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Pharma VOL 8. NO. 2 NOVEMBER 16-30, 2012

Chairman of the Board Viveck Goenka

CONTENTS

Editor Viveka Roychowdhury*

MARKET

Photo Editor Sandeep Patil

'Criteria of speaker selection is important to convey the quality level'

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

Dr Srinubabu Gedela, Director, OMICS Group of Conferences, reveals more to Sachin Jagdale about pharma conferences and their plans for the Indian pharma industry PAGE 25

Bangalore Neelam M Kachhap Delhi Shalini Gupta

PHARMA Pro&Pack Expo 2013 to co-locate Pharmexcil international exhibition iPHEX 2013 PAGE 36

MARKETING Deputy General Manager Harit Mohanty Senior Manager Rajesh Bhatkal

PHARMA TECHNOLOGY REVIEW

PRODUCTION General Manager B R Tipnis

Winners of first ‘Merck Millipore India Innovation Awards’ 2012 announced PAGE 117

Production Manager Bhadresh Valia Asst. Manager - Scheduling & Coordination Arvind Mane

PHARMA LIFE

Asst. Art Director Surajit Patro

Is your company a great place to work?

Chief Designer Pravin Temble

While maintaining a work life balance is in our hands, companies need to be more proactive to make themselves engaging, open and happy places. Shalini Gupta finds out the attributes of a great company to work for PAGE 186

Senior Graphic Designer Rushikesh Konka Layout Rakesh Sharma C I R C U L AT I O N Circulation Team Mohan Varadkar Express Pharma Reg. No.MH/MR/SOUTH-77/2010-12 RNI Regn. No.MAHENG/2005/21398 Printed for the proprietors,The Indian Express Limited by Ms.Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021.

(Editorial & Administra-tive Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright @ 2011 The Indian Express Ltd. All rights reserved throughout the world. Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

November 16-30, 2012

Quintiles Technologies bags ITES award PAGE 188 Dr Arun Bhatt awarded DIA award PAGE 188

MANAGEMENT Leveraging social media for success B Sriram, Executive Director– Healthcare, Direxions Marketing Solutions, advises Indian pharma to deploy social media for marketing PAGE 52

www.expresspharmaonline.com

EXPRESS PHARMA

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EDITOR’S NOTE

Obama’s wins to spell windfall for India’s generics cos In my editorial dated June 29, I had asked, ‘Obamacare passed, but will Obama?’ (bit.ly/UmOwq7). Barack Obama’s decisive win on November 7 clears the deck for the roll out of Obamacare, the Patient Protection and Affordable Care Act (PPACA). Obamacare will give the argument for affordable generics a major fillip as generics are the only way US health authorities will succeed in expanding healthcare coverage to an additional 30 million US citizens.

Making medicines more affordable was also the rationale for the revocation of the patent on Roche's hepatitis C drug Pegasys, but the move was seen as yet another sign that India’s IP laws do not reward and protect innovation. With the compulsory license on Bayer’s Nexavar still a fresh memory, and the Novartis/Glivec case awaiting a final decision from the Supreme Court, MNC pharma companies are probably bracing themselves for the worst.

But the uncertainty on the legal front is a business risk that MNC pharma will have to live with because the economical case for India continues to grow. A recent GBI Research report cites that the overall cost of drug manufacturing is up to 50 per cent cheaper in India than in Western countries, thanks to vast differences in production and labour costs in developed and developing countries. Contract manufacturing organisations (CMO) in countries like India, Korea and China have

22 EXPRESS PHARMA

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started to adopt global CMO business models by integrating service portfolios so that they can position themselves as complete solutions providers to pharma manufacturers.

Thus, increasing levels of pharma outsourcing and generic manufacturing are fuelling the growth of the global CMO market which grew at around 10.8 per cent, from $21.2 billion in 2008 to $28.8 billion in 2011, and is forecast to reach an approximate value of $59.9 billion by 2018 following growth at a CAGR of 11 per cent.

These trends are set to be showcased at the forthcoming CPhI India and its sister events, which has become an annual adda for the global pharma fraternity. This issue of Express Pharma presents key facets of the various industry segments exhibiting at the event and we hope the event sets an upbeat tone for 2013.

But the point to ponder is this: as the country builds a reputation as a reliable source of affordable quality generics and as a CMO destination, big pharma will remain edgy on the IP front. Should we settle for the generics/CMO opportunity at the cost of being written off the innovation map? Hopefully big Indian pharma will lead the way and devise our own strategy to manage a balancing act.

Viveka Roychowdhury viveka.r@expressindia.com

November 16-30, 2012

MARKET

W H AT ’ S INSIDE

THE BUSINESS OF PHARMACEUTICALS

'Criteria of speaker selection is important to convey the quality level' OMICS Group of Conferences is known for organising conferences on issues vital to the Indian and global pharma industry. Dr Srinubabu Gedela, Director, OMICS Group of Conferences, reveals more to Sachin Jagdale about pharma conferences and their plans for the Indian pharma industry Give us some background information about OMICS' 2nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs.

The conference will be held from November 23-24, 2012 at HICC Hyderabad, India. The two-day conference will have four sessions divided into 11 tracks and will witness a plethora of 60 speakers, 350 delegates and about 200 poster presenters from all over the world, together at a single platform to discuss the ongoing research and advancements in the field of pharma regulatory affairs.

Can you describe the nature of the crowd that would participate in this event?

It is going to see a gathering of regulatory experts from across the industry and academia, who will discuss the latest updates and pressing issues in the field of pharma regulatory affairs.

The grandeur of the event can be made out from the number of speakers and delegates that are going to be present at the event, which is expected to

November 16-30, 2012

INTERVIEW

reach a count of almost 400, flying from over 15 countries.

What will the delegates gain from the conference?

Initiation of cross-border co-operations between scientists and institutions is facilitated at the conference. This is an excellent opportunity for delegates from universities and institutions to interact with leading industry experts and debate on the latest regulatory updates. Experts from Food and Drug Administration (FDA) are anticipated as chief

guest for the meeting while prominent personalities like Dr Prakash Nagarkatti (University of South Carolina, US), Dr Patrick L Leoni (Euromed Management, France), Dr Jagat RJ Kanwar (Deakin University), Dr SV Krishna Prasad (Cito Healthcare, India) and Dr Shivanand P Puthli (Panacea Biotech, India) will be the keynote speakers. Pharma2012 is supported by many organisations like RxPharma, P h a r m a P h o r u m , tradeindia.com, Thompson

www.expresspharmaonline.com

Reuter, Innovaro, Conferensum and Aark Store.

Auriga Research is going to be the event partner.

Besides regulatory affairs, which other pharma-related topics have been covered/ discussed in OMICS' conferences till now?

Bioavailability and Bioequivalence ● International Conference and Exhibition on Bioequivalence & Bioavailability: Pharmaceutical R&D Summit, March 1-3, 2010; Marriott Convention Centre, Hyderabad, India with a theme 'Practical Solutions to Pharmaceutical Bioequivalence/Bioavaila bility Implementation.' ● 2nd World Congress on Bioavailability & Bioequivalence: Pharmaceutical R&D Summit, June 6-8, 2011; Las Vegas, US with a theme 'Analyze Novel Approaches of Bioequivalence & Bioavailability Studies.' ● 3rd World Congress on Bioavailability & Bioequivalence: Pharmaceutical R&D Summit, March 26-28, 2012; Marriott Convention Centre, Hyderabad, India

Pharmexcil expects Ministry notification on branding for drug exports within a week PG28

Symposium on evolution of gas chromatography in India - Past, Present and Future PG33

Event briefs PG34

Pharma M&A focuses on increasing product pipelines in Oct 2012 PG38 Aerosol Promotion Council organises 'APC Conference and Exhibition-2012 PG40

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M|A|R|K|E|T with a theme 'Novel approaches in drug development by comparing Bioavailability and Bioequivalence studies.'

Analytical and Bioanalytical Techniques ● International Conference and Exhibition on Analytical and Bioanalytical Techniques, November 1-3, 2010; Marriott Convention Centre, Hyderabad with a theme 'Advanced Scientific Technologies & Industry Insight.' ● 2nd International Conference on Analytical & Bioanalytical Techniques, December 1617, 2011; San Francisco Airport Marriott, US with a theme 'Transforming the future with advances in Analytical & Bioanalytical techniques.'

Pharmaceutics and Novel Drug Delivery Systems ● International Conference on Pharmaceutics & Novel Drug Delivery Systems, June 6-8, 2011; Las Vegas, US with a theme 'Advancements in Pharmaceutics & Novel Drug Delivery Systems.' ● 2nd International Conference on Pharmaceutics & Novel Drug Delivery Systems, February 20-22, 2012; San Francisco, US with a theme 'Cutting edge technologies in Pharmaceutics & Strategies of Drug Delivery.'

Pharmaceutical Regulatory Affairs ● International Conference and Exhibition on Pharmaceutical Regulatory Affairs, September 6-7, 2011; Baltimore, US with a theme 'Advancements in Pharmaceutical

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Regulatory Affairs.'

Biosimilars ● International Conference and Exhibition on Biowaivers and Biosimilars, September 1012, 2012; San Antonio, US with a theme 'A Synergistic Approach towards Biowaivers & Biosimilars.'

Pharmacovigilence ● International Conference and Exhibition on Pharmacovigilence and Clinical Trials, October 13, 2012; Chicago, US with a theme 'Safer Drugs and Good Clinical Practice.'

What are the criteria set by you to select speakers for the pharma conferences?

Criteria of speaker selection are important to convey the quality level and spectrum of learning the attendees expect.

OMICS Group Conferences build a platform for the interaction between the pharma industry experts/professionals, academic delegates (professors/scientists from research organisation or universities), and students; and collaborations between the academia and industry and also between the industries/ companies. Therefore, it’s important to look at both the type of speaker, their reputation when speaking at our conferences and their current personal standing in the field.

But OMICS Group majorly concentrates on industry speakers (especially from regulatory agencies like US FDA, CDSCO, etc) which help to drive more academicians’s, graduates, delegates from other industries.

Does pharma industry/ industry experts play any role in deciding the theme

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for your pharma conferences? If yes, how?

Yes. OMICS Group Conferences, especially for pharma conferences have strong Organising Committee Members (OCM) from both academia and industry. And before taking every step for our conferences, approval is needed from the OCM. According to you, what are the current challenges for the Indian pharma industry?

Also, what are the common/shared challenges for the Indian and global pharma industry?

Current challenges for the Indian pharma industry are that domestic formulations market growth is slowing down.

Also due to cheap imports, domestic bulk drugs industry is facing intense competition.

Competitive rivalry of prices between regional and local pharma companies is also driving down prices, exerting pressure on margins.

MNC pharma companies are getting more aggressive at protecting their patents and defending their market share after patent expiry.

The global pharma industry, especially the Indian pharma industry, today is facing two major challenges, to develop and utilise scientific knowledge to derive new drugs and to do it at an affordable cost.

What are the future plans of OMICS for the Indian pharma industry?

Research in science is important, as it leads to ‘progress’ in education, which further leads to ‘progress in science’ and ultimately accelerating scientific discoveries and technological innovations.

Scientists, researchers, acade-

micians, innovators, industry professionals, scholars and students are constantly in need of information that will benefit their research. OMICS Group Conferences and OMICS Publishing Group provide an open-arena where cutting-edge research ideas and latest happenings in the fields of medicine and science especially pharma sciences are exhibited, which in turn foster new research directions and approaches.

OMICS Group would like to create a platform for Indian pharma industry having vast availability of talented and skilled scientific manpower; to make scientific and business collaborations with all the pharma industries /companies globally with an aim and vision of making INDIA as top player in global pharma industry.

OMICS Group is playing an important role in making healthcare and scientific information open access by running 250 open access journals with the support from 20,000 well qualified scientists as editorial board members. Out of 250 journals, around 25 journals comes under pharma sciences, these are monitored by around 1,500 well qualified scientists as an editorial team. Quality peer reviewed articles published in these journals will be useful to the Indian pharma academics, as well as industry as these are freely available on the web.

A renaissance of scientific discoveries and technological innovations has begun, and OMICS Group is proud to be the one accelerating it. sachin.jagdale@expressindia.com

November 16-30, 2012

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COMPANY WATCH Pharmexcil expects Ministry notification on branding for drug exports within a week Notification to clarify status and expected to bring relief to pharma exporters

Usha Sharma Mumbai n a follow up to the recent directive by the Ministry of Health and Family Welfare specifying that Drug Controllers are mandated to issue licenses for manufacturing solely for generic names of drugs and not on brand names, Pharmexcil officials claim that Ministry officials have lent a sympathetic ear to their concerns.

The industry body in charge of facilitating pharma exports is expecting a notification from the Ministry

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which will clarify matters in their favour, no doubt giving relief to pharma exporters.

The official final notification from the Ministry is expected within a week. It is assumed that the Health Ministry will advise State Drug Controllers to take appropriate action on this issue.

Pharmexcil officials, senior officials from the Ministry of Health and Family Welfare and DCGI had a closed door meeting last Friday, November 2 wherein they concluded that not having the manufacturing license in the brand name will

have no adverse effect on pharma exports.

In an exclusively interaction with Express Pharma, Dr PV Appaji, Director General of Pharmexcil said, “We are very grateful to the Ministry of Health and Family Welfare for addressing the queries raised by us. We have raised our concerns to the Ministry that if brand names are not to be used exports will be adversely impacted. as many importing countries may require a brand name for each product and Indian pharma companies have already established

their presence in these overseas countries. The Indian Government was sympathetic with the point raised and agreed to consider the representation from Pharmexcil.

Now, Pharmexcil is expecting a clarification from the DGCI /Ministry of Health and Family Welfare.”

“We have not conveyed any message to the pharma companies on the brand name issue till now. As mentioned, we have requested the Government to provide a clarification on the said directive,” Appaji added. u.sharma@expressindia.com

Glenmark Generics announces settlement of Paragraph IV litigation with Janssen Pharmaceuticals Glenmark will launch a generic version of Ortho Tri-cyclen Lo tablets as early as December 31, 2015 lenmark Generics Inc, (GGI), the US subsidiary of Glenmark Generics Limited (GGL), announced the settlement of the litigation pending between Glenmark and Janssen Pharmaceuticals over patent

G

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actions concerning norgestimate and ethinyl estradiol tablets USP, 0.18/0.025 mg, 0.215/ 0.025 mg and 0.25/0.025 mg tablets, the generic version of Janssen’s Ortho Tri-cyclen Lo tablets.

Under the terms of

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the settlement agreements, Glenmark will be able to market and distribute its norgestimate and ethinyl estradiol tablets USP, 0.18/0.025 mg, 0.215/0.025 mg and 0.25/0.025 mg tablets under a royalty bearing license from Janssen on December 31, 2015, or earlier under certain circumstances.

Janssen currently markets

its product as Ortho Tri-cyclen Lo in the US, indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Total US sales, as reported by IMS Health, for the 12-month period ending June 2012 were approximately $397 million.

EP News Bureau

November 16-30, 2012

M|A|R|K|E|T

CDSCO drafts guidelines on recall and rapid alert system for drugs The guidelines are biologics and vaccines as well and the targets would be enforced in the next three to four months Usha Sharma Mumbai he Central Drugs Standard Control Organization (CDSCO) has released a draft version of guidelines on recall and rapid alert system for drugs including biologics and vaccines. It has called for suggestions or objections from the industry stakeholders to submit responses before November 7, 2012.

Dr GN Singh, Drug Controller General of India (DCGI) said, “Our mission and vision is to safeguard and enhance public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical device. To comply with this, we will address these aspects before enforcing into an act. We have published draft guidelines on October 22, 2012 and

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gestions or objections, if found to be in public interest will be forwarded to the Ministry of Health.”

“The review process will take 45 days and then will be sent to the Health Ministry and then to the Law Ministry.

Overall, we are expecting that it will take three to four months to become an act,” Singh added.

A rapid alert system is to transmit only those alerts whose urgency and seriousness cannot permit any delay in transmission. Assessment must be made of the seriousness of the defect, its potential for causing harm to the patient or (in case of veterinary product) harm to animals, consumers, operators and the environment.

In the Drugs & Cosmetics Act & Rules, there is a reference for product recalls, com-

THESE GUIDELINES ARE APPLICABLE TO ALL QUALITY DEFECTIVE PRODUCT REPORTS asked the stakeholders to revert back before November 7, 2012. Once we will get responses, we will review them accordingly. The sug-

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plaint and adverse reactions in Para 27 & 28 of Schedule M and also conditions of license for defective product recall in Rule 74 (j) and Rule 78 (i),

www.expresspharmaonline.com

but effective and uniform recall procedure, with time lines at every level of supply chain is required and at present auditing and accountability is not in place. This has been observed in instances where drugs declared as not of standard quality by Government analyst, incidents where serious adverse

VISIT US AT CPhI INDIA 2012, 21-23 NOVEMBER 2012, BOMBAY EXHIBITION CENTRE, MUMBAI STALL NO. G28 (HALL NO.1)

effects or death have been reported, in case of banned drugs under Section 26 A, defects where involuntarily the manufacturer withdraws drugs from the market etc.

These guidelines are applicable to all quality defective product reports and reported incidents of safety and efficacy received for all drugs including vaccines and biologics.

These guidelines are expected to be followed by licensees (manufacturers, importers, stockists, distributors, retailers) and the recall could be voluntary or statutory. The procedure may also

be used by drugs control authorities of central or state when urgent action is required to protect public or animal health.

These guidelines shall help in adopting stepwise procedures to be followed in recall strategy and also help in recall evaluation at every level and achieve compliance within the time frame. Based on the category of risks involved, a time line of within 24 hours up to a maximum of 72 hours for class I recall, for class II recall up to a maximum of 10 days and for class III recall up to a maximum of 30 days is allowed.

The time line for initiation of recall procedure would commence from the receipt of information as notified by the concerned State/Central Drugs Control Department under statutory recall or voluntary recall by the manufacturer on its own.

The recall has to be initiated immediately without any prejudice of the outcome of Section 25(3) and Section 25(4) of the Drugs & Cosmetics Act 1940 for adducing the evidence.

The time line for stopping sale/distribution of defective product under class I shall be ensured within 24 hours and the physical recall being completed within 72 hours. The class II and class III recalls shall be ensured upto 10 and upto 30 days respectively. u.sharma@expressindia.com

November 16-30, 2012

M|A|R|K|E|T

Novartis to construct biotechnology facility in Singapore with an investment of over $500 million Construction of new production facility to start in early 2013 and is expected to be fully operational by the end of 2016

ovartis announced the construction of a new state-of-the-art 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 with the pharmaceutical production site based in Tuas, Singapore. In the future, Singapore is expected to be a technological competence centre for both biotechnology and pharma manufacturing at Novartis.

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November 16-30, 2012

Joseph Jimenez, CEO, Novartis said, “This investment further strengthens our strategy to establish key strategic sites based on technological competencies.

Singapore will be strength-

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 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 ened through a new state-ofthe-art facility for biotechnology which is a growing segment of our business. We have chosen Singapore as a

www.expresspharmaonline.com

The investment decision underlines the long-term strategy of Novartis to establish a worldwide manufacturing network. The ground-

breaking 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. 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 pharmaceutical research pipeline with a trend for future growth.

EP News Bureau

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US FDA approves Synribo for chronic myelogenous leukemia Synribo blocks certain proteins that promote the development of cancerous cells he US Food and Drug Administration (US FDA) approved Synribo (omacetaxine mepesuccinate) to treat adults with chronic myelogenous leukemia (CML), a blood and bone marrow disease.

An estimated 5,430 people will be diagnosed with CML in 2012, according to the National Institutes of Health. Synribo is intended to be used in patients whose cancer progressed after treatment with at least two drugs from a class called tyrosine kinase inhibitors (TKIs), also used to treat CML. Synribo blocks certain

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administered twice daily for seven consecutive days over a 28-day cycle as long as patients continue to clinically benefit from therapy.

Richard Pazdur, Director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research, said, “Today’s approval provides a new treatment option for patients who are resistant to or cannot tolerate other FDA-approved drugs for chronic or accelerated phases of CML. Synribo is the second drug approved to treat CML in the past two months.”

On September 4, 2012, the FDA approved Bosulif (bosutinib) to treat patients with chronic, accelerated or blast phase Philadelphia

SYNRIBO ALSO RECEIVED ORPHAN-PRODUCT DESIGNATION BY THE FDA BECAUSE IT IS INTENDED TO TREAT A RARE DISEASE OR CONDITION proteins that promote the development of cancerous cells. It is injected just under the skin (subcutaneously) twice daily for 14 consecutive days over a 28-day cycle until white blood cell counts normalise (hematologic response). Synribo is then

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chromosome positive CML who are resistant to or who cannot tolerate other therapies.

Synribo is approved under the FDA’s accelerated approval programme, which allows the agency to approve a drug to treat a serious dis-

www.expresspharmaonline.com

ease based on clinical data showing that the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. This programme provides earlier patient access to promising new drugs while the company conducts additional clinical studies to confirm the drug’s TM

2

VISIT US AT CPhI INDIA 2012, 21-23 NOVEMBER 2012, BOMBAY EXHIBITION CENTRE, MUMBAI STALL NO. G28 (HALL NO.1)

clinical benefit and safe use.

Synribo also received orphan-product designation by the FDA because it is intended to treat a rare disease or condition.

The effectiveness of Synribo was evaluated using a combined cohort of patients whose cancer progressed after previous treatment with two or more TKIs. All participants were treated with Synribo.

The drug’s effectiveness in chronic phase CML was demonstrated by a reduction in the percentage of cells expressing the Philadelphia

chromosome genetic mutation found in most CML patients. Fourteen out of 76 patients (18.4 per cent) achieved a reduction in an average time of 3.5 months.

The median length of the reduction was 12.5 months.

In accelerated phase CML, Synribo’s effectiveness was determined by the number of patients who experienced a normalisation of white blood cell counts or had no evidence of leukemia (major hematologic response, or MaHR). Results showed five out of 35 patients (14.3 per cent) achieved MaHR in an average time of 2.3 months. The median duration of MaHR in these patients was 4.7 months.

The most common side effects reported during clinical studies include a low level of platelets in the blood (thrombocytopenia), low red blood cell count (anemia), a decrease in infection-fighting white blood cells (neutropenia) which may lead to infection and fever (febrile neutropenia), diarrhoea, nausea, weakness and fatigue, injection site reaction, and a decrease in the number of lymphocytes in the blood (lymphopenia).

Synribo is marketed by Frazer, Pa.-based Teva Pharmaceuticals. Bosulif is marketed by New York Citybased Pfizer.

EP News Bureau

November 16-30, 2012

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PRE EVENTS Symposium on evolution of gas chromatography in India - Past, Present and Future To be held on November 23-24, 2012 in Mumbai symposium on evolution of gas chromatography in India - Past, Present and Future will be held at BARC Training School Hostel at Anushakti Nagar, Trombay, Mumbai on November 23-24, 2012. The symposium will bring together all those connected with gas chromatography.

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IT WILL ALSO PROVIDE A PLATFORM TO RECOGNISE SCIENTISTS, COMPANIES AND THE PEOPLE WHO HAVE HELPED IN PLACING INDIA ON THE INTERNATIONAL MAP OF CHROMATOGRAPHY Experts will speak on various fields of GC application such as petrochemicals, natural gas, perfumeries, flavours, pharma, forensic, doping, synthetic chemistry, natural products, etc. It will provide a platform to recognise the scientists, companies and the people who have helped in placing India on the international map of chromatography.

The symposium will also provide a platform to recognise the scientists, companies and the people who have helped in placing India on the international map of chromatography. Individuals who have supported the GC industry in India by making available the accessories and columns that are essential to be used with GC instruments will also receive due recognition during this symposium.

EP News Bureau November 16-30, 2012

www.expresspharmaonline.com

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EVENT BRIEF Clinical trials in Southeast Asia (CTSE 2012) Date: November 23, 2012 Venue: Hotel Sahara Star, Mumbai

Date: November 23-24, 2012

Summary: The conference is the first exclusive Southeast Asia focused event in India and will offer delegates the chance to understand the intricacies in conducting trials in Malaysia, Thailand, Indonesia, Singapore and Philippines among other topics. The conference advisory board and the faculty are leading experts from the region, with hands-on experience in clinical trials in Southeast Asia. The agenda tackles the key strategic, regulatory and scientific issues impacting the industry today, as well as perspectives about the future. Practical information and case studies are some of the key points in this conference.

Venue: Hyderabad International Convention Centre

Contact details: Amita Shah Director SSI Events UK Ltd 145 -157 St John Street, London, EC1V 4PW Email: amita@ssievents.co.uk UK Phone: +44 7624095854 India Phone: +91 9769168972 Website: www.ssievents.co.uk

Symposium on Evolution of Gas Chromatography in India - Past, Present and Future Date: November 23-24, 2012 Venue: BARC Training School Hostel at Anushakti Nagar, Trombay, Mumbai Summary: The symposium will bring together all those connected with gas chromatography. Experts will speak on various fields of GC application such as petrochemicals, natural gas, perfumeries, flavours, pharma, forensic, doping, synthetic chemistry, natural products, etc. It will provide a platform to recognise the scientists, companies and the people who have helped in placing India on the international map of chromatography.

Contact details: Dr G Ramakrishnan Convener of the Symposium, Chromatographic Society of India C-1203 Synchronicity, Nahar Amrit Shakti Road, Chandivali, Mumbai - 400072.

Mobile: +91-98200 93260 E-mail: ramakrishnan.g@ chromsocindia.org Website: www.chromsocindia.org

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2nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

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Summary: OMICS is going to host the 2nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs.

The two-day conference will have a total of four sessions divided into 11 tracks and will witness a plethora of 60 speakers, 350 delegates and about 200 poster presenters from all over the world.

The conference will help out in gaining a new vision of current and emerging regulatory prospects and new ideas to build regulatory systems. It is going to gather many regulatory experts across the industry and academia to discuss the latest updates and pressing issues in the field of pharma regulatory affairs.

Vibrant Gujarat 2013 Summit Date: January 11-13, 2013 Venue: Mahatma Mandir, Gandhinagar, Gujarat Summary: The Vibrant Gujarat 2013 Summit is going to be transformational and revolutionary – both in its coverage and scale. It will provide a platform for various states of India and other countries to cooperate and explore attractive business opportunities. One of the focus sectors to be covered will be pharmaceuticals and biotechnology.

Contact details: Industrial Extension Bureau (A Govt of Gujarat Organisation) Phone : +91-79-2325 6009, +91-79-2325 0492 / 93

BioAsia 2013 Date: January 28-30, 2013 Venue: Hyderabad

Contact details: Hyderabad International Convention Centre Novotel & HICC Complex (Near Hi-tech City), PO Bag 1101 Cyberabad Post Office, Hyderabad-500 081, India Tel + 91-40-66824422 / 66134422, Fax + 91-40-66844422 Email: pharma2012@omicsonline.us; pharma2012@omicsgroup.co

64th Indian Pharmaceutical Congress (IPC) Date: December 7-9, 2012 Venue: SRM Institutions Campus, Chennai.

Summary: Association of Pharmaceutical Teachers of India will host the 64th Indian Pharmaceutical Congress.

Contact details: Prof BG Shivananda Secretary-APTI Association Of Pharmaceutical Teachers of India HQ: Al-Ameen College of Pharmacy Opp Lalbagh Main gate, Hosur Main Road, Bangalore – 560027 Email: aptienquiry@gmail.com

Summary: Biotechnology being an emerging industry, game-changing strategies and relevant application of the knowledge-intelligence resource pool, drive the process of growth. BioAsia seeks to enhance, enrich and encourage newer innovations, path-breaking discoveries and effective solutions in the industry by offering a vibrant global platform for convergence of the key stakeholders - Biotech & Biopharma companies, research institutions, investors, service providers, policy makers, regulators and analysts.

Contact details: BioAsia Secretariat 204, Imperial Apartments Greenlands Circle, Ameerpet Hyderabad 500016 Andhra Pradesh, India Tel: +91 40-6644 6477 +91 40-6644 6577 Website: info@bioasia.in

Bangalore INDIA BIO 2013 Date: February 6-8, 2013 Venue: Bangalore, India

Bangalore INDIA BIO has been promoting the Indian biotech industry to the outside world and is one of the biggest event on life sciences.

Bangalore INDIA BIO 2013 will be an opportunity to get insights about the latest trends and biotech business opportunities in India. It will also deliberate on issues related to the latest innovations in biotechnology and focus on business opportunities that exist for companies in biopharmaceuticals, bio-industrial, bioservices, bio-informatics and agribiotechnology in the light of the emerging bio economy.

It will also discuss about collaborative and integrative business models as well as policy, regulation, and investment challenges for biotechnology in a global bio-economy and will provide networking and knowledge sharing platform for business leaders, policy makers, research heads and academia.

Contact details: MM Activ #9, UNI Building, 1st Floor, Thimmaiah Road, Millers Tank Bed, Vasanthnagar, Bangalore - 560 052 Tel: +91 80 4113 1912 / 13 Fax: +91 80 4113 1914 Website: enquiry@bangaloreindiabio.in

PHARMA Pro&Pack 2013 Date: April 24—26, 2013 Venue: Mumbai Exhibition Centre, Goregaon Summary: PPPE 2013 is an initiative of the Indian Pharma Machinery Manufacturers’ Association (IPMMA), jointly with GPE Expo. The event will offer a single platform for more than 200 exhibiting companies from India and across the world to showcase their products.

Contact details: Paresh Jhurmurwala GPE EXPO Global, Opp. Priyadarshini Tower, Near Judges’ Bungalows, Bodakdev, Ahmedabad 380015, Gujarat Tel: +91 79-2687 1390 +91 79-4000 8253 +91 79-4000 8233 Email: contact@pharmapropack. com

Summary: Bangalore INDIA BIO is an annual event organised by Department of Science & Technology Government of Karnataka, under the guidance of Vision Group of Biotechnology. Since 2001,

www.expresspharmaonline.com

November 16-30, 2012

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8th Nutra India Summit 2013: The meeting place for who’s who of nutra industry Event to be held in Mumbai from March 13-16, 2013

November 16-30, 2012

ndia’s biggest nutraceutical, functional foods, dietary supplements and ingredients show, 8th Nutra India Summit, will be held in Mumbai from March 13-16, 2013. The focal theme is ‘Health & Wellness through Nutraceuticals, Nutritionals and Naturals.’ Nutra India Summit will be chaired by Dr V Prakash, FRSC and organised by Council of Scientific and Industrial Research (CSIR), International Society for Nutraceuticals, Nutritionals and Naturals (ISNNaN) along with MM Activ Sci-tech Communications and supported by leading industry associations like Pharmexcil, HADSA, ABLE and ADMA. The international conference at 8th Nutra India Summit 2013 will focus on

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today’s trends and tomorrow’s opportunities. Impact speakers from across the globe will discuss successful marketing strategies, the process of the regulatory mechanism, new ingredients and technologies, new product development and will also look into public awareness and consumer trends. Over 600 delegates are

NUFFOODS,THE HEALTH & FOOD EXPO WILL BE AN APPROPRIATE B2B AND B2C PLATFORM FOR THIS SECTOR

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expected to attend this conference which will be addressed by more than 70 national and international experts.

Participants will get an overview on technology trends, market perspectives and opportunities during the conference. They can interact face to face with the policy makers and industry captains.

NuFFooDS, the Health & Food Expo will be an appropriate B2B and B2C platform for this sector. It will offer great opportunities for brand leaders, as well as small and medium scale enterprises to meet their corporate and business objectives. This expo will be the ideal platform to showcase products, technologies, ingredients and do new product launches to the participating delegates.

Over 5,000 business visi-

tors will visit the NuFFooDS Expo. Exporters, importers, sourcing companies, production and purchase professionals, doctors, nutritionists and R&D heads will attend the event.

The CEO Summit is a special industry networking dinner for delegates and invitees, which will represent the Who’s Who of the nutraceutical, functional food and dietary supplement industry meet. It is a truly unique event with a goal of providing a platform for discussion about global business trends and issues. Annually, the CEO Summit looks at the current business environment from four vantage points – industry growth, strategy, right resources and balanced and strong finance.

EP News Bureau

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Bangalore INDIA BIO 2013 to provide latest trends in biotech business opportunities Event to be held in Bangalore from February 6-8, 2013

angalore INDIA BIO, an annual event organised by Department of Science & Technology (DST) Government of Karnataka, under the guidance of Vision Group of Biotechnology, will give an insight about the latest trends and biotech business opportunities in India. Since 2001, Bangalore INDIA BIO has been instrumental in promoting the inherent strengths of the Indian biotech industry to the outside world and is now acknowledged as the biggest and India’s national event on life sciences.

Bangalore INDIA Bio 2013, to be held from February 6-8, will have multi-track conference,

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international trade show, biopartnering India, vision leadership series, CEO conclave, poster walkway of discovery, Bio Excellence awards, bioquiz and workshops. Bangalore INDIA BIO 2013 will deliberate on issues related to the latest innovations in biotechnology and focus on business opportunities that exist for companies in biopharmaceuticals, bio-industrial, bioservices, bio- informatics and agri-biotechnology in the light of the emerging bio economy. Exhibitors, conference delegates and 5,000 business visitors from across India and abroad will take part in the event.

Discussions will be held on issues such as collabora-

tive and integrative business models as well as policy, regulation, and investment challenges for biotechnology in a global bio economy and will provide networking and TM

VISIT US AT CPhI INDIA 2012, 21-23 NOVEMBER 2012, BOMBAY EXHIBITION CENTRE, MUMBAI STALL NO. G28 (HALL NO.1)

info@idealcures.co.in I www.idealcures.co.in

knowledge sharing platform for business leaders, policy

makers, research heads and academia.

International conference will focus on areas such as Deal Making Trends— Partnerships that take Innovation to Realisation; India and the Shifting Global Regulatory Environment; Potential demand for Biosimilars—Pioneering the Future; Strengthening the Clinical Research Ecosystem; Bioinformatics and Computational Biology; Medical Biotechnology and Biomedical Devices and Equipment; Vaccines and Health Trends; Cell Science and Stem Cell Therapy; Diagnostics and Targeted Therapeutics and Protection of Intellectual Property.

EP News Bureau

BioAsia 2013 to optimise immense business potential in biotechnology To be held at biotech hub of India, Hyderabad from January 28-30, 2013

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ioAsia 2013 will be held at Genome Valley, Hyderabad from January 28 to 30, 2013. The event will seek to enhance, enrich and encourage newer innovations, path-breaking discoveries and effective solutions in the industry by offering a vibrant global platform for convergence of the key stakeholders - Biotech &

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Biopharma Companies, research institutions, investors, service providers, policy makers, regulators and analysts.

With an objective of optimising the immense business potential of biotech, BioAsia enables an effective environment for fostering collaborations, joint ventures, M&As that

www.expresspharmaonline.com

has increasingly become an integral part of industry growth agenda. BioAsia 2013 will provide a dynamic platform for companies to exhibit, launch and showcase their unique strengths, products and services. As an entity committed to the promise of biotechnology, BioAsia encourages knowledge and experience sharing

among industry players, academia, young research scientists to promote innovations and initiatives through appropriate awards and recognitions.

BioAsia is committed to play a key role in advocating issues to the policy makers and in chartering the roadmap ahead.

EP News Bureau

November 16-30, 2012

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CII to organise Life Science Conclave 2012 C onfederation of Indian Industry (CII) is organising the fifth edition of its annual flagship event ‘Life Science Conclave 2012’ on December 11-12, 2012 at New Delhi. The theme of the conclave is ‘Promoting Business Innovation to Drive Growth in Life Sciences.’

The conclave will have deliberations among the life science industry leaders, who would share their experiences and ideas to mitigate with the current market trends and challenges such as drying pipelines in R&D, ineffective business models to survive in the tough market conditions.

Further, growing need for increasing access and affordability of healthcare is adding a new challenge to the life science industry. We feel the deliberations at the conclave will provide adequate inputs to evolve recommendations to put the industry on the growth path.

Contact details: Ravikiran Veligeti, Executive Officer, CII

3rd Floor, IGSSS Building 28, Institutional Area, Lodi

Road, New Delhi-110003, India, Tel: 91-11-45772007

Fax: 91-11-45772014 Email: ravikiran.v@cii.in EP News Bureau

Special features: ● Participation of life sciences industry leaders, policy makers and regulators. ● Life science policy forum – To draw recommendations for the life sciences sector to put the industry on growth track. ● Presentations by the representatives progressive state governments promoting life science industry, to provide information on the infrastructure and the fiscal incentives offered by state governments ● Networking opportunity with the industry, academia and research institutes. ● Life Sciences ExpoOpportunity to showcase products and services by life sciences companies to explore business opportunities.

Date and Venue Start Date: 11-12 December 2012 Venue: Stein Auditorium, India Habitat Center, New Delhi.

November 16-30, 2012

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

Pharma M&A focuses on increasing product pipelines in Oct 2012 Decreased both in volume and value terms M&A (including private equity) trend analysis &A activity in the pharma sector in October 2012 was focused on increasing product offerings, as the companies were looking to expand their existing businesses.

In line with the above trend, Pfizer agreed to acquire NextWave Pharmaceuticals, a US-based speciality pharmaceutical company, for approximately $680 million. This acquisition would enable Pfizer to focus on the expansion of established US brand’s business.

With this transaction, Pfizer will gain access to NextWave’s Quillivant XR, the first once-daily liquid medication approved in the US for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

In another key deal, Japan-based Takeda Pharmaceutical agreed to acquire LigoCyte Pharmaceuticals, a US-based clinical-stage biopharma company for $60 million. This transaction would help Takeda expand its vaccine business. With this acquisition, Takeda will gain access to LigoCyte’s norovirus vaccine, along with a virus-like particle technology, besides, vaccines against respiratory syncytial virus, influenza and rotavirus, for which preclinical development has already been initiated.

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

According to Datamonitor's Medtrack database, the pharma sector recorded 36 M&A transactions in October 2012, against the previous six months’ average of 37 transactions. In value terms, the sector recorded deals worth $3.4 billion against the previous six months’ average of $10.3 billion.

The Indian pharma sector witnessed only one deal during October 2012, against the average of 0.8 deals over the previous six months in which Mauritius-based Citigroup Global Markets acquired 4.5 per cent stake in PI Industries, a manufacturer of chemicals.

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Source:

Top M&A deals (Oct 2012) Rank Date

Target

Acquirer

Deal value ($m)

1

Oct 30, 2012 Schiff Nutrition International Inc (US)

Bayer HealthCare, LLC (US)

1,200.00

2

Oct 22, 2012 NextWave Pharmaceuticals, Inc. (US)

Pfizer, Inc. (US)

680.00

3

Oct 15, 2012 Amdipharm plc (GB)

Cinven Limited (GB)

590.01

4

Oct 29, 2012 Banner Pharmacaps, Inc. (US)

Patheon, Inc. (CA)

255.00

5

Oct 30, 2012 Ceva Sante Animale (FR)

AXA Private Equity (FR)

129.14

6

Oct 4, 2012

Hospira Australia Pty., Ltd. (AU)

120.00

7

Oct 18, 2012 Presidio Pharmaceuticals, Inc. (US)

BioCryst Pharmaceuticals, Inc. (US)

101.00

8

Oct 4, 2012

LigoCyte Pharmaceuticals, Inc. (US)

Takeda Pharmaceutical Company Limited (JP)

60.00

8

Oct 8, 2012

Optimer Biotechnology, Inc. (TW)

Optimer Biotechnology, Inc. - Shareholders

60.00

10

Oct 22, 2012 moksha8 Pharmaceuticals, Inc. (BR)

Undisclosed Acquirer

47.00

11

Oct 8, 2012

NRM VII Holdings I, LLC ; Undisclosed Investors

45.00

Metrics, Inc. (US)

Fibrocell Science, Inc. (US)

Source

Venture financing trend analysis

Venture funding Companies in the pharma sector raised $252 million during October 2012, against the previous six months’ average of $282.8 million. In terms of volume, the sector recorded 23 venture funded deals, compared to the previous six months’ average of 22.1 transactions.

Notes and Definitions

Source:

Top venture financing deals (Oct 2012) Rank

Date

Target

Investors

Deal value ($m)

1

Oct 23, 2012

ZS Pharma, Inc. (US)

Alta Partners; RiverVest Venture Partners ; Salem Partners; Devon Park Bioventures; 3x5 Special Opportunity Partners

46.00

2

Oct 25, 2012

Thrasos Therapeutics, Inc. (CA) SR One; SW Co; Advanced Technology Ventures; Fonds de solidarite FTQ; Lumira Capital Corp; MP Healthcare Venture Management, Inc.; Pappas Ventures

35.00

3

Oct 24, 2012

Mirna Therapeutics, Inc. (US)

Sofinnova Ventures, Inc.; New Enterprise Associates, Inc.; Pfizer Venture Investments; Osage University Partners; Correlation Ventures; Undisclosed Investors

34.50

4

Oct 10, 2012

Genocea Biosciences (US)

Bill & Melinda Gates Foundation; CVF LLC; Polaris Venture Partners; Lux Capital Management; SR One; Johnson & Johnson Development Corporation; Skyline Ventures; Cycad Group, LLC; Auriga Partners; MP Healthcare Venture Management, Inc.; Morningside Ventures

30.00

Aeris Capital AG; BioMedInvest AG; Life Sciences Partners; Novo Nordisk A/S; OrbiMed Advisors, LLC

0.01

5

Oct 8, 2012

Affimed Therapeutics AG (DE)

Medtrack is a comprehensive, fully integrated, global biomedical database providing information on companies, products, patents, deals, venture financing, and epidemiology. It is a live database, constantly updated with news, milestones, trial information, etc.

Medtrack’s unmatched coverage is supported by a userfriendly, highly dynamic set of decision support tools and analytics. In-house analysts and researchers add key insights and conclusions to provide you with the primary and secondary information you need. Key uses of the database include competitive intelligence, target identification, screen potential licensing and investment opportunities, patent assessments, product due diligence, royalty valuations, and developmental benchmarking.

For more information, visit us at www.medtrack.com

Definitions 1. Deal value trend is based on transactions where associate values have been disclosed.

2. Trend analysis excludes rumored and terminated deals.

3. Value and volume analysis excludes private equity exits.

Source:

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www.expresspharmaonline.com

November 16-30, 2012

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PHARMA Pro&Pack Expo 2013 to co-locate Pharmexcil international exhibition iPHEX 2013 DIA to be conference partner PHARMA Pro&Pack Expo 2013

November 16-30, 2012

iPHEX 2013 – an international exhibition on API, bulk actives, additives, exipients, and entire spectrum of the pharmaceutical chemicals will be co-located with PHARMA Pro&Pack 2013.

The event will be organised by Pharmexcil (Pharmaceutical Export Promotion Council of India, Govt. of India) and will be held at the Mumbai Exhibition Centre, Mumbai, India from April 24 to 26, 2013.

The twin international shows at one venue and on same dates will be the highly resourceful for the trade professionals from India and international. iPHEX 2013 will be one of the largest showcases of Indian pharma products and technologies to a global audience. Over 400 overseas buyers from focus areas are being

invited to participate in the exhibition. iPHEX 2013 will offer the industry majors from India and all across the world a great platform to connect and do business. iPHEX 2013 will be the biggest industry event showcasing the diverse range of products in the core sectors of formulations, APIs, AYUSH, nutraceuticals, health services, biotechnology and biotechnology products, R&D services, technologies and consultancy, government/state pavilion, diagnostics/surgical dressings /medical devices, contract manufacturing/research/clinical trials CROs)/custom synthesis.

Among the target visitors will be large volume buyers seeking manufacturers, government procurement agencies, hospitals and health service providers, drug regula-

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tors and FDA officials, private sector hospitals, clinics, daycare centres and institutes, agents/ distributors/dealers, financial institution banks, private equity and venture capital funds, institutional agencies and development aid agencies.

The exhibition having a special focus on promoting ‘Brand India Pharma’ to both the Indian and world pharma industry is being jointly organised by the Indian Pharma Machinery Manufacturers’ Association (IPMMA) and GPE Expo.

Drug Information Association (DIA), will be the conference partner of PHARMA Pro&Pack Expo 2013 (PPPE 2013). DIA will be organising a series of must attend technical seminars alongside the exhibition focusing various aspects on the

pharma formulation manufacturing process and technologies. The seminars will have industry experts from India and abroad as the keynote speakers. DIA in India over the last four years has provided quality programmes, publications, and knowledge resources to regulatory agencies, academia, industry professionals, and patient advocates across the country and Asian continent.

“With the combination of PHARMA Pro&Pack Expo 2013 and iPHEX 2013 exhibitions and highly informative conference organised by the world’s recognised information provider - DIA, the overall event is for everyone whosoever concerned for the pharma formulation manufacturing,” said Rajesh Shah, President – IPMMA. EP News Bureau

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POST EVENT Aerosol Promotion Council organises 'APC Conference and Exhibition-2012' A Exhibition and technical conference were part of the event

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erosol Promotion Council (APC) of India recently organised 'APC Conference and Exhibition – 2012' in Mumbai. The event received overwhelming response from all facets of the aerosol business fraternity of India and abroad. There were two major events: an exhibition and a technical conference.

The International Liason Committee (ILC), a body of heads of aerosol associations from all across the world, that makes global decisions on various aspects of aerosols, held their closed door meeting on the first day.

The conference was very aptly amalgamated with the most current and interesting topics, very important for the booming aerosol industry in India. The highlight of this conference was presence of speakers with a good track record in the field of aerosols from Indian and overseas industries. The conference was inaugurated

by Bhaskar Pandit, the Chairman of the Organising Committee whereas all the speakers, participants and member of APC were welcomed by Bhogilal Patel, President, APC, India.

The exhibition was successful in its objective which attracted visitors on both the days, mainly due to its composition of exhibitors which included all the necessary elements of aerosol industry such as manufacturers of primary and secondary components (aerosol containers, caps and valves), propellants, excipients, perfumes, finished goods and the marketers.

The opportunity to exhibit the products, services and overall business capabilities was utilised to its fullest by many manufacturers from India and overseas.

The visitors also had an opportunity to be familiar with latest innovations and developments in aerosol producing machines and manufacturing facilities situated nationwide and inter-

nationally. Thus the conference encompassed all the aspects of aerosol industry and offered an excellent opportunity to the participants to get rendezvous with success stories of aerosol industry and rich experiences of speakers, knowledge sharing and knowhow for their future needs of successful aerosol business in all the perspectives.

On the pharma front, during the interaction with ILC members, it was observed that the applications of aerosol technologies to pharma is a niche market, built on the main advantage that a hermitically sealed package maintained product integrity and thus prevented contamination. It could be easily appplied to reach areas and with exactly controlled dosages.

The major sectors of the www.expresspharmaonline.com

pharma industry where aerosols are used are the Metered Dose Inhalers (MDI), followed by medical sprays for topical application to veterinary sprays.

While the demand was constantly increasing, it was estimated that the pharma aerosol sector forms about 8-10 per cent of the aerosol industry.

The conference encom-

passed all the aspects of aerosol industry and offered an excellent opportunity to the participants to rendezvous with success stories of aerosol industry and rich experiences of speakers, knowledge sharing and knowhow for their future needs of successful aerosol business in all the perspectives.

EP News Bureau November 16-30, 2012

MANAGEMENT

W H AT ’ S INSIDE

THE BUSINESS OF PHARMACEUTICALS Singapore – A globalAsia pharmaceutical hub PG 47 Discover the hidden OTC Gems of the Indian pharma market PG 49 Leveraging social media for success PG 52 Patents - why and when?

PG 53

November 16-30, 2012

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In mid-October, the Union health ministry's directive to states to cease issuing licences for the manufacture or sale of drugs on the basis of their brand name stirred up a hornet's nest. The ministry was only re-stating the law under the Drugs & Cosmetics Act, but industry representatives, already reeling under the government's initiatives in the past few months to promote generics and control prices of medicines, saw red.

In hind sight it all seems like a “storm in the tea cup”, as Ranjit Shahani, Country President, Novartis India puts it.

Shahani, also President of the Organisation of Pharmaceutical Producers of India, (OPPI) mentions that they got a clarification from the Government that manufacturing licenses will be given in the generic name to the manufacturers but companies can market those products with brand names. “It is clear that GX GX prescription is just not practical for India for a variety of reasons oft repeated,” he avers.

It is clear that in a fragmented Indian pharmaceutical industry, with over 64,000 formulations across therapeutic segments, where about six to 200 brands per molecule compete for the attention of doctors, brands are all important.

Debatable issue But some experts feel that the hue and cry was unwarranted.

order when read with provisions of Drugs and Cosmetics Act 1940.

In fact there was no need for such a direction since the ‘Act’ itself is amply clear that licence of a formulation cannot be given under any brand or trade name as the subject is concerned with the Trade and Merchandise Act. Therefore, it was incorrect on the part of state licensing authorities (SLAs) to issue licences of formulations under trade or brand name till now.”

JAGMOHAN RAI AGARWAL Ex President, Indian Pharmaceutical Association, Indore

It is note worthy that the direction issued u/s 33P of the ‘Act’ has not been addressed to Central Licensing and Approving Authority which is the licensing authority for certain categories of drugs

As per the notice issued by the Ministry of Health and Family Welfare, the States and Union Territories have been informed to stop issuing licenses for the manufacture and sale of drugs on the

turer is also endorsed by the licensing authority along with proper name of the product thereby giving legitimacy to market the drug under the brand or the trade name.

Under the provisions of the Drugs and Cosmetic Rules 1945, applications in various forms for grant/renewal of a license to manufacture for sale or distribution of various categories of drugs, as well as various forms for grant/renewal of such license

DAARA PATEL

NR MUNJAL

Secretary General, Indian Drug Manufacturers' Association (IDMA)

Chairman - Pharmexcil, VC and Managing Director- Ind-Swift Laboratories

It is a myth that generic drugs are cheaper than branded drugs, as the generic drugs procured through tenders cannot be compared to prices prevalent in the open market

Drug regulators have a responsibility and duty to safe guard the quality of the drugs placed in the market. When they are not aware whether the specific brand name is issued to a company or not, how can they control the movement of spurious drugs, if any

require the name of the drug to be specified. Such forms for application as well as grant/renewal of the licenses do not require mentioning of any trade name /brand name. In view

tion the name of active ingredients as well as its strength.

AS PER THE NOTICE ISSUED BY THE MINISTRY OF HEALTH AND FAMILY WELFARE,THE STATES AND UNION TERRITORIES HAVE BEEN INFORMED TO STOP ISSUING LICENSES FOR THE MANUFACTURE AND SALE OF DRUGS ON THE BASIS OF COMPANIES BRAND NAME Jagmohan Rai Agarwal, Ex President, Indian Pharmaceutical Association, Indore says, “I feel that the direction is perfectly in

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basis of companies’ brand name.

It mentioned that it has been observed that at the time of the grant of the license, the manufac-

tion.

Therefore, manufacturing licenses for the drug formulation should be granted in proper/generic name only. In case of drug formulation containing multiple ingredients the licence should be granted under the name of categories of product viz, multivitamin tablet/capsule/syrup, antioxidants and multi-minerals tablets/capsules/ syrup etc. However, the composition of such product shall men-

to these, the grant of drugs manufacturing licenses under a trade or brand name is not in accordance to the spirit of the legisla-

www.expresspharmaonline.com

Raising the voice Commenting on the above notice, Daara Patel, Secretary General, Indian Drug Manufacturers Association (IDMA) opines, “The directions issued by the Central Government are not in accordance with the object of the Drugs and Cosmetics Act, 1940 which is to ensure the availability of safe, standard and efficacious medicines. The Act has nothing to do with brand names.

Also, the directions are contrary to the provisions of Trade Mark Act and therefore such directions cannot be issued taking recourse November 16-30, 2012

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to the provisions of Section 33(P). Section 28 of the Indian Trade Mark Act, 1999, which is a valid law and in force, gives exclusive right to the registered proprietor of the trade mark to the use of the trade mark in relation to the goods or services in respect of which the trade mark is registered.”

NR Munjal, Chairman Pharmexcil, VC and Managing Director- Ind-Swift Laboratories expresses his views and says, “This is a hasty decision by the Ministry of Health and Family Welfare without consulting with the stakeholders like Bulk Drug Manufacturers Association (India) (BDMA), Indian Drug Manufacturers' Association (IDMA), Organisation of Pharmaceutical Producers of India (OPPI), Pharmexcil etc.

This has created a lot of confusion in the industry and in regulatory net work.”

However, Jayant Singh,

November 16-30, 2012

“

WE FIRMLY BELIEVE THAT THIS MOVE WILL EXTREMELY HIT THE EXPORT BUSINESS. HOW CAN THE CENTRE ISSUE SUCH NOTIFICATION WITHOUT CONSULTING THE INDUSTRY STAKEHOLDERS BEFORE ACTING ON IT?

Associate Director, Medical Technology, Healthcare Practice, Frost & Sullivan, South Asia and Middle East feels, “This is one of the long awaited moves in the right direction to make medicines more affordable and thus

www.expresspharmaonline.com

CHIRAG DOSHI CHAIRMAN IDMA-GSB increase accessibility. It is also going to help the Government in fulfilling its objective of free medicine to general public. A cursory glance at any of the branded generics medicines will show a wide differential in pricing

which is minimum to the tune of three to four times of pure generics. Assuming the input costs, quality norms to be similar for all manufacturing companies, no rationale can be attributed to the wide disparity in prices of branded generics and pure generics.

Branded generics were creating a distortion in the market by not allowing a level playing field to all players and also an asymmetry in terms of limiting the patients’ choice as retailers/pharmacists seldom stock and sell pure generic drugs due to the low price and low margins.”

Dr RB Smarta, Managing Director, Interlink also agrees and mentions, ”Certainly, this move will promote affordable medicine with easy accessibility as it pushes for end to sale of branded drugs.”

Hit to exports?

The Government is trying to benefit patients by making

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medicines affordable in the market by issuing these notifications. However, industry experts are concerned that it may be a big huge set back for pharma exports.

Munjal raises his points, “Pharma manufacturing is a complex process and every company has to develop their formulation, standardise the same and establish in the market. Each and every drug of individual company has its own identity. To establish the company's image in the market is a big task in pharma field. Brand names are necessary to identify the product by the company. It is the long practice in the country to get the permission of drugs with brand names. Brands are the only assets of the industry and by removing brands we are putting the assets of lakhs of crores on stake.”

Chirag Doshi, Chairman, IDMA-GSB shares his insights and says, “Jointly IDMA, Confederation of Indian Pharmaceutical Industry (CIPI), OPPI, Federation of Pharma Entrepreneurs (FOPE) and Gujarat Small Drug Manufacturing Association have sent a letter to the Ministry of Health and Family Welfare on the notification asking for clarification. We firmly believe that this move will extremely hit the export business. How can the Centre issue such notification without consulting the industry stakeholders before acting on it?”

“Exports of formulations will be seriously effected.

Most of the formulations are registered in foreign countries with brand names and the registering authorities in the foreign countries always ask for the permission of the product from the local licensing authorities with full par-

JAYANT SINGH

DR RB SMARTA

RANJIT SHAHANI

Associate Director, Medical Technology, Healthcare Practice, Frost & Sullivan, South Asia & Middle East

Managing Director, Interlink

Country President, Novartis India

This is one of the long awaited moves in the right direction to make medicines more affordable and thus increase accessibility. It is also going to help the Government in fulfilling its objective of free medicine to general public

Certainly, this move is promoting affordable medicine with easy accessibility and it is pushing for end to sale of branded drugs

We have clarification from the Government that manufacturing licenses will be given in the generic name to manufacturers but companies can market those products with brand names

of crores on re-registrations and in some cases the buyers may not be interested to buy generics. This is definitely going to give exports a major setback,“ stresses Munjal.

shall be shown immediately after or under the proper name.

Rule 103 of ‘Rules’ requires in case of patent or proprietary medicine the name and address of the manufacturer and true formula or list of ingredients shall be printed or written in indelible ink on the container label. “Drug regulators have a responsibility and duty to safeguard the quality of the drugs placed in the market.

When they are not aware whether the specific brand name is issued to a company

leading generics players. The Government's recent move on anti-branding of pharma drugs is portraying an altogether different stand.

Today, in the Indian market many pharma drugs has multiple version of the same drugs with wide price variation. Patel gives an example that Ciprofloxacin has over 180 brands and Atorvastatin has about 96 brands competing in the market.

Expanding on the point, he says, “We must also understand that it is a myth that generic drugs are cheaper than branded drugs, as the generic drugs procured through tenders cannot be compared to prices prevalent in the open market. The cost of a product after manufacture increases due to various factors such as trade margin to retailers, wholesalers, super stockists, excise duty, additional expenses on freight, insurance etc.

Whereas, in procuring through tenders in bulk volumes, mostly excess production capacities are utilised because prices quoted tend to be based on marginal costing covering only the costs

Regulatory crack down …

Rules’ 71 (6) and 76 (7) of Drugs and Cosmetics Rules 1945 require the applicant to furnish to the licensing authority evidence and data justifying that the patent or proprietary medicines applied for grant or renewal of licence for such category of drugs. Rule 96 (1) (i) (A),

GLOBALLY, INDIAN PHARMA COMPANIES ARE KNOWN AS LEADING GENERICS PLAYERS. BUT,THE GOVERNMENT'S RECENT MOVE ON ANTI-BRANDING OF PHARMA DRUGS IS PORTRAYING AN ALTOGETHER DIFFERENT STAND ticulars including brand name etc. Any changes in the registered product need to be informed and approval has to be taken once again after paying high registration charges. It will force the industry to spend hundreds

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substituted vide GSR 27(E) dated 17.01.1981, and mandates that as far as labelling is concerned, it requires printing of the proper name of the drug in a more conspicuous manner than the trade name, if any, which www.expresspharmaonline.com

or not, how can they control the movement of spurious drugs, if any,” feels Munjal.

… could spell loss of identity?

Globally, Indian pharma companies are known as

November 16-30, 2012

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Always with you www.getinge.com

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incurred on raw materials and packing materials.”

Singh of Frost & Sullivan predicts that, “This move will have an impact on all pharma companies operating in India, most significantly impacted will be the multinationals companies which made significant acquisitions in India, eyeing the lucrative branded generics market.

These companies might have to rethink their strategy for India, as this decision taken by the Government is expected to significantly lower the prices of the drugs thus impacting the profitability. To summarise, 'A good move for patients, but a slightly bitter pill for the pharma companies.'”

Need a balanced view The industry feels that only one side of the picture today is shown to the general public: that medicines are very expensive. Protesting this perception, Munjal emphasises, “We forget that we are the cheapest drug manufacturer in the world, we forget that these new

E|X|P|R|E|S|S

Pharma HEAD OFFICE MUMBAI Rajesh Bhatkal Business Publications Division, The Indian Express Limited., 1st Floor, Express Towers, Nariman Point, Mumbai-400021. India Tel: 67440503 / 02 Fax: 022-22885831 Mobile: 98213 13017 E-mail : rajesh.bhatkal@expressindia.com Branch Offices NEW DELHI Ambuj Kumar Business Publications Division, The Indian Express Limited, Basement, Express Building, 9 & 10 Bahadur Shah Zafar Marg, New Delhi, 110 002 Direct Line: 011-2346 5727 Board Line: 011-2370 2100-107 Ext-727 Mobile: 09999070900 E-mail: ambuj.kumar@expressindia.com CHENNAI Vijay Kulkarni The Indian Express Limited, Business Publications Division, New No.37/C (Old No.16/C) 2nd Floor, Whites Road, Royapettah, Chennai - 600 014 Tel: Board: 28543031/28543032/

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medicines in the last 20 years have saved many lives, normal life expectancy has gone up. These medicines are the biggest tool for the health community. We want cheap medicines available in the country but if the Government wants to take away the right of doing business in this country then what we are seeing now may not always be the case. One can go to another market, flourish, invest in R&D etc then there should be good margins to the operators.

Now, who will decide about the definition of good margins? There we need a balance. This can be created by good governance.

The industry and the Government have to talk one-to-one, instead of only one-sided working.”

Munjal says, “No MNC would launch or introduce the new research products in our country if they cannot create their brand value.

Now with product patent, we will not be able to control the price of the new patented molecules and

28543033/28543034 Fax: 28543035 Cell: 09940047667 E-mail:vijay.kulkarni@expressindia.com BANGALORE Khaja Ali Business Publications Division, The Indian Express Ltd. 5th Floor, Devatha Plaza 131, Residency RoadBangalore - 560 025, INDIA Tel: 22231923/24/41/60 Fax: 22231925 Cell: 09741100008 E-mail: khaja.ali@expressindia.com HYDERABAD E. Mujahid The Indian Express Ltd. Business Publications Division, 6-3-885/7/B, Ground floor, V.V. Mansion, Somaji Guda, Hyderabad - 500082 Tel: 040 - 23418673/ 23418674/ 66631457 Telefax: 040 - 23418675 Mob: 09849039936 Email: e.mujahid@expressindia.com

prices will go very high.

Only if Indian manufacturers exist and flourish can they keep a tab on the activities as in the past efforts by many Indian companies resulted in lot of products being sold at very less MRPs and prices coming down subsequently.”

Clearing the confusion Rai Agarwal raises his point that it is note worthy that the direction issued u/s 33P of the ‘Act’ has not been addressed to Central Licensing and Approving Authority which is licensing authority for certain categories of drugs. Media reports seem to suggest that manufacturers as individuals and their Associations are confused and have misconstrued the said direction.

The direction no where seems to have intended to convey elimination of trade or brand name. It simply says licence of a formulation should be issued under only generic name and not with any brand name. After

Board No. +91-33-2213 8587, 2231 8879 / 80 Fax: +91-33-22138582 Cell: 09830130965 / 09831182580 Email: prasenjit.basu@expressindia.com ajanta.sengupta@expressindia.com KOCHI Dr Raghu Pillai Business Publications Division, The Indian Express Limited, Sankoorikal Building, 36/2248, Kaloor,Kadavanthara Road, Opp. Kaloor Private Bus Stand, Kaloor - 682 017 Tel: (0484) 2343152, 2343328 Fax: 2343153 E-mail: Kochi.bpd@expressindia.com raghu.pillai@expressindia.com COIMBATORE The Indian Express Limited, Business Publications Division, 1st Floor, 731, Avinashi Road, Opp. PRS Grounds, Coimbatore-641 018 Tel: 2212157/2216718/2216732

KOLKATA Prasenjit Basu / Ajanta Sengupta The Indian Express Limited Business Publications Division 5, Pannalal Banerjee Lane (Fancy Lane), 2nd Floor, Kolkata - 700 001 Tel No. (Direct) +91-33-2213 8567 / 8573

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obtaining the licence in generic name the manufacturer is free to assign trade or brand name to the formulation subject to the provisions of Trade and Merchandise Act and to be on the safer side inform the SLA about the trade or brand name under which the licensed generic medicine is intended to be manufactured and marketed. It also means that there is no restriction on the manufactures to market already licensed generic medicine in more than one trade or brand names.”

Certainly, this move seems to be in favour of the end users (patients) but it is also assumed that if this happens then there will be insufficient/unavailability of the medicines in the market.

Though all the key associations have come together and asked the Centre to roll back the notification and clarify its stance, we need to wait and watch whether the Centre does justice keeping in mind both the industry as well as patients. u.sharma@expressindia.com

E-mail: bpdcbe@vsnl.in JAIPUR The Indian Express Limited, C-7, Dwarika Puri, Jamna Lal Bajaj Marg, C-Scheme, Jaipur - 302001 Tel: 0141-370002/371272 Telefax: 91-141-376606 BHOPAL The Indian Express Limited, 6, Vidya Vihar, Professors Colony, Bhopal - 462002, Madhya Pradesh Tel: 0755-2661988 AHMEDABAD Rajesh Bhatkal The Indian Express Limited, 3rd Floor, Sambhav House, Nr. Judges Bunglow Bodakdev, Ahmedabad - 380 015.

Tel: (91-79) 26872481 / 82 / 83 Fax: (91-79) 26873950 Mobile: 98213 13017 E-mail : rajesh.bhatkal@expressindia.com

IMPORTANT Whilst care is taken prior to acceptance of advertising copy, it is not possible to verify its contents. The Indian Express Limited. cannot be held responsible for such contents, nor for any loss or damages incurred as a result of transactions with companies, associations or individuals advertising in its newspapers or publications.

We therefore recommend that readers make necessary inquiries before sending any monies or entering into any agreements with advertisers or otherwise acting on an advertisement in any manner whatsoever.

November 16-30, 2012

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INSIGHT Singapore – A global-Asia pharmaceutical hub GlaxoSmithKline has based its emerging markets and Asia-Pacific headquarters in Singapore to manage all emerging markets – from

Lee Eng Keat, International Director (Asia Pacific) of the Singapore Economic Development Board (EDB), speaks about the synergy between India and Singapore in the pharma industry and how it has established itself as the global hub in Asia ven as an increasing number of Indian companies expanding overseas, Singapore is considered as an attractive investment location. Accounting for 24.3 per cent of all Indian outbound investments between 2008 and 2011, Singapore is Indian companies’ destination of choice, with large numbers hailing from the IT, infrastructure and trading sectors. Another sector that offers synergy between India and Singapore is the pharma industry. Singapore’s strategic location to access global markets, state-of-the-art infrastructure, proven track record in R&D, innovation and manufacturing, and availability of top scientific talent has established it as a global hub in the heart of Asia.

E

“Visit us at CPhI Mumbai, India, November 21-November 23, 2012, at Hall 1, Stand No. I4"

33-year history of partnership with leading pharma companies

Clopidogrel Bisulphate

November 16-30, 2012

Irbesartan

Form-I

active pharmaceutical ingredients & its intermediates* Commercial scale Antitubercular Pyrazinamide# * Isoniazid # *

Singapore: Gateway to other markets Singapore is a trusted location for Indian companies to access and manage global markets. More than 4,000 Indian enterprises have incorporated in Singapore, with a growing number basing their regional or international headquarters there to coordinate overseas operations. Indian companies tap on Singapore’s strong pool of multi-disciplinary talent and business-friendly policies to drive their growth. For example, Fortis Healthcare, one of India’s largest healthcare companies, has established its international headquarters in Singapore and recently announced plans to list its clinical establishment division on the Singapore Stock Exchange.

Within the global pharma sector, eight of the top 10 have regional headquarters in Singapore to drive global business expansion in Asia and across the emerging markets.

Especially with Singapore’s central location and neutral role in Asia, companies can navigate complex Asian regulations and healthcare policies from Singapore.

For example,

Valsartan

Telmisartan

Antimalarial Artesunate Arteether Artemether# * Dihydroartemisinin Lumefantrine# * Piperaquine

Macrolides

Antihypertensive

Azithromycin Clarithromycin Erythromycin base # # Erythromycin estolate Erythromycin ethyl succinate+ Erythromycin oxime (intermediate) Erythromycin stearate #

Irbesartan # Losartan potassium Telmisartan Valsartan

Antihistaminic

Alendronate sodium Zoledronic acid

Sedative, Hypnotic Zopiclone

#

Antifungal Flucytosine

#

Cetirizine dihydrochloride # Hydroxyzine diydrochloride Meclizine diydrochloride +

Antiosteoporotic

#

Antiepileptic Valproic acid

Antidepressant Venlafaxine hydrochloride

Under Development

#

Antiretroviral

Antidiabetic

Hypnotic

Antithrombotic

Ganciclovir Valaciclovir Valganciclovir Maraviroc

Linagliptin Vildagliptin

Eszopiclone

Clopidogrel bisulphate

*WHO APIMF

CEP / COS

* The Technical and Physical manufacturing capabilities exist with us for the above APIs and their intermediates. However these products will be offered only to the markets where any product or process patents are not infringing. During the validity of a patent the research quantities for developing products for regulatory submissions will only be offered to countries where such exemption exists (Hatch Waxman Act / Bolar exemption). While Calyx offers to work with the clients on Patent Status Verification, the final responsibility vests with the buyer. Recipients are requested to make their evaluation and determination as to the patent status prior to their use of the information or materials in their respective jurisdiction.

Products under patent offered only for exempted research, clinical and development purposes. Only non-infringing products and processes are offered, subject to patent status verification by client.

Calyx Chemicals and Pharmaceuticals Limited Reg. Office: Unit No.110, Marwah's Complex, Krishanlal Marwah Marg, Off. Saki Vihar Road, Andheri (East), Mumbai – 400072, Maharashtra, India.

Tel: +91-22-28571191, Fax: +91-22-66466416, Email: sales@calyxindia.com, crams@calyxindia.com USA Contact : 11728 E. Imperial Highway, Norwalk, CA 90650, Tel - 213-291-7773, Email: sales@calyxusa.com, crams@calyxusa.com Website : www.calyxindia.com "Calyx Chemicals and Pharmaceuticals Limited (the “Company”) is proposing to make, subject to receipt of requisite approvals, market conditions and other considerations, an Initial Public Offering of its equity shares (the “IPO") and has filed the Draft Red Herring Prospectus (the “DRHP”) with the Securities and Exchange Board of India (“SEBI”). The DRHP is available on the website of SEBI at www.sebi.gov.in, the website of the BRLMs, i.e. PL Capital Markets Private Limited at www.plindia.com and YES Bank Limited at www.yesbank.in and is also available on the website of the Company at www.calyx-pharma.com. Potential investors should note that investment in equity shares involves a degree of risk. For details, please refer to the DRHP, including the section titled “Risk Factors” of the DRHP. This publicity material does not constitute an offer of securities in any jurisdiction, including the United States of America (“USA”). Securities may not be offered or sold in the USA without registration under the U.S. Securities Act of 1933 as amended, or an exemption therefrom. The Company has not and does not intend to offer any securities to the public in the USA”.

www.expresspharmaonline.com

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Southeast Asia to the Middle East and Latin America.

Indian pharma companies can leverage Singapore’s efficient and pro-business environment, talent and trusted reputation to achieve the next leap in their global ambitions.

Accelerating drug discovery through strong research and top scientific talent The Biopolis of Asia, Singapore aims to be a leading international biomedical sciences cluster advancing human health by achieving excellence across the entire value chain. The government continues to invest in research and innovation, committing S$16.1 billion between 2011 and 2015, of which S$3.7 billion is dedicated to the biomedical sciences.

Singapore has a strong reputation for scientific and clinical excellence. Its scientific foundation includes seven biomedical research institutes and five research consortia in key fields such as clinical sciences, genomics, bioengineering, molecular/cell biology, medical biology, bio-imaging, bioprocessing and immunology.

Its Biopolis biomedical science cluster brings together world-class facilities, scientific expertise and specialised services, with the co-location of public sector research institutes and private sector corporate labs driving crossfertilization of ideas between the public and private sectors. For example, Singapore scientists from the Bio-processing Technology Institute (BTI) have, for the first time, identified the molecular ‘switch’ that directly triggers the body’s first line of defense against pathogens, enabling the development of the most comprehensive and rapid H5N1 bird flu test kit available to date.

In its public research hospitals, Singapore has developed Investigational Medicine Units (IMU) dedicated to First-in-Human/ Early-Phase trials and has committed to double the community of clinician scientists who have deep knowledge of clinical needs and disease biology. Increasingly integrated, the close partnerships between Singapore's public research institutes, hospitals and contract

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IN AUGUST 2012, SINGAPORE’S AGENCY OF SCIENCE,TECHNOLOGY AND RESEARCH (A*STAR) SIGNED AN MOU WITH INDIA’S DEPARTMENT OF SCIENCE AND TECHNOLOGY TO DRIVE GREATER COOPERATION BETWEEN THE TWO COUNTRIES WITH JOINT WORKSHOPS AND GRANT CALLS research organisations offer new models of collaboration for Indian companies seeking to improve R&D productivity.

For example, the newlyestablished Translational Imaging Industrial Lab – a collaboration between the Singapore Bioimaging Consortium (SBIC) and Maccine, a leading nonhuman primate CRO – offers companies innovative research tools and worldclass expertise for preclinical imaging to accelerate the advancement of drug lead candidates. In Singapore, Indian companies can access a global talent base, unique patient pools representative of all major Asian genotypes (Chinese, Malay and Indian) and forge collaborations with www.expresspharmaonline.com

the Singapore-based research community.

Notably, in August 2012, Singapore’s Agency of Science, Technology and Research (A*STAR) signed an MoU with India’s Department of Science and Technology to drive greater cooperation between the two countries with joint workshops and grant calls.

Fast, quality and worldclass manufacturing industry Singapore has a proven manufacturing track record for both speed and quality, where companies can manufacture world-class drugs across various modalities (small- and large-molecule, cell therapy). Manufacturing

output of the biopharma industry reached S$22.8 billion in 2011, expanding by more than 30 per cent from the previous year.

Attracted by the excellent physical and regulatory infrastructure, global connectivity and skilled manpower available in Singapore, seven of the world's top pharma companies have invested in 30 commercial-scale manufacturing facilities. These companies operate multi-purpose plants with the capability to manufacture a wide range of active pharmaceutical ingredients (APIs), biologics and nutritionals. Singapore has made significant inroads in biologics manufacturing, with Baxter, Lonza, GSK and Roche announcing their investments to set up major biologics facilities that amount to $2 billion in capital expenditure. To date, all pharma manufacturing facilities that have commenced commercial operations have received validation from international regulators – the US Food and Drug Administration (FDA), the European Medicines Agency (EMEA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

Singapore offers a stable environment for global manufacturers, including a 360hectare stretch of ready and specifically-zoned land called Tuas Biomedical Park (TBP), for pharma and biologics manufacturing.

Equipped with established infrastructure such as roads, drainage systems, power, water supply, telecommunication lines, third-party utilities (steam, natural gas, chilled water, waste treatment), TBP presents a plug-and-play environment that enables sciences companies to set up manufacturing facilities here with minimal lead time.

Conclusion With Asia's best healthcare system and world-class medical practice, Singapore has achieved world class standards in the sector due to its strong focus on innovation and quality. Singapore continues to be committed to cocreate innovative healthcare solutions with leading company partners.

The author can be contacted at Eng_Keat_LEE@edb.gov.sg November 16-30, 2012

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Discover the hidden OTC Gems of the Indian pharma market Sreedevi Yallamrazu, Sr Strategic Analyst, CubeX, a division of Sorento Healthcare Communications, says that new business models may have to be envisaged to ensure that the growth momentum stays high

indeed it is important to leverage the equity of these

brands by promotionally switching them OTC at the

right time in a planned manner. Heritage prescription

brands can open new doors that marketers may be

World Class Products Outstanding Service New

UV-2600 / 2700 UV-1800

he Indian pharmaceutical market is likely to undergo some major reforms with the proposed policy to regulate the prices of 348 essential drugs gets the green signal. This will add to the woes of marketers who are already battling on many fronts such as the patent cliff and rising input costs. New business models may have to be envisaged to ensure that the growth momentum is high. Further, challenges in global territories are forcing local marketers to peep into their own backyard once again for growth opportunities.

In this scenario, the adage 'old is gold' couldn’t be more relevant. Consumers repeat purchase a brand, once it has been prescribed by a doctor or recommend by a chemist and its efficacy has been tried and tested.

Heritage brands also enjoy the doctors’ trust, even if they may have moved to higher ground with superior products. Many a time, such ‘OTX’ brands lack promotional focus, barring retail push if at all any, though they hold high potential to meet implicit needs of consumers. At CubeX, we call such brands 'Hidden OTC Gems'. And

T

November 16-30, 2012

BioSpec-nano

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GC-2010 Plus

Head Office : 103, S. J .House, 1st Floor, Sitaram Mills Compound, N. M .Joshi Marg, Lower Parel Mumbai - 400 011 T : 022 - 2301 5096 / 6450 7214 F : 022 - 2301 3592 E : info@toshvin.com W : www.toshvin.com Branches : Ahmedabad Bangalore Baroda

Chandigarh

www.expresspharmaonline.com

Chennai

Cochin Goa

Hyderabad Kolkata

New Delhi Pune EXPRESS PHARMA

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seeking, sans the risks involved in new business prospects. The evolving consumer base, supported by the testimony of loyal consumers, can significantly add volumes to offset the slash in prices, if the new pricing policy takes shape.

In the latest report from CubeX, “Discover the Hidden OTC Gems of the Indian Pharma Market” (Version 1 & 2) almost 30 brands have been analysed for their OTC potential.

Discover the 'Hidden OTC Gems' Mass advertised brands constitute merely 38 per cent of the sales of the total Indian OTC market (valued at $2 billion). The remaining 62 per cent of the market ($1.2 billion) comprises non-advertised brands and thus the untapped opportunity is huge (refer to chart 1). The leading categories in terms of nonadvertised brands are Vitamins, Minerals and Supplements (VMS), followed by gastrointestinals with 40 per cent and 22 per cent contribution respectively (refer to chart 2). The propensity to self-medicate after the initial prescription is quite high in both these categories.

The CubeX OTC Brand Evaluation Scorecard Cubex has developed a master tool through their vast experience, The CubeX OTC Brand Evaluation Scorecard, which helps in evaluating the potential of brands to enter or switch to the OTC market.

Each brand is rated on the basis of five distinct parameters to arrive at a weighted score to determine its OTC potential. The proximity of the brand to the ideal scores can be depicted with the OTC Proximity Graph (refer to graph 1). The five parameters have been described below.

Brand strength One of the aspects for a brand’s success in the OTC market lies in its strength to stand out among a plethora of choices that consumers can reach. Brands like Becosules may not stand out in terms of innovative or multiple variants like Shelcal, but they do have inherent brand strength, going by their legacy and popularity among doctors, chemists as well as consumers.

Many prescription brands like Candid may not enjoy

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www.expresspharmaonline.com

first mover advantage in the Indian OTC market, since brands like ItchGuard are well-penetrated in the consumers’ mind. On the flip side, Candid can claim to be the 'doctor recommended anti-fungal.'

Need potential A critical aspect for a brand is its ability to bridge unmet needs or showcase a strong point that creates a need for it. Consumers’ needs can be of varied kind – from quick and long lasting relief to psycho-somatic relief. Constipation is one such 'ailment'. Doctors will vouch that passing three motions in a day or passing once in three days is just as fine. Because the notion of passing motions daily constitutes 'good health and hygiene' is so deeply ingrained, the need for laxatives is high. Surprisingly, there are hardly any products, except few traditional remedies, communicating directly to consumers.

Similarly, the needs of men and women tend to differ significantly in common concerns like headache, fatigue and even in case of fungal infections. Since most anti-itch creams are largely male-centric in their promotion, it creates an apparent need for an 'anti-fungal for women' for specific use.

Market attractiveness Evidently, a growing market can present brand building opportunities through innovative positioning, packaging, communication and similar other avenues.

Certain sub-categories such as topical analgesics are virtually saturated with mass advertised brands contributing close to 80 per cent of the sales. Moreover, general pains and sprains have been addressed by most of the brands and the spray format is becoming a commonplace.

Thus, any new brand entering this segment will need to have a distinct positioning.

Competitive clutter In case of competition, it must be acknowledged that the evolving consumer is exposed to a variety of products and formats that can serve a single need. For example, the need for iron supplementation is wellunderstood by many women.

However, not all of them are November 16-30, 2012

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likely to reach for Dexorange.

Functional foods like Kellogg’s Iron Shakti, which are fortified with iron and mass advertised to consumers, can also fulfill the need. Brands like Women’s Horlicks, Revital Woman, Supractiv Complete Woman, too have iron as one of the ingredients, along with other essential multivitamins and minerals. Consumers may question the need to look for alternate sources, when they can get all the micronutrients from a single source.

Underlining the greater need for iron supplementation in the ‘right dosage’ would help in increasing brand acceptance.

their popularity among consumers and retailers while retaining their hold on doctors with well-devised strategies and are growing at a robust double digit rate (on an average 20-30 per cent as per Nicholas Hall’s DB6 2012 database). They are progressing to be the block-busters of

the OTC market.

Rx to OTC promotional switch can be a milestone in the brand’s history as it provides opportunities for brand building and lifecycle management by catering to the latent needs of consumers, under the aegis of a trusted brand name. It can give tradi-

tional pharma companies a quick head start into the consumer health and wellness domain and also provide targets for synergistic brand acquisitions for those looking to strengthen their presence in the OTC market.

(CubeX is the Strategic

Consulting and Business Intelligence division of Sorento Healthcare Communications with expertise in the Consumer Healthcare and Wellness domain. To know more about reports from CubeX, you can write to reports@cubex.co.in)

Regulatory fit Brands like ViBact can expect a smooth ride, if taken OTC, from the regulatory perspective. Bacterial spores do not fall in the list of prescription drugs, are not price regulated and claims for gastric health benefits are not objec-

REVITAL,VOLINI, OTRIVIN TO NAME A FEW, ARE CLASSIC EXAMPLES OF OTC SWITCHES IN OUR INDIAN PHARMA CONTEXT tionable. Additionally, under a food license, it can be sold at non-pharmacy outlets as well.

Vitamin B complex brands may not be so lucky with the DPCO, but the silver lining is that brand extensions with prophylactic doses or natural supplements can be launched as food supplements.

Rx to OTC – the way to go!

“You can’t just ask customers what they want and then try to give that to them.

By the time you get it built, they’ll want something new.”

Steve Jobs made this statement way back in 1989 in an interview with Inc. magazine but it holds relevance even today.

Revital, Volini, Otrivin to name a few, are classic examples of OTC switches in our Indian pharma context.

These brands are leveraging November 16-30, 2012

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Leveraging social media for success B Sriram, Executive Director– Healthcare, Direxions Marketing Solutions, advises Indian pharma to deploy social media for marketing ocial media is the new and definitive industry buzzword. According to the Neilson Social Media Report (2011) social networks such as Facebook and Twitter and blogs are the top online destinations in each country, accounting for the majority of time spent online and reaching at least 60 per cent of active Internet users. It’s hardly surprising therefore that industries from banking to retail are tapping the social media to initiate new marketing strategies and engage the target audience but the pharmaceutical industry seems to have gotten off to a comparatively slow start. It is mostly American and multinational pharma companies who are making their presence felt on social media for instance, Bayer’s Aspirin has a Facebook page for women; YouTube has hosted promotional videos such as GlaxoSmithKline’s RestlessLegs awareness film; Reckitt Benckiser has used MySpace to distribute advice on kicking the prescription painkiller habit and Pfizer has a Chantix Support Group on drug.com, for tobacco patch users who are trying to quit smoking.

In this article, I’d like to explore the potential of Indian pharma companies to embrace social media tools and leverage the social media landscape of India.

S

Why social media looks promising A report by the Internet and Mobile Association of India expects the Internet subscriber base in India to reach 150 million by end 2012, with active users recording a growth of 19 per cent. There has also been a huge spike in the frequency of Internet usage, from a mere 28 per cent of users accessing the net daily in 2011 to 54 per cent doing so in 2012. Facebook itself has reported that it has 50 million plus active monthly users from India alone, as of July 2012. The Bupa Health Plus Survey 2011 reports that 90 per cent of all Internet users in India search for health-related information with around 70 per cent searching for specific medicine related information.

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This shows that healthcare and especially pharma companies do have a potentially large ‘online’ market that they can leverage using social media tools. There are several benefits of resorting to social media tools, the first being, that such tools have a wide reach, are interactive and at the same time are very costeffective compared to offline advertising. Secondly, with so many Internet users interested in health-related information, there is a lot of ‘patient-generated’ content available. This includes patient feedback, sharing of experiences etc.

Companies, therefore, stand to gain invaluable customer/ patient feedback by just listening in on conversations conducted by patients on social networking websites and contributing wherever applicable.

There can also be a twoway interaction, with the company appointing personnel to answer queries posted by customers online or provide information about research on new drugs. Such a strategy not only keeps customers engaged, but also lends a personal touch to the website, as they interact with the same set of company representatives. Some MNCs are currently using such a strategy.

Sanofi has proved to be one among early entrants by utilising the social media landscape in India for its brand of flu vaccine. They created the ‘Mothers against Flu’ campaign, where they targeted ‘DigiMoms’ or mothers who regularly access social networking sites. This helped them identify and build a target community for their flu vaccine. They launched the campaign on Facebook and through this page, organised a number of polls, quizzes, discussions centred on the topic of common flu and flu vaccines. The campaign has generated more than 12,000 likes to date, with more than 3,000 in the first month itself.

Some companies have adopted a very innovative strategy of supporting unbranded websites, such as iwalkbecause.org etc. The content on such websites is mostly patient generated, allowing the company to gather vital information about the patients’ experiences. At the same time, a link which directs users to the company’s branded website serves the www.expresspharmaonline.com

twin purpose of facilitating a quick market research and fostering relationship with patients’ groups.

Thirdly, social media provides companies with a very novel way of fulfilling their corporate social responsibility.

They can educate the community about health issues/awareness and treatment. For example, Eli Lilly & Company in 2011 launched their ‘Lilly Health Channel’ on YouTube featuring videos on health and wellness, employees and more. Despite so many advantages, why has the pharma industry been reluctant to embrace social media on a larger scale?

Caveats Few regulatory guidelines exist on how companies (in most countries across the globe, including the US, Europe and of course, India) should use social media for creating disease/brand awareness. Companies still seem cagey about what information to share with different target groups such as patients, physicians and the media.

Providing adequate and accurate information is also an onus that rests with the company. With companies fearing the backlash of governing bodies, they are resorting to very limited usage of social media tools.

Also, the wide reach that social media provides could be a potential double-edged sword. If there is a positive customer feedback, millions get to know, but if there is a negative feedback, they still get to know! This makes it possible for even rivals to deliberately post adverse comments and misinform customers. This fear of libel and defamation keeps several companies from adopting social media in a big way.

With the lack of stringent regulations, it becomes difficult for companies to instill faith and confidence in customers that the information being provided to them is honest and accurate is being done with an intention to inform and not promote their own brands. Further, unlike the West, there are very few ‘patient communities’ that are active in India. These communities usually offer user-generated data that companies can use and monitor to gain valuable insights about their target

audience.

Another issue which needs to be addressed is relevancy and recency of information on a social media site. In order to have continued and increased traction amongst user/viewers, both these issues are very important. One envisages a time when pharma companies might have full fledged teams to oversee social media content.

Lastly and most importantly how and what should the measurement metrics be to evaluate the success or failure of using this media. Is it the total number of hits?

Should it be repeat visits? Data analytics will play a critical role in ensuring objectivity to these measurement metrics.

The way ahead Statistics over the years by various surveys and reports confirm that social media is here to stay. Internet users are growing exponentially all across the globe, including India. In general, patients and providers are becoming more empowered on the Internet.

They are willing to interact with a pharma company using this channel if they believe it’s to their benefit and that they can trust the company.

The first step then is obviously to get the governing bodies in India to formulate some guidelines regarding the content that pharma companies can share, information that must be provided etc. But in the meanwhile, companies self-regulate and put in place some of their own guidelines on how to use the social media. They outline the role and responsibilities of employees with respect to use of social media and train them on the dos and don’ts of the same. User-generated content from patients and providers needs to be secured, retrieved, analysed and maintained in a regulatory controlled manner.

Companies should then marry the insights gained from their audience to their marketing strategy.

While there is a lot that is left to be learnt and much to be experimented upon, the time for pharma companies to participate in the technology revolution and adopt social media is definitely NOW! The views expressed in this article are personal. The author can be contacted at bsriram@direxions.com November 16-30, 2012

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Patents - why and when?

Milind Sathe, Deputy General Manager – Projects, Unichem Laboratories gives a rundown on patents, its uses, objectives, limitations and more world famous speaker recently, said “An efficiently operating IP system is critical to our ability to spur innovation and bring new services and products to the marketplace faster”1. Patents benefit society from improved and better products.

Trade in knowledge economy is governed by intellectual property (IP).

Patents provide assured means to earn the revenue from the sales of patented product and that is the best benefit of patents. Patents, a sophisticated entry barrier, are tools with known limitations, to protect the IP. It provides breathing space to develop a business based on an invention. Patents provide benefits in commercial, economic and societal terms.

Commercial or economic benefits mean patentee may choose to make and sell the product, taking advantage of the monopoly rights afforded by the patent or licensing it out. The value of patents must be interpreted in relation with the economic structure of the society where patents are granted a n d practiced.

Patents are of specific importance in pharmaceuticals due to long development and approval periods for a new product, associated huge costs and increased need to prevent copying.

Apart from commercial, economic and societal benefits, the reasons for use of patents in pharma products are i) to deter entry, ii) to enhance favourable conditions for commercial use, iii) out-licensing to secure royalty income, iv) to use in technology negotiations, v) to influence investors perception, vi) to signal to others, vii) for recognition to the inventors or to provide incentive to researchers, vii) to own versatile uses of the product, viii) to increase the returns from innovation, ix) to increase intangible property and internal wealth of the company which is useful during acquisitions and mergers, x) To use in cross licensing, xi) to block competitors’ attempts to patent a

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November 16-30, 2012

closely related invention, xii) to control a technology path, xiii) to eliminate the competition, xiii) to protect

the investment, xiv) to raise finance, 2 xv) commercialisation of technology/product, xvi) to exponentially

improve R&D productivity by avoiding ‘reinventing of the wheel,’ xvii) to sharpen the competitive edge at market place or to retain leadership, xviii) to invent around the patent.

Commercialisation

potential of patents, commercialisation capabilities of patentee, and opportunities directly determine if the patent will be worked or not.

Exposure of patentee and his readiness level determines if he would like to license out

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the patent or not; independent of his abilities or limitations to work it.

Basis of the patent system References 1.http://www.commerce.gov/news/ press-releases/2011/09/16/president-obama-signs-america-inventsact-and-announces-new-steps-hel, Last accessed on 23rd October 2012.

2.Understanding the Rationale to Patent in Pharmaceuticals Henrique Machado Barros, Insper Working Paper, WPE: 084/2007 http://www.insper.edu.br/sites/defa ult/files/2007_wpe084.pdf Last accessed on 19th October 2012.

Ibmec São Paulo;- Rua Quatá, 300; Vila Olímpia; 04546-042; São Paulo-SP, Brazil. e-mail: henriquemb@isp.edu.br 3.Bishawanath Prasad Radhey Shyam v. Hindustan Metal Industries, ((1979) 2 SCC, 511) 4.U.S. v Masonite Corporation, N.Y.1942 5.Griffith Rubber Mills v. Hoffar, C.A.Or. 1963, 313 F. 2d 1, http://www.patents4technologies.co m/PatentLaw.htm#1 Last accessed on 23rd October 2012.

6.http://www.du.edu/techtransfer/i ptips.html University of Denver Office of technology transfer 7.Actions that do affect the marketing of patented invention do not affect the said exclusive right.

Session III Introduction by Alberto BERKOVITZ (Chair) OCDE Madrid 18 May 2006. http://www.oepm.es/cs/OEPMSite/ contenidos/ponen/conferenciantes/archivosPDF/36817271.pdf Last visited 18th October 2012 8.WIPO/IP/ECON/GE/5/10/INF.1, ORIGINAL: ENGLISH, DATE: SEPTEMBER 20, 2010. Patent Rights and Economic Growth: Evidence from Cross-Country Panels of Manufacturing Industries, (Professor Ivan P.L. Png) Geneva, November 30, 2010. Abstract: http://www.wipo.int/edocs/mdocs/ mdocs/en/wipo_ip_econ_ge_5_10/ wipo_ip_econ_ge_5_10_ref_huandpng.pdf 9.The Social Value of Patent DisclosurePatent Disclos Prof.

Dietmar Harhoff, Ph.D., Institute for Innovation Research, Technology Management and Entrepreneurship, Ludwig Maximilians Universität München (LMU)LudwigMaximilians-Universität München (LMU), Munich School of Management, Kaulbachstr. 45, D80539 München, Tel. +49 (0)89-2180-2239, Fax +49 (0)89-2180-6284, harhoff@bwl.unimuenchen.de, http://www.innotec.de Last accessed on 26th October 2012.

10.overfishing models of Barzel (1968) and Dasgupta and Stiglitz (1980b) http://nicomedia.math.upatras.gr/FreeOpenSource/BiotechnologyRelated/I PRights&ResearchToolsInMolecularB iology/books/3.html Last accessed on 23rd October 2012.

11.Patent Rights and Economic Growth: Evidence from CrossCountry Panels of Manufacturing Industries, Albert G.Z. Hu* and I.P.L. Png, February 2009, This version: January 2010 12.best patent will not generate revenue if the firm is not correctly positioned to exploit it (Brooking, 1996) 13.4th Annual Conference of the EPIP Association, Bologna, 2425.09/2009, Economic Strategies and Patent Governance of UK Software Firms: A Study on Financial Benefits, Reputation and Positioning, Birgitte Andersen Professor of the Economics and Management of Innovation, University of London, Birkbeck College, UK, Email: b.andersen@bbk.ac.uk. Ainurul Afizah Rosli Research Fellow and Doctoral student, University of London, Birkbeck College, UK, Email: a.rosli@mbs.bbk.ac.uk

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It is believed that the patent system promotes innovation and economic competitiveness. Trade-related aspects of intellectual property rights (TRIPs) agreement aims to achieve four broad objectives by unified IP and patent frame: i) promotion of technological innovation; ii) the transfer and dissemination of technology; iii) the advantage consumers and inventors; and iv) in a manner conducive to social and economic welfare.

Grant of exclusive privilege to own, use or sell the method or the product patented for a limited period stimulates new inventions of commercial utility3. Patents promote the progress of science and the useful arts; reward of inventors is secondary and merely a means to that end4. Purpose of limitations on patentability was expressed as patents are issued not for private benefit but for public good5.

Availability of patented products benefits to subject population6.

TRIPs Article 28 refers to rights conferred on patentee wrt product or process and empowers patentee with exclusive rights to make, use, offer for sale, sell, or import, to assign, or transfer by succession, the patent and to conclude licensing contracts. It prevents third parties not having the owner’s consent from doing the above acts.

Nowhere has it guided to interpret the text as an exclusive right to patentee 'not to use, not sale, not import'.

Quite clearly patents confer exclusive rights, in the interests of patentee and society.

The effectiveness of patents in protecting property rights is variable. It depends upon the extent to which the property rights can be protected by the local law frame and courts.

Patents create more difficulty for competition but do not completely stop it. It is an effective entry barrier.

Nations retain the power to regulate unfair practices without compromising national patent system.

Prime objective of the patent law is to encourage technological progress and ensure availability of patent-

ed product in the market7.

The objective of patent rights is to foster innovation and economic growth. However, to date, there is little robust evidence that patents “work” as intended8. Richard D. Nelson and Roberto Mazzoleni, Columbia University state 4 broad theories of patents in “Economic Theories about the Costs and Benefits of Patents”.

According to “Invention-inducement Theory” an anticipation of patent/exclusive rights provides motivation for useful invention and provides incentive effects. It believes that without patent protection there will be no invention; or incentives for invention will be too weak to reflect the public interest. It supports stronger patent protection. It presumes that holder wants to prevail in the market. This basic understanding contradicts expansive interpretation and negative version of patents that supports nonworking of patents. Disclosure Theory describes that by inducing inventors to disclose their inventions, patents facilitate wide knowledge about and use of inventions. However not all support this view.

Supreme court in US is of the opinion that there is very little evidence in favor of the positive disclosure story.

There is a feeling that learning from past patents is a highly overrated story, and facts indicate so. Prevailing disclosure style is inadequate and needs stringent disclosure norms9. Better ways of measuring the impact of disclosure are required. There is no evidence to support that disclosures avoid duplication or stop duplication of R&D or ensure cost reduction.

Disclosures are in typical patent language and seldom deliver claimed advantages.

Persons skilled in the art find it difficult to comprehend the technology. It is common www.expresspharmaonline.com

experience that following the technology described in the patent leads to surprisingly different results. Therefore alleged advantages of disclosures are more of theoretical and philosophical in nature.

According to 'Development and Commercialisation Theory', patents induce the investment needed to develop and commercialise inventions. According to 'Prospect Development Theory', patents enable the orderly exploration of broad prospects for derivative inventions.

In a competitive world, quality and quantity of returns are determined, not by who invents first but by who protects first. It increases the total inventive effort by faster or more deployment of 4Ms in inventive activity10. Direct entry by working or licensing enhances revenues and rents, supports R&D and encourages inventive efforts.

Innovation and economic growth Mere grant is not enough. Being a patentee is not enough. It is of paramount importance that patent adds to revenue or protects current sources of revenue, else patenting is shear waste of resources.

Understanding what patentee does with patent tells many other stories.

Important economic strategic benefits sought by patents are (i) financial rewards/monetary benefits to cover R&D expenses and profit, (ii) creating reputation/recognition, (iii) securing market protection, iv) to build networks and corporate relationships such as JVs, alliances, co-marketing, tie ups v) practically creating a protective wall to ensure continuation of monopoly and vii) creating opportunities for product extensions.

Generating economic value is the prime objective of patent. Economic value of IP is company, context, technology and manner of use specific. It is location and economy specific, determined by law of the land, despite TRIPs in existence.

Patentee has to position himself perfectly to generate revenue12.

Differences in motives of patenting and in effectiveness of patents across industries, differences in legal provisions, in economies and in level of

earnings of subject populations determine revenue generation potential and in turn impact investments, expenditures, productivity and activity profile in R&D. Covering R&D expenditures is not the primary motivation for patents but is just one of many. Drive to license out the patent is of critical importance13.

Mazzoleni and Nelson (1998) propagated the theory of benefit and cost of patent which associate patents with a competitive weapon and as a source of unexpected revenues. In either case, patent leads to suppression of technology, product and or process if it is to be used as weapon to prevent competition.

Contradiction of treating markets as platforms for pure economic gains but advertising them as platforms of social relations marks Knowledge economy, in which markets in reality do not follow simple supply and demand curves, described in standard textbooks. Today, a market governed by law of the land is in reality a complex network of social, industrial, financial, political and institutional relationship prone for external influences.

Apex institution and its wings are required to process enforcement of rights, for productive and effective exchange and to ensure balance of interests. Patentee must carry definite burden of performance.

Patentee’s actions and interaction that disrespect / contradict the sovereign or law of the land, despite having information and knowledge, and his tendency to adopt double standards tell a different story about use, utility of patent and motives of patentee.

Advertising market as a social platform is an attempt to gain reputation but patentee contradicts it by his behaviour in litigations against the State and against public interest.

His behaviour against the nation creates hatred about patents, disgust about patentee. It defames the patent system. It exhibits the gap between what is preached and what is practised. There is no sound justification for not working the patent especially when law of the land prohibits it. A sincere desire to work the patent or license out, is a necessary precursor of patenting activity.

November 16-30, 2012

+ Industry expectations high from CPhI India 2012 PG 56

'We have started working more actively on ready-touse products' PG 56

Facing upto the Implementing and adapting to challenge(s) the new EU pharmacovigilance PG 58 regulations PG 60

QbD in tablet film coating PG 66

PROFILES Akums PG 71 SD Fine Chemicals PG 74 Advanced Enzymes PG 73 Granules India PG 75 United Biotech PG 74 Renown Pharmaceuticals PG 75

Industry expectations high from CPhI India 2012 Event to be held in Mumbai from November 21-23, 2012

Usha Sharma Mumbai he pharmaceutical industry is going to witness the largest congregation of pharma professionals this winter. The industry's mega event CPhI India, will be held in Mumbai from November 21-23, 2012. Like every year, the organisers are targeting to make this event an eventful one.

To assist participants, exhibitors and visitors technically, this year, the organisers have introduced mobile APP and online registration. This year it is expected that over 26,000 attendees and more than 800 exhibitors will participate in CPhI India and its colocated events. CPhI India is a gateway to meet key decision

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makers in the pharma industry from 92 countries, including India, China, the US, the UK, France, Italy, etc.

Participants will have an idea about the ingredients and services at competitive prices and also get ideas about the latest innovations, technologies, trends and developments in India's pharma industry. It also gives an opportunity for networking and gaining access to one of the world's fastest growing pharma markets.

Suresh Pareek, Managing Director, Ideal Cures shares his expectations from CPhI India 2012 and said, “This year, we are going to launch our new product Insta Model and Extended Release System for the solid oral dosage forms.

This is the first time in the world that any company has

taken the initiative to develop this product. We are expecting more visitors from the Middle East and South East countries as well. During the CPhI Madrid 2012, we did not come across visitors from these countries. We are also expecting visitors from neighbouring countries like Pakistan and Nepal. Also, we are expecting our old and existing customers to attend this event. I hope this year's CPhI India will have more improved infrastructure and organised especially in the parking and exit areas.”

Dr L Ramaswamy, Managing Director, Sotax India, said, “CPhI /P-MEC has become a big brand now and is the largest pharmaceutical exhibition and knowledge sharing event in India. I see

this as an opportunity to meet a large number of users under one roof and we shall be able to give a demo of our equipment to them. It is one of the most professional conference and exhibition growing in all dimensions year after year.”

CPhI India and P-MEC India are the largest and most comprehensive pharma industry events in South Asia and have gained a reputation as the ‘must attend’ events in this market.

Additionally, ICSE India has gained a positive reputation in the market by offering direct access to the outsourcing and contract services sector, which is one of the fastest growing segments within the Indian pharma industry. u.sharma@expressindia.com

'We have started working more actively on ready-to-use products' Suresh Pareek, Managing Director, Ideal Cures, speaks with Usha Sharma about how Ideal Cures has evolved and very actively engaged in developing ready-to-use extended drug release systems for a number of drug substances

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Over a period of time, Ideal Cures has become a sciencedriven company. Which new researches are in the pipeline?

Ideal Cures realised that ultimately scientific approach and advancement of technologies is going to be the future and hence, we are very much science driven. Ideal Cures has been working very actively to convert the art of film coating into scientific and futuristic film coating (Film coating material for automated like continuous coater) technology. We also started working more actively on ready-to-use products so that we can facilitate the pharmaceutical dosage form research.

The company is at present

very actively engaged in developing ready-to-use extended drug release systems for a number of drug substances.

We are ready to launch our new product range with the brand name Instamodel.

Instamodel is a ready-to-use extended release formulation when clubbed with active drug, which can be conveniently converted into a proper tablet formulation having desired extended release profile.

We have already evolved the satisfactory systems for the drug substances namely— Metformin Hydrochloride, Metoprolol Succinate, Diclofenac Sodium, Acetaminophen (Paracetamol), Carbmazepine, Aceclofenac, Trimetazidine Hydrochloride and Gliclazide. Several other molecules are under active consideration.

The company has also decided to work on the components of MUPS technology, which involves the development of neutral spheres plus development of acrylic polywww.expresspharmaonline.com

mers (for use in pharma dosage forms) especially for delayed, sustained release and immediate release film coating.

Last year Ideal Cures received a US patent for an aqueous film coating composition based on sodium alginate for pharma and nutraceuticals. What impact it had on the company's growth?

Sodium Alginate-based product is for immediate and delayed release film coating mainly for nutraceutical product especially in Europe and North Americas. As a first step, the company has launched the product in selected European markets, for which samples for various nutraceutical products is tested by customers using the Instanute (sodium alginatebased product) IR & DR. Some customers have already gone ahead with the commercial manufacturing using our materials and would soon be launching their product using

Instanute IR & DR. Instanute DR is fully formulated pH dependent aqueous film coating system, designed specifically to meet the regulatory requirements of dietary supplements, nutritional and food products in Europe, the US and other North American region. It offers reliable and reproducible performance as it is optimised for use on tablets and multi-particulates using a fully aqueous coating system which is simple to prepare and meets dietary supplement enteric disintegration requirements.

Film produced by Instanute DR appears smooth, glossy and uniform showing superior mechanical film properties. It provides perfect resistance to the SGF and the reconstitution procedure is very easy. However, Instanute DR disintegrates in SIF, as desired for DR supplements In a year, how many events do you participate domestically and internationally?

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Which events do you consider more fruitful and why?

In India, we mainly participate in CPhI and IPC. Both these events bring together a complete cross section and representation from industry, research, business and academia. These exposure and interactions with the professionals had been very fruitful in a way to understand their requirements and showcase our spectrum. On international scene, we participate in almost half a dozen events worldwide, out of which CPhI Europe is the main event and rest are country or geographic specific exhibitions or trade events. Our experience, over the last 12 years suggests that each event has its own importance and significance. In few cases there it may be reviving the contacts with the existing or old customers and thus enhance the business opportunities. In specific (geographic) events the objective is to find new distributors, business partners and getting introduced to potential customers of our products. These events help us to know the people expectations and how science and technology is paving the way for new launches to facilitate the development and manufacturing.

of our customers in these markets and have in-depth discussion on technical and commercial aspects.

How long you have been

associated with CPhI India and what are you expectations from CPhI India event?

We have been associated with CPhI India right from its first exhibition. We are expect-

ing that we would be able to meet most of our existing customers and will be able to explain and talk to them regarding our new launch Instamodel. We also expect

more visitors from neighbouring countries like Pakistan, Bangladesh, Nepal, the Middle East, Iran, Israel, Syria, Jordan, UAE etc. u.sharma@expressindia.com

Last month Ideal Cures participated in CPhI Worldwide Madrid and now in CPhI India. How do you want to differentiate both the events in terms of participation and its outcome?

In October 2012 we participated in CPhI at Madrid. For us both the events are significant and have different utility.

CPhI worldwide: We had an opportunity to meet all our existing distributors and customers, meeting new customers in Europe and other parts of the world. It cannot be denied that we also get an opportunity to meet our own Indian customers under one roof which otherwise becomes difficult in India due to vast expanse and individual’s own assignments. Purpose of finding new distributors, agents in new territory also get served in such events.

CPhI India: It is more targeted for Indian sub-continent [India, Pakistan and Bangladesh]. Here, we have an opportunity to meet most November 16-30, 2012

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Facing upto the challenge(s) The pharma industry has been in the middle of a whole lot of changes, in the past year and as it gears up to thrive amidst them, Nikhil Bhandare, Principal, Booz and Company (India) shares with Shalini Gupta, the challenges facing the sector and what would help to be better prepared Affordable pricing of drugs: The Government of India is almost close to having 348 drugs under price control, up from an earlier 74 which is set to impact the retail price of drugs. The move would have far-reaching implications on 'brand-name' pharma manufacturers (mostly MNCs, many of whom have patented products) rather than generics manufacturers (mostly domestic companies) whose products are already available at relatively low prices. The former are developing various strategies to manage the government’s emphasis to provide lower prices and affordable drugs to patients in India, including i) 'second branding' strategies (i.e. market and sell global patented branded drug at a lower price in India albeit with a different brand name so as not to dilute the value of the original) (ii) 'local manufacturing' (to reduce manufacturing costs vis-à-vis importing products from outside the country) (iii) patient support programmes (to provide drugs to certain patient segments at affordable rates across a period of time) (iv) public policy strategies to manage stakeholders including government, ministries, patient groups and insurance companies.

Poor healthcare infrastructure: Although the Ministry of Health and Family Welfare (MoHFW) is expanding access to healthcare into Tier-I and II cities through the National Rural Health Mission(NHRM), primary healthcare infrastructure (primary care centres, hospitals, clinics, dispensaries etc.) and physician base remain woefully inadequate in the country (6 per 10,000 compared to 270 in the US).

This coupled with a high out-

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of-pocket-expenditure of patients (>70 per cent of total healthcare costs) implies that many of them living in underinvested areas (i.e., smaller towns and rural areas) either do not have access to healthcare or have to pay significantly higher for healthcare treatment because they travel to the larger cities and often get treated at a later stage of the disease.

While a more widespread infrastructure would enable drugs to be distributed to patients across the country, higher physicians per capita would result in earlier and improved diagnosis as well as reduce healthcare costs to patients.

A fragmented supply chain: 250 out of 20,000 registered manufacturer units account for 70 per cent sales in terms of volume, while there are 65,000 stockists and substockists, many of them subscale. Both pharma manufacturing and distribution

and again higher prices to consumers. In the light of the facts above, pharma companies would benefit from developing a 'capable supply chain'- one that is tailored, agile and cost-efficient – to manage rising complexity associated with new SKUs and pricing pressure from the government. The core elements would include: i) developing a set of tailored supply chains that address segment-specific needs; ii) agility in the supply chain to respond to variability in demand; iii) flexibility in product supply and manufacturing allowing a company to better respond to volatile manufacturing capacity requirements, such as those associated with tenders, and to min-

THE GOVERNMENT IS ALMOST CLOSE TO HAVING 348 DRUGS UNDER PRICE CONTROL, UP FROM AN EARLIER 74 WHICH IS SET TO IMPACT THE RETAIL PRICE OF DRUGS.THE MOVE WOULD HAVE FARREACHING IMPLICATION ON 'BRANDNAME' PHARMA MANUFACTURERS remain fragmented creating several inefficiencies for the broader system. Relative lack of effective inventory management systems (although some stockists have embarked on IMS, barcoding and other supply chain best practices) result in high inventory holding costs, returns etc. Lack of scale at the retail end of the value chain due to domination of small chemists also results in lack of economies of scale www.expresspharmaonline.com

imise underutilisation of capacity; iv) integrated planning capabilities that align key supply chain parameters such as capacity, inventory levels and lead times with market demand, in light of India’s increasing “shift” to chronic and non-communicable diseases.

R&D low on agenda: Historically, India has never been 'R&D'-friendly in the

pharma sector. The process patent regime ensured that Indian R&D was effectively about 'innovatively copying western products.' Also, price controls and controlled margins didn’t allow for large billion dollar R&D budgets, effectively keeping Indian firms out of the ethical market. However, with the introduction of the Patent (Amendment) Act of 2005, which promised a TRIPS compliant regime, the emphasis on innovation in India pharma has increased as product patents have been recognised. Additionally, the 'shift' from acute to chronic diseases, such as diabetes, cancer, CNS and CV diseases has shaped a need to transform product portfolios and develop innovative medicines for untreated clinical needs. Accordingly, several Indian pharma companies have begun to turbocharge their R&D efforts (e.g., Piramal Life Sciences, Ranbaxy, Biocon, Wockhardt) but there needs to be a greater thrust on innovation.

Need for new business models: With increasing governmental pressure on price control and affordable healthcare, coupled with the challenge to innovate, companies will also need to shift to viable business models in order to sustain themselves in the market. These include JVs with domestic companies (e.g., Novavax and Cadila Pharmaceuticals have a joint venture for the development and manufacture of vaccines and other biopharmaceutical products in India), co-marketing partnerships to distribute products in Tier 3/4 cities and rural areas (e.g., MSD and Sun Pharma), licensing arrangements (e.g., Elder has a licensing deal with Enzymotec for the latter’s CardiaBeat drug) and forging M&As (e.g., Abbott acquired Piramal, the fourth Indian formulations company thus making it the leader in formulations in India). shalini.g@expressindia.com November 16-30, 2012

Implementing and adapting to the new EU pharmacovigilance regulations Pharmacovigilance is critical in all phases of drug development process and is based on effective systems and processes that are dependent on regulations in various countries and regions. Dr Pipasha Biswas, Chairperson, Special Interest Network Consultation Committee for Drug Safety & Pharmacovigilance, Faculty of Pharmaceutical Medicine, The Royal College of Physicians, London, UK and Director & QPPV, Symogen, UK, gives an insight on the same harmacovigilance is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems.

Pharmacovigilance (PV) is critical in all phases of drug development process and is based on effective systems and processes that are dependent on regulations in various countries and regions.

December 31, 2010 was one of the most important days in the European pharma industry. Not only was it the very last day of an eventful year in terms of pharmacovigilance, but it was the day when one of the l a r g e s t transformations and changes to the legislation covering PV activities in the European Union (EU) were published in the official journal.

In fact, the approved changes to the new EU PV legislation represents a major overhaul of the current EU PV legislation as described in Vol9a. It has been described as one of the most substantial changes to European PV requirements in well over a decade.

The launch of legislation 1235/2010 and 2010/84, including the 16 sets of guidance notes, has meant that from July 2012 the next evolutionary stage of PV for companies with licenses in the EU begins.

P

The European Community The EU has four main institutions—the European

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Working Party (SAWP), established according to regulation 726/2004.

The legal framework

Parliament (EP), the European Commission (EC), the Council of Ministers ( C M ) a n d the European Court of Justice (ECJ).

Activities of the EMEA The EMEA coordinates the scientific evaluation of the quality, safety and efficacy of medicinal products which fall into the scope of the EU licensing centralised procedure.

In addition, EMEA coordinates the resources for scientific evaluation and assessment regarding products undergoing mutual recognition procedure and the master files for plasma and vaccine antigens. Scientific opinions of the agency are prepared by committees i.e. the Committee for Medicinal Products for Human Use (CHMP), the Committee for

Medicinal Products for Veterinary Use (CVMP), the Committee for Orphan Medicinal Products for rare diseases (COMP) and the new Committee on Herbal Medicinal Products (HMPC).

Another important task of the EMEA is to provide guidance for companies requesting scientific advice (EMEA/H/4260/01) and providing scientific advice before the application of new marketing authorisation for centralised and mutual recognition procedures.

This is done via Scientific Advice

The legal framework of PV for medicines marketed within the EU is provided for in Regulation (EC) No 726/2004 with respect to centrally authorised medicinal products and in Directive 2001/83/EC with respect to nationally authorised medicinal products (including those authorised through the mutual recognition and decentralised systems). Thus the EU legislation is based on regulations and directives.

In addition, Commission Implementing Regulation (EU) No 520/2012 on the performance of PV activities stipulates operational details in relation to certain aspects of PV to be respected by marketing authorisation holders, national competent authorities and EMA.

EU’s PV system All medicinal products in the EU are subject to strict testing and assessment of their quality, efficacy and safety before being autho-

Summary of PRAC Activities & Involvement Activity

Involvement

Risk Management Systems

Agreement on RMPs + Monitoring the effectiveness

Periodic Safety Update Reports

List of harmonised submission frequencies & substances, + assessment + recommendation

Eudravigilance + PSUR Repository

Functional specifications, substantial changes

Medicines Subject to Additional Monitoring

Addition to/removal from list, extension of timeframe, symbol

Signal Detection

Initial analysis + prioritisation, assessment + recommendations

Urgent Safety Procedures for the EU

Assessment, public hearings, recommendations

Post Authorisation Safety Studies

Consultations on requests (pre and post MA), assessment of protocols (incl. amendments) + recommendations, assessment of results + recommendations

Literature Adverse Drug Reactions monitoring

Consultation on list of active substances and medical literature subject to monitoring?

Safety announcements

Advice

www.expresspharmaonline.com

November 16-30, 2012

rised. The EU PV system is one of the most advanced and comprehensive systems in the world and represents a robust and transparent process, thus ensuring a high level of public health protection throughout the EU. The new EU PV regulation includes improving patient safety and public health through better prevention, detection and assessment of adverse reactions to medicines. It also allows patients to report adverse drug reactions directly to the competent authorities.

Additionally, reporting of adverse reactions is broadened to cover, for example, medication errors and overdose.

The main pillars of the new legislation are: ● Proactive and proportion-

November 16-30, 2012

THE APPROVED CHANGES TO THE NEW EU PV LEGISLATION REPRESENTS A MAJOR OVERHAUL OF THE CURRENT EU PV LEGISLATION AS DESCRIBED IN VOL9A. IT HAS BEEN DESCRIBED AS ONE OF THE MOST SUBSTANTIAL CHANGES TO EUROPEAN PV REQUIREMENTS IN WELL OVER A DECADE ate risk management Higher quality of safety data ● Stronger link between safety assessments and regulatory action ● Strengthened transparency, communication and patient involvement ● Clear tasks and responsibilities for all parties (marketing authorisation hold●

www.expresspharmaonline.com

ers, competent authorities, EMA) ● Improved EU decisionmaking procedures (harmonised decisions and efficient use of resources) ● Establishment of a new scientific committee at the EMA: The Pharmacovigilance Risk Assessment Committee

Good pharmacovigilance modules (GVP) The new guidance on good pharmacovigilance practices (GVP) is organised into modules. The EMA has released the GVP guidelines in order to facilitate the performance of PV activities.

These GVP modules replace Volume 9A of, 'The rules governing medicinal products in the European Union – Pharmacovigilance'. GVP are a set of measures drawn up to facilitate the performance of pv in the EU. They apply to Marketing Authorisation Holders (MAHs), the Agency and medicines regulatory authorities in EU Member States, and aim to improve safety for patients by strengthening pv across the EU. These modules cover both, medicines authorised

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centrally via the Agency as well as medicines authorised at national level.

The guidelines on GVP is divided into 16 modules, each of which covers one major process in PV. The Agency published the first batch of seven modules in June 2012, after a public consultation period from February to April 2012, which are listed below and finalised for use from July 2012: ● Module I: PV systems and their quality systems ● Module II: PV systems master files ● Module V: Risk management systems ● Module VI: Management and reporting of adverse reactions to medicinal products ● Module VII: Periodic safety update reports ● Module VIII: Post-authorisation safety studies ● Module IX: Signal management Module III on PV inspections and Module X on processes for additional monitoring of medicinal products were released on June 27, 2012 for public consultation until August 24, 2012. Two further modules, i.e. Module IV on PV audits and Module XV on safety communication, are now released for public consultation over eight weeks.

– released for consultation Module V Risk Management Systems published ● Module VI Management and Reporting of Adverse Reactions to Medicinal Products - published ● Module VII Periodic Safety Update Report - published ● Module VIII PostAuthorisation Safety Studies - published ● Module IX Signal Management - published ● Module X Additional Monitoring – released for consultation ● Module XI Public Participation in Pharmacovigilance ● Module XII Continuous Pharmacovigilance, Ongoing Benefit-Risk Evaluation, Regulatory Action and Planning of Public Communication ● Module XIII Incident Management (tbc) ● Module XIV International ●

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contain all the details of the QPPV, proof that the applicant has a QPPV at the MAHs’ disposal 24/7, details of the Member States where the QPPV resides and carries out his/her tasks, a reference to the site at which PSMF for the medicinal product is located. The PSMF may be requested by the CAs and must be provided within seven days of a request been made, and the PSMF will be one of the reference documents for subsequent pv inspections.

It should be noted that the MAHs shall be required to perform regular audits of their PV systems and processes and must include a note of the main audit findings in the PSMF. Based on these audit findings that MAH should propose a CAPA plan which must be implemented. It is interesting that the new legislation specifically states

Serious HCP

Serious Consumer

Non-Serious HCP

Non-Serious Consumer

Pre July 2012

✓

✗

✗

✗

Post July 2012

✓

✓

✓

✓

●

Collaboration (tbc) Module XV Safety Communication – released

the committee, including clinical pharmacology and pharmacoepidemiology, on

that “once the corrective actions have been fully implemented, the note can

The timelines for reporting (calendar days) for these events are as follows: Serious HCP

Serious Consumer

Non-Serious HCP

Non-Serious Consumer

Pre July 2012

15 days

✗

✗

✗

Post July 2012

15 days

15 days

90 days

90 days

Timelines for finalisation of GVP The full set of 16 final modules is scheduled to be available by early 2013 as listed below. The remaining five draft modules of the GVP package are under development and are scheduled for release for an eightweek public consultation during the third and fourth quarters (Q3 and Q4) of 2012. ● Module I Pharmacovigilance Systems and their Quality Systems - published ● Module II Pharmacovigilance System Master File published ● Module III Pharmacovigilance Inspections – released for consultation ● Module IV Pharmacovigilance Audits

tion, assessment, minimisation and communication relating to the risk of adverse reactions, having due regard to the therapeutic effect of the medicinal product, the design and evaluation of the postauthorisation safety studies (PASS) and pv audit. This committee shall also be responsible for providing recommendations to the CHMP on any question relating to pv. Apart from mandating all RMPs and monitoring their effectiveness and PASS, it will also be reviewing PSUR assessment report conclusions and signal detection activities.

The membership to the PRAC would consist of Member State appointees, patients, healthcare representatives and six members appointed by the European Commission, with a view to ensuring that the relevant expertise is available within

for consultation Module XVI Tools, Educational Materials and Effectiveness Measurement for Risk Minimisation

the basis of public call for expressions of interest.

Changes to the new EU PV legislation

Anyone working in a PV department will know that the current practice according to Vol9a is that, all MAHs should have a detailed description of pv system (DDPS). As per the new legislation, a DDPS will no longer be required and this will be replaced by the PSMF. MAHs will have to produce and maintain a PSMF, which will contain the summary of the applicants PV system and should

●

PRAC and decision making Under the new legislation, Pharmacovigilance Risk Assessment Committee (PRAC) replaces the Pharmacovigilance Working Party, but with increased responsibilities. The formation and creation of PRAC will have the mandate on all aspects of risk management of the use of medicinal products, including the detecwww.expresspharmaonline.com

be removed from the PSMF.”

Obligations of a MAH New requirement by all MAHs to have Pharmacovigilance System Master File (PSMF)

Article 104 and 106a clearly defines specific obligations of the MAH as defined in the new legislation. Article 104: Monitor the outcome of risk minimisation measures which are contained in the RMP or which are laid down as conditions or requirements in the MA. It states the following: Update the risk management system and monitor PV data to determine whether there are new or changed risks or whether there are changes to the benefit-risk balance and November 16-30, 2012

Equally, and according to National regulations, the type of serious reports to be expedited varied between serious expected and unexpected, whereas for the above rules the following is true: Serious HCP

Serious Consumer

Non-Serious Consumer

✗

✗x

✗

Pre July 2012

Serious expected unexpected

Post July 2012

Serious expected AND Serious expected AND Non-Serious expected Non-Serious expected AND unexpected if occurred unexpected if occurred AND unexpected if unexpected if occurred in the anywhere in the world anywhere in the world occurred in the EU EU

take appropriate measures as necessary Specific obligations of the EU QPPV have been substantially amended. This includes that the QPPV must be permanently and continuously at the disposal the MAH; must reside and operate in the community and shall be responsible for the establishment and maintenance of the PV system.

However, there is no men-

or

Non-Serious HCP

tion of having a Deputy QPPV! Article 106a: Inform the authorities at the same time or before the MAH makes a public announcement relating to PV concerns.

Therefore, the QPPV retains a key responsibility for ensuring that the MAH is able to comply with EU PV obligations and must have sufficient and considerable authority to do so. MAHs

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that breach these obligations shall be subject to effective, proportionate and dissuasive penalties!

Adverse drug reaction (ADR) reporting New definition of ADR: A response to a medicinal product that is noxious and unintended NOT only in authorised use in normal doses, but also includes, medication errors; misuse;

abuse and overdose.

Article 107 for the new legislation makes substantial amendments to the reporting requirements. It states the following: MAHs shall record all suspected adverse reactions which are brought to their attention and shall ensure that those reports are accessible at a single point within the community (including reports from post-authorisa-

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63

tion studies). The MAH shall not refuse to consider reports of suspected adverse reactions received electronically or by any other appropriate means from patients and Health Care Professionals (HCPs) and all expedited reports to be be submitted electronically and all such reports to be submitted via one route i.e. to the EudraVigilance.

All MAHs shall submit to authorities: Information on all serious suspected adverse reactions that occur in the community and in third world countries within 15 days following the day on which the holder concerned gained knowledge of the event. All serious reports must be submitted regardless of expectedness.

For post-marketing cases, the reports have to be submitted electronically in the EU within 15 calendar days of being presented with a reporter; event(s); company suspect product; and patient details (four minimum criteria). Under the new legislation there are marked extensions to these expedited reporting requirements as mentioned in the non-serious, suspected, adverse reactions that o c c u r in the community, within 90 days following the day on which the holder concerned gained knowledge of the event.

With the new regulations now in force from July 2012, the number of reports that will be submitted to the regulatory agencies in the EU will dramatically increase, as will the amount of reporting from the pharma companies.

The MAH must establish procedures in order to obtain accurate and verifiable data for the scientific evaluation of adverse reaction reports, and must collect follow-up information on these reports (including, where possible, batch details). This means that some obligations that were previously specified in guidance are now in legislation, making it more tough and mandatory.

MAHs shall collaborate

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with EMA and the Member States in the detection of duplicate adverse reaction reports. Compliance with the new obligations will be examined on inspections performed after implementation.

Processes for the management of adverse reaction reports will need to be reengineered and procedures will need to be amended in order to address the new requirements by all MAHs, and pharma companies who market their products in the EU have to plan for these changes and consider the implications for all relevant areas of the business. Staff will need to be trained on the new requirements and procedures and new SOPs written.

Literature searching As per the new legislation, the EMA shall monitor

cates that the EMA shall establish a list of all medicinal products authorised in the community. For this to come to affect, the following measures needed to be taken: EMA by July 2, 2012 has already made public a format for electronic submission of medicinal product information.

MAHs, by July 2, 2012, shall electronically submit information for all medicinal products authorised or registered in the community, using the format, to EMA. It shall also inform the EMA of any new or varied authorisations.

Development safety update report (DSUR) The guidance was adopted by CHMP in September 2010 and has already been implemented in the EU from September 1, 2011. This

PSURs have been significantly amended in the new legislation. It states the following: For many generic and traditional herbal medicinal products, PSURs will no longer be required.

However, competent authorities can request PSURs for these products on the basis of PV concerns.

As a result of the new requirements for data analysis deliberations, the regulators have recognised that this will take a longer time to prepare for MAHs and a new template is now available and published, but so do the times for being able to prepare and submit the PSURs after the data lock point.

The renewal PSUR will also change, in that previously, there was a renewal PSUR submitted after four years and six months, but

Periodicity of PSURs

Old Timeline

New Timeline

PSURs < 1 year in length

60 days

70 days

PSURs >1 year old

60 days

90 days

Renewal PSUR

4 years and 6 months

4 years and 3 months

selected medical literature for reports of adverse reactions to medicinal products containing certain active substances. It shall publish the list of active substances being monitored and the publications subject to this monitoring.

For products containing the active substances referred to in the list of publications monitored by the EMA, MAHs shall not be required to expedite reports from these sources to the Eudravigilance database, but they shall monitor all other medical literature and report any adverse reactions, as required.

The conclusion is that literature searching will still need to be conducted by the MAHs for the purpose of PSUR production and ongoing safety review.

means that as of September 1, 2011, all MAHs are required to submit DSUR in place of annual safety reports (ASR).

As per the new regulations, the DSUR requires the sponsor to explain the processes and deliberations for potential safety signals and what, if any, new safety signals have meant to the overall benefit:risk profile.

Again the emphasis of the benefit:risk calculation is to explain how this was calculated so that rather than provide an overall conclusion to the benefit:risk profile, the regulators can read the sponsors methodology of calculating the benefit:risk profile to determine if they agree. The length of time to write up such a report (DSUR) still remains 60 calendar days.

EU medical product dictionary

Periodic safety update reports (PSURs)

The new legislation indiwww.expresspharmaonline.com

The

requirements

for

now the submission has to be made in four years and three months, giving the regulators nine months to review, rather than six months previously.

Also, now there will only be one renewal for a product unless there are on-going serious safety concerns, which may result in a further renewal submission.

MAHs shall submit to EMA PSURs containing summaries of data relevant to the benefits and risks of the product and MAHs shall be required to submit PSURs containing, a scientific evaluation of the risk-benefit balance of the product. The evaluation shall be based on all available data, including data from clinical trials in unauthorised indications and populations. All data relating to the volume of sales and any data in possession of the MAH relating to the volume of prescriptions, including an November 16-30, 2012

estimate of the population exposure. PSURs shall be submitted electronically.

In summary, greater emphasis will be placed on the scientific evaluation with benefit/risk evaluations of the product done routinely and Inspectors will have access to data and documents well in advanced prior to any proposed inspection as PSURs will have to be submitted electronically and this may reduce pre-inspection requests.

Signal detection The new legislation indicates that CAs in collaboration with the EMA must monitor the Eudravigilance database and there is a role for PRAC to perform the initial analysis and prioritisation of signals based on seri-

November 16-30, 2012

GREATER EMPHASIS WILL BE PLACED ON THE SCIENTIFIC EVALUATION WITH BENEFIT/RISK EVALUATIONS OF THE PRODUCT DONE ROUTINELY ousness. In addition, there is also an obligation for authorities to inform each other and MAHs when signals are detected.

MAHs are obliged to evaluate all PV information scientifically, consider options for risk minimisation and prevention, as well as take appropriate measures as necessary.

The EudraVigilance database is now made available to various stakeholders for undertaking various activities primarily being signal detection activities through

www.expresspharmaonline.com

the EV web portal in the EMA website.

Risk management plans (RMP) RMP is defined as, “a set of PV activities and interventions, such as studies and reports, designed to identify, characterise, prevent or minimise risks relating to a medicinal product, including the assessment of the effectiveness of those activities and interventions.” As per the new legislation, there is a requirement to have RMP for all

new products which should be risk proportionate. It also states that there should be a legal basis to require a risk management system/plan for all authorised products (if there are concerns about risks affecting the risk-benefit balance). The new legal requirement in this legislation states that 'EMA and MS’s shall monitor the outcome of risk minimisation measures contained in the risk management plans and of conditions.

Post authorisation safety studies (PASS) PASS is defined as, “any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, Continued on Pg 76

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QbD in tablet film coating From January 2013, the US FDA expects drug manufacturers to implement QbD principles in their Abbreviated New Drug Applications (ANDA).

Suresh Pareek, Managing Director, Chetan Rajsharad, Vice President – Technical and Ashok Omray, President – R&D, give an outlook and stresses on the benefits of this notification and how Ideal Cures can help pharma companies to adhere to this new regulations

harmaceutical dosage forms designed for generic products is mostly a duplication/replication effort, whether it is meant for introduction in the domestic Indian market or for registration of generic sales in semi to highly regulated international markets.

At the end, the objective to be achieved is quality equivalent to the innovator/brand product or Reference Listed Drug (RLD) so that quality drugs can be made available to patients at a relatively economic price. Since no compromise on the quality of the product (including the bioavailabilty and therapeutic efficacy) is acceptable, the review of the documents relating to development and the product quality, is going to be very crucial.

New guidelines which are now governing the development and review procedures by US FDA are adopted in the form of ICH Q8, Q9 and Q10 which suggest that quality needs to built up by design and there is a need to justify the design of experiments (DoE), which would ensure and control the product quality for the total life cycle of the products. It must also provide avenues for continuous improvement and risk management for the customer. ICH Q8 (R2) is basically detailing the pharma development whereas Q9 and Q10 deal with the Quality Risk Management (QRM) and Pharmaceutical Quality Systems (PQS).

Moreover, all components and the processes involved in the manufacturing process may have an impact on the

SURESH PAREEK Managing Director Ideal Cures

P

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The US FDA has made a notification that QbD submission will be a requirement for ANDA filings from January 2013 overall quality of the finished dosage form so the concern, consistency, criticality and control has to be at all levels.

ICH has been a very effective platform to provide the uniform standards and understanding all across the globe so that thinking, standards and interpretations have been very well understood.

Pharma development assumes a greater importance since the basic designing of the product is initiated in the laboratory which must ultimately provide consistent quality of the finished product batch after batch. Thus all the controls, specifications, machines/ equipment and process conditions need to be studied and firmed up from the laboratory levels starting from few hundred

units to millions units batch sizes via scale-up and then commercially manufactured.

It has been the goal that the variables must be so standardised and human element must be so limited that the product quality and the performance do not get into danger zone at any time during the process or while on the shelf.

The following aspects which are the backbone for any systematic development and now covered under QbD make a perfect glossary to be always borne in mind – ● Quality Target Product Profile (QTPP)– This relates to the safety, quality and efficacy of the product and needs to be defined right in the beginning or initiation of the project ● Critical Quality Attributes (CQA)– Property that should be within a particular range insuring desired product quality ● Critical Process Parameters (CPP) – It really does not require any elaboration, since all depends on the process and the parameters, if not controlled and monitored there is all the possibility to have inconsistency and variability in the end product. These must be identified and understood during the development stage itself by experimentation Design of Experiments (DoE)– Process parameters selected based on the risk assessment form the basis

GUIDANCE PROVIDED AT CDER SITES TALK ABOUT THE PROTOTYPE DEVELOPMENT PLAN FOR IMMEDIATE RELEASE AND MODIFIED RELEASE TABLETS, BUT STRANGELY THE FILM COATING ASPECTS HAVE NOT BEEN COVERED TO THE DESIRED EXTENT www.expresspharmaonline.com

for design space Involves purposely changing one or more inputs and measuring the effects on one or more outputs ● Differs from the historic approach of employing the Proven Acceptable Ranges (PAR) The benefits to be achieved by adopting QbD are projected to be far beyond the investment of time and resources during the development. A single recall due to quality issues can cause huge losses and will have an irreparable damage to the company image.

Owing to this, the regulatory authorities are going to come strongly on such cases as there is a growing concern about the effect on the patient who may be dispensed such inconsistent / undesired quality product before the remaining batch is recalled from market (if any). The following are few highlights of the type of advantages one can foresee: ●

Enhanced process understanding ●

Higher process capability ● Minimised losses ● Higher productivity ● Better product quality ● Value addition ● Increased flexibility to implement continuous improvement and changes The US FDA has made a notification that QbD submission will be a requirement for ANDA filings from January 2013. This is going to facilitate the review process and will ensure the life cycle management of the quality and continual improvement process.

Guidance provided at CDER sites talk about the prototype development plan for immediate release and modified release tablets, but strangely the film coating aspects have not been covered to the desired extent. Formulation development cannot be limited to the excellent core tablet formulation only if the end product is a film November 16-30, 2012

FILM PROPERTIES AND THE PRODUCT APPEARANCE HAS A MUCH GREATER IMPACT ON THE OVERALL PROFILE OF THE PRODUCT ducted at the end like any other routine activity. We cannot rule out the obvious if the finished product is the film coated tablet, its efficacy and stability is going to be determined by the presence of the film quality and the effectiveness of the entire film coating process.

After all it is the quality of film coating which gives the first impression about the overall quality of the finished product.

The film properties and the product appearance will have a much greater impact on the overall profile of the product.

We film coat the tablets for following attributes, there November 16-30, 2012

can be still many more reasons than what are enumerated below: 1. Elegance (Aesthetic, Appeal, Appearance and Gloss)

2. Product identification 3. Strength differentiation (Same size and multiple strengths) 4. Dust elimination and smooth feel

5. Branding and IPR 6. Palatability (Taste masking and flavoured tablets) 7. Film Coating may be functional (Moisture barrier,

delayed Release/Enteric coated) 8. Facilitating packaging (Dust free operation, Smooth flow, Facilitating count) 9. Improving administer-

® Trademark of The Lubrizol Corporation © 2011 The Lubrizol Corporation

coated one.

At Ideal Cures, we realised that film coating is also a complex activity and what meets the customer’s or the patient’s eyes is the finished product. Hence, the attributes expected of a film coated tablet formulation need to be fulfilled all the time and therefore the core and coated products cannot be viewed independent of each other. We believe that film coating development must be considered right in the beginning when the formulation development work starts. We cannot modify the core tablet characteristics after the formulation has been developed. Any deviation is likely to have an impact on the predetermined quality attributes. For immediate release type product the film coating may be regarded as a very trivial exercise as it is going to be more of cosmetic nature adding to the elegance of the product rather than any therapeutic or functional value.

Since the basic polymer and the colorants are declared, the film coating can be con-

Carbopol® polymers are highly efficient gel matrix formers for controlling drug release in solid dosage forms. They offer versatility and flexibility… a winning combination.

Processing Versatility n Ability to choose various manufacturing technologies n Available in both powder and granular forms (Carbopol® 71G NF polymer) Flexibility n In modulating drug release n In formulation - Actives with different properties can be formulated to achieve various extended release profiles

Carbopol® Polymers High Performance Pharmaceutical Ingredients

Efficiency (low total polymer level) n Enables smaller tablet size n Potential formulation cost savings Synergies with other commonly used controlled release excipients

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Lubrizol Advanced Materials India Pvt. Ltd., Application & Business Center, Jaswanti Landmark, 6th & 7th Floor, L.B.S. Marg, Vikhroli (West), Mumbai-400079 Phone: +91-22-66027800 Fax: +91-22-66027888 www.pharma.lubrizol.com

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ing to patient (Swallowing for children and older people) 10. Film coating may help isolate the incompatible compounds in the same dosage 11. Film coating may enhance the stability of the product 12. Film coating may help extend the shelf life of the product If the above objectives are to be achieved then the film coating cannot be left to be developed at a later stage.

The thoughts have to be initiated in the beginning and the film coating formulation needs to be developed or evolved at the same time.

Undoubtedly, the compatibility of the drug substance will be better known to the development scientist but it is not essential that the person has acquired perfection in balancing the film coating process so that a reproducible and stable film coating is assured.

As a film coating materials manufacturer, Ideal Cures understands its responsibility towards the pharma product and will cooperate with the formulation personnel to evolve a complete strategy/framework for the successful film coated tablet products.

The film coating formulation consists of multiple components having functionality for imparting effective film. The physical attributes of the film, which are to be satisfactorily complied, will be namely – ● Film adhesion, strength and elasticity ● Film texture, ● Uniform thickness, ● Uniformity of colour distribution, ● Film intactness under accelerated stability testing conditions ● Must perform its function if it is a functional coating (barrier to light, water vapours etc. or delayed release) ● Must not come in the way of the profile and performance of the core tablet ● No interaction (physical or chemical) with the core or actives contained therein

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scenario, there are possibilities that the man, machine, material and utilities coupled with precision and control steps may still show up unacceptable behaviour if any of the linkage is overlooked. cGMP compliance and adherence to the specifications of the input materials and the process controls for the manufacturing of film coating formulations (commonly to be referred as coating premix) can be assured and so the consistency of the supplies. The factors which come into prominence are the equipment, tablet characteristics, process controls Ideal Cures will and the batch sizes. cooperate with the Film coating processes formulation personcontinually involve following nel to evolve a operations – strategy/framework ● Distribution of coatfor the successful ing liquid on large number of tablets film coated tablet ● Continuous mixing of products tablets in coating pan The control on the film ● Continuous drying of coating materials, method of the sprayed coating manufacturing, finished liquid product specifications, addi- ● Removal of solvent tional quality criteria for the vapours from the materials to ensure conystem sistency and reproThe distribution ducibility form of coating susIn a basis for the pension by way a complex dialogue of thin uniscenario, there are between form spray possibilities that the the formuover long man, machine, material l a t i o n periods of and utilities coupled with developt i m e precision and control ment scienb e c o m e steps may still show up tist and film most critical unacceptable behavcoating techand this will iour if any of the nologist. It is be determined linkage is overimportant to by properties of looked note that the film the suspension, coating operation use pump, spray guns and the semi finished (uncoatthe quantum of air supplied ed) product at the formulato achieve the above. The tors’ end which will be then spray as a mist or droplets subjected to multiple unit must deposit on the tablet operations involved in film surface without getting dried coating before the finished while in the air. If it dries product is obtained. Tablet while still in the air then manufacturing involves there is a possibility for the mainly the unit processes dried powder settling on the like—milling/communition, surface and resulting into sifting, mixing, granulation spray drying causing rough (wet or dry, aqueous or sol- surface and even failure of vent), slugging, drying, siz- functional coat like enteric ing, lubrication, blending coating. and finally compression. The Continuous mixing at film coating process compul- optimal speed will bring sorily involves - dedusting, about the renewed tablet surmixing, warming/heating, face coming in the spray wetting during spray coating zone providing opportunity (water or volatile organic sol- for uniform spray on entire vents), drying and curing (at tablet bed; therefore the times). In such a complex speed of rotation, the design-

CHETAN RAJSHARAD Vice President – Technical Ideal Cures

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ing of the coating pan and the tablet load will be critical factors to determine the end quality.

The continuous spray of the coating suspension will introduce lot of solvent to the tablet bed and hence the uninterrupted drying by way of adequate air flow and proper temperature coupled with extraction of the solvent saturated air becomes the critical set of operations running concurrently in tablet coating process. The complete coordination of these four operations by way of balancing and arriving at the optimal operational range will ultimately determine the success of the manufacturing and the quality of the product.

We at Ideal Cures have observed that the expertise in the film coating technology in pharma research and development laboratories may not be very easy to achieve and therefore it is very much essential to develop this technology from the basic level. The process may start from somehow attaining a particular shade and coat a limited number of tablets in any type of available set of equipment and reach to a preliminary set of parameters. Many a time no such parameters get evolved in the initial development process. The task is normally assigned to some laboratory technician or laboratory attendant and the process becomes very much personoriented based on that individual’s skill, understanding and moods.

The selection of the laboratory equipment is normally not based on critical reviews and the necessary consideration of the experiments.

Objective is to have a film coating system for the laboratory so any common system (manual/semi – automatic or automated) is considered good for all scales and types of products. Let us accept that especially for film coating, the laboratory scale operations hardly compare with real situations (merely because of the scale of operation). We therefore strongly feel that for adopting a scientific approach and to completely understand the process, the interaction November 16-30, 2012

between the formulation development scientists and film coating technologists must take place in the conceptual stage and the design of experiments must be evolved for a trouble free development cycle.

It needs to be appreciated that as we look for an ideal coating system, likewise, an ideal substrate (core tablets) is equally important for the best results. The basic difference in the tablet manufacturing and tablet film coating is all the unit operations are working at the same time during coating while in tablet manufacturing the operations may get divided or compartmentalised; film coating process therefore need extra consideration and optimisation.

● ●

grants Specific excipients usage Lubricants like magnesium stearate, which may make the

●

surface non-wetting and non-adherent Compressibility and thermal expansion of various ingredients of core tablet

Coating formulation – The most important input is the film coating formulation which conveys the film former onto the surface. It also has all the materials which

will impart the film formation, adhesion, resilience, strength, impermeability etc.

The attributes which are to be controlled – ● Viscosity of the film

Design of experiments and design space The design of ments for the film development will be on the following

expericoating focused factors

THE SELECTION OF THE LABORATORY EQUIPMENT IS NORMALLY NOT BASED ON CRITICAL REVIEWS AND which, we have identified as critical ones starting from the tablets characteristics to the complete coating process, parameters and devices to be used.

Core tablet properties – It is well known fact that the shape, size, markings, surface etc., play a very critical role in optimising the film coating. It is not so simple that the coating suspension spray will give a perfect coat.

The tablets attributes which need to be controlled and optimised for a perfect finish will mostly involve – ● Size and weight ● Shape ● Diameter of curvature ● Hardness and friability ● Logo or score-line or other markings (must preferably be absent) ● Presence of disinteNovember 16-30, 2012

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coating suspension Solid content Particle size distribution of the suspended solids ● Polymer / plasticizer properties and their concentrations ● Opacifier and colorants ● Solvent system Coating machine related – Factors constituting the major problem areas and in many cases the infrastructure related issues may become the constraints for working on other factors for successful processing. The important ones are – ● Coating pan dimensions ● Surface area ● Perforated area ● Balance between inlet drying air v/s exhaust air ● Inlet air volume ● Inlet air temperature ● Exhaust air volume ● Exhaust air temperature ● Tablet bed temperature Mixing efficiency – It is the most important criteria for uniform coating and colour distribution. Various factors which may influence the process are: ● Pan speed ● Tablet load ● Tablet bed porosity ● Baffle design and their numbers Spray gun – It acts as the heart of the whole process since it transfers the film former to the tablet surface and the tablet bed. This device becomes very critical in the complete process and hence, the choice and use has to be done after thoroughly examining the gun quality and adaptability.

Even after selecting the correct type of spray gun, other factors which can influence the overall control of the process are: ● Number of spray guns ● Gun to gun distance ● Gun to bed distance ● Angle of gun to the tablet bed ● Atomising air pressure ● Atomising air volume ● Nozzle orifice diameter ● Fan width control ● Total spray rate ● ●

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ASHOK OMRAY

for all the guns 6. Drying temperature must be within close tolerance of the heating efficiency.

7. Solvent retention on the tablet bed must be completely avoided.

8. Spray rate must be frequently monitored.

9. All the process parameters must be recorded at a predetermined frequency and deviations be immediately reported.

At Ideal Cures, we realised that QbD for film coating is going to be an important area so we have developed the design of experiments keeping in mind Ideal Cures is that the film coating is no geared up to implelonger an art or skill, it has ment the QbD at our evolved into a complete sciown works and supentific process and automaport the industry to tion. From mere observations and experience, the process achieve the best controls have eliminated quality, consistency, human errors and the net product performresult is precision, reproance, risk manageducibility and consistency of ment and control the coating formulation, strategy process and the end product for the customer.

A strict control on ● Balance of the quality and spray rate consistency of in differIdeal Cures raw materials e n t has developed the (from validatguns design of experied and ments keeping in mind approved Important that the film coating vendors) is Do’s and has evolved into a being exerDon’ts for complete scientific cised.

The efficient film process and process paramecoating – automation ters are chalFrom the lenged and safe limabove it can be its are evolved and the understood that each product performance in and every control is going terms of functional attributes to have an impact on the process, product and per- is verified. Control strategy formance. We can in nutshell to mitigate the risk is in place suggest some ideal tips for by way of critical quality attributes of the finished excellent film coating – 1. Film coating suspen- product, which are well consion must not be aerated and trolled at all levels and risk is managed. should be foam free 2. Pan size must be as per the load or batch size of the Important areas and charge avenues for collaboration 3. Uniform mixing and for QbD rolling of the tablets in the It has been amply pan must be ensured. The demonstrated that the film tablet bed should not be sta- coating has been an importionary or fall from a big tant factor to help in product height performance, patient compli4. Compressed air used in ance, reducing the risk and the process must be oil free improving stability therefore and should not carry water the important determinants droplets (must be dry) to achieve the above and 5. Spray rate from each help in QbD: gun must be checked before ● Tablet characteristics start and must be uniform and properties

President – R&D Ideal Cures

www.expresspharmaonline.com

●

●

(Robust / suitable for coating) Film coating formulations (compositions and quality components) Film coating process (machine/operation controls/monitoring)

Ideal Cure approach for development and meeting QbD Most stringent product development processes and quality assurance norms applied to our products.

Product Development (Customer and product based) ● Selection and screening of polymers and plasticisers ● Compatibility trials ● Material sources and suppliers /compendial specifications ● Colour matching systems ● Formulation proto type and optimisation ● Application trials and observations to optimise the critical factors ● Scale-up ● Stability of the formulation and film

Controls and assurance ●

cGMP adherence and continual improvements ● In-process controls ● Quality confirmation of the powder, dispersion and dispersion performance. ● Strict in-house release criteria ● Batch manufacturing and reproducibility as per customer needs. ● Open for customer and regulatory audits and willingness to implement new ideas and mandatory requirements With all the above, Ideal Cures is geared up to implement the QbD at our own works and support the industry to achieve the best quality, consistency, product performance, risk management and control strategy at all levels.

The authors can be contacted at info@idealcures.co.in (Articles in the series will continue in future) November 16-30, 2012

Akums – redesigning & global healthcare A kums Drugs & Pharmaceuticals was established in Haridwar, Uttarakhand in 2004. Its promoters and directors have more than three decades of experience in pharmaceutical marketing and manufacturing. The company began its journey with third party manufacturing at one plant. But, in a span of eight years, established six manufacturing units of international standards manufacturing formulations in practically all dosage forms and therapeutic segments including hormonal, herbal and neutraceuticals.

Quality, timely delivery, reasonable rates, transparency and honesty in dealings have brought popularity to Akums amongst its clients in India and across the globe. Many multi-national and big pharma companies in India are its clients.

This accomplishment has been a result of excellent team work. Today, Akums has become an icon of India’s healthcare industry and a quality pharma manufacturer with a global vision.

reliance on commodity products. Its strengths lies in devel-

oping new formulations, undertaking clinical trials,

obtaining Drugs Controller General of India's (DCGI)

approval for manufacturing and marketing new fixed dose

Infrastructure/facilities To meet the emerging demand of herbal medicines across the globe, Akums has set up a separate state-of-theart-manufacturing facility to produce high quality herbal, nutraceutical and food supplement products at its 100 per cent-owned subsidiary plant— VI in the name of Maxcure Nutravedics.

Sprawling over an area of more than 600,000 sq ft, Akums' six state-of-the-art manufacturing units are of international standards having modern and sophisticated manufacturing facilities which include ultra modern plant, machineries and equipment, in-house testing facilitiesinstrumentations and microbiology laboratories.

Akums has a huge manufacturing capacity in all sections. It has a dedicated facilities for low RH, clavulanic acid preparations.

Business model Akums’ focus rests on specialised products with limited November 16-30, 2012

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formulations (FDCs) and molecules and later offering new formulations with Akums own technology to its customers under their brand names.

The main features of Akums’ business models are: ● Emphasis on research and development of formulations based on NDDs ● Development in process and packaging ● Development of new drugs and obtaining DCGI's approvals ● Development of technology and transfer to others. ● Patenting of innovative drugs ● Service and satisfaction to customers with quality and timely delivery ● Creation and retention of customers with transparent dealings.

Quality / innovative formulations Akums believes that the key to stay ahead in competi-

tion is by meeting quality requirement of the customers first time and every time, meeting international standards. Akums has developed innovative formulations that include: tablets in tablet; sustained release products; antibiotics syrups in ready mix (ready to use); medicines in palatable jelly form; effervescent tablets and powder; tablets and powder in mouth dissolving form; capsule in capsule; multiple tablets in a capsule; liquid vitamins in soft gel; taste masking of bitter drugs and chewing gums (medicinal).

Maxcure Nutravedics, which is US-NSF certified, produces formulations in the form of tablets, capsules (hard/soft gel), liquid orals, powder. Maxcure has developed unique products for most prevailing diseases, such as; male pattern baldness, anxiety, arthritis, hypertension, obesity, uric acid etc. to

name a few. In its six state–ofthe–art manufacturing facilities, Akums produces formulations in different dosage forms

Exports Apart from contract manufacturing for more than 200 leading Indian/multi-national companies for their domestic and export requirements, Akums has also gained entry into the international pharma market and has made its presence in Libya, Nigeria, Belarus, Tajikistan, Russia, Ghana, Ukraine, Venezuela, Myanmar, Sri Lanka, Nepal, Bhutan, Hong Kong, Philippines and is all set to commence business in various other semi-regulated and regulated countries.

Akums has a full-fledged regulatory department with qualified and experienced personnel, who can prepare dossiers as per CTD, ACTD and guidelines of MOH of different countries. Akums has already submitted more than 350 dossiers in different semi and regulated countries.

Company at a glance Location : Six plants located at Haridwar (Uttarakhand) Manufacturing capacity per day: Tablets 52 million, Capsule 10 million, Liquid Orals 0.5 million, Dry Syrup 0.3 million, Soft Gelatin 3.5 million, Injection: Liquid Ampoules & Vials 1.0 million, Dry Powder 1.0 million, Eye/Ear Drops 0.3 million, FFS-100ml infusion 0.1 million Total area: More than 600,000 sq ft.

Products: More than 1,500 different formulations in all dosage forms and practically in most of the therapeutic segments. More than 300 approvals in different dosage forms for New FDCs and molecules developed by its F&D Department have been obtained for manufacturing and marketing from DCGI. Machineries and laboratories: Ultra-modern and sophisticates machineries, 60 packaging lines, five ALU-ALU, two AF150,RMGs, four Fluid Bed Processors, Auto-Coaters, two FFS, six Tunnels, Sophisticated R&D, F&D and microbiology laboratories equipped with latest instruments, 40 HPLCs, 2 FTIRs,

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GC,TOC, DG Sets, 5,000 KVA water systems, Scada, Hot & Cold Loop, 60- AHUs etc.

Quality: Highest quality standards backed by cream of industry’s personnel in QA,QC & production departments.

Accreditations: WHO-GMP, ISO:9001, ISO:14001, HACCP, US-NSF, GMP-Ayush International accreditations : ANVISA-Brazil, NAFDACNigeria, FDB-Ghana, PMPBMalawi, CD&DA – Sri Lanka, DDA-Nepal, DPM-Ivory Coast, MOH- Libya, MOH-Vietnam, MOH-Venezuela, NDAUganda, PPB-Kenya, MOHBelarus Customers: Almost all leading pharmaceuticals companies of India including few MNCs. Domestic Institutional Registration: UNOPS, AFMSD, DMER, ESIC, GMSD, Indian Railways & Municipal Corporation.

Highlights of the company: ● Akums produces the best Quality products. ● Akums has WHO-GMP, ISO:9001, ISO:14001. ● Akums has the highest and probably the best manufacturing capacity in India. ● Akums has the manufacturing facilities for specialised products as well. ● Akums has best sophisticated laboratory, best R&D and F&D centre. ● Akums manufactures highest number of products in India. ● Akums has large number of technical and non-technical personnel. ● Akums product delivery is quickest in India. ● Akums has MNCs and top pharma companies of India/abroad as its clients. ● Akums possesses all essentials of business men, material, machines, money, marketing, management, motivation. ● Akums is professionally managed consisting of its employees with dedication, diligence, devotion, determination, dynamism, discipline and direction. ● Akums knows how to create customers and how to retain customers. ● Akums is a quality pharma formulations manufacturer of India with a global vision.

November 16-30, 2012

Advanced Enzymes ith a history spanning more than half a century, Advanced Enzymes Technologies (Advanced Enzymes) has emerged as a worldwide leader in the production of plant, microbial and animalbased enzymes. In 1957, the Founder, LC Rathi, pioneered the extraction of papain, an enzyme complex derived from papaya fruit and widely used for pharmaceutical and medical purposes.

Since 1989, Advanced Enzymes has continued to grow with that same entrepreneurial and innovative spirit and today, it is the largest manufacturer of enzymes in the Indian subcontinent!

The company prides itself as one of the few manufacturers in the world that produces a full spectrum of enzymes derived from all four natural origins: plant, fungal, bacterial and animal.

The company also manufactures probiotics, especially Bacillus coagulans and Saccharomyces boulardii. The state-of-the-art ISO 9001:2008 certified manufacturing facilities utilise the most advanced, surface and submerged fermentation technologies available.

With environmentallyfriendly biotechnology as thebase, the extensive research advances have led to the development of more than 400 unique enzyme products, making Advanced Enzymes a major value provider to processing industries and nutrition suppliers worldwide.

With the strength of 47+ enzymes today, the company through its technical enzyme expertise is able to create value, and provide solutions, to its clients in 59+ countries globally.

Advanced Enzymes operates in four key verticals: human nutrition, animal nutrition, food processing and industrial processing. For each vertical, the company’s subsidiaries focus exclusively on delivering solutions to the industries that operate within that vertical. Advanced Vital Enzymes (Advenza) is the Human Nutrition vertical, while Advanced Bio-Agro Tech (Bio-Agro) focuses on

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November 16-30, 2012

animal nutrition. Advanced BioPro Solutions (BioPro) focuses on the Food

Processing vertical while Advanced EnzyTech Solutions (EnzyTech) focuses

on the industrial processing vertical. They have also established Advanced

Enzyme Far East (Far East) to cater to the large and growing Chinese market.

YOUR PRODUCTION PROCESS FOR TOMORROW Integrated and tailored solu ons for your process with

Gla Engineering Consul ng Process Engineering General Planning Implementa on Valida on / Qualifica on

GMP-Compliance Services

From the idea to turnkey produc on in the pharmaceu cal and biotech industries

Training

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

Please visit us at Booth D 48, Hall 6 www.expresspharmaonline.com

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United Biotech

nited Biotech, one of the fastest growing pharmaceutical companies in India, was established in 1997. A multi-crore entity, with WHO-cGMP and ISO 9001:2000 certified state-ofthe-art manufacturing facility, its has strategic tie ups with several MNCs, apart from having one of the most exciting product pipelines in the industry today. UBPL embod-

U

ies a very human spirit by always remaining at the forefront to introduce lifesaving drugs. Over the years, United Biotech has earned goodwill for scientific innovation, vision and integrity. The innovativeness, competitiveness and a will to succeed against all odds are the qualities that are at the heart of UBPL culture.

All this synergise the dreams of the founder, who has spent his lifetime in the pursuit of his mission of providing world class medicines at an affordable costs. The vision of the company is to be a prominent company in the national and international healthcare arena, with focus on manufacturing, research, formulation, marketing and to per-

sistently deliver new products from the companyâ&#x20AC;&#x2122;s strong pipeline, penetrating new markets and leveraging its strong position in current markets. The company aims to become the best and most respected pharma company with an eye on cutting cost and providing economical and world class medicine to patients around the world.

In order to achieve success, the company has the following objectives: To be a world class research driven manufacturer of formulations & APIs fully committed to quality, to add ethical value to business practices and conduct business with all integrity, honesty and transparency, to be a leading pharma company through the

launch of latest innovative medicines, to serve the ailing mankind through economical and latest proven molecules, to create value for our customers by bringing innovative products to the market faster and lastly but most importantly doing business without harming our environment.

The company's strength lies in the formulation and manufacturing of the following categories: oncology formulation, liposomal formulation, lyophilised formulation, hormonal products, pre-filled syringes, modified release formulation, sustained release formulations, life saving antibiotics and anti-infectives.

fine/speciality chemicals.

The MPP manufacturing capacity is designed to address semi-bulk requirements of customers, ranging from 50 kgs to a few tons.

The MPP is operated by technical staff having many years of experience in handling difficult reactions, as well as multi-step synthesis.

The MPP is very versatile in its operations, and has the capability to carry out wide range of reactions, involving all phases of media such as solid-liquid, liquid-liquid, liquid-gas, etc. The entire plant can operate under vacuum or inert atmosphere, to facilitate handling, and production of air sensitive, and potentially hazardous entities. It is under environment control, with near zero emission of pollutants.

Moreover, the facility is specifically designed to carry out reactions which require accurate control of process conditions. The matrix of the MPP PLC SCADA, through a network of pneumatically actuated controllers, manages a wide array of parameters, for both utilities, and in-process, which are essential for safe, accurate, and reproducible

multi-step synthesis.

The entire production batch cycle is monitored and, controlled in real time, by data acquisition of all relevant process variables such as RPM, time, temperature, weight, pressure, vacuum etc, which are also recorded in real time. This enables the MPP to document all reaction conditions with precision and therefore comply with most, customer, as well as, regulatory/statutory requirements.

SDFCL has a very strong emphasis on quality throughout the organisation and at all levels of operations. It has a dedicated quality assurance department to audit, as well as develop quality procedures and functions. The company documentations are devised to ensure complete traceability of all processes. The company's ultramodern QC labs are equipped with sophisticated and state-ofthe-art equipment to facilitate accurate and reproducible impurity profiles up to trace levels. Currently, the labs are fully equipped to analyse the entire spectrum of impurities, chemical as well as biological.

S D Fine Chemicals ver the years, S D Fine Chemicals Limited (SDFCL) has developed multiple assets to produce a large range of lab/fine/speciality/rare and research chemicals. It is the only catalogue company in India having the capability to produce high purity solvents, as well as complex organic compounds and analytical reagents for highly critical applications right from grams to several tons.

SCFCL has over 400 employees, including highly skilled and experienced doctorates along with several chemists.

All products are benchmarked with international acceptable standards and their performance is suitable for all demanding applications, across all industries.

SDFCL has 20,000 sq mts of manufacturing facilities, for producing a large range of chemicals which comprises basic chemicals for synthesis, high purity analytical reagents, HPLC solvents, pesticide residue solvents, pharmacopoeia chemicals and other rare/research/speciality chemicals. It has a large and dedicated solvent rectification facility with products like HPLC solvents,

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solvents for pesticide residue, solvents for electronic applications, as well as other organic liquids, from few hundred litres to kilo litres.

The company has another facility that exclusively produces analytical reagents, complex organic compounds with multi-step synthesis, rare and research/specialty chemicals, as well as pharmacopoeia chemicals. In fact, this facility is one of the most modern plants and is FDA approved as well as GMP certified. This makes SDFCL one of the very few catalogue companies in the world, having this kind of infrastructure. All operations in this plant are SCADA controlled and the plant finishing area is under AHU. It also manufactures BP/USP/NF range of pharmacopoeia chemicals as well as intermediates for API in this plant.

With a view to strengthen its manufacturing operations, and exploring new opportunities for growth, the company has constructed a state-of-the-art PLC SCADA Multi-Product Plant (MPP) for producing www.expresspharmaonline.com

November 16-30, 2012

Granules India ranules is a large scale manufacturing company that partners with market leaders to offer pharmaceutical products and services. It has a long history as a producer of APIs, pharmaceutical formulation intermediates (PFIs) and finished dosages (FDs).

As a fully vertically integrated pharma manufacturing company, it has three core lines. In APIs, Granules has three factories manufacturing APIs. Granules also pioneered the concept of PFIs and currently has two factories manufacturing single and multiple-active PFIs. The company's Gagillapur facility has an industry-leading 6 MT single batch size. Granules has a dedicated finished dosages plant at the Gagillapur facility which has the capacity to produce 6 billion tablets annually and is scalable up to 12 billion tablets. The facility has received

G

approval from US FDA, Infarmed and the Australian TGA. The company's integrated model allows it to provide products throughout the value chain in a costeffective and efficient manner. It serves over 300 customers in 50 countries through sales offices in India, the US, the UK, Colombia and China.

Granules has highly sophisticated production processes in order to manufacture a broad assortment of products, thereby supplying a wide range of products and services to our customers in a flexible and reliable manner.

The company's products can be used in a range of pharma applications and is constantly developing new products and variants to meet its customers' specific requirements.

Its product specialists, supported by application

technologists, research scientists and regulatory advisers are able to provide immediate advice and customer support. By offering unique products and a high level of customer support, the company can offer its customers the competitive advantage that is vital in the highly competitive pharma sector.

Granules encourages its customers to replace their conventional strategy of captive manufacturing with prudent outsourcing.

The company's green initiatives will not only help the environment, but will lower operating costs and will support our endeavour to become a preferred partner. Starting from the implementation of 'Environmental Best Practices' at the Gagillapur facility (recognised by CII), the use of sophisticated equipment to collect the dust generated during

process activities and material transfer, having a delegation of eco-friendly measures to employee levels, to converting the entire plant into a non-smoking area, Granules' robust environment management comprises many other efforts. It also conducts wastewater analysis on effluent samples, does frequent tests and monitors the ground water, soil, ambient air, stacks and noise levels.

It has also implemented cleaner technology to minimise liquid effluent, gaseous emission and solid waste.

Hazardous solids from various production stages and effluent collection tanks are sent to the Hyderabad Waste Management Project for safe disposal.

Gaseous emissions too are scrubbed, cleaned and made harmless with suitable chemical reagents before they are released.

entry through production till it reaches finish good stores and sold.

The whole process, from when the time material enters, to exits, is controlled with an ERP system which is US FDA certified. The ERP system is so sophisticated that it allows each department in the organisation to interact with each other. The ERP system produces, saves and processes huge amounts of data such as batch wise reports, QA/QC reports batch wise, Accounting reports, HR reports, purchase reports, sales reports etc., this allows each department of the company to focus on business growth rather than tedious day to day activity.

Renown Pharmaceuticals' quality assurance department ensures consistent quality products by maintaining vigil through QA checks at each stage.

The company employs a

team of qualified, experienced and dedicated professionals. It is backed by a 'best in class' infrastructure and world class technology.

The company believes in Total Quality Management (TQM) System and is highly focused about maintaining compliance of international regulatory standards. This is ensured by the QA team, right from the document preparation, review and record the product and process control to get the consistent quality.

Renown has invested in sophisticated infrastructure which enables it to develop various new dosage formulations in soft gelatin capsules form such as suppositories, inhalant capsules, therapeutics, ayurvedic, nutraceuticals, enteric coated capsules, delay release capsules, sustained release capsules, and cosmetics.

Renown Pharmaceuticals eeping in mind the ever increasing demand for soft gelatin capsules for pharmaceuticals, nutraceuticals, cosmetics and herbals, Renown Pharmaceuticals has set up a state-of-the-art soft gelatin capsule manufacturing facility with a capacity of 3.5 billion capsules a year. This facility is designed keeping in mind international regulatory requirements and the company aims at getting approvals from organisations such as US FDA, MHRA, TGA, WHO-GMP and MCC. It also intends to cater to domestic as well as global customers.

Renown Pharmaceuticals is promoted

by Ramesh Jatia, who is the chairman and managing director.

The company has a vision to be a leader in the contract manufacturing space of soft gelatin capsules by 2014, and aims to provide

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November 16-30, 2012

quality products at competitive cost with a faster product development cycle, by effecting on time delivery and to maintain cordial relations with customers.

The company has invested a significant amount to build a state of the art infrastructure and is currently starting with an infrastructure of two encapsulation lines with a capacity to install another eight lines.

The manufacturing facility is equipped with best of the machinery and technology available in the market. This includes state-of-the-art encapsulation machines which produce up 60,000 capsules an hour, top of the range HVSE system supported with fully functional and sophisticated BMS system, a very sophisticated water and RO system. The facility is also backed by a QA/QC team which is responsible for all the quality tests of material from the time of www.expresspharmaonline.com

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Implementing and adapting...

Continued from Pg 65 confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures’. The new requirements in the new legislation apply to non-interventional PASS. Authorities may require the MAH to submit the protocol and progress reports to the Member States in which the study is conducted. The new legislation also states that the final study reports should be sent to these Member States within 12 months of the end of data collection. Any new information from a PASS which might influence the evaluation of the risk-benefit balance of the product shall be communicated to the national competent authorities where the product is authorised.

For a PASS requested by EU authorities, the draft protocol will need to be submitted for endorsement to PRAC or to the competent authority in the concerned Member State (if the study is only being conducted in one Member State).

Amendments to the protocol will also need to be submitted prior to implementation, as will final study reports and abstracts. As stated before in this article, PRAC may make recommendations concerning the terms of the MA based on the results of safety studies.

One of the key and important aspects in this new legislation is to strengthen the legal basis of PASS, so that regulators can impose PASS on industry at first authorisation and also on post-authorisation. PASS would be a condition of the authorisation which would be legally binding and in the event that the same safety concern applies to more than one product, the EMA/national competent authorities (NCAs) shall encourage the MAHs concerned to conduct a joint PASS, leading to the conclusion that more PASS will be

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done!

In general, there will be more oversight of safety studies that has been included in this new legislation.

Summary of product characteristics (SPC) and patient information leaflets (PILs) The new legislation states that for medicinal products subject to additional safety monitoring under Regulation 726/2004, the SPC shall include this statement, “This medicinal product is subject to additional monitoring,” which will be preceded by a black symbol. At the present time, what type of symbol will be included has not been specified.

Also, for all medicinal products, standard text shall

pv inspections. Inspectors will have the right to inspect the premises, records, documents and PSMF of MAHs or any firms employed by the MAH to perform pv. The Member State Supervisory Authority responsible for EU inspections of MAHs with centrally authorised products will no longer be the Member State where the QPPV is based, but the Member State where the PSMF is located.

Increased transparency, communication and patient involvement As per the new legislation, substantial powers have been given to the regulatory agencies to make information available from all MAHs on their products available on web portal and

web-based structured forms ● Summaries of PSURs and RMPs of medicinal products with PV issues

Conclusion The EU pharma legislation provides extensive rules and guidance on licensing procedures for medicinal products for human use that ensure high quality and safe therapies. The new legal basis will facilitate the integration of the new accession countries and will strengthen the procedures further.

This new EU PV legislation represents the most extensive change to the EU PV requirements for over a decade and biggest changes to human medicines since the establishment of the EMA in 1995. This has

PASS WOULD BE A CONDITION OF THE AUTHORISATION WHICH WOULD BE LEGALLY BINDING AND IN THE EVENT THAT THE SAME SAFETY CONCERN APPLIES TO MORE THAN ONE PRODUCT,THE EMA/NATIONAL COMPETENT AUTHORITIES (NCAS) SHALL ENCOURAGE THE MAHS CONCERNED TO CONDUCT A JOINT PASS, LEADING TO THE CONCLUSION THAT MORE PASS WILL BE DONE! be included in the SPC asking HCPs to report any adverse reaction in accordance with the national spontaneous reporting system. For all medicinal products, standard text shall be included in the PIL asking patients to communicate any suspected adverse reaction to his/her doctor, pharmacist, healthcare professional or directly to the national spontaneous reporting system. The PIL will specify the different ways of reporting adverse reactions to authorities and MAHs.

Quality management systems and PV inspections There will be greater cooperation and more sharing of information between EU competent authorities and EMA for the co-ordination of www.expresspharmaonline.com

in public domain. The documents and information from MAHs that will be made available on web portal for access to the public will include the following: ● Public assessment reports together with a comprehensive detailed summary ● Information on each product, a summary of product characteristics (SPC) and patient information leaflets (PILs) ● A list of all medicinal products that are subject to additional intensive monitoring ● Coordination by EMA on communications of safety issues ● Information on different ways of reporting adverse reactions to the EU competent authorities by health care professionals (HCPs) and patients, including

already had a major impact on existing regulatory processes and there will be a need for numerous new processes.

There has also been major implications on the well trained human resources in the field of PV, IT and regulatory, in addition to financial resources in the pharma industry worldwide. MAHs have already started to realise the huge amount of resources that will have to be put in place and are in the process of planning now to re-engineer processes and databases, revise procedures, train staff etc, and to put in practice the new set of the EU regulations!

The author can be contacted at pipasha.biswas@gmail.com November 16-30, 2012

+ Better late than never PG 78

‘Combining dissolution and hardness testers, we have more than 50 installations in India' PG 82

‘Automation will be the key for Indian pharma machinery manufacturers’ PG 84

Mobile product On line particle measureauthentication: Protecting ment: PAT Solutions for pharbrands globally PG 85 maceutical industry PG 86

Efficient blister package to pass stability PG 89

The Falsified Medicines Directive (FMD): Origin, mission & provisions PG 92

Better late than never The implementation of secondary level packaging delayed was delayed by almost a year. Usha Sharma talks with industry stalwarts and analyses the importance of the track and trace mechanism for the Indian pharma industry

I

India, which is the third largest drug producer globally by volume and 14th by value, has been the target of attempts to derail its global reputation. For example, spurious and counterfeit drugs made in China but labelled as 'Made in India' were found in Nigeria in 2009.

As much as 40 per cent of the Rs 100,000 crore sales of domestic pharma companies comes from exports. In a bid to safeguard exports from India from usch moves, India’s Directorate General of Foreign Trade decreed in 2011, that all Indian pharma manufacturers will have to print unique barcodes on primary medicine packages by January 2013. A high-level task force on pharma manufacturing also recommended the phased adoption of unique code verification technology and mobile SMS authentication for all domestic medicines produced in India. The task force, assembled by the Union Health Ministry last year, undertook research on available track and trace technologies as part of an ongoing effort by the government to curb drug counterfeiting.

According to these new regulation while primary-level packs will see incorporation of 2D bar codes (data matrix symbol) on medicines at strip, vial and bottle encoding of unique product identification code, batch number, expiry date and serial number, similar details

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will be displayed on the secondary and tertiary levels (shipper or carton) using 1D or 2D barcodes.

This vital information saved in the bar code can help regulators track medical consignment to the country of origin and have access to valuable information. The move is not only aimed at improving the reputation of the Indian pharma industry in the international market but it also aims to curb illegal channels of trade.

As per the planned agenda secondary level packaging was initially scheduled to be implemented from January 2012, but

“The track and trace system was new for the Indian pharma industry when launched and many pharma companies had apprehensions regarding the investment needed, implementation time frame, productivity loss etc versus benefits which the system would provide.

There was no clear understanding of the concept of track and trace versus its benefits. This resulted in delay / extension of implementation of the system on secondary packaging.”

Faguni Jain, Sales Manager, Sproxil India also shares similar views, commenting,“The mandated implementation was

SMEs. Also, companies may have to compromise on speed of packaging line after implementation.”

Jain shares her clients' experience that many of them faced problems with other service providers where the solution that was proposed to them by these providers was leading to a significant loss of efficiency on the packaging line and was hence unacceptable. Thus, the industry is still ambivalent about what is the best way forward to implement these changes in a cost effective manner, without compromising on the efficiency of the

AVINASH MANDALE

DIDIER LACROIX

FAGUNI JAIN

Vice President, Technology Business, Bilcare Technologies

Senior Vice President, International Sales and Mark, Cognex

Sales Manager, Sproxil India

There was no clear understanding of the concept of track and trace versus its benefits.

This resulted in delay / extension of implementation of the system for secondary packing

This is a positive step towards controlling illegal counterfeiting of drugs. Apart from installing less expensive hardware, manufacturers mainly in SME segment, are also suggesting the option of a phase-wise implementation of bar-coding which will drastically reduce the immediate financial burden which they are facing today

The recommendations are definitely astute.

In developing economies similar to India, where telecom penetration is high, SMS verification technologies have proven to be very effective in increasing the quality of healthcare being provided

got delayed and shifted to September 2012, however, it did not happened in the said period.

Giving reasons for this delay, Avinash Mandale, Vice President, Technology Business, Bilcare Technologies informs,

delayed because the industry was not ready. A major chunk of pharma exporters from India are from the small and medium enterprises (SME) sector. The capital expenditure required for implementation is large and hence possibly prohibitive for

packaging line.

www.expresspharmaonline.com

SMS verification With India providing a phenomenal proportion of the world's generic medicines - particularly to developing markets - there have also been concerns November 16-30, 2012

that access to essential medicines could suffer as a result of the initiative.

“The industry has been running from pillar to post to convince officials from the Department of Commerce to see reason as they argued that the implementation of bar-coding on secondary level packaging would entail a string of regulatory, technical as well as cost issues, which will harm the pharma exporters in the country,” reveals Didier Lacroix, Senior Vice President, International Sales and Mark, Cognex.

Lacroix identifies that the main problem was, "A major switch such as the one proposed by the (Indian) Government in any production line is a challenging task as other parameters need to be adjusted to sync in line with the changes. Moreover, adopting the 2D bar-coding will mean implementing expensive machinery and process systems.”

“The recommendations

November 16-30, 2012

are definitely astute. In developing economies similar to India, where telecom penetration is high, SMS verification technologies have proven to be very effective in increasing the quality of healthcare being provided. The ability to verify the genuineness of the products empowers the end consumer and closes the feedback loop between the end consumer and the manufacturer,“ confirms Jain.

“This is a positive step towards controlling illegal counterfeiting of drugs.

Apart from installing less expensive hardware, manufacturers mainly in the SME segment are also suggesting the option of a phase-wise implementation of bar-coding which will drastically reduce the immediate financial burden which they are facing today. According to their suggestions, the barcoding system should initially only apply to tertiary packaging (shipper or carton), instead of the current proposal for making it

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mandatory on all including primary, second, and tertiary packaging,” adds Lacroix.

Jain further highlights that Sproxil has seen huge success in economies similar to India – both in consumer engagement and also in law enforcement. He points out, “A very relevant indicator of the success of the SMS verification technology is the number of end consumers served rather than number of units coded.

Sproxil has served more than two million consumers and our consumer participation rates are as high as 20 per cent for some products.

In addition to this, we have seen a huge success with law enforcement with actual cases of counterfeiting caught with evidence and the perpetrators brought to justice by using the Sproxil solution.

Hence, the recomm endation of the task force is very relevant and their vision is very far sighted.”

No preparation for change There are various approaches to optimise cost of implementation of the system depending on the quantum of exports of a given pharma company.

Mandale shows his concern, “It is important to have a clear understanding on various approaches and what is most optimal for a given pharma company. The mandate came all of sudden and pharmacos were not prepared which further contributed to the delay.

However, the understanding is improving which is natural and was to happen as part of the process. The recommendations of the task force are excellent, however, there should have been exposure of the industry to the system through seminars for stakeholders, articles in journals and demos for pharmacos to see how the system works.

Implementation currently has been only at tertiary level by most pharma companies. Few pharma

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companies have already gone ahead with the implementation at secondary level.”

Growth driver Indian pharma companies have a good reputation globally in terms of quality of pharma formulations. It is important that spurious drugs do not impact that credibility. Export products are a sensitive issue with most manufacturers because once they leave the ports, the manufacturer has little control over the supply chain. Hence, these products are susceptible to counterfeiting, theft and other questionable supply chain practices.

Lacroix says, “Being the third largest drug producer in the world, the task force on Track & Trace 2011, evolved as a boon to the

pharma and packaging industry. This is a good and positive initiative taken by the Indian government to curb drug counterfeiting.

This move will even improvise the reputation of the Indian pharma industry in the international market.“ He further informs, “However, not many companies have implemented this system. It is seen that big pharma companies (like Ipca Laboratories, Sun Pharma, Dr Reddy’s apart from others), have implemented it on their production lines. It is observed that medium and small scale industries are expected to adopt and implement the system by the end of December 2012. However, we are receiving satisfactory number of enquiries from the customers on the same.

But government enforce-

ment is required for adopting the system throughout the industry.”

Listing out the benefits of this technology, Jain also highlights, “The mandate to secure exported products by track and trace solutions will help exporters retain a measure of control over their products and brands.

Manufacturers will be able to recapture lost sales and hence increase their sales revenues. Also, they will have the ability to connect with their end consumers in different geographies. Many of our clients who export products to African economies have seen an increase in sales revenue by over 10 per cent simply by being able to recapture sales lost to counterfeit products.

Some clients have recovered lost shipments and many are running marketing cam-

paigns to connect with end users. Hence, there will be an overall improvement in supply chain management, sales and in brand value by this government initiative of mandating track and trace solutions. Yet there still exists some confusion in the market regarding the deadline of implementation of track & trace, as government of India has not yet come up with recent updates.”

There is no argument that the protection of pharma formulations against the menace of counterfeits is very important. The Indian Government initiative therefore is in the right direction and in the interest of pharma companies and patients safety. All that is needed is a rational and well thought out plan to choose and implement a suitable aolution. u.sharma@expressindia.com

P-MEC India 2012 to showcase latest pharma machinery products To be held in Mumbai from November 21—23, 2012 -MEC India, the most talked about pharmaceutical machinery and technology event is going to be held at Bombay Exhibition Centre.

The event from November 21-23, 2012, will see leading Indian and international pharma machinery exhibitors showcase their latest technologies and launch their products.

Halls 5 and 6 will showcase the latest pharma machinery and production processes involved in tablet and capsule filling, coating, packaging, bottle / vial filling. Also, on display will be analytical instruments, clean room equipment, process control automation, filtration/ separation processes and more. P-MEC focuss on key challenges in pharma services to develop more efficient production routes and systems of increasingly complex healthcare products.

At P-MEC India buyers

P

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can connect with sellers of pharma machinery and equipment on an international scale. India’s domestic market is expanding and developing rapidly and so are the opportunities within pharma manufacturing, procurement and technology.

Attendees can actively form partnerships and begin their purchasing process. Senior pharma decision makers from all over the world will come together during the three-day show to conduct business, establish and create new business opportunities, share knowledge and further existing relationships within the industry.

The Indian pharma market is rapidly expanding, presenting exceptional opportunities and P-MEC India will give those involved in pharma manufacturing an unprecedented insight into the future of mechanical equipment and machinery. The exhibition will highlight the latest www.expresspharmaonline.com

knowledge and the newest trends within the industry.

The pharma machinery and equipment sector for the last five years has made P-MEC India the place for exhibiting their latest products and technologies. PMEC India is the preferred venue of leading companies to showcase their latest accomplishments in pharma machinery and equipment.

The exhibit space will be occupied by exhibitors from China, Germany, Italy, India, Switzerland, Spain, Taiwan, the UK the US and other countries.

The flagship event CPhI , along with ICSE and BioPh exhibitions are also co located with P-MEC. With the combined exhibit profiles of CPhI / ICSE / P-MEC / BioPh and over 800 exhibitors, the event will offer the pharma industry a unique value proposition of having under one roof four comprehensive events encompassing ingredients, machinery and technology, contract research and manufacturing and also bio

pharma solutions.

There has been remarkable advancement, particularly in the last two years, in the automation of pharma machinery. Sophistication, greater speed, high quality and appearance are important aspects in addition to the performance of these machines. India has stateof-the-art manufacturing facilities approved by international regulatory agencies. In the long-term, all indications point towards the continued growth of pharma outsourcing to India.

This trend will perpetuate the rising demand for production equipments and related technologies, for which P-MEC India is the leading event platform.

India’s competitiveness has given a further boost to exports and accelerated growth for Indian manufacturers in the recent past.

The staging of such shows is expected to pave the way for the expansion of the country’s pharma manufacturing industry.

November 16-30, 2012

Expectations from P-MEC India 2012 MP Technical Solutions (GMP) has been a regular participant of PMEC India since 2007.

PMEC has always been one of the best platforms in Asia to showcase latest machineries and equipment in the pharma sector. GMP has always displayed its latest offerings at PMEC, even choosing PMEC 2010 as a launch pad for its new Isolator.

One cannot afford to miss out on PMEC, the largest of its kind and risk missing out on the largest gathering of potential customers under a single roof. GMP expects this year’s PMEC to be bigger and better than the previous one and as has always been the case, GMP will showcase its entire array of products at PMEC 2012.

As always, we expect a lot of existing, as well as potential customers to visit us. We put in a lot of thought and efforts on the design of our products and the display stand. This will subse-

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quently help us to generate a large number of potential sales leads. PMEC is a medium that directly brings prospective customers to us helping us in accomplishing multiple objectives at a single stand – sales, marketing, customer relationship management, market research and brand building subsequently generating revenue in the future.

It is not only about the stand though – our products, services as well as our sales team will help attract more attention. Choosing the right exhibition is extremely essential - the right people must be targeted to get the best ROI from your stand and PMEC is undoubtedly the best platform to do this. It will help us in analysing our customers who can share their ideas as well as expectations from GMP and also ultimately help us in developing better products overcome our shortcomings.

uring the PMEC India 2012 exhibition, we plan to launch and showcase our world-class state-of-the-art machines with latest advanced Korean Technology to the subcontinent and global pharma industry.

We expect a successful positive response from the visitors, on our existing machines, as well as newly launched machines with Korean technology. We are sure that our increased product range will be of great interest not only to our existing clients but also attract new potential customers. With our increased product range, we are now in a position to offer total customised solutions to our clients and their needs. Moreover, we are in line with our vision and mission to introduce more new range of products like cleaning & disinfection machines, specialised toolings, etc.

RAVI THAKUR VP-Marketing, GMP Technical Solutions

www.expresspharmaonline.com

D

MUKUND S MODI Sr. Vice President Karnavati Engineering

CG has been building relationships with customers for over five decades now and PMEC provides unparalleled opportunity for us to strengthen ties with our customers. We intend to showcase our new product innovations to thousands of visitors from across the globe that come to India for worldclass pharma machinery and equipment."

A

AJIT SINGH Chairman ACG Worldwide

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'Combining dissolution and hardness testers, we have more than 50 installations in India' The Indian pharmaceutical sector is getting tech savvy as most pharma companies have already become semi-automated. Dr L Ramaswamy, Managing Director, Sotax India explains the usage of automation in different pharma departments including QC and R&D, in discussion with Usha Sharma What is the extent of automation within QC and R&D laboratories and manufacturing within the pharma industry?

In QC and R&D, the concept of automation is growing in terms of dissolution tests and content uniformity (assay, blend) tests. Taking the example of dissolution tests, the time of taking samples manually is over. Most laboratories in India now work in a semi automated manner. But, more and more the concept of full automation is getting accepted and developed. Preparing the media, degassing, filling the vessels, cleaning and flushing the vessels and tuning all these steps are fully automated in a machine like the Sotax AT 70 smart fully automated system. Taking the example of an Immediate release (IR) tablet with a dissolution time of 30 minutes, the Return on Investment (ROI) is extremely quick.

Considering that it takes less than 15 minutes between the end of the first test and the beginning of the new test, it is easy to calculate the gain in terms of time and costs.

INTERVIEW

weight measurement of tablets and capsules with fully automated tablet testers for IPC/IPQC laboratories.

How does automation at the QC and product development lab level benefit pharma companies?

I summarise that the main reason is not only 'speed' but especially the wish to reduce out of specifications (OOS) results. For example, automating all the important steps of a content uniformity test can reduce the risks of OOS dramatically.

All the Sotax automated systems come with CFR Part 11 compliant software which means that each technician has his own user rights.

Therefore, no mistakes can be done in modifying the methods. They just have to log in and start the pre-registered tests, nothing more!

Thus, automation brings a lot of advantages at the QC level.

What are the regulatory guidelines for driving further automation in pharma labs?

CFR Part 11 Compliant guidelines have been given

and physical tablet/capsule testing (hardness and weight) instruments for the pharma industry. Sotax instruments meet all USP, EP, FDA, FIP guidelines. Sotax has the privilege of being the worldâ&#x20AC;&#x2122;s first supplier of dissolution testing systems to receive the seal of TickIT Quality system for software development.

Over the years, Sotax has established an excellent international reputation as a specialist in the development and production of sophisticated test equipment and automated systems. It also

SOTAX NOW HAS ALMOST 100 PER CENT OF THE MARKET SHARE IN THE SEGMENTS FOR FULLY AUTOMATIC DISSOLUTION SYSTEM AND CONTENT AND ASSAY TESTING Three important reasons for laboratories going the fully automated way for their tests are faster, better and safer results.

Which are the processes that have been automated over the years?

Mainly dissolution, content uniformity and also in manufacturing hardness and

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by the US FDA. They limit the access rights in the software and offers a high level tracking of all actions.

What is Sotax's role in this industry segment?

Sotax is a global leader providing high-quality dissolution testing systems, composite assay and content uniformity testing workstations, www.expresspharmaonline.com

offers its know-how as a service to the pharma industry, including installations, maintenance and repair services as well as a comprehensive and careful validation service in compliance with FDA regulations. For helping the pharma companies globally in method development and application, Sotax has created a separate centre

called SPS Pharma Services (CRO) in France, a contract research lab dedicated to dissolution testing research.

Sotax integrated the Zymark automation product line, resources and services in 2008. This has helped Sotax to penetrate to US lab automation market well.

What is its global market share?

After acquiring the dissolution product line from Caliper (Ex-Zymark) we can say that Sotax now has almost 100 per cent market share in the segments for fully automatic dissolution system and content and assay testing. We have almost no competition and are driving the market. In fully automatic tablet hardness testers we are reaching the level of 20 per cent market share.

Every pharma company will have different workflows and products, so is customisation possible in these hardware/software solutions? And does Sotax engage with their customers on this effort?

The goal of Sotax is to reduce customisation by thinking ahead on the different aspects of the automation November 16-30, 2012

concept. But if needed, yes, Sotax can produce some specific solutions (options) for some specific needs.

When was Sotax India set up?

With the objective of serving the Indian pharma industry, Sotax AG formed a 100 per cent own Indian subsidiary in 2010 and appointed me as the Managing Director.

As of today, Sotax India has its registered office at Mumbai and a team of well trained sales and service engineers. Sotax India has also set up a Demo Lab in Mumbai in which most of the Sotax Testing Systems are kept. This is where industry professionals/academia can come and lay their hands on our systems. They can also do some trials on our instruments/machines at the demo lab.

Tell us about the companyâ&#x20AC;&#x2122;s experience in the Indian market? Who are your competitors?

November 16-30, 2012

Most of the multinational pharma companies who use our systems globally are now present in India. This makes our penetration in the Indian market a little easier since they have already experienced our systems and services in other countries.

Our initial responses were from MNCâ&#x20AC;&#x2122;s and in the beginning of our second year many Indian companies have started buying our systems and services. Since Sotax is the pioneer for USP IV (Flough Throush cell), most of the users choose Sotax CE 7 smart only. Combining dissolution and hardness testers, we have more than 50 installations in India. I expect this to cross 200 in the next two years.

For dissolution, the competition comes from both domestic companies like Electrolab, Lab India and multinational companies like Distek, Erwekka etc.

For hardness tablet tester the competition is from Erwekka. And for fully auto-

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matic systems, we have no competition as of now.

What were the global revenues in the last fiscal year and what percentage comes from India sales?

Sotax world wide has a turn over of CHF 50 million and India is currently contributing six per cent of the global revenues. I expect this will enter the double digits by next year.

What is the target growth for the current and next fiscal year?

Globally, we plan for a double digit growth with the introduction of some new products in line. In the current year we have almost doubled the number of installations. I expect to repeat the same in the next fiscal year for Sotax India.

What is the strategy to achieve this growth, given the depressed global economic scenario?

I have laid down a very

clear cut strategy and tactics to achieve an 100 per cent growth in the fast growing Indian pharma market. By further strengthening our service area and enhancing our reach in the Indian market we can penetrate and get more market share than what we have today.

Also channelising our efforts towards promoting the science and development in the field of dissolution with the help of leading and well experienced industry leaders and academia professionals from India and abroad shall help us to carve a niche for Sotax in the Indian pharma industry. My belief is that in spite of a depression in the global economic scenario, the companies involved in healthcare and education may not get affected very adversely since they take care of two very important aspects of human life. Hence I do not see any negative wave for our line of business in the next five years. u.sharma@expressindia.com

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â&#x20AC;&#x2DC;Automation will be the key for Indian pharma machinery manufacturersâ&#x20AC;&#x2122; P V Narayanan, Secretary General, The Institute of Packaging Machinery Manufacturers of India (IPMMI), opines on strengths and weaknesses of Indian pharma machinery manufacturing sector, in an exclusive discussion with Sachin Jagdale What are the major challenges for the pharma packaging machinery manufacturers in India?

The total number of pharma machinery manufacturers is over 500 in India. For them, the challenges would be the quality aspects, meeting the global needs and standards, accuracy, compatibility, versatility, ease in operation and switch over and maintenance. The other aspect would relate to service capability and availability of spare parts.

Tell us about the major achievements of IPMMI. The primary achievement is the success of bringing the major packaging machinery manufacturers together. This has helped in organising various national and international events like exhibitions and conferences and industry meets. The IPMMI could also showcase the capabilities of the members through these forums thereby benefiting them in their market expansion, diversification and possibly overseas collaboration and joint ventures. The IPMMI could also enter into understanding with leading overseas exhibition organisers for organising events in India and promote the interests of members overseas.

There has been a steady increase in the membership of the association including those who offer ancillary equipment and services.

Overseas packaging machinery manufacturers are considered superior to their counterparts in India.

What are the steps needed to be taken to minimise this quality gap?

Speed and automation/ sophistication is expected from Indian pharma machin-

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ery manufacturers. If one carefully analyses this fact, one will bear out the outputs and at the same time acceptance and growing demand for the Indian made machines in various other parts of the world clearly reflects the capabilities of the domestic sector. Also, many overseas leading packaging machinery manufacturers looking at India to market and subsequently resource the domestic capability to produce machinery in India for the global market speaks eloquently of the Indian capability. Yet, the domestic sector may have to address the issues on import substitution of niche component and develop more automated and sophisticated machinery and equipment keeping the future in view. Cost reduction, environmental, ergonomics, quick changeover, reduced waste are some other considerations the industry could look for.

Do you conduct educational activities/seminars for your members? What are the common complaints/suggestion you hear from the participants?

The IPMMI organises series of training and orientation programmes besides national and international seminars. The institute has also organised programmes at the behest of the DSIR, Ministry of Science & Technology, and IIFT, Ministry of Commerce.

Recently, IPMMI conducted an in-house programme for the Fonterra group, at Sri Lanka on packaging technology. The IPMMI has now launched a certificate distance education programme in packaging technology. The training and educational programmes need to be strengthwww.expresspharmaonline.com

INTERVIEW

ened through hands on training and shop floor/operator level programmes need to be implemented to bridge the void currently felt. For the association all our members are equally based and each are specialists in their own fields. Our website will give details of the product/service range of the members. The IPMMI has over 80 members now. Efforts are regularly pursued to increase the membership albeit successfully.

What are the future plans of IPPMI for its members?

We want to increase the membership to strengthen the institute. We also want to set up an exclusive development council for the packaging machinery manufacturers. This will collectively address the industrial and fiscal issues faced by the industry and identify the assistance required to be extended. To extend fiscal assistance for imported niche spares and components, to make the machinery more cost effective, to extend ade-

quate fiscal assistance/financial help for promotion and participation of IPMMI members in international exhibitions, to expand the training and educational activities in all related segments is also on our priority list.

We will work to strengthen and expand the technical services for the packaging sector, packaging audit, packaging design and development, survey and feasibility project studies. We will publish technical reports and industry-related guideline notes. It is necessary to strengthen and expand the directory and newsletters publications with more coverage on a global basis.

Efforts will be taken to liaise with international counterpart bodies to expand information base and provide more opportunities to the members. We also want to participate with national programmes in all related activities including environmental and areas of specific social interests. sachin.jagdale@expressindia.com November 16-30, 2012

Mobile product authentication: Protecting brands globally Dr Ashifi Gogo, CEO and Founder, Sproxil, talks about how Mobile Product Authentication (MPA) helps to curb the multi-billion dollar global counterfeit trade market n the 21st century, technology and computer systems play an integral part of everyday human life.

Technology is being harnessed not only to improve the wellbeing of people, but to protect and save lives. IT systems make information more accessible to patients and provide consumers ways to take greater control of their health and livelihood. One such technology used to protect consumers is the Mobile Product Authentication (MPA) solution. The solution was developed by US-based Sproxil, a venture-backed social enterprise that provides mobile anti-counterfeiting solutions in developing markets.

In an effort to curb the multi-billion dollar global counterfeit trade market, the MPA solution empowers consumers to ensure the genuineness of their products through a simple text message. Although the solution works for any tangible good, including pharma products (medicine), automotive parts, agro-chemicals, food and beverage, and even handbags, Sproxil initially focused on combating counterfeit medicines.

The pharma industry is particularly vulnerable to counterfeiting, and can be quite dangerous and even fatal to consumers. In developing countries, the problem of counterfeiting important goods is exacerbated by weak regulatory oversight and high levels of poverty. In addition, counterfeit drugs cause further devastation in areas where diseases such as malaria, diabetes, AIDS and tuberculosis are rampant, since people do not receive the proper medications. In parts of Africa, over 700,000 people per year are estimated to die from fake1 tuberculosis and malaria drugs alone.

In 2010, Sproxil partnered with Biofem pharma to pilot the MPA solution in Nigeria. The product, Biofem’s flagship diabetes medicine Glucophage, was tested in the pilot.

Within three months after Biofem implemented the MPA solution, Glucophage sales increased over 10 per cent in Nigeria and the company saw a return on investment of over 1,000 per cent. Since the pilot, Sproxil expanded into a total of five countries across three continents – Ghana (also serving the Ivory Coast), Kenya (serving East Africa), Nigeria, India, and the US. By end of 2011, the MPA solution had been used over 1 million times in Nigeria – that is one in every 200 Nigerians.

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November 16-30, 2012

The easy-to use, easy-to-understand MPA solution works right at the consumer level, and takes only a few seconds to use. It is easy as 1-2-3: Immediately after purchasing a product, consumers will find a label on the package that they can scratch-off to reveal a one-time use, item specific code. Then, they text the code to Sproxil’s secure phone number and receive a message confirming that the product is authentic or warning that it may be counterfeit.

In addition to mobile verification, consumers can call Sproxil’s 24x7 consumer support desk for help during the verification process or to get transferred to authorities in the event that they had purchased a potentially fake product. Along with protecting their consumers from harmful replicas of their products and increasing profits once lost to counterfeiters, brand owners can gain valuable market intelligence through the proprietary online Client Portal. The portal, which displays analytics from data collected from the MPA solution, is stored on cloudbased servers for greater security and scalability. This portal allows clients to view market data and analysis pertaining to their product(s) to better understand purchasing habits and connect with their consumers in a way never before seen in cash-based societies.

In various countries, initial efforts to tackle counterfeiting have already begun. In India, the Directorate General Foreign Trade (DGFT) Continued on Pg 88 www.expresspharmaonline.com

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On line particle measurement: PAT Solutions for pharmaceutical industry Stuart Wakefield, Regional Manager - Middle East, and India/ Director - Malvern Aimil Instruments (India) provides an insight about analytical solutions which meet the specific requirements of both active and excipient manufacturers he pharmaceutical industry is characterised by high value products and relatively small tonnage batch processes.

Reliable and consistent product quality is essential.

Historically process efficiency in this sector has been low, relative to other industries, and the adoption of new process technologies slow as a result of process validation requirements. The FDA's Process Analytical Technologies (PAT) initiative is designed to encourage manufacturers to make more use of on- and at-line analysis techniques to increase process efficiency, improve batch-to-batch consistency and reduce risk. As many pharma processes involve particulate handling, online particle size analysis is key.

Malvern's extensive knowledge of the pharma industry has led to the development of analytical solutions which meet the specific requirements of both active and excipient manufacturers. The widespread use and acceptance of Malvern's Insitec technology is testament to its

industrial robustness, relevance and usefulness.

Particle size in the pharma industry ●

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Around 70 per cent of pharma drugs are consumed in solid oral dosage form; efficacy is influenced by the particle size properties of both active pharma ingredients and excipients In general larger particles are easier to handle during manufacturing but smaller particles have better adsorption and dissolution characteristics In the past particle size analysis has been carried out off-line but this approach is often non optimal in certain cases Exposure to product is a particular issue for the pharma industry.

Stringent safety precautions are necessary during sampling

Malvern Insitec An integrated solution meeting industry standards

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process.

Malvern's solutionsbased approach extends to the provision of proven, automated sampling systems. The Jetstream eductor and Gulfstream eductor allow representative sampling from medium to high concentration dry and wet process flows respectively.

For dilute streams the Insitec can be used in-line - a process analyser needs to be flexible in the range of concentrations measured for direct measurement a patented multiple scattering correction algorithm is used which allows the analyser to work at higher concentrations than laboratory units. The range of Insitec process interfaces ensures that the technology is suitable for both pilotscale and full-scale operation.

Two software packages, Malvern Link and RTSizer allow the data measured by the analyser to be effectively used in the manufacturing environment. These packages generate data in the required form, control sampling/analysis, and integrate

Process stream

Particle size range

Analyser

Process interface

Dry powders

0.05-1000 µm

Insitec

Jetstream eductor

Wet suspension

0.05-1000 µm

Insitec

Gulfstream eductor

Dry powders

50-3500 µm

Parsum

In-line probe

Pharmaceutical milling at Siemens Axiva GmbH & Co KG, frankfurt, Germany

86

Particulate systems can be monitored and controlled using a range of Malvern solutions (see table below).

The Insitec system has been specifically developed for industrial use. It employs the industry standard ensemble laser light scattering technique diffraction to rapidly generate complete volumebased particle size distribution data (at rate of up to four distributions per second), and requires no calibration. System reliability is extremely high and maintenance requirements are minimal. Units specifically for pharma use in a GAMP4 environment are available, as is an intrinsically safe design.

Pharma options address issues such as 21 CFR part 11 compliance, materials traceability and software validation. Hygienic fittings allow cleaning of the entire sample path between campaigns; SIP and CIP options are available. An intrinsically safe version, Insitec X, is also available, especially useful when using flammable volatile solvents in the

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Malvern Insitec process analyser

November 16-30, 2012

the system with existing process control platforms, thereby facilitating automated process control. Each element of the

requiring minimal installation work. The probe delivers a chord-length distribution useful in monitoring feeds to mills,

Fig 1: Diagram showing generic pharmaceutical unit operation

Malvern system is tailored to the specific requirements of not only the industry but also the individual user, process stream and plant control system.

and measuring the final grade products from spray driers and agglomerators. Parsum has a range of measurement zone interfaces which allow it to be tailored to the requirements of

Fig 2: Off line and On-line particle size analysis of milled product

Malvern Parsum This technique is based on spatial filter velocimetry, a technique which is used to characterise process streams containing coarse particles.

This analyser has the advantage of a very simple installation, as it is an in-line probe November 16-30, 2012

the process stream, and an intrinsically safe version is also available. Real-time data transfer to the process control system is possible using 4 - 20 mA current loops. Typical installations or applications would be fluidised bed systems, high shear granulation and spray dry applications.

The benefits of on-line analysis Meeting the challenges facing pharma manufacturers The rich flow of particle size data which results from the installation of an process system can be used to significantly improve the efficiency of particulate unit operations such as spray drying, atomisation, granulation, and most commonly milling. On-line analysis allows the effects of any process changes to be instantaneously observed, thereby improving the quality of manual control and increasing process knowledge. Additionally, on-line analysis opens up a route to automated control, facilitating further optimisation and eliminating the need for manual intervention. For pharma manufacturers an Insitec installation typically leads to the following benefits: ● Reduced time to market ● Improved process reliability ● More efficient transient operation with ● Improved start-up/shutdown ● Reduction in risk of operator exposure to product These benefits translate directly into reduced wastage and lower energy consumption. Batch-to-batch consistency can be improved as a result of monitoring all of each batch (as opposed to a small sample), and batch rejection rate is typically reduced as a result of improved process understanding. Rapid process optimisation becomes feasible. The following examples illustrate the achievements made by pharma manufacturers currently using the Insitec system.

“Each gram saved is a real gain and we can now perform much better in a sector where high quality is crucial.”

Herbert Müller, process engineer

Confidence means using better science for more consistent compliance. Agilent’s Enterprise Edition uses a direct, automated approach to consistently perform qualification testing, validate calculations, and harmonize reports. Ensure your consistent, cost-efficient compliance and reduced regulatory risk with Agilent’s Enterprise Edition.

For more information visit: www.agilent.com/chem/comply

Improved process knowledge Reducing mill overloading The product from a pharma mill was found to be of variable quality. Regular off-line analysis showed particle size to be consistently close to set point but on-line data showed something

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completely different (See Fig 3 ) .

On-line data showed that at regular intervals Dv50 and mill current increased significantly. Transmission, a parameter measured by the Insitec, indicative of the concentration of particles in the process stream, simultaneously decreased. It was concluded that material was being forced through the mill at too high a rate leading to 'shortcircuiting' of the classifier. In order to improve mill control, transmission was subsequently used to drive feed rate. Figure 4 shows the improved operation which was achieved. The change resulted in enhanced product quality and yield, smoother mill operation, reduced waste and a reduction in manpower requirements.

Process optimisation Ensuring optimal milling during pilot drug trials A pharma manufacturer carrying out pilot drug trials found mill optimisation using off-line analysis a timeconsuming, wasteful

Figure 3: Periodic fluctuations due to overloading of mill, shown using on-line particle size analysis

process. For each new product the optimisation procedure took around one week.

The typical cost of the products being processed was $0.5 - $1 M/kg; waste was excessive and costly. There was a poor understanding of the effects of air flow rate, air pressure, feed flow rate and mill speed on particle size.

Optimisation was therefore carried out by stepping systematically through the variables to find optimal values.

The process was laborious and mill shutdown frequent.

An in-line Insitec analyser was installed at the mill exit.

Figure 4: Improved control as a result of using on-line analysis

The analyser was used to characterise the whole batch, as it passed through the mill, rather than small samples (3 - 5 g) at periodic intervals.

The impact of mill adjustments could be immediately seen allowing changes to be carried out much more rapidly without stopping and starting the mill. A more complete optimisation study is now possible in only four hours, a saving of 4.5 days for each product. In addition, the amount of wastage has been dramatically reduced; yields of around 98 â&#x20AC;&#x201C; 99 per

cent are now commonplace.

The product can be milled to a specific endpoint, in terms of particle size, rather than for a specific period of time.

Automated mill control is being considered and an investigation of the effects of parameters previously thought too difficult to study is being carried out. Lot size is being increased.

Manpower requirements have been significantly reduced.

The author can be contacted at stuart.wakefield@ malvern.com

awards and grants, such as the Clinton Global Initiative University Outstanding Commitment Award, IBM SmartCamp Regional and Global competitions, and the African Diaspora Marketplace (ADM), to name a few. Most recently, in 2012, Sproxil was won the prestigious World

Business and Development Award.

Mobile product...

Continued from Pg 85 has initiated an action of mass serialisation to protect 'Brand India'. However, there is much confusion and apprehension in the industry on whether mass serialisation can provide a foolproof solution against counterfeiting.

As an experienced, global company, Sproxil understands that developing a truly foolproof solution can seem daunting or too complex. In an effort to alleviate brand owners from the stress of finding a good solution, Sproxil also offers advisory services to help improve supply chain management and safeguard their products from counterfeiting, illegal diversion, and theft, among other risks. By using these tools, the brand

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owner can secure their brand and protect their consumers.

Sproxil has been featured on esteemed global publications such as The Wall Street Journal, The New York Times, The Boston Globe, and CNN. The company was also recognised for its work in developing nations through various www.expresspharmaonline.com

Reference 1 http://www.policynetwork.net/health/media/fakedrugs-kill-over-700000-peopleevery-year-new-report The author can be contacted at ashifi@sproxil.com November 16-30, 2012

Efficient blister package to pass stability A recent white paper by Zuzana Sabova-Kepic, Manager, Honeywell’s Barrier Packaging Analytic Lab in Morristown, NJ, and lead technical specialist for Honeywell’s healthcare and packaging business, covers three guiding principles relevant to barrier films that pharmaceutical companies can employ to reduce the risk of failure, understand the barrier required to pass stability, avoid over-packaging and potential delay harmaceutical companies all share the same goal: delivering safe and effective drugs to patients.

One aspect of achieving this objective is conducting stability studies that demonstrate to regulatory organisations that a drug’s formulation is safe and effective. Stability studies are conducted on each drug and its package to assure that the drug will meet this goal for the shelf life indicated. Often, pharma companies focus on stability studies with minimal consideration for package performance, not realising that a stability test failure may have nothing to do with the drug itself, rather the failure can be attributed to its packaging.

To avoid stability failure and gain understanding of the sensitivity of your dosage, the performance of the drug’s package should be studied at the same time the performance of the drug itself is being evaluated. Package integrity can be determined very early in the stability test’s timeline.

In doing so, a potential cause for failure can be identified and corrected, allowing pharma companies to prevent delays in the launch process due to package failures. This ensures that the drug’s packaging is performing as intended and will pass stability.

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Is your package design suitable?

To optimise the barrier of the blister, pharma engineers should prepare and plan upfront, taking into consideration the drug’s sensitivity, the choice of materials available, and the type of machinery available. Not all machines are capable of processing every material optimally – especially barrier materials—so be sure to discuss compatibility of machines and materials with your machinery and material suppliers respectively.

November 16-30, 2012

The packaging engineer should also pay close attention to package design and tooling.

A successful package design and subsequent tooling design can improve barrier performance dramatically.

Given below are several guidelines for successful tooling design: ● For maximum flexibility, all thermoforming moulds should be designed as dedicated moulds with features recommended for high-barrier materials.

Dedicated moulds provide more uniform thickness distribution than universal moulds which result in improved barrier performance. ● Use a dedicated cavity dimension for each pill size and pill shape. When standard cavities are used for multiple sizes or shapes, the large cavity design will increase the surface area of the cavity which in turn increases moisture permeation of the cavity when packaging smaller pills. ● Calculate the theoretical barrier of the package. (See additional information on barrier prediction methods in the “Weight Gain Test” section).

To optimise package permeation rates, packaging engineers should also consider the following design recommendations: ● Cavity dimensions must allow for proper clearance between the dosage and the lid stock to enable efficient product feeding and proper sealing of the lid stock to the blister. ● For cavities deeper than 6 mm or with a deep draw ratio greater than 3:1, preforming with plug assist is recommended. ● Design reinforcing or strengthening ribs perpendicular to the machine direction. The ribs should www.expresspharmaonline.com

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have a width-to-depth ratio between 2:1 and 3:1 to avoid under-forming.

Sufficient air evacuation ports must be included in the rib design to achieve full forming.

Is your thermoform process correct?

The next consideration is establishing the thermo-forming conditions. This ensures that the package achieves the expected barrier performance and is not vulnerable to compromise. Following are some thermoforming and sealing guidelines to assure a highquality blister: ● Use the proper forming temperature for your material.

Forming temperatures vary with material type, thickness and manufacturer, thermoformer, speed, timing and mould temperature. For additional information on proper Aclar laminate forming, Honeywell developed the 'Aclar Films hermoforming Guideline' for your reference. ● To achieve fully formed blister cavities, avoid cooling the laminate before forming and ensure you have sufficient force to form the parts. For cavities deeper than 6 mm or with a deep draw ratio greater than 3:1, use plug assist in combination with air pressure to improve thickness distribution and barrier performance. ● Different lid stocks require different sealing conditions. For example, when the lid stock is sealed to the Aclar side of a laminate, companies must use proper lid stock seal lacquers designed for this purpose.

If you seal against the PVC side of the laminate, use standard PVC films sealing station set-up.

Good sealing is a critical aspect in attaining package integrity. Consult with your lid stock supplier for sealing recommendations as sealing conditions will vary with pack layout, foil type and manufacturer, line speed and machine type. The selection of sealant is dependent upon the polymer that is in contact with the foil coating. If the contact layer is consistent, no change in conditions is required. For example, PVC mono film, PVdC coated PVC and Aclar

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film laminated to PVC can be sealed using the same foil and conditions providing the foil is sealed to the PVC side in all cases.

Are your testing methods sufficient?

In addition to using the correct design and thermoforming techniques, pharma companies must examine their blister packages in a variety of ways to ensure that the performance of the package matches the theoretical barrier expectations.

Leak detection test One of the most common methods used to test blister packages for leakage is the methylene blue test. The package is placed into a vacuum chamber that is partially filled with a mixture of water and methylene blue dye. The packages are submerged in the liquid and held in place while a vacuum is drawn on the chamber. The package is held at a specified vacuum level for a specified time period. The chamber is vented to atmospheric pressure and each card is inspected to determine if there is evidence of blue dye in the cavities and/or seal areas. One limitation of this method is that the actual samples tested cannot be used for subsequent weight gain testing. A statistical sampling is used to verify that the process is producing acceptable blister cards.

There are also new testing techniques based on overpressurising or under-pressurising the blister cavity that do not use methylene blue dye. They too can reveal whether or not your blister package has open channels.

These methods are nondestructive and can be used to inspect 100 per cent of the samples to be evaluated in the stability test. If no leaks or open channels are found during leak detection testing, be advised that micro channels or stress cracks in the lid stock may be present which go undetected. As a result, additional tests are needed to verify seal integrity as well as ensure proper thickness distribution of the film.

High intensity light test This simple test will check for cracks in the foil and should be done every time you run a stability test. Take the www.expresspharmaonline.com

sealed blister card to a dark room and shine a flashlight through one side of the card.

Look for any light coming through the foil and plastic. If blister packages are made out of opaque film that prevents light from penetrating the blister card, run a few packages with clear material and conduct the test to ensure there are no pinholes in the seal.

Magna-mike test This test measures the thickness distribution of the blister cavity. The MagnaMike is a handheld thickness gauge that uses magnetism to perform reliable and repeatable measurements. These measurements are performed by holding the gauge’s magnetic probe to one surface of the test material and placing a small steel target ball on the opposite surface. A Hall-effect sensor built into the probe measures the distance between the probe tip and target ball. Due to the nature of this test, only certain points of the blister can be measured, rather than the entire blister cavity.

Microtome test This is another test to measure thickness distribution. A laser microtome is used to cut an epoxy mould of the blister cavity for microscopic examination. The test is more time-consuming and expensive than the MagnaMike and is not appropriate for machine setup or trial. The test measures a continual line around the parameter of the cavity and assumes that if the cavity is round, it will have the same thickness distribution throughout. For capsules, two cuts are required: one running lengthwise and one running the width of the cavity.

Although this test will not measure the thickness distribution of the entire blister cavity, it does measure more points than the Magna-Mike test, thereby giving the packaging engineer a greater understanding of the blister’s barrier thickness.

Weight gain test The single most important test for a blister pack is the weight gain test with desiccant. This test, which takes approximately 40 days, is similar to USP <671>, a test that gauges the moisture permeability for multiple unit con-

tainers used for capsules and tablets. By conducting weight gain testing on packages filled with desiccant, the permeation of the package can be studied independently from the drug dosage. A summary for the procedure follows. ● First, the sample size must be statistically significant.

Typically, six to 10 blister cards with desiccants in each card is sufficient for each International Committee for Harmonisation (ICH) condition. (The ICH has set up four conditions for stability studies: 40°C/75 per cent RH; 30°C/65 per cent RH; 30°C/75 per cent RH; and 25°C/60 per cent RH). ● Each blister pack is placed into a properly marked package holder and weighed to determine its initial weight (day zero).

Next, the samples are placed into the humidity chamber with the desirable ICH conditions. ● Samples should be weighed preferably every day for 10 days (at least every other day). More frequent weighing early in the study allows for more rapid assessment of the performance of the cards under test. After 10 days, the test frequency can be reduced to one weighing per week. ● The first 10 days are important when measuring low barrier materials such 40g PVdC at high ICH conditions as desiccant tablets will become saturated quickly and plotted data will not be linear. ● Weight gain results are reported as weight gain (WGdayX) in g/package and plotted on a graph.

When interpreting the results, the packaging engineer should check the graph for linearity.

Nonlinearity may indicate a problem with the samples, saturated desiccant tablets or the data collection method. Similarly, packaging engineers should also check the variation between samples to determine whether or not their design, package, and process are robust.

Assuming the weight gain results are linear, the next step is to use this data to calculate the moisture permeation rate per day for each cavity. These weight gain results are then November 16-30, 2012

compared to the theoretical results determined during the design phase using a barrier prediction method such as Finite Element Analysis (FEA).

In addition to FEA, Honeywell has also developed a simple method to calculate the expected barrier for a given cavity when Aclar/PVC laminate is the material of choice. Because the model doesn’t take into account any layers in the laminate except the Aclar film, the model works efficiently when the Aclar is laminated to PVC as PVC does not provide any barrier properties to the overall structure. This method calculates the thickness distribution in the formed cavity and provides a prediction for the WVTR. For more information on this method contact Honeywell at www.aclar.com.

The results of the weight gain test compared to the theoretical barrier prediction method used should not show a difference greater than 10 to 20 per cent. If the final numbers are within this percentage, the packaging engineer will have documentation that his package successfully passed stability at the end of the 40-day weight gain study.

If the comparison results are greater than 20 per cent, the packaging engineer can stop the stability study early recognising that the package has failed. The weight gain test provides the information needed to determine what packaging changes are required and a new stability test can begin, thereby saving costs and avoiding potential lengthy launch delays.

If after several months, the stability test is not producing favourable or as expected results, the packaging engineer will have enough information to determine that the package is not the reason for failure and alternate causes should be investigated.

Furthermore, the weight gain test provides a wealth of information that has significant benefits for research and development. To help determine the best barrier protection for a drug, the packaging engineer can reference the catalog of weight gain data for different cavity shapes and materials and gain an understanding of design limitations or the forming process. The test is also beneficial for package transfer activities, such as November 16-30, 2012

site transfers, because it allows the company to evaluate the other site’s standards and compare them to its own standards. This helps to ensure consistency of packaging performance across packaging sites.

Conclusion

study with the dosage focuses on testing the drug for efficacy and safety, the weight gain test with desiccant separates the performance of the drug from the performance of the package by testing the package directly without the

The three principles: Suitable design, correct thermoforming, and sufficient examination will produce quality blister packages which will perform as predicted. While the stability

drug’s influence. Combining this information assists in identifying issues with package integrity rapidly, and helps the pharma industry bring drugs to market without delays attributed to packaging.

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The Falsified Medicines Directive (FMD): Origin, mission and provisions Falsification of drug products has been linked to treatment failure and even death, specially in the case of terminally ill patients. Rajkumar Gupta, Managing Director, Perfect Pharmaceutical Consultant and Director, Global Institute of Regulatory Affairs highlights salient features of the Falsified Medicines Directive formulated by European Commission to meet these concerns he commercial activities in pharmaceutical involves manufacturing (own, contract, P to P), importing, indenting and wholesale distribution of excipients, API, finished dosage forms, colours and flavourings. It has been observed that over the years, falsification in the drug manufacturing and supply chain has increased all over the world at an alarming rate.

Falsification is taking place through illegal as well as legal trading channels.

Falsification in drug products has been shown to result in treatment failure including death. Currently, falsification has become potential threat to health of patients specially those who are terminally ill.

Considering this, many countries in the world are serious to bring the falsification of medicines under the legal framework. The first step for the same has been taken by European Commission (EC).

They had framed various provisions to prohibit falsification under directive 2001/83/EC on February 16, 2011 and now the directives are being enacted with effect from January 1, 2013. The focus of the directive is to protect the public against the major health threat that can arise from falsified medicines. The measures introduced by the directive will apply generally to all prescription products unless they are specifically exempted, but not to non-prescription medicines unless they are considered to be at high risk of falsification.

The directive does not deal with unintentional quality defects or the protection of intellectual and industrial property such as registered trade marks or patent rights.

Falsified drugs are not coun-

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terfeit drugs, which often contain no active ingredients.

Rather, falsified drugs may contain substandard ingredients, or active ingredients in the wrong dosage.

To motto of the directive is to enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe.

Modes of falsification as identified and prohibited by the directive The act prohibits falsification in medicines manufactured, imported or indented in EU region.

Followings are some of the most common modes of falsification prohibited under the act: 1. The branding of the product to appear like the

7. Assigning falsified specifications for the ingredients included in the product 8. The manufacturing of the products under unhygienic and non-GMP environment 9. The distribution of the products under falsified (untruthful) records

General provisions of the Directive The general provisions under Falsification Medicine Directive are as per follows: 1. Each person/organisation in supply chain should disclose entire admin/establishment information to the

IT HAS BEEN OBSERVED THAT WITH OVER THE YEARS, FALSIFICATION IN THE DRUG MANUFACTURING AND SUPPLY CHAIN HAS INCREASED ALL OVER THE WORLD AT AN ALARMING RATE competitive brand in the market 2. The designing of the product container to resembles standard approved products 3. The labelling of the product using fonts, texts and diagrams similar to the original product.

4. Assigning the ditto or closely similar name as that of approved product 5. Declaring composition which the drug product does not have actually 6. Including active ingredients/excipients much less or much more amount than indicated on the label www.expresspharmaonline.com

competent authority. Further, they shall disclose the complete list of their products along with the details on valid marketing authorisation issued for each product by the European Medicines Agency or by the Competent Authority in an EEA Member State 2. Each manufacturer shall adopt a system of serial numbers so as to enable verification of the drug authenticity at the pharmacy level.

This could be implemented in a way that would allow pharmacists to determine whether a drug had been recalled or previously dis-

pensed and thus intercept possible falsified medicines before they reach the public.

3. At present, Internet sales of medicinal products are the most important channel by which falsified medicines enter the EU market.

Internet pharmacies will be required to setup a trust mark authorised by member states.

Internet pharmacies would be subjected to increased regulation and registration requirements. In addition, the public would be warned of the potential dangers of purchasing drugs from Internet sites.

4.

MA holders of API/Excipients/Dosage forms should ensure that their products are authentic and comply with GMP 5. Falsification will be recognised as a crime and defaulters will be served with â&#x20AC;&#x2DC;effective, proportionate and dissuasiveâ&#x20AC;&#x2122; penalties 6. Qualified Person (QP) declaration will be required that the manufacture complies with GMP 7. Each supplier will be required to establish and document supply chain traceability 8. Each manufacturer of medicinal products will be required to adopt a system to identify false representations of his products (particularly each individual package of high-risk products) 9. There will be improvement on control at EU external borders to prevent entry of false medicinal products 10. The repackaging of medicines by parallel traders will be permitted but they will be required to build up necessary safety features to prohibit falsification 11. Manufacturers, distributors and brokers should report all suspicious falsified medicines to the regulators 12.

Manufacturers, importers and brokers (a medicine brokers are those who do not handle medicinal products but negotiate for others) should register with the competent authorities of the relevant member state November 16-30, 2012

13. Control over the supply chain will be strengthened .The facilities of manufacturer, importer and brokers will be subjected to regular audits as per EU Directives. Good manufacturing procedures will be formalised 14. Manufacturers will be required to provide a unique identifier as an obligatory authenticity feature on the outer packaging of medicines.

15. Each manufacturer, importer and distributor of active substances will be required to be registered with the Competent Authority of the Member State in which he is established.

Registrations will be entered onto a database operated by the European Medicines 16. Each manufacture/ importer/distributor/indenter will be required to declare the followings: ● Name, address and qualifications for persons responsible for overseeing activities ● The intended end-use of the active substance(s) ● The quantities handled ● Description of arrangements for maintaining records, and any quality system in place ● Details of any other activities taking place at sites named in the registration (e.g. manufacture/distribution of bulk chemicals 17. All registered businesses related to pharmaceuticals will be required to submit an annual statement of changes to the competent authority unless those changes could present a risk to active substance quality or safety in which case they should be notified immediately.

● ● ●

No of persons directly employed at office Name of the drug for which he is broker The details on valid marketing authorisation issued for each drug by the European Medicines

Agency, or by the Competent Authority in an EEA Member State ● Name of trade associations with which he is registered Further, he shall maintain record of all his business

dealings in following format: ● The date of the brokering transaction ● The name of the medicinal product ● The quantity of product brokered ● Name and address of the

●

supplier or consignee, as appropriate (These records should be kept for five years and may be subject to inspection) The broker of medicinal product shall cooperate to respond to Recall

Provisions for brokers of medicinal products As per the provisions of the act each broker of the medicinal products shall register himself with the competent authority in each EU State with the following details: ● Registered address of the business ● Contact name ● Contact telephone number ● Contact email address ● Details on all subsidiaries and branches all over the world November 16-30, 2012

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Notice as and when issued by competent regulatory authorities or by manufacturers or marketing authorisation holders.

He shall also maintain a valid and emergency plan for effective recall of medicines covered under his transactions

Provisions for wholesalers of medicinal products Each wholesaler should register his firm with the competent authority in each EU State with the following details: ● Company name of the firm ● Registered address of the firm ● Contact name ● Contact telephone number ● Contact email address ● Details on all subsidiaries and branches all over the world ● No of persons directly employed at office ● Name of trade associations with which it is registered ● Details on valid Wholesale Drug License issued by national authorities ● Further, he is required to cooperate during inspection of premises by competent authority.

Straightforward inspections can last one full working day. ● He shall follow EU Good Distribution Practice Directives in his day-today business. ● He shall have well defined responsibilities for each staff. ● An appropriate risk management plan shall be duly maintained by him to handle emergency situations. ● Under this directives he shall check that ‘ safety features’ used on the outer packaging of a product are intact and the product is not falsified by any means. ● He shall record the batch number when supplying medicinal products to his customers. Whenever there is a doubt, he shall ensure the truthfulness through cross checking with competent regulatory authorities

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Provisions for the manufacturers of the medicinal products Each manufacturer should register his firm with the competent authority in each EU State with the following details. He must know that inappropriate or incomplete information may require action in accordance to FMD ● Name of the company ● Registered company address ● Contact name ● Contact telephone number ● Contact email address ● Details on all subsidiaries and branches all over the world ● No of persons directly employed at office ● List of the drugs for which he has valid marketing authorizations ● Name of trade associations with which his company is registered. ● Name of the authorised persons for manufacturing, quality control and quality assurance and other critical functions ● He should get audited the suppliers of active substances for ‘GMP’ compliance The manufacturer should assess the risk to product quality originating from inappropriate quality of excipients used in manufacturing the same ● He should ascertain that the appropriate good manufacturing practices necessary to assure the safety and quality of the excipients are followed. ● He should inform both the Competent Authority and Marketing Authorisation Holder in case he has valid information that API/Excipients used by him are falsified in the supply chain ● He shall verify that the suppliers of active substances are registered with the competent authority of the member state ● He shall comply with the relevant GMP as described in Part II of the EU Guidelines on Good Manufacturing Practice

Some queries on the FMD Directive There are few major queries and trade concerns www.expresspharmaonline.com

on the current FMD. ● How will the Directive be applicable to the medicinal products in transit? ● How will the Directive be applicable for medicinal products imported in Europe for re-export to the countries outside EU? ● What are the high risk factors for manufacturers and wholesalers under the act? ● Will the advertising agencies also be covered under the act? ● How will the act be applied to OTC products? ● How will the individual defaulter especially outside EU be penalised? ● Will any action under the act be on case to case basis? ● How can a large number of API facilities in India and China who are the major exporters to EU be inspected? ● What if Indian exporters require time to organise them in accordance with the act? ● Will our exports of API to Europe come to halt? ● Will the medicinal product manufacturers who are also importing, or distributing (including export outside of Europe) active substances also be required to register those activities distinct from their manufacturing authorisations?

It is hoped these queries will be resolved as the act gets enforced.

Summary Falsification is increasing all over the world at an alarmingly high rate. The European drug authorities have become highly vigilant about the whole supply chain involved in manufacturing and distribution of the medicinal products. The Falsified Medicines Directive 2011 will be a great legal instrument to control falsification of medicines at large in coming times.

The author can be contacted at guptarmg1952@gmail.com

www.ema.europa.eu/docs /en_GB/document.../02/WC5 00122160.pdf 2 Presentation - Falsified Medicines Legislation www.ema.europa.eu/docs /en_GB/document.../12/WC5 00119622.pdf 3 Q&A from the first falsified medicines directive www.pqg.org/.../MHRAFMD-Stakeholder-Meeting20120611-Q_A.pdf 4 Falsified Medicines Directive – Public Consultation on Safety www.sidley.com/FalsifiedMedicines-Directive--PublicConsultation-onSafetyFeatures-12-22-2011/ 5 The EU Falsified Medicines Directive www.pmca.at/.../pmca_i mpuls_20120319_bruchet_EUfalsified-MedicinesDirective.pdf 6 Q&A: Directive on falsified medicines europa.eu/rapid/pressrelease_MEMO-11-91_en.htm 7 WHO | Spurious/falselylabeled/falsified/counterfeit (SFFC) medicines www.who.int/medicines/s ervices/counterfeit/en/index. html 8 Implementation of the EU falsified medicines www.ipapharma.org/events/e dqmphotospresentation2012/10.pdf 9 Falsified Medicines D i r e c t i v e (FMD)www.efpia.eu/falsified-medicines-directive-fmdprovisions-relating- importation-apis-third-countries-article-14 10 Falsified medicines | EFPIA www.efpia.eu/falsifiedmedicines 11 Falsified Medicines Directive - Impacts for Wholesalers http://www.imb.ie/image s/uploaded/documents/1.1%20Falsified%20M edicines%20Directive%20%20Impacts%20for%20Whol esalers.pdf 12 The Falsified Medicines Directive into UK legislation. http://www.mhra.gov.uk/ home/groups/es-policy/documents/websiteresources/con1 95909.pdf

References

Perfect Pharmaceutical Consultants Pvt Limited

(As accessed on 30.10.2012) 1 Presentation Implementation of Falsified Medicines Directive

©Copyright Perfect Pharmaceutical Consultants Pvt Limited, Oct 2012. All rights reserved.

November 16-30, 2012

Karnavati Engineering arnavati Engineering brings along a history of nurturing life, both for its employees and customers as well as end users.

It is a company with focus on providing the pharmaceutical industry with global, cutting edge, customised solutions catering to the needs of the pharma machinery sector.

Since its inception in 1981, the company has come of age and carved out a tall name for itself, not only in Indian market but the global market as well, for its outstanding quality and customer services.

Karnavati Engineering is an ISO 9001:2008 certified company, accredited by Government of India as 'Export House'.

The company is in the process of expanding its existing capabilities to new heights by introducing new lines of machines such as granulation line process equipment, wide range of automatic capsule filling machines, packaging machines; re-designing its existing tablet compression machines and allied accessories as well as constantly working on offering machines with newer and advanced features. This vision of Karnavati Engineering is to become a 'One stop solution provider for oral solid dosage line' in the industry and also achieve its endeavour of 'transforming machines to pharmaceutical excellence'.

With the help of excellent team of experts and existing world class state-of â&#x20AC;&#x201C;art, inhouse facilities, Karnavati Engineering is confident that it will be achieving its goals as planned. In order to achieve the same, it plans to join hands in partnership with global leaders who are successful and proven in the pharma machinery industry.

Karnavati Engineering pursues a futuristic way of business, by adopting peoplecentric approach.

Committed to produce world-class products by acquiring cutting edge 'Korean Technology' and continuous focus on R&D, Karnavati Engineering

K

November 16-30, 2012

promises to serve its customer with the finest service.

The company follows an

open culture of hierarchyless communication and open to suggestions from internal as well as external

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customers at all times because it believe in the process of continuous improvement through the

valued feedback of its esteemed customers.

Karnavati Engineering keep its human resource pool at

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High-end machines for a flourishing country Jamal Mokaddam, Sales Director – India, OPTIMA Pharma, talks about the various initiatives, which the company has taken for its growth

PTIMA Pharma is considered to be a leading supplier of turnkey lines and equipment for filling and packaging of pharmaceutical products. In recent years it has become even more apparent that Indian customers are requesting local support from OPTIMA Pharma. In November 2011, the first Indian subsidiary of OPTIMA was founded in Bengalore. OPTIMA Pharma considers the Indian market to be in an exciting phase of growth.

Traditionally, generics manufacturers have constituted a large portion of the Indian market.

Consequently, the most important factors these manufacturers took into consideration when buying capital equipment has been affordable price, short lead times and local service. The domestic market in India till date has been dominated by ampoules and vials. A change is coming. Ready to fill syringes and oncologic products for export are being manufactured in increasing numbers.

Subsequently, the use of containment systems and freeze drying equipment has also been on the rise. In the meantime, India is one of the countries which has the most US FDA regulated manufacturing sites outside the US. This means that, besides the price, delivery time and local service, implemented technologies

O

the pivot of strategy making as they are the most treasured resource. It always believes in the idea of collective growth and hence brought forward systems which facilitate and reinforce the same. Keeping this in mind, Karnavati Engineering aims to provide products and services which will positively contribute to the society and improve the

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are becoming project drivers, especially where exports to the US and Europe are being considered.

Parallel to the above developments, OPTIMA Pharma has been following an exciting course over the past few years. Globalisation and international trade have been responsible for founding several international OPTIMA Pharma subsidiaries. The technological developments which OPTIMA Pharma has actively pursued have also met with market acceptance and led to growth of the company.

OPTIMA pharma has gone through a radical change due to the demand of the pharma industry to provide integrated solutions.

Individual technology specialists are no longer independently sufficient for meeting the needs of pharmaceutical filling and packaging processes, and cooperation of different core technologies in a single company can combine to make a new unified process. The

common term for this is 'turnkey'.

Customers take delivery of a complete package supplied by a single organisation.

OPTIMA Pharma responded to the needs of pharma manufacturers by strengthening its portfolio with a successful integration of freeze drying and isolator technologies into the company. Especially when dealing with freeze drying processes, transition points between filling and final capping are simplified and the design of components has been unified.

Highly potent, often toxic substances, intensify the need for strict separation of the process from the operator – a characteristic generally attributed to isolator technology. This in part also led to the use of disposable product paths for filling systems, which OPTIMA Pharma has focused on.

To extend the shelf life of often very sensitive biopharma substances, freeze drying processes are in increasing demand.

OPTIMA Pharma is still today the

quality of life for its employees, customers and the communities in which they operate.

Speaking about the expectations from PMEC2012, Mukund S Modi, Sr Vice President, Karnavati Engineering said, “During the PMEC 2012 exhibition, we plan to launch and showcase our world-class state-of-the-art, latest,

advanced, Korean technology machines to the sub-continent and global pharma industry. We expect a successful positive response from the visitors, on our existing machines as well as newly launched Korean technology machines. We are sure that our increased product range will be of great interest not only to our existing clients but also

Trend setting technology

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only German manufacturer which has been able to unite these technologies and offer ‘packaged’ solutions.

OPTIMA Pharma has made it a basic principle to manufacture and integrate turnkey solutions for the pharma industry exclusively in Germany.

OPTIMA Pharma offers the same technology regardless of whether the destination is India, the US, China or Europe.

The team at OPTIMA Pharma in India, led by Akshay Chikodi and Jamal Mokaddam offer quick, competent service.

The existing team will be successively strengthened with further colleagues by the end of 2013.

Drugs from India to the US and Europe Many Indian pharma companies are on the lookout for a partner able to safely and routinely translate current worldwide technical standards for filling and packaging into reality. With references at nearly every global drug manufacturer and many internationally active mid-sized companies, OPTIMA Pharma was able to conclude several new projects through its Indian subsidiary. Projects include medium and high speed filling and closing of ready to fill syringes and cartridges Current projects in the third quarter of 2012 include another syringe line.

Prospects for the sale of further vial and 3-piece eye drop projects before the end of the year look promising.

The author can be contacted at Jamal.Mokaddam@optima-pharma.com attract new potential customers. With our increased product range, we are now in a position to offer total customised solutions to our clients and their needs.

Moreover, we are in line with our vision and mission to introduce more new range of products like cleaning and disinfection machines, specialised toolings, etc.”

November 16-30, 2012

Thermolab Scientific Equipments hermolab Scientific Equipments was established in the year 1967

by M L Deshpande (now group chairman) specialised in manufacturing ovens and incubators for the pharma industry. The legacy was continued under the able leadership of Sandip Mhatre and

T

Neelam Mhatre. Thermolab is now a preferred brand in the Indian pharma industry for Stability Chamber and Walk in type Stability Chamber along with other products, manufacturing around 1400 to 1500 equipment per year. Today, Thermolab is a group of six companies serving the phar-

ma industry for varied needs.

Thermolab has dedicated service engineers across the country to reach its customers in the nick of time. Company's prompt response, on time delivery and efficient after sales support network across the country are its main strengths.

Stability Chamber, W alk-in Stability Chamber, Photostability Chamber, Oven, Incubator, BOD Incubator, Economical Oven, Economical Incubator, Lab and Pilot Plant Machines, Pharma Refrigerators and Deep Freezers are some of the key offerings of Thermolab.

Mack Pharmatech: On growth trajectory n the last 15 years, Mack Pharmatech has become the largest and most successful firm of specialist in manufacturing and supplying

I

Badgujar, MD, Mack Pharmatech and Manoj Chaudhari, Director, Mack Pharmatech respectively. The company management

Kiran Badgujar

solutions to meet the strategic goals of company and to provide intelligence to the businesses to make better decisions, using the best of stan-

● UV – VIS Spectrophotometer ● Analytical Balance ● Moisture Balance ● Ultra Sonicator

Manoj Chaudhary

Nasik factory)

pharmaceutical and laboratory equipment. The combination of company's expertise, methodology and experience has helped it officially open its doors to launch new initiatives to achieve the business objectives – MACK AURAA and MACK UNIVERSAL. These initiatives will be run by Kiran November 16-30, 2012

ensures that both the companies will provide its proven effective business analysis and quality standards compliance services to its customers throughout the world to fulfill their requirements.

MACK AURAA and MACK UNIVERSAL were established with the vision of bringing www.expresspharmaonline.com

dards. Both the companies are engaged in supplying a wide range of activities that touch the most basic and far advanced aspects of everyday life in pharma, food, chemical and other similar industries.

Range of Products MACK AURAA

● Vials, Caps, Septa’s, Column & Syringe Filters MACK UNIVERSAL ● High Pressure Washer ● Decontamination Chamber ● Deep Freezer (Up to 86°C) ● Refrigerated Centrifuge ● Magmatherm Muffle Furnace EXPRESS PHARMA

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'Quintiles is uniquely positioned to deliver the data-driven difference' As the newly designated CIO of Quintiles Asia Naz Haji is tasked with developing local, customised solutions for local customers through leveraging global solutions and adapting them to local needs as well as through developing unique, localised solutions. He continues to be Senior Vice President, Information Technology – Client Services, where he focuses on growth opportunities with customers as well as internal efficiencies and says he and his team are “IT’s face to the customer”. Viveka Roychowdhury analyses the technology toolbox that Quintiles brings to the table and its latest addition, Infosario

INTERVIEW

The life sciences industry is knowledge-based and therefore data-driven, whether its drug research or clinical trials. What are the key challenges posed by these defining characteristics?

The life sciences industry is a highly complex and regulated one. The delivery of technology in this sector requires deep domain expertise and the ability to understand and navigate through regulatory complexities across markets.

As you rightly pointed out, the industry is data driven and we handle copious amounts of data. One of the key challenges is to how to use the data to deliver insightful information that will lead to faster decision making, and ultimately more accessible and affordable healthcare.

There are endless needs for information associated with the development and marketing of drugs.

Unfortunately, current IT systems housing this information are extremely fragmented and siloed, consisting of multiple systems and suppliers as well as legacy systems.

Quintiles has developed the technology to take data from multiple source systems and integrate, synchronise and normalise and present this data in near real-time.

Where does Quintiles fit into such a scenario?

Technology within Quintiles is a game changer and has been an area of growing importance and focus. We are recognised as an award winning technology innovator across industries.

Our technology focus is both inward and outward directed.

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Over the last few years, we have meticulously assembled a portfolio of clinical applications and patented technologies that are used internally, integrating and then virtualising them as they are stored in our private cloud. From our cloud, they are available and can be accessed from any device with a net connection – laptops, smart phones, iPads and more. This has been massively scalable because of our high level of virtualisation and compression. In addition, as part of the Infosario suite of offerings, we are able to further drive our customers' clinical development process with our systems as a service offerings. This allows for predictable costs, flexibility, instant scalability, access anytime anywhere, and end to end solutions...all combined with over 30 years of Quintiles clinical expertise.

Externally, we have leveraged technology to address the complex and unique challenges customers face through combining our strong business domain expertise with technology skills to configure unique solutions that address customer requirements.

However, our focus on technology is not just about creating winning products and services but also creating a conducive environment for IT professionals. Not only do we rank as a great place to work as an organisation and in IT, but Quintiles has recently been ranked sixth in this year’s InformationWeek 500, a list of the top technology innovators in the US. The listing spotlights the power of innovation in IT, rather than simply identifying the biggest www.expresspharmaonline.com

IT spenders and we are honoured to be recognised.

How have client/ sponsor demands of their outsourcing partners, especially CROs, changed?

There are a couple of trends we are seeing in the industry. Customers are seeking partnerships that are much more transformational where the outsourcing partner is expected to play a more strategic role and risks are shared. Customers are also looking to make faster, better-informed decisions and seeking early signs of success or failure. Both these trends reaffirm the growing need for and value of technology in the biopharma industry. Technology can play a major role in transforming the healthcare agenda of today’s organisations.

What are the business benefits of the recently launched version of Infosario?

Quintiles Infosario is a award winning solution through which we deliver the data driven difference. The product seamlessly integrates data, systems, processes and Quintiles’ therapeutic expertise to unlock faster, betterinformed decisions from clinical trial planning and design, to trial execution services, through post-market outcome studies.

The recently released next generation of Quintiles Infosario Reporting & Analytics Platform features an interactive, role-based navigation with more customisation built into it. It introduces templates that allow users to create dashboards to view the most relevant data and visualisations for their specific, day-to-day needs. It also offers transparency into critical data at the study, programme and portfolio levels, unlocking valuable insights that enable customers to tackle key challenges, such as real-time oversight, risk mitigation, patient safety, productivity and time to market. Quintiles Infosario Reporting & Analytics Platform is built

upon a patent-pending and system-independent data factory that easily integrates with customers’ existing technology solutions.

With Quintiles Infosario, clinical programme managers can view the overall status of trials in a specific region in near real-time, enabling quick and deliberate decisions to ensure trial success.

Secondly, pharmacovigilance scientists and medical monitors can easily focus on safety-specific data, enabling subtle but important signal detections for improved patient safety. Thirdly, site start-up specialists can seamlessly monitor patient enrollment at specific sites to forecast, benchmark and optimise the patient recruitment processes. It allows for, as part of our systems as a service offerings, predictable costs, flexibility, anytime access, and complete end to end solutions within the Quintiles cloud.

Quintiles' USP is ...?

We provide solutions to our customers, not just technology. We are uniquely positioned to combine 30 years of therapeutic expertise, proven clinical trial processes and technology with an innovative knowledge engine to deliver the data-driven difference.

A 2011 research paper by The Economist Intelligence Unit Research Unit, titled 'Reinventing Biopharma: Strategies for an evolving marketplace', says leading life sciences “make better use of data”. How does Quintiles do this?

The best example of this is Quintiles Infosario. Besides this, more recently, Quintiles’ collaborated with Eli Lilly on an IT-enabled project to reengineer the way clinical trials are planned and designed.

The ultimate goal of this collaboration was to develop an integrated approach that eliminates costly inefficiencies and uses “big data” to drive better drug development decisions. viveka.r@expressindia.com November 16-30, 2012

+ â&#x20AC;&#x2DC;Indian regulatory is more reactive than proactiveâ&#x20AC;&#x2122; PG 100

'Right dose differentiates poison from remedy' PG 102

Claims-based pharmaceutical R&D: Time to walk backwards PG 103

NPD: An idea whose time has come PG 108

'Indian regulatory is more reactive than proactive' The Indian clinical research industry is encountering several obstacles in its growth path. Apurva Shah, Chairman, ACRO, in a discussion with Usha Sharma, talks about the various hitches hindering the industry's progress and suggests appropriate solutions to tackle them

INTERVIEW

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The Association of Contract Research Organizations India (ACRO) is in the process of putting a business code of conduct in place for its members. Please throw some light on it. How will it make a difference in the way the CRO industry is currently perceived in India?

ACRO does not believe in shortcuts or concessions with respect to ethical or quality standards and is willing to match the best benchmarks that are suitable to our country. ACRO recognises the fact that the industry is young and has grown very fast in the recent years, due to the high quality that India has delivered, therefore the regulations haven’t caught up. The government and regulators need to act fast and will have to play a critical role in bringing stability to the industry which is crucial and of national interest. ACRO would like a clean and transparent regulatory process that makes scientific sense, keeping in mind our social-economic environment.

To ensure adherence to the highest standards of business, ACRO members have agreed to work as per the 'Code of Conduct'. This is a clear sign that we are all committed to work in the most ethical manner and have the utmost respect for human life. Our next step will be to introduce

voluntary inspection of our systems by independent inspectors to check if all our members are adhering to the standards we all have agreed to. This will send a clear message to the world that we 'walk our talk'.

As a first step in this direction we have initiated the formation of an independent, common, national database for all healthy volunteers who participate in the BE studies.

Most units in the country have agreed to be part of this system. It will ensure that no volunteer or clinical unit abuses the wash-out period norm and therefore ensure safety of volunteer health and the quality of research data. This will be a unique thing in the world. As such, a lot of our members are already practicing this since a few years.

The CDSCO has recently published draft guidelines for determining the quantum of financial compensation to be paid in case of clinical trials related injury or death.

Do you think these guidelines are difficult/ in favour for the industry?

The guideline for volunteer compensation is a necessity and ACRO has welcomed this. ACRO has perceived this as a welcome step from the regulators. By attempting to clearly direct how the adverse effects from clinical trials are compensated we will be able to respect the life of our people who offer themselves for the betterment of the lives of millions who will benefit from the drugs. This will also clear off the ambiguity and will make everyone accountable for the responsibility they

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should carry when doing clinical trials.

However, the draft compensation guidelines should be reworded such that they are balanced and protect the interest of all stakeholders in the drug development process Further clarification is needed on the following points: SUSAR vs. current Schedule Y requirement of reporting all unexpected SAEs General considerations related to injuries can be physical or psychological/emotional, benchmarking and scaling of the seriousness and severity of the disease, determining the compensation in case of trialrelated injury, and who will be the decision maker for the percentage disability caused to the subject due to clinical trial Many developments are happening on the Indian CRO industry regulation front in an attempt to get it organised. What are your views on these developments?

Some of the recent initiatives at the CDSCO to make the industry look organised are the registration of ethics committees and recording of informed consent for clinical trials: Video recording or fixing volunteer compensation initiatives will go a long way in eliminating a lot of issues related to the “guinea pig” syndrome. It is sufficient if a proper, informed consent process is followed but if the process is recorded as well then it becomes fool proof and will protect the participants.

Having a fair method to evaluate the compensation for the subjects of the trials will eliminate most of the problems that make clinical trials look bad and we will be able to work to get the socio-economic benefits of clinical trials in India. However, one should also realise that fixing up compensation in a varied socioeconomic background requires a great deal of understanding and specifications put up, so that neither the study participants nor the CRO/sponsor undergo undue pressures. ACRO has a major role in making the Indian CRO industry regulations look organised. It engages in a con-

tinuous interaction and dialogue with the CDSCO office on a regular basis and suggests ways to make the system fool proof. Hence, we are looked at with respect.

The registration of Ethics Committees is a welcome step, given the critical role they play in the oversight of a trial. But, do you think that the committee members will be able to implement it effectively?

ACRO believes that Indian CRO’s working with registered Institutional Ethics Committee (IEC) will ensure adherence to the highest standards of business. ACRO also plans to work with registered and rightly formed IECs. It recommends that all the IEC members need to have a basic GCP training and they need to have continuous yearly training to inform them of the changing guidelines. Their effectiveness will be linked to their level of understanding and clarity of the rules drafted by CDSCO and other regulators.

Delay in clinical trial approvals is hampering growth and slowing down the entire process. This, in turn, is resulting in loss to many pharma companies and CROs. How serious is this issue in the industry?

In India, business opportunities worth Rs 200-300 crore must have been lost due to delays in the regulatory process, in the past 12 months. This has forced some local CROs to open up bases in the other Asian countries and has pushed sponsors to consider other locations instead of India.

According to clintrial.gov the number of trials has gone down in India in the past two years, while the numbers have increased in some of the other Asian countries. ACRO believes that India has a lot to gain from having a healthy clinical research activity and therefore is working with the government and regulatory agencies to implement their guidelines and help them plug the holes in the system.

The table shows the drop in the number of trials and the numbers could be a lot worse if the same conditions persist November 16-30, 2012

for long. The world is not waiting for India. These are numbers collected from various government sites and media reports.

On behalf of the entire industry, what suggestion or recommendation would you like to put forward to the Ministry?

In general, we would recommend that the rules be drafted with a scientific and ethical rationale and not succumb to political or media pressures. This will ensure that the rules are clear and sensible and will result in the safety of our volunteers/patients, developing India as a important player in drug research. Some of the key suggestions from ACRO are as follows:

should be held regularly – every 15 days 4. The NDAC members should receive a clear brief about scope of their review.

This would allow focussed discussion on a protocol in a time bound manner 5. The regulatory decision on a clinical trial protocol should be conveyed to the applicant within two months’ of application 6. The draft compensation guidelines should be reworded such that they are balanced and protect the interest of all stakeholders in the drug development process 7. Change the rules for the import of clinical trials samples for bioanalysis to what they were earlier with some safeguards for the smooth working and global competitiveness of the industry

Immediate 1. The NDAC process should become transparent and time bound 2. The process of referral to NDAC should be made efficient. The NDAC members could receive essential information – clinical trial protocol and investigator’s brochure – by email 3. The NDAC meetings

To be achieved over the year 1. Registration of all CROs 2. Registration of ethics committees 3. Registration of investigator sites 4. Regular inspections of clinical trial sites, ethics committees, sponsors and CROs 5. Accreditation / certification of investigator sites

6. Accreditation / certification of ethics committees What are the key problems faced by the Indian CRO industry and how to get rid of them?

The major issues faced on the regulatory front are longer time-lines and lack of accurate guidelines. Indian regulatory guidelines are unable to keep pace with the global regulatory requirements. It is felt that Indian regulatory is more reactive than proactive and it is affected by the negative image created by some section of the media. Sometimes, clinical research policies are being dictated by political pressures rather than scientific reasoning in India.

ACRO believes that India needs to have a strong policy for developing research so that we can stay ahead in the race for R&D and cut short the time for learning how to develop new drugs. It is in our national interest to develop drugs for our local illnesses which don’t even occur in most developed nations in a cost effective manner so that we don’t have to beg and bargain with MNCs all the time.

How large is the Indian CRO industry and what percentages of growth have been registered in the last two to three years?

The overall size of clinical research market globally is estimated to be in the range of $15-17 billion. India currently stands at only $400 million with a potential growth rate of 15 – 20 per cent. At present, there are 100-125 CROs offering various types of services in India with a revenue of Rs 2000-2500 crore presently, but majority of the revenue comes from about 30 per cent CROs. Though the historical growth was close to 20 per cent upto 2010, the growth forecast is approximately 1015 per cent depending on the regulatory environment prevalent in India. The Indian CRO industry is currently going through turbulent times.

While the bio-analytical/bioequivalence market is the major driver of the Indian CRO market, clinical trials from India still remain a huge potential opportunity though business closures and materialisation of large scale deals have been slow. u.sharma@expressindia.com

'We intent a long-term relationship in developing high functioning excipients' Avantor Performance Materials has signed a collaboration agreement with Mumbai-based Rubicon Research, which will aim at combining the latter’s proprietary product technology with Avantor’s expertise in manufacturing and marketing to develop next-generation products for the functional excipient market. Pratibha Pilgaonkar, CEO, Rubicon Research, reveals more to Sachin Jagdale How are the responsibilities shared between Rubicon Research and Avantor Performance Materials in the collaboration pact?

Under the collaboration agreement, Avantor licensed the gastro-retentive excipient technology from Rubicon, and is sponsoring Rubicon to perform product development work and initial process design work in India. For its part, Avantor is developing pilot and production scale processes for future products, detailed characterisation and proof of concept studies, and November 16-30, 2012

INTERVIEW

regulatory support information in the US, as steps towards commercialisation of future products.

What is the advantage of getting into a collaboration with a foreign company?

We believe the combination of Rubicon’s groundbreaking technology with Avantor’s strong, global position in the marketplace for functional excipients will result in outstanding products to help pharma customers in their pursuit of novel drug www.expresspharmaonline.com

delivery systems to meet compliance, efficacy and patient safety requirements.

What is the duration of this collaboration?

Both sides have entered into the collaboration agreement with the intent of a longterm relationship in the development of high functioning excipients, but for the time being our efforts are focused on the gastro-retentive product. The companies expect to launch initial products resulting from the collaboration next year.

Will these functional excipients be marketed in India only? If not, which other countries will these excipients be exported to?

Products developed from this collaboration will be added to Avantor’s global portfolio of excipients.

How are your products different from your competi-

tor's?

The products being developed under our colla-boration agreement are intended to provide a greater range of options for formulators to choose from in their selection of excipients.

Will Rubicon get into same kind of collaboration with other companies as well?

This collaboration agreement is exclusively with Avantor. We don’t comment on possible future plans or actions.

What are your future plans for Rubicon?

With this collaboration, Rubicon is looking forward to develop gastroretentive dosage forms for drugs in various therapeutic categories.

Development of such novel forms will be an important tool for pharma companies as life cycle management options for line extensions of their existing brands.

Sachin.jagdale@expressindia.com EXPRESS PHARMA

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