre, CEO of the Romaco Group.

“We are very satisfied with this positive trend, which will strengthen our strategic alignment as a supplier of engineering and system soluwww.expresspharmaonline.com

tions,” he added.

At 106.3 million euros, the incoming orders also reportedly marked another two per cent improvement on last year’s record. At the end of the 2012 fiscal year, orders on hand were worth 39.1 million euros. The company's invested in the relocation and enlargement of its Brazilian Sales & Service Centre in São Paulo in the previous year. Since March 2013, the Mexico City based Grupo Rasch has been sup-

porting the Group’s sales activities in Mexico. This new cooperation is expected give Romaco a stronger foothold in Central America. “Our goals for the current fiscal year are to maintain our efforts to boost our share of the international markets while consolidating and extending Romaco’s already powerful position in the world’s key regions,”Alexandre emphasised.

EP News Bureau-Mumbai EXPRESS PHARMA

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Bilcare secures Abbott’s exports Offers track-n-trace and authentication technology ilcare, a leading innovation-driven technology solution company, has been associated with Abbot, to provide secure, non-clonable ‘track and trace technology’ for protection of Abbott's exports across globe.

Bilcare will provide end-toend holistic solutions to Abbott for track and trace and authentication as per global standards. Bilcare will also build the ability to scale the service requirements to accommodate future needs.

The association will bring

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multi-level benefits to Abbott including capability to deal with on-going changes in government mandates, reduced spend on IT assets and services, handle high volume (billions of records) serialised data and its retention and allowing the company to manage any country-specific additional data requirements.

Abbott is a key client as it helps reinforce Bilcare’s capabilities to provide value to the pharma industry. Bilcare is confident that the synergy will go a long way with the organisation providing best available solutions to Abbott.

With well-equipped non-

Clonable track and trace technology, the company ascertains that the protection of the export products meets the government standards for export.

Bilcare’s non-Clonable track and trace solution is secure, cost effective which facilitated Abbott to protect it exports brands and comply with Government’s DGFT mandate without hampering current productivity.

This technology provides 'secure track and trace' along with non-ClonableID making it impossible for counterfeiters to copy. Conventional track and trace solution pro-

vide traceability but cannot provide protection from counterfeit which is the key motive to implement the mandate.

Bilcare Technologies’ secure track and trace and authentication solution can authenticate combined with track and trace, manage billions of records of serialised data and retain as per GS1/EPCIS, standardise data exchange with port authorities and importers for international trade, and enable accountability along with integration and outcomes to all stakeholders.

EP News Bureau-Mumbai

Goose launches ‘Quality Manager’ to help pharma industry prevent quality process deviation The solution has been designed to offer real-time corrective measures to tackle deviation across product manufacturing life cycles harmaceutical business re-engineering solutions pioneer, Goose announced the launch of ‘Goose Quality Manager’ to help track and manage the deviations effectively that result in millions of dollars in revenue loss for the industry if not capped.

‘Goose Quality Manager’ provides real time visibility into various quality events and is loaded with critical modules to deal with nonconformances, internal and

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external audits, change management, CAPA (Corrective Action and Preventive Action), complaints and other modules for business functions where quality is of paramount importance. This enterprise scale solution can be integrated with existing ERP applications and includes a built-in document management system along with a powerful collaboration platform.

Available both in basic as well as advanced version, what sets ‘Goose Quality Manager’ apart from currently available solution is

its time to deploy and cost of deployment. The significantly lower investment solution can be deployed in less than three to four months in organisation of any size.

“Each manufacturing cycle consists of hundreds of steps and it is extremely difficult to manage deviations at each step when tens and hundreds of batches of different pharma formulations are running in parallel on any given day. Deviations that are not tracked and corrected can lead to adverse events like customer complaints, alerts and recalls

which cause loss in revenue as well as brand value,” Deb Pattnaik, Founder and CEO, Goose said.

“The easily configurable ‘Goose Quality Manager’ is designed to effectively track and manage a number of critical quality deviations, minimise regulatory pressures, ensure preparedness, reduce the cost of quality and manage problems that arise at every level of product manufacturing life cycle.

Coupled with value pricing strategy our solution also offers greater ROI,” Deb adds.

EP News Bureau-Mumbai

Aptar Pharma unveils multi-language website to meet local customers’ needs Website is available in four more languages ptar Pharma has expanded its worldwide presence through an upgraded multi-language information resources website: www.aptar.com/pharma.

The Aptar Pharma website is now available in four more languages: Chinese, French, German and Spanish. This in addition to English, the original language. Access in other languages, including Portuguese, will be available in 2014. These languages were chosen to meet the

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information needs of our local customers and stakeholders in increasingly important regional markets.

This multi-language information repository is primarily designed to make it even easier for our customers in the biotechnology and pharmaceutical sectors to identify the most appropriate solution to fit their needs. The website also provides information for academics, media, partners and suppliers, as well as other members of the pharma community. www.expresspharmaonline.com

Our website visitors now have easy access in their own languages to comprehensive information about Aptar Pharma. These information resources include a company snapshot with our identity and our strategy as well as key facts and figures; detailed information about our products and services and their therapeutic areas of application; scientific materials for academics and researchers; and media resources for the press.

“Our website is a key element of our customer-

centric strategy, and provides a single entry point to a wide range of information about our company, our products, our technologies and our services. Multilanguage access to this website is a key milestone which will allow us to better provide information to our customers and stakeholders in all markets,” said Pierre Carlotti, Vice-President Marketing and Communication, Aptar Pharma Prescription Division.

EP News Bureau-Mumbai June 16-30, 2013

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PRODUCTS Malvern’s viscometer detector enhances GPC/SEC analysis for polymer development or those working at the forefront of polymer development, adding a Malvern Viscotek viscometer detector into gel permeation/size exclusion chromatography (GPC/SEC) set ups can help deliver the enhanced information need to achieve challenging performance specifications.

Studies with evolving commercial polymers, such as polymethylmethacrylate (PMMA) and polylactic acid (PLA), show how the structural information revealed by measuring viscosity parameters enables researchers to intelligently modify polymer chain length and branching to meet precise goals.

Malvern Viscotek viscometers can be supplied as part of an integrated triple detector Viscotek GPC/SEC system or as an addition to any existing separation system.

GPC/SEC is a central analytical technique for the analysis of proteins, polymers and macromolecules because of its ability to meas-

als may not be available. On the other hand, if molecular weight is directly measured via a light scattering technique, a viscometer enables the quantification of structural characteristics such a chain branching. This information supports the sophisticated control needed to develop materials closely matched to specific applications, to manufacture stable ocular lenses, for example, in the case of PMMA, and to replace conventional polymers with an environmentally benign alternative, in the case of PLA.

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ure defining characteristics such as molecular weight, molecular weight distribution and molecular size. Modern GPC/SEC systems typically incorporate multiple detectors that work together to increase information flow.

Viscosity measurements serve a dual function within this context. When used with

a refractive index (concentration) detector, they give information on molecular weight/density. This permits the determination of accurate molecular weight distributions without a relevant standard, an important benefit for new or significantly modified polymers where appropriate reference materi-

Contact details: Stuart Wakefield Malvern Aimil Instruments Naimex House, BSEL Tech Park, B Wing – 906 Sector 30A, Opp Vashi Railway Station, Vashi, Navi Mumbai 400 705, India Tel: + 91 22 3918 3596: Fax: +91 22 3918 3562 Stuart.Wakefield@malvern. com

Thermo Fisher Scientific releases new small benchtop centrifuge T hermo Fisher Scientific has launched the new Thermo Scientific small benchtop centrifuge, delivering, in a compact footprint, the flexibility to adapt to evolving clinical and research needs alike, including clinical chemistry, cell culture, microbiology and haematology.

Featuring innovative Thermo Scientific technologies, the small benchtop centrifuge is designed for solid reliability and consistent results to reduce the amount of downtime and costly bottlenecks during the separation process.

These small benchtop centrifuges provide: Application flexibility, cleaning convenience, and ease-of-use with Thermo Scientific Auto-Lock rotor exchange; Versatility to spin blood tubes, conical tubes, microtubes and microplate compatibility with sealing options – all in one versatile unit; One-handed sample protection with Thermo Scientific ClickSeal biocontain-

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ment lids, certified by the Public Health Laboratory Service, Microbiology Services, Porton Down, UK Intuitive glove- and detergent-friendly

www.expresspharmaonline.com

interface with a bright backlit display, featuring one-touch operation with pre-set protocol options and optional password protection.

Contact details: Meenal Shinde, Thermo Fisher Scientific +91 22 6716 2259

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VALUE ADD Cost effective ways to test powder flowability Vinnie Hebert, Senior Sales Engineer, Brookfield Engineering Laboratories, elaborates on cost effective powder flow characterisation for formulations, mixes and blends

Figure 1: Brookfield’s Powder Flow Tester

haracterising powder formulations, mixes and blends for flowability is a necessity that is sometimes elusive and frequently done with archaic methods. The reason? There has really been no cost effective way to test and characterise powder flow properties. In some cases this is merely guesswork. Some common tests, such as 'smear' tests, angle of repose, and flow through a funnel have one commonality: They are subjective and do not provide a number or value that correlates consistently with behaviour on the production floor.

Another common method, the ‘tap’ test, calcu-

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Figure 2: Shear Lid used for Flow Function Test

lates values known as the Hausner Ratio and Carr Index; these tests use the measurements for the freely settled bulk density and tapped bulk density to determine flowability.

These indices have been criticised as not having a strong theoretical basis. Legacy types of tests like these can be fraught with errors due to the operator procedure and sample preparation technique, thus making the data that results seem subjective as well.

Sophisticated powder flow measurement tools have been in existence for years, but can be pricey and difficult to use. So this leaves the powder manufacturer with a choice of a subjective test which may cause more problems than it is worth, an expensive time consuming flow instrument that requires a trained operator, or finally the option to send a sample to a powder

analysis house in return for a costly analysis document.

After six years of development in conjunction with the prestigious Wolfson Centre at the University of Greenwich, UK, Brookfield Engineering introduced a low cost, easy to use Powder Flow Tester (see Figure 1 and 2) based on shear cell methodology initially established by the Jenike shear cell from the 1960’s.

The Powder Flow Tester is an easy to use instrument; an operator can be trained on its use in minutes, not days. Totally automated and software driven, the Powder Flow Tester gives comprehensive powder flow data such as powder flowability, bulk density, internal friction angle, arching dimension and rat hole diameter.

All of these parameters can be realised in one 45-minute test. The user can use any or all of these to characterise their powders. For a Flow

Figure 3b: Bulk Density Curve Graph

Figure 4: Normalized Flow Function Graph

Figure 3a: Flow Function Graph

June 16-30, 2013

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Function Test (see Figure 3a), after prepping a sample, the user merely inserts the trough of sample powder into the instrument, enters identity data for the sample, and then presses a software button to begin the test. The user is then free to move on to other tasks while the test runs. In 45 minutes, a comprehensive data set is derived on a small sample of powder (either 263cc or 43cc depending on size of shear cell that is selected).

(See Figure 3b) Powder manufacturers, formulators, and developers now have a way to easily analyse their products for flow behaviour during characterisation, formulation and blending.

The Brookfield Powder Flow Tester allows fast comparison for up to eight data sets.

Thus, formulations, for example, can be verified against known good “controls” to ensure the correct procedure and methods have been ascribed to. But Brookfield takes powder flow analysis a step further.

What if you have two or more separate powders with separate bulk densities? You need to blend them, but how are they going to flow?

What if you have two or more separate powders with separate bulk densities? You need to blend them, but how are they going to flow? You can test them individually, but that doesn’t give a true picture of how these powders will flow when mixed.

What if they jam and cause expensive downtime? Trying to determine the flow problem can waste even more time and money. Why not characterise these powders ahead of time for optimal flow characteristics…but how?

The answer is to use a Normalised Flow Function (see Figure 4), a key feature in Brookfield’s latest release of its powerful software, Powder Flow Pro. This is a flow function that has been normalised for changes in bulk density at increasing levels of consolidating stress, which essentially accounts for the compression of EXPRESS PHARMA

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powder particles in the hopper as the fill level in the bin rises: This approach incorporates the bulk density information from groups of materials, such as formulations of multiple powders. It is the main function that should be used for comparing and ranking the relative flowability of groups of materials.

Consider that the flow function represents the strength of the material (its resistance to flow). The bulk

density or self-weight of the material provides the force to overcome the internal strength. Thus to obtain a valid comparison of different classes of bulk solids, where there could be large differences in the bulk density, it is necessary to normalise the flow function.

The normalised flow function is calculated by dividing the unconfined failure strength by the powder’s bulk density at each consolidation stress and gravity to

give units of length (i.e. the arching potential).

The normalised flow function is interpreted as follows. A free flowing material will have a normalised flow function that is close to horizontal and lies approximately on the consolidation stress axis (i.e. an outlet dimension of zero at all consolidation stresses). A non-flowing material will have a steeply sloped line. Poor flowing materials can be rated by the magnitude of the outlet

dimension and also by the rate at which the outlet dimension increases with increasing consolidation stress.

The Brookfield Powder Flow Tester gives fast, comprehensive data for all facets of major flow characteristics at a very low price point. For the first time in the science of powder flow, there is an instrument that is easy to use, cost effective and gives easy to understand definitive data.

VALUE ADD Building a greener world for today and tomorrow Not only has ACG Worldwide been at the helm of technological innovations in the pharma industry, but has also infused ‘thinking and acting green’ culture within and beyond the organisation n the silent town of Shirwal in Maharashtra, Gram Panchayat Sarpanch Rajesh Tambe is a happy man. Until a year ago, his town – located nearly 200 km away from the bustling life of Mumbai – had no access to clean and safe drinking water. However, that changed when a new water treatment plant, which could help prevent 5,000 families from diseases, was handed over to the villagers.

At the official ceremony, Tambe couldn’t stop thanking ACG Worldwide’s initiative to set up the water filtration plant.

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Small beginning, big impact Just a year before, during a casual dinner, ACG and its leadership team, led by Ajit Singh and Jasjit Singh, recognised that there was severe scarcity of pure potable water in Shirwal, which is not too far from its ACG Associated Capsules and ACG Pharmapack factories. The team then, put their minds to work and immediately set out to address the issue.

Within a year, ACG set up a water treatment plant, which is today capable of filtering three lakh litres of water every day and giving 18,000 people pure and safe drinking water.

For over five decades,

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ACG Worldwide - the integrated manufacturing, packaging and R&D solutions provider for the global pharmaceutical industry - has been at the forefront of technological innovation.

However, the group has always looked at opportunities to bring a positive change in its businesses, processes, partners, as well as locations. This time, too, the group - being a health care service provider - felt the need to contribute beyond the ‘normal’. And, backed by an enthusiastic leadership team, ACG Worldwide took a ‘green’ step ahead. Since then, the group has never looked back for driving sustainability initiatives.

More 'green' steps Today, effluent water treatment systems are an essential component of every ACG plant - existing and new.

Having such systems ensure that the water-based industrial processes are optimised and the waste water does not harm the environment. In fact, at most of ACG’s facilities, waste water is recycled and used for maintaining gardens and lawns, including 6,000-7,000 different species of trees.

In Dahanu, a coastal town situated around 120 km north of Mumbai and home to one of ACG Associated Capsules’ manufacturing facility, ACG assisted tribal farmers by educating and training them about modern agricultural techniques. The group also introduced the concept of ‘One Hut-One www.expresspharmaonline.com

Tree’ to help villagers become self-sufficient and spread greenery. The group also planted 200 trees inside the Dahanu Bus Depot and made provision for drip irrigation.

Aiding organic farming Besides following traditional 3R formula (reduce, recycle and reuse) for sustainability, ACG Worldwide maintains ‘vermicomposting areas’ to recycle biodegradable waste from its canteens across all locations. In vermicomposting, various worms are used to create a homogeneous mixture of decomposing vegetables or food waste.

This has helped produce compost for gardens within the facility as well as for agriculture in neighbouring villages. The local farmers were also demonstrated the benefits of organic cultivation following vermicomposting.

Tapping the sun With depleting nonrenewable energy sources and spiralling energy prices, ACG felt the need to install solar panels in its factories.

One of its plants in Shirwal has solar panels installed and is capable of generating hot water that is sufficient for the plant’s manufacturing process. Not only does this serve as ACG’s commitment towards environment-friendly initiatives, but also ended up in a reduction of 40 per cent in electricity consumption.

Future eco-friendly plans In 2013, ACG Worldwide

is beginning production at its newest facility in Indore, Madhya Pradesh. Set up with an investment of Rs 400 crores, the plant abides by green models and is also set to have solar panels.

ACG also recently launched Bio-D, a unique biodegradable calendared PVC film, that render themselves biodegradable at an enhanced rate when they are exposed to active biological landfill environments.

According to a survey by Perception Research Services[1], 36 per cent buyers are interested in buying environment-friendly packed goods, while a one-third bought more products that were labelled with “made from recyclable material” or “recyclable”. Bio-D film packing increases brand value by being associated with green initiatives, while protecting the product.

Greener world - For today and tomorrow The humble village head Rajesh Tambe, in his thanking speech, had urged other industries to help the village in this kind of innovative and caring initiatives. A year past the ceremony of the water filtration plant in Shirwal, ACG Worldwide has continued its efforts in building sustainable products as well as creating a culture that understands and values the significance of a greener and better world.

1. http://www.prsresearch.com/ about-prs/announcements/ article/eco-friendly-packaginginfluences-shopping-decisions June 16-30, 2013

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VALUE ADD RF ValProbe—Wireless Validation System Asif Gavandi, Manager- India, GE Measurement & Control, elaborates on the advantageous features and myriad applications of RF ValProbe, a wireless Smart Mesh network software ith the advent of new technologies in the wireless domain from the beginning of this decade, there are several instrumentation and measurement applications which can beneficially exploit this technology.

While there are still some challenges with respect to the application of wireless communication for large scale control and automation in a complex process control environment, there are many applications within the industry where it is very much worthwhile to introduce this new technology.

Wireless : Why now in a good manufacturing practices (GMP) environment? Industrial wireless technology is not new, it has been in use in the industry for multiple decades. Legacy wireless systems were used

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transmission reliability.

Redundancy introduced through data-storage eliminates risks of repeat runs.

Security: Immune to RF interference, snooping, insertion of invalid data.

Usability: No RF site surveys required. System works out of the box and can be fully validated.

Smart Mesh Network: The technology Redundant routing is a must have in a real world RF application. A full mesh

Smart Mesh Formation: Each sensor node can act as a router and optimise data routing topology with automatic node joining and healing lets the network maintain long-term reliability.

It works without special-purpose routers. Its implementation in the Kaye product line allows up to 100 sensor nodes to be connected in a

in niche applications but not in broad applications and hence have not been adopted more widely. However, the recent developments of lowcost, low-power radios and self-organising, self healing wireless Smart-Mesh networking software have ignited interest in industrial wireless standardisation.

In a GMP environment, anything which cannot be validated cannot be used.

The new technologies have led to reliability, security and ease of usage.

seamless, reliable and self forming mesh network.

The mesh technology permits nodes to communicate with the base station and each other, correcting for weak RF links and automatically adjusting to dynamic RF environment, e.g. a forklift truck driving into a warehouse blocking a signal.

No special knowledge or expertise is required to install or operate the Kaye RF ValProbe.

Frequency hopping Automatic joining and formation: The Mesh network is self forming and selfoptimising. Each of the nodes discover neighbors, measure RF signal strength, optimise signal paths, dynamically optimise signal routing and route signal traffic from neighbours. A node may also join as an end node, become a routing node due to changing RF conditions and later revert back to an end node.

The SmartMesh technology combines frequency hopping with Time Division Multiple Access (TDMA).

Interference from WiFi and other existing industrial RF networks is removed due to the fre-quency hopping features.

Smart Mesh Network keys to reliability:

● Maintains full path diver-

sity (mesh) ● Frequency

hopping to avoid interferences ● TDMA protocol for data reliability and performance ● Full encrypted data with pre-shared keys on RF level

Validation and mapping The Kaye RF ValProbe system is a wireless thermal validation system that collects temperature and humidity data. The Kaye RF ValProbe system is designed for accurate, convenient, and reliable process validation of environmental chambers and storage areas. These applications include stability chambers, freezers, refrigerators and warehouses. A 2.4-GHz RF mesh network and multiple-redundant data storage support communications and storage of critical validation data, while safeguards guarantee data integrity, storage and compliance with regulatory requirements. The system consists of Kaye RF ValProbe Loggers, a Kaye RF ValProbe Base Station, and Windows-based software for programming and reading the loggers, calibrating loggers,

Smart-Mesh network—Key features Reliability: RF Mesh can provide up to 99.9 per cent June 16-30, 2013

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verifying their calibration, and generating reports.

Data from multiple wireless loggers is combined in a single file from which reports are generated. These reports are designed for implementation of 21 CFR Part 11 requirements for electronic records.

Users can customise the reports by defining process cycles and specify-ing cyclebased calculations.

Case study: Validating 'Steam-In-Place' While the RF ValProbe technology can be deployed in various applications in a GMP setup, it has been used for validating Sterilization-InPlace processes. (SIP).

Safety is of utmost concern in the pharma industry and products are manufactured under strict aseptic conditions. Aseptic guidelines recommend that while sterilising equipment such as large tanks and immobile piping by the passage of pressurised steam, validation should consider temperature and pressure at various locations in order to identify potential 'cold spots'.

SIP is widely used for inline sterilisation of processing equipment in manufacturing of pharma products, dairy products, beverages and in biotechnology. Proper SIP integration with pharma equipment is important for the overall success of the operation.

In the past, wired dataloggers have been used to connect temperature and pressure sensors to the process to validate. However at times, the process lines spread over a large area and are difficult to access due to Clean Room classification.

In such cases it becomes difficult to route wired sensors for long connections to data-logger, and for communicating data to wired loggers kept outside the clean aseptic areas.

Monitoring-LabWatch Pro The Kaye LabWatch system is built as an Enterprise Architecture Model encompassing intelligence and redundancy at multiple levels in the system. Each of the elements in the architecture are robust, complete and independent sub systems. At the primary input of the system lie the extremely accurate calibrated sensor modules (temperature/humidity/CO2/pressure/etc.). These sensor elements feed into the

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RF Valprobe data loggers or the Netpac modules. The battery operated RF loggers store and forward the real time data from the sensor elements at programmed interval to the RF Base Stations. Up to 30000 samples can be stored on these loggers and can be re-trieved in case of a power failure on the base stations or RF transmission issues. The RF Base stations communicate to the LabWatch server via the industry standard OPC server.

With sophisticated monitoring and reporting features, Kaye LabWatch proves to be an effective turnkey solution for your laboratory, warehouse and stability monitoring needs. The system provides a cost effective way to view and collect real time data for regulatory compliant monitoring of your valuable inventory.

Critical environmental information is provided to assure that your equipment is operating within defined parameters, thereby protecting your assets and providing a ready trail of compliance.

Integrating high quality www.expresspharmaonline.com

sensors, latest wire-less and wired technologies for communication and networking abilities into an easy-to-use Information Management

Solution, LabWatch combines precision monitoring with effective alarming, hassle-free reporting, and secure data archiving.

June 16-30, 2013

Express Pharma Business Avenues

June 16-30, 2013

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Express Pharma Business Avenues We care for your family . . .

Anti-Inflammatory Enzymes Serratiopeptidase Peptizyme (enteric coated serratiopeptidase granules) Trypsin Chymotrypsin mix ( 6:1)

Probiotics Saccharomyces boulardii Lactic acid basillus sporogenous

Circulatory Health Nattokinase

Bio Catalysts Immobilized Cal B

Digestive Aids Alpha amylase / fungal diastase / fungal amylase Alpha galactosidase Bacterial alpha amylase Bromelain Hemicellulase Lactase Lipase Ox bile

Papain Pepsin Pancreatin Protease ( acid / alkali)

Advanced Enzyme Technologies Limited Sun Magnetica, 'A' wing, 5th Floor, Accolade Galaxy, LIC Service Road, Louiswadi, Thane(W) - 400604, India Tel: +91 22 41703200, Fax: +91 22 25835159 • E-mail : info@enzymeindia.com • Website: www.enzymeindia.com

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www.expresspharmaonline.com

Non-GMO ISO CERTIFICATION

GOTS CERTIFICATION

Products

WHO cGMP

FDA

June 16-30, 2013

Express Pharma Business Avenues 2

Designers, Engineers & Manufacturers of Machinery & Filteration Equipments for:

es Decad ies.

Over dustr In to e ic 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

June 16-30, 2013

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Product Range Horizontal Plate Filter Press Plate & Frame Filter Press Bag Filter Cartridge Filter Single Plate Filter Holder Basket Filter Rotary Spray Ball Recess Plate Filter Press

Parksan Filters Pvt. Ltd.

103, Laxmi Industrial Estate, Navghar, Vasai Road (East), Dist. Thane - 401 210, India Tel : +91 250 239 1904 Mob : +91 98338 83114 Email : sales@parksanfilters.com Web : www.parksanfilters.com parksan@vsnl.net

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www.expresspharmaonline.com

June 16-30, 2013

Express Pharma Business Avenues

June 16-30, 2013

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Express Pharma Business Avenues CLEANING, SANITISING EQUIPMENTS CLEAN ROOM ACCESSORIES ASEPTIC PIPING , PW / WFI DISTRIBUTION LOOPS

Floor Drain Traps

Hand Sanitiser

Water Saver Cleaninng Nozzles(self-rotating) Nozzles

Shoe Cover Dispenser

Foot Sanitiser

Split Butterfly Valve

Pendents(Service Shafts) CIP/ SIP MODULE We also design & manufacture # IBC Washing/ Drying Modules # Containers/ Glass Ware Wash Modules # FBD Bag Washing/ Drying Modules # Cannisters Washing Modules # Drums Washing Modules

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Wash Down Hose Station

SIP MODULE

8/B, Surat Singh Est ,SV Rd, Jogeshwari(W), Mumbai-400102 Tel; 022-26797941 Telefax:022-26798066 Cell: 9869231815 email: iewi@mtnl.net.in website : www.iewi.net

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Top Tank / Reactor Sampler

Flush Bottom valve

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SILICONE TRANSPARENT TUBING F O R H I G H P U R I T Y AP P L I C AT I ONS

DMF NO: 26710

1 1 1 1 1 1 1 1 1 1 1 1 1

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US FDA regulations CFR 177.2600 for contact with food USP class VI requirements European Pharmacopoeia 3.1.9 Animal derivative free Imported state of the art machine d Highly advanced auto-curing system tifie r e C Excellent heat resistance (-50째C to 250째C) m nroo a e l C Odourless Completely nontoxic Repeatedly autoclavable No leaching of particles Does not support bacteria growth Retains elasticity even after prolonged use

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What do you

want from compression simulation?

A new integrated manufacturing platform to maximize: â&#x20AC;˘ Your choice of excipients (diluents, binders, lubricants) â&#x20AC;˘ Your choice of the best tablet press Roquette and the Institut de la Garonne have pooled their expertise to provide a new service of compression simulation that gives 80% predictive capability.

From the excipient to a robust formula, we deliver!

ROQUETTE, through its production units (in Europe, in Asia and in the United States) and its international distribution network, will assure a constant quality of products and services throughout the whole world.

roquettepharma-services@roquette.com www.roquettepharma.com For your local contact : Roquette India Pvt Ltd Email : pharmabiz.india@roquette.com - Tel : +91 22 2570 6775 Our local Distributor : Signet Chemical Corp. Pvt Ltd - Email : sales@signetchem.com

June 16-30, 2013

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More than 500 units working successfully

Manufacturers of Pharmaceutical Machinery 39/2A, Purna Das Road, Kolkata - 700 029. Gram : Techpharma. Tel : 91 33 2464 4568 / 0457 7253.

Fax : 91 33 2464 7254. Email : mails2neomachine@gmail.com, neocota@sify.com Mumbai : 91 22 2261 4088, Chennai : 91 44 2432 2243 / 2432 8128, Delhi : 91 11 2546 0255

June 16-30, 2013

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Express Pharma Business Avenues Bulk Density Tester

pure science – no fiction

XRD Sample Preparation for Pharmaceutical Industry

Measures the bulk density of fine powders and similar products

Pe r f

ec t of s homo ge mal ni z l qu ant i at io n t ie s

USP, ASTM Compliance Patent Pending

MIXER MILL MM 400 Ideal for drug delivery research Grind size <5 microns Fast grinding of small volumes, dry, wet and cryogenic Grinding jars 1.5 ml to 50 ml, in 6 different materials Adapters for cell disruption/homogenization in microtubes (up to 20 samples per run) ■ Memory for 9 Standard Operating Procedures (SOPs) www.retsch.com/mm ■ ■ ■ ■ ■

Mechanical Spatula Removes Excess Powder

RETSCH INDIA PVT LTD | 1-2-45/1, 2nd Floor, Street No: 2, Kakatiya Nagar Colony, Habsiguda | 500 007 Hyderabad, India Phone: +91 40 2717 2431 | Fax: +91 40 2715 4686 E-mail: info@retsch.co.in | Web: www.retsch.co.in

www.electrolabindia.com

info@electrolabindia.com

Full ISO-grade barcode verifiers Globally acclaimed systems for ISO/ANSI/CEN verification Features to meet 21 CFR Part 11 GS1 reporting template as applicable 12000 range meets ISO 15415, ISO 15426-2, ISO 16022 Single model to handle both LINEAR as well as 2D barcode symbols

AXICON verifiers operating at leading Pharma Companies. Barcode verification as per mandated global standards, aid improving quality, generate quality verification REPORTS

Standards Compliant

Automatic variable aperture adjustment makes for ease in operation GS1 application identifier (AI) checking and validation of encodation Product Look-up facility. Plugins to meet norms of CIP (France) and Turkey Detailed report of verification results for global compliance Ease in operation with comprehensive features, global compliance standards Backed with software updates ensuring compliance to current standards

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#203 Money Chambers, 6 KH Road, Bangalore 560 027 Phone +91 80 6598 8333, 2211 0520 email: gen@sandilyam.com

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June 16-30, 2013

Express Pharma Business Avenues

Plastic Containers (HDPE, LDPE) Rubber Closures, Glass Containers Medical Articles & Packaging Materials Testing as per USP, EP&JP Biological

Chemical • • • • •

• •

Identification tests by MIR, DSC. Container permeation studies.

Extractables and Leachables.

Migration studies.

Physico chemical testing.

Environment Stress Crack Resistance Heavy metals, extractable elements, etc

• • • • • • •

Cytotoxicity; ISO 10993-5, USP <87> Systemic Toxicity; ISO 10993-11, USP <88> Implantation; ISO 10993-6, USP <88> Irritation / Intracutaneous Reactivity.

Hemocompatibility; ISO 10993-4 Sensitization; ISO 10993-10, USP <1184> Genotoxicity: ISO 10993-3

SERVICES

ACCREDITATIONS

Formulation Development.

Microbiological Studies.

Biological Studies.

Pre Clinical Studies.

Analytical Research.

Bio-equivalence Studies.

Clinical Trials.

Dossier Preparation.

USFDA registered cGMP control testing laboratory.

DSIR approved R & D Centre.

Drugs Controller General of India (DCGI).

NABL accreditation for Chemical, Biological.

Medical Testing, Bioanalytical & Mechanical.

Recognized by Bureau of Indian Standards.

Drugs Control Administration (A.P).

Department of Biotechnology approved Institutional Bio-Safety Committee (IBSC).

!"! $!%!&'('%" )*!+",+'- ,% ./012 324. !*' 5'-,&%'5 "6 '%-7*' "6"!8 ,%"'&*,"9: -'+7*,"9 !%5 ;!-"'-" *'"*,'<!8=

ONE STOP SOLUTION FOR PHARMACEUTICAL RESEARCH

SIPRA LABS LIMITED Industrial Estate, Sanathnagar, Hyderabad – 500 018.

Tel: 040-23802000, Fax: 040-23802005 Email:sipra@sipralabs.com web: www.sipralabs.com

June 16-30, 2013

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Advertise in

Business Avenues Please Contact: ■ Mumbai: Rajesh Bhatkal 09821313017 ■ Delhi: Ambuj Kumar 09999070900 ■ Chennai: Vijay Kulkarni 09940047667 ■ Bangalore: Khaja Ali 09741100008 ■ Hyderabad: A K Shukla 09849297724 ■ Kolkata: Ajanta / Prasenjit Basu 09831182580 / 09830130965 ■ Ahmedabad: Rajesh Bhatkal 09821313017

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June 16-30, 2013

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THE UNITED ENGINEERING COMPANY

UNITED “AFS-10” HI – SPEED AUTOMATIC AMPOULE FILLING AND SEALING MACHINE

UNITED “SAL” FULLY AUTOMATIC SELF ADHESIVE VERTICAL BOTTLE LABELING MACHINE FOR ROUND / OVAL / FLAT BOTTLE(SINGLE / BOTH SIDE LABELLING)

OUTPUT: 15000 to 18000 Ampoules/Hour RANGE : 1 ml. – 10 ml.

OUTPUT – 3000 to 12000 Bottles/Hour (Output depends on Bottle size & Label size)

Salient Features : n

n

Salient Features :

In feed of empty washed and sterilized ampoules with the help of conveyor or S.S.

n

Hopper and S.S. Tray.

n

Automatic collection of filled and sealed ampoules in erect position.

n

Vertical & Horizontal adjustment of label applicator and label position to handle

n

Both sides labelling machine is available for flat bottles.

Same machine can handle round and flat bottles with minimum change parts.

n

Individual No Ampoule No Fill Arrangement.

n

S.S. 316 L syringe with rotary valve with a single volume adjuster.

Accurate Label Placement.

Label dispensing with Servo Motor and Servo Drive for better accuracy. different size of bottles by means of Hand wheel.

n

A.C frequency drive & geared motor.

n

n

Fully PLC controlled with touch screen & HMI.

n

n

Machine body fabricated with Stainless Steel 304 quality.

n

Machine body is fabricated with S.S. 304 Structure & Cover.

n

Easy change over with minimum setting time for different size of ampoules.

n

Easy Change Over.

Fully PLC controlled touch screen with HMI & AC Frequency Drive.

“UNITED” PROUDLY INTRODUCES MOST COMPACT HI-SPEED ONLINE VIAL WASHING MACHINE WITH ULTRASONIC WASH AND PLC SYSTEM MODEL – “OL-VW-12”

UNITED HI-PRO “ ARBW” AUTOMATIC ROTARY BOTTLE WASHING MACHINE

CAPACITY - 5ml. to 30ml. Round Vials.

OUTPUT - 10000 to 14000 Round Vials/Hour

CAPACITY - 10ml. to 1000ml. Round Bottles.

OUTPUT - 4800 to 8400 Bottles /Hour.

n

Salient Features : n Most Compact Design.

No Bottle No Washing. n Machine supplied with 2 pumps for two different media of water fitted with filter and s. s. housing. n Conveyor driven by separate motor with AC Frequency Drive n The washing area is covered with acrylic sheet. n All pipes connected to water are as per GMP standard. n Machine can be used for air/water cleaning or even combine cleaning. n Versatile machine used for Glass/PET/HDPE bottles of different shape and size with additional change parts. n Easy change over with variable size. n Automatic loading and unloading of bottles. n After washing the bottles are directly fed to the filling machine without any hand touch. n Machine will stop automatically in case of bottle jammed at out feed. n

Salient Features : Most Compact Design.

n

PLC with HMI and AC Frequency Drive.

n

Minimum change parts.

n

Entire machine and contact parts with water & air are made of S.S. 316.

n

Alarms for Low Pressure of Recycled Water, DM, WFI & Compressed Air.

THE UNITED ENGINEERING COMPANY 132, Damji Shamji Industrial Estate, Mahakali Caves Road, Andheri (E), Mumbai 400 093.

Phone : +91-22-2687 6919 ● Fax : +91-22-2687 6676 ● E-mail : uec.mum2@mtnl.net.in Head Office : 35A, Hazra Road, Kolkata-700 029 (INDIA) ● Phone : +91-33-2475 9744.

Fax : +91-33-2475 7727 ● E-mail : uec@cal2.vsnl.net.in

June 16-30, 2013

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P|H|A|R|M|A| L|I|F|E

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Picture this: You are not feeling well. You go to a doctor who diagnoses your problem and hands you a prescription (that often looks like Greek and Latin). You go to the chemist shop and wait for him to hand over the medicines. During the whole process, one doesn't even bother to ask the doctor or the chemist for the generic equivalent of the same drug or even a medicine that falls within one’s budget without compromising on the efficacy.

Say for example, you have a headache and need a Crocin, a branded drug, with paracetamol as its active ingredient, you could request your physician to prescribe an equivalent and save on your costs.

There has been a proliferation in the number of websites and mobile apps in the US helping consumers choose generics over branded drugs and even choose equivalent cheap branded medicines, thus bringing down consumer spending on prescription drugs. Take for instance GoodRx, a website which also has a mobile app wherein one could type in the drug name and their location. A range of rates at which one could buy the same drug and the pharmacies where it is available appears pronto, along with coupons and discounts one can avail of. However, such apps are a rarity in the Indian scenario. Patients usually rely on the doctor or the neighbourhood chemist (in rural areas) to prescribe the drugs.

There are several reasons why.

Ruchi Dass, Founder and Chief Executive Officer, Healthcursor Consulting offers a perspective, “Most such apps are made by people in the US and have a worldwide audience; very few exist in India. Absence of

June 16-30, 2013

the right infrastructure to expand their reach to the masses does little to help the cause. More so, it makes little business sense when there are already apps and websites providing globally reliable information that is suitably accredited.” With outof-pocket expenditures accounting for more than 70 per cent of health expenditure, empowering the consumer on how they could save costs by dispensing information on medicines could help them take these in consultation with their doctor. However, there are some small steps being taken in that direction. Take for instance healthkartplus, an application developed by online pharmacy and medical retail store, healthkart.com.

The website www.healthkartplus.com, which has built up a database of 10,000 medicines till now, saw close to half a million people use its medicine product information and 50,000 people download its Android, iPhone and Windows 8 apps (which are free) in the past eight months since its launch. The service, currently available in the Delhi-NCR region, started out as a medicine information search engine and mobile app. After seeing traction, user feedback and requests, an inventory of authorised distributors and pharmacies were incorporated into the network.

“Information about medicine is the key challenge we set out to solve. We are trying to make publicly available unbiased information on : the constituents of medicines, their side effects, interactions etc. to patients; not only helping them understand the nature of prescription but also assuring fair prices, authenticity of medicines and products well within the expiry date,” informs Prashant Tandon, Founder, Healthkart.

The website and the app aims to make consumers more aware to help them manage their health by listing relevant clinical information on medicines and comprehensive set of substitute medicines. However, we are a long way from apps which help consumers choose their www.expresspharmaonline.com

RUCHI DASS

PRASHANT TANDON

Founder and CEO, Healthcursor Consulting

Founder, Healthkart

Most such apps are made by people in the US and have a worldwide audience, very few exist in India. Absence of the right infrastructure to expand their reach to the masses does little to help the cause

We are trying to make publicly available unbiased information on : the constituents of medicines, their side effects, interactions etc to patients

generic counterparts and the blame might lie less on technology and more on the situation on ground. Ours is a market which is primarily ruled by branded drugs, despite an increased push by the government towards generic drugs. Early this year, the Medical Council of India (MCI), in a circular addressed to the Dean/ Principals of all the Medical Colleges, Director of all the hospitals and Presidents of all the State Medical Councils, MCI; called upon the doctors practising medicine to prescribe drugs with generic names, as far as possible. Generic drugs are currently available at Jan Aushadhi stores, run on the premises of public hospitals (state and central) either by the hospital’s administration or some NGO. As of February, 147 such stores were in operation. However, their future looks lopsided with several of them having closed even as the government makes ambitious plans to increase their number.

Not only this, the Drug and Cosmetics Act 1945 has set certain rules according to which Schedule H and X drugs cannot be sold without a written prescription by medical practitioners. With 60 to 70 per cent of the drugs falling in this category, online pharmacies have also been slow to integrate such medicines into their network to ward off the risk.

Atul Ahuja, Vice President, Retail, Apollo Pharmacy adds, “As a last mile service provider in the chain, we see our role as limited, we go by demand and give the consumer what he wants.” Most of the online pharmacies in India thus sell, health, wellness and OTC products.

Moreover, online pharmacies in the US have come in the line of fire for operating illegally and even selling drugs of poor quality, with little or no active ingredients listed therein.

It is estimated that more than 65 per cent of the population in India does not have access to medicines. Even amongst those who do, they do not have a choice over what they are prescribed, let alone choose the generic version over the branded one.

Dispensing basic information is a start and would lead to greater awareness and consumer empowerment, but that would be nullified if appropriate steps aren't taken to provide basic infrastructure which ensures that the patient, who is the end consumer in the chain, is an equal participant in the entire process and is treated fairly.

Of course, consumer empowerment also needs to take into account that safe medicines are delivered and the system is not misused. Until then technology will have to wait. shalini.g@expressindia.com EXPRESS PHARMA

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APPOINTMENT USP announces new acting COO Seasoned USP executive advances to senior leadership role he US Pharmacopeial Convention (USP) has announced the promotion of Richard Wailes to the position of acting Executive Vice President and Chief Operating Officer (COO) of the organisation.

Wailes is advancing from Vice President of Sales and Marketing, a position he

T

has held since 2002. In his new role, he will continue to oversee the sales, marketing and customer service operations, and will take on added responsibilities of information services; finance, accounting and treasury; and global communications.

USP is a non-profit scientific organisation that sets standards for the identity, strength, quality, and purity of medicines, food ingredi-

ents, and dietary supplements. The organisation’s drug standards are enforceable in the US by the Food and Drug Administration (FDA), and USP standards are used in more than 140 countries.

Wailes joined USP in January 1999 as Director of Human Resources. He was promoted to Vice President, Human Resources and Client Services in 2000. Prior to join-

ing USP, he had experience in sales and marketing, operations, and human resources at Fortune 500 corporations including IBM, Avery Dennison, WellPoint Health Networks, and Thermo Electron.

Wailes earned an MBA at Harvard Business School and a BA in American studies from Amherst College, magna cum laude.

EP News Bureau - Mumbai

AWARD Biogen Idec employees rally in 11 cities to raise awareness about Multiple Sclerosis Healthcare providers were made aware about the day’s significance and importance of early diagnosis

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iogen Idec India, a leader in research and treatment of Multiple Sclerosis (MS), observed World Multiple Sclerosis Day in India through interactive and educative road shows across India. As part of the initiative, employees rallied across 11 different cities. Cities like Gurgaon, Faridabad, Delhi, Ahmedabad, Kolkata, Mumbai, Bangalore, Chennai, Hyderabad, Cochin and Pune were visited to educate people about MS and express solidarity with people suffering from MS. The aim of the initiative

B

was to raise awareness of MS, solicit public support for improving opportunities and

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outcomes for MS patients and create an environment where people can understand MS

better. The day of service was designed to increase the role of employee volunteerism with focus on patients, healthcare providers and local communities. Wearing a MS tee and a wig, Biogen Idec employees interacted with the local community and distributed information pamphlets at parks, local market and busy streets.

With the theme message of 'Together let’s fight MS,' healthcare providers were also made aware about the significance of the day and importance of early diagnosis.

EP News Bureau - Mumbai

June 16-30, 2013

REGD.WITH RNI NO.MAHENG/2005/21398 REGD.NO.MH/MR/SOUTH-77/2013-15, PUBLISHED ON 5TH & 20TH EVERY FORTNIGHLY & POSTED 6-7-8 & 21-22-23 OF EVERY FORTNIGHLY. POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE.