Express Pharma February 16-28, 2014

VOL .9 NO.8 PAGES 90

www.expresspharmaonline.com

Cover Story: HR Special Quest for talent

Management Wish list of policy changes Pharma Technology Review Need of polymers for solubility enhancement 16-28 FEBRUARY 2014,` 40

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CONTENTS MARKET Vol 9 No.8 FEBRUARY 16-28, 2014

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

WISH LIST

OF POLICY CHANGES

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

With the general elections around the corner, the Finance Minister will present a 'Vote of Accounts' rather than a budget. Express Pharma presents top points from the industry’s wishlist

12

‘ACRO AGENDA IS TO MINIMISE HEADWIND, TAKE ADVANTAGE OF TAILWIND’

14

BUYOUTS TO INCREASE IN CONSUMER, PHARMA, TECH SECTORS IN 2014: KPMG’S M&A PREDICTOR

17

PHARMA EXPORTS TO OVERTAKE DOMESTIC SALES IN FY15: IND-RA

Senior Graphic Designer Rushikesh Konka Layout Rakesh Sharma Photo Editor Sandeep Patil MARKETING Deputy General Manager Harit Mohanty Senior Manager Rajesh Bhatkal PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Rohan Thakkar CIRCULATION Circulation Team Mohan Varadkar

P54: CLINICAL UPDATE NCI launches trial to assess the utility of genetic sequencing to improve patient outcomes

MANAGEMENT

40

‘ENDORSEMENT OF BILL OF ENTRY SHOULD BE RESTARTED AS LOAN LICENSES ARE VERY COMMON IN PHARMA INDUSTRY’

41

‘CREATE RARE DISEASE PATIENTS REGISTRIES BY LINKING ALL INSTITUTIONS’

P58: INSIGHT Need of polymers for solubility enhancement

P60: PTR INTERVIEW ‘We designed our software to wrap around practically any third party instruments’

P84: AWARD KBITS, Govt. of Karnataka announces Bio-Accelerate winners

44

25

ICONIC 2014 FOCUSES ON COPD

TURN TO PAGE 13 TO FIND SPECIAL DEALS

‘THE GOVT SHOULD COME UP WITH SAFE HARBOUR RULES’

Express Pharma Reg. No.MH/MR/SOUTH-77/2013-15, RNI Regn. No.MAHENG/2005/21398. Printed for the proprietors, The Indian Express Limited by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright @ 2011. The Indian Express Ltd. All rights reserved throughout the world.

Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

EDITOR’S NOTE

Recruiting right

B

logging about her recent trip to India, Margaret Hamburg,

However, it’s not just about installing more

Commissioner of the US Food

up-to-date technology and training personnel

and Drug Administration (FDA)

to maintain protocols. Reports are that some of

spoke about the signing of

Ranbaxy’s manufacturing goof ups were caused

reportedly the first-ever Statement of Intent

by disgruntled staff who had been offered a

between her agency and India’s Ministry of Health

voluntary retirement scheme (VRS). The VRS

and Family (MoHFW). The statement is about the two agencies collectively working to improve the lines of communication between them. Here’s hoping that the statement goes beyond being a mere photo op.

The US FDA Commissioner also rues, “many Indian companies that understand good manufacturing and quality processes have been overshadowed by recent lapses in quality at a handful of pharmaceutical firms.” While this statement could be seen as conciliatory, it did not prevent her from rejecting Ranbaxy’s plea to be allowed to export

Coping with the ever evolving industry, HR will have to strategise to identify, recruit and engage with Generation Y. Recruiting right has never been so crucial as today

was part of the company’s attempt to lay off staff and obviously this did not go down well.

Zydus Cadila also faced the backlash of a similar move to reduce headcount when workers went on strike recently.

Managements of global pharma companies are cutting some kinds of jobs while hiring for others.

We decided to chart out these hiring strategies in a special HR-focused issue. So while the cover story highlights the hike in hiring (Hike in pharma hiring on the cards; pages 26-29) the other stories deal with the challenges faced by HR and employees (Time to

from red-flagged facilities while they corrected

get proactive, pages 30-31) as well as the role of

manufacturing lapses.

associations and industry lobby groups (Nurturing

Accompanied by Nancy Powell, US Ambas-

the industry; pages 32-34). The irony is that while we

sador to India, Hamburg’s visit is to underline

have a decent sized talent pool, most professionals

the seriousness of the stress on quality while

are not industry ready. Coping with the ever evolving

acknowledging that “as two of the largest democra-

industry, HR will have to strategise to identify, re-

cies in the world, our countries have enjoyed

cruit and engage with Generation Y. Similarly, GenY

an enduring partnership and commitment to

will have to continuously evolve so that

collaborate on initiatives designed to enhance both

their skill sets remain relevant. Recruiting right has

our economies and the lives of the people in our

never been so crucial as today.

respective countries.” Diplomacy will have its day but manufacturers of medicines will have to

10

upgrade their facilities to meet these norms.

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February 16-28, 2014

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET I N T E R V I E W

‘ACRO agenda is to minimise headwind, take advantage of tailwind’ DA Prasanna, Founder Chairman, Ecron Acunova has taken over as the Chairman of Association of Contract Research Organizations (ACRO INDIA) at a time when the Indian CRO industry is facing multiple challenges. He plans to strengthen the industry base and create healthy interactions with the DCGI and Ministry of Health (MoH). He reveals more details of his strategies to Usha Sharma

Your appointment as the ACRO Chairman comes at a juncture when the Indian CRO industry is facing tough times. How will the current scenario increase your responsibilities?

It is true that the CRO industry in India is facing challenges from multiple fronts.

Global clinical trials have dried up in India, from 500 approvals in 2010 to less than 50 approvals in 2013. Strictures of US FDA on Ranbaxy and Wockhardt is largely focused on GMP compliance in manufacturing. The overall image of Indian CRO services has suffered.

On the other hand, there are positive aspects in the environment for clinical research.

These include outsourcing of back office in PV/safety services, clinical data management (CDM) which continue to enjoy healthy demand. ITES companies benefit more than CROs. There is also a new demand for remote monitoring of global sites from India.

Indian companies do have new chemical entities (NCE), new biological entities (NBE), new cell therapies, new medical devices in the pipeline and these have shown ways for them to grow. Registration in

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February 16-28, 2014

the Indian market will be the key for these products.

Similarly, biosimilars from Biocon, Zydus Cadila, Amneal Pharmaceutical etc. are all keen to launch biosimilars in the Indian market.

Another growth driver is the fact that generic companies are racing against the July 2014 deadline for ANDA filing. So also, they are differentiating with clinical benefits under 505 b (2) pathway. And since demonstration of benefits needs clinical studies, this will be a growth driver for the CRO industry.

What agenda have you set and how will you accomplish it during your tenure ?

ACRO’s agenda is to minimise headwind and take advantage of tailwind!

Due to various factors, the total number of clinical trials conducted in India have declined and some of them have shifted to other countries as well. How will your experience assist in stabilising the industry's position?

Root cause of headwinds is the concern raised by NGOs that attention is not given to patient safety in clinical trials and

There is uncertainty on the time it takes to get approval of applications from MoH, holding meetings of the New Drug Advisory Committees

the regulator (and the Ministry of Health and Family Welfare) is not taking adequate steps. Inadequate response by stakeholders and government forced NGOs to go to the media and litigate through PIL in the Supreme Court. This resulted in global clinical trials coming to a halt, the Ministry of Health (MoH) and Drug Controller General (India) (DCGI) reacting with very stringent regulation and global pharma companies backing out of India due to uncertainty. There is uncertainty on the time it takes to get approval of applications from MoH, holding meetings of the New Drug Advisory Committees (NDAC). Also, the rules related to compensation of clinical trial injury and medical management are onerous.

While officials agree (on this point), they have not changed the onerous rules.

Which will be your top five priorities and why? a) Demonstrate that CRO services are delivered with highest attention to patient safety. Reduce the trust deficit related to patient safety with NGOs and media. And changes related to the clinical research regulations should be in line

with uplifting the industry responsibly without disturbing the growth of the industry. b) Actively engage with DCGI, MoH and Parliamentary Advisory Committee on health, to ensure that uncertainties are reduced on timeliness and NDAC meetings.

Ensure that the New Drugs and Cosmetic Act enables sound decision making and is passed soon.

C) Instill global best practices in Indian CRO service, to deliver highly credible research data to regulators under safe conduct of clinical studies. d) Based on actions in the above three areas, improve the image of Indian clinical research among national and global stakeholders. e) Ensure that the interests of ACRO is aligned to Indian pharma, biotech and device companies and increase co-operation for a better clinical research environment in India.

What new programmes/initiatives are you planning to roll out for the CRO industry's brand building globally?

Brand can be built when we take action. ACRO has been

working quietly in the last few months and a few actions are revealed below. ● Patient safety: We have worked with global insurance companies to cover new compensation risks in a new policy.

This will prove to be helpful to all stakeholders. We have shared with members, a CRO’s best practices to identify patient risk, fire and electrical risks and how to mitigate them.

These would improve India's pharmacology units to highest global safety standards. We have set up a national database and software to prevent cross participation in studies, improve safety. These are a few initial steps. ● Advocacy: With quality time

There are positive aspects in the environment for clinical research.

These include outsourcing of back office in PV/safety services, clinical data management which continue to enjoy healthy demand given by Health Secretary, DCGI and MPs to our problem, we contributed to DCGI publishing timelines for decision on 18 types of applications.

Now DCGI’s timeline for decision on global clinical trial application is 180 days and BE NOC is 45 days! The timetable for NDAC meetings in 2014 is on the CDSCO website. This reduces uncertainty and is welcomed by all stakeholders. ● Best practice: First best

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February 16-28, 2014

practice seminar run by highly credible faculty from pharma companies and CRO leadership was held in Mumbai in January this year. There is more to come. ● Improving image: We plan to publish a quarterly newslet-

ter and distribute it amongst stakeholders. The ACRO website is being transformed into a clinical research portal. As we do more work, we will engage communication channels. ● Co-operation: We plan to work closely with IPA, ABLE

and Pharmexcil to promote India in the clinical research arena.

Tell us about your mission and vision for uplifting the Indian CRO industry.

Our mission and vision is:

responsible clinical research with high attention to patient safety, delivering credible data to regulators and helping to bring new medicines to patients fast. u.sharma@expressindia.com

MARKET COMPANY WATCH

Buyouts to increase in consumer,pharma,tech sectors in 2014: KPMG’s M&APredictor As Indian economy shows signs of bottoming out, analysts expect 2014 to be a much better year with increased M&A sentiment

KPMG’S LATEST Global M&A Predictor, a forwardlooking tool that helps member firm clients to forecast worldwide trends in mergers and acquisitions, shows that healthcare has consistently been one of the strongest sectors for analyst predictions in recent times, and these positive expectations show no signs of diminishing.

With regard to private equity trends in India for 2014, Ashok Mittal, Head-Corporate Finance, KPMG in India says, “With regard to PE investments, whilst the IPO market remains uncertain, secondaries will continue, especially in attractive industries. We are also seeing an increasing trend of buyout transactions, especially in industries where there is good professional talent available such as consumer, pharma, technology.”

Analysing the year gone by, Mittal said, “2013 will be remembered as yet another challenging year for M&A activity in India. A slowing domestic economy, high interest rate environment, lack of progress on much needed reforms and a volatile Indian rupee resulted in depressed M&A sentiment. Having said that, we are beginning to see more traction and interest in the last quarter and expect that 2014 will be a much better year.

The Indian economy is showing signs of bottoming out in terms of growth and that, with increased stability in the global economy, will drive up M&A sentiment.”

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KPMG’s latest Global M&A Predictor predicted forward P/E ratios for healthcare companies rose 24 per cent over the year, followed by industrials (23 per cent) and technology (22 per cent). In terms of capacity, healthcare again leads the way with a predicted rise in capacity of 45 per cent over the next 12 months, as measured by the forecast net debt to earnings before tax, depreciation and amortization (EBITDA) ratios.

The Predictor looks at the appetite and capacity for M&A deals by tracking and projecting important indicators 12 months forward. The rise or fall of forward P/E (price/earnings) ratios offers a good guide to the overall market confidence, while net debt to EBITDA ratios help gauge the capacity of companies to fund future acquisitions.

Across sectors, analysts expect the world’s largest corporates to show a greater appetite for M&A transactions in 2014 than they did last year, according to KPMG International’s latest Global M&A Predictor. Predicted forward P/E ratios, a measure of confidence or appetite, were 16 per cent higher in December 2013 than they were 12 months earlier and an increase of 17 per cent since June. The rise in confidence was mirrored by an increase in share prices, with market capitalisations up 19 per cent over the year. However, the growing confidence is not reflected in transaction volumes or values, which continue to struggle.

Although overall market sentiment is undoubtedly positive, transaction levels have still not caught up.

From 30,945 deals in January 2013, the total number of completed deals fell to 27,194 in December, a drop of over 12 per cent Capacity continues to increase As well as an increase in confidence, analysts also expect corporates to have more capacity to undertake transactions during 2014 than previously, due to falling Net Debt to EBITDA ratios. These are expected to decline by 12 percent over the next 12 months, giving corporates more financial headroom for deal-making.

The US Federal Reserve’s end of year tapering of quantitative easing could have a temporary dampening effect, but overall the combination of growing capacity and rising confidence suggests a potential rise in transaction levels in 2014, as restless investors start to turn up the M&A pressure after several years of inactivity.

“The growing appetite for deals and an increase in pressure to transact are two sides of the same coin,” said Tom Franks, Global Head of Corporate Finance at KPMG International and a partner with the UK firm. “Investors have been patient over the last three or four years; but as deal capacity continues to rise and global markets maintain some stability, the pressure on cash-rich corporates to start deal-making again is going to intensify.”

Share prices benefit from rising confidence The pressure to transact is also reflected in the performance of share prices. Market capitalisations rose an impressive 19 percent between December 2012 and December 2013. This suggests that share prices are being buoyed by the increasing growth expectations of investors; expectations which are unlikely to be met from organic growth alone.

Analysts’ positive expectations were apparent right across the globe. In Europe and North America, forward P/E ratio expectations sky-rocketed 19 and 22 percent respectively between December 2012 and December 2013, along with

Africa and the Middle East which saw an increase of 19 percent since the first half of the year.

Deal volumes still fragile Although overall market sentiment is undoubtedly positive, transaction levels have still not caught up. From 30,945 deals in January 2013, the total number of completed deals fell to 27,194 in December, a drop of over 12 per cent. Deal values also declined, falling around seven per cent over the same period.

“Steadily increasing corporate confidence is still not being reflected in global transaction levels, and deal markets are continuing to struggle. However, this is against a background of a red hot IPO market in the UK and the US, and it will be interesting to see how the M&A situation changes during 2014,” said Franks.

The Predictor covers the world by sector and region. It is produced bi-annually, using data comprised from 1,000 of the largest companies in the world by market capitalisation.

The financial services and property sectors are excluded from our analysis, as net debt/EBITDA ratios are not considered relevant in these industries. All the raw data within the Predictor is sourced from S&P Capital IQ. Where possible, earnings and EBITDA data is on a pre-exceptionals basis with the exception of Japan, for which GAAP has been used.

EP News Bureau – Mumbai

MARKET

Venus Remedies receives Indonesian GMP certification for its Baddi unit The GMP approval will soon pave way for marketing authorisations from Indonesia; Venus expecting registrations for 10 oncology products in next two weeks VENUS REMEDIES has received good manufacturing practices (GMP) certification from Indonesia for its unit located in Baddi, Himachal Pradesh. The Indonesian National Agency for Drug and Food Control (NADFC) granted the certification after an extensive review and audit of the facility. With this, the number of international GMP certifications for Venus Remedies has gone up to 22.

The NADFC is among the drug regulatory authorities of 44 countries which are part of the Pharmaceutical Inspection Convention/Co-operation Scheme (PIC/S). Venus Remedies has already got GMP certification from three other PIC/S members, including Ukraine, TGAAustralia and European Union.

“A potentially lucrative market for our oncology product line, Indonesia records 170-190 new cancer cases annually in a population of every one lakh. We will commercially launch our products in Indonesia by the middle of this year and are projected to generate revenue of $1 million in the first year itself.

With the launch of our oncology products in Indonesia, we aim at capturing the maximum share in the country’s pharma market,” said Dheeraj Aggarwal, Chief Financial Officer, Venus Remedies.

Dr Manu Chaudhary, Joint Managing Director, Venus Remedies and Director, Research, Venus Medicine Research Centre, the R&D wing of Venus Remedies, said, “It is a matter of great pride for us that our tally of PIC/S GMP certifications has gone up to four. We are expecting registrations for our 10 oncology products in the next two weeks. This GMP approval will soon pave the way for marketing authorisations from Indonesia.”

EP News Bureau – Mumbai

EXPRESS PHARMA

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February 16-28, 2014

FULL ATTENTION TO THE TINIEST DETAIL. A big machine with some great details.

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

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

MARKET

Mylan launches first trastuzumab biosimilar, Hertraz,in India

Gilead names Mylan as exclusive branded medicines business partner for India

Its indicated for the treatment of HER2-positive metastatic breast cancer and is available in two strengths

Under the agreement, Mylan will market and distribute in India certain Gilead medications

MYLAN'S SUBSIDIARY, Mylan Pharmaceuticals, has launched trastuzumab biosimilar in India. The product, which will be marketed by Mylan under the brand name Hertraz, is a biosimilar to Roche's Herceptin. Hertraz is indicated for the treatment of HER2-positive metastatic breast cancer and is available in two strengths, 440 mg and 150 mg.

Heather Bresch, Chief Executive Officer, Mylan commented, “Mylan is excited to offer Hertraz to the thousands of women in India suffering from metastatic breast cancer who are in need of a high quality, more affordable treatment option. The launch of Hertraz not only represents a significant milestone in our biosimilars development programme with Biocon, but, more importantly, supports our mission to expand access to high quality medicine around the world and demonstrates our progress against one of Mylan’s key future growth drivers.”

GILEAD SCIENCES has named Mylan Pharmaceuticals, the Indian-based subsidiary of Mylan as its exclusive branded medicine business partner for India.

Under the agreement, Mylan will market and distribute in India certain Gilead medications: HIV therapies Viread (tenofovir disoproxil fumarate), Truvada (emtricitabine/tenofovir disoproxil fumarate) and the newer single tablet regimen Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) AmBisome (amphotericin B liposome for injection), a treatment for lifethreatening, systemic fungal infections, which is also used to treat the parasitic disease visceral leishmaniasis Viread for its indication as a treatment for chronic hepatitis B virus (HBV) infection.

Gilead has partnered with Mylan since 2006, granting the company rights to manu-

Trastuzumab is one of the five biologic products Mylan is developing in partnership with Biocon for the global market Rajiv Malik, President, Mylan added, “The launch of Hertraz is of particular significance as it represents both Mylan’s first biosimilar and the world’s first trastuzumab biosimilar. We look forward to expanding our portfolio of high quality and affordable biosimilar offerings, particularly in the oncology care segment, in India and around the world in the coming years.”

Hertraz was approved by the Drug Controller General (India).

In support of this approval, Mylan conducted an extensive series of physicochemical and functional assays to demonstrate similarity to the reference brand Herceptin. These analytical methodologies confirmed the high degree of molecular

similarity as well as biological activity of Hertraz. In addition, Mylan conducted a multi-centre clinical trial to demonstrate comparable safety and efficacy to the reference product.

Trastuzumab is one of the five biologic products Mylan is developing in partnership with Biocon for the global marketplace. Mylan has exclusive commercialisation rights for biosimilar trastuzumab in the US, Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries and co-exclusive commercialisation rights with Biocon for product in India.

EP News Bureau – Mumbai

facture and sell their own generic versions of licensed Gilead HIV therapies in India and up to 111 developing world countries where the HIV epidemic affects millions of individuals. Mylan will continue to maintain these rights, in addition to those in this new agreement.

“The appointment of Mylan as our branded medicine business partner in India is a result of their strong knowledge of the Indian healthcare system and demonstrated capabilities of supporting and distributing antiretroviral therapies,” said Gregg H Alton, Executive Vice President of Corporate and Medical Affairs, Gilead.

In addition to distributing branded Gilead medicines, Mylan will manage regulatory and pharmacovigilance activities (such as adverse event reporting) as well as broader medical education initiatives.

EP News Bureau – Mumbai

GVK BIO and Aragen Bioscience sign agreement To acquire Aragen Bioscience SMALL-MOLECULE CONTRACT research organisation (CRO), GVK BIO, and US-based Aragen Bioscience, pre-clinical CRO specialising in high-value biologics services, have signed an agreement through which GVK BIO will acquire the capital stock of Aragen Bioscience.

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This deal enables GVK BIO to expand its service offering to a broader base of organisations and gives GVK BIO expertise in biologics services and a significant US presence. The acquisition provides Aragen with the ability to expand its service offerings, access to GVK

BIO’s global sales force and access to new markets.

"As an increasing number of biotech and pharmaceutical companies focus on proteinbased therapeutics and bio-similars, the acquisition of Aragen Bioscience will strategically enhance GVK BIO’s ability to of-

fer high quality R&D services to the industry from a seamless integrated platform,” said DS Brar, Chairman, GVK BIO. "Aragen’s scientific excellence and expertise in largemolecule R&D services combined with GVK BIO’s scale, resources, and global reach will

create significant synergies for both companies,” stated Rick Srigley, President and Chief Executive Officer, Aragen Bioscience.

This is GVK BIO’s first international acquisition. The financial details were not disclosed.

EP News Bureau – Mumbai

MARKET

Pharmaceuticals exports to overtake domestic sales in FY15: Ind-Ra Exports are likely to overtake domestic market sales in FY15, according to the rating agency INDIA RATINGS & Research (Ind-Ra) has revised its outlook for the pharmaceutical sector to positive for FY15 from stable on the back of increased exports to the US and ‘pharmerging’ markets. Profit margins are likely to improve on increased utilisation of manufacturing facilities.

The agency expects credit profiles of the large pharma manufacturers to remain strong while smaller, active pharma ingredients and pharma intermediates manufacturers, with a turnover of up to ` one billion will continue to face liquidity and competitive pressures.

Ind-Ra believes that backed by the increasing traction for generics globally and new generic drug approvals for Indian pharma companies in different jurisdictions, exports are likely to overtake domestic market sales in FY15. The domestic pharma market is likely to see high single-digit revenue growth.

The sector has received more than $12 billion worth of foreign direct investment through various deals since 2006. Manufacturing facilities carrying approvals from regulated markets are likely to be the acquisition targets of domestic and foreign drug manufacturers as a green-field investment involves a two to three year gestation period.

The year also saw increased regulatory action with the Indian government bringing 201 additional drugs under price control, the Supreme Court of India ordering the closure of 157 clinical trials and US FDA issuing warning letters to 10 Indian manufacturing facilities.

While the actions till now are not significant considering the size of the Indian market, any significant increase in regulatory actions will have negative implication for the industry.

EP News Bureau – Mumbai

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MARKET

Generic opportunities in developed markets pivotal for Indian pharma’s performance: ICRA As far as the emerging markets are concerned certain regulatory developments in some of the markets have hindered the growth momentum for a few quarters THE NEAR-TERM outlook for the Indian pharma industry continues to be principally supported patent expiration wave in the US, strong product pipeline of Indian companies and favourable foreign exchange environment says rating major ICRA in its latest update on Indian pharma industry. While growth in the Indian market was muted in first half of the year due to a) inventory cuts by trade channels, b) impact of new pricing policy but it is expected to recover gradually.

As far as the emerging markets are concerned, while the long-term growth prospects remain intact, certain regulatory developments in some of the markets have hindered the growth momentum for a few quarters. Notably, the delays in product approvals and pricing pressure in Brazil and efforts to encourage domestic companies in Russia are some of the key

challenges that Indian pharma companies face at present. Overall, the performance of individual companies would continue to vary depending on the quality of product pipeline in regulated markets, especially US, geographic diversification, and inorganic investment driven strategies. Companies with growing portfolio comprising niche or complex products in regulated markets and strong and established brands in branded generic markets are likely to be better positioned to manage industry challenges, says ICRA. According to ICRA study on 22 leading pharma companies much of the growth has been driven by strong US generic business where Indian pharma continues to leverage on limited competition launches, scale-up in product portfolio and market share gains. These companies have reported a steady growth of 14 per cent in rev-

Relatively low penetration of Indian companies in emerging markets and their growing product portfolio augurs well for the long-term enues and stable EBITDA margins in the 23.5-24 per cent range during H1 2013-14 despite headwinds building up in the domestic, as well as emerging markets.

The growth trajectory has, however, started showings signs

of sluggishness in emerging markets as frequently evolving regulatory developments is impacting the pace of new product approvals, drug pricing and competitive landscape. While these factors have impacted performance of individual companies during the past few quarters, the relatively low penetration of Indian companies in emerging markets and their growing product portfolio augurs well for the long-term, says ICRA in the report.

According to ICRA analysis, companies strong product pipeline in the US, well diversified presence across emerging markets and strong chronic focus in India have continued to perform better. These factors along with favourable growth prospects for generic drug launches in the US and other developed markets will continue to support earnings of Indian companies.

ICRA expects that the foreign exchange environment is likely to be positive for companies that do not have significant US dollar denominated liabilities in their balance sheets or l imited revenue hedges. However, companies with significant forex borrowings or derivative contracts (not covered adequately by export receivables) could see MTM losses during periods of rupee depreciation.

ICRA analysed 45 pharma companies with aggregate debt of ` 173 billion (as on March 2013) to judge the extent of their exposure to forex risk. Around 46 per cent of the debt of these entities was denominated in foreign currency and ~56 per cent was unhedged. While these indicators suggest high vulnerability to INR depreciation, we believe that most of it is offset by higher realisation of revenues from international markets.

EP News Bureau – Mumbai

Venus Remedies bags US patent for Achnil Developed by Venus Medicine Research Centre it will be commercialised in US market through technology transfer/outlicensing of exclusive marketing rights route VENUS REMEDIES has bagged a patent from the United States Patent Office for Achnil, a once-a-day painkiller injection developed by the Venus Medicine Research Centre (VMRC), the R&D wing of Venus Remedies. The patent will remain in force till 2032.

“The formulation will be commercialised in the US market through technology transfer/outlicensing of exclusive

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marketing rights route, and we are open to such deals,” said Dheeraj Aggarwal, Chief Financial Officer, Venus Remedies.

Containing aceclofenac, a non-steroidal anti-inflammatory drug (NSAID), Achnil is a pioneering product developed by the VMRC in its efforts to develop a controlled release formulation based on the novel drug delivery system. While the US represents the largest mar-

ket for pain management worldwide, NSAIDs account for 28 per cent of the global painkiller market, the size of which was $10.22 billion in 2013.

Achnil, the aceclofenacbased formulation can relieve acute as well as chronic pain and inflammation arising from rheumatoid arthritis, osteoarthritis, lower back pain, ankylosing spondylitis, and dental, post-traumatic pain,

gynaecological and cancer related pains. It took the VMRC more than five years to develop this product, which has received an overwhelming response from the medical fraternity in India since it was launched in the country two years ago.

“In view of the rise in the population of elderly people in regulated markets and absence of safer pain management therapies, the demand for better

products to address acute and chronic pains is also on the rise.

We have developed Achnil to address this unmet need,” said Dr Manu Chaudhary, Joint Managing Director, Venus Remedies, and Director, Research, VMRC. Venus has also secured a US patent for its novel research products Elores, Potentox and Vancoplus..

EP News Bureau – Mumbai

MARKET

SPARC gets DCGI nod for breast cancer injection paclitaxel As a part of the arrangement, SPARC is eligible for milestone and royalty income SUN PHARMA Advanced Research Company (SPARC) has received an approval from the Drug Controller General of India (DCGI) for paclitaxel injection concentrate for nanodispersion (PICN), indicated for the treatment of metastatic breast cancer. In a clinical study in metastatic breast cancer patients, PICN was found to be equally effective and safe when compared to Abraxane. PICN is approved in India for both the 260mg/m2 and 295mg/m2 doses to be administered every three weeks.

PICN is a novel formulation of paclitaxel using SPARC’s proprietary Nanotecton platform technology and is a cremophor

PICN is a novel formulation of paclitaxel using SPARC’s proprietary Nanotecton platform technology and albumin-free formulation. It offers the convenience of a quick and easy one-step dilution and infusion preparation for healthcare professionals. PICN can be administered in a short 30 minute infusion and unlike conventional Paclitaxel formulations it does not require premedication with steroids and anti-histamines and does not lead to any significant hypersensitivity reaction in patients.

SPARC has licensed Sun Pharmaceutical Industries Ltd (SPIL) or its assignee to manufacture, promote and distribute PICN in the Indian market. As a part of the arrangement, SPARC is eligible for milestone and royalty income.

EP News Bureau – Mumbai

EXPRESS PHARMA

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February 16-28, 2014

MARKET DEALTRACKER

Expansion of product pipelines towards complementary offerings drive M&A activity Indian pharma sector witnesses no deals during January 2014

M&A ACTIVITY in the pharmaceutical sector was focused on the expansion of product pipelines with complementary franchises, to create blockbuster therapeutic areas.

In line with the above trend, Forest Laboratories agreed to acquire Aptalis, a US-based specialty pharmaceutical company, for approximately $2.9 billion.

This acquisition complements Forest Laboratories’ growing cystic fibrosis business in Europe and enables Forest Laboratories to strengthen its gastrointestinal franchise in the US and Canada. This transaction would help Forest Laboratories to diversify its offering in key therapeutic areas and geographies.

Also, Forest Laboratories will gain access to Aptalis’ manufacturing and commercial operations in the US, the European Union and Canada along with the existing pipeline.

In another key deal, Alnylam Pharmaceuticals agreed to acquire Sirna Therapeutics, a US-based biotechnology company, for approximately $290 million.

This transaction would complement and extend Alnylam’s progress and continued focus on RNAi therapeutics, including siRNA-conjugate technologies. The addition of RNAi technology and intellectual property will advance Alnylam’s efforts to build a new class of medicines.

Additionally, Alnylam will gain access to Sirna Therapeutics’ pre-clinical therapeutic candidates,

20 EXPRESS PHARMA February 16-28, 2014

Figure: M&A (including private equity) trend analysis

Source:

Figure: Venture financing trend analysis

Source:

Top M&A deals (Jan 2014) Rank

Date

Target

Acquirer

Deal value ($m)

1

01/08/14

Aptalis Pharma, Inc. (US)

Forest Laboratories, Inc. (US)

2900

2

01/30/14

Accelrys, Inc. (US)

Dassault Systemes S.A. (FR)

750

3

01/10/14

American Pacific Corporation (US)

H.I.G. Capital, LLC (US)

392

4

01/12/14

Sirna Therapeutics, Inc. (US)

Alnylam Pharmaceuticals, Inc. (US)

290

5

01/21/14

NuPathe, Inc. (US)

Teva Pharmaceutical Industries, Ltd. (IL)

144

6

01/13/14

4-Antibody AG (CH)

Agenus Inc. (US)

50

7

01/06/14

Okapi Sciences NV (BE)

Aratana Therapeutics, Inc. (US)

45.25

8

01/08/14

Auspex Pharmaceuticals, Inc. (US)

Deerfield Management Company L.P.; Thomas, McNerney & Partners; CMEA Capital; Panorama Capital; BioMed Venture GmbH; Costa Verde Capital

20

9

01/07/14

Isarna Therapeutics GmbH (DE)

AT NewTec GmbH; MIG Fonds 2; MIG Fonds 3; MIG Fonds 9; MIG Fonds 5

17.69

10

01/07/14

Bellicum Pharmaceuticals, Inc. (US) AVG Ventures, LP; Remeditex Ventures, LLC

14.7

Source:

chemistry and other delivery technologies.

M&A activity in the pharma sector increased in volume and decreased in value

terms, when compared to the average of the previous six months (July – December 2013). According to Datamonitor’s Medtrack

database, the pharma sector recorded 40 M&A transactions in January 2014, against the previous six months’ average of 32.8

transactions. In value terms, the sector recorded deals worth $5.1 billion, against the previous six months’ average of $7.9 billion.

MARKET The Indian pharma sector witnessed no deals during January 2014, against the average of 0.8 deals over the previous six months.

Venture funding Companies in the pharma sector raised $111.2 million during January 2014, against the previous six months’ average of $278.3 million. In terms of volume, the sector recorded 10 venture funded deals, when compared to the previous six months’ average of 21.5 transactions.

Top venture financing deals (Jan 2014) Rank Date

Target

Investors

Deal value ($m)

1

01/07/14

Blueprint Medicines (US)

Nextech Invest Ltd.; Third Rock Ventures, LLC; Fidelity Biosciences; Casdin Capital, LLC; Biotech Value Fund, L.P; Undisclosed Investors

25

2

01/13/14

Juno Therapeutics, Inc. (US)

Bezos Expeditions; Venrock

25

3

01/10/14

WellDoc, Inc. (US)

Merck Global Health Innovation Fund; Windham Venture Partners

20

4

01/08/14

Auspex Pharmaceuticals, Inc. (US) Oxford Finance Corporation

15

5

01/28/14

Igenica, Inc. (US)

14

The Column Group; 5AM Ventures; OrbiMed Advisors, LLC; Third Rock Ventures, LLC; Undisclosed Investors

Source:

Notes Medtrack is a comprehensive, fully integrated, global biomedical database providing information on companies, products, patents, deals, venture financing, and epidemiology. It is a live database, constantly updated

with news, milestones, trial information, etc. Medtrack’s unmatched coverage is supported by a user-friendly, highly dynamic set of decision support tools and analytics.

In-house analysts and researchers add key insights

and conclusions to provide you with the primary and secondary information you need. Key uses of the database include competitive intelligence, target identification, screen potential licensing and investment opportunities, patent

assessments, product due diligence, royalty valuations, and developmental benchmarking.

Definitions 1.Deal value trend is based on transactions where

associate values have been disclosed.

2.Trend analysis excludes rumored and terminated deals.

3.Value and volume analysis excludes private equity exits.

For more information, visit us at www.medtrack.com

EXPRESS PHARMA

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February 16-28, 2014

MARKET PRE EVENT

Indian Congress of Pharmacy Practice 2014 in Bangalore IACP to host this event and the inaugural convention of the Indian Association of Colleges of Pharmacy THE INDIAN Association of Colleges of Pharmacy (IACP) will host the inaugural convention of the Indian Association of Colleges of Pharmacy and ‘Indian Congress of Pharmacy Practice 2014’ in Bangalore on February 21-22, 2014.

The theme of the congress is ‘Advancing Pharmacy Practice in India. The Next Generation Pharmacist'. The congress will showcase a

scientific programme on emerging advances in pharmacy practice, pharmaceutical care and education. It will also have plenary lectures, symposia, panel discussions, poster presentations and student placement conclaves.

IACP has invited leaders in pharmacy practice and education, and also leaders in the healthcare sector to interact with the new breed of

pharmacists who will radically change India's healthcare delivery. More than 25 leaders in pharmacy practice and education from the US, Australia, the UK, Southeast Asia, the Middle East and Europe have confirmed their participation.

They will deliver talks on the direction pharmacy practice and education will need to take in the future.

EP News Bureau-Mumbai

IDMAand ULIndia to host India Pharma Regulatory & Compliance summit – 2014 INDIAN DRUG Manufacturers’ Association (IDMA) and UL India has announced a summit on ‘India Pharma Regulatory & Compliance summit2014’. The summit will be held on February 20, 2014 in Mumbai. The theme of the conference is ‘Sustaining Regulatory Compliance in the Pharma Industry.’

The summit will bring together a unique group of global pharma thought leaders and practicing professionals in the fields of regulatory compliance

learning, organisational quality and business performance.

Pharma CxO’s, regulatory and compliance heads, quality assurance compliance heads, R&D Heads, training and learning heads, international policy makers, industry stakeholders, learning technology leaders.

The summit will include general sessions, panel discussion , best practices sharing, networking opportunities.

EP News Bureau-Mumbai

POST EVENT

Bangalore India Bio inaugurated with huge fanfare The event was inaugurated by Chief Minister of Karnataka, Siddaramaiah A 3D movie about the new BioTech Incubator centre was the high point of the inaugural ceremony of the 14th edition of Bangalore India Bio, at Bangalore. The event was inaugurated by Chief Minister of Karnataka, Siddaramaiah in the presence of SR Patil, Minister for Information Technology,

22 EXPRESS PHARMA February 16-28, 2014

Bio-Technology and Science and Technology, nobel laureate Prof Sir John Gurdon, World Food Prize Laureate Em Prof Dr Marc Van Montagu, Prof K Vijay Raghavan, Secretary, Department of Bio Technology, Roshan Baig, Minister for Infrastructure Development,

Siddaramaiah, Chief Minister, Government of Karnataka, lighting the lamp at the inauguration of Bangalore INDIA BIO 2014

Information & Haj, Govt of Karnataka, K Govindaraj, Member of Legislative Council, General Secretary, KPCC, Kaushik Mukherjee, Chief Secretary, Government of Karnataka, Dr Kiran Mazum-

dar Shaw, Chairperson, Vision Group on Biotechnology and Chairperson and Managing Director, Biocon; Srivatsa, Secretary to Government, Department of Information Technology, Bio Technology and

Science and Technology.

The chief minister n his inaugural address said, “The State is home to about 52 per cent of the core Biotech companies in the country. In the past decade, Karnataka State

MARKET Government has taken proactive Policy initiatives, which have significantly contributed to the growth of the sector.

The first Biotech Policy in the country was announced by Karnataka in 2001. The Policy, to a large extent, has achieved the objectives. Keeping in view the changing needs of the Biotech Sector, State Government revised and announced ‘Millennium Biotech Policy version 2’ in December 2009.”

Prof K Vijay Raghavan, Secretary, Department of Bio Technology said, “Science and technology are the tools to tackle the socioeconomic problems of the country. Vaccines are essential and should be free from western activitism and wrong morale.

True benefit of universal immunisation needs effective communication.”

All the dignitaries spoke about the future of biotechnology and the emergence of Bangalore as the biotech hub of the world.

On the second day, a keynote lecture was given by

by Montagu. The other dignitaries were Srivatsa Krishna, IAS, Secretary to Government, Department of Information Technology, Biotechnology and Science & Technology and DPAR (e-Governance), Government of Karnataka, GV Krishna Rau, IAS, Additional Chief Secretary and Development Commissioner, Government of Karnataka and Dr KK Narayanan, Managing Director, Metahelix Life Sciences.

In the opening talk Srivatsa Krishna said, “I’ve previously invested in many a biotech projects during my tenure in world bank. But the knowledge on the intricacies of science and agriculture was just about fair.”

Narayanan, added saying, “The importance of agriculture cannot be over emphasized in India or Karnataka, as majority of the population are concentrated in villages. More than the half of the population has itself engaged in agriculture. Development which is equitable in terms of agriculture is not one sided, where only a few developments hap-

EXPRESS PHARMA

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February 16-28, 2014

pened; but instead it should happen in both ways like people and productivity.”

Montagu, in his talk on “The Social and Economic importance of plant biotechnology,” said, “In 1904, a rare disease affected the plant which in those days didn't have a

name and the cause was unknown. Now we know that the disease is Crown gall which was caused by the bacteria called Agrobacterium tumifaciens. In 1974 it was discovered that Ti plasmid from the above bacteria is responsible for that disease. In 1990s

they were able to isolate the genomics and create a product (pesticide) which is resistant to specific pest.”

He concluded by saying, “Genetically modified food is safe for consumption and it is certificated by AAAS and American medical associ-

ation, European commission and have stated that it is safe for consumption. Misinformation about GM creates havoc among people. Public awareness of science is a social responsibility.”

EP News Bureau-Mumbai

EVENT BRIEF FEBRUARY-MARCH 2014 17

11th edition of BioAsia

TH

11 EDITION OF BIOASIA Date: February 17 to 19, 2014 Venue: Hyderabad International Convention Centre th Summary: The 11 edition of BioAsia is dedicated to the theme – ‘Innovate. Evolve’.

BioAsia’s focus on ‘Innovation in lifesciences’ will address the increasing disease burden, and the growing need for more efficacious and affordable healthcare solutions. Panel discussions hosting global industry leaders will deliberate on the path breaking solutions for the sector, from innovative products to models that reduce R&D cost while increasing efficiencies, and innovative financing models, that promote new business ideas. The goal is to highlight innovation as the driver of the lifesciences economy in the coming years.

In addition, a parallel event AgBioAsia focusing on health and nutrition with the theme of ‘Harnessing the potential of the global nutraceutical market’ will be hosted by the Government of Andhra Pradesh in partnership with the International Crops Research Institute for the Semi Arid Tropics (ICRISAT) and the Federation of Asian Biotech Associations (FABA).

Contact details Paridhi Gupta Tel: 040 66446477

INDIA PHARMA REGULATORY & COMPLIANCE SUMMIT - 2014 Date: February 20, 2014 Venue: JW Marriott, Juhu Tara Road , Mumbai Summary: Indian Drug Manufacturers’ Association

24 EXPRESS PHARMA February 16-28, 2014

24

CPHI Quality by Design

(IDMA) and UL India has announced a summit on 'India Pharma Regulatory & Compliance summit- 2014'. The theme of the conference is 'Sustaining Regulatory Compliance in the Pharma Industry'. The summit will bring together a unique group of global pharma thought leaders and practicing professionals in the fields of regulatory compliance learning, organisational quality and business performance. Pharma CxO’s, regulatory and compliance heads, quality assurance compliance heads, R&D Heads, training and learning heads, international policy makers, industry stakeholders, learning technology leaders.

Contact details Indian Drug Manufacturers’ Association 102B, 'A' Wing, Poonam Chambers Dr Annie Besant Road Worli, Mumbai – 400018 Tel: (022) 24944624/ 24974308 Fax: (022) 24950723 Email: ppr@idmaindia.com Website: www.idma-assn.org

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

This event is a unique learning platform combining discussions, case studies and best practice to enhance knowledge sharing and networking; coupled with a practical training component to enhance applied and technical implemen-

4

4th Annual Vaccine World Summit India 2014

tation know-how.

URL: http://www.qualitybydesign-asia.com/?utm_campaign=EVENTLISTING&utm_ medium=MEDIAPARTNERWEBSITE&utm_source=EXPRESSPHARMAONLINE&ut m_content=URL&utm_term= Contact details Marcus Chan UBM Conferences ASEAN Tel: +603 2176 8712 Fax: +603 2176 8786 Email: marcus.chan@ubm.com

4TH ANNUAL VACCINE WORLD SUMMIT INDIA 2014 Date: March 4– 6, 2014 Venue: Hyderabad International Convention Centre, Hyderabad Summary: The fourth Annual Vaccine World Summit India 2014 is the longest running vaccine conference in India which provides an excellent platform for attendees to learn and network with industry front runners. This year, more than 30 industry experts will share their experiences and technical knowledge in this two days conference. On the first day of the conference there will be in-depth discussions on the most pertinent issues in the vaccine market by industry experts while the second day of the conference will feature two streams of topics - ‘Vaccine Manufacturing, Technology and Partnerships’ and ‘Vaccine Clinical Trials’.

Contact details Jen Cheng Number:+65 6493 1871 Fax Number:+65 6722 0649 Website:http://www.imapac.co m/index.php?page=VaccineWorldSummitIndia2014 Email: jen.cheng@imapac.com

4

Smart Pharma Manufacturing India 2014

SMART PHARMA MANUFACTURING INDIA 2014 Date: March 4– 6, 2014 Venue: Hyderabad International Convention Centre, Hyderabad Summary: The Smart Pharma Manufacturing India 2014 is specially tailored for technical directors, heads of operational excellence, plant heads and quality heads looking to transform and optimise its current manufacturing processes to maintain cost advantages and achieve quality assurance at the same time.

This conference serves as a platform for industry stakeholders to meet and discuss the challenges of today and tomorrow.

Key topics that will be discussed include: ● Manufacturing leadership and strategy ● Operational excellence and automation ● Handling GMP and regulatory compliance ● Achieving QBD via PAT ● Cold chain management and distribution for bioPharmaceuticals ●Future manufacturing Contact details Jen Cheng Number:+65 6493 1871 Fax Number:+65 6722 0649 Website:http://www.imapac.co m/index.php?page=VaccineWorldSummitIndia2014 Email:jen.cheng@imapac.com

EMERGING TRENDS IN DRUG DISCOVERY: AICADD – 2014 Date: July 23-28, 2014 Venue: AMRITA Vishwa Vidyapeetham - Amrita University, Coimbatore Summary: Emerging Trends in Drug Discovery: AICADD –

2014 is an international conference organised aims to make a "industry-scientistsacademics" collaboration to meet the major challenges of drug discovery. The emphasis of the conference will be on topics related to the Computer Aided Drug Discovery (CADD). The organisers are expecting more than 500 delegates including Nobel laureates/ scientists/researchers/ students and professionals from academia and industries from all over the country and abroad, will be participating in the conference.

A few identified thrust areas are: clinical pharmacy and pharmacy practice, natural products chemistry, medicinal chemistry, pharmaceutical technology, CADD, pharmacogenomics, pharmacoinformatics, SAR studies and machine learning, drug delivery system, nanomedicine, personalied drug design, bioinformatics and biomedical engineering.

Contact details Dr PK Krishnan Namboori Associate Professor, (Executive Coordinator) AMRITA Insight into Computer Aided Drug DiscoveryAICADD-2014, Computational Chemistry Group (CCG), Computational Engineering and Networking, AMRITA Vishwa Vidyapeetham-Amrita University, Amritanagar, Coimbatore-641 112 Phone:+91 422 2685000 Extn: 5592 Email: aicadd_2014@cb.amrita.edu aicadd2014@gmail.com URL: http://www.amritaccg.in/ Conference URL: http://www.amritaccg.in/ aicadd2014

MARKET POST EVENT

ICONIC 2014 focuses on COPD Jointly hosted by Chest Research Foundation (CRF) and Johns Hopkins Bloomberg School of Public Health, US, the first conference comprised 18 overseas faculty and 15 national speakers ICONIC 2014, the first conference focusing on Chronic Obstructive Pulmonary Disease (COPD) in India, was recently held in Pune. Keshav Desiraju, Secretary, Ministry of Health & Family Welfare, Government of India inaugurated the conference focusing on COPD in India. ‘India needs a National COPD Prevention and Control Programme’ was discussed at the conference. The conference which had 18 overseas faculty and 15 national speakers was jointly hosted by Chest Research Foundation (CRF) and Johns Hopkins Bloomberg School of Public Health, US. It was endorsed by various leading international institutions such as Indian Chest Society, Ameri-

can Thoracic Society, European Respiratory Society and others.

Speaking at ICONIC 2014, Dr Sundeep Salvi, Director, Chest Research Foundation said, “ICONIC brings together experts across the healthcare industry including physicians, public health policy makers and researchers to bridge gaps in the field of COPD prevention, control and management in India. It is an opportunity to share the latest developments in COPD research both from the US and India, which they can use it to treat their patients better.”

Dr Shyam Biswal, Department of Environmental Health Science, John Hopkins School of Public Health, US, said,

“ICONIC serves as a great platform for young researchers and physicians to showcase their research work and receive constructive feedback from the leading experts in the world. It will also help them to polish and shape their research studies so that they can derive meaningful and qualitative data that will benefit the world. Further, it also creates opportunities for doctors in US and India to come together to form collaborations for exchange of knowledge which will help to combat the COPD epidemic.”

According to the experts, COPD is among the top three death causing health conditions in India. Despite this finding, COPD is not considered as

harmful as AIDS or diabetes.

In a country like India, the financial condition of a patient has always remained an issue while deciding the mode of treatment. However, in case of COPD, there is more to worry about than just the ability of the patient to spend on the treatment. Doctors believe that the stigma associated with COPD is perhaps preventing many victims of it from approaching the doctor or sharing their health worries with family or friends.

Ignorance about COPD is also contributing to rising number of such patients. Salvi, informs, “Even policy makers and researchers are not well informed about COPD.”

Dr Robert Wise, Professor of Medicine, The Johns Hopkins University School of Medicine and Johns Hopkins Bloomberg School of Public Health, said, “COPD is a hidden disease in India. COPD is perhaps one of the easiest diseases to diagnose, years before it becomes symptomatic.”

Desiraju stated that traditional ways of cooking food in rural India should be changed. According to him, women and young girls are affected more due to working on chullas and unfortunately they do not understand the harmful effects of such kind of cooking methods.

EP News Bureau - Mumbai

cover )

HIKE IN PHARMA HIRING ON THE CARDS

The buzz at recruitment firms and job portals is that hiring for new jobs, as well as replacements in 2014 will continue to be bullish in India's pharmaceutical sector, with double digit hikes for certain hard-to-find skill sets. An analysis of predicted salary hikes, hiring hot spots, as well as skill sets most in demand

BY VIVEKA ROYCHOWDHURY

INSIDE 30 | Time to get proactive 32 | Nurturing the industry 35 | ‘Agility and flexibility are key company attributes to attract talent’ 36 | ‘The opportunities are going to be better, but for better qualified and experienced candidates’

26 EXPRESS PHARMA February 16-28, 2014

(

THE MAIN FOCUS

Global pharma companies are focussing to increase their presence in emerging countries like China, Brazil and India.

Consequently, global HR honchos have a clear 5-year plan on human capital development which includes globalisation to leverage on talent supply in emerging markets Hussain Tinwala General Manager, Teamlease Services

Despite the recent challenges and concerns in the industry like quality issues/USFDA warnings/stringent price control/ compulsory licensing/ambiguou s patent laws, etc., there are strong macro drivers pushing growth across the sector in India Kamal Karanth Managing Director, Kelly Services India

EXPRESS PHARMA

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February 16-28, 2014

cover )

O

nce touted as a recession proof sector, the balance sheets of global pharmaceutical majors is proof that it is not as insulated as it would like to be. Faced with sluggish low single digit growth in established markets, global pharma majors have turned to emerging/developing markets which still show double digit growth rates.

Even though the Q3 FY2014 results of the Indian pharma sector were subdued, dipping from double digts to around 9.5 per cent in the quarter, this could be explained as the impact of the new pricing policy and trade related standoffs. Some companies have managed to beat the industry average growth rate, proving that the impact of these factors will even out over a period of time as companies and customers adjust to the ‘new normal.’

As Ranbaxy continues to face US FDA scrutiny, with its Toansa plant in Punjab - its fourth facility- was also slapped with an import ban on January 23, industry analysts have been preparing for a scenario when the notinal reputational loss starts impacting the ability to win new manufacturing contracts. Another downer was the news that AstraZeneca would be shutting down its Bangalorebased R&D centre, Avishkar, and releasing around 170 scientists, as part of a pan-global move to consolidate its R&D facilities.

Hiring to pick up in 2014 Hiring trends in 2014 will reflect these news flashes but recruitment agencies and job portals do not seem overly worried.

As Moorthy K Uppaluri, Chief Executive Officer, Randstad India and Sri Lanka puts it, “The Indian pharma sector has always been an active recruiter, with a potential attract high quality talent even during slowdowns as the industry is virtually recession proof.” In fact, Uppaluri discloses that pharma

28 EXPRESS PHARMA February 16-28, 2014

has been a key growth engine over the last two to three years for his company, and they are expecting a 14 per cent hiring growth in this sector in 2014.

In terms of job listings too, the lifesciences sector has been second only to the IT sector according to V Suresh, EVP and Head Sales, Naukri.com. The job portal site first started releasing Job Speak Index, a monthly indicator of job listings on its portal, in July 2008. The Index for the lifesciences sector started with a base of around 1000 listings, spanning pharma and biotech related positions. It peaked at 1603 listings in July 2013 and though the December figures are lower (1333), Suresh expects it to reach 1500-1600 levels in 2014 as well.

These bullish predictions come on the back of industry observers like Kamal Karanth, Managing Director, Kelly Services India expecting an uptick in US FDA approvals for new research molecules from big pharma players. Karanth explains further saying, “This is good news as these companies encouraged by these wins may further advance their new drug pipeline. This means Indian CROs/CRAMS and other contract services will do brisk business, since most of these innovator companies outsource their developmental stages to India.

This translates to more business which in turn translates to companies willing to pay more to hire talent.” Thus he expects that overall the sector will create more jobs in 2014.

Karanth believes that despite the recent challenges and concerns in the industry like quality issues/US FDA warnings/stringent price control/compulsory licensing/ambiguous patent laws, etc., there are strong macro drivers pushing growth across the sector in India. He points out that companies continue to bolster their sales force, launch new products/new therapy segments, and invest in marketing/brand management.

The pharma sector is expected to dole out an above average of around 20 per cent hike to lateral hires this year Moorthy K Uppaluri Chief Executive Officer, Randstad India and Sri Lanka

In terms of job listings, the lifesciences sector has been second only to the IT sector V Suresh EVP and Head Sales, Naukri.com

According to him, India still continues to be regarded as the pharma development/manufacturing outsourcing hub, due to the strong process chemistry/pharma development capabilities, low cost of infrastructure, skilled talent at low cost and some of the finest state- of-the-art manufacturing facilities.

He also points out that due to the sheer size of the population and increasing prevalence of chronic lifestyle diseases, and rising disposable incomes, newer MNCs are setting shop in India, or are scaling operations through launching new innovative products. Better penetration of healthcare and access to medical insurance is also driving pharma growth particularly in Tier II and III towns/cities.

All these factors augur well for pharma companies, especially when compared to their peers in other manufacturingbased sectors. As Hussain Tinwala, General Manager, TeamLease Services says, “As a generic drug maker, it has an upper hand in terms of offering low cost drugs across global platform. This keeps the manufacturing/production tempo moving as compared to overall manufacturing industry.”

Tinwala points out that today only 40 per cent of the Indian population is able to access medical and health assurance benefits. If this is developed, it would boost the domestic pharma sector and higher consumption would motivate them to spend and invest more on research.

Globalisation of talent search Would the reputational loss of adverse decisions from overseas regulators impact hiring trends in India? As of now, this does not seem to be the case.

Tinwala of TeamLease Services feels that global pharma companies are focussing to increase their presence in emerging countries like China, Brazil and India. Consequently, global HR

honchos have a clear five-year plan on human capital development which includes globalisation to leverage on talent supply in emerging cost effective markets. Specific to India, Tinwala says global companies would strengthen their employee base in India and would also look at hiring for back office operations to reduce head count in their base locations.

This trend is already happening: even as Novartis announced job cuts across global locations, a Swiss newspaper reported that some of those positions might be moved to its Hyderabad set up. Earlier this year, the Swiss company reportedly bought 8.7 lakh square feet of office space in Hyderabad, touted as one of the largest deals in office space in the city in recent times. A company official was quoted as saying that the new office space would consolidate its existing operations in the city.

Hiring hot spots The positive buzz is supported by statistics as well; Randstad India recorded a 12-14 per cent hiring growth in the pharma sector in the current fiscal year, says Uppaluri of Randstad India, with much of the demand concentrated in cities such as Mumbai, Bangalore, Hyderabad and Visakhapatnam.

Suresh of Naukri.com says that in terms of lifescience job listigs, Mumbai was the clear leader, followed by Hyderbad, closely followed by Bangalore.

Chennai was at fourth and Ahmedabad at fifth position. In addition to these known hotspots, Suresh says 2014 could see pharma job listings pick up in the Delhi NCR region, Navi Mumbai in Maharashtra, Visakhapatnam and Chandigarh. His prediction is based on three factors critical for expansion, which these emerging hubs have: support from the government in terms of industryfriendly tax rates and the like, availability of land and thirdly, access to talent pool.

( In terms of workforce solutions and levels of hiring, Karanth says contingent hiring (direct-hire basis) at mid levelsupper mid levels makes up 50 per cent of the hiring done for pharma clients. Senior level search and leadership hiring makes up 20 per cent while junior level volume hiring accounts for the remaining 30 per cent.

Temp staffing is not such a regular sought after service by pharma clients, reveals Karanth.

Among Randstad’s services portfolio, Uppaluri reveals that staffing and selection (volume permanent recruitment) are most sought after by pharma clients with the company handling complex, multiple pan India projects.

Double digit hikes...

A recent Kelly Services India Report tracking salary movements across sectors in India too has identified the pharma sector as one of the few sectors where employees can expect decent salary hikes in 2014. Karanth admits that in terms of monetary gains, the sector is relatively conservative compared to its close peers like FMCG/chemicals/medical devices, etc. “However, niche skills in the areas of drug discovery, regulatory affairs, quality systems/compliance, therapy marketing, brand management, CRAMS, R&D programme management, biologics/biosimilars, international marketing are comparatively well compensated, specially at senior levels.”

Uppaluri of Randstad India too predicts that the pharma sector is expected to dole out an above average of around 20 per cent hike to lateral hires this year.

Tinwala conquers with this saying that in terms of increments, companies would come up with double digit appraisals in the range of 14 per cent to 15 per cent against an overall industry standard of 10 per cent to 12 per cent. Besides hikes, there would be a focus on perks or bonuses to segregate top achievers, with many companies offering family leisure trips or stock options. Speaking about some practices followed by global

pharma companies, he points out that they focus more on rewards and performance-based pay outs, with many companies offering a flexible variable basket, allowing employees to decide on the rewards schemes best suited to them.

... for 'in demand' skill sets Karanth of Kelly Services India predicts that in 2014, jobs that will be in demand in India will be in regulatory affairs, supply chain/purchase and environment health and safety.

Tinwala of TeamLease Services puts sales and marketing as the top contributor in terms of openings followed by other functions. Sales openings would flourish more in Tier II cities, as these cities are the growth drivers for organisations. Besides sales and marketing, Tinwala feels WHO and government interventions on transparancy would enable growth in regulatory / legal functions. He also predicts an interesting trend of diversity playing an important role, with companies looking to hire more women employees in Tier II cities and offering flexible working hours.

Alluding to the sheer breadth to talent absorbed by the sector, Uppaluri of Randstand India opines that this highly knowledge-based sector offers candidates a plethora of exciting careers opportunities ranging from medical writers to territory managers to ICU intensivists. At present, he sees a lot of demand for junior and mid level professionals in product development, inventory management and sales and marketing functions.

Beyond these verticals, Uppaluri points out that with pharma companies investing heavily in joint collaborative researches for new drug discoveries, senior level professionals with niche skills and experience such as pharma scientists, radiologists and clinical research associates are being highly sought after.

Competing for talent On the flip side, pharma companies often find themselves competing with other sectors for the same talent pool and are of-

There is consensus that inspite of the attractive hiring trends, both employer and job seeker communities will face a certain amount of frustration ten found wanting. Tinwala feels that limited resources and lack of cross industry movements would make it challenging for pharma companies to attract talent. He points out that medical insurance companies off lately have started hiring pharma graduates to assess drug prescriptions, a part of the claim settlement process. So also, there is a cross movement of talent between pharma and FMCG in sales and Marketing functions for OTC products.

Many personal care companies hire employees with experience in selling or marketing derma based products. Many FMCG personal care companies hire detailing managers with strong technical knowledge or strong connect with consultants / physicians.

While these factors are good news for employees, employers find that they have to stretch to retain talent. In the war for talent, how is the pharma sector attracting and retaining talent?

And in particular are Indian pharma companies fighting a losing battle?

Missing links There is consensus that inspite of the attractive hiring trends, both employer and job seeker communities will face a certain amount of frustration.

The reality is that in lifescience,

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India has the numbers but not the quality of talent.

As Tinwala points out, “Though India has the right supply of pharma graduates, but not all graduates are employable.

They lack soft skills and basic employability skills. This is one of the biggest challenge that Indian pharma is facing.” He opines that India’s biggest challenge is talent management and talent retention; attrition could be as high as 18 per cent – 20 per cent annually.

Uppaluri of Randstad too feels that while from a talent supply point, there’s no dearth of candidates who are keen and passionate to take on pharma as their choice of profession, like other sectors, pharma too is facing skills gap issue. “We have seen that most candidates are strong in the technical knowledge but lack in communication skills.” He says that firms overcome this skills chasm through skill development and training programme initiatives.

Dearth of technical talent The shortage in quality talent or industry ready talent and the gap in demand/supply is ever widening says Karanth of Kelly Services and in fact is already quite critical in techical areas.

For instance, the talent pool in certain specific niche skill areas like translational research, clinical development, drug discovery, medical devices R&D, biosimilars/biologics research are practically reduced to a few people in few companies.

Karanth warns that “unless industry, academia and government do not come together on a common platform to work on producing talent at a university level, things might not improve soon.”

Elaborating further on quality of talent, Tinwala says that the fast growth pace of the industry calls for employees who are risk takers, accountable, creative, innovative and excellent communicators. He rues that this quality “seems to be missing in the fresh bunch.” Since employees working in critical functions like R&D, regulatory, quality and sales / marketing are always in great demand, Tin-

wala observes that these functions also see maximum attrition. Another challenge these companies face are governments interventions on price control regulations, ever rising expense on R&D and patent expiry with no drug replacements.

Some solutions All these factors have forced global pharma companies to focus on developing employees.

Tinwala points out how global companies have invested in training and development of employees saying, “Global companies focus on developing higher efficiency levels of its employees, focusing on driving performance, making employees take risk and plunge into challenges at early stage of their careers.

Developing analytical skillset and changing approach from scientific to analytical.”

Karanth of Kelly Services too confirms that current best practices adopted by big pharma have resulted in all round professional growth and skills development. He also points out that infusion of talent from different sectors and talent from overseas, has challenged conventional thinking/approach and thus resulted in overall quality enhancement of people.

Back home, forward looking companies have already implemented some of the tried-and tested solutions from developed countries. For instance, Biocon has started its own biotech academy to produce biotech specialised professionals, points out Karanth. In a similar vein, there is some movement with several colleges and universities now offering pharma and healthcare management courses, thus improving the quality and number of brand management./pharma marketing professionals.

Thus a globalisation of the workforce benefits both employers and employees; in ways beyond the balance sheet. Both sides can prepare for a year of steady growth, peppered of course with challenges like increased regulator scrutiny and policy changes once the new government takes charge. viveka.r@expressindia.com

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Time to get proactive Caught in the midst of a talent crunch and an industry under strict regulatory lens, HR departments within companies need to rise up to the challenge with innovative strategies to stay afloat in a dynamic environment. Shalini Gupta reports

I

ndia’s pharmaceutical sector is slated to touch $ 45 billion by 2020, according to a report by McKinsey & Company making it the sixth largest market in the world.

Manpower is crucial to bring about this change. Currently employing a cumulative workforce of 45,000 people, the industry will need to sharpen its HR strategies in the light of the recent regulatory turmoil as well to take into account newer business models that give a fillip to innovation with most drugs going off patent in the next few years. We find out how.

Managing talent One of the major challenges undeniably across the board is a rapidly shrinking talent pool of ‘skilled’ scientists and engineers who can keep pace with newer scientific advancements. With more companies exporting to regulated markets like the US and Europe, this demand is going to be further intensified in the coming years specially in areas like R&D, QA/QC, process development and manufacturing in order to meet strict regulatory guidelines. Says Amitava Saha, Head, Human Resources, Biocon, “The skills deficit is turning out to be a major challenge for the Indian biotech and pharma industry and it is impeding India’s emergence as a leading global innovation hub for biopharma. It is also pushing up the

30 EXPRESS PHARMA February 16-28, 2014

Building global and world-class leaders, driving innovation, ensuring integrity, quality and compliance and fostering a culture of continuous improvement will be the top priorities of 2014. The HR function must actively analyse the root causes of compliance failures and find ‘culture’ level answers Dr Sripada Chandrasekhar President and Global Head of HR, Dr Reddy’s Laboratories

costs of companies on account of the investment they need to make to train fresh graduates before they are job-ready.” The company under the aegis of Biocon Academy, a one-of-its-kind Centre of Excellence for Advanced Learning in Applied BioSciences, collaborates with leading academic institutions globally, to bring world class training programmes for biotech students in India and thus de-

( velop a new cadre of life sciences professionals with specialised skills. Training manpower to make them industry ready, then seems to be a viable solution.

Not only this, companies will have to broaden their focus to address the three Ts- Talent Attraction, Talent development and Talent Engagement and retention. “In order to address the shortage of talent, organisations will have to adopt innovative recruitment practices to attract quality talent from academia and non-pharma industries.

This will be especially in field force, as well as technical areas like R&D, QA/QC, process development and manufacturing,” says Jayesh Pandey, Managing Director, Talent & Organisation at Accenture India.

An emphasis on developing talent specifically in the sales, R&D, quality and manufacturing functions would be crucial since those recruited may have little or no pharma expertise depending on the company’s sourcing strategy, he adds. So even as acquiring talent will take its normal course, the real long-term need of the industry is to create new talent pools with pro-active investments in skills creation, opines Dr Sripada Chandrasekhar, President and Global Head of HR, Dr Reddy’s Laboratories.

“We have to add a layer of ‘employability’ to our science, chemistry and pharma graduates by enrolling them early on into industry-relevant skills.

New investment must focus on modernisation of plant and equipment, IT enablement and overseas growth both organic and inorganic,” he echoes. In the light of a dynamic business environment, finding, developing and retaining the right talent will be a great challenge, especially for niche technical and leadership skills. Even as companies adopt practices discussed above, they will also have to ensure better management and optimisation of talent costs, in a scenario where talent demand exceeds talent supply.

Transforming for the better Chandrashekar reiterates

how the HR function has matured over the years from being merely focused on hiring, remuneration, rules and employee welfare to designing and deploying leading-edge practices and more importantly enabling managers to step up on owning and driving exemplary people leadership. “Improving productivity via more tailored skills training, deploying continuous improvement plans, hiring more talented sales leaders, coaching managers to ‘anticipate’ better and helping the organisation generally be more pro-active in its risk mitigation approaches are some of the ways in which HR is facilitating ‘transformation’ on the ground. As we move up this value chain, HR will transform itself into driving business far more from the centre of the company than managing from the margins,” he enthuses. Perhaps this is how the HR can help develop coping strategies in an increasingly dynamic environment beset with regulatory and pricing challenges. As Pandey enumerates below, a few such ways the HR could drive the change include: ❑ Leadership development: Promoter driven pharma companies will have to build a pipeline of professional leaders at the top to manage the growing complexities like product portfolio expansion, enhanced need for innovation, tighter regulatory norms and geographic diversification ❑ Expand reach to deliver seamless employee experiences: As organisations are expanding across different geographies, HR will have to span disciplines and cross boundaries to deliver holistic employee experiences across its workforce. Organisations will focus on improving performance of diverse, knowledge-oriented workforce by customising people practices to address employee needs. ❑ Workforce analytics: With growing scale of operations workforce analytics can provide competitive edge to organisations. Analytics models today can predict talent aspects like future manpower requirements, key drivers of attrition, strategic roles assessment, health of re-

In order to address the shortage of talent, organisations will have to adopt innovative recruitment practices to attract quality talent from academia and non-pharma industries.

Jayesh Pandey Managing Director, Talent & Organisation at Accenture India

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An emphasis on developing talent specifically in the sales, R&D, quality and manufacturing functions would be crucial since those recruited may have little or no pharma expertise depending on the company’s sourcing strategy cruitment function.

At the same time companies will also have to tackle attrition amongst the field force, which has witnessed exponential growth in the last couple of years. This demand supply pressure is likely to continue and impact business continuity along with cost of recruitment and training .Bringing in engagement strategies to increase employee belongingness to organisations, as well as leadership will play an important role in this aspect. Further, building a compelling Employee Value Proposition, could help retention.

A world class culture

The skills deficit is turning out to be a major challenge for the Indian biotech and pharma industry and it is impeding India’s emergence as a leading global innovation hub for bio-pharma.

Amitava Saha Head, Human Resources, Biocon

Even as Indian pharma comes under closer scrutiny of US FDA, there has to be unflinching commitment to bestin- the world quality standards.

And such enduring compliance can be achieved only through a deep institutionalised culture and strongly ingrained ‘values’ across the firm-led through the personal examples of the top leaders, feels Chandrashekhar.

The role of HR in defining and building such a culture by working closely with the rank and file is crucial. “Building global and world-class leaders, driving innovation, ensuring integrity, quality & compliance and fostering a culture of continuous improvement will be the top priorities of 2014. The HR function must actively analyse the root causes of compliance failures and find ‘culture’ level answers,” he adds further.

While there will be a tremendous demand for candidates with niche skills in technical areas like R&D, process develop-

ment, quality assurance, quality of skills will be the prime concern for the pharma industry rather than quantum of hiring.

No single function can be singled out as less important, says Pandey. Hiring will be critical across functions: be it R&D, sales and marketing manufacturing, regulatory, quality, safety or enabling functions of Finance and HR. The pruning, if any, will happen not around function’s but around low value-adding jobs and tasks in each of these functions Grappling with ingraining a robust culture of high integrity, deepening the habits of compliance with world-class standards of quality, fostering respect for IP- challenges which require round the clock attention, companies need to lead from the front to ensure regulators worldwide of our commitment to quality and patient safety.

Apart from this, the industry needs to raise the bar on competitiveness over the long term through more impact seeking R&D that understands ‘patient’ needs across the world. Efficient and timely drug design and delivery are the most critical success factors here. “The twin challenges of quality and effective product development can be handled only through pro-active talent strategies. As always, hiring world class talent and building a culture that fosters uncompromising quality standards while designing and manufacturing essential medicines will remain at the fulcrum of future strategy,” sums up Chandrashekhar. shalini.g@expressindia.com

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Nurturing the industry Industry associations bridge the gap between companies, policy makers and talent pools. A look at some of their initiatives to create a stronger connect between these stakeholders.

By Usha Sharma

T

he Indian pharmaceutical industry has carved its niche in both the markets, domestic as well as international with its expertise in high end IT and cutting edge science technology.

India has strong research and development (R&D) pipeline, maximum number of US FDA approved manufacturing sites outside the US, low R&D costs, innovative scientific manpower with low cost availability which has attracted multinational pharma companies to invest in India. The country’s emergence as an important manufacturing base, as well as a market for the global pharma industry, makes India an attractive sector for young professionals in a wide range of specialities involving drug development, marketing, project management and technology.

Ranjana Smetacek, Director General, Organisation of Pharmaceutical Producers of India (OPPI) emphasises, “The pharma industry needs to retain and nurture existing talent and equip young workers with the skills and knowledge necessary for better understanding of emerging challenges and opportunities to cultivate a strong image of an employer of choice.”

During 2002-09, many

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Indian Pharmacist Association is making all efforts to provide a platform for the budding pharmacist. We are trying to get all the registered pharmacist under the umbrella of IPA so that a unified voice could be made that would enable all the aspiring pharmacist not to be deprived of what they deserve in the pharma industry Abhay Kumar President, Indian Pharmacist Association

multinational pharma companies decided to conduct clinical trials in India. Seeing the boom in the Indian CRO industry, research analysts have projected manifold growth. Also anticipated that the Indian CRO industry will require large number of skilled and talented manpower to meet the demands.

This forecast encouraged pri-

vate institutions like CREMA, ICRI etc. to start offering courses in clinical research for graduates to enhance their skills and meet the needs of the industry. A few institutions have tied up with pharma and CRO companies, as well as universities to give assured placements. This practice was being successfully followed for last few

years but unfortunately, the Indian CRO industry is now seeing some tough times.

Realising that the Indian CRO industry’s growth has unexpectedly become sluggish, investors, as well as Indian CROs became anxious and started looking for reasons for the slowdown.

The climax in the story came when NGOs alleged that

globally Indian subjects are considered as ‘guinea pigs’ and thus forced regulators to start delaying the approval process, as well as strengthen and monitor clinical trial procedures.

Commenting on the current status of the Indian CRO industry, Dr Arun Garg, General Secretary, Indian Pharmacy Graduates’ Associ-

( ation (IPGA) and Prof and Head, School of Medical and Allied Sciences, KR Mangalam University, Gurgaon says, “The clinical trial industry is suffering badly because of Indian regulatory policies. It should protect human volunteers, as well as provide opportunities to good CROs. The current global pharma business of India is promising and is on the track of growth. Inspite of this, Indian CRO industry is facing problems.”

In October 2013, the USbased CRO, Quintiles decided to shut its phase-I facility in Hyderabad due to regulatory hurdles in India. As per the joint venture agreement the decision was taken mutually

by Apollo Hospitals Enterprise and Quintiles. The closed unit had 20 employees who were given the option to switch to another job at Quintiles. The announcement attracted a fair amount of attention in India, as well as in the global media. Quintiles, however, retained its fullfledged Indian operations.

Challenges Highlighting the challenges faced by the Indian CRO industry, DA Prasanna, Chairman, Association of Contract Research Organizations (ACRO) India says that the most serious challenge in 2014 would be motivating and attracting clinicians to conduct clinical trials in India. He also says that though several regulatory changes have been introduced as a result of the concerns raised by NGOs regarding the safety of participating patients, these changes would need the clinicians to spend significantly more time on conducting the study.

Global HR talent Indian has a sixth of the world’s population and a fifth of the global disease burden.

India is therefore a relevant and important country for clinical research since data from Indian patients is important for both global and local

studies. Globally, the CRO industry is attracting highly qualified scientists and doctors to clinical research. But unfortunately due to uncertain career prospects in India, there is a flight of talent from CROs in India. As per Dr Renu Razdan, Chief Operating Officer, Neeman Max and Vice Chairman ACRO, “Retention of bright and internationallycompetitive people in CROs is the biggest challenge. Since the industry is dependent on regulatory changes, some of which are moving at a snail’s pace, young people do not want to endlessly wait and are looking for other options.”

Opportunities Pointing out the global trend Prasanna informs, “There is one technological global trend which is in India’s favour; this is remote monitoring of clinical research sites. One pharma company out of Switzerland has been rumoured to have ramped up nearly thousand clinical research associates (CRAs) at its India research centre. Since India has competency in IT-enabled services, this could be a silver lining in the dark cloud.”

“The global biopharma markets are more mature and the challenges they face are more in terms of providing continued career growth for employees and meeting their growing aspirations. India, on the other hand, is a relatively younger biopharma market and therefore the challenges are more in terms of recruitment and early stages of career growth of employees,” reveals Trupti Talati, Senior Director, HR, Quintiles India.

Commenting on global HR trends Garg says, “The global HR trends are mostly in molecular biology, biotechnology and genomics leading to new drug discovery which are lacking in India.”

HR strategies The most serious HR challenges in the biopharma/lifesciences industry in India are

The pharma industry needs to retain and nurture existing talent and equip young workers with the skills and knowledge, necessary for a better understanding of emerging challenges and opportunities to cultivate a strong image of an ‘employer of choice Ranjana Smetacek Director General, Organisation of Pharmaceutical Producers of India

India is a younger biopharma market and therefore the challenges are more in terms of recruitment and early stages of career growth of employees Trupti Talati Senior Director, HR, Quintiles India

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not very different from those faced by other industries. The industry is trying its best to maintain talent acquisition and talent management via various programmes and initiatives. Finding the right people for the right role always remains a challenge, as is managing employee expectations and aspirations through effective and integrated talent management. Abhay Kumar, President, Indian Pharmacist Association (IPA) comments, “We believe that the demand and supply of HR for the pharma industry will be optimum and will continue to grow as we hope the Indian pharma sector will touch new heights at the global level.”

Talati feels, “While there is no challenge in acquiring talent in India across the skill sets we require, the level of experience and expertise required and availability varies by business. We use a combination of avenues for recruitment, including online portals, campus recruitment, etc. We have a very strong referral programme at Quintiles India and referrals contribute a significant percentage (much above industry average) to our recruitment requirements.”

Across the sector, each department plays an important role in building the company as a successful entity. Similarly the pharma industry, which is mainly backed by R&D timelines, also has several other departments which basically connect the blocks and makes the entire process into one successful entity. Talati presents her own company’s hiring process and informs, “The hiring outlook across departments for companies such as ours continues to be positive. Historically our company began operations in India with core clinical services and therefore we have a very strong team and presence in this segment. We have also been witnessing strong growth over the last few years in our data-driven and technology services

which are a unique strength of ours in the country. Datadriven services and analytics are the future of transformation in clinical development and we are extremely proud of our capabilities in this area.

This is where we expect to see maximum recruitment over the next couple of years.”

Need for diverse skill sets “India is a major hub for data-driven, technology and analytical services given the tremendous pool of skilled talent we have in the country.

Both these factors, as well as the trend of biopharma players outsourcing for greater efficiencies, augur well for continued growth of biopharma companies such as ours in India. Therefore, our requirements are for diverse skill sets and we recruit professionals with medical and life sciences backgrounds, as well as with data management, biostatistics, business processing and technology backgrounds, in addition to functional expertise,” adds Talati.

Retention strategy Pharma is one among the few industries which hires large number of women in various departments within the organisations. Hence, pharma companies are working continuously to create women friendly work culture and policies within the organisation. Revealing more in this context, Prasanna outlines, “There is a great emphasis to adopt progressive and flexible HR practices.

We support women to achieve a work-life balance, particularly in bringing up children and remaining on the job, during those critical years when they may snap, with family and employer expecting them to be super-human.”

In the pharma industry, few departments like R&D, Q&A and Q&C, legal etc. are considered very sensitive as data related to new molecules need to be kept confidential. Talati shares

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cover ) Quintiles’ retention policies, which help the company retain talent, “Today’s workforce is increasingly mobile and keen on exploring varied options from global exposure to opportunities in new verticals/ departments or sometimes just keen to spend more time with their families. Key to ensuring committed and engaged employees is to adapt organisational policies to create an enabling environment and meet the evolving needs of today’s workforce.”

Vital role of pharmacists In India, doctors and pharmacists are considered as God. However, 2013 has a been dry phase for pharmacists as Indian regulators have made regulations stringent in India. Pharmacists are placed in the middle of the supply chain of medicines, and hence their contribution is quite large. Like other professionals from the supply chain of pharma industry, pharmacists also look for better career options. The recent circular issued by the Indian regulators to keep two full time trained and qualified pharmacists at chemist shops for 24X7 creates better prospects to them. This development helped the pharmacists community and at the same time left no choice to chemist owners but to upgrade the chemist as defined by the law and pay decent salaries to pharmacists.

Kumar states, “A pharmacist plays a very vital and decisive role in the pharma industry.

Sadly, there is not much to say about the demand for professional pharmacists in the other fields. Contrary to the pharma industry, the government sector is not so enthusiastic about the importance of pharmacists in the healthcare sector, while in fact they are as essential as the physician/doctors in India.”

Highlighting the current scenario and actions which need to be taken, Garg points out, “A pool of young scientists are available to the industry but there are

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no adequate opportunities.

There is a large pool of M pharm post graduates available for the industry, but there are hardly few takers.

Commenting on the efforts being taken by the IPA for uplifting the Indian pharmacists, Kumar informs, “IPA is making all efforts to provide a platform for the budding pharmacist. We are trying to get all the registered pharmacists under the umbrella of IPA to create a unified voice to ensure that all the aspiring pharmacists are not deprived of what they deserve in the pharma industry.”

Need of the hour In a competitive world, talent needs to be updated to meet the current requirements. Understating the talent crunch in the Indian pharma industry, the OPPI has especially formed a governance and human resources management committee comprising of HR heads of OPPI member companies. One of the key mandate of this committee is to address issues and challenges for attracting talent in the pharma industry.

While revealing more about the initiative and its functionality, Smetacek informs, “Towards this initiative, an OPPI delegation consisting of managing directors and HR directors, visit academic institutions and interact with both students and faculty. These visits allow students a better understanding of growth trends, challenges and business models in the healthcare industry. At the same time, our members get the opportunity to hear from faculties and students about their concerns, suggestions and expectations, while promoting career avenues in our sector.

In the recent past, the Indian CRO industry attracted a lot of criticism on various fronts. This, in turn, badly impacted the industry's growth.

Disclosing ACRO’s initiatives for the Indian CRO industry, Prasanna informs, “ACRO’s key initiative is to promote responsible clinical research in

The clinical trial industry is suffering badly because of the Indian regulatory policies. It should protect human volunteers as well as provide opportunities to good CROs Dr Arun Garg General Secretary, IPGA Prof and Head, School of Medical and Allied Sciences, KR Mangalam University, Gurgaon

The most serious challenge of clinical research in 2014 is its ability to motivate and attract clinicians to conduct clinical trials D A Prasanna Chairman Association of Contract Research Organizations (ACRO) India

OPPI has formed a governance and HRM committee comprising of HR heads of OPPI member companies.A key mandate of this committee is to address issues and challenges for talent attraction in pharma industry

India by working with all stakeholders in clinical research eco-system. There is a trust deficit between NGO, media and clinical researchers on patient safety. Lower the deficit, better the prospects of attracting investigators and talent to conduct clinical research.

Giving insights on maintaining constant inflow of talent in the Indian CRO industry, Prasanna suggests, “From a long-term and capacity building perspective, bioanalytical expertise and biostatistical expertise is in short supply. Expertise in this area is built by practical experience over the years. Intake of students needs to be increased in these two disciplines. Students should be given extensive on-the-job experience through internships. Perhaps pharmacy schools and statistics colleges should have access to CROs and pharma companies like medical colleges have access to patients (hospitals) and students learn in medical schools as residents.”

He continues, “In the short run, we are working on advocacy so that over conservatism in regulation does not choke the sector.

Secondly, we are supporting skill development in CRO sector by contributing to life science skill development council of Confederation of Indian Industry (CII) and Department of Biotechnology (DBT’s) programmes. As far as members of ACRO are concerned, we employ a signifi-

cant proportion of highly educated and trained women in our service.”

Today's pharmacy graduates are going to be the future of the Indian pharma industry. IPGA has also already initiated a job fair during the 65 th IPC Delhi which has helped many students in making their dreams come true.

More than 100 students were placed at the job fair.

Speaking on the other initiatives that IPGA has been trying to inplement, Garg highlights, “Since last five years our recommendations are to change the curriculum with more emphasis on Drug Regulatory Affairs, Intellectual Property Rights (Patents), Molecular Biology, Genetic Engineering, Herbal Drug Technology, Medical Devices etc. Use of computational skills like videos/power point presentations/webinars etc. in teaching.

Improvements in problem solving skill development and documentations. More industry participation in academics through industrial tours, training by experts from the industry in academics.”

Talati suggests, “We need to adopt processes and policies that allow employees the flexibility to choose their career path be it a lateral or vertical move within the organisation. Creating a culture that fosters synergy between an employee’s expectations and an organisation’s objectives will continue to be top priority.” u.sharma@expressindia.com

(

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‘Agility and flexibility are key company attributes to attract talent’ Dietmar Eidens, Executive Vice President, Head of Human Resources, Merck speaks to Viveka Roychowdhury on the HR challenges faced by the global pharmaceutical industry, the evolution of job profiles and shares his top three recommendations for making the industry become an 'employer of choice'

Given the current business scenario what are the most serious challenges that the global pharmaceutical industry faces today, in terms of getting the right people?

The current work force dynamics in the global pharma industry throws up two challenges: How can we continue to attract expertise, particularly in specialist functions such as R&D, and secondly, how do we engage and retain them.

In addition to these main concerns, there are regional issues. The European Union will have different challenges from North America and emerging markets. In many countries of the EU qualified people outnumber the number of vacancies as the EU pharma market is under pressure. Conversely, emerging markets are in a growth phase so employment opportunities are there but the challenge is to find enough qualified candidates. Agility and flexibility are key company attributes to attract talent in these markets.

Mergers and acquisitions that are so common in today’s scenario also contribute to changing organisa-

tions' game plans and creating skill gaps in talent pools.

In addition, the pharma industry is not seen as progressive as other industries, for instance the IT or high-tech industry.

As Executive Vice President, Human Resources, Merck Serono what are some of the trends you see in the evolution of job profiles in the pharma industry?

The nature of many traditional roles in the pharma business is changing. For example, Medical Representatives (MRs) today need to be up-to-date with very specialised medical information as they are dealing with specialists rather than general practitioners. Increasing competition and the "fight for time with the doctor" leads to the need for innovative sales approaches.

A good example of this is what we have piloted successfully at Merck Serono last year: broadband SMS communication with doctors.

IT does not replace the MR, but builds the foundation for a different relationship. Thus the technological approach

ployees are very different.

A country like India is an ‘employee-driven market’ there is high demand for employees with specific skills and customer interaction skills. Candidates and employees alike today are more aware and better-educated, demand empowerment and career opportunities. Along with changing lifestyles this has made balancing work and life more complex for employers as the offerings that need to be provided are diverse and flexible than even 10 years ago. loaded with information leads to a more targeted visit.

The webinar is the use of technology at its best as we are empowering doctors and other decision makers by providing information in a targeted way. This allows the doctor to invest time with the patient and puts the effort where it is needed the most.

Again, flexibility is key we will continue to hire the standard MR profile as well as a cadre of specialised sales consultants for specific products in specific disease areas.

Consequently, the sources from which we hire these em-

How do you keep up with these changes and what is HR's role to keep pace?

This very much depends on the type of position you target and the type of country you are operating in.

Pharma is an industry with many specialist roles that require specialist profiles, such as in R&D. For these, you will go to academic institutions or the competition to find what you are looking for.

There is no difference between mature and emerging markets. It also applies to the fact that, generally speaking, scientists and researchers in

the R&D function often have different interests and drivers from employees in the sales and marketing functions. This is driven by the different nature of work they are expected to do. These factors mean that employees in these areas define organisational culture and job satisfaction differently. As an employer, we must meet the different demands equally well to ensure retention of these key employees.

HR’s role is to stay close to the changing demographics of the workforce and to ensure the company provides the right instruments for attracting, selecting, rewarding and retaining these talents.

HR needs to work closely with the business and demonstrate agility and flexibility in working with the business leaders on successful talent management.

How has your company engaged with the Gen Y workforce?

We have achieved this in a number of different ways.

First, we have adjusted our EVP (Employer Value PropoContinued on Page 31

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‘The opportunities are going to be better, but for better qualified and experienced candidates’ Prakash Shanware, President and Chief Executive Officer, PeopleFirst, in an interaction with Sachin Jagdale, speaks about how the pharma industry is able to provide better prospects to the candidates who are consistent in performance and stay with the company

Do you feel that employment prospects for students are better this year in the pharmaceutical/life sciences industry, given that the sector has proved to be somewhat more resilient than other sectors inspite of the economic slowdown?

The pharma sector in India is growing with both expansion and new facilities are coming up and thus providing employment opportunities for the youngsters. The opportunities are going to be better, but for better qualified and experienced candidates. For freshers in the technical field much will depend on the institute from which the students are passing out and the facilities specially for laboratory and industrial training provided by them. Employers want to hire candidates who has handled laboratory instruments, machines during their studies since they are able to pick up the job much faster at the work place.

For non-technical position there seems to be lesser opportunities since companies prefer to use technology rather than adding people.

Do you feel that the industry is able to meet the aspirations of the desired talent pool, in terms of faster

36 EXPRESS PHARMA February 16-28, 2014

growth, better compensation packages, better exposure, etc?

The pharma industry is able to provide faster growth for candidates who are fast learners, shows initiative and contribute significantly in their area of specialisation. A candidate who is consistent in performance and stays with the company will have better chance to grow than a ‘rolling stone’. Companies are increasingly looking at people who have stayed longer and had grown with a company.

Which sectors compete for the same talent? On what parameters do these sectors score over the life sciences industry, i.e. faster growth, better compensation packages, better exposure, etc?

The alternative opportunity for technical candidates comes from hospitals and pathology labs. But the technical candidate still prefer to work with a pharma company. For nontechnical and sales category, candidates prefer to join IT, retail, FMGC, consulting, since these sectors offer good compensation, faster growth and comfortable work environment.

Many pharma colleges are

hence are not able to get a decent job inspite of spending a considerable amount of money.

Approval to such new pharmacy colleges should be given only if adequate facilities for providing practical experience to students exists so that employable graduates pass out from the institute.

cropping up even in remote areas of the country. What should be done to test the credibility of such institutes?

Don’t you think that students enrolling themselves at such colleges are risking their careers?

There is a spurt of new pharmacy colleges coming up all over the country, some even in remote areas where there is no presence of pharma industry. Such institutes do not have proper facilities, adequate practical exposure, poor faculty and hardly any interaction with the industry. Students get theoretical knowledge and are not able to connect their knowledge with the practical aspect of the job. Students even after acquiring a degree

Should pharma companies open their placement cells at such colleges as well so that deserving talent will not be kept deprived of right opportunity?

With the pressure of hiring suitable candidates increasing on the human resource department, there is hardly any time for them to get involved with the developmental activity of the institutes. Pharma companies who have put up manufacturing facilities in interior tax saving areas, should engage themselves with new and old pharmacy institutes by providing training, interaction, factory visits and even financial help to set up modern laboratories. This will provide proper exposure to the students who ultimately could be hired by them or by any other pharma company. This also could become a part of the companies’ CSR activity. The locals who are educated and trained will

find themselves a job closer to their home. The improvement in the availability of the trained personnel will also reduce the conflict between the locals and outsiders which has been disturbing many organisations who hire people considered to be outsiders since the qualified manpower is locally not available.

How about Indian pharma colleges tying up with counterparts abroad? Is this happening already? Will such association help pharma industry to get desired pharma talent?

The reputed institutes are collaborating with the international institutes, as well as with local and international companies. However, the percentage is too small. As a first stage collaborating with pharma companies, providing them help by taking up small projects will provide the students with the right type of exposure. The supply of pharma graduates is much more than the demand and hence the quality of the product (students) will decide the reputation of the institute.

The Indian pharma industry has come a long way in establishing itself as the global Continued on Page 37

(

THE MAIN FOCUS

Continued from Page 35

Continued from Page 36

‘Agility and flexibility...

‘The opportunities...

sition). Based on our Merck values*, we have defined more clearly what we stand for and modernised the way how this is communicated internally and externally.

Second, we have launched specific development programmes to engage the GenY workforce and build the leadership pipeline by enhancing diversity within our talent pool.

These programmes are targeted at providing accelerated career paths and enriching employee development by fast-track company-internal education.

Third, we develop Gen Y employees primarily through exposure and expe-

hub for generic medicines.

The culture of being truthful, transparent and complied will have to be built up on a priority basis to maintain our creditability. The quick fix approach, jugard, chalta hai approach followed by employees at the shop floor and junior to middle management level will have to change. Data integrity and recording on what is being done and doing what is recorded although seems to be natural, does not happen with a large number of work force.

Building a proper culture and ensuring that everybody is trained and follows the working norms without any compromise is a bigger

rience, rather than formal education and training programmes. This is based on our belief that practical work experience combined with exposure to senior leaders and challenging assignments provides the best framework for job satisfaction and good performance, not only for Gen Y employees, but especially for them.

What are your top three recommendations for making the pharma industry (globally and in India) become an 'employer of choice'?

I believe that the top three priorities for making the pharma industry an ‘employer of choice’ are:

1. Career progression: providing diverse opportunities where an employee benefits from having an exposure to varied experiences to support her/his career 2. Quality of life and content of work: being flexible and attuned to the pulse of the employee 3. Opportunity for learning: to evolve and flourish both personally and on the professional front as well

(*Merck Values: http://www.merckgroup.com /en/company/mission_statement_values_strategy/values.html) viveka.r@expressindia.com

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challenge for the management.

Is reverse brain drain evident in the pharma sector as well?

There are cases where qualified pharma professionals are returning back to India but the numbers are too small and the ones who return also start showing frustration very quickly due to the lack of proper facilities, work culture and quality of life. It is long way for India to get the global pharma talent to move to India, contribute and stay happily.

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EXPRESS PHARMA

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February 16-28, 2014

MANAGEMENT

38 EXPRESS PHARMA February 16-28, 2014

WISH LIST OF POLICY CHANGES

With the general elections around the corner, the Finance Minister will present a 'Vote of Accounts' rather than a budget. Even though the VoA is merely a listing of projected expenses till the new government is formed, and we will most likely see a budget passed in June, representatives of pharmaceutical companies and industry associations are keen to put forth their wishlist in terms of policy changes, probably making sure that the new government is aware of their pain points and demands. Express Pharma presents some of the top points on their wish list

EXPRESS PHARMA

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February 16-28, 2014

MANAGEMENT

‘Endorsement of bill of entryshould be restarted as loan licenses are verycommon in pharma industry’ Indirect taxes The pharma industry faces a huge problem due to the inverted duty structure, i.e. higher duty on inputs at 12 per cent and lower duty on final products (six per cent) and the resulting accumulation of ever mounting cenvat credit.

Hence, we request that parity be introduced in the input/output rates of excise duty for pharma products. Pharma exports should be allowed to be cleared at marginal rate of duty (12 per cent as on inputs).

This would benefit the pharma exporters at no loss or burden to the exchequer and domestic market.

1. Utilisation of cenvat credit for payment of service tax on reverse charge basis must be allowed. Easy and prompt refund of accumulated credit must be allowed under Rule 5 of cenvat credit rules.

2. Refund based on self–assessment and certificate is-

40 EXPRESS PHARMA February 16-28, 2014

sued by chartered accountant can be processed.

3. Scrutiny of refund claims should only be for issue-based cases and that is required to be made only after the sanction of the refund claim.

4. Interest should be paid if the refund claim is not sanctioned within 30 days of the application.

5. Credit of excise duty must be allowed while in the same group of factories having same PAN. 6. Physician samples may be exempted from excise duty as they are just two per cent of the total turnover.

MRP abatement of 35 per cent should be increased to 4550 per cent. Industry was advised to provide reworking justifying increase of abatement.

Industry emphasised that expired goods and distribution cost should be taken while calculating abatement.

Capital goods of Cenvat is

DAARA PATEL Secretary – General, Indian Drug Manufactures’ Association

allowed only twice a year. It should be allowed as is permitted to SSI. Exemption limit for small scale industries be raised to `10 crores.

Endorsement of bill of entry should be restarted as in pharma industry the loan licenses are very common.

Credit should be allowed for service provider.

There is disparity in the rate of interest payable by the taxpayers (@ 18 per cent) and the refund by Government (only @ six per cent) needs to be removed to encourage efficient tax administration. Customs authorities are denying exemption from bank guarantee in respect of advance authorisation where jurisdictional excise authorities have issued an order in original and matter is under sub-judice.

In such cases exemption from bank guarantee should not be denied when the matter is under sub-judice.

1. All life saving drugs should be exempted from customs duty.

2. Life saving medical devices should also be exempted

from customs duty.

3. Basic customs duty on formulations should be reduced to five per cent.

4. Import of all capital goods, raw materials, consumables, and reference standards for R&D purposes should be fully exempted from customs duty and others related duties.

5. Import of reference standards should be totally exempted from customs duty, CVD etc.

Direct taxes IT circular disallowing expenses as gifts, conference visits etc. for doctors should be prospective and defined clearly.

Weighted deduction should be increased from 200 per cent to 250 per cent under 35(2AB).

All expenses including clinical trials, land and building expenses on actual bases must be allowed as weighted deductions under R&D.

MANAGEMENT

‘Create rare disease patients registries by linking all institutions’ I recommend the following for the upcoming budget: 1. Special healthcare policy to include all rare diseases in India for diagnostic, treatment and rehabilitation and supportive care for those where there is no treatment options.

2. Encourage and ease the process for international pharma to introduce Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved orphan drugs for the benefit of Indian rare disease patients.

3. Setting up an exclusive rare disease department/unit under the health secretary to address the needs of rare disease patients. Such a department should have appropriate budget to meet these above needs. A single window for clearance of import of orphan drugs and life-saving drugs would be ideal.

4. Government should clear all hurdles to allow swift review and approvals of well designed clinical trials that meet regulatory compliance.

5. Tax subsidies for companies involved in diagnostics, R&D for rare diseases. This includes genetics, genomics, DNA and RNA sequencing based research, drug development, etc. Without good diagnosis, pharma companies will not invest in India.

6. Conduct and gather comprehensive surveys (e.g., part of census) to understand needs of rare disease stakeholders nationally to incorporate in the government’s healthcare vision document. This can provide the necessary statistics to plan for future budget allocations and strategic initiatives for rare disease community.

7. The medical education and training programmes for government doctors to include not only the most common diseases but help create the next generation of doctors trained in diagnosing and treating rare and genetic diseases. These changes are aligned with the global medical community that is rapidly embracing the practice of ‘personalised’ medicine. Also, the curriculum needs to be updated accordingly for medical education in the coun-

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try to ensure that future doctors are equipped with necessary skills to effectively diagnose/treat rare diseases.

8. Encourage the pharma R&D community to invest in discovery of novel diagnostic methods and orphan drug development by offering incentives. The US, Japan and other countries have enacted Orphan Drug Acts for this purpose in their respective countries since 1983, and the time is ripe for the most populous democracy to act now.

9. Identify key components of an evidence-based value proposition. Make it part of compassionate access programme that would support market access for a treatment for rare diseases.

10. Create rare disease patients registries by linking all institutions etc.

11. All the rare disease patients also need to be included in the disability list to eligible for all the benefits under the law.

12. New born screening to start for a early diagnosis.

13. Genetic counselling centres to be set up across the nation.

EXPRESS PHARMA

41

February 16-28, 2014

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MANAGEMENT

‘Cancer should be made the healthcare priorityunder Companies Bill and should be made a notifiable disease’

T

he cancer problem is growing exponentially in India.

In the West, 65 per cent of cancer patients are cured (no evidence of disease, no medication required and return of normal life expectancy). In India we are able to do this to only 30 per cent of our cases. Inspite of the fact that we have the knowledge and the ability, we are unable to implement for the majority of our patients.

So current measures are not enough, at least a 100 more cancer hospitals are needed.

The funds allocated by the government can be used more efficiently if they partner with NGOs. The cancer NGOs and support groups are those that have a reach, have hands to do

the work and are emotionally committed to do a great job.

Last year, half the amount allotted by the Government of India for cancer control remained unutilised and returned to the central pool.

The government has the money and the intention but cannot implement due to lack of infrastructure and human resources. This is where the NGOs can step in as implementing partners to the government. When all stakeholders come together, advocacy becomes easier and makes a meaningful change, example is the ban on gutkha in almost the entire country thanks to the initiative, ‘Voice of tobacco victims.’

Since the Companies Bill of 2013 has made two per cent

PURVISH PARIKH President, Indian Society of Medical and Paediatric Oncology

spend on CSR compulsory, the projected `30,000 crores from listed and unlisted companies will be available. The Million Death Study in India showed that seven per cent of all deaths in India are due to cancer. So cancer should be made the healthcare priority under this Companies Bill. Cancer should be made a notifiable disease. This will ensure that we can record and track each and every patient across the country, helping us to document its pattern and whether we are allocating the funds to tackle the right cancers and in the right manner.

If this is not possible, all healthcare professionals and health institutions should compulsorily be made

to provide cancer related information to all Cancer Registries in India on a priority basis. Specifically, a policy change is necessary so that hospitals, nursing homes, health facilities and pathologists cannot deny providing such data to cancer registries. This is the only way the government will have enough data to decide future strategy, policy and to tackle the cancer tsunami. All hospitals having a cancer department/facility must have an independent cancer NGO representative on their advisory board.

The name and designation of this member should be prominently displayed in the hospital so that patients can benefit.

‘Government will keep in mind the industrygrowth and will talkabout Advance Pricing Agreements’

T

he expectations from this year’s Union Budget for the pharma sector will be around tax deduction and planned incentives for growth drivers of the sector that includes contract manufacturing, R&D for pharma drug discovery and clinical trials besides the following:

42 EXPRESS PHARMA February 16-28, 2014

1. Cut on excise duty on both chemical inputs and finished pharma products.

2. Export-related fiscal support.

3. Reduce the Minimum Alternative Tax (MAT) on pharma and biotech industry.

4. Nil service tax under reverse mechanism on R&D’s services.

5. Reduction of customs

duty or exemption of customs duty on certain /specified chemical/API in order to promote R&D sector in India, keeping in mind that it is the main key driver in Indian economy’s growth trajectory.

6. We are expecting that the Government will keep in mind the industry growth and will talk about Advance Pricing Agreements (APAs) that

would predominantly assist healthcare and pharma companies to considerably reduce uncertainty on taxation of such international transactions.

7. The Government may want to look at providing weighted reduction to clinical trial expenditure done by nonmanufacturing bodies in approved hospitals.

DR RAJESH JAIN Joint Managing Director, Panacea

MANAGEMENT

'HIVbill which has been pending for over a decade nowshould be introduced at the earliest'

I

n comparison with the western world, Indian government lacks the provision of healthcare reimbursement to its population.

Suggestions under the title of affordable medicines for all could be: A certain section of medical reimbursement for people below poverty, nearing poverty and just above poverty line can come under a nationalised medical reimbursement scheme. Some of these policies are in place but the percentage of reimbursement reaching the masses needs to be increased.

Further, under the SME scheme, companies who can incur low manufacturing cost and provide generic medicines at affordable prices to the common man should be encouraged with a set standard of bioequivalence criteria.

Clinical research industries who do BA-BE studies for such SMEs should be given a direct/indirect tax benefit for such services.

Considering that India is the third largest AIDS/HIV affected country, the HIV Bill which has been pending for over a decade now should be introduced at the earliest, to ensure the equality of treatment to AIDS/HIV patients in all classes.

Service tax By covering all types of drugs research it shall be an incentive for CRO's for export business which shall increase foreign exchange earnings and will be able to meet the in-

APURVA SHAH Group Managing Director and Co-Founder of Veeda Clinical Research.

ternational business requirements and be price competitive as compared to other Asian countries.

Income tax This shall boost the research activities in India and can make India a global research hub by becoming more competitive among other Asian countries.

Both the above amendments shall also increase the employment in the country by way of developing the existing and new units and will also increase export business which shall increase foreign exchange earnings.

EXPRESS PHARMA

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February 16-28, 2014

MANAGEMENT

‘The government should come up with safe harbour rules’

W

e expect the Central Government to notify the safe harbour rule for the entire pharma industry. Since the pharma sector happens to be a major exporter to various countries worldwide, it is exposed to transfer pricing risks.

As of now, big pharma companies dealing in contract research and development (R&D) are getting benefited from the relaxed transaction limit for availing the safe harbour provision in the

pharma industry. However, for generic players with major exports, the safe harbour rule could prove to be a credible alternative to avoid transfer pricing disputes. Therefore, the government should come up with safe harbour rules so as to reduce the cost of compliance and litigation.

Excise duty on active pharmaceutical ingredients (APIs) should be reduced from 12 per cent to match with formulations subjected to central excise duty of only six per cent. A higher rate of central excise duty on APIs as com-

pared to the formulations has been resulting in accumulation of cenvat credit for manufacturers who are dealing only in the domestic markets or have minimal exports.

Furthermore, as there is no provision for pharma manufacturers to get the accumulated cenvat credit refunded, it is eventually adding to their expenses/costs.

As clinical trials are a fundamental requirement for all the research products before introducing them in various markets, all the costs involved, whether in India

or overseas, should be a part of the R&D costs under section 35 (2) AB of the Income Tax Act. On the tax exemption front, the minimum alternate tax (MAT) rate should be reduced and units in backward zones like Himachal Pradesh or Sikkim should be excluded from MAT. This will boost R&D in pharma companies as reduction in MAT rate and exclusion of units from MAT would help in generating good profits.

The pharma industry is an export-oriented one and in

DHEERAJ AGGARWAL Chief Financial Officer, Venus Remedies

the wake of global uncertainties, exports now need some incentives. It is suggested that export-based deductions, like the one under the previous section 80HHC of the Income Tax Act, should be reinitiated.

‘Pharma/healthcare companies sponsoring health checks in communities should be given 50 per cent or 100 per cent taxrebate’

I

n terms of policy, we would like to see a) Tax concessions for spends on diagnosis (as part of preventive health checkups).

Direct tax 1. Companies giving preventive health check-up facilities to their employees maybe granted a tax rebate on such expenses 2. Pharma and other companies in the healthcare sector that sponsor health

44 EXPRESS PHARMA February 16-28, 2014

checks in communities should be given 50 per cent or 100 per cent tax rebate for such expenditure b) Simplification of collection of net taxes by revenue authorities. Asking assesses to pay gross amount first and claim refunds later is time consuming and blocks funds.

Indirect tax Additional Duty of customs (ADC) levied in lieu of local VAT generally at the rate of four per cent. This duty is

RAVI DAWAR Director Finance, BD India

levied in lieu of state VAT and is restored to the assessee either in form of refund (in case of trading of goods) or credit (in case of manufacturers). It can be put forth that the ADC for which refund is sought within one year of payment of duty, can be waived off by the government.

This is because huge cash flow in terms of duty cost, time and efforts is involved in making payment to the government and then obtaining the refunds for the same.

Extra duty deposit (EDD) At one per cent in case of special valuation branch proceedings. The levy of EDD which is deposited in case of associated company imports at the time of provisional assessment, which is later refunded to the assessee on the final assessment may be dispensed with. This is because of practical difficulties in terms of time and costs attached to it, which delays the refund and blocks the cash flow for the assessee.

MANAGEMENT

‘To discourage Chinese units from mushrooming their products in India,audit of all Chinese units should be mandatory’

C

ontentious problem faced by the pharma industry of the huge cenvat accumulations is a cause of worry for all of us. The basic problem of rate anomaly in the excise duty on input vs output and high rate of service tax on input services has not been addressed and further to that the amendment of restrictive transfer mechanism in revised Rule 7 effective 1.4.2012, have aggravated the issue and cenvat accumulation is piling up every year which is resulting in financial loss to the industry as a whole.

Anomaly in excise duty for domestic industry Excise duty on input is higher than on finished goods.

This is resulting in imbalance on inputs vis a vis output. Particularly in excise exempted area, manufacturers have to absorb inputs of excise and cannot pass it on to the finished good buyers.

Affect of China on API industry in India The Indian pharma industry is being fragmented with small balance sheet size. Dependency on import of the API used in formulation is due to cheaper cost of APIs from country like China. More than 65 per cent dependability is on China, particularly on antibiotics etc. If suddenly China

withdraws, what will be the fate of Indian pharma industry and patients as a whole?

Suggestions 1. The government has to come forward with a special scheme to encourage those products to be produced in India itself instead of depending upon China. The scheme can be of cheap and stable power, environmental technology deployment support, conducive norms and fiscal benefits to all bulk drug and intermediate manufacturers etc. Dedicated bulk drug zones to address pollution norms. Revival of PSUs on the basis of PPP mode of encourage fermentation-based products like Pen.G etc. There is a paucity of biological strains in our country. The existing strains have poor yielding capacity.

There is a need to develop the infrastructure and technique of R&D.

BR SIKRI Vice Chairman, CIPI and Director ABS Mercantiles

2. QC Labs are very expensive. We should develop clusters where world class QC labs are set up.

3. Common facilities such as patent libraries, regulatory affairs, etc. should be provided at identified areas.

4. Working capital norms are not workable. There is a need to increase the number of days from 90 days to 150 to 180 days working capital lend-

ing norms keeping the current industry scenario into consideration.

5. Priority allocation of coal and bio fuel natural gas.

6. Soft loan to younger generation who are interested in setting up new pharma API or intermediate industry, without collateral security, less rate of interest and more moratorium.

7. To develop Excise Free Mega Park.

8. Develop clusters of R&D, bio waste management.

9. Rational use of anti dumping duty.

To discourage Chinese units from mushrooming their products in India, audit of all Chinese units should be mandatory, who so ever is supplying APIs to India.

China does not register any unit for any products in India without audit whereas in India we have soft corner for them and without any audit

The basic problem of rate anomaly in the excise duty on input vs output and high rate of service tax on input services has not been addressed and further to that the amendment of restrictive transfer mechanism in revised Rule 7 effective 1.4.2012, have aggravated the issue and cenvat accumulation is piling up every year which is resulting in financial loss to the industry as a whole

we are registering their products and giving everything to them on a platter.

To increase the registration fee of Chinese products in India. At present we charge them very nominal amount whereas they are charging exorbitant amount. this anomaly has to be removed.

Majority of the APIs and intermediates units are in the SSI segment. Special incentive schemes by way of less Income Tax etc. to such category. By this way we can revive many sick units which got closed resulting in depndability more on China.

In 2006, the concept of large taxpayer unit (LTU) was introduced in Bangalore and subsequently this scheme was extended to Chennai, Kolkata and Delhi too. Hyderabad and Visakhapatnam being the hubs of pharma industry, similar facilities under LTU may be extended to these two cities too. Prior to Budget 2011-12, SEZ developers and units were exempted from MAT under section 115 JB(6) of Income Tax Act. During the Budget 2011-12, MAT on book profits of both SEZ developers and units located beside these enclaves was imposed.

It is suggested to exclude them from calculation of MAT Lastly, we should discourage import of APIs through unregistered source

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February 16-28, 2014

MANAGEMENT

‘Hopeful that the government will consider favourable economic policies and fiscal measures in the 2014-15 budget’

T

he Organisation of Pharmaceutical Producers of India (OPPI) acknowledges the efforts of the Government of India in partnering with the pharma industry towards making medicines more accessible and affordable. As an industry, we are hopeful that the government will consider favourable economic policies and fiscal measures in the 2014-15 budget.

There are five key areas where the government can play a key role and promote an environment that is conducive to the growth of the industry while also overcoming healthcare challenges – 1) Healthcare infrastructure building 2) Improving access to medicines 3) Reduction in transaction costs 4) Incentivising R&D 5) Reduction in tax burden.

The OPPI member companies expect that the government will take measures to make all imported lifesaving drugs more affordable to the patients by eliminating the import duty.

Direct taxes ● Rural and semi urban areas in India lack basic healthcare infrastructure which needs to be addressed. In order to boost investment in such areas, tax benefits on capital expenditure incurred in such areas needs to be provided ● Setting up infrastructure

46 EXPRESS PHARMA February 16-28, 2014

involves substantial financial investment and a long gestation period. Hence, tax benefits should be provided for units engaged in the business of R&D and contract manufacturing by way of deduction from profits linked to investments ● Provision should be made specifically for weighted deduction of R&D expenditure in case of companies incurring R&D expenses where a part/entire manufacturing activity is outsourced ● For India to emerge as a low cost healthcare medical destination, greater impetus needs to be provided for the setting up of state-of-the-art healthcare facilities in the metros, Tier-I and Tier-II cities through appropriate tax benefits.

Indirect taxes 1.Basic Customs Duty (BCD) for health supplements should be reduced to five per

RANJANA SMETACEK Director General, Organisation of Pharmaceutical Producers of India

cent and CVD/central excise duty to one per cent or six per cent to make it at par with drugs. This would help in making the said beneficial products affordable to the common man 2. All life-saving drugs (including medical devices) should be exempted from cus-

tom duty. All equipment meant for diagnostic purposes and consumables thereof should be completely exempted from the levy of customs/central excise duty 3.CVD should be charged at a lower rate of one per cent on import of vaccines, specified medicaments and health supplements imported into India. BCD rate on import of formulations should be reduced to five per cent.

Central excise duty 1. The central excise duty rate of API may be rationalised and made at par with pharma goods i.e. excise duty on the inputs (API) may be reduced from 12 per cent to six per cent 2. An abatement of 45 per cent to 50 per cent is necessary to enable pharma industry to cover its costs while calculating the central excise duty payable. This abatement

The OPPI member companies expect that the government will take measures to make all imported lifesaving drugs more affordable to the patients by eliminating import duty.

As an industry, we are hopeful that the government will consider favourable economic policies and fiscal measures in the 2014-15 budget

should be increased to 45 per cent -50 per cent as the current 35 per cent abatement does not even cover the trade margins and the value of R&D costs and other costs associated with the pharma industry such as distribution of many medicines through “cold chain” (for e.g. vaccines)

Value added tax (VAT) The tax rate of four to five per cent on medicines and the list of tax-exempt goods and declared goods should be uniform across all states

Service tax 1. Cenvat credit of service tax paid should be allowed to brand owner on goods manufactured through job worker or brand owner may be allowed to distribute the credit to the job worker to do away with inequitable situation differentiating between manufacture in-house or at the job workers premises 2. Service tax should not be levied on R&D/testing services performed in India where the recipient of service is situated outside India.

3.

Clarification is required on definition of sponsorship service in order to determine service tax liability under reverse charge on such services and also on other services for depositing service tax under the respective heads.

(With inputs from Usha Sharma, Sachin Jagdale and Shalini Gupta)

MANAGEMENT LEGAL EAGLE

Unregulated stem cell therapy– AFrankenstein monster in the absence of effective laws Satish K Gupta, Partner, Rautray and Co Law Firm and Dr BM Gandhi, Chief Executive Officer, Neo BioMed Services, Former Advisor, Department of Biotechnology, Government of India give an insight about the need of safety aspect of the stem cell therapy

THE CLAIMS pertaining to stem cell therapy that it is very effective and affordable without any high costs, risks, side effects, hassles are very prominent and have regularly started appearing not only on various sites of the Internet but also being published in newspapers.

One of the Internet sites has even claimed anti-ageing, health and beauty benefits from stem cell therapy.

In the past few months some of the reports published in daily newspapers states: ● Babies diagnosed with brittle bone disease can now be treated before they are born, thanks to a new stem cell treatment. ● A Pune-based stem cell centre has treated patients with various diseases, such as diabetes mellitus, multiple sclerosis, Parkinson’s disease, duchenne muscular dystrophy, and many others, including rare genetic and hereditary diseases. Among patients there are also people willing to undergo anti-ageing treatment. ● A Bangalore-based hospital had started treatment in regenerative medicine and stem cell therapy three years ago and have achieved significant success. Patients who entered the hospital paralysed below the neck have walked out using a crutch or walker. ● Improvement seen in just five day after stem cell therapy treatment for stroke by a doctor based in Mumbai. ● A private hospital in Delhi had claimed that stem cell therapy has been found useful in over 60 per cent of the patients due for

48 EXPRESS PHARMA February 16-28, 2014

liver transplant and the treatment is not only less cumbersome and risky but costs are also comparatively very reasonable, even less than `50,000.

The report further claimed that all patients responded well to the treatment without any side effects.

Reporting of such medical achievements in the Internet or newspapers by way of advertisements/publications by the doctors involved in stem cell therapy research are in gross violation of the guidelines laid by Government of India. Such publications in newspaper definitely raises expectations in the minds of general public that stem cell therapy is very economical, well tolerated and without any side effects. The researchers in this medical field very well know that safety aspect of the stem cell therapy is yet to be established before putting its use on commercial therapeutic applications.

The Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT) in 2012 had issued guidelines (The Guidelines) to ensure the safety and rights of participants receiving stem cells transplants and patients at large from receiving unproven stem cells therapies. All such research needs to be guided by the principles laid down in the Ethical Guidelines for Biomedical Research on Human Subjects

by ICMR. The Art. 5.7 of The Guidelines states under the subject, “Responsibility for Conduct of Stem Cell Research: Investiga-

SATISH K GUPTA

DR BM GANDHI

Partner, Rautray & Co. Law Firm

Chief Executive Officer, Neo BioMed Services, Former Advisor, Department of Biotechnology, Government of India

tors, Institutions and Sponsors” that the physician/scientist engaged in stem cell research and therapy shall ensure that no hype or unrealistic expectations are created in the minds of subjects or public at large regarding stem cell therapy.

Even the preamble of the aforesaid Guidelines clearly states that stem cell research raises several scientific, ethical and social issues in the development of such applications. Furthermore, there are also potential dangers of tumorigenicity with use of these cells keeping in view their potential for unlimited proliferation and possible introduction of genomic changes and also has limitations of immunological tissue incompatibility between individuals.

The Guidelines issued by the ICMR and DBT are restricted mainly to stem cell research and does not address the major issues of therapeutic applications.

The effectiveness of the Medical

Council of India to regulate clinicians involved in unethical acts is already in controversy.

International Society for Stem Cell Research advocates dissemination of best practices to promote uniform practices worldwide following the guiding principles of responsible science, protection of citizens, intellectual freedom, transparency and integrity towards the welfare of human beings.

The era of using commercially stem cells for therapeutic use for a variety of diseases have set in worldwide and India is emerging as one of the leading centres for stem cell-based research and therapy. The private banking of cord blood is also growing at a fast pace in India.

Clinics have started mushrooming in India which are offering largely unproven stem cell therapy. Such therapy puts desperate patients at health and financial risks. There are reports that unproven injections

being sold for around ` 80,000 and several companies are advertising their therapies and clinical trials as ICMR approved. Others are providing unapproved stem cell therapy underhand providing two to three doses of stem cells for cost ranging between ` 5 to 10 lakhs.

The companies are taking advantage of the lack of effective laws governing the stem cell therapies.

Questionable safety of stem cell therapy Developments in the field of regenerative medicine and stem cell research are relatively new and are associated with complicated ethical, social and legal issues. Doctors have started treating a wide range of diseases by believing that the use of adult stem cells is safe. On the other hand, various studies have shown that adult stem cells can cause severe complications and side effects in the form of cancer or tumour.

It is an admitted fact that very little pre-clinical data on animal models is available and most of the treatment modalities have not gone through rigorous clinical trials to ensure the safety of the treatments.

There is a strong apprehension that the unethical medical practices may grow tremendously in the absence of any effective legal control.

In India there is an urgent need to place legal laws and enforcement agencies in order by the Government before such medical practice goes out of control of any regulatory/legal

MANAGEMENT bodies or otherwise.

At present there is nothing in The Guidelines to outlaw, prohibit or punish those carrying out stem cell therapies. Stem cell treatment in humans must be governed under effective laws which should take care of all the aspects pertaining to its source, storage, research, uses in treatments, as well as punishments and compensations in the event of violation or indulgence in unethical practices in humans.

The advancement of medical treatment is unregulated and taking advantage of this, a large number of hospitals and industry involved in cellular therapies have started providing treatment for which stringent safety aspects are yet to be established.

The immediate need of the hour is to put in place effective regulatory bodies and suitable amendment in the laws to include stem cells before situation goes out of control to check the expansion of unethical services.

It has been recently reported that one of the world’s largest research funder, the National Institutes of Health (NIH), which is a part of the US department of health and human services, has cancelled almost 40 ongoing trials in India. Another 157 trials have been put on hold. The main reason behind this move is unstable regulatory environment in the country.

Guiding Indian policies

Research 2012 Under the Guidelines 2012, even though the stem cell research is promoted for therapeutic purposes, all stem cell therapy in India is considered to be experimental, with the exception of bone marrow transplants. Stem cell therapy is legalised but the use is limited to stem cells from adults, bone marrows or foetal cord blood.

Embryonic stem cell therapy and research is restricted.

Generation of embryos for sole purpose of stem cells is prohibited and requires consent of National Bioethics Committee.

However, use of surplus or supernumerary embryos from registered ART clinics is permitted. Implementing and monitoring is through Institutional Committee (IC-SCRT), Institutional Ethics Committee (IEC) and National Apex Committee (NAC-SCRT).

To regulate the use of stem cells, emphasis is given on basic research involving preclinical, clinical trials and clinical research to prove the efficacy, safety and utility of the cell types used before it is put to therapeutic applications. Strict procedures are prescribed for sourcing and use of stem cells by research institutions, however, the guideline is silent on legal measures on unethical use.

National Apex Committee for Stem Cell Research and Therapy was set up to govern the stem cell-related research and therapy. But the main apprehension is that how in the absence of legal measures this committee will be able to curb unethical stem cell medical practices. At present, if a consumer has a complaint against a stem cell research, the government has no power to act on the complaint. The Guidelines are totally silent on how to prohibit or punish those carrying out unethical stem cell treatments.

◆ Policy statement on ethical guidelines- ICMR 1980 Ethical Guidelines for Biomedical Research in Human SubjectsICMR 2000 ◆ GoI Guidelines for Exchange of Human Biological Material for Biomedical Research Purpose – ICMR 1997 ◆ Guidelines for Accreditation, Supervision and Registration of Infertility Clinics – ICMR 2004 ◆ DBT Guidelines for Genetics and Stem Cell Research- DBT 2002 ◆ Preconception and Prenatal Diagnostic Techniques Act, 2003 ◆ Drugs and Cosmetics (3rd

STEPS initiated by the Government of India to tighten regulatory laws on stem cell therapy

Amendment) Rules 2011 for Cord Blood Stem Cells ◆ Guidelines for Stem Cell Research and Therapy, ICMR DBT 2007 are now the Guidelines for Stem Cell

Government of India and the state authorities have prime responsibilities and jurisdiction to ensure the safety of patients seeking cellular therapy. The laws and regulations must dif-

Generation of embryos for sole purpose of stem cells is prohibited and requires consent of National Bioethics Committee. However, use of surplus or supernumerary embryos from registered ART clinics is permitted ferentiate clearly between standard therapies and other cellular therapies approved for marketing and clinical trials.

Government of India has initiated some steps towards regulating stem cell therapies. The Ministry of Health has issued Drugs and Cosmetics (3rd Amendment) Rules 2011 for manufacture of blood products and collection, processing, testing, storage, banking and release of umbilical cord blood stem cells under the Drugs and Cosmetics Act, 1940 which will govern cord blood stem cells.

The Ministry of Health and Family Welfare also constituted a high powered committee in June 2013 for the regulation of stem cell and other cell-based therapies being practiced in India and to make specific recommendation for effective regulation of stem cell products and stem cell therapy / research.

The Supreme Court of India in an writ petition filed in 2012

by Swasthya Adhikar Manch had directed the Director General, Health Services or the Secretary Ministry of Health to file an affidavit on different aspects concerning the clinical trials of new chemical entities in particular the deaths and adverse impacts that have taken place from 2005 till June 2012.

The apex court had also observed in the aforesaid writ petition that the clinical trials should be conducted in ethical manner in compliance to regulatory provisions and there should be a robust system for regulating such trials in the country. Furthermore, the amount of money paid by the companies to investigators for conducting clinical trials should

be in the knowledge of the regulatory authorities and regulatory provisions may be made to this affect.

Taken note of these observations of the Supreme Court, the Ministry of Health and Family Welfare, Government of India introduced a Bill before the Rajya Sabha in August 2013 for further amending the Drugs and Cosmetics Act 1940, which will be called as the Drugs and Cosmetics (Amendment) Act, 2013.

The Central Government withdrew its earlier Bill of 2007 and introduced the aforesaid Bill 2013 by adding more comprehensive provisions inter alia to regulate clinical trials and exports. The new Bill has included stem cells in the definition of the 'new drug' and also specified it at serial no.12 of the proposed Third Schedule of the Act. This will remove ambiguity, if any, in defining and treating stem cells as drugs if used in patients for treatment or research.

The salient features of Drugs and Cosmetic (Amendment) Bill 2013 Emphasis is mainly given around regulation, ethical supervision of trials, compensation of trial subjects etc. The first paragraph of the preamble itself has been substituted which highlights the objective of the Act ie to regulate the import, export, manufacture, distribution and sale of drugs to ensure their safety, efficacy, quality and conduct of clinical trials and for matters connected therewith or incidental thereto.

The definition of 'New Drug' will now include all vaccines, recombinant deoxyribonucleic acid derived products, living

modified organisms, monoclonal anti-bodies, stem cells, gene therapeutic products and xenografts which are intended to be used as drugs.

The word 'manufacture' will also include in relation to human blood and its components any process or part of a process of collection, processing, storage, packing, labelling and testing for its use, sale, export or distribution for transfusion in human beings.

The aforesaid Bill shall make mandatory for the manufacture of any new drug to obtain prior permission from the central licensing authority. The state licensing authority before issuing any license for manufacture of a new drug shall ensure that the permission from the central licensing authority has been obtained by the manufacturer of new drug prior to applying to the state authority.

As per the aforesaid Bill, the Central Government shall constitute an authority to be known as the 'Central Drugs Authority', which will consist of seven Secretaries of Government of India from different health-related departments including Director General Health Services, Additional Secretary or Joint Secretary in the Ministry of Law and Justice and Additional Secretary or Joint Secretary in charge of the Drugs Quality Control Division in the Ministry of Health and Family Welfare. In addition to this, there will be four experts in health-related subjects and four state licensing authorities to be nominated by the Central Government including Drugs Controller General of India.

The Central Drugs Authority shall be empowered to specify regulations, guidelines, norms, structures and requirements for effective functioning of the central licensing authority and the state licensing authorities. In addition to this, it shall have power to review, suspend or cancel any permission, license or certificate issued by the central licensing authority or the state licensing authorities.

The subject of the clinical trials now has been dealt in the proposed aforesaid Bill. No person will be able to initiate or conduct any clinical trial in respect

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MANAGEMENT of a new drug or investigational new drug in human subjects except with, the permission granted by the central licensing authority. Furthermore, registration with the Central Drugs Authority will be mandatory prior to initiate or conduct any clinical trial.

Penalties and punishments In the 2013 Bill, a separate chapter has been incorporated which contains penal actions against the person conducting clinical trial for violation and non-compliance of the provisions relating to the conduct of such clinical trials.

In the said Bill the provisions have been incorporated wherein if an injury or death of a person occurs due to the clinical trial, the person conducting such clinical trials shall give him, or as the case may be, his legal heir, such compensation as may be decided by the Drugs Controller General (India) or any other authority appointed for this purpose.

Penalties have been imposed in the new amendments Bill. In case where clinical trials are being conducted with new drugs without permission, then the person can be imprisoned for up to three to five years along with a fine up to ` 10 lakhs and in the event of grave injury or death of a participant in clinical trial then the term of the imprisonment can be extended for up to 10 years with a fine which shall not be less than ` 20 lakhs.

International scenario on implementation of laws National regulatory authorities regulate the human cells, tissues, and cellular and tissuebased products intended for implantation, transplantation, infusion or transfer into a human recipient. Each country has its own local, regional and national regulations on the collection, manufacture and distribution of cellular therapy products for which a license is required. Implementation of laws pertaining to stem cell therapy especially the embryonic stem cell therapy is controversial in many countries including the US and these laws vary from country to country.

In the European Union i.e. in

50 EXPRESS PHARMA February 16-28, 2014

In the European Union i.e. in Sweden, Finland, Belgium, Greece, Britain, Denmark and the Netherlands, stem cell research using the human embryo is permitted. While in Germany, Austria, Ireland, Italy and Portugal such research is illegal.

Some states in the US are enforcing a complete ban on stem cell therapy Sweden, Finland, Belgium, Greece, Britain, Denmark and the Netherlands, stem cell research using the human embryo is permitted. While in Germany, Austria, Ireland, Italy and Portugal such research is illegal.

Some states in the US are enforcing a complete ban on stem cell therapy while others are giving financial support to researchers and physicians working on such therapy. Japan, India, Iran, Israel, South Korea, China, and Australia are supportive of this therapy but New Zealand, most of Africa (except South Africa), and most of South America (except Brazil) are restrictive.

(Source Wikipedia).

Leigh Turner, a bioethicist at the University of Minnesota in Minneapolis, agrees. “It is much too simplistic to think that stem cells are removed from the body and then returned to the body without a ‘manufacturing process’ that includes risk of transmission of communicable diseases,” he says. “Maintaining the FDA’s role as the watchdog and regulatory authority is imperative.”

In July 2013, The US District Court in Washington DC in the matter United States of America Vs. Regenerative Sciences affirmed the right of the Food and Drug Administration (FDA) to regulate therapies made from a patient’s own processed stem cells. Stem cells separated from small sample of bone marrow were multiplied and placed back into the patient to repair an injured area. The FDA called this procedure the “manufacturing, holding for sale and distribution of an unapproved biological drug product.” The FDA further held the procedure involved the

manufacture, sale, and distribution of an unapproved biologic drug product and it met the definition of the 'Drug' as it was intended to treat orthopaedic, musculoskeletal, and spinal injuries, and arthritis.

The court upheld the FDA’s conclusion that the production process of the cells was more than “minimal manipulation” and hence agreed that the drug was adulterated as Regenerative did not follow Good Manufacturing Processes. Furthermore, as the drug did not contain labelling and instructions for use, hence, rendering it misbranded. The FDA took the position that regenerative’s actions were unlawful for failure to obtain the necessary approvals for the cell production.

The Texas Medical Board in its new laws has allowed the commercial use of adult stem cells without getting formal mandatory approval from the US Food and Drug Administration (FDA). Texas doctors will have to only get approval from an Institutional Review Board (IRB) and obtain informed consent from patients about the experimental nature of the procedure before they can start the therapy.

An US federal court observed that a stem cell therapy offered by a Colorado clinic, uses stem cells extracted from a patient's own bone marrow to treat bone and joint injuries, that is a medical procedure and not subject to federal oversight.

Celltex, a stem cell bank in Sugar Land, Texas, had claimed that its treatment using autologus cells are not an investigational drug. However, FDA found problems with Celltex's manufacturing process and de-

scribed its product as a biological drug. The company was told to stop treatment of patients in the US unless a number of issues were resolved.

Recently, the FDA ruled that stem cell product “Regenexx-C” is a drug and it falls under FDA regulation because the clinic is engaged in interstate commerce. A process performed at the clinic using the patient's own bodily fluids constitutes interstate commerce because, according to the administration, out-of-state patients using “Regenexx-C” would depress the market for out-of-state drugs that are approved by the FDA. In 2003, the Ministry of Health, South Africa had passed a law which became known as the National Health Act. This law specifically spelt out the regulations which were to regulate stem cell research and utilisation in South Africa. As per the said Act, offenders face up stiff fines and a jail term of up to five years if the law is violated.

Recently, Italy has approved a law that allows limited use of stem cell-based therapy on patients of neurological diseases like spinal cord injury and motor neurone disease. However, the therapy must be carried out under regulatory oversight and using cells made according to the GMPs.

Conclusion Like in many other countries, efforts are being made in India to regulate the stem cell therapy and applicable policies and laws are being enacted.

However, the efforts made so far have not been able to curtail the mushrooming of the clinical healthcare entities providing unapproved therapies by solic-

iting unsuspecting patients through electronic and print media.

There is an urgent need to: ● Enact laws for banning adver-

tising/publicity in electronic / print media or otherwise for anti-ageing, health and beauty benefits with stem cell therapy and make it punishable offence; ● Enact law by which use of cells is allowed for therapeutic purpose only after they have been thoroughly tested for purity, sterility, viability, cytogenic stability and biological potency; ● Make mandatory in the Act for any centre rendering commercial stem cell therapy to obtain license from Drug Controller Authority and this license should be given for specific treatment/indication. Any violation in this regard shall be made punishable offence; ● Enact laws to obtain regular report by officers of Drug Controller on inspection of the facilities provided in the clinic for manufacture stem cells for therapeutic use on regular basis; ● Enact laws which enforce the treating doctors/clinics/institutions to monitor patients who were treated by Stem Cell therapy for minimum five years or may be on longer period before the treatment is advertised for general public and proper data bank is prepared on its long term safety; ● A registry at the central level should maintain total information on the patients having stem cell therapy including the type of cells used, indication in which used, side effects noted etc.; ● Enact law by which government officer/department can be held liable in case gross violation of the Act if takes place by the doctor/clinic/institution situated in their jurisdiction.

The Government of India must ensure that pending Bill is passed at the earliest and notification is issued before unethical stem cell therapies attain stature of Frankenstein.

Disclaimer A number of issues are being flagged by researchers around the globe every day on research and therapeutics aspects of stem cells.

This paper contains some information available from literature in public domain.

MANAGEMENT I N T E R V I E W

‘If we need to be competitive in the global marketplace, we have to adopt biotech solutions’ Novozymes, the world’s leader in bioindustrial solutions recently announced, the BioAg alliance, along with Monsanto to transform research and commercialisation of sustainable microbial products. Shalini Gupta finds out the company’s plans in India in an interview with GS Krishanan, Managing Director, Novozymes South Asia

Give us an overview of the bioindustrial sector in India, its growth, drivers etc.

Bioindustrial sector in India is picking up. However, the sector in China is seven to eight times bigger than India.

The segment itself is growing at a double digit (11 per cent) in India, however, is a miniscule part of the global bioindustrial sector. The sector offers sustainable solutions for industries such as textile, leather pulp and paper, which face challenges such as groundwater pollution, wastewater treatment etc where biotechnology can provide viable solutions. As an example, the Chinese government has taken serious initiatives in this sector, recommending biotechnological solutions. In India, even as the potential is huge, the segment, is growing slowly. We need to realise that if we need to be competitive in the global marketplace, we have to adopt biotech solutions.

What are some of the challenges in the Indian market?

Challenges are more regulatory in nature. For eg in the food segment, the Food and Safety Standards Authority of India (FSSAI) is inching towards having its standards at par with international standards, however, it still takes

three to five years to get an approval for a new enzyme. Regulatory approval is serious and cumbersome worldwide but the process needs to speed up in India. Secondly, there are regulations already which are not enforced.

What are the areas in which Novozymes is developing newer applications?

Textile and detergents followed by biofuels would be the growth sectors for us from an Indian perspective, going forward. Enzymatic detergents which today form 30 per cent of the total detergent market, are catching up in India and offer tremendous opportunities. Textiles finds application in the laundry and to a certain extent the mills sector. In the mills sector, water conservation and reduction of water pollution are concerns of the industry where enzymes would help. Scouring, a technique that helps removal of impurities before the yarn is processed is done by caustic today which leads to pollution. An enzymatic application here is being developed that we think will be a game changer going forward. Similarly, biofuels today are from first generation ethanol from molasses, with little or no use of enzymes We are talking of

the future, which will be second generation ethanol or cellulosic ethanol or ethanol from agricultural residues.

This sector is new and developing and would be the future growth area from a global perspective. Ten years ago, the price of cellulosic ethanol was a cause of concern, however, with continuous innovation and optimisation of enzymes, we have brought it down to one tenth of its initial value.

We are playing the role of a thought leader in this segment in collaboration with the Ministry of New and Renewable Energy (MNRE) and other industry associations GS KRISHANAN, Managing Director, Novozymes South Asia

What are the R&D efforts of the company and the focus areas?

Novozymes invests 13-14 per cent of its revenues in R&D. We not only look at discovery of new enzymes but also application developmentexisting enzymes and a specific new application, as well as specific India related application development. Globally, sandwich breads are used whereas Indians use lawn bread, or roti and we have been successful in looking at this. When it comes to enzymatic detergents, we are now looking beyond common stains such as sauce stain and cheese stains to curry stains.

Curry stains is a combination of oil, fat, turmeric and other spices and are stubborn to get rid of. Indian R&D with our in-

novation centre at Bangalore contributes to global R&D and also looks at local application in collaboration with our partners.

Finally, what do you see as the technology of the future?

With the huge oil import bill making headlines in India recently, biofuels would be the answer to our woes. As per the Biofuel policy announced in 2008, we want to achieve 20 per cent of ethanol blending by 2017 and even today we have not been able to achieve two to three per cent with challenges on interstate duty etc. We at Novozymes understand that there is a need to promote and support second generation biofuels if we need to get over fuel shortage. We are playing the role of a thought leader in this segment in collaboration with the Ministry of New and Renewable Energy (MNRE) and other industry associations. We are looking at seeing the first commercial facility coming from second generation ethanol from Praj industries. The next challenge is government support and incentives to further push this forward. It will reduce oil imports and current account deficit. shalini.g@expressindia.com

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MANAGEMENT I N T E R V I E W

‘In all of Asia, the focus on intangible capital is much underdeveloped as compared to mature markets’ It is not just the physical assets but the intangible assets which help in realising the success of an M&A, rarely considered by companies at the due diligence stage. Mitali Bose, Regional Practice Director – South & South East Asia, Pacific & Africa, Hay Group in a conversation with Shalini Gupta elaborates how this could be a gamechanger

What is intangible capital?

Broadly speaking, intangible capital is of three kinds: ● Organisational capital- the ability of an organisation to innovate, its R&D ability, governance etc ● Relational capital- brand of the company, internal and external networks ● Human capital- quality of employees, their ability and engagement levels Firms which take cognisance of intangible capital at early stages of the deal, actually realise better shareholder value and EBIDTA margins (if listed). It is easy to identify intangible capital, difficult to manage it, because at the due diligence stage it is difficult to get accurate information on it. The more firms delay getting this information, the more delayed they get to realise the value of the merged entity.

Organisations wake up to the need for merging intangible capital, only when they face crises.

What is the value of intangible capital? How does it determine the success of M&As? The important question to

52 EXPRESS PHARMA February 16-28, 2014

ask is- what is the state of intangible capital, for unlike physical or financial assets which are static, it changes.

So for instance if an organisation has a set of motivated employees, the longer it takes for the pre closing and closing stages, there is a chance that employees may get frustrated and disenchanted. Intangible capital changes from an active state to an inert state and the more inert it is, the more difficult it is for an organisation to get any kind of value out of it. For example, a lot of inbound M&A in the generic industry depends on their drug pipeline, or the reach in certain markets. So if we don’t take into account what creates that, is it the dealer network or is it the ability to quickly replicate what is already there in the market and deal with them clearly in the beginning, there is a confusion which results in the merged entity losing value, over a period. So the longer it takes to get to the integration points, the higher the chances of intangible capital becoming inert over the acquisition timeline. Most firms start thinking about intangi-

ble capital once they start facing issues in the early stages and that’s too late. One needs to think of it at the due diligence stage and close out planning at the pre closing stage.

In fact in all of Asia, the focus on intangible capital is much underdevelop ed as compared to mature markets

What have companies doing inbound M&As been looking for?

Inbound M&As in India have been from Japan. The volume of deals have gone down, but the deal sizes have gone up, simply because they are trying to integrate a lot of acquisitions they made earlier. However, some of the issues that they have been facing include- longer than anticipated integration timelines and cultural differences. Generally, for companies entering India the challenges would be around understanding the geographical difference, getting accurate and transparent data, etc. For Japanese companies, stability and risk profiles are important, in India, they find it difficult to get accurate information about intangibles.

MITALI BOSE, Regional Practice Director – South & South East Asia, Pacific & Africa, Hay Group

Are Indian pharma companies proactively looking at enhancing their intangible

capital?

The pharma sector is going through a lot of changes and there is bound to be consolidation. How attractive a company is from that point of view is a function of two things, the industry itself and the companies showcasing the kind of talent they have, the agility they display, their reach and networks. These are some of the intangibles that Indian companies are building upon, but not consciously. But if a deal is imminent, then they are projecting their brand. In fact in all of Asia, the focus on intangible capital is much underdeveloped as compared to mature markets.

How far is valuation an indicator of the intangible capital of a company and how far is it an enabler?

Valuation is a factor of the profitability of the company and its image. The image is in turn driven by the R&D ability and the kind of market it has, reach and access to market(determined by regulators), Brand, agility, quality of supply and distribution networks, quality of key resources. All these attributes

MANAGEMENT determine the valuation of the company and so such companies have a high intangible capital. It needs to be remembered though that there is no valuation on intangible capital.

Has the perception of companies doing inbound acquisitions changed and how far have Indian companies helped change that perception?

Companies doing inbound acquisitions still tend to face red tapism and bureaucracy, general cultural orientations around transparency, data, risk, compliance, governance, etc. most of them underestimate the amount of complexity in the market and therefore most deals take longer. Indian companies are waking up to these challenges to build credibility with the international community.

How do you see the role of PE firms in the M&A environment? What percentage of the deals can be attributed to them (in India and globally) and then specifically in pharma? Elaborate the reasons for the same.

The India pharmaceutical industry is one of the economy’s faster growing sectors.

A diversified portfolio, the benefits of cost efficiency, coupled with the growing optimism and focus on ‘pharmerging’ markets make it an attractive sector for India. In addition, provisions of the new Companies Bill are expected to aid M&As and empower PE investors, so the sector can expect an interest in inbound as well as outbound deals in 2014. Going forward, foreign players are expected to remain interested in gaining access to the pie, even as domestic players look to consolidate their market position.

Rising shareholder activism is influencing corporate governance and increasing the level of broad activity.

Deal terms have come under greater scrutiny. Moreover, companies are looking to

make very specific acquisitions and becoming more targeted in their deal seeking as well – PE firms focus on providing expertise and specific advice on such targeted opportunities. In PE backed firms – they help in capital infusion. PE firms will continue to play a strong role in crossborder deals.

With this in mind, in the past, we have seen private equity firms willing to invest in about half the pharma deals that take place in a year. However, their investments between 2007-09 have not paid off as anticipated, given a slow or negative growth environment, and even issues of corporate governance plaguing high-profile deals. Going forward, while the outlook remains moderately optimistic, we are expecting the momentum to continue, albeit with an enhanced cautiousness about the tangible and intangible synergies expected from a deal.

PE funds are increasingly interested in small R&D based pharma firms. Your comments.

PE funds are focused on deal success; hence they try to look for a win-win approach for both the acquirer

and acquired, or the investor and the investee from a deal fitment perspective. So their investments focus on future growth – be it through R&D, technology, manufacturing, healthcare accessibility, product portfolio, etc. To that extent, a lot of factors come into play – the relationship with the PE firm of both parties, how the relationship between the buyer and seller is cultivated before and after the deal, and so on.

Innovation is the life blood of the life sciences sector and it will continue to play a dominant role in 2014. Major pharma companies will remain focused on building a strong pipeline of initiative products / solutions – leveraging both internal and external assets. In this scenario, high quality / unique assets focused on innovation will continue to generate a lot of interest.

Cultural integration sits at the core of an M&A. What is the perception of Indian companies in this respect globally? Also, how have Indian companies pulled themselves up here in the past few years?

Cultural integration is, in essence, the key component

in the valuation of intangible capital during and before an M&A deal. Hay Group’s research breaks down culture fit into four measurable components – open and honest communication, courageous follow-through, similar risk profiles, and compatible response.

In India, people enjoy discussions. Management should take advantage of this and initiate frank and open dialogues as soon as possible.

If not done so, employees will quickly fill the void with rumors – hence the need for ‘open and honest communication’.

On the other hand, ‘courageous follow-through’ was the missing component in the case of the merger of Air India and Indian Airlines, where the losses escalated post merger. In the six years after the merger, the merged entity had a rotating door of four chairmen with no one willing to bite the bullet on tough decisions like cutting employee-aircraft ratio, standardization of HR policies, or even the type of aircraft to fly.

In measuring ‘risk profiles’, one way is to use Geert Hofstede’s Uncertainty Avoidance Index (UAI), a tool

to measuring a nation’s appetite for risk. UAI scores can range from zero (pure risk takers) to 100 (pure risk avoiders), where India scores 40, indicating a medium-low preference for avoiding uncertainty. This must be factored in the market screening process; the closer two companies’ UAI, the better the outcome.

Finally, ‘compatible response’ is the gauge of whether or not both parties have a similar time-frame in mind for decision-making and execution. In India, we have a tendency to delay decision making in order to gather more or better information. If this style is not shared by the other party, then it will be perceived as hesitation and ultimately, backfire on the deal.

So my take is, there are good deals to be made, if companies keep all four factors of cultural integration in mind.

Armed with the right insights to make the best deal – a clear understanding of what you are buying and how it ‘fits’ with your existing company – M&A can be a winning strategy for driving long-term growth for the future. shalini.g@expressindia.com

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RESEARCH CLINICAL UPDATE

NCI launches trial to assess the utility of genetic sequencing to improve patient outcomes The M-PACT trial is one of the first to use a randomised trial design to assess if assigning treatment based on genetic screening can improve the rate and duration of response in patients with advanced solid tumours A PILOT trial to assess whether assigning treatment based on specific gene mutations can provide benefit to patients with metastatic solid tumours is being launched by the National Cancer Institute (NCI), part of the National Institutes of Health.

The Molecular Profiling based Assignment of Cancer Therapeutics, or M-PACT, trial is one of the first to use a randomised trial design to assess if assigning treatment based on genetic screening can improve the rate and duration of response in patients with advanced solid tumours. A trial in which patients are randomly assigned to various treatment options is the gold-standard method for determining which treatment option is best.

Researchers hope that in addition to the knowledge gained from the trial about assigning therapy based on results of genetic sequencing of tumours, this trial could identify patient sub-groups that are likely to benefit from certain treatments and result in new treatments being developed quickly for some cancers. This could ultimately lead to smaller, more definitive clinical trials, which would be helpful to clinicians and patients in terms of cost and time “Patients will have their tumours genetically screened and if a pre-defined mutation is found, they will receive treatment with targeted agents,” said Shivaani

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Kummar, Head of NCI’s Developmental Therapeutics Clinic and the principal investigator of the trial. “What we don’t know, however, is whether using this approach to assign targeted treatments is really effective at providing clinical benefit to patients, as most tumours have multiple mutations and it’s not always clear which mutation to target and which agent is most likely to provide maximal benefit. This study hopes to address some of these questions in the context of a prospective, randomised trial.”

Very few types of tumours have just one mutated gene that triggers cancer progression.

Once a gene is mutated, it can lead to the activation of multiple pathways, resulting in disease progression and potentially requiring multiple interventions.

Therefore, NCI’s M-PACT trial is designed to determine whether people with specific mutations that have been demonstrated in laboratory systems to affect drug effectiveness will benefit from a specifically chosen targeted intervention and if these interventions lead to better outcomes.

For NCI’s M-PACT study, after screening hundreds of people, 180 patients with advanced refractory solid tumours (those resistant to standard therapy) will be enrolled based on their genetic profile. During the screening process, samples of

This trial could identify patient sub-groups that are likely to benefit from certain treatments and result in new treatments being developed quickly for some cancers the tumours will be genetically sequenced to look for a total of 391 different mutations in 20 genes that are known to affect the utility of targeted therapies. If mutations of interest are detected, using a molecular sequencing protocol for tumour biopsy samples evaluated by the US Food and Drug Administration, those patients will be enrolled in the trial and randomly assigned to one of two treatment arms to receive one of the four treatment regimens that are

part of this study.

To ensure that patients receive the best treatment already known to provide benefit, patients with specific tumour types should have received certain therapies prior to being enrolled in NCI’s M-PACT. Patients with melanoma whose tumours have mutations in the V600E region of the BRAF gene should have received and progressed on a specific BRAF inhibitor therapy to be eligible for NCI’s M-PACT trial. Patients with lung cancer

should have had their tumours tested for the presence of EGFR and ALK gene mutations, and, if mutations were detected, they should have received and progressed on therapies targeting EGFR or ALK, respectively.

Patients with all types of solid tumours will be considered for trial eligibility. For the randomization, patients will be assigned to Arm A (they will receive a treatment regimen prospectively identified to target their specific mutation or relevant pathway) or Arm B (they will receive a treatment regimen not prospectively identified to target their specific mutation or relevant pathway). Patients in Arm B will have the option to cross over to Arm A to receive therapy identified to target their specific mutation or relevant pathway if their disease progresses on their initial study treatment. As of January 2014, the study is open for patient accrual. Clinicians hope that they can rapidly enroll patients and report results of their findings by 2017.

“We believe that this study will aid patients in the trial that will be conducted initially at the NCI, and subsequently expanded to clinical trials sites participating in the NCI-supported Early Therapeutics Clinical Trials Network,” said James Doroshow, Deputy Director for clinical and translational research, NCI.” EP News Bureau – Mumbai

RESEARCH UPDATES

Pain sensitivity may be influenced by lifestyle and environment: Study Pain sensitivity, previously thought to be relatively inflexible, can change as a result of genes being switched on or off by lifestyle and environmental factors, a process called epigenetics RESEARCHERS AT King’s College London have discovered that sensitivity to pain could be altered by a person’s lifestyle and environment throughout their lifetime. The study is the first to find that pain sensitivity, previously thought to be relatively inflexible, can change as a result of genes being switched on or off by lifestyle and environmental factors, a process called epigenetics, which chemically alters the expression of genes.

Published in Nature Communications, the study has important implications for understanding pain sensitivity and could lead to new treatments aimed at ‘switching off’ certain genes epigenetically.

Identical twins share 100 per cent of their genes, whereas non-identical twins share on average only half of the genes that vary between people.

Therefore, any difference between identical twins must be due to their environment or epigenetic changes affecting the function of their genes, making them ideal participants for a study of this nature.

To identify levels of sensitivity to pain, scientists tested 25 pairs of identical twins using a heat probe on the arm.

Participants were asked to press a button when the heat became painful for them, which allowed the researchers to determine their pain thresholds. Using DNA sequencing, the researchers examined over five million epigenetic marks across the whole genome and compared them with a further 50 unrelated individuals to confirm their results. This is the first study to use large numbers of twins with such an in-depth examination of epigenetic signals.

The research team found wide variations between people and identified chemical modifications within nine genes involved in pain sensitivity that were different in one twin but not in her identical sister. The chemical changes were most significant within a known pain sensitivity gene, TRPA1, already a therapeutic target in the development of painkillers (analgesics).

This is the first time TRPA1 has shown the capacity to be switched on and off epigenetically; finding out how this happens could have major implications for tackling pain relief.

Lead author of the study, Dr Jordana Bell, Department of Twin Research & Genetic Epidemiology at King’s College London, said, “The potential to epigenetically regulate the behaviour of TRPA1 and other genes involved in pain sensitivity is very exciting and could lead to a more effective pain relief treatment for patients suffering with chronic pain.”

EP News Bureau – Mumbai

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RESEARCH

Early promise for blood thinner without bleeding risk: Study Scientists found that an injectable antibody protected rabbits from developing blood clots

AN EXPERIMENTAL drug appears to prevent dangerous blood clots, without raising the risk of excessive, at least in animals. Scientists found that an injectable antibody protected rabbits from developing blood clots but didn't cause bleeding complications, a potential side effect of all current anticlotting drugs.

The findings were reported in the journal Science Translational Medicine, are only an initial step. The hope is to eventually bring safer clot-preventing drugs to the market, said researcher Dr Thomas Renne, of the Karolinska Institute in Stockholm, Sweden. Renne said his team plans to test the antibody, dubbed 3F7, in a phase I study, a small trial that tests the safety of a drug in humans. An expert not involved in the research said these early findings “are really quite exciting.”

“The holy grail in this field is to be able to give something that prevents clots, without causing bleeding,” said Dr Alvin Schmaier, a professor at Case Western Reserve University in Cleveland, who wrote an editorial published with the study.

Right now, anti-clotting drugs are given for a number of reasons. Doctors use them, for example, when surgery patients or critically ill newborns have to be hooked up to a heart-lung machine, a scenario, Renne noted, that would instantly cause blood clots if not for the medications. In those cases, an IV drug called heparin has long been the choice for preventing clots,

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but it carries the risk of potentially dangerous, or even fatal, internal bleeding.

Another problem with heparin, Schmaier said, is that it’s messy to make. It’s isolated from pig intestines, and pig farmers in China supply much of the world's heparin. Several years ago, tainted heparin batches from China were tied to an outbreak of severe allergic reactions and more than 80 deaths in the US alone.

Schmaier said an alternative drug that could be manufactured under strict quality control is needed.

Renne’s team developed the new antibody based on research into a blood protein called factor XII. Factor XII is involved in the process of blood clotting, but experts have long known that people

who lack the protein, about one in every one million people, do not have any special risk of bleeding.

So Renne, who is also affiliated with the University Hospital Hamburg-Eppendorf in Germany, and his colleagues studied mice that were engineered to lack factor XII. They found that the animals could not develop blood clots, but, like their human counterparts, did not suffer from bleeding. From there, the researchers developed the 3F7 antibody to block factor XII activity.

The antibody effectively blocked clot formation in rabbits that were placed on a simulation of a heart-lung device. It worked about as well as heparin, the researchers found, but without causing bleeding.

Human studies are still needed, but the researchers already know the antibody blocks factor XII in human blood.

“I think that blocking this target (factor XII) is going to prove very useful in procedures where people have to be hooked up to a machine,” Schmaier said.

Anti-clotting drugs are commonly used outside of hospitals, too. Many people take oral medications, such as warfarin (Coumadin), to prevent clots that could lead to a heart attack or stroke.

Among these are patients with the heart-rhythm disorder atrial fibrillation and those with artificial heart valves.

Since 3F7 is an antibody, it would have to be injected, Renne explained. So, if it pans out, it could be an alternative to the heparin used in hospitals, but it wouldn't replace the oral medications people use long-term.

However, Renne said, drug companies are looking for oral agents that block factor XII. “That is a longerterm goal,” he said.

Schmaier said he expects to see a lot more work aimed at factor XII. “I think this report is the tip of the iceberg,” he said.

Several of Renne’s co-researchers are employees of the pharmaceutical company CSL, which is developing the 3F7 antibody. Renne is named as inventor on a patent application covering the use of factor XII as a target of anti-clotting drugs.

Source: Science Translational Medicine Journal

Study links steroiddependent asthma to depression PEOPLE WITH severe asthma who rely on prednisone are more than three times more likely to be depressed than those with severe cases who don’t use prednisone and those with mild to moderate asthma, according to a new study from The Netherlands.

Prednisone-dependent asthma patients ‘deserve’ screening for depression and anxiety, the authors say, both to alleviate their suffering and possibly improve their physical health through mental health treatment.

“There’s a well-established connection with asthma, as well as chronic illness in general, and higher reports of depression than the general population,” Dr Rebecca Hashim told Reuters Health.

Hashim, an attending psychologist at Children's Hospital at Montefiore Medical Centre in New York, was not involved in the study.

Prednisone is a steroid anti-inflammatory medication used to treat asthma attacks, often among people with severe symptoms.

Previous research has linked steroid use to depression and other mood problems. And links in both directions have been found between depression and the severity of asthma symptoms.

To examine depression risk among asthma patients, Dr Marijke Amelink, from the department of Respiratory Medicine at the Academic Medical Centre at the University of Amsterdam, and Dr Simone Hashimoto, of the Institute of Psychiatry at Leiden University in Leiden, recruited 187 patients.

Among the patients, 67 had severe prednisone-dependent asthma and 47 had severe non-prednisone dependent asthma. Another 73 patients had mild to moderate asthma.

Reuters Health

RESEARCH

Large doses of intravenous vitamin C have potential to boost chemotherapy's ability to kill cancer cells Intravenous vitamin C has been considered an integrative medical therapy for cancer since the 1970s

LARGE DOSES of intravenous vitamin C have the potential to boost chemotherapy's ability to kill cancer cells, according to new laboratory research involving human cells and mice. Vitamin C delivered directly to human and mouse ovarian cancer cells helped kill off those cells while leaving normal cells unharmed, University of Kansas researchers report.

“In cell tissue and animal models of cancer, we saw when you add IV vitamin C it seems to augment the killing effect of chemotherapy drugs on cancer cells,” said study co-author Dr Jeanne Drisko, Director integrative medicine, University of Kansas Medical Centre.

In follow-up human trials, a handful of cervical cancer patients given intravenous vitamin C along with their chemotherapy reported fewer toxic side effects from their cancer treatment, according to the study published in Science Translational Medicine.

“In those patients, we didn't see any ill effects and we noticed they had fewer effects from the chemotherapy,” Drisko said. “It seemed to be protecting the healthy cells while killing the cancer cells.”

Intravenous vitamin C has been considered an integrative medical therapy for cancer since the 1970s, Drisko noted.

But vitamin C’s cancerkilling potential hasn't been taken seriously by mainstream medicine ever since clinical trials performed by the Mayo Clinic with oral vitamin C in the

late 1970s and early 1980s found no anti-cancer effects, she explained.

Researchers have since argued that those trials were flawed because vitamin C taken orally is absorbed by the gut and excreted by the kidneys before its levels can build up in the bloodstream.

But it's been hard to attract funding for further research.

There's no reason for pharmaceutical companies to fund vitamin C research, and federal officials have been uninterested in plowing research dollars into the effort since the Mayo research was published, Drisko said.

This latest investigation began with researchers exposing human ovarian cancer cells to vitamin C in the lab. They found that the cells suffered DNA damage and died off, while normal cells were left unharmed.

The researchers then tested vitamin C on mice with induced ovarian cancer. The vitamin appeared to help chemotherapy drugs either inhibit the growth of tumours or help shrink them.

Finally, the team conducted a pilot phase clinical trial involving 27 patients with stage III or stage IV ovarian cancer.

The patients who received intravenous vitamin C along with their chemotherapy reported less toxicity of the brain, bone marrow and major organs, the investigators found.

These patients also appeared to add nearly 8.75 months to the time before their disease relapsed and pro-

gressed, compared with people who only received chemotherapy. The researchers did note that the study was not designed to test the statistical significance of that finding.

Vitamin C in the bloodstream helps kill cancer cells because it chemically converts into hydrogen peroxide when it interacts with tumours, Drisko said.

“If you can get your blood levels of vitamin C very high, it gets driven into the space around the cancer cells,” she explained. “In that space, it’s converted into hydrogen peroxide.

It's very similar to what our white blood cells do. They create hydrogen peroxide to fight infection.”

Dr Stephanie Bernik, Chief of Surgical Oncology at Lenox Hill Hospital in New York City, said intravenous vitamin C therapy is not unheard of among

cancer doctors.

“I've had patients come in and say they were doing vitamin C intravenous therapy,” Bernik said. “I always tell them we don't know enough to know whether it is good or bad.”

This new research raises interesting possibilities, but until larger clinical trials are conducted Bernik says her advice to patients will not change.

“You have to do a bigger study with patients and look at outcomes. You also have to make sure these treatments don't interfere with the treatments we're giving currently,” she said. “There may be some efficacy in what they're doing. It just needs to be proven. This is just the start of more studies looking at this in-depth.”

Dr Michael Seiden, Chief Medical Officer, The US Oncology Network, agreed.

“It is important to emphasise that many vitamin therapies have shown interesting results when applied to cancer cells in test tubes yet, to date, these approaches typically are not effective and occasionally prove harmful in human studies,” he said. “At this time, there is still no evidence that high-dose vitamin C should be part of the treatment for women with ovarian cancer.”

While she agreed that larger trials need to be conducted, Drisko was not as hesitant.

“It's safe. It’s inexpensive.

There’s a plausible mechanism we’re investigating for why it works,” she said. “We should be using this in patients, rather than dragging our feet and worrying about using it at all.”

Source: Science Translational Medicine Journal

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PHARMA TECHNOLOGY REVIEW INSIGHT

Need of polymers for solubility enhancement Prathamesh Bhide and Amrit Karmarkar, Pharmaceutical and Clinical Consultants, Mumbai, give an overview of the problems of solubility and the role of polymers with focus on some commercial products

SOLUBILITY REMAINS a critical obstacle for pharmaceutical industry in formulation and development of new drugs. Solubility in proportion affects the bioavailability and so safety and efficacy of a drug product. In order to break this chain, solubility enhancement raises as the priority before any formulation. Various commercially available polymeric products are playing magnificent role in solubility aspects.

safety and efficacy of product.

As per FDA, a drug is considered highly soluble when the highest dose strength is soluble in 250 ml or lesser amount water over a pH range of 1 to 7.5. (Volume of 250 ml is estimated from a BE protocol, that prescribe a fasting human volunteer administration of drug, with glass of water). Depending upon the solubility, drugs are classified in Biopharmaceutics Classification System (BCS).

Introduction

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Biopharmaceutics classification system (BCS) It is a system used for the classification of drug substances depending upon their aqueous solubility and intestinal permeability. The main purpose of this is to increase the efficiency of drug development process. As per this system, drug substances are classified into four classes: (Ref Fig 1)

PRATHAMESH BHIDE

AMRIT KARMARKAR

Pharmaceutical and Clinical Consultants, Mumbai

Pharmaceutical and Clinical Consultants, Mumbai

Considerably large amount of drugs (approximately 70 per cent) fall into class II, and according to BCS, bioavailability for this class may be enhanced by increasing the solubility as drug release from dosage form and dissolution rate in GI track are the only rate limiting steps.

Other class of drugs i.e. I, III and IV occupy five per cent, five per cent and 20 per cent

approximately.

FIGURE 1: BCS CLASSIFICATION OF DRUGS

PERMEABILITY

It is an analytical composition of a saturated solution expressed as a proportion of a designated solute in a designated solvent, as defined by IUPAC. But more precisely, solubility can be described as, a ‘chemical property referring to the ability of the given substance (solute) to dissolve in a solvent’, a simple and well known quantitative terminology of science. It ranges widely from infinitely soluble or fully miscible to poorly soluble. For poorly soluble or very poorly soluble compounds, insoluble term is often applied. In the pharma industry as estimated, approximately 40 per cent of all the drugs, which are currently in the market and 90 per cent of compounds in drug delivery pipelines, are poorly water soluble. Thus low aqueous solubility create problem in reproducible absorption from gastrointestinal track, ultimately affecting the bioavailability, as well as

compounds can be translated into medicines, along with improvement in efficacy, safety and reduction in cost. Need for solubility enhancement is more in case of solid dosage forms like tablets and capsules, as oral route is most convenient and commonly employed route of drug delivery.

Class II low solubility high permeability

Class I high solubility high permeability

Class IV low solubility low permeability

Class III high solubility low permeability

SOLUBILITY

Need for solubility enhancement As stated in the beginning, almost 90 per cent of the drugs are poorly soluble, creating problem in all aspects of formulation, administration, efficacy and so the financial calculations. Cost effective manufacturing without any market issues, maintaining the image and standard, is the main objective for any industry. So thinking about this aspect, the pharma industry always tries to overcome all the issues regarding quality and efficacy of products. Lower bioavailability due to poor solubility, lead to decrease in efficacy of a drug product along with patient-topatient variability (both inter and intra) and side effects.

Hence, research strategy to overcome solubility issues play a key aspect in drug development process, so as more

Techniques for solubility enhancement So what can we do to enhance solubility? Various solubility enhancing techniques can be used. These techniques can be categorised in physical, chemical and miscellaneous modifications in drug formulations. Physical modification consists of reduction in particle size, modification of crystal habit, drug dispersion like solid dispersion.

Chemical modification encompasses pH change, use of buffer, derivatisation techniques etc.

Miscellaneous techniques include use of adjuvant like surfactant, solbiliser, excipients, polymers etc. A popular approach to overcome solubility issues is use of polymers as solubilising excipients.

Use of technologies for solubility enhancement Advanced technologies, innovated for the purpose of bioavailability enhancement in drug products, include some of the following: ● Spray –Dried Dispersion (SDD) ● Hot – Melt Extrusion (HME)

â—?

Solid NanoCrystalline Dispersion (SNCD) â—? Spray-Dried NanoAdsorbate Technology (SDNAD) These technologies make use of various solubilising excipients, polymers etc resulting in increase in solubility of poorly soluble drugs. Amongst the technologies mentioned, spray-dried dispersion (SDD) and HME are the most common technologies used for solubilisation using cellulosic polymers.

Kolliphore TPGS (BASF): Kolliphore TPGS (d-a-tocopheryl polyethylene glycol 1000 succinate) is a D-alpha vitamin E ester derived from vitamin E. Kolliphore TPGS, is used for increasing solubility in tablets and capsules, by hot-melt granulation technique using TPGS as binder.

Use of polymers for enhancement of solubility Amongst the various different troubleshooting options in modifying formulations, we will focus on polymers.

Polymers are the substances which consist of a large number of repeating units of monomers and whose molecules have high molar masses. These are both naturally occurring as well as synthetic. Polymers like protein, starch cellulose etc are some examples of naturally occurring polymers while plastic, resins etc belongs to synthetic polymers. In synthetic polymers, only one monomer is used but in some, two or three different monomers may be combined.

Effective solubilising polymers incline to be amphiphilic in nature, i.e. they have both hydrophobic and hydrophilic sites that helps them to interact favourably with low-solubility (i.e., hydrophobic) compounds and disperse and dissolve in aqueous environments such as the gastrointestinal (GI) tract.

Interaction of polymer like self interaction, with API, with aqueous medium results in solubilising structures like micelles, colloids and ionic complexes. Solubilising polymers are used in formulations depending upon the route of administration, properties of API and formulation type.

Polymers used in formulation and drug development Ethylcellulose, cellulose acetate phthalate (CAP), acrylate polymers, hydroxypropyl methylcellulose phthalate, polyvinyl acetate phthalate

Effective solubilising polymers incline to be amphiphilic in nature, i.e. they have both hydrophobic and hydrophilic sites that helps them to interact favourably with low-solubility (i.e., hydrophobic) compounds and disperse and dissolve in aqueous environments such as the gastrointestinal (GI) tract (PVAP) are some of the polymers used as solubilising excipients in formulation.

These polymers, commercially, are being manufactured by industries like DOW, FMC Biopolymer, BASF, Evonik etc., under trade names like Solutol HS, Soluplus, Aquacoat, Ethocel, Eudragit and many more.

These products containing different polymers are used in a variety of ways to achieve the final purpose i.e. solubility enhancement. For example, Aquacoat by FMC biopolymers (ref: www.fmcbiopolymers.com)

is of three different types: Aquacoat ECD, Aquacoat ARC and Aquacoat CPD; used for sustained release coating, alcohol resistant coating and enteric coating respectively.

Some key polymers for solubility enhancement As stated above, a variety of products consists of polymers, which are commercially developed and manufactured by a number of industries as solubility enhancement solution. These polymers differ in structure, properties, ap-

pearance. Some examples of commercially available products, their role in solubility enhancement, are as follows: Soluplus (BASF): Soluplus is polyvinyl carpolactampolyvinyl acetate-polyethylene glycol graft co-polymer. Soluplus have many applications but is generally used as a binder in wet granulation or dry binder in direct compression for weak soluble drugs, thus increasing its solubilisation capacity in a simple process.

Eudragit (Evonik): It is basically used for BCS class II, III and IV drugs. Eudragit helps in enhancing solubility by using it as a carrier; drug can be dispersed into polymer as crystal or amorphous particle.

Due to decrease in particle size to molecular level, solid solution provides greater effectiveness for solubility increase.

Like some of these examples, there are a number of products derived from polymers and are used in formulation, development process with necessary safety data provided for the usage of these products. In short, it can be said that, polymers have made the way easy through obstacle of solubility and hence improving efficacy, bioavailability of products, playing a big helping hand for the industries.

Conclusion Research and development has contributed to the pharma industry upto a much greater extent with new innovation and strategies.

These innovations have played a big role in overcoming various issues like poor solubility. Polymers, polymer derived products are contributing these formulations to a much greater extent, improving efficacy along with cost-effectiveness. Various different advanced technologies, applications using polymers, excipients also have also resulted in improvement of properties of drugs and resulting final quality of products. New R&D strategies and technologies will still be developed as an evolution or replacement to existing ones in near future. This chain will continue but at last it will prove beneficial for the growth of the industry.

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PHARMA TECHNOLOGY REVIEW I N T E R V I E W

‘We designed our software to wrap around practically any third party instruments’ Steve Crouse, Vice President-Marketing, FreeSlate gives an outlook about automation in the drug discovery process adopted by pharma and bio pharma companies

How is the world market evolving for high throughput robotic systems, considering the basic research activities in pharma and biopharma?

Pharma and biopharma have successfully adopted automation in the drug discovery process. While real innovation has come from this adoption, it has created new bottlenecks in drug development. Introducing automation in drug development, both drug substance and drug product development, is where we are seeing pharma and biopharma focus their investments. This includes early development, where they are trying to shorten the time for human trials and later in development where they are trying to reduce the risk in the manufacturing process.

How has market perception changed for faster research and process development using HTR and regulation as per QbD by US FDA? Our approach to High Throughput Research (HTR) combines: a) a statistical experimental design – including the ability to import designs from DoE software, b) material savings by

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miniaturising formulations and reactions, increasing the number of experiments that can be conducted with the same material c) improved reproducibility of data, comparability of data and data integrity through automation and d) powerful data management tools. This allows for a deep understanding of the design space and manufacturing risks much faster than could previously be accomplished. This supports both faster drug development and a deeper understanding of the drug product and process supporting QbD initiatives.

What challenges have Freeslate identified and how do you plan to overcome them?

Our systems go far beyond traditional automated liquid handling to address more complex research processes encountered in drug development. Applying automation to novel application areas has forced us to be innovative in how we design our automation systems. For example; for polymorph, salt selection and crystallisation studies, we have designed a crystallisation assembly, heated filter block, heated liquid dispense

Our systems go far beyond traditional automated liquid handling to address more complex research processes encountered in drug development STEVE CROUSE, Vice President Marketing, FreeSlate

element, powder dispense element and universal substrate to allow for 96 samples to be analysed in parallel. Since this application had not really been addressed with automation previously, we had to design an approach basically from scratch. Other examples include automated approaches to microscale viscosity measurements or higher throughput pH measurements. Designing automation for more chemical research applications required us to invent quite a number of new approaches.

While a thoughtful approach to automating a process is critical, invention is only the first step. The systems need to perform their functions robustly. For complex processes like protein formulation, small molecule crystallisations or organic synthesis, it means the equipment needs to be thoroughly tested in real world studies with relevant samples. Along with our own internal development work, we are also working with our customers to thoroughly test these systems. This includes testing customer samples in delivering a system, using our systems to offer contract research services to leading

pharma companies and collaborative partnerships, like our recent work with the medicines for malaria venture. Being able to run such a large number of diverse studies through the systems has allowed us to hone the systems for target applications.

Another challenge that took some time to overcome was data management. The large amount of data automation can just create a new bottleneck – effectively managing the data. Data generated only offers value if it can be pulled together in a way that allows for informed decision making. We designed a software package that links analytical data to sample creation and sample processing information in a centralised database to ensure data integrity and easy reporting for decision making. A number of processing steps and analysis require the use of third party equipment. We might need to use a UV/Vis plate reader for measuring protein concentration, or HPLC or XRD for analysis. We designed our software to wrap around practically any third party instruments, controlling them and then capturing all

PHARMA TECHNOLOGY REVIEW critical information back into the database and linking it to the sample information. This not only makes for a powerful data management tool, but it also provides a high level of data integrity.

Presently, how big is Freeslate’s market share in the life sciences segment and what are the new application areas you are working on?

Freeslate is a market leader for automation systems for small molecule preformulation and process chemistry and for large molecule pre-formulation and formulation. Our expertise in this area and ongoing discussions with customers are allowing us to recognise unaddressed bottlenecks. For biologics formulation for example, we have identified a bottleneck in the visual inspection of vials and visible particle detection. Scientists are literally spending hours looking for visible particles in vials and recording the number of particles they see.

There is no stored image that can be referenced later, and the potential for variability from one scientist to another is high. We designed an automated approach for this visible inspection. The system automatically spins a vial and counts the number of visible particles, measures turbidity of the solution and assesses colour changes. So you are going from a tedious, variable process that doesn’t allow you to review the scientist’s findings, to an automated, highly reproducible process that stores an image of the analysis in our database. That can have a real impact on productivity and data integrity.

Why should a company spend huge amounts on robotics automation for high throughput activities?

The value of automation can be easily justified through the productivity gains provided by the systems. Scientists can eliminate tedious, time consuming tasks and focus on solving

Freeslate is a market leader for automation systems for small molecule pre-formulation and process chemistry and for large molecule pre-formulation and formulation. Our expertise in this area and ongoing discussions with customers are allowing us to recognise unaddressed bottlenecks

critical scientific challenges.

This only scratches the surface of the real value these systems offer. By allowing scientists to generate a wide range of data quickly in drug development, organisations can build a deep understanding of the drug product and its behaviour that can have a meaningful benefit as the drug is moved through the development process. Furthermore, the data generated can be compared over long time periods, since all of the experiments are performed by a single automation platform and saved in a central database. The knowledge from this accumulated data can then be used to inform future experimentation and formulation designs. It is this build-up of organisational knowledge that leads to dramatic, and often unexpected, impact on productivity and innovation.

Presently, how many new systems and platforms are offered by Freeslate for cost effective HTR applications?

Freeslate has automation systems for small molecule solid form screening (preformulation), process chemistry and biologics formulation and formulation assessment.

These specific systems are all based on two fundamental automation platforms offered

by Freeslate.

The first is the Core Module 3 (CM3), our larger automation platform. This is a configurable system that allows for researchers to define a system that

addresses their specific research need. Designed for chemical research, there are a range of capabilities available on the CM3 including pH measurement, heating, stirring, powder dispensing, viscous liquid dispensing and high pressure /high temperature reactors. The CM3 can also physically integrate with third party analytical instruments (UV/Vis plate reader, for example) and processing equipment (for e.g. centrifuge). The smaller automation platform is the CM Protégé. This system is designed for specific applications like powder dispensing, polymorph screening or biologics formulation assessment.

What are your plans for the Asian and Indian markets?

Pharma and biopharma are making significant investments in Asia and India at this time. This includes both regional companies, as well as investments from the US and European companies. We believe our products can help to maximise the benefit of these investments; therefore, we are taking a multi-pronged approach.

First, we want to make sure scientists understand how our products might be able to help them. We have established distributors and agents in these regions that will help us raise awareness of our solutions. We have established reference labs in these regions including partnerships with Lupin Pharmaceuticals in India and Crystal Pharmatech in China. This allows interested scientists

the opportunity to see the systems first hand. We have a global technical sales organisation that ensures we work with prospective customers to understand what their research need is and deliver a system that will have a meaningful impact on their productivity.

Secondly, we want to make sure our customers have a positive experience with our systems. We have established a global support organisation that is well-positioned to provide our customers with a positive user experience. Part of this is simply solving any issues that might come up with the system, but we see customer support as a step beyond this. We work with customers on software training, experimental design or whatever other help they might need to allow them to quickly get value from the systems. Since Freeslate has been active in high throughput research in these fields for nearly 15 years, we have built up expertise that we want to pass along to our customers.

How does a high throughput screening system contribute to a company’s success and how to exploit the system in the best manner?

Automation needs to be a tool that scientists are using to advance science. We find customers that have the most success understand how automation fits into an overall drug development strategy.

There needs to be commitment from all relevant stake-

holders on how the system will be utilised. Our software really fosters collaboration by allowing for experiments to be designed and shared among colleagues – even across different sites. Project teams can work together to define experimental parameters and really understand what data they need to reach a specific scientific decision.

When talented scientists work together to use automation thoughtfully in a drug development process, it can have a dramatic impact on what they can achieve directly and how well they can support other parts of the development process.

Automation should also be a tool that builds knowledge in an organisation.

Companies that take advantage of our centralised database and reporting tools to build knowledge – not just data sets – really see significant long term impacts to their productivity.

How important is the Indian market for Freeslate and what initiatives are being taken to support Indian customers?

The Indian market is a very important market for Freeslate. Pharma and biopharma companies are making significant investments in R&D in India, with spending increasing by more than 20 per year over year.

Skytech is our channel partner in India who have significant market information and reach in life sciences segment. We want to make sure we are working with companies to help them get the most productivity and innovation out of these investments. We see this as a real opportunity for not only automation, but specifically for Freeslate. To support this we will be attending a number of conferences in India this year, sponsoring a meeting to raise awareness to the value of automation, and will be working with Lupin Pharmaceuticals as a reference lab.

We’re pretty excited about the year we have planned.

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PHARMA TECHNOLOGY REVIEW VENDOR NEWS

College prof’s patent for new particle fractionator bags industry partner Dr Amit Kumar Goyal’s patented tech improves product yield, collection efficiency, and is more energy efficient

SPRAY DRYING is an important step in the pharma production process; yet poor yield rates, low thermal efficacy and a collection process which is both tedious and non-continuous remain major drawbacks of most spray drying set ups.

A recipient of the Innovative Young Biotechnologist Award -2009, Dr Amit Kumar Goyal, Associate Professor, ISF College of Pharmacy, Moga, Punjab used his project funding to develop a more efficient spray drying technology. In May last year, he and fellow investor Gaoutam Rath were awarded a patent (No. 1489/DEL/2013 date on 20/05/2013) for their design for a particle fractionator.

The technology was later transferred/licensed to Labultima, Mumbai for further development. Labultima is a manufacturer and supplier of precision laboratory spray driers and accessories in allied R&D fields.

According to Goyal, the spray drying process is used to produce a particulate of desired analytical and physical properties from a liquid recipe in a single operation.

This is a unique drying process having where the particulate is subjected to drying temperature for less than 0.21 seconds resulting into the only method for production of heat sensitive particulates/ molecules.

The dried produce can be in crystalline/amorphous form, in uniformly spherical,

62 EXPRESS PHARMA February 16-28, 2014

Dr Amit Kumar Goyal receives the award

needle shaped microscopic structure; desired particle size distribution from nano particles to granules; crushable/non crushable agglomerates as desired based on the selected composition of the liquid feed.

Spray drying is widely used in all disciplines of pharmaceuticals for API, Generics, Formulations; neutraceuticals, probiotics, prebiotics, enzymes, steroids, hormones, milk products; allied food products; flavours and fragrances and speciality ceramics; dyes and pigments etc.

Irrespective of its wide commercial application, con-

ventional spray drier suffer from some inherent drawbacks such as poor yield ranging from 10-15 per cent, low thermal efficacy as a large volume of heated air is passed through the chamber without coming into contact with the particles. Further, the closed cycle drier and multiple cyclone makes the collection process tedious and non-continuous.

Recently, there have been many attempts to improve product yield and generate nanoparticles using spray drying technology. A few of them were successful in achieving higher product yield

and nanoparticles generation using advanced sophisticated devices. However, the induction of the above technology makes the spray dryer expensive and difficulty to handle and maintain.

Goyal's major areas of interest are novel controlled and targeted drug delivery systems, vaccines delivery systems and nano-technology.

His new technology attempted to address these critical impediments related to conventional spray driers.

According to him, the present innovation provides a dynamic solution and opens a new avenue in spray drying

technology especially in terms of product yield and particle separation efficacy.

The new innovation discloses a spray drying device with the following benefits: ● Improved collection efficiency of desired particles including nanoparticles ● In-situ collection process ● Improved product yield making the process more economical ● Greater energy efficiency and much shorter drying time ● High reliability, low maintenance ● Compact size, easy to clean assembly ● Easy installation with any type of spray dryer Based on latest global trends and client feedback, the current licensee of the technology, Mumbai-based Labultima, is an ISO 9000:2001 certified company involved in similar product development activities at their inhouse R & D facility with pilot plant spray driers.

They are engaged in development of particulate of desired analytical/physical properties with yields and scale up from lab to pilot to plant level spray driers.

Besides being engaged in research on spray driers to cater to tomorrow’s needs, they have developed their own sophisticated data logging software compatible with US FDA 21 CFR PART 11 as well ultrasonic spray systems for generation of nano particles.

EP News Bureau-Mumbai

PHARMA TECHNOLOGY REVIEW

Almac publishes breast cancer chemotherapy response assay in JNCI The assay was developed by Almac in collaboration with Queens University, Belfast and the Mayo Clinic, Rochester, US

ALMAC’S DIAGNOSTICS business unit announced the publication of its breast cancer chemotherapy response assay in the Journal of the National Cancer Institute (JNCI).

The article entitled “Identification and Validation of an Anthracycline/Cyclophosphamide– based chemotherapy response assay in breast cancer” led by Almac’s medical director, professor Richard Kennedy gives detail on the development and initial validation of a predictive gene signature for chemotherapy response in breast cancer.

Breast cancer is the world’s most common cancer among women with one in eight diagnosed in their lifetime. Although modern chemotherapy reduces the risk of recurrence for some patients, not everyone benefits. At present there is no means of identifying those patients who will and will not respond to first line therapy. Almac’s objective in the development of this assay was to provide a means of identifying those breast cancer patients more likely to respond to standard of care chemotherapy treatment.

The assay was developed

by Almac in collaboration with Queens University, Belfast and the Mayo Clinic, Rochester, US. Almac carried out microarray analysis of patient samples and identified a molecular subgroup with a deficiency in DNA damage repair, termed DDRD for DNA Damage Repair Defi-

Almac carried out microarray analysis of patient samples and identified a molecular subgroup with a deficiency in DNA damage repair, termed DDRD for DNA Damage Repair Deficient. Almac then developed a 44 gene classifier capable of prospectively identifying this molecular group in patient tumour samples cient. Almac then developed a 44 gene classifier capable of prospectively identifying this molecular group in patient tumour samples.

The DDRD signature was then initially validated in a neo-adjuvant breast cancer cohort. In the neo-adjuvant setting the assay predicted complete pathologic response with an odds ratio of 3.96, meaning those patients that were DDRD positive were almost four times more likely to respond to treatment compared to patients that were DDRD negative. In the adjuvant setting, a DDRD positive result predicted five year relapse free survival with a Hazard Ratio 0.37 compared with test negative patients.

“The publication of this data represents a significant milestone for Almac as we transition this assay into the clinic. The publication of these results combined with our recent out-licensing of the assay to Genomic Health for use in breast cancer patients, highlights the quality of the science being carried out here in Almac” said Professor Paul Harkin, President and Managing Director of Almac’s Diagnostics business unit.

The test has been developed and validated exclusively using formalin fixed paraffin embedded (FFPE) tissue using Almac’s own proprietary Breast Cancer DSA. EP News Bureau-Mumbai

Multisorb Technologies appoints Paige Weis to HealthCare Packaging Group Will be responsible primarily for providing sales and service support to the diagnostic market in North America

MULTISORB Technologies has appointed Paige Weis to the position of Business Development Leader, Healthcare Packaging. In this role, Weis will be responsible primarily for providing sales and service support to the diagnostic market in North America in addition to supporting the medical device and dietary supplement market segments.

Based in the Dallas/Fort Worth area, Weis will report to Chris Gilmor, Market Leader, Healthcare Packaging, North America.

Under Gilmor’s direction, Weis will provide technical sales and support through the implementation of the Calculations through Operations Program, Multisorb’s consultative business model.

“We are pleased to have Paige join our team,” said Gilmor. “Her life science experience and technical skills make her a great addition, and her appointment will position Multisorb’s Healthcare Packaging sector for continued long-term success.”

Weis comes to Multisorb with more than 15 years of experience in the life sciences industry, which includes research, technical services, technical sales, business development, and project management. In addition, Weis has a bachelor’s degree

in biology and a master’s degree in biological sciences from Texas Tech University.

Weis’ strong industry background and customer focused experience will be beneficial for expanding Multisorb’s relationships with key customers and develop relationships with new and prospective customers.

EP News Bureau-Mumbai

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PHARMA TECHNOLOGY REVIEW

Phenomenex releases Updated Product Guide for 2014/2015

Agilent Technologies introduces newversion of Intelligent System Emulation Technology

New guide is available online or in a full-colour print version

ISET enables emulation of Waters Acquity UPLC, Shimadzu Prominence HPLC

PHENOMENEX HAS published its updated product and services guide for 2014/2015. Covering the company’s comprehensive lines of HPLC/UHPLC Columns, GC Columns, and SFC columns and sample preparation products, this year’s catalogue includes many new offerings, including a new Yarra analytical dimension and prep column and a new Aeris Peptide 2.6μ column.

The 412-page guide incorporates a Kinetex column selection guide, new excipient applications on Phenogel GPC columns and new chiral column comparisons. Also new this year is a sample request tool for solid phase extraction tubes, Verex certified vials, and Phenex

AGILENT TECHNOLOGIES introduced the third version of its Intelligent System Emulation Technology for the1290 Infinity Binary LC and 1290 Infinity Quaternary LC systems. The new ISET version allows emulation of the Waters Acquity UPLC and Acquity H-class systems and the Shimadzu Prominence HPLC system.

ISET provides a seamless transfer of methods between varying LC technologies, delivering unchanged retention time and peak resolution. The 1290 Infinity LC is now the world's most adaptive LC system, as it can execute other HPLC and UHPLC methods and deliver the same chromatographic results without any instrument or method changes.

syringe filters.

The new guide is available online or in a full-colour print version. Online, the guide includes links to new corporate videos as well as Phe-

nomenex’s unmatched range of web tools that enable customers to easily find applications, select columns and accessories, and access round-the-clock support.

Multiple country-specific print versions have been published this year for the convenience of customers in key geographic areas.

“Our guide is extremely easy to use and full of useful products, technical tips and applications,” said Kari Kelly, Corporate Marketing Manager, Phenomenex. “It’s an excellent complement to our award-winning website and comprehensive collection of web tools and resources, which we are continually developing.”

EP News Bureau-Mumbai

The 1290 Infinity LC, together with ISET, allows users to: ● Emulate other (U) HPLC instruments with a simple mouse click ● Run existing (U) HPLC methods without modifying method or system ● Deliver same retention times and peak resolution for -enhanced method transfer "ISET enables highly regulated laboratory environments, such as pharmaceutical quality control, to globally transfer methods between different instruments," said Christian Gotenfels, Agilent's senior product manager for liquid chromatography. He added, "With this unique technology we are addressing a major gap in the workflow of our customers."

EP News Bureau-Mumbai

SCHOTT issues a million certificates on glass tubing The certificates assist the pharma industry on tracking pharma tubing

SCHOTT ISSUED its one millionth certificate for its FIOLAX glass tubing recently.

These certificates help to identify the products shipped as tubing that are subsequently processed into pharmaceutical packaging, vials or syringes, for example. These documents contain detailed information on the dimen-

64 EXPRESS PHARMA February 16-28, 2014

sional quality and the quality of the glass which enables pharma companies to track their packaging all the way back to the raw material 'glass tubing', if necessary.

Reportedly, SCHOTT is the first company in the industry to allow for all of the pharma tubing it manufactures to be identified back in 1999. The

certificates are applied to the pallet in a clearly visible position and enable customers to inspect incoming shipments more easily because they contain plenty of detailed information. One part of the certificate can be detached and stored for documentation purposes and used to perform subsequent tracking & tracing

inside the e-commerce portal.

SCHOTT’s certificates, besides a description of the product including all of the characteristics of importance to the customer, also contain detailed specifications on tolerances. “In other words, we offer our customers the highest possible transparency and reliable quality,” concludes Jürgen

Achatz, Global Sales Director for Pharmaceutical Tubing at SCHOTT. SCHOTT manufactures FIOLAX in Germany, Spain, Brazil and India. Each year, SCHOTT reportedly manufactures around one million km of pharma tubing.

EP News Bureau-Mumbai

PHARMA TECHNOLOGY REVIEW

Wipro cited as leader in global research and advisory firm report The report evaluates worldwide life science manufacturing and supply chain ITO services providers across 24 criteria

WIPRO, global information technology, consulting and outsourcing company has been named ‘Leader’ by technology global research and advisory firm International Data Corporation (IDC) in its report IDC MarketScape: Worldwide Life Science Manufacturing and Supply Chain ITO 2013 Vendor Assessment, Doc #HI244265, November 2013. IDC evaluated leading life science manufacturing and supply chain ITO services providers across 24 criteria relating to current offering, strategy and market presence

based on client inquiries, user needs assessments, and vendor and expert interviews. It identified Wipro as a leader in worldwide life science manufacturing and supply chain ITO. Elaborating on Wipro’s experience with life sciences clients, the report states that “Wipro has extensive experience working with medical device companies, complemented by mid-level experience with pharmaceutical and biotech companies as well.

The vast majority of Wipro's life science customers are large corporations with revenues of over

$1 billion, with a smaller portion spread across midsize and small firms. While more than half of its client base is North American based, it does have a significant client base across all regions of the world, including Europe, Asia, and Latin America, with multiple delivery centres in each region as well.”

IDC has rated Wipro highly for client centricity based on customer interviews conducted across all the vendors. The report further states, “Relative to other vendors discussed in this report, and based on feedback

from multiple customer references, Wipro scored the highest among all vendors for account management capabilities and received high marks for technical skills and overall level of value delivered to its clients.”

Elaborating on Wipro's vision and focus, Nitin Raizada Global Practice Head - Industry Solutions Group, Life Sciences, Wipro said, “We continue to consolidate our position and strengthen our performance.

I believe this increase in momentum is the result of a set of structured things we are doing

to drive ‘sustainable’ and ‘predictable’ growth. Our continued focus on patient centricity, compliance and commercial effectiveness is showing results.

We have gained traction in winning large transformation and domain specific deals by pursuing Wipro’s three-pronged strategy of programmatic mining of existing accounts, new logo pursuits and creating differentiated domain offerings to solve real problems faced by clients.”

warnings if temperature exceeds set point and silences automatically when set point is restored. Rugged cabinet design withstands travel inside and outside your facility.

Composite vacuum-insulation panels with CFC-free foam strengthen and protect from

high ambient temperatures.

Molded-in handles make the freezer easy to grip and move.

EP News Bureau-Mumbai

PRODUCT

New portable ultra-low temperature freezer COLE-PARMER OFFERS light weight portable temperature freezer, developed to bring ultra-low 86°C temperature storage to places conventional compressor freezers cannot go or won’t work. It weighs less than 42 lb (19 kg), making it ideal for benchtop or field applications. It offers secure mobile transport of biological specimens. Ideal for use within biorepositories, and other applications associated with pharmaceutical distribution.

The easy-grip molded-in handles offer comfortable transport and the instruments can be connected easily to a

mobile power supply.

Operating on a stirling engine, the freezer requires no compressors, dry ice, or LN2, and draws the same amount of energy as a conventional light bulb, making it environmentally friendly and cost effective. The Humm freepiston stirling engine contains two moving parts that float on helium gas bearings to eliminate contact wear. The linear driver modulates engine power to deliver cooling on demand for straight line control without on/off cycling.

Freezing is performed by the thermosiphon evaporator. A

microcharge of environmentally friendly cooling medium creates a uniform ultra-low temperature by a continuous process of evaporation and condensation within the sealed tube.

Weather-resistant touchpad controller features a digital temperature display indicating interior temperature and error codes if detected. Temperature preset buttons allow you to quickly choose -20, -40, or -86°C (default at startup); easily raise and lower temperature at 1°C intervals. The over/undertemperature alarm activates visual and audible beep

Contact details Application Specialist at 022-67162209/22 response@coleparmer.in www.coleparmer.in.

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We care for your family . . .

Anti-Inflammatory Enzymes Serratiopeptidase Peptizyme (enteric coated serratiopeptidase granules) Trypsin Chymotrypsin mix ( 6:1)

Probiotics Saccharomyces boulardii Lactic acid basillus sporogenous

Circulatory Health Nattokinase

Bio Catalysts Immobilized Cal B

Digestive Aids Alpha amylase / fungal diastase / fungal amylase Alpha galactosidase Bacterial alpha amylase Bromelain Hemicellulase Lactase Lipase Ox bile

Papain Pepsin Pancreatin Protease ( acid / alkali)

Advanced Enzyme Technologies Limited Sun Magnetica, 'A' wing, 5th Floor, Accolade Galaxy, LIC Service Road, Louiswadi, Thane(W) - 400604, India Tel: +91 22 41703200, Fax: +91 22 25835159 • E-mail : info@enzymeindia.com • Website: www.enzymeindia.com

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Non-GMO ISO CERTIFICATION

GOTS CERTIFICATION

Products

WHO cGMP

FDA

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CLEANING, SANITISING EQUIPMENTS CLEAN ROOM ACCESSORIES ASEPTIC PIPING , PW / WFI DISTRIBUTION LOOPS

Floor Drain Traps

Hand Sanitiser

Water Saver Cleaninng Nozzles(self-rotating) Nozzles

Shoe Cover Dispenser

Foot Sanitiser

Split Butterfly Valve

Pendents(Service Shafts) CIP/ SIP MODULE We also design & manufacture # IBC Washing/ Drying Modules # Containers/ Glass Ware Wash Modules # FBD Bag Washing/ Drying Modules # Cannisters Washing Modules # Drums Washing Modules

Wash Down Hose Station

SIP MODULE

8/B, Surat Singh Est ,SV Rd, Jogeshwari(W), Mumbai-400102 Tel; 022-26797941 Telefax:022-26798066 Cell: 9869231815 email: iewi@mtnl.net.in website : www.iewi.net

Top Tank / Reactor Sampler

Flush Bottom valve

Product Range

Parksan Filters Pvt. Ltd.

Horizontal Plate Filter Press Plate & Frame Filter Press Bag Filter Cartridge Filter Single Plate Filter Holder Basket Filter Rotary Spray Ball Recess Plate Filter Press

103, Laxmi Industrial Estate, Navghar, Vasai Road (East), Dist. Thane - 401 210, India Tel : +91 250 239 1904 Mob : +91 98338 83114 Email : sales@parksanfilters.com Web : www.parksanfilters.com parksan@vsnl.net

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Technology that’s Instrumental In Your Success MOLECULAR WEIGHT MOLECULAR SIZE MOLECULAR STRUCTURE PARTICLE SHAPE PARTICLE SIZE SOLUTION VISCOSITY RHEOLOGICAL PROPERTIES ZETA POTENTIAL CHEMICAL IDENTIFICATION

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Manufacturers of Pharmaceutical Machinery

39/2A, Purna Das Road, Kolkata - 700 029. Gram : Techpharma. Tel : 91 33 2464 4568 / 0457 7253 Fax : 91 33 2464 7254. Email : mails2neomachine@gmail.com, neocota@sify.com Website : www.neocota.com, www.neomachine.in Mumbai : 91 22 2261 4088, Chennai : 91 44 2432 2243 / 2432 8128, Delhi : 91 11 2546 0255

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SILICONE TRANSPARENT TUBING F O R H I G H P U R I T Y APPLIC AT IONS

DMF NO: 26710

1 1 1 1 1 1 1 1 1 1 1 1 1

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US FDA regulations CFR 177.2600 for contact with food USP class VI requirements European Pharmacopoeia 3.1.9 Animal derivative free Imported state of the art machine ed Highly advanced auto-curing system rtifi e C Excellent heat resistance (-50째C to 250째C) m nroo Clea Odourless Completely nontoxic Repeatedly autoclavable No leaching of particles Does not support bacteria growth Retains elasticity even after prolonged use

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ONE STOP SOLUTION FOR PHARMACEUTICAL RESEARCH

Innovation is our culture…

Quality in our genes…

!"#$%&%'($%)# )& +"'),-%#(#$ .+)$"%#/ (/ ."+ 012 31415.(6"7 8"/$"+# -9)$7 2".$%!" ,(..%#6: ;#(9</%/ )& .+)$"%# %,.=+%$%"/ %# +"'),-%#(#$ .+".(+($%)#/ >"#" ?=(#$%&%'($%)# -< @A52B@ C9"'$+).D)+"/%/ /</$",/ E)9"'=9(+ /%F" !"$"+,%#($%)# 31CB: B9%#%'(9 -%)'D",%/$+< (#(9</%/ G".(+%# 7C#)H(.(+%#7 G=,(# 1"+=, ;9-=,%# (#(9</%/

I%)9)6%'(9 ;'$%J%$< 3 K( (#! (: BD(.$"+ LMNOP: 2<+)6"# A"/$%#6 3BD(.$"+ LONOP: I('$"+%(9 C#!)$)H%#/ 3BD(.$"+ LMNP: 1$"+%9%$< A"/$%#6 3BD(.$"+ LQOP: E"$D)! R(9%!($%)# (/ ."+ BG ;EC1 A"/$ (/ ."+ SCB4 TQO 2+"/"+J($%J" C&&%'('< A"/$ 3BD(.$"+LNOP: I%)9)6%'(9 @"('$%J%$< &)+ 2('U%#6 E($"+%(9 (/ ."+ 3BD(.$"+LMQP7LMMP:

BIOSIMILAR TESTING

SERVICES

ACCREDITATIONS

Biological Studies Pre Clinical Studies Analytical Research Formulation Research Microbiological Studies Bio-equivalence Studies Clinical Trials Dossier Preparation

USFDA registered cGMP control testing laboratory Department of Science & Technology approved R & D Centre Drugs Controller General of India (DCGI) NABL accreditation for Chemical, Biological and Medical Testing Recognized by Bureau of Indian Standards Drugs Control Administration (A.P) Department of Biotechnology approved Institutional Bio-Safety Committee (IBSC)

4($( E(#(6","#$ .+('$%'"/ %# 1 2@; V;I1 (+" !"/%6#"! $) "#/=+" $)$(9 %#$"6+%$<7 /"'=+%$< (#! &(/$"/$ +"$+%"J(9 )& !($(W

SIPRA LABS LIMITED Industrial Estate, Sanathnagar, Hyderabad – 500 018.

Tel: 040-23802000, Fax: 040-23802005 Email:sipra@sipralabs.com web: www.sipralabs.com EXPRESS PHARMA

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PHARMA LIFE NAUKRI JOB SPEAK INDEX

Hiring activity in pharma sector stabilises in Jan’14 Signals better times ahead for the sector NAUKRI JOB Speak Index for the month of January 14 reflects stability for the pharma sector.

An month-on-month analysis reveals that index has grown by one per cent in January 2014 as compared to December 2013.

Yearly comparison shows a 13 per cent increase in January 2014 if compared to same month of previous year.

About Naukri.com Naukri.com, India’s No. 1 job site and the flagship brand of Info Edge introduced the concept of erecruitment in India. Since its inception in 1997, Naukri.com has seen continued growth while outperforming its competitors in every sphere. Info Edge was the first Internet Company to be

listed in India. The site enjoys a traffic share consistently over 60% as per the Comscore data.

Naukri.com is a recruitment platform that provides hiring-related

services to Corporates/ recruiters, placement agencies and to job seekers in India and overseas. It offers multiple products like Resume Database Access,

listings and Response Management Tools. With 230000 jobs live at any point and over 33 million CV’s, Naukri.com serviced over 48000 corporate clients in

2012-2013. The company has over 2500 people operating through 57 offices in 36 cities in India and overseas offices in Dubai, Riyadh, Abu Dhabi and Bahrain.

JOBS FROM Naukri.com Product Manager

Job Id: 010214000610

Company: Alchem International Exp: 3-8 Location: Delhi Job Id: 121113003201

Research Investigator Applid Biotechnology

Asst. manager Company: Harman Finochem Exp: 6-11 Location: Aurangabad Job Id: 081213000192

Shift Incharge Production Company: SanmarSpeciality Chemicals Exp: 2-5 Location: Hosur Job Id: 201113901018

Export ExecutiveInternational Marketing Company: Gujarat LiquiPharmacaps Exp: 5-7 Location: Vadodara/Baroda

Company: Syngene International BBRC Exp: 1-4 Location: Bengaluru/Bangalore Job Id: 230713003197

Analytical/organic Chemist Company: Sami Labs Exp: 4-7 Location: Bengaluru/Bangalore Job Id: 240114002258

Area Business Manager Company: Finecure Pharmaceuticals Exp: 3-5 Location: Agra Job Id: 170114004258

Executive - Analytics Company: Pharmaffiliates

Analytics Synthetics P Exp: 1-2 Location: Panchkula Job Id: 100513001804

Team Member Corporate Legal Team Company: Dr. Reddys Laboratories Exp: 6-10 Location: Hyderabad / Secunderabad Job Id: 290114000445

Marketing Area Head Company: Brilliant Bio Pharma Exp: 5-7 Location: Lucknow Job Id: 070214004654

Creative Copy Writer Company: IndegeneLifeSystems Exp: 3-8 Location: Bengaluru/ Bangalore

Job Id: 291113001360

Human Resources Administration Executive Company: K N M Pharma Exp: 2-7 Location: Ahmedabad Job Id: 070214004463

Location: Hyderabad / Secunderabad Job Id: 070214004013

Regional Sales Manager - Veterinary Company: Carevetpharma Exp: 3-7 Location: Ludhiana Job Id: 310114003816

Medical Representative Company: Torrent Pharmaceuticals Exp: 0-5 Location: Allahabad Job Id: 070214004154

Logistic Manager Company: Yash Pharma Laboratories Exp: 2-4 Location: Thane Job Id: 070214003803

Procurement Manager Company: Archana Ampoules Exp: 3-5 Location: Mumbai Job Id: 070214004056

Microbiologist Freshers

Sr Product Sppt Specialist Company: Quintiles Exp: 4-8 Location: Bengaluru/Bangalore Job Id: 070214900688

Company: Makro Technologies Exp: 0-0

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PHARMA LIFE AWARD

APPOINTMENT

KBITS announces Bio-Accelerate winners

Bayer CropScience, India appoints Richard van der Merwe as MD

Out of 30 entries, six competitors were shortlisted KARNATAKA BIOTECHNOLOGY and Information Technology Services (KBITS), Government of Karnataka, organised a programme â&#x20AC;&#x2DC;Bio-Accelerateâ&#x20AC;&#x2122; during Bangalore India Bio 2014, wherein 30 entries were selected. Out of them six competitors were shortlisted and given 15 minutes for the presentation. They were asked questions and evaluated by a jury consisting of Dr Anand Anand Kumar from Cellworks, Dr Ram Ramaswamy from CCAMP, Dr Jagadish Mittur from KBITS, Dr Gutam from ABLE, Dr Jitendra Kumar from IBAB / KBITS. Poster awards, BioExcellence awards, Exhibitors and InterlinX partnering tool awards were also presented at Bangalore INDIA BIO 2014.

The name of three winners were OncoStem, a Bangalore-based start-up pro-

84 EXPRESS PHARMA February 16-28, 2014

The awards were presented

by SR Patil, Minister for Information Technology, Biotechnology and Science & Technology moted by Dr Manjari Bakre; Mir Life Sciences, a threeyear-old start-up which is being incubated at IBAB where Dr Charishiela Ramkumar is the chief scientist. Ramkumar is spear-heading the diagnosis and prognosis for oncologists to make better treatment decisions. The third winner was String Life Sciences, a start-up promoted by Dr Ezhil Subbiane, which is involved in creating solutions in environmental problems using genetically engineered micro organisms.

The name of the three finalists were Module Innovations, the start-up being incubated at NCL Venture Centre, Pune, which is working on low cost rapid detection of micro organisms; MatSyntoForma, a technology being incubated at TERI and deals with waste water purification at oil fields with an additional benefit of production of specialised industrially used chemicals and Life Catalyst Technologies, promoted by Dr Sagar Laygude, based out of IIT Madras and is involved in de-

veloping a low cost diagnostic blood glucose sensor.

The awards were presented by SR Patil, Minister for Information Technology, Biotechnology and Science & Technology; Planning and Statistics, and Infrastructure Development, Government of Karnataka, World Food Prize Laureate 2013 Em. Prof Dr Marc Van Montagu and nobel laureate 2012 Sir John Gurdon, Kt DPhil DSc FRS, Distinguished Group Leader, The Wellcome Trust/Cancer Research UK, The Gurdon Institute, University of Cambridge, UK in the presence of Srivatsa Krishna, IAS, Secretary to Government, Department of Information Technology, Biotechnology and Science & Technology and DPAR (e-Governance), Government of Karnataka and SS Nakul, Director, IT and BT. EP News Bureau-Mumbai

In addition, he will be the Bayer representative for South Asia, based in Mumbai

RICHARD VAN der Merwe has been appointed as the Managing Director and Vice Chairman, Bayer CropScience, which was effective from February 1, 2014. In addition, he will be the Bayer Representative for South Asia, based in Mumbai. He succeeds Stephan Gerlich, who will take over new responsibilities as the new Bayer Representative for Mexico. Stephan Gerlich has been the Country Head of Bayer in India since 2003.

EP News Bureau - Mumbai

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