Express Pharma November 16-30, 2014

VOL. 10 NO. 2 PAGES 64

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Cover Story Rising Stars Market ‘We are open for acquisitions and mergers in future’ Pharma Technology Review 16-30 NOVEMBER 2014,` 40

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CONTENTS MARKET Vol.10 No.2 NOVEMBER 16-30, 2014 Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das

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‘WE ARE OPEN FOR ACQUISITIONS AND MERGERS IN FUTURE ‘

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HILLEMAN LABORATORIES SIGNS MOU WITH BANGLADESHBASED ICDDR,B

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SANOFI PASTEUR LAUNCHES PAEDIATRIC PENTAVALENT VACCINE IN INDIA

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DIPP CONSTITUTES IPR THINK TANK

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GVK BIO SIGNS AGREEMENT TO ACQUIRE VANTA BIOSCIENCE

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FIP RELEASES OATH FOR PHARMACISTS

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

LEAP INTO THE FUTURE As newer therapies for cancer hit the market, there's a silent churn going on as diagnostic companies prepare for the future by stepping into unchartered territories | P24

Photo Editor Sandeep Patil

P17: GROWTH TRACKER

MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Sanghamitra Kumar - East Harit Mohanty - West

P19: PRE EVENT

Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Yuvaraj Murali Ajanta Sengupta PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Rohan Thakkar CIRCULATION Circulation Team Mohan Varadkar

IPM clocks `6898 crores in October 2014

PHARMA TECHNOLOGY REVIEW

66th IPC to be held in Hyderabad

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P20: POST EVENT Patients, access and innovation take centre stage

MANAGEMENT

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LACK OF SUITABLE RESOURCES LIMITING EBOLA DIAGNOSES IN WEST AFRICA: GLOBALDATA

RESEARCH

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PSORIASIS OR RHEUMATOID ARTHRITIS LINKED TO HEART RISK

OVIYA MEDSAFE LAUNCHES PHARMACOVIGILANCE CONSULTING AND DRUG SAFETY SERVICE PACKAGES

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BASF TO INCREASE PRODUCTION CAPACITY FOR TBA PLANT IN CHINA

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ELANPRO SHOWCASES BIO MEDICAL PRODUCTS AT ASTICON 2014

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

Peering into the crystal ball

A

s we discussed themes for Express Pharma’s 20th Anniversary series which kicks off with the December 1-15 issue, we were struck by the fact that many Indian pharmaceutical companies, mere toddlers in 1994, are today truly transnational. With an ever expanding global footprint and in some cases, global acquisitions, it is almost difficult to imagine the Indian pharma market without a Sun Pharma (which will be the biggest company by sales once it completes the Ranbaxy acquisition). Sun Pharma was founded in 1983 with a two-member marketing team and was listed in 11 years later, in the year that our publication, then Express Pharma Pulse, first made its appearance.

How many of today’s start ups will remain relevant a few years down the line? What are the realities of surviving in the pharma industry today? What are the business models in vogue today which have evolved in response to these challenges? Over the next year, we will profile promising companies and their leadership teams to answer some of these questions. We hope that at least some of these will be part of the next crop of winners in India’s life sciences universe. In this issue, we spotlight two companies with very different growth strategies.

Dr Rama Modali, a molecular biologist from National Institute of Health (NIH) and National Cancer Institute, founded BioServe in 1989 in Washington. It set up India operations thanks to venture funding from Ventureast and was reportedly the first company to provide DNA synthesis, DNA sequencing and related services in the country. Over 12 years of operations, BioServe India, headquartered in Hyderabad’s Genome Valley, evolved from being a molecular kit manufacturer into a state-of-the-art genomics services provider, to top Indian pharma and biotechnology companies as well as research labs and hospitals. Further proof of its worth came this August, when it was acquired by US-based Cancer Genetics. Now as Cancer Genetics India, the company is slated to evolve further along this path, offering cutting edge biomarker analysis and oncology diagnostics services. In a country where more than one million new cancer cases are diagnosed each year, there are many more companies offering similar services, so will Cancer Genetics India be able to leverage its legacy? The management is betting on labour arbitrage and

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Over the next year, we will profile promising companies and their leadership teams.We hope that at least some of these will be part of the next crop of winners in India’s life sciences universe

market demand and hoping that the use of genomics in therapy will change the way medicine is being practised in this country. There are signs that this is already happening, but will the cost of such cutting-edge services, in a predominantly out-of-pocket market, prove to be a stumbling block? The company does have a solid reputation on the research side as well, so we’ll have to wait and see.

And at the other end of the spectrum, we profile Akumentis Healthcare, just four years old but already anointed as the ‘fastest growing Indian pharma company’, rising steadily up AIOCD’s Top 50 ranks. Thanks to an aggressive sales strategy in carefully selected niche therapeutic areas, and relying completely on contract manufacturing, the company exemplifies a new breed of pharma entrepreneurs who prefer an asset-lite approach to the sector. But will this strategy suffice as it comes up against more established brands, some of them enjoying ‘heritage brands’ status? As it moves up the rankings, it is also a matter of scale: at the top of the AIOCD rankings is Abbott (including Abbott Healthcare and Novo Nordisk) which has a MAT of `5029 crores. At the 38th position, Akumentis with a MAT of `401 crores seems aeons away but as the adage goes, Rome was not built in a day.

A more serious issue is marketing ethics. With a more aggressive customer, the much maligned nexus between pharma companies and doctors is getting repeatedly exposed, on prime time TV as well as in other media. Will companies like Akumentis and its peers stay on the narrow path or devise more creative means to climb up the sales rankings? And lastly, its reliance on contract manufacturing exposes it to risks from the quality perspective. Quality issues have plagued the biggest names in the Indian pharma, the most prominent being Ranbaxy Laboratories. In early November, the US FDA revoked tentative approvals given to Ranbaxy for exclusive marketing of generic Valcyte and Nexium as the manufacturing facilities mentioned in the company's applications were later found to be non-compliant to US FDA norms.

Do write in and tell us which companies deserve to be in the next edition of ‘Rising stars’.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET I N T E R V I E W

‘We are open for acquisitions and mergers in future’ Accutest Research Laboratories India, a global Contract Research Organisation (CRO), is a leader in conducting BA/BE studies. Dr Satish Sawant, CEO, Accutest Research Laboratories India, reveals more in an exclusive interaction with Sachin Jagdale Being one of the first entrants into the Indian CRO space, how will you describe the transformation of the Indian CRO market?

India has grown leaps and bounds as a clinical research (CRO) industry and is becoming the hub of the CRO industry due to cost effective expertise available to handle all kinds of complexities and regulatory challenges, ultimately leading to successful launch of the drug product.

Indian CROs have started transforming their business models through focusing on higher value-added services and turn-around-time, moving away from basic clinical development services. They are also catering to both, multinational pharmaceutical companies as well as their Indian counterparts. Indian CROs are also exploring acquisition opportunities.

Going global offers them an extended market reach where they can offer their services to clients in multiple geographies obviating the need to work with multiple service providers. Moreover; CROs in India are today enhancing their delivery model to look beyond Indian shores.

Bioavailability (BA)/Bioequivalence (BE) has always remained a backbone of your business. Why? Accutest is a leading global CRO, offering end-to-end product development and clinical research under one roof, with an estimated market

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share of 20 per cent in BA/BE space.

Our vast experience and track record of successfully conducting challenging studies allows us take up and execute challenging studies and also, to conduct multiple studies simultaneously. Our significant global regulatory experience plays a vital role to successfully conduct BA/BE studies in alignment with specific regulatory requirements. Dedicated team of professionals liaison with the regulators and ensure the regulatory approval process is managed efficiently.

We have an unmatched track record of 62+ successful inspections from global regulatory bodies like U S Food and Drug Administration (USFDA) World Health Organisation (WHO), European Medicines Agency (EMA), Drug Controller and General of India (DCGI), The Brazilian Health Surveillance Agency (ANVISA), ISP, Medical Counseling Commettee (MCC), Ministry of Health (MOH)-Turkey, Ministry of Health (MOH)UAE, National Pharmaceutical Control Bureau (NPCB), Thai-FDA etc.

Our state-of-the-art infrastructure contributes to build an unmatched platform to tap the global BA/BE opportunities with Good Clinical Practices (GCP) and Good laboratory Practices (GLP) compliant facilities in India and other countries too.

Accutest has Certified

Our vast experience and track record of conducting challenging studies allows us take up and execute challenging studies and also, to conduct multiple studies simultaneously

Authorisation Professional (CAP) and National Accreditation Board for Testing and Calibration Laboratories (NABL) accredited Clinical Laboratories with 376 beds capacity, over 450 bioanalytical methods, a large pool of 44 LC-MS/MS and biologics laboratories with high-end machines complemented with in-depth expertise to design customised solutions as needed, while delivering quality results with quick turn-around-times exceeding our client’s expectations and market benchmarks.

Thus, we are the undisputed leader with an experience of conducting over 2,200 studies for pharma companies across the world including US, Europe, Brazil, South Africa, China, South East Asia, India and more.

In the last couple of financial years, Accutest’s clinical trial business couldn’t give much profit to the company due to unsatisfactory regulatory environment in India. However, Accutest considers the clinical trial segment as the main growth driver for the company in future. Why? It is true that in last couple of financial years Accutest’s clinical trial business did not contribute substantially to its profit; the same case was with other players too. Now the scenario has changed in India.

In last six months Drugs Controller General of India

(DCGI) has published new guidance and regulations clarifying ambiguity in conduct of clinical studies in India. Similarly pending legal cases are now almost concluded by Supreme Court.

Hence, considering this favorable changes and environment in India, Accutest expects that clinical trial industry will be back to normal rather back to flourishing in the country, and as a result will contribute to our profit margins.

Clinical trials are integral part of drug development; without clinical trial no new dug or product can be introduced in the market.

Moreover, with increased complexity of diseases and niche treatment, the clinical trial industry will keep on growing and has great potential. Assuming our success in BA/BE segment and supporting our drug development partners, we are confident on our success in this space as well. We understand our clients, their requirements, and time pressure to launch of new drug / new product in the market.

Therefore we have changed our approach and strategy.

Until last financial year, our focus was limited to India delivery centers; however, in this financial year we have taken few steps and have added new geographies in our delivery capabilities. We have opened operations in Latin America and very soon we will be having our foot prints in Asia, and Eastern Europe.

We are the market leader in BA/BE segment, and have numerous clients happy with our procedures and relationship. Offering clinical trial services to the clients becomes synergetic to our existing business and in our approach; hence we consider clinical trials would be a new growth driver for Accutest in the years to come!

In 2004 you were the first CRO to get approved by the US FDA. What have been the subsequent achievements of Accutest?

Few of our key milestones are: ◗ 2004: first USFDA approval for BA/BE site ◗ 2005: approval from MCCSouth Africa ◗ 2006: WHO and ANVISA approval ◗ 2007: approval from EMEA & MOH- UAE ◗ 2008: Initiated clinical trial operations ◗ 2009: Started operations in Mexico and Brazil ◗ 2010: Achieved milestone of 1500 BA/BE Studies ◗ 2011: approval from ISPChile ◗ 2012: Initiated Biologics services business ◗ 2013: Executed First to File ANDA, Approval from MOH, Turkey ◗ 2014: First DCGI approval for Quantimmune solutions (subsidiary of Accutest), approval from NPCBMalaysia What is the current size of your company?

Currently, we have 700+ employees working with us.

Our GLP laboratories are spread across 35,000 sq ft and fully equipped with best in class instruments.

Bioanalytical labs have a large pool of 44 highly sensitive and latest LC-MS/MS instruments spread over four sites across India and Mexico.

Besides our existing geographic expansion plans, we are also open for acquisitions and mergers in future.

Tell us about your expansion plans.

We have our future plans

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to grow our business through organic expansion, joint ventures and acquisitions. We are planning to invest $15-20 million in three years to grow our business through organic expansion as well as through joint ventures, acquisitions and partnerships.

We are also introducing the latest technology

We consider clinical trials would be a new growth driver for Accutest

platforms, while adopting new quality concepts and processes to cater and anticipate the changing needs of our clients. Apart from service expansions, our growth strategies are intended towards penetrating new markets and countries to offer end-toend product development

and clinical research services with a meticulous, structured and best-in-class approach. 70 per cent of our business is generated overseas in the US, UK, South-East Asia, Brazil and Europe.

We are aggressively expanding further. sachin.jagdale@expressindia

MARKET COMPANY WATCH

Hilleman Laboratories signs MoU with Bangladesh-based icddr,b To fast track clinical trials, product licensing and commercialisation of the product HILLEMAN LABORATORIES, an equal joint-venture (JV) partnership between Merck & Co and Wellcome Trust, has signed a Memorandum of Understanding (MoU) with Bangladesh-based icddr,b (formerly the International Centre for Diarrhoeal Disease Research, Bangladesh), an international public health research organisation, and Incepta Vaccine based in Bangladesh in a bid to fast track clinical trials, product licensing and commercialisation of the product.

As per the terms of reference of the MoU, Hilleman Laboratories will provide its expertise in further development which will include the process, formulation and pre-clinical development of the vaccine. icddr,b will provide expertise with respect to clinical development and studies of

Hilleman Laboratories will provide its expertise in further development which will include the process, formulation and pre-clinical development of the vaccine. icddr,b will provide expertise with respect to clinical development and studies of the vaccine candidate the vaccine candidate and Incepta will support the development programme in the area of process development, scale-up and cGMP manufacturing for pre-clinical and clinical studies.

“We are thrilled to partner with icddr,b and Incepta, two highly specialised entities head quartered in Dhaka. This collaboration will allow the three organisations to work together and bring forward a cheap effective cholera vaccine to meet the needs of the devel-

oping world,” said Dr Davinder Gill, Chief Executive Officer, Hilleman Laboratories.

“We are sensitive to the fact that cholera is endemic in developing nations, especially in the Bengal delta and sub-Saharan Africa. Identifying like-minded partners within four months of attaining the world-wide rights to the vaccine candidate in a strategic collaboration with Gotovax AB, has given a boost to our confidence in accelerating the process of optimising the

oral vaccine candidate and offer increased shelf life and reduce the projected gap in supply of cholera vaccine by the current manufacturers,” added Gill.

“We are happy to collaborate with Hilleman Laboratories and icddr,b and aim to provide an effective cholera vaccine at a significantly lower cost than currently available in the market. Increasing access to high impact vaccines will be the key to eradicate diseases such as cholera. We look for-

ward to reducing the supply gap and reaching the needy across the globe with this oral cholera vaccine at the earliest,” said Abdul Muktadir, Managing Director, Incepta Vaccine.

Expressing his views, Dr John Clemens, Executive Director, icddr,b said, “Cholera is a major public health problem in several developing countries and we are excited to have the opportunity to translate research into prevention. An important challenge is to understand the effectiveness of vaccines in resource poor, highrisk settings. For a variety of reasons, responses to oral vaccines in the developing world are often lower than those seen in industrialised countries. Optimising a vaccine candidate to fit such settings and saving lives is synonymous with our philosophy.”

EP News Bureau-Mumbai

Sanofi Pasteur launches paediatric Temasek acquires stake in Intas Pharma pentavalent vaccine in India The launch of Shan5 vaccine receives pre-qualification status from the World Health Organization SANOFI PASTEUR, the vaccines division of Sanofi, has launched Shan5, its paediatric pentavalent vaccine developed and manufactured by its affiliate Shantha in India. The launch of Shan5 vaccine received pre-qualification status from the World Health Organization (WHO) in April 2014.

Shan5’s prequalification gives many more children in India access to the latest high-

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quality, fully-liquid, 5-in-1 vaccine. Further, the prequalification helps Shan5 secure the supply of pentavalent combination vaccines in over 50 emerging and low-income countries.

It adds to the existing list of four vaccines that Shantha manufactures, including Shanchol, the innovative cholera vaccine.

“A significant number of babies born every year in India do not have access to modern vacci-

nation programmes. The launch of Shan5 in India means that 27 million babies born annually in India will have access to vaccination, to protect them from five potentially deadly diseases. By launching Shan5, Shantha will be contributing to filling this immunisation gap for the benefit of babies and their parents,” said Dr Harish Iyer, Chief Executive Officer, Shantha.

EP News Bureau-Mumbai

SINGAPORE INVESTMENT company Temasek has acquired a 10.16 per cent equity stake in Intas Pharmaceuticals by way of secondary purchase of shares from private equity investor ChrysCapital.

Binish Chudgar, Vice Chairman and Managing Director, Intas Pharmaceuticals said, “ChrysCapital has been a valuable partner for Intas over the years. We are delighted to have lived up to the expectation of ChrysCapital and now look forward to wel-

coming a globally reputed investor like Temasek to enable Intas to reach greater heights in the years to come.”

Sanjiv Kaul, Managing Director, ChrysCapital said, “Intas has been an excellent investment for ChrysCapital with the company having grown revenues at 27 per cent CAGR since its investment in CY06. ChrysCapital reaffirmed its faith in the company with a fresh Rs 300-crores investment from a separate fund in CY12 .”

EP News Bureau-Mumbai

MARKET

DIPP constitutes IPR think tank To draft the National Intellectual Property Rights Policy and advice on IPR issues DEPARTMENT OF Industrial Policy and Promotion (DIPP) has constituted a IPR think tank to draft the National Intellectual Property Rights Policy and to advice the Department of Industrial Policy and Promotion on IPR issues.

The think tank will have six members in the panel. They are Justice (Retd) Prabha Sridevan, Chairperson, IPR Think Tank; Pratibha M Singh, Senior Advocate, member, Punita Bhargava, Advocate, Inventure IP,

member, Dr Unnat Pandit, Cadila Pharmaceuticals, member, Rajeev Srinivasan, Director, Asian School of Business, Thiruvananthapuram, member and Narendra K Sabarwal, Retired DDG, WIPO, member and convener.

The functions of think tank are to draft National Intellectual Property Rights Policy, to identify areas in the IPRs where study needs to be conducted and to furnish recommendations in this regard to the Ministry, to provide views

The think tank would advise on best practices to be followed for a transparent system in offices dealing with IPR

on the possible implications of demands placed by the negotiating partners, to keep the Government regularly informed about the developments taking place in IPR cases which have an impact upon India's IPR policy, to advise the government on best practices to be followed in trademark offices, patent offices and other government offices dealing with IPR in order to create an efficient and transparent system of functioning in the said offices, to prepare periodic reports on

best practice followed in foreign countries, to highlight anomalies in the present IPR legislations and to advice possible solutions to the Ministry, to give suggestions on the steps that may be taken for improving infrastructure in IP offices and Tribunals, to examine the current issues raised by industry associations and those that may have appeared in media and to give suggestions to the Ministry on such issues.

EP News Bureau-Mumbai

innovation loves a guiding hand Trapped in a solubilization maze? Our enabler, Vaishali Tawde, can help you find the way out. She and her colleagues at BASF work tirelessly to support customers’ success. Backed by the resources of the world’s largest chemical company, our experts develop next-generation excipients to solve the toughest solubilization and bioavailability challenges. Opening up a whole new world of innovative applications and exciting possibilities.

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MARKET

GVK BIO signs agreement to acquire Vanta Bioscience

FIP releases oath for pharmacists

The acquisition enables GVK BIO to offer GLP toxicology services for pharmaceuticals, agrochemicals, nutraceuticals, and cosmetics

It is intended for use at events in schools of pharmacy to launch students towards their studies

GVK BIO has signed a definitive agreement to acquire Vanta Bioscience, a full service preclinical GLP toxicology and safety assessment contract research organisation operating out of Chennai.

Complying with OECD GLP, ISO, USFDA GLP (21 CFR Part 58 rev. 2009) regulatory guidelines, the company offers toxicology evaluation services for the pharmaceutical, biotech, food supplements and feed additives industries. Vanta Bioscience also offers toxicology services using alternative methods for the cosmetics industry.

The state-of-the-art facility is GLP and AAALAC accredited, is armed with highend equipment, and has infrastructure like ‘Individually ventilated Cages’ and `Intelligent Building Management’ systems. The facility houses GLP trained scientific personnel with experience and expertise in study design and execution of regulatory directed studies leading to IND filings.

The state-of-the-art facility is GLP and AAALAC accredited, is armed with high-end equipment, and has infrastructure like ‘Individually ventilated Cages’ and Intelligent Building Management’ systems Manni Kantipudi, Chief Executive Officer, GVK BIO, said, “The acquisition is in line with our business strategy of being an integrated drug discovery services provider for our customers.

We are constantly investing in upgrading our capabilities to provide world-class R&D services. Vanta Bioscience further advances our position as we expand our service offering in GLP toxicology.”

Gerard Schwickerath,

Vice President and General Manager, Vanta Bioscience said, “Vanta Bioscience team is pleased that the worldclass research GLP and AAALAC accredited organisation will continue under the direction of GVK BIO. We are delighted to transition into an organisation that can expand our offerings and provide further opportunities to our clients and staff.”

EP News Bureau-Mumbai

AN OATH for pharmacists has been officially released by the International Pharmaceutical Federation (FIP). It is intended for use at events in schools of pharmacy to launch students towards their studies or at public events such as graduation ceremonies and professional conferences. Pharmacy associations and institutions around the world may also choose to use the FIP oath as a model to be adapted according to their countries’ needs.

Developed by FIP’s Working Group on Pharmacist Ethics and Professional Autonomy, the wording of the oath was adopted by the Council of FIP in Bangkok, Thailand, on August 31. “Although some pharmacy oaths already exist, an advantage of the FIP model is that pharmacists can be confident it was prepared with an international perspective, taking into account the most fundamental principles that guide the ethical behaviour of members of our profession,” said William Zellmer, Co-Chairman of the working

group.

In an article published in the International Pharmacy Journal explaining the background to the oath and emphasising its value, he and working group co-chair, Betty Chaar wrote, “An oath of a pharmacist, if used properly, can be an important instrument in deepening pharmacists’ sense of professional obligation.” Contained in the oath are vows to protect confidentiality and to nurture the preparation of future members of the profession.

“All health professionals regularly face ethical and moral challenges and can benefit from a reminder, from time to time, of the commitment they made to support, above all, the health and well-being of those they serve. Pharmacists might even consider posting a copy of the oath in their practice setting,” they added.

The printable version of the oath is available in four languages, English, German, Spanish and Mongolian, with more translations to come.

EP News Bureau-Mumbai

Steered by HLL,GAPLexpands operations in Goa First GAPL Medicentre public pharmacy outlet inaugurated in Panaji GOA ANTIBIOTICS and Pharmaceuticals Ltd. (GAPL) has set out on a path of expansion following its acquisition by central public sector enterprise HLL Lifecare Ltd (HLL), with the company’s first public pharmacy outlet opening in Panaji today.

The store which opened at 18th June Road in Goa’s capital city is the first in a chain of retail pharmacy outlets branded ‘GAPL Medicentre’ to be set up

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in hospitals and public places in the state. Dr M Ayyappan, Chairman and Managing Director, HLL said GAPL is in the process of scaling up its operations by supplying pharmaceutical products across the country.

GAPL has been operating 24X7 pharmacy outlets in major government hospitals in Goa for more than a decade; this is the first store to operate in a public place. The uniqueness of

GAPL is being ‘holistic’. It offers a range of medicines across allopathic, homeopathic, ayurvedic, siddha and unani medical practices.

Located in the village of Tuem, Pernem in North Goa, GAPL provides employment to around 300 people in the locality. The company is targeting multi-fold growth in the next couple of years.

HLL acquired a 74 per cent

equity stake in GAPL from the Government of Goa in March 2014. The Mini Ratna public sector enterprise under the Ministry of Health and Family Welfare, has already made its presence felt in the pharma industry by offering a basket of women’s healthcare products.

It has a strong distribution network, reaching out to over 30,000 medical professionals and over 3,500 hospitals in the

country.

“We are enhancing the pharma manufacturing capabilities of GAPL to cater to the market potential. This is in tune with our diversification plans across the health segment, including project management consultancy, manufacture of vaccines, establishment of diagnostic centers and generic medicine outlets,” said Ayyappan.

EP News Bureau-Mumbai

MARKET GROWTH TRACKER

IPM clocks `6898 crores in October 2014 The Jharkhand market grew the highest, followed by Madhya Pradesh and Odisha THE INDIAN Pharma Market (IPM) has clocked ` 6898 crores in October 2014. It has grown at 5.2 per cent in the said month. Amongst the top 10, GlaxoSmithKline Pharmaceuticals (GSK) grew by 12.8 per cent followed by Ranbaxy at 12.4 per cent and Mankind at 10.2 per cent. 27 corporate have crossed the growth of IPM amongst top 50. Amongst the top 50 corporates, Akumentis has the highest growth of 66.1 per cent followed by Ajanta at 22.9 per cent and

Merck at 22.4 per cent. 15 corporates have shown growths more than 10 per cent amongst the top 50.

Amongst the 11-20 ranked corporates, Macleods has the highest growth of 22 per cent followed by USV at 16 per cent and Intas at 13.3 per cent.

Amongst the 51-60 ranked corporates, Allergan has grown at 18 per cent followed by Troikaa at 13.3 per cent and Panacea at 12.5 per cent.

Amongst the 61-75 ranked corporates, Boehringer grew by

59.5 per cent followed by East India at 14.5 per cent and Tablets India at 12.7 per cent.

Indian companies have grown at five per cent versus 5.7 per cent for MNCs in October 2014. Amongst the top 50 in MNCs, Merck grew by 22.4 per cent followed by GSK at 12.8 per cent and Ranbaxy at 12.4 per cent. Under the nonNational List of Essential Medicines (NLEM) category Indian companies grew at 6.7 per cent whereas MNCs grew at 6.9 per cent.

The DPCO 2013 containing molecules market de-grew at 2.4 per cent whereas the nonDPCO market grew by 6.8 per cent resulting in an overall growth of 5.2 per cent for October 2014. NLEM and nonNLEM category showed negative unit growth at -5.7 per cent and -1.7 per cent respectively. The DPCO 2013 portfolio for Pfizer grew at 1.5 per cent, GSK 3.5 per cent, Ranbaxy 18.1 per cent.

From the therapy perspective, nine therapies have out-

grown the IPM growth and five therapies have double digit growths. The respiratory market grew at 6.7 per cent, gastrointestinal market grew at 6.8 per cent, pain and analgesics market grew at 5.9 per cent whereas the anti-infectives grew at 3.3 per cent.

The anti-diabetic market grew at 13.5 per cent and the cardiac at 1.9 per cent in chronic business. The derma market grew by 10.3 per cent and the urology market at 21.1 per cent. From the regional

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MARKET perspective, 15 regions have outgrown the IPM growth. The Jharkhand market grew the highest at 20.4 per cent followed by the Madhya Pradesh market at 17.2 per cent and Odisha at 16.5 per cent. Five regions had negative growth in October 2014.

Amoxycillin + Clavulanic acid market grew at 5.9 per cent whereas Glimepiride + Metformin grew at 6.1 per cent at No 2.

The markets of paracetamol grew at 12.2 per cent, Atorvastatin 4.4 per cent, Azithromycin at 8.5 per cent, Probiotic Microbes at 20.6 per cent, Cefixime -5.9 per cent, Pantoprazole 5.7 per cent, Montelukast + Levocetrizine at 13 per cent, Glimepiride + Metformin + Pioglitazone at 17.2 per cent, Vitamin-D at 22.3 per cent, Hydroquinone + Mometasone + Tretinoin at 15 per cent, Voglibose + Metformin + Glimepiride at 39.2 per cent, Leveteracetam at 25.5 per cent.

Mixtard continues to lead the pack with ` 29.5 crores for October 2014 with a growth of 12.2 per cent. Lantus grew at 26.8 per cent, Glycomet- GP grew at 25.2 per cent, Augmentin grew at 24.9 per cent, amongst the top 10 brands.

Amongst the brands who have gained ranks include Augmentin (+5), GlycometGP (+4), Lantus (+9), Dexorange (+6), Galvus Met (+12), Skinlite (+10), Spasmoproxyvon Plus ( +84), Pan (+11), Thyronorm (+19), Pan D ( +26), Jalra M (+48) amongst Top 100 Brands over October 2013.

Amongst the top brands in the IPM, Spasmoproxyvon Plus (116.9 per cent), Taxim (32.7 per cent), Galvus Met (31.6 per cent), Lantus (26.8 per cent), Glycomet – GP (25.2 per cent), Augmentin (24.9 per cent), PAN (24.2 per cent), Skinlite (22.6 per cent), grew fastest amongst the top 30 brands over October 2013.

A total of 167 brands were launched in October 2014.

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 Total MTH – Month Val (Cr) – Value in Crores MS per cent – Market Share in Percentage GR per cent – Growth in percentage.

For more information, visit http://www.aiocd.net

18

EXPRESS PHARMA

November 16-30, 2014

WITH BONUS UNITS AT FULL VALUE Val in Crs COMPANY

Rank MAT

MAT Oct -14 MTH

Val (Cr)

MS%

GR%

Val (Cr)

MS%

81103

100.00

9.6

6898

100.00

5.2

1

4373

5.39

14.4

376

5.46

8.5 9.5

IPM Sun Pharma

1

Oct-14 GR%

Cipla

2

2

4069

5.02

11.2

349

5.06

Zydus Cadila

3

4

3175

3.91

7.6

262

3.80

1.6

Ranbaxy

4

3

2938

3.62

7.0

268

3.89

12.4

Mankind

5

5

2922

3.60

11.6

253

3.66

10.2

Glaxo

6

8

2761

3.40

-7.0

224

3.25

12.8

Lupin

7

7

2721

3.36

12.7

225

3.26

5.2

Abbott HC

8

9

2690

3.32

-0.5

218

3.15

-9.1

Alkem

9

6

2612

3.22

14.0

230

3.33

3.9

Pfizer

10

11

2367

2.92

8.1

201

2.92

9.8

Macleods

11

10

2316

2.86

23.9

203

2.94

22.0

Intas

12

12

2120

2.61

15.6

190

2.75

13.3

Aristo

13

13

2039

2.51

20.6

183

2.66

9.9

Sanofi India

14

14

1979

2.44

0.4

169

2.44

2.8

Torrent

15

16

1772

2.18

4.9

141

2.04

-5.1

Glenmark

16

15

1758

2.17

15.2

151

2.18

2.4

Dr. Reddys

17

17

1723

2.12

9.3

140

2.04

2.5

Abbott

18

19

1614

1.99

13.8

139

2.01

12.3

Micro Lab

19

21

1572

1.94

10.2

122

1.76

-9.5

USV

20

18

1562

1.93

16.0

139

2.02

16.0

Ipca

21

20

1469

1.81

23.0

128

1.86

0.7

Emcure

22

22

1405

1.73

20.0

116

1.67

3.2

Novartis

23

23

1150

1.42

0.0

100

1.45

5.8

Alembic

24

24

1108

1.37

13.1

95

1.38

5.2

Wockhardt

25

25

995

1.23

6.1

80

1.16

3.3

Val in Crs

MAT Oct 14

Month Oct-14

Super Group

VAL IN CRS

VAL GR%

VAL IN CRS

VAL GR%

IPM

81103

9.6

6898

5.2

ANTI-INFECTIVES

13148

5.7

1153

3.3

CARDIAC

9994

9.0

821

1.9

GASTRO INTESTINAL

9309

11.0

769

6.8

VITAMINS / MINERALS / NUTRIENTS

7301

10.2

613

4.8

RESPIRATORY

6312

12.2

561

6.7

ANTI DIABETIC

6015

19.4

524

13.5

PAIN / ANALGESICS

5825

8.9

501

5.9

NEURO / CNS

5049

7.5

417

1.1

DERMA

4603

15.7

400

10.3

GYNAECOLOGICAL

4151

4.0

336

1.8

OPHTHAL / OTOLOGICALS

1478

12.5

132

17.0

HORMONES

1336

4.4

112

2.7

ANTI-NEOPLASTICS

1319

27.1

107

7.9

VACCINES

1144

-8.2

89

-6.2

BLOOD RELATED

973

2.2

76

-9.3

OTHERS

879

7.7

76

10.9

UROLOGY

834

18.6

76

21.1

ANTI MALARIALS

615

9.2

70

-0.8

SEX STIMULANTS / REJUVENATORS

454

2.4

35

-5.3

STOMATOLOGICALS

365

11.7

30

3.2

MARKET PRE EVENT

66 IPC to be held in Hyderabad th

The event, held from January 23-25, 2015, will be organised by Indian Pharmaceutical Congress Association and hosted by All India Drugs Control Officers' Confederation 66TH INDIAN Pharmaceutical Congress (IPC) will be held at Hitex, Hyderabad from January 23-25, 2015. The event will be organised by Indian Pharmaceutical Congress Association and hosted by All India Drugs Control Officers’ Confederation. The theme of the Congress is ‘India-Pharmacy of the World-Role of Indian Regulators and Pharma Industry’. It will cover various issues related to the industry, academia and community pharmacy by technical and professional intellectuals from the relevant branches of pharmacy from all over the globe.

More than 10,000 national and international delegates are expected to attend the event which will provide a common platform to all the stakeholders to facilitate interaction among peers and to update their knowledge to serve better in their field. On this opportune occasion, a documentary record of collection of scientific, professional and marketing literature in the form of a Souvenir-66 IPC will be released and presented to each one of the delegate/ participant.

Concurrently with the Congress, a Pharmaceutical Expo – 2015 Exhibition by FICCI will be held. It would project latest technological developments, upgradation and adaptation in pharma industry with a display of equipment, instruments and utilities.

Venkat Jasti, President, IPCA said, “As all of us are aware that the 66th IPC will be held at Hyderabad and they are making a new beginning by conducting this IPC in January rather than in December which is convenient to all because there is no worry on account of holidays.”

EP News Bureau-Mumbai

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November 16-30, 2014

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MARKET POST EVENT

Patients,access and innovation take centre stage Participants at DIA's 9th Annual India meet analyse the current scenario and brainstorm on possible future models of healthcare delivery DIA'S RECENT 9th Annual India conference, in Mumbai had as its theme: ‘The Future of Indian Healthcare: Patients, Access and Innovation’.

Chaired by Prof Ranjit Roy Chaudhury, Chairman, Task Force for Research Apollo Hospitals Group and Alexandra Pearce, Senior Vice President and Head Global Regulatory Affairs, Glenmark Pharmaceuticals, the threeday conference saw animated participation from a wide spectrum of the industry.

The first day focused on patients and included sessions on topics like patient health safety and compliance for prescription medicine, patient participation in clinical trials, universal health coverage and health insurance, medicine pricing and reimbursement, compulsory licensing, innovations in healthcare solutions etc.

Eminent speakers including MK Bhan, Former Secretary Department of Biotechnology (DBT), Govt of India; GN Singh, Drug Controller General of India; Kiran Mazumdar Shaw, Chairperson and Managing Director, Biocon; Urmila Thatte, Professor and Head, Seth GS Medical College and KEM Hospital; YK Gupta, Professor and Head Department of Pharmacology AIIMS; Swati Piramal, Vice Chairman Piramal Enterprise; and Sudharshan Jain, Managing Director, Healthcare Solutions Abbott India were speakers at various sessions.

Nata Menabde, Representative to India, WHO, India chaired a plenary session on the second day. The session got the panelists to analyse the current scenario from their

20 EXPRESS PHARMA November 16-30, 2014

Nata Menabde (third from left), Representative to India, WHO, India chairing a plenary session on the second day of DIA's 9th Annual India conference, titled ‘The Future of Indian Healthcare: Patients, Access and Innovation.’ Also seen in the picture: from left to right: Swati Piramal, Vice Chairman, Piramal Enterprise, Ferzaan Engineer, Co-Founder and Chairman, Cytespace, and Rajesh Balkrishnan, Associate Professor Health Outcomes, University of Michigan, US

perspective and suggested healthcare models based on their place in the healthcare value chain. The common element to these perspectives was the attempt to leverage the principles of accessibility, affordability and accountability by adopting a patient-centric approach towards delivery of quality healthcare to the masses. The panel members and participants also touched on the possible impact and adoption of healthcare economic outcomes research (pharmacoeconomics), health insurance, PPPs, diagnostics and pharma industry, thus spanning the entire healthcare value chain.

In her introductory remarks, Menabde said, "The world is re-visiting models of healthcare. Holistic, integrated solutions are required."

Representing the pharma industry's perspective on the current drug pricing policies, Piramal opined, "When you re-

duce the cost of the drug to the cost of the chemical but exclude the cost of safety, then price control does not help access."

Sharing her experience of the Piramal Enterprise's Sarvajal project, where water purifiers were installed in remote villages, she pointed out that it was not about supplying the product, but building a system and infrastructure to manage and maintain the machine. Extrapolating this to the access to medicines issue, she said that ensuring access was not about pricing but about management and policy, she concluded.

Suggesting that homebased care could be adopted as a future model of healthcare delivery, Ferzaan Engineer, CoFounder and Chairman, Cytespace made his point by saying, "Home-based care could become the Flipkart of healthcare. Entire housing societies could subscribe to a health plan, which is based on incentives to take care of people's

health rather than curing them after they fall sick. When subscribers do fall ill, it is detected early so costs of care are less.

The home health model could also take primary care home so that people fall ill less often."

Engineer is also co-founder, Medwell Ventures, a recent entrant into the home healthcare market. He also made the point that this model can be used not just for chronically ill patients, and the geriatric segment but also for the rehabilitation and physiotherapy of accident victims, which takes place over a period of time.

Participating in the discussion via telecon, Dr Devi Shetty, Chairman, Narayana Hrudayalaya Group of Hospitals, in his characteristic blunt fashion opined that the lack of skilled manpower was at the root of healthcare delivery issues in India. Analysing the genesis of the problem, he said, "Though we produce a lot of doctors, India still lacks doctors. We

have a first world regulatory structure with a third world infrastructure. We need to liberate medical education from the license raj."

On the availability of healthcare facilities, he rued the fact that all major hospitals were coming up in major cities resulting in patients from rural areas being forced to leave their homes and flock to cities for healthcare. He suggested that each district hospital should be connected to major city hospitals and converted into training centres, alluding to the model followed in the US and the UK. He also suggested that India should have a large scale insurance scheme to take care of the cost of accessing healthcare.

Rajesh Balkrishnan, Associate Professor Health Outcomes, University of Michigan, US felt that, "India's healthcare system has to improve on three parameters: Effectiveness, Efficiencies and Equity.

Comparative effectiveness is very relevant to India when resources are few. " He also drew attention to the huge time bomb of NCDs combined with CVD which will impact healthcare delivery in India.

Summing up the discussions, Menabde said, "We cannot have pro-poor policies which are poor policies. We should have a combination of private and public insurance.

Access should be independent of the ability to pay so do not ask the private sector to reduce prices. Instead, the government and private sector should work together to improve access."

EP News Bureau-Mumbai

EVENT BRIEF DECEMBER 2014 - JANUARY 2015 6

Bio-Invest in Gujarat

BIO-INVEST IN GUJARAT Date: December 6, 2014 Venue: Mahatma Mandir, Gandhinagar, Gujarat Summary: Government of Gujarat will organise ‘Bio-Invest in Gujarat’, which will be supported by the Department of Science and Technology (DST), Gujarat State Biotechnology Mission, Govt of Gujarat (GSBTM), Association of Biotechnology Led Enterprises (ABLE) and KPMG. The event will see scientists, senior government administrators and industry leaders. Approximately 500 attendees are expected to participate.

Anandiben Patel, Chief Minister, Gujarat will inaugurate the event. Dr K Vijay Raghavan, Secretary DBT and DST (Government of India) will give the keynote address.

Sir John Burn from Institute of Human Genetics, UK, Prof Ken-ichi Arai, Chair Programs Committee, Biotech Japan, Dr S Ayyappan, Secretary, DARE & DG ICAR, Dr Harkesh Mittal, Secretary, TDB and Dr Renu Swarup, Managing Director, BIRAC besides other CEOs are likely to participate in the event.

8

The expo will be accommodating 400 booths to the exhibitors. Major OEM

Asia Pharma Expo-2015 suppliers from Asia, Europe and the US are likely to participate.

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Email: ceo@GPEexpo.com Website: www.asiapharma.org

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ASIA PHARMA EXPO-2015 Date: January 8-10, 2015 Venue: Bangabandhu International Conference Centre, Dhaka, Bangladesh Summary: Bangladesh Association of Pharmaceutical Industries will host international exhibition on South Asian Pharmaceutical industry, Asia Pharma Expo-2015.

The exhibiting companies from more than 26 countries across the world are expected to participate.

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November 16-30, 2014

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22 EXPRESS PHARMA November 16-30, 2014

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November 16-30, 2014

cover )

Leap into the future As newer therapies for cancer hit the market, there's a silent churn going on as diagnostic companies prepare for the future by stepping into unchartered territories

BY SHALINI GUPTA

I

n 1989, Rama Modali founded Bioserve. Bioserve India headquarted in Hyderabad started out as a molecular kit manufacturer serving both the research and clinical markets and has grown its clinical diagnostics capabilities in oncology and next-generation sequencing today to position itself as a state-of-the-art genomics services provider. Operating out of a state-of-the-art 14,000square-foot genomics facility, it also managed to get a backing from Ventureast, a pioneering venture capital institution, that has enabled over 80 seed, early and growth stage businesses in a broad array of sectors including technology, life sciences and clean environment so far.

A nascent yet promising market The feather in the cap came recently when it was acquired by Cancer Genetics Inc (CGI), A US-based company, which is emerging as a leader in DNAbased cancer diagnostics, servicing some of the most prestigious medical institutions in the world. To be renamed Cancer Genetics India, the new company will become a subsidiary of CGI, and will be renamed Cancer Genetics India.

CGI plans on retaining all 33 current employees of BioServe India, and further expanding and strengthening the sales

24 EXPRESS PHARMA November 16-30, 2014

and clinical teams in India. The transaction worth $1.9 million (primarily in CGIX stock and other deferred consideration) is expected to close during the third quarter of the year.

The acquisition is a prime example of the seeds of consolidation in a highly fragmented market in the country like India and perhaps shows the way forward for it to thrive. A look

at the numbers explains the potential attractiveness of the Indian market. The global diagnostics market is close to $60 billion and is growing at a rate of three to four per cent, with a

third of it spent on oncology.

The Indian diagnostics market on the other hand is a measly $2 billion with an estimated growth rate of 18 per cent per annum. Personalised oncology

( tureast enumerates, “Diagnostics has been transformed over the years by the use of applied genomics. Conventional methods which are more culture based are now evolving into

molecular diagnostics which is in turn getting sophisticated, for eg, are you looking at a single nucleotide in a combination being different versus seeing a combination of genes which is

THE MAIN FOCUS

different. Big pharma is backing their data of why a drug works and why it doesn't with a lot of genomic analysis to understand the mechanism of action. We are also seeing compa-

nies where half of their drug development is focussed on companion diagnostics.� He is quick to note that diagnostics of cancer is still based on visualisation(CT scans, biopsies etc).

Structurally, we are beginning to see a lot of M&As in the sector, that is a driver for a lot of consolidation that is happening, be it small or big companies Panna Sharma President and Chief Executive Officer, CGI

is a nascent part of the market, but it is gradually moving in that direction. The increasing incidence of cancer and a burgeoning middle class represents an emerging market of patients and clinicians who want clinically validated tests that comply with the standards of US healthcare companies.

At the same time there is a significant intellectual shift going on amongst pathologists and clinicians who increasingly want genomic assessments of cancers. However, there are very few providers with the quality and expertise required to meet the demands of the Indian market. This is where the unmet need lies and hence there is a strong demand for companies providing high quality, clinically validated tests at a cost point that makes sense for the broader Indian market.

Cancer Genetics India is well suited to serve these needs.

The market is also shifting from biological testing to genomics testing with genetics testing being used widely for detecting breast cancer, colorectal cancer etc. Usage of diagnostics as a part of clinical trials, approval of personalised diagnostics by the FDA, and increasing consumer awareness are some of the other drivers.

Ravi Jain, Principal, Ven-

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November 16-30, 2014

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cover ) That is slowly changing with oncologists looking at genetic testing for diagnosis and prognosis of the diseases owing to an increasing awareness.

The right fit Chips in Panna Sharma, President and Chief Executive Officer, CGI, “Structurally, we are beginning to see a lot of M&As in the sector, that is a driver for a lot of consolidation that is happening, be it small or big companies. For us, BioServe India was an attractive company for a variety of reasons. It had a history of being an entrepreneurial company that was able to adapt to a variety of challenges, a solid management team, great technical expertise, and excellent relationships with customers and top Indian research institutions.

With a desire to move into the clinical oncology market, it demonstrated a willingness to transform their business model. This was a critical piece in our decision to acquire it.”

“The company already had started on next-generation sequencing efforts, with a founder (Modali) who was very familiar with American business and could help bridge any cross-border or cultural integration issues that might arise during such an acquisition,” he adds.

Bioserve has operations both in the US and India, when Ventureast backed it, the Indian arm was almost non existent. “The fact that it had operations in India made the case of the acquisition stronger given the labour arbitrage and market demand which was expected to show up after a few years. Usage of genomics in therapy will change the way medicine is being practised in this country. Bioserve has the core competencies for next generation sequencing, bioinformatics, capability for analysis and manufacturing competency for probes and conducting the tests,” says Jain The acquisition further positions CGI to access the highgrowth Indian healthcare and diagnostics market, and increases its global presence in personalised cancer care.

26 EXPRESS PHARMA November 16-30, 2014

The regulatory pathway for approval of companion diagnostics is very different and varies country by country.And that is where the complexity of delivering a companion diagnostics come in, because its extremely important that a companion diagnostic also goes through companion testing BioServe India has the equipment and scientific experience required to integrate CGI’s DNA-FISH probe manufacturing and proprietary FHACT business into the Indian market that accounts for more than 25 per cent of the global deaths attributed to cervical cancer. FHACT is a non-invasive genomic test that can work as a reflex test from a pap smear and that can identify cancer and pre-cancer lesions caused by persistent HPV infection. The test can provide physicians with crucial information in making treatment decisions in cervical and HPVrelated cancers.

It has been launched for clinical use through a collaboration with Kamineni Hospitals.

Sharma has a three-step plan to expand CGIs portfolio in India.

He says, “We have further plans to put this test into the hands of hospitals and women’s health groups throughout India. Secondly, we plan to launch a cancer hot spot panel that utilises Next Generation Sequencing (NGS). This would be launched through our own lab and part-

nerships with leading hospitals and cancer research institutes.

Finally, we plan to transfer CGI’s proprietary portfolio of launched tests for leukemia, lymphoma and kidney cancer into the Indian market. In order to ensure quality and clinical relevance of these tests for the Indian context, they’ll require re-validation since those validated in the US may not have the same levels of underlying mutations as present in the Indian subcontinent. This is essential in order to provide highquality personalised medicine.”

The future While the Indian market is still figuring its act, there is a lot of buzz surrounding companion diagnostics in the US. There are a number of drugs being used under the guidance of clinicians (which are not FDA approved) and a number of tests being conducted, so there is a lot of testing that guides those decisions.

However, there are only 19 FDA approved companion combinations where a drug and a test are combined and most of them are for HER-2, which is for breast

cancer. Many more might get approval in the coming years, and the pipeline looks quite significant. “This is good news for us at Cancer Genetics. We have almost 20 different trials going on for companion diagnostics specifically in pharma at our company, so it is a big growth area of the future. We have high quality labs to actually do the testing, validate the results and do that on a global basis,” stresses Sharma.

The regulatory pathway for approval of companion diagnostics is very different and varies country by country. And that is where the complexity of delivering a companion diagnostics come in, because its extremely important that a companion diagnostic also goes through companion testing. There are several hundreds in testing right now, however, with a cumbersome regulatory pathway, it takes large scale trials, and it is not going to get any simpler, which is why we are seeing a lot of consolidation in the industry with mergers and small companies getting picked up by big companies in order to meet the de-

mands, he emphasises.

With diagnostic tests driven by genomic data, as this data becomes more and more important as opposed to biology, cost cutting will be imperative. “The bottleneck in the future is not going to be biological testing, but rather the cost, time and the managing of the data, it then makes sense to have operations in India and China is a huge advantage,” says Sharma.

Jain offers an investors point of view and adds that two areas look full of possibilities. Low cost diagnostic products which can reduce the margin of error and increase the specificity and accuracy of the test and point of care diagnostic devices that solve the problem of fragmentation by providing standardised tests.

“Specialist diagnostics chain model will emerge in the future.

Right now, when the size of the market is small, it is difficult to scale up given the subjectivity in diagnosis. Point of care diagnostics and proprietary tests identifying unique biomarkers will be the differentiating technologies of the future,” he adds. Sharma has put plans in place for the next two years. “We intend to expand our footprint in the clinical market and deepen our presence among the research and biopharma customers. Our goal is to triple the workforce, further support large scale adoption of our cervical cancer test, and increase revenues by five to six times with the services we offer,” he concludes. shalini.g@expressindia.com

(

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A leader in the making?

Just four years old and Mumbai-based Akumentis Healthcare has doggedly risen through the ranks of the Top 50 pharmaceutical companies in India, but will it be able to sustain this performance? Dr Rajaram Samant, Chief Executive Officer and Chief Mentor is confident that it will

BY USHA SHARMA

Team Akumentis at their Mumbai headquarters

AKUMENTIS HEALTHCARE is one of many start-ups in the highly competitive Indian pharmaceutical industry (IPM). But it has managed to make its mark, thanks to a savvy sales and marketing strategy. As of October, just four years after its launch, the company ranks 38th in the monthly listing compiled by market research firm All India Organisation of Chemists and Druggists (AIOCD) based on sales at chemists and druggist outlets across the country.

To subscribe: bpd.subscription@expressindia.com

We are committed to make Akumentis a place which will identify and nurture the true potential of its people. We believe ‘happiness’ of our employees is vital and creating a workplace filled with happiness and fun is vital to our growth Dr Rajaram Samant Chief Executive Officer and Chief Mentor, Akumentis Healthcare

Dr Rajaram Samant, Chief Executive Officer and Chief Mentor, Akumentis is confident about the company's performance and comments, “Akumentis is aiming to enter the top 30 in 2014-15 and top 20 by 2017-18 in the IPM study.”

Not so smooth Akumentis' rise up the ratings has seen some rough patches.

As per information shared by the company, Akumentis started its journey in 2011 with a focus on women healthcare and

EXPRESS PHARMA

27

November 16-30, 2014

cover ) orthopaedic segments. AIOCD AWACS figures show that between August - October 2013, the company was positioned at the 49th position but slipped off the list from November to January 2014, appeared in February, fell off again in March, only to come back and stay on the list more consistently in the subsequent months.

The management seems to have given considerable thought to the vision and mission: making a difference in lives of people suffering from complex lifestyle related health issues. Its sales record is a testimony to its sharp focus on identifying need gaps in existing therapeutic segments and launching ‘first-to-market’ solutions.

Success mantras A key success strategy has been Akumentis’ focus on the niche segment of women's healthcare and hence infertility management, obstetrics and gynaecology, and osteoporosis management are a key part of its product basket. And this focus has paid off: Samant reveals that it is already at the 10th position in women healthcare and orthopaedic areas.

Other areas where the company has products are pain and inflammation management, paediatrics and geriatrics nutrition, gastroenterology, ophthalmology, dental care, acute and chronic infection.

Akumentis has 30 products in women healthcare, orthopedic segment, cosmetology therapeutic segment and some of its products are top sellers in their respective segments like All9 (pronounced as All Nine), Newbona, Oosure, Clomipure, Ovacet, Dinofirst.

The Indian market is primarily a branded generics market and there are upto 70000 brands competing for market share and visibility among doctors. How strong is the company’s product pipeline of launches? And are they differentiated enough to stand out?

According to Samant, “We have launched around 30 products for the first time in India in women healthcare, or-

28 EXPRESS PHARMA November 16-30, 2014

thopaedic and cosmetology therapeutic segments. We have 50 more new products in the pipeline which are awaiting regulatory approvals. These products will be commercialised over the next 36 months.”

The company has plans to move into other therapeutics areas as well. Samant discloses, “For the current year, we plan to launch products in the cardiology and diabetology segments.

In the next two years, we will enter nephrology and central nervous system (CNS) catalogue by 20152015-16 respectively.” In addition to this the company is developing and nurturing a pipeline of human talent.

Another reason for Akumentis’ rapid sales growth is that it has steered clear of product categories under price control. As Samant confirms, “We do not have anti-infectives where the Drug Price Control Order 2013 (DPCO) has maximum impact.”

Minimum investment, maximum strategy At present, the company

ACHIEVEMENTS ❖ Akumentis was awarded as ‘Emerging Company of the Year 2012’ by Ministry of Commerce. ❖ Dr Rajaram Samant, CEO and Chief Mentor, was awarded as ‘Dynamic Entrepreneur of the Year 2012’ by his Excellency K. Shankaranarayanan, Hon.Governor of Maharashtra. ❖ Samant was awarded as ‘First Generation Entrepreneur of The Year’ ❖ Akumentis entered the Top 65 list in its first year with turnover in excess of Rs 90 crores. ❖ Akumentis further sharpened its focus on its core areas and entered cosmetology in the third year. ❖ Entered Top 50 ranks within three years of its launch in India

does not have its own manufacturing facilities. “We get our products manufactured through third parties. We have exclusive agreements with Akums Drugs and Pharmaceu-

ticals, who are leading players in contract research and manufacturing services (CRAMS) with more than seven plants located in Haridwar,” shares Samant.

Thus, with minimum investment in physical infrastructure, but sound marketing strategies, Akumentis seems to have achieved its goals faster than other companies of a similar vintage.

In terms of headcount, Akumentis has 3000 people within its fold and predicts that this will increase to 4000 over the next two years.

While talking about the company's plans for the international market, Samant reveals, “Our global expansion will start post 2017.”

Work culture A healthy work environment is the pillar of existence of an organisation and a friendly culture motivates employees to associate better with a company. Akumentis believes in core values like innovation, hard work, honesty, deepest care with passion, tolerance for honest mistakes and

organisation growth and development of its employees.

In Samant’s words, “Ours is an innovation driven culture, wherein we are introducing innovative products (first time in India)- this helps our field force get maximum time with doctors and is directly proportional to business and successthis is the biggest motivator to our employees. And we have special programmes to identify and help them build on their personal dreams.”

Samant was awarded as ‘CEO with HR orientation’ in the World HRD Forum this year. “We believe, apart from R&D innovation, it is the passion of people which builds organisations. We are committed to make Akumentis a place which will identify and nurture the true potential of its people.

We believe ‘happiness’ of our employees is vital and creating a workplace filled with happiness and fun is vital to our growth,” says Samant.

Giving an example of the company’s efforts to ensure employees feel cared for, he says, “We celebrate birthdays and anniversaries of all family members (including kids) of our employees – a special note from the CEO, with a bouquet of flowers, cake and gift is delivered to the house of each and every family member of our employees.”

During the last fiscal, the company achieved a turnover of `250 crores with 50 per cent growth. This fiscal, the company is targeting to touch `450 crores. Samant sum ups, “We are looking at a turnover in excess of `1000 crore from India alone by 2017.”

The company may still be small, when compared to the larger companies in the AIOCD listing and as with most young companies, it may not be fair to expect the same blistering pace of growth as its revenue base increases. But the spirit of the company exemplifies an entrepreneurial zest typical of start ups. It is most definitely a rising star today and a company to watch out for. u.sharma@expressindia.com

MANAGEMENT REPORT

Lack of suitable resources limiting Ebola diagnoses in West Africa: GlobalData Poor logistics is a more difficult problem to solve, as the reagents used for testing require constant refrigeration during their movement through the supply chain POOR LOGISTICS AND Low trained staff numbers are two of the greatest limitations to providing a sufficient molecular diagnostic capacity for Ebola in West Africa, where only 56 per cent of cases are described as confirmed and the remaining cases are probable or suspected, according to an analyst with research and consulting firm GlobalData.

Andrew S Thompson, GlobalData’s Senior Analyst covering in vitro diagnostics,

states that if the number of diagnosed Ebola cases in West Africa increased to 10,000 per week, as recently predicted by the World Health Organization, local diagnostic laboratories would need to be capable of processing at least 3,400 specimens per day collectively, to support the number of positive tests and repeat negative tests expected.

Thompson says, “While modern molecular diagnostic testing is the most sensitive and precise way to detect the

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Ebola virus, it is complex and expensive to perform. It is therefore extremely challenging to implement this technology in poorer regions of the world, where the healthcare infrastructure is inadequate, or even non-existent. At present, there continue to be only a few established diagnostic facilities in West Africa, and while donor countries are increasingly providing mobile laboratory facilities, these can only slightly narrow the gap in the testing capacity.”

The analyst notes that while the shortage of trained staff can be filled by deploying skilled scientists from outside the region, poor logistics is a more difficult problem to solve, as the reagents used for testing require constant refrigeration during their movement through the supply chain.

Thompson continues: “One solution might be to introduce molecular diagnostics suitable for the African environment. These could include reagents that are not depend-

ent upon refrigeration, as well as instruments that are lowcost, self-powered, simple to use, and can be implemented quickly on short notice by governments in the region.

“This approach would provide a more robust model for responding to sporadic emergencies than the current approach, which depends on coordinating a global response and typically lags behind the first occurrence of the outbreak.”

EP News Bureau-Mumbai

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MANAGEMENT LEGAL EAGLE

Competition issues in the Indian pharma sector

ABIR ROY, Partner, Khare Legal Chambers

The Competition Commission of India has undertaken capacity building exercises and have received specialised training in relation to business issues in the pharmaceutical sector. An insight by Abir Roy, Partner, Khare Legal Chambers THE COMPETITION Commission of India (CCI), which is the regulatory authority set up under the Competition Act, 2002 (as amended) (Act), regulates both behavioural (i.e. anticompetitive conduct in the form of anti-competitive agreements (including cartels) and abuse of dominance) and structural activities (i.e. mergers and acquisitions) of the enterprises. The CCI has been established to ensure that enterprise carry out their business in a competitive manner and their activities do not cause or likely to cause an appreciable adverse effect on competition (AAEC) in India.

Based on the decisional practice of the CCI, the CCI has reviewed the practices in the pharmaceutical companies the most in the last three years. It is noteworthy that CCI has undertaken capacity building exercises and have received specialised training in relation to business issues in the sector. It must be noted that the activities which have already been investigated by CCI to date are more on cartel activities, whereas now the CCI is investigating highly complex issues in the pharma industry now, like ‘pay for delay’, and most importantly, phase II investigation of the merger between Sun Pharmaceuticals and Ranbaxy. The CCI has invited comments from the competitors on the said merger and based on the newspaper reports, it is highly likely that CCI will clear the transaction, subject to fulfilment of commitment by the parties which may be behavioural remedies (like access remedies,

30 EXPRESS PHARMA November 16-30, 2014

IP remedies) or structural remedies (divestures).

The first phase 2 investigation: Merger of Sun and Ranbaxy The CCI had issued a show cause notice to Sun Pharmaceutical Industries and Ranbaxy Laboratories as to why the deal should not require an in depth investigation. Based on the procedure mentioned under the Act for reviewing combination, the CCI had to pass a prima facie order within 30 days of the notification. At the end of the 30 day period, excluding clock stops, the CCI can clear the transactions (with or without commitments) or can issue a show cause notice to the parties as to why a detailed investigation is

not required. To date, the CCI has cleared all the transaction within the said period of 30 days.

This was the first time where the CCI has issued a show cause notice under Section 29(1) of the Act to the parties (Sun and Ranbaxy in this case) as to why a detailed investigation is not required. The said show cause notice pointed out deal will result in significant market domination by one company and could affect the prices of essential life-saving drugs in the domestic market. Further, it was identified that the deal could be against ‘national interest’. It has been pointed out that if the deal goes through, the resultant entity will have significant market presence in the market and it will have market domination in

the merged entity’s portfolio of 46 drug formulations. Post the show cause notice and reply by Sun Ranbaxy, CCI referred the matter to a phase II investigation and it sought comments from any person (including competitors) on the merger and their views on the competition law impact of the said deal.

Market analysis1 Sun-Ranbaxy would be the top player in 13 disciplines, including a few critical care areas. The combined entity would be a market leader in disciplines like psychiatry, neurology, cardiology, orthopaedics, ophthalmology, gastroenterology, nephrology, diabetology, dermatology and urology among others. If the merger goes through, it will cre-

ate India’s biggest drug maker with an 9.2 per cent share of India’s pharma market, worth an annual ` 76,000 crores by sales.

The CCI, in merger analysis, views the market very narrowly and analyses the competitive impact of the said combination in such narrow market. Thus, based on the decisional practice of the CCI, they will review each category as a separate relevant market in itself. CCI can also analyse the market on a molecule basis. Based on the FormIV2 published by the parties, the combined share of Sun Ranbaxy is as high as 90 per cent in certain molecules.

Further, the combined entity would create the top Indian pharma company in the US, the world’s largest drug market, with over $2 billion in sales and pipeline of 184 ANDAs (Abbreviated New Drug Applications) including high-value FTFs and will be the top player in generic dermatology business and the thirdlargest in branded segment.

Indian market The combined entity will overtake Abbott India to become the top seller of medicines within India. The combined market share of 9.2 per cent and Abbott will have a 6.5 per cent share. As such, the CCI is unlikely to take the entire Indian pharma market as the relevant market, but will break it into categories, where the combined entity in 46 drug formulations has high market share. The CCI can, as a matter of process, ask the director general, the investigative authority created under the Act to

MANAGEMENT undertake a detailed analysis of the deal.

Commitments It has been widely reported that the CCI may clear the transaction, subject to fulfilment of the parties of certain commitments/ remedies. Merger analysis is a forward looking exercise and it is an enormous task for the regulators to appropriately analyse the competitive effects of a transaction in the future. To address any competition law concerns, the competition regulators have the power to issue commitments/ remedies to the parties to ensure that the behavioural conduct of the parties to the merger, post the consummation of the merger, does not create any competition law concerns. It must be noted that while issuing a commitment, the regulator has to consider the following: (a) the reasons which lead companies in the sector to seek a merger, in particular efficiencies and technical innovation; (b) any serious competition issues to which some mergers may give rise, for example the risk of foreclosure; and (c) the outcome for consumers as the main beneficiary of welfare enhancing competition policy interventions3. Further, the regulators have to keep in mind that since divestiture is typically permanent in nature and relatively invasive, the authorities have to be confident that their recommendation is proportionate to the competition threat created, that the divested assets remain viable, and that the buyer of the divested assets will not itself use the assets to threaten the competitive process. Given that the Act is patterned on the EU law, it is likely that the CCI will refer to the EU jurisprudence for guidance. The EC Notice on

CCI has become a very aggressive regulator and have already levies multiple headline fines

Remedies4 was published on October 22, 2008 in order to provide guidance regarding remedies acceptable to the EC, and to provide clarifications regarding: the general principles applicable to acceptable remedies and the types of commitments acceptable to the EC; the proposal compliances in both phases of

the procedure; and the implementation of commitments.5 The remedies mentioned under the said EC notice included:(a)Structural remedies i.e. divestment of a part of business.

The divestment must consist of a viable business, which in the hands of the purchaser, is capable of competing with the

merged entity. In order to determine the scope of the business to be divested, all tangible and intangible elements- including intellectual property rights, knowhow and goodwill, must be specified.6 The most important factor that needs to be kept in mind is that the said divesture must be pragmatic enough to be

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implemented i.e. plain vanilla divesture may not be enough to obviate any competition law concerns but must be coupled with trained personnel and manpower to ensure that the purchaser of the business, post the divesture, can compete with the merged entity and can impose a competitive constraint on the

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MANAGEMENT merger entity7. (b)Behavioural remedies which included access remedies (i.e. commitments regarding the grant of access to key infrastructure, networks, key technology, including patents, know-how or other intellectual property rights, and essential inputs, usually on a non-discriminatory and transparent basis, have been accepted by the EC.8) or commitment with respect to re-branding.

It will be interesting to see how the exercise of commitments will be carried out by the CCI. It must be noted that issuing commitments is a very difficult task and the CCI must be sure that the commitment so issued will obviate competition law concerns. The commitments so issued can be mix of both behavioural and structural remedies.

Enforcement CCI has become a very aggressive regulator and have already levies multiple headline fines.

The CCI has also reviewed the conduct of Chemist and Druggist Associations in the pharma sector under Section 3 of the Act, which prohibits anti-competitive agreements (particularly cartels) and declares them void. The CCI has broadly held9 that the following practices of such Chemist and Druggist Associations are anti-competitive: ◗ Non-appointment of a stockist or a wholesaler from amongst the non-members of the respective trade association; ◗ Requirement of a NOC from the association for appointment of a stockist or wholesaler. ◗ Associations fixed trade margins below which the stockists were not allowed to sell; ◗ The distributors/ retailers were not allowed to give discounts to customers; ◗ Compulsory approval from the trade association for introduction of drugs in the market; and ◗ Requirement for routing bids for supply of drugs to the government and the hospitals through authorised stockist only.

The CCI has held that the above terms and conditions amounted to the restriction the ability of enterprises to supply and sell drugs in the market. In this regard, it should be noted that the CCI has not only imposed penalties on the trade associations themselves, but has also issues fines on the office bearers of such associations10.

Based on the same, it must be noticed that CCI has invoked personal liability doctrine11 and has pierced the corporate veil and imposed fines on the officers involved. Further, now CCI is now reviewing complex competition law issues in pharma sector like pay for delay and it would be interesting as to how CCI views such practices.

References 1. Market analysis is done based on industry reports and newspaper articles 2. Form IV is a form under Section 29(2) of the Act where the CCI requires the parties to publish details of the combination for bringing to

the knowledge or information to the public and persons affected by such combination 3. Thomas Hoehn, Suzanne Rab and Grant Saggers, ‘Breaking up is hard to do"- National Merger Remedies in the Information and Communication Industries’, European Competition Law Review, Issue 5, 2009 4. EC notice on remedies acceptable under Council Regulation (EC) No 139/2004 and under EC Regulation (EC) No 802/2004 (Text with EEA relevance) OJ C 267, 22.10.2008, p. 1–27Available at: http://eur-lex.europa.eu/legalcontent/EN/ALL/?uri=CELEX:52 008XC1022(01)#ntr74C_2008267EN.01000101-E0074 5. Paragraphs 2 and 3 of the Notice 6. Paragraphs 23 and 27 of the Notice 7. Please see Western Digital Ireland/Viviti Technologies (Case COMP/M.6203) OJ C 241/06 of 23 November 2011 8. Paragraph 62 of the Notice 9. Varca Chemists and Druggists v.

Chemists and Druggists Association, Goa (MRTPC 127/2009/

DGIR4/28), decided on 11 June 2012; Vedant Bio Sciences v.

Chemists &Druggists Association of Baroda (C-87/2009/DGIR), decided on 5 September 2012; M/s Santuka Associates Pvt. Ltd. v. All India Organisation of Chemist and Druggist (AIOCD), Organisation of Pharmaceutical Producers of India (OPPI) and Indian Drug Manufactures Association (IDMA) (Case No. 20/2011), decided on 19 February 2013; M/s Sandhya Drug Agency v. ADDA, BDDA, AIOCD, IDMA, OPPI, (Case No. 41/2011), decided on 9 December 2013; Peeveear Medical Agencies v. AIOCD and Janssen (Case No. 30/2011), decided on 9 December 2013; and Arora Medical Hall v. Chemists and Druggists Association, Ferozepur (Case No. 60/2012), decided on 5 February 2014.

10. In re Bengal Chemist and Druggist Association, 02/2012 11. Please see Section 48 of the Act Abir is a competition law partner at Khare Legal Chambers. He has authored a book on “Competition law in India” published by Eastern Law House in 2014.

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RESEARCH RESEARCH UPDATES

Psoriasis or rheumatoid arthritis linked to heart risk Patients with psoriatic arthritis were 36 per cent more likely than the comparison group to suffer a heart attack SEVERAL CONDITIONS that stem from a malfunctioning immune system — psoriasis, psoriatic arthritis and rheumatoid arthritis — may create a higher than average risk for heart-related problems and death, a new study finds.

“It’s not terribly surprising that there is an increased risk of

heart disease because of the similar levels of systemic inflammation,” said co-lead author Dr Alexis Ogdie of the rheumatology division in the Perelman School of Medicine at the University of Pennsylvania in Philadelphia.

Whole-body inflammation has also been linked to prema-

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ture plaque buildup in the arteries, Ogdie told.

The rough, red skin patches characteristic of psoriasis are caused by a chronic autoimmune disease affecting 7.5 million people in the US, according to the National Psoriasis Foundation, and can be treated with topical creams, ultraviolet light

therapy or drugs.

10 to 20 per cent of people with psoriasis also develop a form of inflammatory arthritis associated with the disease, according to the Centers for Disease Control and Prevention.

Rheumatoid arthritis is a systemic inflammatory disease caused by the immune system as

well. It affects more than one million U.S. adults, mostly women, according to the American College of Rheumatology.

“Psoriasis and rheumatoid arthritis have previously been linked to heart disease but there have been limited studies in psoriatic arthritis,” Ogdie said.

For the new study, Ogdie and

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RESEARCH

her colleagues used primary care medical records in the UK to compare more than 138,000 adults with psoriasis, another 8,700 with both psoriasis and psoriatic arthritis and almost 42,000 people with rheumatoid arthritis to more than 81,000 other adults with none of the conditions.

The analysis followed all the subjects between 1994 and 2010.

More than half of those with rheumatoid arthritis or psoriatic arthritis had been prescribed a disease-modifying antirheumatic drug (DMARD) such as methotrexate, sulfasalazine or azathioprine, or a biologic DMARD like adalimumab.

Patients with any of the conditions were more likely to suffer a heart attack, cardiac arrest or stroke, or to die from one of those, over the 16-year period.

Those with psoriatic arthritis were 36 per cent more likely than the comparison group to suffer a heart attack, regardless of whether they had been prescribed a DMARD. A similarly heightened risk was seen among patients with severe psoriasis who had been prescribed a DMARD and those with rheumatoid arthritis who had not been prescribed a DMARD. Those with rheumatoid arthritis who had been prescribed a DMARD had the greatest risk, almost twice that of people in the comparison group, of suffering a heart attack, according to the results in the Annals of the Rheumatic Diseases.

There was a comparable increase in risk for cardiovascular problems generally. Those with psoriasis who had not been prescribed a DMARD, and therefore probably had less severe disease, had the smallest increase in risk.

“Theoretically, treatment of the systemic inflammation and improvement of disease activity through the

use of immunosuppressive medications should then decrease the development of atherosclerosis and the risk of heart disease,” Ogdie said.

But it is very hard to make that judgment based on this kind of retrospective study, she said.

People with the most severe disease are also the most likely to be receiving rigorous treatment, she said, so it is hard to say whether the immune disease or the treatment is linked to their increased risk of heart disease.

The findings of increased risk are not new, said Dr Dafna Gladman, who studies rheumatic diseases at the University of Toronto but was not involved in the analysis. What is new, she said, is the study looked at “a huge number of patients.”

However, the number of patients with psoriatic arthritis in the study seems quite low, said Gladman, since up to 30 per cent of people with psoriasis also develop arthritis, and that may affect their results.

“A lot of people with psoriasis actually have arthritis even though doctors don’t recognise it,” Gladman said.

But that doesn’t detract from the results. In fact, the increased risk for people with psoriatic arthritis may be even higher than what they found here, she said.This study and others have found moderate increases in heart risk, Ogdie said.“Cardiovascular disease remains a leading cause of morbidity and mortality,” said Dr Ole Ahlehoff of the Cardiology Department at The Heart Centre at Copenhagen University Hospital Rigshospitalet in Denmark, who was not part of the new study. “Patients with psoriasis, psoriatic arthritis and rheumatoid arthritis should be educated that there is more to these conditions than skin and joint symptoms,” Ahlehoff said.

EP News Bureau-Mumbai

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RESEARCH

DRDO scientists develop Ayurveda-based drug for leucoderma DIBER has transferred the technology of the drug, which is being showcased at the ongoing Arogya Expo 2014 INDIA’S DEFENCE scientists have developed a drug from medicinal plants that is proving to be effective for leucoderma (white patches on skin), considered an incurable disease. It is currently on display at Arogya Expo of World Ayurveda Congress.

The herbal drug, Lukoskin, has been developed by the scientists of Defence Bio-Energy Research (DIBER), Haldwani (Uttarakhand), a laboratory of Defence Research and Development Organisation (DRDO), Defence Ministry.

36 EXPRESS PHARMA November 16-30, 2014

DIBER has transferred the technology of the drug, which is being showcased at the ongoing Arogya Expo 2014 alongside the 6th World ayurveda Congress, to AIMIL Pharmaceuticals India Ltd for its commercial production and sale.

Dr Mohammad Junail, AIMIL said his company has signed an agreement with DRDO for the commercial launch of three of their herbal products. “Lukosin has already been launched. The two other products will soon be commercially launched in Indian mar-

kets,” he informed.

Leucoderma is generally considered an incurable disease, but Lukosin has been extremely effective against it.

“The quest to cure leucoderma (vitiligo) has finally ended with the development of the new herbal product with extensive studies by the scientists of DIBER. It can effectively combat the ailment and render the much needed service to mankind,” Dr W Selvamurthy, DRDO. EP News Bureau-Mumbai

PHARMA TECHNOLOGY REVIEW VENDOR NEWS

Oviya MedSafe launches pharmacovigilance consulting and drug safety service packages OVIYA MEDSAFE, a global pharmacovigilance consulting and drug safety services company based out of Coimbatore, India and London, UK has launched comprehensive drug safety service packages in line with the compliance requirements for pharmaceutical companies and marketing authorisation holders operating in the RoW (Rest of World) region.

Oviya MedSafe will also render pharmacovigilance consulting support to the regulatory agencies and the pharma industry in this region. This strategy is aimed at promoting the adoption of international standards of pharmacovigilance practices, especially among small and mid-sized innovators and generic drug marketers of any size in the fast-emerging RoW region, by fulfilling their endto-end drug safety obligations in an economical and efficient manner.

The term RoW region, traditionally meant to refer to the countries in the Asia Pacific, Latin American, Eastern Europe, African and Middle East regions, is an important market for exporters of pharma products and medical devices globally, in terms of business expansion and revenue. The need for pharmacovigilance compliance in RoW assumes more significance as the demand for harmonisation and implementation of regulations is growing across all markets.

Dr J Vijay Venkatraman, Managing Director and Chief Executive Officer, Oviya MedSafe said, “Drug safety regulations across the globe are becoming more and more stringent, especially in the emerging markets. While drug safety systems geared to comply with

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PHARMA TECHNOLOGY REVIEW stringent regulations are already in vogue in developed countries, establishing such systems in the RoW region remains a huge challenge for the pharma industry due to various reasons such as relative unavailability of relevant expertise, differences in regulatory requirements within the RoW countries, limited budget allocations for pharmacovigilance activities and so on.”

Oviya MedSafe’s comprehensive service packages include assessment of the marketing authorisation holders’ obligations and execution of the applicable pharmacovigilance tasks such as adverse event reporting (including electronic submissions where required), literature monitoring, aggregate reporting, risk management planning, signal detection and any other services, as appropriate.

EP News Bureau-Mumbai

BASF to increase production capacity for tBa plant in China Strengthens BASF’s global leading position in tertiary butylamine BASF WILL expand the production capacity of its existing world-scale production plant for tertiary Butylamine (tBA) at the Nanjing Chemical Industry Park in China. tBA is a primary aliphatic amine that is used in the pharmaceutical and agricultural industries as a building block as well as an intermediate for the production of accelerators for the rubber and tire industry.

According to a company release, the company plans to increase the existing production capacity from 10,000 tonne to 16,000 tonne per year. The expansion is ex-

BASF APPOINTS SANJEEV GANDHI TO THE BOARD OF EXECUTIVE DIRECTORS The Supervisory Board of BASF has appointed Sanjeev Gandhi to the Board of Executive Directors effective December 1, 2014. He has been head of BASF’s Intermediates division since 2010.After 12 successful years on the Board of Executive Directors, Dr Andreas Kreimeyer will retire with the expiration of his contract following the Annual Shareholders’ Meeting on April 30, 2015.

pected to come on stream in early 2015, subject to regulatory approval.

“The expansion will enable us to continue meeting the notably increased demand of our customers in Asia especially China reliably out of our local assets in China. We are proud to support the growth of our customers as their reliable local supplier with our commitment in product stewardship and high safety standards,” said Guido Voit, Senior Vice President, BASF Intermediates Asia Pacific.

EP News Bureau-Mumbai

Waters Centers of Innovation Programme honours Colorado State University Laboratory Proteomics and metabolomics facility recognised for innovation in biological mass spectrometry WATERS CORPORATION officially welcomed Colorado State University’s proteomics and metabolomics facility into its Centres of Innovation Programme in a recently held ceremony at Colorado State University’s Fort Collins, CO campus. The proteomics and metabolomics facility is equipped with a Waters Xevo G2 QToF, Xevo G2 ToF, and two Xevo TQ-S systems, all paired with Waters ACQUITY UPLC systems, an instrument for separating sample components from one another and precisely delivering the analytes one by one into the mass spectrometer where the amounts of each analyte are

38 EXPRESS PHARMA November 16-30, 2014

measured and identified.

Under the direction of Dr Jessica Prenni, the facility has earned a reputation for excellence in applying non-targeted proteomics and metabolomics using liquid chromatography and mass spectrometry (LC/MS) to advance food and veterinary science and clinical and microbacterial research.

“We take pride and ownership that our discoveries will have a meaningful impact and we recognise the importance of partnerships with corporations like Waters,” said Alan Rudolph, Vice President for Research, Colorado State University. “We’ve seen the impact on science that instrumenta-

tion, microfluidics separations, higher resolution, and the ability to look at complex mixtures, can have both here and abroad. We are excited about our partnership with Waters as a way to fuel new discoveries and allow us to live up to our land grant ethos.”

As part of its academic mission, the proteomics and metabolomics facility develops and validates assays, tools and techniques. In the last year, Prenni’s team has assisted over 200 principal investigators in 24 departments at six colleges.

“One of the biggest advantages of our partnership with Waters is early access to tech-

nology, such as the ionKey/MS system,” said Dr Prenni. “Using this technology, we developed an assay for one of our clients for five clinically-relevant steroidal compounds which has been applied to a clinical data set of 1,000 serum samples from postmenopausal women. The method showed significant increases in sensitivity, decreases in solvent consumption as compared to traditional assays as well as an ability to separate structural isomers.

This project is a great example of how our collaboration with Waters has led to the development of new technologies and allowed us to advance the way

we answer important biological questions.”

Eric Fotheringham, Director, Waters Centers of Innovation Programme also congratulated the team.

In conjunction with the centres of innovation programme ceremony, Colorado State University (CSU) and Waters Corporation co-organised a symposium on Advances in Biological Mass Spectrometry featuring presentations by Prenni and Dr Karen Dobos of CSU, Dana Sedin of the New Belgium Brewery and Vladimir Shulaev of the University of North Texas.

EP News Bureau-Mumbai

PHARMA TECHNOLOGY REVIEW

Elanpro showcases bio medical products at ASTICON 2014 The products are widely used in hospitals, laboratories, pharmacies, blood banks, research centres and universities ELAN PROFESSIONAL Appliances (Elanpro), a leading commercial refrigeration company, showcased its entire range of bio medical refrigeration products including pharma refrigerators, chest freezer, medicine coolers, solar and battery freezer, ice lined refrigerator and ice flakers and ice cube machines, at the recently held 38th annual conference of Indian Association of Sexually transmitted disease and AIDS (ASTICON 2014).

The expo was held in Chandigarh.

Chest freezer/chillers, solar/battery freezer, ice line refrigerator/ freezer, medicine coolers, pharma refrigerator, laboratory freezer and refrigerator — frostfree, laboratory freezer and refrigerator static, upright freezers — static, upright freezers — frostfree, ice cube machine and ice flaker were showcased during the conference.

Elanpro’s Biomedical Refrigeration product range provides safe storage, transport and handling of temperature-sensitive preparations in the appropriate optimum conditions without any risks. The company has been supplying its products to leading names like AstraZeneca, Apollo Hospitals, Wockhardt etc. Elanpro also offers a comprehensive range of

The products showcased covered the spectrum of the specific and exacting needs for hospitals, laboratories, pharmacies, blood banks, research centres and universities commercial refrigeration and foodservice products, serving the hospitality, retail and life sciences sector.

Sanjay Jain, Director, Elanpro said, “We offer an exclusive range of products catering to the needs of various vaccination programmes to fight deadly diseases. Our focus is on energy efficiency and cost effectiveness.

We also provide secure life sciences solutions.”

The products showcased

by Elanpro cover the spectrum of the specific and exacting needs for hospitals, laboratories, pharmacies, blood banks, research centres and universities. Elanpro provides specially designed pharma refrigeration solutions to meet the requirements of civil aid organisations for the transport of temperature sensitive supplies such as blood and blood products, vaccines, plasma, blood samples and pharmaceutical products.

EP News Bureau-Mumbai

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November 16-30, 2014

PHARMA TECHNOLOGY REVIEW PRODUCTS

Cognex introduces next-generation handheld readers COGNEX CORPORATION has launched the next generation DataMan 8600 series of handheld direct part mark (DPM) barcode readers. The DataMan 8600 provides unparalleled barcode reading performance for manufacturers implementing part traceability programmes across the automotive, consumer electronics, aerospace, and oil and gas industries.

DataMan 8600 series readers combine industry-tested 2DMax+ algorithms and patented Cognex UltraLight technology to read the most challenging DPM codes on the widest range of materials and surfaces.

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Baltimore Innovations launches automated packaging systems BALTIMORE INNOVATIONS has launched a new range of automated packaging systems designed to add desiccants to high-speed production lines. The new desiccant dispensing machine can insert silica gel or molecular sieve sachets directly into pharmaceutical bottles, or place the desiccants onto diagnostic medical devices as they are packaged into protective film pouches using flow-wrapping systems.

It will offer a desiccant label applicator which heat-stakes desiccant-plastics directly

40 EXPRESS PHARMA November 16-30, 2014

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November 16-30, 2014 53

PHARMA LIFE I N T E R V I E W

‘LSSSDC expects reducing spending on employees training vastly’ It has been found that incidence of fake degrees and certificates is the highest in the life sciences sector and companies are facing difficulties in appointing qualified manpower.

To overcome these issues, Indian pharma and academic associations have formed a new body called Life Sciences Sector Skill Development Council (LSSSDC) to streamline the process and avoid misconduct. Ranjit Madan, Chief Executive Officer, LSSSDC shares details of its working mechanisms and vision, with Usha Sharma The National Skill Development Corporation (NSDC) has been mandated to set up Sector Skills Councils for addressing the skill shortfalls in various sectors, including the life sciences sector. Tell us more about it and the steps it would implement?

NSDC is a public private partnership (PPP), a first-ofits-kind model with 51 per cent from private and 49 per cent public holding. It has been mandated to skill 150 million people by the year 2022. A key vehicle for delivery of this is the Sector Skill Councils (SSCs), which are being set up to address the issue of skill shortfalls in key sectors. The Life Sciences Sector Skill Development Council (LSSSDC), set up by NSDC, in co-operation with CII and Satish Reddy, Chairman, Dr Reddy’s Lab as its Chairman, was registered as a society in May 2014. It will focus on skill deficiencies in pharma, biotechnology and clinical research sectors. The skill shortfall issue is especially relevant for the life sciences sector. In a recent study, it has been found that incidence of fake degrees and certificates, is the highest in the life sciences sector, with about 35 per cent found indulging in this fraud. With this background, LSSSDC aims to certify skilling of approximately 3.4 million over

54 EXPRESS PHARMA November 16-30, 2014

a 10 year period. It will do so, by first and foremost, mapping all job roles (estimated to be around 100), across functional areas and levels in the life sciences sector, and developing National Occupation Standards (NOSs) for each of the roles, with inputs from industry. This exercise has commenced, and NOSs for four roles relating to medical sales representative, production chemist, quality assurance chemist, quality control chemist have already been put up on websites of NSDC and LSSSDC, undergoing further industry validation. A fifth, related to machine operator for tablet and capsule manufacture is almost completed. NOSs for balance roles are expected to be developed within February, 2015. The next steps in the skilling process involve, accreditation of suitable ‘Training Partners’, helping them dovetail curriculum for specific courses related to job roles, so that they mesh with the NOSs, helping conduct ‘Training of Trainers’ with the aid of Master Trainers (inducted from industry), and finally certification of skilled trainees by the council, with help from assessors (again possibly with industry experience).

Which major associations have been involved in the formation of the LSSSDC?

LSSSDC was set up in May 2014, and founding members of its Governing Body had IDMA, BDMA, Pharmexcil, ABLE and ACRO from the industry and , NIPER and DIPSAR from the academia.

Thereafter, other major industry associations viz IPA, OPPI and CIPI have come on board. Today, we can proudly say that all major associations in the life sciences sector are on our governing body. CIPI is the largest association representing small scale sector. For inclusivity, it was important to have this association, so that inputs and viewpoints of small scale sector are taken into account in all that we do.

In a recent study, it has been found that incidence of fake degrees and certificates, is the highest in the life sciences sector

What is the objective behind setting up the LSSSDC? How will it function and what are its mechanisms?

The life sciences sector faces a significant skill gap across levels, in both qualitative and quantitative terms. The LSSSDC seeks to address this by focusing on sector-specific competencies/skills, quality assurance through accreditation of the skills acquired by trainees, curriculum development for the skills training, qualification framework and setting of standards and benchmarks, facilitating recruitment and placement of trained and skilled workforce, and

ultimately becoming a repository of information. It will do so by adopting a quality focused, comprehensive, scalable and sustainable model which has full support and involvement of industry. In executing this, it will rely heavily on its governing body which has members from all major associations in Life Sciences IPA, OPPI, IDMA, BDMA, CIPI, Pharmexcil, ABLE and ACRO, Academia— NIPER and DIPSAR. It will also leverage its principle stakeholders, including CII and NSDC and its partners, such as KPMG (inducted as a ‘Knowledge Partner’).

LSSSDC will first focus on the five major pockets of concentration of Life Sciences industry- Baddi in HP, Hyderabad, Ahmedabad/Gujarat, Mumbai/Vapi/Vadodara cluster and Bangalore.

Activity in Baddi and Hyderabad has already been kicked off through a seminar and a workshop respectively, and potential ‘Industry Partners’ identified in each.

Objective will be to develop, with support of industry partners, an entire ecosystem (comprising training partners, master trainers, trainers and assessors) conducive to skilling—in and around each pocket of concentration.

Does this type of initiatives

PHARMA LIFE exist in other countries too?

Countries such as Germany, the UK, Australia and Switzerland recognised the importance of skill development a long time ago and this initiative is well entrenched there. In fact, Germany and Switzerland owe much of their success of competitiveness and being leaders in manufacturing in specific sectors due to this initiative.

How will the funds be raised for accelerating the LSSSDC's programme and by when will it become selfsufficient?

LSSSDC, like other SSCs, is a ‘not for profit’ organisation. Funding for the first three years will be through grant from NSDC, as also contribution from the industry, via the mentioned associations. Thereafter, the council aims to become selfsufficient through revenue flows, triggered from accreditations, assessments and certifications.

Which are the portfolios in the industry that face maximum issues due to scarcity of qualified workforce and why?

First of all let us put things in perspective, life sciences, comprising pharma, bio technology and clinical research, is a highly fragmented sector with estimated over 10,000 units, bulk of which are in the small and unorganised sector. It is also highly globally connected, with over 50 per cent of revenue coming from exports, a high volume of imports, and an increasingly visible outsourcing trend. The challenges and complexities related to skill shortfalls are expected to vary greatly depending on the type of skills (hard and soft), size and type of organisation (small/ unorganised, Indian/MNC), the sub- sector, functional area in question, and indeed the region of location. Just as an example, skill needs and shortfalls in MNC’s may be more skewed in favour of sales and marketing (as opposed to manufacturing/ R&D in Indian

The vision of the council is to create a robust and vibrant eco-system for the development of a skilled workforce matching globally recognised standards for life sciences sector in India firms); small and unorganised sector may have many job roles intertwined and combined into one, whereas large firms may have clearly segregated job roles. For the more technical roles, the level of technical skills of those hired in Gujarat and Maharashtra may be higher than say in North, whereas, the same variance may not hold when it comes to softer skills. Further details relating to the question posed, especially with above backdrop, are rather sketchy at this point. A comprehensive skill gap study needs to be done and is currently under way with the help of KPMG. This is expected to be completed in the next few months. What we can say with certainty is that job roles where volume is highest are more likely to be in pharma sector at the entry level (bottom of the pyramid), in functional areas relating to manufacturing and QC, R&D and sales and marketing.

Reasons for skill shortfalls are many, complex and interrelated. These include, absence of job standards and benchmarks, inadequate infrastructural facilities (so vital in a manufacturing sector such as life sciences), inadequate funding to set up skilling facilities, shortage of

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trainers, as also rather low interest on part of students to make a career in Life Sciences sector.

How will LSSSDC recognise the people enrolled for the programme? How will it prove effective to them in their professional career?

LSSSDC will be responsible for keeping a check on quality right through the ‘skilling chain’, including crucially, certifying those skilled for specific job roles.

The expectation is that the industry will recognise the difference in quality (skills) between those certified by LSSSDC and others, which will then promote hiring of the former ie those certified by the Council. The fact that we have all the major associations represented on our governing body, should enable message to percolate in the sector through ‘word of mouth’. One of the advantages of a paradigm shift from a ‘supply determined’ system as exists at this point in the country (where students get diplomas/degrees, and upon joining the workforce in any sector, are found wanting in skills), to a ‘demand/industry - led’ model, where requirements of each job are detailed in the form of ‘Occupation Standards’, is that anybody certified by a skill

council, can hope to seamlessly move not just vertically, but across functions, and indeed sectors. All that a person would need to do is bridge the gap between NOSs that he or she has already attained, and requirements of where the person aims to get to. And this can then be done through either on the job training (OJT) or undergoing ‘skilling courses’ or both.

What is the average spend of individual pharma companies on employees' training programmes? How will LSSSDC help pharma companies reduce this amount?

On the average an organisation in life sciences is estimated to be expending 50 per cent of CTC of a person hired –on skilling/ re-skilling, as also associated costs of attrition, low productivity.

Through the processes outlined above, LSSSDC expects this to be vastly reduced.

Share details of LSSSDC's curriculum and what are the priority areas?

As shared, we have just started a detailed study on skill gaps leading to development of NOSs. In between, there will be a series of processes involved in the skilling chain. We will also aim

to have a robust LMIS in place in three years time and Academies of Excellence (for example one with a pool of ‘Master Trainers’), and possibly having an annual function to recognise and award the best trainers and master trainers. The process should though culminate in, and this is crucial, a set of job ready - skilled workforce who should get employed in the industry. The industry must support this so that the model remains strong.

In terms of priorities, there are three areas we must be very cognisant of 1) Quality: Recognising that cost of errors in this sector is not just in financial terms, but impacts human life. This is highest priority 2) Inclusivity: Knowing that almost 90 per cent of the units in this fragmented sector are in the small and unorganised sector, and so that we can help those from rural settings to find gainful employment at the ‘bottom of the pyramid’ 3) Global standards: Realising that this is a highly globally interconnected sector, the benchmarks and standards, at least for specific job roles, should be international How many skilled force will you be able to give to the industry in the next two to three years?

We aim to provide certified skilled professional of around 10,000, across functional areas/ levels, over next three years.

What is the vision of the LSSSDC? The vision of the council is to create a robust and vibrant eco-system for development of a skilled workforce matching globally recognised standards for life sciences sector in India, benefiting all stakeholders.

This, whilst ensuring a sustained supply of skilled workforce, across functional areas and levels, will provide meaningful livelihood opportunities to a multitude of people in pharma, biotechnology and clinical research space in India. u.sharma@expressindia.com

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PHARMA LIFE APPOINTMENT

JP Nadda is new Health Minister Nadda will replace Dr Harsh Vardhan AS PART of PM Narendra Modi’s Cabinet reshuffle/expansion over the weekend, Dr Harsh Vardhan has made way for JP Nadda. The former was shifted to the relatively low profile Science and Technology, Earth Sciences portfolio but political observers say the lighter profile will allow him to take a more active role in the BJP’s Delhi Assembly campaign as elections are due to be held early next year.

Nadda, born December 2, 1960) is a Rajya Sabha MP from Himachal Pradesh and was the former member of Himachal legislative assembly and a member. More recently, he is believed to be behind the removal of Sanjiv Chaturvedi from the post of chief vigilance officer (CVO), AIIMS. EP News Bureau-Mumbai

INITIATIVE

Merck lends support in fight against Ebola Donation of € 250,000 made to the German Red Cross GLENMARK PHARMACEUTICALS has won the Civic Award 2013-14 for Social Development by the Bombay Chamber of Commerce and Industry (BCCI). The accolade was presented to Glenmark for its exemplary initiatives in the area of Corporate Social Responsibility (CSR) through which the company has positively impacted over 600,000 lives till date.

The award was received by Cheryl Pinto, Director Corporate Affairs - Glenmark in Mumbai recently. The Bombay Chambers Civic Awards was instituted in 1984 with an objective of promoting good corpo-

56 EXPRESS PHARMA November 16-30, 2014

rate citizenship and rewarding and recognising the best practices in CSR. Pinto said, “The award is a testament to our continued commitment of enriching lives and making a positive difference in the communities in which we operate. It acknowledges Glenmark’ s contribution in impacting over 600,000 lives through our initiatives in child health, sustainable livelihood, providing access to healthcare through medicine donation and global employee volunteering programmes.”

Thanking the company’s employees and NGO partners for

their unstinted support and dedication, she added, “I am sure this recognition by a leading industry body will provide us the impetus to pursue our mission of enriching lives with renewed vigour.”

Instituted with the mission of ‘Enriching Lives’; Glenmark Foundation, the CSR arm has been implementing several projects for the benefit of the less privileged sections of the society under three core areas: child health (flagship programme), sustainable livelihoods and employee volunteering.

EP News Bureau-Mumbai

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.

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