Express Pharma August 1-15, 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 August 1-15, 2012 ` 40

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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 August 1-15, 2012 ` 40

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VOL 7 | NO. 19 | PAGES 66

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Contents

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Pharma VOL 7. NO. 19 AUGUST 1-15, 2012 Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury* Photo Editor Sandeep Patil BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bangalore Neelam M Kachhap

Quote It is apparent that the Russian government is in the process of strengthening the domestic market, a move that could seemingly hamper the export of Indian drugs to Russia. However authorities in India and Russia are working towards promoting the trade of pharmaceuticals between the two countries. Bilateral trade between India and Russia in 2011 stood at $5.965 billion. Both sides have set a target of achieving $20- billion trade by 2015

MARKETING

Hitesh Gajaria Partner KPMG

Deputy General Manager Harit Mohanty Senior Manager

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Rajesh Bhatkal PRODUCTION General Manager B R Tipnis Production Manager Bhadresh Valia Asst. Manager - Scheduling & Coordination Arvind Mane Asst. Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka Layout Rakesh Sharma

interviews ‘DuBiotech and IDMA to promote two-way investment between UAE and India’ Companies operating in DuBiotech are keen to invest in the Indian market. Likewise Indian pharmaceutical companies are ready to expand their footprint in the Middle East. To strengthen this relationship, IDMA and DuBiotech are going to sign an MoU. Marwan Abdulaziz, Executive Director, TECOM Science Cluster, shares details with Usha Sharma

Pharma associations propose enforcement of marketing code In a move to curb the use of unethical marketing practices in the pharma industry in India, the Department of Pharmaceutical (DoP), Ministry of Health (MoH), Medical Council of India (MCI), National Pharmaceutical Pricing Authority (NPPA), Department of Consumer Affairs met key industry stakeholders who have agreed to enforce marketing codes in India Page 19

product Page 16

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 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)

‘Our technical expertise result in the right solution approach for our customers’ Bangalore-based Ion Exchange Services Ltd (IESL) is a leader in water and environment management, providing services for any make and type of water treatment plants in India and overseas across diversified sectors such as pharmaceuticals, breweries, food and beverages, hotels, hospitals and software technology parks, to name a few. Dinesh Sadasivan, CEO, IESL, reveals more about his company, its goals and plans to Sachin Jagdale

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August 1-15, 2012

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Editor’s Note

A Lakshman Rekha in pharma FDI NC pharmaceutical companies and global investors hoping for an easing of FDI norms have

been disappointed by the July 24 decision of the inter-ministerial group. The group’s decision that the Foreign Investment Promotion Board (FIPB) will need to clear foreign investments

resulting in higher than 49 per cent equity stakes in an Indian pharma company is sure to make investors think twice. Another dampner is the caveat that MNCs exceeding this Lakshman Rekha will have to maintain the same level of investment in research activities and production of essential medicines for five years. These restrictions stem from the Government’s stance that the MNC investors’ gameplan for India may not always gel with the country’s healthcare needs and realities. Indeed, it would seem that India’s policy makers view home-grown pharma companies with the same jaundiced eye. After months of stalemate between the health, pharma and commerce ministries, the PM Manmohan Singh had to step in and decide that 100 per cent FDI in greenfield investments through the automatic route will be allowed. This decision raised hopes that direct FDI in smaller pharma companies might be allowed via the direct route, with the inter-ministerial group setting a turnover cap. But the July 24 meeting dashed this hope too. Of course, this is not the last word on the FDI in pharma debate. In fact it’s just the beginning. As pressure from different stakeholders, both global and local, builds up, its anyone’s guess how things finally pan out once it reaches the PMO for final approval. It is ironical that one camp of policy makers blocks access to the Indian market, another pushes for access into global markets. Our cover story in the Market section, ‘So near and yet so far’ highlights the strategies of India-based pharma companies to make inroads into Russia’s pharma market and mentions Union Minister Anand Sharma’s recent efforts to lobby that country’s authorities to, among other suggestions, “streamline the registration process”. But it seems that policy makers are allowed to have double standards. While the US’ Affordable Care Act is all about making healthcare affordable for US citizens, there are loud protests when India does the same. Compulsory licensing of Bayer’s Nexavar was the latest flashpoint, even though the US had invoked similar legislation when faced with the anthrax attack scare in 2001 and again in November 2005 when avian flu threatened to attain pandemic propotions. But the point is, policy makers in India need to adapt fast to new realities and move forward like other global regulators. For instance, faced with a 25 per cent drop in clinical trials, the EU Commission is proposing a re-think of the 2001 Clinical Trial Directives, hoping to attract more clinical trials. Unfettering FDI, with a minimal Lakshman Rekha, will help take the pharma industry in India to the next level. Someday we will have to stop relying on compulsory licensing to meet our healthcare needs. Only then can we aspire to discover the next Nexavar right here in India. Viveka Roychowdhury viveka.r@expressindia.com

10 EXPRESS PHARMA

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Market

THE BUSINESS OF PHARMACEUTICALS

UPFRONT EU Commission proposes revamp of clinical trial rules aced with a decrease of 25 per cent in the number of clinical trials conducted in teh EU between 2007 and 2011, the EU Commission recently proposed simplifying the rules for conducting clinical trials. Aimed at boosting clinical research in Europe, the proposals once implemented are expected to speed up and simplify the authorisation and reporting procedures, while maintaining the highest standards of patient safety and robustness and reliability of data. The measures will also better differentiate the obligations according to the risk-profile of the trial, and improve transparency including on trials done in third countries. With over 20 billion euros of investment per year in the EU, clinical trials makes a significant contribution to the growth policy of the Europe 2020 agenda. After discussion in the European Parliament and in the Council, the July 17 legislative proposal is expected to come into effect in 2016. Expanding on the rationale behind these proposals, John Dalli, European Commissioner for Health and Consumer Policy, said, “Patients in Europe should have access to the most innovative clinical research. Clinical trials are crucial for developing new medicines and improving existing treatments. This is why (this) proposal significantly facilitates the management of clinical trials, while maintaining the highest standards of patient safety and the robustness and reliability of trial data. 800 million euros per year could be saved in regulatory costs and boost research and development in the EU, thus contributing to economic growth.” The proposed Regulation, once adopted, will replace the ‘Clinical Trials Directive’ of 2001. The release noted that while it ensured high level of patient safety, its divergent transposition and application led to an unfavourable regulatory framework for clinical research, resulting in 25 per cent decrease in clinical trials conducted between 2007 and 2011.

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here is no doubt that Russia’s pharma market is one of the fastest growing markets in the world, and is the largest pharma market in central and eastern Europe. The Russian pharma market witnessed a growth of 15 per cent (CAGR 2006–2010) to exceed ¤14 billion in 2010, with its dominant segment, ethical drugs, witnessing growth of about 18 per cent (CAGR 2006–2010) to reach about ¤10 billion in 2010. The Russian pharma market is expected to grow at eight per cent (CAGR 2010–2015), to reach over ¤21 billion in 2015. But these growth figures also come with challenges. The Russian pharma industry which is mandated to abide by Good Manufacturing Practice (GMP) regulations by 2014 which facilitate drug quality and compliance in line with global standards, is also likely to improve Russian pharmaceutical exports. However the domestic industry would seem to have a long way to go towards achieving this goal as in 2011, it was estimated that only 10 per cent of 1,100 plants fully complied with GMP regulations in Russia. In 2010, a law on medicine distribution was introduced, which requires a manufacturer to register the maximum selling price of their drugs, listed in Essential Drug List; this law restricts companies from increasing drug prices at their discretion. Analysing the hurdles, Hitesh Gajaria, Partner, KPMG says, “The Russian market is unique in its own capacity. Entry into the Russian market has always been a challenge owing to the non- tariff barriers Russia imposes which makes it difficult for foreign companies to enter this market, in terms of drugs registration and research and development (R&D) of new drugs. However, it cannot be ignored that the market is gaining traction and there are many opportunities. Indian companies would have to be cautious about investing in Russia. If the governments of both countries can amicably reach an agreement on mutual investment policies, it is certain that both countries would have much to gain from each other.” These concerns got highlighted on the recent visit of Union Minister for Commerce & Industry and Textiles, Anand Sharma to Russia. In his bilateral meeting with D Rogozin, Deputy Prime Minister of Russian Federation, at St Petersburg, the Minister pushed for the opening up of opportunities to Indian pharma companies for favourable joint venture partnerships in Russia. He pointed out that Indian pharma products are of international standards and cheaper than other markets on an average by 30-40 per cent. He outlined specific steps that need to be taken in this direction, mentioning that if Indian pharma companies wanted to participate in the Pharma 2020 Programme of Russia by setting up production units in Russia, this would

HITESH GAJARIA Partner, KPMG

It is apparent that the Russian government is in the process of strengthening the domestic market, a move that could seemingly hamper the export of Indian drugs to Russia. However authorities in India and Russia are working towards promoting the trade of pharmaceuticals between the two countries. Bilateral trade between India and Russia in 2011 stood at $5.965 billion. Both sides have set a target of achieving $20- billion trade by 2015 require suitable facilitation by Russia. He also asked for the streamlining the registration process, sharing of information on drugs that are imported by Russia and on assessed production volumes of strategically identified medicines. “We are keen to participate in the Pharma 2020 programme of Russia where the Russian Government has ambitious plans to develop the pharma industry with an objective to reducing healthcare cost. I believe that India is best suited to partner with Russia in this endeavour and I would like our industry and regulatory bodies to work together to see that we are able to achieve the social health objective,” said Sharma. Notwithstanding the many obstacles, Indian pharma companies have managed to operate in the Russian market. Companies like Glenmark Phama, Themis Medicare, Ranbaxy, Cipla, Torrent, Himalaya, Shreya Life Sciences and a host of other pharma companies have established their presence in the Russian market. Gajaria points out, “Though the returns are very low as compared to highly regulated markets, companies believe that eventually the Russian market will yield benefits owing to an evolving regulatory and political regime.”

Market scenario The Russian pharma market is dominated by foreign manufacturers’ branded generics. From 2007 to 2008, drug consumption increased by approximately 26 per cent, while the share of domestic manufacturers fell to two per cent. In 2008, the share of domestic drugs in Russia was approximately 23 per cent in terms of value. The market share of biological products was approximately 39 per cent, of which domestic pharma companies manufactured only two per cent. The Russian pharma industry is directly dependent on imports of bulk drug substances, approximately 70 per cent of which come from China and India. Imports have been increasing in recent years while domestic manufacturers’ share has been falling. Conversely, in the hospital sector, domestic drugs’ market share increased from 19 per cent in 2008 to 22 per cent in 2010. In terms of life-threatening diseases, the share increased from a negligible figure in 2008 to 10 per cent in 2010. In 2010, there were 15,280 trade name drugs distributed in Russia, of which 13,860 were formulations and 1,420 were bulk drug substances. In 2008, although Russia had approximately 600 licensed pharma manufacturing companies, the collective market shares of 10 major companies amounted to more than 30 per cent. “The Russian pharma market is fairly fragmented, and the top three companies in the ethical and OTC drugs segment contribute about 10 per cent and 21 per cent, respectively in 2010; Bayer commanded a three per cent share of the Russian ethical drugs market in 2010. The key players in the market include Pharmstandard (Russian), Novartis, J&J, Novartis, Sanofi Aventis, Teva, GSK and Gedeon Richter. These players (with the exception of Pharmstandard) are MNCs based in the US or Europe. Indian players thereby have a market share of less than two per cent”, adds Gajaria.

Government's role According to a GlobalData report the Russian pharma industry will continue to expand due to government initiatives and increased healthcare spending, predicts a new report by healthcare business specialists. The report states that Russia’s efforts to boost its pharma sector have been rewarded with strong and steady growth and the increased implementation of domestically produced treatments. In 2010, the Government of Russia announced several initiatives aimed at promoting the local pharma industry and reducing its dependence on imports. By 2020, the government aims to increase local pharma manufacturers’ contribution to 50 per cent (with about 80 per cent of these being innovative drugs). To give a boost to this plan, the Russian government introduced a new

Glenmark’s spokesperson in charge of the Russia market It’s definitely an entry barrier for new players, but not a hindrance for established players like Glenmark operating in the Russian market for around three decades now. On the positive side, it ensures a level playing field and ushers greater quality

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Sun Pharma's spokesperson Many of the drugs that are on the reimbursed list had seen price cuts, and this is likely to continue. But volumes continue to increase. So companies will have to decide on their strategies carefully law in 2010 which stated that foreign manufacturers must also conduct clinical trials in Russia prior to registration, and the results of international trials will only be accepted if they were conducted with the participation of Russian patients. Glenmark's spokesperson in charge of the Russia market, opines, ”The new law requires clinical trials to be conducted locally in Russia, as per GLP norms. It’s definitely an entry barrier for new players, but not a hindrance for established players like Glenmark operating in the Russian market for around three decades now. On the positive side, it ensures a level playing field and ushers greater quality.” Sun Pharma's spokesperson seem to see a positive side to this move on the Russian government's part, opining that though there have been regulatory changes like biostudies in local population, this is true of several other markets as well. “Many of the drugs that are on the reimbursed list had seen price cuts, and this is likely to continue. But volumes continue to increase. So companies will have to decide on their strategies carefully”, he opines. He highlights the therapeutic areas with good potential in Russia oncology, cardiovasculars, diabetes and asthma;

August 1-15, 2012

these areas that the Russian government is addressing on priority. More complex drugs would stand a likelihood of not being brought under price control. Gajaria concedes that the rationale behind the new law is to establish the efficacy / safety profile for a drug in keeping with the Russian population, because there are geographical factors that play a role in the patient profile and testing the drug on Russian patients will ensure that the drug is safe and efficacious for the Russian population. But he believes that this an extra hurdle that pharma companies have to cross to enter the Russian markets as it leads to delay in conducting clinical trials. “A clinical trial is a tedious and expensive procedure and may demotivate companies from targeting the Russian market,” he opines. He continues, “In the light of the Russian market introducing various legislations to promote setting up operations in the domestic arena and at the same time discouraging imports, JB Chemicals & Pharmaceuticals Ltd (JBCPL’s) move last year to sell their portfolio at a good price was a wise decision. It was reported that JBCPL wanted to expand its reach in the Indian drug market. The deal created many opportunities for JBCPL in terms of increasing

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its financial flexibility and making it possible for it to focus on the Indian market and other markets of interest. The Indian pharma industry has been witnessing an ongoing trend of companies selling their leading brands/divisions. The sale of the I-pill from Cipla to Piramal, the Abbott- Piramal deal and the Reckitt – Paras deal are all examples of this trend. But looking ahead Gajaria seems to have a positive outlook saying, “It is apparent that the Russian government is in the process of strengthening the domestic market, a move that could seemingly hamper the export of Indian drugs to Russia. However authorities in India and Russia are working towards promoting the trade of pharmaceuticals between the two countries. Bilateral trade between India and Russia in 2011 stood at $5.965 billion. Both sides have set a target of achieving $20- billion trade by 2015. As far as the entry of Indian players into the Russian market is concerned, both governments have expressed interest in collaborating (JVs) in the pharma space. It is hoped that the recent meeting between Union Minister, Anand Sharma and the Russian Deputy Prime Minister will result in faster action on this front. u.sharma@expressindia.com

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M|A|R|K|E|T INTERVIEW

‘DuBiotech and IDMA to promote two-way investment between UAE and India’ Companies operating in Dubai Biotechnology & Research Park are keen to invest in the Indian market. Likewise Indian pharmaceutical companies are ready to expand their footprint in the Middle East. To strengthen this relationship, Indian Drug Manufacturers’ Association and DuBiotech are going to sign an MoU. Marwan Abdulaziz, Executive Director, TECOM Science Cluster, shares details with Usha Sharma Tell us more about Dubai Biotechnology and Research Park. The Dubai Biotechnology and Research Park (DuBiotech) is the only free zone in the Middle East which is dedicated to the life sciences industry. It was launched in 2005 under the patronage of Sheikh Mohammed bin Rashid Al Maktoum, Vice-President and Prime Minister of the UAE and Ruler of Dubai. A member of TECOM Investments, DuBiotech accommodates the entire life sciences value chain by providing key facilities, investing in infrastructure and creating a unique free zone environment that incorporates industrial, academic, commercial and residential projects. The Park integrates tailored facilities such as the nucleotide lab complex, multi-purpose warehousing facilities, adaptable and premium offices at the DuBiotech Business Centre, as well as land to support the rigorous requirements of research and development (R&D), manufacturing, distribution, hospitality, residential, retail, healthcare and high value-added services. DuBiotech partners enjoy special privileges such as 100 per cent foreign ownership, tax-free operations, and repatriation of profits, as well as effortless visa and license issuance procedures. It offers unique services that include regulatory affairs management, partner development, registration and licensing, in addition to leasing and government services to facilitate the growth of domestic and international companies operating in the park. Furthermore, DuBiotech hosts LEED certified green buildings which can support the rigorous requirements of scientific research and development. At present how many companies are part of the cluster? DuBiotech now hosts 95 international and local companies in the pharmaceutical, biotechnology, medical devices and agri-business segments. The presence of these companies at DuBiotech is contributing to the development of the cluster and the industry in the UAE. How many Indian companies or subsidiaries of multinational companies have their operations at DuBiotech?

According to the Consulate General of India in Dubai, in 2011, India remained the largest trading partner for Dubai accounting for 19 per cent of Dubai’s foreign trade; amounting to $37.3 billion in 2011

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Dubai has transformed itself as a major hub for many biotech companies in the last few years. Most of these companies like Pfizer, Amgen, Genzyme, Bristol Meyers Squibb, Firmenich, and MerckSerono, have their base in DuBiotech where they use the Park as a base for their regional operations. It also hosts major Indian companies such as Sun Pharma, Wockhardt, Lupin, NeoBiocon, Life Cell and Vins Life Science. Why do you want Indian biotech/pharma companies to be part of DuBiotech? What subsidies is the Dubai government ready to offer? India and Dubai enjoy a long history in trade and economic relations. IndiaUAE trade, valued at $180 million per annum in the 1970s, which is today in excess of $44 billion, which makes the UAE one of India’s leading trade partners. In bilateral trade - approximately 80 per cent is accounted for by Dubai alone. In fact, according to the Consulate General of India in Dubai, in 2011, India remained the largest trading partner for Dubai accounting for 19 per cent of Dubai’s foreign trade; amounting to $37.3 billion in 2011. Among the emerging economies, the Indian pharma industry is the largest and most advanced. DuBiotech would like to support the expertise of the Indian biotech companies in Dubai in order to explore opportunities for collaboration. Furthermore, Indian companies will find Dubai an ideal destination for business expansion in the Middle East that bridges the east with the west. DuBiotech offers services in regulatory affairs management, partnership development, registration and licensing, leasing and government services to help companies set up their base with ease and achieve their respective commercial targets. The free zone allow partners to enjoy a strategic location coupled with world-class facilities and infrastructure, ranging from offices and laboratories to warehouses and land plots within a vibrant life sciences community. It also offers tax advantages and services such as 50 years’ exemption from personal, income and corporate taxes, long-term land leases, 100 per cent foreign ownership and repatriation of profits. By offering these benefits, DuBiotech is the perfect place for any Indian company engaged in life sciences who is looking to expand their operations in the Middle East in general and particularly the Gulf Cooperation Council. How strong is the infrastructure in DuBiotech and how further it will help the Indian companies? All buildings in the free zone are constructed to support the rigorous requirements of scientific R&D, and are LEED certified green buildings. The free zone provides various options for companies

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depending on the type of activities they plan to conduct and the investment that they want to make. These options include warehouses, laboratories and the business centre, which is a perfect solution for small and medium businesses. What basic criterias have you designed for establishing presence in DuBiotech? We have created a number of standards to enable successful establishment of the company: first, we divide the segments of the industry. For example, we register companies that function in the following segments: biotech, medical, industrial, agricultural, environmental, equine/animal/marine, pharma, neutraceuticals, nanotechnology, medical devices, bioinformatics, and forensic science. We have even divided these segments into more detailed functions such as industrial biotech activities. This segment includes diagnostics, research and development for drug discovery, manufacturing, storage, sales and marketing, distribution, consulting/service providers, as well as industry specific training. We encourage companies at the Park to lead R&D initiatives. We are also in discussions with the federal health authorities to create specific regulations for such activities. Additional standards that are being considered at DuBiotech include commitment to educating the public and raising awareness on the need for science in each individual’s life. DuBiotech is in the process of collaborating with universities, medical research institutions, and nongovernmental organisations in the UAE; with the aim of strengthening the biotechnology industry. What benefits will Dubai get by signing the MoU with Indian Drug Manufacturers’ Association (IDMA) and why would you like to promote Indian formulation players? India remains one of the leading countries in the field of biotech and pharma, which makes it essential to add such expertise to our current portfolio. The MoU will, therefore, encourage the establishment of joint ventures (JVs) between companies within DuBiotech and IDMA members, especially focusing on the small and medium size enterprises (SMEs) that account for 87 per cent of India’s total pharma by volume, which comprise a major part of total global production. DuBiotech can act as the ideal platform for SMEs to obtain the necessary global exposure in order to increase business prospects, thus, enabling them to become tomorrow’s multi-national corporations. DuBiotech and IDMA will promote two-way investment between the UAE and India within the life sciences industries. The MoU will also facilitate information sharing on direct investment and trade leads; knowledge and expertise exchange; joint participation in events; and mutual delegation hosting. August 1-15, 2012

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Besides getting entry into the GCC countries, which other markets can be accessed by Indian players? DuBiotech is ranked by the Financial Timesâ&#x20AC;&#x2122; FDI survey among the top five global destinations and hosts regional headquarters for many international companies such as Pfizer, Firmenich, Maquet, MerckSerono, BMS and more. Dubai is also a major investor in other countries, allowing businesses to grow and diversify. Additionally, DuBiotech Partner Development Management Department is dedicated to facilitating mutual exchange of expertise; disseminating best practices and knowledge; and supporting companies to explore other global markets in order to build strong synergies between our clients and industry leaders.

and the actual agreement may take some time to be finalised. How much investment you have made so far? DuBiotech has already built significant infrastructure and now features state-of-theart laboratories and warehouses. In fact, infrastructure worth AED1.5 billion ($408 million) has already been constructed within DuBiotech. It

took two years to construct the infrastructure and another two years to complete the buildings with development completing in 2010. Which other markets are you keen to follow and why? Our other targeted markets are China, Germany as well as North and South Korea as they hold high potential. Furthermore, our sense is that these target markets will align

with our current business partners as well as new business partners who we hope will join us from India. Why do you like to promote SMEs and mid-sized companies? SMEâ&#x20AC;&#x2122;s are an optimal option for companies interested in testing the GCC and MENA markets as well as for those with limited budgets. Additionally, DuBiotech pro-

vides flexible and reasonable offerings for SMEs to set up their presence within the region. In fact our ongoing support of SMEs within DuBiotech has resulted in regional recognition. In February 2012, Dimensions Healthcare (DHC), a dynamic and energetic SME was recognised by Dubai SME 100 as the number one from company among 72,000 SMEs. u.sharma@expressindia.com

How will DuBiotech and IDMA form a strategic alliance and what benefits will be shared between the parties as well as their members? IDMA and DuBiotech are dedicated to the development of the pharma industry. Notably, a plethora of companies operating in DuBiotech are interested in the Indian market while Indian companies are looking to expand their footprint into the Middle East. Such companies will gain an opportunity to forge alliances as well as participate in knowledge and expertise exchange. We at DuBiotech believe that we can act as a facilitator and access point for companies to make the most of these opportunities. Is the MoU only for IDMA members or is it for other pharma companies as well? The MoU with IDMA is a tool to offer IDMA members direct access to DuBiotech. The MoU will facilitate collaborations and alliances between IDMA members and the DuBiotech community. However, establishing base in DuBiotech is open to all companies and associations from the global life science industry. DuBiotech is also supportive of other activities within the life sciences. When is the MoU likely to be signed? We are looking forward to signing the agreement as soon as possible so that we can engage with and support IDMA members. However, the MoU must go through a necessary approval process August 1-15, 2012

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Amra Remedies targets turnover of ` 100 crore in FY 2012-13 Plans capex of ` 40-45 crore Usha Sharma Mumbai he ` 15 crore Mumbai-based pharmaceutical company, Amra Remedies, established in 2010 has targeted a turnover of ` 100 crore in financial year 2012-13. The company also plans to enter the diabetes therapeutic segment by 2014 and provide full line of treatment. It is currently in talks with a Japanese company manufacturing glucometers and a multinational company for obtaining co-marketing rights for the Indian market. Talking exclusively with Express Pharma, Partha Banerjee, MD and CEO, Amra Remedies said, “We are in talks with the Japanese company for co-marketing of their glucometers in India. With the help of this agreement, we will be able provide to full line of treatment to patients. We are also in talks with another multinational phar-

ma company as they hold the patent on our research molecule. We are in the final stages of discussion for co-marketing the diabetes product in India. Presently, it is available globally and we are targeting to launch the product by 2014 in India.” Presently, Amra Remedies has over 45 products in its kitty for cardiovascular, dermatology, gynaecology, oncology, nutraceutical, anti-microbial, gastrointestinal and respiratory therapeutic segments. To continue its growth, the company plans to launch has five more new products in its existing therapeutic areas (two for dermatology and one each for anti-microbial, oncology and FMCG). Banerjee highlighted, “We are mainly focusing on the anti-microbial therapeutic segment as we consider that this therapeutic segment has major scope and there is unmet demand in the market.”

With a manpower strength of 850, Amara Remedies plans to hire 650 more by 2013. 90 per cent of the new recruitment will be medical representatives as it has extensive expansion plans in order to have a pan India presence. While sharing the company’s future plans, he mentioned, “As of now, we don't have any plans to establish our presence in the international market. We feel that the domestic market has better promise and good business opportunities for companies like us. Presently we do not own any manufacturing facility but we are in the process of acquiring one manufacturing facility in Mumbai, which will be in an excise free zone. Both the facilities are likely to get commissioned by 2014. Overall, we have a capex plan of ` 40-45 crore.” The company has recently introduced toilet seat sanitizer spray elav O in India. u.sharma@expressindia.com

FDA raids cause chemists to return MTP kits, contraceptives Confusion over state FDA order leads to knee jerk reaction from chemists Sachin Jagdale Mumbai aharashtra FDA’s efforts to curb female foeticides has resulted in an unexpected side effect: a growing number of chemists are returning MTP kits, and in some cases, even contraceptives to their distributors. Officials of the state FDA body had noticed several bulk purchases of Medical Termination of Pregnancy (MTP) kits by certain distributors and chemists. On the assumption that these unusually high orders of MTPs were linked to terminate pregnancies after sex determination tests, the state FDA gave instructions to raid chemist shops dispensing MTP kits in the absence of legitimate prescriptions. As a consequence of this crackdown, many chemists in the state have started returning MTP kits to the distributors/ manufacturers, fearing action from FDA authorities. Moreover, many chemists are now wary of stocking even contraceptive pills in their premises. This preemptive action could result in the shortage of these items. According to FDA authorities, the

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circular from the Maharashtra FDA Commissioner spurring these reactions has been “misunderstood” by chemists. While speaking about the entire controversy, Dilip Kadam, Executive Member, All India Organisation of Chemists & Druggists (AIOCD) and

Many chemists in the state have started returning MTP kits to the distributors/ manufacturers, fearing action from FDA authorities

Maharashtra State Chemists and Druggists Association (MSCDA) , said, “Chemists from areas where there is no practicing gynaecologist are mainly inclined towards returning back MTP kits. It is also true to some extent that chemists are giving back contraceptive pills as well, which are actually Government approved. Chemists are

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ready to do away with these products instead of getting questioned, harassed or raided by FDA authorities.” He adds, “In rural Maharashtra well qualified doctors are a scarcity. Many hospitals are run by doctors who have BHMS, BAMS etc degrees. These hospitals do have visiting gynaecologists who are allowed to prescribe MTP kits. However, since the prescription is made on the hospital's prescription pad (which are operated by doctors with degrees like BHMS, BAMS), the question is: will a chemist be legally right in honouring such a prescription? We are not clear on this point.” Sources say that the trend of returning contraceptive pills and MTP kits is expected to gain momentum in the coming future inspite of the clarification. A source from a leading chain of chemists in Mumbai said, “If a chemist works as per rules, then there is no harm to him or to his business. It is true that there is panic among chemists. However, I think FDA should come clear on its guidelines. This will only help to sort out the current confusion.” sachin.jagdale@expressindia.com August 1-15, 2012

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Pharma associations propose enforcement of marketing code IPA proposes for independent ombudsman Usha Sharma Mumbai n a move to curb the use of unethical marketing practices in the pharma industry in India, the Department of Pharmaceutical (DoP), Ministry of Health (MoH), Medical Council of India (MCI), National Pharmaceutical Pricing Authority (NPPA), Department of Consumer Affairs met key industry stakeholders who have agreed to enforce marketing codes in India, which will restrict pharma companies from offering gifts or sops to doctors in order to prescribe their medicines. The industry was represented by associations like Indian Drugs Manufacturers Association (IDMA) Organisation of Pharmaceutical Producers of India (OPPI) and Indian Pharmaceutical Alliance (IPA) and Confederation of Indian Pharmaceutical Industry (CIPI) at a recently held meeting. Speaking with Express Pharma, DG Shah, Secretary General, IPA said, â&#x20AC;&#x153;In the meeting with Department of Pharmaceutical (DoP) and major industry associations pharma companies have agreed for the enforcement of the marketing code as actions in against companies indulging in unethical marketing practices.â&#x20AC;? IPA has proposed appointing independent ombudsman who will work along the lines of the Press Council of India (PCI). This will help members of the public to file a complaint against any unethical prac-

tices they may be aware of. Last year, DoP had formulated a voluntary marketing code with an aim to end

the alleged practice of pharmaceutical firms giving incentives to doctors to prescribe their medicines.

DoP has asked other industry associations about IPA proposal of ombudsman and upon their confirming

acceptance the DoP will decided on self regulation by the industry. u.sharma@expressindia.com

IPA has proposed appointing independent ombudsman who will work along the lines of PCI

August 1-15, 2012

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DNDi and Cipla to develop antiretroviral drug combination New formulation to provide appropriate HIV medicines for infants and young children n the eve of the XIX International to early diagnosis and immediate ART therapy in a fixed-dose combination of AIDS Conference in Washington, with safe, potent, child-friendly treatment Lopimune Sprinkles, combined with one of two other powerful ARV drug combinaDC, the Drugs for Neglected combinations. Dr Yusuf K Hamied, Chairman and tions, abacavir/lamivudine (ABC/3TC) or Diseases initiative (DNDi), a not-for-profit research and development (R&D) Managing Director, Cipla said, “Cipla is zidovudine/lamivudine (AZT/3TC). Cipla organisation, announced a new collabora- fully committed to take its ARV work for will work to produce an appropriate 4-intion with Indian drug manufacturer Cipla children with HIV/AIDS a step further. 1 combination sachet product, in which to develop and produce an improved first- We have already been working with the the four ARV drugs will be in tasteline antiretroviral (ARV) combination Medical Research Council Clinical Trials masked, granular form, for easy mixing therapy specifically adapted to meet the Unit (MRC CTU) in the UK and their pae- into food or liquids such as water, juice, treatment needs of infants and toddlers diatric colleagues in Zambia and Uganda or breast milk, with the aim of registering living with HIV/AIDS. The goal of the col- for several years, first producing several the drug by 2015. Dr Unni Karunakara, President, MSF laboration between DNDi and Cipla is to appropriate baby pill formulations for develop a 4-in-1 ARV combination prod- infants and children, and more recently International said, “The lack of appropriuct for HIV-infected children under the we have produced a new sprinkle of ate treatments for young children with age of three years, including those who lopinavir-ritonavir. Cipla and DNDi are HIV/AIDS has been devastating. This inihave been exposed to drugs while in the now joining forces to produce further tiative responds to our call for attention womb, and also those who are co-infect- drug formulations for HIV-infected chil- and resources to be directed towards giving these kids the medicines, life, and digdren in poor countries.” ed with TB. nity they deserve.” Once delivered, this new paediAs the industrial partner, Cipla atric ARV combination could help will take responsibility for producto accelerate the provision of care to Within the new collaboration, tion, registration, and distribution of the world’s youngest children living the product and will thus retain all with HIV/AIDS, who are at very Cipla will provide its intellectual property (IP) related to high risk of dying without treatthe new formulations. Should Cipla ment. An estimated 3.4 million chillopinavir/ritonavir (LPV/r) opt out as industrial partner, DNDi dren have HIV/AIDS, but less than will be granted non-exclusive, worlda quarter currently have access to 40-/10-mg sprinkle formulation wide, royalty-free licences to the IP. antiretroviral therapy (ART), comIn addition, the collaboration aims to pared with 54 per cent for adults. (‘Lopimune Sprinkles’) and bring the cost of the final ARV prodWithout treatment, more than half uct in the public sector substantially of children with HIV/AIDS will die work with DNDi and other lower than the cost of the products before their second birthday, and 80 used separately. Cipla and DNDi will per cent will die before partners to test new establish a detailed drug access and they turn five. implementation plan to ensure delivHistorically, major pharmaceuticombinations of HIV treatment ery of the new product to patients. cal companies have invested little in Dr Bernard Pécoul, Executive R&D specifically aimed at addressfor infants and young children Director, DNDi said, “This partnering the needs of young children ship with Cipla and other collaborawith HIV/AIDS largely because of Within the new collaboration, Cipla tors provides us a critical path to developthe absence of a viable market. The virtual elimination of mother-to-child trans- will provide its lopinavir/ritonavir ing better paediatric antiretroviral formumission of HIV in high-income countries (LPV/r) 40-/10-mg sprinkle formulation lations for the youngest, most vulnerable means that nearly all HIV-positive chil- (‘Lopimune Sprinkles’) and work with patients living with HIV/AIDS. Young dren live in low—and middle-income DNDi and other partners to test new com- children living with – and dying from – countries, with over 90 per cent in sub- binations of HIV treatment for infants and HIV/AIDS deserve the best that science Saharan Africa. The global strategy to young children. The initial data on the has to offer. We will concentrate our every eliminate new infant infections through lopinavir-ritonavir sprinkle – being gener- effort to ensure that we get to the right prevention of mother-to-child transmis- ated by Ugandan paediatricians and MRC treatment as soon as possible to save the sion (PMTCT) by 2015 will be confronted CTU in partnership with Cipla (CHAPAS 2 lives of the over 600 HIV-positive children with the reality that some children contin- trial)—will be essential for DNDi and its who die silently every day.” EP News Bureau ue to be infected and urgently need access partners to develop an optimised first-line

Taro's Special Committee rejects proposal from Sun Pharma Offer deemed "inadequate, not in the best interests of Taro’s minority shareholders" t seems that Mumbai-based drug manufacturer Sun Pharmaceutical Industries (Sun Pharma) will have to wait a little longer to control its Israeli subsidiary Taro Pharmaceuticals. According to a press release issued by Taro Pharmaceuticals, a Special Committee of Taro's board of directors unanimously rejected the Indian company's offer to purchase all issued and outstanding shares of Taro not currently

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held by Sun Pharma for $24.50 per share. Sun Pharma, which already holds 66.32 per cent stake in Taro, had made the non-binding offer for the remaining stake on October 18, 2011. A Sun Pharma spokesperson declined to comment on this issue. Taro's Special Committee judged that Sun Pharma's offer was "inadequate and not in the best interests of Taro’s minori-

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ty shareholders". The press release stated that the Special Committee reached its conclusion after a thorough review of Taro’s business and prospects with its independent financial advisor Citigroup Global Markets, and its independent legal counsel Goldfarb Seligman & Co as its Israeli legal counsel and Willkie Farr & Gallagher LLP as its US legal counsel. EP News Bureau August 1-15, 2012

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Domestic pharma companies likely to see steady growth in Q1 FY13: Analysts Tax rates hikes and forex losses could however cloud the picture for certain companies nalysts are predicting that the the domestic pharma companies will see a strong and steady growth in first quarter (Q1) of financial year 2013 (FY 13). According to a Q1 FY13 preview from Standard Chartered Securities, based on 10 top pharma companies in their universe, the companies are likely to report 27 per cent revenue growth, US formulations growth of 32 per cent y-o-y, organic domestic growth of 16 per cent y-o-y. It is estimated that EBITDA margin will expand 200 bps y-o-y to 22.1 per cent and PBT to grow 29 per cent y-o-y. The Standard Chartered analysts estimate that these companies are is likely to witness robust revenue outlook. Sales in Q1FY13 are estimated to grow 27 per cent y-o-y, led by US formulations (61 per cent y-o-y, helped by currency and FTFs) and domestic formulations (18 per cent y-o-y). Organic base business (ex FTFs and acquisitions) is likely to grow at 19 per cent y-

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o-y, aided by ~12 per cent y-o-y currency depreciation, 20 per cent y-o-y constant currency growth in base US business and 16 per cent y-o-y organic growth in domestic formulations. Dr Reddy's Laboratories (DRL), Lupin, Ranbaxy and Sun Pharma are expected to register revenue growth in excess of 25 per cent y-o-y. According to estimates done by Kotak Institutional Equities Research, Q1FY13 is likely to be a strong and steady quarter though not a spectacular one, marred by hikes in tax rates and forex losses for certain companies under their coverage. While y-o-y sales growth is expected to remain strong for all, the PAT growth is expected to be mixed with a few companies reporting flat/PAT decline y-o-y due to hikes in tax rates, lower EBITDA margin y-o-y, forex losses (Jubilant, Glenmark, Ranbaxy and Cadila) and absence of licensing income. Most of the frontline generic companies are expected to report strong sales growth of above 25

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per cent boosted by higher realisation in rupee terms, exclusivity sales in US for DRL, Lupin Ranbaxy, Glenmark and Sun Pharma on account of Ziprasidone, Lipitor, Cutivate and Stalevo and Lipodox respectively. EBITDA margin trends will remain mixed across companies and it is expected that EBITDA margin to decline y-o-y for Glenmark, Cadila and Glaxo on account of high base last year, higher import content leading to higher import cost for Glaxo and consolidation of lower-margin businesses of Biochem and Bremer Pharma. DRL, Sun, Lupin and Ranbaxy are likely to report highest EBITDA margin improvement y-o-y of over 100 bps due to ongoing sales from exclusivities in US and operating leverage benefits due to pick-up in base business sales growth for SUN and Ranbaxy. However, it is expected that PAT will remain flat/decline yoy for Cadila, Glenmark, Dishman, Jubilant and Ranbaxy. EP News Bureau

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Zydus Urosciences launches Udenafil The inhibitor has been launched for the first time in India to cure erectile dysfunction ydus Urosciences, the specialty division of Zydus Cadila a global healthcare provider, has launched Udenafil a next gen therapy for the treatment of ED (erectile dysfunction). Udenafil, a newly developed, potent and selective PDE5 inhibitor approved for the treatment of ED, has been launched under the brand name ‘Udzire’. The group has an exclusive license to market this patented molecule developed by Dong-A Pharmaceuticals of Korea, in India. Phosphodiesterase 5 (PDE5) inhibitors are the first line therapy for ED. Currently, only two molecules – sidenafil and tadalafil from this group are available for the treatment of ED in India. Sildenafil has a rapid onset of

action but duration of action is shorter. Tadalafil has a longer duration of action but is associated with side effects of muscle pain and back pain. Udenafil, is the fourth amongst the PDE5 inhibitors class and fulfills this need for a molecule having advantages of the existing agents with a better tolerability profile. Udenafil has been found efficacious in the treatment of various causes and severity of ED with no muscle pain/back pain being reported in the clinical trials. The treatment with this therapy has also resulted in significant improvement in erections in ED patients with hypertension or diabetes mellitus in specific clinical studies. Erectile dysfunction continues to

remain a common disorder. It is said to affect as much as 10 per cent of the male population. The incidence is fairly common in men above the age of 40 with nearly 52 per cent of men in this age group being affected with this disorder. The number of males suffering from ED is estimated to exceed 320 million men worldwide by the year 2025, with the largest projected increases in developing continents such as Africa, Asia, and South America, Udzire (Udenafil) is a new addition to the current management of ED and will assist medical practitioners in customising treatment regimens to the unique needs of the patients with ED in India. EP News Bureau

Canada-India Business Council signs MoU with Gujarat govt To focus on sectors like pharmaceuticals, telecom, energy and finance anada India Business Council (CIBC) has signed a Memorandum of Understanding (MoU) with the Industrial Extension Bureau (iNDEXtb), an economic development organisation representing the Government of Gujarat. The MoU provides a framework for both organisations to proactively work towards increasing trade and investment between Canada and Gujarat. Following the MoU signing, the CIBC hosted an exclusive roundtable discussion with the Gujarat delegation composed of senior management from several of India’s leading companies including Reliance Industries, Adani Gas, Suzlon Energy, Hazira LNG among others. The delegation from India was

led by JD Pandian, Principal Secretary, Energy & Petrochemicals Department, Government of Gujarat. “While there has been much recent discussion about India’s slowing growth rates, this conversation largely overlooks the significant differences between the diverse regional economies of India. Canadian companies such as McCain Foods and Bombardier recognise this and have taken a more local focus. Both already have major plants in Gujarat. The Council knows that a growing number of other Canadian companies are looking to use Gujarat as the launch point from which to enter the broader Indian market,” added Rana Sarkar, President and CEO, C-IBC.

“The C-IBC is pleased to lead the discussion on the progress of Canada’s engagement with Gujarat. The roundtable will focus on identifying remaining challenges and highlighting emerging opportunities. The MoU provides a practical framework for achieving these objectives,” said Peter Sutherland, Vice—Chairman, C-IBC. The sectors represented include pharmaceuticals, telecom, energy and finance. During the facilitated member only sessions, senior management from five Canadian companies participated in focused B2B discussions with Gujarat delegates to identify potential sales opportunities in manufacturing, IT, clean energy and infrastructure. EP News Bureau

Novartis Q2 result enhances future growth prospects Achieves eight significant regulatory milestones in the same quarter ovartis has posted its second quarter (Q2) result. The group’s net sales reached $14.3 billion in Q2, with growth from recently launched products more than offsetting the loss associated with the Diovan patent expiration. Currency had a negative impact of five percentage points as a result of the strengthening of the dollar against most major currencies. Products launched since 2007, which include Lucentis, Gilenya, Afinitor, Tasigna and Galvus, continued to perform strongly. These recently launched products grew eight per cent to $4.1 billion and now comprise 29 per cent of Group net sales, up from 25 per cent a year ago. Pharmaceuticals had another quarter of good underlying growth despite the Diovan patent expiration in Europe, with

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net sales of $8.3 billion. Excluding Diovan, net sales grew eight per cent, demonstrating the strong underlying performance of the division. Recently launched products, the key growth driver for pharmaceuticals, generated $2.8 billion of net sales, growing 28 per cent over the same period last year. These products now represent 34 per cent of division sales, compared to 28 per cent in the yearago period. Alcon’s net sales grew one per cent to $2.6 billion in the quarter. This robust performance was led by strong surgical sales growth of three per cent, benefitting from strong cataract product sales in the US and emerging growth markets, as well as contact lens sales growth of two per cent, underpinned by the solid uptake of

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new products such as the LenSx femtosecond refractive cataract laser and silicone hydrogel lens Dailies Total. Sandoz net sales declined 13 per cent to $2.1 billion driven by seven percentage points of price erosion. Vaccines and diagnostics net sales were up 17 per cent to $349 million. Sales growth was driven by Menveo, which continued to see doubledigit growth in the US, as well as the timing of bulk pediatric shipments in 2011, which produced a weak comparative quarter. Consumer Health, which includes OTC and animal health, declined 24 per cent to $904 million in the quarter, impacted by the suspension of production at the Lincoln, Nebraska manufacturing site. EP News Bureau August 1-15, 2012

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Seminar on EU-GMP Regulations Date: August 6 & 7, 2012 Venue: Hilton Hotel near Sahar Airport, Mumbai Summary: The seminar to be held for the first time in India, will be important for persons of Regulatory Dept./ QA/QC/Production of pharmaceutical companies. Senior Inspector Knud Ryhl of Danish Medicines Agency (a Danish Government Organisation) will give a presentation on EU-GMP regulations. Visitors will be able to gain first hand knowledge from a senior inspector of government agency who has done number of inspections worldwide including India. Discussions will be held on some of the most important aspects coming up in 2013 in EU-GMP Regulations. Contact details: Bharati Phone: 25360198/9867026512 M/S Trends Exports

IT Life Sciences Summit 2012: Technology Enabled Pharmaceutical Business Transformation Date: September 6-7, 2012 Venue: The Lalit Mumbai, Sahar Airport Road Summary: The summit will provide a platform for the life sciences industry, regulators and information technology (IT) and IT enabled services industry to converge and consider IT intervention for enhancing competitiveness, reducing costs and bringing affordable medicines to market. Contact details: Manoj Trivedi Senior Manager Marketing & Program Development Drug Information Association A 303 Wellington Business Park I, Marol, Andheri - Kurla Road Andheri (East) Mumbai - 59 Tel: +91 22.2859476 Cell: +91 98.19777493| Fax: +91 28.594762 Email: Manoj.Trivedi@diaindia.org

Pharmac India 2012 Date: September 8-10, 2012 Venue: Gujarat University Exhibition Hall, Ahmedabad Summary: Pharmac India 2012 is the third international exhibition of India’s prominent pharma machinery, equipment and material industry. The exhibitions' aims to bring pharma manufacturers, pharma packag-

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ing material and machinery along with API’s ,bio pharma with largest suppliers, distributors under one roof. Contact details: Varsha Surve Project Coordinator Orbitz Exhibitions 402, Navyug Industrial Estate, T.J. Road, Sewri (W), Mumbai 400015 Tel: +91 22 2410 2801-03 Fax: +91 22 2410 2805 Cell: 09322037955 www.orbitzexhibitions.com www.pharmacindia.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 Mohamed Sathak AJ College of Pharmacy, Chennai, Tamilnadu will host 2nd International Symposium on Frontiers in Pharmaceutical Research and Nanotechnology (Nanopharma2012). The focus of this symposium '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 project 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 Tel: 91 9894286283

In Silico Drug Discovery & Advance Cheminformatics Workshop Date: September 28-30, 2012 Venue: Pune Summary: RASA Life Science Informatics, will conduct the 'National In Silico Drug Discovery & Advance Cheminformatics Workshop.’ The workshop is a joint initiative by RASA Life sciences & Alard College of Pharmacy.The three-day comprehensive workshop aims at providing systematic handson-training on using advanced Bioinformatics and Cheminformatics

applications/tools for drug discovery. The workshop has been conceptualised by eminent | scientist having substantial experience in the field of drug discovery. Contact details: Sapana Mehendale Founder & Entreprenure RASA Life Science Informatics Mob: 9689904372 email:Sapana@rasalsi.com Web:www.rasalsi.com

CPhl India 2012, P—MEC India 2012 Date: November 21-23, 2012 Venue: Bombay Exhibition Centre, Mumbai Summary: CPhI India into its sixth year, it is 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, with the theme: 'Pharmacy Education: Innovation, Strategies and Globalization'. Contact details: Prof BG Shivananda Secretary-APTI HQ: Al-Ameen College of Pharmacy, Opp Lalbagh Main gate, Hosur Main Road, Bangalore – 560027 Email: aptienquiry@gmail.com

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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, pathbreaking 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, AP Tel: +91 40 6644 6477 +91 40 6644 6577 Web: info@bioasia.in

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 and materials, API, bulk actives and pharma chemicals, lab instruments and consumables, utilities, biotechnology, research, consultants, trade associations and publications and related services. Professionals and decision makers, regulatory officials, from India, SAARC region, Gulf region will attend. Contact details: Paresh Jhurmurwala GPE EXPO Global, Opp. Priyadarshini Tower, Near Judges’ Bungalows, Bodakdev, Ahmedabad 380 015, Tel: +91 792687 1390 / 4000 8253 / 4000 8233 Email: contact@pharmapropack.com August 1-15, 2012

Management

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Maharashtra Food and Drug Administration’s (FDA) decision to forbid Ayurveda, Yoga and Naturopathy, Unani, Siddha, Homeopathy (AYUSH) doctors from prescribing allopathic medicines, sent a strong wave of resentment among these practitioners. Sachin Jagdale analyses the ‘whys’ and ‘why nots’ associated with this issue hough against the law, prescribing allopathic products by Ayurveda, Yoga and Naturopathy, Unani, Siddha, Homeopathy (AYUSH) doctors is a regular phenomenon. Even today, a large chunk of population relies heavily on AYUSH doctors to fulfill their healthcare needs. However, recently Maharashtra Food and Drug Administration (FDA) decided to come down strongly on chemists who entertain allopathic prescriptions from homeopathy doctors. This diktat evinced severe protests from AYUSH doctors. Chemists across Maharashtra chose another way to show their displeasToday, pharma ure for this diktat. They decided to work industry is like a only from 10 am – 6 pm sharp and refuse helpless audience. to honour prescriptions for allopathic medicines from AYUSH doctors, which in They may like the turn had caused lot of distress to the local drama but can’t populace. This move put the Maharashtra appreciate the scene. Government in a quandary since the agiIt will be interesting to tation would have seriously compromised see when the the healthcare services in the state. Today, Maharashtra Government, in principle, curtains fall has agreed to allow AYUSH doctors to prescribe allopathic medicines. However, on the other hand, Indian Medical Association (IMA) has raised strong objections against any such move by the Maharashtra Government.

Legally right... Legal provisions justify IMA’s stand but it is also a known fact that the healthcare system in Maharashtra, or for that matter any state in India, would collapse if AYUSH doctors are not allowed to prescribe allopathic medicines. Thus, it is nothing short of a tricky balancing act for the Maharashtra Government to safeguard the interests of all the said parties. Shashank Sandu, Managing Director, Sandu Pharmaceuticals says, “AYUSH doctors are not trained in allopathic medicines. So, they are not

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expected to be experts in this form of medicine. Further there is a Supreme Court judgement which prohibits therapeutic pluralism, this was sometime in 1990 and due to which cross practice is prohibited. On the reverse side, under the Maharashtra Medical Practitioners Act 1961, in parts A, A-1, B & D, Maharashtra Government passed a GR allowing AYUSH doctors to cross practice and prescribe allopathic medicines. Due to these reasons they cannot protest but the AYUSH doctors are a confused lot.” “I don't think that the pharma industry has any role in this matter as it is upto the government to take a decision by Though AYUSH keeping in view the need of the people doctors have and factual position of health services in been blamed for the State,” opines Dr Bahubali Shah, crosspathy, President, Maharashtra Council of according to experts, Homeopathy (MCH). Dr Jayesh Lele, State Secretary, IMA, MBBS doctors Maharashtra, takes a strong dig at the do sometimes Government. He says, “There are not prescribe ayurvedic enough laws to tackle quackery. medicines Government has an inadequate approach to health and medical education matters, at the State as well as at the Centre. There are not sufficient plans and fund allocation for looking into the future of healthcare. And moreover, there is a lot of political interference.” According to Lele, at least today Government of Maharashtra and other associations have admitted that as on date they have no permission or know-how or legal provisions to use allopathic medicines. So they should accept the fact and stop prescribing allopathic medicines on the pretext of a scarcity of doctors in rural areas. There are many such doctors practicing in city areas, who keep their consultancy fees low, to make up for their inadequate knowledge and treat needy patients. “We have no correct and proper law to curb the menace of misuse of medicines which is

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August 1-15, 2012

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SHASHANK SANDU

DR JAYESH LELE

DR BAHUBALI SHAH

Managing Director, Sandu Pharmaceuticals

State Secretary, Indian Medical Association (IMA), Maharashtra

President, Maharashtra Council of Homeopathy (MCH)

AYUSH doctors are not trained in allopathic medicines. There is a Supreme Court judgement which prohibits therapeutic pluralism. This was sometime in 1990 and due to which cross practice is prohibited

We have no correct and proper law to curb the menace of misuse of medicines and the same is being exploited by all. In India anybody and everybody can give medicines

It is upto the government to take a decision by keeping in view the need of the people and factual position of health services in the State

being exploited. In India, it seems anybody and everybody can prescribe medicines,” says Lele.

No crosspathy

others by teaching a one year certificate course,” opines Lele. Pharma industry has to follow the FDA rules as these rules are based on the Government rules and notifications. The issue of allowing prescriptions of allopathy medicines by other than MBBS doctors is started by Government of Maharashtra in spite of the Supreme Court and MCI guidelines in this matter. According to Lele, pharma industry shall follow the FDA and surely support the cause as well as oppose the anti-quackery mission.

Pharma industry, the loser? Though it would seem the pharma industry would be one of the biggest losers (in terms of sales) if the AYUSH doctors are not allowed to prescribe allopathic medicines, there seems to be no reaction/protest from the pharma industry to this controversy. Lele points out that the pharma industry can never be the loser even if a ban is imposed on crosspathy practice and their prescriptions are not honoured by chemists, since a patient would take help and treatment from doctor. He explains, “Pharma industry cannot support crosspathy but they follow notifications from the FDA. Also, FDA can put pressure on them to follow the guidelines. Sale of medicines will not be affected. In fact, chemists and druggist associations are going to be the key partner if we really want to do something to curb the quackery.” Though the Government of Maharashtra has showed a flexible approach towards allowing AYUSH doctors to practice allopathic medicines, IMA seems to be in no mood to end the fight. Not just the organisations representing AYUSH doctors but also the Maharashtra Government will have to fight the legal battle against IMA. However, Sandu doesn’t find anything unusual in IMA’s approach as this is an association of MBBS doctors and hence he feels that they will obviously protect their constituents' rights and practice territories. Sandu explains his stand, “We, as an ayurvedic medicines manufacturer, meet ayurvedic, homeopathic, unani and allopathic doctors. We cannot comment on IMA’s stand as it is a body of professionals.” Shah refused to comment on IMA’s stand but he asserted that the Maharashtra State Government has taken this policy decision to render best of health services to the people of the state after a series of legal consultations and in the capacity of rights availed as per constitution of India.

EXPRESS PHARMA

IMA has always been against crosspathy. “We have many times approached various authorities without luck. This is again because many States have not implemented the Supreme Court judgements on this matter. These need to be taken into account by all States. But they are not doing so again on the premise that there is lack of doctors in rural areas. It is

A ‘Play safe’ approach

a failure on part of the Government to provide infrastructure of Primary Health Care (PHC) as well as small hospital in villages,” says Lele. In fact IMA has now 191 branches with over 30000 members, across all districts of Maharashtra. According to IMA authorities, they are ready to help Government to tackle the issue. Also now there are nearly 1,00,000 doctors registered with Maharashtra Medical Council. “IMA cannot support this prescription practice, as there is lot of difference in learning, diagnosing and treating. It is not a question of just obtaining a certificate of one year of pharmacology; we need to have a complete learning of the MBBS process. The validity of such certificate is again questionable,” stresses Lele. Though AYUSH doctors have been blamed for crosspathy, according to experts, MBBS doctors do sometimes prescribe ayurvedic medicines. So should they also be blamed for quackery? “It is possible that some MBBS doctors may be prescribing medicines like liniments or some herbal tonic preparation but it is very minimal. But this cannot be the basis to allow allopathic practice to all

www.expresspharmaonline.com

There are no two opinions on the fact that the pharma industry has to stick to the rules and laws formulated by the Government. However, though the pharma industry is expected to make its stand clear on this issue, they seem to have no option left but to wait and watch. As mentioned earlier, pharma players will have to follow the rules. Moreover, not all doctors prescribe allopathic medicines may necessarily be quacks. Every effort made to get the views from the pharma industry proved futile as none of the pharma companies (allopathic medicine manufacturers) who were been approached seemed interested in explaining their stand on this issue. This is perhaps the most awkward situation that the pharma players have ever come across in India. Any move by them would end up in harming their own interests in this most productive market of India. Though Maharashtra Government has made up its mind to allow AYUSH doctors to prescribe allopathic medicines, an official notification hasn’t yet been released. This stand by the Government is in fact good news for the pharma companies. However, this outcome would perhaps be celebrated back stage. Today, on this issue, pharma industry is like a helpless audience. They may like the drama but can’t appreciate the scene. It will be interesting to see when the curtains fall. Meanwhile, taking a leaf out of the Maharashtra episode, AYUSH doctors in Karnataka have also decided to press their Government to allow them to prescribe allopathic medicines. sachin.jagdale@expressindia.com August 1-15, 2012

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

Global biotech’s financial performance stabilising: EY report The global biotechnology industry has witnessed a second straight year of increasingly stable financial performance in 2011, according to Ernst & Young’s 26th annual biotech report, Beyond Borders but the industry still faces many challenges. Excerpts from the report he global biotechnology industry may have recorded a second straight year of increasingly stable financial performance in 2011, but longerterm sustainability remains challenging, predicts Ernst & Young’s 26th annual biotech report, Beyond Borders: Global biotechnology report 2012 released recently, wit the traditional funding-andinnovation model for pre-commercial biotech firms under unprecedented strain and the industry’s efforts to date to “do more with less” uncertain to deliver significant productivity gains. Established biotechnology markets have registered more than 10 per cent revenue growth for the first time since the start of the global financial crisis. Glen Giovannetti, Global Life Sciences Leader, Ernst & Young said, “In this capital-constrained environment, the inefficiency and duplication of the drug R&D paradigm is an indulgence we can no longer afford. Moreover, the industry needs to remove duplication, encourage pre-competitive collaboration, pool data and allow researchers to learn.”

vation have not been able to make a sizeable impact on the industry. Many of them are facing funding constraints as the investor community has shied away from investing in early stage ventures. With the lack of funding, many innovative companies will be forced to shut shop or

become service providers rather than innovators. The Government, on its part, has introduced several schemes to fund biotech start-ups. As an incentive for in house R&D, the government also provides 200 per cent weighted tax deduction, which has been extended till 2017 in this

US biotechnology at a glance, 2010-11 (US$b)

A new model for industry R&D The report finds that drug R&D needs a new approach that is iterative, fast, adaptive, cost-efficient and open. The report propose such a new model, the holistic open learning network (HOLNet). These networks of diverse entities — drug firms, providers, patient groups, social media networks, data analytic firms and more — would pool vast amounts of data, share real-time insights from across the health care ecosystem, and adapt rapidly. HOLNets would build on existing trends and, critically, connect information from across the value chain and cycle of care.

Source: Ernst & Young and company financial statement data. Numbers may appear inconsistent because of rounding.

Canadian biotechnology at a glance, 2010-11 (US$m)

India scenario The biotech industry in India is at a critical juncture. While the industry has been growing at a double-digit rate over the last five years (CAGR 19.2 per cent, 2007–2011), it has concurrently been facing diverse challenges that have prevented the industry from transcending to the next level. The industry size stood at $4 billion for FY 2010 - 2011. The biopharma industry constitutes 60 per cent of the biotech industry in India and grew at 21 per cent y-o-y to reach $2.3 billion in 2010–2011, which is approximately 15 per cent of the Indian pharma industry. Vaccines, insulin, erythropoietin and monoclonal antibodies have been the mainstay of the biopharma segment.

Source: Ernst & Young and company financial statement data. Numbers may appear inconsistent because of rounding.

Australian biotechnology at a glance, 2010-11 (US$m)

Key concerns Within the domestic market, companies have not been able to launch new products at a pace that they would have liked. Dealing with multiple regulatory bodies typically results in serious delays. To overcome this, the Government of India proposed to set up the Biotechnology Regulatory Authority of India (BRAI) through an act of the Parliament. Companies focused on inno-

EXPRESS PHARMA

Source: Ernst & Young and company financial statement data. Numbers may appear inconsistent because of rounding.

www.expresspharmaonline.com

August 1-15, 2012

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year’s budget. While India has a substantial number global one. The revenues of US publicly traded of graduates and post-graduates in biotech and relat- biotech companies declined in 2011, but this was ed fields, they are not optimally trained to cater to driven by the acquisitions of Genzyme, Cephalon industry demand. Companies therefore have to sig- and Talecris by non-biotech acquirers. After normalnificantly invest in their training and development ising for these large acquisitions, the US industry’s before they become ready to contribute to the busi- revenues increased by 12 per cent, outpacing the 10 ness. There is a need to revamp the course structure per cent growth rate seen in 2010 and 2009 (adjustand design of biotech education to improve the qual- ed for the Genentech acquisition). R&D increased by ity of graduating students. Towards this end, the nine per cent on a normalised basis, after having Government of Karnataka has started biotech finish- declined sharply in 2009 and increasing by a modest ing schools to train and empower students to be three per cent in 2010. The number of companies equipped to address industry demand. There is a held steady and employees grew by five per cent on need for many more such biotech schools to come a normalised basis — identical to the increase in up across the country to plug the manpower gap that headcount in 2010. the industry is facing. In terms of infrastructure, several biotech parks Europe: Net profits up, R&D spend up have been set up in India in the last five years with In Europe, as in the US, publicly traded biotechpublic private partnerships. The industry, however, nology companies increased their top lines by 10 per believes that most of biotech parks are more congen- cent, compared to 12 per cent in 2010 and eight per ial to biotech services and diagnostics firms rather cent in 2009. R&D expense, which had declined by than pure-play biotech manufacturing companies. To two per cent in 2009 and increased modestly by five support bio-manufacturing activities, the govern- per cent in 2010, grew by a much more robust nine ment should evaluate the feasibility of making avail- per cent in 2011. A significant difference from the US able land at subsidised rates, uninterrupted power at performance, however, was on the bottom line. competitive prices, good quality water supply and While US companies’ net profit decreased in 2011, effluent treatment facilities to improve the efficiency European companies went in the other direction, and productivity of pharmaceutical companies. essentially bringing the industry to the brink of Ajit Mahadevan, Partner, Ernst & Young said, aggregate profitability for the first time in its history. “India is already facEuropean biotechnology at a glance, 2010–11 ($m) ing stiff competition from China, Korea, Singapore, and more recently Malaysia, in terms of attracting investments from MNCs. This has been enabled due to better technological and scientific competence, better infrastructure, tax and duty exemptions, and easier regulatory procedures as compared to India. Thus, there is strong call for action for the government to act swiftly to carry out regulatory reforms, develop infrastructure and provide more incentives to the biotech industry Source: Ernst & Young and company financial statement data. to remain competi- Numbers may appear inconsistent because of rounding. tive and spur growth FDA product approvals, 1996–2011 in the industry. The industry, on its part, needs to come up with a concerted action plan to utilise the available infrastructure and resources more efficiently and focus on nurturing innovation to take the biotech industry to new heights.”

Global biotech scenario US: Revenues dip but R&D spend up As always, since the US accounts for a large majority of the industry’s revenues, the US story is very similar to the

EXPRESS PHARMA

The FDA approved 24 new molecular entities and 6 biologic license applications in 2011 — the second-highest total in the last dozen years.

www.expresspharmaonline.com

August 1-15, 2012

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However, this was essentially driven by a single event at a commercial leader: Elan’s sale of its drug technology to US-based Alkermes for $500 million. The number of employees increased by four per cent, compared to one per cent in 2010 and 2009 — another positive indication. Canada: Overall 53 per cent increase in financing The financial performance of Canadian publicly traded biotech companies continued to decline in 2011. Revenues decreased 21 per cent to $998 million. R&D expenditures fell for the third consecutive year, to $431 million, driven largely by continued cost cutting measures. This drive to achieve efficiencies and cut costs also resulted in a fall in employment in the sector. There are, however, some signs of hope. After the financial crisis in 2008, the Canadian biotech sector responded with cost-cutting and efficiency measures. The drive to do more with less has in turn led to some successes on the product development front, and many Canadian biotech companies announced positive clinical news in 2011 — a trend not seen for a while. Some companies obtained clinical and regulatory successes and others announced that they successfully advanced their products. These promising results were rewarded with an overall 53 per cent increase in financing in 2011. However, despite this significant increase in financing over 2010, the sector is still below financing levels of 2005, 2006 and 2007. Australia: Robust improvement The performance of Australian publicly traded biotech companies showed robust improvement in 2011. Revenues grew by six per cent, R&D expenses by 13 per cent and the collective bottom line improved by 15 per cent relative to 2010. The 2011 numbers were affected by transaction-related events at a couple of other Australian firms. Melbournebased Mesoblast saw a significant improvement in its top and bottom lines thanks to a $263 million upfront payment from US-based Cephalon as part of a strategic alliance in which Cephalon acquired global rights in three treatment areas to products derived from Mesoblast’s adult mesenchymal precursor stem cell technology. Similarly, results at Acrux were considerably boosted by a milestone payment of $87 million from US-based Eli Lilly and Co after the FDA issued marketing approval for Axiron.

Products and pipeline For much of its history, the biotech industry has attracted researchers, entrepreneurs, investors and strategic partners because of its promise — the game-changing potential of innovative platforms and targeted, vastly efficacious therapies. In recent years, however, investors have been less allured by biotech’s promise and more concerned about paths to commercialisation and returns on investment. This has, at least in part, been driven by concerns about an uncertain regulatory environment.

In 2011, there were signs of a different kind of promise. The US FDA approved more new drugs than at any time since 2004, when the recalls of Vioxx and other COX-2 inhibitors spawned the current environment of heightened concerns about drug safety. The agency also reported progress on the speed with which these new medicines were approved — all but one of the drugs approved in fiscal year 2011 were approved on or before their target dates, and 70 per cent of them were approved in the US before they received approval anywhere in the world. These are certainly encouraging developments, and continued progress on this front will be a critical part of the answer to the challenge of sustaining biotech innovation. While the FDA pointed out that “over half” of the drugs approved in FY2011 were approved on the first cycle of review (i.e., without requests for additional information) the industry remains concerned about the unpredictability of the requests for additional information, adding to the cost, time and risk of drug development. Ultimately, an approval process that is more transparent, predictable and timely is not just important for sustaining biotech innovation. With aging populations and large unmet medical needs, an efficient regulatory regime will be required to develop cures for neurodegenerative diseases such as Alzheimer’s disease and Parkinson’s disease and more targeted and efficacious treatments for chronic ailments such as diabetes. By making such changes, regulators will help the industry fulfill another promise — its commitment to bring patients better treatments and cure to address the most critical ailments.

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FDA product approvals, 1996–2011 There were a number of noteworthy drugs approved in 2011, including two new medications for hepatitis C, a viral infection that affects an estimated 130 million–170 million people, or approximately three per cent of the world’s population. Massachusetts-based Vertex Pharmaceuticals’ much-anticipated Telaprevir was approved in May, and sales of the new product soon catapulted Vertex into the ranks of the industry’s commercial leaders. Earlier that same month, Merck & Co gained approval for its competing drug, Victrelis (boceprevir), setting up a contest between the two products. Reflecting the strength of the industry’s pipeline in oncology, a number of the new approvals were for various types of cancer. One of the promises of applying genetic engineering techniques in this area is, of course, the potential for personalised medicine approaches that are many shades more efficacious in specific cancer subtypes. In this regard, it is worth noting that two of the year’s cancer approvals were approved with companion diagnostics: Genentech/ Roche’s Zelboraf (vemurafenib) for late-stage melanoma and Pfizer’s Xalkori (crizotinib) for latestage lung cancer.

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Key results Revenue stabilises: Companies in the industry’s established biotech centres (US, Europe, Canada and Australia) achieved revenues of $83.4 billion in 2011, a 10 per cent increase from 2010 on a normalised basis (after adjusting for the acquisition of three large US-based biotechs by non-biotech buyers) R&D rebounds: After slashing R&D spending in 2009 and increasing it modestly by two per cent in 2010, the industry grew R&D by a healthy nine per cent (on a normalised basis) in 2011. Overall funding explodes, but “innovation capital” stays flat: Biotech companies raised a staggering $33.4 billion in 2011, second only to 2000, when the genomics bubble was at its height. However, this increase was driven by a handful of commercial leaders with revenues in excess of $500 million that took advantage of low interest rates to raise large sums of debt. Importantly, capital raised by the rest of the industry (innovation capital) remained largely unchanged from the previous four years at $16.8 billion. IPO buyers remained selective, with only 16 IPOs and aggregate proceeds of $857 million, compared to $1.3 billion in 2010. M&As up, but big pharma largely absent: Mergers and acquisitions involving European or US biotechs increased from 49 deals in 2010 to 57 deals in 2011. However, big pharma was the buyer in only seven of these 57 deals, a potentially troubling trend given pharma’s critical role in supporting biotech innovation. Ernst & Young estimates that the “firepower” of the top 28 drug companies to support biotech innovation declined by 30 per cent between 2006 and 2011 — a situation that is not expected to improve with more patent expiries and investor pressure ahead.

August 1-15, 2012

www.expresspharmaonline.com

EXPRESS PHARMA

Research

EXPERTISE FOR DRUG DEVELOPMENT

Piramal Healthcare gets DCGI nod for phase II clinical trial of P276 Will help in reducing serious radiation induced mucositis in patients of head and neck cancer iramal Healthcare has received approval from the Drug Controller General of India (DCGI) for conducting the phase II clinical trial of P276 in combination with chemoradiation for the reduction of serious radiation-induced mucositis in patients of head and neck cancer. The phase I studies were completed in Canada and India. The drug is likely to reach phase III in early 2013. Dr Swati Piramal, Vice Chairperson, Piramal Healthcare stated, “Severe radiation induced mucositis is a debilitating toxicity of

chemoradiation in head and neck cancer patients and can limit the

treatment dosing and frequency. By developing P276 for the treatment of radiation induced mucositis, we hope to provide benefit to patients both clinically, and in terms of a better quality of life, thereby addressing this unmet medical need.” Commenting on the development, Dr Alan Hatfield, Executive VP, Clinical Research, Piramal Healthcare said, “The DCGI decision to allow us to proceed with this study in collaboration with many expert investigators throughout India will be of great benefit to patients suffering from head and neck can-

cer.” Radiation Induced Mucositis (RIM) is a common and painful side effect of radiation and chemoradiation in head and neck cancer patients. Serious radiation induced mucositis (RIM) occurs in 40-65 per cent of all patients who receive radiation courses for head and neck cancers. Prevalence of Head and Neck cancer in India is amongst the highest in the world. Even within India, this cancer is common with roughly 150,000 to 200,000 cases identified each year. EP News Bureau

Scientists call for increased surveillance on HIV resistant drugs Study shows rising rates in some areas of Africa rug-resistant HIV has been increasing in parts of SubSaharan Africa since the roll-out of antiretroviral therapy (ART) nearly a decade ago. This is the first study by The Lancet to systematically assess the prevalence of HIV drug resistance in low-income and middleincome countries, where over 90 per cent of people with HIV live and 97 per cent of new infections worldwide are to be found. “Without continued and increased national and international efforts, rising HIV drug resistance

EXPRESS PHARMA

could jeopardise a decade-long trend of decreasing HIV/AIDS-related illness and death in low- and middleincome countries,” warns Silvia Bertagnolio from the WHO, Geneva, and Ravindra Gupta at University College London, UK, who led the research. “Nevertheless, estimated levels, although increasing, are not unexpected in view of the large expansion of antiretroviral treatment coverage seen in low-income and middle-income countries. In 2011, about 8 million people in these countries received ART, a figure 26 times

greater than the number in 2003.” After searching systematically for studies over the past 10 years containing data on HIV drug resistance in untreated adults, and using data from the WHO HIV drug resistance surveillance programme, the researchers identified 162 reports and 27 unpublished datasets including over 26 000 individuals (aged 15 years or older) from sub-Saharan Africa, Asia, and Latin America. They estimated levels and changes in the prevalence of HIV-1 drug resistance since the scale-up of ART. Overall, their findings suggest a significant increase in prevalence of drug resistance over time since antiretroviral roll-out in regions of sub Saharan Africa. This rise is mainly driven by non-nucleoside reverse transcriptase inhibitors (NNRTI) resistance in East and Southern Africa. The most rapid increase in drug resistance occurred in East Africa, at 29 per cent per year, reaching an overall prevalence of 7.4 per cent, eight years after rollout. This was considerably higher than the estimated 14 per cent rise in Southern Africa, where the prevalence of drug resistance reached three per cent, six years after roll out. Rates of resistance for NNRTIs were slightly higher, rising by 36 per cent per year in East Africa and 23 per cent per year in Southern Africa. Gupta and his colleagues noted no change in resistance over time in

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Latin America and in West and Central Africa, while the heterogeneity between countries in Asia made it impossible for them to assess time trends in this region. According to the authors, “In view of these findings, urgent action is clearly needed to maximise the long-term effectiveness of available first-line regimens and to enhance population-level resistance surveillance and prevention efforts in national HIV treatment programmes. This should include the establishment of robust supply chains to prevent drug stock-outs and treatment interruptions and early identification of individuals failing therapy.” In a linked Comment, Douglas D Richman from the University of California San Diego in the US says, “Many of these missing resources and capabilities are components of the WHO/UNAIDS Treatment 2.0 goals, which if achieved could avert an additional 10 million deaths by 2025.” The Lancet August 1-15, 2012

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New drug combination offers hope in fight against tuberculosis new combination of drugs to treat tuberculosis (TB) could offer renewed hope in the fight against the disease, thought to kill around 1.4 million people every year. The results of a phase II trial involving 85 patients show that the new combination could kill more than 99 per cent of patients’ TB bacteria within two weeks, and could lead to improved treatment for patients infected with forms of TB that are resistant to existing drug treatments, as well as those infected with drug-susceptible TB. Scientists working in Cape Town, South Africa, tested the new combination of drugs, which consists of PA-824 (a new TB drug candidate), moxifloxacin (an established antibiotic currently in development for use as a first-line TB treatment), and an existing TB drug called pyrazinamide, on patients infected with TB. Assessing patients over a period of two weeks, they found that the effectiveness of the new combination was comparable to and could be more effective than the existing standard regimen for treating drug-susceptible TB, with the significant advantage that PaMZ could potentially be used to treat patients infected with drugresistant forms of TB. “Treating drug-sensitive and drug-resistant TB with the same regimen can simplify the delivery of TB treatment worldwide”, according to the study’s lead author Dr Andreas Diacon, of Stellenbosch University, Cape Town, South Africa. “The results of this study give healthcare providers on the front lines of the TB epidemic hopes for better, faster tools needed to stop this disease.” The new combination also has the potential advantage of being usable by TB patients who are also HIV positive and using antiretroviral drugs; many existing treatments cannot be used alongside antiretroviral drugs, which is a huge problem as globally TB is the most common cause of death in people infected with HIV. The research was presented at the 2012 International AIDS Conference, and was conducted by a team of researchers based at Stellenbosch University, Karl Bremer Hospital, Groote

August 1-15, 2012

Schuur Hospital and University of Cape Town Lung Institute in Cape Town, South Africa; the University of Otago, Dunedin, New Zealand; the Medical Research Council, Pretoria, South Africa and the nonprofit organisation TB Alliance, based in New York, USA and Pretoria, South Africa.

Dr Giovanni Battista Migliori of the WHO Collaborating Centre for Tuberculosis and Lung Diseases, describes the study as making “several important contributions to the existing body of knowledge,” including the promising signs that PaMZ could be used to treat drug-resistant forms of the disease and also those

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patients using antiretroviral drugs. However, Dr Migliori also points out that promising new drug regimens such as those described by Dr Diacon and colleagues will need to be used carefully if health care providers are to avoid repeating the mistakes of the past, adding that “The international community has the

chance to prevent the misuse of new drugs and regimens. To protect the investment in these drugs, the rational use of antibiotics within strengthened health systems is necessary to avoid the real risk of losing these new agents in a time shorter than that needed to develop them.” The Lancet

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Amag to pitch anemia drug for wider indication mag Pharmaceuticals said its drug Feraheme met the main goal of improving hemoglobin levels in anaemia patients in a late-stage study, clearing it to be pitched for approval in the US and Europe for a wider indication. The drug, which is already approved for the treatment of iron deficiency anaemia in chronic kidney disease patients, is being tested as a treatment for iron deficiency anemia regardless of the underlying cause. "With both phase III studies in our global registrational program for

Feraheme now complete, we will seek approval for Feraheme for the treatment of a broader population of patients," Lee Allen, Amag's chief medical officer, said. The company plans to submit a marketing application for the US approval of Feraheme for the expanded indication by the end of this year. Partner Takeda Pharmaceutical plans to file for approval in Europe next year, it added. Patients on Feraheme showed a statistically significant increase in hemoglobin level, compared with those on placebo, Amag said. The late-stage study, which tested

the efficacy of Feraheme on 808 patients across US, Canada, India, Latvia, Hungary and Poland, met the targets set by US and EU health regulators. Amag said there were three deaths reported during the second late-stage study. Two of them were in the Feraheme-controlled group, but none related to the drug. These results follow data released in March from another successful pivotal trial testing the drug on 605 patients at 74 sites in Europe, Asia Pacific and Australia. Reuters

AstraZeneca starts new study of heart drug versus rival London straZeneca is to conduct a new global clinical trial of key new heart drug Brilinta involving 11,500 patients with peripheral artery disease, Britain's second biggest drugmaker said. Peripheral artery disease affects around 27 million people in Europe and North America, with sufferers at high risk of heart attacks, strokes and other complications. The new study will compare AstraZeneca's medicine, currently only approved for patients with acute coronary syndromes (ACS), against older rival Plavix. Sanofi's and Bristol-Myers's Plavix, which used to be the world's secondbiggest selling drug, with annual sales of $9 billion, is now off patent and available as a cheap generic under the chemical name clopidogrel. That poses a major challenge for AstraZeneca, which must differentiate its new product if it wants to win business from

cost-conscious insurance companies and state healthcare providers. Annual sales of Brilinta were forecast to reach $1.2 billion by 2016, according to a poll compiled by Thomson Reuters Pharma. Brilinta has already proved itself against Plavix in a study of patients with ACS, or obstructed coronary arteries, and AstraZeneca hopes to extend that edge into another disease area. The London-based drugmaker is facing loss of patent protection on many of its biggest-selling drugs, making Brilinta a particularly important new product. The latest study is part of a wider program of clinical trials involving Brilinta and

designed to show the benefits of the drug in reducing adverse cardiovascular events and death. In total, the program is designed to include more than 51,000 patients worldwide. Reuters

Novartis gets US approval to buy Fougera Washington wiss drugmaker Novartis has won US antitrust approval to close its purchase of generic dermatology products maker Fougera. The Federal Trade Commission said that as a condition of approval, Novartis agreed to give up the rights to market three topical skin care medicines

made by Tolmar and to cancel a deal for a fourth. Novartis said in May that it would buy Fougera for $1.53 billion from a consortium of private equity funds led by Nordic Capital, DLJ Merchant Banking and Avista Capital Partners. The three generic creams that Novartis must give up marketing rights to are a topical solution to treat psoriasis, a local anesthetic, and a

cream to treat rosacea, which causes chronically red skin, the FTC said. In addition to generic dermatology products, Fougera also has a branded specialty pharmaceuticals business. It had 2011 sales of $429 million. Fougera, based in Melville, New York, will be folded into Novartis' Sandoz generics unit. Reuters

Galena's breast cancer vaccine gets exclusivity until 2028 alena Biopharma said its breast cancer vaccine received a patent granting it exclusivity until 2028. The vaccine, NeuVax, gives immunity against the relapse of breast cancer in patients who have low-to-intermediate levels of HER2, a protein that can affect the growth of cancer cells. NeuVax is being tested in a late-stage study under a special protocol assessment agreement with the US

EXPRESS PHARMA

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Food and Drug Administration (FDA). Once approved, it will be administered as an injection once a month for six months, followed by a booster injection once every six months. According to the National Cancer Institute, more than 230,000 women in the US are diagnosed with breast cancer annually, the company said. Reuters

August 1-15, 2012

Pharma Ally INTERVIEWS

‘Our technical expertise result in the right solution approach for our customers’ A pioneer in India’s cleanroom market, GMP Technical Solutions, has incorporated unique ways to convey the quality and standards of its range of products. Ravi Thakur, Vice President – Marketing, GMP Technical Solutions, speaks with Usha Sharma revealing the company’s current position and future plans What high tech solutions do GMP Technical Solution (GMPTS) provide for the life sciences industry? Today, we are the leading solution provider in the pharmaceutical and biotech spaces offering integrated solutions for various needs of the respective markets. With an array of products and services covering concept building, engineering, modular cleanroom panels, cleanroom equipments, process skids and equipment, qualification and validation services GMP ensures high-end international regulatory compliant solutions for the life sciences industry with a strict adherence to project timeliness which in turn assures optimum returns on investment. How large is the Indian cleanroom market and what percentage of the market has been captured by GMPTS? The organised cleanroom market in the life sciences industry is pegged at about ` 500 crore and GMP today has garnered a share of about 18 to 20 per cent of Indian cleanroom market. Tell us about the speciality of the cleanrooms products and how it differentiates your company from others? Is it a cost effective option? Today, GMP boasts of being the sole manufacturer of all varieties of cleanroom partitions ranging from PCGI (powdered coated GI), SS (stainless steel), HPL (high pressure laminate), GRP (Glass Reinforced Polymer) to Eco GI (Pre painted GI). The GMP product basket offers unique product features coupled with price points which can cater to a wide range of customers based on specific requirements and budgets across industries.

Tell us the USP of your products? Our products are client focused/ client-centric. We believe in quality service with a lifelong commitment to our esteemed clients. GMP is focused on client-specific requirements right from the inception of project work, which ensures in correct translation of customer requirements into seamless solutions. Hence, customised solutions are worked out in the best interest of the client. We have come of an age where the world has converged into a global village. Keeping this in mind, GMP has incorporated a unique way to convey the quality and standards of its range of products – by seeking accreditation and endorsements of globally reputed agencies empowering clients through expertise. Knowledge is power and GMP believes in sharing this power of knowledge with its customers. Many times, it is not possible for the customers to keep a track about the developments in the ever-evolving world of technology. GMP empathises with its customers and provides technical expertise, valuable information that assists the customer in selecting the right technology, resulting in the right solution approach for their needs. What marketing/branding exercises do you conduct or perceive? GMP takes special pride in the fact that the GMP brand uniformly portrays “QUALITY” across the globe. Quality that is reflected through its brand features, brand attributes and brand benefits. Brand features are the wide range of products which are tailor-made to suit every need and budget; brand attributes are the flexible solutions to the customised products and the brand benefits are those that

We have come of an age where the world has converged into a global village. Keeping this in mind, GMP has incorporated a unique way to convey the quality and standards of its range of products – by seeking accreditation and endorsements of globally reputed agencies empowering clients through expertise 38

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GMP offers extensive quality services that include calibration, validation and comprehensive knowledge consulting of current regular standards under its subsidiary “QA Technical Services”. QA Technical Services specialises in calibration, qualification, validation of cleanrooms and equipments, facilities and utilities in pharma as per current international standards. To serve the Indian clients better, QA Technical Services has full fledged calibration laboratories in Mumbai, Goa, Bangalore, Ahmedabad, Indore, Baddi and Sikkim.

speak about the turn-key expertise across a wide range of services— cleanroom solutions, HVAC expertise, civil, BMS and IBMS offerings all under a single roof at any given point of time. We regularly participate in various exhibitions in India and abroad. Print media is yet another branding exercise ensuring top of the mind brand recall. What promotional activities have you undertaken and how it is beneficial for your customers? We have done a series of seminars on containments and particle counters in various cities across India. We plan to conduct more such seminars to impart knowledge about the ongoing trends in the international pharma market. The idea behind conducting such seminars would be to provide our customers with informed decision. What benefits have you registered from the above metioned activities? We have increased the market penetration. GMP has immensely benefited in terms of gaining increased opportunities there by creating a global Indian brand through active participation in international exhibitions. GMP engineers and technicians have extensive experience in the establishment of in-house calibrations programmefor both large and small scale facilities

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Who are your major clients? GMP has an impressive client list that includes the top 50 pharma giants in India such as Alembic, Cipla, Cadilla, Dr Reddy’s, Ranbaxy, Panacea Biotec, Wockhard etc. What are your offerings for the global market? Globally, we have our presence in more than 20 countries.In the international market, GMP has laid stress on turnkey approach. So our offerings include design – build – validate solutions. Globally, we also offer the complete range of our in-house manufactured products like cleanroom panels, ceilings, fire rated doors, cleanroom equipment and containment solutions, isolators services such as HVAC, clean utilities and integrated building management systems. What are your future plans? To cater to the ever growing demand for cleanrooms and isolators, GMP has decided to invest in a new facility in western India. International markets are on top agenda for future expansion. Intensive marketing in the international arena shall open new avenues and opportunities for expansion. Understanding customer needs and offering new solutions to our existing and prospective customers in the Indian market is the right way to delight customers and expand the base. With a view to bring flexible containment solutions within local reach, GMP has entered into a tie up with US-based ILC Dover, a pioneer in flexible containment solution. ILC Dover is a 65-year-oldcompany and which will benefit the Indian pharma clients immensely. u.sharma@expressindia.com August 1-15, 2012

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‘Our technology helps in corrective form of maintenance instead of going for the damage control later’ Bangalore-based Ion Exchange Services Ltd (IESL) is a leader in water and environment management, providing services for any make and type of water treatment plants in India and overseas across diversified sectors such as pharmaceuticals, breweries, food and beverages, hotels, hospitals and software technology parks, to name a few. Dinesh Sadasivan, CEO, IESL, reveals more about his company, its goals and plans to Sachin Jagdale What are the market opportunities for Ion Exchange Services Limited (IESL) in India? Supply of spares and consumables, annual maintenance contracts, operation and maintenance contracts as well as upgradation for water treatment plants are the business opportunities for IESL in this country. Depending on the requirement, be it US Pharmacopeia Grade or water for injection grade, the right treatment scheme is designed and supplied by our parent company, Ion Exchange India. The treated water required by the pharma industries is of such critical quality that the plant requires high level of monitoring continuously by personnel with process and instrumentation expertise. High end technologies such as post ultrafiltration plants, short cycle automatic demineralising plants, “Swift” and Reverse Osmosis – Electro deionisation (RO – EDI) systems form part of the treatment schemes. Since they have high degree of automation and instrumentation and expensive spare components and membranes, they require focussed attention in operation and maintenance; obviously, customers look for prompt and quality service and the same are offered by IESL. The opportunities in waste water related areas however, are limited. How critical is water management in the pharma industry? Application of water is extremely crucial and critical. The very technology that caters to water treatment in the pharma sector is unique and specialised. Documentation and validation procedures can be handled effectively by only a branded company with good expertise. After sales, services in the pharma industry is also an important criteria as there is no margin for errors. Quality norms that are followed here are of the highest orders. Pharma is a very unique sector, which is expected to be consistent in quality and standards. What percentage of your revenue comes from the pharma industry? Who are your clients from the pharma sector? About 15 per cent of revenue comes from the pharma industry for IESL. We want to serve multi-location clients. We have just signed a annual maintenance contract with Cipla for nine locations. Multi location concept works as it helps to provide uniform service to same brand in different locations. Our pharma clients include Dr Reddy’s Labs, Shantha Biotech, Wockhardt, Cipla, Johnson and Johnson, Gland Pharma and so on. Tell us about your remote monitoring services. In remote monitoring, as the name suggests, equipment can be placed anywhere. However critical parameters of this equipment would be controlled from the central cell in Bangalore. We are using SIM-based technology for data transfer. Live plant operation parameters would be seen on the screen in Bangalore. Any variation in the parameters can be detected with remote monitoring. This technology helps in corrective form of maintenance instead of going for the damage control later. It doesn't add much to the cost. Technology of monitoring is not very high but the damage prevention with it is enormous. Please explain us the concept of PLATUNUM ANNUAL MAINTENANCE We have developed PLATINUM ANNUAL MAINTENANCE package for catering to this segment which looks for high end attention. Closer to the clusters, Mumbai, Gujarat, Pune, Aurangabad, Hyderabad and selective areas in the northern part of the country, we have housed service engineers who are also backed by instrumentation and automation team since the plants are with high end automation as mentioned above. We also organise, as part of enhancement of brand image, 'Loyal Customer meet' and 'Knowledge Forum', mainly comprising customers of this segment, periodically at strategic locations to update on the products and services offered by us and our parent company. sachin.jagdale@expressindia.com August 1-15, 2012

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Waters Corporation breaks ground on new mass spectrometry HQ in Wilmslow, UK Ties up with Fera and opens new lab-based training facility S-based Waters Corporation recently held a groundbreaking ceremony for its new Mass Spectrometry Headquarters planned for completion in 2014. George Osborne MP, Chancellor of the Exchequer, joined Waters for the event and put the ceremonial spade in the ground. A copper beech tree was planted onsite to mark the occasion. The new facility intended to unite Waters’ existing mass spectrometry operations, consisting of more than 500 employees, currently located on four separate sites in South Manchester and Altrincham. Plans for the new facility includes state-of-the-art customer demonstration laboratories, research and development capabilities, and an expanded manufacturing capacity. VINCI Construction UK has been selected as the principal contractor for the development. The works entail the design and construction of the new two storey headquarters including, external services, roads, car parks and landscaping. Osborne said, “It is a great honour to be part of this special day. Water Corporation's decision to make this major investment in Wilmslow is a vote of confidence in the Cheshire economy and the British economy.” Brian Smith, Vice President, MS Business Operations, Waters Corporation said, “I am excited that we now have the ability to move our high technology business forward and provide a world class centre for innovation in mass spectrometry. The new Waters MS Headquarters will be designed to accelerate the rate of innovation with increased access for the world’s scientific thought-leaders. Science is such a major contributor to the history of Manchester and we are honoured to be writing a new chapter in its rich heritage

George Osborne MP and Brian Smith, VP, Mass Spectrometry for Waters plant a copper beech tree at the site of Waters’ new Mass Spectrometry HQ

with our custom built headquarters in Wilmslow.” Terry Shortt, Vice President of Global Quality Assurance and MSHQ Project Director at Waters Corporation said, “We remain committed to the sustainability of the project and protecting the local flora and fauna.” The Food and Environment Research Agency (Fera) based in York, UK, and Waters Corporation based in the US have also opened a laboratory-based training facility, combining their respective regulatory, scientific and industry expertise to help solve the global food safety challenge. This will help testing organisations to better detect contaminated food at farms, ports and manufacturing plants and increase compliance with food regulations, ensuring food is safe before it reaches the table. The training facility will primarily train those concerned with exporting foods to Europe. Adrian Belton, CEO, Fera said, “This is an excellent collaborative opportunity which will lead to real benefits throughout Europe and beyond. Fera’s food science experts are internationally recog-

nised and now they will be able to pass on that expertise through this new purpose built training centre. This initiative is just one of several recent developments that support the development of a science and innovation campus at this site.”At the Fera laboratory, Fera scientists will lead intensive training programmes on EU-recommended testing methods for detecting possible contaminants in food using the latest technology and equipment. Courses will focus on detecting chemical contaminants preparing and testing samples according to fitfor-purpose methods to allow scientists to validate and use results to make the right decisions about whether food is safe and meets regulatory requirements. As part of the collaboration with Fera, Waters will help establish the laboratory’s construction, provide analytical systems and assist Fera in designing training programmes. The facility will be equipped with Waters’ state-of-the-art ACQUITY, UPLC -MS/MS systems, sample preparation components, and mycotoxin analysis tools. EP News Bureau

Agilent Technologies launches Agilent CrossLab Will help in maximising investments and increasing laboratory productivity for customers using analytical instruments gilent Technologies has launched their aftermarket solutions 'Agilent CrossLab.' Agilent CrossLab is the combination of multi-vendor services as well as supplies to customers who use non-Agilent instruments. Agilent had launched multi-vendor support services to customers as early as January 2010. Recently, Agilent combined supplies and services under one umbrella called Agilent CrossLab for ease of customer understanding. Among others, Agilent supports equipment and supplies of companies like Bruker, Dionex, Perkin Elmer, Shimadzu, Thermo Scientific and Waters. The advantages of Agilent CrossLab Services and Supplies are:

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Agilent service engineers are certified through direct hands-on training with original equipment from leading manufacturers; Agilent maintains a multimillion dollar inventory of service parts for both Agilent and non-Agilent equipment; Agilent-developed service protocols and checklists assure consistent, high-quality service; Agilent’s fully automated compliance engine provides the safest, most efficient qualification of all leading chromatography and spectrometry systems. In India, more than 500 other manufacturers of non-Agilent instruments are under CrossLab Services; Agilent has deployed more than 40 engineers who are certified to service other man-

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ufacturer LC and GC across India; More than 15 top pharma companies in India are already availing CrossLab Services. By continually raising the standards for technologies that support routine analysis, Agilent’s R&D efforts have led to breakthroughs such as: Brand new supplies portfolio for major brands of non-Agilent analytical instruments; Manufactured to work seamlessly with a variety of systems including: GCs from Bruker, Varian, PerkinElmer, Shimadzu and Thermo Scientific; HPLCs from Waters, Shimadzu, and Dionex; CTC GC and LC autosamplers. Siva Kumar Pasupathi, Country Manager for Life August 1-15, 2012

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Sciences & Chemical Analysis Business in India, said, “With the launch of CrossLab, we are now closer to the customer than ever. And we have invested in every sphere of customer touch points, whether it is the number of engineers in the field, their training and certification, or maintaining an exhaustive inventory. We are well positioned to bring delight to each and every customer, even if their original equipment of choice was not from Agilent.” Parmeet S Ahuja, President and Country General Manager, Agilent India, commented, “Agilent service quality and expertise is well-recognised in the industry. It is our commitment to our customers in India that this same expertise is available to them, even if they have equipment that is non-Agilent. In fact, in most cases, Agilent supplies enhance the performance of their non-Agilent equipment. That is a testament to Agilent innovation.” EP News Bureau

Thermo Fisher Scientific to buy One Lambda for $925 million The transaction is expected to be completed in fourth quarter of 2012 hermo Fisher Scientific has signed a definitive agreement to acquire One Lambda, the leader in transplant diagnostics, for $925 million in cash, subject to a postclosing adjustment. The purchase price includes the cost of a three-year retention programme established by One Lambda for the benefit of key employees, amounts payable to certain shareholders for non-competition agreements, and a one-year earn-out provision based on the achievement of certain financial targets. The transaction, which is expected to be completed in the fourth quarter of 2012, is expected to be immediately accretive upon close and add $0.09 to $0.11 to Thermo Fisher’s 2013 adjusted earnings per share (EPS). “One Lambda is an exciting addition to our specialty diagnostics portfolio. The One Lambda team has pioneered market-leading tests that are widely used across the transplant-testing workflow to improve patient outcomes. With its strong technology platform, high margin profile and good growth prospects, the business is perfectly aligned with our specialty in vitro diagnostics strategy,” said Marc N Casper, President and CEO, Thermo Fisher. “One Lambda gives us access to the attractive transplant diagnostics market and complements our existing immunosuppressant monitoring assays. It also offers the opportunity to leverage our global commercial infrastructure to serve growing transplant needs in emerging markets. From a financial perspective, we expect One Lambda to be immediately accretive to our adjusted EPS and to yield a strong return on invested capital,” Casper said. George M Ayoub, Co-Founder, President and CEO, One Lambda said, “We are excited about the opportunities ahead as we join Thermo Fisher’s specialty diagnostics business. I believe that, together, we will increase the use of human leukocyte antigen (HLA) typing and antibody detection to accelerate growth and improve the success rate of transplantation. Importantly, we will continue to fulfill our mission, which is to improve the quality of life for transplant patients and their families.” One Lambda is a pioneer in transplant diagnostics its diagnostic tests are used by transplant centres for tissue typing, primarily to determine the compatibility of donors and recipients pre-transplant, and to detect the presence of antibodies that can lead to transplant rejection. One Lambda is privately held and has approximately 320 employees, primarily based in Canoga Park, California, who serve more than 1,400 laboratories worldwide. EP News Bureau

August 1-15, 2012

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BASF named world’s most transparent chemical company globally Rating based on openness, transparency, and steps to fight corruption ermany-based chemical company BASF has been named the world’s most transparent chemical company globally, in a new global ranking by non-governmental organisation Transparency International. BASF was also the top rated German-headquartered company of any industry. Transparency in Corporate Reporting scored 105 of the top publicly-traded companies based on their public commitment to transparency. Company scores were based on public availability of information about anti-corruption systems, transparency in reporting on how they structure themselves, and the amount of financial information they provide for each country they operate in. “This type of reporting responds to the pressing need for improvements in

corporate transparency and helps restore public trust. Companies in Asia, including India are therefore increasingly embracing this trend even though there are no legal requirements. Our triple bottom line reporting sets benchmarks in governance and promotes transparent communication and open dialogue with the communities in which we operate,” said Prasad Chandran, Chairman, BASF Companies in India & Head South Asia. BASF India has been publishing an integrated report since 2009. The BASF in India Report 2011 documents the development, progress and performance of the company’s activities in India across the three spheres of local influence — economy, ecology and society. Several of BASF’s social projects aim to improve governance standards and fight corruption in India. Through the

'Million Minds' project, BASF in India focuses on sensitising the citizens of India to the evils of corruption and encourages them to take a firm stand against it. BASF’s ‘Good Governance Icon Series’ is a unique initiative within the 'Million Minds' project that highlights the achievements of men and women of high integrity who have upheld the highest levels of good governance while succeeding in their fields. BASF in India also runs a ‘Seminar Series on Corporate Governance and Business Ethics' at educational institutes. The idea is to instill good practices among future corporate citizens —i.e., students who are on the threshold of entering corporate India—and offer training on the practical aspects of governance and ethical issues. EP News Bureau

CritiTech in pact with Finoso Pharma To provide alternative API size reduction technology and particle design services to the pharmaceutical industry ritiTech Inc and Finoso Pharma have formally established a joint venture (JV) which will be named Finotech Pharma with a business office in Lawrence, KS, US. This JV will provide alternative API size reduction technology and particle design services to the pharmaceutical industry with associated formulation services to meet R&D and early clinical trial supply needs. The particles have been designed to be used in a variety of

(L-R) Dr David Johnston, Dr KR Kumar and Dr Bala Subramaniam during the signing ceremony

formulated products that enable the delivery of oral dosage forms, intravenous suspensions and inhalation products Consistent with the agreement, announced recently the companies are participating in a 50/50 JV. Finoso Pharmaceuticals has contributed its existing facility and experienced staff located in Hyderabad. CritiTech is providing specialised fine-particle production equipment, new technologies, technical expertise and business and marketing support. This exciting development is the first time that CritiTech’s technology has been deployed outside of the US and reflects the growing importance of repositioning existing products through innovative delivery technology. Dr Kumar Kurumaddali, Managing Director, Finoso Pharma, said, “This JV is a strategic opportunity for both parties. By combining our experience in the domestic and international product development market with CritiTech’s technology and expertise, our clients will receive a higher level of service and new drug delivery options for their products.” “CritiTech is pleased to be expanding the access to its technology in India to address emerging needs and improve access to technology that enables different drug delivery options. India represents a key market for Finotech Pharma as we continue with our geographic expansion strategy," said Dr David Johnston, Chief Executive Officer, CritiTech. EP News Bureau

CMC Machinery receives Export Excellence Award Award recognises the company's engineering excellence combined with consistent track record in exports MC Machinery, a group company of Cadmach Machinery, a pioneer and leader in manufacturing and exporting of pharmaceutical machinery, has received an export excellence award from the Engineering Export Promotion Council (EEPC). At the recently held award ceremony in Mumbai, Dr Anup Pujari, Director General of Foreign Trade presented the award to Vinit Khambhatta, Executive Director, CMC Machinery. The company has bagged the award for the fourth time since the inception of these awards by EEPC. CMC Machinery was the only pharma machinery manufacturer selected for the award for engineering excellence combined with a consistent track record in exports. The star performers from other engineering sectors included companies such as Kirloskar Brothers, Batliboi International, Mahindra and Mahindra, Essar Steel, Wellspun Industries, Larsen and Toubro, SKF Industries and Voltas, etc. EP News Bureau

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August 1-15, 2012

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Lonza launches next generation GS Gene Expression System Will be available for use globally in all major pharmaceutical and biotechnology markets, including Asia onza, a leader in gene expression and biopharmaceutical development of protein therapeutics, has launched GS Xceed Gene Expression System. This is the latest generation of Lonza’s world renowned GS System, which has already been used to create over 100 high producing cell lines and 13 therapeutic drugs currently on the market. The GS Xceed System has been shown to reduce cell line development timelines by up to six weeks over the existing CHOK1SV-based system and has achieved titers of up to 6 g/L. Both

emerging and established companies with protein therapeutics in their pipeline can access this new system by either a Research Evaluation Agreement or a Commercial License. The new system is also available worldwide, allowing multinational companies global access to the system in all pharmaceutical and biotechnology markets. “We are pleased to offer our global customers a robust, easy to use, next generation expression system, based on the proven GS technology that has become the industry standard. Our

The key element of the new system is the CHOK1SV GS Knock-out host cell line, which is a derivative of Lonza’s suspension adapted CHOK1SV host cell line in which both alleles of the endogenous glutamine synthetase gene have been “knocked out”

new GS Xceed Gene Expression System allows our customers to significantly reduce their timelines for the generation of clinical supply material while continuing to achieve titers well above industry standards,” said Janet White, Head, Lonza Development Services. The key element of the new system is the CHOK1SV GS Knock-out host cell line, which is a derivative of Lonza’s suspension adapted CHOK1SV host cell line in which both alleles of the endogenous glutamine synthetase gene have been “knocked out”. Cell lines are selected in Lonza’s Version 8 (v8) Commercial Platform Process which allows for faster future scale-up into a GMP manufacturing system. Successful cell line construction, selection and development are on the critical path to achieving first in human studies. By shortening the development timeline by up to six weeks, customers gain a significant advantage in their product development lifecycle. The complete GS Xceed System includes, cGMP banked CHOK1SV GSKO host cells, GS expression vectors, full protocols, access to Lonza’s latest Commercial Platform Production Process (chemically defined, animal component-free media and feeds system) and access to Lonza’s GS technical team. EP News Bureau

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Hosokawa launches Alpine 50 AS Spiral Jet Mill, air jet sieve and Alpine AFG osokawa has launched Alpine 50 AS Spiral Jet Mill, air jet sieve and Alpine AFG. The Alpine 50 AS Spiral Jet Mill has been designed for laboratory applications, and the processing of small batches of material. This jet mill can be utilised for ultra fine size reduction of dry materials with a crystalline structure up to Mohs hardness of three and production of a powder with a high ultra fine portion between 0.5 and 30µm. The design permits ease and thoroughness of cleaning. After being dismantled into its component parts, the Alpine 50 AS Spiral Jet Mill can be dry cleaned in an ultrasound bath or autoclave. This compact and portable design meets the highest pharmaceutical standards, and is ideal for operation in an isolation containment device. The Alpine 50 AS Spiral Jet Mill is optimised for applications in highgrade pharma and fine chemicals. Consisting largely of a one piece mono-block construction, this mill has a minimum number of components, a surface finish of Ra=<.08µm and an individual component weight of less than five kg, making it ideal for pharma operations. The Alpine air jet sieve is a standard analysis device for particle size analyses and particle quality control by means of dry sieving, for production monitoring and quality assurance as defined in ISO 9001. The only thing that moves the material being analysed is the air flow. The strong jet of air exiting the rotating slotted nozzle purges the sieve gauze continuously. In their new Air Jet Sieve e 200 LS a1n integrated minicomputer regulates, monitors and controls the entire sieving process. This brings time savings brought about by optimisation of the

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sieving times and reduced effort with periphery units as well as higher quality through automatic controls and default settings. Operation is easy and intuitive with the touch screen. The ergonomic design is functional and elegant at the same time. The e 200 LS delivers (at the same underpressure and same sieving duration) exactly reproducible particle size analyses in the range 10 µm to 4000 µm at any time. It is employed in almost all branches of industry, for example, for building materials, chemicals, foodstuffs, plastics and pharmaceuticals. The new e 200 LS is available in three variants, namely Basic, Advanced and Professional. What is also new with the e 200 LS is that any sieves can be used, regardless of make and 200-LS version. Alpine sieves equipped with a transponder chip are recognised and identified by the integrated software. The Alpine AFG relies purely on particle to particle attrition in the centre of a fluidised bed of material. This is achieved by focusing three or more compressed gas jet nozzles into the milling chamber thereby accelerating the particles to produce intense particle to particle attrition. No particles pass down the high velocity nozzle jets, reducing wear and product contamination. Consistent control of product particle size is achieved by a variable speed high efficiency air classifier installed in the upper part of the AFG jet mill. Only particles of the desired size can exit the mill with oversize being returned to the grinding zone. The classifier can be single or multi wheel, dependant on the process, and can be ceramic lined for abrasive materials. Gentle low temperature pro-

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cessing of the material can be achieved giving a product with a steep particle size distribution and minimum ultrafines. The Alpine AFG microniser can also be designed for use with sticky, hard to process materials. The modern AFG consumes less energy than conventional jet mills by up to 50 per cent, is quiet in operation achieving less than 85dB(A), is fully automatic and design ensures minimum wear and product contamination. The system range comprises 13 standard machines with air volumes from 50 to 11,500 m3/hr. Each model can be supplied in any of four variations, and customised systems can be supplied for specific applications such as Pressure Shock Proof design and CIP and SIP operation. Considerable investment in research and development by Hosokawa Alpine over many years has meant that the AFG jet mill has evolved into a dynamic product range. Over 1600 Alpine AFG mills are currently operating worldwide in many industries and diverse applications such as minerals, pharmaceuticals, powder paints, food and chemicals etc, producing many well known products and intermediates. Contact details: Hosokawa Micron India 2112, 13th Main Road, Anna Nagar West, Chennai-600040, Tel: 04426211257 / 286, Fax: 044 26211295, Email:mail@hmindia.hosokawa.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

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MET B Pharm student tops Mumbai University Saniya Malim from MET Institute of Pharmacy (MET IOP) has secured almost 80 per cent in final year B Pharm exams 2011-12, topping Mumbai University

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AWARD

FIP’s Ton Hoek named Officer in the Order of the Orange-Nassau He has been with FIP since the last 13 years on Hoek, CEO and General Secretary, International Pharmaceutical Federation (FIP) has been named an Officer in the Order of the Orange-Nassau, a royal declaration bestowed by the Queen of the Netherlands and handed over in person by the Mayor Fons Hertog of Huizen. Hoek's accomplishments have been self-evident throughout his 13 years at the helm of FIP, but also in

his positive impact on the federation’s partners throughout the world. This global outreach was recognised at the ceremony as well, with an honorary resolution from the American Pharmacists Association (APhA) citing his active dedication to pharmacy and a joint congratulatory letter from the APhA, the American Academy of Colleges of Pharmacy (AACP), the American Academy of Pharmaceutical

NOMINATION INVITED

IHPA invites nomination for awards ndian Hospital Pharmacist’s Association (IHPA) has been honouring pharmacy profession by awarding KK Acharjee Memorial Award and Schroff Memorial Award. For inspiration and guidance to the younger generation, friends and admires of professor Schroff instituted a Schroff memorial fund under the auspices of IHPA. The awardee is selected for his outstanding contribution to the overall development of the profession of pharmacy from amongst scientists, teachers, administrators; hospital, community and industrial pharmacist. IHPA has requested to recommend the names of the person with their detailed bio - data for the said awards for the year 2012. Entries may be sent by October 15, 2012 to the managing trustee, Schroff Memorial National Award, C/o Department of Pharmacy, St Stephens Hospital, Tis Hazari, Delhi-110054. EP News Bureau

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Sciences (AAPS) and the American Society of Health-Systems Pharmacists (ASHP). Hoek has dedicated his career not only to the world-wide promotion of pharmaceutical care, but to the global advancement of pharmacy, the pharma sciences and pharmacy education through visionary leadership and influence, all to much success. EP News Bureau

CAMPUS BEAT

Sinhgad College of Pharmacy, Pune conducts workshop on researcg orientation More than 150 students take part in it inhgad College of Pharmacy (SCOP) Vadgaon (Bk) has recently organised a workshop on 'Research Orientation in Pharmaceutical Sciences.' Around 150 students from different colleges attended the workshop. Dr KN Gujar, Principal, SCOP gave the key note actress. Students who are currently doing their Masters in Pharmaceutical Sciences or are going to complete their degree course, attended the workshop. Eminent speakers from academics as well as research were invited to guide students in selecting work area, planning and execution of work, and analysis as well as documentation of the results or overall study. Dr VM Kulkarni, Emeritus Professor, BV’s Poona College of Pharmacy, appealed to the students for basic research in the field of Medicinal Chemistry. Dr BR Mardikar, Senior Researcher and Scientist, expressed his views for Exploring the Potential of Natural Products and Traditional Wisdom in Modern Drug Therapy. Dr MM Ghaisas, Principal, Indira

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Eminent speakers from academics as well as research were invited to guide students College of Pharmacy guided students about how to proceed with the project. He also highlighted about the common mistakes which are made and how to avoid them. Dr VB Pokharkar, Professor, BV’s Poona College of Pharmacy shared her experience and knowledge of designing drug delivery systems to serve the mankind. The workshop was coordinated by Dr Nisharani Ranpise, Professor, SCOP. The valedictory speech was given by PM Jamkar, Professor, SCOP. EP News Bureau

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

MET B Pharm student tops Mumbai University aniya Malim from MET Institute of Pharmacy (MET IOP) has secured almost 80 per cent in final year B Pharm exams 2011-12, topping Mumbai University. She has topped throughout her eight semesters, securing regular distinctions. Malim was felicitated by Chhagan Bhujbal, Chairman, MET IOP and Pankaj Bhujbal, Secretary, MET IOP in the presence of institute director, principal and academicians for this feat. Malim said, â&#x20AC;&#x153;MET IOP had been very supportive and encouraged me all the time. I am glad that I have secured first rank at the University of Mumbai.â&#x20AC;? EP News Bureau

OBITUARY

Chhagan Bhujbal (R), Chairman, MET and Pankaj Bhujbal (L), Secretary, MET, felicitating Saniya Malim, MET Institute pharmacy student

Founder of Glenmark Pharma passes away Gracias Saldanha had retired as Chairman and Non-Executive Director in 2011 racias Saldanha, who started Glenmark Pharmaceuticals in 1977, recently passed away in Mumbai. A veteran of the pharmaceutical industry, he remained a guiding force to the management for the next three decades, retiring as Chairman and Non-Executive Director in 2011.

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Armed with a Masters Degree in Science from the Bombay University and a Diploma in Management Studies from the Jamnalal Bajaj Institute of Management Studies, Mumbai Gracias was associated with a number of multinational pharma companies from 1964 to 1977 before setting up Glenmark Pharmaceuticals.

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Under his guidance the company tapped the capital market in 2000 two years after his son Glenn, presently Chairman and Managing Director, joined the company. In the last fiscal, the company recorded sales growth of 36 per cent, crossing ` 40 billion in revenues. EP News Bureau

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REGD.WITH RNI NO.MAHENG/2005/21398 REGD.NO.MH/MR/SOUTH-77/2010-12, PUBLISHED ON 5TH & 20TH EVERY FORTNIGHLY & POSTED 6-7-8 & 21-22-23 OF EVERY FORTNIGHLY. AT IND.EXP.PSO.

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