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16-30 N ovember 2012 I Vol 1 I N o 10 I `100

www.modernpharma.in

In Conversation With 20 Scan this code on your smart phone to visit www.modernpharma.in

Ganesh Sambasivam Co-Founder & CSO, Anthem Biosciences

Roche’s Avastin wins EU approval

Roche’s Avastin won EU approval for use in the treatment of recurrent, platinum-sensitive ovarian cancer. The drug is already cleared by EC, for use in combination with gemcitabine and carboplatin to cure patients with first recurrence of platinum-sensitive ovarian cancer. The additional clearance of Avastin is important for ovarian cancer for patients that are now able to obtain Avastin along with chemotherapy in case of recurrence. EU approval was supported on the phase III OCEANS study, which reflected that the patients with recurrent, platinum-sensitive ovarian cancer who were on Avastin along with chemotherapy lived longer without any serious progression in comparison to the those who obtained only chemotherapy.

Big pharma cos behind campaign against tobacco: ITGA

International Tobacco Growers Association (ITGA), which opposes some of the articles of World Health Organization’s (WHO) Framework Convention on Tobacco Control (FCTC), has alleged that big pharmaceutical companies are behind the campaign. It said this was to reduce cigarette production and thereby increase nicotine patch sales, which is used to help people quit smoking. The FCTC has been adopted by 176 countries, including India since its inception in 2005. The measures are aimed at promoting alternatives to tobacco growing, production, besides reducing the acreage of plantation. India is also one of the countries that has adopted the FCTC.

Scientists test 5,000 combinations of 100 existing cancer drugs to uncover more effective treatments

Scientists in the US have tested all possible pairings of the 100 cancer drugs approved for use in patients to discover whether there are any combinations not tried previously that are effective in certain cancers. Dr Susan Holbeck, a biologist in the Division of Cancer Treatment and Diagnosis at the National Cancer Institute (USA), and her colleagues have completed testing the 100 drugs, with 300,000 experiments to test the 5,000 possible drug combinations in a panel of 60 cell lines developed by the National Cancer Institute (NCI-60 panel). “The goal is to identify novel drug combinations that are more active than the single agents alone. Since these are all approved agents, there is the potential to rapidly translate these combinations into the clinic,” she said.

Special Focus 26 Policies & Regulations 28 Loopholes in the QA & QC system Need to clear the ambiguities

Orphan drugs for orphan diseases How the concept is ‘orphan’ in India?

Case study 31 Benefits of ‘Machine Vision’ Helping Indian manufacturing to be globally competitive

Construction started for Novartis’ Singapore facility Novartis recently announced the construction of a new state-of-theart biotechnology production site in Singapore with an investment valued at over $ 500 million. The new facility will focus on drug substance manufacturing based on cell culture technology. It will be co-located

Jimenez

with the pharma production site based in Tuas, Singapore. In the future, Singapore is expected to be a technological competence center for both biotechnology and pharma manufacturing at Novartis. “This investment further strengthens our strategy to establish key strategic sites based on technological competencies. Singapore will be strengthened through a new state-of-the-art facility for biotechnology, which is a growing segment of our business,” said Joseph Jimenez, CEO, Novartis. “We have chosen Singapore as strategic supply point as it offers a wide range of advantages due to its strong local biomedical presence and knowledge, skilled labour as well as proximity to growth markets in Asia.”

The investment decision underlines the long-term strategy of Novartis to establish a worldwide manufacturing network of technology centres of excellence. The groundbreaking for the new production site is scheduled for the first quarter of 2013, while the new facility is expected to be fully operational by the end of 2016. The site will be designed to operate in a flexible manner to handle small and large scale volumes. Further, it is planned to support both clinical and commercial production of potential new products that include monoclonal antibodies for use in helping patients with diseases in autoimmune, respiratory and oncology indications. The biologics pipeline currently accounts for 25 per cent of the clinical pharma research pipeline with a trend for future growth.

IAIA elects new team Indian Analytical Instruments Association has elected its new executive member committee. K V Venugopalan has been elected as the new President, who is also the President of Waters India Pvt Ltd; while C Ravindranath and Dr Ashes Ganguly will take over as Vice President. New IAIA secretary position would be held by Gautam Rajan, existing MD of Marsap Services Pvt Ltd; Vipul Chhatbar, the acting MD of MEDISPEC INDIA LTD

and BioTek Instruments (I) Pvt Ltd will be the new Treasurer for IAIA. Current CEO Skytech Systems India Pvt Ltd will take over as Joint Treasurer. IAIA team comprises total 78 members, including 59 corporate life members and 19 individual life members from various organisations such as Perkin Elmer, Lab India, Cryogen, Spinco, Dionex, Ind tech, Thermo Fisher Scientific, Ranbaxy Fine Chemicals and Waters etc.

Venugopalan

Piramal in pact with Fujifilm Piramal Enterprises’ Healthcare vertical has entered into a strategic alliance with Fujifilm Diosynth Biotechnologies. The two parties will offer seamless contract development and manufacture Antibody Drug Conjugates (ADCs), a growing niche in the development of biopharmaceuticals. The deal will allow customers to benefit from the experience and assets of both organisations, while simplifying the supply chain and vendor management Shah relationships, leading to shorter time to clinic. Piramal is a world leader in antibody drug conjugation, while Fujifilm Diosynth Biotechnologies is one of the

world’s leading providers of contract development and manufacturing services for biopharmaceuticals. The combined experience covers work on more than 150 biopharmaceuticals and over 300 batches of ADCs spanning over more than 30 different NCEs, including the world’s only FDA-approved ADC. For Fujifilm Diosynth Biotechnologies, this is part of an ongoing programme to expand its offering in mammalian-based biopharmaceuticals. The company recently announced an expansion of its cGMP manufacturing facilities at both its RTP, USA and Billingham, UK sites.

Vijay Shah, Executive Director & COO, Piramal Enterprises said, “We are delighted to join with Fujifilm Diosynth Biotechnologies to offer a seamless service to customers for the production of antibody conjugates. Fujifilm Diosynth Biotechnologies has a long track record in delivering successful biologics programmes, and this alliance will combine strengths from both companies for the benefit of our customers, and ultimately patients.” Stephen Taylor, Commercial Vice President, Fujifilm Diosynth Biotechnologies, said, “This strategic alliance with Piramal is an important step for us in bringing a new, hightechnology offering to the market place. Our customers will benefit from high quality, consistent material, rapid service and shorter logistical chains, saving time on the critical path of drug development. Piramal is a recognised world leader in this area and we are delighted to be partnering with them.”


M o d e r n Pharma•16-30 N ov em be r 2012

CONTENTS In Conversation With

20

Ganesh Sambasivam Co-Founder & CSO, Anthem Biosciences

Special Focus

20

26

27

28

Quality compliance - GMP, GLP, FDA

22 26

Standardisation and quality compliances The growing need amid upcoming challenges Loopholes in the QA & QC system Need to clear the ambiguities

Interface

27

Rangarajan Subramanian Independent Advisor; Former President, Global Quality Control and Compliance, Glenmark Pharmaceuticals Ltd

Insight & Outlook

28

Policies & Regulations Orphan drugs for orphan diseases: How the concept is ‘orphan’ in India? Tapan Ray, Director General, OPPI

www.modernpharma.in

Case study - Benefits of ‘Machine Vision’ Helping Indian manufacturing to be globally competitive Didier Lacroix, Global Senior VP (Sales & Marketing), Cognex Inc

Interface

30 FOUNDER & EDITOR, NETWORK 18 Raghav Bahl

32

Philippe Soldati Resident Area Manager, Marchesini Group India

Event Preview

36

PMEC & CPhI India 2012 Aiming to transcend success boundaries

Event Report

PRESIDENT & EDITORIAL DIRECTOR, TV 18 Senthil Chengalvarayan SENIOR EDITOR Manas R Bastia FEATURES EDITOR Arshia Khan EDITORIAL TEAM Chandreyee Bhaumik, Parita Dholakia, Pallavi Mukhopadhyay, Rishab Kothari Nikunj Sharma (Delhi) Jasleen Kaur Batra (Bengaluru) ASSISTANT ART DIRECTOR Varuna Naik DESIGN Varghees Tharakan

37

India Lab Expo 2012 Opening the technology windows for the future 4th International Nutraceuticals Conference Focussing on a healthier tomorrow

38

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REGULAR SECTIONS 7 Editorial / Guest Editorial 9 News, Views & Analysis 33 Projects 34 Tenders 35 Event List 39 Book Review 40 Products 43 Marketplace 44 List of Products & Advertisers

Highlights of Next Edition Special Focus: Pharma packaging Note: ` stands for Indian rupee, $ stands for US dollar and £ stands for UK pound, unless mentioned otherwise

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Mo de rn Ph a rm a •16 -3 0 N ove m be r 2 012

Editorial

7

The Land Bill: Need for a safe landing!

F

Editorial Advisory Board Ajit Singh

Chairman, ACG Worldwide & Head, ISPE

Dr Abraham Patani Past President, IDMA & CMD, Inga Laboratories

Dr Gopakumar G Nair IPR Consultant & Advisor

Dilip G Shah

Chairman, IGPA & Secretary General, IPA

Daara Patel

Secretary General, IDMA

or a vast sub-continent like India, the importance of land, and in particular, that of land acquisition for industrial development cannot be overemphasised. Unfortunately, the policy flip flops over this sensitive subject witnessed in the recent times have only added to the other woes of the industry at large in a pathbreaking phase when the nation surely needs another booster dose of economic acceleration. In this backdrop, the recent clearing of certain crucial government legislations, which have been pending since long, perhaps could not have been better timed! Case in point is the recent clearing by the Group of Ministers (GoM) the land bill, a much needed exercise on its 117-year-old extension that according to industry sources has been creating a lot of confusion and worse, litigation related to setting up of development projects. The Bill in its new avatar (Land Acquisition, Rehabilitation and Resettlement Bill, 2011) requires the consent of only two-third of the people affected in private and Public Private Partnership (PPP) projects, instead of the earlier mandated 80 per cent. Hopefully, this will not only provide more clarity on project execution but also facilitate timely implementation thereof. According to a clause in the Bill, it is to be applied from an unspecified cut-off date. Although the cut-off date, as per official sources, is most likely to

Guest Editorial

be decided before the Bill is cleared for introduction in the Winter Session of the Parliament, it has left most in the industry with fair amount of worries. Thankfully, the Bill, which initially had provisions for retrospective application of the law in cases where the land had not been awarded or where compensation had not been paid, does not have this clause any more. Thus, this prospective clause should be industry-friendly. While the less percentage of landowners’ consensus needed for clearing of land for projects seems to be a practical and forward-looking step, the amount of compensation and its impact on project cost remain a concern. These are early days considering the extent of value addition that still remains to be made in order to make this Bill a progressively effective one. Apart from defining the ‘purpose’ of the land acquisition without any ambiguity whatsoever, the Bill has to factor in several inter-state and intrastate scenarios as well as existing restrictions on the use of agricultural land for industrial use. Only a complete and competent enough Land Bill can decisively address the complexities of this subject.

Manas R Bastia manas@network18publishing.com

Pricing of patented new drugs

A

las! We, Indians, are unique in ways more than one. When in the pharma territory, the paradox multiplies. We have been struggling for more than a decade to finalise a pharma policy. The pricing mechanism and the ‘basket for price control’ have been in debate and dispute for long enough. The journey is still on, presently settled ‘cozily’ in the Supreme Court of India. The very same civil society who has been vociferously arguing for continuing a cost-based price control system as against a market-based mechanism, had a different take when it came to patented drugs. The Ministry (Department of Pharmaceuticals) had constituted a committee for inviting & deliberating on proposals for finalising a pricing policy for patented, but mostly imported new drugs. NIPER could have been entrusted for evaluating the costs to arrive at a price. Weighted averages of prices to NIH or government procurement prices overseas could have been another option. However, the pharma NGO lobby opposed fixing of prices of patented drugs. They argued that once government fixes prices of patented (which are most often imported) drugs, it will defeat the Compulsory Licensing

(CL) system. The argument of the civil society groups was that once the government fixes the price, how can the government accept that the price is exorbitant? Till date only one CL has been granted in India. Grant of a CL can only happen if an Indian pharma manufacturer applies for a CL. The larger Indian pharma sector is looking forward to working with the MNCs and abhors CLs and prefers Voluntary Licensing (VL). SMEs simply do not have the logistic capabilities to comply with the data required to be submitted along with a CL application. Data collection in the absence of pharmacovigilance and related practices is not easily achieved. Grant of a CL is further, finally, in the hands of a single individual, the Controller General of Patents. While Sec 83 is wide and powerful in intent, handling subsequent Sections such as Sec 84, 85 & Sec 87 requires a lot of communication, courage as well as rational and national prioritisation. It all depends on the courage, conviction, national spirit and intent of one individual. Seeking not to finalise a pricing policy for imported patented drugs and just waiting for CLs to be granted, appears to be like the proverbial ‘Pelican waiting for the rain.’

Once a CL applicant comes forward, a practical pricing can be arrived at. However, till such time, it may be a better idea to link the pricing of imported patented drugs to the regulatory mechanism. While receiving the new drug application for patent-protected dosage form for import and marketing in India, the DCG(I) could ask the applicant to declare the proposed price and the therapeutic benefits of the drug over others in the same category. The DCG(I) could consider the new drug application in the light of pricebenefit ratio to the patients. Similar practices exist in many developing countries. In the meantime, an advisory body may be formed to assist the evaluation. The NIPERs, CSIR Labs such as NCL, IICT and DST/DBT could be part of this advisory body. DCG(I) could consult the Department of Pharmaceuticals/ NPPA in this exercise or even communicate his decision for better co-ordination. While a CL may lead to drastic reduction in the domestic price, a fairly evaluated price may be good both for the patentee, patients, the health care sector and the nation. Dr Gopakumar G Nair

IPR Consultant and Advisor


Mo de rn Ph a rm a •16 -3 0 N ove m be r 2 012

News, Views & Analysis

Bristol-Myers Squibb Foundation to host Centers of Excellence Conference The Bristol-Myers Squibb Foundation (the Foundation) and its partners have launched a Centers of Excellence Conference for communitybased viral hepatitis interventions to share best practices from the flagship hepatitis programme ‘Delivering Hope,’ which this year Damonti celebrates its 10th anniversary. The Asia-Pacific region is heavily burdened by viral hepatitis. It is estimated that China and India together have 123 million people infected with chronic hepatitis B and 59 million people chronically infected with hepatitis C. All countries in the South-East Asia region consider hepatitis B and C urgent public health issues, however awareness of hepatitis is considerably low, and many countries lack the resources to co-ordinate and implement programmes to control the viruses or provide citizens with vaccinations for hepatitis B. ‘Delivering Hope’ works to reduce these health disparities by funding and initiating programme grants to increase awareness, treatment and care. To date, the programme has awarded $ 11.8 million in grants to 45 programmes across the region. “Hepatitis B and C are serious global health threats, especially in China and India, and are responsible for more than 80 per

cent of all liver cancer in Asia,” said Charles Gore, President, World Hepatitis Alliance. “The BristolMyers Squibb Foundation’s Delivering Hope programme, and its partners have funded research and pilot programmes that have really affected policy decisions and made a big difference in how we approach prevention, care and support for those affected by viral hepatitis, as well as their families and communities. We must all work together to ensure that viral hepatitis continues to have a really high national and international priority.”

Continuing the legacy of Delivering Hope: Centers of Excellence Conference

In the past five years, the BristolMyers Squibb Foundation has expanded its efforts considerably across India, providing more than $ 4 million to support 18 grants in many states of the country. The work of the Delivering Hope grant recipients has greatly impacted their communities. A recent evaluation report developed jointly by several partners found that a rural health care provider training programme implemented through a Delivering Hope grant improved rural health care providers’ understanding of illness and medication. Liver Foundation West Bengal, Hope

Initiative in Uttar Pradesh and Hepatitis Foundation of Tripura have developed and implemented groundbreaking interventions in awareness, prevention, capacity building and promoting harm reduction. These groups shared their best practices with additional organisations at the Center of Excellence conference in Kolkata, West Bengal, India on November 4. As a next step, Liver Foundation West Bengal will consolidate best practices learned from the work of these groups, and package this, along with consultations with government and other roleplayers in health care and hepatitis, for organisations with similar missions to use. “Over the past 10 years, Delivering Hope has benefitted more than eight million people including students, women, health workers, healthcare professionals, migrant workers and the general public in both rural and urban areas. The programme works to harness the power of local communities to enact change and progress for viral hepatitis,” said John Damonti, President, BristolMyers Squibb Foundation. “The Foundation remains committed to this programme and raising awareness to help fight this deadly disease. We look forward to seeing how the sharing of best practices through our Centers of Excellence conferences can further extend the ripples of change that our partners have helped create into ever widening circles of hope and promise for more people across the AsiaPacific region.”

In Brief Boehringer Ingelheim presents robust pipeline highlighting its respiratory R&D

At its 3rd International Research & Development press conference, Boehringer Ingelheim unveiled a pipeline of unique asthma, Chronic Obstructive Pulmonary Disease (COPD), Idiopathic Pulmonary Fibrosis (IPF) and lung cancer compounds that builds on the company’s vast respiratory experience over many decades. At the press conference, Prof Andreas Barner, Chairman - Board of Managing Directors, Boehringer Ingelheim, and scientist within Boehringer Ingelheim’s own R&D division in Biberach, Germany revealed details of the company’s extensive overall pipeline.

Glenmark settles patent case with Janssen for generic tablets

Glenmark Pharmaceuticals has settled litigation with Janssen Pharmaceuticals Inc over patent actions regarding generic oral contraceptive norgestimate and ethinyl estradiol tablets. Glenmark Generics Inc, subsidiary of Glenmark Generics Ltd, has announced the settlement of litigation pending between Glenmark and Janssen Pharmaceuticals Inc (Janssen) over patent actions concerning norgestimate and ethinyl estradiol tablets, Glenmark Pharmaceuticals said in a statement. Under the terms of the settlement agreements, Glenmark will be able to market and distribute its generic tablets under a royalty bearing licence from Janssen on December 31, 2015, or earlier under certain circumstances, it added.

Novartis India Q2 net profit down by 8.89 per cent

Novartis India’s net profit declined by 8.89 per cent to ` 39.34 crore for the quarter ended September 30, 2012 over the same period last fiscal. The company had posted a net profit of ` 43.18 crore for the quarter ended September 30, 2011. Net sales of the company, however, rose to ` 237.43 crore for the quarter under consideration from ` 218.97 crore for the corresponding period previous fiscal.

Dr Reddy’s Q2 stand-alone profit up

Dr Reddy’s Laboratories Ltd reported second-quarter standalone net profit of ` 363.03 crore, up from ` 138.50 crore for the quarter ended September 30 last year. Total income increased to ` 2,272.44 crore from ` 1,660.03 crore in the corresponding quarter of the preceding year. On a consolidated basis, its second-quarter net profit rose to ` 407.44 crore from the ` 307.80 crore in the year-ago quarter. Total income grew to ` 2.920.49 crore from the ` 2,289.31 crore in Q2FY12.

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Mo de rn Ph a rm a •16 -3 0 N ove m be r 2 012

News, Views & Analysis

Chromatographic Society of India to host a symposium on the evolution of gas chromatography Chromatographic Society of India will be organising a symposium on the evolution of Gas Chromatography (GC) in India at the Bhabha Atomic Research Centre’s (BARC) Training School Hostel Auditorium on November 23 and 24, 2012. The purpose of the symposium is to walk down the memory lane of developments and contributions India has made to gas chromatography instrumentation research, manufacturing and industrial applications. Experts from the fields of GC application such as petrochemicals, natural gas, perfumeries, pharma, forensic, flavours, synthetic chemistry, etc will talk on the topic.

The symposium will also serve as a platform for experts in the field to share their knowledge and guide younger scientists and students. Exhibition booths will be set up to display GC products, accessories and consumables. Speaking about the symposium, Dr G Ramakrishnan,

Dr Ramakrishnan

President of Chromatographic Society of India, said, “I feel proud that Chromatographic Society of India is celebrating the Diamond Jubilee Year of Nobel Prize given for GC, and that we are able to bring together the scientists and companies that have worked to make India a significant country in manufacturing GC, accessories and consumable. I am hopeful that this symposium will be an eye opener especially for young scientists and students of India to pause and look back at the contributions India has made in gas chromatography and how our industries have benefitted from it.”

Aurobindo Pharma soars on heavy volumes, stock surges 100 per cent in 2012 Aurobindo Pharma has soared over 8 per cent to ` 171 on back of heavy volumes on the Bombay Stock Exchange on hopes of healthy revenue growth from US market driven by Abbreviated New Drug Application (ANDA) approvals received from USFDA. The stock opened at ` 159 and has seen around three-fold jump in trading volumes. A combined 4.85 million shares have already changed hands on the counter so far against an average 1.7 million shares that were traded daily in past two weeks. The

stock of pharmaceutical company continued at its upward march and is one of the out performers in 2012, has rallied 100 per cent from ` 85 at the beginning of current calendar year. The benchmark index Sensex has

gained around 20 per cent during the same period. “Aurobindo has a total of 157 ANDA approvals (131 final approvals including one from Aurolife Pharma LLC and 26 tentative approvals) from the USFDA. Overall, the company expects around 7-8 players in the product. Given the size of the product, the product can contribute around $2030 million for the full year,” said Sarabjit Kour Nangra, Analyst, Angel Broking, in a recent report.

In Brief Indoco’s revenues grows by 13.5 per cent

Indoco Remedies Ltd recorded a growth of 13.5 per cent in the revenues at ` 1645.3 million during the second quarter of FY 2012-13 as compared to ` 1449.8 million over the same quarter last year. The unaudited results for the second quarter of the financial year 2012-13 were announced by the Board of Directors of Indoco Remedies Ltd at their meeting. Commenting on the performance, Suresh G Kare, Executive Chairman, said, “Our domestic business is doing well with growth rates better than that of industry average for the current as well as previous quarter. On the international business front, the projects signed with alliance partners are getting commercialised. As envisaged, the company is set to take a big leap by registering higher growth consistently.”

Aarti Industries Ltd net profit increases 58.14 per cent to ` 28.26 crore

Aarti Industries Ltd (AIL) recently declared its financial results for the second quarter and half year ended September 30, 2012. The company reported a healthy increase of 58.14 per cent in its net profit to ` 28.26 crore for Q2 FY13, as compared to ` 17.87 crore in the corresponding quarter of last fiscal. Total income for the quarter ended September 30, 2012 stood at ` 469.62 crore, up by 17.71 per cent, as compared to ` 398.97 crore in the same period last year. The Board has declared interim dividend of ` 1.50 per equity share of ` 5 each. Rajendra Gogri, CMD, Aarti Industries Ltd, said, “Exports of the company has grown significantly during the period. We are pleased that contribution of export has more than 50 per cent during the period. This is for the first time that contribution of exports to the total revenue has crossed 50 per cent mark.”

New drug found that significantly lowers LDL levels

For many people with high cholesterol, statins serve as the first line of treatment. However, some patients are unable to effectively reduce their Low-Density Lipoprotein cholesterol (LDL cholesterol) or ‘bad cholesterol’ levels with statins, due to their bodies’ inability to tolerate or sufficiently respond to the medicine. Now researchers at Brigham and Women’s Hospital have shown that in patients already on a statin, the addition of a new drug, called AMG 145, can reduce LDL cholesterol levels by up to 66 per cent after 12 weeks.

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Mo de rn Ph a rm a •16 -3 0 N ove m be r 2 012

News, Views & Analysis

13

Merck Millipore India announces the winners of the first ‘Merck Millipore India Innovation Awards’ 2012 Merck Millipore (India), the life science division of Merck KGaA of Darmstadt, Germany recently announced the first set of winners of the ‘Merck Millipore India Innovation Awards’ 2012 (MMIIA). The MMIIA was set up in 2011 to recognise exemplary research undertaken by scientists from government-funded and non-profit public research institutes in the fields of life science, ie green chemistry, medicinal chemistry, chemical and bio-analytics, proteomics,

genomics, drug discovery and delivery, bio-manufacturing, biomarkers and synthetic biology. The first prize of ` 30,00,000 went to Dr Tapas Kumar Kundu, Dr Ruthrotha Selvi Bharatha Vikru, Hari Kishore Annavarapu, Dr Mantelingu Kempegowda from Jawaharlal Nehru Centre for Advanced Scientific Research, Bengaluru. The second prize of ` 20,00,000 to Dr Dhiraj Kumar, Dr Ahmad Faisal Karim, Pallavi Chandra, Aanchal Chopra,

Zaved Siddiqui, Dr Ashima Bhaskar, Dr Amit Singh from International Centre for Genetic Engineering and Biotechnology, New Delhi. And, the third prize of ` 10,00,000 to Dr Rita Kumar, Dr Abha Joshi, Dr Anil Kumar, Dr Tushya Kumar Saxena from Institute of Genomics and Integrative Biology, Delhi. Addressing the selection process, Dr Theodor Dingermann, Director, Institute of Pharmaceutical Biology, Goethe-University

GSK enters into phase three trials of mepolizumab GlaxoSmithKline Plc (GSK) has entered into Phase III trials of mepolizumab, an investigational IL-5 antagonist, for application in severe uncontrolled refractory asthma. The study would comprise two major programmes including MEA115575 and MEA115588. MEA115575 programme would comprise a 24-week randomised, double-blind, placebo-controlled, parallelgroup, multicentre study to evaluate the use of mepolizumab 100 mg subcutaneous adjunctive therapy every 4 weeks to reduce steroid use in patients with severe refractory asthma. MEA115588 programme would consist of a 32-week multicentre,

randomised, double-blind, double-dummy, placebocontrolled study in patients with severe uncontrolled refractory asthma. The primary endpoint of the study is to evaluate the efficacy of mepolizumab 75 mg intravenous (iv) and 100 mg subcutaneous every 4 weeks versus placebo on the frequency of clinically significant exacerbations in patients with severe refractory asthma. Commenting on the new trials Steve Yancey, Vice-President and Head of the mepolizumab development team, said, “The progression of this Phase III programme represents a significant milestone in the clinical development of

mepolizumab as a potential treatment option for patients with severe uncontrolled refractory asthma.” The Phase III trials will also incorporate safety extension studies, which will further evaluate cure of subsequent asthma attacks in mepolizumabnaive apart from previously treated individuals. Mepolizumab is an investigational fully humanised IgG monoclonal antibody specific for interleukin 5 (IL5), which is in development for severe refractory asthma in patients who exacerbate despite high-dose inhaled (ICS) or Oral Corticosteroids (OCS) and long-acting beta-2 agonist use.

and a Member, Scientific Advisory Board, MMIIA, said, “I am honoured to be a part of the MMIIA selection panel that aims to nurture the budding scientists and appreciate their significant contribution to the field of lifesciences. The final selection criteria were based on the relevance of the project for the Indian society, novelty, the application, sustainability, commercial potential and impact of the project at the regional, national and global level.”

Kaushik Desai elected as Associate Executive Committee Member, DIA Kaushik Desai, Director, Drug Information Association (DIA), India and immediate past Chairman, Industrial Pharmacy Division of the Indian Pharmaceutical Association (IPA) has been elected to the committee of Industrial Pharmacy Section, FIP as associate executive committee member (Associate Ex Co) Desai for the year 2013. The announcement was made at the recent FIP 2012 Centennial Conference held at Amsterdam. As the associate executive committee member, Desai will

be taking up responsibility in assisting regulatory affairs activities and identifying the programme contents for the development of the industrial pharmacy profession. The new executive committee members are Linda Hakes (President), Ulf Janzon (Secretary), Erik Naeser (Treasurer), Michael Anisfeld (Vice President), etc. The next FIP Congress will be held between August 31 and September 5, 2013 at Dublin, Ireland.


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News, Views & Analysis

Enanta’s lead Hepatitis C compound advances into a Phase 3 clinical trial through its collaboration with Abbott Enanta Pharmaceuticals, Inc, a R&D-focussed biotechnology company dedicated to creating small molecule drugs in the infectious disease field, announced that Abbott initiated an interferon-free combination Phase 3 clinical trial for Hepatitis C (HCV) that included the collaboration’s protease inhibitor, ABT-450. This trial was initiated following the Luly release of positive results from the study known as ‘Aviator’, a Phase 2b trial designed and conducted by Abbott. The initiation of this Phase 3 trial, part of Abbott’s global registration programme, triggered a collaboration milestone payment to Enanta. The focus of ABT-450 development is to study the compound in combination

with other antiviral agents in Abbott’s HCV portfolio. The three direct acting antivirals, or triple DAA cocktail, studied in the Phase 2b interferonfree Aviator trial included ritonavir-boosted protease inhibitor ABT-450/r, non-nucleoside polymerase inhibitor ABT-333 and NS5A inhibitor ABT-267. “The high SVR12 rates achieved in the genotype 1-infected population and the tough-to-treat IL28B non-CC genotype patient populations are very encouraging,” said Jay Luly, President and CEO, Enanta. “We look forward to the Phase 3 development of this interferon-free, oral treatment regimen containing our collaboration’s HCV protease inhibitor, ABT-450.”

Ion exchange to display high purity water solutions for pharma industry at PMEC 2012

Ion Exchange (India) Ltd will display the INDION RO-EDI High Purity Water Generation and Distribution System at PMEC 2012, Hall 5, Stall L42, Bombay Exhibition

Centre, Mumbai, from November 21-23, 2012. Ion Exchange has maintained a close, productive association with the pharma industry for over 48 years. Its complete, integrated, specially designed solutions include – demineralised water, purified water, pyrogen-free water and water for injection that are critical to the pharma industry’s processes. Dedicated experience in total water and environment solutions, technological expertise and extensive R&D enable Ion Exchange (India) Ltd to deliver customised, speciality systems that meet stringent requirements for high purity water generation and distribution.

Elder Pharmaceuticals gets suitability certificate from EDQM for Diosmin Drug firm Elder Pharmaceuticals announced that it has received a certificate of suitability for ‘Diosmin API’, a drug used for the treatment of diseases related to veins, from the European health authority. The company has received the ‘Certificate of Suitability’ (COS) from European Directorate for the Quality of Medicines and Healthcare (EDQM) for Diosmin API, Elder

Pharma said in a statement. “The recognition by EDQM shall immensely help the company to further enter the regulated markets of European Union,” said Alok Saxena, Joint MD, Elder Pharma. Diosmin is an oral phlebotropic drug used in the treatment of venous system related diseases including chronic venous insufficiency and haemorrhoidal disease.

Spectrum appoints Joseph Turgeon, as Senior VP, Sales & Operations Spectrum Pharmaceuticals recently announced the appointment of Joseph Turgeon as Senior VP - Sales & Commercial Operations. Turgeon will be responsible for the commercialisation and sales of all Spectrum products; currently, Spectrum markets Fusilev® (levoleucovorin)

for injection; Folotyn® (pralatrexate injection) and Zevalin® (ibritumomab tiuxetan) Injection for intravenous use. Turgeon brings over 25 years of pharma sales experience, including various executive

Turgeon

leadership roles at Amgen. He will be reporting to Ken Keller, EVP and COO. “With three anticancer drugs on the market now bringing nearly $ 300

million in pro forma revenue and nearly ten drugs in clinical development, we are committed to strong growth in the next five years,” said Rajesh C Shrotriya, MD, Chairman, President and CEO, Spectrum Pharmaceuticals, Inc. “I am excited to head Spectrum’s sales and commercial

operations, especially in light of the recent Allos acquisition, which I believe represents a strong opportunity for expanding sales. I look forward to working with the team in this capacity and building on Spectrum’s growth momentum,” stated Turgeon.


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News, Views & Analysis

Mayne Pharma announces in-licensing agreement Mayne Pharma Group Ltd has signed a licensing and distribution agreement with Intas Pharmaceuticals Ltd (Intas) for a large range of injectable products for the Australian market. Mayne Pharma will initially gain rights to 11 hospital products. The current market sales of these products are $ 73 million per annum (IMS Health, MAT June 2012) and Mayne Pharma expects to file these products with the Therapeutic Goods

Administration (TGA) during the 2013 calendar year. In addition, Mayne Pharma has also secured a right of first refusal for the exclusive distribution of another 30 pipeline injectable products across a range of therapeutic areas with current market sales of $ 140 million per annum (IMS Health, MAT June 2012). To date, there are no generic equivalents to 15 of these pipeline products and the company expects several

of these will be the first generic versions approved. All products will be developed and supplied by Intas from their TGA and US FDA-approved facilities. Scott Richards, CEO, Mayne Pharma, said, “Mayne Pharma is committed to building its domestic business. One of the avenues to achieving this goal is by in-licensing attractive niche products with low competitive dynamics while at the same time delivering cost-effective medicines to patients. “

Results from the largest known cholesterol survey conducted in the US Results from the USAGE survey, the largest known cholesterol survey in the US involving more than 10,100 statin users, were presented at the American Heart Association’s Annual Scientific

Sessions, the leading gathering of cardiovascular disease experts in the US. The USAGE survey ‘Understanding Statin use in America and Gaps in Education’ is the first survey-of-its-kind to

uncover the reasons why patients stop taking their cholesterol statin medications. High cholesterol is one of the leading risk factors of heart disease, the number one cause of death in the US.

In Brief Biocon delivers healthy growth in H1FY13

Biocon announced that the research services and branded formulations propel strong growth. The revenues were ` 1235 crore Earnings Before Interest, Taxes, Depreciation and Amortization (EBITDA) is ` 305 crore, Profit After Tax (PAT) ` 169 crore. Commenting on the results, Dr Kiran MazumdarShaw, CMD, Biocon stated, “We continue to deliver good performance across verticals this fiscal. At the half year, we have seen a 23 per cent y-o-y increase in revenues attributable to both volume growth as well as better export realisation on account of a depreciating rupee. Active Pharmaceutical Ingredient (APIs) and biosimilar insulin have seen significant business Dr Mazumdar-Shaw expansion in the emerging markets. Further, branded formulations and research services continue to deliver strong growth. R&D expenditure rose significantly this fiscal and stands at ` 79 crore for H1, a 54 per cent increase over the same period last fiscal. Finally, I am pleased to announce the proposed investment by GE Capital in our subsidiary Syngene, which we believe establishes a base valuation, an important milestone towards the future public offering.”

IGI Laboratories gains authorisation to launch IGI label topical prescription drug IGI Laboratories, Inc, a New Jersey-based topical generic pharma company, recently announced that the company will launch its first IGI labelled generic products later this year. IGI has a broad and extensive partnership with Medimetriks Pharmaceuticals, Inc (Medimetriks), a branded speciality pharma company dedicated to the dermatology market. This relationship includes IGI’s appointment as Medimetriks’ authorised generic distributor for certain products. Medimetriks recently launched its first product in its Synalar® (fluocinolone acetonide) line of prescription topical products, and IGI gained authorisation to launch generic distribution of certain of these products. Jason Grenfell-Gardner, President and CEO, commented, “Medimetriks is an important partner for IGI. We will work closely with Medimetriks to help ensure the successful launch of these generic topical prescription products, as we believe this launch is an essential part of IGI’s long-term strategy. Current market conditions indicate a total addressable market for our first three products of approximately $ 30 million, of which we expect to achieve a meaningful market share.” Grenfell-Gardner continued, “Launch activity has begun and with this authorisation to go to market, there are only a few steps left before our first IGI labelled generic topical product is ready to launch.”

FDA expands use of Xarelto to treat and reduce recurrence of blood clots The USFDA expanded the approved use of Xarelto (rivaroxaban) to include treating Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE), and to reduce the risk of recurrent DVT and PE following initial treatment. Xarelto is already FDA approved to reduce the risk of DVTs and PEs from occurring after knee or hip replacement surgery and to reduce the risk of stroke in people who have a type of abnormal heart rhythm called non-valvular atrial fibrillation.


Mo de rn Ph a rm a •16 -3 0 N ove m be r 2 012

News, Views & Analysis

Bosch provides custom-made consulting for pharma labs Bosch Packaging Technology is providing custom-made consulting for pharma labs to meet the needs of individual manufacturer. The company operates various facilities equipped with the advanced machinery and systems for pharmaceutical solids, which can be hired by customers for research activities and on-site testing. Bosch

delivers consistent and quick support to customers across the globe with its innovative

formulation and process development concepts. Bosch consultation service is driven by different aspects such as state-ofthe-art laboratories for product development and scale-up; Implementation of advanced lab concepts in other key markets; Hüttlin Service Center, a 300 square metres of advanced equipment; and broad array of seminars and training courses.

Indian pharma to join top ten global markets by 2020 According to a joint report by CIIPwC, the Indian pharma industry is forecast to register significant growth to join top ten global markets, in terms of value through 2020. However, regulatory interventions would play as a decisive factor in the projected growth path, which would be driven by several factors such as good economic growth and higher disposable incomes, enhanced healthcare financing, high load

of disease, and development of healthcare infrastructure. At present, the Indian pharma sector is growing at a CAGR of over 15 per cent during last five years and offers considerable growth prospects in future. Though, the industry needs to revive its business strategy and novel business ideas to sustain the growth. Pharma companies are expected to register continuous

Mettler-Toledo Garvens rolls out XD Series Checkweigher Mettler-Toledo Garvens rolled out the XD Series Checkweigher, a high precision, high-quality weighing technology in Shanghai for local manufacturing. Through strategic launch, the company is looking forward to tap Asian and Chinese markets for matching local and global weighing standards in export activities. In addition, export market accounts for about 40 per cent of Chinese GDP as well as growing demand for pharmaceutical and food safety compliance in the country offers significant prospects for growth to the newly launched product range. The new XD Series offers a costeffective measurement technique for weight verification of all kinds of boxed and bagged products along with products packaged in cans and jars. In addition, local manufacturing would allow quick deployment of equipment in Asian factories along with fast turnaround and less shipping expenses. XD Series Checkweigher is available in six variants for meeting diverse weighing needs and conveyor sizes. Other features include rugged construction for use in harsh environments; reliable operations; automatic rejection of overweight products; an optional feedback control design that links to filling lines; compact design for easy integration across the manufacturing lines; user-friendly, touch-screen interface; flexible technology design to choose from 10 different options to meet specific product characteristics and dimensions. Speaking at the launch Jin Yue, Head of Product Inspection, Mettler Toledo International Trading Shanghai, said, “The- XD Series is a turnkey solution to satisfy the unique needs of the Asian manufacturing marketplace. By producing these machines locally we can enable Asian manufacturers to respond more quickly to ever-changing quality standards, at a competitive cost.”

growth both inorganically and organically through M&A activities and focusing on increasing productivity and operational efficiency. Expansion in the health insurance, mobile telephony and medical technology segments will also drive the sector’s growth by eliminating physical and financial bottleneck to healthcare access in the country.

In Brief Hikal’s Q2 sales up by 5.5 per cent

Hikal Ltd’s Q2 sales grew by 5.5 percent. The company revealed in its FY 2013 financial results, for a period of six months ended on September 30, 2012. The net sales of Hikal rose to ` 153 crore against ` 145 crore in Q2 FY2012. EBIDTA growth was recorded at 13 per cent reaching ` 43 crore than ` 38 crore in 2011 for the same period. The company’s pharmaceutical division growth was impacted by excess inventory stocks maintained by its customers, which brought down the pharmaceutical sales by 8.5 per cent to ` 80 crore in Q2 FY2013 in comparison to previous year’s record of ` 87 crore corresponding Q2 FY2012. The company reported a dip in net profit by 81.9 per cent at ` 2 crore against ` 11 crore on a year-on-year basis, due to loss on forex contracts that will expire in 2012.

Cumberland Pharmaceuticals, Inc receives second Acetadote® patent notice of allowance

Cumberland Pharmaceuticals Inc recently announced that it has received a Notice of Allowance from the United States Patent and Trademark Office for a second patent relating to its new formulation of Acetadote(®) (acetylcysteine) injection, which is used to treat acetaminophen overdose. The new patent includes claims regarding the use of the 200 mg/ml Acetadote formulation to treat patients with acetaminophen overdose.

FDA approves Synribo for patients with CML

The FDA recently approved omacetaxine mepesuccinate to treat adults with chronic myelogenous leukaemia, the second drug approved to treat the disease in the past 2 months

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News, Views & Analysis

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Dataman 100/200 Barcode readers now feature 2DMax+ technology Cognex Corp, the global leader in industrial ID, has integrated advanced 2DMax+™ code reading software technology into the compact DataMan® 100 and 200 fixed-mount barcode readers. With 2DMax+, the readers can now identify and decode severely damaged or poorly marked 2-D matrix codes. Most importantly, the barcode readers are unaffected by variations in lighting, marking method,

code quality or surface finish. “2DMax+ is a proven breakthrough in 2-D decoding and is based on our existing patented, industryleading software,” said Carl Gerst, VP and Business Unit Manager, ID Products. He continued, “Following the success of 2DMax+ in the advanced DataMan 300 and 500 series of fixed position barcode readers, we are now delivering it to end users who need a smaller form factor.

This functionality is especially helpful in the food, beverage, pharma and consumer goods packaging sectors.” Though Data Matrix codes have built-in error correction, ‘no-reads’ can still occur when codes are incomplete. 2DMax+ can read Data Matrix codes even

when critical elements are missing. 2DMax+ can also locate and decode Data Matrix

codes that are overexposed or underexposed, without requiring multiple retries. This improves throughput, speed and overall reliability. The DataMan 100 series provides USB and RS-232 communication options. The 2DMax+ algorithm is now shipping with all DataMan 100X and 200X models as well as the DataMan 300X and 500X readers.

New FBRM G600L offers real-time particle monitoring in smaller lab vessels Mettler-Toledo is pleased to offer to the market its new Focused Beam Reflectance Measurement (FBRM®) technology for tracking the rate and degree of change to particles, particle structures and droplets at full process concentration. FBRM® G600L quickly captures particle

change information for fast optimisation of crystallisation, particle and droplet processes. Fewer experiments mean lower ramp-up costs and faster time-tomarket. With a pneumatic probe ideal for use in classified laboratory hoods, FBRM® G600L can be used in vessels from 500 ml-10 L or inserted into a continuous pipeline.

Roche introduces Cedex Bio HT analyser Roche introduced Cedex Bio HT analyser for use in reliable analysis of substrates and metabolites in microbial and mammalian cell fermentation. The new solution provide highly accurate analytics, across a wide test portfolio to enable flexible adaption of other test menus apart from added convenience through automated platform processing that lasts up to 120 tests in 60 minutes. The new Cedex Bio is developed for high-throughput applications, for example in-process development, and allows data comparison directly with data generated other Cedex Bio systems across the globe. The new system is useful for high scale biotech production units. The company also offers technical service and application support worldwide. Speaking at the launch, Ruedi Stoffel, Head - Custom Biotech, Roche, said, “The Cedex Bio HT analyser sets a new gold standard in bioprocess analytics. Its precise test results and high data consistency help to create optimal conditions for fermentation processes, which in turn result in high product quality and yield. The Cedex Bio HT analyser is able to deliver the high data precision and reproducibility for critical process parameters that are essential to the successful implementation of authority’s regulations in biopharmaceutical production. As a result, one of our early customers entirely switched to the Cedex Bio and new Cedex Bio HT analysers in their biomanufacturing network.” New analyser offers improved precision, linearity and sensitivity over the devices based on membrane technology. The system comprise three different measuring techniques that allows the analysis of immunoglobulin G, lactate dehydrogenase and many other metabolites and substrates such as glutamine, glutamate, sodium, ammonia, glucose, potassium and lactate.

In each application, FBRM® G600L enables chemists and engineers to quickly link experiment variables to changes in particle dimension, shape and count using the same sensitive FBRM® technology Mettler-Toledo applies in its other series entries (FBRM G400, FBRM G600Ex and FBRM G600 Production).

This ability to characterise particle or droplet system response to changing experiment parameters allows for faster process performance improvement, more uniform particle distribution, and enhanced product quality. In its standard design, the FBRM® G600L probe can be used in temperatures from

-10°C to 150°C, with an option for use down to -80°C. A variety of available seal types help FBRM® G600L meet regulatory or pressure requirements. It is also compatible with iC FBRMTM software for powerful data acquisition and interpretation enabling scientists to quickly and easily evaluate experimental data.


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In Conversation With

Innovation is the sole way to achieve success and also the only way to survive in this competitive sector …informs Ganesh Sambasivam, Co-Founder & CSO, Anthem Biosciences. In a candid conversation he shares his experiences of working at Anthem and also explains why innovation has become the key to success in the contract research sector. Excerpts of the conversation...

Jasleen Kaur Batra chandreyee.bhaumik@network18publishing.com

Kindly take us through the evolution of Anthem through the years. We started the operations of Anthem Biosciences in June 2007 with 100 employees and today we are a 400+ employee company. We came together and formed this company as we saw little growth in our previous organisations. We wanted to do something different, and wanted to innovate in the field of contract research. Today, after being in this company for five years, I feel not just me, but the whole team as well as the company has evolved. Today, we see a lot of traction within the area of intellectual property rights, and we have created a few. Also, we are coming up with our products, which serve as a tool for discovery. We have also come up with a product called the ‘genotoxicity platform.’ This is a cell-based platform. Today, genotoxicity is a big issue and many products have been pulled out from the market because of this. Thus, we felt that there is an unmet need in this space, and hence, we engineered a cell. We have compared this with the current tests that USFDA has prescribed and have got an exciting score; we will be sharing this with other regulatory bodies soon. Genotoxicity is not only for the pharmaceuticals industry but for anything that comes in

contact with the human body. Thus, this has huge potential and will definitely be helpful to many companies. On the whole, with innovation we have been able to come up with a few amazing products. This definitely shows how we as a company have evolved. In the coming years with the hard working team that we have, I am sure we will come up with many such concepts and will be able to take Anthem to the next level and would be making a huge impact in the global market.

In a contract services segment one needs to be able to innovate with their models as there can be no fixed model. How has been your experience of working in Anthem? My journey has been very exciting and enriching. When we started Anthem we had certain broad ideas in mind. And I am truly happy the way things have shaped up. The journey of working on a product and then see people make use of it is definitely interesting and I am happy to be a part of it. What is the business strategy adopted by Anthem? In a contract services segment one needs to be able to innovate with their models as there can be no fixed model. I was responsible for setting up the very first CRO in India in 1994;

Quick bites What are the three qualities you value in your employees? As we are in the scientific field - sincerity, being a team player and the right attitude towards work are the qualities that I admire the most in my employees. Who has been your role model in life? Bill Gates has definitely been a role model because of the way he has been able to set up an empire and also contribute to the fraternity by setting up a huge fund to do research in areas that the big pharma companies are not interested to look into. How do you spend your leisure time? I enjoy listening to Carnatic music and heavy metal and also like to read books on philosophy. Which is your favourite book? One of my favorite books Autobiography of a Yogi.

is

called

The

Photograph: Shrikant SY

from that time till date, there have been several models that have come and they are being improvised upon. But as a CRO one needs to innovate on the model to see that what model suits the client, depending on the nature of the work. So definitely, there is the need to innovate here as well and no one model can be used. What are the future plans? In the coming future we will be expanding our manufacturing facility and will be putting up a huge facility in Kanakpura, Bengaluru. We are currently in the process of getting the regulatory licenses for the construction of the facility. Besides this, we are also in the process of expanding our current facility. We have also increased our map space by three times and would also be bringing in more GLP labs. The reason behind expanding our facility is to be able to

provide our services to as many costumers as possible; any hopefully the expansion will help us achieve that. What are the future goals of Anthem? A while back we crossed ` 100 crore in terms of revenue and in future our goal is to cross this number and also innovate in our space and come up with various new techniques that our clients and the CRO segment at large can benefit from. What does success mean to you? Success to me means that we need to put in more effort to make sure that we do well and continue our success rate. What are your catalysts of success? I strongly believe that innovation is the sole way to achieve success and also the only way to survive

in this competitive sector. We do have proof with the products that we are coming up with; innovation makes people look up to you and we believe that we are making an impact in the global pharmaceutical market. Any particular advice you would like to give to the budding entrepreneurs in the field of CRO? My only advice to budding entrepreneurs would be that they should choose the area they would like work in as there are many areas one can pursue today. I also feel that anything that is backed up with innovation would definitely take them a long way ahead. So they should be confident about what they are doing and do it whole heartedly and success and fame will definitely come their way.


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Special Focus

Standardisation and quality compliances

Chandreyee Bhaumik chandreyee.bhaumik@network18publishing.com

H

aving proper quality control checks is the requirement of any industry. There must be a well-defined procedure, which covers all the aspects pertaining to the sample, ie receipt of the consignment, sampling techniques to be adopted, storage and handling of samples recording and reporting of analysis. Every sample that is received must have a distinct number, which should appear on the label of the sample and should be stored in the prescribed conditions. Further, there must be a well-defined sampling procedure in place, which should categorically specify in detail the sampling procedure. If the blending of sample is permitted, how many can be blended together, etc. Then, each laboratory should develop a well-defined protocol in order to carry out the test and these protocols should also be categorically mentioned.

The growing need amid upcoming challenges Standardisation is the key for the pharma industry and it is essential to have proper formulation and implementation of rules. A sneak peek into the quality compliance issues and the ways to resolve them.

Need for standardisation

Every laboratory should maintain records of all the tests performed, any of the graphs pertaining to IR, HPLC, etc should be stored along with the raw data. Further, for a quick reference, access to records should be restricted to an authorised person and these records are preferably stored under lock and key. There should be adequate facilities and accessories to provide safety for personnel involved in drug testing, suitable equipment for fire extinguishing in case of accidents. Next, the Quality Assurance Department of the laboratory should constitute a committee who will regularly audit their facilities to ensure compliance to GLP requirement. Talking about standardisation, Dr Madhuri Jadhav, Global Head - Quality Assurance, Compliance & Training, Karmic Lifesciences, avers, “Every player in the clinical research industry is delivering services but the ‘quality standards’ may be very subjective. One may look for a 99 per cent accuracy rate but someone else could be satisfied with 85 per cent. Hence, if the outcome of clinical research is to help the society at large by getting safe and efficacious drugs in the market, we need to have uniform quality standards across the industry.” Continuing in this regard, Dr Jadhav adds, “Though India’s contribution to global clinical trials is less than 2 per cent, out of the 37 USFDA GCP inspections conducted in India since 2005, so far we have fared good, with no critical observations of the ‘Official Action Indicated’ category. This does speak volumes about the

Government’s role

Government’s role is extremely important in bringing changes. Dr Jadhav suggests that government should act in the following ways to bring about regulatory compliance: Need to have and/or implement regulations for registration of ethics committees/sites/ institutions/CROs based on minimum eligibility criteria Have a mandatory centralised GCP certification for all members involved in clinical research Mandatory Continuing Medical Education (CMEs) for investigators participating in clinical research Strengthen the process for conducting inspections of ethics committees/sites/ institutions/CROs/sponsors and to make the inspection observations public (similar to USFDA) Having a control on the curriculum of clinical research training institutes and including ‘ethics’ and ‘quality’ in the curriculum System of penalising the non-compliant parties Elaborating on the government’s role, Dr Ajmani says, “Government is responsible for formulation and implementation of rules. This needs to be done on a regular/consistent basis with the help expert groups from all stakeholders.”

A picture of things to be

good work being done in global trials. But we have no data from the CDSCO/DCGI inspections of Indian players.” Discussing about standardisation in India, Dr Ranjeet S Ajmani, CEO, Plasmagen Biosciences Pvt Ltd, avers, “It is important as India is emerging as one of the most important developing economies and can play a very important role in supplying/ providing pharma products/ healthcare services to many other territories at a competitive price, but it has to match the standard of the international market and that is why it is important and pertinent to bring standardisation at all levels and face the competition. Also, this would certainly help in evaluating our own system in a much more objective way and make improvements and eventually improve the overall patient care.”

Filling the need gaps

While standardisation is the requirement for the industry there seems to be several need gaps and challenges that need to be taken care of. Challenges such as awareness about the GCP environment; knowing the

expectations/responsibilities as a stakeholder and interpretation of regulations. Dr Jadhav believes that there are loopholes such as inadequate oversight by concerned parties; inadequate implementation of regulations and inadequate knowledge. Seconding the above thought, Dr Ajmani explains, “Some

We need to work on the concept of ‘Quality by Design’ by building QC and QA checkpoints for each process and also have quality metrics. Dr Ranjeet S Ajmani CEO, Plasmagen Biosciences Pvt Ltd

of the major problems are poor knowledge/awareness level of regulators/inspecting authorities; compliance is low along with too many level of regulations with no clarity.” He adds that the IP also needs to be looked into. Discussing the changes that are required, he continues, “We need a change in the overall policy of pharma products and the regulatory process. It should be made more objective, transparent and efficient. There is a tremendous need of capacity building at all fronts. While offering suggestions, Dr Jadhav says, “We can have a ‘Quality Consortium/Quality Circle’ group wherein key personnel can join hands to develop ‘Standard Quality Metrics’ for every process. This would help in setting up the expectations for minimum quality standards. We can also plan to have some kind of certification/ accreditation.” She adds the ‘Quality Plan’ (methods, tools and skills) needs to be prepared prospectively, ie before getting into the operational mode. On an on-going basis, the services should then be evaluated against the planned quality criteria.

Standardisation is the way to go forward. Talking on how the situation will change in the coming years, Dr Ajmani says, “We need to work on the concept of ‘Quality by Design’ by building QC and QA checkpoints for each process and also have quality metrics. This calls for an alignment between sponsors, CROs, investigators, ethics committees and also the regulators so that expectations can be set. Successful regulatory inspections would be the measure to pass the litmus test for quality. We have done well with the USFDA inspections. But of course the recent unethical cases in Madhya Pradesh and some other instances remind us that we yet have miles to go. The situation would surely improve in the coming years as can be seen by various regulations being defined by the CDSCO. Of course, the challenge lies in its implementation wherein a joint effort is the need of the hour.” Thus, only by bringing this standardisation one would be able to place India on the international map and this requires huge effort in terms of changing our attitude towards quality issues, its real and perceived value and its impact on patient care.


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Special Focus

Loopholes in the QA & QC system

Nikunj Sharma nikunj.kumar@network18publishing.com

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ith the projection for steady growth for Indian pharmaceutical sector reaching about $ 13 billion, understanding of regulatory compliance has a crucial role to play. Despite continuous upgradation on standards and serious discussions about the ill practices in pharmaceutical sector at various check points, the loopholes in the system are being exploited by the drug manufacturers, distributors and other stakeholders in the network.

Need to clear the ambiguities Pharmaceutical industry is said to have stern regulatory and monitoring system in place, still the loopholes in most common regulatory standards including GMP, FDA, GLP are being exploited by malicious stakeholders. Apart from unethical malpractices in industry, the regulatory network in the country is also bugged with various issues such as lack of efficient and effective regulatory workforce, corruption, leniency in law-enforcement and non-uniform framework.

Taming the hurdles

According to a news report in Hindustan Times on September 25, 2012, ‘In the year 2012, country’s largest health scheme NRHM had major brunt from the loopholes in the pharma regulatory standards in one of the most populated state. The UP Health and Family Welfare Department bought drugs worth crore from the suppliers that are blacklisted in other states. The purchasing authorities violated the mandatory norms of buying drugs from GLP manufacturers only; later the contracts were cancelled and fresh tenders were invited.’ Dr Gopakumar Nair, Patent Attorney and CEO, Gopakumar Nair Associates, says, “In regulatory fields, India is unique in many ways. India is the only country, till now, having multiple patent offices in all metros, which leads to non-uniform patent practices and poor centralised controls. Similarly in pharmaceutical regulations, India is unique that as per Drugs & Cosmetics Act, 1940, we have a concurrent regulatory practice, which involves the Central Regulatory Agency, the office of the DCG(I) (Drugs Controller General of India) under Central Drugs Standard Control Organization (CDSCO) with zonal offices and the State FDAs, often poorly manned, poorly headed by non-qualified pharmacists, which leads to non-uniform implementation of regulatory standards. Malpractices and corrupt practices also abound in few non-frontline states.” The loopholes in GMP, GLP & FDA standards arise out of lack of will both on the part of the regulators, as well as manufacturers. A natural instinct to ‘cut corners’ and earn a quick buck is very common among relatively illiterate entrepreneurs, who enter this field to exploit the weak and meek patient population. He further adds, “Existence of a ready and willing, parallel unethical

and highest number of FDA approved plants outside the USA, India’s position as a quick achiever in pharmaceutical sector cannot be undermined. The Indian pharma industry quickly learnt and mastered the techniques of managing costs at home as well as delivered FDA-quality drugs at attractive prices abroad, which proved to be a winner at M&A through effectively exploiting R&D opportunities and turning around semi-sick acquisitions into ‘out & in’ licensing; and JVs with MNCs to exploit lucrative regulated and emerging markets etc.”

Grey areas

distribution channel, which is more active in poor largely illiterate parts of India also a loophole. Continued irrational and illegal practice of medical profession by quacks, illegal ‘self-proclaimed doctors’ and cheats also is a matter of concern. These loopholes can only be closed by serious action both on the part of the regulatory as well as enforcement agencies.”

Wide coverage

The loopholes are not limited to the markets or manufacturers

Existence of a ready and willing, parallel unethical distribution channel, which is more active in poor largely illiterate parts of India also a loophole. Dr Gopakumar Nair, Patent Attorney and CEO, Gopakumar Nair Associates

only; the regulatory system is not spared from these abnormalities. Big players are capable of presenting their case smartly to the regulatory authorities, in order to receive the verdict in favour. As per the July 15, 2012 report in New York Times, “The extraordinary surveillance effort grew out of a bitter dispute lasting years between the scientists and their bosses at the FDA over the scientists’ claims that faulty review procedures at the agency had led to the approval of medical imaging devices for mammograms and colonoscopies that exposed patients to dangerous levels of radiation.” Under some existing FDA regulations and norms, pharma companies are able to push several ineffective medical devices or drugs in the market. In that perspective, India is a major scapegoat in absence of a medical device regulatory and lack of will by the policymakers to standardise the process. In another FDA ruling, drug companies need not to disclose adverse events during trials in case the adverse reaction is less than a certain percentage or not beyond the double of the placebo trials, which provides the drug makers an opportunity to use the clause in their favour. NDAs filed by the drug companies also have support

data in parts pertaining to various locations, which illusively restrict a reviewer to converge the information along with the falsely represented safety concerns in context with the trial about a particular drug. As a result, further evaluation is deferred and approval is granted. Devinder Pal, Founder President & CEO, Catalyst Pharma Consulting, comments, “From almost nowhere in 1947 to a major drug supplier, with highest share in DMFs, ANDAs

The Indian pharma industry quickly learnt and mastered the techniques of managing costs at home as well as delivered FDAquality drugs at attractive prices abroad Devinder Pal, Founder President & CEO – Catalyst Pharma Consulting - Mumbai

The recent super status given to generic drugs by FDA have posed fresh challenges to the suppliers. On the top of FDA local office and US, EU and Japan becoming members of a larger group of regulators dedicated to enforcing worldwide standards, Generic Drug User Fee Amendments of 2012 (GDUFA), on generic brand-name and generic drug makers, is expected to supply nearly half of the FDA’s $ 4.5 billion budget. Synergistic effect of these will be a force multiplier and enable FDA to significantly tighten its watch on quality. Pal informs, “An analysis of 17 consent decrees signed since 1989 shows that 65 per cent are yet to reach a resolution. Most companies that did manage to end their consent decrees, took anywhere between 5 and 12 years and billion plus dollars, out of which five had to be sold off.” Given the wide scope of improvement across different regulatory and practice environments in diverse markets, to devise a perfect framework that does not allow any kind of discrepancies in the entire network of pharmaceutical drug manufacturing; right from R&D, to trials to application filings and approval, is a tedious job. The whole process of a drug approval is highly complicated and costlier, which binds manufacturers to exploit the system loopholes for making the best of money pumped into the development of a drug. The governments and other regulatory agencies must exercise a less tedious and common programme for a drug’s clearance procedure, at least in one country, as increasing globalisation and subsequent expansion opportunities are the lure of profit making aspects, which left SMEs in lurch due to lapses in national regulatory standards that are not at par with the global benchmarks.


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Special Focus: Interface

27

It is critical that standardised product and services are rendered to obtain the results as intended Chandreyee Bhaumik chandreyee.bhaumik@network18publishing.com

What is the need of standardisation in pharma industry? Standardisation is a must for the pharma industry. And it is extremely important for the drugs to be formulated, manufactured and distributed in a standardised manner. In the healthcare industry, people are being provided services for pain relief and treatment. Hence, it is critical that standardised product and services be rendered to obtain the results as intended. How is India placed as far as the quality standards in the pharma industry are concerned? Are we at par with the developed countries? In this regard it must be mentioned that although we are supplying products to the US, Europe, China, Japan and other countries to a large extent, when it comes to domestic manufacturing in India there is a long way to go in reaching the same standards of products and services to the domestic consumers and patients. According to me the internal discipline among the regulatory enforcement agencies in India

and the internal discipline of the pharma manufacturing and service providers are not at par with what I perceive has been implemented in most of the advanced countries and few emerging technologically advanced countries. What are the challenges for quality compliance (GMP, GLP and FDA)? What are the primary loopholes in this regard? The basic consideration at the moment is how we bring about standardisation. We have to ensure that all the pharma companies are meeting the required standards. We need to have proper standardisation principle and good policy in place at all levels of governmental executive control, policy making bodies of pharma manufacturing companies and the regulatory enforcement agencies in India. Considering that the majority of our Indian population is poor, we also have to make our drugs cheaper and easily accessible, with quality factor intact. And, thus, in a country with a varied climate ranging from Kashmir to Kerala bringing about standardisation in manufacturing, supplying and distributing under controlled conditions, is a challenge. What is the government’s role in bringing changes

‌says Rangarajan Subramanian, Independent Advisor; Former President, Global Quality Control and Compliance, Glenmark Pharmaceuticals Ltd. Here, he talks about his field of expertise - quality compliance - and suggests few recommendations.

in standardisation and quality compliance? It is extremely important to have a proper policy-making body in place that will be ensuring enforcement of regulations.

Government should be ensuring continuous training and guidance to the regulatory administrators, inspection agencies and there is a need to continuously evaluate and amend archaic regulations

and statutes. They have to be at par with the international regulatory bodies. China has been recently working on this with all vigour and the enforcement actions have made salutary effect on the Chinese pharma industry. And in India the actions have been slow, half hearted and not very effective. We must remember that compliance is the primary requirement of all manufacturing and product servicing activities. This would require government regulatory inspections at regular frequencies using trained inspection teams, who are experts in respective areas of pharma manufacturing, quality and control. They must use tools, which are modern, risk-based and have a constant reviewing mechanism for rating performance of the individual industry that determines their ability to provide quality of products. Will the situation improve in the next few years? USFDA and European inspection agencies have significantly contributed for establishing a quality culture in India in the pharma industry. However, the situation has to continuously improve at a significant rate to be able to achieve the increasing demand of drugs, pharmaceuticals and complexity of disease portfolio.


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28 Insight & Outlook: Policies & Regulations Orphan drugs for orphan diseases

How the concept is ‘orphan’ in India?

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ccording to experts, diseases manifesting patients representing maximum 6 to 8 per cent of the world population are defined as ‘rare diseases’ and most of such diseases are being ‘orphaned’ by the global pharma industry, mainly because of commercial considerations, are termed as ‘orphan diseases.’ Consequently, when any drug is developed specifically to treat an ‘orphan or a rare disease’ condition is called an ‘orphan drug.’

Though the percentage of patients suffering from ‘rare diseases’ in India is reportedly higher than the world average, even today such cases get little help from our government. Here’s why new regulations should be brought in place for treating orphan diseases.

Grim situation

According to SanOrphan SA, Geneva, Switzerland, around 65 per cent of rare diseases are serious and disabling. More interestingly, about 250 new rare diseases are discovered each year, corresponding to five new rare diseases per week. However, without appropriate ecosystem being in place, developing a new drug (orphan drug) specifically to treat a small number of patient populations suffering from any particular type of rare disease through highly cost-intensive R&D initiatives, generating a low return on investments has been extremely challenging for any pharmaceutical company. Public awareness drives for ‘orphan diseases’ first originated in the USA with the formation of a rare disease support group representing around 200,000 patients suffering from such ailments. However, very limited market especially for those ‘orphan drugs,’ which are meant for the treatment of a single rare disease, has been discouraging the large pharma players to make major R&D investments for such molecules, as mentioned above. In response to the public awareness campaigns and realising the commercial imperatives of the pharma companies in developing ‘orphan drugs’, a path breaking legislation was formulated by the US government way back in 1983, known as the ‘Orphan Drugs Act (ODA)’. The key purpose of ODA was to incentivise R&D initiatives for such drugs to treat around 25 million Americans suffering from ‘orphan diseases.’ Though similar legal and policy interventions are of utmost importance to allay the sufferings of millions of patients fighting rare diseases in India, precious little has been initiated in this direction by the government, thus far. USFDA provides orphan status to drugs and biologics, which are defined as: Those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that

affect fewer than 200,000 people in the US Or, those affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.

Looking at the ‘Indian’ part of it

For the first time in India, to increase awareness for the rare diseases, ‘Rare Diseases Day’ was observed in New Delhi on February 28, 2010. Subsequently, 2nd and the 3rd ‘Rare Disease Days’ were observed in Chennai and Mumbai in 2011 and 2012, respectively. About 6,0008,000 rare diseases, mostly genetic in nature, have been identified in India. It was initially estimated that over 31 million Indians are suffering from rare diseases in the country; many of these diseases still do not have any cure. However, The Hindu in April 2012 reported, “Taking the lower limit of global prevalence estimate, populous nations such as India and China should have more than 70 million rare disease cases each.” ODA, when enacted in India, should not be a half-hearted approach or be

a zero-sum game for all. It should come with adequate financial and other incentives to create a sound business sense in this new ball game for the pharmaceutical players in India. Thanks to this Act, currently around 230 ‘orphan drugs’ are available in the US for the treatment of around 11 million patients suffering from rare diseases. With the help of ‘Human Genome Project’ more orphan diseases are expected to be identified and newer d rugs will be required to treat these rare ailments of human population.

Providing care to ‘rare’

As stated above, 1983 signaled the importance of ‘orphan drugs’ with the ODA in the US. A decade after, in 1993, Japan took similar initiative followed by Australia in 1999. Currently, Singapore, South Korea, Canada and New Zealand are also having their country specific ODAs. Following similar footsteps, India should also encourage its domestic pharmac industry to get engaged in research to discover drugs for rare diseases by putting an ‘Orphan Drugs Act’ in

place, extending financial support, tax exemptions and regulatory concessions like smaller and shorter clinical trials, without further delay. Every day millions of Indians will continue to suffer from ‘orphan diseases’ without affordable treatment, in the absence of an appropriate policy framework in the country for ‘orphan drugs’. A new report from Thomson Reuters indicate that the global market for ‘orphan drugs’ was over $50 billion in 2011. It has also been reported that ‘orphan drugs’ contribute 6 per cent of $ 880 billion global pharmaceutical market with a CAGR of 25.8 per cent as compared to 20.1 per cent for ‘non-orphan drugs’ during 2001 to 2010. The issue of patients’ access to affordable ‘orphan drugs’ is considered to be the most challenging part in the fight against ‘orphan diseases.’ For obvious reasons, the prices of ‘orphan drugs’ are usually very high, some even costs as high as $ 400,000 annually and thus beyond affordability of many who are outside the purview of any drug price reimbursement scheme. It is interesting to note that some

of the ‘orphan diseases’ are now being diagnosed also in India. As the nation takes rapid strides in the medical science, more of such ‘orphan diseases’ are likely to be diagnosed in our country. Thus, the moot question is how does India address this pressing issue with pro-active measures, now? One of the ways to properly address this issue in India could well be to follow the model of our very own the Council of Scientific and Industrial Research (CSIR) for an ‘Open Source Drug Discovery’ (OSDD) programme with global partnerships, wherever necessary. Thus, with an appropriate ODA in place, leveraging the knowledge of OSDD acquired by CSIR and framing a robust win-win PPP model to discover and commercialise the ‘orphan drugs’, India could well demonstrate that the concept of orphan drugs for orphan diseases is really not orphan in India. Tapan Ray Director General, Organisation Of Pharmaceutical Producers Of India (OPPI) tapan.ray@indiaoppi.com


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Advertorial

29

Roha: The 40-year journey of colour in black & white

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lobally, Roha has offices in 14 countries, 9 application labs, a sales presence in 120 nations and is the largest manufacturer of synthetic colours. But that is today, after forty years of sweat and toil. Back in 1972, when Roha was started, this was but a dream. Not one person would have imagined back then that an Indian company, that too, a start-up, would one day be leading the world in its chosen industry. The company was incorporated in 1972 as Idachem, with a small production unit in the Kurla suburb of Mumbai. The beginning was small, but the dream was big. And very soon the dream began to assert itself. In 1974, a factory was started in the Roha township of Raigad district in Maharashtra and Idachem was renamed, RohaDyechem. With 10 clients and a total sale of 2 tonnes of colour per month, Rohabegan a phase of focussed growth. Research and quality of product were the core areas of concentration. In 1978, the leadership baton of Roha was passed on to other hands: Mr.Ramakant Tibrewala, the son of the founder, joined the company as a director and took charge of the company’s affairs. And the company began to grow by leaps and bounds. By 1980, the company was manufacturing and marketing 10 metric tonnes per month. It wasn’t just growth for the sake of growth, though. There was a vision involved as well in shaping the future of the company. Technology was harnessed to give Roha products an edge. A spray drying facility was introduced and helped production grow to 25 metric tonnes per month by 1990. This, by the way, was the first spray dryer to be installed by an Indian company. Obviously, with technology being infused into the company at a quick pace, the quality of the products soon became best-in-class. A large multinational beverage brand started buying from Roha in India. This led to other MNCs following suit and the expansion of Roha became the order of the day.

Today, in 2012, Roha is also expanding product line. Essenzia, Roha’s brand of animal feed additives has been launched this year. Expansion plans for more offices in the Africa, the Americas and Europe are on the anvil. Finding that we could satisfy the tough quality control tests of MNCs, Roha began to dream bigger. Not satisfied with being one of the bigger players in India, we wanted to plant the Roha flag overseas. In 1989, this too came to pass. We received a trial order from Indonesia. Since then Roha has not looked back. First Indonesia, then Thailand and then Singapore became Roha countries in quick time. Roha used this global expansion to become a global citizen; at home in every country and its culture. Wherever we went, we adapted to the local ways of business, blending right in with the local values. The local offices, steeped in the local culture and staffed by the local natives made these countries comfortable with the Roha family. Offices were soon opened

in Europe and the Americas; a logical progression. Today we have offices in Philippines, Indonesia, Thailand, Spain, US, UK, Mexico, Italy, China, France, Vietnam, South Africa, Russia and of course, India. This expansion was not just geographic in nature. Roha was also expanding its product list at the rate of knots. In 1990 Roha started manufacturing lake pigments especially for the pharmaceuticals’ industry. This was soon followed by the launch of dispersions for the pharmaceutical and confectionary industries. Between all the Roha brands, i.e. Idacol, Idacos, Idalacol and Idacoat everything in the synthetic colours market was covered. Food & Beverages, cosmetics, pharmaceuticals; every industry was saturated by Roha colours.

Roha was the first manufacturers in India to become a 0 carbon footprint company with 7.5 MW wind energy plant in the Sangli district of Maharashtra in 2007.

There was but one way left to go natural colours were launched under the brand name Natracol. The world had been slowly moving towards natural colours; colours that were extracted from fruits and plants. These colours have extra vitamins and antioxidants among other health benefits. Looking at the future, Roha started a facility for natural colours and in 2005 took over the biggest natural colour manufacturing facility in Spain. In the meanwhile, just a year before, in 2004, a spanking new corporate headquarters was founded at Andheri in Mumbai. This marked the beginning of a new phase in Roha’s life cycle. The journey towards global leadership was well on its way. Today, in 2012, Roha is also expanding product line. Essenzia, Roha’s brand of animal feed additives has been launched just this year. Expansion plans for more offices in the Africa, the Americas and Europe are on the anvil. With all this in place, it is no wonder that 40 year journey has taken themfrom a 2 tonne a month manufacturer to the world’s number one manufacturer of synthetic colours; making about 1500 metric tonnes a month. With all this, what’s been really important is that they have been

responsible corporate citizens of the planet. Roha has tried to give back to the world.Over the years they have found ways to do the world a little bit of good. A housing colony for employees in Roha; education programmes for the mentally and physically challenged; a University in Rajasthan; health programmes and hospitals in various parts of India– these are some of the things Roha has funded and continues to fund. The latest cause they have espoused is clean energy. Roha was the first manufacturers in India to become a 0 carbon footprint company with 7.5 MW wind energy plant in the Sangli district of Maharashtra in 2007. To add to that, they now have 25 MW Solar plant in the Charanaka district of Gujarat, since 2012. They hope to be able to manufacture 500 MW of clean energy across the world by December 2013. They would like to take this opportunity to promise all their customers and friends that Roha will continue this journey with the highest and most ethical business practices and hope that another 40 years on, a new generation shall be saying the same things about this continued journey.


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30 Insight & Outlook: Strategy

Emerging opportunities for pharma

Widening the market

Will new medicine course work emphasising on rural areas, as proposed, be beneficial for achieving universal healthcare? The 3-year rural MBBS course and something on similar lines may also provide a power boost to the pharma industry. Here’s how...

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ecent estimates by the Medical Council of India (MCI) reveal that India has a doctor-patient ratio of 1:1700 as compared to the world average of 1.5:1000. According to a vision document prepared in March 2011, within two decades MCI has targetted to achieve a national average of one doctor for a 1,000 people. A major problem affecting healthcare delivery in India is the excessive concentration of medical personnel in the metros with an acute paucity of doctors in rural areas. Nurses, paramedical workers, etc who work in the Primary Healthcare Centres (PHCs) too double up as doctors in their homes not simply to earn a quick buck but to ensure that some sort of medical facility is available in their hamlet. Despite the mandatory government bond for fresh MBBS graduates to serve in rural areas, PHC are devoid of doctors. Consequently, medical treatment in remote areas is provided by native vaidyas, ayurvedacharyas, homoeopaths or quacks. There are several reasons for MBBS doctors’ failure to settle in rural areas. Also, since current recruitment norms prohibit qualified practitioners of alternative medicine (BAMS, BHMS, BUMS, Siddha) the healthcare system in the country is unable to make use of their services. This is a colossal waste of human talent in a country where the healthcare delivery facility is dismal.

Proposed move

Two recent announcements by the government bring hope to improve the situation. There is a move by the Government of Maharashtra to allow doctors qualified in alternative medicine to practice allopathy after they undergo a short training in allopathic pharmacology and medicine. The idea is to ‘upgrade’ these physicians to practice modern medicine and use their services in rural areas. The union government too has been toying with the idea of introducing a short course, likely to be called ‘BSc Medicine’, to produce doctors specifically meant for rural areas. A few years ago, it was reported that there was a move to start a 3-year ‘MBBS (Rural)’ degree course. Fortunately, it was shot down due to the obvious fact that any qualification which appeared identical to the existing 5½-year MBBS course

would lead to malpractice. Besides, these short-course personnel would use their semiMBBS certificate to illegally practice in metros, thereby undermining the very purpose for which the course has been started.

Opportunities galore

For pharmaceutical companies, both these proposals are a shot in the arm. It ensures that rural areas will get good quality medical service and the number of qualified prescribers of allopathic medicines will increase. Pharmaceutical companies will have access to a greater pool of patients in villages who get quality medicines from genuine medical personnel. In order to understand the actual impact of these government decisions, one needs to understand the differences in the existing medical courses. While the 51/2 year course includes one year of rotating internship after the elaborate academic training, the proposed 3-year course will have a cursory teaching of human body, pharmacology, basic life support, first aid and general medicine. The latter will ensure that this ‘doctor’ is able to give primary care in any medical situation after which he will seek the help of the appropriate expert. This short course throws in ample opportunity to the pharmaceutical industry to upgrade the knowledge of

these medical personnel while simultaneously providing succor to the suffering villagers.

Basic differences

All courses, including the traditional and alternative ones have an extensive academic syllabus spread over 4½ years. The syllabus of anatomy and physiology is similar in all the courses as they include the structure and function of the human body. The variation in different streams of medicine lies in the subjects such as pathology, pharmacology

By the time the government is ready with its proposed plans to boost healthcare, if the drug industry too complements its efforts, everyone stands to benefit. and general medicine. The differences are complex since the pathology described by ayurvedic or homoeopathic system may not have an identical equivalent in allopathic system. For this reason, the treatment recommended will follow distinctly different principles in some diseases. Treatment principles in traditional systems such as ayurveda (BAMS degree) seek to rebalance the altered levels of certain ‘humours’ in the body.

MBBS students learn modern (allopathic) pharmacology wherein pure, refined, chemical substances derived from various sources are used to correct imbalances in blood or specific tissues / organs. Homoeopaths (BHMS degree) give significant weightage to the emotional/ mental aspect of the patient’s history prevailing from birth to childhood to adolescence and adulthood. The pills in homoeopathic medicine are potentised, energised, highly diluted chemicals, which enter the system through the tongue. While allopathy has a systematic approach to classifying disorders based on different functional systems and treat primarily with chemicals, the others have a more holistic approach where greater stress is placed on diet and exercise than on medications. However, the most significant difference is in the realm of emergency medicine where modern allopathic medicine scores over the others.

Capitalising the market

The pharmaceutical industry has always strived to build up the practice of young physicians so as to ensure their own sales objectives. This was done by conducting medical camps on specific diseases, providing literatures, drug samples etc. These efforts produced a two-fold response: more goodwill with the budding

physician as well as increasing the patient flow into the clinic. The same methodology could be adopted by the pharmaceutical industry in the mofussil areas. Whether it is a BSc Doctor, an ayurvedic physician or a homoeopath, so long as he or she is authorised to prescribe allopathic drugs, drug manufacturers can support his practice and consequently help the villagers to have better medical care. Most of these physicians would be hungry for allopathic knowledge and hence would be willing to attend lectures, seminars and workshops. Specialists from nearby cities can be engaged professionally to deliver lectures to these groups at regular intervals. Such an arrangement can help the pharmaceutical company in multiple ways: Strengthen bond with the specialist enhancing their goodwill with him Provide platform to experts who are willing to teach but do not have attachments to teaching hospitals Provide a source of professional income from the pharmaceutical company particularly for youngsters in the early days of private practice Increase the level of knowledge of the attending ‘half-doctors,’ which helps them to leverage their practice Improve the quality of healthcare service in the interiors of the country And finally, increase bottom line by getting more prescriptions from the teacher as well as the taught!

Magic number: 70 per cent

As with all government relief and welfare schemes, it is not clear whether the new course would start from the forthcoming academic year. Yet, in all probability, it should take off soon as this is an easier option for the cashstrapped government rather than start new MBBS medical colleges from scratch. The MCI vision is a massive leap in the number of legitimately prescribing physicians. For the pharmaceutical industry, it could mean a massive 70 per cent spike in drug sales, provided they have been able to capitalise on the new generation of upgraded physicians. By the time the government is ready with its proposed plans to boost healthcare, if the drug industry too complements its efforts, everyone stands to benefit. In the final analysis, it is rural India that will be the real winner. Dr Rajan T D Pharma Consultant & Practising Dermatologist rajantd@gmail.com


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Insight & Outlook: Case study

31

Benefits of ‘Machine Vision’

Helping Indian manufacturing to be globally competitive India is ranked as one of the fastest growing markets and has seen an upsurge in the number of manufacturing facilities across the country. Despite this, it remains grossly underinvested in factory automation – necessary for long-term competitive success in both domestic and foreign markets.

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uring the past decade, India has emerged as one of the key manufacturing hubs for global manufacturing companies in the automotive, pharmaceutical, packaging, food processing and textiles industries. In 2010, Deloitte Touche Tohmatsu ranked India as offering the second best global manufacturing platform in the world, above traditional manufacturing countries such as the US, Germany and Japan. Innovation combined with a talent pool of scientists, researchers and engineers is more critical to manufacturing growth on the global stage rather than low cost energy, labour and regulations, it stated. Within the country, the domestic manufacturing sector accounts for nearly 17 per cent of India’s total GDP and employs nearly 100 million people (per ASSOCHAM estimates). Frost & Sullivan’s IPC Practice predicts that by 2020, this would generate 25 per cent of the country’s GDP. However, Frost & Sullivan analysts add that this growth will only be realised through adoption of factory automation that enable greater efficiency, productivity, sustainability, global competitiveness and standards compliance.

Cognex’s machine vision enhances factory automation

Cognex Corporation is a leading supplier of machine vision systems. It’s ID and Vision systems address all three critical areas in the manufacturing process: inspection, identification and guidance for industries including automotive, electronics, pharmaceutical, food processing & packaging and consumer goods, Cognex’s image-based ID systems can meet all the 1-D barcode and 2-D codereading requirements. Since its inception in 1981, Cognex has shipped more than 500,000 machine vision systems representing more than $ 2.5 billion in cumulative revenue. Despite all this, the domestic manufacturing industry is facing competition from emerging manufacturing hubs in Asia and South America. Increasing material and labour costs coupled with process inefficiencies are

dulling India’s competitive edge. India’s future depends on adopting appropriate automation, innovation, technology and empowers its talented, English-speaking workforce.

India, automation and global competition

Automation in India has always been a shop floor tool rather than a ‘business performance enabler.’ When it comes to core manufacturing processes, manufacturers rely on labour-intensive methods. Even with factory automation in place, when compared to world standards, the technology threshold is fairly low, due to lack of knowledge and awareness. Based on their prior experience, significant investment is being done by established manufacturing hubs in the US and Japan in India to increase efficiency and flexibility of their supply chains while improving upon product features and quality in the automotive, pharmaceutical and food processing industries. An increase in the demand for such solutions is already being witnessed in the Asian region. Automation technology providers offer variety of factory automation technologies, including ‘Machine Vision.’ Manufacturing equipment and robotics ‘make’ products, while machine vision provides

quality assurance, product tracking and documentation for standards compliance.

Machine Vision: Key to improving quality, productivity

Machine vision systems address three critical areas in the manufacturing process: identification, inspection and guidance. Identification refers to tracking and tracing raw materials, components and products throughout the

Even with factory automation in place, when compared to world standards, the technology threshold is fairly low, due to lack of knowledge and awareness. production cycle. It tracks any industrial code, including engraved or embossed serial numbers placed on a product, tells manufacturer how, when and where it was produced and raw materials used to manufacture the product, supplier identification and any number of other important production data. Inspection refers to presence or absence checking and dimensional checking where manufacturers

make sure that a part is manufactured to critical dimension. Guidance is the use of vision to locate a part, feature, or pattern to automate the mechanical handling of that part during assembly, material handling and packaging processes. Machine vision systems can be broadly categorised into two different types of systems that use the same underlying technology: Identification (ID) systems: When used separately or together help manufacturers improve their manufacturing process and cut costs. Create total visibility and measurement by automatically retrieving codes and other identifying marks on raw materials, components and products as they move through the manufacturing supply chain. Enable accurate, timely information about a specific item, which can be stored, retrieved and analysed in an easy-to-use manufacturing databases that, in turn, help manufacturers with: Removing hidden inefficiencies in material handling productivity Tracking the flow of operations One such company is Proteck, a Chennai-based leading manufacturer of printing equipment. Its printing operations use a

variety of printing presses from different manufacturers, each with its own unique setup and quality needs. To streamline operations Proteck installed two Cognex In-Sight Micro cameras to detect registration marks on printing plates and automate the set-up process. Cognex’sPatMax and In-Sight Explorer software handled different positioning requirements in the same machine, while Vision View terminal provided a way to view information such as plate positions, before-andafter position correction and the presses’ operating status. At P&G India, Cognex’s In-Sight Vision System verified that right packaging and Manufacturer’s Recommended Price (MRP) were used for 50 detergent variants, each with similar colour and features. Previously, quality checks for the detergent packaging, was done manually in two separate rounds of inspection and verification. After deploying Cognex InSight Vision System along its packaging line, P&G has increased the line speed and bottom line as both inspection and verification are done simultaneously, eliminating packaging errors. Didier Lacroix Global Senior VP (Sales & Marketing), Cognex Inc sales.in@cognex.com


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32 Special Focus: Interface

The Indian market is in fact a very interesting one, especially with reference to the pharma industry Pallavi Mukhopadhyay pallavi mukhopadhyay @network18publishing.com

Provide a brief overview of the company. Marchesini Group is a leading supplier of complete packaging lines and machines. We handle the entire packaging process, upstream and downstream, as well as standalone automatic packaging machines — both primary and secondary — for the pharmaceutical and cosmetics industries. In 2011, we have installed over 9,000 packaging lines worldwide, and group revenues of €188,5 million have been generated (+ 4 per cent compared to 2010). Who are your clients? Approximately 85 per cent of the Group’s production is devoted to the pharmaceutical industry, where

Marchesini is a major point of reference, not only for multinational enterprises including GSK, Novartis, Sanofi Aventis, Wyeth, BMS and Pfizer, but also for small and mediumsized businesses, companies working in generics and pharmaceutical contracting business. The remaining 15 per cent of production concerns the cosmetics industry, where Marchesini offers innovative cosmetic packaging solutions tailor-made for top level clients, such as L’Oréal, Procter&Gamble, Dior Parfum, Guerlain Paris, and Yves Saint Laurent Beauté. What will be your marketing strategy in India? Our strategy is to provide the latest available technology in the market. We produce the same quality and technology for all our customers, worldwide. Marchesini packaging lines are produced and tested in the same production facilities in Italy. Our mission is to give turn- key solution,

…says Philippe Soldati, Resident Area Manager, Marchesini Group India. He also talks about the future of Marchesini and the latest products being developed there.

complete in-house, patented, robotised technology and track & trace integration. What challenges do you face as an innovation company? The innovation challenges are in Marchesini Group’s DNA. Since day one, we aim to offer original solutions for markets in constant development and are ever focussed on flexible mechanics. We have made challenging achievements, thanks to continuous investments in research and availability of cutting-edge instruments, CAD design stations, a rapid and cutting edge prototyper, an experiment laboratory fitted out with the most modern of technological equipment and employing highly specialised personnel. What do you do differently? Marchesini’s mission is to offer complete packaging lines, highly profiled for the end client: an on-demand offer, customised and adapted to meet the needs of different clients. A tailor-made approach for packaging line projects, focussed on sales, after-sales and assistance worldwide. The future strategy of Marchesini Group focusses on R&D in order to keep on providing its clients with an increasingly widened products array. What countries are you planning to reach out to with your new product? With exports accounting for over 85 per cent of sales revenue, Marchesini is clearly an internationally driven company. Today, Marchesini is present in over 100 countries around the world, with 11 divisions in its reference marketplaces such as Great Britain, the United States, Scandinavia, Switzerland, Germany, France, Benelux, Spain, India, the Middle East and Asia Pacific. Marchesini has an extensive network of 20 representation agencies that have grown together with the company in order to foster each day the company’s commitment to stay close to its customers. With these foreign offices, Marchesini Group aims at consolidating its tradition on looking towards emerging markets, while maintaining its core industry manufacturing plants in Italy. What are your expectations from India? The Indian market is in fact a very interesting one, especially with reference to the pharma industry. More than thirty leading companies over the recent years have recorded considerable production volumes and multinational pharmaceutical enterprises have also set up production factories in this country. India is a market that is growing constantly year after year. The demand is high for machines and lines for pharmaceutical packaging. It is in this context that the blister lines, those for filling rigid tubes, liquid fillers, (also in a sterile environment), syringe lines and other types of systems produced by Marchesini Group have skillfully conquered the Indian market, thanks to the reliability, flexibility and high technological standard of solutions offered. Due to the importance of this market, Marchesini Group decided to open a foreign department of the Group in Mumbai, and has transferred me here as the Resident Area Manager.


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Projects

Projects

New projects and expansion activities are the barometers of industrial growth. These also present business opportunities to service providers like consultants, contractors, plant & equipment suppliers and others down the value chain. This feature will keep you updated with vital information regarding new projects and capacity expansions being planned by companies in the pharma/lifesceinces industry. Bulk drugs manufacturing unit Project type: New facility Project news: Bulk drugs (10.50 TPM) manufacturing unit at Plot No 28, Raichur growth centre industrial area, Village Chicksugur, District Raichur, Karnataka by M/s Vaidhatru Pharma (Pvt) Ltd.

Bulk drugs manufacturing unit Project type: New facility Project news: Bulk drugs (30.85 MTPM) manufacturing unit at Plot No 27, Raichur growth centre industrial area, Village Chicksugur, District Raichur, Karnataka by M/s Trimax Bio Sciences Pvt Ltd.

Project location: Raichur, Karnataka Project cost: NA Implementation stage: Ongoing

Project location: Raichur, Karnataka Project cost: NA Implementation stage: Ongoing

Contact details: Vaidhatru Pharma Pvt Ltd Plot no 7, Road No 7 Sri Lashmi Srinivasa Nilayam Czech Colony, Sanath Nagar Hyderabad -500018 Andhra Pradesh Tel : 040-40126589 Email : vaidhatrupharma@gmail.com

Contact details: Trimax Bio Sciences Pvt Ltd Plot No 7, Road No 1, Sri Lakshmi Srinivasa Nilayam Czech Colony, Sanath nagar, Hyderabad -500018 Andhra Pradesh Tel : 040-40126589

Bulk drugs manufacturing unit Project type: New facility Project news: The project involves for setting up of bulk drugs manufacturing unit (240 MTPM) at Sy No 61, Village Ankhol, Tehsil Kadi, District Gandhi Nagar, Gujarat. No rehabilitation & resettlement is involved. Project location: Gandhinagar, Gujarat Project cost: ` 5.2 million Implementation stage: Ongoing Contact details: Nebula Health Cares F. 19/20, Milennium Swaminarayan Temple, Plaza, Opp. Premchannagar Road, Vastrapur -380015, Gujarat Tel : +(91)-79-30120615/ +(91)-79-32933441 Fax : 079-32933442/26855561 Email : nebulahealth@gmail.com Bulk drug unit Project type: New facility Project news: Virupaksha Organics Pvt Ltd have proposed bulk drug unit at Sy No 544-546, Village & Mandal Bikanoor, District Nizamabad, Andhra Pradesh. Active Pharmaceutical Ingredient (API), API intermediates, fine chemicals and natural products will be manufactured. Total project area is 30 acre. No forest, national park or sanctuary is located within 10 km of the project site.

33

Project location: Nizamabad, Andhra Pradesh Project cost: ` 20.00 million Implementation stage: Ongoing Contact details: Virupaksha Organics Pvt Ltd Plot No. B-4, IDA Gandhi Nagar, Ranga Reddy 500038 Tel : 91-40-23075816,23073079 Fax : 040-23720738 Email : info@virupaksha.com Bulk drugs manufacturing unit Project type: Facility expansion Project news: Delta Fenochem (P) Ltd has proposed expansion of bulk drugs manufacturing unit at Gat No 350, Village Wadhirwarhe, Tehsil Igatpuri, District Nasik, Maharashtra. Project location: Nasik, Maharashtra Project cost: ` 9.50 million Implementation stage: Ongoing Contact details: Delta Finochem Pvt Ltd 121, MIDC, Satpur, Nasik-422007 Tel : 02553-306251/52 Fax : 02553-306260 Email : deltafinochem@gmail.com,sales@ deltafinochem.in

Information courtesy: www.tendersinfo.com 1, Arch Gold, Next to MTNL Exchange, Poisar, S V Road, Kandivali (W), Mumbai - 400 067, Maharashtra, India • Tel: 022 28666134 • Fax: 022 28013817 • Email: parmeet.d@tendersinfo.com


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34

Tenders

Latest Popular Tenders Brought to you by www.tendersinfo.com Spectrometer Org : Indian Institute Of Technology Delhi TRN : 13032934 Desc : Supply of one unit of Electro Spray Ionization Mass spectrometer (ESI-MS-MS). BOD : November 26, 2012 Loc : Delhi BT : Domestic (NCB) Org : Indian Institute Of Technology Kanpur TRN : 13032224 Desc : Supply of UV-Vis-NIR spectrophotometer with specular reflectance accessory BOD : November 26, 2012 Loc : Kanpur, Uttar Pradesh BT : Domestic (NCB)

Org : Hll Lifecare Limited TRN : 13001277 Desc : Supply of filling machine and lyophiliser at BCG vaccine laboratory BOD : November 30, 2012 Loc : Chennai, Tamil Nadu BT : Domestic (NCB)

Drugs/Medicines

Drugs/Medicines : : : : : :

Org : Department Of Atomic Energy TRN : 12797694 Desc : Supply of atomic absorption spectrometer with accessories BOD : November 29, 2012 Loc : Mumbai, Maharashtra BT : Domestic (NCB)

Filling machine and lyophiliser

Spectrophotometer

Org TRN Desc BOD Loc BT

Spectrometer

Government Of Uttar Pradesh 13050194 Supply of Homeo-pathic globules November 27, 2012 Lucknow, Uttar Pradesh Domestic (NCB)

Spectrophotometer Org : Directorate Of Groundnut Research TRN : 12812075 Desc : Supply of UV-VIS double beam spectrophotometer BOD : November 28, 2012 Loc : Junagadh, Gujarat BT : Domestic (NCB)

Org

: Dr Bhim Rao Ambedkar Memorial Hospital TRN : 13056701 Desc : Supply of generic medicines BOD : November 30, 2012 Loc : Raipur, Chhattisgarh BT : Domestic (NCB)

Drugs/Medicines Org TRN Desc BOD Loc BT

: : : : : :

District Health Society 13050003 Supply of drugs & medicines for JSSK November 30, 2012 Bikaner, Rajasthan Domestic (NCB)

Drugs/Medicines Org : Western Coalfields Ltd TRN : 12883147 Desc : Supply of medicine items Tab Chloroquin DS qty 2000,Tab CPM 4 mg qty 50000,Cap Nifedipin 10 mg qty 10000,Tab Ibuprofen 400 mg + PCM 325 mg qty 20000, Tab Domperidon 10 mg qty 5000 etc BOD : November 30, 2012 Loc : Chhindwara, Madhya Pradesh BT : Domestic (NCB)

Drugs/Medicines Org

: State Pharmaceuticals Corporation Of Sri Lanka TRN : 12985206 Desc : Supply of MMR vaccine BOD : December 3, 2012 Loc : Colombo, Sri Lanka BT : Global (ICB)

Drugs/Medicines Org

: State Pharmaceuticals Corporation Of Sri Lanka TRN : 12985205 Desc : Supply of rabies vaccine (human use) BOD : December 3, 2012 Loc : Colombo, Sri Lanka BT : Global (ICB)

Org: Organisation’s name; TRN: Tendersinfo Ref No; Desc: Description; DSLD: Doc Sale Last Date; BOD: Bid Opening Date; Loc: Location; BT: Bidding Type Information courtesy: www.tendersinfo.com

1, Arch Gold, Next to MTNL Exchange, Poisar, S.V. Road, Kandivali (W), Mumbai - 400067 Maharashtra, India Tel: +91 22 28666134 • Fax: +91-22-28013817 • Email: parmeet.d@tendersinfo.com


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Event List

35

N AT I O N A L E V E N T S Symposium on ‘Evolution of Gas Chromatography in India- Past, Present & Future’

floor; November 21 - 23, 2012, Bombay Exhibition Centre

This will be a celebration of the Diamond Jubilee year after Dr Martin and Dr Synge got their Nobel Prize for GC in 1952.During this symposium, the contributions of a few Indian industries and individuals, who have made immense contribution in the GC field would be acknowledged. The number of delegates will be restricted to 300 only. The organisers feel that this symposium is a unique opportunity for all delegates to share the knowledge regarding the past, present and future of the GC technology, industry, market and applications; November23-24,2012, BARC Training School Hostel, Mumbai

For details contact: Chaitali Davangeri UBM India Pvt Ltd Tel: +91-22-6612 2642 Email: chaitali.patil@ubm.com Website: http://www.pmec-india.com/

For details contact: Chromatographic Society of India (CSI) Tel: +91 98200 93260 Email: ramakrishnan.g@chromsocindia.org Website: www.chromsocindia.org

P-MEC India P-MEC India, the most well attended and talked about Pharmaceutical Machinery, Equipment and Technology event. In this event the leading Indian and international pharmaceutical machinery exhibitors showcase their latest technologies and announce product launches. P-MEC focuses on key challenges in pharmaceutical services to develop more efficient production routes and systems of increasingly complex healthcare products. Technology demonstrations and onsite seminars will complement your visit to the show

Pharma Biotech Expo & Conferences

CHENNAI

LUDHIANA

Tamil Nadu, Nov 22-25, 2012

Punjab, Dec 21-24, 2012

INDORE

AURANGABAD

RUDRAPUR

HYDERABAD

Madhya Pradesh, Jan 11-14, 2013

Maharashtra, Feb 1-4, 2013

Uttarakhand, Feb 23-26, 2013

Andhra Pradesh, May 31- June 3, 2013

India’s premier industrial trade fair on products and technologies related to Machine Tools, Hydraulics & Pneumatics, Process Machinery & Equipment, Automation Instrumentation, Packaging & Auxiliaries, IT Products, Electrical & Electronics, Material Handling and Safety Equipment.

For details

Network18 Media & Investments Ltd

Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028. • Tel: 022 3003 4651 • Fax: 022 3003 4499 • Email: engexpo@network18publishing.com

Pharma Biotech Expo & Conferneces is an exciting new networking platform & international exhibition for pharmaceutical machinery & equipment, biotechnology & applications industry. The event will be a preferred destination for the pharma and biotech and it will attract more than 10,000 visitors & exhibitors with 100 stalls; November 21-23, 2012, Hotel Le Mariet, Baddi

a focus on ‘Frontiers of Nanotechnology: Impact on India’; December 5-7, 2012, Hotel Lalit Ashok, Bengaluru

For details contact: Paramount Exhibitors Tel: + 91 172 2274801 Fax: + 91 172 2274803 Email: contact@paramountexhibitors.com Website: www.paramountexhibitors.com

Pharma Technology Show – Delhi

Bangalore Nano Bangalore Nano event has truly emerged as the premier event for research fraternity and industry to come together and explore emerging opportunities in this sector. The event comprising of exhibition & conference will encompass two full days of presentations and discussions and interactive networking activities; a meeting place for the global scientists, industry, academia & government with

For details contact: MM Active Bengaluru Tel: +91 80 41131912 Fax: +91-80-41131914 Email: jagdish@mmactiv.in Website: www.mmactive.in

The event aims at bringing together world renowned companies as well as newly launched companies on one platform. It is an invitation to all those who want to seize this opportunity and to further galvanizing their position to take share of this lucrative market. The expected visitors will be the CEOs & top executives from pharma manufacturing industry, executives from production, quality control, R&D & purchase departments, professionals from R&D institutions, pharmacists from trade & profession, biotechnology specialists, top officials from regulatory agencies; December 7-10, 2012, India Expo Centre and Mart, Greater Noida

For details contact: Print Packaging.com Pvt Ltd Tel: +91 22 27812619 Fax: +91-11 41722130 Email: info@indiapackagingshow.com Website: www.print-packaging.com

Pharma World Expo Pharma Bio World Expo is one of the foremost shows for pharma and biotech industry in India. The show aims to be one of the largest exhibition and conference for chemical and pharma industry. There will be visitors and exhibitors from pharma processing, plants & equipments, pharma packaging machinery & materials, API, bulk drugs, additives, intermediates, analytical laboratory supplies (instruments, glassware, laboratory reagents / chemicals), environment control equipment & services, etc). This event aims to be a perfect meet for the entire industry; January 15-18, 2013, Bombay Exhibition Centre, Mumbai For details contact: Chemtech Foundation Tel: +91 22 22874758 Fax: +91 22 22870502 Email: conferences@jasubhai.com Website: www.chemtech-online.com

I N T E R N AT I O N A L E V E N T S International Conference of National Strategies for Torch International Conference of National Strategies for Torch, Chlamydia trachomatis and human papilloma virus will address the latest clinical diagnostic, economic and scientific achievements in the practical and scientific medicine to meet the needs and interests of immunologists, allergists, laboratory specialists, gynaecologists, dermatovenereologists, infectology, microbiologists, health professionals. In addition, there will also be a large industrial exhibition in the new and interesting way; November 15-16, 2012, Kiev, UK For details contact: NBScience Ltd Tel.: +38 044 233 27 70 Email: med@nbscience.com Website : www.nbscience.com

ICAR2012 The second International Conference on Antimicrobial Research (ICAR2012) will be a forum for the presentation, exchange and dissemination of information and experiences on anti-microbe strategies, in biotic or abiotic environments, in planktonic or adhered states, in biologically specific or unespecific ways, in vitro or in vivo, in a general context marked by the threat posed by the increasing antimicrobial resistance of pathogenic microorganisms; November 21-23, 2012, University of Lisbon, Portugal

For details contact: Formatex Research Centre Tel: +34 924 258 615 Fax: +34 924 263 053 Email: info@icar-2012.org Website: www.formatex.org

ICBMS’12 International Conference on Biological and Medical Sciences (ICBMS’12) aims at presenting the current research being carried out in that area. This conference is covered under International Multi-Conference on Chemical, Ecological and Biological Sciences (IMCEBS’12). The idea of the conference is for the scientists, scholars, engineers and students from the universities all around the world and the industry to present ongoing research activities, and hence to foster research relations between the universities and the industry. This conference provides opportunities for the delegates to exchange new ideas and application experiences face to face, to establish business or research relations and to find global partners for future collaboration; December 29-30, 2012, Grand Seasons Hotel, Kuala Lumpur, Malaysia For details contact: International Scientific Academy of Engineering & Technology Email: at info@isaet.org Website: www.isaet.org

BIOSIGNALS 2013 The purpose of the international conference on Bio-inspired Systems and Signal Processing is to bring together researchers and practitioners from multiple areas of knowledge, including biology, medicine, engineering and other physical sciences, interested in studying and using models and techniques inspired from or applied to biological systems. A diversity of signal types can be found in this area, including image, audio and other biological sources of information. The analysis and use of these signals is a multidisciplinary area including signal processing, pattern recognition and computational intelligence techniques, among others. With this vision in place the event aims to reach out to the industry professionals; February 11-14, 2013, Barcelo Sants Hotel, Barcelona, Spain

biology, including for example the use of statistics and algorithms to understanding biological processes and systems, with a focus on new developments in genome bioinformatics and computational biology; February 13, 2013, Barcelona, Spain For details contact: Bioinformatics Secretariat Tel.: +351 265 100 033 Fax: +44 203 014 5436 Email: bioinformatics.secretariat@ insticc.org Website :www.bioinformatics.biostec.org

International Conference on Life Science & Biological Engineering

Bioinformatics 2013

The aim objective of LS&BE 2013 is to provide a platform for researchers, engineers, academicians as well as industrial professionals from all over the world to present their research results and development activities in networking and digital society. This conference provides opportunities for the delegates to exchange new ideas and application experiences face to face, to establish business or research relations and to find global partners for future collaboration; March 15-17, 2013, Tokyo, Japan

The purpose of the international conference on bioinformatics models, methods and algorithms is to bring together researchers and practitioners interested in the application of computational systems and information technologies to the field of molecular

For details contact: Kwansei Gakuin University Tel: 81 798 54 7394 Fax: 81798 54 6082 Email: craig.mark@kwansei.ac.jp Website : www.lsbe.org

For details contact: Biosignals Secretariat Tel.: +351 265 100 033 Fax: +44 203 014 5436 Email: biosignals.secretariat@insticc.org Website: www.biosignals.biostec.org

The information published in this section is as per the details furnished by the respective organiser. In any case, it does not represent the views of Modern Pharma.


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36

Event Preview

PMEC & CPhI India 2012

Chandreyee Bhaumik chandreyee.bhaumik@network18publishing.com

I

ndia’s pharmaceutical machinery and equipment market is growing. Decision makers from all over the world are increasingly looking at India for sourcing pharma machinery and equipment. At P-MEC India, one has the unique opportunity to showcase the products in front of an august audience, building brand awareness and gaining new leads from over 85 countries. This year, the available space will be occupied by over 76 international and 186 Indian pharma machinery, equipment and technology companies.

Aiming to transcend success boundaries This year P-MEC/CPhI/ICSE and BioPh India will take place at the Bombay Exhibition Centre, from November 21-23, 2012. The 3-day exhibition will be humming with activity from pharma machinery segment, that is those involved in tablet and capsule filling machinery, coating, packaging, bottling, vial filling, etc. A curtain raiser…

Co-located events P-MEC India is co-located with CPhI India, a sister brand of CPhI Worldwide the ‘must attend’ event in the international pharma industry. Into its 5th year, P-MEC India and its co-located events are the largest and most comprehensive pharma industry events in South Asia. P-MEC India is a great platform for one to: Showcase high-quality pharma machinery and equipment Meet with key decision makers in pharmaceutical industry from over 85 countries, including India,

Glimpses from the last year

China, the US, the UK, France, Italy, etc Network and build your brand in one of the world’s fastest growing pharma markets The idea of having PMEC India co-located with CPhI /ICSE/BioPh India, is to have the global pharma fraternity networking at a single platform. The unique combination of four umbrella events will

showcase manufacturing and product capabilities of high value. It is convergence of companies investing in technology, applications development and sophisticated manufacturing capacities. The top 15 countries participating in the event include Bangladesh, China, Germany, Indonesia, Iran, Japan, Korea, Nepal, Philippines, Russian Federation, Singapore, Taiwan, UAE, UK and the US.

Last year… There were exhibitors from the field of analytical equipment, automation & robotics, batching systems/equipment, cleanroom equipment, filling equipment, filtration/ separation/purification, health & safety products, instruments, laboratory products and equipment, machinery, packaging equipment and supplies, plant/facility equipment, process automation & controls, processing

equipment, RFID, tabletting/ capsule fillers, testing & measurement, validation. Last year, the event witnessed 825 exhibitors from 21 countries and regions and 27,437 attendees from 96 countries and regions in six exhibition halls spread over 48,000 m2 of exhibition space. Further, there were visitor delegations from the Middle East, Indonesia, Nigeria, Nepal, Korea and the USA. (With inputs from Pallavi Mukhopadhyay)

Exhibitors’ views Sunil Aggarwal,

Nishant Thakre

Director, Airtech Systems

Manager , Corp Marketing Group, Ion Exchange India

We will be showcasing HVAC and cleanroom equipment. We hope that this event will be helping us in leveraging the vast customer base. Though at the moment the market is having slow growth, it will gain momentum increasing soon.

Ion Exchange India a pioneer in water and environment management and will be showcasing its range of INDION Resins for the pharma industry at CPhI 2012, Mumbai. INDION Resins lead the way in the Indian market and are exported worldwide.

Dhaval Shah

Salil Sansare

CEO, Shah Brothers

Director - Business Development, Lab Guard

We will be showcasing a complete range of filtration products: from lab to process. At this event we are expecting a good turnout of customers and an effective discussion with them. Indian pharma market is growing and it is here to stay. Thus, this type of events helps in leveraging existing opportunities.

We are showcasing fume hoods and laboratory furniture. We are now seeing an upward trend in the market. At the exhibition, we are expecting to meet old contacts, generate new leads and showcase our newly launched range of products to the customers.


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Event Report

37

India Lab Expo 2012

Opening the technology windows for the future Nikunj Sharma

Enthralled by the success of three previous editions, India Lab Expo entered the fourth edition with enhanced strategy and theme. About 250 exhibitors from 15 countries participated in India Lab Expo 2012. While majority of the previous year exhibitors re-appeared in the show, global community also reflected increased involvement. A report.

nikunj.kumar@network18publishing.com

I

ndia Lab Expo remains a onestop shop to provide immediate and accurate access to the equipments, products and cuttingedge technologies. The trade show also offers significant prospects to the exhibiting companies to display their products, innovations and services to the prospective consumer base under one roof. In addition, the platform also provides professionals and industry people an opportunity to access comprehensive information about the latest trends in laboratory, analytical, biotechnology and scientific equipment.

Covering the latest industrial trends India Lab Expo is a major trade show dedicated to the scientific and laboratory sector in India, to showcase latest trends and technology in the industry. The event was organised from November 2 to 4, 2012 at Hitex Exhibition Centre in Hyderabad, India. This year’s theme was ‘Laboratory and Analytical Techniques and Instrumentation.’ The three-day long technology fair was inaugurated by Dr Ahmed Kamal, Director, Indian Institute of Chemical Technology, Hyderabad. The show was knitted around extensive marketing programmes to ensure the right connection between the supplies and the consumers.

Programme highlights The three-day technology fair was started with significant boost from various stakeholders from diverse background across the globe. The participant community comprised research professionals, manufacturers, service providers and industry professionals. One day conference ‘Bio Lab Analytika

The knowledge-sharing platform emphasised upon educating industry professionals about the laboratories guidelines, analysis, management & development in quality control and quality analysis laboratories. 2012’ was organised on November 2, 2012 based on laboratory guidelines, management and analysis. The conference witnessed participation from 200 delegates from around the world. The knowledge-sharing platform emphasised upon educating industry professionals about the laboratories guidelines, analysis, management & development in quality control and quality analysis laboratories. On November 3, 2012, ILE seminar was held that focussed upon general laboratory & analytical trends & techniques. This comprehensive seminar was attended by 500 global and Indian professionals from diverse background. The eminent speakers provided an insight

Audience admiring the show

into the most recent developments in the area of laboratory and analytical instrumentation. Vivek Vikram, Project Head, India Lab Expo 2012, said, “India has established itself as a major hub for pharmaceutical and food processing industries and is an emerging market for biotechnology and lifesciences. India Lab Expo is looked upon as the most important platform to connect with international and national laboratory and analytical community. India has pioneered as a global centre for drug discovery, pharmaceutical manufacturing, food processing and healthcare services and the event provided a platform to support their laboratories needs.”


38

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Event Report

4th International Nutraceuticals Conference

Focussing on a healthier tomorrow Pallavi Mukhopadhyay pallavi mukhopadhyay @network18publishing.com

T

The 4th International Nutraceuticals Conference held at the SciTech Centre in Mumbai, highlighted topics such as public acceptance and evolution of nutraceuticals, and its market potential. Speakers discussed how the nutraceutical industry in India needed a revamp. Areas such as regulation, categorisation and commercialisation were of utmost importance to all participants. Here is a lowdown on the event.

he 4th International Conference on Nutraceuticals was held at the SciTech Centre in Mumbai on November 6, 2012. Organised by FICCI and Health Foods and Dietary supplements association of India (HADSA), the conference saw the coming together of doctors, researchers and CEOs from the field. Mahesh Zagade, Commissioner, FDA, was the Chief Guest. The conference highlighted on the nutraceutical industry needed from authorities, public acceptance and evolution of nutraceuticals and its market potential.

Hindrances faced by the industry The largest market for nutraceuticals is the US, followed by Europe and Japan. India, China and Brazil are developing nations but also show huge potential for the nutraceuticals market. Each of the countries in the BRIC region is in different evolutionary stages of development and nutraceuticals are subject to differences in regulation, nutrition awareness, consumer demand, biological support and affordability. China and Brazil have an advanced regulatory framework for the approval of nutraceuticals and their advertising. However, the nutraceutical industry in India is in its first year of evolution. The FDA does not still have a clear understanding of traditional medicine. Besides, the industry faces challenges such

An

Functional foods/nutraceuticals/ health supplements The Food Safety and Standards Regulations, 2011 notified in the Gazette of India came into force on August 5, 2011 to regulate manufacture, distribution and sale of nutraceuticals, functional foods and dietary supplements in India.

In the spotlight

(L to R) Dr Smarta; Zagade; Munesh Khanna, Senior Partner, Grand Thornton India and Puranik

as poor infrastructure, lack of adequate facilities for storage, transportation and cold storage facilities. While the Indian regulators have worked to improve the regulatory framework, there is still plenty of confusion around rules, regulations and licensing for a variety of different commodities. Ranjit Puranik, CEO, Shree Dhootapapeshwar Ltd, laid out a list of amendments that needs to be made in order to have a better functioning of the industry. He said, “Vague laws and senseless litigation should be avoided. Better internal communication should be facilitated. There should be proper categorisation and understanding of the products to simplify the import-export process and lastly the authorities should

be updated regarding different kinds of formulations.”

Nutraceutical regulation in India Nutraceuticals were clubbed under Prevention of Food Adulteration Act and Rules (PFA). Food was classified as either fortified or propriety. Later in 2006, all the existing laws were consolidated to form one single statute in order to ensure systematic and scientific development of the food processing industry. Food was classified under the following heads: Novel foods Genetically modified food Propriety food Standardised food Foods for special dietary use

Zagade, said, “This conference brought about sensitive issues about the industry. A report should be filed and sent to the Government of India.” He also added, “I hope the nutraceutical industry contributes to bringing about a vibrant economy in India. FDA will strive to bring the industry at par with international practices. It is important to regulate the quality of products, and carry out raw material testing batch testing for efficacy. FDA is a partner in the food and drug business.” Dr R B Smarta, Managing Director, Interlink Marketing Consultancy Pvt Ltd, said, “There was a good interaction between speakers regarding regulatory issues and many participants were benefitted through the panel discussion and inauguration session. As an industry interface, I thought of bridging the gap between the industry and state FDA. I proposed HADSA to assist the industry in taking up issues with state FDA so that the state can take it to the centre.”

invite that

rewards as well... Dear Reader, ‘Modern Pharma’ solicits original, well-written, application-oriented, unpublished articles that reflect your valuable experience and expertise in the pharmaceutical industry. You can send us Technical Articles, Case Studies and Product Write-ups. The length of the article should not exceed 1,200 words, while that of a product write-up should not exceed 100 words. The articles should preferably reach us in soft copy (either E-mail or a CD). The text should be in MS Word format and images in 300 DPI resolution & JPG format.

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Prof Ranjit Roy Chaudh Chairman, Task ury Force for Research Hospitals Educatio , nal and Research Apollo Foundation

Eli Lilly annou clinical trial nces late-stage Alzheimer results of disease candi Eli Lilly and date Co

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Pharma manufa cturing in India Moving against several odds

ARC sensor technology Revolutionary analytics

Energy Mana gement 31 Energy

LifeCell launch es ‘BabyShie ld’ newborn

The guiding

brokers ‘energy’ in companies

LifeCell Interna announced stage clinica latetional announ l trial results launch of ced the Alzheimer ‘BabyShield,’ of its disease candid and non-in an solanezumab. ate, named vasive newbor advanced programme. n screening that the new The company claimed BabyShield lead to a lifetime of can identify 118 health with previou study in combination regret. Newbo conditions over screening s at birth, making is recomm the most rn August, 2012 results presented ended by advanced councils it in medica revealed 34 newbor across the service in the occurrence per cent less world and l mandatory world. Import n screening of mental is performed for is antly, this test loss in patient with mild several countr all babies born in symptoms s thereby making a non-invasive manner in of Alzheim during a USA, Germa ies including the er comparative UK, simple to implem it safe for the baby ny, Japan period of study for and I strongly and Austra ent in a healthc one a lia. recommend Newborn are setting. company may and half year. The to invest all parent conduct further in a screeni and preven screening is an early s gather sufficie tive ng trials preven at treatm to birth, tion nt ent initiated in is as approval applica data to file the drug order to safegua that can be BabyShield always better than cure. tion. The compa severe harm is rd them from expected to such non-invasive a simple, safe and ny is take up the physical abnorm as mental retarda Unveiling the secure service a FDA author matter with tion, programme absolutely alities, bone that causes ities no harm to liver dysfun deformity, necessary steps. to discuss the further ction the baby.” Dr Mayur Speaking The BabySh or even death. Abhay a, at the occasio & Execu Presid ent launch, n tive Direct is performed ield screening program SMS Pharm me Profess Dr James Shoemaker, of the Internationa using a few or, a sells Vizag Associate collected from drops of blood or, Edwar l, said, “BabyS LifeCe ll Mylan Lab for unit to a revolu Center Depart d A. Doisy Resear hield is tionar y at birth and the baby’s umbilical ch field SMS Pharm $ 33 million ment of cord and urine sample of newborn develo pment in aceuticals Biochemistry Molecular 48 hours of retrieved after has sold manufacturing screening Biology, Saint for the baby’s its University unit in Visakh results are birth. The Louis compra completely pain-f allowing School of to global apatnam available within test said, major ree and ehensive of the arrival “Giving birth Medicine, USA, a few days way for $ 33 million Mylan Laboratories of safeguarding infants to a baby of the . The money diagnosis and of samples. It aids is one one-tim against any through the early mome most exciting and diseases. raised timely treatme sale will be e investm rewarding improving An nt for parent some existing used ent of a child’s chance nt, thereby times parents can s. Howev debts, cut overheato clear healthy and the child relax peacefu ` 4,990, er, in addition normal life. s of living a life-th may be prone at that their child lly to strengthening d costs, reatening will grow to knowing production to and diseases be healthy undiagnosed normal. facilities and existing We are capital. The at an early which if pleased working extremely agreement to launch stage can has been signed with Mylan this facility 100 cities and across in India.” take a couple the legal process would of months. Lupin Ltd has annou subsid iary nced Dr Reddy’s launch Lupin Pharm that its Aventi Inc (colle es anti-as s US, aceuti cals Dr Reddy’ ctively s Laboratories thma drug Avapro tabletsLLC’s (Sanofi Aventi receiv ed Lupin ) that it has s) is an announced , 75 mg, has 300 final appro 150 mg and launched angiot ensin mg irbesar tan val for montelukast sodium oral tablets , 75 its tablet strengths. Lupin’s antago nist II granul irbesartan and 300 s, 75 mg, mg, 150 and is indicarecept or generic version es, a bioequivalent mg from mg 300 the treatm 150 mg ted for the mg market a ent of hypert of singula and nephr granules, generic versio US FDA to equiva are the AB-ra ted ir oral ension and in opathy in generi lent of n of Sanofi drug is used the US market. The type 2 diabet Sanofi Avent c patien ts. Avapr o® for Avapr o® ic is’s annua seasonal allergie treating asthma and tablet s. tablet s l US sales Irbesa rtan s. The move had the approv of approx follows $ 400.7 million al by the imatel y USFDA of . Reddy’s ANDA Dr for monte sodium oral lukast granules. The oral granul Singulair es brand The recentl had US sales of approx y released imately $ report expects 2QFY13 reporte 61 million the most for in US. US recent twelve coverage universd sales growth for ending July, sales in INR months the e to be upward also benefit terms will according 20 per cent Health. Dr from to IMS s of (20 be Taro EBITD y-o-y except per cent y-o-y). currency tailwind Domestic A margin—the sodium oral Reddy’s montelukast increase is market growth for Cipla. price expected in to be 14-16 is are availab granules in 4 mg US dermat portfolio to per cent except expected ology le in unit broadly sustain and Lupin, package of for Sun dosage in whose The report . 30. case growth to be performance expects an improv higher (20-22 it expects ed US, it expects for Dr Reddy per cent). In Lupin receiv build a ’s and sequential (in $ terms) the sequential additio its Kurvelo®es FDA approval for margins by recovery n to core sales tablets in 280 bps FTF) to be (excluding Lupin Ltd (basis points) The recent strong for recently announ . US (exclud Sun launches subsidiary Pharma ing Taro), a key factor Lupin Pharma ced that its will be Ranbaxy Dr. Reddy’ (collectively ceuticals Inc and improvement for the sequen s. Further, Lupin) has tial Taro . remain In received final approval for sales to Lupin, EBITD stable margin is expect A For Sun and on a sequential basis. Kurvelo® tabletsits oral contraceptive 220 bps driven ed to improve Dr Reddy’s, Further, the by is driven by this additio by ethinyl estradio (levonorgestrel and a report moderation R&D costs n Pharm recent launch l tablets, in (remains a will deliver reveals that Sun Ranbaxy the es while for mg/0.03 mg USP) 0.15 volatile on quarterly core sales strong earnin for the quarter from the basis—litigati a from post will gs market a US FDA benefit —core is one-fourth on expens 180-days sales sales and profit to generic version growth of e Caduet. The of R&D). of Lipitor/ 38 Branded of Teva presence impact of Pharmaceutic cent respect per cent and 28 of cash flow Given the letter resolut the per build Nordette® ively on a als hedges, we ion (in July warning expects tablets (levono (Teva) Cadila is EBITDA marginy-o-y basis. It sales improved realisation 2012) for and ethinyl not likely for both Lupin for US cent) to estradiol tablets, rgestrel (at 40.3 to during the 0.15 mg/0.03 and Dr Reddy’ current quarterbe reflected EBITD remain stable sequen per on a sequen USP), mg. tial basis. Again, s A margin Glenmark, tially. drug . For Lupin/ is not compa it domestic price policy on a y-o-y gains to drive expects market share rable The impact will basis due the increm report shows be focus. to change inventory ental additio accounting in details that n 1QFY1 policy (from on drug pricing it expects the 3). The key announced policy to get monitorable before the will earnin start of the gs season.

Lupin receive

s FDA app

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Growth in key to remain healthy: Kotregions (India, US) ak Institution al Equities

The final decision regarding the selection and publication of the articles shall rest solely with ‘Modern Pharma’. Authors whose articles are published will be sent a complimentary copy of that particular edition. Published by Network18 Media & Investments Ltd, ‘Modern Pharma’ is one of the leading fortnightly magazines exclusively meant for producers and user fraternities of the pharmaceutical industry. Well supported by a national readership of over 80,000 and our strong network of 26 branch offices across India, this magazine reaches out to key decision makers among the Indian manufacturers of pharma products, machinery and allied sectors. Brought out in association with Hong Kong-based Ringier Trade Media Ltd (one of the world’s largest trade publishing houses with more than 200 special interest titles and offices in every major country), it ensures that advertisers are able to promote their products and services across the globe at no extra cost. So get going and rush your articles, write-ups, etc… Thanking you, Yours sincerely,

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Mo de rn Ph a rm a •16 -3 0 N ove m be r 2 012

Book Review

Quality Control in the Pharmaceutical Industry – Vol 1 The editor, with his vast experience in microbiology and the pharmaceutical industry, has put together a brilliant compilation of chapters dealing with Quality Control (QC) issues in the pharma industry. In the first volume, issues related to sterility testing, antibiotics, preservatives, safety testing, facility design, education and regulation of QC are discussed as individual chapters. The contributing authors have maintained a fairly easy to understand language and good flow of information to make it a good read. A great stress is put on laminar airflows and techniques of asepsis in the first couple of chapters. The editor’s specialty in microbiology is brought out fairly in the chapter dealing with sterilisation of antibiotics and tests to evaluate sterility. The use of illustrations, actual workplace photographs and real-time examples help understand the issues better. The book also stresses the need for education in QC right from the days of pharmacy school to inculcate the habit in young minds. Thus, this can be said as a great first volume in the treatise on QC.

Editor: Milton A Anderson Price: ` 2,100/-

Publisher: Informa Healthcare Distributor: Wisdom Book Distributors, Hornby Building, 1st Floor, 174, D N Road, Mumbai 400 001, Tel: 022 2207 4484/6631 8958, Telefax: 022-2203 4058 Email: thadam@vsnl.com

GLP Essentials: A Concise Guide to Good Laboratory Practice Concise and easy to follow, this book explains the implementation of Good Laboratory Practices (GLPs). GLP principles have become a standard in every avenue in the pharmaceutical industry. GLP steps are quite extensive, precise and seem quite intimidating. The GLP literature too is voluminous and occasionally too mechanistic. This book provides a glimpse into the world and practices of GLP and introduces the reader to its concepts in an easy way. In this book, in less than a 100 pages, t4he author manages to sensitise the reader to the history, basic facets, international perspective, application and training related to GLP. The book is in no way an alternative to conventional GLP resources but a good introduction into some keys areas of GLP. This book will serve as a good read for anyone who wishes to initiate into the world of GLP and pharmaceutical industry, especially for pharma professionals and academicians.

Reviewer: Dr Mandar Kubal, Director, Infectious Diseases & Pulmonary Care Pvt Ltd

39

Editor: Murray S Cooper Price: ` 4,500 (3-volume set)

Publisher: Pharmaceutical Press Distributor: Wisdom Book Distributors, Hornby Building, 1st Floor, 174, D N Road, Mumbai 400 001, Tel: 022 2207 4484/6631 8958, Telefax: 022-2203 4058 Email: thadam@vsnl.com


40

Mod er n P har m a•16 -3 0 N ovem b er 2 012

Products

Looking For A Specific Product? Searching and sourcing products were never so easy. Just type MPH (space) Product Name and send it to 51818 eg, MPH Laboratory software and send it to 51818 Capsule manufacturing machine

Disinfectant

C a p s u l e manufacturing machine has production capacity of 1.5 million capsules per day. It has servo controlled dipping operation and is independent and easily programmable for cap and body sides. These machines are designed and built to last for decades. All operations are controlled by PLC with touchscreen user interface. Safety measurement in all critical areas is provided to prevent accidents. It complies with cGMP guidelines.

Preventol is a ready formulated disinfectant concentrate with cleaning power, highly effective in combating and eliminating a broad spectrum of microbial activity arising from bacteria, viruses, fungi and spores. This formulation combines the benefits of new generation phenolic active ingredients and stabilised aldehyde-based active ingredient to create a synergistic combination. It is proven to be effective where there is a high combination of blood and/or protein and against naked viruses. It is perfectly suited for surface disinfection in hospitals, clinics, nursing homes, commercial establishments, manufacturing areas and animal

Safrroys Machines Pvt Ltd Kolkata - West Bengal Tel: 033- 22897248, 22897341 Fax: 033-22897412 Email: safrroys@gmail.com Website: www.safrroys.com

houses. It is also ideal for protecting medical devices and instruments. Lanxess India Pvt Ltd Thane - Maharashtra Tel: 022- 25871000/25871540 Fax: 022-25826742 Email: sunder.rajan@lanxess.com Website: www.lanxess.com

High purity water solution

on single skid, hot water sanitization, fully functional FAT (factory acceptance test), compliance with latest USP, Ph Eur, cGMP/cGAMP & ISPE specifications and design standards, fully automated with SCADA. It is complete, integrated, specially designed solutions and includes - demineralised water, purified water, pyrogen-free water and water for injection that are critical to the pharma industry’s processes. They deliver customised, specialty systems that meet stringent requirements for high purity water generation and distribution. Ion Exchange (India) Ltd Mumbai – Maharashtra Tel: 022-39890909/30472042 Fax: 022-24938737 Email: ieil@ionexchange.co.in Website: www.ionindia.com

High purity water generation and distribution system is fully pre-validated to industry accepted standard, packaged

Gear head Planetary gearboxes for Servo Motors offers high precision, low backlash unit. They are available as both inline units and in right angle configuration. These units are available in 3 levels of backlash: Precision which has less than 3 arc minutes, low back lash which has less than 5 arc minutes and standard which has less than 15 arc minutes. These gear heads come in various frame sizes which range from A to E with allowable torques upto 92 Nm and peak Torques of upto 274 Nm. Gear ratio are available from 1:3 to 1:100. These can however be ordered to suit any Motor brand like Siemens, B&R, Indramat etc. The gear heads have a lifetime lubrication and need no periodic maintenance. Strategi Automation Solutions Pvt Ltd Bengaluru - Karnataka Tel: 080-32329798, 32467879 Fax: 080-41163047 Email:sales@strategiautomation.com Website: www.strategiautomation.com

Particle counter It is the only particle counter in the world that measures down 0.3 micron at 100 lpm flow rate with a theoretically perfect counter. Counting efficiency is an expression of the probability that a particle counter will sense and count a particle passing through its sample volume. This probability is a function of size up to a certain critical size above which all particles are normally sensed and counted. The model’s most sensitive threshold for 100 lpm flow rate is 0.3 microns. The counting efficiency for 0.3 microns is 50% and for 0.5 microns it is 100%. MeasureTest Instruments Mumbai- Maharashtra Phone: 022-2202 7982 Email: sheesh@mtnl.net.in Website: www.measuretest.com


Mo de rn Ph a rm a •16 -3 0 N ove m be r 2 012

Products Laboratory spray dryer Laboratory spray dryer is used for safe, fast and efficient spray drying of aqueous and organic solutions. Spray drying is a speedy, time saving and gentle method of obtaining even the smallest quantities of substance in power form. The very short residence times and the cooling effect resulting from evaporation make it possible to process even temperature sensitive products in a gentle manner. If the use of organic solvents is involved, the thermal load is reduced to a minimum. Many other processes can also be completed in a single stage like: Modification of particle size, agglomeration of nanoparticles, drying suspensions, particle coating, immobilization of liquids and solid materials in a matrix and manufactures of microcapsules Aero Therm Systems Pvt Ltd Ahmedabad - Gujarat Tel: 079-25890158 Email: contact@aerothermsystem.com Website: www.aerothermsystem.com

Hot Water Systems Hot water systems provide highly efficient solution to instantaneous hot water generation using energy efficient heat exchangers such as funke brazed, gasketed plate heat exchanger or Ecoflux* corrugated tube heat exchanger. HRS hot water systems can also be installed with storage vessel for semi-instantaneous

applications and in conjunction with solar based hot water systems. A Hot water system not only heats the water to a desired temperature using low pressure steam but also maintains the required temperature of water with better temperature control using automation and control. Application areas include Pharma – single fluid heating and cooling systems, food, HVAC, hospitals, hotel, textile, breweries. HRS Process Systems Ltd Pune - Maharashatra Tel: 079-25890158 Tel: 020-2566 3581 /82, 9096699998 Fax: 020- 2566 3583 Email: info@hrsasia.co.in, Website: www.hrsasia.co.in

High speed centrifuge High speed centrifuge features a 100,000 xg top speed performance and supports high-throughput sample processing from 50 mL conical tubes and microplates to 1 L bottles, up to six-litre capacity, meeting the evolving needs of academic research and production facilities alike. Run set-up is easy with the intuitive touchscreen interface featuring a

bright, highly visible and durable display, while on-board video tutorials and access controls, such as user login with password protection provide advanced training and programming options. High speed centrifuge series features built-in safety and rotor technology innovations that shorten run set-up time and increase security using secure, push-button auto-lock rotor exchange in less than 3 seconds which ensures that the rotor is automatically and securely locked and will not loosen during a run. It is lightweight and has corrosion-resistant carbon fiber rotors including the new Fiberlite LEX designs and improved ergonomics. . Thermo Fisher Scientific India Pvt Ltd Mumbai – India Tel: 022- 67162200, 67162259 Fax: 022- 67162244, 1800 22 8374 Email: qfc.customercare@thermofisher.com Website: www.thermofisher.com, www.thermo.com

Deep Freezer Deep freezer has freezing temperature range upto -86° c. It has vacuum insulation panel and no doorjamming feature. Hot gas bypass tube is installed to minimise frost on the triple-silicon door lip and the equipped decompression valve balances the low air pressure built inside the freezer for an effortless door opening. It has temperature stability of ± 1° C. Available sizes are 175,340,515, 690 and 1000 litres. ± 3° C uniformity inside

41

the whole cabinet ensures that the samples are stored inside a guaranteed temperature range. Mack Auraa Nashik- Maharashtra Mob: 9325858585, 9225508585 Fax: 2551- 230877 Email: sales@mackauraa.com Website: www.mackauraa.com

Barcode reader B a r c o d e reader has an integrated advanced 2DMax+™ code reading software technology. Readers can now identify and decode severely damaged or poorly marked 2-D matrix codes using 2DMax technology which also makes the barcode reading unaffected by variations in lighting, marking method, code quality or surface finish. Data matrix codes have built-in error correction but “no-reads” can still occur when codes are incomplete. It is exceptionally small with an industrialrated housing measuring just 23 x 42 x 64mm and it also supports ethernet connectivity with a wide range of industrial protocols, for real-time part tracking, image archiving, data transfer and seamless integration with plant controllers and information networks. Cognex Sensors India Pvt Ltd Pune- India Tel: 020- 40147840, 9881466003 Fax: 020-66280011 Email: sisd.support.asia@cognex.com Website: www.cognex.com


42

Mod er n P har m a•16 -3 0 N ovem b er 2 012

Products

Aerosol photometer The latest version, Model 2i, is used for leak testing of HEPA filters. The upstream aerosol mass concentrations are displayed in actual mass concentration values of micrograms per litre (µg/l). Other features include user settable Aerosol Noise Suppression (ANS) which allows for more stable aerosol measurements when poor mixing is present, three unique data report functions – continuous, monitoring and summary modes, large 4.3” LCD display, thermal printer option to meet documentation requirements and USB output.

TTL Technologies Pvt Ltd Bengaluru - Karnataka Tel: 080-2525 1859 Email: tmidirect@ttlindia.com Website: www.ttlindia.com

automated, microprocessor-controlled electrolyte system that use current ISE technology to make electrolyte measurements. It is compact, economical and easy-to-use. The instrument has long life, provides high-performance and has maintenance-free electrodes.

Linear bottle washing machines

Sensa Core Medical Instrumentation Pvt Ltd Hyderabad - Andhra Pradesh Tel: 91-8455-223400 Mob: 09866861878 Email: sales@sensacore.com Website: www.sensacore.com

Remi Elektrotechnik Ltd Mumbai - Maharashtra Tel: 022-40589888 Mob: 09820627422 Email: sales@remilabworld.com Website: www.remilabworld.com

Microfluidiser processor

Pharma refrigerator The linear bottle washing machines facilitates inline washing operation and are built on rigid structure and are enclosed with elegant matt finished SS body cover. The cleaning is supported by tow inbuilt water tanks and pumping system. The output ranges from 3000 to 4200 bottles, and direction of movement is left to right.

MeasureTest Instruments Mumbai - Maharashtra Tel: 022-2202 7982 Email: sheesh@mtnl.net.in Website: www.measuretest.com

Electrolyte analyser

The ST-100 electrolyte analyser is used for measurement of sodium, potassium and chloride in whole blood, serum, plasma and diluted urine. This also has a built-in lithium ion battery with power back-up of 10 hours. The ST-100 is completely

research labs. The brushless induction motor with variable frequency drive is suitable for continuous operation. The powerful fan motor is available for forced air circulation to maintain uniform conditions inside the chamber and has hermetically sealed compressor with CFC free refrigerant.

National Pharma Machinery Ahmedabad - Gujarat Tel: 079-30903433, 30933433 Email: sales@nationalinda.co.in Website: www.nationalpharmamachinery.com

The portable M-110P microfluidiser processor is a bench-top lab machine that requires no compressed air or cooling water. Designed to operate up to 30,000 psi process pressure, this portable microfluidiser processor requires a standard 20 A, single-phase household electrical outlet and is easily incorporated into any laboratory setting. Utilising Microfluidics’ fixed geometry diamond interaction chamber technology and ceramic plunger, the processor easily enables the production of nanosuspensions and nano-emulsions, as well as liposomal encapsulation and cell disruption with the fewest number of passes.

Orbital shaking incubators Orbital shaking incubators are designed for precise temperature control and simultaneous shaking applications required in fermentation studies, enzyme reactions, life science, tissue culture and biotechnology

The pharma refrigerator has double walled chamber, with two different inner chambers. The two chambers are connected with common wall between the two chambers. Interior and exterior is made of stainless steel. Upper chamber temperature is – 20° C, lower chamber temperature is 2 to 8°C and temperature uniformity is ± 1°C. Newtronic Equipment Company Pvt Ltd Mumbai - Maharashtra Tel: 022-28679326 Mob: 9821089932 Email: nmehta@newtronic.in Website: www.newtronic.in The information published in this section is as per the details furnished by the respective manufacturer/distributor. In any case, it does not represent the views of

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In Convers

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22

Prof Ranjit Roy Chaud Chairman, hury Task Force Hospitals Educational for Research, Apollo and Resear ch Found ation

Eli Lilly clinical announces latetrial resu stage Alzheimer lts disease of Eli Lilly candidate and Co stage

Special

Focus 24

Pharma manufactur ing in India Moving against several odds

Automat ion Tren ds 30 ARC sensor Revolutionartechnology y analyt ics

Energy Manage ment 31 Energy broke

LifeCell lau nches ‘B abyShield’ newborn screening The guidin g ‘energ

y’

rs

in compa announced nies clinic LifeCell lateAlzheimer al trial result Internationa launch s of l annou of solanezum disease candi nced date, nameits and non-i ‘BabyShield,’ an advan the that the ab. The comp programme nvasive newb any claim d new study orn screen ced with previ ed 118 health . BabyShield can ing ous result in combinatio August, identify n s prese the most conditions at 2012 lead to nted in birth, makinover occurrence revealed 34 a service in advanced newb per screening lifetime of regre orn screen g it with mild of mental loss cent less the world is recom t. Newb is perfor coun . in patien ing Impo orn mend symp cils rtantly, med in ed during toms of ts this test a non-i thereby a comp mandatoryacross the worldby medical Alzheimer nvasive making arative period for all manner it safe for and is study for simple to of several babie imple company one and half coun the a USA, Germ tries inclu s born in may Newborn ment in a health baby and gather suffic conduct furtheyear. The care setting any, Japan ding the UK, screening and preve I stron r trials to ient data . and Austr gly recom approval is an initiated ntive treatment early to inves application. to file the drug alia. mend in expected t The comp severe harmorder to safegu that can be prevention in a screening all parents to any is ard them FDA autho take up the such as physical matter from BabyShield is always betterat birth, as with abnormalit mental retard necessary rities to discuss Unveiling ation, liver dysfu non-invasi is a simple, than cure. the furthe steps. ies, bone the progra nction r deformity, mme or even absolutely ve secure servic safe and a The BabyS death. SMS Phar e Speak no that hield is perfo causes ing at Dr Mayu harm to the rmed using screening progr launch, Mylan Labma sells Vizag the occas baby.” r Abha amme Dr collected & Exec ya, Presi Professor, James Shoem ion of the from the a few drops of SMS Pharmfor $ 33 milliounit to aker, blood at birth Internatioutive Direc dent Edward and urine baby’s umbilical tor, Center manufactur aceuticals has n nal, A. Doisy Associate a 48 hours Depa cord sample revol ution said, “Baby LifeC ell Research retrieved and Mole rtment of to globa ing unit in Visak sold its of the ary devel Shield is results l field of cular Biolo Biochemist hapatnam are availa baby’s birth. The after Unive for $ 33 major Mylan newborn opme ry for gy, Saint ble within of the Labor test said, rsity Schoo screening nt in a comp arrival Louis through million. The mone atories l of Medi a few days of samp allowing “Giving letely diagnosis the comprehen cine, USA, y raised les. birth of the some existin sale will be sive way pain-free and used most exciti to a baby improving and timely treatmIt aids early infants of safeg is one moment in additi g debts, cut overh to clear against ent, thereb a child’ ng uarding healthy on one-time for paren and rewar any and norm s chances of living y times production to strengthenin ead costs, ding investmen diseases. ts. al life. paren g existin An a life-t the child may However, facilities t of capital. at that ts can relax hreat and work g The be peacefully ` 4,990, their child undiagnoseening diseases prone to ing with Mylan agreement has knowing will grow and been d at an which take a coupland the legal proce signed to be health if please normal. We early stage e of mont ss would y are extre can 100 d to launc hs. Lupin mely h this cities in Ltd has facility Dr Reddy India subsi acros anno ’s .” s diary unce Dr Redd launches anti-a Inc (coll Lupi n Phar d that its sthma drug y’s Labor Aventis that it mace utica atories recei ved ectiv ely has launc announced US, ls LLC’ Lupi n) Avapro sodium s (Sano irbes artan final appr oral granu hed monteluka oval for has 300 mg tablets, 75 mg, fi Aventis) generic les, a bioeq st and 300 table ts, 75 strengths. is 150 version mg, 150 its table ts, granules, of singu uivalent Lupin’s mg and antagan angio tensi market mg from the mg 300 75 mg, in the lair oral irbes n II onist a gener drug is US FDA recep and is 150 mg artan the used for US market. ic versi to equivmg are the treatment indic ated tor The on of treating seasonal and AB-r ated alent Sanofi of asthma neph allergies. for hypertens of Sano gener ic ropa and Avap ro® the appro The move ion and patie nts. thy in type table ts. fi Aven tis’s Reddy’s val by the USFD follows 2 diabe Avap ro® annu al Irbes artan tic table ts sodium ANDA for montA of Dr US sales oral $ 400.7 had oral granu granules. The elukast million. of appro xima tely of appro les brand had Singulair ximately The recen US the most $ 61 millio sales 2QFY13 tly released repor recent n for ending reported July, accortwelve mont coverage sales growt t expects in Health. hs US. US h for the Dr Redd ding to IMS 20 per universe to be sales in sodium also cent y-o-y upwards y’s mont INR terms oral granu Domestic of (20 benefit from elukast excep are avail will t currency for Cipla per cent les in be Taro to be 14-16market growt . tailwind 4 mg y-o-y). package able in unit h EBITDA increase of 30. and Lupin per cent excepis expected margin—t dosag e is , in whos he price t for Sun portfolio expected in US growth derm Lupin recei to be highe e case it expec to US, it expec r (20-22 The reporbroadly sustain. atology its Kurvelo ves FDA appr per cent). ts performan t expects (in $ terms ts the seque oval for an impro Lupin Ltd ® tablets ntial additi In ce for ) to core build ved FTF) to Dr Redd sales (exclu on a subsidiary recently annou be y’s and nced margins sequential ding (excluding strong for recov (collectively Lupin Pharmaceuti that its by Sun Pharm Taro), The recen 280 bps (basis ery in Dr. Redd Lupin) cals Inc a Ranb approval has receiv t US a key remain y’s. Further, Taroaxy and launches points). ed final factor Kurvelo® for its oral stable on will be sales contracepti impr for For Sun tablets to a seque ovement. the seque ethinyl (levonorges ve and Dr ntial In margin estradiol Reddy’s, ntial basis. is driven trel and is expec Lupin, EBIT mg/0.03 tablets, this by recen Furth 220 bps DA ted to mg from USP) 0.15 Ranbaxy t launches addition Pharm er, the repor impro market drive the US while for a will delive t reveals that R&D costs n by a mode ve by a from post the core sales Branded generic versio FDA to for the Sun will benef ration 180-days (remains quarterly quarter—c r strong earni n Caduet. in volatile Nordette® Pharmaceuticals of Teva ngs is The impac sales of Lipito it growth ore basis sales on a —litigatio of 38 letter resolu one-f and r/ cent t of the and ethiny tablets (levon (Teva) tion (in respectivel per cent and profit prese ourth of R&D n expense warni Cadila nce of 28 July 2012) ng expec y on a 0.15 mg/0. l estradiol tablet orgestrel is not cash flow ). Given the y-o-y basis.per build likely to during 03 mg. for cent) ts EBITDA s, USP) improved the hedges, margin be , to realis we (at 40.3 It sales for Glenmark, current quarter. reflected EBITDA remain stable both Lupin ation for per on For it expec sequentiall US gains to margin a seque ts mark Lupin/ on drive the ntial basis. and Dr Redd is not a y-o-y y’s comparabley. drug price incremental et share Again, inventory basis due domestic addition to chang The repor policy impact will be focus e in 1QFY13). accounting t shows policy details that The key . monitorab (from anno on drug pricin it expects the unced g policy le will before to get earnings the start of season. the

Lupin rec

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generic

Avapro®

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Gr to remainowth in key reg ion healthy : Kotak s (India, US ) Instituti onal Eq uities

http://esh

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Mo de rn Ph a rm a •16 -3 0 N ove m be r 2 012

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RNI No: MAHENG / 2008 / 27125, Postal Regd No: G / NMD / 122 / 2011 - 13, Posted at P.C Stg. Office, GPO, Mumbai 400 001 On 19th & 20th Of Every Month, Date Of Publication: 16th Of Every Month

48

Modern Pharma - 16-30 November 2012  

Modern Pharma is a leading fortnightly business magazine in India, catering to the pharmaceutical industry. Published by Network 18 Ltd., it...

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