Express Pharma January 1-15, 2014 by Indian Express

VOL .9 NO.5 PAGES 72

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Market Whatâ&#x20AC;&#x2122;s in the cards for 2014? Management Time for an alternative patent system? Pharma Life Resolutions for 2014 1-15 JANUARY 2014, ` 40

CONTENTS Vol 9 No.5 JANUARY 1-15, 2014

Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury* BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das 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 Layout Rakesh Sharma Photo Editor Sandeep Patil MARKETING Deputy General Manager Harit Mohanty Senior Manager Rajesh Bhatkal PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Rohan Thakkar CIRCULATION Circulation Team Mohan Varadkar

MARKET

Resolutions for 2014 Anewyear signifies different things to different people: newhope,a newstart,plans to take one more shot at tasks left half done ...or a chance to chart a newpath completely.Getting into the spirit of the season, Express Pharma asks veterans of the Indian pharmaceutical industryto share their goals and resolutions for 2014 | P62 P23: GROWTH TRACKER IPM clocks `6291 crores in November 2013

P34: RESEARCH UPDATE

Romaco’s FK HelpLine is FrymaKoruma’s new point of contact

PLAN GOALS ON MONTHLY BASIS TO ACHIEVE YEARLY GOALS

‘A BOUQUET OF FITNESS REGIMES FOR THE NEW YEAR’

HIRING ACTIVITY IN PHARMA SECTOR DIPS 4 PER CENT IN NOVEMBER

Anshul Life Sciences partners with JH Nanhang

P39: PRODUCT

‘INDIA IS ONE OF THE FOCUSSED COUNTRIES FOR MENARINI IN TERMS OF INVESTMENT’

LILLY ENTERS BRANDED GENERICS MARKET WITH LAUNCH OF LIL THERAPEUTICS

INDEGENE AND DRUGLOGIC TO OFFER FULL LIFECYCLE DRUG MONITORING

BIOCON INKS LICENSING PACT WITH US-BASED QUARK PHARMA

CII ORGANISES 3RD NATIONAL

PHARMA LIFE

New drug target brings malaria cure closer

P38: VENDOR NEWS

CONFERENCE ON AGRI-BIOTECHNOLOGY

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

Prognosis for 2014: Healthy but regulatory reform remains a concern

he last month of 2013 had a significant number of fairly high profile, high value private equity (PE) deals focused on the pharmaceutical and healthcare sectors. While Blackstone sold its stake in Emcure Pharmaceuticals to Bain Capital, Carlyle picked up minority stakes in Medanta Hospitals, and Quadria Capital bought majority stakes in Medica Synergie. Late December also saw GlaxoSmithKline (GSK) announce an open offer to raise its stake by around 25 per cent in its Indian pharma arm, intending to take it up to 75 per cent. The company had already done the same in its consumer health arm earlier this year. November’s announcement of an investment of `864 crores to set up its sixth manufacturing unit in the country, is another serious vote for India. And Torrent Pharma’s buyout of Elder Pharma’s domestic formulation business once again raises hopes that the long-over due consolidation among domestic companies will finally pick up momentum. Torrent jumps up five places in market share rankings and analysts have hailed this deal from all angles. So will 2014 see more consolidation in the fragmented Indian pharma industry? Will ‘selling the family silver/selling out’ be seen as a much more strategic tactic rather than merely survival? And what about MNCs like GSK who are digging themselves deeper into the trenches in developing markets like India? Is GSK’s move a reaction to the flak it is facing from China’s regulatory whips? Is India seen as a softer regime, when it comes to such regulatory matters? Growth in the matured markets like the US and EU has, well, matured to low single digit growth and many pharma MNCs are girding themselves up for even worse times, as the Affordable Care Act and the Sunshine Act gather momentum in the US market. In preparation for such moves, MNCs like GSK and AstraZeneca have already announced measures to fall in line, by withdrawing sponsorship of doctors for conferences as well as de-linking performance assessments of their sales personnel from prescriptions generated. Developing/emerging markets (EMs) are thus where the volume growth is projected to come from, especially as the spend on medicines per person is far below global figures. The Indian pharma market too has seen

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There is a growing school of thought that developing nations need an alternative patent system.The WIPO is already doing this for traditional knowledge and cultural expression (imagine that the numerous Indian folk arts and crafts can be protected by patents!)

shrinking sales, hit by new pricing norms. The many policy changes (clinical trial regulations, FDI policy) as well as impending general elections seem to have spooked most corporates into a wait-and-watch mode. On the patent front, the stand off between developing and developed nations is set to reach new flashpoints in 2014, as the later try to get the former to sign regional trade pacts beyond existing ones like ACTA and TRIPS. There is a growing school of thought that developing nations need an alternative patent system. The World Intellectual Property Organization is already doing this for traditional knowledge and cultural expression (imagine that the numerous Indian folk arts and crafts can be protected by patents!) To take the discussion further, Express Pharma gets two experts from opposing sides to present their arguments. Dr Gopakumar Nair, founder of Mumbai-based Gopakumar Nair Associates, argues that provisions like Sec.3(d) which has helped restrict ‘ever-greening’ need to be further strengthened. In an equally meritorious counterargument, Dr Kristina Lybecker, Associate Professor in The Colorado College’s Department of Economics & Business points out that 63 per cent of the drugs on the WHO’s Essential Drug Lists are follow-on drugs and incremental innovation is especially critical to developing world patients as such innovations provide for more convenient, extended-release dosing and formulations that do not require refrigeration or are less temperature sensitive, which are valuable characteristics in developing country settings. (Read more on pages 30-33) In the light of all these changes, Express Pharma asked industry leaders to share their plans for 2014. Everyone seems anxious to bury 2013, confident that 2014 will be better for business though some analysts predict that the Indian pharma market will lag other EMs. Read more in our cover story (pages 8-16). But life is more than a corporate snakes-andladders game. With increasing stress levels, maintaining a work-life balance, (with family, friends, fitness regimes and hobbies), is more than important. We got top honchos to share their New Year Resolutions with us (pages 62-66). And with that, I wish our readers all the very best for 2014 ... VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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WHATâ&#x20AC;&#x2122;S IN THE CARDS FOR 2014? Most pharma leaders want to bid adieu to annus horribilis 2013 and ring in the new year with renewed focus and vigour. What's on their road map for 2014? Which global trends and events will impact Indian pharma the most? Express Pharma gets industry leaders and sector analysts to share their predictions for 2014 and beyond

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cover ) Adieu annus horribilis 2013

he year 2013 was probably one of the worst years for the Indian economy, with inflation running unbridled and economic growth grinding down to a level below five per cent. Unfortunately, the pharmaceutical sector also witnessed an unprecedented slowdown growing at barely 5.2 per cent in 2013 against an average growth of 12 per cent the previous year. The negative impact was further compounded with adverse policy decisions w.r.t pricing, FDI, clinical trials and compulsory licensing in India. An overactive US FDA issuing notices to some of the leading Indian pharma companies tarnishing the image of the sector. Collectively all this made 2013 an 'Annus Horribilis’ for the Indian pharma sector.

The silver lining However, on the brighter side, India took the lead of developing and adopting biosimilar guidelines which enabled the approval of world’s first biosimilar of Herceptin for breast cancer, developed in India by Biocon and Mylan. The introduction of biosimilar Trastuzumab in India in 2014 will offer an affordable option for millions of cancer patients in India and in the other world markets subsequently.

2014: A promising year of positive change 2014, as the year of general elections, is expected to lead to a stable majority government at the Centre. Hopefully, that will be a starting point for some of the challenges to be addressed through bold policy

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KIRAN MAZUMDAR SHAW, Chairperson and Managing Director, Biocon

Year 2014 can be a year of positive change if every Indian citizen commits itself to engage with the political process reforms. We hope that the new government will be able to manoeuvre the winds of change and create real jobs, provide good infrastructure for industrial growth, ensure safety and security for women and promote better governance. We will need innovative solutions to address these numerous challenges and emerge as a robust economy.

Healthcare for all is a critical need which can only be addressed through access to affordable medicines. The government needs to enable affordable innovation by defining a smarter regulatory pathway that cuts the cost of drug development. Regulatory reforms that address issues related to Intellectual Property and clinical development coupled with use of technology for procurement will enable better access to drugs. The Indian pharma sector also needs to take corrective action to address non-compliance issues to regain the reputation of a provider of good quality affordable generics for the patients and healthcare systems across the globe. India has successfully leveraged its strengths of ‘low cost manufacturing’ and ‘quality of talent pool’ to gain global recognition, however, it now needs to ensure that it has rigorous processes for self -audit to ensure zero tolerance to non-compliance. For Biocon, 2014 holds good promise as we bring the world’s first biosimilar Trastuzumab to cancer patients in India, our novel biologic Alzumab makes a positive impact on the lives of several patients, our Malaysia plant nears completion and all our business verticals continue to report a robust growth. Year 2014 can be a year of positive change if every Indian citizen commits itself to engage with the political process, plays the role of an active citizen and demands good governance. Citizen participation is critical for creating an economically strong India that can gain global recognition.

Biopharma sector to continue on growth path

he biotechnology industry in India continued to see strong growth in 2013 on the strength of biosimilars; in terms of domestic market growth, exports, product/clinical development, new product launches and product-based partnerships. This trend is expected to strengthen further in 2014. At the same time, the industry has had to face several challenges in 2013, particularly with price erosion, greater competition, constraints in capital markets, currency depreciation and more stringent regulations for biotherapeutics. The industry would continue to face these challenges in 2014. Biotechnology is changing India in several ways: a) Making India largely self-sufficient in the critical medical product category of vaccines, plasma proteins and biosimilars b) Bringing biopharmaceutical (biosimilar) products and vaccines at affordable prices, thereby helping affordability and preventing use of sub-optimal dosages c) Bringing novel proteins and vaccines to address unmet medical needs d) Developing stem cell therapies to not only address unmet needs, but also to bring about a new era in regenerative medicine e) Enabling high-end molecular diagnostics and molec-

KV SUBRAMANIAM, President and Chief Executive Officer, Reliance Life Sciences

ular genetics to enable superior health care at competitive prices and obviate the need for patient samples to be sent to developed countries for testing f) Creating new export opportunities for India g) Enabling a contemporary innovation node in India h) Above all, helping improve the quality of health care in the country India has been able to make a mark in the world of biotechnology as a large producer of public-health vaccines and biosimilars at very competitive costs for global supplies.

Reliance Life Sciences and biotech Reliance Life Sciences has Continued on Page 11

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Rely on innovation, growth follows

ur focus is to expand and further our vision to develop new vaccines to combat infectious diseases that affect emerging markets. For Bharat Biotech the biggest aspiration for year 2014 is Rotavac roll out. We had a successful 2013 when we added two more important socially relevant public health driven vaccines Typbar TCV Typhoid Conjugate Vaccine and Jenvac (inactivated Japanese encephalitis vaccine) in our product portfolio. We also announced successful completion of Rotavac phase III clinical trials. The future seven billion populace of the emerging markets continue to offer the biggest growth opportunities with rising incidence of infectious diseases and growing public health problems that seek preventive public healthcare solutions. Going forward, we would also like to expand our collaborations with academic research groups and

global health agencies to bolster early drug discovery efforts, speed up basic science and translational research. Essentially we like to excel in all: innovation, product development, regulatory submissions, regulatory approvals, commercial launches. Immunisation against childhood diseases is one of the most cost-effective public health interventions for prevention of child illness and death. We hope the Government expands the list of vaccines under the national immunisation programme in 2014 and help reduce the nation’s disease burden. Vaccines are an integral part of development of nations, since their ROI is similar to that of investments made into primary education. As a new vaccine development and manufacturing company our goal is to support the government national immunisation initiatives in a manner that can lead to a healthy country and a healthy industry. Bharat Biotech is also en-

DR KRISHNA ELLA CMD, Bharat Biotech

hancing and consistently upgrading its quality management systems in compliance with global health agencies and international markets, to ensure a consistent supply of affordable quality vaccines. Our investments in R&D and in manufacturing facilities will also remain consistent with our

growth plans. We believe vaccines produced in the region have the potential for global use because of their affordable cost (and assured quality). This potential will provide for regional vaccine security. With this perspective in view, there are challenges that must be overcome for the region to realise its full potential in achieving self-reliance in the production of affordable vaccines of assured quality which can happen with wider public private partnerships. A classic example of PPP has been for the rotavirus and Jenvac Vaccine Development programmes where Bharat Biotech and governmental agencies collaborated right from identification of strain, the early research programmes, clinical trials, eventually leading to successful clinical trial successes. Our R&D pipeline continues to be strong with seven vaccine and three therapeutics product development programmes that

are under various stages of development. We are presently carrying out research on bioantibiotics, combination probiotics, lysostaphin, THR-100 (Recombinant staphylokinase Injection), chikungunya vaccine, oral rotavirus vaccine, malaria vaccine, and Staphylococcus aureus vaccine. In order to foster academic excellence, Bharat Biotech is supporting a M.Tech and PhD. programme for its employees. Several employees have benefited from the academic tie-up with Jawaharlal Nehru Technological University, Hyderabad for their M.Tech and PhD. degrees. Similar tie-ups are being worked out with other universities. Our effort is to maintain and enhance the momentum of progress achieved over the previous decade to make lifesaving vaccines available to the world’s children, in partnership with Global Alliance for Vaccines and Immunization (GAVI Alliance) and realising our pledge of a $1 vaccine for the world.

num. Within the biotech sector, the prospects are undoubtedly bright for vaccines and biosimilars, given the strong position that India has created, its competitiveness and the fact that a large majority of people in the world have limited or no access to biotech products. In order to achieve full potential of biotech sector, there is a need for partnership between industry and government, which recognises opportunities for the Indian biotech industry to be a global

leader, particularly in vaccines, biosimilars and regenerative medicine, and institutionalises policies that enable faster market entry at lower costs, without compromising product quality, safety and efficacy.

Biopharmaceutical sector.... Continued from Page 10 created a strong foundation in medical biotech with a range of products and services across plasma proteins, biosimilars, specialty pharmaceuticals, regenerative medicine, molecular medicine and novel proteins. It is now scaling up its product-market play. There are several products in clinical development, some novel proteins in pre-clinical stage and a host of product registrations in overseas countries that are currently underway. Concurrent with this, Reliance Life Sciences is

expanding manufacturing capacities consistent with the need for higher scales of production. In case of biosmilar products, Reliance Life Sciences has the distinction of launching three of the world’s first biosimilars – interferon beta, human chorionic gonadotropin and reteplase. It currently markets eight biosimilars and has 20 more under development. Some of the innovative work that Reliance Life Sciences has been doing is in de-

veloping therapies that meet unmet needs relevant to India – cord blood stem cell transplant for beta thalassemia and other blood disorders, siRNA molecules for anti-cancer and anti-viral (dengue fever), melanocyte stem cell therapy for pigmentation disorders, novel fusion proteins for head and neck cancer and biomarkers for oral cancer.

Future roadmap The biotech industry in India has the potential to grow at 20 to 25 per cent per an-

2014 outlook Reliance Life Sciences looks forward to 2014 with expectations of higher growth and profitability, on the basis of the depth of its product pipeline and diversity of its market participation.

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Will look to redesign product portfolio

he year 2013 was a mixed one for Indian pharmaceutical industry. Driven by regulatory reform and the desire to rein in healthcare expenditure, many developed countries have increased the use of generic products. These efforts have led to increased opportunities for Indian companies where pharma exports have shown robust growth. Many Indian companies have launched new products in the US and other advanced markets. Depreciation of the Indian rupee vis-a-vis major world currencies have

also aided the export growth. The growth in the domestic market, however, has slowed down considerably to 9.8 per cent in 2013 from 16.6 per cent in 2012. Drug Price Control Order 2013 has had an impact on the topline growth of pharma companies. Challenges with product offtake by stockists and introduction of free medicine schemes in some states have also impacted growth in the domestic market. Delays in approvals for clinical trials as well regulatory issues like restriction on FDI in pharma, uniform code for sales and

marketing, compulsory licensing have also had an adverse impact on the pharma sector in India.

2014: Renew and redesign

SUJAY SHETTY, Leader - Pharma and Life sciences, PwC India

Looking ahead to 2014, Indian companies will look to redesign their product portfolio keeping in mind the price control requirements. They will look to take advantage of the opportunities offered by biosimilars. To be able to capitalise on these opportunities, Indian pharma companies would need to renew their focus on manufacturing quality to ensure that they are adher-

ent to the norms of the regulatory agencies. They would also need to focus on enhancing the productivity of their sales forces, improving the manufacturing and supply chain efficiency and improving compliance. Information technology will play a major role in achievement of these objectives. India has a large pharma industry which has been providing low priced medicines not just for the Indian market but for global customers too. Pharma industry thus has a major role to play in ensuring health security for all.

cover ) Making healthcare affordable,accessible

ales performance of Indian Immunologicals Ltd (IIL) till December 2013 has been satisfactory. The sales performance represents double digit growth compared to the previous year. IIL through its quality products is currently catering to some of the key disease control programmes in the country such as Foot and Mouth disease (FMD), Brucella and Pest Petits Ruminants (PPR). IIL is playing a crucial role in control of FMD by supplying close to 80 per cent of the vaccine requirement for the FMD Control Progarmme (FMDCP). Retail sales of Animal Health (AH) division continues to show good growth. AH Division obtained manufacturing license for Bruvax Plus, a modified vac-

cine Brucella abortus S19 strain for control of brucellosis. Another product Bruvax Delta, containing Brucella abortus RB 51 strain has been licensed. Both the products are being made available to the farmers for the first time. These new vaccines are going to play an important role in providing protection to female calves and adult animals. In the formulations market, IILâ&#x20AC;&#x2122;s star formulation product, Nimovet has exceeded sales of Rs one crore per month. Sales in the Companion Animal Health (CAH) segment have been strong with about 38 per cent growth. Raksharab a rabies vaccine for companion animals continues to keep its leadership position. In the Human Health (HH), IIL has been identified as one of

DR K ANAND KUMAR, Deputy Managing Director, Indian Immunologicals

the most preferred supplier of paediatric vaccines to the Uni-

EMs to show higher growth

he developed markets of North America, Europe, and Japan will see very modest single-digit spending growth, due to a combination of economic and healthcare austerity measures and the savings realised from the growing availability of lower cost generic versions of brands following their patent expiry. In contrast, many (but not all) leading pharmerging markets, show much higher double-digit growth rates due to a combination of economic growth, demographic and epidemiologic changes, increased access to medicines as infrastructure and health systems evolve and improved state and private insurance funding for healthcare and medicines.

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versal Immunization Programme (UIP) of Ministry of Health and Family Welfare. IIL has supplied more than a 100 million doses of DPT vaccine and has orders to supply more. The supply of life saving rabies vaccine, Abhayrab to various state governments is consistent during present financial year. On the export front, IIL continues to do well and has bagged key orders for supply of its human Rabies vaccine to Turkey. IIL commissioned its new veterinary formulation facility at Biotech Park Phase III in Karakapatla, Hyderabad. It has started commercial production in June 2013. The human vaccine facility in Karakapatla is expected to start commercial production during first quarter of

next financial year. Continuing with the legacy of introducing new vaccines through in-house R&D, IIL is in an advanced stage of introducing new vaccines for animal health as well as human health. Animal health vaccines include blue tongue vaccine, multivalent companion animal vaccine, classical swine fever vaccine, goat pox vaccine, infectious bovine rhinotracheitis vaccine etc. Some of the human health vaccines are undergoing preclinical and clinical studies such as tetravalent vaccine, pentavalent vaccine, JE vaccine, chikungunya vaccine, HPV vaccine. IIL as an organisation is committed to its mission of making healthcare affordable and accessible.

EMs gain global attention

AMIT BACKLIWAL, Managing Director, IMS Health - South Asia

ith rapid economic growth and an ambition to improve the standard of living, emerging markets are gaining global attention. It is estimated that the emerging markets will represent 30 per cent of the global pharma market in the next five years. Due to increased focus on maximising profits and bringing down costs to provide affordable healthcare, the coming years will register a major acceleration in the generics supply, with a total market expected to be around $400 billion, constituting 35 per cent of the total pharma market, as compared to 25 per cent in 2011.

NEHA AMBARDAR, Solution Consultant, Life Sciences (India) Thomson Reuters

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Outlook quite positive for 2014

VRINDA MATHUR, Director, Healthcare and Lifesciences Advisory, Grant Thornton in India

MAHADEVAN NARAYANAMONI, Partner - Advisory Services, Grant Thornton in India

dressed at the soonest, to ensure the sector realises its full potential in the medium term. Consolidation in smaller pharma companies will be imminent once the Uniform Code of Pharmaceutical Marketing Practices (UCPMP), which is currently voluntary, is finalised and made mandatory by the Department of Pharmaceuticals (DoP) for all players (domestic and international) operating in India.

e expect to see several more transactions led by both financial as well as strategic investors, a greater focus on regulatory compliance by Indian companies and continued challenging of patented drugs in therapeutic areas such as oncology. A number of regulatory matters such as FDI, new product launches, clinical research approvals do need to be ad-

A number of regulatory matters such as FDI, new product launches, clinical research approvals do need to be addressed at the soonest, to ensure the sector realises its full potential in the medium term

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cover ) India to lag nearest EM compatriots

ooking purely at the pharmaceutical segment of the wider healthcare industry, the historical reputation of this market as 'recessionproof' is foundering. The reputation was built over strong incremental growth over the decades between the 1960s and 1990s, as the pharma industry was seen as a safe haven amid periodic outbreaks of economic uncertainty. After all, the fundamentals of the market are inarguably favourable: demographics in both developed and emerging markets point towards increased consumption of pharma amid rising rates of diabetes, oncology, and various lifestyle-related illnesses. And who stops taking their insulin even if there is a recession? And which government would dare to say no to the latest life-saving cancer treatments?

Not a pretty picture anymore Until recently, the answer to those questions were a resounding ‘no’ – but over the last few years, coinciding with the wider global economic downturn, it is proving to be a far more complex issue, and one which looks to continue to be an issue in the near-term future. Certainly, the picture of the pharma industry is not a particularly pretty one: there is widespread cost containment, restrictive reimbursement conditions, a tough R&D climate, major patent expirations and intellectual property challenges, as well as increasing difficulties in obtaining investment from an increasingly risk-averse financial community. The traditional Big Pharma companies are shedding staff all over the place, struggling to adapt their business models amid the loss of exclusivity of key pharma agents that drove

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their growth over the years. Others are almost in a perpetual motion of re-organisation, seeking to find the precise organisational structure that will strike the right balance between innovation and risk management, and devolution versus integration. It’s hard to find the bright spots, but they do exist, and strikingly, one primarily finds it in companies which are devoting themselves to only one or very few therapeutic areas. They have generally been able to entrench themselves in that particular therapeutic area, drive the innovation story and benefit from their strong relationships in that particular community of healthcare delivery.

Roadblocks in developed markets ... However, a key roadblock is the same for everyone: market access. Market access has evolved dramatically over the last few years amid a sea change in pricing and reimbursement (P&R) mechanisms around the world, as governments have sought to reign in or rationalise healthcare expenditure by targeting the pharma segment. In 2012-2013, this was particularly true, as the industry adapted to the end of true free pharma pricing in the key market of Germany, and a series of price cuts in other major markets. The continuing economic turmoil in Southern Europe also translated into negative growth in the pharma markets in this region, and drug shortages continue to rage in hard hit countries such as Greece and Romania. Indeed, these markets are banning the parallel exporting of select drugs out of the country in order to preserve the supply in the domestic market. And indeed the Greek government has asked foreign governments to stop referencing pharma

... and turmoil in emerging markets

GUSTAV ANDO, Director & Head, Life Sciences Business, Healthcare IHS prices in Greece due to the temporary, exceptional hardship in the country which is resulting in unusually low prices from a series of price cuts. But the turmoil is by no means confined to Southern Europe, and there has been a dramatic drop in pharmaceutical expenditure in several Nordic markets in 2013 – once considered another regional safe haven for pharma companies. Even the US, the key growth engine for the global pharma industry, has experienced a yearon-year drop in drug expenditure, the first in living memory, as the market absorbs several years’ of major patent expirations as well as increased pushback from payers seeking to limit uptake of expensive, innovative medications. Indeed, although healthcare reform in the US has not been accompanied by any formal pricing rules, there has been increasing pressure from grassroots public campaigns as well as from critical healthcare institutions for pharma companies to lower their prices – famously this resulted in a 50 per cent price cut for a major new oncology medication.

And looking away from the key developed market, there is also major turmoil in emerging markets, Russia is in the midst of major healthcare reform but is explicitly seeking to develop its domestic pharma industry, hence is adopting pro-domestic legislation at the expense of major pharma multinationals. China is rapidly expanding its healthcare insurance to nearuniversal coverage, but is at the same time looking at tightening its pharma pricing rules in 2014. China also launched an unprecedented clampdown on the marketing practices of pharma companies in 2013, resulting in a major shift in the strategic thinking for global drug firms operating in the market.

So where does India fit Amid all this upheaval, where does India fit in? India experienced a tumultuous 2013, and this looks set to continue well into 2014. For global drug operators, India is generally speaking among the lowest-priority markets among the top tier emerging markets. This is down to a confluence of factors: a comparatively poor healthcare infrastructure; a highly complex, regionalised market dynamic; a lack of proper healthcare insurance; and one of the most uncertain intellectual property environments in the world. At the macro-level, inflation continues to be a major dampener on the overall economic outlook, and political instability continues to affect healthcare policy. The Indian government has sought to grapple with its healthcare system, and put the reform of its pricing and reimbursement system at the top of its priorities in 2013. Ultimately, the reforms went through a series of iterations

and counter-reforms as priorities changed, and it looks like further reform continues to be on the agenda. The new internal referencing system ended up having a more significant impact than initially anticipated, and continues to scare away global operators seeking to launch important, innovative medicines onto the Indian market. The situation is compounded by a series of watershed court cases on the country’s intellectual property environment: and suffice to say, the courts tended to side with the country’s domestic generic operators. All this means that India will continue to lag behind its nearest emerging market compatriots in the pharmaceutical arena, although there is significant investment in the surrounding healthcare infrastructure which bodes well for the longer-term. Globally, as we look ahead into 2014, we see a modest but important recovery for the pharma industry as we see the back of the worst of the patent cliff, and an incremental improvement in macro-economic trends. The innovative drug sector has been comparatively successful in avoiding the worst excesses of the global P&R clampdown in key markets, as governments have often targeted the generic industry for the most severe price cuts. However, for all the political talk of investment in hi-tech sectors, there are few openly pro-innovation governments which drug firms can currently point to, although Japan may be an important exception here in 2014 as it looks to potentially reward innovative medicines with relaxed pricing rules and fewer price cuts for these products. The worst may be over, but undoubtedly there continue to be troubled times ahead.

MARKET I N T E R V I E W

‘India is one of the focussed countries for Menarini in terms of investment’ Girdhar Balwani, Managing Director, Menarini India, speaks to Viveka Roychowdhury on the company’s strategy to strengthen its presence in the Indian market by acquiring Invida India

The Menarini Group currently ranks 17th in Europe and 34th worldwide with annual revenues of $4.2 billion. What is the Group’s current ranking in the APAC region specifically? What percentage of revenues come from the APAC region? Which APAC countries currently make up the Group's operations? The Group’s ranking in the APAC region (Menarini APAC) is 73 among all pharma firms or 24 amongst MNCs. Close to six per cent of the revenues come from the APAC region. Menarini operations in the APAC region currently comprise 13 countries within Asia Pacific region - Singapore (HQ), Malaysia, Thailand, Vietnam, Indonesia, Hong Kong, China, Philippines, South Korea, Australia, New Zealand, Taiwan and India. What are the company’s leading brands?

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MARKET Dermatix is the No.1 brand for Menarini Asia-Pacific with an annual sales of $22 million. How does India shape up as an investment destination compared to other APAC regions? (In terms of ease of doing business, FDI norms, etc.) India is one of the focussed countries for Menarini in terms of investment. This is substantiated by the acquisition of the Shalaks portfolio. We continue to look at inorganic opportunities as well as entering into consumer health as investment areas to further accelerate the growth of Menarini in India. In general, the environment to invest has its own challenges in terms of the government regulations, trade association, new product registrations etc. These challenges though surmountable involve increased timelines and the need for patience. What was the strategy behind Menarini’s acquisition of Invida India? Menarini acquired Invida Asia-Pacific on November 11, 2011 and due to that acquisition, Invida India became part of the Menarini group. While the acquisition of Invida Asia-Pacific helped Menarini to enter into the high growth Asia-Pacific market, for Invida this has offered access to the partnered products and to the R&D capabilities of Menarini. The Invida management has been retained at both the regional and country level. Before this acquisition, Menarini had a minor presence in India through a joint venture with the Raunaq

group and the entity was called as Menarini Raunaq. Post Menarini acquiring Invida, Menarini Raunaq is in the processes of getting merged with Menarini India (erstwhile Invida India). What was the cost of the acquisition? These figures are not in the public domain therefore we are unable to share the same. The Group has reportedly charted out an aggressive growth strategy in India. What kind of companies/tie ups/JVs/etc are in the pipeline and what is the timeline to these potential deals? Is the due diligence process on on any of these currently? Is the thrust on acquiring brands, physical manufacturing assets or other considerations? We currently market two products of Sinclair Pharmaceuticals, Paris and further launches of their brands are planned including line extensions. We are currently assisting the clinical trials for registration of products of Actelion Pharmaceuticals, Switzerland and Ipsen, France and are also going to market a product of Meda from Q2 2014. We are in advanced stages of finalising with a North American company to register and launch a derma filler in India. While we are open to looking at various other inorganic opportunities (local acquisitions), there are no proposals active at this stage. Our sourcing strategy involves getting our brands manufactured at third party loca-

While the Indian pharma market has been registering robust growths over the years, the recent past has seen a plateau. Price control, lower general economic growth are some of the growth challenges we foresee in this market

EXPRESS PHARMA

January 1-15, 2014

general economic growth (raising inflation), lack of confidence by innovators on existing patent protection are the growth challenges we foresee in this market. Our strategy is to focus on areas where we can have differentiated products in therapeutic segments which can offer profitable growth opportunities.

India is one of the focussed countries for Menarini in terms of investment. This is substantiated by the acquisition of the Shalaks portfolio GIRDHAR BALWANI, Managing Director,Menarini India

tions which meet our GMP standards. We have no intentions to setup / acquire a manufacturing location in India. India is tipped to be one of the fastest growing pharmaceutical markets in the world but there could still be speed breakers. What growth challenges do you foresee and what are the risk management strategies to cope with these challenges? While the Indian pharmaceutical market has been registering robust growths over the years, the recent past has seen a plateau. Price control, lower

How will the country’s new drug pricing policy and intellectual property regime impact the company’s growth targets? We are fortunately not significantly impacted due to this because of our strategy as mentioned above. What is the Group’s future strategy in India and the APAC region for the next financial year? The Group’s future strategy involves having a very robust range of products which are differentiated and offering profitable growth. The focus now is on sales force effectiveness through ethical marketing and training and development of the sale force Looking ahead, what are the future investments/ growth plans for the next five years? We plan to drive our existing portfolio through consolidation of our existing brands within the primary care and dermatology therapeutic categories. We also plan to launch new products thought partnerships with mid-sized international companies, while continuing to focus on sale and marketing effectiveness. We will explore acquisition opportunities in the Indian market as well as evaluate direct to consumer approach for select brands of the existing portfolio. In terms of therapy/ treatment/R&D areas, which will be the focus areas in India? Our current focus is into the primary care ( gastroenterology, antibiotic and pain management) and the dermatology therapy areas. We plan to enter into the consumer health seg-

ment in 2014. The R&D activities are championed from our R&D centers in Europe and there are no plans to shift those to India. What percentage of the Group's global revenues are ploughed back into R&D and will this be maintained for the India operations in India as well? The R&D operations would continue to be from the centres we have in Europe and we have no plans to shift the same to Asia-Pacific. Within Asia-Pacific the major investments are for conducting clinical trials mainly to meet regulatory requirements. In 2013 we have invested $4.4 million for conducting clinical trials. Besides investment in company's growth, are there any other activities that the company plans to engage in? We have initiated various patient / therapy related engagement activities to enhance the awareness or formulate treatment guidelines based on latest international guidelines / expert opinions. The two major initiatives are Aanchal and Scar Management Guideline. Aanchal is a platform initiated by Menarini to educate mothers of newly born children. There would be doctor - mother interactions facilitated during which various topics like, vaccination, breast feeding, massage etc would be discussed and queries of the mothers would be addressed by the doctors. As part of the Scar Management Guideline, we have formed the 'Indian Scar Forum' wherein leading plastic surgeons, gynaecologists and dermatologists meet and discuss the latest developments in the management of Scars. We have formulated the Asia-Pacific guidelines on Scar management and the same was released in 2013. The Indian Scar Forum is in the process of formulating an Indian guidelines on scar management which is expected to be released by April 2014. viveka.r@expressindia.com

MARKET COMPANY WATCH

Lilly enters branded generics market with launch of Lil Therapeutics Announces launch of drugs in breast cancer and colo-rectal cancer segment ELI LILLY and Company India has entered the branded generics segment with the launch of Lil Therapeutics, an expansion of its oncology division that will help expand delivery of cancer drugs to patients at an affordable cost. India becomes the first country to witness the launch of branded generics from Lilly with the launch of four new drugs, Lilbecep (Epirubicin), Lilmantro (Anastrozole) sand Lilxapla (Oxaliplatin) and Lilrincan (Irinotecan) for the treatment of patients with breast cancer and colo-rectal cancer respectively. These molecules are well established and time tested across the treatment algorithm of oncology. Lilly has been dedicated to delivering solutions that accelerate the pace and progress of cancer care and enhance the lives of people living with cancer. In India, Lilly has cultivated a strong equity in the lung cancer segment with innovative brands Gemcite and Alimta. With

launch of Lil Therapeutics, Lilly aims to expand patients’ access to high-quality cancer drugs. Commenting on the development, Edgard A Olaizola, Managing Director, Eli Lilly says, “Lilly is committed to improving outcomes for individual patients around the world. We understand that cancer medicines of the highest quality continue to be an unmet need in India and as a responsible organisation, we have been working over the years to make cancer drugs affordable to better serve Indian patients. This launch reaffirms our commitment to reach more patients and play a leading role in fighting cancer in this country.” He also mentioned, “Though Lilly is launching branded generics in the oncology segment, we will continue to discover and develop innovative new therapies for patients worldwide.” EP News Bureau – Mumbai

Though Lilly is launching branded generics in the oncology segment, it will continue to discover and develop innovative new therapies for patients worldwide

EXPRESS PHARMA

January 1-15, 2014

MARKET

Indegene and DrugLogic to offer full lifecycle drug monitoring

Merck signs license agreement with CNIO

To help for insightful analysis of drug behaviour, interactions, and safety

New agreement aims to translate CNIO research into new potential treatment options for cancer patients

INDEGENE AND DrugLogic announced a joint offering for pharmaceutical companies and healthcare organisations that would combine the extensive medical expertise of Indegene with the sophisticated Big-Data analysis capabilities of DrugLogic’s Qscan. This knowledge and expertisebased offering combines sophisticated evidence-based statistical results, with experience-based physician monitoring, to help decipher a drug’s clinical behaviour and detect signals related to its safety and interactions with other factors. “Drug monitoring requires the integration of medical review coupled with sophisticated signalling and analytic systems,” said Dr Sheila Weiss, Chief Science Officer, DrugLogic. “By joining together we can rapidly deploy expert teams with immediate access to data and the analytic capa-

MERCK SERONO, the biopharmaceutical division of Merck, has signed a license agreement has been signed with the Spanish National Cancer Research Centre (CNIO) in Madrid in the area of cancer drug development. The global agreement will build upon CNIO research discoveries to encourage the development and commercialisation of new compounds in the field of oncology. Under the terms of the license agreement, CNIO has granted to Merck exclusive rights to develop and commercialise their new inhibitors of the ataxia telangiectasia and Rad3-related (ATR) kinase. In exchange, Merck will make an initial payment along with other potential income of up to nearly € 19 million, as well as royalties on net sales. The agreement encompasses the licensing of two series of ATR inhibitors, as well as a screening

bilities that drug safety requires.” The joint solution draws synergistically upon the expertise and experience of Indegene’s team of 400+ in-house physicians and the 14+ years of application legacy of Drug Logic’s Qscan. The IndegeneDrugLogic team will offer the best of both approaches during drug discovery, through clinical trials, and post-launch. The team will provide efficient pharmacovigilance-based on many years of experience to address challenging questions. The solution will use the analytical capabilities of DrugLogic’s Qscan, an application that has been used with over 12 different databases and billions of records and extensive knowledge and expertise of Indegene’s TrialPedia platform, the most comprehensive clinical trial analytics platform with over 200,000 trials across

200+ clinical indications. The team will adapt the best data from adverse events, claims, medical records and prescription monitoring programmes that are both publically and privately available. “By putting massive amounts of data and insightful statistics in the hands of clinical experts, we will quickly, accurately, and efficiently shorten the time to understand and react to a drug’s behaviour and safety profile,” said Dr Rajesh Nair, President, Indegene. DrugLogic’s Qscan is a platform that has been applied to several different types of databases. These include the FAERS, VAERS, and WHO databases. It has also been applied to larger medical record and claims databases, such as Medicare, Medicaid, private, and de-identified medical data. EP News Bureau – Mumbai

platform to validate the compounds, which have currently reached an advanced preclinical stage. “Part of Merck's commitment to oncology includes the focus on strategic agreements that allow us to foster a constant flow of innovations,” said Andree Blaukat, Head of Translational Innovation Platform Oncology for Merck Serono. “As a research organisation, the CNIO is committed to fostering and promoting innovation. Among other initiatives, the CNIO's Experimental Therapeutics Program carries out early drug discovery projects. The CNIO is delighted to be working with Merck to hopefully translate this research into potential new treatment options for patients with cancer,” said María Blasco, Director, CNIO. EP News Bureau – Mumbai

US FDAapproves Cymbalta Used for the treatment of depression, Indian drug makers to be benefitted IN A MAJOR boost to some Indian drug makers, the US Food and Drug Administration (US FDA) has approved the first generic versions of Cymbalta (duloxetine delayed-release capsules), a prescription medicine used treat depression and other conditions. According to a US FDA press release, Aurobindo

20 EXPRESS PHARMA January 1-15, 2014

Pharma, Dr Reddy's Laboratories, Lupin, Sun Pharma Global FZE, and Torrent Pharmaceuticals have received the regulatory nod to market duloxetine in various strengths, besides Teva Pharmaceuticals, US. Cymblta garnered $ 1.1 billion revenues for the quarter ended September 30, 2013 and $ 3.4 bil-

lion for the nine months period in the US market, according to a report by Eli Lilly. Eli Lilly in the Q3 results statement said, "The company would lose effective exclusivity for Cymbalta in the US on December 11, 2013 and several manufacturers have received tentative approvals to market generic duloxetine.” Kathleen

Uhl, Managing Director and Acting Director of the Office of Generic Drugs in the FDA's Centre for Drug Evaluation and Research, said healthcare professionals and consumers can be assured that these FDA-approved generic drugs have met our rigorous standards. Generic drugs offer greater access to

healthcare for many people. Duloxetine and other anti-depressant drugs have a boxed warning describing the increased risk of suicidal thinking and behaviour during initial treatment in children, adolescents, and young adults aged 18 to 24. EP New Bureau – Mumbai

MARKET

Biocon inks licensing pact with US-based Quark Pharma To develop a range of siRNA based novel therapeutics BIOTECHNOLOGY MAJOR Biocon has inked a pact with Quark Pharmaceuticals to develop a range of siRNA (small interfering RNA) based novel therapeutics. According to a PTI report, the companies have entered into a licensing and collaboration agreement for the development of a range of siRNA (small interfering RNA) based novel therapeu-

tics, Biocon said in a statement. “This collaboration will enable Biocon to co-develop, manufacture and commercialise QPI-1007, a novel siRNA drug candidate for ophthalmic conditions, for India and other key markets," it added. As part of the agreement, Biocon will have access to Quark's innovative and propri-

etary siRNA technology platform that can be leveraged for the development of novel therapeutics for various unmet medical needs. The company, however, did not disclose financial details. Commenting on the development, Kiran Mazumdar Shaw, Chairperson and Managing Director, Biocon said, “Quark is the world leader in

GSK to increase stake in its pharmaceuticals subsidiary in India Offer to start from February 7 and close on February 22 GLAXOSMITHKLINE (GSK) announced a voluntary open offer to increase its stake in its publicly-listed pharmaceuticals subsidiary in India (GlaxoSmithKline Pharmaceuticals) from 50.7 per cent to up to 75 per cent at a price of ` 3,100 per share. The offer period will start from February 7 and will close on Fenruary 21. Securities regulations in India require a minimum public shareholding of 25 per cent for a company to maintain a public listing in the country. GSK intends to keep the company publicly-listed. The offer, which is made pursuant to the rules of the Securities and Exchange Board of India (SEBI), is to acquire up to 20,609,774 shares, representing 24.3 per cent of the to-

22 EXPRESS PHARMA January 1-15, 2014

tal outstanding shares of the Indian company. The offer represents a premium of approximately 26 per cent to the company's closing share price on the National Stock Exchange of India (NSE) on December 13, 2013. This closing price represents an appreciation of 19 per cent over the last 12 months. The potential total value of the transaction at the offer price is approximately ` 64 billion or £629 million. David Redfern, Chief Strategy Officer, GSK said, "For GSK this transaction will increase exposure to a strategically important market and for our Indian pharma subsidiary's shareholders we believe it offers a good liquidity opportunity at an attractive premium. GSK has a proud heritage in India. Today's

announcement is a further demonstration of our long-term commitment to the country having increased our holding in our consumer business earlier this year and more recently committed to a significant manufacturing investment.” The transaction will be funded through GSK's existing cash resources, will be earnings neutral for the first year and accretive thereafter and will not impact expectations for the Group's long-term share buyback programme. Payment for the shares will take place shortly after close of the offer. The company's shares are traded on the Bombay Stock Exchange and the NSE. EP News Bureau – Mumbai

this technology and their joint development efforts on QPI1007, targeting ocular neuroprotection, aims at providing relief to several patients suffering from serious ophthalmic conditions. This collaboration reinforces our commitment to develop and introduce innovative therapeutics to India to meet the unmet medical needs. We

hope to use this technology for developing several other novel therapeutics" . Daniel Zurr, Chief Executive Officer, QuarkPharma said the collaboration will position Biocon as the leading siRNA company in India and as an international player in this new drug category. EP News Bureau – Mumbai

Torrent to buy Elder’s branded formulations biz To fund acquisition through mix of internal accruals, bank borrowings TORRENT PHARMACEUTICALS will acquire Elder Pharmaceuticals' branded formulation business in India and Nepal for ` 2,000 crores. Elder's India business comprises a portfolio of 30 brands including some market leading ones in women healthcare, pain management, wound care and neutraceuticals. Torrent would fund the acquisition through a mix of internal accruals and bank borrowings, the company said. “The transaction is a strategic fit for Torrent and will strengthen its core prescription based business. This acquisition strengthens our position in the women health-

care, pain management,” Sudhir Mehta, Group Chairman, Torrent said. Alok Saxena, Chief Executive Officer and Managing Director, Elder said, “This path breaking domestic consolidation by Torrent addresses our recent challenges and will significantly help Elder leverage its balance sheet.” According to a PTI report, the transaction has been approved by the boards of both the companies and is subject to approval by shareholders and other necessary regulatory nods. The deal is expected to close in the first half of 2014. EP News Bureau - Mumbai

MARKET GROWTH TRACKER

IPM clocks `6291 crores in November 2013 After three continuous months of volume degrowth, market sees seasonal change THE INDIAN Pharma Market (IPM) clocked `6291 crores in November 2013. It has seen a growth at 6.9 per cent for November 2013. Macleods becomes the 10th biggest company in IPM versus 11th of last month. November 13 growth driver split shows positive on the parameter of volume and new introductions leading to overall positive growths over October 2012 Amongst the top 10, Sun Pharma at 17.1 per cent followed by Alkem at 12.5 per cent. 34 of the top 50 corporates have crossed the growth of IPM for November 2013. Amongst the top 50 corporates, Corona Remedies has the highest growth of 87.2 per cent followed by Biocon at 49.6 per cent and Ipca at 28.3 per cent. Glenmark has shown the highest growth at 25.6 per cent followed by Aristo at 20.8 per cent and USV at 20.6 per cent. Akumentis has entered the `250 crore club, BMS the `100 crore club. Amongst the top 50 in MNCs, AstraZeneca grew the highest at 20 per cent, followed by Allergan at 16.5 per cent and Merck at 12.1 per cent. The DPCO 2013 containing molecules market was at –8.6 per cent whereas the non-DPCO market grew by 9.5 per cent resulting in an overall growth of 6.9 per cent for November 2013. The DPCO 2013 portfolio for GSK de-grew at 31.8 per cent and Ranbaxy de-grew by 20.7 per cent, whereas Sun Pharma had the least impact with its DPCO 2013 portfolio de-growing at 6.8 per cent. The unit market grew positively after a long time. From therapy perspective, eight therapies have outgrown the IPM growth. The gastrointestinal market grew at 8.4 per cent, anti-infective market had a growth of 2.6 per cent whereas respiratory market had a 15.1 per cent growth. The anti-diabetic market grew at 6.1 per cent and cardiac at 7.2 per cent in chronic business. Anti-malarials grew by

With Bonus Units at Full Value Rank COMPANY

MAT

(Val in Crs)

MAT Nov -13 MTH

IPM

Nov-13

Val (Cr)

MS%

GR%

Val (Cr)

MS%

GR%

72772

100.00

5.3

6291

100.00

6.9

Sun Pharma

3873

5.32

17.4

357

5.67

17.1

Cipla

3694

5.08

5.6

328

5.22

12.2

Zydus Cadila

2987

4.10

13.7

262

4.16

9.9

Ranbaxy

2916

4.01

2.1

251

3.98

2.1

Glaxo

2886

3.97

-10.5

221

3.51

-20.1

Abbott HC

2702

3.71

1.1

232

3.69

3.3

Mankind

2627

3.61

6.8

232

3.68

10.4

Alkem

2283

3.14

8.5

206

3.27

12.0

Lupin

2197

3.02

6.6

195

3.09

9.9

Macleods

1878

2.58

7.5

167

2.66

11.7

Intas

1853

2.55

12.9

160

2.54

12.0

Aristo

1736

2.39

7.2

166

2.63

20.8

Pfizer

1627

2.24

-1.3

124

1.97

-16.6

Dr. Reddys

1618

2.22

8.5

139

2.22

7.2

Glenmark

1543

2.12

15.0

146

2.31

25.6

Abbott

1419

1.95

3.6

125

1.98

10.7

Super Group

MAT Nov13

GR%

Mth Nov 13

GR%

IPM

72772

5.3

6291

6.9

ANTI-INFECTIVES

12505

1.1

1092

2.6

CARDIAC

8975

8.6

761

7.2

GASTRO INTESTINAL

8278

5.2

671

8.4

VITAMINS / MINERALS / NUTRIENTS

6402

4.1

527

6.2

RESPIRATORY

5646

6.7

592

15.1

PAIN / ANALGESICS

5239

3.5

452

5.4

ANTI DIABETIC

5031

9.2

432

6.1

GYNAECOLOGICAL

4650

3.5

372

3.1

NEURO / CNS

4551

8.4

383

5.1

DERMA

3938

8.7

363

15.2

OPHTHAL / OTOLOGICALS

1321

7.9

111

12.8

HORMONES

1242

5.9

107

2.0

ANTI-NEOPLASTICS

980

23.5

15.7

OTHERS

952

3.1

5.7

BLOOD RELATED

875

2.7

3.1

VACCINES

835

-3.3

-8.2

ANTI MALARIALS

598

-2.2

21.2

SEX STIMULANTS / REJUVENATORS

423

7.8

-3.2

STOMATOLOGICALS

331

7.3

12.5

21.2 per cent, whereas derma market was at 15.2 per cent. Bonus in the anti-infective segment grew by 5.1 per cent, whereas in respiratory market it has seen 19.1 per cent growth. From regional perspective Bihar has grown the highest at 16.6 per cent whereas Delhi has registered 16.4 per cent. Biggest region Tamil Nadu de-grew at 7.5 per cent and Andhra Pradesh rest de-grew at 5.2 per cent. Two regions have had negative growths in November 2013. The biggest molecule Amoxycillin + Clavulanic grew by 9.7 per cent, whereas Cefixime grew at 2.3 per cent. Paracetamol grew at 5.1 per cent and Azithromycin grew by 2.7 per cent. The markets of Vitamin- D grew by 49.5 per cent, Glimepiride + Metformin grew at 40.8 per cent, Rosuvastain, Levocetirizine + Montelukast & Telmisartan by 22 per cent. Amongst the top brands in the IPM, Phensedyl has shown 63 per cent growth, GlycometGP shows 62 per cent growth, Moxikind – CV at 33 per cent and Clavam at 29 per cent.

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

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

EXPRESS PHARMA

January 1-15, 2014

EVENT BRIEF JANUARY - FEBRUARY 2014 17

5th FICCI-HADSA Nutraceutical Conference

5TH FICCI-HADSA NUTRACEUTICAL CONFERENCE Date: January 17, 2014 Venue: Sci-Tech, Jogeshwari, Mumbai Summary: The objective of this conference is to enable nutraceuticals stakeholders to understand the'Business Dynamics of Nutraceuticals in India’. Discussions will be held on issues such as implications of regulations, product development, chain management, commercialisation and financial challenges. The summit aims to provide an opportunity to the Indian nutraceutical / dietary supplements industry to network and interact with various representatives of government and semi-government institutions along, with other stakeholders from private sector, financial institutions, R&D to further resolve challenges being faced by this industry. Contact details Nandini Aggrwal Asst Director - Wellness and Nutraceuticals Federation Of Indian Chambers Of Commerce and Industry 33-B, Krishnamai Sir Pochkhanwala Road Worli, Mumbai - 400030. Tel: (022) 2496 8000 Mob: 9869132887 Email: nandini.aggrwal@ficci.com

BANGALORE INDIA BIO 2014 Date: February 10- 12, 2014

24 EXPRESS PHARMA January 1-15, 2014

Venue: The Lalit Ashok Bangalore Summary: Bangalore INDIA BIO is organised by the Government of Karnataka and the Vision Group on Biotechnology - an apex advisory body consisting of members from both public and private sectors in association with MM ActivSci-Tech Communications, engaged in creating knowledge and business fora across frontier technologies and emerging sectors. The international conference will deliberate on key issues such as biosimilars; drug discovery and vaccine development through partnerships; stem cells and regenerative medicine; clinical trials; digital health fueling; pharmacogenomics, biomedical informatics and personalised medicine; investment and entrepreneurial finance for bio business; agribiotech and food security; secondary agriculture; bio energy and energy security. It will consist of multitrack conferences, international trade show, distinguished lecture and keynote talks, interlinXBioPartnering, CEO conclave, bio-excellence awards, poster session, BioQuiz and other Networking Events.

11TH EDITION OF BIOASIA Date: February 17 to 19, 2014 Venue: Hyderabad International Convention Centre Summary: The 11th edition of BioAsia is dedicated to the theme – ‘Innovate. Evolve’. BioAsia’s focus on ‘Innovation in lifesciences’ will ad-

Bangalore INDIA BIO 2014

dress the increasing disease burden, and the growing need for more efficacious and affordable healthcare solutions. Panel discussions hosting global industry leaders will deliberate on the path breaking solutions for the sector, from innovative products to models that reduce R&D cost while increasing efficiencies, and innovative financing models, that promote new business ideas. The goal is to highlight innovation as the driver of the lifesciences economy in the coming years. In addition, a parallel event AgBioAsia focusing on health and nutrition with the theme of ‘Harnessing the potential of the global nutraceutical market’ will be hosted by the Government of Andhra Pradesh in partnership with the International Crops Research Institute for the Semi Arid Tropics (ICRISAT) and the Federation of Asian Biotech Associations (FABA). Contact details Paridhi Gupta Tel: 040 66446477

CPHI QUALITY BY DESIGN Date: February 24 – 26, 2014 Venue: Kuala Lumpur, Malaysia Summary: CPhI – Quality by Design will focus on the drivers, regulatory framework, risks, principles and approach for QbD, and the benefits for the pharmaceutical industry in Asia to implement QbD to compete in the global arena. This event is a

11th edition of BioAsia

unique learning platform combining discussions, case studies and best practice to enhance knowledge sharing and networking; coupled with a practical training component to enhance applied and technical implementation know-how. URL: http://www.qualitybydesign-asia.com/?utm_campaign=EVENTLISTING&utm _medium=MEDIAPARTNERWEBSITE&utm_source=EXPRESSPHARMAONLINE&ut m_content=URL&utm_term= Contact details Marcus Chan UBM Conferences ASEAN Tel: +603 2176 8712 Fax: +603 2176 8786 Email: marcus.chan@ubm.com

EMERGING TRENDS IN DRUG DISCOVERY: AICADD – 2014 Date: July 23-28, 2014 Venue: AMRITA Vishwa Vidyapeetham - Amrita University, Coimbatore Summary: Emerging Trends in Drug Discovery: AICADD – 2014 is an international conference organised aims to make a "industry-scientists-academics" collaboration to meet the major challenges of drug discovery. The emphasis of the conference will be on topics related to the Computer Aided Drug Discovery (CADD). The organisers are expecting more than 500 delegates including Nobel laureates/ scientists/researchers/ students and professionals from academia and

CPhI Quality by Design

industries from all over the country and abroad, will be participating in the conference. A few identified thrust areas are: clinical pharmacy and pharmacy practice, natural products chemistry, medicinal chemistry, pharmaceutical technology, CADD, pharmacogenomics, pharmacoinformatics, SAR studies and machine learning, drug delivery system, nanomedicine, personalied drug design, bioinformatics and biomedical engineering. Contact details: Dr PK Krishnan Namboori Associate Professor, (Executive Coordinator) AMRITA Insight into Computer Aided Drug DiscoveryAICADD-2014, Computational Chemistry Group (CCG), Computational Engineering and Networking, AMRITA Vishwa Vidyapeetham-Amrita University, Amritanagar, Coimbatore-641 112 Phone:+91 422 2685000 Extn: 5592 Email: aicadd_2014@cb.amrita.edu aicadd2014@gmail.com URL: http://www.amritaccg.in/ Conference URL: http://www.amritaccg.in/aica dd2014

MARKET POST EVENTS

65 IPC: More power to the pharmacist The pharmacist stood at the centre of the three-day event that witnessed scientific symposia, poster presentations, a job fair and saw huge participation from students, academia and industry

Shalini Gupta New Delhi TH

THE 65 Indian Pharmaceutical Congress(IPC), a threeday conference was held from December 20-22 at the sprawling campus of Amity University, Noida. Hosted by IPGA (Indian Pharma Graduates Association) with the underlying theme of ‘Empowering the Pharmacist’, the event was attended by more than 5000 delegates from India and abroad. The first day saw the inauguration by the Chief Guest, Dr VM Katoch, Secretary Department of Health Research, Ministry of Health & Family Welfare and Director General - Indian Council of Medical Research along with the Guest of Honour, Dr GN Singh – Drugs Controller General of India, Atul Kumar Nasa, President, Indian Pharmaceutical Congress Association, Dr Ashok K Chauhan, Founder President, Amity Group and Chief Patron of IPC, SB Shashank, Special Secretary Health, Government of Delhi and RC Juneja, Chairman cum Managing Director, Mankind Pharma. An award distribution ceremony coordinated by Rajesh Madan, Executive Director, Medicamen Biotech and delivered jointly by members along with DG, ICMR, VM Katoch was also held that recognised achievers. In his inaugural address,

Guest of Honour, Dr GN Singh, Drug Controller General (India), inaugurates the 65th IPC with the traditional lighting of the lamp followed by other senior dignitaries

Dr Katoch said, “Pharmacy is one of the few professions linked with the future of the country. However, even after passing out with diplomas or degrees, they are disheartened to find less employment opportunities in this field.” He raised concern about the implementation of the suggestion during seminars in the practical aspects of pharmacy and suggested that corporates must work closely with the academicians in this regard.

In line with its theme of ‘Empowering the Pharmacist’, the event began with the President’s Symposium, with eminent members sharing their views and apprising the audience of the pivotal importance of a pharmacist in today's environment. Dr B Suresh, President, Pharmaceutical Council of India and Vice Chancellor, JSS University, Karnataka kicked off the session by giving an educational

perspective on the topic. While thanking the speakers, Atul Kumar Nasa, President, 65 th IPC, touched the pulse of the audience, especially the huge contingent of pharmacy students, that he would try his best to make the amendment of Rule 71, 76 of the Drugs and Cosmetics Act allowing only a pharmacy graduate to be recognised for the post of competent technical staff, a reality. This drew a huge round of applause from

the audience. RC Juneja, Chairman, 65th IPC, Local Organising Committee (LOC), and Managing Director, Mankind Pharma in his welcome address expressed joy at having got an opportunity to interact with professional pharmacists and learn at the grass root level. “Pharmacists play a vital role in boosting the sales of drugs and will also be instrumental in changing the image of India as the generic capital of the

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world,” he said. He also thanked the students and LOC members for their hard work and contribution to make the event a success. Chauhan delivered the vote of thanks to students, exhibitors, central council members, National Council and advisors for their support. Addressing the gathering of scientists and distinguished academicians, he further sought their participation to achieve the target of filing 200

26 EXPRESS PHARMA January 1-15, 2014

patents within two to three years and papers in various peer reviewed journals.

Memorial lectures The second day saw Dr HG Koshia, Commissioner, Food & Drug Control Administration, Government of Gujarat deliver the BV Patel Memorial Lecture on the topic ‘Innovative use of Technology in Drug Regulatory System – FDCA Gujarat.’ He stressed that even as Food & Drug Control

Administration (FDCA) is responsible for issuing licenses to manufacturer, sales licenses to retailers wholesalers, distributors, stockists and C&F agent dealing with pharma and related product, it is also mandated to monitor the quality of drug being manufactured in Gujarat or coming from other states. Hence, timely recall of sub- standard / spurious drugs, after proper laboratory testing, is also an important function of FDCA.

Around 1,700 paper presentations spread across 40 plenary sessions across three days, saw experts deliberate on topics such as ‘Molecular & Cardiovascular Pharmacology’, ‘Sustaining quality in Pharma Education’, ‘Novel drug delivery system’, ‘Pharmacovigilance’, ‘Advances in regulatory science & affairs’ to name a few. More than 180 exhibitors showcased their new products and technologies under the

Pharmaceutical Expo.

IPC’s first job fair Amidst all this, it was the pharma job fair at the venue that was choc-a-bloc with students registering themselves for interviews with companies keen to tap talent. This initiative has been taken for the first time at an IPC and has surely been a hit. It was ably supported by a job portal set up by the organisers in the run up to the event, to

MARKET facilitate registrations even before the event. Clearly, the planning paid off. Talking about how registrations have exceeded all expectations, AK Gupta, Chairman, Pharmajob Committee said, â&#x20AC;&#x153;While 650 students registered online, 50 of them did so at the venue on December 21.â&#x20AC;? As many as 22 companies were at the fair, including Mankind Pharma, Medicamen Biotech, Alchem Phytochemicals, Akums Drugs and Pharmaceuticals, Ravian Labs, Lark Labs, Percos India. ITL and Vival Labs, Abbott India visited on the last day of the show. 218 students were interviewed on the first day, of which 52 were shortlisted by companies.

Resolutions beyond the event The closing ceremony was presided over by Union Minister Oscar Fernandes, Dr BN Singh, Managing Director, Alkem, Nasa, Chauhan and Juneja. A resolution was also passed by PD Sheth, Vice President, International Pharmaceutical Federation(FIP) proposing that it be mandatory for a Registered Pharmacist to be present in the pharmacy/medical stores throughout its opening hours and dispense medicines. Winners of the poster competition were also felicitated as a part of the ceremony. The event organisers also made sure that the attendees could bond in more relaxed settings. Bollywood actress and Loksabha Member of Parliament Jaya Prada inaugurated the musical cultural night on the first day wherein singer Aditya Narayan (son of singer Udit Narayan) and Priya Patel mesmerised the audience with their performances. Well known beautician Shahnaz Hussain inaugurated the cultural evening on the second day which featured performances from Rhythm Troupe, Prince Dance Group and Neha Kakkar who regaled all present. shalini_g@expressindia.com

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CII organises 3rd National Conference on Agri-biotechnology Vision 2025 report unveiled

CONFEDERATION OF Indian Industry (CII), organised the 3rd National Conference on Agri-biotechnology, with the theme 'Biotechnology a Versatile Tool for Agriculture in the Emerging Context' in Bangalore. Eminent personalities from industry/research/academia and government shared their views and deliberated on how biotechnology can be leveraged to improve the yield levels of various crops and thereby help the country achieve the growth rate of four per cent envisaged in the 12th Five Year Plan. The objective for the conference is to holistically discuss the opportunities and concerns related to enhanced use of biotechnology in agriculture and finalise recommendations for necessary and timely actions by Ministries of Agriculture, Science and Technology, Ministry of Environment and Planning Commission. CII also unveiled a report ‘Indian Biotech Agriculture Industry: Vision 2025' during the conference. During his inaugural address Krishna Byre Gowda, Minister of Agriculture, Government of Karnataka said that transformation of agriculture must be the top priority concern of our public policies including science and technology. According to him one of the ways to achieve the targeted growth of four per cent in agriculture as indicated in the 12th Five Year Plan period is to explore bio agriculture technologies. Indian bio agriculture sector is currently estimated at $7.8 billion (including crops produced from GM Technologies) which is poised to grow to an estimated amount of $25 billion by 2025. Ashwin Shroff, Chairman,

28 EXPRESS PHARMA January 1-15, 2014

CII Sub Committee on AgriBiotechnology and Chairman, Excel Crop Care emphasised the role of IT which played a significant role in the advancement of science in making this world a global village, helped put India on a world map, the agribiotechnology in this century can play a equally significant role and again like in IT seizing opportunities available in agribiotechnology and make its mark not only in India but also in the global scenario. Agribiotechnology is a versatile tool, a powerful technology in varied applications which can play a wide ranging role in various dimensions of agriculture and food, be it soil and soil health, water, planting material, crop nutrition, crop protection, farm energy and last but not the least climate change. Dr Kiran Mazumdar-Shaw, Chairman, CII National Committee on Biotechnology and Chairman and Managing Director, Biocon reiterated that biotechnology is safe and its commercialisation does not pose any risks since it passes

through a stringent regulatory process that takes more than five years for a product to hit the market. Agriculture is the root and heart of inclusive economic development and biotechnology has a key role to play in the sector as the second ‘Green Revolution’ in the country will be led by biotechnology. Shaw stated that biotechnology is a precise and predictive technology, products like drought and saline resistant genes allow farmers to overcome natural disasters in a country where agriculture is largely dependent on natural resources. Today Bt Cotton has proven to be a boon to farmers and they will testify to that fact. She also highlighted the fact that it is the choice of the farmers whether they want to use Bt seeds or not and this should not be decided by an external body. Dr K Narayana Gowda, Vice Chancellor, University of Agricultural Sciences (UAS) said they are actively working on educating people on the various possibilities of biotechnology. They have conducted study

classes for farmers in Bangalore and Mysore recently to clear the myths with respect to biotechnology. There is a vast potential for the sector in Indian agriculture which will help in improved yield and reduce the use of chemicals in farming. He called for some joint initiative to be taken along with CII to initiate further debates and discussions to clear the misconceptions on biotechnology. According to Dr Deepak Pental, Former Vice Chancellor, University of Delhi, more than 42 per cent of India’s population will still depend on agriculture post 2050. He emphasised the fact that we need a renewed and focused approach to boot agricultural growth to seven to eight per cent. 170 million hectare of land is used worldwide for biotech farming which is more than the total area utilised for agriculture in India. He stressed on the need for universities to be allowed to conduct tests in biotechnology. Pental said that science and technology should be brought to the forefront of India’s agricultural sector.

On the last day, an interesting mix of topics including climate change, emerging and future technologies, regulatory policies and issues, myths prevailing among public and hence need for effective communication vis-à-vis biotechnology were discussed at length during the conference. The conference started with highlighting the emerging context and major issues facing humanity such as food security for an increasing population, declining farm productivity, limitations, both economical and ecological, of the tools used currently in agriculture along with climate change and food inflation and food quality and others. Two dimensions of biotechnology’s potential for addressing these issues were discussed during the conference. The first set of issues were soil and soil productivity, planting material, crop nutrition, crop protection, water, energy needs, coping with adverse climate change etc and the second one, Genetically Modified (GM) crops. A common consensus of the conference was the need for the Government to take stock of the current and emerging situation especially with respect to food security and take firm measures to promote new versatile technologies like biotechnology, while taking care of the interests and concerns of farmers,consumers and the environment. The need to constantly and effectively communicate the responsible and safe use of biotechnology by government agencies, academia and the private players was emphasised. EP News Bureau-Mumbai

MARKET

BD Medical - Pharmaceutical Systems organises Technovation seminar for pharma cos Seminar addresses challenges faced by manufacturers in their endeavour to reach global markets BD MEDICAL-PHARMACEUTICAL Systems recently organised its 4th Annual Technovation Seminar with this year’s focus on ‘Safety’ which is gaining momentum world over. At a time when world over legislations are being written to reduce the incidence of needle stick injuries and related challenges for healthcare workers and patients, this seminar was well poised to address the challenges faced by manufacturers in their endeavour to reach global markets.

Alex Jaksch, Director- WW Strategic Marketing, Safety, BD Medical-Pharmaceutical Systems apprised the audience on the needlestick legislation which could possibly be the differentiator for companies eyeing the exports and domestic markets. Murli Sundrani, Business Director- BD Medical-Pharmaceutical Systems – India said, “With more than 115 years of expertise in manufacturing and processing technology for parenteral drug delivery systems, BD understands how best to meet the

demonstrates our commitment to developing innovative solutions that help address our customers’ unmet needs. We are glad that Technovation Seminar is able to bring forth the expertise and share knowledge with our esteemed customers.” Tom Koning, Director- WW Commercial Development, Safety, BD Medical-Pharmaceutical Systems elaborated on the portfolio of BD Safety & Needle Shielding Systems. pharmaceutical industry’s delivery requirements for injectable

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MANAGEMENT

TIME FOR AN

ALTERNATIVE

PATENTSYSTEM ? Do developing nations need an alternative patent system? Viveka Roychowdhury presents two diametrically opposing views on this contentious issue. Dr Gopakumar G Nair, CEO, Gopakumar Nair Associates, Mumbai supports such a move, arguing that India should provide the leadership for such an initiative while Dr Kristina M Lybecker, Associate Professor, Department of Economics & Business, The Colorado College, argues that India's IP policies represent a â&#x20AC;&#x153;sacrifice of future industrial success for short-term current gainâ&#x20AC;?

30 EXPRESS PHARMA January 1-15, 2014

India, Brazil, China, Russia, Indonesia and South Africa should take initiative in pushing forward the agenda for an alternate patent system. India will not be isolated DR GOPAKUMAR G NAIR

All innovation should be valued, protected and rewarded. By failing to do so, India turns her back on innovation, medical progress and patients

CEO, Gopakumar Nair Associates

DR. KRISTINA M LYBECKER Associate Professor, Department ofEconomics & Business,The Colorado College

DR GOPAKUMAR G NAIR | CEO, Gopakumar Nair Associates

â&#x20AC;&#x2DC;India should provide leadership to the initiativeâ&#x20AC;&#x2122; Do developing nations need an alternative patent system? And if yes, what should be the deviations from the existing Western system? In light of the aggressive trends from developed countries through the Trans-Pacific Partnership (TPP) Agreement, the developing countries must get together to discuss the need for formulating an alternative patent system. The TRIPs Agreement has been put on the backburner, by the developed countries while they tried to conclude the Anti-Counter-

feiting Trade Agreement (ACTA). While ACTA failed, TPP is being pursued with an agenda which boarders on 'IP/patent terrorism'. Once TPP is concluded, the TPP member countries will force all others with whom they (TPP members) have trade relations to sign TPP or agree to TPP agenda and terms. To pre-empt such arm-twisting of weaker nations, the third word countries must enter into SouthSouth discussions and negotiations sooner to evolve the strategies and policies. The major deviations

from the existing Western system, should be to seek mechanisms and statutory provisions to improve affordable access to the life saving medicines. The provisions like Sec.3(d) which has helped to restrict 'evergreening' need to be further strengthened. Voluntary licensing, as in the case of copyrights need to be liberally extended to patents in developing countries. Voluntary licensing with royalties should be made obligatory on the part of patent holders of life saving medicines.

India has been often called a 'international outlier' on IP. And its stance on Glivec, and other judgements related to Sec.3(d) have been seen as evidence of a 'pattern of IP erosion'. Does India risk being isolated on global trade due to this stance? And if yes, what should be the way forward for policy makers, corporate management? India, Brazil, China, Russia, Indonesia and South Africa should take initiative in pushing forward the agenda for an alternate patent system. India will not

be isolated. Other developing countries are looking forward to India to take a lead. India's IP policy and patent law provides appropriate balance of rights and obligations as is expected from the Paris Convention to TRIPs (Article 7 & 8). Specific to biopharma and lifesciences, it is important to note that TRIPs is anyway redundant, since the requirements of renegotiation of Art.27(3)(b) has not taken place within four years (1999) as required under TRIPs. What is the stand of other

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developing nations? Are there any others pushing the envelope on this front? South Africa is keen on such a move. Brazil will also come forward. What is needed, is for India to provide a leadership to the initiative. Unfortunately, we do not have a national leader or a leader from the Government who can provide impetus and motivation. The Government of India must support private initiative, from the Indian generic pharma industry to take up this cause. It is Big Pharma who is pushing the TPP agenda on behalf of the US. We (India) or BRICS does not have the muscle power or financial strength which the TPP has. However, the BRICS initiative will be people-driven and affordable access driven.

The movie ‘Fire in the Blood’ has become the most recent critique of the pharma industry's monopolistic practices. Do you feel Dr YK Hamied's strategy on ARVs will stand the test of time, given today's business realities? Eventually, use of science for innovation must benefit the people. The inventions relating to life saving drugs must reach the needy patients. What has done good for HIV patients, must be extrapolated to cancer patients and others suffering from life threatening diseases. If the patent system does not take along the needs of the patients, the system will collapse sooner or later. The Wikileaks-leaked TPP negotiating text (http://keion-

TPP agenda, like the failed ACTA is being built on the foundation of greed and IP/ patent overexploitation line.org/node/1825) reportedly shows that it currently includes some of the harshest

provisions against access to medicines ever included in a trade agreement and some analysts are predicting that this will harm the health interests of developing nations. Governments of some developed nations including Canada, and other nations like Chile, New Zealand, Malaysia and Singapore are pushing back against some aspects of the US position with their own proposal that better protects access to medicines; according to MSF. Your comments on this trend. Does this mean that some developed nations too are diluting their IP stand selectively? TPP agenda, like the failed ACTA is being built on the foundation of greed and IP/patent over-exploitation. ACTA failed

because of the ruthless approach to label all generics (other than inventor molecules) as counterfeits. TPP is being pushed with an extremist IP agenda. The more equitable, reasonable and practicable countries whose governments read the 'pulse' of the people, will insist on a 'humane' approach to life saving drugs, their access and affordability. Any proposal through TPP Agreement, if finalised will need to incorporate the people's/patient's aspirations. It is heartening to note that few of the member countries are already realising this. Without the middle/moderate approach in TPP, either TPP will fail or will impact other pacts like ASIAN and even TRIPs & WTO to fail.

DR KRISTINA M LYBECKER | Associate Professor,Department of Economics & Business,The Colorado College

Intellectual property policy in India: Sacrificing the future and undermining health progress DESPITE PROMINENT declarations to the contrary India is hostile to innovation, a position confirmed by recent court decisions again and again. Recently, Nirupama Rao Indian ambassador to the US claimed, “India makes a priority of complying with international treaties such as the Trade Related Intellectual Property Rights (TRIPS) Agreement of the World Trade Organization” (Rao, 2013). Not only are recent decisions by the Indian Supreme Court an abuse of the global intellectual property (IP) framework, they represent a sacrifice of future industrial success for short-term current gain, and have the potential to significantly undermine public health advances. Through these legislative decisions, India is abolishing all incentives for innovation and simultaneously signalling that the foreign direct investment that fosters such innovation is no longer welcome.

32 EXPRESS PHARMA January 1-15, 2014

Critics of the global IP system argue that the existing system is 'broken' and fails to provide access to medicines for the world’s poor and vulnerable. These claims fail to stand up to even the mildest scrutiny, as evidenced by the tremendous innovations that continue to improve public health and greatly enhance and extend life. First, the existing system provides the incentives necessary to encourage the investment of time, talent and other resources to the development of breakthrough medical therapies. Without this the very development of these treatments, access is not an issue. Pharmaceutical innovation must take place before these drugs can be available to anyone, whether they be patients in industrialised nations or in the developing world. Contrary to the claims of critics, innovation will not happen without a strong IP system and the preservation of the incentives that motivate

these discoveries. Moreover, these discoveries are critical to the future and success of the Indian pharma industry. The Indian pharma industry is expected to grow from an estimated $21 billion in 2013 to $56 billion by 2020 (Tyer, 2013). As almost exclusive producers of generic drugs, the industry’s current success and future growth is contingent on the innovation of others. As such, any threat to the level of global innovation will have serious consequences for industries like those of India, who imitate

rather than innovate. The shrinking of the blockbuster drug pipeline should concern Indian firms and provide tremendous cause to safeguard the incentives for future innovation and breakthroughs. The declining R&D productivity is clearly a concern for generic pharmas – eventually there would be fewer drugs to copy on patent expiry. This may lead to a potential long-term de-rating of India’s generic pharma sector.” (Bakhru and Park, 2013). Recent decisions by the Indian Supreme Court are indicative of an undeniably shortsighted view of intellectual property rights, given the dependence of the Indian industry on the innovation of others. Nearly ten years after the amendment of the Indian Patent Act, thousands of process patents have been issued by promise of new chemical entities (NCEs) remains unfulfilled. The unmet health needs of patients around the

world, especially those in developing nations such as India, remain unmet. Moreover, “analysts note that the lack of transparency in the Indian drug regulatory system and weak patent laws are a major challenge for foreign multinational companies attempting to enter or expand in the Indian healthcare market” (Tyer, 2013). Specifically, Section 3(d) of the Indian Patent Act forbids the patenting of new forms of existing drugs unless the new form markedly improves efficacy and generates therapeutic benefits. Consequently, much of the incremental innovation that is done on existing treatments will no longer be patentable in India. For public health practitioners, incremental innovation ensures an array of drugs are offered within a therapeutic class which gives physicians the ability to precisely treat the individual needs of diverse patients. In addition, incremental innovative improvements can poten-

MANAGEMENT

tially: increase the number of available dosing options, reveal new physiological interactions of existing medicines, allow for reformulations to encourage children’s compliance, increase the shelf-life or heat-stability of a given medicine to secure effectiveness in diverse environments, minimise or eliminate treatment-limiting drug reactions or side effects, and improve patient compliance (Wertheimer, Levy and O’Connor (2001) among others). These distinct characteristics increase a patient’s probability of finding a treatment that is both effective and tolerated. Moreover, since first-inclass drugs are rarely optimal, incremental innovations may become best-in-class and first line therapies. Given this it is not surprising that a significant share of existing therapies resulted from incremental innovation. Cohen and Kaitin (2008) find that 63 per cent of the drugs on the World Health Organization’s Essential Drug Lists are follow-on drugs. Finally, incremental innovation is especially critical to developing world patients. Incremental innovations provide for more convenient extended-release dosing and formulations that are do not require refrigeration or are less temperature sensitive, valuable characteristics in developing country settings. These are innovations that should be encouraged and incentivised: something that Indian Patent Law does not do. The picture of the Indian pharma industry becomes even bleaker when one considers the future of pharma research and profitability, biologics. A “biologic medicine is a large molecule typically derived from living cells and used in the treatment, diagnosis or prevention of disease. Biologic medicines include therapeutic proteins, DNA vaccines, monoclonal antibodies, and fusion proteins.” (Amgen, 2012). As opposed to small molecule drugs which are produced through chemical synthesis, biologics are primarily produced using recombinant DNA (rDNA) technology and are made by genetically engineering living cells to produce the required pro-

teins. Given this, the complexity and sensitivity of these large proteins make them more difficult to characterise and to produce such that even minute differences in the production processes or cell lines may result in variations in the resulting protein. Fundamentally, this sensitivity makes quality control all the more important and production complications more disastrous. This does not bode well for India, a nation that faces serious challenges in regulating clinical trials with a drug regulatory system that falls far short of world standards. Quality control and precision are essential for biologics and failures can be devastating. Beyond the disability and deaths resulting from 500 cases of fungal meningitis linked to contaminated injectable corticosteroids formulated by the New England Compounding Center and the 150 deaths resulting from tainted Chinese heparin, immunogenicity problems may even result from small changes made by the innovator company under the best of controlled conditions. An example is useful to illustrate the potential consequences of producing biologic medicines in an environment such as India’s. Consider the case of EPREX as described by BIO, the Biotechnology Industry Organization: Immunogenicity is an important concern regarding the safety of biologics. This occurs when our bodies treat a protein as if it is a foreign substance and try to attack the protein with antibodies. Unlike chemical drugs, all biologics have the potential to stimulate antibody production in patients and such responses are highly unpredictable. Sometimes the antibodies produced in response to a biologic have no effect. Other times they bind and inactivate the biologic, causing disease progression. In still other cases, they can bind to and inactivate a patient's naturally occurring protein, which means that the patient may be left with no options other than regular blood transfusions. One example of immunogenicity occurred a few years ago when, at the request of the European Health Author-

The Indian pharma industry is touted as the ‘pharmacy to the developing world’. While they do provide affordable drugs to developing nations, this market is not their ‘bread and butter’ ities, Johnson & Johnson made a change in the manufacturing process for its EPREX product, a product that had been marketed for a decade with no evidence of immunogenicity problems. The change caused a serious adverse reaction in a small number of patients. These patients lost their ability to make red blood cells because they produced an antibody (triggered by the EPREX) that inactivated both the administered protein (EPREX) and the body's natural protein that is essential for red blood cell production. Johnson & Johnson eventually was able to determine the cause of this adverse reaction and correct it, but only after a very lengthy and expensive investigation. The EPREX case shows that one protein can be different from another in ways that cannot be detected in the laboratory, but are seen only by the body's exquisitely sensitive immune system. If one change to a well-established complex manufacturing process, made by the manufacturer who has intimate knowledge of the process, can cause a problem with immunogenicity, surely the risk is even greater with an entirely new manufacturer and process - as will be the case with follow-on

biologics. (BIO, 2012) Biologic medicines are extraordinarily sensitive, which points to the challenges of defining the parameters of protection and the importance of safety. Considerations that are significant to the most technologically advanced nations and sorely absent in India. Biologics are the future of medicine and safety must be a priority in their development, production and protection. Since a minute alteration in the raw materials, temperature, pH, cell line, or manufacturing process can result in a significant change in the medicine’s quality, efficacy or safety, the interchangeability and substitutability of these products must be approached with extreme caution. The Indian pharma industry is touted as the “pharmacy to the developing world”. While they do provide affordable drugs to developing nations, this market is not their “bread and butter”. This is clearly reflected in the fact that the Indian industry is globally the third largest in terms of volume, but 13th in terms of value. The Indian pharma industry’s profits come from industrialised nations, and these are their most important markets. There is no denying that these are profitdriven companies and that this is their true focus. Realistically, generic Indian producers focus on getting the six months of market exclusivity that is granted to “first to file” generics. Why? Because this exclusivity allows generic producers to sell their version at 90 per cent of the branded drug’s price. Not surprisingly, Indian companies currently hold 21 per cent of the US generic market for annual sales of close to $12 billion. The vast majority of patients served by Indian pharma companies are in the US, Europe and Japan. At the same time, the unmet need in their own backyard is staggering. “Currently, around 67 per cent of India’s population, or 742 million people live in rural areas, but rural markets contribute only 17 per cent of overall market’s sales.” (Shetty and Hiremath, 2013). The Indian pharma industry fails to address their own domestic

needs. “India is an emerging healthcare market that has remained unsaturated due to the limited penetration of healthcare insurance and poor access to healthcare facilities, especially in rural areas.” (Tyer, 2013). Moreover, the success of the industry has been built upon an industrial policy based on weak patent laws, a reliance on compulsory licenses and a lack of regulatory transparency. India’s use of compulsory licenses is an abuse of both the spirit and intent of the TRIPS Agreement provisions which were intended to help the most vulnerable and respond to genuine need. Rather than addressing public health crises and national emergencies, India has turned to issuing compulsory licenses as a deliberate strategy and tool of industrial policy. The disease states and conditions for which India has recently issued compulsory licenses are for relatively small patient populations, not health emergencies as envisioned by the international trade agreement. One such example is Naxavar, a treatment for kidney cancer and the drug at the centre of Natco vs Bayer. Strikingly, in many countries the prevalence of kidney cancer is so low that it is classified as a rare disease. GLOBOCAN, the United Nation’s cancer project, estimates the total number of kidney cancer patients in India at less than 9,000. That constitutes less than 0.00073 per cent of the population. Decisions by the Indian Supreme Court to weaken intellectual property protections fail to recognise that every innovation is valuable, both breakthrough discoveries as well as improvements to existing therapies. These decisions undermine the incentives to innovate, the foundations of India’s pharma industry success, and the potential for cures and treatments to the world’s most challenging ailments and afflictions. All innovation should be valued, protected and rewarded. By failing to do so, India turns her back on innovation, medical progress and patients.

EXPRESS PHARMA

January 1-15, 2014

RESEARCH RESEARCH UPDATES

New drug target brings malaria cure closer Scientists discover a chemical modification in the DNA of human malaria parasite

SCIENTISTS HAVE discovered a chemical modification in the DNA of human malaria parasite, a discovery that could help develop a new drug to kill the deadly parasite that is becoming resistant to existing drugs. Researchers from the University of California, Riverside trying to understand the biology of the parasite have discovered a potential weakness - low levels of DNA methylation in Plasmodium's genome. The weakness “May be critical to the survival of the parasite,” said Karine Le Roch, an associate professor of cell biology, who led the research. DNA methylation is a biochemical process involving the modification of DNA that plays an important role in development and disease. DNA methy-

lation is a big deal in humans; it is so essential for normal development that abnormal DNA methylation patterns have been linked with many diseases, including cancers and neurological disorders, such as Alzheimer's. Until now, the existence of DNA methylation in the Plasmodium parasite was disputable, Le Roch said. Researchers were also able to confirm low levels of methylation using classical molecular approaches as well as new sequencing technology. The DNA methylation enzyme found in Plasmodium is also quite different than the one in humans, Le Roch said, “And because it is different we can eventually find a way to target it and shut it down. If a drug can be developed that specifically inhibits the methyla-

tion enzyme, it could kill the parasite in infected humans.” Researchers are keen to find a new drug against malaria, since mutations in the parasite have made it resistant to the most effective drugs on the market. “We need a new drug every five years because the parasites always find a way to develop resistance against a drug,” Le Roch said. Le Roch's ultimate goal is to map the regulatory networks controlling the entire life cycle of the Plasmodium parasite. She reasons that researchers really need to understand the entire biology of the parasite and how it replicates. The study has appeared in the journal Cell Host & Microbe. PTI

FDArejects Actavis’contraceptive patch,seeks more data Actavis’ contraceptive skin patch is designed to provide continuous delivery of the hormone norethindrone ACTAVIS PLC said US health regulators denied approval to its contraceptive patch for women and asked for more data. The US Food and Drug Administration questioned the differences in size and formulation of the patch used in trials and the to-be-marketed patch. The generic drugs maker, which received a "complete response letter" from the FDA, said it planned to work closely with the agency to address the

34 EXPRESS PHARMA January 1-15, 2014

questions. Such letters typically lay out FDA concerns that need to be addressed before a treatment is approved. Actavis' contraceptive skin patch is designed to provide continuous delivery of the hormone norethindrone, a type of progestin, during a onceweekly, seven-day dosing regimen. Progestin, the synthetic form of female sex hormone progestogen, inhibits ovula-

US FDA questioned differences in size and formulation of patches used

tion and thickens the layer of mucus at the cervix so sperm cannot enter the uterus. The treatment will compete with Johnson and Johnson's Ortho Evra, an estrogen/progestin combination contraceptive patch. Estrogen is another female sex hormone. A progestin-only patch can be safer than combination patches as high levels of estrogen are often linked to blood clotting disorders and an increased risk

of cancer. The company also filed an application to market the generic version of Merck & Co Inc's NuvaRing, a estrogen/progestin combination hormonal contraceptive vaginal ring. Actavis said it may be the first applicant to file the application, which, if approved may entitle it to 180 days of generic market exclusivity. Reuters

RESEARCH

New finding could lead to Genetic flawmay trigger liver cancer, better malaria treatments The drug situation for malaria is becoming very serious London SCIENTISTS HAVE identified a new method to stop malaria parasites from multiplying, paving way for new treatments for the deadly mosquito-borne disease. Researchers found that blocking the activity of an enzyme called NMT in the most common malaria parasite prevents mice from showing symptoms and extends their lifespan. The team are working to design molecules that target NMT more potently, and hope to start clinical trials of potential treatments within four years. Although a variety of antimalarial drugs are available, some strains of the parasite are resistant to treatment. These strains are becoming more common, with treatment failures reported across multiple frontline drugs. If acute illness is cured, the parasite can remain dormant in the blood and return to cause ill-

ness later. Malaria vaccines have been researched intensively, but none have been introduced into clinical practice. The new study shows that NMT is involved in a wide range of essential processes in the parasite cell, including the production of proteins that enable malaria to be transmitted between humans and mosquitoes, and proteins that enable malaria to cause long-term infection. The researchers have tested a handful of molecules that block the activity of NMT in the parasite living inside human red blood cells, and in mice, but further refinement will be needed before a treatment is ready to be tested in humans. "The drug situation for malaria is becoming very serious. Resistance is emerging fast and it's going to be a huge problem in the future," said Dr Ed Tate, from the Department of Chemistry at Imperial College London, who led

the project. "Finding an enzyme that can be targeted effectively in malaria can be a big challenge. Here, we've shown not only why NMT is essential for a wide range of important processes in the parasite, but also that we can design molecules that stop it from working during infection. It has so many functions that we think blocking it could be effective at preventing long-term disease and transmission, in addition to treating acute malaria. We expect it to work not just on Plasmodium falciparum, the most common malaria parasite, but the other species as well. We need to do some more work in the lab to find the best candidate molecule to take into clinical trials, but hopefully we'll be ready to do that within a few years," Tate said. The study was published in journal Nature Chemistry. PTI

Sandozstarts late-stage trial with copyof AbbVie's Humira drug The trial will study patients with moderate to severe plaque-type psoriasis London SANDOZ, THE generics division of Novartis, said it had initiated a late-stage clinical trial with its so-called biosimilar version of AbbVie's best-selling drug Humira. It is Sandoz's sixth copy of a biotech medicine to enter Phase III trials and could

represent a major prize, since the Humira drug for rheumatoid arthritis, psoriasis, and Crohn's disease is the world's top-selling prescription product with sales of around $10 billion a year. The trial will study patients with moderate to severe plaque-type psoriasis and is designed to support registration

in the US and Europe. Creating copies of such antibody drugs is complicated because they are produced in living cells, bringing inevitable unpredictability. As a result, copies can only ever be "similar", not exact replicas. Reuters

diabetes in men

Findings also showed that prior to cancer development there were occurrences of glucose intolerance

Washington RESEARCHERS HAVE discovered a genetic deficiency in males that can trigger the development of one of the most common types of liver cancer and diabetes. Michigan State University researchers found that when the NCOA5 gene, present in both men and women, was altered in male mice to a deficient level, a spontaneous reaction occurred producing cells that can lead to hepatocellular carcinoma, a type of liver cancer found to be twoto-four times more prevalent in men than women. Findings also showed that prior to cancer development there were occurrences of glucose intolerance, a prediabetic condition that is believed to increase the risk of type 2 diabetes in humans. Conversely, the study showed female mice did not develop these diseases. "Essentially, what this provides is evidence for a genetic susceptibility in males to this particular type of liver cancer and diabetes," said Hua Xiao, lead researcher of the project and associate professor of physiology in MSU's College of Human Medicine. "Ninety-four per cent of the male mice we looked at developed the liver cancer, while 100 per cent of these mice developed glucose intolerance," Xiao said. Xiao noted the reason for the distinct outcomes be-

tween males and females also may have to do with the different levels of hormones between genders. "Because estrogen may function through the NCOA5 gene and previously has been found to play somewhat of a protective role against both diseases, the result is a decreased risk in females," he said. "Since males produce lower amounts of estrogen, this can contribute to their susceptibility," he added. Type 2 diabetes has been widely associated with liver cancer as a common risk factor. "At this point, it's not known if the genetic deficiency can be reversed and needs to be investigated further," Xiao said. "But if it can somehow be changed through treatments such as drug therapies, this could substantially increase the chances of men in particular warding off these diseases," he said. The research was published in the journal Cancer Cell. PTI

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January 1-15, 2014

RESEARCH

FDAapproves another GSK, Theravance lung drug

Skin can ‘talk’to liver Researchers worked with so-called knock-out mice

London SCIENTISTS HAVE found that the skin is capable of communicating with the liver, a surprising discovery that may advance the understanding of how skin diseases affect the rest of the body. Researchers from the University of Southern Denmark, in experiments with laboratory mice, discovered that the skin, which is the body's largest organ, can "talk" to the liver. "We have showed that the skin affects the metabolism in the liver, and that is quite a surprise," said researcher Susanne Mandrup and Ditte Neess, former student in the Mandrup research group and now laboratory manager in Professor Nils Faergeman's group at the Department of Biochemistry and Molecular Biology. Researchers worked with so-called knock-out mice, in which a specific fat binding protein called acyl CoA binding protein has been removed (knocked out). Some knock-out mice produced by the researchers had a strange greasy fur, and they had difficulties being weaned from their mother. Analyses also showed that the mice accumulated fat in the liver at weaning. "At first we thought that the fat accumulation in the liver was linked with the fact that the gene was missing in the liver of the knock-out mice. But this was ruled out by a series of studies, and we had to find another explanation," said Neess. She and her colleagues took another look at the rumpled and weak knock-out mice. Their fur was greasy, and they had a leaky skin from which they lost more water than normal mice. "When they lose water, they also lose heat. We there-

36 EXPRESS PHARMA January 1-15, 2014

Anoro Ellipta was developed along with US partner Theravance

THE US Food and Drug Administration approved GlaxoSmithKline Plc's new lung drug for treatment of chronic obstructive pulmonary disease (COPD), commonly known as smoker's lung. However, the inhaled treatment, Anoro Ellipta, will carry a warning that one of its components increase the risk of asthmarelated death, FDA said. Anoro Ellipta was developed along with US partner Theravance Inc, in which Glaxo owns a 27 per cent stake. The drug combines

fore asked ourselves whether this water and heat loss could be the reason why the mice accumulated fat in the liver and became weak when weaned from their mother," said Neess. To clarify this, the researchers made some mice that lacked the fat binding protein only in the skin. Similar to the full knockouts these mice had difficulties after weaning and accumulated fat in the liver. This showed that lack of the fat-binding protein in the skin was sufficient to induce accumulation of fat in liver. To get to the bottom of how a defect in the skin 'talks' to the liver, the researchers decided to cover the mice with vaseline. This would prevent water evaporating from the skin and thus stopping the heat loss. As a result the fat accumulation in the liver dis-

appeared. But as vaseline contains fat, that could theoretically be absorbed by the skin or ingested by the mice, the researchers were a little unsure if there were side effects from the vaseline. A student proposed to cover the mice with liquid latex. Having covered the mice in blue latex the researchers saw that fat accumulation in the liver again disappeared. "We believe that the leaking of water from the skin makes the mice feel cold, and that this leads to breaking down of fat in their adipose (fat) tissue. The broken down fat is then moved to the liver. The mice move energy from the tissues to the liver," researchers said. PTI

balance in the number of non-fatal heart attacks experienced by patients on Anoro in certain trials, compared with a placebo. Glaxo and Theravance received FDA approval for another COPD drug, Breo Ellipta, in May. Breo Ellipta, an inhaled combination of vilanterol and corticosteroid fluticasone furoate, was launched in October. Analysts on average expect Anoro Ellipta to generate annual sales of about $2.65 billion and Breo Ellipta of about $2.22 billion by 2018,

The warning on the drug’s label is one of the strongest issued by the regulator and relates to the effect of LABA drugs on asthma patients vilanterol, a long-acting beta-agonist (LABA) that opens the airways, and umeclidinium, a long-acting muscarinic receptor antagonist (LAMA) that improves lung function. The warning on the drug's label is one of the strongest issued by the regulator and relates to the effect of LABA drugs on asthma patients. An FDA advisory panel in September voted unanimously in favor of the drug's efficacy but had expressed concerns about its safety profile. The panel highlighted im-

according to Thomson Reuters data. COPD is the third leading cause of death in the US, according to federal data. The disease, mostly caused by cigarette smoking, can lead to coughing, wheezing, shortness of breath and tightness in the chest. Novartis AG, AstraZeneca Plc and Boehringer Ingelheim have drugs to treat COPD, but Glaxo's Advair, with sales of about $8 billion a year, is the market leader. Reuters

RESEARCH

Silencing signals sent by parasite could aid sleeping sickness fight Untreated, it can damage the nervous system A NEW discovery by scientists could help combat the spread of sleeping sickness. Insights into how the parasites that cause the disease are able to communicate with one another could help limit the spread of the infection. The findings suggest that new drugs could be designed to disrupt the flow of messages sent between these infectious micro organisms. Sleeping sickness is transmitted by the bite of the tsetse fly, and more than 69 million people in Africa are at risk of infection. Untreated, it can damage the nervous system,

leading to coma, organ failure and death. During infection, the parasites – known as African trypanosomes – multiply in the bloodstream and communicate with each other by releasing a small molecule. When levels of this molecule become sufficiently high, this acts as a signal for the parasites to stop replicating and to change into a form that can be picked up by biting flies and spread. A team led by researchers at the University of Edinburgh was able to uncover key components of the para-

sites’ messaging system. They used a technique known as gene silencing to identify those genes that are used to respond to the communication signals and the mechanisms involved. Professor Keith Matthews, of the University of Edinburgh’s School of Biological Sciences, who led the research, said, “Parasites are adept at communicating with one another to promote their survival in our bodies and ensure their spread but by manipulating their messages.” EP New Bureau – Mumbai

US FDAapproves Novo Nordisk’s drug for rare blood clotting disorder Tretten was studied in 77 patients THE US Food and Drug Administration said it has approved Novo Nordisk's drug Tretten to prevent bleeding in patients with a rare blood clotting disorder. Patients with congenital Factor XIIIA-subunit deficiency do not make enough of the Factor XIII protein that is important for normal blood clotting, the FDA said. Factor XIII is composed of subunits A and B and Factor XIII deficiency is usually caused by a deficiency of the A subunit. Tretten was studied in 77 patients with the disorder and was effective in preventing bleeding in 90

per cent of the patients when given monthly, the FDA said. Side effects included headache, pain in the extremities and at the injection site. Congenital Factor XIII affects an estimated one in 3 million people globally and is associated with life-threatening bleeding, impaired wound healing and miscarriage. The drug is expected to generate sales of $84 million by 2018, according to the average estimate of three analysts polled by Thomson Reuters. Novo Nordisk acquired the rights to Tretten from ZymoGenetics in 2004.

Novo agreed to pay a royalty on sales, although details of the royalty payment were not disclosed. ZymoGenetics was acquired by Bristol Myers Squibb Co in 2010. The product was approved last year in Europe and Canada. It is sold in Europe under the brand name NovoThirteen and contains the active substance catridecacog, which is structurally the same as the human Factor XIII A subunit. It is produced by genetically engineered yeast cells. Reuters

Paracetamol poisoning could be better treated: Study Treatment with acetylcysteine often causes vomiting PATIENTS WITH paracetamol poisoning could be helped by a new way of delivering an antidote, researchers say. Treating patients with the common antidote remedy – acetylcysteine – over a shorter time period than currently applies leads to fewer side-effects, a trial study found. Patients are normally given the drug by intravenous drip over a 21hour period, with a large part of the dose given very quickly. In a study, patients who received the same dose of acetylcysteine more gradu-

hospitalised for paracetamol poisoning. The pilot, led by University of Edinburgh scientists, treated more than 200 patients and is the largest trial of its kind for paracetamol poisoning. The treatment for poisoning was first used and developed by University of Edinburgh doctors in the 1970s. Professor Nick Bateman, of the University of Edinburgh’s BHF Centre for Cardiovascular Science, said, “Our finding offers a major advance in treating paracetamol poisoning, both in terms of fewer unpleasant

Paracetamol is the most common cause of overdose in the UK and every year around 45,000 people are hospitalised for paracetamol poisoning ally over a 12-hour period experienced less vomiting and fewer associated reactions. Their treatment was also less interrupted than those receiving conventional treatment with a 21-hour drip. Treatment with acetylcysteine often causes vomiting, a drop in blood pressure and other side-effects such as flushing, rashes and difficulty breathing. Paracetamol is the most common cause of overdose in the UK and every year around 45,000 people are

side-effects for patients and a shorter hospital stay. We need to do more work on a larger population group to find out whether treatment over a shorter time frame is as safe as the current standard.” The study, published in The Lancet, was carried out with the Universities of Newcastle and Aberdeen and funded by the Chief Scientist Office of the Scottish Government. EP New Bureau – Mumbai

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January 1-15, 2014

PHARMA ALLY VENDOR NEWS

Anshul Life Sciences partners with JH Nanhang To be sole distributor for Povidone (PVP) range of polymers in India, Sri Lanka, Bangladesh and Pakistan ANSHUL LIFE Sciences has partnered with JH Nanhang (JHNH) as their sole distributor bringing pharmaceutical grades of Povidone, Crospovidone and Copovidone to the users of India, Sri Lanka, Bangladesh and Pakistan. Povidone range has varied applications in pharma industry. Povidones and Copovidones are used as binders whereas Crospovidones are used as disintegrants in formulations. The value proposition offered by this alliance is a blend of quality, compliance

and reliability through superior quality products complying with international standards along with strong technical services and reliable supplies. JHNH, backed by $7 billion Jianhua Group, is the leading PVP manufacturer in China. As Jianhua Group has acquired most of the share holding in the joint venture between Zhejiang Jianhua Group and Nanhang Industrial, the name was changed to Quzhou JH Nanhang Industrial, which now also owns the

‘Nanhang’ brand. The products offered by JHNH are from the manufacturing facility at Quzhou which is the only site approved by the Chinese FDA for excipients, complying with all the current pharmacopoeial standards (USP/EP/JP/IP). All statutory approvals including the registration with US FDA, Certificate of Supply for European supplies, ISO certifications and all the necessary documents required for regulatory compliance are available for the Quzhou site of

JHNH. The products and the above mentioned regulatory documents of JHNH are available through Anshul Life Sciences, their authorised and sole distributor. Anshul Life Sciences is one of the leading supplier of excipients that includes MCC from Mingtai, Lactoses from Meggle, Gum bases from Cafosa, Starches from Ingredion and Ethyl Cellulose from Asha Cellulose to the pharma Industry. Apart from excipients, Anshul also supplies specialty chemicals, raw materi-

als and filtration systems catering to the pharma, nutraceuticals, cosmeceutical, personal care, agrochemicals, automotive and other specialty segments. Headquartered at Mumbai, Anshul Life Sciences has eight offices all over India at major business locations like Ahmedabad, Hyderabad, Chennai, Bangalore, Chandigarh, Kolkata and Delhi with four warehouses at Mumbai, Hyderabad, Chandigarh and Ahmedabad. EP News Bureau-Mumbai

Schreiner MediPharm product wins international award The innovative solution was developed in cooperation with Baxter Healthcare Corporation SCHREINER MEDIPHARM product has joined the international list of the label industry’s best. Pharma-Tac Plus, the multi-functional label solution for infusion bottles took first place in the 2013 TLMI Awards competition of the North American Tag and Label Manufacturers Institute in the 'Multi-Process' category. The innovative solution was developed in cooperation with Baxter Healthcare Corporation. The TLMI Awards judging team places particular importance on the attributes of innovation as well as printing and manufacturing quality of the product entries. The PharmaTac Plus label convinced

38 EXPRESS PHARMA January 1-15, 2014

judges due to its superior printing expertise and high quality level. Furthermore, the sophisticated design spoke for itself. The goal of the innovation was to equip a label for infusion bottles with enough space for extensive information, ensure stable hanging and, additionally, allow easy documentation of administration. An integrated booklet label, a hanger and detachable label parts achieve these functionalities. “The earlier we are involved in the customer’s product development process, the greater our ability to target the specific requirements and apply our know-how,” says Ann L Merchant, President,

structions for use. It is firmly connected to the plastic base label, and can be opened and closed with ease by means of a starter tab. The robust hanger is an integral component of the label, and is easy to separate from the label construction for activation. The detachable documentation labels ensure reliable tracing of the medication and allow safe handling, even while wearing gloves. “With the Pharma-Tac Plus label, we developed an intelligent solution that upgrades infusion bottles and optimises the end user’s processes,” says Merchant. Schreiner MediPharm. The paper booklet provides

an extended area for multi-lingual text on ingredients and in-

EP News Bureau-Mumbai

PHARMA ALLY

Biomay completes interim analysis of phase IIB studywith innovative 3rd generation grass pollen allergyvaccine BM32 Study has enrolled 180 patients and is designed to show a treatment effect over two consecutive pollen seasons BIOMAY ANNOUNCED that an interim analysis for futility has been successfully completed for an ongoing phase IIb study (clinicaltrials.gov identifier NCT01538979) with its 3rd generation grass pollen allergy vaccine BM32. The study has enrolled 180 patients and is designed to show a treatment effect over two consecutive pollen seasons. An independent data management committee (DMC) has been appointed to analyse the data from the first treatment year with respect to the primary endpoint combined symptom and med-

ication score (SMS) as well as the safety aspects of the treatment. The DMC has recommended continuation of the study into the next treatment year. All patients on active treatment will receive the lower of the two initial doses. Rainer Henning, Chief Executive Officer, Biomay, commented, “We are satisfied with the result of this interim analysis of our most advanced product BM32. Reaching this milestone is an important step in the validation of our peptide carrier fusion protein vaccine platform. We are now looking

forward with great confidence to the final read-out of the study in the fourth quarter of 2014.” Biomay will welcome a partner for phase III development, registration and marketing of BM32 as well as for the peptide carrier fusion protein platform. BM32 is an innovative grass pollen allergy vaccine based on recombinant peptide carrier technology invented in the lab of Prof Rudolf Valenta at the Medical University of Vienna. This is a revolutionary concept, which offers potential for a paradigm shift in the treatment of allergies.

The carrier peptide fusion proteins are constructed from the immunogenic viral coat protein PreS from HBV and peptides from the IgE binding epitopes of the allergens in question; the latter have been engineered to lose their IgE binding capacity. BM32 has been designed to protect patients from the debilitating effects of grass pollen exposure and possibly provide long term cure. The product requires only three to four annual injections and promises to have very limited side effects. The ongoing phase IIb trial is con-

ducted in 11 leading allergy clinics in 6 European countries and has enrolled 180 patients. The study is coordinated by Prof Johannes Ring (Klinik am Biederstein, Technical University Munich, Germany). Based on the same technology platform, additional vaccines targeting different allergies (house dust mite, ragweed, birch and cat dander) are in preclinical development and will be advanced to clinical trials in the near future. EP News Bureau-Mumbai

PRODUCT

Romaco’s FK HelpLine is FrymaKoruma’s new point of contact FRYMAKORUMA has set up a new telephone hotline, the FK HelpLine, as a central point of contact for emergency operating and process help. The FK HelpLine team takes the customer’s call and passes the case on to the FrymaKoruma expert who is most competent to handle it. The HelpLine will allow a wide range of questions and problems to be dealt with swiftly by a qualified person.

Whatever the challenge, FrymaKoruma gets together with the customer to develop a suitable solution and assist with the technical implementation. Queries linked to processing or formulations, for example, are assigned to a specialist at ProTec, the process technology and training centre. If electronic control or hardware aspects need clarifying, on the other hand, the automation department

has the necessary know-how. Finding the right person to talk to fast matters particularly when a machine malfunctions and immediate action is imperative. The installation of the FK HelpLine reflects the Romaco Group’s customer philosophy. Efficiently organised technical support means less downtime and higher productivity with FrymaKoruma technologies around the globe. The tele-

phone hotline can be reached at any time of the day (CET). As an alternative, enquiries can also be addressed to a special e-mail account: fkhelpline@ romaco.com. The electronic mailbox is checked constantly during business hours to make sure each case is processed promptly no matter where the customer happens to be in the world. The fact that the HelpLine services are free of

charge throughout the warranty period is a further highlight. Contact details Susanne Silva Market Communications Romaco Group Am Heegwald 11 76227 Karlsruhe Germany Tel. +49 (0) 721 4804 0 Fax +49 (0) 721 4804 225 susanne.silva@romaco.com

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PHARMA ALLY VALUE ADD

Remote visual inspection in cleaning validation Ramesh Kumar Sahu, Product Manager, Skytech Systems analyses the expectations of regulators on cleaning validation and the ongoing debate on criticality of visual inspection in cleaning validation

PHARMACEUTICAL AND biopharmaceutical manufacturers use many kind of reactors, vessels, pipelines which are exposed to the product directly and cleanliness of the same is greatly impacted on the proceeding batch product quality. These process equipment are either glass lined or electro-polished to ensure the smooth surface and also inert to the reactions. It is also fact that the same assembly of process equipment are also used for many batches of different kind of chemical combinations. Ensuring right equipment and optimum level of cleanliness is the key to get a higher product quality. Maintaining product quality through contamination control is very much important. It is also important to clean the vessel before use for the next batch to ensure zero cross contamination. Cleaning processes are one of the primary means of contamination control between production batches. Generally the reactors and the pipelines are cleaned with water, detergents, WFI etc. The process of cleaning is decided based on the chemical characteristic of the previous batch (last batch) ingredients. The cleaning cycle to be developed should take the following into consideration â&#x2014;? Surfactant concentration

40 EXPRESS PHARMA January 1-15, 2014

Residue found in the shaft of the spray ball

Inspecting an inlet line fitted with globe valve

A visually cleaned surface of a glass lined reactor

Pan-Tilt-Zoom Cameras (PTZ)

PHARMA ALLY

● Solvent / water ● Time ● Temperature ● Imparted mechanical

Energy ● Developing a proper mix of the above will ensure the equipment are clean enough to use for the next production batch. Once the SOP of cleaning is laid down it has to be validated and periodically verified by ● Visual inspection ● Analytical Testing (HPLC/TOC) Both the above steps have to be performed and documented to certify the cleaning process is good enough to clean all the residue of the last batch. These process are very much dependent of the person who does it. In case of visual inspection it is very much dependent on the person at the same time documenting is also an issue. There are few other difficulties / hassles are there in term of personal safety and health hazard. These activities owe for a confined space entry clearance from the EHS and need to take prior precaution and documentation before we send a person for the job. So it is always point of discussion whether to do that or not and decided to skip and follow only the analytical testing. The analytical testing will definitely find out the residue more in micro level but fail to identify the cleanness at the places which is difficult to reach and which might be a place where even the washing might not reached. To eliminate all the ifs and buts it is advisable to use a camera which take the picture of the critical surfaces which are hard/difficult to reach, it help to document the visual inspection process. These cameras should have extended arms which can be put inside the vessels or pipes and take pictures at most difficult or complex structures which should be defined in SOP based on the vessels shape, size and utilities fitted in it. once the camera is being sent

Video Borescope Inspections

inside it should be articulated in every direction to get picture of different surfaces to ensure the cleanliness uniformity. The all pictures or videos should be kept along with the validation document. So using such camera will eliminate the risk of non compliance, downtime and unnecessary EHS documentation hassles and provide high degree of assurance of the cleaning process. Remote Visual Inspection (RVI) procedures using video borescopes and Pan-Tilt-Zoom (PTZ) cameras provide an alternative to costly disassembly procedures or confined space inspections which are time-consuming and hazardous due to life-risk associated with entry into hazardous locations.

Pan-Tilt-Zoom Cameras (PTZ) PTZ cameras offer the greatest flexibility for large tank inspection. With integrated lighting and an optical zoom capability of up to 36X, PTZ cameras can be lowered into reactor vessels and be remotely controlled to perform a full tank inspection. PTZ camera systems include a camera Controller Unit (CCU) which is capable of capturing still images or motion video. An accessory laser measurement system allows defect measurements to be performed on target inspection areas based upon known

spacing of the projected laser targets. PTZ camera systems can also be fitted with UV filters to allow CIP (Clean-In-Place) inspections using a Riboflavin Rinse technique prior to activation of a tank cleaning spray-ball. The source of the UV light can either be an integrated PTZ light source or a secondary UV illumination source, video borescope Inspections Traditionally, video borescopes have not been used to perform general tank inspections – primarily based on the large distances and surface areas required to be inspected. Video borescopes are best suited to perform specialised inspections, such as inspecting the seal integrity of a reactor vessel, or the efficiency of the cleaning process around the top-cover penetrations. When used in conjunction with guide tubes, a video borescope can generally be directed to inspect any area of a vessel. In the past, if a video borescope needed to inspect at distances exceeding 12 inches, or even closer when using high-magnification optical tip adapters, the inspection image was very dark. Modern video borescopes now offer a 'Long Exposure' mode of operation whereby the CCD imager collects image signals for a longer period of time resulting in a brighter, crisper image.

Value story for use of video inspection equipment

The use of video inspection equipment assists in identifying potential problems associated with incomplete vessel cleaning or damaged seals can easily costjustify the investment in video inspection equipment. If it was found at a later time that a vessel was in fact improperly cleaned, up to $100,000 per

month of product may be required to be scrapped. If product manufactured in contaminated vessels was shipped into the commercial distribution channels, a product recall, potentially costing millions of dollars may be required. (The author can be reached at rsahu@skytechindia.com)

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PHARMA LIFE

Resolutions for 2014 A new year signifies different things to different people: new hope, a new start, plans to take one more shot at tasks left half done ... or a chance to chart a new path completely. Getting into the spirit of the season, Express Pharma asks veterans of the Indian pharmaceutical industry to share their goals and resolutions for 2014 ...

â&#x20AC;&#x2DC;SIMPLE RESOLUTIONS FOR THE NEWYEARâ&#x20AC;&#x2122;

RANJIT SHAHANI Vice Chairman and Managing Director, Novartis India

62 EXPRESS PHARMA January 1-15, 2014

013 has been a particularly challenging year for industry, pharma industry included. From a slack economy to runaway prices we have seen it all. Low gross domestic product (GDP) growth and deferred capital investments meant that India had a tougher job than anticipated. The uncertainties that abounded only served to add fuel to a fire that was all but raging. The authorities kept the price control under suspense and until the drugs price control order (DPCO) was finally announced it kept hanging like a Damocles sword. Once announced there appeared to be complete lack of clarity for a while with several members of the industry going to court

over the impracticality of the time limit to withdraw drugs, re-label them and have them back in the market with the new prices. Revenues were severely impacted and the trade did little to ease the situation and stood their ground over their reduced margins even though the new margins were dictated by government. Speculation was rife in the media about more compulsory licenses to come and this only served to stoke the embers. Implementation of intellectual property continued to be plagued by uncertainty. The Glivec patent was lost in the Supreme Court. The Merck Glenmark patent row only served to exacerbate the global view that Indiaâ&#x20AC;&#x2122;s patent environment was volatile and

uncertain. Extreme views on FDI in pharma made one wonder if India was actually going back in time. We are stepping into 2014 and with the New Year comes new hope. National elections of course means that the next six months will see little meaningful business being transacted as all political parties get into election mode. And yet there is hope. Hope that once we have a new government in place we will see positive traction in the economy. That we will move forward to move further up the value chain across industries and that the economy will see growth that is nearer double digits. The innovative pharma industry hopes for more predictability in the manner in

which intellectual property rights are implemented and for more transparency and growth. New years are a time for making resolutions and while companies are constantly going through periods of self-renewal this becomes a time to introspect. At Novartis in India we would like to see more partnerships with multiple stakeholders as we work towards a common goal of healthcare for all. We would certainly like to see a higher work ethic from all segments of society. We would like to see better engagement with NGOs and less rhetoric. Like most others I too look at making personal resolutions for the new year. What will be my resolutions for 2014? Well, I would certainly like to be able to exercise

greater control over the choices of what I eat so that I eat right and eat healthy. Health is truly our greatest wealth and as societies get more developed we tend to

ardent lover of music and spending time on this gets increasingly harder. I believe, and rightly so, that in the stress of our everyday lives and as we chase

opt for richer and better foods that are not necessarily good for us. More than anything else, I would like to make time to do the things I enjoy. To find time to paint,visit art galleries and enjoy looking at works of others. I would also like to find more time to spend on listening to music. I am an

chimeral goals we lose track of the simpler things in life. Things that bring us true joy. My advice to the younger generations is this – make sure you always find time for meaningful and simpler things in life; the things that you will truly cherish and bring joy to others.

‘NEWYEAR RESOLUTIONS ARE EASYTO MAKE BUT EXTREMELY DIFFICULTTO MAINTAIN’

feel the secret of living a positive, fulfilling and a happy life is to maintain a proper balance between spending time at work, with family or friends and also focusing on your health and fitness. So my New Year Resolution is to maintain a healthy work life balance as well as turning the spotlight on my fitness. Being the Chief Executive Officer of a global pharma company with operations spread across diverse geographies can be tough on your work-life balance. But you need to strike a way out. I have always realised that it is important to spend time with your family and friends, but have not been able to do proper justice because of my hectic and demanding work schedule. My two daughters – Aisha and Rayna are my recharge tablets and this year I resolve to spend more quality time with them; along with my wife and other family members.

GLENN SALDANHA Chairman and Managing Director, Glenmark Pharma

Along with your family, dedicating some time for friends can be equally pleasurable and unwinding. So, allocating more time for my good old friends is also on my New Year resolution list. Another area of focus for me in 2014 will be my fitness. I do play badminton around three times a week which serves as a decent workout but I need to create a consistent workout routine. So, on the agenda are plans like daily

brisk walking and keeping a tab on my diet i.e. eating healthy and saying no to junk food. However, I do realise that New Year resolutions are easy to make but extremely difficult to maintain for any professional, where work dictates your priority. But I sincerely hope that I am able to keep my resolution of striking a health balance between my work on one hand and family, friends and my health on the other.

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THIS YEARS’RESOLUTION WILL BE BRINGING THE INDUSTRYTOGETHER AND MAKING IT STRONGER

PLAN GOALS ON MONTHLY BASIS TO ACHIEVE YEARLY GOALS

he year 2013 was one of the most challenging years for the pharma industry. We have seen all the hurdles in this year: implementation of new drug pricing policy (DPCO-2013), requirement of efficacy data by the DCGI for all FDCs, introduction of bar code system, COPP issue, introduction of GLP, GDP. Industry suffered heavily due to the new pricing policy and sudden change in Government policy on FDCs. On DPCO front, there was a huge divide between manufacturers, stockists/distributors and retailers, because of which 2013 was one of the most unproductive years, which dragged this so called ‘recession proof industry’ into the worst recession I have observed in my entire career. The pharma industry was the only industry which was growing at healthy pace of 15 to 17 per cent, but this year it witnessed single digit growth. Owing to reduction in retailers margin from 20 per cent to 16 per cent in the wake of new drug pricing policy, no retailer was ready to purchase material from the manufacturers thereby resulting in vacuum of medicines in the market and suffering by patients. Consequently, the pharma manufacturing industry, which works in India with an objective to serve common man, buckled under pressure and decided to pay 20 per cent commission to retailers by cutting their own margins. However, now the pharma industry is trying to put this

64 EXPRESS PHARMA January 1-15, 2014

BR SIKRI Director, ABS Mercantiles

difficult phase in the past and is looking forward for the positives which are in store for the industry in the coming years. We can proudly say that Indian generics have very well established itself in the global market due to consistent supply of good quality medicines at affordable prices. Global pharma industry cannot ignore Indian pharma industry, as we have the talent, infrastructure and willingness to grow. Indian pharma industry is expected to touch `1,25,000 crores in years to come. It implies that there is huge opportunity for all of us. There is strong potential for exports of generic pharma from India given the country’s comparative advantage in manufacturing of generics. India’s share in the global generic market is roughly five to six per cent and likely to reach 25 to 30 per cent over a period of time. Pharma exports from India continue to grow at a healthy rate of 18 per cent unaffected by the challenges that are being faced by other industries at a govern-

ment level or at a macroeconomic level. In fact the recent depreciation of the Indian rupee against US dollar has added fuel to the fire and affected the growth potential of this business adversely. So all of us should take a resolution for 2014 that we will all work together and will make India a most sought-after destination for any pharmaceutical product. On the personal front, in 2014, I would like to concentrate more on bringing the industry together and make it stronger to face the challenges and its growth in double digit. Our loyalty towards the great country has to remain unflinching. Although lot of tsunamis may come in between, we have to go a long way to grow to bring strength to the economy of our country because youth, which counts for more than 60 per cent population of this country, looks forward towards seniors like us and we owe this responsibility to the country. Also, it is observed that stakeholders are going to court for each and every issue and getting their grievances redressed but my resolution for 2014 will be to humbly request the Government to sit with stakeholders, give them a patience hearing and resolve the issue internally with the industry so that valuable time of court, government machinery and industry is not wasted and we do more of the constructive and positive work for the overall growth of the nation. Jai Hind!

ew years are always exciting and more amazing are the list of resolutions or plans you want to achieve. But 90 per cent of us don’t even remember it when half year is through. But I define new year resolution as new year plan which contains my goals for the year; they are both personal and professional. I plan my goals on monthly basis which helps me to achieve my yearly goal. This helps me too be more focused and regularly work for it. Secondly, you should follow an organised manner both at home as well as at work. For e.g., whether you want your home organised enough that you can invite someone over on a whim, or your office organised enough that you can find the stapler when you need it, these tips and resources should get you started on the way to a more organised life. Read something which is not of your profession or interest. This will help you to know more about other things in life which can be beneficial some way. This is called sponging. I learnt this technique from a serial entrepreneur named Jeff Hoffman. He used to daily read something of different fields and interests and note the points which interests him. So after a month he decided to combine them and he founded a company named

PARTH PATEL Director- Online Marketing and Sales, West-Coast Pharmaceutical Works

Your new year resolution should be inspirational, big and should motivate you to achieve them priceline.com. A company founded out of sponging is now valued as a $60 billioncompany with revenues of around $25 billion and is present in over 180 countries. So your new year resolution should be inspirational, big and should motivate you to achieve them. I would like to conclude with a quote from Donald Trump: THINK BIG AS YOU ARE GOING TO THINK ANYWAY

PHARMA LIFE

WILL DEVELOP NEWER APPROACHES TO RESOLVE ISSUES'

he coming year â&#x20AC;&#x201C; 2014 will bring newer dimensions not only for the pharmaceuticals and healthcare industry, but the nation. Newer political equations, explosive growth across emerging sectors, converging technologies and globally changing dynamics promise an interesting tomorrow, everyday. In 2014, the industry will continue to be challenged by key patent expiration and continued pricing pressures, amid changing healthcare access and funding issues. At the same time, emerging markets such as China, India and Brazil, will continue driving sales of pharma. Our goals in 2014 are to expand our large volume parenteral (LVP) manufacturing ca-

pacities and penetrate further into the national markets. Adding value to all our products and offerings through strong research and development is a key component of our vision for 2014. Marck Biosciences will also play a stronger role globally this year, having been awarded TGA Australia and MCC South Africa certifications. We will be focussing on internal corporate restructuring to make the organisational structure more decentralised; thereby more responsive. Additional recruitment in the sales team will help us penetrate the national market further. We keenly anticipate a great response from hospital administrators, doctors and paramedicals, which in turn will help us strengthen delivery mechanisms in our products. At

BHAVESH PATEL Managing Director, Marck Biosciences

Marck, the founding principle is Innovision â&#x20AC;&#x201C; a dynamic principle of order, manifesting itself in change, not in rigidity. Due to Innovision, we are an organisation that undergoes change without becoming chaotic, an organisa-

tion that can re-engineer itself to remain relevant in a continuously dynamic environment. We at Marck thrive on change and thus having imbibed a culture conducive for knowledge based activity and have geared our production facilities to become a versatile manufacturer. Our new Goa plant is fully operational and will add to our top-line while servicing the domestic and global markets both. On the personal front, I have three priorities to focus on in 2014, for an enhanced work â&#x20AC;&#x201C; life balance: 1. Fitness 2. Music 3. Reading on military history For almost two years now, I have been adhering to a fitness regime under an expert trainer. I feel happy and regret not

starting this earlier. I have been also learning music since the last five years but have not been able to put sincere efforts in the last year. I also read extensively on military history and would continue to do so. Interestingly, earlier, the thought of work and life balance never crossed my mind. There was no single hobby which I would pursue systematically and methodically. Maybe my focus was different in those days. Today, I feel amazingly energised through the day; by following regular exercise regime and focussed music lessons and have benefited enormously. In-depth reading of military history stimulates lateral thinking and helps me break monotony. I can develop newer approaches to resolving crucial issues.

ITWAS AYEAR WHICH HELPED US GROW OUR HORIZON

ast year has been very eventful and we have come to an end of the year. Professionally for Protiviti and for me, it was a year which helped us grow our horizon across different segments and strengthen our relationship with the clients. Our revenues, resources and loyal clients have all grown and our reputation in the market has expanded considerably. We started with seven people in October 2006, have grown considerably over last seven years and today our strength is more than 300 people. We are a stronger firm today thanks to the efforts of our team to embrace and successfully execute our strategy. We are facing lot of uncertainties in business environment in India due to global as well as domestic factors and are hopeful that the New Year will be different (better). We would like to do the following in next year:

Strengthen client relationship: We would like to strengthen our relationships with clients and would like them to look at us as someone they can count for support in managing business challenges. This will also help us become trusted advisors which is a core to our growth. We have acquired lot of large clients across different industries in last year and would like to strengthen our relationship with them. Knowledge sharing: We would be more active in professional associations as this helps us demonstrate our capabilities and develop our skills. These associations have people who are very experienced and interaction with them helps you understand different view points for some of the issues and challenges. At Protiviti, we believe it sharing knowledge and have a website (knowledgeleader.com), through which we share various documents such as question-

AKHILESH THAKUR Director, Protiviti Consulting

naires, work programmes, articles etc with people at large. Strong people: We have lot of talented people working with our organisation which has helped us be successful in the market. We will be looking for them to take up larger roles and fulfil their professional aspirations. We believe in faster growth for the deserving candi-

dates and will continue to provide them opportunities to grow faster. We have developed training programmes for our employees to equip them with the requirements in consulting and internal audit and will be enhancing the training so that they can get more benefit from the structured programmes. We will also encourage them through incentives and other rewards to actively participate in developing new training programmes. We will be strengthening our mentoring programme as it is very important from an employee retention point of view. The above three resolutions sum up what we are looking at doing professionally in the next year as loyal clients, employees and knowledge are three main pillars for our success will help us in achieve the following objectives: Grow business: Be known for quality of service we provide leader in internal audit and busi-

ness consulting Be preferred place to work On personal front, I would like to do the following: Spend more time with family: We have been travelling continuously due to professional and client commitments and in the entire process, the family suffers a lot. I would like to spend more time with my kids and my wife. I would like to go on a couple of vacations where I am not bothered by e-mails, messages and phone calls. Fitness: I have been trying to get some time out for exercise in last few years, but have not been successful. I would like to see myself devote time for fitness and may be participate in one of the marathons next year. Social events: I am the kind of person who is not very active in social events and I would like to change that. I will put in more efforts to ensure that I am actively involved with social events/ programmes.

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PHARMA LIFE

A BOUQUET OF FITNESS REGIMES FOR THE NEWYEAR

n the New Year, I would like to remember a few golden thoughts, a few words of wisdom and put them into action. Doing justice to our forefathers when there is potential for convergence emerging into the tomorrow of 2014 where, “AAP, HUM and WOH” are coming together in the capital of India, in competition to deliver, I believe is the right time to make your dreams into realities. Our country has all the potential to lead and succeed. As Swami Vivekananda said, “Awake, arise, wait not till the goal is reached”, we need to make our citizens follow the call of the hour. In 2014, I would request one and all to work together in Parliament to make the “fundamental duties” enshrined in our Constitution namely Art.51(A) and more particularly the Art.51(A)(h) which reads as follows: It shall be the duty of every citizen of India: to develop the scientific temper, humanism and the spirit of inquiry and reform. With the world’s highest percentage of youth population and the best opportunities for higher education within the

country with largest network of Council of Scientific and Industrial Research (CSIR), Universities and Centres of Excellence in science and technology India could become a powerhouse of science, knowledge and innovation. “A healthy mind in a healthy body”. Fitness is the secret of health, financial fitness for corporates, knowledge fitness for IP professionals, cGMP fitness for pharmaceutical manufacturers, cGLP fitness for CRO’s and mental, emotional, psychological and financial fitness for the individuals. 2013 has been a relatively tumultuous year, disturbing for many mentally, emotionally and financially. The best New Year resolution is to develop a ‘healthy mind through a healthy body’. Health of Indian API industry needs attention. Indian professionals are working in China to upgrade their US-EU compliant standards, while Indian law makers and NGO’s are working overtime to kill whatever is left over of the glorious API years of 1980’s and 90’s in India. Rebuilding and regaining the health of the API industry must be one resolution for 2014.

DR GOPAKUMAR G NAIR CEO, Gopakumar Nair Associates

The health of the Indian CRO’s has taken a dip, at least in part due to their own unacceptable actions and activities. For the sake of the health of Indian biopharma industry as a whole, vigilance and proactive initiatives are essential to convince the Apex Court and clear the reputation for regaining a foothold on the CRO front, which is important for the future of biosimilars in 2011 and thereafter. The legal health of the Indian generic industry could be better. The provisions of granting exemption to generic pharma In-

dustry such as Sec.107 A(a), to obtain regulatory approvals, manufacture and offer for generic launches post patent expiries are under constant attack, through anti-competitive practises resulting from abuse of dominant position by some MNC’s. This needs to be tackled in 2014. The health of the generic pharma industry in India needs nurturing and protection from ACTA, IMPACT, SSFFC, TPPA etc. There is tremendous potential for improving health of the herbal and nutraceutical industry in India, especially since the global market needs are visibly attractive. However, the badly implemented Biodiversity Act, the TKDL based “all is taboo” approach and the apathy of the Executive is causing serious road blocks even for sustainable benefit shared practical model for development and growth of herbal based pharma , bio and nutra. A ‘live and let live’ model should evolve for the “essential-medicines providers”, and their beneficiaries without excessive distinctions such as patentees vs. generics, MNCs vs. Indian companies, brands vs. INNs,

public vs. private, NGOs vs. industry, doctors Vs. patients and above all the Government Department should work for a common national goal: “ Health for all from 2014”. This is my wish and my dream. I would like to see our nation moving into that “heaven of freedom” of self reliance with high scientific temper. To quote India’s Nobel laureate Rabindranath Tagore, Where the mind is without fear and the head is held high Where knowledge is free Where the world has not been broken up into fragments By narrow domestic walls Where words come out from the depth of truth Where tireless striving stretches its arms towards perfection Where the clear stream of reason has not lost its way Into the dreary desert sand of dead habit Where the mind is led forward by thee Into ever-widening thought and action Into that heaven of freedom, my Father, Let my country awake

THE NEXTTWO YEARS ARE VERY CRUCIAL

BHAVIN M MEHTA Director, Kilitch Drugs

66 EXPRESS PHARMA January 1-15, 2014

irstly, the last two years been very slack in terms that our company Kilitch Drugs India has been registering products in West African countries like Burkina Faso, Mali, Ivory Coast, Togo, Benin and others. As the gestation period for the same is around one and half years to two years, we now have received registration from all these countries. Hence 2014-2015 shall be the year where I shall be

travelling almost 7-15 days a month to launch our company in various countries along with my team of lieutenants who are go getters. Secondlly, I am a great lover of golf, have been playing it for a while but want to master the same. I have planned to devote my Saturdays and Sundays, early morning, for golf. Thirdly, off late I have been spending less time with my family and hence decided to stay away from work on week-

ends. After all whom are we running for? If quality time cannot be spent with our family then we need to slow down and introspect for self realisation of our existence. And lastly, I shall be spending two days every two months at Katarkhadak, near Pune where my guru has built a gurukul to be in silence and energise myself. This is very much required for all of us, as we face so many people daily, who have either given up or are very

negative in life which either drains our energy or diverts us to their path of negativity. We get disturbed several times a week if some work is not done or some people don't respond to you. In order to remove all the negativity and regain our positive attitude which is a must for the benefit of business, I will be spending time at Katarkhadak Gurukul. This is essential as the next two years are going to be very crucial for my company.

PHARMA LIFE NAUKRI JOB SPEAK INDEX

Hiring activity in pharma sector dips 4 per cent in November Year-on-year analysis shows seven per cent increase in hiring activity in comparison to last year NAUKRI JOB Speak Index for this November reflects a rough month for the pharma sector. An M-O-M analysis reveals that index has gone down by four per cent as compared to October 2013. Yearly comparison shows an eight per cent increase in November if compared to same month of previous year.

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