ExpExpress Pharma September 16-30, 2012 by Indian Express

I N D I A’ S F O R E M O S T P H A R M A & B I OT E C H P U B L I C AT I O N September 16-30, 2012 ` 40

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Contents

E|X|P|R|E|S|S

Pharma VOL 7. NO. 22 SEPTEMBER 16-30, 2012 Chairman of the Board

quotes

Viveck Goenka

CDSCO to increase headcount of NDAC, MDAC committees

Editor Viveka Roychowdhury* Photo Editor Sandeep Patil BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das

We believe FDI in the industry is necessary as it enables domestic companies to get patient capital to invest in R&D and high-risk, high-return areas such as biologics and biosimilars. It also helps ease the pressure on companies which are carrying high-cost debt

Bangalore

Mahadevan Narayanamoni Partner Corporate Finance Grant Thornton India

Neelam M Kachhap Delhi Shalini Gupta

Page 18

MARKETING Deputy General Manager Harit Mohanty

The compensation is for serious adverse event—permanent injury OR death. Why should severity be judged to determine compensation?

Senior Manager Rajesh Bhatkal PRODUCTION General Manager

Dr Arun Bhatt President Clininvent Research

B R Tipnis Production Manager Bhadresh Valia

In order to bring more transparency, consistency and accountability in the approval process of drugs, Central Drugs Standard Control Organization (CDSCO) is increasing the number of members of New Drug Advisory Committees (NDACs) and Medical Devise Advisory Committees (MDACs). CDSCO plans to increase the number of members to around 30 and it has invited applications for the same. The last date for the submission of applications is on September 28, 2012 Page 19

Asst. Manager - Scheduling & Coordination

CLINICAL UPDATE Photonics to aid understanding of early defence systems in humans

Arvind Mane Asst. Art Director Surajit Patro

Page 32

Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka Layout Rakesh Sharma C I R C U L AT I O N Circulation Team Mohan Varadkar Express Pharma Reg. No.MH/MR/SOUTH-77/2010-12 RNI Regn. No.MAHENG/2005/21398 Printed for the proprietors,The Indian Express Limited by

INTERVIEWs ‘We see a fast-growing pharma market in India’ With a strong international presence, Schott considers India as a one component to its flexible worldwide production network. Its goals is to enable the upcoming Indian companies to produce high quality primary packaging that meet international standards. Sundeep Prabhu, Vice President Marketing and Sales, Tubing Division, Schott Glass India, reveals company's business-related functional activities with Usha Sharma

Dr Rao Papineni's laboratory at Carestream, US, is utilising optical imaging technologies in understanding the early responses of living systems to infection and various chemical and mechanical insults Page 46

Page 48

Ms.Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administra-tive Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021)

*Responsible for selection of news under the PRB Act. Copyright @ 2011 The Indian Express Ltd. All rights reserved throughout the world. Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

September 16-30, 2012

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EXPRESS PHARMA

Editorâ&#x20AC;&#x2122;s Note

Converting India Biotech Inc's potential into reality n a day that saw one vaccine major announce a major collaboration in the generic and branded

pharma space, another player reiterated their reasons to stick to their forte. Both perspectives reflect the different strategies at play in the biotechnology industry in India.

Panacea Biotec's strategic collaboration with Osmotica Pharmaceuticals seems to have got the thumbs

up from the stock market, with the scrip seeing a hike of almost 20 per cent on the BSE soon after the deal was announced. The move could be seen as an attempt of India's second largest vaccine player to focus on the pharma side of its product portfolio. This seems to be a smart move from the balance sheet point of view, as the vaccines business is a volumes play and is largely a tender-driven business. The sector is made more vulnerable by the fact that organisations like WHO and UNICEF are in turn dependent on donors to fund their vaccine access programmes. Indeed, with the global economic crisis, many donor nations had to be prodded into meeting their commitments last year. But in spite of this vulnerability, Serum Institute's founder Cyrus Poonawala, India's largest vaccine manufacturer, has decided to focus on vaccines. There have been recent reports on the company selling its stakes in past investments like the UK-based Lipoxen Plc (now Xenetic Biosciences, a company with a pipeline of protein drugs and vaccines) and US-based Akorn (which manufactures and markets sterile specialty pharmaceuticals). Speaking on the sidelines of the third edition of BIO India, Poonawala indicated that he is also waiting for an opportune time to exit from Orchid Chemicals even though he had once considered a possible acquisition of the company. Poonawala also spoke about plans to use the recent acquisition of Netherlandâ&#x20AC;&#x2122;s state-owned vaccine maker Bilthoven Biologicals as a manufacturing base for the EU markets. Inspite of the vulnerability of the vaccines sector, he says there's a huge opportunity as well, provided players stick to cGMP norms and do not take short cuts, especially during the production ramp up process. The biotech sector as a whole in India does have opportunities but leader speak at BIO India this year reflected the fact that regulations could make or break the sector. A joint statement released by the organisers after a biopharma regulatory and policy roundtable commends the draft biosimilar guidelines but cautions that such regulations need continued refinement over time. The statement also urges that a first priority should be to streamline and rationalise the necessary clearances in order to eliminate unnecessary processing delays. It also hints that moves like compulsory licensing could impact the development of new, innovative biotech products for Indian consumers and makes a case for both incentives such as intellectual property rights to develop these needed products and a system for providing them to those who need them. Clearly, the statement reflects the fact that we are drawing closer to a final verdict in the Novartis-Glivec case which is casting a shadow on the entire lifesciences sector. It will take the concerted efforts of industry as well as policy makers to find a middle path and convert the sectorâ&#x20AC;&#x2122;s potential into reality. Viveka Roychowdhury viveka.r@expressindia.com

Corrigendum In the article, 'FDI tangle: And the vote goes to....?' published in Express Pharma (August 16-31, 2012 issue) the incorrect image of S Ramesh President - Finance & Planning, Lupin was carried. We regret the error and apologise for the same. The online version of the story reflects the right image of the author.

12 EXPRESS PHARMA

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September 16-30, 2012

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Market

THE BUSINESS OF PHARMACEUTICALS

UPFRONT Venus Remedies bags patent for Vancoplus from Canada enus Remedies has secured its first patent from Canada for its novel antibiotic adjuvant entity ‘Vancoplus’. The patent, granted by the Canadian patent office, is valid up to May 2027. The company is planning to launch the product in Canada in the next two years. Dr Manu Chaudhary, JMD, Director- Research says, “We are really enthusiastic over the receival of this Canadian patent for Vancoplus, which will prove to be a fertile ground for the success of this product not just commercially but also in terms of catering to the constantly rising Methicillin Resistant Staphylococcus aureus (MRSA) infection rates in Canada.” Dr Chaudhary further added, “Vancoplus seems to be the only effective and safe option to curb the notorious MRSA strain. As the Canadian pharma market is the third fastest growing market globally, it shows the great growth potential for R&D players in the industry to create better drugs to curb such diseases. With this patent, we are hopeful of capturing a significant share in the Canadian pharma market.” Dr Mufti Suhail Sayeed, Sr Vice President, Venus Medicine Research Centre (VMRC) stated, “Vancoplus is an ‘Antibiotic Adjuvant Entity’ (AAE) constituting Ceftriaxone plus Vancomycin along with an adjuvant which restricts the production of toxin by MRSA pathogens and is highly effective in combating MRSA along with other advantages of reduced treatment time, cost and adverse effects.” The company is marketing Vancoplus successfully in India and emerging markets across the globe. Venus Remedies’ Baddi facility is already approved as per EU GMP for manufacturing of Vancoplus, which is in line with the Canadian regulatory authorities to market the drug. Apart from Canada, the patent for this product has already been granted from the US, South Africa, New Zealand and Ukraine and Australia authorities.

September 16-30, 2012

CDSCO to increase headcount of NDAC, MDAC committees In order to bring more transparency, consistency and accountability in the approval process of drugs, Central Drugs Standard Control Organization (CDSCO) is increasing the number of members of New Drug Advisory Committees (NDACs) and Medical Devise Advisory Committees (MDACs). CDSCO plans to increase the number of members to around 30 and it has invited applications for the same. The last date for the submission of applications is on September 28, 2012

Page 19

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EXPRESS PHARMA

M|A|R|K|E|T &As have for long been the route to faster inorganic growth for companies looking to ramp up their presence in an increasingly competitive market. With the Indian pharma industry expected to grow at a CAGR of 15 per cent till 2014, one of the fastest in the world, it has always been topmost on the expansion strategy of big pharma. After the big ticket deals that India saw till 2010, including the takeover of Ranbaxy Laboratories by Japan-based Daiichi Sankyo and Piramal Healthcare Solutions Business unit by Abbott Laboratories in the US, the M&A bull run seems to have mellowed down almost giving an impression that it is missing in action (MIA). However, scratch the surface and there are new trends and a cautiously positive outlook despite gloomy figures that convince us otherwise.

KARAN SINGH

KRISHNAKUMAR V

Head, Asia Healthcare Practice Bain & Company

Partner Ernst &Young

Slow and steady

The outlook for inbound M&As remains more cautious owing to the brownfield expansion uncertainty from expansion of price controls, the recent compulsory licensing move and unclear FDI norms

Globally the pharmaceutical business model is going through the 'perfect storm' and is evolving to one of risk-sharing partnerships. The number of such partnerships/alliances has doubled to ~ 300 in the year 2011, up from the level of ~ 150 per year seen during 2008-2010

Practice, Bain & Company, “The outlook for inbound M&As remains more cautious owing to the brownfield expansion uncertainty from expansion of price controls, the recent compulsory licensing move and unclear FDI norms.” FDI is required even for domestic consolidation in the form of private equity. “We believe FDI in the industry is necessary as it enables domestic companies to get patient capital to invest in R&D and high-risk, high-return areas such as biologics and biosimilars. It also helps ease the pressure on companies which are carrying high-cost debt,” says Mahadevan Narayanamoni, Partner, Corporate Finance, Grant Thornton India.

slowed down inbound deals, Indian companies investing abroad have become cautious. This is a far cry from a few years back when they were aggressive in their pursuits. “Till early 2008, Indian companies, driven by the availability of cheap capital, indulged in international M&A without clear focus on valuations and the strategic-fit of the targets to their business objectives,” pitches in Krishnakumar V, Partner Ernst & Young. “Bulk of these deals were funded by capital raised through FCCBs during the years 2006 and 2007. Indian pharma companies had mobilised around $ 2.3 billion through FCCBs during these two years. Increased market uncertainty, weak capital markets and poor performance of the acquired businesses have helped tone down the frenzy since then, and

Last year saw key outbound acquisitions by Zydus (Nesher Pharma) and Vivimed Labs (Uquifa), and inbound acquisitions by Hikma (Unimark), Akorn (Kilitch), Par Pharma (Edict), Cilag GmBH (JB’s Russian brands) and Aventis (Universal Medicare) along with a few smaller domestic transactions in the formulations space. The most notable transaction was the disposal by Strides Arcolabs of its Australian business to Watson Pharma, for nearly $393 million. However, M&A activity in the first half of 2012 has been the lowest in three years down 19 per cent from the corresponding period last year, although pharma, biotech and healthcare together accounted for the second highest share of 15 per cent (Source: Dealtracker Pharma, Grant and Thornton). Analysts also point out other reasons, specific to the sector, for the sober performance.

Regulatory slowdown Towards the end of 2011, a stricter regime for foreign acquisitions was launched requiring existing Indian companies to seek government approval for FDI with all future proposals to be routed through the Foreign Investment Promotion Board (FIPB). This has increased the time length of approval thus making companies approach any deals gingerly. The sentiment is echoed by Karan Singh, Head Asia Healthcare

From aggression to caution While regulatory pressures have

Deal value vis-a-vis deal volume Year

Total Deal Value ($mn)

Total Deal Volume (No.)

First half of 2012 (Jan-Jul)

612

First half of 2011 (Jan-Jul)

499

First half of 2010 (Jan-Jul)

4,056

(Source – Bain Analysis) *Deal value is based only on deals reported in public domain

Eight new deals approved n August 25, 2012, the FIPB approved eight FDI proposals worth ` 1,842.55 crore including Pfizer’s ` 800 crore proposal for 'induction of foreign equity in an operating-cum-investing company to carry out the business in pharmaceutical sector', Mumbai-based Arch Pharmalabs’ proposal for inducting ` 372 crore of foreign investment for manufacture and sale of APIs. Others include, Sutures India, Bangalore (` 200 crore), B Braun Singapore, Singapore (` 248.40 crore), Stellence Pharmscience, Bangalore (` 100 crore) and Zim Laboratories, Nagpur (` 50.44 crore).

O 16

EXPRESS PHARMA

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the handful of mature buyers left in the Indian pharma market today, are more focused than ever before on strategic fitment of targets – in the form of products, clientele, market-access, technology, IP and regulatory-approvals."

High valuations Indian

pharma

companies

are

September 16-30, 2012

M|A|R|K|E|T valuations rich given their strong generic capabilities. Expectations have been high after historic deals such as Ranbaxy (sold at four times its sales), Piramal Healthcare (sold at nine times its sales) and Paras Pharma (eight times its sales). There have not been many deals with promoters wanting excessive valuation / big valuation. However, various small deals with valuation of $ 50-

they don't have), the transaction opportunity here is not possibly being maximised.

No product differentiation Most of the Indian companies have grown in size by focussing on a single product. “This leaves only a few handful targets which remain attractive in terms of their product pipelines thus

manufacturing capacity across the generic pharma spectrum (especially in areas such as injectables, with only a few US FDA approved facilities abroad). Access to a fast growing Indian pharma market, talent and R&D capability / facilities for new product development alongwith domestic consolidation in several sub-sectors (APIs, intermediates and branded generics) would work in

Break up of deals by number First half of the Year

Total Deals by number

Inbound (No.)

Outbound (No.)

Domestic (No.)

(Both players publicly listed companies)

2012

2011

2010

(Source – Bain Analysis) *Deal value is based only on deals reported in public domain 100 million such as Universal MedicareSanofi and Biochem PLC- Zydus have taken place recently. Analysts believe that companies genuinely wanting to sell are willing to transact at reasonable valuation.

making them ready assets for companies on the look out. With MNCs already having a historical presence in India and similar product offerings of , there is less value a deal offers to a foreign investor,” opines Shiraz Bugwadia, O3 Capital Advisors.

Unrealised potential There are a lot of companies with capacity willing to cede controlling stake in the API intermediates space. However, with an increasing demand for US FDA approved facilities (which

September 16-30, 2012

Future Trends According to Narayanmoni, India would continue to be an attractive investment destination for companies since it offers access to good quality

www.expresspharmaonline.com

its favour, he adds. There are other trends that would define the deals going ahead.

Emerging markets ahoy! Traditionally, Indian companies began by acquiring companies in the US and EU, but this is finally giving way to newer, emerging markets with untapped potential, where the outlook for generics is favourable. Several companies are looking at markets such as Indonesia, Latin America and Africa to

EXPRESS PHARMA

M|A|R|K|E|T expand their footprint by aligning or tying up with distribution partners, given an increasingly competitive and regulated domestic pharma market. This helps build up their value, as they in turn would be deemed attractive targets by global pharma companies looking to expand their footprint in these new markets. Japan has historically been the slowest developed market to make a move towards generics, but it looks promising in the coming years.

MAHADEVAN NARAYANAMONI Partner Corporate Finance Grant Thornton India

AJAY KUMAR SHARMA Associate Director - Pharma & Biotech – Healthcare Practice South Asia & Middle East Frost & Sullivan

Can’t acquire? Partner Says Krishnakumar of EY, “Globally the pharmaceutical business model is going through the 'perfect storm' and is evolving to one of risk-sharing partnerships. The number of such partnerships/alliances has doubled to ~300 in the year 2011, up from the level of ~150 per year seen during 2008-2010.” This statement is echoed by Ajaykumar Sharma, Associate Director Pharma & Biotech – Healthcare Practice, South Asia & Middle East, Frost & Sullivan, “M&As are giving way to JVs, wherein both partners focus on their core competency while still retaining their identity. It is a win-win partnership for both unlike M&As where the freedom comes with riders.” Regulatory reforms, India’s strength in manufacturing and a reluctance of Indian companies to sell off would see foreign partners looking to participate by inking strategic alliances.

Selective acquisitions While a desire to scale up and get market access in emerging markets (irrespective of the product portfolio)

M&As are giving way to JVs, wherein both partners focus on their core competency while still retaining their identity. It is a win-win partnership for both unlike M&As where the freedom comes with riders

a leadership position in the segment in the Indian market. There are few companies of their ilk in India who would have such an acquisition strategy and

R&D driven deals While outbound deals would not be R&D driven on account of the historical inability of Indian companies to meet

PE deals by number and volume Year

Total Deal Value ($ million)

Total Deal Volume (No.)

First half of 2012 (Jan-Jul)

First half of 2011 (Jan-Jul)

First half of 2010 (Jan-Jul)

(Source – Bain Analysis) *Deal value is based only on deals reported in public domain would drive mid-scale companies, companies looking to be global players, would rather look at the specific products in the basket before making the decision. For instance, Abbott bought the domestic formulations business of Piramal Healthcare to gain

financial bandwidth to execute a mid to large transaction. Companies are also rethinking their strategies after having seen the consequences of the Biocon-Pfizer deal and Dr Reddy’s acquisition of Betapharm and hence they are careful, remarks Sharma.

Deal potential in the coming years ●

Smaller domestic pharma companies (in formulations or APIs) are struggling to scale and therefore looking to sell out at reasonable valuations. Injectables and niche APIs remain an attractive sector

●

Companies are becoming available in developed markets at attractive valuations, and with good facilities / product capabilities

●

Entrepreneurs have started realising that valuations that the likes of Piramal secured were exceptional and not the norm in branded generics

●

Branded generics space in the domestic market might see mid-sized companies acquiring smaller companies to gain access to specific geographies or product baskets.

●

PE investments in contract manufacturing and niche API/formulations businesses. At least one mid to large size inbound strategic acquisition in the sector with more clarity on FDI policy.

EXPRESS PHARMA

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valuation expectations of such targets overseas, there are a limited number of companies that will be attractive to a global pharma player from a pure R&D perspective in India with respect to inbound deals. “We have to understand that R&D is more than just developing NCEs or NBEs, the product development aspect of R&D is also critical and valuable and can be a key driver for inbound deals going ahead,” asserts Narayanmoni.

Consolidation in domestic formulations Plagued by challenges in competing without scale, pricing pressure in some areas with price control norms and succession planning issues, small to midcap companies with revenues ranging from ` 30-150 crore having a specific geographic focus or product portfolio are increasingly looking at selling out. With valuation expectations normalising, this segment will see increasing consolidation. shalini.g@expressindia.com September 16-30, 2012

M|A|R|K|E|T

CDSCO to increase headcount of NDAC, MDAC committees The last date for submitting the applications are on September 28, 2012 Usha Sharma Mumbai n order to bring more transparency, consistency and accountability in the approval process of drugs, Central Drugs Standard Control Organization (CDSCO) is increasing the number of members of New Drug Advisory Committees (NDACs) and Medical Devise Advisory Committees (MDACs). CDSCO plans to increase the number of members to around 30 and it has invited applications for the same. The last date for the submission of applications is on September 28, 2012. In an interaction with Express Pharma, Dr GN Singh, Drugs Controller General India said, “The Parliamentary Standing Committee has suggested increasing the existing staff members from across India and has advised us to appoint members from universities and hospitals.” CDSCO is in the process of expanding the pool of such experts in areas of oncology, gastroenterology, hematology, opthalmology, gynaecology, immunology, cardiology, nephrology, psychiatry, urology, paediatrics, rheumatology, microbiology, pharmacology medicine, anesthesiology, vaccines and dental.

September 16-30, 2012

Singh commented, “In each and every committee, we plan to increase the number of members to 25 - 30. We also have permission from the Ministry of Health and Family Welfare to recruit more people from the Centre if required. In MDACs, we plan to have 30 members depending upon the nature of the drug which needs to be approved. Out of the total number, we will be inviting only 10 members at a time for discussion.” The experts will evaluate the proposal under Terms of Reference (TOR) spelling out their responsibilities which range from advising DCGI in matters related to regulatory approval of new drugs, global clinical trials, fixed dose combinations, medical devices; preparing guidelines for clinical research industry in evolving acceptance criteria for marketing approval of new drugs of different therapeutic categories. The experts are also tasked with defining a roadmap for research of new drugs relevant to the Indian population. The applicants will be evaluated either through meetings or by circulation. For review of each proposal, experts will be paid an honorarium of ` 1,000 as per government rules, Travelling Allowance (TA) and Daily Allowance (DA) for attending the meetings. The expert nominated as a member for the committee

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should not have any conflict of interest as per the declaration given in the annexure. The members of the committee will hold office for three years but will be eligible for re-nomination provided the persons nominated continue to hold their offices in their respective organisations by virtue of which they are nominated. In case a member retires during the terms of validity, a suitable alternative member probably from the same institute or from some other institute will be nominated as the member for the committee. The members of these committees should be in a position to give their expert opinion within a period of six weeks from the receipt of such proposal. The members of these committees should follow the principle of confidentiality with respect to the documents submitted by the applicants. While speaking about the payments, Singh said, “The Centre will pay these members similar to what it is paying other members.” Experts interested in such positions have a month to apply in the set format, more details of which can be found on the CDSCO website. Singh said, “After this deadline, we will take another two months to finalise the appointees.” u.sharma@expressindia.com

EXPRESS PHARMA

M|A|R|K|E|T

Orchid Pharma signs agreement with Hospira for $200 m To transfer its penicillin and penem API business and its API facilities in Aurangabad hennai-based Orchid Chemicals & Pharmaceuticals (Orchid) has entered into a Business Transfer Agreement (BTA) with Hospira for the sale and transfer of Orchid’s penicillin and penem API business and the API facility located in Aurangabad (Maharashtra) together with an associated process R&D infrastructure located in Chennai for a total cash consideration of approximately $200 million. This business transfer includes the related penicillin and penem product portfolio and pipeline. Approximately 830 employees would be transferred to Hospira, as part of this business transfer. As some of Orchid’s API requirements for the non-penicillin, non-penem, noncephalosporin (NPNC) business were

supplied by the Aurangabad facility, Hospira will supply such NPNC API to Orchid through a long-term agreement that both companies have entered into. This agreement builds on the existing product development and commercialisation relationship between Hospira and Orchid. Orchid would continue to supply its cephalosporin APIs to Hospira in accordance with the long-term supply contract. The proceeds from this business transfer will be utilised for de-leveraging Orchid’s debt position and also pave the entry for the company’s foray into newer product verticals. K Raghavendra Rao, Chairman and MD, Orchid Chemicals and Pharmaceuticals said, “Orchid’s business model has crossed many mile-

stones over the years. With investments across the pharma value chain ranging from research to API and finished dosage form (FDF) manufacturing, we have harnessed key product opportunities and built a strong revenue base. Moving on, we would like to replicate this success by creating more niche product and therapeutic verticals which will continue to power our growth. This business transfer agreement with Hospira will help us fasttrack our future growth while maintaining a healthy debt profile in our balance sheet. Given the current scenario, it is a prudent decision for Orchid to monetise these verticals and bring in cash to deleverage its debt position and fund newer growth horizons. EP News Bureau

US FDA to continue review of Crofelemer new drug application FDA action on Crofelemer NDA anticipated by end of 1Q-CY2013 lenmark’s collaborative partner, Salix Pharmaceuticals announced that the Food and Drug Administration has advised the company that the New Drug Application (NDA) for Crofelemer 125 mg tablets, indicated for symptomatic relief of non-infectious diarrhoea in patients with HIV/AIDS on antiretroviral therapy, is still under review and that a final action will not be taken by the scheduled Prescription Drug User Fee Act (PDUFA) goal date of September 5, 2012. Glenmark has exclusive rights for Crofelemer in diarrhoea indications in nearly 140 countries including India and is the sole API supplier globally for Crofelemer (ex-China). Salix, stated in its note, “The FDA continues to work collaboratively with Salix to progress this important product through its full review. By taking no action at this time, the FDA has allowed for the currently ongoing dialogue between Salix and the FDA to continue. The continuing dialogue should allow further collaboration between Salix and the Agency, a collaboration that has resulted in substan-

tial progress in handling topics important to crofelemer and botanical products in general. The primary topic is the production and control of the crofelemer active pharmaceutical ingredient, a complex mixture that is the first botanical product to be reviewed by the Agency for oral use. This focus is needed to ensure compliance with the manufacturing and product quality requirements of the Food, Drug & Cosmetic Act. Both Salix and FDA are committed to a robust level of cooperation and data exchange with the goal of providing crofelemer to patients suffering from this very important unmet need. Salix looks forward to this continuing collaboration and anticipate an action by FDA by the end of the first quarter of 2013.” As reported earlier in Express Pharma , the International Centre for Dispute Resolution (ICDR) ruled in favour of Glenmark on the arbitration claim it filed on August 8, 2011 against Napo Pharmaceuticals seeking, among other things, a ruling that Glenmark's exclusive rights to develop, commercialise and distribute Crofelemer in 140

countries for treatment of diarrhoeal diseases. The claim also includes the exclusive rights to distribute though relief agencies in these countries and an injunction prohibiting Napo from sharing confidential information concerning the manufacture of Crofelemer. The ICDR ruled that Glenmark’s exclusive rights to commercialise and distribute Crofelemer include the exclusive right to distribute Crofelemer through relief agencies to 140 countries that comprise the Glenmark territory. The ICDR also ruled that Glenmark has two years from the time Crofelemer is approved in India (on an indication by indication basis) to file for regulatory approval in 140 countries in its territory. Finally, the ICDR found that Napo breached the collaboration agreement by disclosing confidential information concerning the manufacture of Crofelemer to Aptuit Laurus and enjoined Napo from disclosing such confidential information to third parties and from purchasing or obtaining Crofelemer from Aptuit. EP News Bureau

Wockhardt gets US FDA nod for Parkinsonism drug Requip XL The drug will be manufactured at its facility in Aurangabad ockhardt has received US FDA approval for marketing a generic version of 2 mg, 4 mg, 6 mg, 8 mg and 12 mg extended-release tablets containing ropinirole hydrochloride, which is used in the treatment of Parkinson’s disease. Ropinirole extended release tablet is the generic name for the brand Requip XL, marketed in the US by GlaxoSmithKline. Soon the company will launch the product in the US market.

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Dr Habil Khorakiwala, Founder Chairman and Group CEO, Wockhardt said, “This is the sixth US FDA approval for Wockhardt in the past two weeks. Three of these have been for extendedrelease products. This continues to demonstrate Wockhardt’s capability in developing technologically challenging products.” In the US generic pharmaceutical market, Wockhardt has been consistently

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growing market shares for all its products. In many instances, Wockhardt, by virtue of being amongst the few players to market technically challenging products has reaped the advantage of being an early entrant. Wockhardt will be manufacturing the extended release tablets of ropinirole at its facility in Aurangabad. The technology for the tablets was developed in-house. EP News Bureau September 16-30, 2012

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AYUSH proposes to set up Central Drug Controller Office Gets approval of ` 80 lakh from Department of Expenditure

Usha Sharma Mumbai n order to boost the acceptability and export of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) , the Department of AYUSH, Ministry of Health and Family Welfare, Government of India, has proposed to set up a Central Drug Controller’s Office for AYUSH drugs. It will be headed by Additional Drug Controller General of India (AYUSH). The Department of Expenditure has allocated ` 80 lakh in the annual plan 2012-13 for creating 40 posts in the proposed Central Drug Controller’s Office (AYUSH). Commenting on the recent proposal made by Union Minister for Health and Family Welfare, Ranjit Anand Puranik, Executive Director, Shree Dhootapapeshwar and ExGeneral Secretary, Ayurvedic Drug Manufactures Association (ADMA) said, “Currently, there are around 10,000 drug manufacturing units in India and nearly 9,000 AYUSH manufacturing units. I feel the budget allocated is very less in comparison to the pharmaceutical sector. There is going to be a tough war between Ayush regulatory authority and DCGI because traditional medicines are extremely expensive and cost involved in monitoring this are much higher.” Shashank Sandu, Managing Director, Sandu Pharmaceuticals said, “We came to know about the recent proposed move on AYUSH by Ministry of Health and Family Welfare. Though it is a good initiative by the government, I am not sure how much time it will take to be implemented.” As per the information shared recently by Ghulam Nabi Azad, Union Minister for Health and Family Welfare in the Lok Sabha, the Expenditure Finance Committee (EFC) ch aired by Secretary (Expenditure) has approved the proposal on October 4, 2010 for creating 40 posts in the proposed Central Drug Controller’s Office (AYUSH) including 25 regular and 15 contractual/outsourced posts

September 16-30, 2012

and for supporting engagement of 330 scientific manpower in the state drug testing laboratories. The matter for creation of required manpower is under examination in consultation with t he

Department of expenditure and a n allocation of ` 80 lakh is made in the annual plan 2012-13 for this purpose. At present, 44 drug testing laboratories are approved for testing AYUSH drugs as

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per the provisions of Drugs & Cosmetics Rules 1945. The department has launched a scheme for voluntary quality certification of ASU Drugs in collaboration with the Quality Council of India

(QCI). The Health and Family Welfare ministry has made mandatory Good Manufacturing Practices (GMP) compliance for licensing of AYUSH drugs. u.sharma@expressindia.com

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Sun Pharma ranks 38 in Forbes 100 innovative companies’ list One of five Indian companies in the listing n a survey conducted by US-based business magazine, Forbes, Sun Pharma bagged the 38 rank. There were a total of five Indian companies who made the list. They are Larsen & Toubro (09), Hindustan Unilever (12), Infosys (19), Tata Consultancy (29). Other US-based pharma companies, which were ranked in Forbes list were, Alexion Pharmaceuticals (2), Edwards Lifesciences (8), Perrigo Pharmaceuticals (17). Commenting on the recognition from Forbes, a spokesperson of Sun Pharma said, “Our focus has been for a complete basket of products including the latest

treatments, which we have done consistently over the last 25 years, creating value for the long term. Even though we are a branded generic/ generic company, through our investments in R&D, we have deployed technology to create patient- friendly solutions, as in monthlong depot injections or safer anti-cancer drugs.” Forbes requires at least seven years of financial data for a given firm in order to be considered on its list of most innovative companies. It also use a 'research and development' screen requiring that companies make some investment in R&D. Also, to control for

size differences, it includes only those with a market value greater than $10 billion. In very rare cases when a company derived more than 80 per cent of their revenues from a single high economic growth market (e.g., India, China). Forbes assumed a small portion of the company’s innovation premium was derived from higher domestic market growth rather than entering new products, services, or markets. EP New Bureau (With inputs from Usha Sharma) u.sharma@expressindia.com

India to draw blueprint to curb spurious and not-of-standard medicines soon International consultation on developing blueprint to combat spurious drugs with use of technology ndia will soon start work on creating a blueprint strategy with a clear-cut timeline to curb growth of spurious and notof-standard medicines. This will entail a robust detection and authentication mechanism based on modern technologies to identify genuine quality and safe medicines from spurious and unsafe medicines in the supply chain and take prompt action against manufacturers and dealers trading with fake and unsafe medicines and violating our existing mandatory standards and provisions of the law under the Drugs & Cosmetics Act, 1940 (amended upto 2008). At an international workshop, it was announced that Government of India, World Health Organization and Partnership for Safe Medicine (PSM) India will collaborate to find an effective mechanism to ensure patients safety prevail over commercial interest and regain consumer confidence in the existing supply chain. The need for the use of user-friendly technologies to make detection of spurious medicines in the supply chain. “The partners will work closely to develop a blueprint with a specific timeline to design a strategy to implement the use of detection and authentication technologies to make spurious and unsafe medicines easily detectable and take prompt action against all such manufacturers who violate the laws and standards of our country by working closely with the state regulators and law enforcers,” said Bejon Misra, Founder Director, Partnership for Safe Medicines (PSM) India. For its part, the Government of India has demonstrated its commitment within the framework of World Health Organisation and has started upgrading the capacity of the state governments by equipping the State Drug Testing Laboratories with modern technology and latest rapid testing equipment. It has also considered giving price advantage to companies if they make their technology public beyond the 74 medicines notified

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in the DPCO that are subject to bar coding and regulatory tracing and tracking system. Misra added, “Monitoring of, and control over the pharmaceuticals ought to be more stringent since it concerns health and safety of the citizens and especially in those cases where even minor lapses can lead to losses of life. But, unfortunately we, in India do have adequate regulations to check such malpractices but the enforcement mechanisms need to be further strengthened to ensure effective and efficient implementation. The industry uses technology only to check brand protection and market share but due to lack of uniform mandatory regulation, doesnot readily agree to share such information in a transparent and accountable manner. ” Participants in the workshop included key government officials, regulatory bodies and leading civil society groups working in India in the interest of the patients and consumers. Key dignitaries included PK Pradhan, IAS, Secretary to the Government of India, Ministry of Health & Family Welfare; Dr Jagdish Prasad, Director General of Health Services, Government of India, CP Singh, IAS, Chairman, National Pharmaceutical Pricing Authority (NPPA) India. Dr Arun Kumar Panda, Joint Secretary to the Government of India, Ministry of Health & Family Welfare; Dr Nata Menabde, WHO Representative to India; Dr Michael Deats (WHO HQ) and Dr Madhur Gupta, (WHO India Country Office); Dr GN Singh, Drug Controller General of India; Anil Rajput, Chairman, FICCI CASCADE. Sudip Bandyopadhyay, Minister of State for Health & Family Welfare, Government of India was the chief guest at the event, who inaugurated the Workshop. Expressing grave concern on the conflicting data on sale of spurious medicines in developing countries such as India, the stakeholders agreed on the need to develop a common framework under which such drugs can be studied in detail and also bringing clarity on the definition of spurious, which will be acceptable global-

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ly. It was also alleged that a few countries were illegally using brand India to market such drugs overseas in their own interest. Experts cautioned, unless checked this could undermine the image and credibility of the pharmaceutical manufacturing companies, especially the small and medium scale companies, who are the biggest contributor to low cost medicines, not only in India but across the world. Jeffrey Gren, Director, Office of Health and Consumer, Goods, US Department of Commerce said, “No doubt technology can play a major role to track and trace the menace of spurious drugs but the need of the hour is to evolve a more holistic approach that ensures involvement of all stakeholders in the supply chain.” Acknowledging that the laws in India were adequate to deal with counterfeiters, officials were of the view that the regulators and industry needed to work in tandem to safeguard public health by availing latest technologies that facilitate consumers to make informed choice and access to quality medicine. Current technologies available to detect spurious medicines include serialisation, non-clonable packaging and 2D barcoding to name a few. PSM India also will be conducting a study in the coming months by engaging with all the stakeholders, especially Government of India on making a comprehensive report on the level of spurious medicines in supply chain in India. This will be based on an agreed methodology arrived at and outlined by Former President of India Dr AP J Abdul Kalam at an event on October 3, 2011 organised by PSM India. “The technology is cheap and affordable and does not cost more than ` 1.50 for a strip or packet. Now everyone has a cell phone and basic know how of technology products. Therefore accessing technology for checking spurious drugs will not be difficult for patients,” informed Misra. EP News Bureau September 16-30, 2012

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AsiaPac records highest fall in volume of pharma M&A in August: MedTRACK M&A activity in the pharmaceutical market recorded a downturn of 38 per cent in August M&A (including private equity) trend analysis

Mergers and acquisitions &A activity in the pharmaceutical segment continued to decline by recording a downturn of 38 per cent in volume terms across the globe. While, the Asia-Pacific region witnessed the highest fall in volume terms, recording only one transaction in August 2012, a significant decrease of 89 per cent over the previous six months’ average of 9.5 transactions in this region. In one of the key deals announced during the month, Sunovion Pharmaceuticals acquired Elevation Pharmaceuticals, a US-based biopharmaceutical company for approximately $430 million. The acquisition will further strengthen and diversify Sunovion’s respiratory pipeline, and enable Sunovion to continue to meet the needs of people living with respiratory diseases, along with the healthcare providers who treat them. With this transaction, Sunovion will gain access to EP-101, an inhalation solution of a long-acting muscarinic antagonist (LAMA) bronchodilator that is in phase 2b of clinical trials, indicated for the treatment of patients with moderate to severe chronic obstructive pulmonary disease (COPD). EP-101 is currently the only LAMA in late stage development in nebulsed form, providing a significant opportunity to address the needs of patients struggling with the control of their COPD, using handheld inhalers. The M&A activity in the pharma sector decreased in both volume and value terms, when compared to the average of previous six months (Feb 2012–Jul 2012). According to Datamonitor’s MedTRACK database, the pharma sector recorded 28 M&A transactions in August 2012, against the previous six months’ average of 45 transactions. In value terms, the sector recorded deals worth $2.9 billion against the previous six months’ average of $10.3 billion. The Indian pharma sector witnessed no deals during August 2012, against the average of 1.5 deals over the previous six months.

Source:

Top M&A deals (Aug 2012)

Venture financing trend analysis

Venture funding Companies in the pharma sector raised $100.1 million during August 2012, against the previous six months’ average of $255 million. In terms of volume, the sector recorded seven venture funded deals, compared to the previous six months’ average of 23.5 transactions.

Notes and definitions 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 userfriendly, 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.

Source:

Top venture financing deals (Aug 2012)

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

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.

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September 16-30, 2012

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Bangalore INDIA BIO 2013 to provide latest trends in biotech business opportunities

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Event to be held in Bangalore from February 6-8, 2013 angalore INDIA BIO, an annual event organised by Department of Science & Technology (DST) Government of Karnataka, under the guidance of Vision Group of Biotechnology, will give an insight about the latest trends and biotech business opportunities in India. Since 2001, Bangalore INDIA BIO has been instrumental in promoting the inherent strengths of the Indian Biotech Industry to the outside world and is now acknowledged as the biggest and India's national event on life sciences. Bangalore INDIA Bio 2013, from February 6-8, will have multi-track conference, international trade show, biopartnering India, vision leadership series, CEO conclave, poster walkway of discovery, bio excellence awards, bioquiz and workshops. Bangalore INDIA BIO 2013 will deliberate on issues related to the latest innovations in biotechnology and focus on business opportunities that exist for companies in biopharmaceuticals, bio-industrial, bio-services, bioinformatics and agri-biotechnology in the light of the emerging bio economy. Exhibitors, confer-

ence delegates and 5,000 business visitors from across India and abroad will take part in the event. Discussions will be held on issues such as collaborative and integrative business models as well as policy, regulation, and investment challenges for biotechnology in a global bio economy and will provide networking and knowledge sharing platform for business leaders, policy makers, research heads and academia. International conference will focus on areas such as Deal Making Trends—Partnerships that take Innovation to Realisation; India and the Shifting Global Regulatory Environment; Potential demand for Biosimilars—Pioneering the Future; Strengthening the Clinical Research Ecosystem; Bioinformatics and Computational Biology; Medical Biotechnology and Biomedical Devices and Equipment; Vaccines and Health Trends; Cell Science and Stem Cell Therapy; Diagnostics and Targeted Therapeutics and Protection of Intellectual Property. EP News Bureau

Pharmexcil introduces iPHEX 2013 harmaceuticals Export Promotion Council of show and Pharmexcil is creating a sustainable India (Pharmexcil), the leading industry pharma industry platform with a special focus on body focussing on pharmaceutical exports exports market development. In addition to a from India, has launched iPHEX 2013 - the largest world class exhibition and meeting place for exhibition of Indian pharma products and tech- Indian companies and global buyers, Pharmexcil nologies. The mega exhibition will be held in plans to organise several thematic seminars and Mumbai from April 24-26, 2013. NR Munjal, Chairman, Pharmexcil, informed that iPHEX 2013 brochure was recently launched by Rajeev Kher, Additional Secretary, Ministry of Commerce and Industry, Government of India, together with senior members and officials from Pharmexcil. Mridul Jain, Joint Secretary, Ministry of Commerce and Industry, Government of India, was also present during the launch. “iPHEX 2013 shall fulfil the longawaited demand of Indian pharma L to R: Nipun Jain, SME Panel Chief (Pharmexcil), Mridul Jain, Joint industry to have their own show and Secretary ,Ministry of Commerce & Industry, Govt of India, Bhavin we endeavour to bring together the Mehta, iPHEX 2013 Committee Chief (Pharmexcil), Rajeev Kher, drugs, pharmaceutical and healthcare Additional Secretary, Ministry of Commerce & Industry, Government of industry—all under one roof. We are India, Ashutosh Gupta, Vice Chairman (Pharmexcil), Dipak Desai, thankful to the support provided by Committee Member ( Pharmexcil), Abhay Sinha, Regional Director the Ministry of Commerce and (Pharmexcil), and Sooraj Dhawan, iPHEX 2013 event manager Industry, Government of India in making this happen,” said Munjal. Dr PV Appaji, Director General, Pharmexcil, conferences on the sidelines as well. These shall stated that iPHEX 2013 will be the biggest indus- include Pharma sector investments, R&D and try exposition showcasing the diverse range of Innovation, overseas market entry strategies, said products and will include formulations, APIs, Bhavin Mehta, Committee Chief, iPHEX 2013. “iPHEX 2013 is co-located with Pharma Ayush, nutraceuticals, health services, biotechnology and biotechnology products, R&D Pro&Pack Expo 2013 which is an international exhibition featuring the complete spectrum of the Services etc. “Indian pharma exports are currently at $13.4 latest pharma manufacturing technologies. bn and iPHEX exhibition will be a catalyst in help- Pharma Pro&Pack Expo 2013 is an initiative of the Indian Pharma Machinery Manufacturer's ing us reach $25 billion by 2014,” said Appaji. “We are inviting over 400 international buyers Association (IPMMA) and we look forward to a to visit iPHEX 2013 and an international outreach close association,” advised Mehta. Nipun Jain, SME Panel Chief, Pharmexcil, felt campaign shall be launched soon to promote the event to overseas buyers. We also intend to invite that Indian SME industry in the pharma sector will Drug Regulators and FDA officials along with gov- get excellent exposure at iPHEX 2013. “The indusernment procurement agencies, hospitals and try is very enthusiastic about iPHEX 2013 and we health service providers,” informed Ashutosh plan to make this as an annual feature,” added Jain. Gupta, Vice Chairman, Pharmexcil. EP News Bureau “iPHEX 2013 will be a complete value chain

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September 16-30, 2012

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CPhI Worldwide 2012 to raise success story of Indian pharma industry Event to be held in Feria de Madrid, Spain from October 9 to 11, 2012 he CPhI Worldwide exhibition at Feria de Madrid, Spain, from October 9-11, 2012, will attract over 29,500 attendees from over 130 countries and 2,200 exhibitors. The conference aims to increase industry awareness through rigorous analysis of global and regional trends—from sourcing APIs to advancing drug delivery. 2012 marks the 23rd edition of this industry leading event. From just 250 delegates at the inaugural convention, visitor numbers have subsequently grown more than one hundred fold to over 29,000 attendees from over 140 countries. The event now covers more than 60,000 square metres of exhibition space, hosting over 1,900 exhibitors and is the market leader for the global pharmaceutical ingredients industry. India’s key objectives at the event will be to improve the credibility of Indian pharma industry; to increase business on a sustainable basis and take it to the next orbit; to raise the awareness of Indian pharma success story; to create awareness that Indian generics are not counterfeits and they are bonafide medicines of standard quality; to protect it from dubious allegations by vested interests; to position India as global pharmacy of world and to highlight the growth drivers-government support and regulatory framework, cost efficiencies, technical capabilities. Pharmexcil is organising India Show during CPhI World Wide 2012. This is for the first time that Ministry of Commerce, Govt of India has approved a pharma specific India Show. In line

Anand Sharma, Minister of Commerce and Industry, Government of India with other top government officials are expected to take part in the event. Formal showcasing of Brand Pharma India logo, brand positioning statement, business kit, film release and website at various platforms and options are being considered during CphIWorldwide. Pharmexcil is also arranging for networking opportunities such as CEOs Forum: CEOs of Indian companies are invited to give presentations to their business prospects in specially designed area in Theme Pavilion. Companies can register with Pharmexcil for the space (free of cost) to use the space for up to 20 minutes for presentation and interaction. Only pre—registered companies can avail this facility. FDA Centre: Pharmexcil is inviting regulators from major markets and scheduling an interaction with them in Theme Pavilion. These invited regulators will be available in Theme Pavilion to meet, interact and provide insight into the regulatory aspects of their respective countries. FDA Center includes some States and Central drug regulatory authorities in addition to four overseas regulators Innovation Award Ceremony: Pharmexcil is sponsoring Innovation Award Ceremony during the evening reception organised by UBM on October 9, 2012. Pharmexcil will also give two important awards to Indian companies during this event. Minister of Commerce and Industry,

with its Brand India Pharma Campaign, Pharmexcil has major activities planned at CPhIWorldwide this year. The key objectives are of the campaign are as follows: ◆ To raise the awareness of Indian Pharma success story ◆ To create awareness that Indian generics are not counterfeits and they are bonafide medicines of standard quality ◆ To improve the credibility of Indian Pharma industry ◆ To protect it from dubious allegations by vested interests ◆ To position India as global pharmacy of world ◆ To increase business on a sustainable basis and take it to the next orbit ◆ To highlight the growth drivers-government support and regulatory framework, cost efficiencies, technical capabilities In order to achieve these objectives Pharmexcil members can ◆ Showcase their products and services in the India pavilion ◆ Participate in a Buyer Seller Meet (BSM) in a specially designed Theme Pavilion. The meet is being organised to bring more business opportunities to participating companies and business visitors

Anand Sharma will be gracing the event. Business Seminar: A seminar titled ‘Generics from India: Quality and Affordability’ is being organised on October 10, 2012 at the venue in Seminar Hall. Members of Pharmexcil can avail this opportunity for networking with invited overseas business visitors. Evening Reception and Cultural Programme: Pharmexcil is organising an Evening Reception and Cultural Programme on October 10, 2012 at Hotel Villa Magna. A cultural programme will be hosted by Minister of Commerce and Industry and top Indian and overseas CEOs will participate. This would be an excellent opportunity to network with invited guests and participants. Apart from this, press conferences and media interviews highlighting India’s pharma sector and its strength, showcasing of products from India by Council’s members in India pavilion, global buyer seller meetings in India theme pavillion; business seminar including presentations by global/Indian pharma CEO’s on demand/supply positions, have been planned. CPhI Worldwide is organised by UBM Live, a division of UBM Plc, a leading provider of business information services to many industries.

September 16-30, 2012

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IDMA-APA-PAC 2012

Date: September 21-22, 2012 Venue: Hotel Hyatt Regency, Mumbai Summary: Indian Drug Manufacturers’ Association (IDMA) and Association of Pharmaceutical Analysts (APA) will organise the 15th Pharmaceutical Analysts’ Convention (PAC) 2012. The main theme for this year's convention is 'Conformance to Emerging Global Quality Standards'. Eminent technical personnel from the Indian pharma industry, research and academia will converge and get-together to interact on various recent developments. Dr Kamal Sharma, Managing Director, Lupin will be the Chief Guest and the keynote speaker. Dr Nitya Anand – Chairman, Ranbaxy Science Foundation will be felicitated with the Padmashree Award. Topics likely to be discussed at the convention are: Toxicology of Pharmacopoeial Impurities; New Developments in Chiral Chromatography; Quality Risk Management in Analytical Laboratory; Using QbD for Monitoring Product Quality; Pharmacoscintigraphy for Preclinical Evaluation of New Drugs and NDDS; Cultivating a GMP Culture; Disinfectant Qualification – Why and How; Microbial Films – A Growing Concern; Labelling Innovations and Solutions; Retrofitting of Labs in Green Way; Analytical Methods Update on Technology Transfer – SOP and Practice; Application of Separation Techniques in Pharma and Bio Pharma. Contact details: Prachi Rane, IDMA 102/B, A Wing, Poonam Chambers Worli, Mumbai-400018 Tel: +91 22-24974308 / 24944624; Fax: +91 22-24950723 Cell:+91 9867634383) Email: ppr@idmaindia.com

2nd International Symposium on Frontiers in Pharmaceutical Research and Nanotechnology (Nanopharma2012) Date: September 28-29, 2012 Venue: Mohamed Sathak AJ College of Pharmacy, Sholinganallur, Chennai - 600119, Tamil Nadu, India Summary: Clinfocus Research Pvt Ltd, India in collaboration with

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Mohamed Sathak AJ College of Pharmacy, Chennai, Tamil Nadu will host the 2nd International Symposium on Frontiers in Pharmaceutical Research and Nanotechnology (Nanopharma2012). The focus of this symposium is The future vision and challenges in Nanotechnology'. On this platform, experts from different fields from different geographical locations will come together to discuss, to explain and share their future ideas suitable for profitable research. Participants can expect expert advice in the special discussion forum which is the speciality in this symposium. Students can start their projects based on the novel ideas discussed, teachers can update their knowledge and researchers can widen their knowledge by attending this symposium. Contact details: G Karthikeyan, M Pharm Convener-Nanopharma 2012 Cell: 91 9894286283

Pharma Legal & Compliance Summit 2012 Date: October 5, 2012 Venue: Hotel Holiday Inn, Mumbai Summary: India’s first comprehensive discussion will deal with important issues affecting the industry on governance, ethics, compliance, contracts management, licensing agreements and developing a proactive legal strategy for patent litigation. The fullday convention aims to offer an opportunity to all stakeholders in the industry, including law firms, pharma and bio pharma firms, bio tech firms, copyright societies, regulatory and patent filing consultants to share their views on the grave concerns affecting their business. The expert speakers’ panel will feature more than twenty proficient speakers consisting Partner, VPs, functional heads, legal head, general counsel, general manager legal and compliance and company secretary of industry’s few best known companies. some of the key areas of debate will focus on Fraud and corruption management, legal and regulatory compliance of ethics for pharmaceutical and bio-pharma companies in India, legal risk management strategies for new product launches, current regulatory developments and implications of changes to regulatory framework, trends in patent opposition and litigation, recent developments in pre-grant

and post-grant opposition, Settlement strategies, key elements of a compliance programme, recent changes in clinical trials documentation requirements in India, current legal issues in domestic and cross border site contracts and contracts, claims and counter claims and licensing agreements. Contact details: Bhupinder Kaur Special Initiatives Team Lex Witness - India's 1st Magazine on Legal & Corporate Affairs Tel: +91.9654155065 Mobile: +91.11-43440010 B 1/6, Hauz Khas New Delhi – 110016 Email: bhupinder@witnesslive.in Website: www.witnesslive.in

CPhl India 2012, P—MEC India 2012 Date: November 21-23, 2012 Venue: Bombay Exhibition Centre, Mumbai Summary: CPhI India into its sixth year, with its co-located events with more than 800 exhibitors, is the largest and most comprehensive pharma industry event in South Asia. CPhI India is a great gateway to meet with key decision makers in pharma industry from around the world including India, China, Japan, the US, the UK, Germany, France, Italy, etc. P-MEC India is South Asia’s number one pharma machinery and technology exhibition and will give those involved in pharma manufacturing an unprecedented insight into the future of mechanical equipment and machinery. The exhibition will highlight the latest knowledge and the newest trends within the industry. Contact details: Milind Dixit Director - Exhibitions UBM India Tel: + 91 22 66122600, Fax: + 91 22 66122626 Email: milind.dixit@ubm.com

64th Indian Pharmaceutical Congress (IPC) Date: December 7-9, 2012 Venue: SRM Institutions Campus,Chennai. Summary: Association of Pharmaceutical Teachers of India will host the 64th Indian Pharmaceutical Congress.

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Contact details Prof BG Shivananda Secretary-APTI Association Of Pharmaceutical Teachers of India HQ: Al-Ameen College of Pharmacy Opp Lalbagh Main gate, Hosur Main Road, Bangalore – 560027 Email: aptienquiry@gmail.com

BioAsia 2013 Date: January 28-30, 2013 Venue: Hyderabad Summary: Biotechnology being an emerging industry, game-changing strategies and relevant application of the knowledge-intelligence resource pool, drive the process of growth. BioAsia seeks to enhance, enrich and encourage newer innovations, path-breaking discoveries and effective solutions in the industry by offering a vibrant global platform for convergence of the key stakeholders - Biotech & Biopharma companies, research institutions, investors, service providers, policy makers, regulators and analysts. Contact details: BioAsia Secretariat 204, Imperial Apartments Greenlands Circle, Ameerpet Hyderabad 500016 Andhra Pradesh, India Tel: +91 40 6644 6477 +91 40 6644 6577 Web: info@bioasia.in

Bangalore INDIA BIO 2013 Date: February 6-8, 2013 Venue: Bangalore, India Summary: Bangalore INDIA BIO is an annual event organised by Department of Science & Technology Government of Karnataka, under the guidance of Vision Group of Biotechnology. Since 2001, Bangalore INDIA BIO has been promoting the Indian biotech industry to the outside world and is one of the biggest event on life sciences. Bangalore INDIA BIO 2013 will be an opportunity to get insights about the latest trends and biotech business opportunities in India. It will also deliberate on issues related to the latest innovations in biotechnology and focus on business opportunities that exist for companies in biopharmaceuticals, bioindustrial, bio-services, bio-informatics and agri-biotechnology in September 16-30, 2012

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the light of the emerging bio economy. It will also discuss about collaborative and integrative business models as well as policy, regulation, and investment challenges for biotechnology in a global bio-economy and will provide networking and knowledge sharing platform for business leaders, policy makers, research heads and academia.

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attend the event. Contact details: Paresh Jhurmurwala GPE EXPO Global, Opp. Priyadarshini Tower, Near Judges’ Bungalows, Bodakdev,

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PHARMA Pro&Pack 2013 Date: April 24—26, 2013 Venue: Mumbai Exhibition Center, Goregaon (East), Mumbai Summary: Indian Pharma Machinery Manufacturers’ Association (IPMMA), will be organising PHARMA Pro&Pack Expo 2013 (PPPE 2013), an international exhibition to showcase the brand India pharma machineries and allied products/services. The event is an initiative of IPMMA and is being jointly organised by the IPMMA and and GPE Expo. The event will offer a single platform for more than 200 exhibiting companies from India and across the world to showcase their products/ services to entire pharma fraternity of India and neighbouring countries. Exhibitors’ profile includes pharma processing and packaging machinery September 16-30, 2012

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DIA, India organises ‘IT Life Sciences Summit 2012: Technology Enabled Pharmaceutical Business Transformation’ Participants were from Life Sciences, Contract Research Organisations (CROs), and Information Technology product and services providers IA recently organised 'IT Life Sciences Summit 2012: Technology Enabled Pharmaceutical Business Transformation'. The event was held at ITC—The Maratha, Mumbai. This was the very first DIA India conference on the theme of information technology in life sciences. Participants were from life sciences companies, Contract Research Organisations (CROs), and information technology product and services providers. The conference began with a guest of honour address from Milind Khamkar, CIO (India and South Asia), Sanofi-Aventis. Following that a very insightful keynote speech was delivered by Anil Raghavan, MD, Quintiles India, on the dynamic scenario of technology, process and people in major business segments of life sciences sector. The second keynote speaker was Sairamkumar J, Global Delivery Head, Life Sciences, Cognizant. He shared his valuable thoughts on the latest advances and also challenges in the life sciences IT space. Through the two days of this conference, the attendees heard about latest developments, case studies and solutions from life science industry experts. Sessions featured expert presentations on the latest trends and technology advances that are reshaping the life sciences industry. Sessions were segmented into pre clinical and discovery, clinical development, manufacturing, commercialisation, regulatory and quality. Panel discussions on thought provoking topics were also scheduled on both the days. Following the keynote addresses, the first panel discussion was titled—‘Is Pharma Exploiting IT Enough to get Competitive Advantage’. This discussion brought out some of the most interesting technology solutions being used or developed by various life sciences organisations. The second panel discussion on 'Bridging Pharma and IT in the Future' featured excellent discussions between industry leaders with participation from the floor. In the new health landscape social media is turning into a critical communications engine for healthcare and life sciences organisations. The final session was a high energy discussion between media experts from the industry and the press. Attendees also had an opportunity to network with life sciences organisations and technology companies to build collaborative relationships with peers, thought leaders; current and future vendor and partners. DIA has added this summit to the annual calendar of global meetings and expects it to be a major global event in a few years. EP News Bureau

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Guest of honour: Milind Khamkar, CIO (India & South Asia), Sanofi-Aventis

Anil Raghavan, Managing Director, Quintiles India

Delegates during the event

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September 16-30, 2012

Management

INSIGHT FOR MANAGING PHARMA

Page 34

September 16-30, 2012

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DR SM SAPATNEKAR, Medical Director, Karmic Lifesciences tion, authority to decide its quantum and confounding factors (like adverse events with placebo or an approved drug) have not been considered in totality. With such vagaries in rules, insurance premier cost will be heavy, and that may impact the business. I have worked out five scenarios (see table below) and that did not take me more than 40 minutes – that too trying to understand the formula. The multiplier B in the formula is a reproduction of ANNEXURE 6 SCHEDULE IV to Workmen’s Compensation Act, 1923. It is therefore not arbitrary. These are not “Rules” to lay down the tortuous liability in a Civil Court. The intent is to y first reaction to the draft of the said guidelines is that of welcome. The effort is timely. Also, it has taken important variables into consideration. It can be super fined to adjust for, say, phase of trial or else alternate use of pre-marketed drug. But then, the guidance is meant for use of Ethics Committees. Any complex mathematical model will be intimidating to the members of Institutional Ethics Committee (IEC). For IECs it has given direction, clarity and simplicity. While the proposed compensation rules have sound moral basis, the draft leaves certain areas nebulous. Definitions of injury, eligibility to seek compensa-

provide a benevolent gesture to anyone participating in clinical trials. Granted that there is implicit “Nofault-liability”. I do not think the industry should be touchy about it, essentially because the maximum amount of compensation can be covered by incredibly small premium. Limitation of the formula is that the compensation cannot be worked out if the subject is below 16 years age. Also, if a ceiling on the amount of compensation is not kept, then the hunt will be for poorer subjects. This is not desirable. A large number of volunteers in BA/BE studies are college students. To decide the multiplicand (A in the formula) there needs to be further guidance for such eventual-

Five scenarios Monthly Income `= A

Age Multiplier = B Before trial

Trial

Administered Outcome = D Risk factor = F Disability

20000

226.38

Healthy

BA/BE

Trial Drug

Death

20000

226.38

Healthy

RCT

Placebo

Death

20000

226.38

Diseased

RCT

NCE

Death

20000

226.38

Healthy

RCT

Comparator

Injury

20000

117.41

Diseased

RCT

NCE

Death

here are several issues with these guidelines. Today, there are several concerns about ethics committee functioning. How competent such ethics committee are in deciding compensation? The preamble to the guideline describes injuries as physical or psychological/emotional psychological/emotional injuries are difficult to define and are likely lead to unnecessary debates/claims. In step 4, there is a scale to determine the seriousness and severity of the disease. The compensation is for serious adverse event—permanent injury OR death. Why should severity be judged to determine compensation? Such a scale is arbitrary and likely to lead to different assumptions by different stakeholders leading to unnecessary debates and delays. To determine the compensation in case of trial related injury, percentage disability is to be determined. Who will/how to decide percentage? This also seems to be arbitrary and will lead to controversies and debates. It seems that proposed quantum compensation guidelines will serve the need but still there are a lot many if and buts prevalence into it. It is now on the Ethics Committee to present fine tuned guidelines.

APURVA SHAH, Chairman, ACRO

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40%

Note: These are rapid calculations, with possibility of calculative errors

DR ARUN BHATT, President, Clininvent Research

ities. I am sure, there will be more gaps to be filled in. The right course for industry now is to provide practical suggestions, before guidance is released. It will be a great step forward if the DCGI convenes a meeting with representation from industry and Insurance Regulatory and Development Authority (IRDA) to consider compulsory insurance for every subject in every clinical trial. My uneducated guess is that the premium will drop drastically. Also, if we hold that a volunteer obliges mankind by participating in a clinical trial, this compulsion ought to be acceptable. I feel, it is now a question of “How to do it”? rather than “Whether to do it? or Why it is wrong!”

ast year in October ACRO welcomed the move making registration mandatory for Ethics Committee. 1. Registration of Ethics Committees: This is a necessity and we welcome this. As a matter of fact we helped them collect the names of the IEC names our members work with and have requested all of them to get registered. 2. Composition of Ethics Committee By having a more clear guideline on the following issues a lot of issues can be avoided later (a) Essential to describe quorum requirements as (½ x total number of members) + 1 (b) Definition of lay person (d) Certificate of training in areas mentioned in the clause (e) Essential to give definition of basic medical scientist

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3. Compensation This is an another welcome step from the regulators. By attempting to clearly direct how the adverse effects from clinical trials are compensated we will be able to respect the life of our people who offer themselves for the betterment of the lives of millions who will benefit from the drugs. This will also clear off the ambiguity and will make everyone accountable for the responsibility they should carry when doing clinical trials. We believe it’s a good draft but there are the following areas which need clarity: a. Suspected unexpected serious adverse reaction (SUSAR) vs current Schedule Y requirement of reporting all unexpected SAEs b. General consideration. Injuries can be physical or psychological/emotional. Psychological/emotional injuries are difficult to define and are likely lead to unnecessary debates / claims. A scale of 0 to 100 shall be used for determining the seriousness and severity of the disease Such a scale is arbitrary and likely to lead to different assumptions by different stakeholders leading to unnecessary debates and delays. c. To determine the compensation in case of trial related injury d. It is percentage disability caused to the subject due to clinical trial. Who will / how to decide percentage?

September 16-30, 2012

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SUNEELA THATTE, Executive Director, Customer Operations, Quintiles India Specifically on each of the guidelines

verall, in spirit and intent, we believe that the guidelines are an extremely important step forward in addressing some of the key concerns and challenges in doing clinical trials in India. There is clear intent to provide clarity, introduce governance and provide transparency which is indicative of Central Drugs Standard Control Organization (CDSCO’s) seriousness in moving the industry forward. What is also important is that what has evolved is as a result of collaborative discussions between the government, regulators, the industry, not for profit organisations and other key stakeholders while ensuring that the interests and safety of patients are kept foremost.

The registration of Ethics Committees is a welcome step given the critical role they play in the oversight of a trial. There are, however, a few areas within the guidelines that need to be addressed, most importantly what one does in the interim period between when a registration is submitted and registration is granted. We also need to understand what happens if registration is declined so that a patient’s safety is not compromised. More clarity as to what constitutes a quorum as also the definition of a lay person and medical scientist is also required. We need more clarity on which guidelines need to be followed as there are references to compliance with both ICMR and Indian GCP guidelines which are not really consistent with each other. While we have never disputed the need to pay compensation, there was a need to develop clear guidelines in determining the quantum of compensation in respect to studyrelated injuries to ensure fairness to the subject (or their heirs) and consistency for the sponsors/administers of clinical trials. While the CDSCO Guidelines have recommended a system for computing compensation, such a system needs to be robust and must

leave no room for ambiguity. For instance, in recommending a scale of zero to 100 to be used in determining the seriousness and severity of the disease, the guidelines leave a lot of room for subjective opinion which could cause confusion and debate, thereby delaying the process of awarding compensation. Similarly, there are no details about who determines the percentage of disability and how this percentage is to be determined or how one determines the risk factor. There is no information either on who determines whether an injury/death is study related and what formula is to be calculated for those under 16 years or above 65 years. Unless we have fool proof and objective criteria to determine compensation, we will be in a situation where objections and counter objections will set the process back rather than take it forward. So, while we welcome the move to create a formula for determining compensation, it needs to be reviewed and made fool proof. Overall, as we have stated in the beginning, these are initiatives in line with what we at Quintiles are firmly committed to—patient safety, ethics and quality— and we look forward to a more regulated industry that will have patient interests at its core.

VIJAY MOZA, Chairman, Clinical Research Education and Management Academy

compensation has to be on the same pattern as is prevalent internationally. Present compensation is inadequate irrespective of whether patient is terminally ill. Lack of proper compensation will always be discouraging patients to go for trials. Ethics committees should play a constructive role in determining the quantum of compensation which should be binding on sponsor.

u.sharma@expressindia.com

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Achieving high performance in pharma through supply chain analytics Soumendra Mohanty, Global Lead, Information Management Services, Accenture, gives an indepth idea about how stronger analytical capabilities help pharma companies consistently deliver higher margins he global pharmaceutical industry is weathering a storm due to unprecedented market conditions. Over the past five years, patent protection has expired on products accounting for more than $80 billion in annual sales and inspite of steadily rising R&D costs, pipelines have failed to deliver replacements. Against this background of looming competition from generics, the industry is holding as much as $46 billion in excess inventory. In this environment, it is no surprise that companies throughout the industry are hungry for opportunities to improve the efficiency of their operations, understand their customers’ demands better, and devise creative responses to the marketplace’s challenges. Supply chain analytics provide a key to progress in each of these areas.

Analytics matters Analytics is about making better decisions, faster. Past performance is certainly an important input, but analytics seeks to not only understand what happened, but also ask: What does it mean? The emphasis moves from measurement to understanding, incorporating statistical techniques, along with modelling and forecasting tools to develop insight into trends and then translate that insight into action. Analytics are critical for making and sustaining both operational and strategic improvements across the functional areas of the supply chain. Research reveals that stronger analytical capabilities (e.g., closer integration with customers on demand forecasting) help companies consistently deliver higher margins. Beyond these, analytics play a critical role in identifying and building on competitive strengths which will become increasingly important as pharma companies are forced to operate in a less blockbuster-driven model.

Delivering results with analytics While one can list down all possible ways in which a pharma company can leverage analytics, it is best to look outside the pharma world for examples of how analytics has driven improved performance in other industries. A leading big-box retailer in the US has been able to leverage two decades of experience in collecting and reporting on product data to radically democratise decision making, pushing decisions on reorder points, product mix and discounting to a local level and allowing store employees to custom-fit sale items to conditions in the community. Forward-thinking internet retailers in several categories have invested heavily in developing predictive models of user behaviour which helps them in advertising and product recommendations, based on users’ likely preferences, their own inventory and margin requirements. One of the world’s largest manufacturers of building materials uses a predictive model of traffic and weather conditions which allows them to guarantee a 20-minute arrival window for perishable mixed cement, a capability which has

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enabled them to charge premium prices for the most basic of commodities. A leading global beverage manufacturer relies on statistical modelling with weather inputs to determine the appropriate product mix and stock points before the fourth of July holiday in US. Several common themes emerge from these examples. One is a cultural focus on analytics; high performers have a quantitative mindset, constantly using data to challenge assumptions and separate 'what we know' from 'what we think we know.' Equally important is a focus on using analytics to drive differentiation—analytics are used to seek out prospective sources of competitive advantage, rather than just measuring past performance. Finally, these companies have moved beyond internal data to draw information from the outside world where necessary. All these capabilities come together to make analytically

advanced companies more customer-centric than their competitors.

How can we get better? Data availability, a must-have for strong analytic capabilities, is where the pharma industry continues to struggle. Supply chain data are typically scattered throughout a fragmented landscape of manufacturing execution systems, enterprise resource planning systems and laboratory information management systems which do not exchange information. The data landscape is further complicated by multiple instances or platforms for each type of system running within the same company. In addition, most pharma companies have not been able to effectively pull information from outside the organisation. Few have been able to develop tight links with customers, and even where these links are in place, the companies find themselves challenged by the fact that their customers’ data are often of less-than-sterling quality. But having the data, while necessary, is far from sufficient to develop strong analytics. Learning where the organisation can produce reliable data (or perhaps where it cannot) is a problem that can only be solved through experience and experimentation. Companies that have advanced analytical capabilities typically developed them by focusing first on using the best data they had, and working to increase the quantity and quality of data

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only after building an ability to make meaningful data-based decisions. In fact, organisational factors which break the link between data and decisions are often the biggest obstacles to overcome. Too often, supply chain organisations in the pharma industry operate in disconnected functional silos which encourage decision making based on tradition, rather than data. Perhaps the most critical first step toward better analytics is to develop a focus on facts and a willingness to challenge assumptions. 'Traditional' thinking, for example, might dictate a decision like the following: “We manufacture life-saving drugs. Stock-outs are intolerable, and we will work to maximise our delivery to customers’ requested dates and quantities, building inventory if necessary to ensure that all orders are fulfilled.” Analytical thinking might suggest a very different approach: “Pharmacies and distributors both retain some stock level of our products. Given their inventory levels and patient demand, what level of order performance must we achieve to ensure that patients have the drug when they need it?” As organisational capabilities mature and data quality improves, focus will shift from using analytics to enhance the effectiveness of traditional processes to building new ways of operating. In the consumer goods industry, for instance, manufacturers are increasingly turning to point-of-sale data from their retail customers to design algorithms which allow product manufacturing and replenishment strategies to be tailored to the stages of the product lifecycle in real time. This analytically driven nimbleness has allowed leading consumer goods manufacturers to increase their speed-to-market while improving their management of working capital—critical capabilities in a world where product lifespans are shrinking year-after-year. Moreover, the industry’s current focus on improving product traceability and supply chain security will tend to build exactly the kind of links with customers and distribution partners that can provide the data to drive more analytically-oriented forecasting and replenishment.

Way forward If the challenges facing the pharma industry are large, so are the opportunities. The recent wave of merger and acquisition activity offers tantalising opportunities for the consolidated companies. Improved analytics in the areas of business simulation, network optimisation and risk modelling offer the potential for greatly enhanced synergies, and a quantum jump in supply chain capability. The path blazed by pioneers in other industries offers pharma companies the prospect of comparatively rapid advance toward strong analytical capabilities and the benefits that go with them. (The author can be contacted at soumendra.mohanty@accenture.com) September 16-30, 2012

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hough hailed as a scenic and tourism friendly state, Goa was considered an industrially backward state for a long time. However, though today tourism remains the backbone of Goa's economy, the state government has also understood the importance of industrialisation. Almost two decades back, with the government's pro-industry approach, many industrial giants, including pharmaceutical companies, started approaching Goa. Today, there are many big pharma companies operating in Goa and many more reportedly eager to join this league.

benefits. Meanwhile, request from the Goa government to extend tax holidays was also rejected. The question arises, should the tax benefits to a particular state be extended if companies do not want to relocate to other states? However, on the other hand companies enjoying tax

purposes, not for tax incentives. An extension of tax benefits can be linked to new employment creation as well. “This is the need of the hour. The government has to offer tax benefits for the second wave of development of the pharma industry

ations in Goa. Many of them have even expanded their operations in the state. Speaking about Indoco's existence in Goa, Kare-Panandikar says, “Indoco operates with a long term goal and the tax benefits are one of the criteria for selecting the location

Tax holidays are needed for small states like Goa. Goa is very small in size and also a tourist destination. The land required for industry is expensive and availability is also less. I would recommend tax holiday for small states and specific industries such as pharma.

The facilities in Goa are approved by regulatory authorities from across the globe, which takes a considerable investment, hardwork and patience, thereby compelling companies to operate these units for longer term, irrespective of the tax benefits.

The subsidy should be available in all states but inversely proportional to the national development index of the state. This will ensure to have development in all states equally over a period of time

Goa has the potential In terms of area, Goa is the smallest state in India. However, it is also one of the richest states with a GDP per capita that is two and a half times more than that of the country as a whole. As far as pharma industry is concerned, its interest in the state is phenomenal. But, whether Goa has the potential to become a pharma hub in India is still being debated. “Goa is most suitably placed and has great potential of being a hub for the pharma industry in India. The factors that go in favour of Goa are English-speaking population, availability of pharma professionals from two big pharmacy colleges, natural ports with infrastructure for customs clearance of materials, connectivity with all the metro cities by road and air and cluster of existing world class pharma manufacturing facilities,” opines Aditi KarePanandikar, Managing Director, Indoco Remedies. Nitin Borkar, CEO, Vergo Pharma, agrees with KarePanandikar's views and adds, “Goa can be a hub for global pharma industry, especially for drug product manufacture and R&D. Presently there are 80 successful pharma units developed in the past 15 years, with the majority involved in CRAMS for developed countries. The policy of Goa supports clean industries as IT and pharma manufacture of drug products. The progressive FDA leadership, good port connectivity, availability of trained manpower, fair share of electricity from the national grid and potential of good water supply makes the state a good target for becoming a pharma hub.”

Should tax benefits be extended? During the limited period of tax benefits, pharma companies constructed their plants in Goa. However, post tax holidays, many companies shifted their operations to other states who were offering tax September 16-30, 2012

Dattaprasad Bhonsle Global Head- supply chain management Capricorn Logistics

holidays are also expected to keep their business strategy ready as they were aware of the last date of tax benefits. “Tax holidays are needed for small states like Goa. It is very small in size and also a tourist destination. The land required for industry is expensive and availability is also less. I would recommend tax holiday for small states and specific industries such as pharma, R&D and also in the field of education,” says Dattaprasad Bhonsle, Global Head— Supply Chain Management, Capricorn Logistics. According to Borkar, tax holiday benefits have caused migration of pharma units thereby causing problems to the land. Luckily, Goa always had good facilities for export

Aditi Kare-Panandikar Managing Director Indoco Remedies

within the state. The competitive scenario is changing very rapidly across the globe and the advantages like cheap labour and economic power supply no longer exist. Cost advantage drives business, whether locally or internationally, apart from quality and other parameters,” says Kare-Panandikar. She adds, “The tax advantage will partially help in making the pharma sector in Goa competitive. With the tax holiday, many pharma manufacturers came to Goa and over a period of time have expanded their presence.”

Goa still a favorite There are many companies that have enjoyed tax benefits in Goa and expiry of tax benefits has not deterred them from continuing oper-

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Nitin Borkar Chief Executive Officer Vergo Pharma

of our manufacturing facilities. Moreover, learning and skill sets for the employees and the organisation evolves over a period of time and by continuous upgradation, these facilities add tremendous value to the customer and to the company.” She adds, “The facilities are approved by regulatory authorities from across the globe, which takes a considerable investment, hardwork and patience, thereby compelling companies to operate these units for longer term, irrespective of the tax benefits. Thus, the business strategy does consider tax benefits which are beneficial in the initial period but the long term perspective is to develop a world class facility that will be operational and bring employment to the state.” EXPRESS PHARMA

Tax benefits were not available for R&D centres. So, Borkar strongly feels that most new R&D companies should get a seed capital subsidy for equipment and instruments to support growth in the early phase. Capricorn is a service provider for the industry in Goa. According to Bhonsle, there are many industries which started right after Goa was liberated and are still operating in the state irrespective of a tax holiday being there or not. Therefore specialised services such as imports, custom clearance, exports, warehouse management, transportation would be needed, especially for the pharma industry. Goa is home for Indian companies like Ranbaxy, Lupin, Cipla, Cadila, Dr Reddy's Laboratories, FDC, Glenmark Pharmaceuticals and Unichem Lab. These companies have made huge investments in Goa. MNCs like Wyeth, Aventis Pharma and Merck are also operational in the state. There are some developments for the pharma industry in Goa to rejoice, such as the issual of the final notification to give

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the status of a notified port to Mormugao port. This will allow the import of pharma products through this port that have been mentioned in the Drugs and Cosmetics Act List. Expiry of tax benefits hasn't affected service providers like Capricorn. With the opening of Assistant Drug Controller's office in Goa, now exports can be done directly from Goa. This will only increase company's business opportunities and portfolio.

Equal benefits Varying periods of expiry of tax benefits, in different states across India, has largely caused industry shifts from one state to another. To prevent this 'loss and gain' situation is it necessary for the government to implement benefits at one time to all states and also revoke them on the same day? Industry opinion varies on this issue. Kare-Panandikar explains, “Creating pharma clusters in different states at different times have been beneficial and the pharma industry has been highly benefitted by spreading their manufacturing and development activities in different states. Also, pharma companies do not easily ‘shift’ from state to state. They may take macro decisions to not expand infrastruc-

ture at any one location.” Bhonsle says, “Central Government must ensure fair playing field for small states. Normally small states are the sufferers. Tax holiday can also be given by local Government to attract industries which make sense for Goa. Specially high technology, R&D in pharma, where pollution is minimum. Recently Goa Government has reduced VAT on petrol thereby reducing the cost of petrol. This has helped the two wheeler users a lot. Similar solutions could be thought about for industries also.” According to Borkar, the subsidy should be available in all states but inversely proportional to the national development index of the state. This will ensure to have development in all states equally over a period of time.

Goa to propel growth Kare-Panandikar feels that Goa has to keep its identity, which is unique and green. This puts a limitation on expanding the industry which pollutes the environment and changes the landscape completely. “Fortunately, pharma industry is non-polluting and due to its compact sized plants, it does not vitiate the surroundings. Goa, therefore,

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appears to be the destination of choice for the entire pharma industry and given the opportunity, the industry can expand to twice the size that it is today in the next five years,” says, optimistic, KarePanandikar. According to Borkar, the pharma industry will do well and expand the facilities. However, adding more new industries will be limited by not having good industrial estates with large land mass and facilities as Verna Industrial Estate. He adds, “The availability of export/import of pharma materials and products from the port will help the CRAMS business. Also the network of air, rail and road connectivity of Goa will further help the business.” With Goa government supporting industrial development in the state, not just pharma, but there are big clusters of other industries coming up in the state as well. Tourism remains a major bread winning industry in Goa, however, growth of industries like pharma is also commendable. If industry experts are to be believed, this is just a beginning. In future, many chapters will be added to the success story of the pharma industry in Goa. sachin.jagdale@expressindia.com

September 16-30, 2012

Micro Labs: Seeking new horizons Micro Labs has one of the largest pharma facilities in Goa. Sachin Jagdale provides a lowdown on the features of this facility

ndustrial tax holidays lured many big pharmaceutical companies to Goa and Micro Labs wasn't an exception. The journey of Micro Labs, from being 'one of them' in 2004, when the company first set its base in Goa, to 'pick of them', was really an exceptional one. This transformation is the tale of a lot of hard work, self belief and an intelligent leadership. Micro Labs is making the headlines since the last four decades. With humble beginnings at M/S Dadha & Co, pharma distributors, Bangalore, GC Surana, Founder, Micro Labs, grew in experience and hard work to start his own marketing and distribution of medicines for the entire southern states for the Delhi-based pharma company called Lamedica. In 1973, he started manufacturing of ethical pharma prepa-

rations under the name and style of Micro Labs at Madras (Chennai). Yet another manufacturing facility at Sipcot Industrial Complex, Hosur, Tamil Nadu, was opened in June 1983 to meet the increased demand for the products. During this period, Surana also started another pharma unit, Brown & Burk Pharmaceutical at Sipcot Industrial Complex, Hosur, Tamil Nadu. In December 1990, the company started a new manufacturing unit, Micro Nova Pharmaceutical, at Peenya Industrial Area, Bangalore to cater to the needs of Karnataka state and government supplies.

Chain of manufacturing plants The demand for Micro Labs’ products kept increasing and once again to meet increasing response from the market, in October 2000,

instead of setting up new manufacturing plant, a sick unit at Kumbalgodu Industrial Area on Mysore Road was purchased and manufacturing of sustained release medicines was started. During this period, the company set up a stateof- the-art facility for manufacture of oral solid dosage form at Baddi, Himachal Pradesh as well. In 2002, the company started a new manufacturing unit, Micro Labs Eros plant at Peenya for the manufacture of oral solid dosage form. Micro Labs continued adding to its existing chain of manufacturing plants. In 2004, the company started a new unit at Puducherry to meet the supply demands of Central Government and defence establishments. In March 2004, a new facility was operational at Goa Industrial area. It is a formulations plant with US FDA approvals. Another pharma unit Brown & Burk Pharmaceutical was started at Sipcot industrial complex at Hosur. One more state-ofthe-art facility for the manufacture of tablets and capsules was started at Veerasandra Industrial area. In January 2006 a new plant started production at Bommsandra in Karnataka. It is an automated plant specialised to handle only penicillin-based products. Another state-of-the-art ophthalmic plant, which is the first of its kind in Asia, started production from July 2006. This plant will manufacture only ophthalmic range of products. In 2007, an API plant started production at Bommsandra to meet EU&US regulatory standards.

The glittering stars of the company are 12 oral formulation plants including an injectable unit, a bulk drug facility, offices located overseas, and a strong distribution network. The marketing efforts span into 14 divisions, with each division specialised to cater to various therapeutic segments Dilip Surana Chairman and Managing Director Micro Labs

network. The marketing efforts span into 14 divisions, with each division specialised to cater to various thera-

The journey of Micro Labs, from being 'one of them' in 2004, when the company first set its base in Goa, to 'pick of them', was really an exceptional one. This transformation is the tale of a lot of hard work and self belief These units cater exclusively to the domestic and export requirements of Micro Labs. Today, Micro Labs and its associate companies is a multi-faceted organisation with an annual turnover of ` 1,726 crore, including exports that contribute ` 509 crore. Dilip Surana, Chairman and Managing Director, Micro Labs, says, “The glittering stars of the company are 12 oral formulation plants including an injectable unit, a bulk drug facility, offices located overseas, and a strong distribution

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peutic segments.” However, Surana insists that the organisation’s most important component remains its 7,300 dedicated employees.

Making it big in Goa Micro Labs understands the importance of technology in the production of quality medicines. No wonder everything that is latest in the field of technology could be seen implemented at Micro Labs' Goa facility. Whether its manufacturing site or the warehouse, best possible September 16-30, 2012

use of technology has been ensured by the management. The new facility in Goa is a state-of-the-art tablet manufacturing plant with a built up area of around 20,000 sq metre which is an extension of the existing facility connected with a double-storeyed bridge for man and material movement. This new facility will be functioning under the same quality management system and key technical personnel at site. Surana provides more details about the facility, “This new facility is equipped with the best of the imported high speed machinery's having the capability to deliver high quality, zero defect product through automated controls in place. In core area all the walls are built with the help of modular panels to facilitate cleaning and ensure maximum insu-

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lation to maintain the required temperature and relative humidity to support the product requirement. We have adopted the latest technology for the warehouse management by installing Automated Storage and Retrieval System (ASRS) and Track and Trace to handle all incoming starting materials and outgoing finished goods without any physical human intervention.” This huge warehouse consists of 6100 sq. metre and can accommodate around 6,000 pallets. Ultra modern QC has been set which is housing 30 HPLCs along with other sophisticated instruments to name. “At present from the existing facility, we are catering our own products to the US and EU markets. We also manufacture for our strategic partners for EU markets. Keeping into consideration, the future volume of business and enormous overseas opportunities, this new facility has been built which need not wait for fresh approvals from the regulatory authorities to export the goods to their countries. This new

facility being an expansion, we do not have to do technology transfer to produce bigger volume of the existing products, so the revenue generation will be faster with this arrangement compared to building a new facility at a different site,” adds Surana. This facility is equipped with higher capacity, high-speed equipment which will further bring down the production cost through enhanced productivity keeping quality in the prime focus. “We believe in delivering quality product at affordable price,” insists Surana.

Export from Goa Besides being a state-of-the-art facility, the Goa manufacturing unit is an export-oriented plant. Surana explains, “Our Goa unit started in the year 2004 with an intention to cater only to the domestic market and avail of the tax benefit. After the tax holiday was over, all the domestic products were shifted to our newly built Baddi plant and the Goa unit started producing for the export market where majority of the

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supplies are to the US and EU markets after been approved by US FDA, UK MHRA, MCC South Africa and WHO Geneva.” The company has marketing and distribution subsidiaries in 28 countries and exports to over 60 countries worldwide. Micro Labs is well poised to achieve the status of 'Big Generic Company' in the global pharmaceutical space. The company is building critical mass in the European, Asian, South American and African markets and developing business in markets like the US, East Europe, North Africa and SC America.

Charity A very motive of any business would be to earn profits and make money, which, in fact is the criteria for the survival of business. However, business is not everything for Surana. He is equally aware of the fact that there are many in the country whose survival will also be guaranteed if he donates part of his earnings for

September 16-30, 2012

their well-being. Surana finds himself happiest when he does most for

others. Surana was awarded the 'Great son of Karnataka' by All India Conference of Intellectuals, Bangalore on December 23, 2011, at a ceremony which was held at Arasu

Bhavan, Bangalore. Dr HR Bharadwaj, Governor of Karnataka presented the award to Surana. The award is given to individuals who have made significant difference to the society at large by their out-

standing services, achievements and contributions. As said by Peter Singer, an Australian moral philosopher, Hebrew word for charity, 'tzedakh', simply means 'justice' as this sug-

Awards/achievements.... 2009: Micro Labs wins a Gold Award and two Silver Awards in IDMA Quality Excellence awards under the category of best formulation units. 2009: Micro Labs wins ‘Company of the Year’ award in Pharmaceutical leadership summit 2009. 2010: Dilip Surana, CMD, Micro Labs Limited awarded as 'Dynamic Entrepreneur of the Year' at 3rd Annual Pharmaceutical Leadership Summit 2010. 2010: Brand Dolo wins 'Best Managed Brand Award' awarded by the Institute of Pharmaceutical Healthcare Management & Research’s conference. 2010: Micro Labs wins a Gold Award and three Silver Awards in IDMA Quality Excellence awards under the category of best formulation units. 2011: Micro Labs awarded as 'India’s Most Admired Pharma Company 2011' by India's leading bi-monthly pharma magazine and the IACC (Indo-American Chamber of Commerce), in recognition of remarkable display of achievement and contribution to the growth and development of the Indian Healthcare Industry 2011: Micro Labs wins a Gold Award and three Silver Awards in IDMA Quality Excellence awards under the category of best formulation units. 2012: Micro Labs awarded as ‘India’s Most Valuable Pharmaceutical Company’ at 3rd Annual India Leadership conclave & Indian Affairs Business Leadership Awards 2012, in recognition of outstanding and remarkable achievement in business leadership 2012: Micro Labs Baddi Unit bags Gold Award at India Manufacturing Excellence Awards (IMEA) in the first ever audit conducted by Frost & Sullivan (An international growth consulting company)in association with Economic Times.

Patient support welfare activities ● ● ● ● ● ●

Sponsored the construction of Diabetics care centre at Vasanthnagar and JP Nagar, Bangalore Contributions to the Heart Care Foundations at Jain Hospital, Narayana Hrudhayalaya Charitable Trust, Jayadeva Institute of Cardiology, Bangalore to perform heart surgeries on poor and needy patients. Runs Sri GC Surana eye care project ‘Drushti’ at Bangalore Rehabilitation centre in Bangalore for mentally challenged children Patient sponsorship programs for severe ailments like—Cancer, Parkinson, Renal disorders and Mentally challenged children Contributions to Dental care and research centre, Bangalore, Kidwai Memorial Institute for cancer care, Manipal Foundation for renal patients and Bhagavan Mahaveer trust for renal patients

Joint ventures

Religious and social welfare activities ● ● ● ● ● ● ● ● ● ● ●

Active participation in supporting disaster relief fund—Flood rehabilitation in Karnataka Sponsored a residential block for Dharmashala at Sri Jain teerth, Ram Deora, Rajasthan Contributed to the Sindhi foundation Bangalore for Health related activities Contributed to Narayan Seva Sanstha for social welfare Formed a trust which runs Susheel Parshwa Dham, a Jain temple in Bangalore. Contributed to Karnataka Marvadi Youth Federation for flood rehabilitation Contributed to Rotaries Bangalore Brigade trust Bharatiya Vidya Bhavan Contribution towards social welfare for Jain Mahilamandal and Sevamandal Formed GDA foundation which runs Surana College and Surana PG centre in Bangalore. Contributed to Baba Saheb Ambedkar Sahata Manavatha Seva Samithy Trust for providing scholarship to the under privileged students Contribution to various infrastructure needs of hospitals and nursing homes

Education forum ● ● ●

Sponsorship of scholarship funds for under privileged children Providing support to education needs (graduation and post graduation) of youth through own college institutions Providing foundation training and scholarship to the poor and meritorious students

Animal welfare activities ● ● ● ●

Consistent contribution towards ‘People for Animals’ Organisation Substantial contribution to Sri Umed Ghoushala, Pali, Rajasthan Substantial contribution to Pinjrapole—animal welfare organisation, Bangalore Contribution to Sri Sumathi Jeeva Rakshak Kendra—Siroi, Rajasthan

Other activities ● ●

Constructed a new building for a police station in Chamarajapet, Bangalore and contributed to the police welfare funds Contributed to the JITO training foundation providing scholarship to the poor and meritorious students.

September 16-30, 2012

gests, for Jews, giving to the poor is no optional extra but an essential part of living a just life. One would see the reflection of this thought in Surana's life. Micro Labs has been conducting various health camps, health recovery programmes, free medical treatment camps and many other educational programmes for patients and doctors. Micro Labs has collaborations with Bausch & Lomb, a eye healthcare company, for manufacturing of eye products. There is a pharma agreement with Litha Healthcare to offer the South African public further access to quality medicines targeting infectious as well as chronic disease. In future, the company wants to focus on brand building in India and emerging markets. They are also interested in building critical mass and developing business in generic drugs in the regulated markets. Micro Labs will be opened for JVs for in-licencing of new molecules in India. With an expansion of the existing facility in Goa, Micro Labs has shown that Goa would remain an important location for its business activities. The Goa facility is completely meant for export purposes. Looking at the company's endeavour towards quality, Micro Labs is the real representative of Indian pharma industry in the foreign market to show the quality standards that Indian pharma company can follow. sachin.jagdale@expressindia.com

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‘Goa still continues to be an ideal destination for the pharma industry’ Salim Veljee, Director, Food and Drug Administration (FDA), Government of Goa, in discussion with Sachin Jagdale, provides his perspective about the pharma industry in Goa Goa is the preferred destination for many big pharma companies. What are the key attractions for the global pharma industry in Goa? Goa under its historic tourist destination choice has turned out to be a pharmaceutical hub of quality units and during the last one and half decade, it has attracted both India-based medium and large units as well as MNCs. All these units have state-of-the-art manufacturing facilities with all modern-day machineries and technologies meeting all the international and overseas standards, who are largely engaged in the exports of their various drugs formulations. Strictly speaking after the initial tax holiday in 1991, when Goa was declared ‘industrially backward’, the real influx of pharma industry took place in the next 10 years. Although after the expiry of the tax holiday period, Goa still continues to be an ideal destination mainly because of its clean environment, good connectivity by rail, road and air, peaceful work environment and a very enabling and friendly approach regulatory enforcement department; Today, even the Government of India's initiative through its CDSCO office has notified Goa MPT Port as a Designated area under Rule 43-A of the Drugs & Cosmetics Rules 1945, which shall facilitate the import and export of pharma products from the tiny state itself and provide the necessary boost and motivation to the industry to grow

tional approvals to venture in to large exports of their products;

by leaps and bounds. What efforts have the government taken to retain the pharma industry/companies of Goa as tax holidays are already over? As on date, there are no special incentives for the pharma industry in the state. However, the overall policy of the Goa Government in not encouraging polluting units in the state has provided one platform of a clean enabling environment for pharma investment in the state. Despite certain constraints on the water and power front, which the new government is striving to address, most of the pharma units are growing and leading to expansion of their existing facilities, only because of the good quality of life and work culture and peaceful work environment with no major labour related issues. Secondly being a tiny state in the country, where the government is easily accessible to the industry in terms of addressing their day-to-day issues at the possible shortest time. The problems of the industry are well addressed by all the government-based agencies in the state, which has resulted that no unit till date has exited from this state, despite the available opportunities at other country-based location like Baddi, Sikkim, etc. for tax incentives. Local-based units have set up additional separate units for the domestic markets at the other tax holiday site locations, while upgrading and updating their Goabased facilities to secure interna-

The state of Goa has around 75 pharmaceutical units with their own independent state-of-the-art of manufacturing facilities, manufacturing almost all categories of drugs formulations and around 205 pharma firms who are also engaged in the manufacture of their drugs formulation on loan licenses

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How many pharma companies are operational in Goa? The state of Goa has around 75 pharmaceutical units with their own independent state-ofthe-art of manufacturing facilities, manufacturing almost all categories of drugs formulations and around 205 pharma firms who are also engaged in the manufacture of their drugs formulation on loan licenses. To add to this, the state of Goa has around 38 manufacturing units who are holding WHO-GMP Certification approval for their own premises and around 27 firms who manufacture on loan licenses and have WHO-GMP certification approvals. What is the growth percentage of pharma industry over the last few years in Goa? The number of units have not grown substantially in the state since the last five to seven years, but definitely there has been a significant expansion of facilities within the existing units to cater to larger variety and categories of products as well as capacity enhancement, In fact, Goa-based pharma industry is a mixed blend of domestic and exports production, and by and large on account of their export enhancement, one could say that the production is registering around 20 per cent growth in tune with the national trends in the country. What do you see as the challenges in future? Challenges in terms of infrastructure, availability of land, addressing the water/power constraints and the new government with its dynamic Chief Minister who is industrial sensitive to their concerns and visionary both in building infrastructure for the state and also in generating revenues for the state. I am confident that in the coming years one can remain positive to see the government addressing all these challenges for ensuring more pharma exploration of investments in the state, especially in the bio-technology sector. How will you differentiate Goa from other states as far as the pharma industry friendly environ-

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ment is concerned? Goa with its small size and high literacy coupled with the clean environment definitely enjoys a distinct advantage in comparison to other states, as it stands at a leading advantage to attract pharma investment in the state. The friendly environment approach is not only in terms of peace, work culture, good connectivity, but also from all other government agencies, which finds a positive approach on account of the value addition that this pharma industry gives to the state both in commercial revenue as well as in quality. The pharma industry generates a lot of pollutants. Is this a cause of concern in Goa? How are the government authorities tackling this issue? The pharma units set up in the state are all formulation units engaged in the manufacture of all categories of drugs and cosmetics formulations and thus generation of pollutants from such formulation units is virtually ruled out. It is the API/bulk drugs units that have the possibilities of generating such pollutants. But the policies of the state government which is not encouraging such API/bulk drugs units, renders the environment considerably safe. Thus this is not a concern for the state of Goa as far as pharma industry is concerned. sachin.jagdale@expressindia.com September 16-30, 2012

â&#x20AC;&#x2DC;Goa is one of the hot spots for bio-diversityâ&#x20AC;&#x2122; Sandu Pharmaceuticals is among the very few ayurvedic pharma companies operational in Goa. Umesh Sandu, Executive Director, Sandu Pharmaceuticals, explains why Goa is a preferred destination for them, in an interview with Sachin Jagdale Which are the other ayurveda related activities you are dealing with in Goa? Apart from our manufacturing and marketing activities we are also involved in many ayurveda related activities. We are involved in contract farming whereby farmers and poor people are encouraged to grow medicinal plants and our company assures a ready buy back for the medicinal plants grown. Similarly, we are also involved in educating and facilitating the tribals and people who stay near the forest area whereby they do not go for tree cutting but we teach them the use and how to go ahead with the growing and cultivation of medicinal plants as a alternate form of livelyhood. We are running a joint programme with the local state Government where-

by we are providing free service to poor and needy people at the Panchayat office whereby the people do not have to travel to long distances to see a doctor and we also make available at cheaper prices. What are your future plans for Goa facility? We are in the process of enhancing our production capacity by minimum 200 per cent. Moreover, we are increasing the product categories and adding external preparations and tablets to the existing range of product categories. We want to create a world class facility for testing of RM and finished goods. Process is on to acquire a WHO Certification for our existing manufacturing facility. sachin.jagdale@expressindia.com

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There are no big ayurvedic companies in Goa. Why? I agree. there is a dearth of big ayurvedic companies in Goa. The reason being that there are not many industrial estates due to paucity of land in Goa, as a result the state govt has faultered by not going after ayurvedic companies. In fact ayurvedic companies generate more employment as ayurvedic industry is more labour intensive as compared to other types of pharma companies. Goa is blessed with many medicinal plants. Don't you think that Goa is perhaps the most appropriate place to be at for ayurvedic companies? Yes, very true. In fact Goa is one of the hot spots for bio-diversity. It is a home to a lot of rare medicinal plants. The Western ghat bio diversity project realises the importance of Goa being at a very crucial and critical stage. Even now the state Government can work towards popularising ayurveda and bio technology projects in the state. Which are the current product categories that you manufacture at Goa? There are different varieties of product categories that we deal with. To name a few, asav arishtha kadha, syrup, tab / gutika, powder/ churnas, aveleha, oils are some of the product categories that we manufacture at our facility in Goa. September 16-30, 2012

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Research

EXPERTISE FOR DRUG DEVELOPMENT

US FDA approves new orphan drug for chronic myelogenous leukaemia The US Food and Drug Administration approved Bosulif (bosutinib) to treat chronic myelogenous leukemia (CML), a blood and bone marrow disease that usually affects older adults. Bosulif is intended for patients with chronic, accelerated or blast-phase Philadelphia chromosome positive CML who are resistant to or who cannot tolerate other therapies, including imatinib. Bosulif works by blocking the signal of the tyrosine kinase that promotes the development of abnormal and unhealthy granulocytes

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Photonics to aid understanding of early defence systems in humans Biophotonics is a growing field, bringing together latest technologies along with biology and medicine Sachin Jagdale Mumbai r Rao Papineni's laboratory at Carestream, US, is utilising optical imaging technologies in understanding the early responses of living systems to infection and various chemical and mechanical insults. Rao and his group show unique characteristics of plants and their response to stimuli. They observed that plants emit light when subjected to physical insults such as exposures to harmful radiation and respond differently from the normal. In addition, plants also release singlet oxygen called ROS (Reactive

Oxygen Species) as a first line of defence. The results will be presented at World Molecular Imaging Congress (WMIC 2012) to be held in Ireland soon. The results clearly show that curcumin, a compound derived from turmeric protects leaves from such UV radiation insults. Papineni pointed to the fact that the early response characteristics seem to be similar between plants and humans. As a part of his lab's major thrust in biomedical research, his recent work on human breast milk shows that mother’s milk is packed with good-sized ammunition of ROS defence elements and when

challenged with bacteria triggers robust ROS production fighting the bacterial intruders. “Biophotonics is a growing field bringing together cameras, optical lenses, electronics, advance software along with biology and medicine. This field of integrated technology has become a part and parcel of pre-clinical and clinical settings. Applications of these light-based technologies are seen in life science, medicine, and agriculture, particularly in microscopy and whole animal molecular imaging, almost mandatory tools in determination of the mechanism of a disease such as cancer, and in drug discovery.

Currently, the technology is making an entry in hospitals, particularly in surgery suites, for image-guided surgery,” informs, Papineni. sachin.jagdale@expressindia.com

New data for Novartis Lucentis confirms efficacy, safety profile of individualised treatment Novartis will submit for regulatory approval in this indication in the EU in the third quarter of this year and in Japan by 2012 end ew data for Novartis drug Lucentis (ranibizumab), the only anti-VEGF therapy licensed across three ocular indications, show that individualised treatment with Lucentis provides sustained improvement in vision with a low number of injections. It is estimated that over 80 per cent of visual impairment is preventable when due to conditions such as wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and visual impairment due to macular edema secondary to retinal vein occlusion (RVO). These conditions can eventually lead to blindness if left untreated. In a company release, Tim Wright, Global Head of Development, Novartis Pharma said, "Lucentis has become the standard of care in wet AMD and has helped to significantly improve vision in a majority of patients with this disease. These new data confirm that an individualised treatment approach can lead to optimal improvements in vision with a low average number of treatments,

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thus ensuring that patients with retinal diseases are not over- or undertreated. In addition, these data add to the well-characterised safety profile of Lucentis." Lucentis also demonstrated benefits in visual acuity outcomes in patients with visual impairment due to choroidal neovascularisation (CNV) secondary to pathological myopia (PM). Lucentis is currently not approved to treat this condition. Novartis will submit for regulatory approval in this indication in the European Union in the third quarter of this year and in Japan by the end of 2012. The REPAIR study performed in 12 centres in the UK explored the efficacy and safety profile of 0.5 mg Lucentis administered on an individualised basis in 65 patients with myopic CNV. After six months of treatment, mean visual acuity improved by 12 letters. Patients received an average of three Lucentis injections with 29 per cent requiring no further treatment beyond the first injection. This analysis shows that Lucentis therapy leads

to improvement in visual acuity in patients with this condition. The sixmonth interim results and the full one-year data will be presented at Euretina. Currently, photodynamic therapy with Visudyne (verteporfin) is the only approved medical treatment for this condition. In the RESTORE extension study, 240 patients with DME received individualised treatment with Lucentis according to a regimen consistent with the European Union label. Results showed that patients who were originally treated with Lucentis received an average of 13.9 injections over three years. 19-25 per cent of patients across all study arms did not require any Lucentis injections during years two and three. An average of 3.7 injections in the second year and 2.7 in the third year were sufficient to fully maintain the mean of seven letters of visual acuity gained in the RESTORE core study. The safety profile was consistent with previous studies conducted in other indications. There were no cases of endophthalmi-

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tis reported within the RESTORE core and extension studies. "The results of this study show that individualised treatment with Lucentis can lead to a significant improvement in vision and that these improvements are sustained in the long term. It is important that we explore how these insights apply to real-world clinical practice to ensure that we are providing the best possible care for our patients," said Professor Francesco Bandello, Department of Ophthalmology, Hospital San Raffaele, University Vita Salute San Raffaele, Milan, Italy and president elect of EURETINA. The Luminous programme is one of the largest observational studies in ophthalmology and consists of two parts launched in 2011. The retrospective part comprises pooled data from four European registries of nearly 4,500 patients with wet AMD treated with Lucentis. These data showed no new safety signals for Lucentis and reinforces its well-characterised safety profile. EP News Bureau September 16-30, 2012

R|E|S|E|A|R|C|H

US FDA approves new orphan drug for chronic myelogenous leukaemia The safety and effectiveness of Bosulif was evaluated in a single clinical trial that enrolled 546 adult patients he US Food and Drug Administration approved Bosulif (bosutinib) to treat chronic myelogenous leukemia (CML), a blood and bone marrow disease that usually affects older adults. Bosulif is intended for patients with chronic, accelerated or blast-phase Philadelphia chromosome positive CML who are resistant to or who cannot tolerate other therapies, including imatinib. Bosulif works by blocking the signal of the tyrosine kinase that promotes the development of abnormal and unhealthy granulocytes. Richard Pazdur, Director of the Office of Hematology and Oncology Products in the FDAâ&#x20AC;&#x2122;s Center for Drug Evaluation and Research said, "With the approval of tyrosine kinase inhibitors, we are seeing improvements in the treatment of CML based on a better understanding of the molecular basis of the disease. These improvements have been observed in chronic and accelerated phases of CML." An estimated 5,430 men and women will be diagnosed with CML in 2012. Most people with CML have a genetic mutation, called the Philadelphia chro-

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mosome, which causes the bone marrow to make an enzyme called tyrosine kinase. This enzyme triggers the development of too many abnormal and unhealthy white blood cells called granulocytes. Granulocytes fight infection. Other drugs recently approved by FDA to treat various forms of CML include imatinib (2001), dasatinib (2006) and nilotinib (2007). The safety and effectiveness of Bosulif was evaluated in a single clinical trial that enrolled 546 adult patients who had chronic, accelerated or blast phase CML. All patients had disease that progressed after treatment with imatinib or imatinib followed by dasatinib and/or nilotinib, or who could not tolerate the side effects of prior therapy. All patients in the trial were treated with Bosulif. In patients with chronic phase CML, efficacy was determined by the number of patients who experienced a major cytogenetic response (MCyR) within the first 24 weeks of treatment. Results showed 34 per cent of patients who had been previously treated with imatinib achieved MCyR after 24 weeks. Of the patients who achieved MCyR at any time, 52.8 per cent had their response

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last at least 18 months. Among patients previously treated with imatinib followed by dasatinib and/or nilotinib, about 27 per cent achieved MCyR within the first 24 weeks of treatment. Of those who achieved MCyR at any time, 51.4 per cent had their MCyR last at least nine months. In patients with accelerated CML previously treated with at least imatinib, 33 per cent had their blood counts that returned to normal range (complete hematologic response) and 55 per cent achieved normal blood counts with no evidence of leukemia (overall hematologic response) within the first 48 weeks of treatment. Meanwhile, 15 per cent and 28 per cent of patients with blast phase CML achieved complete hematologic response and overall hematologic response, respectively. The most common side effects observed in those receiving Bosulif were diarrhea, nausea, a low level of platelets in the blood (thrombocytopenia), vomiting, abdominal pain, rash, low red blood cell count (anemia), fever and fatigue. Bosulif is marketed by New York City-based Pfizer. EP News Bureau

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Pharma Ally Understanding pharma water systems (Part II) Kishor Datar, Chief Technical Officer, Technolutions Projects, in the second part of his article on understanding pharma water systems, talks about contaminants in water and sources of water

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‘We see a fast-growing pharma market in India’ With a strong international presence, Schott considers India as an important component of its flexible worldwide production network. Its goal is to enable the upcoming Indian companies to produce high quality primary packaging that meets international standards. Sundeep Prabhu, Vice President Marketing and Sales, Tubing Division, Schott Glass India, reveals company’s business-related functional activities with Usha Sharma Tell us about SCHOTT tubing's journey in India and its ongoing activities? The international technology group Schott has been active in India since 1998. At that time, we acquired Bharat Glass (Jambusar) and started our pharma tubing business in India. Ever since, we’ve constantly enhanced our market share and consider ourselves as market leaders today. Our production facilities in India are the hub for supplies to the Asian region. To underline our claim of leading the market, we have launched FIOLAX Academy. The aim of this event series is to pass on knowledge about glass and containment to pharma companies. Tell us about the glass technology you have developed. How is it shaping the company's future? How many products are there in your kitty and how many are in the pipeline? Within our pharma tubing unit, we develop, produce and deliver high-quality glass tubes. Our flagship is Schott Fiolax, a premium glass of the first hydrolytic class that complies with all international pharma regulations. Schott is able to manufacture a broad range of dimensions and thus tailor the product to the customers’ needs. We also offer an amber version for protection against ultra-violet rays and short-wave visible light. Fiolax has been on the market for over a century now and still sets worldwide standards. To enhance our portfolio, we have been developing new scientific services to help our customers to produce high-quality packaging for the pharma industry. With FIOLAX Academy our customers experience even further value from their business with Schott.

INTERVIEW

What safety measures do you adopt for better stability and safety during shipment? We attach great importance to a safe shipment. A scratch-resistant coating of the tubing and a patented packaging technology with shrink foil at both ends ensure utmost stability during transportation.

dards and therefore seek to increase their exports to western markets. Looking up the value chain, this also has positive effects on the packaging and tubing industry. Regarding the addressable market for Schott Pharma Tubing – high-end drugs and injectables – we expect a growth rate of five to six per cent per year. Who are the leading players in this segment? While preferring not to comment on our competitors, we can state that Schott definitely belongs to the leading players in the tubing segment in India.

How is glass tubing for the pharma industry different from that of any other sector? Not all glass is the same. Pharma companies and their partners along the value chain are obliged to highest diligence and quality. This particularly applies to the primary pharma packaging. Our customers require a comprehensive risk management. This applies to both, the constant quality of the product itself – the physical data and chemical resistance and composition must never vary – and a steady supply from several worldwide production sites, if necessary.

Tell us more about Otto Schott Research Centre in Mainz’s glass research institute. How many scientists are linked to the Schott Research Centre and on which new technology are they working on? More than 600 researchers and developers work in Schott's R&D centers in Mainz and elsewhere. They concentrate on new and improved glasses and glass-ceramics, process development in the areas of melting and hot forming as well as coating technologies. The Group’s new product rate accounts for over 30 per cent of the annual sales.

How big is the Indian glass tubing industry for pharma packaging? How rapidly is this market growing? We see a fast-growing pharma market in India. This is for two reasons: On one hand, multinational companies use India as a manufacturing hub. On the other hand, local pharma companies are more and more compliant with international quality stan-

What standardised parameters are required for glass tubing packaging and how able are you in meeting those standards? In general, the glass tube must provide high hydrolytic resistance and low alkali content so that interactions between the glass and the drug can virtually be excluded. The key to Schott’s high-quality approach is that all our manufacturing sites meet

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the same high quality standards. These are consistently defined in our technical terms of supply. All plants have been certified according to ISO 9001. Further certification in accordance to GMP (Good Manufacturing Practice) are being rolled out.

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How many pharma companies are using Schott Tube and why? What is the USP of your products? Literally all important multinational pharma companies use containers made out of Fiolax tubing. And it is quite comprehensible why Schott is one of the most preferred glass tube providers: proven accuracy over decades. The physical and dimensional consistency Schott has been providing enables converters to supply packaging solutions that offer an excellent performance on high-speed lines by ensuring low breakage risk and constant filling levels. Presently, how many people are associated with Schott Pharmaceutical Tubing and do you plan to hire more in the future? Worldwide about 1,700 employees work for Schott‘s business segment tubing, 300 of whom in India. Here, we operate our largest production site beside Germany. How large is your international presence and do you have plans to explore any another geographies? Strong international presence is another USP of Schott. India is one component of our flexible worldwide production network. In addition, we operate tubing factories in Germany, Spain, and Brazil. So we are already present on three continents and in an excellent position to reliably serve all important markets. What are the company's corporate plans for 2012-14? One of our goals is to enable the upcoming Indian companies to produce high quality primary packaging that meet international standards. We will do this by our Fiolax product portfolio, combined with the scientific services and further Fiolax Academy events. This will help us to increase our market share in India even further. u.sharma@expressindia.com September 16-30, 2012

P|H|A|R|M|A| A|L|L|Y INSIGHT

Understanding pharma water systems (Part II) Kishor Datar, Chief Technical Officer, Technolutions Projects, in the second part of his article on understanding pharma water systems, talks about contaminants in water and sources of water n the previous article, we saw the fundamentals of water and the properties of water due to its molecular structure. So, how does it affect the water used in pharma industry? It is evident and clear that

Suspended These are the particles suspended in water and don’t have any other chemical bonding with water molecules. Normally they are dirt,

have suspended particles in the form of dirt/fibre etc. The sources for these contaminants are from atmosphere, surface etc. These contaminants are easy to remove by

dust, fibres, colloids etc. The particles which are not chemically bonded or dissolved but are suspended in liquid are called as suspended contaminations. Water will

filtration method. However suspended particles also have colloidal material. They carry a slight negative charge, which causes them to repel each other like two south

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when a drug is administered to a patient it is importantto ensure that only the drug having therapeutic use and the excipients required to ensure that the drug is administered properly are present in the product. Hence, in the pharma industry it is important to ensure that contamination of the product is avoided. This means that the materials forming part of product or used in the process are assuredly free of contamination or it is kept within a limit prescribed for such a product type. As we learnt, water is a universal solvent and will have contamination. However, it is used in the pharma industry for various process steps, including cleaning. So, it is essential to see that the water used in such processes must have contamination within limits. Thus, evidently it is necessary to have a treatment system to ensure that such contaminations are removed from water to make it usable in the pharma industry. However, let us first understand the type of contaminations which can be present in water, before we move on to handling them. This will enable you to understand the further subject with better clarity. Generally contaminants found in water are divided as follows: September 16-30, 2012

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poles of a magnet. Although they do not readily dissolve in the water, they repel each other and form a stable suspension in water. Since these are very tiny particles and are slightly charged negative, repelling each other, makes evenly distributed suspension. Colloids are the one which are most difficult silts to be removed.Also these particles, being tinny in nature, if not removed, clog the physical filtration mechanism and hence are very important aspect in purification.

Bacteria These are living organism and are found in water, even if it is treated and purified. Water has other contaminants like dissolved ions, salts, oxygen etc. All these find the nutrients available from living organism and hence these are always present in water. The graph clearly indicates that with time, initially bacteria growth takes place and reaches to maximum level, it than matures and remains stationary. At this point of time, some of bacteria starve for nutrient and deaths take place. These dead bacteria cells becomes nutrient for the remaining bacteria and again the growth phase starts.

method of using charged particles of opposite charge to adsorb cations/anions and removing these adsorbed during wash cycle. Physical filtration method using cross flow filtration membrane to remove due to porosity of membrane. To reduce bacteria: Bacteria are living organism. They are organic compounds and hence generally following methods are used: ● Chemical method to oxidise – This is used by dosing higher reducing agents like Cl2/ Ozone. Which provides Nascent Oxygen to react with organic cells to reduce them. ● Temperature – Bacteria decompose

During earlier days of human life, human developed the colonies near the natural water sources like lake, river etc. As the colonies started increasing it was not possible for humans to remain close to such natural sources. However, water was need for life and hence during the process of urbanisation, using technology, humans developed two basic methods of water sources. Even today these are used as main sources of water. Surface water: Water available on surface of earth is referred as “surface water” This can be through rivers, natural lakes. Humans have developed the method of blocking water during rainy

Bacteria normally have following life cycle graph,

Gases Water can dissolve gases though not in large quantities but enough to make it non-compliant to pharma specifications. Most common gases which are found dissolved in water are O2 and CO2.

Dissolved ions/ inorganic salts Many ions/inorganic salts are dissolved in water. The maximum limit for each ion in dissolved condition depends on the temperature, pH etc. With above contaminants known, it is clear, that water if it is to be used in any process, needs to be purified to remove contaminants which are not acceptable for the process or its end use. The type of methods used to remove such contaminants depends on the water analysis and end use requirement. However, generally the following systems are used: To reduce suspended particles: Filtration, a process of trapping the suspended particles using filter media. To reduce colloidal: Agglomeration, a process of using natural or poly electrolyte material to react with colloids and neutralise negative charge on them so as to agglomerate them to precipitate out. To reduce dissolved gases: To reduce dissolved gases various methods are used, like changing pH value of water. For e.g. at pH more than 8.2, CO2 can’t remain in dissolved condition in water. Degasser units are also used for reducing the dissolved gases. To reduce dissolved solids: Chemical

at higher temperatures. This physical property is used to reduce bacteria by heating water above 60° C temperature. ● Using membrane filters – Membrane filters have ultra low porosity. The size of bacteria are higher than these porosity and hence gets removed from water stream.

Sources of water We took a brief look at water contaminants and most commonly used treatment methods for reducing contaminants. Now let us try and look at the natural sources of water and how the source affects the contamination. This will probably bring in further clarity regarding the basics to understand further series of articles. We all know the water cycle. Water is available naturally through rains/snow falls. During sunny days, this water evaporates and forms a water vapour. These vapours, in turn, form clouds and during rainy/snow fall season, water reaches to earth again. The water stored on earth surface, penetrates through layers of earth and gets stored below the earth surfaces. These are natural resources of water that are available to us.

It is clear that water, if it is to be used in any process, needs to be purified to remove contaminants which are not acceptable for the process or its end use

season in the form of dams and utilising the same throughout the year. Water, available through natural sources like rain/snow fall, is transported on the earth surface due to natural slopes etc. and by constructing dams, this water is blocked in going to river and sea. Such water travels on the earth surface for long distances and carries dirt/dust/fibres/organic compounds etc. on earth. This also is referred to, as surface water. Surface water has higher degree of contamination of dirt, dust, fibres, colloidal, biological and vegetative organic contaminants and lower degree of contamination of dissolved ions and gases. Ground water: Water is also stored inside the earth surface in the form of dam, river, lakes etc. penetrates through surface of earth. It is referred to as ground water This penetration action takes place due to a physical process called 'Osmosis'. While the Osmosis takes place, water, as we learned, due to polar nature, captures the metals, solids in the earth layers and hence becomes vulnerable to such dissolved contamination. However since it gets stored in the earth surface due to Osmosis process, it has limited ways to have dirt/dust/fibres/organic compounds etc. By drilling hole in the earth surface to the required depth, this water can be sourced. Ground water has higher degree of contamination of dissolved ions and gases: especially Calcium, other divalent salts and silica salts while there is a lower degree of contamination of dirt, dust, fibres, colloidal, biological contaminants. The author can be reached at kd.datar@tppl.net.in

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September 16-30, 2012

P|H|A|R|M|A| A|L|L|Y VENDOR NEWS

ACG Pharmapack’s ‘Alukbliss – alu look film’ wins award for excellence in packaging Receives INDIASTAR 2012, an award for excellence in packaging CG Pharmapack, a member of ACG worldwide has won INDIASTAR 2012, an award for excellence in packaging. Alukbliss – alu look film from ACG Pharmapack won this award in the ‘Packaging Material and Adjunct’ category. Indian Institute of Packaging announced its 30th annual INDIASTAR award last week. Out of a total 507 participants across categories, the maximum for INDIASTAR ever, Alukbliss was awarded the best product in packaging material and adjunct category. The call for nominations was performed earlier this year. With a jury consisting of eminent personalities like Kiran Prayagi (Printing Consultant, Graphic Arts & Technology & Education), NC Saha (Director-IIP & Chairman of the Jury), Prof GG Ray (Professor & HeadIDC, IIT-Mumbai), Hemant Ranadive (Production Head, FCB Ulka Advertising) and Pradyumna Vyas (DirectorNational Institute of Design (NID), Ahmedabad) ACG Pharmapack was a unanimous choice for this category in their jury meet at IIPMumbai. The official award ceremony is scheduled on January 29, 2013, in concurrence with INDIASTAR 2013 at Hotel Leela Kempinski, Mumbai. Receiving this award qualifies ACG Pharmapack to nominate itself for ASIASTAR 2012 and WORLDSTAR 2012. “INDIASTAR award is definitely an appreciation that every company related

to packaging aspires for. We are proud that Alukbliss was selected as the best product in packaging material and

adjunct category. We would definitely strive more towards coming up with innovative products like

Alukbliss that would help the pharma industry as a whole to fight drug counterfeiting as well as have a

unique brand identity,” said Michael Franklin – CEO, ACG Pharmapack. EP News Bureau

Out of a total 507 participants, Alukbliss was awarded the best product in packaging material and adjunct category September 16-30, 2012

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Cole-Parmer releases 6th annual catalogue for India marketplace The 288-page catalogue has numerous unique and new products ole-Parmer, a global leader with more than 50 years of experience in fluid handling, life science, general laboratory products, instrumentation, and equipment, released its 6th annual catalogue for the scientific and process industries. The company also released another version of their annual catalogue specifically for the food and beverage industry. The new 2012 catalogue underscores the company’s reputation of bringing the latest, hard-to-find products to customers. The 288-page catalogue has numerous unique and new products, as well as returning favourites. Users can select highly efficient laboratory essentials, lab equipment, fluid handling, and

process equipment and find exactly what they need for their application from research and development to pilot plants to scale-up. The catalogue also has convenient dual pricing featuring custom duty exempt prices and prices in rupees, making it handy for users to set up supply contracts. At the catalogue launch, Rakesh Aggarwal, Director of Operations, ColeParmer India, said, “We are working in an arena of customisation where customers prefer to have scalable solutions tailor-made to their application needs, and we offer this choice. Apart from offering this option of customisation, we widen the horizon by giving customers-the convenience of product

bundling combined with pre- and postsales service and expert application support.” The catalogue includes a wide portfolio of products to address customers’ demanding manufacturing and process applications needs. Featured products in the catalogue include Masterflex L/S Variable-Speed Digital Standard Drives, IKA RCT basic IKAMAG Stirring Hot Plate, Cole-Parmer Ultrasonic Processors, IKA RW 20 Digital DualRange Mixer, Cole-Parmer Polystat Cooling/Heating Circulating Baths, picoSpin-45 Benchtop NMR Spectrometer, and Cole-Parmer TouchScreen Pump, to name a few. EP News Bureau

ClinACE to conduct long-term stem cell clinical development programme The partnership aims to enhance the quality and accelerate clinical development activities of stem cell therapies linACE has announced its long term collaboration with a renowned stem cell banking and therapy company, for conducting end-to-end clinical development programme for all their stem cell therapy. ClinACE has already commenced a clinical study initiation for the sponsor involving stem cell therapy for patients with Type II diabetes. “This partnership aims to enhance the quality and accelerate the clinical development activities of stem cell therapies. We remain adherent to our strategy of 'cost-effective coupled with qualitative productivity, as we expand into the pharmaceutical, device and biotech

research industry,” said Jayesh Chaudhary, Chief Executive Officer, ClinACE. The ICMR has laid down clear guidelines for the conduct of clinical studies involving stem cells. Every aspect of these studies is approved and monitored by the Institutional Committee of Stem Cell Research (ICSCR) and National Apex Committee of Stem Cell Research (NAC-SCR). ClinACE has planned its clinical development programme involving stem cell research, in complete adherence to these guidelines. The last few years has seen a remarkable growth in the stem cell

research segment. According to a report by Research and Markets, the global stem cell market is estimated to be $88.3 billion by 2014, growing at a CAGR of 14.8 per cent from 2009 to 2014. Given the upward trends in this industry, ClinACE has designed its future business plan duly offering its services to the biopharma market. Stem cell studies represent the dynamic and fascinating realm of regenerative medicine. Being an upcoming and a challenging therapeutic area, the team at ClinACE has begun work on this project with great enthusiasm. EP News Bureau

Mettler Toledo publishes white paper on bioprocess monitoring Reviews four examples of how the inline probe-based technologies provide real-time information on fermentation processes ettler Toledo has published a new white paper on bioprocess monitoring entitled 'Fermentation: Inline Real-Time Monitoring of Key Process Parameters.' It reviews four examples of how the inline probe-based technologies, ReactIRTM inline mid-IR spectroscopy and Focused Beam Reflectance Measurement (FBRM), provide realtime information on fermentation processes, enabling immediate detection of process deviations and sound decisions on effective process control. Each case study illustrates that the noninvasive and non-destructive inline monitoring technologies such as ReactIRTM and FBRM will continue to gain ground in bioprocess manufacturing as consumer demand for pure, safe, bio-active products increases. Inline ReactIR mid-IR spectroscopy simultaneously measures, in real time, the concentration of multiple components of the growth medium and metabolites during the course of a fer-

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ReactIRTM monitored the concentration of key media components, tracking nutrient consumption and metabolite production mentation process. In the first two case studies, ReactIRTM monitored the concentration of key media components, tracking nutrient consumption and metabolite production. The recent advances in hardware and software have made ReactIR amenable for use by those not experts in spectroscopy or

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process modeling. In the last two case studies, FBRM tracked changes in biomass concentroation and morphology in real time. This information was used to control feed strategies that met the high metabolic demands of each culture medium. FBRM sensitivity to bacteria size, shape and count provided critical information on the degree and rate of change for both high-density and complex filamentous bacteria cultures. Overall, the profiled experiments indicated that inline measurements of key process parameters provide significantly more high-quality data from start-to-finish than can typically be gained by using either traditional inline bioreactors or offline sampling. In turn, those measurements enabled the implementation of effective process control strategies that can help reduce batch-tobatch variability and improve product recovery when necessary.. EP News Bureau September 16-30, 2012

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Telstar develops three integrated lines for bulk production of potent sterile antibiotics for Hisun Pharmaceutical This is the largest integrated project using proprietary dosing, freeze-drying, sterilisation, unloading and packing technologies elstar has successfully developed three integrated production lines incorporating proprietary dosing, freezedrying, unloading and end packing technologies for the manufacture of bulk sterile antibiotics for Hisun, one of the largest Chinese producers of active pharmaceutical Ingredients (API). This is the largest integrated project to be carried out in China in which a single company, Telstar, provided all of the technology for the entire primary packaging process. The integrated freeze-drying system features an automatic loading and unloading system operating under sterile conditions within a production isolator. Specifically designed for the freeze-drying of antibiotics, the system incorporates a sterile isolator which protects the operator and provides an ISO 5 class manufacturing environment. Production operations are carried out by automation systems inside the isolator so the

risk of contamination during human manipulation of the product is eliminated, while the operators are also protected from the potency of the product. The first stage of the process (freeze-drying) consists of three GMP production freeze-dryers and automatic tray loading and unloading systems installed inside sterile isolators, together with equipment to dispense the liquid product into trays. After the freeze drying cycle is complete, vacuum unloading systems move the freeze-dried product into IBC containers. The project also includes steam autoclaves and various restricted access barrier (RAB) and isolator systems necessary for other applications associated with the production process. The second stage of the process involves weighing and packing support for each of the freeze-drying systems. An integrated autoclave is used to steam-sterilize aluminium canisters, which are then dosed from the IBC with a weighed quantity of the freeze-dried product. Packing then completes the process, all of which will operate within an isolator to guarantee operator safety and ISO 5 classification. Telstar has supplied this complete system in triplicate, thereby giving the client greater flexibility in carrying out large-volume production. Also designed into the system is the possibility to expand the production in the future by incorporating new freeze dryers and sharing much of the existing equipment. Telstar's capability to develop and manufacture this system entirely in-house provides the client with a costeffective solution and assures quality control over the whole process. EP News Bureau September 16-30, 2012

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P|H|A|R|M|A| A|L|L|Y POST EVENT

ValueForum 2012: From surviving to thriving Rockwell Automation's recently held ValueForum 2012 profiled how automation technologies, powered by software solutions, are helping smart companies get better results, inspite of global economic challenges. A report by Viveka Roychowdhury he past five years have seen the global economy dip, then recover slightly and then dip again. The double dip recession has been particularly harsh because companies who invested during the brief recovery are now stuck with excess capacity. The recently held ValueForum 2012 gave Rockwell Automation, a global provider of industrial automation, power, control and information solutions, an opportunity to showcase its solutions which are reportedly helping companies not just survive, but thrive in these challenging times. Introducing the speakers for the day, Rachel Shi, Marketing Programs AP, Rockwell Software indicated that while Shanghai was the venue for Asia’s first ValueForum, having the ValueForum in India this year signified the importance of the country as a recognised global growth opportunity. Welcoming attendees at India’s first edition of the company's six-year old ValueForum series, Dilip Sawhney, Regional Director, Rockwell Automation (RA) spoke about how companies are going beyond surviving economic cycles, by increasing efficiencies and innovating faster. He urged delegates to experience the theme message of this edition of ValueForum: Smarter Business, Better Results. He stressed that while 40 per cent of a company’s business might be driven by technology, the rest is actually about application of this technology and hence it is crucial that there is interaction and sharing of ideas and experiences between user groups. The ValueForum was conceptualised as a meeting ground where RA and information solutions partners like Cognizant, Emergys and MESTech services can engage with existing and prospective clients, with the highlight being the interactive customer speaker sessions.

Dilip Sawhney, Regional Director, Rockwell Automation, India

Michael Cahill, Solution Architect, Fonterra Co-operative Group, New Zealand

Smart is the new green Giving the keynote address, Anand Rangachary, Partner and MD, Frost & Sullivan, spoke about how the business environment has become very complex, therefore very competitive and how leading firms are transforming their future by driving growth through innovation. "Innovation is the key to unlocking these complexities like resource scarcity, climate change, etc. Sustainability is no longer just a CSR activity, he opined, as stakeholders demand sustainability. Thus 'smart is the new green', when a company meets clean/green goals along with profitability. In conclusion, Rangachary opined that the downturn is a good opportunity to determine where the innovation should be.

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Panelists at the lifescience and consumer products industry breakout session

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September 16-30, 2012

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Expanding on the philosophy behind the Rockwell Software Solution Portfolio, Swaroop Balakrishnan, Director, Information Solutions Sales, Asia Pacific, RA explained how the economic crisis calls for greater productivity and the need to align how different departments across an enterprise look at productivity. This calls for a ‘manufacturing convergence’ and RA’s response to this scenario, is to “enable smart manufacturing, by providing the tools, solutions and designs to achieve this,” said Balakrishnan. For instance, FactoryTalk Pharma Suite Dispense helps ensure regulatory compliance while reducing risk within weighing and dispensing operations. Drilling down to the details, Alec Konynenburg, Regional Manager, Information Solutions, RA spoke about how the integrated architecture of RA's solutions like FactoryTalk meant that the same solution could be deployed from 'shop floor to top floor'. This meant that manufacturing data could be converted into real knowledge/information that could be used to drive business results, said Konynenburg.

Taming the technology Post lunch, the delegates took a leap into the future with technology as KV Rehani, ex-Chief Engineer, Hindustan Unilever and currently proprietor, KVR Consulting, spoke about the manufacturing challenges in the consumer products and life sciences segments and the differences and similarities between the two sectors. He had a very important message for companies looking at deploying technology: “The complexity of

The event ended with a consensus that being more productive, innovative and sustainable were the three imperatives for any company to be globally competitive September 16-30, 2012

systems could lead to a mismatch between plant and corporate (teams/agendas). Only if technology is tamed right in the beginning, can it lead to results." The audience got the opportunity to hear from one such pharma company, Dr Reddy Laboratories, (DRL) which seems to have tamed the technology. In his imitable style, Ramchandra Pandian, Director and Head

- CTO Engineering, DRL engaged the audience on DRL’s year journey of deploying RA's integrated platform for MES and process automation control in their API plant. Sharing the learnings from the threeyear project, Pandian said it was important that managements spoke to all stakeholders across the company to understand their requirements before deploying any

Enabling smart manufacturing

technologies. He also opined that there is no successful mediator who makes it right the first time but if the lessons learnt are tabulated, the next project would be better, though still not perfect. The session concluded with a panel discussion moderated by Michael Cahill, Solution Architect, Fonterra Co-operative Group, New Zealand which

saw an interactive exchange of insights and experiences. The event ended with a broad consensus that being more productive, innovative and sustainable were the three imperatives for any company to be globally competitive and technology solutions like RA's FactoryTalk could be harnessed to acheive these goals. viveka.r@expressindia.com

Plays well with others For solid oral medications, Carbopol® polymers are ideal playmates with a wide range of active and inactive ingredients, and maintain their performance in virtually every manufacturing process. So you can produce customer-preferred smaller tablets and highly-effective time-release medications at a greater cost savings. Versatile and flexible…a winning combination. n

Synergies with other commonly used controlled release excipients Reliability and quality for a wide range of dosage forms Flexibility in a variety of manufacturing processes and equipment

Noveon, a leading name in polymers and controlledrelease oral solid dosage ingredients, is now Lubrizol Advanced Materials. For Proven Polymers, Trust Lubrizol.

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P|H|A|R|M|A| A|L|L|Y PRODUCTS

Phenomenex launches Kinetex Core-Shell Technology

henomenex, a global leader in the research and manufacture of advanced technologies for the separation sciences, has launched Kinetex Core-Shell Technology chromatography column line in India. The Kinetex core-shell

chromatographic methods in India can be completed at a fraction of the time previously required, without sacrificing performance and with potential reduction in solvent usage. Researchers who have already invested in

wide range of applications, including food testing, environmental analysis, drug discovery and clinical research. Kinetex core-shell columns are available in four particle sizes, from 1.3 to 5 µm, and six phases. Method transfer challenges,

products, which have been extremely well received worldwide, meet researchers’ need to improve results and increase productivity without large capital expenditures. Phenomenex opened an office in Hyderabad last year. With the addition of the new 5 µm particle size, HPLC and PREP LC analysts now have a simple-to-use solution for improved performance. By delivering significant gains in speed and separation efficiency over traditional fully porous columns, Kinetex columns enable chromatographers to get improved results and performance on any LC instrument platform. Now

UHPLC instrumentation can also see substantial performance gains with the Kinetex 2.6, 1.7, and 1.3 µm particles. With traditional, fully porous particles, efficiency decreases as flow rate increases, resulting in loss of resolution and sensitivity, which slows the overall analysis time. Kinetex CoreShell Technology enables high resolution and sensitivity over an extended linear velocity without generating excessive back pressure, along with significantly lower limits of detection and quantitation. Kinetex Core-Shell Technology is ideal for a

common with traditional sub-2 µm products, are eliminated with Kinetex. Methods developed with Kinetex columns are scalable and can be transferred to any LC system. Contact details: Kris Chu Global Marketing Manager Phenomenex 411 Madrid Avenue, Torrance, CA 90501 Tel: 310.212.0555 Ext. 3213, Fax: 310.328.7768 Email: krischu@phenomenex.com Web: http://www.phenomenex.com

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September 16-30, 2012

P|H|A|R|M|A| A|L|L|Y Cognex Corporation launches DataMan 100 and 200 fixed-mount barcode readers ognex Corporation, the global leader in Industrial ID, has integrated advanced 2DMax+ code reading software technology into the compact DataMan 100 and 200 fixed-mount barcode readers. With 2DMax+, the readers can now identify and decode severely damaged or poorly marked 2-D matrix codes. Most importantly, the barcode readers are unaffected by variations in lighting, marking method, code quality or surface finish. Carl Gerst, Vice President and Business Unit Manager, ID Products said, â&#x20AC;&#x153;2DMax+ is a proven breakthrough in 2-D decoding and is based on our existing patented, industry-leading software. Following the success of 2DMax+ in the advanced DataMan 300 and 500 series of fixed position barcode readers, we are now delivering it to end users who need a smaller form factor. This functionality is especially helpful in the food, beverage, pharmaceutical and consumer goods packaging sectors. Barcode reading in these industries are often challenging due to poor print quality, varying part sizes, curved surfaces and labels damaged by environmental factors or supply chain activity. 2DMax+ helps these users achieve the highest reading yields and maximise throughput.â&#x20AC;? Though Data Matrix codes have built-in error correction, 'no-reads' can still occur when codes are incomplete. 2DMax+ can read Data Matrix codes even when critical elements are missing. 2DMax+ can also locate and decode Data Matrix codes that are overexposed or underexposed, without requiring multiple retries. This improves throughput, speed and overall reliability. The DataMan 100 and 200 readers are excep-

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Pharma HEAD OFFICE MUMBAI Rajesh Bhatkal Business Publications Division, The Indian Express Limited., 1st Floor, Express Towers, Nariman Point, Mumbai-400021. India Tel: 67440503 / 02 Fax: 022-22885831 Mobile: 98213 13017 E-mail : rajesh.bhatkal@expressindia.com Branch Offices NEW DELHI Ambuj Kumar Business Publications Division, The Indian Express Limited, Basement, Express Building, 9 & 10 Bahadur Shah Zafar Marg, New Delhi, 110 002 Direct Line: 011-2346 5727 Board Line: 011-2370 2100-107 Ext-727 Mobile: 09999070900 E-mail: ambuj.kumar@expressindia.com CHENNAI Vijay Kulkarni The Indian Express Limited, Business Publications Division, New No.37/C (Old No.16/C) 2nd Floor, Whites Road, Royapettah, Chennai - 600 014 Tel: Board: 28543031/28543032/

September 16-30, 2012

tionally small with an industrial-rated housing measuring just 23 x 42 x 64mm. The DataMan 200 series incorporates variable focus liquid lens technology for applications that require a larger depth of field or refocusing after a product changeover. The DataMan 200 models also support Ethernet connectivity with a wide range of industrial protocols, for real-time part tracking, image archiving, data transfer and seamless

28543033/28543034 Fax: 28543035 Cell: 09940047667 E-mail:vijay.kulkarni@expressindia.com BANGALORE Khaja Ali Business Publications Division, The Indian Express Ltd. 5th Floor, Devatha Plaza 131, Residency RoadBangalore - 560 025, INDIA Tel: 22231923/24/41/60 Fax: 22231925 Cell: 09741100008 E-mail: khaja.ali@expressindia.com HYDERABAD E. Mujahid The Indian Express Ltd. Business Publications Division, 6-3-885/7/B, Ground floor, V.V. Mansion, Somaji Guda, Hyderabad - 500082 Tel: 040 - 23418673/ 23418674/ 66631457 Telefax: 040 - 23418675 Mob: 09849039936 Email: e.mujahid@expressindia.com

integration with plant controllers and information networks. The DataMan 100 series provides USB and RS-232 communication options. Contact details: Sunil Vaggu Cognex Sensors India Mob: 9881466003 Email: vaggu.sunil@cognex.com

Board No. +91-33-2213 8587, 2231 8879 / 80 Fax: +91-33-22138582 Cell: 09830130965 / 09831182580 Email: prasenjit.basu@expressindia.com ajanta.sengupta@expressindia.com KOCHI Dr Raghu Pillai Business Publications Division, The Indian Express Limited, Sankoorikal Building, 36/2248, Kaloor,Kadavanthara Road, Opp. Kaloor Private Bus Stand, Kaloor - 682 017 Tel: (0484) 2343152, 2343328 Fax: 2343153 E-mail: Kochi.bpd@expressindia.com raghu.pillai@expressindia.com COIMBATORE The Indian Express Limited, Business Publications Division, 1st Floor, 731, Avinashi Road, Opp. PRS Grounds, Coimbatore-641 018 Tel: 2212157/2216718/2216732

KOLKATA Prasenjit Basu / Ajanta Sengupta The Indian Express Limited Business Publications Division 5, Pannalal Banerjee Lane (Fancy Lane), 2nd Floor, Kolkata - 700 001 Tel No. (Direct) +91-33-2213 8567 / 8573

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E-mail: bpdcbe@vsnl.in JAIPUR The Indian Express Limited, C-7, Dwarika Puri, Jamna Lal Bajaj Marg, C-Scheme, Jaipur - 302001 Tel: 0141-370002/371272 Telefax: 91-141-376606 BHOPAL The Indian Express Limited, 6, Vidya Vihar, Professors Colony, Bhopal - 462002, Madhya Pradesh Tel: 0755-2661988 AHMEDABAD Rajesh Bhatkal The Indian Express Limited, 3rd Floor, Sambhav House, Nr. Judges Bunglow Bodakdev, Ahmedabad - 380 015. Tel: (91-79) 26872481 / 82 / 83 Fax: (91-79) 26873950 Mobile: 98213 13017 E-mail : rajesh.bhatkal@expressindia.com

IMPORTANT Whilst care is taken prior to acceptance of advertising copy, it is not possible to verify its contents. The Indian Express Limited. cannot be held responsible for such contents, nor for any loss or damages incurred as a result of transactions with companies, associations or individuals advertising in its newspapers or publications. We therefore recommend that readers make necessary inquiries before sending any monies or entering into any agreements with advertisers or otherwise acting on an advertisement in any manner whatsoever.

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Testo India launches thermal imagers - testo 882 hermal imagers measure the infrared energy emitted by surfaces remotely. The infrared energy emitted by the object is focused on to an infrared detector. By the laws of physics the infrared energy emitted by the object is related

to the temperature of the object. The thermal imager converts this infrared energy into a heat picture of the object which in thermal imaging

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terminology is known as a thermogram. Different temperatures in the thermogram are represented by different colours. The distribution of temperature on the object gives the user vital information on the operating condition of the machine which helps the user take corrective actions. T h e r m o g ra p hy has been used for many years by preventive maintenance engineers to inspect motors, circuit boards, switchgear, electrical connectors, bearings and pumps etc. The thermal imager testo 882 in ergonomic pistol design, with 320 x 240 pixels. With 76,800 temperature measuring points in every image it sees every detail on the measured object. This makes it easier to detect anomalies and weaknesses from greater distances,

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Salient features of the thermal imager 882 are resolution 320 x 240 pixels; wide field of view 32째 horizontal; very high image quality due to NETD < 60 mK; voice recording with every image through external headset; built-in digital camera with power LEDs; in camera analysis, one point measurement, two point measurement, hot and cold spot recognition, isotherms, area min max. The thermal imager comes with professional reporting and analysis software and a host of accessories Standard temperature measurement is from 20 to 350 degree centigrade and through optional filter can be extended up to 550째C. Typical applications include electrical maintenance; mechanical maintenance; research and development; PCB repairs; buildings maintenance. Contact details Amit Magar Sr Executive - Marketing Communications Testo India Plot No. 23, Sind Society, Baner Road, Aundh, Pune - 411007 India Tel: + 91 20 65 600 212 Fax: + 91 20 258 500 80 Email: amagar@testoindia.com Web: www.testo.in

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Pharma Refrigerator Incubator Oven Stability Chamber Walk-in Stability Chamber

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OSWORLD QUIZ

Q1) Not everyone experiences the same response to the same dose of a drug. Of the following, which would have the LEAST effect of an individual’s response to a drug? Age Gender Overall Health Genetics Q2) What is the only expectorant approved for use in OTC cough remedies? Codeine

Guaifenesin

Ephedrine

Phenylpropanolamine

Q3) Which of the following should be an instruction given to patients taking antipsychotic drugs? Limit intake of milk products Avoid sunbathing

Increase intake of iron Take daily temperature readings

Q4) Iron can be found stored in the body in all of the following sites except: Kidney Liver

Bone Marrow Spleen

Q5) Which are the most effective nonspecific antidiarrheal agents? Absorbents Opiates

Anticholinergics Intestinal modifiers

For more details about Osworld and our products: Osworld Scientific Equipments Pvt. Ltd., B-44, New Empire Industrial Premises, Kondivita, J.B. Nagar, Andheri(E), Mumbai - 400 059 Tel.: +91-22-28320880/ 28390487, E-mail: info@osworldindia.com Send your answers to info@osworldindia.com . All correct answers win you a surprise gift! Disclaimer: Quiz reproduced by Osworld from various sources. Any errors regretted. Advertisement inserted to enthuse readers.

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September 16-30, 2012

Flammable cabinets

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H HEALT

N LATIO

â FIRE RESISTANCE OF 105 MINUTES (ABOVE THE REQUIREMENT) â HEALTH AND ENVIRONMENTALLY SAFE â PURIFIED FUMES â EASY TO INSTALL â GOOD STORAGE BY CHEMICALS FAMILIES â IN CONFORMITY WITH PUBLIC HEALTH REGULATIONS â BETTER FINDING OF POSSIBLE LEAKS â SAFE PRODUCTS AGAINST MALEVOLENTLY â IDENTIFIED HAZARDS

Imported and Distributed in India by: LOBA CHEMIE PVT. LTD. September 16-30, 2012

REGU

The manufacturer keeps the right to modify technical characteristics without notice. Edition 02/2011.

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HPTLC CAMAG TLC / HPTLC – MS Interface

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Sinhgad College of Pharmacy conducts Entrepreneurship Development Programme More than 100 students benefitted from this programme

Page 82

INTERVIEW

‘Companies are hiring in R&D and regulatory divisions’ Kamal Karanth, Managing Director, Kelly Services, a staffing solutions company, speaks with Shalini Gupta about hiring trends in the pharmaceutical sector What are some of the job profiles in the pharmaceutical industry that are in demand? The pharma industry is growing at a phenomenal rate and has a very strong chance of doubling the industry size. They are increasingly looking at investing in R&D, and regulatory divisions. Hence job profiles across these two sectors have seen a spike in hiring at critical positions. Both are high paying jobs. With pharma companies exploring newer emerging markets which in turn have their unique regulatory requirements, there is a greater need to have personnel stationed in these markets to ensure a smooth entry for their drugs. Any failure to do would result in heavy losses to the company with each drug on an average costing $300-400 million. Where is the healthcare sector sourcing its workforce from? Four to five lakh new jobs are being created in healthcare sector which is witnessing a robust growth. Not being a very evolved sector, there is a severe crunch of readily available workforce. So the pharma workforce happens to be the choice of preference for them, since both have a sales driven culture with evolved processes and technology. So, we can say that pharma is providing replacement workforce to healthcare. This is responsible for a fair amount of attri-

tion at the mid to senior level in pharma companies. Are there any new jobs being created in pharma like healthcare? New job creation is happening in the pharma sector at the back end in production level, where the demand seems to be, barring a few companies who are expanding in India. There is a lot of hiring at technical level in companies which are expanding. Hospira, Glenmark, Lupin, Cipla, Strides Arcolab, Sun are all on a hiring spree. Bal Pharma, a subsidiary of Microlabs has opened a big plant in Uttarakhand. Unless it is a new company, it is unlikely that the plant would generate more jobs at front office. The plants supplement exports to international markets. How has hiring been across levels in the past year? On an average there has been 40 per cent hiring at entry level (freshers). But for a company like Abbott it would be higher at around 50 per cent, since more people would need to be deputed across various locations in India. These are at the sales level. 30 per cent hiring happens at the next level i.e, area managers etc at the factory level. The rest comprise the leadership team including the CEO, business heads, product heads, regulatory heads. In the existing market, there is 25 per cent attrition at

the entry level and 15-20 per cent at the middle management. Rest of the categories, attrition is less than 10 per cent. Which others sectors in pharma are on an upswing? There are many new companies coming up in diagnostics. Additional penetration of medical insurance, an affluent middle class, awareness of testing and a reasonable amount of people being pushed to middle age is fuelling the growth of diagnostic companies. These are growing at the rate of 50 to 60 per cent and hence continously need employees. This puts additional pressure on the pharma sector because that is from where most recruitments happen. Companies in clinical research are also on a steady growth curve and require people for back office work. There is a 20 per cent job addition on an annual basis in these companies. The devices sector which has small, profitable market, with Abott, J&J, Becton Dickinson as the major players must have hired 30 per cent more as compared to last year. What are the challenges while hiring for R&D divisions? Companies ideally expect to hire a post doctoral candidate from abroad with a commercial background. What they don't realise is that people already absorbed in the workforce

abroad are less likely to return back to India as compared to someone who is an academician. There have been instances wherein highly qualified candidates with Ph.D. from a reputed Indian university and international recognition for research have been turned down by companies on account of lack of experience. Finally, these people end up getting absorbed in sales function of MNCs, instead of R&D where their skills lie. shalini.g@expressindia.com,

CAMPUS BEAT

Oriental College of Pharmacy conducts seminar on cancer research Attended by over 300 delegates riental College of Pharmacy, Sanpada, Navi Mumbai recently conducted a seminar on ‘Anti-Cancer Drug Development—From Research to Practice.’ The seminar focused on three major areas—Cancer basic concepts, newer classification methods, preclinical models in drug development and clinical trials – safety and efficacy issues. Dr Dnyanesh Limaye, Professor and HOD Pharmacology, Oriental College of Pharmacy, Mumbai University, convenor of the seminar empha-

September 16-30, 2012

sised on prevalence of cancer in India and need for newer drugs. Waseem Khan, MD, Oriental College focused on the link between information technology and diagnosis, treatment of cancer. Dr Shanker – Medical Advisor Oncology – BMS India spoke on basics of cancer and current treatment of cancer. Vinod Varadan – Oncology Head – BMS India spoke on cancer market, drug development, challenges in drug development, Dr Sasikumar Menon – Director TDM Labs, Sion deliberated on animal models in www.expresspharmaonline.com

anticancer drug development, and Almas Sayed spoke on Pharmacovigilance aspects of Drug Development. Most impressive part of this seminar was poster session with 94 participants focusing on formulations, new targets, resistance to anticancer drugs and role of pharmacists in cancer management. The seminar was attended by 300 delegates which included faculty, students and industry professionals. EXPRESS PHARMA

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

Sinhgad College of Pharmacy conducts Entrepreneurship Development Programme More than 100 students benefitted from this programme

inhgad College of Pharmacy (SCOP) Vadgaon (Bk) recently organised a one-day workshop on 'Entrepreneurship Development Programme.' Dr KN Gujar, Principal, SCOP has initiated the activity to make the Entrepreneurship Development Cell at SCOP vibrant with the vision of developing more opportunities for pharmacy students to select as a career. Around 100 students from different colleges benefited through this programme. Prof Deepak Bhivpataki, Management Consultant and Professor Emeritus, the guest of honour for the occasion delivered the key note address. Chief guest DP Keskar, Regional Officer, MCED Pune, briefed about various government schemes for entrepreneurship development. Prasanna Chaudhari, MD, Nutra Supplements Pune shared his experiences and also addressed students to identify their strengths and weaknesses. Ankur Tandon from entrepreneur facilitation centre, Pune guided students about various facilities they provide to begin as a small enterprise. Dr AM Avchat, Professor and Training and Placement Incharge, SCOP, was the convener of the programme. PM Jamkar, proposed the vote of thanks. EP News Bureau

APPOINTMENT

L- R: Dr AM Avachat, Professor, SCOP, felicitating Prassana Chaudhari, MD, Nutra Supplements Pune

Pradeep Karnik joins Omron Industrial Automation as MD Karnik will be responsible for strategic growth and expansion in India mron Industrial Automation, a global manufacturer of automation products and a leading provider of application expertise, has appointed Pradeep Karnik as its Managing Director (MD) for India. Karnik succeeds Takaaki Ombe who will take on a different role at the company after ensuring a smooth transition to the new leadership. As the new MD, Karnik will be responsible for Omron Industrial Automation’s strategic growth and expansion in India, bringing global best practices and technologies to critical Indian industries. Karnik is a veteran of the industrial automation industry with a cumulative experience of 24 years across multiple disciplines and vertical industries. He joins Omron from Schneider Electric where he served as VP—Industry Business, responsible for building up Automation systems Business in sectors like steel, chemical, textiles, automobiles, F&B and pharmaceuticals. Prior to

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this, he has also held leadership roles at companies such as Siemens and NELCO. Commenting on the appointment, Takaaki Ombe said, “We are glad to have Karnik on the management team here in India as we believe that the macro-economic indicators will provide the industrial automation industry tremendous scope for growth. A strong leadership will ensure that we leverage this opportunity and Karnik's technical expertise combined with a deep understanding of the market and customers is the perfect mix.” Karnik said, “Omron is a global leader in the industrial automation space and has proven its superiority across multiple disciplines time and again. I believe that India is ready for the same level of excellence demonstrated across the world and therefore I am excited about the opportunity to replicate that success in India.” EP News Bureau September 16-30, 2012

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