Express Pharma November 1-15, 2013 by Indian Express

VOL .9 NO.1 PAGES 92

www.expresspharmaonline.com

Market To FDI or not to FDI? Management Strategies for success 1-15 NOVEMBER 2013, ` 40

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CONTENTS Vol 9 No.1 NOVEMBER 1-15, 2013

Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury* BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das

TO FDI OR NOT TO FDI?

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

As the Health Department mulls over the report of the Parliamentary Standing Committee over FDI in the pharma sector amidst concerns of a threat to domestic pharma industry,we tryand find out answers from a public health and industryperspective | P8

Senior Graphic Designer Rushikesh Konka Layout Rakesh Sharma Photo Editor Sandeep Patil

P56: RESEARCH UPDATE Regeneron, Sanofi drug slashes cholesterol in late-stage trial

MARKETING Deputy General Manager Harit Mohanty

P85: AWARDS

Senior Manager Rajesh Bhatkal

ABLE, Dept of Biotechnology conducts 5th edition of BEST awards in Bangalore

PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Sr. Executive- Scheduling & Coordination Rohan Thakkar CIRCULATION Circulation Team Mohan Varadkar

P86: CAMPUS BEAT VES organises national symposium

P87: APPOINTMENT Jai Murthy joins Avantor Performance Materials

PHARMA ALLY

‘WE WILL CONTINUE TO BE COMMITTED TO INDIA AND WORK CLOSELY WITH THE GOVT’

BIOSIMILAR CHARACTERISATION R&D FACILITY OPENS IN AUSTRIA

QUINTILES, NOVARTIS IN 2013 WORLD’S BEST MULTINATIONAL WORKPLACES LIST

AESICA PLANS TO OPEN LEAD TECHNICAL CENTRE

MARKET

GLOBAL MARKET FOR BIOMARKERS IS LIKELY TO TOUCH $34 BILLION BY 2017

CDSCO APPROVAL TO MARKET RANBAXY’S SYNRIAM IN INDIA FOR TREATMENT OF MALARIA

DIGISIGHTS INDIA 2013 TO BE HELD IN MUMBAI

PHARMATECH EXPO 2013 SHOWCASES LATEST PHARMA, LAB AND PACKAGING EQUIPMENT

EXPRESS PHARMA WISHES YOU A HAPPY DIWALI

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

Strategies for tough times

queezed between stringent regulations on the home front and sluggish global economic conditions, the Indian pharmaceutical market would seem to be a harrowing place to be. But a few savvy players are playing out that old tried and tested adage: when the going gets tough, the tough get going. And such players have managed to carve a niche for themselves, even converting adversity to opportunity. Express Pharma’s Anniversary issue focuses on what should be the ‘Strategies of Success’ for players. For instance, while Ajaz S Hussain, a former deputy director at the US FDA’s Office of Pharmaceutical Science exhorts companies to adopt strategies for making high pharma quality affordable; Ranjit Shahani, Vice Chairman and Managing Director, Novartis India believes that ethical behaviour will drive success. On the business strategy front, many Indian pharma companies have morphed with the market. For instance, Pawan Chaudhary, Chairman and Managing Director, Venus Remedies points out how his company focused on unmet segments as revenues from the antibiotic segment started fading. On the intellectual property (IP) front, India as a country continues to invite censure. A recent release from the US Chamber of Commerce’s Global Intellectual Property Center urges India to ‘encourage innovation in the country and strengthen its IP laws to utilise its vast knowledge pool and create more jobs’. India’s Government cannot be faulted for doing its best to protect the interests of its people. In fact there are signs that even bodies like the World Trade Organization (WTO) will side with the ‘Davids’ on this issue. The island nation of Antigua has suffered major losses in the past decade when the US blocked Antigua-based online gambling sites in the US. Even though the WTO ruled in favour of Antigua in 2004, the US refused to change its stance. In retaliation, the island nation approached the WTO asking for a suspension of US IP rights to make up its losses from online gambling. In spite of objection from the US, in 2007, the WTO granted the island nation preliminary rights to ignore US IP claims. Antigua has now

6 EXPRESS PHARMA November 1-15, 2013

The ruling of the WTO dispute panel in favour of Antigua could have implications for many Indian pharma companies who have been dubbed pirates of pharma IP

got permission for permanent suspension of US IP rights, thereby legalising its stance. The island nation is reportedly taking steps to set up a platform to allow it to monetise or otherwise take advantage of this latest decision of the WTO. This ruling of the WTO dispute panel could have implications for many Indian pharma companies who have been dubbed pirates of pharma IP. Even though there is global criticism of India’s IP laws, industry observers point out that these complaints have never been taken to the WTO. Perhaps such India baiters feared that the WTO would side with India, like they did with Antigua. But there is no doubt that the pharma sector in India is being over-regulated. Policy makers are deciding to err on the side of safety. For instance, the FDI policy is causing a lot of heartburn to global companies like Mylan. In his article, Rajiv Malik, President, Mylan chronicles his company’s successful innings in India but clearly states that unfavourable developments in FDI policy could “force us to reconsider our investment plans for India, delay greenfield developments indefinitely, or postpone expansion plans for capital and/or technology.” Similarly on the clinical research and trials front, major regulatory changes in the last year seem to have given the jitters to global players. Quintiles recently closed down a Phase 1 facility in Hyderabad, which was a joint venture with the Apollo Group, citing the challenging regulatory environment. It is not just MNCs who are feeling frustrated with the current scenario. FICCI’s Business Confidence Survey for July and August showed that India’s business confidence was at its lowest during the last 17 quarters. Midst the gloom and doom scenario, Express Pharma decided to look beyond the near term and focus on the big picture. Our forthcoming issues continue in the same vein: the issue dated Nov 16-30, also our CPhI/P Mec/BioPh India special issue, we focus on some of the proven ‘Paths to Success’. Do write to me for more details. VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

VISIT

it’s all in the mix

pharma products, people & solutions

3-5 December 2013 Bombay Convention & Exhibition Centre Mumbai, India

Online Registrations Now Open !! WHY REGISTER ONLINE? • To get FREE ENTRY to the CPhI and P-MEC halls

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MARKET

87.35

million

FDI IN GREENFIELD PROJECTS

TO FDI OR NOT TO FDI? As the Health Department mulls over the report of the Parliamentary Standing Committee over FDI in the pharma sector amidst concerns of a threat to domestic pharma industry, we try and find out answers from a public health and industry perspective. BY SHALINI GUPTA

8 EXPRESS PHARMA November 1-15, 2013

2.02

billion

FDI THAT CAME INTO BROWNFIELD PHARMA FROM APRIL 2012 - 13

“The share of MNCs in the top 20 companies has increased from 14.4 per cent in 2005 to 21.6 per cent in 2012. Whereas only one MNC was ranked among the top five companies (by sales) in 2005, three MNCs were among the top five companies by 2012” Dr Sakthivel Selvaraj

“Considering that exports form a

large chunk of company sales, along with the government implementing price control over a growing basket of drugs, where is the threat to the domestic pharma industry? If there is one, I certainly do not see it as coming from FDI into the sector” Mahadevan Narayanamoni

Senior Health Economist, Public Health Foundation of India

Partner, Corporate Finance, Grant and Thornton

The share of MNCs in the top 20 companies rose from 14.4 per cent in 2005 to 21.6 per cent in 2012

66 out of of 67 FDI investments uptil 2011 were in brownfield

Greenfield FDI

21.6% (2012) 14.4% (2005)

Abbott went from being the 14th ranked company (with two per cent market share) in 2005 to the number one company in 2012 (seven per cent market share) after its takeover of Piramal Healthcare’s generics business unit in 2010

n perhaps the first ever landmark deal in the pharmaceutical sector this year, the US-based Mylan’s `5,168-crore proposal to acquire Indian company Agila was approved by the Foreign Investment Promotion board after intervention from an inter-ministerial group led by the Prime Minister himself. One wonders if this was the precursor or the final nail in the coffin for FDI in the sector, since shortly thereafter the Department of Industrial Policy and Promotion(DIPP) sent out strong signals with a Cabinet

note taking stock of FDI in pharma till date and proposing restrictions on any further acquisitions in the brownfield or existing pharma companies. The move has elicited a mixed reponse. While public health activists commend it, others are questioning the very logic behind the move. As per data in the note, a whopping 66 out of of 67 FDI investments uptil 2011 were in brownfield pharma, which it says is a cause of concern. This was largely due to no distinction between greenfield and brownfield by the RBI. This lag prevented framing of suitable policies to countercheck such investments, to which the Foreign Investment Promotion Board (FIPB) approval in Octo-

ber 2011 came to the rescue ensuring that no pharma company had a dominance in the Indian marketplace. So while investments in new projects (greenfield) were allowed automatically, those in brown-field were routed through the FIPB. However, according to RBI data, even after re-routing investment through FIPB, FDI worth $2.02 billion came into brown-field pharma between April 2012 and April 2013, while greenfield projects could attract only a mere $87.35 million. April to June 2013 saw perhaps the highest FDI in pharma sector as compared to the same quarter over the previous year, which further sent alarm bells ringing. In view of the statistics, fears over indiscriminate

Brownfield FDI

FDI worth $2.02 billion came into brownfield pharma between April 2012 and April 2013, while greenfield projects could attract only a mere $87.35 million

take overs of Indian pharma companies have risen which DIPP thinks could skew the balance in the favour of MNCs.

Is there a real threat or percieved? Mahadevan Narayanamoni, Partner, Corporate Finance, Grant and Thornton believes that there is an urgent need to define ‘domestic pharma industry’ given that even for large pharma companies, majority of the sales come from exports. While Dr Reddy’s ranks highest with over 80 per cent of their sales coming from exports, Cipla is at the bottom rung. Leading API and intermediates companies such as Divi’s Labs, Shasun Drugs, Neuland Labs, Laurus Labs

and several others, are no different in this respect, he adds. “Considering that exports form a large chunk of company sales, along with the government implementing price control over a growing basket of drugs, where is the threat to the domestic pharma industry? If there is one, I certainly do not see it as coming from FDI into the sector,” he stresses. However, Dr Sakthivel Selvaraj, Senior Health Economist, Public Health Foundation of India points out that increased acquisitions by MNCs over the past few years have lead to a considerable jump in their market share. For instance, Abbott went from being the 14th ranked company (with two per cent market share) in

9 EXPRESS PHARMA November 1-15, 2013

MARKET 2005 to the number one company in 2012 (seven per cent market share) after its takeover of Piramal Healthcare’s generics business unit in 2010, he cites. Taking it a step further he corroborates, “The share of MNCs in the top 20 companies has increased from 14.4 per cent in 2005 to 21.6 per cent in 2012. Whereas only one MNC was ranked among the top five companies (by sales) in 2005, three MNCs were among the top five companies by 2012.” The increasing market share of MNCs aside, Narayanamoni is of the view that strengthening regulatory muscle could better help the domestic companies. This ranges from working upon the inability to implement regulations (product approvals, GMP compliance, pollution control norms etc), the failure to adequately incentivise R&D and the total lack of framework to encourage start-ups and early stage companies and invest-

Even as the Health Ministry is mulling an overhaul of the policy, it has been suggested that FDI in critical pharma sector be restricted to 49 per cent to prevent takeovers ments in the pharma and biotech phase. “The pharma world is moving towards biotech drugs (seven of the topten drugs in 2012 were biotech drugs) and India is far away from being able to replicate its generics success story in the biotech / biosimilars space, without serious FDI and strategic investments,” he chips in. Allaying apprehensions on drug affordability and accessibility, he further goes on to say that a robust framework for approving or rejecting M&As under the Competition Commission and an efficient process for carrying out clinical trials or launching new drugs in the market, would further ensure that these inbound acquisitions do

not have an unfavourable impact on pricing in the long term. However, Sakthivel feels the effects might be opposite should the spate of acquisitions continue unchecked. These range from distortions in production patterns, increased export orientation of firms and neglect of the local market, increased dependence on imported medicines, greater consolidation within therapeutic categories and subsequent loss of competitive edge leading to higher drug prices.

A closer look, a more balanced approach Even as the Health Ministry is mulling an overhaul of the policy, it has been suggested that FDI in critical pharma sec-

tor be restricted to 49 per cent to prevent takeovers. Foreign investors should also be mandated to create at least 25 per cent additional capacity and generate additional employment in the such projects. Critical sectors earlier identified by DIPP include vaccines, injectibles, and oncology (cancerrelated) injectibles, however, it has left the identification of these sectors to the MoHFW. But how do we define what is critical, is the current definition justified? Throwing some light on the same, Narayanmoni says, “The current definition of 'critical areas', is not really based on volume or value of consumption – rather these are the more technically complex

areas of pharma manufacturing. By encouraging and incentivising investments and technology transfers in these areas, both of which would require FDI (financial and strategic), India would be able to ensure their continued manufacturing, notwithstanding the spate of inbound acquisitions.” However, Selvaraj feels that these ‘critical areas’ (for example, vaccines market, antibiotics, oncology market) are also where the current market reflects a monopoly/oligopoly scenario and have a high public health significance, hence, the impact of acquisitions cannot be discounted. “Several segments in vaccines, human insulin, oncology and cardiovascular care have a high concentration with four firms capturing 80-100 per cent of the total market share. Antiepileptics, antibiotics and antipsychotics also demonstrate moderate concentration. Continued on Pg 13

MARKET I N T E R V I E W

Global market for biomarkers is likely to touch $34 billion by 2017 The development and application of biomarkers as key role indicators in health diagnostics has become a central strategy in the general re-evaluation of drug discovery processes and points the way to major changes in health diagnostics and clinical research. Shalini Gupta finds out more in an interview with Sanjeev Johar, Chief Executive Officer, Alere India

How huge is the global biomarker diagnostic test market? While some estimate the market to be between $16 to $17 billlion, as per GIA estimates, the global market for biomarkers is likely to touch $34 billion by 2017. It is growing at a healthy pace of around 18 per cent compound annual growth rate (CAGR) and has immense growth potential over the next 10 years. The global biomarker disease indication market comprises segments such as oncology, cardiology, neurology, HIV, renal disorders, diabetes, arthritis, tuberculosis and so on. Oncology accounts for the biggest share, driven by the need for early diagnosis of tumour cells. Biomarkers have come to occupy an important place in diagnostic procedures worldwide. They not only improve diagnostic accuracy, but also provide information about the present disease state, thereby aiding clinicians in deciding how aggressively the disease needs to be treated. Diagnostic tests incorporating molecular biomarkers contribute the most to the advancement of personalised medicine. What is the current market for biomarker-based diagnostic tests in India?

12 EXPRESS PHARMA November 1-15, 2013

The market in India for biomarker-based diagnostic tests is currently small but expanding fast. The key is to create awareness in the country about biomarkers as vital investigative modalities. For this purpose, we organise an annual event called Alere Biomarker Conclave where medical experts from all over India assemble to discuss the most up-to-date standards in clinical application of biomarkers for early diagnosis and better prognosis. Tell us about the range of tests offered by Alere. Alere has one of the widest and most comprehensive test portfolio in cardiovascular, infectious diseases and womenâ&#x20AC;&#x2122;s health segments. Alere is the largest purveyor of POC diagnostic tests. We believe that the POC diagnostic is the future and it will assume more importance in saving lives and improving health outcomes. For instance, in cardiovascular, markers such as BNP and Troponin can help healthcare professionals to start treatment immediately by providing critical test results in minutes compared with time taken in traditional modus operandi of lab testing. The diagnostics market in general is quite fragmented

The market in India for biomarkerbased diagnostic tests is currently small but expanding fast SANJEEVJOHAR, Chief Executive Officer,Alere India

in India, yet it is rapidly changing. Enumerate the pros and cons of operating in such a market. The healthcare industry is growing at a fast pace in India. The diagnostics and laboratory services segment, worth over $2 billion, is

expanding rapidly because effective diagnosis is the first step towards treatment. There is a huge untapped potential in tier III and IV towns for more diagnostic facilities as the Indian healthcare market beyond the metros is hugely underserved by diagnostics. Diagnostic centres existing in major cities are upgrading their systems with latest technologies including semi- and fully automated instruments. Molecular diagnostics is a big area of growth. The spending power of people has increased over the years and they can now afford sophisticated and comprehensive tests which are a little expensive than usual. There are strong drivers of growth for the diagnostics industry in India. More hospitals are being set up, healthcare infrastructure is being strengthened, medical equipment is advancing, and there is more demand from patients for quick, goodquality diagnostics. This gives an opportunity for a company like Alere to penetrate the Indian diagnostics market which is currently nascent, fragmented and largely unorganised. We aim at expanding point care diagnostics to reduce dependence on labs and empower patients as well

as doctors. In India, the trend is rapidly changing. There has not only been an increase in the complexity of diseases, the disease profile itself is slowly shifting from communicable disease to chronic disease like diabetes, heart disease, and cancer due to unhealthy lifestyles. All of these require frequent diagnostic testing. Challenges include a lack of awareness, skilled labour to operate the equipment and carry out tests along with the unregulated nature of the industry which gives no guarantee of patients receiving quality diagnostics. What are the unmet needs of the Indian diagnostic industry? Indian market offers a huge opportunity for Alere. The biggest unmet need in the country is an absence of high-quality diagnostic facilities that makes the practice of good therapy ,difficult. Affordability is another issue, even the fact that the Indian market is essentially non-reimbursed market. However, with the government initiatives and with the penetration of health insurance, the affordability issue will be addressed at least in the urban areas. However, many more interventions are

MARKET Continued from Pg 11

needed on the supply side so as to reduce the costs of delivering diagnostic tests to patients. Accessibility is also a challenge. There is limited awareness and even less availability of modern medicine and treatments in tier-III and IV cities, small towns and rural areas. Alere aims to be the diagnostics and health management powerhouse in India and make our products and services the first choice of consumers. To be more cost efficient, we have set up local manufacturing facilities in the country and reach out to consumers through efficient distribution channels.

TO FDI...

Accessibility is also a challenge. There is limited awareness and even less availability of modern medicine and treatments in tier-III and IV cities, small towns and rural areas The companion diagnostics market has seen impressive growth in the last few years and has become one of the most promising areas within the IVD market. The worldwide market for this segment is still evolving. Many biomarkers are now being co-developed as companion diagnostic tests for drugs that are still in development. This can have a huge impact on the way new drugs are developed and commercialised. The drugs would become safer

Predictive biomarkers such as companion diagnostics could change the future of drug development research. What is Alere doing towards this?

Further, consolidation in any of these segments poses a serious threat to competitiveness,patient access and affordability,” he adds. Both Narayanamoni and Selvaraj strongly insist that there is a need to evaluate proposed investments, with no mechanism for monitoring in place currently. “Future investment in pharma brownfield should remain outside the ‘automatic’ route. A case-by-case approach must be followed in vetting each proposal which takes into consideration all aspects that could impact health security with well defined . specific obligations for each case in granting the clearance,” elaborates Selvaraj. Narayanamoni pitches in, “I don’t believe the approval route should be used, to 'rein in' FDI. The objective should be to understand the drivers behind the transaction and review the potential impact

with better therapeutic outcomes, thus trimming healthcare costs. Drug development firms and diagnostic companies need to work in close coordination with each other to take this exciting new segment forward so that it becomes the cornerstone of modern medicine. In India, Alere is working with several pharma companies to comarket our POC tests with drugs. shalini.g@expressindia.com

of the transaction on long-term accessibility and pricing.” He suggests the Mylan - Agila deal as an example enumerating that the US competition authorities reviewed the transaction and its impact on pricing or availability because of Mylan’s exclusive control over certain generic injectable products and approved the deal subject to Mylan / Agila hiving off those products to a third party. Opposing points of view aside, the government should take into consideration the recommendations of the parliamentary committee at the same also asessing the impact of FDI on the Indian pharma industry in the past while also pontificating any repurcussions in the future. The opportunity should be utlised to take the right decisions to steer the industry in the right direction, while ensuring India retains a competitive edge. shalini.g@expressindia.com

34-year history of partnership with leading pharma companies

active pharmaceutical ingredients & its intermediates*

Commercial scale Macrolides

Antihypertensive

Pyrazinamide# * Isoniazid # *

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

Irbesartan # Losartan potassium Telmisartan Valsartan

Ganciclovir Valaciclovir Valganciclovir Maraviroc

Sedative, Hypnotic

Antidiabetic

Antifungal

Linagliptin Vildagliptin

Antihistaminic

Flucytosine #

Hypnotic

Antimalarial Artesunate Arteether Artemether # * Dihydroartemisinin Lumefantrine # * Piperaquine

Antiosteoporotic Alendronate sodium Zoledronic acid US DMF

Under Development

Antitubercular

WHO APIMF

CEP / COS

Cetirizine dihydrochloride # Hydroxyzine dihydrochloride Meclizine dihydrochloride+

Zopiclone

Antiretroviral

Antiepileptic

Eszopiclone

Valproic acid

Antithrombotic

Antidepressant

APProVED

Clopidogrel bisulphate

Venlafaxine hydrochloride

CTD ling under process

*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 rest 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”.

COMPANY WATCH

CDSCO approval to market Ranbaxy’s Synriam in India for treatment of malaria The phase III clinical trials for the drug conducted in India successfully demonstrated the efficacy and tolerability of Synriam as comparable to chloroquine RANBAXY HAS received approval from the Central Drugs Standard Control Organisation (CDSCO), Government of India, to manufacture and market Synriam (arterolane maleate and piperaquine phosphate tablet 150+750 mg) for the treatment of uncomplicated malaria in adults caused by the Plasmodium Vivax parasite. The phase III clinical trials for the drug conducted in India successfully demonstrated the efficacy and tolerability of Synriam as comparable to chloroquine. Last year on World Malaria Day, April 25, Ranbaxy had launched India’s first new drug, Synriam, for the treatment of uncomplicated Plasmodium Falciparum malaria in the country. Since its

launch, Synriam has successfully treated around one million patients. The company has also received permission to conduct phase III clinical trials for the paediatric formulation in paediatric patients of uncomplicated Plasmodium Falciparum malaria. Commenting on the approval, Arun Sawhney, Chief Executive Officer and and Managing Director, Ranbaxy, said, “Synriam is a new-age cure for malaria and is fast emerging as the preferred option in the hands of doctors. This approval makes Synriam one of the few therapies in the world that successfully treats both, Plasmodium Vivax and Plasmodium Falciparum malaria. Ranbaxy re-

mains committed in its fight against malaria and we are making all efforts to make this new therapy accessible to patients around the world.” Ranbaxy is working to make this new treatment available in African, Asian and South American markets where malaria is rampant. The company has filed New Drug Applications (NDAs) for marketing Synriam in some

African countries and will be filing in more applications during the year. Once approved, the product will be launched in these markets. Synriam provides quick relief from most malaria-related symptoms, including fever, and has a high cure rate of over 95 per cent. It conforms to the recommendations of the World Health Organization (WHO) for using

Ranbaxy is working to make this new treatment available in African, Asian and South American markets where malaria is rampant

combination therapy in malaria. As the dosage regimen for Synriam is simple, it leads to better compliance. A patient is required to take just one tablet per day, for three days, compared to other medicines where two to four tablets are required to be taken, twice daily, for three or more days. The drug is also independent of dietary restrictions for fatty foods or milk, as is the case with older anti-malarial therapies. Since Synriam has a synthetic source, unlike artemisinin-based drugs, production can be scaled up whenever required and a consistent supply can be maintained at a low cost. EP News Bureau-Mumbai

Novozymes Biopharma in collaboration with Almac To provide a combined service for drug development applications in the field of drug targeting and pharmacokinetic improvements NOVOZYMES BIOPHARMA, part of Novozymes, a world leader in bioinnovation, has collaborated with Almac, to provide a combined service for drug development applications in the field of drug targeting and pharmacokinetic improvements. The collaboration will allow clients to utilise Almac’s world-class manufacturing assets and protein conjugation capability to link Novozymes’ Recombumin Flex technology successfully to their peptide and small molecule drugs. This subsequently improves the pharmacokinetics and has already been shown to improve drug target-

14 EXPRESS PHARMA November 1-15, 2013

ing in oncology and rheumatoid arthritis. Collaborations with commercial partners have already begun and will continue to expand in early 2014. Novozymes and Almac have a history of cooperation in peptide and small molecule conjugation projects. The formalisation of this collaboration offers drug developers the immediate benefit of continuity of service provision through the stages of clinical development delivering efficiencies in time and internal resource, whilst increasing the chances of clinical success. Clients are also expected to benefit from exten-

sive experience in product and service provision to the pharma industry with access to a comprehensive level of both technical and regulatory support. Novozymes’ Recombumin Flex technology will be the focal point of this collaboration. Novozymes has modified the amino acid sequence of human albumin to increase its receptor affinity, providing novel properties including improved half-life extension and drug targeting. This technology naturally complements Almac’s expertise in peptide and small molecule manufacturing, and can also be allied to its world-class protein

conjugation technology offerings. As a result, clients will be able to successfully use Almac’s technology to link Recombumin Flex to their drug products as part of one contract service offering. “By working alongside Almac, we are confident that we will be able to create more opportunities for developers seeking to benefit from the Recombumin Flex technology,” stated Dermot Pearson, Marketing Director, Novozymes Biopharma. “The advantage of working with two companies well versed in providing products and services to the pharma

industry is that customers gain the assurance that their needs will be provided for, not just in the short term, but right through to commercial supply.” Denis Geffroy, VP Business Development, Almac stated, “This alliance has clear benefits for companies involved in both drug development and delivery technologies: a complete service can be recommended utilising the core expertise of both parties at an early stage of clinical development, thus significantly enhancing the success of drug development programmes.” EP News Bureau-Mumbai

COMPANY WATCH

Janssen submits marketing authorisation application to European Medicines Agency Seeks approval for its fixed-dose combination tablet of HIV-1 medicine JANSSEN-CILAG International NV (Janssen) has submitted a marketing authorisation application to the European Medicines Agency seeking approval for a once-daily single tablet fixed-dose antiretroviral combination product containing darunavir, a protease inhibitor developed by Janssen, with cobicistat, a pharmacokinetic enhancer or boosting agent, developed by Gilead Sciences (Gilead) for use in combination with other human immunodeficiency virus (HIV-1) medicines. Once-daily darunavir is marketed as Prezista in the European Union. Prezista is always taken with and at the same time as ritonavir, a boosting agent, with food and in combination with other HIV medicines. If approved, the fixed-dose combination tablet will be marketed under a new brand name and will, for the first time, offer an option that eliminates the need to take a boosting agent in a separate tablet with once-daily darunavir. In 2011, Janssen and Gilead entered into a license agreement for the development and commercialisation of a once-daily, single tablet fixed-dose combination product of darunavir and Gilead's cobicistat. Janssen and its affiliates are responsible for formulation, manufacturing, registration, distribution and commercialisation of the darunavir and cobicistat fixed-dose combination worldwide. Gilead retains sole rights for the manufacture, development and commercialisation of cobicistat as a standalone product and in combination with other agents. EP News Bureau - Mumbai

15 EXPRESS PHARMA November 1-15, 2013

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COMPANY WATCH

Pharma market sees growth of 1.8 per cent in September 2013 Anti diabetics, cardiac and derma therapies have shown strong growth ACCORDING TO IMS Health, the pharma market was reported at Rs 6834 crores for the month of September 2013, with a growth of 1.8 per cent. For the first time in 2013, IMS sees that the MAT growth for the industry has dipped below the 10 per cent mark. A combination of factors driven primarily by the weak overall economic growth, the DPCO 2013 regulation and the ban on certain molecules has contributed to this dwindling growth. According to Kumar Hinduja, Sr Director Strategy Planning and Business Development, the pharma market has remained almost static in the July-September 2013 quarter. The NLEM segment still continues to impact market uptake, following the DPCO 2013 notification. Products impacted by this regulation

posted a decline of seven per cent in current month, as compared to September 2012 - on account of price reduction as well as the delay in delivery of newer stocks with changed prices. On the other hand, the non-NLEM segment which contributes ~80 per cent of the market, has posted a growth of five per cent over the same period last year.” Hinduja further said, “The seasonal factor also appears to have contributed to some extent to the lower monthly growth of 1.8 per cent. The market in September 2012 had posted a strong performance on the back of a monsoon revival across the country; the monsoon this year in September has been relatively milder. This has resulted in a decline in certain therapies slowing down, and consequently impacting the market perform-

6883

6744 6370 5956

5790

6883

6834

4.8

1.8

Aug 13

Sep 13

6262

5768

13.9

13.5

11.4 8.9

8.4 6.8

5.9

Jan 13

Feb 13

Mar 13

Apr 13

May 13

June 13

Source: IMSHealth TSA, September 2013

Growth (%)

Market ( ` Cr)

July 13

2013 Market Growth Trend

11.5

11.1

11.0

10.8

10.7

10.5

10.2

10.8 10.0

10.0

10.3

10.0

9.3

9.5 9.0

Pharma Market Trend (Rs Crore)

8.5 8.0

7,500.00 7,000.00 6,500.00 6,000.00 5,500.00 5,000.00 4,500.00 4,000.00 3,500.00 3,000.00

Jan 13

Feb 13

Mar 13

Apr 13

M ay 13

June 13

July 13

Aug 13

Sep 13

Growth (%)

2012

2013

2013: Industry Growth Trend By Company Type

Therapy

September 2013 Value Rs Crore

Contribution % Growth %

Total Market

6834

100

1.8

Acute

4853

-2.8

Chronic

1981

15.2

Source: IMS Health TSA, September 2013.

16 EXPRESS PHARMA November 1-15, 2013

Jan 13

Feb 13

Mar 13

Apr 13

May 13

June 13

July 13

August 13

September 13

■ Indian

12.0

9.2

7.2

15.8

7.5

10.2

15.3

5.7

2.0

■ MNC

10.1

6.7

3.4

12.3

5.4

5.5

10.1

2.8

1.3

COMPANY WATCH

LEADING CORPORATIONS PERFORMANCE ance. For example, anti-infectives and respiratory drugs which contribute to 24 per cent of the market, de-grew by 19 per cent and seven per cent respectively as compared to September 12.” For the period MAT September 2013, the pharma market was reported at Rs 76,198 crore, with a growth of 9.3 per cent, over the same period last year. For the month of September 2013, Sun Pharma was the fastest growing corporations among the Top 10, while six of these companies posted negative growths. Zydus Cadila climbed one rank in the month of September 2013, at the expense of Ranbaxy, which dropped by one

The Top-10 Corporations for the month of September 2013 were as follows: SEP ‘ 13 Ranking Mat

rank; ranks of other corporations remained unchanged for the month. For the month, both local companies and MNCs have grown at almost the same pace (2.0 per cent vs. 1.3 per cent) For the month of September 2013, anti diabetics, cardiac and derma therapies have shown strong growths. On the other hand anti-infectives and respiratory drugs have declined as compared to last year.

18 EXPRESS PHARMA November 1-15, 2013

Moving Annual Total

MS %

Val Gr%

MS %

Val Gr%

TOTAL MARKET

6834

100

1.8

76197.82

100

9.3

ABBOTT

452

6.6

-3.1

5200

6.8

4.4

CIPLA

322

4.7

0.8

3715

4.9

6.6

SUN

313

4.6

17.8

3474

4.6

17.7

ZYDUS CADILA

268

3.9

1.8

2969

3.9

6.2

RANBAXY

267

3.9

-4.5

3005

3.9

1.3

GLAXOSMITHKLINE

260

3.8

-6.2

3005

3.9

1.8

ALKEM

244

3.6

-4.1

2574

3.4

11.2

MANKIND

227

3.3

-7.4

2503

3.3

5.5

PFIZER

208

-0.8

2431

3.2

7.3

MACLEODS PHARMA

202

0.7

2159

2.8

14.7

Source: IMS Health TSA, September 2013.

LEADING THERAPY PERFORMANCE Mat

Mon

2 3

THERAPY SUPERGROUP

Month

Moving Annual Total

Val Crs.

MS %

Val Gr%

Val Crs

MS %

Val Gr%

TOTAL MARKET

6834

100.00%

1.8

76198

100.00%

9.3

Anti-infectives

1087

15.90%

-19

11844

15.50%

Cardiac

795

11.60%

15.6

9033

11.90%

12.1

Gastro Intestinals

696

10.20%

4.6

7950

10.40%

9.4

Pain / Analgesics

550

8.10%

0.2

6191

8.10%

8.1

Vitamins / Minerals / Nutrients

532

7.80%

5867

7.70%

8.2

Respiratory Drugs

519

7.60%

-7.1

6051

7.90%

9.3

Anti Diabetics

501

7.30%

25.9

5482

7.20%

19.2

Dermatology

406

5.90%

15.7

4362

5.70%

Neuro / CNS

399

5.80%

10.6

4535

6.00%

10.1

Gynaecology.

375

5.50%

7.2

4222

5.50%

6.5

Source: IMS Health TSA, September 2013.

LEADING BRANDS PERFORMANCE SEP'13 Ranking Mat

Mon

Month BRANDS

Moving Annual Total

Val Crs.

MS %

Val Gr%

Val Crs.

MS %

Val Gr%

TOTAL MARKET

6834.1

100

1.8

76197.8

100

9.3

AUGMENTIN

27.7

0.41

1.4

286.5

0.38

1.4

MONOCEF

26.4

0.39

-20.4

242.8

0.32

9.1

COREX

24.2

0.35

-7.3

299.9

0.39

DEXORANGE

21.3

0.31

20.3

203.1

0.27

16.5

GLYCOMET-GP

0.29

65.3

197.1

0.26

57.9

PHENSEDYL COUGH

19.9

0.29

-3.7

300.1

0.39

17.2

BETADINE

19.7

0.29

5.7

204.4

0.27

9.4

LIV-52

19.4

0.28

-9.5

214.7

0.28

HUMAN MIXTARD30/70

0.28

-9.6

261.3

0.34

2.2

REVITAL

18.1

0.26

17.1

196.3

0.26

8.6

Source: IMS Health TSA, September 2013

EP News Bureau-Mumbai

Month Val Crs.

SEP '13 Ranking

A combination of factors driven by weak overall economic growth, DPCO 2013 regulation and the ban on certain molecules contributed to this dwindling growth

CORPORATIONS

Mon

COMPANY WATCH

Arvind Remedies signs MoU with four institutions Together they have developed patented medicines which are useful for the treatment and management of neuro-degeneration disorder ARVIND REMEDIES has signed a memorandum of understanding (MoU) with four institutions namely Banaras Hindu University (BHU) Varanasi, Adesh University, SRM University and Genome Foundation for the manufacture and marketing of medicines from a botanical source. Under the agreement, Arvind Remedies and the institutions together have developed and patented medicines which are useful for the treatment and management of neurodegeneration disorder (like Alzheimer's, Parkinson's disease) and neuropsychiatric disorders (like depression). The said medicines have been patented in India, the US and Europe. Dr Lalji Singh, Managing Director, Genome Foundation and the Vice Chancellor of BHU, Prof GS Yadav, Registrar of the University, Anand Shah, Vice President, Arvind Remedies, (Lt Col) GPI Singh, Vice Chancellor of Adesh University, and Ponnawaiko, Vice Chancellor of SRM University, Tamil Nadu were present at the signing of the MoU The agreement was signed by the four institutions in December 2012, to do the research from their respective fields and since then continuous research and developmental activiites were taking place. Dr Arvind B Shah, Managing Director and Chief Executive Officer, Arvind Remedies said, “We are excited about the MoU as it will help us to enhance our product portfolio and also improve our revenue in the near future.” GP Dubey said, “The modern medicines have side effects, but medicines from botanical source are not only economical but are free from side effects.”

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19 EXPRESS PHARMA November 1-15, 2013

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MARKET GROWTH TRACKER

IPM posts first ever negative growth in Sept Valued at ` 6331 crores in September 2013; it has grown at -1.80 per cent THE INDIAN Pharma Market (IPM) is valued at `6331 crores in September 2013 and has grown at -1.80 per cent. The month also saw the launch of Lipaglyn (Saroglitazar) by Zydus in India. Amongst the top 10, Sun Pharma has seen a growth of 16 per cent followed by Zydus at 3.1 per cent and Lupin at three per cent. 29 corporates have crossed the growth of IPM for the month of September 2013 amongst the top 50 corporates. Amongst the top 50 corporates, Corona Remedies has seen the highest growth of 58.4 per cent followed by Biocon at 40.6 per cent and Eris at 24.7 per cent. Amongst the top 50 in MNCs Allergan grew the highest at 19.1 per cent, followed by Astra Zeneca at 8.5 per cent and MSD at 2.3 per cent. ohnson & Johnson and Merck were better than IPM growths. Amongst the 11-20 ranked companies, Glenmark shows a high growth at 23.7 per cent followed by USV at 18.2 per cent and Intas at 14 per cent. Amongst upcoming corporates, Corona Remedies has seen a growth of 58.4 per cent, Eris at 24.7 per cent and Akumentis at 20.6 per cent. Dr Reddy’s Laboratories has crossed the `1600-crores mark, UCB gets to `150 crores in the IPM. Corona on MAT Basis have entered the top 50 in IPM. Amongst the top 50 in MNCs, Allergan grew the highest at 19.1 per cent, followed by Astra Zeneca at 8.5 per cent and MSD at 2.3 per cent. Johnson & Johnson and Merck were better than IPM growths. The DPCO 2013 containing molecules market degrew by 14.7 per cent whereas the nonDPCO market grew by a meagre 0.4 per cent resulting in an overall growth of -1.8 per cent for September 2013. The DPCO 2013 portfolio for

20 EXPRESS PHARMA November 1-15, 2013

With bonus units at full value Rank CORPORATE

MAT Sep -13

Sep-13

MTH

Val (Cr)

MS%

GR%

Val (Cr)

MS%

GR%

72343 4923

100 6.80

6.8 2.7

6331 409

100 6.46

-1.8 -7.8

Sun Pharma

3776

5.22

18.0

348

5.49

16.0

Cipla

3659

5.06

5.8

308

4.87

-2.0

Zydus + Biochem

3250

4.49

16.4

282

4.45

3.1

Glaxo

3048

4.21

-4.2

238

3.76

-21.0

Ranbaxy

2966

4.10

5.0

245

3.88

-9.4

Mankind Alkem + Cachet + Indchemie Lupin

7 8 9

8 7 9

2614 2533 2189

3.61 3.50 3.03

10.2 10.1 8.4

232 234 191

3.66 3.69 3.02

-9.7 -3.2 3.0

Pfizer + Wyeth

2147

2.97

-0.5

170

2.68

-17.9

Macleods

1870

2.58

10.5

167

2.64

-5.0

Intas

1827

2.53

14.5

161

2.54

14.0

Emcure + Zuventus

1757

2.43

11.4

158

2.50

6.1

Aristo

1705

2.36

8.3

165

2.60

-4.3

Dr. Reddys

1611

2.23

10.1

148

2.34

8.1

Sanofi-Aventis + Universal Glenmark USV Micro + Bal

16 17 18 19

18 15 19 20

1541 1510 1335 1311

2.13 2.09 1.85 1.81

2.9 15.5 16.7 2.4

125 156 119 118

1.98 2.47 1.88 1.86

-5.6 23.7 18.2 3.3

IPM Abbott + Abbott HC + Novo

MAT

(Val in Crs)

Super Group IPM ANTI-INFECTIVES CARDIAC GASTRO INTESTINAL VITAMINS / MINERALS / NUTRIENTS RESPIRATORY PAIN / ANALGESICS ANTI DIABETIC GYNAECOLOGICAL NEURO / CNS DERMA OPHTHAL / OTOLOGICALS HORMONES OTHERS ANTI-NEOPLASTICS BLOOD RELATED VACCINES ANTI MALARIALS SEX STIMULANTS / REJUVENATORS STOMATOLOGICALS

GSK degrew at 25.4 per cent and Ranbaxy degrew by 7.7, whereas Sun Pharma had the least impact with its DPCO 2013 portfolio

MAT Sep13 72343 12634 8866 8152 6340 5589 5260 4964 4643 4478 3860 1303 1247 983 960 871 849 597 422 325

GR% 6.8 4.5 9.5 5.8 5.3 7.4 4.4 11.0 4.6 9.5 8.4 8.1 9.5 8.2 22.3 3.3 -0.8 -1.9 11.2 7.5

degrowing at 6.4 per cent. The market has witnessed a negative growths in the units as well in both the categories.

Mth Sep13 6331 1126 762 705 551 477 462 441 386 386 354 117 108 93 81 77 67 76 32 29

GR% -1.8 -14.8 9.3 -0.8 -1.9 -8.2 -4.8 11.9 -1.5 6.9 9.6 6.5 -3.1 15.0 8.1 4.3 -6.2 -22.5 -2.9 10.0

From a therapy perspective, 11 therapies outgrew IPM growth. The anti-infective market has a degrowth of -22.5 per

cent whereas the respiratory market is at -8.2 per cent growth. The anti-diabetic market grew at 11.90 per cent and cardiac at 9.30 per cent in chronic business. Stomatologicals grew by 10 per cent, whereas derma market was at 9.6 per cent. Bonus in the anti-infective segment degrew by -16.7 per cent, whereas in respiratory market it was -13.8 per cent. At the regional level, 15 regions have outgrown the IPM growth. Karnataka grew highest at 6.4 per cent whereas UP East registered low growth in August 2013. The biggest region Tamil Nadu degrew at -2.1 per cent and 13 regions have had negative growths in August 13. The biggest molecule Amoxycillin + Clavulanic degrew by 10 per cent, whereas Cefixime degrew at 28.9 per cent. Paracetamol degrew at 25.8 per cent and Azithromycin at 23.2 per cent. Glimepiride + Metformin grew at 42.6 per cent, Telmisartan grew by 21 per cent and Rosuvastain by 23.8 per cent.

About PharmaTrac PharmaTrac is a the secondary sales data audit conducted by AIOCD Pharmasofttech AWACS, a pharmaceutical market research company formed by All Indian Origin Chemists & Distributors (AIOCD ) in a joint venture with Trikaal Mediinfotech. AWACS (Advanced Working, Action & Correction System) reflects the underlying philosophy behind AIOCD AWACS' research tools to reduce time to information by 50 per cent or more and to significantly improve on accuracy of information.

Terminologies used MAT – Moving Annual TotalMTH – MonthVal(Cr) – Value in CroresMS per cent – Market Share in PercentageGR per cent – Growth in percentage. For more information, visit http://www.aiocd.net

MARKET PRE EVENTS

DigiSights India 2013 to be held in Mumbai Conference in Mumbai on November 15, 2013 will project thoughts from Indian marketers, including some case-studies MEDIAMEDIC Communications is organising DigiSights India 2013, a digital marketing conference for pharmaceutical and healthcare marketers in Mumbai on November 15, 2013. The first of its kind in India, DigiSights India 2013 will host some well known national and international speakers who have worked on digital projects in healthcare and have a knowhow of the same. A plethora of topics including the changing habits and attitudes of HCPs, rise of the ePatient etc will be covered. Apart from a couple of panel discussions, the other subjects will be rise of social media and its impact, mobilebased health solutions, usage of digital for category building, measurement of ROI, newer trends in multichannel marketing and the changes that an organisation needs to draw internally to adapt to digital. The conference will project thoughts from Indian marketers including some casestudies. Global learnings will be brought in by well-known international speakers including Andrew Spong and Dr Bertalan Mesko. Spong is a trusted industry thought leader from UK and has worked with pharma industry, patient associations, and agencies on digital health solutions. He is also the co-founder of Twitter-based community Healthcare Social Media Europe and the digital pharma podcast Digitally Sick. Dr Bertalan Mesko is the Managing Director of Webicina.com, a service that curates medical and health-related social media resources for medical professionals. He is also the author of the 'Social Media in Clinical Practice' handbook. Express Pharma is the exclusive media partner for DigiSights India 2013. EP News Bureau-Mumbai

21 EXPRESS PHARMA November 1-15, 2013

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MARKET

Innovation to drive the agenda at th 11 edition of BioAsia Event to be held at HICC from February 17 to 19, 2014 THE 11 th annual international lifesciences conference, BioAsia - the Global Biobusiness Forum, will be held in Hyderabad from February 17 to 19, 2014 at the Hyderabad International Convention Centre. BioAsia has emerged as the industry forum in the region for the lifesciences industry and hence the 11th edition of BioAsia is dedicated to the most cogent theme – ‘Innovate. Evolve’. BioAsia 2014, hosted by Government of Andhra Pradesh with the support of FABA and Pharmaceuticals Export Promotion Council of India (Pharmexcil) will feature comprehensive breakout sessions on bio-energy, drug discovery, Bio-IT, bio-therapeutics, regenerative medicine and medical electronics and devices to discuss the contemporary developments in science and technology. The event is expected to at-

BioAsia’s focus will address the increasing disease burden, and the growing need for more efficacious and affordable healthcare solutions tract participants including corporates, global thought leaders, scientists, regulatory bodies and foreign delegates from across the world. BioAsia’s focus on ‘Innovation in lifesciences’ will address the increasing disease burden, and the growing need for more efficacious and affordable healthcare solutions. Panel discussions hosting global industry leaders will deliberate on the path breaking solutions for the sector, from innovative products to models that reduce R&D cost while increasing efficiencies, and innovative financing mod-

els, that promote new business ideas. The goal is to highlight innovation as the driver of the lifesciences economy in the coming years. In addition, a parallel event AgBioAsia focusing on health and nutrition with the theme of ‘Harnessing the potential of the global nutraceutical market’ will be hosted by the Government of Andhra Pradesh in partnership with the International Crops Research Institute for the Semi Arid Tropics (ICRISAT) and the Federation of Asian Biotech Associations (FABA). Talking about BioAsia

2014, Shakthi Nagappan, Chief Executive Officer, BioAsia said, “BioAsia has always been about coming together to discuss the most relevant and futuristic trends around lifesciences. Exclusive and interesting topics pertaining to the need of the changing times have been discussed at this forum in the past. This year BioAsia takes another leap by bringing innovation at the center stage of discussion.” “Lifescience is an innovation intense industry. Traditionally, the Asian lifesciences businesses are centered around established markets

for their clearly defined products or services with little experimentation, which to a great extent can be attributed to low risk appetite investor climate. However, the situation is changing and there is an increasing recognition that innovation is essential for sustenance and growth, even within established businesses. Hence, we are confident that the global business leaders, with demonstrated innovative capabilities coming together at BioAsia 2014 will add significant impetus to the India’s innovation path,” he added. For more than a decade, BioAsia has built a formidable reputation for convening a high caliber network of lifescience executives to exchange views, analyse, showcase, explore and connect strengths that extend the visible horizons in the sector. EP News Bureau-Mumbai

65th IPC to be held in Delhi Around 8000 plus delegates are expected to attend the event THE 65TH Indian Pharmaceutical Congress (IPC) will be held in Delhi NCR from December 20-22, 2013. The theme for this year's event is 'Pharma Vision 2020Empowering Pharmacist'. The event will be hosted by Indian Pharmacy Graduates' Association, and will focus on bringing pharma experts across the globe to a single platform where pharmacy education and practices as well as their development shall be the main issues for

22 EXPRESS PHARMA November 1-15, 2013

debate and deliberation. Empowering pharmacists implies developing leaders in the sector from diverse backgrounds who shall provide their invaluable input in the growth of pharma as a profession and an industry. The venue of the conference is Amity University Campus, Noida. The PHARMAceutical EXPO 2013, concurrent with the 65th IPC, will be organised by FICCI. Around 8000+ delegates are expected to attend the 65th

IPC. There will be plenary sessions, scientific sessions and scientific poster paper presentations. For plenary and other scientific sessions, around 80 speakers are expected out of which around 30 will be foreign speakers. Students can present their research papers in various scientific sessions viz, pharma technology, medicinal chemistry, pharmacognosy, indigenous drugs, herbal formulations and phytochemistry, pharmacology and toxicology, clinical research and

pharmacovigilance, biopharmaceutics, pharmacokinetics and drug metabolism, pharmaceutical analysis and quality assurance, biotechnology and biotherapeutics, hospital, community and clinical pharmacy, pharma education and professional pharmacy, drug regulatory affairs, pharma management, pharmacoeconomics and pharmacoepidemiology. Various scientific symposia will be held, which are: Presidents symposium on empowering pharmacists; Standard-

isation of biological products; Advances in regulatory sciences and education; Pharma industry: From here to where; Role of community pharmacist in implementing public health policy; Molecular cardiovascular pharmacology; Pharma policies and export; Empowering pharma students through leadership development; Drug development regulations; and Strategies to strengthen practice services. EP News Bureau-Mumbai

MARKET

FEAPM,CIPI join PHARMAPro&Pack Expo 2014 Special pavilion for analytical instruments products and services THE 2ND international exhibition on pharma manufacturing technologies, PHARMA Pro&Pack Expo 2014, Mumbai, has received a good response from the industry. The exhibition is going to be held from April 24 to 26, 2014 at Mumbai Exhibition Centre, Mumbai. More than 54 per cent of the exhibit space has been confirmed and booked by the 2013 exhibiting companies at the exhibition venue on the last day of the PHARMA Pro&Pack Expo 2013, Mumbai Exhibition. Over a period of time, more and more companies have started joining the exhibition by confirming their exhibit space. The successful exhibition has left a strong footprint in the Indian pharmaceutical sector and has provided the best opportunity and the ideal platform to the industry to promote the Brand India concept. With the show being initiated, promoted and organised by industry itself, it helped in providing a common platform to one and all with a micro scaled entrepreneur sharing and exhibiting alongside the industry giants and promoting their skills and services. Various trade associations have extended their non-financial support to the exhibition, which include Federation of East African Pharmaceutical Manufacturers (FEAPM) and Confederation of Indian Pharmaceutical Industry (CIPI). Joining of FEAPM and CIPI are major driving force through their role played in building up the pharma fraternity along with trade. A special pavilion has been allocated for the analytical instruments’ companies, especially the member companies of the Indian Analytical Instrument Association (IAIA), also one of the supporting association of the exhibition. Rajesh Shah, Chairman, Maharshi Udyog and President, Indian Pharma Machin-

23 EXPRESS PHARMA November 1-15, 2013

ery Manufacturers Association (IPMMA) informed, “PHARMA Pro&Pack Expo ex-

hibition has been well recognised in its launch edition. PHARMA Pro&Pack Expo

2014 offers an excellent branding and promotions opportunities for the entire industry in a

cost effective manner.” EP News Bureau - Mumbai

EVENT BRIEF NOVEMBER 9

Margi Memorial Lecture

MARGI MEMORIAL LECTURE Date: November 9, 2013 Venue: Law College Complex at SVKM, Vile Parle, Mumbai Summary: The first Margi Memorial Lecture will be delivered by Dr Yusuf Hamied, Chairman and Managing Director, Cipla and an exponent of IPR in pharma. A commemorative publication of fond memories of Margi Patel Choksi through short articles and photographs will be published on the occasion. Announcement will be made about the proposed Margi Patel Choksi Memorial IPR Foundation, which will be a registered Public Trust (to be known as Margi Memorial Foundation) Contact details C/o. GNA Patent Gurukul 3rd Floor, Shivmangal Next to Big Bazaar Akurli Road, Kandivli (East) Mumbai – 400101 Tel: (022) 28872058 / 40895454

analytica Anacon India 2013

Chakala,Andheri (East) Mumbai - 400 099 Mobile: 98205 82197 Email: anish.gangar@mmi-india.in

PHARMABIOTIKA 2013 Date: November 21-23, 2013 Venue: Hitex Exhibition Centre, Hyderabad Summary: Doctors, nursing homes and hospitals, formulation organisations, API organisations, machinery and packaging, laboratory and analytical equipment, diagnostics, contract manufacturers and clinical research organisations will take part. The event will be colocated with IndiaLabExpo 2013. Contact details Atanu Bhattacharya Director Human Crayon Management Services C-28, Sector - 4 Noida - 201301, India Tel: (0120) 6528801 / (011) 65378800 Mob: 9810303916 (Delhi) / 9167280126 (Mumbai) Email: atanu@crayon4.com Website: www.pharmabiotika.com

ANALYTICA ANACON INDIA 2013 Date: November 12-14, 2013 Venue: Bombay Exhibition Centre, Mumbai Summary: The seventh international trade fair and conference for laboratory technology, analysis, biotechnology and diagnostics will have visitors from various domains like, pharmaceutical, chemical and petrochemical, health care, food, electrical engineering and electronics, medical laboratory, medicine, universities, research institutes and more. Contact details Anish Gangar Sr Manager - Marketing Communications MMI India 507/508, INIZIO Cardinal Gracias Road

24 EXPRESS PHARMA November 1-15, 2013

PHARMAbiotika 2013

senting diverse industries are expected to participate in the expo. The focus of the exhibition will be on the latest trends and technologies in the areas of laboratory and analytical instrumentation, chromatography and spectroscopy, biotechnology and life sciences, process control and reactors, medical and clinical diagnostics, clean room and sterilisation, quality control and environmental, educational labs, measurement and testing, liquid handling and filtration, laboratory consumables and allied products, laboratory furniture and construction. Contact details Karuna Vaid SD (India) Corporation 14 Mall Road, 1st Floor, Hudson Lane, Delhi-110009 Tel: +91-11-43003757 / 08130990660 Email: info@indialabexpo.com Website: www.indialabexpo.com

5TH INDIA LAB EXPO

INNOVATION IN OTC BUSINESS: FROM CONCEPTS TO ACTION

Date: November 21-23, 2013 Venue: Hitex Exhibition Centre, Hyderabad Summary: The exhibition will showcase laboratory, analytical, biotechnology, life science, material testing, and laboratory consumable products and instruments. The expo organisers are expecting more than 50 foreign companies to participate directly and 400+ foreign principals through their channel partners in India. The foreign companies are likely to come from Germany, the US, the UK, Hungary, Switzerland, Italy, Canada, China, South Korea, Russia, Taiwan, Sweden, Netherlands etc. 300+ exhibitors and 10000+ visitors repre-

Date: November 22, 2013 Venue: The Westin Mumbai Garden City, Goregaon, Mumbai Summary: CubeX, in association with Nicholas Hall & Company is organising a one-day conference, Innovation in OTC Business: From Concepts to Action. Nicholas Hall will give expert views on innovation as a significant growth driver for OTC industry. Also, network with other expert speakers who have developed innovative strategies, spanning across various aspects such as business models, products, processes, marketing and channel management, into real-life action.

Innovation in OTC Business: From Concepts to Action

Contact details CubeX (A Division of Sorento Healthcare Communications) Unit No. 12, Garodia Estate 3/A Udyog Nagar, S.V. Road Goregaon (West) Mumbai - 400 064 Maharashtra Tel: (022)4036 2008 Email: rshriyan@cubex.co.in

2013. The event will be organised by Indian Pharmaceutical Congress Association. The academic partner for the event is Amity University, Noida. Contact details Dr Arun Garg General Secretary IPGA Director PDM College of Pharmacy Bahadurgarh, Haryana Mob: 09416056213

CPHI INDIA Date: December 3-5, 2013 Venue: Bombay Exhibition Centre, Mumbai Summary: Reflecting the continued growth in the API, generics, fine chemicals and bio-pharmaceuticals industries on the Indian sub-continent, CPhI India and related pharma services events saw an increase in visitors and exhibitors. CPhI India will bring pharma professionals from all over the world to Mumbai and facilitates initiating and closing business deals. Take this opportunity to showcase your products and services while enhancing your brand at South Asia's leading pharma industry event. Contact details Chaitali Patil UBM India Times Square Unit No 1 & 2, 'B' Wing, 5th Floor Andheri Kurla Road Marol,Andheri (East) Mumbai - 400 059 Tel: (022) 61727162 Fax: (022) 61727273 Email: chaitali.patil@ubm.com

65TH IPC, 2013 Date: December 20-22, 2013 Venue: Amity University, Noida Summary: Indian Pharmacy Graduates’ Association will host 65th IPC, 2013. Express Pharma has been chosen as the "Exclusive Official Media Partner" for the 65th IPC,

11TH EDITION OF BIOASIA Date: February 17 to 19, 2014 Venue: Hyderabad International Convention Centre Summary: The 11th edition of BioAsia is dedicated to the most cogent theme – ‘Innovate. Evolve’. BioAsia’s focus on ‘Innovation in lifesciences’ will address the increasing disease burden, and the growing need for more efficacious and affordable healthcare solutions. Panel discussions hosting global industry leaders will deliberate on the path breaking solutions for the sector, from innovative products to models that reduce R&D cost while increasing efficiencies, and innovative financing models, that promote new business ideas. The goal is to highlight innovation as the driver of the lifesciences economy in the coming years. In addition, a parallel event AgBioAsia focusing on health and nutrition with the theme of ‘Harnessing the potential of the global nutraceutical market’ will be hosted by the Government of Andhra Pradesh in partnership with the International Crops Research Institute for the Semi Arid Tropics (ICRISAT) and the Federation of Asian Biotech Associations (FABA). Contact details Paridhi Gupta Tel: 040 66446477

MARKETS POST EVENT

Pharmatech Expo 2013 showcases latest pharma,lab and packaging equipment PharmaTechnologyIndex.com with IDMA, Pharmexcil and Ministry of MSME organise ‘central India’s largest pharma expo’ THE SECOND edition of Pharmatech Expo 2013 was held at the Brilliant Convention Centre, Indore (MP). The event showcased a wide range of pharma machinery, laboratory and packaging equipment. It was jointly organised by PharmaTechnologyIndex.com (a KNS group of company) jointly with Indian Drug Manufacturers’ Association (IDMA) and in association with Pharmexcil and supported by Ministry of MSME. The three-day exhibition was inaugurated by Dr VG Somani, Joint Drugs Controller General (India), who was the Chief Guest for the ceremony. Dr DS Mandloi, Director, MSME Development Institute, Indore was the Special Guest of the ceremony. Other dignitaries who addressed the gathering were Daara Patel, Secretary General, IDMA, India, Ramesh Shah, Chairman, PharmaTechnologyIndex.com, Paresh Chawla, Chairman Local Organising Committee and SV Veeramani, Vice President South, IDMA. The MP state board of IDMA was inaugurated by Mahendra Hardia, Minister of Health and Family Welfare, Madhya Pradesh. Chawla was elected as the Founder Chairman of MP State board. Somani said that Madhya Pradesh is fast catching up with neighbouring states like Maharashtra and Gujarat due to the presence of pharma manufacturers such as IPCA Laboratories, Lupin, Cipla, Ranbaxy, Pentagon, Plethico, Alpa labs, MCW Healthcare, IMA-PG etc. The event was supported

by Madhya Pradesh Pharmaceutical Manufacturers Organisation (MPPMO), Pithampur Audhyogik Sangathan, Indian Analytical Instrument Association (IAIA) and MPSSDMA. IMA-PG India was the industry partner for the show and Newtronic Life care Equipment was the Conference Partner for the show. Cadmach and Modern Institute of Pharmaceutical Studies were among the sponsors for the show. Express Pharma was the media partner. Around 100 companies from all over India participated in the event, besides companies from South Korea, Germany, the US, China and Hong Kong. All companies exhibited their latest technologies and products. Exhibitors at the expo consisted of processing plant and machinery, packaging materials and machinery, lab equipment and lab wares, R&D and quality control etc. Participants were also from the environment and pollution control as well as trade associations and promotion bodies. The expo displayed latest products, machinery, equipments for business generation and up-gradation. It had projected quality controls as well as government regulations & controls. It also projected the brand value of organisations, joint venture firms, partnership firms, project collaborations, transfer of technology, investments and R&D. A full-day seminar on 'Pharmaceutical Stability Study' was organised on the second day which was conducted and sponsored by

Newtronic Lifecare Equipment. The seminar was inaugurated by Daara Patel, Secretary – General, IDMA and the proceedings were carried forward with opening remarks along with a technical presentation by the sponsor Navin Mehta of Newtronic Lifecare Equipment. Kapil Bhargava, Deputy Drugs Controller, India (Retired), made some interesting presentations during the seminar on the regulatory issues vis-à-vis stability chambers. The next was a presentation on regulatory and stability issues by Arun Gosavi, Research and Development Incharge, Alpa Labs, Indore. Ramesh Shah, Chairman of PharmaTechnologyIndex.com thanked all participants, visitors and keynote speakers. The second session of the conference was conducted by MSME on the barcoding systems of the pharma industry and VP Sharma gave detailed information on the barcoding and its application. Jigish Chiniwala of Condot Systems gave exquisite details about barcoding applications. The third day saw poster presentations by the final year students of many pharmacy colleges in and around Indore on the various latest technological advancements of pharma products. The best poster presentation was selected from amongst the participants by Prof SK Jain of Smruti College of Pharmacy and Anil Kharia of Modern College of Pharmacy. More than 700-800 students took part in it. EP News Bureau - Mumbai

25 EXPRESS PHARMA November 1-15, 2013

cover )

26 EXPRESS PHARMA November 1-15, 2013

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THE MAIN FOCUS

Pg 28. AJAZ S HUSSAIN-Strategies for making high pharma quality affordable | Pg 30. RANJIT SHAHANI-Ethical behaviour will drive success | Pg 32. RAJIV MALIK-Strategies to stay ahead in the race | Pg 33.PAWAN CHAUDHARYThe right mix for success | Pg 34. DR AJIT DANGI-Leadership plays a key role in driving the company to success | Pg 36. UTKARSH PALNITKAR-Growth is impressive, generic opportunity is shrinking | Pg 38. SATISH KHANNASuccess strategies for pharma firms | Pg 39. DR CHANDRASHEKHAR POTKAR-Clinical trial reforms - two steps forward, one step back | Pg 40. GOPAKUMAR G NAIR, KARTHIKA NAIR-India needs to adopt bold strategies | Pg 43. DR MILIND ANTANI, ANAY SHUKLA-Navigating the Indian legal maze: Challenges | Pg 45. BOB RHOADESPositioning for success: Protecting market share with sustainable compliance | Pg 48. ABBY PRATT-Critical success factors for the medical device industry | Pg 50. T NICHOLAS MITCHELL-Migration to a disruptive innovation model | Pg 53. PRVS VARMA-Bigger is not better â&#x20AC;&#x201C; Sample preparation in pharma industry

Strategies

for success

On our 19th Anniversary, Express Pharma invited industry experts and thought leaders to share their insights on what could be the best strategies for success in India's biopharmaceutical sector

27 EXPRESS PHARMA November 1-15, 2013

cover ) AJAZ S HUSSAIN, Former Deputy Director Office of Pharmaceutical Science at the US FDA and currently the Founder of Insight, Advice & Solutions, Frederick, Maryland, US gives an Indian-American and an ex-US FDA leader’s perspective on the current challenges related to cGMP noncompliance

Strategies for making high pharma quality affordable

erception/belif can change efficacy and safety of a drug product via placebo and nocebo effects. It is time to ensure we move towards the same standards of quality for all citizens of the world. We must improve our ability to identify and correct the cause of human error (in development, technology transfer, and manufacturing, quality control and quality assurance). We also need objective ways to distinguish human error from misconduct early on. I posit that the solution is in incentivising the right human behaviors and for this senior management involvement, understanding and direct support of quality a key to effective solution. I believe the period 2014 – 2020 is critical for Indian pharma sector to reevaluate, modify, strengthen and effectively execute their business strategies to ensure their ability to grow and succeed in India, US/EU, Asian markets, and rest of the world. Maximising revenues and profitability in the process of making high quality drug products that patients all over

28 EXPRESS PHARMA November 1-15, 2013

the world can access is an ideal goal for a pharmaceutical company. Several challenges have to be addressed in achieving this goal; understanding what is high quality and how to deliver it reliably is one challenge that we often take for granted. The recent cluster of US FDA observations of cGMP non-compliance, import alerts and warning letters issued to leading companies in India has come as a surprise to many. The serious implication of these observations and an apparent thread of similarity in these observations across several companies has contributed to making this a topic of frequent discussions and comments in the local and international news and social media. The question – “Is the quality of products available in India different from quality of product exported to the US?” – is often raised in these discussions. Significant cGMP noncompliance are also observed in the US and elsewhere; yet, somehow, there is a palpable concern - within and outside the Indian pharma sector -

I believe the period 2014 – 2020 is critical for Indian pharma sector to reevaluate, modify, strengthen and effectively execute their business strategies that something is different about the current cluster of findings in India. Why may the US FDA observations on

cGMP non-compliance in India be different and pose a serious concern? Other important questions confronting the sector are: How can the impacted companies’ best overcome this challenge? And, what specific steps, if any, should be considered by the sector to ensure that these observations do not hold back progress towards the aspirational goal of being recognised as ‘pharmacy to the world’? In this article, aimed primarily at an audience in India, I seek to provide an IndianAmerican and an ex-US FDA leader’s perspective on the current challenges related to cGMP noncompliance. I have selected to do so by answering the four questions described above. Is the quality of products available in India different from quality of product exported to the US? The notion of ‘domestic’ and ‘export’ quality has been embedded in the fabric of many developing economies and over time, as these economies grow, these differ-

ences are minimised. Growing up in Powai, in the northern part of Mumbai, I can recall many instances within my circle of friends, when someone would often note with pride that a certain item he had acquired was of ‘export’ quality. This notion of ‘domestic’ vs. ‘export’ quality is still prevalent in the Indian economy. Living abroad (e.g., America) it is not uncommon to receive requests from friends and relative in India to bring for them, on the next visit, certain over the counter drugs and house-hold products because they perceive these products to be ‘more effective’. Similarly, when a relative is in a hospital in India and there is a need to arrange for medications – we often take significant steps to seek out drugs from ‘trusted’ companies and suppliers. These subjective anecdotes suggest that many perceive/believe that quality of drugs available in the US to be superior to those available in India; is this perception/belief fact-based and accurate? Consider the conclusions

( of a study, conducted at the Massachusetts Institute of Technology (MIT) published in the Journal of the American Medical Association, March 5, 2008—Vol 299; in which 82 healthy subjects were randomly assigned to two groups, Group 1 received a product which was described as an expensive ($2.50/tablet) drug for reducing pain and Group 2 a product described as a cheap (10 cents/tablet) drug for reducing pain. The two groups were subjected to carefully calibrated electric shock sessions and had to note the pain reduction from the products they received. Subjects in Group 1, who were told they received the expensive drug, experienced a significantly greater pain reduction (p=0.02) than those in Group 2, who were told they received the cheaper drug. However, both groups had received the same placebo (i.e., inert sugar pill) product. sugar pill) product. This study points to certain challenges in general acceptance of generic drugs; now consider generic drug associated with concerns related to their manufacturing and quality. The Indian and US regulatory requirements for pharmaceutical quality are perceived to be sufficiently different that many companies maintain distinct facilities for these markets; therefore, the quality of products available in these markets must be different in some aspects. How relevant is this difference to patients in terms of clinical efficacy and safety? A complicated question to address when considering that lack of access (e.g., affordability) is a serious risk factor. However, for the growing middle class and the elite – wouldn’t the perceptual difference be sufficient? Perception/belief can change efficacy and safety of a drug product via placebo and nocebo effects. It is time to ensure we move towards the same standards of quality for all citizens of the world.

THE MAIN FOCUS

The Indian and US regulatory requirements for pharmaceutical quality are perceived to be sufficiently different that many companies maintain distinct facilities for these markets; therefore, the quality of products available in these markets must be different in some aspects Why the US FDA observations on cGMP non-compliance in India may be different and pose a serious concern? A thread of concern regarding ‘data integrity’ runs through many of the recent US FDA observations. This aspect makes the issues at hand more serious – as this brings the intention of impacted companies, and possibly the sector, under a cloud of suspicion. Many in the Indian pharma sector would agree with my concern that there is a tendency to incentivise behaviors on outcome at the expense of the process of getting to the outcome and this is a potential problem. Organisations that have not strengthened their corporate quality policies and business decision systems would specially be in a vulnerable position and would find it difficult to overcome the suspicion of data integrity. Although the regulatory requirements in India have all the same elements in what constitutes cGMPs; the expectations and inspectional approaches are different from that of the US FDA. For example, final product testing appears to be considered ‘conclusive’ and the role of procedural documentation is not considered as seriously as in the case of the US regulatory expectations. For most pharma processes the type of quality control testing conducted is primarily for the purpose of verifying that a product is con-

forming to pre-set specifications when all set procedures have been followed (and documented). For QC testing to be conclusive, in and by itself, it would need to be far more extensive and statistically justified. The cliché “Where there is smoke there must be a fire?” may be relevant here. I would argue that a segment (which may be a minority segment) in the Indian pharma sector have misunderstood the importance of following set procedures in cGMPs and have rationalised that the product produced is good by virtue of testing conducted. By this mind-set their practices have brought into suspicion the reliability of documentation produced for cGMP compliance. And, data integrity concerns undermine the credibility of testing conducted. Furthermore, considering that judicious compliance with cGMPs brings with it costs that impact manufacturing efficiency – deviations, root cause investigations, batch rejections, etc. Data on manufacturing efficiency at Indian companies will now be suspect; often FDA investigators have casually commented that manufacturing data at some companies in India appears to be “too good to be true”. Now with a cloud of suspicion one should expect more rigorous and frequent inspections with a focus on exposing issues pertaining to data integrity. How can the impacted companies’ best overcome this

challenge? Remediation of cGMP issues is a difficult and a very expensive challenge. For example, recently in the US several companies (e.g., Novartis, Ben Venue, etc.) opted to shut down some facilities after spending hundreds of millions of dollars on improvement and consulting fees on cGMP remediation. The high profile case of Ranbaxy in India is another example – after many years of cGMP remediation efforts another, newer, plant was recently implicated. Why is this so? Clearly the remediation efforts are not getting to the root cause of non-compliance. Then, any corrective and preventive actions taken may only create the illusion that issues have been corrected and their recurrence prevented. To improve root cause investigations in the cGMP environment, we have to go beyond SOPs and checkbox verification of training records. We must improve our ability to identify and correct the cause of human error (in development, technology transfer, and manufacturing, quality control and quality assurance). We also need objective ways to distinguish human error from misconduct early on. I posit that the solution is in incentivising the right human behaviors and for this senior management involvement, understanding and direct support of quality a key to effective solution. Hiring of a cGMP expert

consulting firm from the US will only be effective when their expertise is optimally utilised in the context of company culture and systems. It is essential that the senior management recognise and address potential ‘blind-spots’ in the organisation before embarking on a remediation plan. Senior management’s understanding of what it takes to deliver high quality, their involvement in quality policy and planning, monitoring, review and incentives they provide are essential elements for success. Working with external experts’ to confirm data integrity is an important step and should occur prior to other improvement efforts to be undertaken. Without this step the quality of data and decisions taken may not be correct. A comprehensive remediation plan that adequately considers – across several functions or departments – the development technical factors, SOP’s and human factors linked to effective training (preferably in local languages) can then be executed. On a recent visit to India I had an opportunity to meet several leaders of the pharma sector. In my discussions the point that ‘the product produced is good’ invariably comes up; in part, possibly a means for rationalisation. Does this suggest a ‘blind spot’ that could be holding back many from making tough decisions needed to make the necessary corrections? Note that with an elaborate pharmacovigilance system and adverse event reporting in countries like the US it is still difficult to identify negative impact of quality issues on patients. This is often due to inadequate reporting, lack of availability of reported data for analysis at the right time and place and the bluntness of available tools to detect a signal from the noise in the available databases. Lack of reports does not mean that

29 EXPRESS PHARMA November 1-15, 2013

cover ) issues are not present. Hence, we must take proactive steps as per our current scientific understanding to prevent poor quality products to be released in market. The heparin contamination tragedy of 2008 in the US where many were injured and some lost their lives was due to a contaminant which was not detectable by quality control tests that had been established at that time. And, the tragedy of repeating cases of diethylene glycol (DEG) contamination of medicinal products is another example of lax or non-compliance with cGMPs; the US Center for Disease Control website reports that over the past 70 years at least 12 occurrences of DEG contamination in oral and topical medications have resulted in at least 450 deaths in developing countries.

What specific steps, if any, should be considered by the sector to ensure that these observations do not hold back progress towards the aspirational goal of being recognised as ‘pharmacy to the world’? For the Indian pharma sector to claim and maintain the title “pharmacy to the world” a major portion of the sector needs to be successful and not just one or two companies. Leaders of the sector should consider working together in pre-competitive space such as training and education of new entrants, current staff and creating venues for dialog with regulators to improve understanding and to seek out solutions to common challenges. I recognise that not all of the US FDA requirements

may clearly contribute to ensuring the quality, safety and efficacy and sometimes it may appear that GMP is an acronym for Great Mounds of Paper. One must constantly work to improve the system and this is done by working collectively as a scientific community. US FDA itself continues to improve the system, e.g., the initiatives on Process Analytical Technology and the Pharmaceutical Quality for the 21st Century. It is interesting to note that these initiative were in response to warning letters and consent decrees in the US. Fourteen years later the cycle seems to repeat but now in India. Where are we today with these initiatives? Reflecting back to the November 28, 2001 meeting of the US FDA’s Advisory Committee for

Pharmaceutical Science where I had articulated “Vision 2020 - I can see clearly now” for the PAT Initiative: (1) Quality & performance by design + Continuous “real time” monitoring of quality, (2) Specifications based on mechanistic understanding of how formulation and process factors impact product performance, (3) High efficiency and capacity utilisation, and (4) “Real time” review and inspection from Rockville, White Oak, NJDO, etc. Today, with the active encouragement of the US FDA, there is visible progress in the area of continuous monitoring and manufacturing of pharma API’s and products in an integrated manner – a potential shift in paradigm in the making. Companies such as Novartis and others in Europe and the US have pro-

gressed this concept beyond pilot scale and are planning commercial facilities by 2015. They have taken a different path for making high quality affordable and by this laid a foundation for a different platform to reclaim the title – “pharmacy to the world.” I believe the period 2014 – 2020 is critical for Indian pharma sector to reevaluate, modify, strengthen and effectively execute their business strategies to ensure their ability to grow and succeed in India, the US/EU, Asian markets, and rest of the world. Increasingly patients across the globe will ask the question “who makes the drug I take”; and trust and credibility will be critical. Let’s hope the strategy that reliably makes high quality affordable wins!

RANJIT SHAHANI, Vice Chairman and Managing Director, Novartis India elucidates about India’s pharmaceutical sector, which is going through a trying period

Ethical behaviour will drive success

he corporate world is a reflection of society. Or is it the other way around is a question I sometimes ask myself. After all, we live in a challenging world where wants have far outstripped needs sometimes driving people to do the unthinkable. The pharmaceutical industry in India, as elsewhere in the world, is going through a particularly

30 EXPRESS PHARMA November 1-15, 2013

trying period. There is a high deficit of trust. Incidents of the recent past have made it even more important for organisations to reinforce ethical behaviour. If you look at the world around you, you will find that the global economy is not in very good shape. For the pharma industry it is taking ever longer to bring a new molecule to market. The cost

of failure has gone up exponentially and with it the cost of success. Governments and payors worldwide are putting ever increasing pressure on the pharma industry to bring down costs. This is indeed a dichotomous situation. What then can pharma companies do to achieve success? Do they need to relook at their strategies that brought them success in the

past? There is no magic mantra but here according to me is what all of us in the pharma industry in India can do to achieve success.

Collaborate for the larger good The days of individual players leading success are over. The sooner that all stakeholders realise this, the better it will be for them-

selves and more than that the better it will be for the patient. There are several unmet medical needs and collaboration will help leverage resources for the ultimate benefit of the patient. Countries like ours are in dire need of building and improving healthcare infrastructure. While primary responsibility for this vests with government, various

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There clearly exists an opportunity for India to be a hub of innovation but for that to happen we first need to put in place an ecosystem that fosters innovation. Innovation goes beyond research and development to find new medicines for unmet medical needs. It encompasses everything that an organisation does and could include something as basic as supply chain or delivery systems or even in how an organisation interacts with the medical fraternity.

stakeholders could come together to help steer this in the right direction. We need to do this on a war footing or else as I oft say â&#x20AC;&#x153;Even if we were to parachute free medicines in India they would be useless unless we have medical infrastructure in place to diagnose and treat diseases.â&#x20AC;?

Innovate in all spheres The pharma market is expected to grow double digits in the next few years and therefore presents an opportunity. India is increasingly getting harmonised with global standards. There clearly exists an opportunity for India to be a hub of innovation but for that to happen we first need to put in place an ecosystem that fosters innovation. Innovation goes beyond research and development to find new medicines for unmet medical needs. It encompasses everything that an organisation does and could include something as basic as supply chain or delivery systems or even in how an organisation interacts with the medical fraternity. We need to incorporate innovation in our DNA. The Indian pharma industry has made its presence felt as a formidable player on the global map as a maker of quality generics. We are on the cusp of a great opportunity and the time is right to move up the value chain to

being a true innovator of medicines to address public health needs. This is what will eventually drive success.

Leverage today for tomorrow Clinical trials in India have all but come to a standstill given the current scenario in the country. The challenging regulatory environment currently in the country has served to severely impact the clinical research industry with inordinate delays in getting approvals for new clinical trial applications becoming the norm. Over the last few of years, but more particularly in 2013, the regulators have introduced a slew of measures to improve the overall governance for clinical research in the country. However, there is much more that can and needs to be done, especially in ensuring that these criteria are strictly adhered to and enforced as appropriate. For too long have we in India relied on clinical trials conducted in other parts of the world to approve drugs meant for use here. We need to recognise that our body systems are different and in this day and age we must but insist that medicines go through local clinical trials. It is good that the Government at all levels recognises the importance of clinical research for the

ous stakeholders involved to leverage today for tomorrow.

We need to recognise that our body systems are different and in this day and age we must but insist that medicines go through local clinical trials

country. The ability to make available newer treatment options for the average Indian patient in a variety of ailments, including life-threatening indications, depends on the ability to conduct good ethical clinical research in the country. The future of the industry will depend on how quickly the Health Ministry and the regulators are able to streamline rules and regulations governing clinical research. It is up to the vari-

The vexing issue of pricing Price is an issue that has increasingly plagued the industry in recent times. Never mind if we do not have enough primary healthcare centres in the country or that our ratio of doctors and nurses per 1000 population is poor making the cost of medicines irrelevant when diagnosis and treatment is an issue. It becomes easy to ignore the various factors that are responsible for the poor healthcare of our country and point fingers at the pharma industry. So we have price control in an industry where several companies compete in any case for a single therapeutic area. And we have talk of referencing pricing against per capita income for patented molecules. Perhaps it is time for the pharma industry to sit back and take stock of its pricing system and together with other stakeholder look at a mechanism where the rich are not subsidised for the poor. Perhaps we need to devise a system that makes it possible to have differentiated pricing while protecting the innovator from parallel trade.

Make reputation the holy grail Reputation is all there is

finally for if you lose reputation everything is lost. It takes years to build a reputation but one solitary incident and a few moments of indiscreet behavior to lose it all. Reputation of the pharma industry is at an all-time low. We as an industry need to rethink our strategy from a reputation point of view. We need to look at how we get back to the position where we are viewed as being in existence for the well-being of the patient. We need to engage more with the media so that we see more positive news flow around all the good being done by the pharma industry. We must remember that the pharma industry is concerned about the health of the nation and is here to stay! Finally, it all boils down to ethics. So, whether it is about being compliant with the laws and regulations of the land or whether it is about being transparent in its clinical trial processes it is all about ethics. And this I might add holds true not just for the pharma industry but for all of us. It is just that one comes to expect that little bit more from an industry that touches each one of us in some way or the other. May we live to see the day when the pharma industry thrives in India and we have a molecule that has been innovated in India!

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cover ) RAJIV MALIK, President, Mylan outlines the strategies that Indian pharmaceutical firms should implement to ensure growth in the midst of regulatory reforms and bleak economic realities

Strategies to stay ahead in the race

hat should be the strategies pharma companies in India should adopt to be successful, given the global economic realities as well as new regulations in India and globally? As a starting point, it’s worth noting that the Indian pharmaceutical sector is very diverse. There are domestic companies, some of which operate solely in India and some of which operate globally. There are multinational firms that operate and invest in India in a variety of ways; some, for instance, focus predominantly on developing speciality products, while others are more focused on generics. Each company’s strategic priorities differ. As such, the effect of evolving domestic regulations and global economic conditions on these companies can vary substantially. This is why it is so important for policy makers to carefully consider the impact of their decisions and make sure that regulations truly serve the purpose for which they are intended: to fuel the nation’s economic growth and create confidence – through transparency and stability - in its future; enhance its research and development (R&D) capabilities; elevate its manufactur-

32 EXPRESS PHARMA November 1-15, 2013

ing quality standards; and provide its people with access to high quality medicine. As a case in point, Mylan is a multinational firm that operates and invests in India. Although, we are headquartered in the US, more than half of our 20,000-strong workforce is based in India. Our mission is to provide seven billion people – including India’s – with access to high quality medicine. Our significant R&D presence and manufacturing base in the nation is helping us fulfill this ambition. And, unlike many companies that hesitate to invest in R&D in India because of concerns around intellectual property protections and other issues, Mylan continues to increase its investment significantly. Mylan has spent approximately `350-400 crores annually on R&D over the last several years and we look forward to continue ramping up our R&D spend. Indeed, India is one of Mylan’s primary R&D hubs, and we have more than tripled the number of scientists we employ here over the last several years. Mylan has grown organically in India and through acquisitions. Both avenues have resulted in additional job growth and investment in the region. In addition, we have

Our long-standing reputation for quality is reflected in our application of one global standard across all of our facilities and products, regardless of market

formed strategic collaborations with domestic Indian companies, such as Biocon, Natco Pharma and Famy Care. These arrangements are creating growth opportunities not only for Mylan, but for our partners

as well. We also have been investing over the last few years in greenfield and brownfield projects to expand our operating footprint. Today, our operations include eight active pharmaceutical ingredient units, including one greenfield site under expansion; two finished dose form units that make oral solid dosage forms, one oncology injectables plant, and one injectables pilot plant for R&D. Importantly, our longstanding reputation for quality is reflected in our application of one global standard across all of our facilities and products, regardless of market. That means that our facilities in India are world class, whether they make products for export or the domestic market. This commitment to quality also translates to an investment in our 10,000 person workforce in India. We provide rigorous training in global quality standards and cultivate a culture of ‘doing what is right, not what it easy.’ Our workforce takes enormous pride in delivering high quality products in every market in which we operate. This quality culture is necessary for India to continue to thrive on a global scale and overcome the quality concerns that have become increasingly

prevalent in recent years. We believe our relentless commitment to quality, and our willingness to invest in the training, technology, equipment and other resources required for high quality operations, will raise the bar for quality across the industry. This investment is invaluable. The scale of our operations and our focus on quality are directly benefiting patients in India by making sure they have access to safe, effective and affordable medication. We currently offer antiretroviral (ARV) products for the treatment of HIV/AIDS and a women’s health portfolio. We expect to launch additional portfolios in oncology and critical care. Further, our commitment to making a difference in people’s lives is evident in the results we’re achieving in various therapeutic categories. Our ARV portfolio is a great example. Today, approximately 40 per cent of patients being treated for HIV/AIDS in the developing world rely on a Mylan product. That penetration reflects in part our significant role in reducing massively the annual cost of second-line therapies, from approximately $15,000 to around $150 today. That penetration is also due to our leader-

( ship in providing important innovations to these medicines. For instance, we have introduced combination products that reduce pill burden, formulations for paediatric use and heat-stable products that can be distributed in climates where refrigeration is not widely available, such as in parts of India. And we have delivered these innovations at affordable prices. No wonder Mylan is one of the leading ARV suppliers to India’s National AIDS Control Organization (NACO) and that in 2012 our company won the Pharmexcil award in the Gold category for Formulations as well as its Innovation award on patents. Mylan wants to continue to grow in India because we believe passionately in the quality of its workforce and in our ability to meet the nation’s

growing need for high quality, affordable medicine. Therefore, we are watching closely the evolution of India’s foreign direct investment (FDI) policy. We expect that the current rethinking of FDI policy could cause significant uncertainty and create an environment that discourages investment – both within the pharma sector and beyond it. Policies that restrict freedom of trade and investment, entry or exit, are of concern to all companies, domestic or foreign. In fact, we believe that many are holding back on investing in India for this very reason and not because of the global economic slowdown. Further, a cap on FDI would limit competition as well as slow down the growth of the Indian generic industry. It

would be a move contrary to the Government’s goal of enhancing access to medicines. It also would discourage domestic companies from advancing research and development, investing capital in their businesses and growing their workforce. Certainly, unfavourable developments in FDI policy could force us to reconsider our investment plans for India, delay greenfield developments indefinitely, or postpone expansion plans for capital and/or technology. Sound FDI policies foster competition and collaboration, create jobs, and provide access to high-tech equipment and processes. One can distinguish between FDI flow that supports, and commits to grow the manufacturing base and R&D for innovations, versus market-

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ing networks and promotional activities. Conducive and stable policy environments foster R&D as this requires large investments. Liberal FDI policy stimulates increased transfer of technology and R&D. Domestic opposition to FDI by pharma firms often is based on unfounded fears and the general perception that foreign players will increase prices and/or curtail supply of drugs to the domestic market. The diversity, scale and competitiveness of the industry in India make this highly unlikely. Further, India has many policies and regulations in place to help monitor pharma companies, prevent abusive pricing and ensure drug availability – and all market participants must adhere to them. It is in India’s best interest to foster FDI policies that are

stable, predictable and transparent – and that apply to all industries, including pharma products. Any reduction in the FDI cap in the pharma sector will cause alarm among all foreign investors, adversely affect the growth of the Indian pharma industry and the prospects for the nation’s healthcare sector overall. Further, such a cap would create a ripple effect of uncertainty across all industries, as companies in every sector around the world question the stability of our regulatory regime and question the wisdom of doing business in a country with constantly shifting policies. No company contemplating significant investments can afford to continually look over its shoulder and wonder whether the next policy change could render that investment worthless.

PAWAN CHAUDHARY, Chairman and Managing Director, Venus Remedies opines that a multi-pronged strategic approach is essential to success in the Indian pharma industry

The right mix for success

hen you start a business from scratch, it takes years of hard work, dedication and ups and downs to make it flourish. In a business of generics and me-too drugs, survival is the utmost challenge for any company. Thus, adopting new techniques, approaches and strategies to stay in the competition and overcome it is the only way to success.

Growth and success in the pharma industry depends on a perfect multi-pronged strategic and systematic blend of research products, generics drugs, innovative marketing techniques and talented professionals. Inventing a new molecule can be an easy task, but developing that molecule into a novel drug which caters to unmet medical needs and then positioning it correctly in the

market is the key to success. With this approach, Venus Remedies was brought to life. Founded in the year 1989, Venus started its journey with the vision of establishing a business that preserves and improves human life through innovation. For the first few years, intravenous fluids and generics contributed to the product range. These products were highdemand, low sales volumes due

to cut-throat competition, but helped Venus stand on its feet in the hospital care market because all were injections or infusions. By the late 90s, when the Indian pharma industry was emerging as a global player in generics drugs and later succeeded in luring many pharma companies, small and medium sized companies like Venus faced intense competition for

survival. It started facing price erosion and hurdles to sustain and retain its growth. To curb this, we conducted market and industrial surveys and analysis, in line with our vision of preserving and improving human life through innovation, to understand the unmet segments and the needs of the society. This is when we realised that we should focus on R&D. Venus touched new heights

33 EXPRESS PHARMA November 1-15, 2013

cover ) with its changed approach and focal point. Gradually, we shifted our focus from generics to a research-driven company which is involved in path-breaking innovations (patent-protected drugs). By 2005, when the pharma industry was witnessing sweeping changes in the patent regime governing drugs, Venus developed considerable expertise in critical care and superspeciality segments, including anti-infective (antimicrobial resistance), anti-cancer, neurology, pain management and skin and wound care. Until then, India had been benefiting from the research and developments in other countries and securing one’s knowledge/research product from copying was the biggest challenge. Later, when the patent regimen shifted to product patent, the share of the Indian pharma industry in the total pie of approvals for generics rose steadily. This was our time to harvest the benefits of our focused approach and constant efforts. The generics players did exploit the spawned opportunity to its fullest, but then soon came the emergence of R&D in the pharma industry with many companies adopting this approach to deal with the increasing competition. Venus, being an early entrant in the R&D segment, benefited and secured patents more than any other Indian pharma company till now. Nothing can be achieved without a dynamic team of intellectuals and that is the biggest strength of any company, especially in an industry like pharma. Venus can boast of a highly dedicated, skilled and self-groomed force of mixed specialities, responsible for taking the company to greater heights. Venus is regularly involved in conducting market surveys to understand the unmet needs in the market and the demand gaps. The company could foresee the potential of antibiotics fading away and thus focused its approach on the unmet segments in the pharma industry to carve a niche for itself. It is

34 EXPRESS PHARMA November 1-15, 2013

the result of its focused approach that Venus today owns some of the most effective, patent-protected superbug-tackling drugs in its product kitty. With a market size of `915 crores, the anti-infective segment is one of the largest and most unmet segments in the pharma industry of India. The ever increasing resistance against the present blockbuster drugs is contributing strongly and making it grow at a rate of 15.4 per cent. Venus is one of the few R&D-led companies which is working in this segment and has established a name for itself. Soon after, we started signing strategic tie-ups for marketing and distribution of our research products pan-India and started exporting to the emerging markets. Today, we have our presence in 60 countries and are known worldwide as a research-focused pharma company which concentrates on technologically complex products and has developed a niche in the injectable segment of the pharma industry worldwide. With intensifying competition, slow regulatory clearances, poor research funding and lack of copyright protection, even the research and development in the pharma industry in India has slowed down considerably. An increase in the average cost of developing a new drug, longer R&D cycle with very limited outcome, weak patent laws, lack of transparency in the regulatory system, new policies on clinical trials by the Government of India and slow returns on investments are the key factors that are keeping big pharma giants off R&D, especially in the short life cycle product range like antibiotics. However, there is a huge scope for R&D-driven companies and generics players to replace most of the innovator drugs that are going off patent by 2015 and establish their brand names in India and across the world. As Venus has secured more than 90 patents for its 15 research products

The company could foresee the potential of antibiotics fading away and thus focused its approach on the unmet segments in the pharma industry to carve a niche for itself

from across the globe, the company is hopeful of making the most of this opportunity. To stay abreast of the competition and establish the brand globally, Venus has been investing more than 15 per cent of its total revenue in research and development on a yearly basis. This helps the company in funding its intellectual property wealth initiatives as well as drug development research regularly. Recently, Venus had entered the over-the-counter (OTC) segment with its first herbal stress reliever candy, ‘Ezenus’. Today, India is among the Top 5 emerging pharma markets across the globe and a frontrunner in a wide array of specialities such as manufacturing of complex drugs and research and development of new drug molecules and tech-

nologies. But to sustain oneself in this dynamic market and retain the growth of a company, it is imperative for pharma companies today to look at new avenues, niche segments and global tie-ups for research and marketing. Contract manufacturing, contract research, biopharma products, new drug research and so on are the other potential areas for thriving in the pharma industry. The Indian pharma industry is a knowledge-based industry which is growing steadily and is expected to record a growth of 10-12 per cent in 201314. As a result, the pharma industry of India is expected to touch $35.9 billion by 2016 and $56 billion by 2020. As per a report of IMS Health, the domestic pharma market has registered a growth of 6.8 per cent with total sales of $1.03 billion in May 2013. Exports form a major chunk of the total pharma market in India, up from $13.2 billion in 2011-12 to $14.6 billion in 2012-13. As per a report by India Brand Equity Foundation (IBEF), the generics exports from India are growing tremendously at nearly 30 per cent annually. The growth of generics, coupled by the R&D initiatives of Indian pharma companies, is the first step that the Indian pharma industry should take to establish itself as a leading global player. Export being a huge growth factor for the Indian pharma industry, many government and private firms are trying everything possible to boost the export capability of Indian pharma companies. For instance, Exim Bank has decided to expand the scope of its finances for extended repayments to all the pharma firms. For companies like Venus, where a large portion of the total revenue comes from exports, exclusive and nonexclusive marketing deals for their research products and generic drugs with well-established pharma giants across the world play a very important role. Furthermore, the depreci-

ation of rupee has also increased the rich inflow of the currency against which the rupee is devalued. Besides this, export is the best way possible to drive growth under the new Drug Pricing Policy Order, which has brought 348 medicines in the National List of Essential Medicines. Export is the only hope for big pharma companies to gain momentum for the overall growth of the industry. Apart from export, India is also known as the most preferred destination for diagnostic outsourcing and clinical trials. A majority of the international pharma companies look up to India for outsourcing a wide range of drug development activities, like conducting clinical trials of new drug molecules, diagnostic research, analytic and biochemical studies and so on. India has not only emerged as the most desired destination for a rich talent pool of professionals, it also offers highly cost-effective research services complemented by high-quality data generated with the help of enabled IT infrastructure. These factors provide a conducive environment to all the R&D-led domestic pharma players to make the most of it and contribute significantly to the global pharma industry by coming up with efficacious and cost-effective drugs. With a DSIR-approved and GLP-certified research centre, the Venus Medicine Research Centre is working in collaboration with many national and international firms and medical institutions to invent breakthrough remedies and serve mankind with affordable drugs. In a nutshell, R&D, coupled by the right mix of marketing techniques and talent pool, is the key to marking your presence and establishing yourself in this dynamic and fast-growing industry. So, to establish yourself in the pharma industry, it is important in today’s time to come up with innovative solutions which are within the reach of a common man.

(

THE MAIN FOCUS

DR AJIT DANGI, President and Chief Executive Officer, Dansssen Consulting talks about some critical strategic drivers to survive and succeed in the current environment

â&#x20AC;&#x2DC;Leadership plays a key role in driving the company to success'

oday we all live in a VUCA (Volatility, Uncertainty, Complexity and Ambiguity) world. To succeed in such an ever changing environment, companies not only require to be agile but need to continuously monitor global trends and adapt swiftly. Below are some critical strategic drivers to survive and succeed in the current environment. Leadership: Over 80 per cent of so called 'great' companies slide to mediocrity in a short span of time largely because of poor strategic decision making and tardy execution, often fuelled with complacency. Leadership therefore plays a key role in driving the company to success. A competent and independent management board with domain expertise in finance, marketing, technology and above all corporate governance can make all the difference. Leveraging based on current and historical cash flows and leverage based on future income are two different things. Many companies today are suffering from the later. World is a market. No longer we can focus our attention only on domestic market and survive. With a global pharma sales touching $980 billion in 2012, it is disappointing that

Indiaâ&#x20AC;&#x2122;s contribution to global sales is less than two per cent in spite of having leadership position in all parameters such as number of US FDA approved manufacturing facilities, ANDAs, DMFs, FTFs etc. outside the US. The reason is we have commoditised our industry to selling generics which is a high volume low margin business. We have also failed to build any global brand. We need to therefore move up the value chain from 'cost arbitrage' to 'intellectual arbitrage' by investing in innovative delivery systems and processes and leveraging intellectual property not as a defensive but competitive strategy. While organic growth strategies can give results in the long term, inorganic growth through mergers, acquisitions, JVs, collaborations, tie ups, co- marketing etc. can help in tapping the huge global market. Many MNCs today are exploring hybrid models of selling patented medicines in the developed markets and branded generics in rest of the world by tying up with Indian companies who are low cost, good quality generic manufacturers. Quality risk mangement: Recent debacles of companies like Ranbaxy, Wockhardt, Fresenious Kabi etc. who were

We need to move up the value chain from 'cost arbitrage' to 'intellectual arbitrage'

hauled up by the US FDA for non-compliance of GMP and sometimes outright fraud show that quality continues to remain a major concern of developed markets for medicinal products coming from India. The concept of quality by design (QbD) has to be internalised in the organisation with zero tolerance for GMP non compliance and unethical and fraudulent practices. Cost optimisation: With rigid price controls, cost escalation in utilities, inflationary pressures on wages and com-

pensation, depreciating Indian Rupee, liquidity crunch etc., cost optimisation and productivity improvement not only in manufacturing but also in field force effectiveness and marketing investments are key to maintain profitability. One must continuously benchmark all key activities with successful companies and try to match or surpass them. Government relations: In a country like India where regulations and government policies are continuously evolving (e.g. DPCO 2013, New Companies Act, Clinical Trials Amendments, Biotechnology Regulatory Bill, Central Drug Authority, GST, transfer pricing, GAAR etc.) it is important to continuously remain engaged with policy makers either through industry associations or through own efforts and anticipate emerging regulations and shape the environment through dialogue and advocacy. Remaining 'future ready' is the key. Product portfolio: It is important to make a critical review of the product portfolio periodically and weed out nonperforming products based on analysis of market attractiveness, profitability etc. Gone are the days of cross subsidising loss making products or SBUs with profitable ones.

Proliferation of SKUs and pruning them based on current market need are very important. Talent management: Finally, attracting, developing and retaining good talent will continue to remain key differentiating factor for successful companies. Proactive and progressive HR policies such as performance based competitive compensation, fast track career growth for Hi Potentials (HIPOs), job rotation and exposure to global markets, continuous training and learning, gender diversity (nine CEOs in the Indian banking industry are women. What is our track record?) etc. will create a vibrant and result-oriented organisation. Many companies today offer their own explanation and justification for underperformance by citing exogenous factors such as government regulations, business cycle, macroeconomic environment etc. Whilst these factors can certainly influence company performance, such explanations do not always cut ice because within the same sector some companies succeed consistently. If one analyses the management strategies of successful companies, most of them follow the above success factors.

35 EXPRESS PHARMA November 1-15, 2013

cover ) UTKARSH PALNITKAR, Partner and National Head Pharma & Life Sciences, KPMG in India, aims to capture the opportunities (product-related, business model related and market-related) that companies can capitalise on

‘Growth is impressive, generic opportunity is shrinking’

he Indian pharmaceutical industry has performed consistently despite the global slowdown. The industry has witnessed a Compounded Annual Growth Rate (CAGR) of ~15 per cent over the last five years and is currently the third-largest market in the world by volume. India’s growth in this market is not only indicative of its acknowledged strengths (generics) in pharma but is also a reflection of a thriving healthcare sector and improving healthcare standards in the country. Emerging countries continue to play a key role in the global pharma market and are firmly placed in the growth strategies of global players. India too, is high on the global pharma agenda, and its contribution to the growth of the global pharma market in absolute terms is pegged at a cumulative $10 billion between 2010 and 2015. India’s growth story has been primary fuelled by exports. Indian pharma companies have capitalised on export opportunities in regulated and semi-regulated markets and pharma exports from India grew at a CAGR in excess of 20 per cent from 2006 to 2012. Currently India

36 EXPRESS PHARMA November 1-15, 2013

is the third-largest exporter of Active Pharmaceutical Ingredients (APIs). Indian pharma exports are expected to bring in an estimated $25 billion by the end of 2014. While the growth is impressive, the generic opportunity is shrinking. The addressable opportunity from Para-IV filings, in revenue terms, has declined from a peak of $24 billion in 2007 to $3 billion in 2012 compelling Indian companies to revisit their strategies to maintain the current growth trend. This article is an attempt at identifying and defining a few strategies that pharma companies could adopt to ensure growth amidst the various challenges that are an inherent part of the pharma landscape. In essence, these strategies are pointers towards leveraging India’s competitive advantage to sustain growth. The article aims to capture the opportunities (product-related, business model related and marketrelated) that companies can capitalise on. The objective of the article is also to highlight the challenges that companies will need to encounter and address as they devise and execute these strategies.

India’s growth story has been primary fuelled by exports. Companies have capitalised on export opportunities in regulated and semi-regulated markets Remodeling the product pipeline ● Biosimilars: The global opportunity in the area of biosimilars is estimated at $5 billion by 2015. India currently accounts for only three per cent of the global biosimilars market after China and South Korea. A few Indian companies currently

have a strong biosimilars pipeline and the untapped potential in the segment is significant. However, clarity on the US regulations governing biosimilars will be key to capitalising on the biosimilars opportunity. In the current regulatory environment, the significantly high cost of trials dilutes the cost savings, therefore, reducing the potential of the segment ● Niche products: Indian companies are increasingly focusing on niche segments and products that involve a higher level of technology and complexity. Glenmark, for example, continues with its strategy of focusing on niche filings in areas such as dermatology and oral contraceptives, which face less competition and command relatively higher value

new needs are emerging, leading to new opportunities. Areas such as geriatrics, sports medicine and neutraceuticals are gaining impetus and giving rise to new segments for pharma players ● Value added generics: While niche and complex molecules are a part of the diversification strategy that companies can adopt to build a sustainable portfolio, value- added generics are a means to enhance present offerings. Indian companies must innovate and look at generating value from ‘supergenerics’, which can deliver additional benefits – increased efficacy, improved ADME characteristics, etc. – to patients

● New Drug Delivery Systems (NDDS): Indian companies can capitalise on the opportunity presented by delivery-based drug systems. Technologyintensive products such as extended-release tablets, patches and inhalers may help companies create a more differentiated portfolio ● Emerging therapeutic areas: With increasing healthcare awareness in the country,

India’s position as an attractive outsourcing partner has placed it favourably on the global pharma map; however, outsourcing remains concentrated in areas of manufacturing, chemistry and clinical research (though clinical research in recent terms has seen a dramatic downturn). With growing strengths in biology, and building on our chemistry strengths, drug discovery

Exploring untapped outsourcing (widening offerings portfolio) and licensing potential

( services present an opportunity that can be leveraged. Bioinformatics, protein expression and in-vivo pharmacology studies are various areas that can be explored for building possible outsourcing competencies. Developing capabilities and infrastructure in these areas may help Indian players become preferred outsourcing partners for pharma research. Other than the outsourcing angle, Indian companies can also look at capitalising on licensing opportunities presented by MNCs as they increasingly invest in emerging economies in accordance with the ‘Look East’ policy.

Seeking new export markets to sustain export revenue Companies with a high dependence on the US/EU for export revenues have been facing various compliance-driven challenges in the recent past. Tightening scrutiny in these geographies is threatening export revenues and Indian companies would have to look at risk mitigation strategies. Markets such as Japan, Oceania, GCC and CIS remain untapped and can be explored. For instance, India’s exposure to Japan – the second-largest pharma market in the world and also one of the most difficult pharma markets to access – is a mere one per cent. However, Lupin’s success in establishing significant presence in Japan shows that building a footprint in this market is not impossible. Indian companies can also look at establishing foothold in other managed markets such as South East Asia and Africa. Liaisons in these developing markets can be facilitated more efficiently by collaborating with international agencies or via government intervention.

Indian companies will have to work towards building R&D units which are integrated, efficient and are capable of managing risk exception. Improving R&D efficiency is imperative to sustain growth in the pharma industry. However, R&D units across therapy areas in many midsized pharma companies are disconnected, leading to inefficiencies. Indian companies will have to work towards building R&D units which are integrated, efficient and are capable of managing risk. Effective best practice sharing and continuous information exchange can help maximise returns on R&D investment. To ensure that R&D investment is channeled optimally, it is also important that companies formulate robust processes and frameworks that help them gauge risk and measure returns. Biocon, for instance, has devised an innovation-risk matrix, which determines the optimal investment in specific areas based on the risk proposition of the endeavour. Indian companies must focus on the following three pillars to foster R&D productivity and harness innovation: Leveraging enabling technologies, harnessing core competencies to unleash synergies, ensuring adequate funding and incentivisation Indian companies/institutes could focus on funding boutique firms/start-ups to harness domestic innovation. The Manipal Group for example has partnered with Stempeutics Research, which is engaged in developing stem cell-based medicinal products.

Increasing R&D efficiency and incentivising innovation

Capitalising on emerging distribution channels

Innovation is inextricably linked to the economic growth of any country and India is no

There has been a noted rise in the number of distribution channels emerging in the

Indian pharma industry: ● Organised pharma retail is emerging fast in India. Estimates suggest that the penetration of organised drug retail increased from a mere five per cent in 2011 to ~20 per cent by the end of 2012. ● Drug distribution channelised via government tenders is also on a rise with increasing evidence of Government involvement in drug procurement in states such as Tamil Nadu, Andhra Pradesh and Karnataka. ● The hospital procurement channel is another distribution channel that is gaining ground and can be leveraged These channels are characterised by their organised nature and inherent legalities. Companies may have to remodel their current commercial channels to leverage the opportunity that these new channels offer.

Building brand credibility An important component of success is to build a credible brand. The pharma industry has often been brandished as a profit-centric industry with relatively low regard for public welfare. Companies should work towards uplifting the image of the industry and dispelling negative stigmas associated with it. ● In light of increasing healthcare awareness and literacy, launching patient programmes to connect directly with patients may help create a positive image of the industry ● The large volumes of counterfeit drugs that find their way into the market play an instrumental role in diminishing the credibility of the Indian pharma

THE MAIN FOCUS

industry. With recent allegations of falsified generic medicines manufactured in Nigeria and China carrying the ‘Made in India’ tag, the situation is likely to worsen. It is imperative that the Government of India and pharma companies implement initiatives to tighten and secure supply chains and prevent such occurrences While the above-mentioned strategies could play an important role in propelling India’s pharma growth story, there are a number of challenges that continue to affect the industry. These challenges require careful deliberation by players as they contemplate strategies in the pursuit of growth. ● Pricing policy: The Drugs Price Control Order (DPCO) 2013, which replaced the DPCO of 1995, seeks to reduce the prices of 348 drugs that are deemed to be essential medicines, leading to an erosion of `1,600 crores from the industry’s topline. ● Compulsory Licensing (CL): The implications of CL have far reaching consequences for the industry. While triggering of CL in the case of pandemics is readily understandable, the criterion of affordable pricing is today a reality. Resistances to introduction of new products by innovators as well as the perception of CL as a new channel to market by generic producers are two aspects that will need to be balanced. Perhaps an amicable agreement on market access by licensing and marketing partnerships could possibly be a way out. Early and continuous engagement with the Government is an imperative in this regard. ● Non trade barriers from US/EU: Various non-trade barriers existing in the US and the EU, which are primary export destinations for Indian pharma companies, have impacted the growth of the industry: Generic Drug User Fee Amendments (GDUFA): On July 9, 2012, the US Government passed the GDUFA 2012. This policy, which

is being considered a historic first, has been drafted in a bid to accelerate the review of applications for generic drugs. In effect, the policy is expected to facilitate the accessibility of safe and efficacious drugs to the larger population in a shorter time frame and at a lower cost to the industry. However, the GDUFA may impact the margins of a number of large and mid-sized pharma companies that will have to pay the proposed fee for selling their products in the US. The fee for re-inspection of FDA-approved facilities and on DMFs is a further burden that these companies will have to bear. EU Quality Protocols: The new quality guidelines imposed by the European Medicines Agency (EMA) for drugs being exported to Europe create further compliance issues for Indian manufacturers exporting drugs to EU countries.

Conclusion The Indian pharma industry has witnessed continual growth and has the potential to reach an estimated $45 billion by 2020 (from the current $22 billion). Increasing disease burden, coupled with the rise in disposable income and heightened healthcare awareness are driving the industry forward. However, to succeed in the long term, companies will have to modify their current business models and make adequate changes to leverage the opportunities that will present themselves in the near future. It is important that companies give due regard to compliance and quality and move up the value chain to remain relevant globally. Disclaimer The views and opinions herein are those of the authors and do not necessarily represent the views and opinions of KPMG in India. All information provided is of a general nature and is not intended to address the circumstances of any particular individual or entity.

37 EXPRESS PHARMA November 1-15, 2013

cover ) SATISH KHANNA, Director, Valmax Corporate Services and Ex Group President of Lupin India, elaborates on the various approaches that can be implemented by pharma firms to prevent stagnation and pave the way for further growth

Success strategies for pharma firms

harmaceutical market in and from India is on a twin-engine-powered growth path. The domestic engine continues to log 15+ per cent CAGR on a growing base and exports engine is ascending at even higher pace. Both engines are likely to maintain existing growth trajectory with impressive intensity even in the coming years. Despite the fact that Indian companies, through credible performance, have created respectable position both in the developed and the emerging markets, a few blind spots remain: ● Indian pharma industry, despite efforts by many, has not done much in two very potent global markets i.e. Japan and China ● On the credibility front too we have faltered more often than what we should have due to short cuts adopted by few companies for cutting down on timelines or costs of execution ● On the innovation front, Indian pharma industry has nothing much to claim, yet ● Industry has neither focused much nor achieved enough on the brand building exercise; just having the cost advantage can make it grow further, but to a limited extent Indian pharma industry has done well so far because it is quite competent, competitive

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and capable. And if we are able to address the above blind spots too, the industry can create much bigger opportunities for itself. However, addressing these blind spots is not within the reach of every pharma company, as each of these require deeper pockets, unwavering commitment and lots of patience, which barring very few companies, the Indian pharma industry can afford. The industry will still continue to grow, but for creating more and bigger success stories in this huge possible opportunity, just a linear extension of the past mindset and approach may not be adequate. New entrants will have to find out newer and disruptive business models to create a place for themselves in this crowded but lucrative industry. Existing smaller players will have to either grow or go; medium players will have to grow bigger through strategic alliances or deeper arrangements with national or international biggies; larger ones can not keep on doing more of the same for migrating from their current orbit of $1-2 billion annual sales size to the next orbit of $10 billion annual sales; they have to be undoubtedly more credible, more innovative and more focused players in whatever they do. Basket approach of multiple products

New entrants will have to find out newer and disruptive business models to create a place for themselves in this crowded but lucrative industry

in multiple therapies and multiple geographies can create unimaginable and unmanageable level of complexities and that route may not be the right path for them to shift to the next orbit of the $10 billion annual sales club. Teva, Mylan, Watson and the likes have reached or are

planning to reach this club largely through aggregation of businesses by deploying lots of inorganic strokes and even they are finding that they have to grow differently here on. Teva, the giant generic company, is now banking on biosimilars and OTC for their next orbit and even they have realised that they can not do it on their own and hence have tied up with Lonza and P&G respectively. Mergers and acquisitions to propel growth does not always create the desired value, on the contrary sometimes it erodes the value. If the target is not strategic, or valuation is unjustified or the post acquisition integration process is not effective, it becomes a problem child and a big drag on the new parent. Experience of most of the Indian companies who ventured out in the last five-10 years to buy pharma assets or businesses in Europe, the US or elsewhere have not been favourable, mainly because most of these inorganic moves were done with the objective of top line growth and at much higher valuations. In most of the cases, post acquisition synergies either could not be created or could not be effectively leveraged. We know the experience of Wockhardt, Ranbaxy, DRL and many more is not pleasant, however, there are exceptions like Lupin and Sun.

Following ‘what more’ and ‘what better’ can only enhance business excellence and thereby the quality of business; it is the ‘what new’ that needs higher attention. So far many of the Indian companies, including the large ones have followed the ‘me-too’ approach and that has eroded their value. Companies have not only copied each other’s processes and products, but also each other’s business approach. This may sound as a simpler and quicker way for growth but without much of the bottom line; thereby restricting the depth of pockets for all in the game and not leaving enough gunpowder within the industry to take a shot on some of the areas that have now become the above-listed blind spots. Companies are not leveraging or even exploring the idea of deploying collective wisdom and collective resources to resolve the blind spots and tackle challenges that are too big for a company on its own. The issues would become more manageable, if pursued collectively. But, shared resources, shared wisdom and shared risks would mean sharing the fruits of achievements and that is where our industry has issues, our industry does not have a sharing gene in its DNA.

Continued on Pg 55

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DR CHANDRASHEKHAR POTKAR, Editor, Perspectives in Clinical Research, Indian Society for Clinical Research, examines the implications of the Expert Committee report on clinical research in India

Clinical trial reforms two steps forward, one step back

rofessor Ranjit Roy Chaudhury Committee’s report on the topic of ‘To Formulate Policy and Guidelines for Approval of New Drugs, Clinical Trials and Banning of Drugs’ was recently uploaded on the CDSCO website. Post the notification of the Compensation Guidelines on January 30, 2013, this Expert Committee was entrusted a task, by the Ministry of Health & Family Welfare, to formulate policy guidelines and SOPs for approval of new drugs, clinical trials, and banning of drugs. The committee met with various stakeholders during the first half of the year toward this objective and submitted its report in July to CDSCO. This report was perhaps the most anxiously awaited report from the clinical research community in the context of declining research fortunes in India. Key recommendations from this report can be broadly classified in two categories – positive recommendations and areas of concern. Even under positive recommendations, there are a few challenges that need to be addressed to enhance the impact of these recommendations. First, this report makes

several recommendations to provide reassurance and confidence to the general public on the clinical research process. A number of these recommendations are unprecedented and bound to have a long term impact on the research community. These changes include: ● Establishment of a central accreditation council ● Conduct of clinical trials only at accredited sites and by investigators under oversight of accredited ethics committees ● Creation of a framework for registration of studies, which includes recommendations for situations in which no trials may be justified, data from global trials can be relied on, and where local data generation will be mandatory ● Requirement of post approval studies over four to six years to gather real world safety experience on a new drug ● Clarifications on compensation definition including adopting relatedness as a critical determinant of compensation eligibility ● Simplification of regulatory review process with a technical review committee replacing 12 New Drug

The Expert Committee has appropriately identified the above areas as critical themes, which when implemented correctly, will have a significant impact Advisory Committees (NDACs) and an assurance on turn-around time for review ● Improving robustness of the informed consent process through audio-visual (AV) recording in cases of vulnerable subjects

● Adoption of information technology at each step to improve transparency The Expert Committee has appropriately identified the above areas as critical themes, which when implemented correctly, will have a significant impact on improving the quality of research and public faith in the research process. This is perhaps the first comprehensive articulation of all gaps in the research processes in India that will work towards restoring public confidence. However, there are a few challenges even in these positive recommendations. These include: ● Inconsistencies leading to different interpretations: An example of inconsistency is the proposal on audio visual recording of informed consent. In the salient recommendations, on page 2-3, the report states the requirement of audio visual recording of informed consent while later on, in page 79, it states this requirement is for vulnerable subjects. Another area is about the proposal on the sample size of subjects required for registration. On page 21, the report mentions the requirement of a statistically significant number of subjects

in India, whereas on page 23 it states the need for adequate number of subjects to show an effect. These inconsistencies can lead to differences in the interpretations of regulatory requirements, impacting compliance. ● Unwarranted over regulation: The recommendations on the randomisation cell of the Ministry of Health & Family Welfare recommending a list of accredited sites for inclusion in a protocol after approval from the technical review committee is an example of getting carried away after beginning with a good intention. This will be in deviation from GCP and a logistical nightmare. ● Absence of a roadmap for translating intent to action: While the Expert Committee’s remit was to put forth proposals for policy reforms, these recommendations may only remain as such, without an operational plan to convert them into reality. Even the best of intentions are not useful when the roadmap for their implementation is not available. Recommendations on clinical trials to be done at accredited sites are an example of this category. Without information on how the central

39 EXPRESS PHARMA November 1-15, 2013

cover ) accreditation council would come into being, these recommendations appear to be distant dreams. Also, there are a few areas of concern in the way they appear in the report. ● Sample size for registration studies: In either scenario - Indian patients’ data from global trials or local phase III requirement for registration – the proposal on sta-

tistically significant or adequate (where we have highlighted the inconsistency in an earlier section) negates the basic premise of International Conference on Harmonization (ICH) which evolved to avoid duplication and ensure consistent standards. The requirement for significant numbers in Indian studies will, in fact, lead to a duplication of the entire clinical programs leading to increased cost of devel-

opment with no added scientific value. This may in effect adversely impact global clinical development in India. ● Provision for medical care: While provision of medical care to patients suffering an AE/SAE is humane and is aligned with a physician’s duty and responsibility to providing care, putting a blanket financial responsibility of this care on investigator/sponsors is unjustified and not aligned

with global practices. When an AE/SAE is assessed to be related to a study, this proposal would be ethical and valid, however, for non-related AE/SAEs an alternate mechanism must be put in place. Overall, this report is a step in the right direction. With several recommendations bound to overhaul the clinical research system in India, this report is seminal in its intent. Unfortunately, areas

of inconsistencies, a few critical red flags and absence of linkage with an implementation roadmap might derail the intended transformation. The next steps on this report would be to include fixing the issues cited and a quick communication of the Ministry of Health & Family Welfare’s position on these recommendations. Quick and swift action would help arrest the decline of research in India.

As MNCs ‘stretch out’ leading Indian pharma companies through protracted litigations, GOPAKUMAR G NAIR, Founder and KARTHIKA NAIR, Legal Associate, Gopakumar Nair Associates advise the latter to take advantage of the flexibilities and safeguardsbuilt into India's patent laws

India needs to adopt bold strategies

he road from Doha of 2001 has been going downhill with regard to the issue of affordable access to essential lifesaving medicines. Para. 6 of the Doha Declaration which was received by much enthusiasm could not move forward to implementation in view of the tough procedures pronounced in 2003 by the General Council of WTO. There is an understanding in place among member countries not to file any non-violation complaints until the TRIPs Agreement is revised and reviewed. Even otherwise under Art.27(3)(b) there is a clear agreement to review

40 EXPRESS PHARMA November 1-15, 2013

tracted litigations.

Table : 1 Form27 (Working of patents) Bottles imported 2008 2009 in the year Nil

2010

4665 packs

these provisions with four years of TRIPs Agreement becoming effective, i.e. 1999. No such review has taken place. In the meantime, the extension for implementation of TRIPs compliant patent regime by Least Developed Countries (LDCs) upto 2016 (granted at Doha) has further been extended to 2021, with a provision for further extension. However, it is indeed

2011

2012

No import only sample packs.(340 units) Not available 11536 units

surprising that export of generic medicines to these countries (LDCs) have not been picking up as much as it should. This is partially because Indian pharma companies are unable to obtain and operate regulatory approvals such as drug licence for new drugs on the face of stiff litigation being pursued by innovator companies. Infringement suits initi-

ated by innovator companies against smaller Indian pharma API and formulation companies, purely challenging attempts to obtain regulatory approval are pending for preliminary hearing even after two to five years with continuous adjournments. MNCs appear to be successfully ‘stretching out’ leading Indian pharma companies such as Cipla and Natco, through pro-

Sec.107 -A(a) Plethora of infringement litigations on frivolous grounds, such as applying for regulatory approval has been a deterrent. The Indian pharma companies have failed to avail the benefit under Sec. 107-A(a) adequately. It may be noted that (unlike in EU) India allows any act of making, constructing (using, selling or importing) a patented invention solely for uses reasonably related to the development and submission of information required under any law for the time being in force, in India or in a country

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Table 2: Sec.83 of The Patents Act. other than India, that regulates the manufacture, construction, use, sale or import of any product; in 107-A(a). The Indian Judiciary has not been appreciating the essence of the exception in Sec.107A(a) and has been erroneously and irrationally upholding that drug approval from DCGI or FDA amounts to infringement, leading to arbitrary grant of injunctions, in spite of prior judgments, by Single Bench and Division Bench of High Courts which has been ratified by the Supreme Court.

Compulsory Licence under Sec.84 Compulsory Licence was granted to NATCO for Bayer’s drug ‘sorafenib tosylate’ which is sold under the name ‘Nexavar’. Sorafenib tosylate is a palliative drug for patients suffering from Renal Cell Carcinoma (RCC) and Hepato-Cellular Carcinoma (HCC) at stage IV. It is helpful in treating terminal cancer of kidney and liver. Of late, the indication for breast cancer is also under approval for sorafenib tosylate. Even though, Bayer’s patent for sorafenib was granted in 2008, as per details submitted by Bayer to Patent Office in Form 27 (Working of patents) as illustrated in the Table 1 below, the sorafenib dosage for (Nexavar) has only been imported and not worked in the territory of India. Further, the quantum of imports has been far too low compared to demand in the country. To add insult to injury, the price has been extremely exorbitant. Considering all these factors under Sec.83 (refer Table:2) and Sec.84 (refer Table:3) of Patents Act, 1970 the Compulsory Licence was granted to NATCO by the Controller General of Patents. The General Principles applicable to working of patented inventions as illustrated in Table 2 are substantially reproduced from Art.7 and Art.8 of TRIPs and vari-

Sec.83: General principles applicable to working of patented inventions:Without prejudice to the other provisions contained in this Act, in exercising the powers conferred by this Chapter, regard shall be had to the following general considerations, namely-

a) that patents are granted to encourage inventions and to secure that the inventions are worked in India on a commercial scale and to the fullest extent that is reasonably practicable without undue delay; b) that they are not granted merely to enable patentees to enjoy a monopoly for the importation of the patented article. c) that the protection and enforcement of patent rights contribute to the promotion and enforcement of patent rights contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations; d)that patents granted do not impede protection of public health and nutrition and should act as an instrument to promote public interest specially in sectors of vital importance for socio economic and technological development of India; e) that patents granted do not in any way prohibit Central Government in taking measures to protect public health; f) that the patent right is not abused by the patentee or person deriving title or interest on patent from the patentee, and the patentee or a person deriving title or interest on patent from the patentee does not resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology; and g) that patents are granted to make the benefit of the patented invention available at reasonably affordable prices to the public.

Table: 3 Sec.84 of The Patents Act. Conditions to be met for Compulsory Licence under Sec.84 1.At any time after the expiration of three years from the date of the grant of patent, any person interested may make an application to the Controller for grant of Compulsory licence on patent on any of the following grounds, namely:-

ous provisions of Paris Convention. For third parties to be eligible to apply for Compulsory Licence, the conditions as in Table 3 need to be met. The compulsory licence for sorafenib has been granted on condition that NATCO will sell sorafenib tablets at `8,800 for a month’s treatment, while Bayer’s price for the same unit dosage was `2,80,428. The compulsory licence was granted to Natco with many conditions, as in Table – 4. After NATCO’s sorafenib was officially launched in India, Bayer filed a contempt suit for invalidating the com-

a) that the reasonable requirements of the public with respect to the patented invention have not been satisfied, or b) that the patented invention is not available to the public at reasonably affordable price, or c) that the patented invention is not worked in the territory of India.

pulsory licence against NATCO alleging that NATCO has violated the terms by exporting the product. NATCO claims to have not exported the product themselves. In the meantime Bayer filed an appeal with the Intellectual property appellate Board (IPAB). IPAB after hearing both parties dismissed the appeal and confirmed the grant of compulsory licence to NATCO by the Controller General of Patents. IPAB, however, increased the quantum of royalty payable by NATCO ( which is fixed by the CGPDTM) from six per cent to seven per cent. This order has now been challenged

through a writ petition by Bayer in the High Court of Bombay. From all indications, it appears that this compulsory licence case will also travel all the way upto the Supreme Court as in the case of Gleevec of Novartis. Future compulsory licence applicants may be watching the progress of these litigations. The high cost of litigation in India, which runs into crores, as in developed countries like the US, must be acting as a deterrent to future compulsory licence applications over and above the indecision from the Government of India to fully exploit the flexibilities enshrined in the

Patents Act, 1970.

Compulsory Licence under Sec.92 The Hon’ble Union Minister of Commerce as well as Health as well as Secretaries have repeatedly been announcing that compulsory licence under Sec.92 is going to be granted. However, no such grant has taken place till date. Either there are only ‘crocodile tears’ or are being met with stiff resistance internally and externally due to overemphasis by legal circles that Sec.92 is only to be invoked under national emergency or extreme urgency. It is to be noted that compulsory licence can be granted under Sec.92 for ‘public non-commercial use’ also. In those cases of anticancer drugs, where the imports into India has been negligible as disclosed in Form 27 or where the imports have been coming down over the years in spite of increasing demand for such anti-cancer drugs, Sec.92 could well be invoked for grant of compulsory licence, under “public non-commercial use” clause.

Compulsory Licence under Sec.92-A Doha had, once for all, declared that countries like India are free to exercise sovereign rights for healthcare and affordable access to medicines by adopting and using needful provisions. India has not been adequately exercising their rights to fulfill this objective. India has introduced Sec.92-A to enable India to cater to export orders from LDCs and other developing countries with no drug manufacturing facilities of their own, against a compulsory licence or government certified order from that importing country which is an LDC with no Patent Office. Even the 2003 procedure announced by the General Council of WTO for implementing compulsory licence under Para.6 of Doha is

41 EXPRESS PHARMA November 1-15, 2013

cover ) TABLE: 4 TERMS AND CONDITIONS cumbersome and impractical, India should take a lead in granting compulsory licence under Sec.92-A more boldly and liberally, in view of the fact that it is agreed that no member country will approach the WTO DSB (Dispute Settlement Body) for any healthcare related patent violation. The export-oriented pharma companies from India should also take some initiatives to pursue this option and opportunity.

Sec.100 and 101 India has not given adequate attention to invoking Sec.100 and Sec.101 of the Patents Act, 1970. With the very large network of Government hospitals under ESIS, Defence, Zilla Parishads and rural health programmes, India government should be able to use provisions of Sec.100 and Sec.101 to make available lifesaving anti-cancer and other highly essential but unafforadably priced drugs, free to patients by getting the same manufactured by WHOGMP compliant Indian pharma companies as per provisions of Sec.101, for free distribution.

Form 27 and working of patents Patentees and assignees of many granted Indian patents relating to lifesaving medicines have not been providing serious response to the requirements of filing of Form 27 and making available details of working of patents in India. The Patent Office has made available the details on their official website (www.ipindia.nic.in). The Indian pharma companies should study this information and provide feedbacks or representations to enable Patent Office to revoke patents which are not worked or on which Form 27 are not filed. This will help eligible GMP compliant Indian pharma companies to introduce these lifesaving drugs at five per cent to 10 per cent of the

42 EXPRESS PHARMA November 1-15, 2013

The Compulsory Licence was granted to Bayer subject to following terms and conditions: a.The price of the drug covered by the Patent, sold by the licensee shall not exceed Rs.8880 for a pack of 120 tablets, required for one month's treatment. b.The licensee shall maintain accounts of sale etc. in a proper manner and shall report the details of sales to the Controller as well as the Licensor on a quarterly basis, on or before fifteenth day of the succeeding month. c.The licensee shall have the right to manufacture the drug covered by the Patent only at his own manufacturing facility and shall not in any whatsoever outsource the production. d.The license is non-exclusive. e.The license is non-assignable. f.The licensee shall pay royalty at the rate of 6% of the net sales of the drug on a quarterly basis and such payment shall be affected on or before fifteenth day of the succeeding month. g.The license is granted solely for the purpose of making, using, offering to sell and selling the drug covered by the patent for the purpose of treating HCC and RCC in humans within the Territory of India. h.The licensee shall supply the drug covered by the Patent to at least 600 needy and deserving patients per year free of cost.The licensee shall annually submit in the form of an affidavit the details of such patients, i.e. name, address and the name of the treating oncologist, to the Office of the Controller of Patents and such report shall be submitted on or before 31 st January of the year, in respect of the preceding year. i.The licensee shall not have the right to import the drug covered by the Patent. j.The license is for the balance term of the patent. k.The license does not include any right to represent publicly or privately that the Licensee's product is the same as the Licensor's or that the Licensor is in any way associated with the Licensee's product.The Licensee's product must be visibly distinct from the Licensor's product (e.g. in color and I or shape); the trade name must be distinct, and the packaging must be distinct.The Licensor will provide no legal, regulatory, medical, technical, manufacturing, sales, marketing, or any other support of any kind to the Licensee. l. The Licensee is solely and exclusively responsible for its product and for all associated product liability. The Licensor, its Directors, Officers, Employees, Agents, and affiliates shall not be held liable in any manner whatsoever for any action of the licensee. m. The Licensor is free to do whatever it wishes with its residual patent rights subject to the non-exclusive license to the Licensee, and is free to compete with the Licensee and to grant licenses to third parties to compete with the Licensee.

TABLE 5: SEC.86 (LICENCE OF RIGHT IS A FORM OFAUTOMATIC COMPULSORY LICENCE) Sec.86 : Endorsement of patent with the words" Licences of right". (1) At any time after the expiration of three years from the date of the sealing of a patent, the Central Government may make an application to the Controller for an order that the patent may be endorsed with the words "Licences of right" on the ground that the reasonable requirements of the public with respect to the patented invention have not been satisfied or that the patented invention is not available to the public at a reasonable price. (2) The Controller, if satisfied that the reasonable requirements of the public with respect to the patented invention have not been satisfied or that the patented invention is not available to the public at a reasonable price, may make an order that the patent be endorsed with the words "Licences of right". (3) Where a patent of addition is in force, any application made under this section for an endorsement either of the original patent or of the patent of addition shall be treated as an application for the endorsement of both patents, and where a patent of addition is granted in respect of a patent which is already endorsed under this section, the patent of addition shall also be so endorsed. (4) All endorsements of patents made under this section shall be entered in the register and published in the Official Gazette and in such other manner as the Controller thinks desirable for bringing the endorsement to the notice of manufacturers.

imported price, which will help affordable access in abundance. India needs to find a breakthrough for facilitating smooth availability of life saving medicines at affordable price. The patent litigation costs, not only in imaginary or perceived infringement suits extending over four to five years and still remaining unheard or undecided, is running into crores. Compulsory licence cases are also following the trend of multi-stage appeals and writ petitions travelling all the way to higher courts. The Sec.92-A for exporting under compulsory licence is also made nonworkable or impracticable by the circuitous procedures prescribed which are openended and not time bound. The global pharma giants and developed countries are moving outside TRIPs and WTO to restrict legitimate trade through ACTA (AntiCounterfeiting Trade Agreement), TPP (TransPacific Partnership) etc. and introducing new interpretations to ‘counterfeits’ as perceived or alleged patent infringing drugs, jeopardising generic pharma operations. TBTs (Technical Barriers to Trade) and NTBs (Non-Tariff Barriers to Trade) have become the order of the day. There is a moratorium on challenge in DSB (Dispute Settlement Body) relating to patents in healthcare issues. Art. 27(3)(b) which needed (‘shall’ be review) statutory review within four years from 1995 (1999 deadline) has not yet been undertaken. Under these circumstances, India needs to consider re-introducing ‘Licence of Right’ (refer to Table 5) in the Patents Act, 1970 and relating to patents for lifesaving medicines. This could generate some heat and dust and an outcry from the developed countries. However, it is worth at least a debate to evaluate the pros and cons.

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DR MILIND ANTANI, Head, Pharma and Life Sciences and ANAY SHUKLA, Member, Pharma and Life Science team, Nishith Desai Associates give an insight on handling the legal angles of the Indian pharma sector

Navigating the Indian legal maze: Challenges

round 30 years ago when eminent author Robert Schuler penned down one of his excellent works ‘Tough Times Never Last but Tough People Do’, he would not have thought that this will hold so true for the pharmaceutical industry in present day India. 2013 has been a particularly tough year for the Indian pharma industry. This is in sync with the slowdown of Indian economy and the record depreciation of its currency. To add to the woes, the pharma sector was adversely affected by unpredictable and often sweeping changes in the Indian legal and regulatory regime. The legal woes were accentuated as Indian courts put emphasis on ‘public interest’, placed premium on therapeutic efficacy like never before, and expressed concern on clinical trial subjects. It has also been a year when various malpractices committed by Indian pharma companies were reported and led to serious consequences. These developments have placed some pharma companies in a tight spot with their stocks taking a heavy beating at the stock markets and adversely affecting their growth prospects in both India and

overseas markets. In this backdrop, it is imperative to understand the legal developments as well as why and how pharma companies can adopt various risk mitigation strategies to ensure adequate adherence to the laws. This year, Indian pharma companies received an unprecedented number of import alerts from United States Food and Drug Administration (US FDA). An ‘import alert’ is an announcement by the US FDA when it determines that there is considerable possibility of a drug produced at a certain facility being adulterated, misbranded or unapproved. A drug produced at a facility that has been issued an import alert is detained by the FDA or denied admission within the territory of the US. Naturally, import alerts result in significant loss of revenue as well as reputation to a company. As per the official data available at this time, 19 facilities located in India received import alerts in 2013. The principal reasons for a spurt in these alerts are as follows. First, US FDA has increased the number of inspectors assigned to India who conduct unannounced inspections, a practice which

It is imperative to understand the legal developments as well as why and how the pharma companies can adopt various risk mitigation strategies to ensure adequate adherence to the laws was not followed earlier. Second, there are reports of possible non-compliance by Indian companies. An analysis of import alerts issued to Indian facilities indicates that most defaults were due to absence of data integrity and

vendor due-diligence. The reason for this was possible lack of awareness. It is extremely important that each individual in the production chain is made aware of legal risks of non-compliance. Due-diligence of vendor must not be compromised since it will expose the history of non- compliances and lead to potential recall of products as per the applicable law. Also, this year, India’s product patent regime has faced intense criticism from media as well as the industry bodies for its failure to protect pharma patents. Principally, the criticism is on three grounds 1) denial to award patent for improvement or modification; 2) possibility of grant of compulsory license, and; 3) option to apply for revocation of existing patents. Section 3(d) of the Patents Act, 1970 covers the subject of patentability of improvements or modifications of a known substance. It holds, amongst other things, that a new form of a known substance that does not result in enhancement of the known efficacy will not be considered as an invention hence is not patentable. In the Novartis case, the Supreme Court of India found Novartis’ molecule to be a ‘new form of

known substance that did not result in enhancement of known efficacy’. In arriving at this conclusion, the Court chose to interpret efficacy as ‘therapeutic efficacy’. The critics of the case observe that the Court has defined ‘efficacy’ too narrowly, and thus weakened intellectual property protection afforded in India to innovator drugs. Though the merits of the judgement will continue to be debated, the industry must learn from the Supreme Court ruling and take effective measures to ensure that it is not caught on the wrong foot. All innovating companies must ensure that their patent application contains data that indicates 'therapeutic efficiency' in their innovation. This can help negate a possible challenge under Section 3(d) in future. The catch here is that, the data to indicate 'therapeutic efficiency is not usually available at the time of making a patent application. So, the validity of patent claim may boil down to the proper drafting of a patent application. Next, let us examine the controversy surrounding compulsory licensing. As per the World Trade Organization (WTO), compulsory licensing is

43 EXPRESS PHARMA November 1-15, 2013

cover ) when a government allows someone else to produce the patented product or process without the consent of the patent owner. In the context of pharma patents, it means that compulsory licensing is a license granted to an applicant to manufacture and sell a drug over which there is a patent in existence. Compulsory licensing arrangements are usually coupled with revenue sharing. Till date, India has granted only one compulsory license to Natco pharma for Bayer’s cancer drug ‘Nexavar’. In contrast, it is reported that fifteen countries, including developed and developing countries, have issued more than 35 compulsory licenses. The licensing authority took strong note of the fact that Nexavar was not domestically produced and records showed that its import into India had not been consistent. Thus, the exorbitant price of the drug coupled with absence of access to the drug contributed to the Government’s decision. Each player in the pharma industry who may be affected by this decision should take some cues from the approach of the licensing authority. It should ensure availability of the patented drug in quantity in the Indian market that is sufficient to meet public requirement. Secondly, it should ensure that its patents are ‘working on a commercial scale’, that is, its patent drugs are utilised by the public in a commercially meaningful way. It is vital for the patent holders to file Form 27 to show working of patents. It is equally important to furnish adequate and correct information so as to avoid the risk of being penalised under the provisions of the Act. Further, all efforts must be made by the patent holder (either directly or through its licensees in India) to work the patent in India, else the patent may become susceptible to compulsory licensing. The expressions like ‘public requirement’, ‘commercial scale’ and ‘reasonable price’ are terms whose interpretation will

44 EXPRESS PHARMA November 1-15, 2013

The expressions like ‘public requirement’, ‘commercial scale’ and ‘reasonable price’ are terms whose interpretation will depend upon facts and circumstance of each case and legal precedents decided by a court of law. Therefore, it is suggested that the industry should keep itself abreast of such legal developments depend upon facts and circumstance of each case and legal precedents decided by a court of law. Therefore, it is suggested that the industry should keep itself abreast of such legal developments. Lastly in relation to product patents, let us examine the issue of patent revocation. The international media has taken strong note of the fact that in the past one year, India has denied or revoked nearly halfdozen patents. The Patents Act, 1970 allows opposition to a patent after it has been granted to a patentee within one year of the grant of the patent. This provision has been used by numerous generic companies and non-governmental organisation to oppose grant of patents. It is to be noted here that the post-grant opposition may be made only on a limited grounds specified under Section 25(2) of the Patents Act, 1970. Furthermore, the success of grant of opposition of patent only indicates that it did not deserve patent in the first place. In addition to the patent law related developments, the industry witnessed quite a few regulatory changes this year. Two of them have had the most significant impact on the industry – the introduction of a new drug price control regime and notification of rules for compensation to be provided in case of clinical trial related death or injury. Let us examine each of the development separately in the following paragraphs. The new drug price control

regime regulates prices of essential medicines only. The price of the medicines is fixed based on the average of the market price of drugs belonging to the same category. This is major deviation from the earlier price control regime. The new regime affects 21 per cent of the industry, as opposed to the old regime which affected 4.5 per cent of the industry. The new drug price control regime is captured under the Drug (Prices Control) Order, 2013 and the priced fixed by the Government is referred to as ‘ceiling price’. The implementation of this regime has posed unique questions before the industry. What happens when the drug is the only drug in its category? What happens if a competitor deliberately prices its drug below its cost price as a form of predatory pricing? The industry is also faced with certain practical difficulties. The 2013 order mandates that the new ceiling prices must be reflected on all drug containers and packages within 45 days of notification of the price. The easy solution to this problem would be if the players in the supply chain, which include the carrying and forwarding agent, the stockists, the distributors, the retailers etc. who are in possession of the drugs could stick a new price label to the drug. However, any form of alteration or modification to label is prohibited by The Drugs and Cosmetics Rules, 1945 as well as Central Excise Act, 1944. The government agency that is enforcing the 2013 order is

unable to seek some sort of reprieve from the government agencies enforcing the 1945 Rules and the1944 Excise Act due to co-ordination issues. This possibly will lead to either product recall or challenge before a court of law. Recall is not feasible since it procedurally impossible to recall products in 45 days from the market. This leaves affected companies with no other option but to challenge the 2013 order in court of law. We will also discuss the formal framework on compensation to be granted to clinical trial subjects for clinical trial related injuries or deaths. This was put in place by the Indian government in January this year by amending the Drugs and Cosmetics Rules, 1945. Under the present framework, the compensation is decided by the Drugs Controller General of India on the recommendation of an expert committee. The process for compensation has been made automatic which gets triggered as soon as an injury or death occurs. The new framework also imposes a strict liability on the sponsor of the trial to pay for compensation as well as pay for medical management of the subject for any injury that may arise in course of the clinical trial even if the fault lies with the investigator or the site. The compensation awarded by the DCGI may range between `4 lakhs to `72 lakhs. These changes have created concerns with 'claimsbased' clinical trial insurance policies as technically the victim or his or her representative

usually claims from the investigator. It is suggested that all existing insurance policies must be vetted to ensure adequacy of coverage. It appears that the new framework will not apply retroactively because the amendment does not expressly provide that it will apply retroactively as well, and there is some judicial precedent to adopt his view. Apart from the insurance policy, the language in the contract between various stakeholders will play significant role in deciding the liability of providing compensation. Another regulation that is likely to impact pharma industry in India is around product promotion. Though the Code of Marketing Practice for Indian pharma industry by the Dept of pharmaceuticals is voluntary at the moment, it will have far reaching impact, as it is also linked to the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, once it becomes legally binding. It is important that the companies have their strong policies regarding product promotion to avoid prosecutions in future. The last legal development worthy of analysis and discussion concerns both policy and law - foreign direct investment (FDI) in a pharma company. At present, FDI up to 100 per cent is allowed in a green field company without prior approval of Foreign Investment Promotion Board (FIPB) and up to 100 per cent is allowed in a brownfield company with approval of the FIPB for a company in pharma sector. Since FIPB has been granted the power to impose conditions when granting approval, it can add to the legal hurdles which a foreign investor has to cross. This can adversely affect in-bound investment in Indian pharma sector. However, all is not lost for the India pharma sector. Those industry players which are efficient, innovative and manage to safely navigate the legal maze will come out winners.

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BOB RHOADES, Vice President, Quality and Compliance Consulting, Quintiles gives an insight about the essentiallity of the real-time information about the specifications and compliance of every batch to protect the market share and reputation of India’s biopharma sector

Positioning for success: Protecting market share with sustainable compliance

gainst a backdrop where as many as 40 per cent of all drugs taken by Americans are imported, and some 80 per cent of the active pharmaceutical ingredients in those drugs come from foreign sources,1 it is not hard to see why the US Food and Drug Administration (US FDA) is increasing its focus on inspections in emerging markets. India – which has about 200 FDA-approved manufacturing facilities – is the largest exporter of medicines to the US, supplying some 40 per cent of generics and over-thecounter products and around 10 per cent of finished dosages. The country’s drug exports to the US totaled $4.2 billion in 2012, an increase of almost one-third on the previous year2. The recent crop of warning letters issued to Indian companies is a direct result of this heightened FDA activity, and a reminder of the essential nature of regulatory compliance. To date in 2013, Indian manufacturing plants have received 13 import alerts, compared with seven in China and two each in Australia,

of compliance, even greater rewards are possible. Such strategies facilitate sustainable compliance as well as systematic, data-driven medical product development.

8 PILLARS OFAN EFFECTIVE QUALITY SYSTEM

Traditional compliance: Complex procedures, point polutions

Canada and Japan. To protect the market share and reputation of India’s biopharma sector, rapid achievement of baseline compliance – far beyond simple documentation of processes, and instead reflecting true, real-time information about the specifications and compliance of every batch – is essential. This will build the foundation for sustainable, best-in-class compliance practices. From over 30 years of experience in advising on quality and compliance issues,

India is by no means alone in facing compliance challenges. In other emerging and developed markets, economic uncertainty and industry consolidation are forcing biopharma and device companies to do more with less. Without the right attention, systems and processes can weaken, domain and critical thinking expertise can erode, and core quality principles can be neglected, leaving companies vulnerable to compliance lapses and enforcement action. In today’s heightened reg-

ulatory environment, even traditional compliance – where quality assurance and compliance are backroom cost centres – is insufficient. However, good leaders realise that quality and compliance are the ‘tickets to play’ in the global healthcare products space. Enlightened leaders know that best-in-class compliance is an opportunity for market differentiation. By applying systems-based thinking and aligning compliant quality systems with key business processes, practicing the art

A traditional compliance approach is often distinguished by a complex array of quality policies, standard operating procedures, and work instructions that may bear only passing resemblance to the way work actually gets done. Although the good manufacturing practice (GMP), good clinical practice (GCP) and good laboratory practice (GLP) regulations require some 200 procedures, it’s not atypical for biopharmaceutical companies to have thousands of such procedures. Paradoxically, while a complex network of procedures is designed to compel consistency and compliance, without careful attention, procedural complexity is more likely to result in non-compliance and inefficiency. Another traditional

45 EXPRESS PHARMA November 1-15, 2013

cover ) compliance approach is to rely on reactive, point solutions to address problems. Point solutions typically flow as follows: find a problem, add a procedure, and fix only that problem. Historically, the prescriptive nature of approval and GMP requirements inadvertently reinforced companies’ reluctance to make systemic changes to products or systems, favouring use of more focused point solutions. But point solutions tend to fix symptoms rather than systemic causes. They similarly falter when they do not address the same issues that may be present elsewhere in the company. The confluence of point solutions with complex procedures makes it impossible to achieve sustainable compliance -- with interlinked processes and systems that help an organisation respond to problems, maintain compliance, and prevent non-conformities from occurring. The FDA’s approach to sustainable compliance involves eight pillars (Figure 1). FDA’s focus on supportive management as one of the eight pillars of an effective quality system underscores a principle implicit in the current philosophy of global regulatory bodies. Consequently, it is both a strategic and sustainable compliance imperative that management teams of today’s healthcare product companies fully engage in their organisation’s quality management and compliance activities.

Moving up the compliance maturity curve How does a company move compliance from a baseline, traditional approach to a fully effective quality system that is not only compliant but efficient and integrated to key business processes? Think of this in terms of a compliance maturity curve, with four stages of maturity (Figure 2). At Stage 1, companies have complex, ineffective and

46 EXPRESS PHARMA November 1-15, 2013

impractical quality systems that are typically broken and in fire-fighting mode. Stage 1 companies are reactive and continually remediating processes that don’t work. Companies at Stage 2 are slightly ahead on the curve. They are more likely to make timely and effective fixes, but all too often slide back down the curve as their processes get increasingly complex or their solutions are not sufficiently systemic. At Stage 3, a company has an effective, fully functioning and compliant quality system. When done right, the same methodology used to achieve Stage 3 compliance can be taken to Stage 4, a processdriven and sustainable compliance framework integrated with business processes to facilitate business effectiveness, efficiency, and innovation. Stage 4 is distinguished by applying critical systems and process approaches not only to quality systems, but to other key product development activities and business decision making. Management input and oversight is critical to ensure Stage 4 success. To reach stage 4 sustainable compliance, companies must use a three-step approach involving Assessment, Solution Design, and Implementation (Figure 3). Step 1: Assessment Begin with an objective, rigorous assessment of the current situation. Enlist the best critical thinkers and problem solvers in your organisation, or get experts to help. The assessment should include:

Identify and prioritise gaps Regulatory requirements are constantly changing. Identify the risk areas where processes are not sufficiently robust to consistently meet regulatory requirements. Anticipate regulatory changes that could be proactively

WHERE IS YOUR COMAPNY ON THE COMPLIANCE MATURITY CURVE

ASCENDING THE COMPLIANCE MATURITY CURVE

addressed. Prioritise the key gaps compared to the regulatory requirements based on compliance risk and strategic imperatives. Short-term and long-term goals will vary based on the company’s current stage of the compliance maturity curve. Ask whether all key processes are adequately

staffed? Does management make quality a priority – in words and actions?

Examine systems and root causes Assess what matters most for the product and customer. How does work currently get done? What are the detailed activities, drivers, and owners? What could be

eliminated? Undertake a critical analysis of the root causes of past problems. What systems have failed and why? Get to the root cause of the problem using proven techniques like ‘the five whys,’ causal factor tree analysis, failure mode and effects analysis, fishbone diagrams, contradiction tables, and design of experiments.

( Examine all quality subsystems (quality, facilities and equipment, materials, production, packaging and labelling, and laboratory control), with a focus on vulnerable processes such as change control, validation, and complaint handling; consider the entire product life cycle.

From over 30 years of experience in advising on quality and compliance issues, India is by no means alone in facing compliance challenges

Determine opportunities Define performance improvement opportunities. How do the current approaches align with industry-leading practices and organisational models? Are communication and decision making linkages between geographies, business units and functions sufficiently strong?

Assess critical drivers Identify the key drivers for product development ‘stagegates’ used to make decisions. What information is needed in order to ‘fail fast’ or maintain funding? What are the logical linkages between product development processes and quality system processes? Are metrics established that are both meaningful and attainable to drive performance and assess effectiveness? How do key performance indicators compare against industry benchmarks? How should quality data feed into business processes? How engaged are business leaders and do they convey a consistent philosophy? Step 2: Solution Design Develop the future-state operating model and optimised quality system. Addressing sustainable compliance requires a comprehensive solution, taking into account the company’s strategic priorities, goals, and objectives and typically encompasses the following steps: ● Establish a multifunctional steering committee chaired by a high-level process leader.

THE MAIN FOCUS

STREAMLINED R&D SOPs

● Facilitate strategic design workshops to get insight and buy-in from key stakeholders. ● Systematically develop proposed solutions using techniques like sequential design of experiments to optimise every step of the process. ● Simplify, and where appropriate, reduce the number of procedures and processes that reflect how work actually gets (or will get) done. ● Drive internal control ownership and accountability. Tie updated processes to individual job responsibilities. ● Take a broad approach: focus on the organisation as a whole and not silos, on global harmonisation and not individual facilities or product lines. Regulators increasingly expect solutions to be applied systemically throughout the organisation. ● At the same time, balance the need for consistent compliance against the temptation to apply a ‘one size fits all’ approach. What works for one geography, division or product area may not be effective or possible for another. If customisation is necessary, develop and apply umbrella corporate procedures, and allow individual units the flexibility to develop compliant procedures within the umbrella. A different yet still compliant approach is better than forcing a single paradigm is not consistently followed. Step 3: Implementation

Never underestimate the importance of a properly planned and executed implementation plan, especially if the solution is transformative in nature. Key areas of focus for implementation include: ● Change management. Involve key stakeholders during the process to ensure engagement. Communicate throughout the organisation to keep staff informed and in step with the transition. ● Continued engagement and regular communication by senior leadership. Consider broadening participation in key review boards, to keep quality and compliance issues visible to business leaders. ● Delivery and process transformation. Allow for staged transition from the current to future state. ● Judicious use of technology. Provide the tools, knowledge repositories, and management support infrastructure to transition from tribal knowledge to fully integrated quality systems and business processes. ● Evaluate effectiveness. All corrective actions must be evaluated to ensure effectiveness. Consider a design of experiments approach to systemically evaluate the effectiveness of new processes. Expect changes to be needed. Think of a Stage 4 sustainable compliance system as a living organism requiring regular care and feeding to remain healthy.

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cover ) Conclusion: A proactive approach is best Quality problems or enforcement actions may drive a company to begin its journey up the compliance maturity curve, but the best time to take action is before such problems surface. Timely and proactive efforts to drive sustainable compliance minimise the risk of quality problems or enforcement action. Importantly, when not distracted fighting fires, leaders have the relative luxury to practice the art

of compliance – to think more strategically and design and implement a Stage 4 solution. Sustainable compliance is the art and science of managing a business with a clear view of the regulatory requirements. It is a fundamental requirement– and one that can profoundly affect the financial health of the enterprise. It deserves as much attention to excellent planning and flawless execution as any other activity. Done well, it provides competitive advantage, growth

and financial health for the shareholders; done poorly, it can mean interruption of supply to customers, longterm decline of a firm’s credibility and the ultimate demise of the business enterprise. Understanding compliance as a core business process and integrating it into the way the organization lives and breathes is the way to success – in India, and around the world. The time is now. Regulators typically take enforcement action against a

company when they see quality and compliance lapses that lead the agency to conclude the company is ‘just not getting it.’ But they also take action against entire industries—with additional and more onerous requirements—when they view the industry as a whole as having eroded quality principles, weak systems, and with top leadership giving more attention to the bottom line than to fundamental quality and compliance. In this current era of heightened enforcement, it’s

more critical than ever to get it right. Sustainable compliance is not just nirvana for the process gurus, it’s an imperative. And getting it right will firmly position India’s biopharma sector for continued global success.

References 1.http://www.fda.gov/NewsE vents/Speeches/ucm294978. htm 2. Rhoades, R, Sustaining Compliance: Strategies for Maintaining Drug Quality, FDANews, 2005.

The under-penetration of medical devices in India provides a compelling opportunity for medical device manufacturers to increase their presence in the country. ABBY PRATT, Associate Vice President, Global Strategy & Analysis, AdvaMed answers on what’s critical to the success of the medical device industry

Critical success factors for the medical device industry

ith over 62 million diabetics, India is fast becoming the diabetes capital of the world. One of every three adults here has high blood pressure. Hypertension kills nine million people every year. Medical devices have been playing a tremendous role in mitigating India’s disease burden. While coronary stents have cut the number of patients dying from heart attacks in this country by half, implantable cardiac defibrilla-

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tors have increased the chances of surviving a sudden cardiac arrest from five per cent to 98 per cent. Diabetics can now use glucose monitoring technologies to escape hypoglycemia, blindness and peripheral nerve damage, and patients in general can spend less time in hospital owing to the minimally invasive technologies used to conduct heart, spine, metabolic and neurosurgeries. Yet, despite the fact that medical technology is such an

important pillar of the healthcare system, the medical device industry in India, valued at about $3 billion, contributes to only eight per cent of India’s $40 billion healthcare sector. It is somewhat startling that less than $2.50 (approximately ` 155) is spent on medical technology per person. The under-penetration of medical devices in India provides a compelling opportunity for medical device manufacturers to increase their pres-

ence in the country and expand access to healthcare. Established medical device manufacturers had traditionally focused on the development and marketing of devices in western markets but for some years now, companies have prioritised expansion in low and middle income countries. Medical device companies have realised over the years, that creating appropriate and customised solutions for countries like India, which have massive populations and high

(and increasing) disease burdens would not only help serve their business interests but also help solve India’s healthcare challenges. As health insurance coverage increases and the burgeoning middleclass demands better healthcare services, India’s medical device market is projected to reach $6 billion by 2015. However, the industry will still have to respond to a range of challenges – poor public health infrastructure, a staggering out-of-pocket

( healthcare spend of over 60 per cent, a weak regulatory framework, lack of adequate trained healthcare personnel and devise an India-specific strategy to realise its potential. I believe that for the industry to be successful and address the country’s healthcare challenges, it will be critical for companies to innovate and create shared value through partnerships and collaborations. It will be equally important for the government to reform the regulatory framework. Each of these factors are elucidated in turn.

Innovation for success In a recent conference on medical technology organised by the Confederation of Indian Industries (CII), Dr Naresh Trehan, Chairman and Managing Director, Medanta, the Medicity, vociferously stated that medical device manufacturers in India need to innovate, it is not enough to simply reverse-engineer. The ‘Medical Technology Innovation Scorecard’ prepared by PricewaterhouseCoopers finds that advanced economies in general do not face the dire need for innovation that emerging economies do. One of the main drivers of medical device innovation in India has been its distinctive disease profile – for instance, manufacturers have had to provide in-vitro diagnostics for malaria, dengue and other communicable diseases. Infrastructural constraints and climactic conditions have also led to the ‘tropicalising’ of medical technology. In this context, it is important to appreciate that medical device innovation refers not only to the invention of new devices but also to incremental improvements to efficacy and adapting devices to different settings. While GE through its healthymagination platform has developed an ECG machine suitable for portable use in challenging environments, Medtronic has created a leadless pacemaker that can

be monitored remotely. Stryker by collaborating with Stanford’s Biodesign Group, the Sanjay Gandhi Postgraduate Institute of Medical Sciences and the All India Institute of Medical Sciences hired and trained indigenous R&D talent to develop and launch India-specific products at affordable prices. Frugal innovation has been the buzz-phrase in the developing world as far as medical technology is concerned, with manufacturers realising that they need to cater to the increased demand for effective, safe and low-cost medical devices from emerging economies, particularly China and India. For instance, in 2009, GE launched the Lullaby Warmer in India, which provides direct heat in an open cradle to new-born babies, and priced it at $3000 per unit against its starting price in the US of $12000. Foreign players have set up centres to focus on medical technology innovation – GE and Stryker each have centres in Bangalore while Stryker, Covidien and Johnson & Johnson have centres in Gurgaon, Mumbai and Hyderabad respectively. Companies are becoming increasingly attuned to the needs of the patients they serve – 3M’s Customer Training Centers, for example, 3M’s Customer Training Centers serve as a platform for active engagement of customers in new product development through direct interfacing with 3M’s scientists in India and abroad. Going forward, emerging economies are expected to spend more on R&D, have the human capital needed for research and see more support from the investment community, all of which will be triggers for innovation. The PwC report indicates that the epicenter of the innovation ecosystem for medical devices is shifting towards emerging economies in general and India and China in particular. To

Going forward, emerging economies are expected to spend more on R&D, have the human capital needed for research and see more support from the investment community achieve this though, companies need to invest more in R&D, undertake collaborations to reduce cost, locally adapt sales and distribution to improve delivery and actively engage in skill development.

Creating shared value through partnerships Michael Porter and Mark Kramer define ‘shared value’ as “enhancing the competitiveness of a company while simultaneously advancing the economic and social conditions in the communities in which it operates”. In low and middleincome countries like India, medical device companies could create shared value by engaging in collaborations and partnerships that would be beneficial for the collaborators as well as the patient population. Factors like low government spend on healthcare, poor doctor to patient ratio and the vast geography of the country make access difficult. These pain points can be addressed through partnerships at various levels.

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By collaborating with the government, medical device companies can leverage the government’s strengths to expand access to affordable healthcare to a larger section of the population. This would help companies serve more patients and realise economies of scale. The government in turn would benefit from the companies’ ability to provide quality healthcare. As part of its ‘inclusive growth’ policies, the Government is paying close attention to healthcare and education. This would be the ideal time to position the medical device industry as a partner that will work towards strengthening India’s public health system. Companies like GE and B Braun are already partnering with state governments under the PPP route to provide affordable and accessible healthcare, while organisations like Johnson & Johnson have partnered with the Public Health Foundation of India (PHFI) to train thousands of physicians on managing gestational diabetes here. Through its PPPs, Siemens delivers tailored solutions for medical equipment – access to state-ofthe-art medical systems and services with a duration of 1540 years, full refreshment cycles and the possibility of varying equipment specifications over the contract period. Companies can also create shared value by setting up alliances with other companies in the private sector, and mutually benefit from each other’s expertise through technology transfers, knowledge spillovers and skill development. When Medtronic realised that one of the major access challenges was diagnosing the need for a pacemaker, not in the provision of the device itself, it partnered with Maestros, a provider of telemedicine-based EKG interpretation services to improve access to cardiac screening. Going forward, companies should consider ramping up their collaborative efforts. Partnering with pharmaceuti-

cal companies and hospitals, for instance, could provide advantages of size and strength while simultaneously filling gaps in companies’ offerings. Medtronic recently announced a collaboration with Apollo Hospitals to market an innovative, affordable and portable hemodialysis system in India to help improve access for End Stage Renal Disease (ESRD) patients who need Renal Replacement Therapy (RRP). Companies could set up teams to develop partnerships (for instance, Becton, Dickinson and Co. has a global health team for this) and collaborate with funders and implementation partners to increase their market shares while simultaneously improving India’s health outcomes. The vast geographies of the country make it difficult to have a skilled workforce in smaller cities. This provides the ideal opportunity for enhancing collaboration – a shared workforce for smaller cities with a focus on improving patient outcomes.

Improvements to the regulatory framework Regulations play a key role in ensuring that the objectives of Universal Health Care (UHC) are met. They can also help provide an environment of innovation and growth for the industry. For the medical device industry to succeed and try to fill the critical gaps in India’s healthcare system, several external factors – a supportive regulatory framework, a supportive investment ecosystem, better health infrastructure and an expanded health insurance cover – need to come together. Here, I will pick up on what would most significantly impact med-tech manufacturers’ ability to respond to India’s healthcare needs– an appropriate regulatory framework – and discuss some of the changes that could boost the growth of the industry. The medical devices industry in India faces several

49 EXPRESS PHARMA November 1-15, 2013

cover ) regulatory challenges. Although there are over 14,000 types of medical devices (according to the Global Medical Device Nomenclature), only 22 are regulated in India. Under the Drugs and Cosmetics Act of 1940, these are regulated as drugs. This is problematic, to say the least, because medical devices are very different from drugs. In recognition of dramatic differences in diversity, industry composition, product development and patent structures, pharmaceuticals and medical devices are regulated separately across the world. India has woken up to these differences by seeking to add a chapter on medical devices to the Bill. The Drugs &

Cosmetics (Amendment) Bill 2013 that was tabled in this year’s Monsoon Session of the Rajya Sabha, recognises the industry as a distinct and crucial element in the healthcare delivery system. The Bill marks the beginning of the creation of an appropriate and robust regulatory framework for medical devices. Further, the draft provisions laid out are largely in line with standard international practices developed by the International Medical Device Regulators Forum (IMDRF). Even though it will be a while before the Bill becomes an Act, the move has infused great hope in the industry. However, there is still plenty to do. To ensure that medical devices in India meet glob-

al standards of quality, safety and efficacy, the government should ensure that all regulations are harmonised with international best practices such as the International Organisation for Standards (ISO) and IMDRF and, perhaps, adopt a risk-based approach to the regulations. Also, industry consultation will be important in the aftermath of the Bill being tabled to ensure that the interests of all stakeholders are considered. To help the industry reach its nascent potential, the government, which spends only one per cent of GDP on healthcare, a figure that is pitifully low compared to the spending of other emerging economies like Brazil and South Africa,

must increase its overall expenditure. This in turn would help provide training to build capacity; promote disease awareness; increase insurance coverage and government spending on healthcare; promote public-private partnerships; and create incentives for R&D. To elaborate this last point further (because the government’s role in providing an enabling ecosystem for innovation cannot be emphasised enough) the government needs to give companies adequate incentives to make products for India. At the same time of course, companies need to approach the Indian market differently and consider India’s unique needs in terms of access

and affordability. The medical devices industry in India is poised for growth. As India’s burden of disease transitions from communicable to noncommunicable diseases, driven by socio-economic advancements, medical devices will play a critical role in helping the government diagnose and manage these. However, for the industry to make this quantum leap, the industry itself needs to innovate and collaborate, while the government has to create a conducive environment. With inputs from Gautam Khanna, the Executive Director of 3M and Sushobhan Dasgupta Dasgupta, Managing Director of Johnson & Johnson Medical India

Trapped within the mental constructs of the nominal innovation model, the pharmaceutical industry is not able to harness the tools innovative life science companies are providing to the market. It is now time to migrate to disruptive innovation, says T NICHOLAS MITCHELL, Managing Director, Phenomenex India

Migration to a disruptive innovation model

here is a primary research and development model that for decades, we as professionals in life sciences, pharmaceuticals, and biotechnology companies typically pursue, namely the nominal advancement model of innovation. The nominal advancement model is well known; it takes an

50 EXPRESS PHARMA November 1-15, 2013

existing technology and measures the parameters that afford the product’s benefits. Then it considers incremental advancements or improvements to some or all of these parameters, and projects the measured increase to the product benefits. The associated costs for these improvements are formalised, and the feasibil-

ity of accomplishing the advancement is predicted to determine the level of risk associated with the potential decision to go ahead with the advancement. Upon a successful debate within management, the development proceeds. Throughout the lifecycle of the nominal advancement model, there can be ‘breakthrough

innovation steps’ which allow the product to take a major leap ahead, but in a study over time, a relatively linear curve is still realised for the advancements. Take, for example, the development of a new processor for standard desktop PC. The graph on Moore’s Law (Figure 1) illustrates how PC

technology has advanced over the last 40 years. Moore’s Law clearly indicates the nominal advancement model in action (http://www.planetfuture.info/en g/e_index.htm). The associated performance improvement curves relate to the speed of the device, the amount of memory/storage the device contains,

(

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Figure 1

and the relative amount of space (foot print) required for the device. All of these parameters are marginally improved (or improved 1x, 2x, etc.) in each successive generation. The proportionally expanding customer base for the products appreciates the advancements and typically accepts a similar incremental increase in the price based on the new value. A primary example of this type of innovation for Phenomenex and the HPLC column industry has been the progression of the spherical silica base material to smaller and smaller particle sizes over the last four decades. Starting in the 1970’s and early 1980’s with particle sizes of 15-20 micron, over the 40 years that the products have been available the charted migration to ‘sub-2 micron’ particles has moved the performance of the commercially available tools to increasing levels of performance, similar to that of the improvements of the microprocessors within the computer industry across the same timeline. This migration to smaller particle sizes has led to the increase in efficiency (N, or theoretical plates per meter), the major parameter measured by column manufacturing companies and our customers, to indicate the level of performance the column is achieving (Figure 2). A higher efficiency value means many benefits for the chromatographer, the primary two being higher sensitivity (detecting lower quantities more accurately) and faster run times, increasing laboratory throughput and decreasing turnaround times for analysis. Accordingly, the user base has also expanded from being a technology used primarily by analytical chemists to finding its way throughout a variety of laboratories in the pharma development process, including formulations, process chemistry, and drug metabolism and clinical trials segments (often outsourced today

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As liquid chromatography proceeds through its fifth decade of commercial existence, let us consider a newer model, disruptive innovation, to more rapidly advance our progress and change our present paradigm. According to Harvard Professor Clayton Christensen, ‘Disruptive innovation’ transforms a product that was historically so expensive and complicated that only a few people with a lot of money and/or a lot of skill had access to the technology; a disruptive innovation makes it more affordable and accessible, that a much larger population have access to it (Clayton Christensen; http://www.claytonchristensen.c om/key-concepts/). Disruptive innovation is typically reserved for larger market sectors, such as the IT or telecommunications. But, one globally recognised disrup-

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tive innovator comes from right here in India, namely Tata’s Nano automobile. (Figure 3: Taken from: http://mashable.com/2011/10/09/ 7-disruptive-innovations/) The major barrier to this model in our industry is the sharing of knowledge across the supplier-customer-regulatory interfaces. While the pharma and biotech pharma companies must keep their research efforts confidential to protect their position in the most competitive of markets, openness to collaboration with your life science partners like Phenomenex can afford an entire new rate of innovation.

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Additionally, the subsequent acceptance of these new innovations by the regulatory agencies that govern our testing environments will require a collaborative presentation of the developments to assure these groups there has been absolutely no compromise to the quality of the results delivered by these new testing methods. Today there are two major platforms within the analytical chromatography arena that are not being utilised in many cases to even 25 per cent of the capacity for which they were originally designed – namely Ultra High Performance Liquid

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Chromatography (UHPLC) and Supercritical Fluid Chromatography (SFC). Why? Perhaps it’s because we are trapped within the mental constructs of the nominal innovation model? Perhaps it’s because at the intersection between the science and the business of the science some of the most effective communicators are not taking the time to consider the advantages of a disruptive model and subsequently developing better game plans for educating the masses on both sides of the equation? Whatever the reason, now is the time to move beyond these barriers and

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cover ) Figure 3

begin making more substantial progress with the tools the most innovative life science companies are providing to the market. One of the technologies that Phenomenex has introduced to be used within these two instrument platforms is our Kinetex Core-shell Technology. Using sol-gel processing techniques that incorporate nano-structuring technology, a durable, homogeneous porous shell is grown on a solid silica core to create a core-shell particle. This particle morphology results in less band broadening compared to fully porous particles and thus delivers extremely high efficiencies (http://www.phenomenex.com/Kinetex/CoreShell Technology). At present, neither of these two platforms, nor these incredibly advanced consumable technologies that are incorporated into them may be considered disruptive innovation as defined by Christensen. Disruptive innovation challenge in pharma / life sciences in India ● The time is now to realise a disruptive innovation within our industry. In order to achieve this innovation, three things have to happen: Common goals and incentives must unite us ● Lowering the cost of global healthcare ● Lowering the cost of R&D as a percentage of pharma expenditure ● Offering awards and recognition to those organisations that significantly advance the initiatives of the challenge Scientists must have better platforms to communicate ● Develop forums where these collaborations can be regularly pursued and tracked ● Develop on-line technologies to facilitate more interactions and exchanges Government agencies need to offer their support and commitment

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● Approval

processes incorporating these new technologies need to be passed through the regulatory hurdles with little or no delay, perhaps even expedited when possible to show the global governments’ commitment to these initiatives.

Figure 4

O=C=O

Metrics for success The emerging testing markets here in India and in some of the impoverished nations surrounding us will be the measurement for success. When food testing and environmental testing laboratories that cannot currently afford our state-of-the-art technologies for their testing requirements are capable of outfitting their laboratories with our products, then we will realise as a scientific community that we can count this accomplishment as one of our successes. Phenomenex India is doing our part to assure these strategies for success. At present, we

are working more closely with our customers than we ever have before, sharing information about the research and development of our product technologies and interfacing with our customers technically in a number of different ways: Phenomenex seminars are being conducted in India by US-based research and development scientists for a number of our product technologies that are based on the core-shell technology. We are regularly presenting detailed specifications about the development of

the products, and we are encouraging our clients to further intensify their use of these technologies in their laboratories. Phenomenex deminars are being conducted within the laboratories of some of our closest clients, to challenge the limits of conventional thinking by working side by side and pushing these clients to move out of their comfort zone of standard method development parameters and enter a new age of lightning fast analyses. Phenologix is full-service

analytical support laboratory within Phenomenex that specialises in method development and optimisation. Here, we bring your most aggressive challenges back to our laboratory and develop methods to specifications agreed upon in advance, and with our commitment to be as efficient and reproducible as possible. Phenomenex India Management is working closely with Confederation of Indian Industry (CII) and the Life Sciences Panel of Andhra Pradesh, as well as Indian Analytical Instruments Association (IAIA) on a number of initiatives that we hope will begin educating the young workforce just now coming into the laboratories of Indian pharma and biotechnology companies to empower them to promote these changes to the research and development processes established within the industry today.

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PRVS VARMA, Country Manager, Retsch India speaks on the trend to have small samples with controlled particle size and how companies can strategise to meet this market need

Bigger is not better – Sample preparation in pharma industry

n the analysis of solid material, the popular adage that ‘bigger is better’ certainly does not apply. The goal is to produce particles that are sufficiently small to satisfy the requirements of the analysis while ensuring that the final sample accurately represents the original material. The ‘particles’ of interest to the analyst generally range from 10μm to 2mm. Additionally there are many applications, where even finer sizes are needed. One example is active ingredients, where it is necessary to grind in the submicron range. Finally for DNA or RNA extraction mechanical cell lysis is well-established. Materials differ widely in their composition and physical properties. Hence, there are many different grinding principles that can be applied, and this, together with other variables such as initial feed or ‘lump’ size, fineness needed and amount of sample available, results in a wide range of models available to the researcher. Some grinding processes may require aids that will help the size reduction process while

at the same time, leave the material uncontaminated or unaltered in any way. The most common example of such an aid is that of cryogenic grinding where soft material (animal tissue/plastics) will not grind unless it is made brittle through the use of dry ice or liquid nitrogen. Finally, choosing the most appropriate mill will often require the help and support of the manufacturer. This process may include a trial test sample to help finalise the decision.

Smaller particles, finer grinding In the pharmaceutical industry the science and study of particles including their size and shape are very critical. Particle characteristics can affect many different areas including inhalation delivery systems, tablet dissolution characteristics, formulation quality and solubility or absorption. As in many industries, there is a move towards smaller particle sizes and therefore, there is an increasing need to grind finer and finer. The following sections address specific applications

In the pharma industry the science and study of particles including their size and shape are very critical

that are common to the pharma industry:

Animal/human tissue In order to extract DNA and RNA from mammalian tissue, the material has to be homogenised or ground as part of the procedure. Since most animal tissue, and particularly lung, liver and mus-

cle, is soft at room temperature and also susceptible to damage due to the heat naturally generated during the grinding process, it is necessary to chill the material in liquid nitrogen prior to or during grinding. Cryogenic mills or small mixer mills are ideal for this since the grinding vessel, complete with material and media, is either permanently cooled in LN2 during grinding (for example, in the Retsch’s Cryo Mill) or can be completely immersed in liquid nitrogen prior to the process. The powerful grinding action will result in complete homogenisation before the sample has had a chance to warm up. This method also can be applied to some of the harder tissues, such as bone or cartilage, as well as plant material.

but at the same time, the jar rotates on its own axis in the opposite direction to the ‘system’ rotation. This generates very high milling energy resulting in fast reduction to very small sizes. Single micron and sub–micron sizes can be achieved through wet milling, usually in alcohol, and dry milling is used when the size reduction demands are not as high. Grinding jars are available in a number of different sizes and materials, the latter being necessary to avoid contamination from heavy metals, for example, during the grinding process. The smaller mixer mills mentioned above can also be used for size reduction of active ingredients and are particularly useful when small sample amounts are available or the material requires prechilling prior to grinding.

Active ingredients Active ingredients in the sub-micron range can be achieved by Retsch’s planetary ball milling where the material is processed in a jar using grinding media made of the same material as the jar. In a similar manner to the solar system, the mill rotates the jar on a turntable

Finished products In the pharma industry, finished products often exist as tablets or capsules and these bring their own sets of challenges when it comes to grinding. Classical size reduction techniques involve methods such as grinding the tablets in a mortar, which is

53 EXPRESS PHARMA November 1-15, 2013

cover ) both time consuming and labour intensive. Grinding mills can do the job in a fraction of the time; produce a much more consistent sample and free technicians for more productive tasks. The following techniques can be used for tablet grinding as well as other pharma applications: •Retsch’s mixer mills are particularly suitable for the rapid and efficient grinding of tablets and capsules. Grinding takes approximately two minutes and the use of a closed jar guarantees loss-free grinding. The process is suitable for tablets of different sizes and hardness with a capacity up to 20mL of tablets. • Retsch’s knife mills are the ideal choice for coated tablets since these will not be crushed in a mixer or ball mill due to the coating usually made of sugar or gelatin. With capacity over 100mL, such a mill is also suitable for grinding large tablets. • Retsch’s ultra-centrifugal mills have a wide range of applications. The unique grinding action makes it suitable for grinding medium to large tablets when strongly varying quantities (25mL – 5L) are required. •Retsch’s mortar mill, the mechanised version of the classic hand pestle and mortar, is well suited for tablet grinding as well as mixing and homogenisation of powders, suspensions and pastes.

Other pharma applications There are other applications that involve the production of 'particles' used in pharma and medical applications. An interesting application is the grinding of human cortical bone to produce raw materials used in various preparations for use in bone grafts and implants. The bone material is often processed in tissue banks around the country and then reprocessed in the companies who produce the final products. The process usually requires two different mills, the first of which is a cutting mill. These heavy-duty mills are designed to reduce larger pieces of bone down to sizes of a few millimetres or less. Some of the

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The importance of the pharma industry in particle technology cannot be overstated. It has been responsible for many of the advances that have occurred during the past few years

material produced by this mill can be used without additional processing but the remainder is then processed in an Ultra Centrifugal Mill such as Retsch’s ZM 200. This versatile mill will then further reduce the size of the bone pieces to the sizes needed for their intended use. The whole process is fast, efficient and has an excellent recovery rate. Both mills have designs that make cleaning easy and include many safety features to protect the users from possible injury.

Conclusion The analytical world is getting smaller both figuratively and literally. The importance of the pharma industry in particle technology cannot be overstated and, directly and indirectly, it has been responsible for many of the advances that have occurred during the past few years. In size reduction technology, there is a trend towards smaller samples that have a smaller and more controlled particle size and yet remain representative of the material being analysed. Companies must offer a selection of size reduction equipment and accessories that can meet these demands.

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Continued from Pg 38

Success strategies for pharma firms There is no serious effort in that direction. Why not? That’s not clear. However, LAZORR initiative was a pilot experiment that succeeded and could have opened up future collaborative roads that do not exist but can be co-created. In the field of growth through generics business currently, everyone is referring to the same database to do business planning for the future, pursuing the same macro business approach for growth, same or similar products, similar processes, with same set of moving professionals from one organisation to another, trying to tie-up with the same distribution channels and finally what happens, a dozen strong companies land up in the market on the day-one with the same product, when the patent expires. Not that the industry does not know about this phenomenon, but little effort is being made to avoid wasting precious resources doing the same activity that another dozen companies are doing at the same time, without any real innovation. Fortunately, there are some companies doing better than others, despite the above rat race, but, are they so differentiated in their approach that they can expect to continue doing better year after year for the next 10 years? Probably not. Have we not seen Ranbaxy, Cipla, DRL, Lupin, Wockhardt, faltering at times whether it is on the financial front, strategy front or on the credibility front. The journey of all these companies will become tougher and filled with challenges, even though some of these are or were amongst the best in the breed of Indian pharma companies. There is no single recipe that can create newer ways of ensuring sustainable profitable growth, I definitely don’t have it. There are better doctors

In the field of growth through generics business, everyone is referring to the same database to do business planning for the future, pursuing the same macro business approach for growth seated within the industry guiding healthy growth for their respective companies with their tons of experience and wisdom. But, I am sure even they must be grappling with issues like how to differentiate and grow to the next orbit in a manner that creates significantly higher new value, rather than just doing the incremental play to satisfy the investment community for quarter-onquarter or year-on-year performance. Even they feel relieved that this quarter or the year has done well but do not have much confidence about the next one’s performance. I will try to share my thoughts as to how pharma companies, divided into few categories, can create their success strategies. This aligns the possible scene ahead, resources required and the challenges to be encountered while following an approach that is just the opposite of ‘me-too’. SME API companies: Small sized companies, just generic APIs with sub-economical capacities and unintegrated with key building blocks related plays will not sustain for long. API manufacturing business necessitates handles of 3D chemistry (dirty, dangerous, demanding). For scale play of 3D, one needs high capex (capital expenditure) and high opex (operating expenditure). SMEs would find it challenging to manage and will continue to drain their resources if they continue to dabble with 3D chemistry. Way forward: Have strategic access to unique green tech-

nologies (bio-transformations, green solvents, chiral synthesis etc.) that can reduce or eliminate complexities arising out of the 3D aspects of this business. Create global capacities with credible facilities deploying unique and exclusive technologies and be a preferred source of APIs to Indian or international biggies. Such an approach would create sustainable and profitable growth. SME pharma marketing companies: Small size may be favourable initially but it soon becomes a liability. So, companies then tend to grow panIndia by recruiting large sales force and diversifying into multiple therapies or sales divisions However, soon the diversity with large size also becomes a liability; thereafter working capital, supply chain and managing the prevailing unethicality in the market place becomes a liability. But there are some success stories too, which later have graduated to large players. Current breed of large Indian pharma companies were SMEs in the last three decades of the previous millennium but the times were different then. It does not mean that new SMEs will not become future large pharma companies, many will but only those who develop and follow a business model that is relevant to the emerging scene where regulations of all kinds would be stricter and immense competition from big Indian and MNC companies would exist. Way forward: Have focused play in chosen therapies with products that are

unique and exclusive. Have international, smaller to medium companies on your side for obtaining strategic access to exclusive products, delivery systems that can address unmet needs. Be proactive in the game. Do not chase size but do chase exclusivity. Large pharma companies: Typically they are already doing well, barring some occasional financial or compliance-related hiccups. These are companies who have significant integrated play and operate a very diverse portfolio of products, diverse therapies, multiple links of the overall value-chain and have good geographical presence, directly or indirectly. These are the ones which have successfully migrated to the current orbit after having managed the challenges of being an SME in the past. But now they have a new set of challenges. The biggest is managing complexities emerging out of too much diversity. The other challenge is that they are yet to discover the growth path which would take them to the next orbit without further addition of complexity, which could be exponential in nature. Only very few large companies have a proven track record of global alliances, for e.g. Zydus (they have three 50:50 JVs running with large companies from three different continents). So, in a way, these companies want to pursue a solo journey, at least they say so. But can a solo journey give them enough energy to take their company to the next orbit of $10 billion club? The answer could be ‘Yes and No’.

Yes, if they change their course and No if they do not. Way forward: Large companies will have to implant the missing gene of working through strategic alliances and address some of the above listed blind spots. Successful alliances can happen only if the mind-set of shared risks and shared benefits are honestly implanted in the corporate DNA. Alliances could be amongst large Indian companies or it could be with global players. Imagine, entrepreneurship and vision of Sun Pharma, management bandwidth of Lupin, Zydus’ ability to partner with MNCs and some such traits of other good companies are deployed to strike appropriate alliances for creating a unique kind of fresh value in the industry. Similarly, imagine if the innovation of Japan, building blocks from China, manufacturing and development skills of India and marketing reach of global companies are put to some integrated play, what kind of fresh value can be created. Establishing credibility and trust would, however, be a very essential requirement before such alliances are struck. Such an approach may sound like an utopian thought to some but to me it sounds doable and worth exploring. Another aspect for big companies is to be focused and be the best player globally in that focused area, be it a therapy, platform, geography or combination of these. We know there are multi billion dollar companies doing business only in Opthal, Derma or other fields. Why shouldn't Indian companies follow such an approach? Fortunately, large opportunity, good track record, good capability level and desire to move on to the next orbit exist in the pharma industry and appropriate success strategies will continue to evolve for even happier times ahead.

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RESEARCH RESEARCH UPDATE

Regeneron,Sanofi drug slashes cholesterol in late-stage trial It has been touted by industry analysts as a potential blockbuster that could bring annual sales of over $3 billion

New York/Paris A NEW type of cholesterol drug from Regeneron Pharmaceuticals and Sanofi, when used by itself, cut levels of 'bad' LDL cholesterol almost in half in the first of a dozen late-stage trials of the medicine. The injectable drug, called alirocumab, is from a promising new class of medicines called PCSK9 inhibitors also being developed by Amgen and other drugmakers. It has been touted by industry analysts as a potential blockbuster that could bring annual sales of over $3 billion. These man-made antibodies block a protein that prevents the body from eliminating LDL cholesterol from the bloodstream and offer a new way of fighting the build-up of artery-clogging fatty deposits that put patients at risk of heart attacks. They work differently from widely-used statins - pills that inhibit the liver's production of LDL cholesterol in the first place, and to which some patients don't respond well. In earlier mid-stage studies, when combined with statins, alirocumab and Amgen's own PCSK9 drug cut levels of LDL cholesterol by close to 70 per cent, more than statins alone. But the phase III study unveiled involved patients who either took just alirocumab, or just Merck & Co's cholesterol drug Zetia (ezetimibe) - a pill often used by patients who cannot tolerate statins, whose side effects can include muscle pain. In

56 EXPRESS PHARMA November 1-15, 2013

this 103-patient study, alirocumab, which has to be self-injected every two weeks, reduced levels of LDL cholesterol by 47.2 per cent after 24 weeks of treatment, compared to 15.6 per cent in those taking daily 10-milligram doses of ezetimibe. "What we're seeing in the first phase III trial of our drug is in line with what we saw in phase II," George Yancopoulos, Research Chief, Regeneron, said. Patients taking alirocumab started out with a low 75-milligram dose every two weeks, but this was increased to 150 milligrams at week 12 if their LDL levels at week eight were above 70. Most patients, however, remained on the low dose throughout the study because

they got their LDL levels below that threshold - an aggressive LDL target - by the eighth week. "It shows that a low dose, when used as a monotherapy, can be quite effective," Yancopoulos said, noting that no worrisome side effects were seen in the study nor in earlier trials. Citi analyst Andrew Baum said the monotherapy data was "incrementally positive" but further trials on targeted patient groups, such as patients with high cardiovascular risk, were needed to really assess the drug's utility. Patients in the so-called Odyssey Mono trial had high cholesterol levels but were deemed to have only moderate

cardiovascular risk due to the absence of many other risk factors. The Odyssey Mono study is the first of 12 phase III trials on some 23,000 patients and the drug's ultimate success will depend on longer-term studies, some of which will only give results in around five years. But Sanofi and Regeneron are hoping positive trial data could be enough to get the drug approved for some patients and on the market before then. PCSK9 drugs are mainly aimed at the millions of people who either cannot tolerate statins such as Pfizerâ&#x20AC;&#x2122;s Lipitor or AstraZeneca Crestor or who cannot get their cholesterol levels under control with statins alone. Yancopoulos said Regeneron and Sanofi hope to seek regulatory approvals by late 2015 for their drug, for use by itself and with statins. Yancopoulos said Amgen's rival drug might reach market soon after alirocumab, or even before. But he predicted neither drug would have much of an advantage by getting approved first. "But we're hoping to have bragging rights for the first approval," Yancopoulos said. At an investor conference last month, Chris Viehbacher, Chief Executive Officer, Sanofi, said the drugmaker could look at nearly doubling its stake in Regeneron, voicing confidence in the drug's success. Sanofi holds about 16 per cent of Regeneron. Reuters

US FDA probes Ariadâ&#x20AC;&#x2122;s cancer drug THE US Food and Drug Administration (US FDA) is investigating an increasing number of reports of serious and lifethreatening adverse events in patients taking Ariad Pharmaceuticalâ&#x20AC;&#x2122;s leukaemia drug, Iclusig. In a safety notice posted on its website, the regulator advised patients taking Iclusig to seek immediate medical attention if they experience symptoms suggesting a heart attack. The notice comes after Ariad disclosed that the US FDA asked the company to stop enrolling patients in clinical trials of Iclusig. The agency had identified a number of patients who had experienced blood clots and heart damage after taking the drug. Iclusig was approved by the US FDA in December 2012 to treat adults with two rare types of blood cancers chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia. The drug's label contains information about the risks of blood clots. The company is testing the drug in seven mid-stage studies for lung cancer, thyroid cancer and another form of blood cancer. Reuters

RESEARCH

Gilead drug works against leukaemia Idelalisib is part of a new class of medications designed to selectively block a type of protein known to promote tumour growth in certain types of blood cancer A PIVOTAL trial of Gilead Sciences drug idelalisib has been stopped early after independent monitors determined that the drug was shown to be effective against leukaemia. The phase-III trial compared treatment with idelalisib and another drug, Rituxan, to treatment with Rituxan alone in patients with chronic lymphocytic leukaemia who were not eligible for treatment with chemotherapy. Idelalisib is part of a new class of medications designed to selectively block a type of protein known to promote tumour growth in certain types of blood cancer. Gilead said an interim analysis by the Data Monitoring Committee overseeing the trial found that the drug had a significant impact on the length of time patients survived without their disease getting worse. Gilead said it is discussing the trial results, and a potential regulatory filing, with the US Food and Drug Administration. The company filed last month for FDA approval of the drug as a treatment for non-Hodgkinâ&#x20AC;&#x2122;s

Genmab announces positive results for sclerosis drug candidate Copenhagen

lymphoma. Idelalisib patients in the recently stopped trial will continue receiving the drug, while others will be offered the option of switching to

the experimental pill, Gilead said. Gilead, which has dominated the market for HIV drugs and is vying for a lead position in therapies for hepatitis

C, is testing idelalisib as a treatment for a number of different blood cancers.

DANISH BIOTECH firm Genmab announced positive results from a phase II study of its sclerosis drug candidate ofatumumab. In a randomised study of 232 patients with relapsing remitting multiple sclerosis, treatment with ofatumumab significantly reduced the cumulative number of new brain lesions, the company said. Relapsing-remitting multiple sclerosis is the most common form of multiple sclerosis, which is an inflammatory disease of the central nervous system. Ofatumumab is being developed under a co-development and commercialisation agreement between Genmab and Britainâ&#x20AC;&#x2122;s GlaxoSmithKline. Ofatumumab is sold under the name Arzerra for the treatment of blood cancer.

Reuters

Novartis drug reduces itch of severe chronic hives The drug was nearly twice as effective versus a placebo in improving life quality within 12 weeks of treatment Zurich ACCORDING TO a late-stage study, Swiss-drugmaker Novartis said its drug omalizumab was almost doubly effective in improving quality of life for patients with a severe form of hives. The third and final late-

stage study of omalizumab for treating the skin disease chronic spontaneous urticaria (CSU) found the drug was nearly twice as effective versus a placebo in improving life quality within 12 weeks of treatment, while also significantly reducing itch and hives caused by the

condition. Novartis said it had filed applications for the approval of omalizumab for treating patients with CSU to the US and European Union health authorities in the third quarter. Reuters

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RESEARCH

FDAapproves Baxter’s intravenous nutritional supplement Clinolipid is an injectable source of calories and essential fatty acids designed for adults who cannot eat or drink THE US Food and Drug Administration (US FDA) has approved Baxter International nutritional supplement Clinolipid, moving quickly to alleviate a drug shortage. Clinolipid is an injectable source of calories and essential fatty acids designed for adults who cannot eat or drink. It contains a mixture of refined olive and soybean oils. “The FDA has been concerned about the short supply of injectable lipid emulsion products,” said Dr Donna Griebel, Director of the agency’s gastroenterology division. “Today's approval will help

in the effort to resolve this shortage.” Clinolipid was compared in tests with soybean oil-based lipid emulsions. The agency said the omega-3 to omega-6 fatty acid ratio in Clinolipid has not been shown to improve patient outcomes more than other lipid emulsions. The most common side effects of Clinolipid include nausea and vomiting, excess fat in the blood, high blood sugar, low levels of protein in the blood and abnormal liver function tests. The product is not approved for use in children. Reuters

Mercksees long-term growth in cancer drug Erbitux Erbitux accounts for about 60 per cent of colorectal cancer cases Darmstadt, Germany

GERMAN HEALTHCARE company Merck expects to get a long-term boost from study results in June that showed its main cancer drug Erbitux has an edge over rival product Avastin. Erbitux, which accounted for roughly eight per cent of Merck's 10.7 billion euros ($14.6 billion) in sales last year, in June was shown to be more effective at prolonging the lives of colorectal cancer patients than Roche’s Avastin. Only patients whose tumours contain

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the non-mutated version of a gene called KRAS took part in the trial. Erbitux is only approved in this patient subgroup, which accounts for about 60 per cent of colorectal cancer cases. “We still have room to grow in colorectal cancer due

to our personalised KRASapproach,” Belen Garijo, Head of Merck’s prescription drugs division, said. She said the study results would help her marketing teams argue the case for Erbitux, which unlike Avastin, requires doctors to perform a genetic test

Only patients whose tumours contain the non-mutated version of a gene called KRAS took part in the trial

on the cancer tissue before starting therapy. Depending on the country, the testing can delay treatment by anything from a few days to one and a half weeks, making it a priority for Merck to provide support for faster testing and lab procedures, Garijo said. Merck has the marketing and development rights to Erbitux outside North America, while Bristol-Myers Squibb sells the product in North America with Eli Lilly receiving royalties. Reuters

Merck drug triggers response in 24% of lung cancer patients EARLY DATA from a small trial of Merck & Co’s experimental immunotherapy cancer drug, known as MK-3475, showed that about a quarter of lung cancer patients responded to the treatment. The antibody drug, once known as lambrolizumab, is part of a new class of compounds designed to block the activity of a receptor on immune cells called programmed death 1 or PD-1. The aim of the drugs is to spur the body's own immune system to attack cancer cells. Merck said results from 38 patients whose cancer had stopped responding to earlier rounds of treatment showed that 24 per cent had an immunesystem response to the drug. The trial also showed that 21 per cent of patients experienced tumor shrinkage. The most common side effects seen in the trial were fatigue, rash, itching and diarrhoea. Schott said Bristol-Myers Squibb Co is still leading the race to develop PD-1 drugs, with more data on nivolumab also expected at the Sydney conference. Reuters

PHARMA ALLY I N T E R V I E W

‘We will continue to be committed to India and work closely with the govt’ UPS, a supply-chain solutions provider, has expanded its Asia healthcare distribution network and aims to work with the Indian government. Lim Bee Koong, Director, Healthcare Strategy, UPS Asia Pacific reveals more about the company's plans, in an interaction with Usha Sharma

Tell us about UPS’s contribution to the Indian pharmaceutical industry? With our extensive global network and industry-leading products and services, we have been assisting the Indian healthcare businesses of all sizes to expand across AsiaPacific and globally. We have invested heavily in temperature sensitive services such as UPS Temperature True which helps maintain shipment visibility and integrity, ensuring that shipments arrive in perfect condition. Our healthcare facilities across the world, with the closest one to India located in Singapore, connects our customers to the global key markets. We expect the business to expand at strong pace with the growth of the healthcare industry in India. How big is the Indian pharma supply chain market and what is its growth rate? Pharma logistics is a big market in India. The projections for this market in India are certainly positive. According to the Business Monitor International (BMI), India is noted to be the second fastest growing market in APAC through 2020. This aligns with the findings from The UPS Pain in the (Supply) Chain survey, which reveals that India (13 per cent) is the second top market in Asia for expanding companies, just after China (27 per cent). Unlike other industry, the

pharma industry is very sensitive particularly in the supply chain. What do you have to say on this? The pharma industry is very sensitive as the integrity (or quality) of healthcare products needs to be maintained if compromised, damaged product can result in very severe consequences or even death. In fact, some healthcare products are very delicate and need to be handled with great care every step of the way. According to the latest UPS Pain in the (Supply) Chain survey, product damage and spoilage is one of the top three supply chain concerns of the healthcare executives, cited by 67 per cent of healthcare executives in Asia – versus only 38 per cent in North America and 34 per cent in Western Europe. Trade and healthcare regulations vary across the different countries throughout Asia. Increased awareness and rapid growth in the sector, especially in new therapy areas, is contributing to increased oversight and caution by the authorities. Coupled with a relatively immature transportation infrastructure, the potential for shipment delays is higher than that in the mature markets. Transportation delays, such as customs hold, could cause products to experience temperature excursions and be damaged. Healthcare companies are

cold-chain transportation and storage to safeguard product integrity. To protect these high-value products, manufacturers are looking to invest in temperature sensitive services such as UPS Temperature True solutions to maintain shipment visibility and integrity.

We expect the healthcare sector in India to grow at a strong pace with the growth in manufacture of generic medicines LIM BEE KOONG, Director,Healthcare Strategy, UPS Asia Pacific

constantly seeking appropriate solutions and technologies to ensure adequate protection and visibility to ensure supply chain efficiency. Time and temperature-sensitive products also require constant

Share the highlights of the global healthcare survey report on ‘Pain in the (Supply) Chain’. Healthcare companies in India share similar business and supply chain concerns as their peers in Asia: Top business concerns The top business concerns in Asia this year are: Increasing regulations is the top business concern, cited by 52 per cent of healthcare logistics executives in Asia; increasing competition is the second business concern at 51 per cent; healthcare reform/ changes in legislation came in third at 48 per cent; patent expiration is also a concern in Asia, as cited by 41 per cent of executives – more than in any other region of the world. Top supply chain concerns Product security is the number one supply chain concern in Asia, as cited by 76 per cent of healthcare logistics decision makers - the highest worldwide. Regulatory compliance was the second top issue, cited by 70 per cent, product damage and spoilage came in third, cited by 67 per

cent of healthcare executives in Asia – versus only 38 per cent in North America and 34 per cent in Western Europe. Executives in Asia report large gaps between their supply chain concerns and success levels in addressing concerns, signifying that new strategies and more progress are needed in these areas. Like last year, the UPS PITC survey shows that healthcare companies are still coping with the regulatory compliance, product security and cost management, underscoring the importance of continuing efforts required to implement strategic supply chain initiatives to address these issues in Asia. What are the topmost problems in the industry in Asia? How can these be solved? Product security is the number one supply chain concern in Asia, as cited by 76 per cent of healthcare logistics decision makers, the highest worldwide. This is due to the geographical dispersed nature of the region as well as infrastructure challenges in developing markets, hence the need for added measures to protect products. Healthcare companies are taking several measures to address this concern. Logistics and distribution partnerships, IT investment, shipment insurance and supply chain optimisation analysis are some of the

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PHARMA ALLY strategies companies are employing. Technology investment has also become one of the top strategies for healthcare executives in Asia, with 72 per cent planning to invest in new technologies with special focus on order management, serialisation technologies and securityspecific technologies in the next three to five years to heighten monitoring and visibility capabilities. Temperature-sensitive products also require constant cold-chain transportation and storage to safeguard product integrity. To protect these high-value products, manufacturers are looking to invest in temperature sensitive services such as UPS Temperature True solutions to maintain shipment visibility and integrity. The report survey discovered that primary concern areas are regulatory compliance, product security and cost management. According to you, which one of these needs immediate attention and why? Will these actions improve the supply chain? For the first time, product security has surpassed cost management and become the second-top global supply chain pain point. 76 per cent of the executives in Asia are concerned about product security. This is significantly more than their peers in North America (45 per cent) and Western Europe (47 per cent). This new trend is alarming and companies must start combating this issue before it is too late. Healthcare companies are taking several measures to address this concern. Logistics and distribution partnerships, IT investment, shipment insurance and supply chain optimisation analysis are some of the strategies companies are employing. Technology investment has also become one of the top strategies for healthcare executives in Asia, with 72 per

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Pharma logistics is a big market in India. The projections for this market in India are certainly positive. According to the Business Monitor International, India is noted to be the second fastest growing market in APAC through 2020 cent planning to invest in new technologies with special focus on order management, serialisation technologies and security-specific technologies in the next three to five years to heighten monitoring and visibility capabilities. It is predicted that the top three growth strategies for healthcare executives over the next five years are technology investment, global market expansion and increased use of new distribution channels. What are your strategies on these fronts to stay ahead in this competitive scenario? Healthcare is a key target growth industry for UPS and we will continue to invest in our healthcare business and network. UPS aims to deliver value to healthcare companies through a broad portfolio of specialised freight and small package transportation and distribution services in Asia and around the world. To date, our global healthcare network is made up of 41 dedicated healthcare facilities encompassing 595,000 sq m and offers services such as temperature-sensitive handling, geographic-specific regulatory compliance, monitoring and security, kitting and labelling, as well as order management. Along with our facility in Singapore, our new healthcare facilities in Hangzhou, Shanghai and Sydney have significantly expanded UPS’s Asia healthcare distribution network. The state-of-the-art facilities have industryleading technologies to maintain product safety and integrity and allow us to offer seamless, global solutions to healthcare companies looking

to expand into, transport within, and export in Asia. We are investing in our new global healthcare IT platform including enhancements to office services, warehouse, and inventory and transportation management services. We are also continuously introducing new services and will continue to invest in building out our healthcarespecific services and offerings based on evolving customer needs. Globally, pharma companies are optimistic about the economy even during the downturn. Which countries do you prefer as an investment destination? Healthcare executives are optimistic about the economy and 74 per cent are planning to expand their businesses globally in the next five years, according to the latest PITC survey. The survey also reveals that the top markets for expansion over the next 18 months are China, the US, Brazil and India. While this trend is mirrored in Asia, especially expansions into China and India which are the two largest growing markets of the middle class and of the healthcare industry, the US remains a priority market for the most number of companies surveyed. India is facing issues due to lack of infrastructure in the pharma and healthcare industry. Moreover, there is a lot happening on the regulatory front of these sectors as well. What suggestions do you want to put forth to the Government for a better supply chain and regulatory system in India? At UPS, we move about two per cent of the world’s GDP on

any given day. We operate in over 220 countries and territories and work closely with the governments in the markets that we operate to ensure we best serve the country and its companies through our industry leading products and services, such as UPS Temperature True solutions. While we are not in the position to comment on the India government’s policies and plans, we will continue to be committed to the country and work closely with the government to further the supply chain industry in India. Which compliance issues are the Indian pharma industry facing and how can these be overcome? Regulatory compliance was the second top issue, cited by 70 per cent of the healthcare executives in Asia, according to the latest PITC survey. It is imperative for healthcare companies around the world to continually increase their standards and getting ahead of evolving regulations in anticipation of regulatory changes. It is critical for all healthcare companies to employ best practices, especially in areas of sourcing, manufacturing and sale of healthcare products. Partnerships with third parties became a strategic move that allows companies to assist them with expertise in relevant areas while they focus on their core business. What suggestions would you like to give for better compliance system in the Indian pharma industry? It is imperative for healthcare companies to continually increase their standards in anticipation of

regulatory changes that may impact the sourcing, manufacturing, or sale of healthcare products. UPS has a dedicated team of healthcare logistics professionals in Asia which includes operations specialists, information technology professionals, control tower staff, solutions engineers and quality assurance experts who ensure the entire supply chain is managed with strict adherence to global, regional and local healthcare regulations. As part of UPS’s commitment to our customers, we provide solutions to help meet the rapidly changing needs of pharma companies today. We work very closely with our customers on strategies that ensure products are delivered to patients in the most appropriate and time efficient manner. Our approach is to provide logistics services for healthcare products across the supply chain to help our customers grow in key markets, while providing them with seamless connectivity and quality service. How promising is the future of the Indian pharma supply chain industry? As mentioned earlier, pharma logistics is a big market in India. The projections for this market in India are certainly positive. We expect the healthcare sector in India to grow at a strong pace with the growth in manufacture of generic medicines along with increased consumption of healthcare services in the country. u.sharma@expressindia.com

PHARMA ALLY VENDOR NEWS

FDA APPROVED TESTING LABORATORY (L-R) Wulff Niedner, Director of HPLC Marketing, Thermo Fisher Scientific; Andreas Premstaller, Head, Sandoz Pharmaceuticals Schaftenau production site; Prof Christian Huber, Head, new Doppler Laboratory; Alain Guiller, Vice President of Global Sales, Life Science Mass Spectrometry, Thermo Fisher and Kornelia Weidemann, Europe Commercial General Manager, Thermofisher

Biosimilar characterisation R&D facility opens in Austria University of Salzburg, Sandoz and Thermo Fisher Scientific collaborate to advance protein-based pharmaceutical development THE CHRISTIAN Doppler Laboratory for Biosimilar Characterisation has opened at the Paris-Lodron University of Salzburg, and scientists there have commenced developing new methods for characterising proteins to be used in biopharmaceuticals. The new facility, cofunded by the Austrian Federal Ministry of Economy, Family and Youth, as well as the County of Salzburg through the Christian Doppler Society, was established to develop and transfer to practice novel and more efficient methods to characterise the active ingredients in protein-based medicines. Scientists from University of Salzburg, Sandoz Pharmaceuticals and Thermo Fisher Scientific are collaborating in these efforts. “The more physical, chemical and biological data we can obtain for proteinbased drugs, the more certain we can be that they will produce the desired effects and will not produce unexpected adverse effects,” explained Christian Huber, Head of the new Christian Doppler lab. “Here, we are joining expertise in protein production and characterisation, structural biology and synthetic chemistry at the

University of Salzburg to develop innovative characterisation tools to determine the efficacy and safety of protein-based medicines,” he added. “As the leader in protein characterisation technology, we are confident that we will make a significant technical contribution to the detailed analysis of biosimilars and their quality control,” observed Dr Alain Guiller, Vice President of Global Sales, Life Science Mass Spectrometry (LC-MS), Thermo Fisher Scientific. “This is a rapidly-developing field, and this close cooperation with the University of Salzburg and Sandoz will increase our understanding and help us to serve the emerging needs of the pharma industry. Thermo Fisher’s participation will focus on providing expertise for applying Orbitrap-based LC-MS technology, nano-UHPLC (ultra highperfomance liquid chromatography) systems and columns, and software to future workflows for protein-based drug characterization and quality control.

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61 EXPRESS PHARMA November 1-15, 2013

PHARMA ALLY

Quintiles,Novartis in 2013 World’s Best Multinational Workplaces list To qualify, companies must have at least 5,000 employees worldwide and count at least 40 per cent of their global workforce outside the company's home country QUINTILES AT the 18th place and Novartis at the 25th are the only two companies from the lifesciences industry segment to make it to the World’s Best Multinational Workplaces list this year. Quintiles has been named to the Best Multinational Workplace list in each of the ranking’s three years of existence. To qualify for the World’s Best Multinational Workplaces List, companies must have been selected for at least five national ‘Great Place to Work ‘ lists, have at least 5,000 employees worldwide and count at least 40 per cent of their

The list measures workplaces through five dimensions: credibility, respect and fairness (attributes of trust), as well as pride and camaraderie global workforce outside of the company’s home country. Quintiles received individual Great Place to Work awards in 2013 for its operations in Canada, Germany, Ireland, Italy, Mexico, the Netherlands, Scotland, Spain and the UK.

Novartis qualified for the Top 25 World's Best Multinational Workplaces as a result of being included in 11 Great Place to Work lists in Argentina, Brazil, Chile, Colombia, Ecuador, Germany, Greece, Mexico, Portugal,

Spain and Venezuela. The list measures workplaces through five dimensions: credibility, respect and fairness (attributes of trust), as well as pride and camaraderie. Novartis ranked highly on the pride associates take in their work, their teams and the organisation. The company also scored well for its credibility and camaraderie among employees. Overall, Novartis received a high score on the Trust Index, which measures employee perceptions of their workplace.

mercial stage, with the ability to switch easily between initial nebulised products (i.e. a low cost entry to early clinical trials) and dry powder inhalers for use in later clinical trials. This flexible on-site approach also means that the company can reduce time to market with 24/7 capabilities, which has allowed the company to deliver on every client clinical date. Ian Lafferty, Site Director for Aesica Nottingham, commented, “Inhalation is a rapidly growing market with many US companies looking to bring NCE production to Europe, whilst we also see a dramatic growth for products going into China and SE Asia, particularly amongst generic formulations.” EP News Bureau-Mumbai

EP News Bureau-Mumbai

To increase its range of inhalation services and products

62 EXPRESS PHARMA November 1-15, 2013

niques delivered through a partnership with Upperton, and a powder filling technology delivered through 3P’s Fill2Weight. The plan marks a systemic shift in the wider market with clients now looking for CDMOs to have a wider range of development technologies, delivery expertise and the ability to take a project right through to commercialisation. Another key factor in the company’s growth within this market has been the adoption of non-IP protected products, which enables Aesica to concentrate with the client on developing the right formulation irrespective of delivery mechanism. These new technologies have provided a huge advantage to customers in terms of lowering costs, particularly for

re-formulations of generic products, whereby the cost of set-up is highly prohibitive to new market entrants and this is forecast to be a rapidly expanding sector. Building on these successes Aesica is researching both internally and externally for new innovations in formulation technologies to complement its suite of services and it envisages opening a new inhalation lead technical centre by the end of 2014. The Nottingham site currently has over five years’ experience developing new generic inhalation products alongside many new chemical entities (NCE) for trial. Aesica is increasingly looking to work with clients over the longer term and is concentrating on taking new drug targets right through to com-

Will focus on training and market support throughout Europe IMCD GROUP has significantly expanded its laboratory capability with the addition of a new pharma laboratory in Huerth (near Cologne), Germany. This new space totals over 120 sq m of laboratory, office and conference facilities. The IMCD Pharmaceutical Technical Centre (PTC) will focus on training and market support throughout Europe. By the end of the year the PTC will be equipped to support activities for solid-dose development, tablet-coating and the development of suspensions and syrups. Dr Alen Guy, Technical Director, IMCD Pharma says, “This laboratory is a substantial investment in IMCD’s capabilities and provision of essential service to its many customers. Strategically located in Europe, this laboratory allows us to greatly enhance our internal training and technical support for the rapidly expanding number of projects we are involved with.” Significantly, IMCD has established a true IMCD Technical Centre in Europe alongside the Coatings laboratory, quality control laboratory and sampling centre already located on the same premises. This will allow the Group to maximise scientific resources and create a solid technical interaction across the company. It is the eighteenth laboratory for IMCD, following six laboratories in coatings, six in personal care and five in IMCD’s food and nutrition business groups.

Aesica plans to open lead technical centre AESICA, THE global contract development and manufacturing organisation (CDMO), has announced its intention to increase its range of inhalation services and products in development, with a new lead technical centre also envisaged in the near future. A key part of this inhalation drive has been the company’s focus on the intake of skilled staff, coupled with the commercial development of several leading inhalation technologies and the company is actively partnering with other innovative companies and universities to discover and engineer new technologies for commercial applications. Aesica currently has two new development technologies available to clients, including spray drying tech-

IMCD Group opens its first pharma lab

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PHARMA LIFE AWARDS

ABLE,Dept of Biotechnology conducts 5th edition of BESTawards in Bangalore 149 teams vied for top honours with 20 of them travelling to the Biotech Capital of India THE Association of Biotechnology Led Enterprises (ABLE) recently conducted its 5th edition of Biotechnology Entrepreneurship Student Team (BEST) event, in collaboration with the Department of Biotechnology in Bangalore. The event witnessed 149 teams vying for top honours with 20 of them travelling to the Biotech Capital of India. Five teams succeeded in bagging the three top spots out of the 20. With their innovative glucose sensor the youngest team (average age of less than 22 years) from IIT Madras was declared the top team whereas the teams from IISc and Centre for Converging Technologies CCT, University of Rajasthan and Amity Institute of Pharmacy, Noida combo team were joint second. Stanford India BioDesign Center, AIIMS- New Delhi and ICT Mumbai bagged the joint third. The top five teams will attend ABLE's BioInvest Conference to present their business plans to venture capitalists, private equity fund managers and other investors. Dr PM Murali, President, ABLE said, “This was the essence of young Indian entrepreneurs’ innovative thinking. Some of us who were part of the jury felt absolutely thrilled to be associated with this programme. Ultimately, we are beginning to realise that Indian science is in the capable hands of these youngsters. We are thankful to the Department of Biotechnology, Ministry of Science & Technology for their continued support and encouragement in conducting the BEST programme.” After two

IIT Chennai's team bagged first prize for an innovative glucose sensor

The Stanford India Biodesign, AIIMS team won the joint third place for designing a wearable smart hand sanitiser for healthcare professionals

The IISc, Bangalore team won the second place for its project on highly sensitive optical detection of malaria pigments for malaria detection

Institute of Chemical Technology, Mumbai bagged the joint third place for its project on dual stent therapy for tumour targeting and capturing circulating tumour cell as a novel approach to prevent metastasis

and a half days of mentoring and interacting with company heads like Kiran M Shaw, Managing Director, Biocon, Anand Anandkumar, Managing Director, CellWorks, Sohang Chatterjee, Chief Executive Officer, Theramyt Biologicals, Deepanwita Chattopadhaya, Managing Director, IKP and others, over 90 students from 20 teams presented their case to a jury of six hardcore professionals. Each team had 20 minutes to prove the scientific and business merit of their idea or product. EP News Bureau - Mumbai

The top five teams will attend ABLE's BioInvest Conference to present their business plans

The comb team from Centre for Converging Technologies, University of Rajasthan and Amity Institute of Pharmacy,Noida bagged a joint second prize for coming up with a diagnostic kit for the early stage detection of female breast cancer by a simple blood test

85 EXPRESS PHARMA November 1-15, 2013

PHARMA LIFE AWARDS

Jubilant Life Sciences wins SupplyChain Excellence Award Accreditation recognises Jubilant Life Sciences as a company practicing manufacturing supply chain best practices in the chemical sector JUBILANT Life Sciences has been declared winner of ‘Supply Chain Excellence Award’ at the recently held 7th Express, Logistics & Supply Chain Conclave 2013 in Mumbai. The award recognises Jubilant’s significant achievements realised in the chemical supply chain category. Amongst the nominees, in this

category, were Tata Chemicals, BASF India, Clariant Chemicals, United Phosphorous, Linde India and Rallis India. “The award is a testimony of our robust processes and systems that are streamlined and integrated to appropriately include our customer expectations. The award became possi-

(L-R) Andrew J Clark, Managing Director, Logistics Help, Dr DY Patil, Director, Bharati Vidyapeeth and Manoj Soni, President, Supply Chain, Jubilant Life Sciences

ble owing to our collaborative model and I attribute this award to the entire team at Jubilant Life Sciences,” said Shyam Bang,

Executive Director, Manufacturing & Supply Chain, Jubilant Life Sciences. This is the seventh year that

the Awards were conducted and every nomination was researched and evaluated by the research partner ‘Leapridge Consultants.’ Dignitaries present on the occasion were Andrew J Clark, Managing Director, Logistics Help and Dr DY Patil, Director, Bharati Vidyapeeth's Institute of Management Studies & Research. The award was received by Manoj Soni, President, Supply Chain, Jubilant Life Sciences on behalf of the company. EP News Bureau - Mumbai

CAMPUS BEAT

VES organises national symposium 150 delegates comprising students, academicians and pharma industry people attended VIVEKANAND Education Society (VES), Mumbai recently celebrated its 50 years of existence in the field of education. In continuation with the Golden Jubilee celebrations VES College of Pharmacy organised a two-day national symposium on ‘Innovative Frontiers in Green Chemistry.’ . The symposium was attended by as many as 150 delegates consisting of students, academicians and pharma industry people. Speakers of national and international repute presented their lectures on various aspects of green chemistry which included fundamentals of green chemistry and its principles, methods for safer chemical processes and green analytical techniques, reduction of hazardous chemical wastes, and microwave assisted chemical syntheses etc.

86 EXPRESS PHARMA November 1-15, 2013

The symposium was inaugurated by Prof BP Bandgar, Ex-Vice Chancellor of Solapur University, who was also the keynote speaker. The symposium included scientific sessions by Dr Sanjay Poman, Business Development Manager, Merck Millipore, Dr Kushal Manudhane, Senior Scientist, Dr Reddys Laboratory, Hyderabad, Dr Rakesh R Somani, Associate Professor in Pharmaceutical

Chemistry, VES College of Pharmacy, Prof SH Bhosale, Professor in Pharmaceutical Chemistry, Poona College of Pharmacy, Pune, Prof KS Jain, Principal, Jondhale college of Pharmacy, Asangaon, Dr SS Dhage, Former Deputy Director, NEERI, Mumbai, Dr BB Shingate, Assistant Professor, Department of Chemistry, Dr BAMU, Aurangabad and Prof Vijay Khanna, Head, Organic

and Drug Chemistry, Ahmednagar College, Ahmednagar. It also included poster presentations from delegates. A total of 25 posters were presented based on the theme of the symposium. Principal of the college and symposium convener, Dr Supriya S Shidhaye welcomed the guests and thanked the speakers for sharing their knowledge and experience. Dr Rakesh Somani, Associ-

ate Professor and HOD, Dept of Pharmaceutical Chemistry, was the symposium co-convener. The inaugural programme was attended by BL Boolani, the Founder Trustee and Trustee In-charge of the college. He appreciated the efforts taken by the college for such initiatives. The organising committee, principal and the co-convener thanked the management and delegates for their support to this endeavour. The two-day symposium was successful in drawing attention of budding scientists towards emerging frontiers in green chemistry. The organising committee was highly appreciated by the delegates for their efforts in providing a platform to showcase their work and interact with eminent speakers. EP News Bureau - Mumbai

PHARMA LIFE APPOINTMENT

IPAannounces Jai Murthy joins Avantor Performance new office bearers Materials Life sciences and chemical industries veteran takes over as Vice President and Business Manager of Global Pharmaceuticals to lead global business management for manufacture and supply of high-performance chemistries

AVANTOR Performance Materials, a global manufacturer and supplier of high-performance chemistries and materials, has appointed Jai Murthy, as the Vice President and Business manager, Global Pharmaceuticals. He will work in Avantor’s pharma chemicals business unit, where he will focus on developing and executing global sales programmes, new business initiatives and expansion of the company’s presence in existing and new markets. Murthy has an extensive background and expertise in the healthcare and life science industries, including various roles in R&D, product and sales management, and strategic marketing. His work included multiple R&D roles with early-stage molecular genetics companies, as well as market development at Beckman Coulter, where he helped launch a novel IVD platform. He then joined Thermo Fisher Scientific in a global product management role and later became responsible for leading the company’s supplier strategy in Asia Pacific. While at Thermo Fisher, Murthy also served as global director for a worldwide chemicals business. Murthy earned a bachelor’s degree in biology from the University of Texas, and a doctorate in molecular and cellular biology from Harvard University. After his doctoral work, Murthy served as a visiting scientist at the MIT Center for Cancer Research. He has also co-authored publications in the areas of molecular genetics, population genetics, and human and animal genomics. EP News Bureau - Mumbai

Jai Murthy

He will focus on developing and executing global sales programmes, new business initiatives and expansion of the company’s presence in existing and new markets

Satish Reddy, DRL and Nilesh Gupta, Lupin appointed President and Vice President INDIAN Pharmaceutical Alliance (IPA) has appointed Satish Reddy, Vice Chairman and Managing Director of Dr Reddy’s Laboratories (DRL) as the President for 2013-15 and Nilesh Gupta, Managing Director, Lupin as the Vice President. Reddy steers DRL's Pharmaceutical Services & Active Ingredients (PSAI) and Global Generics businesses, two of the company’s core revenue generating streams. He joined DRL in 1993 as Executive Director responsible for manufacturing and new product development and became the Managing Director in 1997. Reddy holds a degree in chemical engineering from Osmania University, India and an MS in medicinal chemistry from Purdue University, US. He has been the executive council member of the IPA, national council member of the Confederation of Indian Industry (CII), chairman of CII National committee on Drugs and Pharmaceuticals, served as member of the board of Drugs Technical Association Board (DTAB) of India and trustee of Dr Reddy’s Foundation (DRF). Gupta joined Lupin in 1996 and has led the company's research, supply chain, manufacturing, quality and regulatory operations. A chemical engineer from the ertswhile University Department of Chemical Technology, Mumbai, and an MBA from the Wharton School, he has not only been responsible for transforming Lupin’s research programme and expanding the company’s manufacturing operations, but also been instrumental in

Satish Reddy

Nilesh Gupta

formulating and executing the core strategy that has helped Lupin emerge as a global speciality pharma major. EP News Bureau - Mumbai

87 EXPRESS PHARMA November 1-15, 2013

PHARMA LIFE NAUKRI JOB SPEAK

Hiring activity in the pharma sector dips 7 per cent in Sept ’13 over previous month Year-on-year analysis shows seven per cent increase in hiring activity in comparison to last year

THERE SEEMED to be less action in the recruitment front for the pharmaceutical sector in September 2013. What is worrying is the fact that the hiring activity in the sector has been dipping consecutively for the past two months. The Naukri Job Speak index for the sector at 1295 in September

2013 is seven per cent lower than August 2013. However, a year-on-year analysis shows a seven per cent increase in the hiring activity in September 2013 in comparison to what it was a year ago.

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tently over 60 per cent as per the Comscore data. Naukri.com is a recruitment platform that provides hiring-related services to Corporates/ recruiters, placement agencies and to job seekers in India and overseas. It offers multiple products like Resume Database Access, listings and Response Management Tools.

With 230000 jobs live at any point and over 33 million CV’s, Naukri.com serviced over 48000 corporate clients in 2012-2013. The company has over 2500 people operating through 57 offices in 36 cities in India and overseas offices in Dubai, Riyadh, Abu Dhabi and Bahrain.

JOBS FROM Naukri.com SR. MANAGER Company: Famy Care Exp: 8-12 Location: Navi Mumbai Job Id: 190913003345

BUSINESS EXECUTIVE Company: Biocon Exp: 1-3 Location: Chandigarh Job Id: 260913000562

RISK ANALYST Company: Dr. Reddys Laboratories Exp: 2-4

88 EXPRESS PHARMA November 1-15, 2013

Location: Hyderabad / Secunderabad Job Id: 060913001006

MANAGER PROCESS ENGINEERING

MANAGEMENT STAFF - SITE QA

Company: Ind Swift Laboratories Exp: 5-10 Location: Chandigarh Job Id: 300913001141

Company: Cipla Exp: 5-7 Location: Panjim Job Id: 260913002064

DGM PURCHASE Company: Wockhardt Exp: 8-13 Location: Mumbai Job Id: 270913002008

SENIOR SAS PROGRAMMER Company: Parexel International (India) Exp: 4-9 Location: Hyderabad / Secunderabad Job Id: 250913002618

SAFETY OFFICER Company: IOL Chemicals

Pharmaceuticals Exp: 2-3 Location: Barnala Job Id: 240913002808

DEPUTY MANAGER Company: Piramal Enterprises Exp: 3-7 Location: Mumbai Job Id: 300913001065

SAP SD FUNCTIONAL Company: InterBase Exp: 4-8 Location: Mumbai Job Id: 250613004390

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