Express Pharma October 16-31, 2014 by Indian Express

VOL. 9 NO. 24 PAGES 74

www.expresspharmaonline.com

Cover Story Ajit Singh: Pioneer of pharma packaging Market ‘DNA-based diagnostics present tremendous opportunities for us to invest’ Management Re-building Indian Pharma Inc 16-31 OCTOBER 2014,` 40

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CONTENTS MARKET Vol.9 No.24 OCTOBER 16-31, 2014 Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das

DNA-BASED DIAGNOSTICS PRESENT TREMENDOUS OPPORTUNITIES FOR US TO INVEST

GOI, PHARMA INDUSTRY JOINTLY FORM INDIA – RESPONSIBLE HEALTHCARE TRUST

STRIDES ARCOLAB TIES UP WITH SHASUN PHARMACEUTICALS

Bangalore Neelam M Kachhap Delhi Shalini Gupta DESIGN National Art Director Bivash Barua Deputy Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka

PM Modi's ‘Make in India’campaign highlights pharma as one of the keysectors for growth but it is essential to first rebuild Indian Pharma Inc’s reputation which has taken a hit in the last fewyears | P26

Senior Artist Rakesh Sharma Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Sanghamitra Kumar - East Harit Mohanty - West Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Yuvaraj Murali Ajanta Sengupta PRODUCTION General Manager B R Tipnis

P35: CLINICAL UPDATE

MANAGEMENT

Novartis’ Gilenya reduces brain shrinkage matters for people with MS

PHARMA ALLY

IKA LAUNCHES MOBILE APPLICATION LABORATORY VAN

SIGNET TIES-UP WITH 3V SIGMA SPA

P38: VENDOR NEWS IDT Biologika sets up new multipurpose biologics and vaccines facility 38

P68: AWARD Glenmark bags Civic Award 2013-14

Manager Bhadresh Valia Scheduling & Coordination Rohan Thakkar

P68: CAMPUS BEAT

CIRCULATION Circulation Team Mohan Varadkar

HK College of Pharmacy celebrates 6th Scientific Day

‘IRHT WOULD FOCUS ON AFRICA, JAPAN AND LATIN AMERICA AS POTENTIAL MARKETS OF THE FUTURE’

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

EDITOR’S NOTE

Playing the frenemy card

he pricing pill looks set to choke pharmaceutical companies in India again. On October 9, barely a fortnight after the National Pharmaceutical Pricing Authority (NPPA) withdrew its now infamous ‘internal guidelines’, a Spicy IP blogpost reported that the All India Drug Action Network (AIDAN) had filed yet another PIL in the Delhi High Court. The AIDAN’s PIL alleges that the NPPA’s volte face was a result of ‘browbeating’ by the Secretary, Department of Pharmaceuticals (DoP). The PIL reportedly refers to internal memos where the DoP has sent an endorsed copy of its opinion on the guidelines and directed the NPPA to withdraw them. AIDAN alleges that this amounts to ‘sabotaging the efforts of the Union Government and the stand taken by the Union Government in their two affidavits’ at ‘huge financial benefits to the pharmaceutical industries.’ Will the AIDAN’s argument, that the NPPA is an independent body, and cannot be dictated to by the central government, prevail? The Spicy IP blog post comments that apart from its consequences for pharma companies and patients, the petition throws up interesting and important Constitutional and Administrative law questions. But organisations like the AIDAN are not alone in questioning the escalating prices of medicines. On October 2, Senator Bernie Sanders (who is also the chairman of a US Senate health care subcommittee) and US Rep Elijah Cummings (a ranking member of the US House oversight committee) announced that they have written letters to 14 pharma companies, asking them to explain why there are “huge upswings in generic drug prices that are hurting (US) patients.” Prominent Indian companies like Dr Reddy’s Laboratories, Sun Pharmaceutical Industries, and Zydus Pharmaceuticals (US) as well as the likes of Actavis, Mylan and Teva are some of the 14 companies who have been sent such letters. How will big generic pharma respond to these letters? Most probably by going on the offensive and questioning the data. Commenting on the SandersCummings report and its impact on the global generics industry, Bhavik Narsana, Partner, and Sameer Sah, Principal Associate, Khaitan & Co say that if the data is accurate, there is definitely a cause for concern. They are not surprised that a US congressional investigation was initiated given the Obama administration’s healthcare reform agenda. But they stress that it remains to be seen whether

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The Gilead- Sovaldi deal signals that innovator and generic companies are now firm frenemies: friendly enemies who are increasingly open to collaborate for mutual benefit.But will these partnerships result in the ‘greater common good’?

the data is indeed reliable. They caution that if the (US) government does take some remedial action, it is bound to hit manufacturers’ toplines as the US is an important market for generics manufacturers, including Indian exporters. Sanders’ and Cummings’ letters were followed by a hard hitting report on CBS’ 60 Minutes, aired on October 5, questioning the rationale for increasing prices of cancer drugs. Keeping the drug price issue on the boil is an easy task for the media, patient groups and politicians but this pressure seems to be one of the reasons why some pharma companies are re-thinking pricing strategies. The most recent example could be Gilead Sciences’ decision, to license seven Indian generic drug companies to make and sell Sovaldi at a lower cost. Though critics say this is just a smart way to negate competition, and avoid patent challenges from these generic companies, the deal signals that innovator and generic companies are now firm frenemies: friendly enemies who are increasingly open to collaborate for mutual benefit. But will such partnerships result in the ‘greater common good’? The Government of India and regulatory bodies like the NPPA will have to increase their vigilance to prevent monopoly-like situations in the market. The Sanders-Cummings report has to be seen in the same light but governments/regulators also have to find a way to reward companies who invest in R&D. Unfortunately, when politicians get involved, the public backlash forces regulators to swing to the other extreme, as we have seen in the case of the amended clinical trial regulations. On the IPR front, Prime Minister Modi has managed to hold the line during his US trip. He has agreed to form a high level working group on IP where both the US and Indian sides will present their interpretations of the sticky points. This should not be seen as a capitulation but an engagement. It appears that he is intent on following the pre poll manifesto of his party, the BJP, which mentions that the country should “embark on the path of IPRs and patents in a big way” and “establish an Intellectual Property Rights Regime which maximises the incentive for generation and protection of intellectual property for all type of inventors.” Seems like PM Modi too is playing the frenemy card: keep your friends close, but your frenemies even closer! VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET I N T E R V I E W

DNA-based diagnostics present tremendous opportunities for us to invest VC firms are integral to a thriving ecosystem, for both entrepreneurship and new start-ups in new emerging areas of the future. Bobba Venkatadri, General Partner, Ventureast discusses this and more in an interview with Shalini Gupta

What are some of trends you see in the lifesciences and biotechnology space as a venture capitalist? We are in the middle of a biomedical revolution which in my view is more profound and far reaching than the industrial and digital revolutions that we have seen. The DNA was discovered in the late 70s and the birth of Genentech, Amgen and such companies happened in the 80s. Now a third of the new drugs approved by the US FDA are for large molecules which address complex diseases. Genomics, MRI, stem cells and bioinformatics are offering new possibilities that not only heal but predict and prevent. Doctors may do a genetic test for certain diseases which helps detect and diagnose a disease earlier such as cancer. Biomarkers are replacing biopsies for detecting tumours, treatments are designed for particular genetic defects, the world is moving to personalised diagnostics and genetic biomarkers. Big data is another trend with electronic hospital records giving us insight into how and why patients taking the same class of drug show different outcomes. The mining of data has revealed that a drug which is used as an antidepressant could also have a side effect of killing tumour cells. This discovery enabled

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a company here in Bay Area to get into human clinical trials in one tenth of the time it takes to get into human clinical trials normally and at a fraction of the cost. Where does India stand on the investment map? What potential do you see? From a venture capital perspective, in the last ten years, percentage of medicines consumed by emerging countries such as China, Brazil, Russia has gone up significantly. This number has risen from 10-15 per cent to 20 per cent in 2011. The total pharma market is estimated to be $1.2 trillion in 2016. In 2011, the US accounted for 50 per cent of the sales, with the US, Japan and the UK together making 80 per cent of the market, now they make 50 per cent combined, as the emerging countries comprise 30 per cent. Our market share is increasing because of improvement in economies. Total per capita consumption of drugs in India is $33 and the lowest is BRIC countries, with $180 in Brazil, $333 in Indonesia and the US at $800. Indian pharma market is growing 15-20 per cent whereas the US and Europe are growing barely at two to three per cent. That also tells you why large companies are getting into India. M&As have been an expansion tool for companies such as Abbott.

From a venture capital perspective, in the last ten years, percentage of medicines consumed by emerging countries such as China, Brazil, Russia has gone up significantly

These deals either help get market access or product access, geographic expansion in emerging markets or can be mega deals such as Pfizer acquiring Abbott. Interestingly, 60 per cent of M&As add value and 40 per cent of them destroy value. From 2010-2013, pharma index has gone up 60 per cent and biotech index has gone up 113 per cent. Those investing in biotech companies in the advanced world are making more money than those investing in pharma companies. There is also a big blur between traditional big pharma and biotech companies, both in the US and India, as companies realise the importance of innovation and large molecules. How is the VC ecosystem in India? From a VC perspective, it is a very difficult route to get to an IPO and access capital, unlike China. As a VC, when we invest money in a company, IPO is not the easiest exit, so we have to look for strategic exits, PE guys buying them out. The ecosystem includes the science at the university level, and the skill level of graduate and PhD students. However, we have to admit that we don't have world class scientists and nobel laureates yet. In the basic breakthrough sciences we're not there yet compared to

the US, Europe or Japan where all innovation is still taking place. Then there is a skill gap between the graduates passing out and what the industry expects out of them. One of the key ecosystem component is industry, government and academia working together and we have long way to go there. TDB and DBT are doing things, but there's bureaucracy still. The ecosystem still needs a lot of improvement. What are the investment opportunities of the future? Biosimilars, biobetters, vaccines, and DNA-based diagnostics present tremendous opportunities for us to invest. Injectable drugs is one of the hottest areas, tablets and capsules, low barrier entries are what we're looking at. We invested in Gland Pharma, back in 90s and have invested in Evolva (genetic chemistry), and Bioserve (DNA sequencing company) based in Hyderabad and the US that got acquired by Cancer Genetics Inc. In Bangalore, we have invested in Richcore which makes recombinant enzymes, and Biocon. Besides this, we have also invested in a couple of device companies in the US into cardiology and oncology. It is going to take India a while to get good in discovery sciences. We should licence

discovery from wherever we get it, be it Japan, the US or Europe. The government needs to be the change agents to increase cooperation between themselves, academia and industry. The focus needs to be on improving labs, quality of training, Masters and PhD programmes. Within that the specific opportunities for investment are specialty pharma. How do you invest in a company? We get a number of business proposals. A few questions that we ask are: Is the area large enough or a

The government needs to be the change agents to increase cooperation between themselves, academia and industry. The focus needs to be on improving labs, quality of training, Masters and PhD programmes nice focus area? Does the company have a track record? Are they bringing something new to the table? How does this differentiate? For example, we invested in Portea Medical, which is breaking new frontiers of homecare. We are also investing in a saliva-based point of care test in the US

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for diabetes. We look at the technologies which differentiates the companies and it is judgemental, there' no magic formula. At the end, it is human judgement. Biosimilars present the next opportunity ten years hence despite challenging

times. Your comments. The problem is that it is very expensive to develop a biosimilar, it is not like a generic chemistry molecule, from phase I to phase II and then getting them into markets such as the US and Europe. Companies like Doctor Reddyâ&#x20AC;&#x2122;s Labs

developed the molecules and marketed them in the emerging world, as they couldn't afford to fund clinical development they teamed up with Merck KGaA. It is a very good example for India, where we need to establish production capacity, develop the technology using

expression systems or cell lines from the US and concentrate on what we do best- process development. A lot of Indian companies put blinders on emerging trends in expression systems and want to do it on their own, instead of collaborating. shalini.g@expressindia.com

MARKET COMPANY WATCH

GoI,pharma industry jointly form India – Responsible Healthcare Trust To give more thrust to the Brand India Pharma campaign GOVERNMENT OF India (GoI) and the major pharmaceutical industry organisations have come together to form the India – Responsible Healthcare Trust to power the Brand India Pharma campaign. A one-of-its-kind public-private partnership, the formation of the Trust represents the commitment to both drive and safeguard the interests of the Indian pharma industry. The Trust chaired by the Commerce Secretary comprises key stakeholders, namely, the Indian Pharmaceutical Alliance (IPA), Indian Drug Manufacturers’ Association (IDMA), Bulk Drug Manufacturers Association (BDMA), Association of Biotechnology Led Enterprises (ABLE), Pharmaceutical Export Promotion Council of India (Pharmexcil) and In-

The India – Responsible Healthcare Trust is expected to take the Brand India Pharma campaign to the next level. The primary objective of this Trust will be to position India as a Responsible Healthcare provider dia Brand Equity Foundation (IBEF). The Trust aims to combine both financial and non-financial resources towards a common agenda. The Trust aims to create better awareness and develop an informed perspective about Brand India Pharma in both the domestic and global mar-

kets. “The India – Responsible Healthcare Trust will spearhead the Brand India Pharma initiative through the second phase. The industry-government partnership is an important milestone in the campaign,” said Rajeev Kher, Commerce Secretary, Govern-

matic disorders. It is 30 per cent more effective than conventional products, as proven by a series of toxicity and safety studies. It has 150 per cent enhanced retention for longer effect, improved relief and better mobility,” said Dr Manu Chaudhary, Joint Managing Director and Director, Research, Venus Remedies.

RANBAXY LABORATORIES has launched ABSORICA (isotretinoin) 25 mg and 35 mg capsules into the US healthcare market. ABSORICA has become the most prescribed branded oral isotretinoin in the US, as per a recent independent survey conducted with dermatologists. The product is licensed by Ranbaxy from Cipher Pharmaceuticals. It is indicated for the treatment of severe recalcitrant nodular acne in patients 12 years of age and older. Due to its high lipophilicity, oral absorption of isotretinoin is enhanced when given with a high-fat meal, however, ABSORICA, which is formulated using patented Lidose technology, can be given without regards to meals. The fasted AUC0-t of ABSORICA is approximately 83 per cent greater than that of Accutane, while both products are bio-equivalent under fed conditions. ABSORICA is therefore not interchangeable and not substitutable with generic products of Accutane. Dr Ashish Anvekar, Vice President of Brand Division North America, Ranbaxy, said, “Since isotretinoin dosing is weight-based, we are pleased to make available these valuable, additional dosing options exclusively for ABSORICA. This will give prescribers the enhanced flexibility, to tailor the isotretinoin therapy depending on the patient’s weight, and benefit the group of patients who are in that weight range, irrespective of their dietary intake. Ranbaxy continuously seeks to innovate and bring value based options to the speciality of dermatology and patients.”

EP News Bureau- Mumbai

ment of India. The Brand India Pharma campaign was launched under the aegis of the Department of Commerce at CPhI Japan in March 2012. The Brand India Pharma showcase has made its presence felt at prestigious events like CPhI Worldwide consistently over the past two years. The Department of Commerce along with IBEF and Pharmexcil has invested huge resources with measurable and impacting results in the first phase of the Brand India Pharma campaign. The India – Responsible Healthcare Trust is expected to take the Brand India Pharma campaign to the next level. The primary objective of this Trust will be to position India as a Responsible Healthcare provider. EP News Bureau- Mumbai

Venus forays into Singapore’s topical pain management market Gets marketing authorisation and patent for its pain reliever Trois VENUS REMEDIES has entered Singapore’s topical pain management market with a marketing authorisation and patent for its herbal nanotechnology-based pain reliever Trois. The company is holding talks with various pharmaceutical firms for tieups to market Trois in Singapore. A product for topical use, Trois provides quick and last-

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ing relief to patients suffering from rheumatic disorders, low back pain, osteoarthritis, rheumatoid arthritis, gout, knee pain, ankylosing spondylitis, fibromyalgia and pain originating from muscles and tendons. Currently, more than 1.5 billion people worldwide suffer from chronic pains of varying degree. The company has filed the product, process and use patent

for Trois in 46 countries. Pawan Chaudhary, Chairman and Managing Director said, “This is a great opportunity for us to capture a sizeable share in this segment of the Singapore pharma market. Trois has a huge potential in Singapore.” “Trois is the safest known topical product for management of pain and inflammation associated with rheu-

Ranbaxy launches ABSORICA in the US

MARKET

Strides Arcolab ties up with Shasun Pharmaceuticals Creates vertically integrated pharma company with multiple revenue streams THE BOARD of Directors of Strides Arcolab and Shasun Pharmaceuticals have approved a scheme of amalgamation between the two companies. The combination creates a vertically integrated pharmaceutical company of scale with strong presence in front-ended regulated markets finished dosages, emerging markets branded generics, institutional business, active pharmaceutical ingredients and contract research and manufacturing services. The combination will significantly enhance finished dosages portfolio in niche and complex domains with a pipeline of over 100 products and accelerates product filings

with a combined R&D strength of over 400 personnel. It will significantly de-risk its operations with the combined entity having 12 manufacturing facilities including three US FDA approved finished dosage manufacturing facilities, two US FDA approved API manufacturing facilities, one US FDA approved CRAMS facility and six manufacturing facilities catering to the emerging markets. The merged entity will leverage Shasun’s best in class API manufacturing capacities and shift focus towards niche API’s aligned with finished dosages portfolio and pipeline. It will significantly synergy opportunities in operations and cost sav-

The merged entity will leverage Shasun’s best in class API manufacturing capacities and shift focus towards niche API’s aligned with finished dosages portfolio and pipeline ings through economies of scale. The amalgamation will create a top 15-listed Indian pharma company by revenue with increased scale and visibility to drive future growth of the group. Arun Kumar, Founder and Group Chief Executive Officer,

Strides stated, “Since the divestment of our injectables business, which resulted in significant value creation for our shareholders, Strides has refocused on its oral finished formulation business. Today’s proposed combination with Shasun accelerates our strategy and

growth prospects by creating a larger scale, fully integrated, leading Indian pharma company with multiple growth drivers and synergies that will allow for enhanced profitability and more efficient use of our combined infrastructure and enhanced value creation opportunities for the combined shareholder group.” Abhaya Kumar, Chief Executive Officer and Managing Director, Shasun stated, “Strides and Shasun bring complementary strengths and shared values of developing products and market opportunities across geographies and the combination accelerates both scale and scope.” EP News Bureau- Mumbai

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MARKET

Decreasing herb production could hamper Ayurveda industry Shortages, fears of dilution could prevent industry tapping increasing demand

Steena Joy Kochi THE AYURVEDA industry is facing problems on the production front, which if not sorted out immediately, could impact the long-term growth prospects of the industry. Alerting the industry to some of these problems Dr GG Gangadharan, Medical Director, Institute of Ayurveda and Integrative Medicine (I-AIM) Healthcare Centre and Chairman, National Steering Committee for Global Ayurveda Festival, (a biennial get together of the Ayurveda fraternity from the world over), said, "On the one hand, mass production of Ayurvedic medi-

cines is diluting the science. On the other, a shortage of herbs required to produce these medicines is looming. When the demand for Ayurveda increases, how will the treatment centres get the plants and herbs needed for production? Ayurveda uses some 1600 plants and herbs of which only 120 are in actual usage. Of these about 60 are not easily available.” Alluding to the potential of the industry, Gangadharan said,“The global wellness market is worth some $five trillion. India earns ` 9,000 crore from Ayurveda services alone and we have not even seen the tip of the iceberg as far as this science is concerned. Ayurveda is

The global wellness market is worth some $five trillion. India earns ` 9,000 crore from Ayurveda services alone

To invest about $36.65 million over three years on areas including machinery and equipment for the facility

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United States and European Union over Tehran's nuclear programme, allows trade in humanitarian goods such as food and medicine, not many Indian drugmakers have significant presence in Iran. "Cipla has been providing medicines to patients in Iran for several years and believes that Iranian patients cannot be denied to medicines due to sanctions," the company said in a statement to Reuters. "We have observed a high prevalence of respiratory disorders and cancer cases in

herbs like gugulu which is the most used in Ayurveda is difficult to cultivate. So the government has to subsidise farmers and have a buyback arrangement.” Baby Mathew, Chairman and Managing Director, Somatheeram Ayurveda Group, opined, “It is good that the government has implemented GMP in Ayurvedic medicine manufacturing. But sadly, there are no high standard research facilities for Ayurveda like the IITs for technology. The government has finally given approval for setting up an Ayurveda University, so at least the health department are on the right track. steena.joy@expressindia.com

Novartis announces change in Executive Committee

Cipla to set up a manufacturing unit in Iran CIPLA HAS agreed to set up a manufacturing plant in Iran, as part of its strategy to boost its presence in the country's $4 billion pharmaceuticals market that is growing at about 13 per cent annually. Cipla, which will own 75 per cent stake in the plant being set up in partnership with its local distributor, will invest about $36.65 million over three years on areas including machinery and equipment for the facility. Although the sanctions regime, imposed by the

the only area where India is 5,000 years ahead of other countries. But this success story is in danger. Now even other countries like Switzerland, and Sri Lanka our neighbour are offering Ayurveda. As Ayurveda is not officially recognised by many countries, it is difficult for patients travelling to India for Ayurveda to get medical insurance.” Gangadharan felt that a strong backward integration model needs to be adopted. “We have urged the government to implement a nursery technology programme to step up cultivation. Here again, some plants need to be cultivated 'in situ' in their original environment or they will lose their medicinal value. Some

Iran. There were also patients suffering with diseases like thalassemia, HIV/AIDS and heart diseases, who have been at a risk due to the impact of sanctions," it said. Setting up the plant will help in faster registrations of new products and will improve its competitive position, the company said, adding it does not expect any impact on its US and European businesses due to its investments in Iran. Reuters

NOVARTIS CONFIRMED that following completion of the transactions with GlaxoSmithKline (GSK) and Eli Lilly and Company (Lilly) in the coming months, the three business leaders of the Novartis divisions at the centre of the transaction will leave the Executive Committee of Novartis (ECN). The expected changes to the ECN are subject to the closing of the transactions announced on April 22, 2014. Novartis expects the transaction with GSK to be completed in the first half of 2015, and the transaction with Eli Lilly for its animal health business to close in the first quarter of 2015. George Gunn, currently Division Head, Novartis Animal

Health, will reach his contractual retirement age in July 2015 and will retire from Novartis. Upon closing of the animal health transaction with Lilly he will leave the ECN. Brian McNamara, currently Division Head, Novartis OTC, will transition to GSK as Head of Americas and Europe for the consumer health businesses, reporting to the President of GSK Consumer Healthcare, effective at closing of the transaction. Andrin Oswald, currently Division Head, Novartis Vaccines, will be leaving Novartis to pursue other opportunities following closing of the transaction with GSK. EP News Bureau- Mumbai

MARKET

Strides Arcolab,GMS Holdings agreement Announces strategic investor for its greenfield biotech project STRIDES ARCOLAB has entered into an agreement with GMS Holdings whereby GMS will invest $29.10 million for a 25.1 per cent stake in Stelis Biopharma, the biotech arm of Strides Arcolab, to fund its greenfield project. The transaction is expected to close in Q4 of 2014 and is subject to customary closing conditions, regulatory and corporate approvals, as may be required. Joe Thomas, Chief Corporate Development Officer, Strides and Head – Biotech division stated, “We are pleased

The transaction is expected to close in Q4 of 2014 and is subject to customary closing conditions, regulatory and corporate approvals, as may be required

to have GMS Holdings as our strategic partner for the emerging Biotech business. GMS Holdings has a track record of having partnered in successful businesses, with a strong presence in the MENA region.” Ghiath Sukhtian, Chairman, GMS Holdings stated, “We are delighted to be partnering with Strides on this ex-

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citing venture. Strides has a long track record of building

successful pharma platforms and we believe that by joining

our efforts on this investment we can create significant

value for both our groups.” EP News Bureau- Mumbai

MARKET

Merck Serono to collaborate with The Institute of Cancer Research,London and Wellcome Trust To co-develop anti-cancer drugs MERCK SERONO, the biopharmaceutical division of Merck, The Institute of Cancer Research (ICR), and the Wellcome Trust, London, announced a co-development and license agreement building on two independent research programmes at both the ICR and Merck Serono to identify inhibitors of tankyrase, an enzyme of the poly (ADP-ribose) polymerase family. The collaboration will be jointly funded by Merck Serono and the Wellcome Trust. The existing drug discovery programme at the ICR is supported by a Wellcome Trust Seeding Drug Discovery Award. In a joint effort, a team led by Dr Chris Lord and Professor Alan Ashworth at the ICR and a research group at Merck Serono will aim to progress chemical compounds that have emerged from both organizations’ tankyrase inhibitor programmes towards

clinical development. At the end of the collaboration period, Merck Serono will take over full responsibility for the selected clinical development candidate, with the goal of bringing a new cancer therapeutic drug to patients. Lord, Team Leader in the Division of Breast Cancer Research at The Institute of Cancer Research, London, said, “Tankyrase inhibitors provide a unique opportunity to target one of the most common characteristics of cancer cells - their dependency on the so-called ‘Wnt signaling’ pathway. Both Merck Serono and the group at the ICR have already made notable progress in developing tankyrase inhibitors. Working with Merck Serono will allow us to jointly accelerate our programme with the aim to ultimately make tankyrase inhibitors available to cancer patients.” “We are delighted to work together with Dr Chris Lord

The collaboration will be jointly funded by Merck Serono and the Wellcome Trust. The existing drug discovery programme at the ICR is supported by a Wellcome Trust Seeding Drug Discovery Award and Professor Alan Ashworth. With this partnership, we aim to harness the already well advanced tankyrase programmes at both ICR and Merck Serono and hope to ultimately translate these in to novel treatment options for cancer patients. We will build on a joint compound base of potent tankyrase inhibitors and will leverage both sites’ scientific knowledge about the ‘Wnt pathway’ that plays a major role in signal transduction

for tumor growth”, said Dr Andree Blaukat, Head of the Translational Innovation Platform Oncology at Merck Serono. “The interest of the Wellcome Trust shows its belief in our researchers’ scientific data. It also shows the importance of cademia-industry collaboration models in pharmaceutical development to progress the most promising investigational compounds into clinics with the aim of bringing them to patients.”

“This agreement highlights the importance of translational funding, such as the awards provided under the Seeding Drug Discovery scheme, to reduce the risk of drug discovery programmes so that they become attractive to partners who have the ability to bring a product to market”, said Dr Ted Bianco, Director of Innovations at the Wellcome Trust. Some of the most promising advances in cancer research have been small-molecule inhibitors which block the activity of members of the poly (ADP-ribose) polymerase (PARP) enzyme family, which includes the enzyme tankyrase.1

References 1. JL Riffell et al, Tankyrase-targeted therapeutics: expanding opportunities in the PARP family. Nat Rev Drug Discov. 2012 Dec;11(12):923-36. doi: 10.1038/nrd3868 EP News Bureau- Mumbai

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services introduced by your organisation for our various sections: Pharma Ally (News, Products, Value Add), Pharma Packaging and Pharma Technology Review sections. Related photographs and brochures must accompany the information. ❒ Besides the regular columns, each issue will have a special focus on a specific topic of relevance to the Indian market. ❒ In e-mail communications, avoid large document attachments (above 1MB) as far as possible. ❒ Articles may be edited for brevity, style, and relevance. ❒ Do specify name, designation, company name, department and e-mail address for feedback, in the article. ❒ We encourage authors to send their photograph. Preferably in colour, postcard size and with a good contrast.

EXPRESS PHARMA

October 16-31, 2014

Email your contribution to: The Editor, Express Pharma, Business Publications Division,

The Indian Express Limited, 1st Floor, Express Towers, Nariman Point, Mumbai - 400 021. Tel: 91-22-2202 2627 / 2285 1964/ 6744 0000 Fax: 91-22-2288 5831 editorial.ep@expressindia.com

MARKET

Sun Pharma and Merck in agreement Sun Pharma will acquire worldwide rights to tildrakizumab for use in all human indications from Merck in exchange for an upfront payment of $80 million MERCK & CO, known as MSD outside the US and Canada, and Sun Pharmaceutical Industries through their respective subsidiaries, entered into an exclusive worldwide licensing agreement for Merck’s investigational therapeutic antibody candidate, tildrakizumab, (MK-3222), which is currently being evaluated in phase III registration trials for the treatment of chronic plaque psoriasis, a skin ailment. Under terms of the agreement, Sun Pharma will acquire worldwide rights to tildrakizumab for use in all human indications from Merck in exchange for an upfront payment of $80 million. Merck will continue all clinical development and regulatory activities, which will be funded by Sun Pharma. Upon product approval, Sun Pharma will be responsible for regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialisation of the approved product. Merck is eligible to receive undisclosed payments associated with regulatory (including product approval) and sales milestones, as well as tiered royalties ranging from mid-single digit through teen percentage rates on sales. “Consistent with our previously announced global initiative to sharpen our commercial and R&D focus, including prioritising our late stage pipeline candidates, we are pleased to enter into this agreement with Sun Pharma to help realise the potential of tildrakizumab for patients with chronic plaque psoriasis,” said Iain D Dukes, Senior vice president, Business Development and Licensing, Merck Research Laboratories. "Sun Pharma is pleased to enter into this collaboration with Merck, a recognised

EXPRESS PHARMA

October 16-31, 2014

leader in the field of inflammatory/immunology therapies,

for this late-stage candidate for chronic plaque psoriasis,” said

Kirti Ganorkar, Senior Vice President, Business Develop-

ment, Sun Pharma. ” EP News Bureau- Mumbai

FULL ATTENTION TO THE TINIEST DETAIL. A big machine with some great details. The CP400 marks a milestone in packaging technology: in 1993 it was the world’s first machine in which the classic vertical shaft was replaced by servo-motor drive of all functional units. After some 20 years of ongoing development, the CP400 has reached a unique degree of maturity; its exemplary GMP design guarantees maximum production security.

For further info please contact our local partner: www.salesworthsynergies.com or check www.mediseal.de

MARKET POST EVENT

AWACS felicitates pharma achievers The awards were divided in three categories AWACS AWARDS in Marketing Excellence 2014 took place recently at the Nehru Centre Auditorium in Mumbai in the presence of pharma bigwigs from across India. It was the first edition of these awards. AWACS is a market research agency with syndicated audit Pharma Trac. These awards are instituted to recognise and reward top performers of the domestic pharma industry. The AWACS awards were divided in three categories, namely, top 20, companies ranked between 21-50 and

20 EXPRESS PHARMA October 16-31, 2014

above 50. The last financial year was one of the most challenging in recent times, however, certain brands have shown remarkable volume growth post getting a huge top line hit due to DPCO. For such products AWACS created a special category on best DPCO revival. They were classified by company size, and under acute and chronic categories, as well as under specialty brand. Ameesh Masurekar, Director, AWACS, said, “There are a lot of people in the industry

The awards are instituted to recognise and reward top performers of the domestic pharma industry

that are working hard but do not get individual credit. These awards will help to achieve this.” Ganesh Nayak, Chief Operating Officer and Executive Director, Zydus Cadila, said, “AWACS has added a lot of value in terms of business intelligence to sharpen our strategies. AWACS Pharma Trac has created a competition which has in turn helped us in getting better services.” He added that the pharma industry earlier didn’t have a platform which recognised the

top performers. He suggested, “AWACS should institutionalise these awards in such a way that every year we will look forward for it.” Dr Tarun Gupta, Professor Emeritus at School of Business Management and Chairman, MBA - Pharmaceutical Management School of Business Management SVKM’s NMIMS was conferred with the Lifetime Achievement award for his exemplary contribution towards the pharma industry. EP News Bureau

EVENT BRIEF NOVEMBER 2014 - MAY 2015 3

Multicentre International Data Integrity Workshop

MULTICENTRE INTERNATIONAL DATA INTEGRITYWORKSHOP Date: November 3-4, 2014 Venue: New Delhi Date: November 6-7, 2014 Venue: Mumbai Date: November 10-11, 2014 Venue: Hyderabad Date: November 13-14, 2014 Venue: Bangalore Summary: Members of the US Food and Drug Administration along with other international regulatory agencies such as the European Directorate for the Quality of Medicines & Healthcare (EDMQ) and others will be hosting a two-day workshop. It will provide an opportunity to build awareness for regulatory agencies and industry regard-

ing the importance of integrity in pharmaceutical science. The workshop will include focused discussions related to trends concerning data integrity, and the exploration of potential solutions. Contact details: Manoj Trivedi Sr Manager (Mktg & Program Development) DIA (India) Mob: +91 9819777493 Email: Manoj.Trivedi @diaindia.org

ASIA PHARMA EXPO-2015 Date: January 8-10, 2015 Venue: Bangabandhu International Conference Centre, Dhaka, Bangladesh

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Asia Pharma Expo-2015 Summary: Bangladesh Association of Pharmaceutical Industries will host international exhibition on South Asian Pharmaceutical industry, Asia Pharma Expo-2015. The exhibiting companies from more than 26 countries across the world are expected to participate. The expo will be accommodating 400 booths to the exhibitors. Major OEM suppliers from Asia, Europe and the US are likely to participate. Contact details: Tel: +91 7940008233/ 53 Mob: +91 8000481114 Email: ceo@GPEexpo.com Website: www.asiapharma.org

PHARMA Pro & Pack Expo 2015

PHARMA PRO & PACK EXPO 2015 Date: May 13-15, 2015 Venue: Mumbai Exhibition Centre, Mumbai Summary: PHARMA Pro & Pack Expo 2015 will be organised by IPMMA. 20,000 pharma trade professional/ decision makers and 250 industry majors will exhibit their technologies/ services. Visitors' profile include biotechnology specialists, plant management, CEOs, engineers, technocrats and scientists, policy makers, diplomats and foreign commercial corp, compliance, process engineering, corporate management, procurement department, custom manufacturing/ marketing

services, purchase officers, equipment suppliers and distributors, quality assurance/ quality control, maintenance engineering, R&D professionals, manufacturing/ production engineering, regulatory officers, operations management, validation, packaging engineering, vendor development, pharmacists. Contact details Indian Pharma Machinery Manufacturersâ&#x20AC;&#x2122; Association (IPMMA) 52, 1st floor, Suyog Industrial EstateLBS Marg, Vikhroli (West) Mumbai - 400 083 Tel: +91 22 6561 9272/ 2578 6007/ 2685 5108

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cover )

22 EXPRESS PHARMA October 16-31, 2014

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PACKAGING SPECIAL

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cover ) (L-R): Jasjit Singh, Ajit Singh and Karan Singh

he history of Indian pharma packaging machinery sector would be incomplete without mentioning Ajit Singh, Chairman of ACG Worldwide. His contribution to the industry has been immense as he has brought in a revolution in the attitude of Indian pharma machinery manufacturers — from 'can we?' to 'we can'. Singh's success is a tale of struggle, efforts, persistence, confidence and dedication etc. Honesty and integrity have been his constant companions in this decades long journey.

A born fighter From setting up a small unit in the jungles of Kandivli, to establishing world-class plants in India and globally, Singh has come a long way. Recollecting about his first unit and the challenges he faced in operating it, Singh narrates, “In the distant outreach of Greater Mumbai we had jungles and marshland around us. No city car could reach upto the factory. We went by horse and carriage for the last kilometre.” It is often found that there are picturesque scenarios waiting at the end of difficult terrains. It was true in Singh's case as well. From humble beginnings, Singh has become a name to be reckoned within the pharma packaging industry globally, today. Like any new start-up, finding and retaining good managers was another problem for Singh, as also acquiring new technology. However, every obstacle was converted into an opportunity by him. He informs, “We created managers by training and enthusing our workmen and supervi-

24 EXPRESS PHARMA October 16-31, 2014

Many honours and recognitions that have remained elusive to its domestic counterparts, came ACG's way, thanks to Singh's visionary leadership. The contribution of his brother Jasjit Singh, Managing Director of the company, also proved instrumental in the company's overall growth sors. The technology we had to develop by ourselves. Our growth perhaps took longer than it would have if we had gone public in the early years. But the only time we were desperately short of cash was when we were putting up our new plant at Dahanu, now Asia’s largest capsule plant.” He adds, “The erstwhile BCCI Bank was the only one that came to our rescue. I learnt some valuable marketing lessons from them. Overcoming problems in real life teaches you more than the best business school. We are glad we did not go public. We have retained enormous flexibility, and we can react to change with speed. We have now reached a size and growth that we don’t need to raise money by diluting our stock. Unlike many of our

global competitors, neither our plants nor people are for sale or purchase.”

Global recognitions Singh's considerable domain knowledge and expertise in pharma packaging helped him to raise his company to greater heights. His efforts received recognition from the industry and the governments in India and Croatia, where ACG has a plant. “The Croatian Government, in public forums and TV, has twice described ACG as the ideal investor whom they welcome. In the last four years, two successive Presidents of Croatia have visited our plant at Ludbreg. They appreciated our efforts and contribution to Croatia in creating employment, innovation, technology creation and mak-

ing it the third largest supplier of capsules in Europe through export of 95 per cent of our production,” informs Singh. He adds, “Our company has also been nominated to represent Croatia for a top European Business Award. In Brazil, we have been recognised by the Association of Pharma Manufacturers as the best supplier of pharma equipment and consumables.”

Why only ACG? Many honours and recognitions that have remained elusive to its domestic counterparts, came ACG's way, thanks to Singh's visionary leadership. The contribution of his brother Jasjit Singh, Managing Director of the company, also proved instrumental in the

company's overall growth. “It was not easy. And we were determined. We generally do not get into any product line which is simple to get into, which needs only investment. Our leadership is largely due to our advanced technology and quality. And due to the talent and dedication of our people led by our Managing Director, Jasjit Singh. He is a brilliant engineer, and very modest. He’s also a great manager and much liked. His son and my nephew Karan, who’s increasingly taking over, displays strong, positive aspects of both of us,” informs Singh. According to Singh, his company's achievements are a result of vision, patience, ambition, global networking, worldwide distribution and international advisors. Singh is optimistic about the growth of the industry as well. He says, “I’m sure other Indian manufacturers will also make their mark globally. They need to think long term and fortunately for them technology and manufacturing is now becoming a commodity. Acquiring proficiency here is not the great effort it was for us. Though achieving consistent quality is.”

50 decades.... and going strong Singh is a walking encyclopedia on the pharma packaging industry. Many other big names in the industry have grown up in their respective domains by taking a leaf out of Singh's book of experience. Who knows better about the ingredients of success than Singh himself? “To remain for decades as a market leader and still keep going strong needs certain

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attributes, a certain mindset, and some luck. As known, nine out of 10 start up businesses close down. Even the life span of a large, apparently strong company seldom equals that of its key personnel. The first attribute is a passion for the product and business – the more you focus on and understand your product and processes, the greater the passion becomes. Particularly, if you develop expertise and develop a size that makes your company and yourself respected worldwide in your field,” says Singh. He adds, “Another requirement is to look after your people. Only if you nurture them and help them to grow will they have the motivation and commitment to look after your customers. And satisfied customers are a key reason for continued existence and survival of a business. To succeed, one needs to envision the future and plan for it. Even better, to try and create it, or at least plan for it. Particularly important is planning for continuity and succession of key personnel. This is a delicate matter. My brother, Jasjit and I have worked out our own succession plan. Along with our very competent global head of HR Sunil Jha, we are now working on succession plans for other key positions. It is a difficult job, but, if not done it creates even more difficulty.” It is the characteristic of a leader and a leading company to continuously reinvent the organisation and its products. 'Be Close to Your Customer' – is a constantly heard management jargon. According to Singh, it has a deeper meaning than giving great service, new varieties of product and

Stjepan Mesic, (then the President of Croatia) during his visit to ACG Lukaps in 2009. Also seen in the picture is Devendra Aajgaonkar

ingh’s business acumen is well known, however, he is also a philanthropist. One day he saw Devendra Aajgaonkar (now his personal assistant), working at the Fellowship for Physically Handicapped (FPH). Impressed by potential within this short man, he offered Devendra an opportunity to work with him. Since mideighties, Devendra has been a close confidant of Singh.“He made my life. Because of him people treat me with respect, which otherwise I would not have got that easily,” says an emotional Devendra. According to Devendra, Singh doesn’t like anybody calling him ‘Chotu’. His boss would

listening to customers. As an example, ACG group is involved in training over 2,000 professionals from the global pharma industry every year through seminars and in-house training. Singh asserts, “You need to be regarded as a source of knowledge and guidance, and be recognised not only as a supplier but also as a friend and colleague.” Singh was lucky in a way that he had a completely trusted and competent partner. In his case, it is his brother and life partner, Jasjit. Singh describes, “We work as a seamless unit, bringing our differing strengths to the business. Some time back we were joined by my nephew Karan. He is a fast learner and combines the strengths of us both. In the last

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argue,‘Devendra is such a nice name, why should he be called Chotu?’ Devendra has visited countries like Germany and Croatia with Singh. He informs,“Singh would never hide his opinions about anything. He himself is a good human being and he likes to be among people with good moral values.” Today the entire Indian pharma industry associates Devendra with ACG Worldwide and he gives all the credit to Singh for the same. Devendra has spent close to three decades at ACG and wants to continue his association with the company, and more importantly, with his boss, Singh.

ACG is a dream that Singh has lived day and night for several decades. He is as passionate about the company as he used to be 50 years back

few years we have also learnt, with great benefit, the importance of bringing in great team members often with competence greater than our own.”

Future expectations ACG is a dream that Singh has lived day and night for several decades. He is as passionate about the company as he used to be 50 years back. Over the years, the company has achieved many milestones under his leadership and Singh wants his company to grow with the same spirit and enthusiasm. He wants his company to be a world leader in each of its main products apart from being one of the best companies to work in, globally. Being a caring person by nature,

Singh wants to continue to make products for the pharma industry that improves health and well being, reduce pain and suffering and continue to get the blessings of people from around the world billions of times a year. Singh feels that a vital ingredient for continued success is to be very conscious of your inadequacies and missed opportunities. And learn from them. “Though we may become a world leader in sales of product lines we need to learn how to think and, more importantly, act like a world leader. But we are getting there,” says a humble Singh.

Conclusion Associating Singh only to his company would be an injustice to his hard work in the last many decades. Today, he represents not just ACG Worldwide but the entire Indian pharma packaging machinery sector in the global market. Singh has achieved a lot today but like a true entrepreneur he always believes in taking a step further. Instead of predicting the future he wants to create the future and this thinking makes him stand apart from his colleagues in the industry. American philosopher, Andrew Bernstein's words, “The hero is the man who lets no obstacle prevent him from pursuing the values he has chosen,” describes Singh to a 'T'. The Indian pharma machinery manufacturing industry has matured a lot over the last few years. Its overseas counterparts are looking at it as a serious competition. To keep this competitive edge alive, the role of a visionary like Singh would prove crucial. sachin.jagdale@expressindia.com

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MANAGEMENT

26 EXPRESS PHARMA October 16-31, 2014

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MANAGEMENT

ecently the Government of India has identified 25 key sectors in which India has the potential of becoming a world leader and the pharmaceutical sector is one of them. And, with an aim to turn the country into a global manufacturing hub, to ensure that India is not treated as a ‘Market’, and to retain homegrown talent, on September 25, 2014, Prime Minister (PM) Narendra Modi (Just before his first visit to US after becoming the prime minister of India) launched the ‘Make In India’ campaign. Responding to the ‘Make In India’ campaign, Kiran Mazumdar-Shaw, Chairman and Managing Director, Biocon comments, “Make In India campaign reflects PM Modi’s

commitment to make India the preferred global destination for manufacturing. His assurance towards ‘Ease of Business’ and ‘Speed of Business’ through simplified rules and self regulation, is likely to win investor confidence and usher in a new wave of investments in the country.” Dr Rajaram Samant, Chief Executive Officer and Chief Mentor, Akumentis Healthcare says, “This is a great initiative by our PM to give push to Indian manufacturing sector. In fact, the pharma manufacturing sector is making news globally. India is likely to emerge as third biggest market globally in terms of volumes after the US and China. A word of caution ‘We need to commit to global quality standards’ to turn this vision in to

reality and make India shine.” Thus it seems that the ‘Make in India’ campaign has been received well within the country, however, the global scenario doesn’t seem very conducive for its success at this point of time.

Stiff competition China, one of our strongest competitors has also launched a similar, ‘Made in China’ campaign with a host of tax concessions to boost its manufacturing prowess. India imports nearly 60 -70 per cent of its required active pharmaceutical ingredients (APIs) from China and is still largely dependent on the Chinese APIs manufacturers.

Reputation at stake Right before the Indian PM’s

visit to US, Washington-based American Enterprise Institute (AEI) published the findings of a ‘study’ as a working paper in the National Bureau of Economic Research (NBER) series. The study claims to assess “the quality of 1470 antibiotic and tuberculosis drug samples that claim to be made in India and were sold in Africa, India, and five mid-income non-African countries” based on samples “from pharmacies in 22 cities of 18 low- to mid-income countries between 2009 and 2012.” The India Brand Equity Foundation (IBEF), on behalf of the Government of India (GoI), has taken a strong objection to the study and called it “a smear campaign being orchestrated by the AEI against the whole Indian

n October 2013,the US FDA had inspected Amanta Healthcare’s (formerly known as Marck Biosciences),manufacturing facilities located in Kheda,Gujarat.The company is a specialist in manufacturing and marketing of sterile dosages and blow-fill-seal (BFS).The US FDA regulators made several observations, including on various aspects of documentation and maintenance of records as well as issues outside the facility.The company claims that it has submitted all required documents to the authority within one months time and gets the warning letter from the US FDA on 8 July,2014.It is important to note that the facility has been certified by MCC South Africa,TGAAustralia,MCAZZimbabwe,UK MHRA,SGS (Malaysia) and SGS India. One of the interesting aspect in this case is that the company has no exports to the US market as of now nor it has any immediate plans.However,it intends to take all the US FDA’s observations extremely seriously and reapply for certification within the next 12 months.Bhavesh Patel,Managing Director, Amanta Healthcare shares,“At the time of inspection,we didn’t have any business in the US markets.However,we are working on the product pipeline and we intend to achieve full compliance meeting US FDAwithin 12 months.”

28 EXPRESS PHARMA October 16-31, 2014

US FDA had inspected the company’s Kheda facility in October 2013 and 18 observations were made.Patel shares the key finding of the US FDA inspection,“In some cases,the US FDA report have been ambiguous and left to imagination.The dead frogs were found outside the exit door,closer to our construction site.It was not and cannot be inside the manufacturing block. Subsequent inspections have taken the cognition of this fact.Subsequent to those observations,we submitted corrective action plan and compliance within the stipulated 21 working days i.e.by the end of November 2013. We also had attached relevant photos of corrective action taken wherever required and possible in our compliance report.” According to the company sources,US FDA, as a matter of practice,had shared this report with UK MHRA.And few weeks later,UK MHRA team consisting of two members spent five days at the company’s site and were satisfied with the company’s compliances procedures.The UK MHRA team had also met the commissioner of Gujarat FDA before and after inspection and expressed their satisfaction. For renewal of CE certification,UK MHRA had directed SGS Malaysia to inspect the plant and cleared the facility.UK MHRA and SGS

Kiran MazumdarShaw, CMD, Biocon

A CASE STUDY OFAMANTA HEALTHCARE

PM Modi's assurance towards ‘Ease of Business’ and ‘Speed of Business’ through simplified rules and self regulation, is likely to win investor confidence and usher in a new wave of investments in the country

inspection were specifically focussed on observation made by US FDA.Patel informs, “All these inspections subsequent to the FDA survey have found that Amanta had satisfactorily met the requirements and no adverse observation or comments or advisory was issued.After US FDA inspection,the company responded with thorough compliance and in subsequent inspection by UK MHRA and SGS Malaysia.We could show them the same compliance.They had an opportunity to see ground reality which probably resulted in both compliances.” Mistake known to be a best teacher which teaches from its last mistake.And a smart person always learns a lesson from its last mistakes and never repeats it in future.Patel shares learnings from the US FDAwarning letter and comments,“We face more than 100 inspections a year from various regulatory authorities and customers.Every inspection had potentially a learning value.No organisation can be build based on one or two experiences.It’s a process by itself.” He continues,“We are having manufacturing partnership with some of reputed pharma companies.We are glad that we have met their expectations and with the same spirit we intend to meet US FDA’s expectations as well.”

It is incorrect to say that Indian companies are not following set standards and are incapable of delivering quality medicines to the world. If it was indeed so, the exports would not have grown year after year at 18 to 20 per cent per year and reached $13 billion DG Shah, Secretary General, Indian Pharmaceutical Alliance

MANAGEMENT

There seems to be a deliberate campaign to malign the Indian pharma industry Dr PV Appaji, Director General, Pharmexcil India

pharma industry. It seems that the effort is to tarnish the image of the Indian pharma industry which it has painstakingly developed over the years and is often recognised as ‘Pharmacy of the World’”. The conclusions of the study are disputed not only for methodology and ethics but also for the poor treatment of data sampling used. Protesting against the study, Dr PV Appaji, Director General, Pharmexcil India highlights the lack of ethics in the study and says, “There seems to be a deliberate campaign to malign the Indian pharma industry. The minimum requirement would be to give an opportunity to the labelled manufacturers to give their comments against their test observations.” DG Shah, Secretary General, Indian Pharmaceutical Alliance (IPA) takes up a strong stand and says, “The study recognises that products with “Made in India” label may not be actually made in India. The study also recognises that transportation and storage conditions could have impacted the quality of products. But ignoring these realities, it still attributes poor quality (of drugs at the consumer end) to manufacturers and the Indian pharma regulator.” This is not only strange but reflects of a smear campaign with an ulterior motive rather than actually being concerned about quality issues.”

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October 16-31, 2014

MANAGEMENT Appaji points out at least eight technical issues with the sampling and data techniques, “Samples were not authenticated either from the source or from the regulators of the local country; samples were not referred to manufacturers to ascertain their genuineness. Authors have not ascertained the source of supply of the drug and not indicated in the report. They directly pointed out that they are from India; the names of the manufacturing firms were not disclosed; the study fails to indicate the reference standards used. Based on the above observations, the report has no value on the face but they have published this report to damage the image of India in the international market.” Sudhanshu Pandey, Joint Secretary, Department of Commerce, Government of India comments, “Quality is one of the major focus for pharma exports from India. Indian companies meet the quality requirements of all our importing countries. India looks at healthcare as a holistic issue rather than just commercial business.”

US FDA alerts In the last one and half years’, India’s reputation as ‘Pharmacy of the World’ has been

somewhat tarnished in the global pharma space. Pharma exports from India to the US have been in the news, but for the wrong reasons as there have been constant regulatory alerts from the US FDA authority. India has the maximum number of US FDA approved facilities outside the US, but in the last one and half years many Indian pharma firms have received warning letters, 483s or import alerts due to data reliability/integrity issues. Ranbaxy, Wockhardt, Sun Pharma are the most affected Indian pharma firms and there are many more midsized pharma companies who have come under the US FDA scanner in the recent past. India is not the only country who has been receiving the US FDA warning letters. Pharma firms from other countries including the US and Europe have also received warnings from the US regulatory authority, yet the slant put on the warning letters received to Indian firms have been completely different. As a result the brand reputation of the Indian pharma industry has been adversely impacted. On a larger spectrum it shows that Indian pharma companies are not following set standards and are inca-

pable of delivering quality medicines to the world. It also questions the capability of the Indian regulatory mechanism as many of these manufacturing facilities (Under US FDA scanner) are approved by the Indian regulators. However, the Indian pharma industry believes that it is being victimised and the hype has hurt the image of Indian pharma industry. Shah says, “It is incorrect to say that Indian companies are not following set standards and are incapable of delivering quality medicines to the world. If it was indeed so, the exports would not have grown year after year at 18 to 20 per cent per year and reached $13 billion.” Commenting on the US FDA warning letters, Dr Ajit Dangi, President and Chief Executive Officer, Danssen Consulting says, “Statistically, incidence of the number of such US FDA warnings compared to the total number of US FDA approved manufacturing facilities and ANDA/DMF/ FTFs granted which are highest in the world outside US, appear to be hyped.” He emphasises, “It is important to distinguish between GMP non-compliance and outright frauds. For in-

stance, the Ranbaxy matter came to light due to whistleblowing by its own scientist Dr Dinesh Thakur.” He also admits, “The primary responsibility for producing and marketing a safe and efficacious product is that of the manufacturers. This is why the quality assurance starts from the top management of the company. If the CEO of the company is not conscious about the quality standards the same cannot be imbibed in the junior level personnel. Hence, the top management needs to be fully aware of implications and the risks involved in non conformance of quality.” SV Veerramani, President, IDMA informs, “I think, the multiple warning letters are confined to a few companies and more so in the areas of documentation, rather than the quality of the finished products. The hype with respect to India is more to put down the image of the Indian pharma industry, which is providing pharma products to more than 200 countries.” He further adds that Indian pharma companies has come a long way and today is considered as one strong force which can really take on the world market. He further recommends immaculate and

The basic weakness in Indian regulatory framework is that we lack a central regulatory authority that is similar to US FDA Dr Ajit Dangi, President and CEO, Danssen Consulting

The hype with respect to India is more to put down the image of the Indian pharma industry, which is providing pharma to more than 200 countries S V Veerramani, President, IDMA

KEY STEPS TO RE-BUILD THE INDUSTRY'S IMAGE IN THE GLOBAL PHARMAWORLD DR AJIT DANGI ◗ It is important to have a written down whistleblower policy where any employee of the company no matter how junior, should be able to get in touch with a board member and report any wrongdoings in the company. ◗ Companies need to conduct regular training programmes on ethics and good governance for the employees and keep them updated on new laws,regulatory changes which are taking place globally. Training in behavioural modification to develop culture of Zero Tolerance to non conformance needs to be given periodically. ◗ While testing the finished product for quality is important, it cannot guarantee good quality consistently. The company

30 EXPRESS PHARMA October 16-31, 2014

needs to adopt Quality by Design (QbD) structure to assure good product quality consistently. The focus should be to build quality in to the product at every stage with thorough understanding of the product and processes through which it is developed and the knowledge of the risk involved in non conformance.

SV VEERAMANI ◗ Implement and build concept of UNLEARNING and RELEARNING into GMP systems of the company. Basics of building quality to the product from formulation development level till it is approved and passed for marketing by QA has to be taken with utmost seriousness including documentation process. Training programme for employees at all levels to be

implemented and monitored stringently to ensure every employee will RELEARN right things and right way. Annual employee evaluation to include additional criteria of measuring current knowledge levels on his area of expertise. This can be done in-house or outside expertise can be used. It is important for every company to make their employees understand their commitment to GLOBAL healthcare. It has to percolate TOP down and employee should be made aware that any wilful wrong doings (if proved) affecting image of the company and that of the country will not be taken lightly. ◗ Build up the image of Indian Pharmaceuticals through Media and Promotions. ◗ To make all the corrective actions as necessary and provide confidence to the buying countries including US.

We are working with industry stakeholders, including regulators, to ensure Indian pharma’s positioning as a responsible healthcare provider Aparna Dutt Sharma, CEO of India Brand Equity Foundation

MANAGEMENT legible documentation, proper following of laid down QMS and recording of data with scientific reasoning for further progress of the Indian pharma in the next couple of years at a fast pace. However, the industry also accepts that there is an urgent need to rebuild the image of Indian pharma and bring back the trust that it has lost.

Image re-building Speaking on the measures being implemented to achieve this aim, Aparna Dutt Sharma, Chief Executive Officer, India Brand Equity Foundation (IBEF) comments, “India is known as the pharmacy to the world. The recent opening of markets like Argentina and the opportunities in Japan, indicate the position that Indian pharma occupies in the world. We are

working with industry stakeholders, including regulators, to ensure Indian pharma’s positioning as a responsible healthcare provider.” Pointing out that regulators play an important role in buildingt the image of an industry in the global market, Dangi says, “The basic weakness in Indian regulatory framework is that we lack a Central Regulatory Authority that is similar to the US FDA. The Union Cabinet proposed and approved the formation of Central Drug Authority (CDA) way back in the year 2005, however, due to vested interests, the plan was put on a back burner. While India has Central Drugs Act, its implementation is carried out by states in varying forms. While some states like Maharashtra, Gujarat, Karnataka etc. have a reasonably good regulatory set

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India is likely to emerge as third biggest market globally in terms of volumes after the US and China. Word of caution ‘We need to commit to global quality standards’ to turn this vision in to reality and make India shine Dr Rajaram Samant, CEO and Chief Mentor, Akumentis Healthcare

up, some of the smaller states have a very weak set up to say the least. Unfortunately, drugs manufactured in such states can be marketed all over India.” Thus while the country has some good examples of streamlines regulatory processes, there is a need to implement them across India backed by good governance. Veeramani opines, “Current crop of regulators, be it state or central, there is a good trend in their approach which can be seen during respective GMP audits. It would do good to many serious pharma players if the regulators can play the role of mentors than regulators. Indian regulators can also participate actively in the International Forums of Global Regulators.” Dangi spells, “If this trend continues, not only it will tarnish the reputation of Indian

pharma industry globally but may impact ANDA/DMF / FTF approvals due to additional scrutiny resulting in more delays in drug approval process.” He continues, “Now that the US FDA has a dedicated team for India, led by US FDA Country Director, India, Dr Altaf Lal, industry seniors should have a continuous dialogue with them to understand the US FDA requirements and to iron out any real or perceived differences to maintain our reputation of being a reliable source of quality medicines at affordable prices.” Mazumdar sums up and says, “Modi’s commitment to FDI, ‘First Develop India’, resonates well with the industry. India needs to align democracy, demographic dividend and demand to make India the global manufacturing hub. However, we need to benchmark some of

EXPRESS PHARMA

October 16-31, 2014

MANAGEMENT our policies related to manufacturing, labour laws, land acquisition, environment, health and safety, with some of the best countries in the world. We must address infrastructure challenges related to power and water, roads and railways on priority for ‘Make In India’ campaign to be really successful.”

The way forward Recognising the need for some constructive action to mitigate the challenges in Indian pharma and bring it back to its earlier glory, the Government of India and major pharma industry organisations namely

Company

Indian Pharmaceutical Alliance (IPA), Indian Drug Manufacturers’ Association (IDMA), Association of Biotechnology Led Enterprises (ABLE), Bulk Drug Manufacturers Association (BDMA), Pharmaceutical Export Promotion Council of India (Pharmexcil) and India Brand Equity Foundation (lBEF) have come together to form the 'India – Responsible Healthcare Trust' to power the Brand India Pharma campaign, which was launched under the aegis of the Department of Commerce at CPhI Japan in March 2012.

Plant

Responsible Healthcare Trust represents the commitment to both drive and safeguard the interests of the industry

Nature of voliations

A one-of-its-kind public-private partnership, the formation of the Trust represents the commitment to both drive and safeguard the interests of the Indian pharma industry. The Trust chaired by the Commerce Secretary comprises key stakeholders from above mentioned associations. It aims to combine both financial and non-financial resources towards a common agenda, create better awareness and develop an informed perspective about ‘Brand India Pharma’ in both the domestic and global markets. This spreads a strong message to the world community.

On an inaugural launch of the entity, Rajeev Kher, Commerce Secretary, Government of India. highlights, “The India – Responsible Healthcare Trust will spearhead the Brand India Pharma initiative through the second phase. The industrygovernment partnership is an important milestone in the campaign. ” Hopefully, the government's new initiatives and industry associations' efforts will help the industry to overcome all the challenges and pave the path for further progress. u.sharma@expressindia.com

Status

Date of import alert

Latest warning letter date

2014 Sun Pharmaceuticals

Karkhadi , Gujarat

Violations of (cGMP) regulations for formulations & API's

Import Alert

13-Mar-2014

7-May-2014

Apotex Pharmachem India

Bommasandra, Banglore

Violations of (cGMP) regulations for API's

Import Alert

1-Apr-2014

16-Jun-2014

Apotex Research Private Limited

Bommasandra, Banglore

Violations of (cGMP) regulations for formulations

Import Alert

22-Sep-2014

USV

Govandi , Mumbai

Violations of (cGMP) regulations for formulations

6-Feb-2014

Marck Biosciences

Kheda , Gujarat

Violations of (cGMP) regulations for formulations

8-Jul-2014

Smruthi Organics

Solapur, Maharastra

Violations of (cGMP) regulations for API's

6-Mar-2014

Canton Laboratories

Vadodara, Gujarat

Violations of (cGMP) regulations for API's

27-Feb-2014

2013 Agila Specialties

Bommasandra, Banglore

Violations of (CGMP) regulations for formulations

9-Sep-2013

Posh Chemicals

Jeedimetla, Hyderabad

Violations of (cGMP) regulations for API's

2-Aug-2013

Wockhardt

Chikalthana, Maharastra