Express Pharma May 1-15, 2013

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Market Access to medicines: Beyond 2Ps Management Accident analysis Research Developing a herbal-based drug for hepatitis B 1-15 MAY, 2013, `40

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V O L 8 . N O . 1 3 M AY 1 - 1 5 , 2 0 1 3

CONTENTS

Chairman of the Board Viveck Goenka

MANAGEMENT

Editor Viveka Roychowdhury*

Accident analysis

BUREAUS

PAGE 22

The ‘new’ patent law, policy

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

and strategy

PAGE 25

'Tweet-talk' your customers with new age

Bangalore Neelam M Kachhap

marketing

Delhi Shalini Gupta

PAGE 27

RESEARCH

MARKETING

Developing a herbal-based drug

Deputy General Manager Harit Mohanty

for Hepatitis B

Senior Manager Rajesh Bhatkal

Key link between obesity and type 2 diabetes discovered

PRODUCTION

PAGE 29

PAGE 30

Diabetes trials worldwide are not addressing

General Manager B R Tipnis

key issues in affected populations

Production Manager Bhadresh Valia

PAGE 31

PHARMA ALLY

Asst. Manager - Scheduling & Coordination Arvind Mane

Pharmaceutical supply chain–Indian

Asst. Art Director Surajit Patro

perspective

Chief Designer Pravin Temble

Intox expands experimental animal house facility

Senior Graphic Designer Rushikesh Konka

PAGE 33

PAGE 35

Eppendorf India celebrates 10th anniversary PAGE 36

Photo Editor Sandeep Patil Layout Rakesh Sharma

PHARMA LIFE

C I R C U L AT I O N

A Global Manager – Made in India

Circulation Team Mohan Varadkar

with lessons from Japan

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

May 1-15, 2013

PAGE 59

AmeriCares India Spirit of Humanity Awards 2013 held in Mumbai

PAGE 60

Eisai India wins CII Excellence Award for EHS

MARKET Access to medicines: Beyond 2Ps

PAGE 61

PAGE 11

‘Manufacturers should engage the USFDA early during drug approval for naming of a product’

PAGE 14

Pfenex, Agila Biotech announce JV

PAGE 16

Sun Pharma gets ANDA approvals for anti-diabetes drugs IPM grows at 5.6 per cent in March 2013 Goa set to become key pharma hub

PAGE 17

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EDITOR’S NOTE

A paucity of perception

EXTERNAL EXPERTS CAN BE CALLED IN TO SUPPORT OR ARGUE THE TECHNICAL MERITS OF A CASE BUT WHAT HAPPENS WHEN THE LEGAL INFRASTRUCTURE ITSELF IS PERCEIVED TO BE WEAK?

A fortnight after the Supreme Court of India delivered its judgment in the Novartis/Glivec case, the US Supreme Court heard arguments on the patent-eligibility of breast cancer genes BRCA1 and BRCA2 in the Association for Molecular Pathology (AMP) vs Myriad Genetics case. While the Indian court tried to futher define efficacy under Section 3d, the US case is all about deciding whether human genes are patentable.

AMP's argument is that granting patents on these genes to one company would restrict cancer research as well as hamper diagnosis of cancer in patients as it would restrict genetic testing for these genes to one company.

Patents on genetic material have been controversial in the past as well. In March last year, the US Supreme Court had ruled in the Mayo vs Prometheus case, that the latter could not patent a diagnostic test based on the discovery that there was a correlation between blood levels of particular chemicals to drug dosage. (See editorial on the case at this link: http://pharma.financialexpress.com /20120415/editorial01.shtml) Though the Prometheus case is not directly linked to the Myriad Genetics case, it revealed the fine tuning of legal doctrine and a certain line of reasoning being pursued in such cases.

Blogging on SpicyIP, on the AMP vs Myriad case, Samantak Ghosh narrates how one judge observed that “patent law is filled with uneasy compromises.”

The blog post goes on to highlight how the Justices were concerned about the “substantial arguments” that patents may be necessary to incentivise private investment in the discovery of DNA sequences and tried to figure out whether alternative forms of incentives such as recognition, process patents on uses of DNA, and patents on primers and probes, could sufficiently inspire potential investors.The final judgment on the patent-eligibility of the BRCA1 and BRCA2 genes, expected in June, will be closely watched as it will have huge implications for the patenting of biological material and its applications.

As legal minds bend their considerable intellect to understand the technicalities of the subject under debate, they are fully conscious of the weight of their decisions, on future policies as well as research and industry.

The burden is double as they may have to deviate from, and even reverse, previous judgments of their peers. For instance, patents on around 2000 isolated human genes had already been granted in the US before the AMP vs Myriad Genetics case came up but on April 15, the Justices heard and debated all the oral arguments afresh. In India, three patents were revoked last year: Sutent, Pfizer's cancer drug; Pegasus, Roche's hepatitis C treatment and the patent on the aerosol formulation of Merck's anti-asthma drug; these are still under appeal.

One of the US Justices at the April 15 hearing sportingly joked about the lack of his scientific expertise, and it is true that most judges face this handicap, especially when it comes to chemical structures and complex genetics. External experts can be called in to support or argue the technical merits of a case but what happens when the legal infrastructure itself is perceived to be weak ?

For instance, the Intellectual Property Appellate Board’s (IPAB) recently released annual report for 2012-13 shows that while it has disposed off a record number of cases this year, it is still facing a shortage of legal personnel, insufficient funds and infrastructure as well as a lack of clarity on certain procedures to be followed.

The IPAB is concerned that these constraints will impact 'the quality of justice', with the annual report pointing out that “the orders of the IPAB, especially in pharmaceutical patents, attract notice the world over and the quality of the justice delivery system in the IPAB will depend on the strength of the infrastructure.”

There is no doubt that the legal system in India is not the only one wrestling with the burden of balancing profits with public good. But all their efforts may be in vain if the judgments are perceived to be compromised due to these handicaps and cannot stand up to global scrutiny.

Post the April 1 SC judgment on Glivec decision, Ranjit Shahani, Vice Chairman and Managing Director, Novartis India had commented that in India it was ever-greening, but ever-delaying of patents, alluding to the long drawn out legal process. It is high time the legal infrastructure in the country is shored up so that there is no slur on the quality of the judgments or the delivery system.

Viveka Roychowdhury viveka.r@expressindia.com

8 EXPRESS PHARMA

www.expresspharmaonline.com

May 1-15, 2013

It's the turn of Directors and CEOs of midsize businesses to take the spotlight. 8% of India's GDP has been steadily contributed by the SME sector, despite the volatilty in the global economy. And the hunt is on for the leaders who excel as a habit.

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Get recognized as India's Finest Completely Boss Challenge is being held in seven cities - Delhi NCR, Bangalore, Ahmedabad, Pune, Hyderabad, Chennai and Mumbai.

These cities represent the core of the mid-market sector in India. Three finalists from each city will contend at the national Grand Finale of the Completely Boss Challenge.

Become a symbol of excellence The premise of the Completely Boss Challenge is that "It's not about being the biggest or the fastest growing; it's about demonstrating excellence in business!" Winners of the Completely Boss Challenge will earn the gold star for excellence across the entire sector.

MARKET

W H AT ’ S INSIDE

THE BUSINESS OF PHARMACEUTICALS

‘Manufacturers should engage the USFDA early during drug approval for naming of a product’ PG 14 Pfenex, Agila Biotech announce JV PG 16 Sun Pharma gets ANDA approvals for anti-diabetes drugs PG 17 IPM grows at 5.6 per cent in March 2013 PG 18 Goa set to become key pharma hub PG 21

MANAGEMENT 22 RESEARCH 29 PHARMA ALLY 33 PHARMA LIFE 59 May 1-15, 2013

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Access to medicines remain one of the most crucial factors for achieving Millennium Development Goals (MDG) of 2015 as per the MDG Gap report released late last year by the United Nations. The problem is compounded in developing countries as compared to their developed counterparts. Key issues such as sustainable financing, availability and affordability of essential medicines; price and quality control; dosage and efficacy of medicines; procurement practices and procedures, supply chains, etc. if worked upon, could further fuel access to those who need it the most.

India has taken steps to improve access to medicines to its population, be it putting together a pricing policy that brings a larger list of essential medicines under price control or utilising the flexibilities in TRIPs to its advantage by

I N T E R V I E W Jayasree Iyer, Head of Research Access to Medicine Foundation What are the key indicators that signal greater access to medicines by pharma companies?

The methodology framework of the 2012 Access to Medicine Index captures seven areas: general access to medicine management, public policy and market influence, research and development, pricing, manufacturing and distribution, patents and licensing, capability advancement and donations and philanthropic activities. All the indicators that fall under these areas are

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JAIDEEP SINGH PANWAR revoking patents or issuing compulsory licences for drugs that are not available to the public at 'reasonable' prices: moves which have invited criticism and analysis from its peers worldwide. We shall take a look at pricing policies and intellectual property rights (IPRs)- two highly visible barriers to access and reflect on others beyond these two.

As per the Global Use of Medicines Report released by IMS Institute last year, the global spending on medicines will grow from ~$856 billion in 2010 to ~$1095 billion in 2015. While the share of US and European countries will decline, the share of 17 emerging markets including India and China is all set to increase (second to the US) in 2015.

Generics will contribute upto ~40 per cent of the spending, almost double from that in 2005. While the data above points out to governments spending more on procuring medicines, with generics forming almost half of it, accessibility and affordability is important too. WHO's World Medicine Report 2011 enumerates medicine availability and prices in both public and private sectors as key indicators of access to treat-

relevant for access, and the weights of the groups of indicators are determined through stakeholder input.

Research and development (20 per cent) and pricing, manufacturing and distribution (25 per cent) weighted more even as the weight of the performance set of indicators was increased to 40 per cent of the total score.

What have been the findings?

17 out of 20 companies have risen in their scores, based on the entire overall number of indicators.

Out of the 66 indicators, their combined average score increased in 52 of them since 2010. Not only are they developing more products for more diseases that particularly affect the world’s poor, and collaborating more in the process, but also setting targets and paying attention to codes of conduct while also rewarding accessoriented behaviour in employees.

Access to medicines in developing countries has increased in priority in many companies.

Senior Principal Consulting IMS Health

Manager Research products Sustainalytics

So far, access to medicines programmes of companies have often been add-ons and not necessarily integral to company strategy. While MNCs will continue to hold their prices where they can, they will be challenged to simultaneously stay ahead of the curve of regulatory action

Access to medicines is the responsibility of multiple stakeholders in the healthcare system and not just the pharma companies. Law makers and regulatory authorities, health ministry officials, medical practitioners, providers, Insurance companies (payers) and NGOs will all have to play a role together

ment. As per the report, private sector scored higher visa-vis public sector on the availability of generic medicines in all regions. In countries where patients pay for

medicines in the public sector, generic medicines were found to be priced 1.9 to 3.5 times higher than international reference prices (IRPs) in the Eastern Mediterranean and

How many companies have a more managed approach to access? What is driving it?

Access is an important part of the business strategy with more than 60 per cent of companies having direct board-level ownership for access with better organisation of policies and procedures that lead to better performance its monitoring. Not only do they realise that access to emerging and new markets is important for their sustainability, they also feel more social responsibility to ensure medicines for a growing global population. 17 companies have tiered pricing initiatives for developing countries, including India.

The impact of tiered pricing on making drugs affordable is not clear. Your comments One of the main goals of the Index is to encourage transparency, which presents a particular challenge in the area of pricing. We aim to encourage suppliers (in this case pharma companies) to disclose their

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NEERAJ VASHISHT

prices and strategies for reaching target populations through price setting. However, other parties (procurers, governments, manufacturers, policy makers) in developing country supply chains affect pricing through indirect costs and hence they need to engage in dialogue with pharma companies to increase transparency and to ensure affordable pricing.

What remain some of the areas of improvement?

One for affordable pricing, that I mentioned above, the other is to ensure that the quality of medicines available is not compromised, by aligning pharmacovigilance programmes from companies and developing countries. Moreover the creation and sharing of data is important for a healthy pipeline to address unmet medical needs as well as strengthening of supply chain capabilities to ensure adequate supply of medicines. shalini.g@expressindia.com

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Western Pacific Regions, respectively. Originator brand medicines were 5.3 times to 20 times IRPs. The situation gets worse when patients purchase medicines from the private sector with lowest priced generics 2.6 (South-east Asia) to 9.5 (in US) times IRPs. Prices of originator brand products take the cake with private sector prices at least 10 times higher than IRPs in all WHO regions. Patients pay four times more on an average when originator brands are prescribed and dispensed for products that are also available in generic form.

Price control: Government or pharma companies?

The role of policy regulations in controlling price cannot be discounted. It is pertinent to note that governments worldwide have set regulations in place to bring prices under control, be it the Affordable Care Act (ACA) of US, price cuts in Japan, reduction in off patent and generic drugs in Spain and Italy, costbenefit evaluation of new medicines in Germany or price

May 1-15, 2013

cuts in the wake of Universal Health Coverage (UHC) in China. India's National Pharmaceutical Pricing Authority (NPPA) came up with a pharmaceutical pricing policy last year, expanding the ambit of essential medicines from the earlier 74 to 348, in a move that was met with both criticism and relief. After seven years of deliberation, the government decided to go with market-based pricing of

its impact. “The answer to whether pricing regulations improve access to medicines is mixed. It really depends on which section of the Indian population is being examined.

The reason: medicines are the last frontier in healthcare delivery,” he emphasises. He is of the opinion that while the proposed pharma policy may reduce prices for certain sections of the population, it may not have a significant impact

EVEN AS GOVERNMENTS WORLDWIDE, TIGHTEN THE NOOSE ON PRICE REGULATIONS, PHARMA COMPANIES OFTEN COME IN THE LINE OF FIRE FOR THEIR EXORBITANT PRICING AND RISING PROFIT MARGINS drugs, a move that was unwelcome to civil society groups who demanded a cost-based approach. While the effects of the policy are still to trickle down, Neeraj Vashisht, Senior Principal, Consulting, IMS Health is not so gung ho about

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on those at the low end of the socio-economic strata. They have to overcome several other barriers such as availability of doctors, quality of care etc. which become increasingly significant as one moves beyond urban areas, as

revealed by a survey conducted by IMS. Even as governments worldwide, tighten the noose on price regulations, pharma companies often come in the line of fire for their exorbitant pricing and rising profit margins, to which they have found a solution: tiered pricing. While some have it for institutions (hospitals and/or government supplies), others target trade/pharmacies.

MNCs with speciality care portfolios (e.g. costly patented medicines in areas like cancer) also have patient access programmes, offering drugs at discounted prices. However, it is not clear as to how many of Big Pharma have such programmes in place in developing countries, even if they do, there’s not much clarity on the methodology. Jaideep Singh Panwar, Manager, Research Products, Sustainalytics, a research firm based in Amsterdam, gives a perspective. “So far, access to medicines programmes of companies have often been add-ons Continued on Pg 19

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‘Manufacturers should engage the USFDA early during drug approval for naming of a product’ United States Pharmacopeia's new monograph naming policy is all set to come into effect by May this year. Srini Srinivasan, Executive Vice President - Global Science and Standards & Chief Science Officer, USP gives Shalini Gupta more details on this policy as well as insights into USP's activities and future plans Tell us about the medicines compendium and its adoption by drug manufacturers?

The Medicines Compendium (MC) is a free, online resource (www.usp-mc.org) providing public quality standards for medicines approved in any country, including India. Standards in the MC establish an article’s identity, strength, quality and purity and include documentary standards (in the form of monographs and general chapters) and allied reference materials for chemical and biologic medicines and their ingredients.

Monographs contain two components: a performancebased monograph listing quality specifications, and a reference procedure for testing conformance to the specifications. MC monographs are typically referenced general chapters (citing tests, proce-

INTERVIEW

dures or general information) from USP’s compendia, United States Pharmacopeia and the National Formulary (USP–NF) available on the MC website.

Manufacturers of drugs usually are expected to comply with the official standards of the country in which the drugs are intended for sale (e.g., drugs marketed in India must comply with the Indian Pharmacopoeia). When a destination country’s standard does not exist for a particular product, it may adopt the USP–NF standard (India, Canada, and others) for that product. Adopting countries may indicate other sources for

SP is evolving a ‘Reference Procedure’ approach that supports a globally harmonised drug substance and product monograph.

We are looking at intense collaboration with Indian stakeholders, including the Indian Pharmacopoeia Commission (IPC), government bodies and Indian manufacturers

What have been the activities of USP in the past one year in India?

In 2011, USP expanded its site in Hyderabad, India.

Today, the USP-India site is 12,000 sq m, of which 7,000 is dedicated to laboratory space, making it the second-largest of USP’s sites worldwide with a staff strength of 142 Indian nationals.

Our laboratories are equipped in spectroscopy and separations enable us to play an important role in collaborative testing that support USP–NF as well as MC. For the MC, USP-India is specifically involved in the development of public standards for both chemical and biological medicines. It is also engaged in USP’s Verification Program, conducting testing related to the verification of drug substances, dietary supplements and excipients. while also auditing activities and document reviews for USP’s Verification Programme.

The Indian Pharmacopoeia Commission (IPC) is invited to use any of the monographs published in the MC without cost or need for attribution to USP.

ROGER WILLIAMS CEO, USP

Microbiological control of sterile and non-sterile pharma products is impor-

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standards, or choose not to apply any standards to products in their marketplace at all. Regulators, industry representatives and other stakeholders in the pharma arena may translate an MC monograph into any language, and may otherwise adopt or adapt the standards, without charge or prior permission from USP. USP’s standards that appear in USP–NF are specified in the adulteration and misbranding provisions of the US Federal Food, Drug, and Cosmetic Act and are applicable to medicines that are marketed and/or manufactured or imported into the US. However, their enforcement is the responsibility of the USFDA and other government authorities in the US and elsewhere.

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tant to ensure the safety of drugs. What is USP doing towards this?

Manufacturers must always consider the extent of microbial contamination in a finished product. USP’s standards address microbial presence and absence in both sterile and non-sterile pharma products. Non-sterile drugs, such as oral dosage forms or topicals allow for the presence of small amounts of microorganisms (low bioburden).

Sterile products, on the other hand, which include parenteral drugs, must be manufactured and handled to avoid any microbial presence, given that they are administered into the bloodstream.

Microbial contamination in sterile drugs can cause disease and in some cases, death.

While all products marketed in the US that are subject to USP-NF standards and purport to be sterile have to meet the requirements of USP’s General Chapter <71> Sterility Tests or risk being deemed adulterated or misbranded, sterility assurance is gained only through the use of robust and validated sterilisation processes. USP is also developing informational general chapters on distinct processes for sterilisation, how they are to be conducted and what types of materials are suitable for their use.

What are some of the alternate and modern microbiological methods that can be used for drug testing and quality verification?

Conventional microbiology tests found in the pharmacopeias, such as sterility tests, rely on the demonstration of microbial growth. However, they have low sensitivity while being time- and labourintensive in nature. USP is seeking to identify new referee tests or procedures (used by the USFDA or a third party to assess regulatory compliance) based on modern methods that can detect and enumerate microorganisms in a more rapid and sensitive manner.

These would include any May 1-15, 2013

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validated methods based on technologies that look at phenotypic and/or genotypic microbial characteristics. The USP Microbiology Expert Committee also is updating General Chapter <1223> Validation of Alternative Microbiological Methods to enable users to validate alternate microbiological methods, including those based on modern technologies.

compounded preparation formulated with a salt of an acid or base will use the active moiety—the portion of the molecule responsible for clinical activity—in the title of the monograph emphasising that the moeity represents the strength of the product or preparation. We believe this will create consistency and clarity regarding names for

products and preparations.

Manufacturers from any country, including India, should engage the US FDA early in the drug approval process with regard to naming of a drug product. The product should be named according to its active moiety as per this policy when determining its dosage. USP is currently reviewing FDA-approved

drugs without a USP monograph. No name changes will be required for those products with a salt in the name and for which strength is expressed in terms of that salt. For products that have a salt in the name, but for which strength is expressed in terms of the active moiety, the USP monograph name will be determined on a case-by-case basis.

Exceptions will be made to the policy (i.e., the salt remains in the name of drug) when the inclusion of the specific salt form of the active moiety in the name provides vital information from a clinical perspective or to maintain consistency with other dosage form monographs in a particular “monograph family.” shalini.g@expressindia.com

WHO held a meeting last November to promote the prevention and control of substandard/spurious/falsely-labeled/falsified/counterfeit” (SSFFC) medical products. Are there any stringent measures being taken by USP towards this?

USP is developing a suite of general chapters on good distribution practices for drug products; drug substances; excipients; dietary supplements; compounded preparations and other subcategories of compendial articles. These will cover quality management systems; environmental control management; importation and exportation and supply chain integrity—all critical elements in the prevention and control of SSFFC medical products.

USP's new monograph naming policy is all set to come into effect by May this year.

What does this mean for Indian manufacturers?

USP’s new Monograph Naming Policy, which will

USP’S NEW MONOGRAPH NAMING POLICY, WHICH WILL BECOME OFFICIAL ON MAY 1, 2013, WILL APPLY PROSPECTIVELY TO DRUG PRODUCT AND COMPOUNDED PREPARATION MONOGRAPHS THAT APPEAR IN USP–NF become official on May 1, 2013, will apply prospectively to drug product and compounded preparation monographs that appear in USP–NF. According to the new policy, a drug product or May 1-15, 2013

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COMPANY WATCH Pfenex, Agila Biotech announce JV To develop biosimilars for the global market gila Biotech, a subsidiary of Strides Arcolab and San Diego, California-based Pfenex have entered into a joint venture (JV) to develop, manufacture and commercialise an initial pipeline of six biosimilar products for the global market.

As per the JV agreement, wherein both parties will equally share in decision making regarding product development and commercialisation, Agila Biotech will be a 51 per cent equity stakeholder. This multi-product JV combines Pfenex’s industryleading expertise in strain engineering and process development with Agila Biotech’s biologics manufacturing and clinical development excellence.

The lead product for the JV is Interferon beta-1b, a biosimilar to Betaseron, indicated for relapsing-remitting and secondary-progressive

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forms of multiple sclerosis, commencing human clinical trials by Q4 2013. Under the terms of the agreement, Pfenex will assume primary responsibility for development of an optimised production strain, process and analytical package for each product, while Agila Biotech will be responsible for preclinical and Phase 1 development, as well as cGMP manufacturing.

The JV will then progress the products through Phase 3 and into commercialisation.

Manufacture of the collaboration products will be carried out at Agila Biotech’s state-of-the-art manufacturing facility being built with Bio-XCell at Nusajaya, Johor, Malaysia – a 160 acre site comprised of customised biotech facilities.

“One of the global challenges for the future of healthcare is to develop and produce products within the confines of a constrained cost environment,” said

Dr Bertrand Liang, CEO, Pfenex. “Biosimilars are and will play an increasingly important role in patient disease management. This venture between Pfenex and Agila Biotech will allow us to leverage our infrastructure for the development of safe, reliable and cost-effective therapies for patients to address unmet medical needs all over the world,” he added.

“Successful foray into the biologics space for companies like Agila Biotech would hinge not only on building state-of-the-art infrastructure and a strong technical foundation, but also on creative partnerships such as the one that Agila Biotech has entered into with Pfenex.

This will allow us to not only leverage time and cost advantage of developing products in India and Malaysia, but also serve as a gateway to a vast region in South Asia, South-East Asia and the OIC region currently underserved as a result of the

lack of high quality, cost effective biologics,” said Dr Anand Iyer, CEO, Agila Biotech.

Iyer also noted that its facility in Malaysia represents a strategic move to bolster Agila Biotech’s manufacturing presence in the region and tap into unmet global demand for quality biologics at affordable prices.

Pfenex is a biotech company developing biosimilars and innovative vaccines to address unmet and growing global healthcare needs. Utilising the company’s core technology, Pfenex Expression Technology for recombinant protein expression, Pfenex is able to rapidly develop and produce high quality therapeutics. In addition, Pfenex also produces and markets research proteins and reagent proteins for the research and drug development community through its Reagent Proteins division.

EP News Bureau-Mumbai

Orchid enters strategic partnership with Allecra Therapeutics Company’s will assign IP pertaining to a lead antibiotic compound hennai-based global pharma major, Orchid Pharma (‘Orchid’) has entered into a strategic partnership with Europe-based venture capital funded Allecra Therapeutics to develop novel antibiotics to combat multi-drug resistant bacterial infections. As part of its investment into Allecra, Orchid has assigned to Allecra Intellectual Property (IP) related to an antibiotic discovery programme which will then be pursued through further trials by Allecra.

Established in 2013, Allecra is based on a strategic partnership between Orchid Chemicals and Pharmaceuticals (Chennai, India) and its lead investors: Forbion Capital Partners and Edmond de Rothschild Investment Partners. Allecra is focussed on the development of novel treatments to combat multi drug-resistant bacterial infections. It is

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based in the European BioValley Life Sciences cluster located in the Upper Rhein valley encompassing northwest Switzerland, south-eastern Germany and the Alsace Region of France.

Under the terms of the agreement, together with shareholding, Orchid will also be paid an upfront sum and is eligible to receive further royalties and exit bonuses based on Allecra’s progress.

Allecra’s ¤15 million Series: A financing round was co-led by Edmond de Rothschild Investment Partners and Forbion Capital Partners. EMBL Ventures also participated. Orchid was represented by the law firm Latham and Watkins.

Bacterial resistance to current antibiotics is widespread and growing exponentially leading to increased urgency to combat what has been called the “epidemic of antibiotic-resistance”. Allecra will aim to contribute to this cause by developing new www.expresspharmaonline.com

treatments which overcome emerging bacterial resistance mechanisms, thereby saving lives of patients whose infections may otherwise be inadequately treated.

K Raghavendra Rao, Chairman & Managing Director, Orchid said, “We have always believed in building collaborative business models to achieving our vision. This strategic partnership with Allecra is yet another demonstration of how we can create value by harnessing the relative strengths of each company.”

Nicholas Benedict, CEO, Allecra said, “To combat the increasing threat of bacterial resistance the medical community is trying to conserve the use of currently available antibiotics. At the same time, the biopharma industry is working to find new antibiotics. These objectives are complimentary activities in the increasingly urgent battle against bacterial resistance.

Allecra has been formed in order to find new cures for

some of the most widespread and hardest to treat resistant infections.”

Orchid Chemicals & Pharmaceuticals (Orchid) was established in Chennai, India in 1992 as an export-oriented unit (EOU) and is today globally present across 70+ countries. It is a vertically integrated company spanning the entire pharma value chain from discovery to delivery with established credentials in research, manufacturing and marketing.

Orchid today ranks among the top 15 pharma companies in India and enjoys a multi-therapeutic presence across segments like anti-infectives, anti-inflammatory, central nervous system (CNS), cardio vascular segment (CVS), nutraceuticals and other oral and sterile products. Orchid’s pharma solutions include APIs, finished dosage forms, new drug discovery (NDD), novel drug delivery systems (NDDS) and CRAMS. EP News Bureau-Mumbai May 1-15, 2013

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Sun Pharma gets ANDA approvals for anti-diabetes drugs Tentative approvals for ANDAs for sitagliptin tablets, metformin HCl extended-release tablets un Pharmaceutical Industries announced that the US FDA has granted its subsidiary, two tentative approvals for its Abbreviated New Drug Applications (ANDA) for generic version of Januvia, sitagliptin tablets and generic version of Glumetza, metformin HCl extended-release tablets. Januvia is a registered trademark of Merck Sharp & Dohme Corporation (MSD)

S

Indoco receives ANDA approval for Glimepiride tablets from USFDA

while Glumetza is a registered trademark of Santarus.

The announcement has stirred interest in the industry as Sun Pharma was a co-plain-

tiff in MSD's appeal to the Delhi High Court move to block Glenmark Pharma's April 2 move to market its generic versions of MSD's Januvia and Janumet, named Zita and Zita Met. Sun Pharma has a license from MSD to sell these drugs as its brands,

Istavel and Istamet, in the India market.

Sitagliptin tablets, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus, have annual sales of approximately $2.7 billion in the US. Metformin

HCl Extended-release tablets have annual sales of approximately $140 million in the US. They are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus.

EP News Bureau-Mumbai

A formulation is only as good as the ingredients that comprise it. When creating your drug, improving patient welfare is your mission. Every molecule that goes into your product matters.

By providing the right materials for every stage of drug development, from discovery to production, we help you formulate, manufacture and innovate with confidence.

The approval is for Glimepiride 1mg, 2mg and 4mg tablets which are prescribed for type-2 diabetes patients to enhance glycemic control ndoco Remedies has received the USFDA approval for its Abbreviated New Drug Application (ANDA) for Glimepiride 1mg, 2 mg and 4 mg tablets.

Glimepiride is indicated for type-2 diabetes mellitus treatment as an added therapy with diet and exercise to improve glycemic control in adults. The market size of this product in the US is $90 million and the API consumption is approximately 2000 kg growing at 11.2 per cent.

“This is the first ANDA approval for solid dosages for Indoco and the Company is fully integrated to manufacture this product. The product will be launched in the US in the month of May 2013”, said Aditi Kare Panandikar, Managing Director, Indoco Remedies. Four of Indoco’s products are already available in the US market against the ANDAs filed and approved through partners.

Additionally, Indoco has 37 ANDAs at various stages, out of which, 13 will be in the Company’s name and the rest through partners in the US market.

EP News Bureau-Mumbai

I

May 1-15, 2013

Avantor™ Performance Materials, a global supplier of high-quality ingredients to pharmaceutical manufacturers, has brought its recognized manufacturing and quality expertise to its new facility in Panoli, Gujarat, India <

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Complies with Indian Pharmacopoeia (IP), United States Pharmacopeia (USP), National Formulary (NF), European Pharmacopeia (EP), Japanese Pharmacopeia (JP) and British Pharmacopeia (BP)

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www.expresspharmaonline.com

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GROWTH TRACKER IPM grows at 5.6 per cent in March 2013 Valued at Rs 5,653 crores With Bonus Units at Full Value Val in Crs

Rank

COMPANY

MAT

MAT Mar -13

MTH

IPM

Mar-13

Val (Cr)

MS%

GR%

Val (Cr)

MS%

GR%

70529

100.00

11.9

5653

100.00

5.6

Cipla

1

2

3528

5.00

7.2

277

4.91

-1.1

Sun Pharma

2

1

3482

4.94

20.3

301

5.32

18.0

Glaxo

3

4

3238

4.59

11.7

234

4.15

-7.8

Ranbaxy

4

5

2945

4.18

8.1

227

4.02

1.5

Zydus Cadila

5

3

2848

4.04

21.0

240

4.25

20.0

Abbott HC

6

6

2706

3.84

8.0

218

3.86

4.5

Mankind

7

7

2564

3.63

22.7

209

3.70

7.7

Lupin

8

8

2162

3.06

14.3

176

3.11

16.0

Alkem

9

9

2138

3.03

12.1

162

2.86

5.0

Macleods

10

11

1816

2.57

21.3

142

2.52

7.8

Intas

11

10

1734

2.46

18.7

146

2.58

17.9

Pfizer

12

12

1715

2.43

17.1

130

2.31

9.0

Aristo

13

13

1627

2.31

10.5

124

2.20

1.4

Sanofi-Aventis

14

16

1422

2.02

10.9

114

2.02

2.3

Abbott

15

15

1404

1.99

8.8

115

2.04

5.2

Glenmark

16

14

1396

1.98

19.5

116

2.05

12.4

Dr. Reddys

17

17

1370

1.94

13.1

112

1.98

10.4

Micro Lab

18

19

1259

1.79

7.7

103

1.82

4.9

Ipca

19

20

1258

1.78

15.8

97

1.71

10.5

USV

20

18

1243

1.76

21.2

103

1.83

9.2

Val in Crs

18

Super Group

MAT Mar 13

GR%

Mth Mar 13

GR%

IPM

70529

11.9

5653

5.6

ANTI-INFECTIVES

12520

9.8

945

2.1

n March 2013, the Indian pharma market (IPM) has been valued at Rs 5,653 crores and has seen a growth of 5.6 per cent.

For the month of March 2013, among the top 10, Zydus has seen a growth of 18.3 per cent, Sun Pharma at 18 per cent and Lupin at 16 per cent. 25 corporates have crossed the growth of IPM for the said month.

Without bonus, Sun Pharma is ranked at the second position for the month and MAT for March 2013 amongst corporates.

Amongst the top 50 corporates, Merck has the highest growth at 35.6 per cent followed by Bharat Serums at 33.9 per cent.

Amongst the 11-20 ranked companies, Intas has shown high growth at 17.9 per cent followed by Glenmark at 12.4 per cent and DRL at 10.4 per cent.

Albert David has moved up one rank from the last time to be the 49th biggest corporate in March 2013.

Amongst upcoming corporates, Corona Remedies grows at 111.6 per cent, Akumentis at 42.6 per cent.

From the therapy perspective, 10 therapies have outgrown the IPM growth. The anti-infective market has a growth of 2.1 per cent whereas respiratory market is at 6.5 per cent growth. The anti-diabetic market grows at 7.3 per cent and cardiac at 5.8 per cent in chronic business. Amongst top 10 therapies, Neuro/CNS market shows highest growth at 7.7 per cent.

I

About PharmaTrac PharmaTrac is a the secondary sales data audit conducted by AIOCD Pharmasofttech AWACS, a pharma market research company formed by All Indian Origin Chemists & Distributors (AIOCD ) in a joint venture with Trikaal Mediinfotech.

AWACS in AIOCD: AWACS stands for Advanced Working, Action & Correction System – reflecting the underlying philosophy behind AIOCD. AWACS' research tools reduce time to information by 50 per cent or more and significantly improve on accuracy of information. Accurate and faster information flows from the market will help clients grow topline and bottom-line.

CARDIAC

8666

14.5

714

5.8

GASTRO INTESTINAL

8058

13.4

640

5.6

VITAMINS / MINERALS / NUTRIENTS

6273

13.0

500

5.8

RESPIRATORY

5368

8.4

444

6.5

PAIN / ANALGESICS

5228

8.8

409

3.8

GYNAECOLOGICAL

4609

9.3

380

6.5

ANTI DIABETIC

4583

16.4

376

7.3

Terminologies used

NEURO / CNS

4303

11.6

357

7.7

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

DERMA

3701

12.3

296

5.5

OPHTHAL / OTOLOGICALS

1265

13.0

107

10.5

HORMONES

1217

17.5

100

12.8

OTHERS

957

15.9

81

12.4

BLOOD RELATED

869

11.0

69

5.1

VACCINES

866

7.3

77

3.9

ANTI-NEOPLASTICS

682

13.9

62

19.5

ANTI MALARIALS

650

16.1

36

4.5

SEX STIMULANTS / REJUVENATORS

399

16.7

34

4.4

STOMATOLOGICALS

314

12.7

25

2.4

EXPRESS PHARMA

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

May 1-15, 2013

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Access to medicines...

Continued from Pg 17 and not necessarily integral to company strategy. While MNCs will continue to hold their prices where they can, they will be challenged to simultaneously stay ahead of the curve of regulatory action.

MNC pharma has struggled to move out of entrenched high prices – low volumes business model. The companies which shed that mould are likely to meet with greater mass-market success in developing markets that demonstrate the willingness to impose price restrictions.” However, there are exceptions in companies such as GlaxoSmithkline, which has a more integrated and synchronised access to medicine strategy, demonstrating a relatively higher state of readiness for operating environments in which pricing is increasingly a critical factor.

To patent or not to patent The past one year has seen India take bold moves, utilising the provisions in TRIPS for the larger benefit of its population, which has ruffled feathers of MNC pharma companies operating in the country.

The latest ruling against Novartis could be aptly termed a shot in the arm, however that doesn’t relegate those espousing the demerits of patent protection, even as voices negating evergreening reach a crescendo. It helps to understand the reason.

“Patent protection is required if newer drugs have to be discovered and made available to the public. The key to improving access to medicines is to make sure that these are made accessible to the public through insurance cover or a reimbursement mechanism.

Many developing countries cover the cost for such expensive products - especially in areas like cancer and HIV. Unless a payer steps in to fund these drugs, access will always be a challenge in a country like India,” chips in Vashisht.

The degree of reimbursement could vary depending on nature of the disease, treatment costs and the economic status of the patient. This requires strengthening of the overall healthcare system with appropriate funding while also ensuring strong governance and monitoring mechanisms for proper functioning. On the other hand, one can’t help but notice the work on Medicines May 1-15, 2013

Patent Pool (MPP), created in 2010 in order to increase access to affordable and quality HIV drugs to the world’s population by enabling voluntary licensing of HIV medicines. A new report released

by WTO, WIPO and WHO released earlier this year commends MPP’s work saying that patents can be used “expressly to leverage public health outcomes” when licensed with the right terms and conditions. Patent pools were a key recommendation of an expert working group at WHO on incentivising research and development (R&D) for the developing world. MPP was endorsed in a 2011 UN Political Declaration on HIV/AIDS to help reduce the price of medicines and encourage the development of needed new formulations. It is also encouraging to note that as a part of the Access to Medicine Index 2012, prepared by the Access to Medicine Foundation based in Netherlands, 16 companies are engaged in patent pooling for R&D through partnerships for product development to share data for R&D purposes (although agreements about patents vary by partnership).

As we discuss further, one thing is clear, there are more than two barriers to access.

The focus needs to be broadened to include factors such as poverty, taxes and tariffs, corruption and pharma counterfeiting. Each of these elements inhibits access to medicines, through financial challenges, higher prices, shortages, and spurious products. Improving procurement and monitoring systems could be a major step while widening the ambit of factors even as we look for solutions to these problems.

“Access to medicines is the responsibility of multiple stakeholders in the healthcare system and not just the pharma companies, law makers and regulatory authorities, health ministry officials, medical practitioners, providers, insurance companies (payers) and NGOs will all have to play a role together. Pharma companies can make drugs available and affordable, but unless the entire healthcare system is overhauled and strengthened, access will always be a challenge,” sums up Vashisht. One thing is clear, access will remain an illusion as long as we work in silos. shalini.g@expressindia.com www.expresspharmaonline.com

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EVENT BRIEF Pharma Project Management conference

strategies for critical path identification and innovative strategies for effective time management.

Date: May 8-10, 2013 Venue: Mumbai Summary: CPhI in association with PMI India will hold Pharma Project Management conference, customised specifically for pharmaceutical industry’s high end project needs around cost, quality and time.This strategic conference aims on discussing best practice strategies to implement project management from the leaders of the industry who have successfully handled complex projects themselves.

This distinctive conference has received a lot of interest and has already confirmed industry leaders to present including Sanjit Singh Lamba, Managing Director India, President, Global Brands Business Unit Eisai Knowledge Centre; Swaminathan Srinivasan, Director Project Management, Dr Reddy’s Laboratories (UK); Sanjay Bhanushali, Director International Operations, Cipla; Mohan Pandey, Director R&D operations, Bristol-Myers Squibb; Dr Varada Bapat, Head-Project Management, Wockhardt and many more.

The event will feature in-depth discussions on streamlining end-to-end product life cycle management, minimising project risk management, overcoming application challenges in R&D, clinical research, engineering, SCM and manufacturing. It will also help in understanding application of theory of constraints specific to complex pharma projects, best

20

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Contact details: Tel: (022) 61727001 Email: conferencesindia@ubm.com (Promo Code: EXP-DISC10) Website: http://www.pharmaprojectmanagement.com?utm_campaign=MEDIAPARTNER &utm_medium=EVENTLISTING&utm_source=EXPRESSP HARMA

ships. RDD Europe conferences highlight innovative research contributions through podium and scientific poster sessions.

These are enhanced by 12 technical interactive workshops from vendors and service providers in the industry.

In all sessions, the latest technological advances related to nasal and pulmonary drug development will be presented.

Contact Details: Marion Baschet Vernet London, Great Britain Tel: +44 (0)797 609 41 00 Email: mbvernet@gmail.com

RDD Europe 2013 Date: May 21-24, 2013 Venue: Intercontinental Hotel, Berlin, Germany

Drug Delivery & Complex Generics Conference Date: May 28-30, 2013 Venue: Mumbai

Summary: The Respiratory Drug Delivery (RDD) Europe 2013 scientific conference will welcome pulmonary and nasal drug delivery experts from all over the world to Berlin, May 21-24, 2013.The three-day interactive symposium of the highest level will begin with a plenary lecture titled “Biomarkers and Targeted Treatments for Small Airways Diseases – The Past, Present and Future”.The symposium will also focus on drug development – new drugs, targets and formulations, weighing the evidence in support of bioequivalence, orphan drugs – opportunities, regulatory and clinical challenges, harmonising the clinical requirements for lab/ ICS combinations in the US and Europe, designing devices for the marketplace, optimising formulation and device partner-

Summary: With the patent cliff reaching its peak, complex generics and innovations in drug delivery present huge opportunities for the pharmaceutical industry to gain the first mover advantage. Visitors will be able to delve deeper into innovative formulation and manufacturing techniques and latest drug delivery systems orals, injectibles, nasal, transdermal and opthalmics by attending the conference.

Latest case studies on controlled release formulations, HME and spray drying techniques, depot injections, nanoparticle technology will be discussed. A workshop will be held on how to ensure smooth scale-up of complex generics that will address all critical scale-up issues - from concept to commercialisation.

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Contact details: Tel: (022) 61727001 Email: Conferencesindia@ubm.com Website url: http://www.drugdelivery-complexgenerics.com?utm_campaign=MEDIAPARTNER&utm _medium=EVENTLISTING&ut m_source=EXPRESSPHARMA

the distinguished alumni of the college. It will also involve talks about how professional pharmacists can serve the patients and consumers better.

Contact details: Email: goldengcp@gmail.com

Pharma Quality by Design Govt. College of Pharmacy, Bangalore (Golden Jubilee Celebrations) Date: June 1-2, 2013 Venue: Government College of Pharmacy (GCP), Bangalore Summary: The Government College of Pharmacy (GCP), Bangalore will celebrate the 50 years of beginning of pharmacy education in the state of Karnataka.A local organising committee has been formed with Professor S Shashidhara, Principal of the college, Shiva Hiremath, President of the Alumni association, GCP, and KP Ravindra, President of American Association of GCP Alumnae, US. Dr S Ramachandra Shetty, Professor in the college is the organising secretary. Sessions will be held on – Remembering 50 Golden Years (Reminiscence); Pharmacists: Professional Challenges for better service to patients; Challenging Technologies – with moving times; and Bridging the Generation Gap: Present and Past in pharmacy.

Apart from honouring the retired professionals and faculty members of the college, the two-day celebrations will have group discussions led by

Date: June 12-14, 2013 Venue: Mumbai Summary: The 2nd Annual Pharm QbD Forum will have case study sessions on various dosage forms (pulsatile drugs, solid oral dosage, lyophilised products), on API synthesis and scale up, on various analytical sciences and development. Workshop on DOE covering all the basic statistical approach all supported with different case studies will be held. Speakers who have been implementing and working on the QbD principles for their respective organisations like Dr Reddys Laboratory, Emcure, Lupin, Jubilant Life science, Teva Pharmaceuticals, BristolMyers Squibb, Orchid Pharmaceuticals will attend the event.

Contact details: Tel: (022) 61727001 Email: Conferencesindia@ubm.com Website url: http://pharmaqbd.com/?utm_campaign= MEDIAPARTNER&utm_medium=EVENTLISTING&utm_sou rce=EXPRESSPHARMA

May 1-15, 2013

M|A|R|K|E|T

POST EVENT Goa set to become key pharma hub IPA Convention 2013 gets overwhelming response from pharma industry across India Sachin Jagdale Goa epresentatives from all the major pharma companies across India participated in the recently concluded Indian Pharmaceutical Association (IPA) Convention 2013 that took place in Goa. The phenomenal response of the pharma industry to this convention underlined the fact that Goa is very much on the path to becoming a pharma hub in India. Even officials from top regulated markets, the USFDA and MHRA,were present for the event in large numbers.

It was a historic moment for Goa as the state was hosting the IPA Convention after a long gap. “The Indian pharma industry has been on the global map for many decades. Goa is an investor friendly destination and the Goa Government is also proactively supporting the pharma industry. Goa also has an advantage of environment friendly units.

Almost every major pharma company has set up its base in Goa,” informs Salim Veljee, Chairman LOC and President, IPA Goa branch.

He adds, “Besides the pharma companies, IPA Convention 2013 saw the presence of many senior government officials from all the major states across India as well. We designed different sessions in such a way that every key issue related to Indian pharma industry would be addressed during the Convention.”

R

May 1-15, 2013

Content of the program me included deliberations and discussions, an exhibition of current issues of importance to the pharma industry and moreover, participation of national and international expert faculties to back these proceedings, made the conference a highly successful event. IPA Convention 2013 definitely displaced the myth that conference and conventions are occasions where nothing concrete is discussed and achieved.

Goa is offering many advantages to the pharma industry. A new sub zonal and port office has been opened by the Central Drug Standard Control Organisation (CDSCO) in Goa to facilitate export of pharma products. This office has also been authorised to issue a certification on behalf of World Health Organisation-Good Manufacturing Practice (WHO-GMP) to the exporters.

Ripples of recent pharma controversies were evident in IPA Convention 2013 as well. During the panel discussion on the theme, “Indian Pharma Industry: Strategies for Excellence”, Dr Shailesh Ayyangar, MD, Sanofi India, stressed that India does respect innovation. India has the ability to do innovation and India should not use Compulsory Licensing (CL) indiscriminately. Senior pharma professionals present during the event unanimously endorsed the fact that IPA Convention 2013 was one of the most successful conventions in the recent years.

With Goa aggressively

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making inroads into the pharma industry, traditional pharma hubs of India like Maharashtra are surely need

to work hard to preserve their decades old dominance in this sector. sachin.jagdale@expressindia.com

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W H AT ’ S INSIDE

MANAGEMENT INSIGHT FOR MANAGING PHARMA

The ‘new’ patent law, policy and strategy PG 25 'Tweet-talk' your customers with new age marketing PG 27

RESEARCH 29 PHARMA ALLY 33 PHARMA LIFE 59 22

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May 1-15, 2013

M|A|N|A|G|E|M|E|N|T

M

Minor accidents in industrial plants are part and parcel of any work day and are in fact considered 'occupational hazards'. However, a recent fire at a well known pharmaceutical company in Mumbai, Aarti Drugs, claimed lives as well, has once again raised serious doubts over the reliability of safety arrangements at such plants.

Unfortunately, this is not an isolated incident. Over the last few years, such mishaps across different pharma plants have significantly added to the list of casualties. The irony is that these pharma companies claim to be in the business of delivering 'lifesaving' medicines to patients, but do not seem to value enough the lives of their plant operators and other staff at their manufacturing plants.

Feeling the heat Despite an enormous improvement in the technology and techniques used to construct manufacturing plants, we continue to hear of incidences like gas leakages, boilers exploding, or an entire pharma /chemical plant razed to the ground by fire. So don't we have foolproof technology or were the accidents man

made errors?

“Modern chemical and pharma industrial plants are by no means immune from catastrophes, as the events at Chernobyl and Bhopal in the past and more recently, in Japan have shown,” points out Dr Suresh R Saravdekar, Consultant-healthcare, pharmaceuticals, medical devices and diagnostics.

“It is safe to assume that no man-made system is foolproof, and in industries where a catastrophic failure in a safety system would have devastating effects on both the workforce and those living around it, plans must be made to deal with the worst-case event,” says Saravdekar.

He adds, “The main reasons for this type of mishaps in India, are non-observance/ compliance of standard norms of safety by the industry,

DR SURESH R SARAVDEKAR Consultant-healthcare, pharmaceuticals, medical devices and diagnostics

ARCHANA SOHONI Principal Architect, Arena Consultants

May 1-15, 2013

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laxi-ty on the part of regulators and legislators with regards to efficient and strict implementation of industrial safety rules. Total indifference about safety parameters, lack of training and awareness among management and employees also plays crucial role. No provision of appropriate safety devices and arrangements in the premises is yet another culprit.”

Not just manufacturing plants Though recent mishaps were predominantly confined to manufacturing plants, the pharma industry does have many work areas that can follow the fate of plants that were gutted by fire or any such incident. In fact there were sporadic incidences of fire that took place at research laboratories as well.

Archana Sohoni, Principal Architect, Arena Consultants, explains, “Research areas/ labs are no different from manufacturing plants, since the processes/ functions remain almost same only difference being the scale. Any company, SME or multinational, can choose to set up an R&D lab and the area occupied by these facilities can be as small as 1000 sq.ft. In fact, they are more prone to accidents since there are fewer regulations set for such kind of facilities.”

Salil Sansare, Director, Labguard, endorses Sohoni's views. He says, “Labs are also susceptible to fire hazards or chemical spillage or a blast. In the last three years, there have been several cases reported.

These range from a fire breaking out in a fume hood or reaction going wrong on lab table, spillage of chemicals on user’s body.”

Inferior infrastructure According to Sohoni, worldwide research has proven that its ‘human error’ that is most responsible for mishaps. “To simply put it, the ‘attitude’ of a lab personnel is one of the most important factors in the safety of a lab. If the attitude/ approach is right and proactive then most accidents

Some recent accidents in pharma/ chemical industry 1.

2.

3.

4.

5.

6.

7.

8.

24

Aarti Drugs, Boisar, Mumbai - March, 2013 Hetero Drugs, Vizag, Andhra Pradesh - January, 2013 Jagadia Industries, Ankleswar, Gujarat - February, 2013 Auctus Pharma, Vizag, Andhra Pradesh - October, 2012 Alembic India Vadodara, Gujarat - August, 2012 Dashmesh Medicare, Chandigarh - April, 2012 Aurobindo Pharma, Hyderabad, Andhra Pradesh - November, 2011 Sun Pharma, Vadodara, Gujarat- January, 2011

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can be avoided,” asserts Sohoni.

During the recent fires that took place in manufacturing plants or in laboratories, the fire brigade took a long time to douse the blaze. One of the reasons put forward by the fire officials was that the materials that were used to build the lab/ plant were very quick in catching fire.

“In many cases there is little importance given to the use of the right type of materials while the laboratories are being set up. The stakeholders are often not aware of active and passive fire hazardous materials and these set ups are planned like any other commercial premises. Such under designed infrastructure leads to propagation of fire accidents. Infrastructure also includes safety devices, alarm systems and various sensors that give advance notifications. Facilities devoid of these are mainly responsible for catastrophes,” informs Sohoni.

Sansare adds to the points mentioned by Sohoni. He says, “A majority of lab accidents have happened due to the wrong selection of infrastructure. For example, if you use wood in lab furniture, it can catch fire. Also, if you do not store flammable chemicals in dedicated flammable chemical cabinets; it may not withstand fire.”

SALIL SANSARE Director, Labguard

KAPIL BHARGAVA Consultant and advisorPharma Compliance Alliance

He adds, “Every unit likely to be engaged in manufacturing and synthesis of chemicals and pharmaceuticals has to obtain a license/ certificate from these regulatory authorities. In order to obtain a 'Building Completion Certificate' (BCC), it is mandatory to get these certificates/ licenses from the respective departments. A regular periodic renewal of all these licenses is also mandatory. In spite of these regulations in place, accidents are taking place repeatedly. This clearly points to the fact that regulatory authorities had either failed or were not strong enough to tackle this issue.”

Fixing responsibility

Rules are meant to be broken?

Recent explosions at the manufacturing plant saw senior officials fleeing the spot to evade Government authorities. In all such cases the owner of the pharma / chemical company was not punished or put behind bars.

Unless it is clear who will bear the responsibility and held guilty for such accidents, the culprit cannot be brought to book. Giving his views on this issues, Kapil Bhargava, Consultant Pharma Compliance Alliance, asserts, “The management and the site head should be held responsible.”

Saravdekar says, “Basically, management of industry and four main regulatory authorities are responsible for industrial safety of an unit, namely, Directorate of Industrial safety & Health, Maharashtra Pollution Control Board (MPCB), Directorate of Steam Boilers, Directorate of Explosives and Directorate of Maharashtra Fire Services.”

Repeated accidents only point to the fact that safety norms are not been followed as they are supposed to be.

One accident can be excused as coincidence but repeated accidents fall under the category of mistakes and negligence. Since the Government has formulated safety rules, either the Government itself is not implementing them seriously or pharma companies are not paying heed to them.

Bhargava opines, “I have always been asking manufacturers for their practices of safety audits. To my surprise most of the site personnel have replied that there is no formal safety audit at their site and some report is made to ensure compliance of 'Labour Laws'. Though Hazard and Operability Study (HAZOP) and Hazard Analysis and Critical Control Points (HACCP) has been an important aspect for such industries, this aspect was neglected at sites in India. Most MNCs have good Environmental Health & Safety (EHS) policies

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where good emphasis is given for safety audit. This may happen because their principles insist this. I hardly see a designated post of "safety officer" on the site.”

He adds, “I feel many companies flout safety rules quite often. Safety has not been considered an important aspect in the pharma industry and expenditure incurred on this is not considered worthwhile.”

Saravdekar narrates how on visits to industrial belts, he comes across instances where units have closed down but neglected to properly dispose off unused chemicals/remnants. Consequently, tanks of such hazardous material, either full or partly filled, still exist at the location of such closed units, waiting for accidents to occur.

He warns, “It is also seen that the proper segregation of different chemicals, as per their inflammable potential, toxic potential, is not done, which leaves a possible health-threat to the lives of the people handling these chemicals.” A number of pharma units and chemical plants are increasing and so are the dangers associated with them.

Building a foolproof unit is important but employing staff that knows how to handle such units is even more important.

Incidences of explosions, leakages at the pharma/chemical plants can be reduced, provided the Government ensures that rules are strictly being followed.

It is equally essential that managements of pharma/ chemical companies elevate plant safety as a top priority and take responsibility for ensuring that the right technologies and trained people are in place. sachin.jagdale@expressindia.com May 1-15, 2013

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LEGAL EAGLE The ‘new’ patent law, policy and strategy Anand Nandkumar, Assistant Professor of Strategy, Indian School of Business, provides an overview of the long-term implications of the recent Supreme Court’s decision on Glivec along with some of the key trends on IP litigation in India. He also provides pointers on how companies seeking to operate in India can overcome some challenges imposed by the current patent regime he recent Supreme Court decision in the case of Novartis’s Glivec brings several important trends to focus. This case is just only one of the many pharmaceutical patents cases heard by the Indian Patent Office or courts in the recent past and is symptomatic of India’s arrival to the big league.

Patent litigations are typically concentrated in markets with large consumer bases and in technologically advanced nations. More often than not they take place between two or more technologically-proficient firms. Even in developed countries patent litigations are more prevalent in markets in which technology is a significant source of competitive advantage. While the fact that India is a large pharma market has never been in question, the recent spate of patent litigations is another pointer to the growing technological proficiency of the domestic industry.

Prior to 1972, when India’s patent law was a continuation of the British Patents and Design Act 1911 and in many ways similar to the current law, there were very few IP law suits. The number of IP law suits heard by Intellectual Property Appellate Board, High Courts or the Supreme Court of India between 2005 and 2010 is about 2.5 orders of magnitude the number of IP litigations between 1911 and 1972. In the case of Glivec, both the plaintiff and the defendants were technologically sophisticated firms that were prolific inventors themselves. Also, in another recent case involving Merck and Glenmark, the defendant Glenmark, an Indian company, is another prolific inventor. These numbers once again point to the growing stature of the Indian pharma industry.

Many have rightly hailed

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May 1-15, 2013

the Supreme Court’s decision as timely and something that will likely protect the interests of an average consumer. However, very little has been written or spoken about what the longterm implications might be.

Economists point out that, the tradeoff implicit in patents is that while stronger patents result in short-term losses by providing temporary monopoly to inventors which increases prices, it also will likely result in longterm gains, by providing inventors long-run incentives for innovation.

The fact that big pharma companies rely on blockbusters has often been misconstrued as these companies make big profits on every drug. Since very few drugs succeed, the question is whether big pharma companies make super normal profits on average – average calculated across both successful and unsuccessful drugs. It is worth noting at this point that the return on assets between discoverybased big pharma companies and generic firms do not look vastly different. This suggests that the big discovery led pharma firms, do not on average make big profits and even the super-normal profits on blockbuster drugs is necessary for them to recover the huge upfront R&D investments on both successful and unsuccessful drugs that often exceed $1 billion as a target proceeds from the bench to the bedside.

Policy makers need to take into account whether weaker patents might harm the long-term medical needs of developing countries such as India. After all, very few companies that are in the business of generic medicines indulge in drug discovery themselves and what is critical is whether decisions such as that of Glivec would likely slow down or even www.expresspharmaonline.com

abort R&D, which addresses the needs of patients suffering from diseases that are idiosyncratic to developing countries such as India. And even if that does not happen, since generics cannot exist without original drugs, muting the incentives for drug discovery should surely decrease the number of varieties of generics that an average consumer would have access to in the long run. It is worthwhile for governments to think about whether the long-run solution is to mandate big pharma companies to decrease prices even if that implies that their incentives to enter India or do India related R&D diminishes or subsidise medicines and make them accessible to the poor. With many countries like Australia, keen on replicating India’s patent provisions concerning ever greening, it is important for the policy makers to really think hard about the implications of such provisions in the long run and whether such a policy can be counter balanced with subsidies for medicines

to the poor.

In the shadow of the recent decisions, foreign companies that seek to operate in India would have to explore a variety of India specific strategies to be successful. Given that countries like India and China offer significant growth opportunities to foreign companies despite its weaknesses, giving up these opportunities may not augur well for them in the long term. For one, they would have to figure out how to optimally protect their innovations when salts or other derivatives of a free form cannot be patented in India. Second, they may have to explore ‘co-operative’ strategies such as voluntary licensing to domestic firms and hope that such a strategy will likely enable them patent challenges and ward off compulsory licensing. In fact, a recent phenomenon that has received sparse attention thus far is the growing use of voluntary licensing, as a strategy to participate in Indian markets, especially between foreign and domestic EXPRESS PHARMA

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companies. Among the top 10 domestic firms (firms that had the largest revenues in 2012), in-licensing activity grew from about 0.2 deals per firm in 1994 to about 4.4 deals per firm in 2008. With top 10 foreign firms outlicensing deals were virtually non-existent in 1994, whereas in 2008 the number of out-licensing deals was about 1.5 deals per firm.

Equally significant, is the fact that some voluntary licensing transactions have occurred even when the licensor did not have a patent in India such as in the case of Gilead’s tenofovir disoproxil fumarate.

This ‘co-operative’ strategy is perhaps one of the reasons for the continued dominance of Indian pharma companies even after India opened up the industry to foreign competition through increased FDI and the new patent law. In 1994 before the first set of Trade Related Aspects of the Intellectual Property Rights (TRIPs)based reforms to the Indian patent law was passed, only 13 of the top 20 firms in the Indian pharma industry were Indian firms whereas in 2008, four years after the final set of patent reforms were ushered in, 15 of the top 20 firms in the Indian pharma industry were

Indian firms. While innovative activity around new pharma products among Indian entities increased moderately between 1994 and 2008, the relatively larger increases in process patenting among domestic entities was perhaps to facilitate assimilation of in licensed foreign technology.

Also, the relatively larger surges in patenting especially by newer foreign entities were in part due to the intent to license rather than to enter product markets. As a result, the relative dominance of domestic firms remained intact even after India opened up its shores to foreign firms.

Interestingly, this is quite contrary to how the Indian pharma industry was structured prior to 1972, the last

time when India had a ‘liberal’ patent law. In 1971, only six of the top 20 Indian pharma firms were domestic companies while the rest were of foreign origin (ordering based on revenues) and this was also when prices of drugs were generally high because a lot of the chemical ingredients were imported making several important drugs inaccessible to many. But given that the current patent law is similar in many ways to the law that existed before 1972, why hasn’t history repeated itself? One reason is that back then, the domestic industry was relatively under developed and offered very limited possibilities for licensing. When capabilities are fragmented such that only a few firms can produce proprietary technology of their own, or only a sub-set of firms have market access, domestic firms in our context, licensing may just be a better strategy.

Voluntary licensing may not only enable foreign companies to deal with the looming threat of compulsory licensing even if multinational companies successfully get a patent in India, but just as importantly they may enable

them to avoid large upfront investments in manufacturing and distribution.

Voluntary licensing thus may in fact not only be a safe bet but also a very efficient strategy to operate profitably in India.

That said, the jury is still out on whether or not such a strategy is sustainable especially when the new patent law is yet to be fully tested in the Indian courts. With a few exceptions, most licensors may not out-license in the absence of a patent and it is yet unclear whether patents truly confer property rights to the patent holder in India which is likely to affect the attractiveness of licensing as a strategy. However, what is clear is that, that countries like India and China offer significant growth opportunities to foreign companies and despite their weaknesses, these markets may be too valuable to give up, just yet. The new imperative for foreign companies will be to also innovative on business models to compete in such markets.

(The author is the assistant professor of strategy at Indian School of Business, and researches the implications of patents on innovation, entrepreneurship and industry structure)

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May 1-15, 2013

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DIGITAL DOSE 'Tweet-talk' your customers with new age marketing As a continuation to the series of articles titled ‘The Digital Dose for Indian Pharma’, Dinesh Chindarkar, Co-founder & Vice President – Operations, MediaMedic Communications, focuses on specific social media platforms gives an outlook on the most popular social networking and micro-blogging platform – Twitter

ne thing similar between a celebrity and a common man is – they both 'tweet'. From announcing the birth of a baby to rocking the nation, people share their hearts out on this micro-blogging website called Twitter.

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So what exactly is Twitter?

Twitter is nothing but a network pool of real time information that connects you

with the latest news and information on topics of your interest and much more.

When we say real-time, it means new information is uploaded almost every second! That’s the speed at which you reach your viewer.

At the core of Twitter is a 'tweet', which is a short text message of 140 characters in length. This message is more like an SMS but displayed to the public or a large number of audience.

How does Twitter work?

Just like any social media channel, Twitter can help you network with your colleagues, associates and other professionals from the industry. It also helps to stay in touch with various companies. You can follow them and they can follow you. You will be able to see a Twitter feed real time on your account of

all the different accounts that you follow. Similarly, whatever you tweet is seen by your followers.

You can also check which profiles are followed by your peers and associates, to help you decide whom to follow.

But, how can these little tweets help our pharma companies in increasing their business? Just like any social media channel, Twitter is like a PR tool to build up your reputation and interact with the masses at large. As a corporate, pharma companies can talk about their initiatives in terms of patient education, CSR, latest technology adoption, new product launches and also about their financial achievements.

How to make Twitter work for you?

The trick with Twitter is effective communication.

To grab the attention of customers, one needs to also use or follow the appropriate hashtags. A hashtag will group your tweets in conversations related to healthcare, where it will create greater visibility. For

example; on Twitter if you type ‘#pharma’ in the search section, you will see all the tweets containing ‘#pharma’.

This will help you identify all the discussion happening around pharma. Similarly, when you post some update related to pharma and you use this hashtag, your conversation will be grouped with others and people who like it may start communicating or following you. That is the beauty of Twitter and it can give rise to meaningful conversation and dialogue around geographical boundaries and help connect with varied people.

A pharma company has to strategise the use of Twitter, define the objectives and then get on with the implementation. It can create a hype by broadcasting the company’s latest news, latest research done on its molecule, create awareness on a particular disease or condition, interact with doctors and patients alike, enable easy internal collaboration and group communication etc. Rather than keeping a one-way broadcasting outlook, a company

Industry insights How Indian pharma can use Twitter differently: Tweet beyond regular investor updates: Most Indian corporates use Twitter as an investor information dissemination. But, there is little creative thought given beyond this by pharma companies. They can talk about causes, disease awareness and management, corporate sustainability etc. Here are few ways in which the pharma sector can use Twitter differently: 1. With so many healthcare and medical conferences around pharma, expand the live conference participation beyond the confines of conferences. Smart use of hashtags and live tweeting can not only take your conference participation beyond the confines of halls, but can also prolong it by providing a platform for customers to interact even after conferences. That is the true potential of the medium where the learning, discussion and engagement goes beyond the mundane classrooms.

Creative use of tweet pics: Picture sharing over twitter is an underutilised area, especially in India. Interaction using pictures and videos inter-

May 1-15, 2013

nationally amongst medical communities is something that can be done here.

Use of promotional tweets: Twitter is one of the more serious platforms where promotions can work better. Promotional tweets can also dramatically expand the reach of any promotional campaigns among the follower community. It can be an excellent tool to build up a good PR around the corporate/brand.

2. Driving in-clinic conversations between doctors and patients with social media and ever present educative material on the Internet is a great opportunity for pharma companies to bridge the education divide between doctors and patients. Companies who are able to do that can help create better and favourable conversations between doctors and patients. This would be a win-win for all doctors, patients and will also help pharma firms in driving adherence and compliance to treatments.

Few roadblocks Old mindsets: The usual mindsets block the ability to see the change even though it is quite

www.expresspharmaonline.com

Pankaj Dikholkar, Chief Manager Corporate Initiative, Abbott apparent and staring in the face. Democratisation of information via social media and digital platforms is one such Big Bang change.

Old methods to digital platforms: In manyto-many conversations one-on-one communication tools and techniques have limited use.

Pharma firms need to evolve better ways and means to exploit it. Expecting immediate or short term ROI in terms of sales is not a valid equation.

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can get into meaningful conversations.

Doctors too are changing and, especially the younger ones, are adapting to Twitter fast and can definitely be connected. They seek and share information on twitter and can strike a conversation with any pharma company that they wish to. Pharma can look into creating groups within healthcare providers (HCPs) and engage with them by giving them personalised information that they wish to get.

Twitter can be an incredibly powerful tool, provided it is used strategically with clearly laid down objectives.

Current users of Twitter There are a few Indian pharma companies who have effectively started using Twitter to connect with their customers and consumers.

One of the few top Twitter pharma handles that are currently in use is @Pfizer_news where Pfizer gives out real time information about the company. @Diabetes_Sanofi is another great example of a pharma company connecting with its patients. This handle posts real time case studies and blogs of its consumers while promoting awareness

about diabetes.

Some relevant hashtags to use while tweeting are: #pharma, #hcsmin, #healthcare, #ehealth, #indiahealth

Making a Twitter in the market With Twitter, newer platforms of interactive communication with customers, clients, consumers, and competitors can be explored as it holds a lot of benefits.

The key lies in understanding the medium completely. It

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not only allows the pharma company to build their brand’s image but also build the category in which it is operating. With approximately over 10 million Twitter users in India, and majority of them using to get latest news, pharma companies have ample opportunities to showcase their true marketing potential through Twitter. Moreover, it is extremely cost effective as one simple tweet is reaching a huge number of audience

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compared to the traditional methods of marketing.

As the world moves on to newer avenues of marketing, Twitter is that one potential avenue which needs to be explored by Indian pharma.

Once they get on the roll in tweeting, then they can easily connect with their customers, patients and stakeholders. In this era of ‘disease management’ and ‘partnering for healthy outcomes’, it is a critical medium to reach these TGs.

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May 1-15, 2013

RESEARCH

W H AT ’ S INSIDE

EXPERTISE FOR DRUG DEVELOPMENT

Developing a herbal-based drug for Hepatitis B Dr Pralhad Patki, Head, Medical Services & Clinical Trials, The Himalaya Drug Company, narrates how the company applied their knowledge of liver disease and herbs to develop a herbal-based drug for Hepatitis B: Liv.52 HB

oday, a lot is being written about the potential of herbal medicine.

Therapeutic benefits of herbs like turmeric, ginger and winter cherry (ashvagandha) are being researched across the world.

As a herbal healthcare company, Himalaya has been developing phytopharmaceutical formulations for the past 80 years. Herbal medicine, if backed by modern research, can become the first line of treatment for several conditions, and at other times, contribute to a holistic regimen that improves quality of life.

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Enter: Liv.52 Himalaya’s flagship brand, Liv.52, developed in 1955, is the result of years of research. For many years, Himalaya’s scientists were working on a natural remedy to improve liver function. It was during the 1950’s that clinical trials were performed on several coded liver formulations, and one of them, coded 52, showed remarkable results in the treatment of hepatitis. This led to wider product testing and further investigation. Tests conducted across India with formula May 1-15, 2013

52 showed significant improvement in liver function. The samples of formula 52 were in great demand from doctors who conducted the trials. Subsequently, the product was called Liv.52, the brand name to aid doctor recall.

Today, Liv.52 is backed by 250 clinical studies and is the only herbal drug with a metaanalysis study in infective hepatitis. It is registered in over 65 countries, including Russia where is prescribed as an adjuvant to counter the side-effects of anti-TB medication. In 2013, Liv.52 occupied the number seven position in a list of top bestselling drugs in India, as per the Indian Pharmaceutical Market (IPM) review.

Initially, Liv.52 was recommended for the treatment of jaundice. Over the years, Liv.52 has proven effective for the treatment of liver disorders including fatty liver and as an adjuvant to hepatotoxic drugs like statins, chemotherapeutic agents and antitubercular agents.

What about Hepatitis B? As makers of Liv.52, Himalaya had already carried out a lot of research on liver

disease and herbs that work best for the treatment of liver conditions. Applying this knowledge to develop a drug for Hepatitis B was, therefore, a natural extension.

For this purpose, 120 plants were screened by the research team. Scientists were looking for a plant that exhibited hepato-protective activity as well as antiviral activity against the Hepatitis B virus. Among these, Nut Grass (Cyperusrotundus or Musta) and Umbrella’s Edge (Cyperus scariosus or Nagaramustaka) revealed potent antiviral properties.

The formulation, containing extracts of the two herbs, was first tested in vitro on hepatic cell lines. The infected cell lines, when treated with the extracts, multiplied without the virus. Results showed that the drug suppressed the replication of viral DNA involved in HBV, and eliminated the virus by reverse transcriptase inhibition. In fact, the formulation was successful in suppressing HBV surface antigens (HBsAg) in in vitro experiments.

The success of the in vitro experiments encouraged the scientists to move on to the next phase of preclinical evaluation - in vivo experiments (a recognised model for screening Hepatitis B virus in animals, recognised by WHO). Animals infected with Hepatitis B revealed that extracts of two plants were highly efficacious in treatment of this disease. These tests helped establish efficacy of the drug and arrive at a dosage. The experiments were repeated a number of times and produced encouraging results.

We then undertook preclinical toxicity studies including acute toxicity, subchronic and chronic toxicity studies to understand the effect of long-term administration of the drug on body organs, blood chemistry, hormones etc. We also conducted carcinogenic studies. www.expresspharmaonline.com

Mutagenicity studies in bacteria, conducted as per WHO guidelines, revealed that the drug did not produce any adverse effects or mutations in future generations/progeny.

After establishing the safety of the drug through in vitro and in vivo experiments, we moved on to human clinical trials after obtaining ethical clearance. Phase I of these trials conducted in 20 healthy individuals, established the safety of this drug.

The studies showed that the drug did not produce any adverse effects even when given for longer duration.

In Phase II clinical trials, the drug was tested in a small sample of Hepatitis B patients who were not undergoing any other treatment.

We conducted these tests in two hospitals in Bangalore and Baroda Govt. Medical College and Hospital, Baroda.

These tests helped us establish the efficacy and safety of the drug in the prescribed dosage. Again, the results were encouraging.

Patients taking the drug showed symptomatic relief, biochemical relief and sero conversion.

In Phase III clinical trials, we tested the drug on a substantial number of patients. This was a double blind placebo controlled randomised study.

The trials were conducted in leading hospitals and institutes across India including Osmania Medical College Hospital, Hyderabad, Maulana Azad Medical College in Delhi, Government Medical College, Baroda, and Sanjay Gandhi Postgraduate Medical Institute, Lucknow among others. The tests revealed the beneficial effects of the formulation in clearance of HBs antigen in some patients. The results of these tests have been published in peer review and leading medical journals, including Antiviral Research.

Launched in 2011, Liv.52 HB has received an encouraging response. Available at the fraction of the price of available treatment of Hepatitis B, Liv.52 HB is affordable, efficacious and completely devoid of side effects.

Key link between obesity and type 2 diabetes discovered PG 30 Diabetes trials worldwide are not addressing key issues in affected populations PG 31 Oncolytics lung cancer drug effective in mid-stage trial PG 32

PHARMA ALLY 33 PHARMA LIFE 59 EXPRESS PHARMA

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RESEARCH UPDATES Key link between obesity and type 2 diabetes discovered Cases of diabetes have more than doubled since 1980

ew research published in the journal Cell Metabolism has identified a key mechanism in the immune system involved in the development of obesitylinked Type 2 diabetes. The findings open up new possibilities for treatment and prevention of this condition, which is becoming increasingly prevalent worldwide. The study is

by Dr Jane Howard and Professor Graham Lord, King’s College London, UK, and colleagues, and is funded by the UK Medical Research Council.

There are an estimated 371 million people with diabetes in the world, with around 90 per cent of these cases type 2 diabetes. By 2030, there will be some 550 million with diabetes based on current trends.

Cases of diabetes have more than doubled since 1980, with 70 per cent of the trend due to ageing populations worldwide and the other 30 per cent estimated to be due to increasing prevalence of risk factors including obesity.

The association between obesity and diabetes has long been recognised but the molecules responsible for this association are unclear. Dr Jane Howard, lead author in this research and colleagues from King’s College London, studied mice genetically engineered to lack T-bet, a protein which regulates the differentiation and function of immune cells. They found that the mice had improved insulin sensitiv-

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ity despite being obese. ‘When T-bet was absent this altered the relationship between fat and insulin resistance: the mice had more intra-abdominal fat but were actually more sensitive to the glucose lowering effects of insulin,’ says Dr Howard. ‘As fat accumulation in the abdomen is typically associated with worsening insulin resistance and other features of the metabolic syndrome, the findings seen were both unusual and unexpected.’

It turned out that the intraabdominal fat of these mice contained fewer immune cells and was less inflamed than that of normal mice. The researchers then went on to

discover that by transferring immune cells lacking T-bet to young, lean mice they were able to improve insulin sensitivity. ‘It appears that T-bet expression in the adaptive immune system is able to influence metabolic physiology,’ added Professor Lord.

Although human obesity is often associated with insulin resistance and diabetes, this is not always the case. ‘Our data suggests that obesity can be uncoupled from insulin resistance, through the absence of T-bet,’ says Dr Howard. Several of the main drugs currently used to treat Type 2 diabetes work by improving insulin sensitivity.

Further studies would be needed to identify other molecules in the pathway of action of T-bet which could pave the way for future drug development in the treatment of Type 2 diabetes. The administration of specific immune cells as immunotherapy to improve insulin resistance may also one day become a therapeutic possibility. ‘This is just the start,’ says Dr Howard, ‘the idea that the immune system can impact on metabolism is very exciting, but more research needs to be done before we can bring this work from the bench to the bedside for the benefit of patients.’

EP News Bureau-Mumbai

Drug-eluting stent use in peripheral artery disease shows promising results Drug-eluting stents could offer a less invasive option

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he use of stents that not only open a clogged artery but also provide targeted release of a drug is demonstrating favorable results.

There is controversy over whether the drug-eluting stent or the bare metal stent has superior clinical benefit.

Numerous studies, however, are indicating successful trials of procedures using the drugeluting stent to keep vessels in the leg open.

The authors of an article published in the Journal of Endovascular Therapy compare the use of bare metal stents with drug-eluting stents in the treatment of infrapopliteal occlusive dis-

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ease. The article is a metaanalysis of the results of six studies four randomised trials and two observational studies that included 544 patients.

Peripheral artery disease affects a significant portion of the population. With the rising prevalence of diabetes, severe limb ischemia is also expected to increase. Reconstruction of the arteries through surgery is the primary treatment, but drug-eluting stents could offer a less invasive option.

The drug-eluting stent releases drugs to the vessel wall to prevent inflammation and proliferation of cells, thus improving treatment outcomes. At the one-year point, www.expresspharmaonline.com

the results of these studies are promising. Patency of the vessel to allow free flow of blood and clinical improvements have increased, and revascularization of the target lesion due to reclosure is low.

What these studies are not able to tell us at this point is whether longer-term effects will be as encouraging.

Parameters such as saving of limbs and healing of wounds have yet to be assessed.

The authors discuss the pros and cons of meta-analyses. They compare megatrials—which offer to definitively settle an issue by studying large numbers of subjects—to a Big Mac, while they describe

systematic reviews and metaanalyses, which pool results of smaller studies, as a bowl of Cheerios.

Despite the recent burst of popularity for meta-analyses within the literature, the authors praise the careful analysis of drug-eluting stents presented in this issue of the journal. They caution that not all types of drug-eluting stents are equal and that these study findings should not be generalised to all types.

Nevertheless, they find this analysis to be “recommended reading” for endovascular specialists.

Journal of Endovascular Therapy May 1-15, 2013

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Diabetes trials worldwide are not addressing key issues in affected populations Research published in Diabetologia, the journal of the European Association for the Study of Diabetes n analysis of diabetes trials worldwide has found they are not addressing key issues relating to the condition with almost two thirds focusing on drug therapy while only one in ten addresses prevention or behavioural therapies. The research is published in Diabetologia, the journal of the European Association for the Study of Diabetes (EASD), and is by Dr Jennifer Green, Duke University Medical Centre, Durham, NC, USA, and colleagues.

There are an estimated 371 million people with diabetes in the world. By 2030, there will be some 550 million with diabetes based on current trends. As such, research addressing the whole spectrum of diabetes care and treatment is essential. To examine whether current studies adequately address these needs, Green and colleagues analysed diabetesrelated trials registered with ClinicalTrials.gov from 2007–2010.

The researchers found 2,484 interventional trials by selecting those with disease condition terms relevant to diabetes. Of these, 75 per cent had a primarily therapeutic

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purpose while just 10 per cent were preventive. Listed interventions were mostly drugs (63 per cent) while few were behavioural (12 per cent).

Most of the studies were also small to medium sized, and were designed to enrol 500 or fewer participants (91 per cent) or 100 or fewer (59 per cent) participants, with mean/median times to completion of 1.8/1.4 years.

A very small proportion of trials targeted persons aged 18 years and under (four per cent). This may be appropriate given the number of children currently affected by diabetes; however, the estimated three per cent annual increase in incidence of Type 1 diabetes may warrant greater representation.

Furthermore, the increase in Type 2 diabetes among adolescents, particularly noticeable in wealthier nations, is of considerable concern, since as Dr Green notes “It is unclear whether findings obtained from trials of adults with diabetes are readily translatable to paediatric/adolescent populations.”

And despite the fact that nearly 20 per cent of adults worldwide aged 65 years and over have diabetes, less than one per cent of trials specifically targeted this age group, while 31 per cent actually excluded patients over 65

years and almost all excluded those over 75 years. “Only a tiny proportion of the trials analysed — 1.4 per cent — listed primary outcomes including mortality or clinically significant cardiovascular complications,” says Green.

“Furthermore, distribution of registered trials by country does not reliably correlate with diabetes prevalence.”

The International Diabetes Federation list of the 10 locations most affected by diabetes includes six Middle Eastern countries in which diabetes prevalence among adults is approximately 20 per cent (Kuwait, Lebanon, Qatar, Saudi Arabia, Bahrain and the United Arab Emirates).

However, this analysis by Green and colleagues, suggests that this region is minimally involved in the registered diabetes-related trials.

Comparison of trial activities in countries with the highest diabetes prevalence among adults revealed 1126 trials in the US. China, India and Mexico participated in 101–250 trials each; however, the Russian Federation (12.6 million persons with diabetes) and Brazil (12.4 million) are involved in fewer than 100 registered trials despite these heavy disease burdens.

Green also says: “Rates of complications including dia-

betic retinopathy, lower extremity amputation, and end-stage renal disease vary among ethnic groups. To achieve the greatest impact upon clinical care, trials should enrol patients representative of populations disproportionately affected by diabetes and its complications.

A better understanding of responses to interventions among diverse individuals and groups may inform individualised treatments of greater effectiveness and tolerability.”

She concludes, “The majority of diabetes-related trials include small numbers of participants, exclude those at extremes of age, are of short duration, involve drug therapy rather than preventive or nondrug interventions, and do not focus upon significant cardiovascular outcomes. Recently registered diabetes trials may not sufficiently address important diabetes care issues or involve affected populations.

Although many trials will provide valuable information upon completion, our review suggests that the current portfolio does not adequately address disease prevention, management, or therapeutic safety. This information may be meaningful in the allocation of future research activities and resources.”

EP News Bureau-Mumbai

Autism risk not increased by early vaccines: Study Researchers said that there is no link between receiving a number of vaccines early in life and autism n a study slated to appear in The Journal of Pediatrics, researchers said there is no

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association between receiving "too many vaccines too soon" and autism, despite some fears among parents around the number of vaccines given both on a single day and over the first two years of life. As

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many as one in 50, US schoolage children have been diagnosed with autism, up 72 per cent since 2007.

Researchers from the Centers for Disease Control and Prevention and Abt Associates analysed data from children with and without autism spectrum disorder (ASD), according to a statement from the journal.

Researchers examined each child's cumulative exposure to antigens, the substances in vaccines that cause the body's immune system to produce antibodies to fight disease, and the maximum number of antigens each child received in a single day of vaccination, the journal's statement said.

The antigen totals were the same for children with and

without ASD, researchers found. Autism runs a spectrum from a profound inability to communicate and mental retardation to milder symptoms seen in Asperger's Syndrome. While scientists believe genetics account for 80 to 90 per cent of the risk for developing autism, a growing number of studies are beginning to suggest that a father's age at the time of conception may play a role by increasing risks for genetic mistakes in the sperm that could be passed along to offspring.

Worries about a link between vaccines and autism have persisted for years, despite a growing body of scientific evidence disproving such an association.

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CLINICAL UPDATES Oncolytics lung cancer drug effective in mid-stage trial The drug, Reolysin, was used intravenously in combination with chemotherapy drugs carboplatin and paclitaxel on patients with squamous cell lung cancer ncolytics Biotech said its experimental lung cancer drug was found to be more effective in a midstage trial study. The main goal was to see if nine or more patients had a partial or better response to the treatment in the second stage trial, which studied 36 patients. The endpoint was met after 21 patients were treated. Nine of them showed

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response. “Based on the positive data seen to date, we intend to conduct further studies in this indication,” said Brad Thompson, Chief Executive Officer, Oncolytics Biotech. The secondary objectives of the trial, for which data is yet to be released, includes assessment of progression-free survival and overall survival for the treatment regimen in the study population, the company said.

Reuters

partial response, while another nine showed stable disease and three showed progressive disease. The drug, Reolysin, was used intravenously in combination with chemotherapy drugs carboplatin and paclitaxel on patients with squamous cell lung cancer.

The US mid-stage trial was divided into two parts. The first part of a mid-stage trial had earlier met the main goal of showing patient

AP Pharma's drug for chemo-induced nausea denied approval AP Pharma resubmitted U its application in September last year after switching to a single-syringe system and conducting additional metabolism studies as required by the FDA

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S health regulators denied approval to AP Pharma's drug for treating chemotherapy-induced nausea and vomiting (CINV), and asked for additional analysis of latestage data on the drug.

In a complete response letter to the company, the US Food and Drug Administration also asked for a study that can test the usability of the drug's syringe system and pointed out certain deficiencies identified during inspections of its manufacturing facility. The FDA asked the additional analysis of the late-stage trial data to reclassify patients into those receiving moderately vomit-inducing chemotherapy and highly vomit-inducing chemotherapy. The agency earlier rejected the approval of the drug, APF530, in March 2010, citing concerns about its two-syringe administration system and deficiencies in the company's contract manufacturing facilities.

AP Pharma resubmitted its application in September last year after switching to a single-syringe system and conducting additional metabolism studies as required by the FDA. “While disappointed in today's notification, we believe that the issues raised in the complete response letter are addressable, and we remain firmly committed to the successful development of APF530,” Chief Executive Officer, John Whelan said.

The company, which had planned to launch the drug in

the second half of 2013, now expects to launch it in the first half of 2014. AP's drug is delivered using a system that is designed to release the medication over a four- to five-day period. The drug contains granisetron, a widely

available generic, also sold as Kytril by Swiss drugmaker Roche, to treat CINV. GlaxoSmithKline's Zofran and Japanese drugmaker Eisai's Aloxi, given in a single intravenous dose, are the other drugs used to treat both

acute and delayed onsets of CINV. Nausea and vomiting are the major reasons why many cancer patients prematurely discontinue chemotherapy treatment.

Reuters

Novavax vaccine meets mid-stage trial goal The vaccine against respiratory syncytial virus could induce immune responses at levels that can protect infants through a transfer of antibodies from the mother ovavax said its vaccine to treat a virus that causes respiratory tract infections met the main goal, of immunising women of childbearing age, in a mid-stage trial. The vaccine against respiratory syncytial virus (RSV) could induce immune responses at levels that can protect infants through a transfer of antibodies from the mother, Novavax said citing trial data.

The vaccine was well-tolerated, with a safety profile similar to its early-stage trial.

The trial on 330 women tested 60 microgram and 90 microgram doses of the vaccine, with and without an adjuvant — an agent to boost immune response. The women received either one or two injections of a single dose of the vaccine, or a placebo. The adjuvant showed a greater response in both regimens.

"The study was dose confirmatory at 60 micrograms. They will go with an adjuvant and will prob-

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ably go forward testing two doses administered a month apart, because the greatest response was with using a two-dose regimen," MLV & Co analyst George Zavoico said.

Zavoico said the vaccine was ahead of rivals in development. Novartis and GenVec are also testing RSV vaccines in pre-clinical studies. Novavax would have to do reproductive toxicity tests in animals before test the vaccine on pregnant women, Zavoico said.

The company is also testing the vaccine in an early-stage study with elderly patients. “With the robust response in this trial, I believe that they will see a response in the elderly as well,” Zavoico said.

Reuters

May 1-15, 2013

PHARMA ALLY INSIGHT Pharmaceutical supply chain–Indian perspective Geetha Vaithyanathan – Domain lead, Beroe Inc elucidates on the machinations of the pharma supply chain and gives an insight into the Indian scenario ndian pharmaceutical industry was valued $12 billion in 2012 including domestic production of drugs, exports and imports.

Technical and infrastructure capabilities of pharma companies, cost effective production process and reduced time to market drugs due to domestic regulations are the key factors driving the growth of Indian pharma segment.

Indian API manufacturers produce close to 1000 APIs for various therapeutic segments such as oncology, anti-infectives etc. India has more than 120 FDA approved sites and close to 90 MHRA approved plants. Efficient

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infrastructure facility coupled with relatively reduced labour cost enables the Indian pharma segment to attract foreign direct investments (FDI). The FDI flow is also reflected in the form of increased partnerships – either through mergers or acquisitions, including that of Abbott – Piramal (2010), Strides Arcolab – Aspen (2010), Solvay Pharma – Abbott Capital (2010), Hospira – Orchid Chemicals (2010) etc.

India is viewed as one of the most preferred and cost effective outsourcing partners for pharma MNCs. Outsourcing of bulk drugs

by big pharma is slated to grow by $3 billion while the CMO market in India is expected to grow at a rate of 20 per cent till 2015. In terms of capacity, currently, the Indian pharma industry is operating at an average of 60-65 per cent. Henceforth, these major MNCs are planning to utilise the remaining 15-20 per cent for their outsourcing activities.

Indian pharma supply chain Indian pharma supply chain follows a symmetric network with distributors, wholesalers and retailers occupying a major portion of the segment. However, it is different from the US supply chain in the following two aspects Insurance providers as ad hoc segment: US pharma

supply chain has insurance providers as an integrated segment whereas Indian pharma supply chain is currently in an ad-hoc stage and not integrated completely with insurance providers and other service providers.

Increasing partnerships with medical device companies: Major pharma companies such as Bayer, Boehringer Ingelheim have collaborated with medical device companies such as Aptar, Nypro and Gerresheimer, starting from Phase I development of drugs, for developing formulations for pre filled syringes and inhalers. Such a collaborative approach calls for reducing the time to market these products in India, since the medical device companies are involved in design

W H AT ’ S INSIDE

Intox expands experimental animal house facility PG 35 Eppendorf India celebrates 10th anniversary PG 36 Waters Empower 3 goes mobile with new laboratory analytics capabilities PG 37 Spinchrom Life Sciences to market BLItz platform from Pall India PG 38

Innovative R&D alliances ● ●

GSK Pfizer

Created a globally specialised HIV company to focus solely on research, development and commercialisation of HIV medicines.

Increased ROI, through expertise and technology sharing in R&D. avoided duplication of R&D efforts. On the whole, efforts were aimed to reduce time to market of drugs

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Mental Health Research Institute (Australia) ● Astra Zeneca

Collaborated R&D to identify early stages in Alzheimer’s disease.

Efforts were oriented to reduce the overall complexity in the supply chain by early detection and cure

●Pfizer ●Protalix

Entered into an agreement to develop and commercialise potential treatment of Gaucher’s disease (which is quite a rare disease).

Innovative R&D approach to cater to the niche market of rare disease

●Pfizer ●Strides

Joint venture enabled Pfizer to commercialise off patented sterile injectable and oral products whereas licensing will be carried out by Strides Arcolab.

Reduced time to market of drugs as the complex processes viz. licensing and branding are carried out by two different entities

●Eli Lilly ●Chorus

Chorus, Eli Lilly’s subsidiary has been established to carry out virtual R&D. The purpose is to quickly take the molecules to the proof of concept stage and outsourcing other stages of clinical trials.

Eli Lilly has transformed itself from a traditional integrated pharma company to a pharma network by leveraging on its innovation base especially in virtual R&D.

●Eli Lilly ●Piramal

Lilly has collaborated with CROs/CMOs such as Piramal Life Sciences, Hutchinson MediPharma and Suven Life Sciences for developing molecules.

Collaboration efforts were aimed towards reducing time to market of drugs as most of the R&D process was outsourced.

●Debiopharm

A Swiss based global biopharma company with focus on developing innovative new drugs that target unmet medical needs. It in-licenses and develops small molecules which are already in clinical phases I, II or III and sells it to major pharma companies.

Bypasses critical supply chain component Drug development and allows the major companies to focus more on marketing and branding which reduces overall supply chain complexity.

Arcolab

Life Sciences, Hutchinson MediPharma and Suven Life Sciences

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and manufacturing of medical device components right from Phase I development of drugs.

Indian pharma landscape – A comparative analysis While global pharma MNCs are well advanced in terms of innovative R&D, technology partnerships, open innovation and crowd sourcing, domestic Indian players

are yet to follow the race.

However, this type of technological innovation is yet to take shape in India, as Indian companies are not investing in R&D due to lack of adequate required capital. There are no companies in India who have already come up or are planning to install full-fledged virtual R&D centres for the lack of technology and other fund-

ing requirements in India.

Globally, the following sample alliances (See Table: Innovative R&D alliances) indicate the highly innovative ventures taken recently by major pharma companies. The reactive nature of Indian pharma industry might act as a barrier to run in the global race where innovation tends to be the major factor to differentiate one pharma major from the other.

Regulatory work: CRO help pharma companies expedite regulatory work (Clinical trial material import etc.)

Data management: Though data management services are majorly provided

by BPOs (TCS, Accenture, Cognizant), some leading CROs in India (SiroClinpharm, Quintile) do provide these services as well.

Logistics and distribution network

Primary reasons to revamp a pharma supply chain in India can be outlined as a shifting global trend towards in-life licensing, continuous manufacturing and value based pricing. There is a huge potential left in terms of ‘innovation’ in which the aforementioned three parameters play a vital role.

Indian pharma companies are yet to bring innovative R&D and patient management and assistance programmes integrated into the supply chain and are dependent on the high volume segment – generic drugs. Indian pharma industry is currently in a nascent stage in terms of technological innovation and new advancements such as open innovation, crowd sourcing etc. The socio-economic conditions in India are driving the patient segment towards low cost drugs. Hence, generics segment in India is growing at a faster rate when compared to patented drugs. Though, global pharma companies are innovating in terms of technology, open innovation, crowd sourcing, in-licensing etc., Indian pharma companies are yet to follow the global race.

However, Indian pharma segment has an intensive patient pool with varying genotypes when compared to developed regions. Global pharma MNCs can leverage the patient pool for conducting their clinical trials in India.

This will provide opportunities for increased partnerships (which leads to increased R&D trials) of global pharma MNCs with domestic CROs. A shift in industry trend from high volume to high value can be expected if pharma MNCs focus to drive to increase their R&D spend. This will increase vertical integration in terms of increased partnerships from raw material manufacturers (APIs, excipients and other chemicals – back ward integration) to pharma distribution companies (forward integration) in the overall pharma supply chain.

Pharma wholesaler or distributor sector is fragmented.

The first point of contact after the manufacturer is the carry forward agent. In each State there will be one or two carry forward agents who pay the deposit fee and carry pharma inventory. Since India has a double taxation system for every state – central sales tax and state sales tax, possessing CFA in every state will avoid multiple tax payments for the same goods.

Integrating CROs with pharma companies CROs form an integral part of the pharma supply chain and they assist major pharma companies in cost effective drug development process.For example in India, CROs assist pharma companies in: Providing staff: (Clinical Research Associate or CRAs) for monitoring clinical trials

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Need to revamp Indian pharma supply chain

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VENDOR NEWS Intox expands experimental animal house facility Dedicated SPF facility meets new regulatory requirements Sachin Jagdale Mumbai oxicological Contract Research Organisation (CRO), Intox, which is also a unique example of an independent venture founded by scientists, without any external support or funding, recently expanded its facility

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in Pune. Intox also features among a very few Indian CROs, which have been GLP certified by an OECD member country. Intox has expanded the existing GLP certified facility with addition of state of the art equipments, manpower, infrastructure/ building etc.

The company has expanded its experimental animal house by building up a new animal test facility comprising of 25 rooms. Dr Mukul Pore, CoFounder and Director, Intox,

and also a European Registered Toxicologist (ERT), says, “This dedicated Specific Pathogen Free (SPF) facility is well equipped to take care of the current market needs in compliance with various regulatory/animal welfare guidelines. The double corridor system with epoxy flooring, polyurethene coated walls, air showers, air locks, centrally air conditioned, automatic power backups, automatic temperature/humidity con-

trollers etc. provides all necessary inputs required for SPF facility.” He adds, “Recently purchased inhalation equipment (CH Technologies, US) is state-of-the-art technology for inhalation studies.”

Intox has expanded and upgraded its capabilities in analytical chemistry to meet the new regulatory requirements of developed countries including Brazil, Argentina, US, Japan etc. sachin.jagdale@expressindia.com

SJRI, Bangalore, honoured by Waters for Center of Innovation Programme Structural Proteomics Laboratory directed by Prof Amit Mandal recognised for global disease research

(L-R) Dr John Gebler, General Manager, Waters Centers of Innovation Programme, Dr K Srinivasan, Dean, St John's Research Institute, Dr PR Krishnaswamy, Professor and Consultant, St John's Research Institute, Prof Amit Mandal and KV Venugopalan, President, Waters India at the awards ceremony

t Johns Research Institute (SJRI), Bangalore, part of the St John’s National Academy of Health Sciences, which is run by the CBCI Society for Medical Education, has been honoured by Waters for its Centers of Innovation Programme for research in the field of structural proteomics. SJRI is the first institution in India to receive the designation of a Waters Center of Innovation.

Under the direction of Amit Mandal, Professor of Molecular Medicine and Clinical Proteomics, St John’s has earned a reputation for its research in blood disorders and other diseases that disproportionately affect disadvantaged populations.

“What you see today is a

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culmination of a great amount of dedication and passion on the part of Mandal. Our relationship with Waters is not just one of a client and vendor; it is a true working partnership and has been ever since this laboratory came into existence in 2009,” said K Srinivasan, Dean, St John’s Research Institute.

On hand to congratulate, Mandal and his team was KV Venugopalan, President, Waters India. “We are proud to be associated with Mandal’s outstanding and pioneering work in structural proteomics,” he said.

“Partnering with St John’s Research Institute is a reflection of our mutual interests in serving society by improving the health

of patient communities through science.”

Mandal said that as a physical chemist with a special interest in molecular structure, he came to mass spectrometry in 2005 when his professor encouraged him to learn mass spectrometry. “The boss is always right I guess,” he said. “I did an Internet search and found the citation report for Prof John Fenn’s paper on electrospray mass spectrometry of large molecules. The citation index growth of this paper convinced everyone that electrospray mass spectrometry was an important breakthrough in science. So I gradually started learning about mass spectrometry. It’s made all the difference.”

EP News Bureau-Mumbai

GE Healthcare Life Sciences, Sigma-Aldrich announce distribution partnership in India Expands availability of GE Healthcare’s innovative Whatman products to India E Healthcare recently announced the signing of a new agreement with SigmaAldrich to distribute its Whatman range of products in India. The Whatman range of innovative papers and filters includes sample collection and storage cards (FTA cards), filter papers, and specialist diagnostic membranes used in a wide range of applications such as forensics, neonatal screening, environmental screening, quality control of pharmaceuticals, food

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and beverage production and in the manufacture of in-vitro diagnostic tests. Many leading Indian companies and institutions use Whatman products for advancing their life sciences research and medical technology applications.

Anurag Gupta, Managing Director, GE Healthcare Life Sciences South Asia said, “We are delighted to announce this distribution agreement with Sigma Aldrich which will allow GE Healthcare to cvfbring its innovative Whatman products to a much wider range of customers in a variety of academic and industry www.expresspharmaonline.com

settings across India.”

Raja Ram, Managing Director, Sigma-Aldrich, India said, “Continuing to deliver on our mission of enabling science to improve the quality of life, we are excited at the partnership we have forged with GE Healthcare Life Sciences to distribute Whatman products. The partnership will enable customers to benefit from Sigma-Aldrich’s established standards of service and operational excellence within India.”

GE Healthcare Life Sciences provides expertise

and tools for a wide range of applications, including basic research of cells and proteins, drug discovery research, as well as technologies for start-to-finish largescale manufacturing of biopharmaceuticals.

The company has been steadily increasing its footprint in India through the establishment of an R&D centre, Fast Trak BioPharma Services to support the rapidly growing biopharma industry in India, and a customer training and education centre in Bangalore.

EP News Bureau-Mumbai EXPRESS PHARMA

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Eppendorf India celebrates 10th anniversary Over the last decade, it has grown to 135 employees, and revenue in excess of Rs 100 crore s Eppendorf India completes a decade of direct operation in India, the company thanks customers, distributors, suppliers, media and employees for the support during the last 10 years and hope to continue to receive this support in the

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years to come as well.

Headquartered out of Chennai, Eppendorf India was launched in April 2003, as a small organisation with 23 people. Over the last decade, it has grown to 135 employees, and revenue in excess of Rs 100 crore, with branch offices in nine locations and satellite operations in various cities in order to reach customers nationwide.

Adding another feather to the cap is the Pipette Calibration Centre in Chennai which received ISO 17025:2005 accreditation from National Accreditation Board for Testing and Calibration Laboratories (NABL). To cater to the needs of customers at their doorstep, the company also launched Pipette Calibration on Call (PCoC), a mobile

pipette calibration facility.

The growth of the organisation continued with the acquisitions of New Brunswick Scientific and DASGIP by Eppendorf AG. Eppendorf belief in being a solution provider and the core values contribute to making customers appreciate Eppendorf as a global brand.

EP News Bureau-Mumbai

Govt support essential for growth of chemical industry: Lanxess MD Also recommends that India’s chemical industry should work towards improving its own perception anxess, a global specialty chemicals company and a leading player in the Indian chemical industry recently gave its perspective on the policy reforms need to revitalise investments in India's chemical industry. This was part of a discussion on the challenges faced by the industry at a recent conference held in Mumbai.

The theme for this conference was ‘Novel technologies and new markets – the opportunities and challenges for India’s fine and specialty chemicals industries.’ Dr Joerg

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DR JOERG STRASSBURGER, MANAGING DIRECTOR AND COUNTRY REPRESENTATIVE, LANXESS INDIA STATED THAT INDIA HAS THE POTENTIAL TO BUILD A $80 TO $100 BILLION SPECIALITY CHEMICAL INDUSTRY BY 2020 AND ASIA PACIFIC REGION NOW FORMS NEARLY 42 PER CENT OF THE GLOBAL MARKET FOR CHEMICALS 36

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Strassburger, Managing Director and Country Representative, Lanxess India represented the industry’s problems and solutions and recommended some possible solutions.

At the outset, Rajeev Pandia, an industry veteran and the moderator for the opening panel congratulated Strassburger, for building a strong case for the Indian chemical industry by not only establishing a successful business in India but by expressing his views on the operating environment for chemical businesses in India.

Strassburger stated that India has the potential to build a $80 to $100 billion speciality chemical industry by 2020 and Asia Pacific region now forms nearly 42 per cent of the global market for chemicals, clearly making it the largest contributor. The strong domestic demand will be supported by the rising middle class household consumption, increase in discretionary spending by middle-class households and buoyant exports. This further implies that India can leverage this shift in speciality chemical landscape.

Addressing the challenges that can deter the growth of the chemical industry in India, Strassburger made some www.expresspharmaonline.com

strong recommendations to improve logistics and infrastructure support for chemical plants, to accelerate the implementation of PCPIRs (Petroleum, Chemicals and Petrochemicals Investment Region) and to enhance the competitiveness of the Indian chemical industry.

He underlined that that government support in terms of improvement in infrastructure like road, rail and land availability; introduction of favorable policies to attract investment, to attract key raw material suppliers and anchor investors in PCPIRs; and in increasing the speed of implementation of different projects, for example, through single window clearance, is quintessential for the growth of the chemical industry.

On the other hand, Strassburger also prescribed that the industry needs to take some pro-active steps in improving its own perception and it is very important that the chemical companies act responsibly towards people and environment. He added that the jobs in this industry should be made more lucrative for the right talent. “India is undoubtedly one of the large potential markets in Asia which is not yet fully leveraged. Nevertheless the indus-

try needs to consciously contribute towards changing its image by practice rather than preaching”, concluded Strassburger, strongly encouraging the industry to leverage its full potential.

The audience and panelists resonated the views of Strassburger about the industry and agreed with him on the corrective actions required. Other speakers in the opening panel included Dilip Chandwani, Vice President, Manufacturing Competitiveness and Technology & Manufacturing Economic Practice, Kline & Company US and Manish Panchal, Practice Head Chemical, Life Science & Energy Industries, Tata Strategic Management Group.

Around 150 delegates from different areas of the chemical industry attended the conference.

As a leading speciality chemicals company with sales of ¤9.1 billion in 2012, Lanxess has roughly 17,200 employees in 31 countries, with 49 production sites worldwide. The core business of Lanxess is the development, manufacturing and marketing of plastics, rubber, intermediates and specialty chemicals.

EP News Bureau-Mumbai May 1-15, 2013

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Waters Empower 3 goes mobile with new laboratory analytics capabilities New Empower release features tablet and smartphone accessibility and built-in analytics for critical system usage information aters Corporation unveiled mobile access and new laboratory analytics enhancements to its class- leading Empower 3 Chromatography Data Software.

These improvements are designed to ensure that scientists have wireless flexibility and can assess meaningful performance metrics regarding their laboratories.

Allowing users to monitor chromatography systems anywhere and anytime from their tablet or smartphone, the new Empower Mobile can be installed on an Empower Software network in either workgroup or enterprise configurations. Beyond mere convenience, mobile access allows scientists to

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easily find and share results remotely, expedite workflow for signoff on reports, and reduce sample and mobile phase waste.

Empower Mobile offers connectivity with Apple iPads, iPhones, Android tablets and smartphones.

The new Empower Laboratory Analytics capability assembles and displays critical chromatography performance data in easyto-view, graphical dashboards so that users can focus on what’s most important?the interpretation of key metric information, not its collection.

Dr Rohit Khanna, Vice President of WW Marketing and Informatics, Waters Division said, “To sum up the improvements to empower in one word, they are all about access.

Consistent with today’s laboratory practices, users can now access

empower information using popular wireless devices.

And the new analytics dashboards will provide scientists with streamlined access to important data to quickly and accurately determine laboratory efficiencies.”

The Empower Laboratory Analytics prebuilt dashboards provide system summaries, system usage, project usage analysis, user analysis and methods analysis. Examples of maximising system utilisation using Empower Laboratory Analytics includes identifying training needs, identifying error messages that affect your workflows, planning for capital expenditures, and identifying opportunities to shorten run times with ACQUITY UPLC technology.

Empower 3 Software, Waters’ chromatography data software (CDS), makes it easier than ever to run

chromatography samples and produce meaningful results without experiencing downtime for training, re-engineering workflow, or adding new software to support instruments or advanced chromatographic techniques.

Empower 3’s interface is designed to maximise productivity, improving how you collect, process and print chromatography data.

Capabilities include: Customisable data reports; integrated custom calculations; relational data so all your meta data is traceable back to the raw data; optimised workflow for different users and different analyses.

With enhanced 21 CFR Part 11 compliance capabilities, Empower 3 takes user’s ability to manage data integrity, advanced security features, and audit trails to new levels.

EP News Bureau-Mumbai

Merck Serono collaborates with BioMed X Innovation Center in Heidelberg, Germany Constitution of a new class of innovation model to leverage external resources to contribute to Merck Serono’s research efforts erck Serono, a division of Merck, Darmstadt, Germany, announced a collaboration to start innovation projects under the roof of an innovation centre operated by BioMed X. This new research laboratory will establish a new way of fostering innovation.

With the support of BioMed X, it will allow Merck Serono to run research projects with interdisciplinary project teams of young talented scientists, coached by a supervisor at Merck Serono and an experienced academic in an open-innovation laboratory facility in Heidelberg. The new innovation concept has been co-developed by Merck Serono and BioMed X. Top young talent from leading academic institutions world-wide will be selected through assessment centres based on their scientific expertise, creative energy, and

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passion for product-oriented pre-clinical research and development. Interdisciplinary project teams will collaborate with guidance of experienced mentors while expanding their scientific network and receiving an intensive entrepreneurship and leadership training.

The laboratory will be placed at a global innovation hotspot, the life science campus of the

funded by Merck Serono. The project teams will work on new approaches for the therapy of cancer. Further details of the agreement and financial terms were not disclosed.

“Our goal is to seed and boost early stage research projects by placing them into a vibrant environment, bringing in top young talent to work at the interface between industry

MERCK SERONO WILL RUN ITS OWN RESEARCH PROJECTS IN THE BIOMEDICAL RESEARCH LAB IN HEIDELBERG OPERATED BY BIOMED X University of Heidelberg, providing access to a broad academic network and a creative environment.

Under the terms of the agreement, Merck Serono will run its own research projects in the biomedical research lab in Heidelberg operated by BioMed X. The projects will be www.expresspharmaonline.com

and academia in one of the top European research hubs in Heidelberg. We expect this concept can result in a constant flow of innovative projects and creative talent into Merck Serono,” said Bernhard Kirschbaum, Head of Global Research and Early Development at

Merck Serono.

Merck Serono is committed to providing guidance and coaching and to ensuring the highest industry quality standards.

Furthermore, participants will have access to Merck Serono’s technical expertise and research infrastructure.

In addition to operating the innovation centre, BioMed X will be responsible for worldwide recruiting of young talents, providing education to teams and securing access to academic research infrastructure in Heidelberg.

Christian Tidona, Founder and Managing Director, BioMed X said, “I believe forming teams of top life science talents from around the world and providing experienced mentors from academia and industry is a critical step to success. Our strength lies in embedding these teams in a strong local network and leveraging the opportunities of an innovation hotspot such as Heidelberg."

EP News Bureau-Mumbai EXPRESS PHARMA

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Spinchrom Life Sciences to market BLItz platform from Pall India The platform is an offering from ForteBio Division of Pall India and it enables label-free analyses of proteins using small sample volumes, easily and cost-efficiently all India has entered into an exclusive India distribution agreement with a biosupplier, Spinchrom Life Sciences, a division of Spinco Biotech. Through the agreement, Spinchrom will become the exclusive distributor to market in India ForteBio’s BLItz system, a platform that enables scientists to conduct label-free analyses of proteins using small sample volumes, easily and cost-efficiently at their laboratory bench.

ForteBio is a division of Pall Life Sciences and a leading supplier of label-free technolo-

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gy that accelerates the development of biotherapeutic and pharma products.

The BLItz system is small — taking up less surface area than a tablet personal computer — so it can fit easily in an individual scientist’s workspace. It is simple to use and requires only four microliters of sample — 15 to 20 times less volume than needed for traditional, surface plasmon resonance (SPR)-based labelfree assays or microplatebased ELISA assays. The BLItz system is designed for any researcher working with proteins, particularly those who analyse column fractions, monitor protein expression, perform reagent QC, identify mechanism of action and signaling and run protein engineering studies. Additionally,

the BLItz system’s Dip and Read assays utilise disposable, ready-to-use biosensors that provide results in seconds to minutes.

“Given the growing biosimilar and proteomic activity in India, scientists’ ability to understand protein interactions is increasingly a key success factor. The BLItz technology offers great value by means of a very cost-effective, simple and fast technology platform,” says Sachin Indane, Director – BioPharm, Pall India. “The BLItz platform will revolutionise the use of label-free protein analysis here by making it more accessible than ever to individual bench scientists and this will help to further advance biotherapeutic development in India.”

The BLItz system utilises the Bio-Layer Interferometry (BLI) technology that powers ForteBio’s flagship Octet instrumentation platform, which enables real-time kinetics, affinity and quantitation measurements in highthroughput applications, with ease of use and cost-efficiency.

“We are excited about teaming with Pall. This partnership enables us to position the innovative BLItz label-free protein analysis technology as a complementary tool to our existing proteomics portfolio thereby offering customers comprehensive solutions for protein characterisation and interaction studies,” says C Ravindranath, Managing Director, Spinco Group of Companies.

EP News Bureau-Mumbai

Sigma-Aldrich launches Vetec Brand in India New brand brings Sigma-Aldrich reliability to reagents for everyday use igma-Aldrich Corporation, a leading life science and high technology company, has introduced its new Vetec brand product line in India.

The Vetec portfolio is aimed at meeting the everyday needs of scientists in India and consists of a growing collection of over 400 reliable-quality laboratory reagents, competitively

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priced to enable their use in routine research. Vetec products are thoroughly tested to ensure that they meet SigmaAldrich quality control standards for integrity, consistency and reliability and come with Certificates of Analysis, MSDS information and spec sheets.

Vetec, backed by SigmaAldrich’s industry-leading quality and supply chain excellence, offers customers a strong alternative to the

brands that currently serve India’s 'everyday' research market and includes solvents, buffers, carbohydrates, detergents, inorganic salts and synthetic reagents.

The brand is aimed at providing reliable, easy-to-order, readily available products for everyday laboratory use.

“Sigma-Aldrich has been conducting business in India for more than 20 years. Our success will continue to be based upon our capabilities

and the ability to customise our offer to meet the demands of the local market,” said Jason Apter, Vice President and Managing Director, Asia Pacific. “In October, 2012, the Vetec brand was introduced in China. Its launch in India, and subsequently into other countries in the Asia Pacific region supports our company’s strategy of ‘international localisation’.”

EP News Bureau-Mumbai

GMP Technical Solutions conducts seminars on flexible containment technology Speakers emphasised efficiencies of these technologies MP Technical Solutions had organised full day seminars on flexible containment technology in different parts of India for their clients

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from the pharma industry on April 3-4. The main objective of the seminars was to introduce the most critical sector of the market with the efficient technology of flexible containment which has many advantages over old technologies.

This technology is relatively new to the pharma industry and is expected to grow exponentially in coming years.

Scott Patterson, Vice President Commercial Sales from ILC Dover was the eminent speaker for the seminar.

He specialises in flexible high containment for pharma and bio-pharm processes and enlightened seminar attendees about the advantages of this technology for their different process in manufacturing, R&D, and QC/QA for pharma industry.

Mohit Kumar, Head www.expresspharmaonline.com

Engineering and Projects, Ranbaxy, graced the occasion as the Chief Guest for the Mumbai seminar. In his inaugural speech he put more emphasis on the current market scenario and the future market condition which will impact the pharma industry.

Emphasising the role which containment solutions will play in this field in coming years, he encouraged seminar attendees with his exceptional informative views on the technology.

The seminar addressed issues and queries about flexible isolators, efficient powder charging and discharging systems etc. Informative videos on how to operate these new products were shown. GMP also had live demonstrations of flexible isolators, new crimp technology and powder charg-

ing and discharging bags.

All the participants from different fields of top pharma companies exchanged their views about flexible containment technology and found the seminar very informative.

They have been searching for this solution for their respective processes. The interaction between GMP representatives and the participants was remarkable.

The seminar witnessed a good turnout of participants and the session was quite intriguing. Having introduced ILC and its products in India, GMP Technical Solutions now looks forward to establish itself as the leading solutions provider of flexible containment solutions and PAPRs in the Indian subcontinent.

EP News Bureau-Mumbai May 1-15, 2013

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G Silicone & Viton Sheets

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Express Pharma Business Avenues World Class Bottle Packaging line solution from Countec, Korea New!!! 200 Bottles/minute Tablet-Capsule Bottle Packaging Line

Twice the speed, half the space!!!

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Our range of packaging systems include 60BPM, 120BPM & 200BPM container packing line · ·

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Express Pharma Business Avenues WE PUT SOME OF THE RAREST THINGS IN OUR MACHINES. AN EYE FOR DETAILS, FOR INSTANCE.

We, at Promas, believe that excellence is just a sum of several small but great efforts. That's why, we make sure that we follow stringent quality standards at every stage of production.

We are an ISO 9001 : 2008 certified company and our products are designated GMP/USFDA compliant (with CE markings) and Defence Acceptable. Not to forget, the faith and trust of hundreds of our esteemed customers that have come our way.

• More than 20 equipment designs under Vacuum Drying, Blending, Processing and Explosive Product Blending category for Food, Pharmaceutical and Explosive Product Industries.

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Reactor

We have expertise in - Jet Mill, Blenders and Mixers with Spraying arrangement, Planetary Mixer under Vacuum & Various Blade Designs, Sigma Mixers, Plough Shear Mixers, Ribbon Blenders, Distillation & Fractionation Columns, Agitators and Reactors.

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Tablet Grinder RM 200 ■ Mixing and homogenization of powders, tablets and pastes ■ Gentle grinding down to <10 microns, dry and wet ■ Ideal for the preparation of homeopathic medicine & tablets ■ Cryogenic grinding of frozen yeast cells ('noodles') possible ■ Mortars and pestles in 7 different materials ■ Easy to use and clean www.retsch.com/rm200 RETSCH INDIA PVT LTD, 1-2-45/1, 2nd Floor, Street No: 2, Kakatiya Nagar Colony, Habsiguda, 500 007 Hyderabad, India Phone: +91 40 2717 2431, Fax: +91 40 2715 4686 E-mail: info@retsch.co.in, Web: www.retsch.co.in

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START YOUR SECOND CAREER !!!

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1. Sub chronic oral Toxicity 2. Bacterial Mutation Assay.

3. Micro Nucleus test 4. Bone marrow chromosome aberration test.

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May 1-15, 2013

A Global Manager – Made in India with lessons from Japan Mohan Joshi, an independent Strategic Advisor for Global Alliances, gives an insight about how Japan should eye new emerging markets and how Indian managers should learn from Japan’s success stories ●

apan has amply demonstrated its lack of interest in the emerging markets of the world. Its focus has been on Japan, Europe and the US – the developed economies; its eyes always on the top rungs of the consumer pyramid. This strategy paid off for Japan in the Western world. But what it did not see coming was the sluggish growth in these markets.

Despite this, Japan turned a Nelson’s eye to the emerging markets (BRIC) – Brazil, Russia India and China. And as they would soon learn, they were in for shocks that devastated portions of their business world, like the tsunami of 2011.

Japanese companies led markets in the West – names like Hitachi, Panasonic, Sony, Toyota always won consumer confidence and respect. But in the emerging markets, they went somewhat cold. What did them in, in the emerging markets? Let’s go over the chinks in the armour of Japan’s management practices.

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The weak areas in Japanese management practices ●

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Using the one-size-fits-all model all over the world: Japan used the same high-end product model from their developed markets in emerging markets and failed miserably, unlike counterparts that used lowend models for the emerging markets and ended up as market leaders. Typical examples are the consumer electronics markets where Koreans (LG) lead and the automobile markets where Hyundai and Volkswagen lead the emerging markets with their competitive pricing model; whereas, the highend Panasonic and Toyota from Japan are struggling among the lower ranks in brand successes.

Going for a closed-fisted model of operations and human resources even in emerging markets: The Japanese do not invest in native human talent. They believe it is

May 1-15, 2013

●

in their best interests to keep all the top management positions to themselves. Local competency is doubted. This has led to situations where the Japanese do not know enough about native needs, wants, tradition and culture – strategies are thus masterminded with the seed of failure sown in its depths.

The Japanese companies are averse to mergers and acquisitions (M&A): Leveraging the equity of home-grown businesses in native markets is a good strategy for success; but the averseness of the Japanese to M&As puts them miles behind in the race to the top.

If they follow the Maruti-Suzuki example, they will succeed. Even today, after the Maruti and Suzuki split, Suzuki is doing well in India.

The credit goes to Suzuki’s strategy of partnering with a local Indian automobile company - Maruti, who knew the market, consumer behaviour and Indian culture like the back of its hand.

Lack of investment in new markets: Japanese companies have never taken investing in new markets seriously. As part of their global strategy, their presence is more often than not, restricted to having branches of Japanese companies outside Japan. Investing in fixed assets like land and plants in new markets has never been their cup of tea.

billion revenues by 2014-15.

Let’s now take a look at what has made the successful Japanese companies successful in the emerging markets. What are those management practices of the Japanese, the Indians and others can learn from?

What can Indian managers learn from Japan? ●

●

Japan is changing – seeing the emerging markets with new eyes Today, however, Japan is changing.

Companies there are learning from past mistakes and focusing on emerging markets with an open mind. There are Japanese companies like Unicharm, a personal care products company which leads in Indonesia, Thailand and China in diapers and Daikin, an air-conditioner manufacturer which is fast making inroads in the emerging markets of India and China.

Hitachi, Japan's largest industrial power and electronics conglomerate has formulated a 'India business strategy 2015' plan to make the country one of its top markets and has announced $800 million expansion plans that include building five manufacturing plants. Panasonic too has lined up more than $200 million investments in a new plant at Haryana and targets $4

●

Adherence to seniority: This point is better explained with the way Indians follow this practice. The Indians too demonstrate respect for seniority with a regard for age and designation. But what is missing is teamwork. Whereas, the Japanese respect seniority and adhere to it completely by following it up with total teamwork. In Japan, individual contribution does not count; it is always the teamwork that counts. In India, it is exactly the opposite. E.g.: An American delegation had gone to a Japanese company in Japan. There was a Japanese girl co-coordinating and arranging meetings etc. for three to four days that the delegation was there. The Americans were happy with her work and at the end of the meeting publicly acknowledged her contribution. It led to a very embarrassing situation, as in Japan, it is always teamwork that gets recognised and no one publicly acknowledges individual contribution.

A decision once taken is abided by: The Japanese are known for the long periods taken for decision making. But a decision once taken is always abided by every person involved or affected. On the contrary, Indians also take a long time for decision-making, but there is no guarantee that the decision thus taken may not be challenged – Indians may challenge the decision taken at any point in time just to prove a point or establish their individuality.

Total commitment to a cause /company/work: The Japanese are a committed lot. Whether it’s a cause, work or their company or their country, they are totally committed and go about their duty with 100 per cent attention not leaving any gaps in performance.

This is best explained with two examples. E.g: Outside Tokyo Metro Station; below the escalator,

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you will find senior citizens, retired Japanese people, who ask you to watch your step just as you get off the escalator. They look in your eyes and voice the same lines to each and every person with equal interest and concern. Such is their commitment. Whereas, if we got Indians in their place, you would find them talking with their friends on phone or listening to music while going about their task. If you got the Germans here, they would automate the whole exercise, so that there is no need of any human interface anywhere. What we can learn from the Japanese is that given a job, they will deliver it to their best, whatever the level of difficulty or trouble. ● Polite communication: For the Japanese, silence is the new language of communication.

A Japanese manager will not immediately voice his opinion, views or decision. He will take his time and till then remain silent.

What he is really saying is, “I am thinking, give me some time to think it over.” Whatever the decision, however, unpleasant to any party, the Japanese will never ever lose their polite demeanor, unlike the Germans who prefer to say a blunt ‘No’.

Japan has been improvising on its weak areas and Japanese businesses and managers are learning from past failures; they are looking at the Asian tigers and other emerging markets with new eyes.

Now it’s the turn of the Indian managers to learn from Japan’s success stories, to imbibe the good management practices, improve the weak areas and truly ready themselves to take on the mantle of a Global Manager.

The author can be contacted at mohan.joshi@global-alliances.in EXPRESS PHARMA

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AWARDS AmeriCares India Spirit of Humanity Awards 2013 held in Mumbai Recognises NGOs under six categories

he fourth edition of the AmeriCares India Spirit of Humanity Awards 2013 was recently held in Mumbai. This year a total of 22 NGOs were shortlisted across the six categories; Child Nutrition, Infections, Jury's Choice, Neurology, Oncology Service and Women's Health. The Chief Guest for the awards function was Suresh Shetty, Health Minister, Maharashtra.

Gram Chetna Kendra received the award in Child Nutrition category, followed

by TB Alert India in

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Infections Category; Udaan For the Disabled in Neurology/Mental Health; RM Pain & Palliative Care trust in Oncology Service; Fluorosis Research & Rural Development Foundation in Women's Health Category and Magic Bus India Foundation in Jury's Choice category.

Entries were invited in October 2012, where over 200 NGOs sent their entries for the six categories.

Nominations were open to Indian individuals (adults) and Organisations (regis-

tered since at least three years). Screening of all nominations received was done by screening committee members which consisted of experts from fields including healthcare, social sector etc.

All the 22 shortlisted nominees made an oral presentation to an eightmember jury consisting of eminent people from different sections of the society.

Jury members included Hasit Joshipura, Managing Director, GlaxoSmithKline and Anil Matai, Chief

Executive Officer, Novartis, amongst others. The entire process was supervised by KPMG, the Knowledge partner. After the presentations, all the nominees interacted with each other and with the jury members.

The winners were given a cheque of Rs one lakh, a trophy and a certificate.

The Child Nutrition category award was supported by Abbott Nutrition, the Oncology Service by Novartis Oncology, and the Jury’s Choice by ICON. EP News Bureau-Mumbai

Jubilant Life Sciences receives 'NDTV Profit Business Leadership Award 2012' Awarded under Corporate Social Responsibility category ubilant Life Sciences has received ‘NDTV Profit Business Leadership Award 2012’ in the category of ‘Corporate Social Responsibility’ at a recently held award ceremony. On behalf of the company, Shyam S Bhartia, Chairman and Managing Director, Jubilant Life Sciences received the award from Chief Guest Dr Montek Singh Ahluwalia, Deputy Chairman, Planning Commission, Government of India.

Speaking on the development, Shyam S Bhartia and Hari S Bhartia, Co-Chairman and Managing Director said,

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“We are delighted to receive this award, Corporate Social Responsibility is an integral part of how we conduct our www.expresspharmaonline.com

business. Our efforts are directed towards empowering communities, we believe that for sustainable social inter-

vention, the people themselves would have to be the drivers. We focus on community development through intervention in primary education, basic healthcare service, and livelihood generation programmes targeted on improving the employability of women and local youth.”

The social initiatives of the company are carried out under the aegis of Jubilant Bhartia Foundation (JBF). The foundation follow 4P model (Public-PrivatePeople-Partnership) and it covers 65 villages in India, educating over 13,500 children, providing basic healthcare to 350,000 people and training up to 2500 youth every year.

EP News Bureau-Mumbai May 1-15, 2013

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Eisai India wins CII Excellence Award for EHS Visakhapatnam facility ranked best under pharma-food-refinery, as well as amongst Medium Scale Industries isai Pharmatechnology & Manufacturing, Visakhapatnam (Eisai) has been awarded the prestigious Environment, Health, and Safety (EHS) Excellence 2012 Award by the Confederation of Indian Industry (CII) Southern Region. Eisai is a 100 per cent subsidiary of Eisai Japan, which ranks among the top 25 pharmaceutical companies in the world by revenue.

The Eisai facility at Visakhapatnam was ranked best under the pharma-foodrefinery sector. It also bagged the top honour amongst the Medium Scale Industries.

More than 100 companies participated in the award competition. CII auditors made an on-site assessment of all the participating companies and evaluated their EHS systems and practices on about 150 parameters.

The aim of this award is to recognise, motivate, facilitate

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and acknowledge extraordinary contribution by organisations to adopt excellent practices in environment, health and safety.

On receiving the award, Sanjit Singh Lamba, Managing Director of the company said, “Achieving the CII recognition within three years of commencement of operations validates the company’s sound EHS systems, work culture, and practices. It inspires us to strive harder for sustained excellence”. Eisai's corporate human health care (hhc) mission is to give first thought to patients and their families, and to increase the benefits that healthcare provides. The company believes that increasing patient satisfaction through the development of innovative new medicines exemplifies its important mission, he added.

In line with its human health care (hhc) mission, EISAI is committed to improving global access to medicines over medium to long-term through partnership strategies that involve working with governments,

(L to R) K Srinivas Rao, Deputy Manager, EISAI; Anand Galphade, Deputy General Manager, EISAI; Sunil Kumar, Vice President Operations, EISAI receiving the award from CII international organisations, private entities and non-profit organisations.

The Visakhapatnam plant is central to EISAI’s efforts to supply its offpatent medicines at affordable prices to patients in India as well as across the developing world. Production at Visakhapatnam, which is cost-competitive and high quality, helps EISAI expand access to medicines in developing countries. The

company is also committed to supply 2.2 billion tablets of DEC (Diethylcarbamazine) free of charge to the World Health Organization (WHO).

The medicine, essential for elimination of the neglected tropical disease lymphatic filariasis, will be manufactured at Visakhapatnam for free supply to 250 million people in developing countries around the world through WHO. EP News Bureau-Mumbai

Dr Suresh Bandari, Principal, St Peter's Institute of Pharmaceutical Sciences receives award Award was bestowed for his research contribution in the area of improvement of bioavailability for poorly soluble drugs and his achievements r Suresh Bandari, Principal, St Peter's Institute of Pharmaceutical Sciences, Hanamkonda, Warangal, Andhra Pradesh,

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has received the Association of Pharmacy Professionals (APP) Young Scientist Award2013 at APP 2nd Annual National Convention, at SSDJ College of Pharmacy, Chandwad, Nashik, Maharashtra. On this occasion he delivered an invited

lecture on 'Enhancement of Bioavailability—The Key Issue in Formulation Development.'

The young scientist award was bestowed up on him for his research contribution in the area of improvement of bioavailability for poorly solu-

ble drugs and his achievements. Bandari, recipient of a National Doctoral Fellowship from AICTE for his doctoral studies, had one patent and 35 publications in national and international journals to his credit.

EP News Bureau-Mumbai

APPOINTMENT Peder Holk Nielsen is new President and CEO of Novozymes Taken over as CEO from Steen Riisgaard eder Holk Nielsen has been appointed as the President and Chief Executive Officer, Novozymes. “I am proud and honoured to lead this great company forward,” says Nielsen. “Novozymes is in a very strong position, and we will continue with our over-

P May 1-15, 2013

all strategy. Our success rests on our ability to bring new innovation to our customers, and our ability to find new ways in which biotechnology can help them improve their products and make more with less. A key focus for me will be to make sure we bring these innovations to the market even faster than we do today,” he added. www.expresspharmaonline.com

Nielsen has played a central role in the development of Novozymes in its current form. His 28-year career in Novozymes and Novo Industri/Novo Nordisk spans management positions across business development, research and development, quality management and sales and marketing. Up until his appointment as Chief

Executive Officer, he served as Executive Vice President and Head of Enzyme Business from 2007-2013.

Peder Holk Nielsen takes over as CEO from Steen Riisgaard, who steps down after 12 years in the company’s top post and 33 years in Novozymes and Novo Industri/ Novo Nordisk..

EP News Bureau-Mumbai EXPRESS PHARMA

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P|H|A|R|M|A| L|I|F|E

JOB TRENDS Hiring sentiments remain upbeat in pharma sector Hiring activity up by 14 per cent in March 13’ over Feb 13’ he pharmaceutical sector is likely to drive the hiring growth in 2013. The sector has emerged as a powerful employer with the hiring activity being up by

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ter than what it was an year ago.

According to the Naukri Job Speak the index value of the sector has also been the highest in the last one year.

growth while outperforming its competitors in every sphere. Info Edge was the first Internet company to list in India. The site enjoys a traffic share of around 61 per cent as per the Sept

products like Resume Database Access, and Response Management tools and its services include job postings, and recruiter branding solutions on the site.

The site has a database of over 29 mil-

The Naukri job speak index for the pharma sector is a monthly report that indicates hiring trends across industry sectors, geographies and functional areas 14 per cent in March 13’ over Feb 13’. Although the overall hiring sentiment is reflecting a cautious hiring scenario, the pharma sector has grown remarkably well with its hiring activity being 36 per cent bet-

About Naukri.com Naukri.com, India’s No. 1 job site and the flagship brand of Info Edge revolutionised the concept of recruitment in India. Since its inception in 1997, Naukri.com has seen continued

Comscore data.

Naukri.com is a recruitment platform that provides hiring-related services to corporates/recruiters, placement agencies and to job seekers in India and overseas. It offers multiple

lion resumes and has serviced over 46000 clients in FY-2012. The company has over 2000 people operating through 48 offices in 31 cities in India and overseas offices in Dubai, Abu Dhabi, Riyadh and Bahrain.

Jobs from Naukri.com Various positions in product management. PMT Experience Mandatory

Clinical Data Programmer Company:

Company:

Cadila Pharmaceuticals Limited 5-10 Ahmedabad 080213002037

Exp: Location: Job Id:

Exp: Location: Job Id:

Icon Clinical Research India Private Limited 2-7 Chennai 020413002368

Sr Manager - Engineering/ehs/admin & Facility Company: Exp: Location: Job Id:

Albany Molecular Research, Inc 10-12 Hyderabad/Secunderabad 020413001509

Assistant Manager - IT Electrician-maintenance Company:

Nitika Pharmaceutical Specialties Pvt Ltd. 0-5 Nagpur 020413000905

Exp: Location: Job Id:

Manager Legal Company: Exp: Location: Job Id:

Nagarjuna Agrichem Limited 10-15 Hyderabad/Secunderabad 080113000229

Company: Exp: Location: Job Id:

Biocon Limited 6-10 Bengaluru/Bangalore 010413002387

Relationship Executive Company: Exp: Location: Job Id:

Lifecell International Private Ltd 0-2 Mumbai 280313002227

Management Trainee

Scientific Editor, Editor, Copy Editor, Content Editor Company: Exp: Location: Job Id:

Indegene LifeSystems Pvt Ltd 1-5 Bengaluru/Bangalore 020413001671

Medical Writer I/ II Company: Exp: Location: Job Id:

inVentiv International Pharma Services Pvt. Ltd 3-5 Gurgaon 040313000677

Dataware housing Architect Company: Exp: Location:

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EXPRESS PHARMA

UnitedHealth Group 5-8 Hyderabad/Secunderabad

Company: Exp: Location: Job Id:

Strides Arcolab Ltd. 0-2 Mumbai 020413001579

www.expresspharmaonline.com

May 1-15, 2013

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