Modern Pharma - 1-15 September 2012 by Infomedia18

1-15 Sept ember 2012 I Vol 1 I No 5 I `100

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In Conversation With 17

Special Focus 18

Interface 21

Automation Trends 22

Shyam S Bhartia CMD, Jubilant Life Sciences Ltd

Funding in biotechnology A wavering graph

Anuradha Acharya Founder & CEO, Ocimum Biosolutions

Plant automation Reducing cost in ensuring regulatory compliance

Pharma industry pegged to grow to $ 60 billion by end of 12th Plan UR Associates recently released its report on pharma sector. According to the report, overall pharma industry was pegged at ` 1000 billion with the domestic pharma industry at over ` 600 billion in 2009-10. The Indian pharma industry accounts for 20 per cent of the global generics industry. During the 11th Plan, the domestic market grew at 14 per cent CAGR and exports grew at 19 per cent CAGR with anti-infective, anti-asthmatic and anti-hypertensive being the major therapeutic categories.

Universal flu vaccine in reach, says NIH THE first universal flu vaccine for all ages is in reach, thanks to a DNA vaccine prime, according to the US National Institute of Health (NIH). The quest for an influenza vaccine that can protect against all strains of the virus has been difficult. However, using a prime-boost vaccine regimen in mice paves the way for delivery; the team found that the correct antibodies could be produced even with preexisting immunity to flu.

Bilcare to sell global clinical supplies biz for ` 340 crore BILCARE Ltd recently stated that it will sell its global clinical supplies business in the US and UK for $ 61 million (around ` 340 crore) to Ireland-based United Drug Plc. The two parties have signed a definitive agreement for the sale. The agreement will allow Bilcare GCS Asia to leverage United Drug’s deep capabilities and resources in US and Europe.

FDA approves Lucentis to treat diabetic macular edema THE US FDA approved Lucentis for the treatment of diabetic macular oedema, a sight-threatening eye disease that occurs in people with diabetes. The drug’s safety and effectiveness were established in two clinical studies involving 759 patients who were treated and followed for three years. Lucentis is marketed by Genentech.

AstraZeneca MD resigns ANANDH Balasundaram has resigned as MD and member of the Board of AstraZeneca Pharma, India. The company said that he would be relived with effect from August 31. The company has, as an interim measure, appointed Jonathan Hunt as COO and President, for a period of four months commencing September 1.

Post quarterly results: Challenges expected in the future THE financial results of pharma companies for the quarter ending in June 2012 have been mixed bag. Despite registering immense growth, several challenges stay lined up for the future. The general trend observed in this quarter is the significant rise in the sales but a decline in the profits. The reasons stated by companies for these thin margins are Forex losses and delays in product launches. Aurobindo Pharma’s net sales increased but suffered a net loss due to increase in manufacturing costs and Forex losses. Despite tremendous increase in sales the companies have recorded comparatively lesser profit. Ranbaxy Laboratories reported a ` 586 crore loss due to foreign exchanges despite sales in the US. The government projected the growth of the pharma industry to be around 18 per cent by 2016-2017. Industry gurus predict several challenges that pharma companies are likely to face in future, unpredictable government policies being prima facie. The uncertainty about the implementation of the National Pharmaceutical Policy 2006 that was proposed to control the price of 348 essential drugs is expected to meddle with the plans of many pharma companies. Post the quarterly results, the predicted growth appears a challenge with changes expected in the government policies. Dr Ajay Kumar Sharma, Associate Director - Pharma & Biotech, Healthcare Practice, Frost & Sullivan, South Asia & Middle

Dr Sharma

Dr Dangi

East, said, “The projected domestic growth rate of 21 per cent seems to be unrealistic on revenues. With National Pharmaceutical Pricing Authority (NPPA) contemplating the idea of reducing prices and bringing almost 70 per cent of the industry under price control this figure looks highly unlikely.” The government also plans to bring all patented drugs under a reference pricing model and this is also expected to have a major impact on the industry. Dr Ajit Dangi, President and CEO, Danssen Consulting, explained, “Research-based MNCs have also hit the pause button on introducing new patented drugs in India due to recent development of granting compulsory licensing for patented drugs to Indian generic manufacturers based on ambiguous criteria of ‘affordability’ and ‘patent not worked in India’.”

For example, Nexavar of Bayer and now Sprycell of BMS. The compulsory licensing of the drug Nexavar from Bayer to being its price down by 97 per cent and has led to a debate between innovation and affordability. Novartis has also filed a case to maintain the exclusivity rights of its cancer drug Glivec. Uncertain government policies are likely to have a great effect on the investment in this sector. Dr Dangi explains, “Slowing down of economic reforms and downgrading of Indian economy by major international rating agencies as well as ambiguity of FDI in pharma sector has also made investment climate uncertain not only for MNCs but also for Indian companies looking for JVs, collaborations etc. It is estimated that over ` 3,000 crore Continued on page 8

Anthem to expand its facility in Bengaluru ANTHEM Biosciences, a Bengaluru-based Discovery Research Alliance Partner (DRAP) company dedicated to supporting research efforts in the discovery of new compounds by pharmaceutical, biotechnology, speciality chemicals, agriculture chemicals and material science companies, is in the process of expanding its existing facility at Bommasandra, Bengaluru. The facility is expected to be functional in the next three months. The main function of this facility will

be to provide early stage pre-clinical drugs testing along with production of small scale proteins and enzymes and large scale chemical synthesis. Sharing details on the same, Ajay Bharadwaj, CEO, Anthem BioSciences, said, “We are expanding our facility by adding another 200,000 square feet of new labs, which would include a GMP animal facility, fermentation pilot facility and also new labs. In addition to this, we are also adding more chemistry synthesis labs.

Sharma

We would also be increasing our manufacturing capacity by tripling the existing capacity.” To set up this facility Anthem has invested ` 25

crore. It would also be increasing its manpower with an aim to undertake more projects in future. “We started with 200 people and today we have 400 people working with us. In future as the project nears completion, we would be adding another 100 people,” informed Bharadwaj. Anthem would also be investing ` 100 crore in setting up another facility in Kanakpura, Bengaluru with the motive to provide large scale chemical synthesis and fermentation to its clients. - Jasleen Kaur Batra

M o d e r n P harma• 1- 15 Sep t embe r 2012

CONTENTS In Conversation With

Shyam S Bhartia CMD, Jubilant Life Sciences Ltd

Special Focus

Biotech Funding in biotechnology A wavering graph Technological advances in biotech BIG data a bigger concern?

Interface Anuradha Acharya Founder & CEO, Ocimum Biosolutions

18 20 21

Insight & Outlook Automation Trends Plant automation: Reducing cost in

ensuring regulatory compliance

P K Kulkarni, MD, Technolutions Projects Pvt Ltd FOUNDER & EDITOR, NETWORK 18 Raghav Bahl

Event Preview Pharmac India 2012 A business platform for SMEs

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5 Editorial / Guest Editorial 7 News, Views & Analysis 24 Tenders 24 Projects 25 Event List 26 Book Review 27 Products 28 Marketplace 30 List of Products & Advertisers

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Mo de rn Ph a rm a •1 -15 S e pt e m be r 2 012

Editorial

A need-based approach to IP protection elcome to the new world order in pharma, where countries are no more simply following in the footsteps of a few preferred patent laws of the West. Given the dire need to ensure the 3As (affordability, availability and accessibility) of an effective pharma cum healthcare ecosystem, most developing countries today are giving due emphasis to aligning their patent laws with production of low-cost versions of patented drugs in certain situations, especially national emergencies. Although it seemed as a surprise initially, it is true that the global takers for Indian Intellectual Property (IP) regulations are on an increasing mode. The reason that has apparently attracted the countries is the adequate provision in India for a flexible approach to make generic versions of drugs-indemand. In essence, India’s IP laws seem to have struck a good balance between respecting innovation in one hand and meeting the public health needs, on the other. It is interesting to note here that only a few months ago China has amended its IP laws, by which it allowed local companies to make low-cost versions of patented drugs under certain conditions. These include meeting public health needs. Further, Argentina and the Philippines are reportedly adopting similar provisions. In view of these developments, the first compulsory licence issued by India barely

Editorial Advisory Board Ajit Singh Chairman, ACG Worldwide & Head, ISPE

Dr Abraham Patani Past President, IDMA & CMD, Inga Laboratories

Dr Gopakumar G Nair IPR Consultant & Advisor

Dilip G Shah Chairman, IGPA & Secretary General, IPA

Daara Patel Secretary General, IDMA

a few months back, wherein Natco Pharma was given a go-ahead to manufacture and sell a low-cost version (at only 3 per cent of the original medicine’s price) of Bayer AG’s patented cancer drug Nexavar on the grounds that the latter’s drug was not meeting public health requirement, assumes global significance. While the jury on whether this step by India could have led to China’s move, is still out, the fact of the matter is that amendment of an IP law is a country’s prerogative based on its healthcare policy as well as requirement. At the same time, one needs to factor in the combined population of the countries mentioned here (India, China, Argentina and the Philippines) and their sizeable share in the world. This directly translates to having the right IP strategy in order to have an optimum access to these fledgling markets and the pharmaceutical products thereof. While it feels good to have followers of a good practice, it is equally important to put in place effective mechanisms to ensure that the delicate balance between successful amendment of IP laws and use of the compulsory licence provision remain strategic as well as special.

Manas R Bastia manas@network18publishing.com

Guest Editorial

Policy re-look: Key for biotech industry growth mong the knowledge-driven industries, biotech is the fastest growing sunrise industry. Its rise is led by skilled manpower, competitiveness, cost-efficient strategy and huge market potential. Indian biotechnology sector saw phenomenal growth in recent years with revenues crossing $ 3 billion. The key growth drivers were the diversification strategy of pharma industry with low cost manufacturing capabilities to commercialise over 40 biosimilar products in the Indian market driven by the fact that biopharmaceuticals are set to lose patent protection globally by 2015. Biosimilars are technically complex to develop. Its success depends on amendment as well as strengthening of the national guidelines for preclinical toxicity studies in addition to clinical trial requirements for biotech products based on WHO and ICH guidelines. On the positive side, the Department of Biotechnology (DBT) in consultation with the industry and the Central Drug Standard Control Organization (CDSCO) announced the much awaited guidelines on pre-clinical development of similar biologics for approval of recombinant bio-therapeutics and monoclonal antibodies. However, a pressing need exists to ensure the early availability of authorised reference biologics and a proactive licensing mechanism for reference biologics in India for the acceptance of its biosimilars in the global market.

While the Indian government has assured that it will not agree to data exclusivity clause in bilateral/multilateral trade agreements, similar policy if followed by other developing countries will adversely impact our presence in the unregulated markets. The challenge for Indian companies is to compete for the 12 - 13 years data exclusivity space with foreign biosimilar companies and build capabilities to leverage this time to develop next generation patent potential products to gain competitive edge and stifle innovation threat by the competitors. While the lack of innovation forced companies to toe the generics line, it helped them sustain and increase profitability by optimising operational efficiency thereby accelerating clinical development. Vaccines are a rapidly growing segment with expected revenues of over $ 34 billion this year. Vaccine manufacturers traditionally produced childhood vaccines and are dependent on tender-based institutional sales and the UNICEF market. The retail market however for vaccines in India is very low. Indian vaccine manufacturers which traditionally follow the GMP requirements of the National Regulatory Authority will have to increase their Capital Expenditure (CAPEX) to meet the up-to-date WHO guidelines. Though Advance Marketing Commitment (AMC) and long-term purchase agreements of UNICEF and GAVI for WHO pre-qualified vaccines assure constant revenue flow, drastic

cost cuts have deflected the business strategy from being price driven to volumes that have hurt organisational profits. This proved counter productive and detrimental for diversification and R&D innovation in the postTRIPS era. Yet over the years India has produced and delivered billions of doses of quality vaccines certified by the National Regulatory Authority to meet national and export requirements. In the future, we foresee co-development; licensing and marketing partnerships will play a key role in the growth of new product pipeline and markets. This will enable entry into untapped markets and assist both Indian and foreign companies to expand their product portfolio and share R&D and capital investment. The Government of India on the other hand can help the biotech entrepreneurs to achieve progress through five rational steps: (a) simplification of statutory procedures for accelerated drug approvals, (b) funding clinical development of novel products, (c) providing tax exemption or invest in equity, (d) harmonise the country’s regulatory regime with international requirements for safety, quality and efficacy, and (e) revise the funding strategy to support high-risk innovative biotech ventures.

Dr Krishna Ella CMD, Bharat Biotech

Mo de rn Ph a rm a •1 -15 S e pt e m be r 2 012

News, Views & Analysis

West sets up new facility in India WEST Pharmaceutical India Packaging Pvt Ltd, an indirect subsidiary of West Pharmaceutical Services, Inc, Lionville, PA, USA, hosted a ground breaking ceremony to mark the start of construction of its new compression molding facility located in Sri City, India. The plant will become part of West’s global supply chain for its world class, standardsetting pharmaceutical packaging components. In June 2012, West signed a 99-year lease on 72,800 square meters of land in the Sri City Special Economic Zone (SEZ). “We are experiencing an exciting period of growth and business expansion in Asia and we are proud to begin construction of our first facility in India,” said Donald E Morel, Jr, Chairman and CEO, West Pharmaceutical

India Packaging Pvt Ltd. “The plant in India will help West meet market demands and establishes a west presence near our pharmaceutical customers in India. On behalf of West’s Board of Directors, I would like to thank the many representatives of the Indian government for their support throughout the planning process. Our future facility in Sri City will provide much needed capacity to satisfy the needs of a dynamic, growing market in both India and the Asia Pacific region.” Construction of phase 1 will begin in August 2012 that will produce metal and elastomeric pharmaceutical components used in primary packaging of injectable medicines manufactured by West’s pharmaceutical and biopharmaceutical

Pfizer and AstraZeneca enter into agreement for OTC Nexium PFIZER Inc has entered into an agreement with AstraZeneca for the OTC rights for Nexium, a prescription drug currently approved to treat the symptoms of gastroesophageal reflux disease. Under the terms of the agreement, Pfizer will acquire the exclusive global rights to market Nexium in the US, Europe and the rest of the world. It will also make an upfront payment of $ 250

million to AstraZeneca along with which AstraZeneca will also receive milestone and royalty payments based on product launches and sales. Nexium was launched by AstraZeneca in Europe in 2000 and US in 2001. AstraZeneca will continue to manufacture and market the prescription product, as well as supply Pfizer with the OTC products upon the receipt of regulatory approval. Paul Sturman, President, Pfizer Consumer Healthcare, said, “Nexium is one of the most recognised and respected products in its class with tremendous brand equity and loyalty. We are proud to be AstraZeneca’s partner and by working with AstraZeneca we are taking another crucial step to empower consumers by providing convenient access to important healthcare products.” Tony Zook, Executive VP, AstraZeneca Global Commercial Organisation, said, “This agreement will help AstraZeneca realise the substantial, long-term value of this brand and potentially other brands in our portfolio.”

Bedwell

customers in India and the wider Asia Pacific region. The built-up area of Phase 1 will be 15,300 square meters, with commercial production of metal components expected to begin in the first quarter of 2014. Production of a range of West’s high-quality standard elastomeric components is expected to begin in the first quarter of 2015. The capability to produce ready-tosterilise components will be available by 2016. The built-up area for the plant

and office will eventually reach 37,700 square meters at the completion of Phase 3 in 2023. “This investment is important to our strategy of partnering with customers in India and the Asia Pacific region to help them provide medicines to patients more efficiently, reliably and safely,” said Warwick Bedwell, President, Pharmaceutical Packaging Systems, Asia Pacific Region. “When the facility is completed, we anticipate a reduction in lead times for supply to our customers in India. By leveraging our global sourcing activities and process engineering expertise, we will be able to carefully manage the overall costs of production.” West plans to file Drug Master Files (DMF) for the plant with the US FDA and Heath Canada’s Bureau of Pharmaceutical Sciences.

China to double pricecontrolled drugs list by year end: Paper CHINA is set to increase the number of products on its price-controlled ‘essential drugs’ list to 700 from 307 by the end of the year. The move would signify a scaling back of plans announced in February to increase the number to 800, as Chinese pharmaceuticals companies struggle. The essential drugs list is a key tool for the government in its attempt to provide affordable, universal, high-quality healthcare to a population of 1.3 billion, many of them poor, while cracking down on corruption and over-prescription problems common in Chinese hospitals. However, Beijing has struggled to balance the desire to provide the social benefit of cheap drugs with its strategic goal of creating a profitable pharmaceutical industry. Five Chinese drugmakers, including United Laboratories International Holdings Ltd, issued profit warnings in March. On August 9, United Labs warned again that profits were likely to miss estimates due to general drop in average prices of the Group’s products. Some analysts believe the low pricing will benefit the largest players in the industry by forcing consolidation.

Mod er n P har m a•1 - 15 S ep t em b er 2 012

News, Views & Analysis Continued from page 1

of FDI in pharma sector is on hold.” The major losses in the first quarter of pharma companies were due to rupee depreciation. While this situation has greatly benefitted the drug exporters, it has greatly increased the cost of inputs since most of the APIs are imported. Dr Dangi added, “Generics is a key comparative advantage for India and most Indian majors have healthy pipeline for ANDAs, FTFs and DMFs. Healthcare reforms in several developed countries including US, Europe (and now Japan), which depend heavily on generics to contain the healthcare costs are likely to benefit Indian exporters.” Dr Dangi explained the impact of Generic Drugs User Fee Act by USA, which levies user fee for

role in development of generic exporters, is likely pharmaceutical industry to increase the cost of doing business in the US, Regulatory agencies in any country. With the uncertain policies, impacting profitability play an important the whole pipeline of marginally. He added, “With over $ 51 billion of role in development the pharma industry biologics going off patent of pharma industry is expected to suffer. in any country. Dr Dangi added, “The in next 5 years, it offers With the uncertain bureaucratic delays in a golden opportunity to Indian biotech players, policies, the whole granting approvals for new drugs, clinical trials, although biosimilar research pipeline of the and regulatory pathway is industry is expected etc as well as controversy arising from Parliamentary quite complex. National to suffer. Committee’s recent Biotechnology Regulatory Authority Bill (NBRA) is indictment of CDSCO still awaiting parliamentary have sent negative nod resulting in biotech signal to the investors manufacturers requiring approval resulting in significant fall in clinical from multiple regulatory bodies.” The trials outsourcing.” The Income Tax regulatory agencies play an important Department sent a recent circular to

Indian pharma delegation in Sri Lanka to facilitate a pharma hub RECENTLY, a delegation of the Indian pharma industry arrived in Sri Lanka with a proposal for setting a pharma manufacturing hub in Sri Lanka. The delegation was led by Pharmaceutical Export Promotion Council of India (Pharmexcil). During this meet, Anand Sharma, Indian Minister of Industry, Commerce and Textiles also attended this meet. Elaborating on the meet and discussion forum, Dr P V Appaji, Director General, Pharmexcil, informed that companies such as JB Chemicals, Wockhardt, Dr Reddy’s, representatives from Ramky and many others were also a part of this discussion. Besides, Sri Lanka’s Industry Minister, Economics Minister, Health Minister, DPI minister, and others were also a part of this forum. State Pharmaceutical Corporation who is the major buyer of

Dr Appaji

pharmaceuticals on behalf of Sri Lankan Government was also present at the forum. Dr Appaji commented that there were discussions on how the JVs and investments from India will help. He highlighted, “They have shown us two potential places of 100-150 acre for establishing a pharma hub. The pharmaceutical hub will be involved in the manufacturing of bulk drugs, intermediates, formulations and also medical devices.” Adding to this, he said,

Cipla launches a four drug kit for HIV/AIDS CIPLA has launched ‘Qvir’, a novel four drug kit for treating HIV/AIDS that consists of two tablets, one

Dr Hamied

containing a combination of tenofovir plus emtricitabine and the other containing a combination of atazanavir plus ritonavir. Both these tablets

are packaged together in one strip, which represents a single day’s treatment.With this new packing the patient does not have to remember which tablet he took and cannot mistakenly take two of the same tablet. Also, the patient cannot run out of any one of the tablets. Dr Y K Hamied, CMD, Cipla, said, “While we are committed to making drugs affordable and accessible, we also endeavour to have more options for HIV-infected patients which are potent, effective, patientfriendly and easy to take.” The ‘Qvir Kit’ is manufactured in Cipla’s world class manufacturing facility in Patalganga, approved by international regulatory bodies. It will cost ` 158 per kit and is available in the market.

“This initiative will help in attracting global investments from all over the world. And India will be helping in establishing production of quality pharmaceutical at affordable prices. Sri Lankan Government has assured to give land and other related incentives in terms of tax reliefs, power at concessional rate, etc.” He continued, “We are in talks with the Indian industry. Further, we are required to submit a report to the Sri Lankan Government in 3 months time. Besides, we are also interacting with members and will soon issue circulars regarding this. Dr Appaji said, “We have also discussed several issues and assured the Sri Lankan Government that Pharmexcil will extend full co-operation in supplying quality medicines to the country. They have agreed to attend to our representations on some important export related matters.” - Chandreyee Bhaumik

disallow freebies and hospitality given to medical profession by pharma companies as expenses and Ministry of Health’s proposal to make uniform code of pharma marketing practices mandatory are also causing some discomfort among the manufacturers. Dr Dangi explained, “The discomfort is not because industry is against these proposals but because of ambiguities in enforcing them resulting in fear of return of the ‘Inspector Raj’.” While the growth opportunities are immense, there are also hurdles lined up in the path. It would be interesting to see how the industry will face the storm of regulatory policies and given the track record Dr Dangi believes that the industry will pass this hurdle as well. - Shibani Shah

HRS’ solutions at Pharmac India 2012 HRS Process Systems Ltd (HRS PSL), part of HRS Group, UK, are all set to participate in Pharmac India 2012, India’s 3rd International exhibition of prominent pharma machinery, equipment and material industry to be held between September 8 –10, 2012 at the Gujarat University Exhibition Hall, Ahmedabad. With an aim to expand its customer portfolio, HRS is planning to showcase information on their range of innovative heat exchange solutions such as Ecoflux* Corrugated Tube Heat Exchangers, Funke Plate Heat Exchanger, HRS Hot Water Systems including

solar-based systems. “Our foremost aim through this expo is to reach customers in the pharma processing industry in the state of Gujarat. HRS’ heat exchangers are a trusted choice of major blue chip pharma companies in India,” said V Gokuldas, MD, HRS Process Systems Ltd. HRS offers cost effective heat transfer solutions through application engineering and design expertise for API, bulk drugs and formulation units in key applications such as primary condensers, vent condensers, reboilers, sub-coolers, heating and cooling applications.

Wockhardt to launch generic Uroxatral® WOCKHARDT has received final approval from the US FDA for marketing 10 mg extended-release tablets of alfuzosin hydrochloride, which is used in treatment of benign prostatic hyperplasia or enlarged prostate. Alfuzosin is the generic name for the brand Uroxatral®, marketed in the US by Sanofi-Aventis. “Developing extended-release formulation has been a core competency of Wockhardt’s R&D over the years and extended release alfuzosin is yet another product in the NDDS technology space” said Dr Habil Khorakiwala, Founder Chairman & Group CEO, Wockhardt. Wockhardt will be manufacturing the alfuzosin hydrochloride API in its facility at Ankleshwar, India, and the extended-release tablets of alfuzosin at its facility in Aurangabad, India.

CDSCO approvals up to July 2012 IN a written reply to Lok Sabha recently Ghulam Nabi Azad informed about the total number of new drug molecules of biologicals and non-biologicals approved by CDSCO and the number of them that underwent trials. In 2009, 72 drugs were approved and 60 drugs were approved with clinical trials. In 2010, the number of drugs approved dropped to 65 and the number of drugs approved with clinical trial was 52. While in 2011, the number of drugs approved with clinical trials were 38 the total number of drugs approved were 41. In 2012 up to July 14 drugs have been approved and 9 drugs are approved with clinical trials. New drug applications are examined in consultation with twelve New Drug Advisory Committees (NDACs) and medical colleges across the country. The Department related Parliamentary Standing Committee on Health and Family Welfare has made certain observation regarding the approval of new drugs without clinical trials on Indian subjects. An Action-Taken-Report would be submitted to the Committee.

Ranbaxy withdraws 27 drugs from US RANBAXY Laboratories has withdrawn 27 drugs from the US market due to commercial reasons. The company has determined that certain products with negligible commercial impact should be withdrawn to enable the organisation to focus resources on other applications that are of greater importance and value to the US business and healthcare system. However, as per information available on the US Government Printing Office (GPO), which provides publishing and dissemination services for the official and authentic government

publications to Congress and federal agencies, Ranbaxy requested withdrawal of approval under a consent decree. Ranbaxy requested withdrawal of approval under a consent decree of permanent injunction filed on January 26, 2012. The decree specifies that Ranbaxy must never submit another application to FDA for these withdrawn drug products and must never transfer these ANDAs to a third party. The list of drugs which the company has withdrawn from the US market includes ofloxacin and fluconazole tablets.

Mo de rn Ph a rm a •1 -15 S e pt e m be r 2 012

News, Views & Analysis

Harvard School introduces online course on clinical research U NDER the recent collaboration between Harvard University and MIT called EdX, a new introductory course on clinical research has been introduced at the Harvard School of Public Health. The course is called Quantitative Methods in Clinical and Public Health Research. Dr Swati Piramal, Vice Chairperson, Piramal Enterprises, who was recently elected on the Harvard Board of Overseers was instrumental in bringing this course. The course will be offered online by Harvard School of Public Health to

Dr Piramal

students in India and around the world beginning in October 2012. According to Dr Piramal, an alumna of Harvard School

PhRMA disputes claim that response to cancer drug shortage is a compulsory license PHARMACEUTICAL Research and Manufacturers of America (PhRMA) Vice President of International Jay Taylor recently stated the following. “In a recent interview with a section of the Indian media, a trade association that represents several major generic drug manufacturers in India attempts to justify the issuance of compulsory licenses by alleging that the US has done the same by allowing temporary importation of certain drugs. This assertion is wrong for several reasons. The US FDA’s decision to allow temporary importation to address critical cancer drug shortages is not a compulsory license – no patents were revoked, waived or violated. The US government only resorts to temporary importation of foreign drugs when a shortage is critical to patient health and cannot be resolved by manufacturers of the approved US drug. Importantly, this is done with the consent and cooperation of the manufacturer. Temporary importation is not used to resolve intellectual property disputes nor does it address pricing issues. The drugs prescribed in crisis are not necessarily patented and the importation of a substitute product may not be covered by the patent or have any intellectual property implications. The drugs prescribed were not under patent, nor were prices of imported drugs manipulated or altered by the process. As set out under the WTO TRIPS Agreement, compulsory licensing is a valuable tool for addressing true public health emergencies. It is not intended as a mechanism for furthering local industrial policies or achieving commercial advantage. Compulsory licensing will never cure the many issues facing healthcare around the world, many of which are attributable to a lack of core healthcare infrastructure and inadequate financing mechanisms. This is acutely evident in India, where less than one percent of all medicines in the market are patented and none of the medicines on India’s essential drug list are patented. Nevertheless, the World Health Organization estimates that a mere 20 per cent of the country can afford those off-patent treatments.”

of Public Health, a course like this is a great opportunity for physicians in India. “One of the big shortages we have is the lack of research curriculum in our medical training,” she said. “Providing medical doctors an introduction to the science of quantitative methods can be the first step toward helping our physicians to become top professionals in clinical research and become investigators for clinical trials,” added Dr Piramal, who is also a member of the Board of Dean’s Advisors at Harvard School of Public Health.

Glenmark gets arbitrator nod to sell crofelemer drug AN international arbitrator ruled that Glenmark Pharmaceuticals has the right to sell its HIV-associated diarrhoea drug crofelemer in 140 countries. Glenmark had developed crofelemer with US-based partners Napo Pharmaceuticals and Salix Pharmaceuticals Ltd. Further, shares in Glenmark rose 2.3 per cent. It can be said that Salix Pharmaceuticals was to sell the drug in regulated markets such as North America, Japan and Europe. Further, according to Glenmark, the

International Centre for Dispute Resolution (ICDR) found that Napo breached the agreement by disclosing confidential information about manufacturing crofelemer to another drugmaker Aptuit Laurus.

Wockhardt to launch generic Plendil® WOCKHARDT has received final approval from the US FDA for marketing extended-release tablets containing 2.5 mg, 5 mg and 10 mg Felodipine, the generic version of the brand Plendil®, marketed in the US by Astra Zeneca.

According to IMS Health, the total market for this product in the US was over $ 66 million. Dr Habil Khorakiwala, Founder Chairman & Group CEO, Wockhardt, said, “This definitely is a reflection

of Wockhardt’s R&D prowess in indigenously developing such products.” Wockhardt will be manufacturing the Felodipine API in its facility at Ankleshwar, India and felodipine ER tablets in Aurangabad, India.

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News, Views & Analysis

Clinical trial market sees a positive metamorphosis: Frost & Sullivan A large, easy-to-access, treatment-naive population; cost arbitrage of up to 30-50 per cent over US and an improved regulatory environment is driving the Indian Clinical Research Organisation (CRO) market forward. The market is growing at a rate of 11-13 per cent as the country builds its track record and gains increasing favour as a base for global clinical trials (phase I-IV). New analysis from Frost & Sullivan, strategic analysis of the CRO market in India, finds that the market in India earned revenues of $ 485 million in 201011 and estimates this to cross $ 1 billion in 2016. The participants operating in the Indian segment include multinational CROs that still dominate the nation’s market, Indian CROs, multinational pharma companies and Indian pharma companies. While the first three categories of companies are into global trials, Indian pharma companies usually look at conducting local trials. “Therapeutic areas in which research can be conducted in India are varied, and this is likely to result in more number of studies in the country,” said a Research Analyst, Frost & Sullivan. “Emerging areas, such as diagnostic research,

are also expected to drive the Indian CRO market.” Market growth is further bolstered by the Indian Government’s (the Drug Controller General of India (DCGI)) efforts to create a favourable environment for clinical trials. The improved regulatory environment possessing stringent enforcement laws will also bring more credibility to trials in India. However, increasing competition, quality concerns and lack of quality infrastructure in smaller tier II sites are some factors that impede the growth rate of the CRO market. Reliability and consumer confidence in Indian clinical

Piramal Enterprises operating income up by 46 per cent PIRAMAL Enterprises Ltd recently announced results for Q1 FY2013. The total operating income for the quarter grew by 46 per cent from ` 512.0 crore in Q1 FY2012 to Rs 747.2 crore in Q1 FY2013. Further, income from investments for the quarter was lower at ` 32.1 crore as compared to ` 71.0 crore in Q1FY2012 due to the investment of ` 5,862 crore to acquire approximately 11 per cent equity stake in Vodafone India Ltd. Further, financials for Q1FY2013 results also included

NCE R&D expenses of ` 33 crore on demerger of NCE R&D unit of Piramal Life Sciences into Piramal Enterprises, hence Operating Profit (OPBITDA) for the quarter remained unchanged at ` 78.4 in spite of higher sales. In addition, the operating profit margin for the quarter was lower at 10.5 per cent as compared to 15.3 per cent in Q1 FY2012. Net Profit for the quarter was ` 4.1 crore as compared to Net Profit of ` 89.2 crore in Q1FY2012.

trials data is lacking, greatly impacting the CRO market. Elaborated the analyst, “This is the result of a number of smallscale CROs having compromised on the standard of their studies in their bid to compete.” As more established CROs continue to grow, with reliable data and wellestablished clientele, the impact of this restraint is expected to diminish. The market will also be supported by India’s attractiveness as a small base with low costs, high-standard practices and growing interest from multinationals to include the country as a preferred clinical trials site for their studies. “Developing a single-window clearance for clinical trials as well as clear guidelines on the types of international/global trials that can be performed on the Indian population will shore up CRO market growth,” noted the analyst. “Indian CROs should focus on developing a steep learning curve by collaborating with selected international CROs and merge their talents.” Overall, market participants need to balance regulatory issues, breadth of services and data quality with cost competitiveness, a bigger footprint and innovation to grow their market share.

Wockhardt receives tentative approval for generic Geodon® PH A R M AC E U T IC A L and biotechnology major Wockhardt has received tentative US FDA approval for marketing a generic version of 20 mg, 40 mg, 60 mg & 80 mg capsules of Geodon® containing ziprasidone hydrochloride used in the treatment of bipolar disorders and schizophrenia. Geodon® is marketed in the US by Pfizer and Wockhardt will launch the product on Sept 2, 2012. According to IMS Health, the total market for this product in the US is about $ 1.3 billion. Dr Habil Khorakiwala, Founder Chairman & Group CEO, Wockhardt, said, “Wockhardt’s R&D has ensured a steady stream of new products, which has translated into a varied product offering in the US markets.” Wockhardt will be manufacturing the ziprasidone HCl API in its facility at Ankleshwar, India and the capsules of Ziprasidone at its facility in Aurangabad, India. The technology for the API and the capsules were developed in house.

Navamedic launches its third generic drug NAVAMEDIC, the Norwegian pharma products company, has launched its third generic pharma product. The launch is an important step in becoming a significant Nordic generics provider. DonepezilR is a drug used by patients suffering from Alzheimers disease and other dementia conditions. The product can replace Pfizer’s Aricept. Further, the patent for Aricept expired in February this year. And Navamedic has launched the drug in the Danish market and will launch also in Sweden and Finland shortly. The sequence of launches is determined by the national tender processes in the respective countries. The markets for generic pharma are growing rapidly, as health authorities

Sun Pharma to take Taro Pharma

Aarti Drugs Ltd’s record sales growth of 30 per cent

SUN Pharmaceutical Industries Ltd and Taro Pharmaceutical Industries Ltd have entered into a merger agreement together with certain affiliates of Sun Pharma. The merger agreement provides that all shareholders of Taro other than Sun Pharma and its affiliates will receive a cash payment of $ 39.50 per share upon the closing of the merger. Sun Pharma and its affiliates collectively own approximately 66 per cent of the outstanding Taro ordinary shares and 100 per cent of Taro’s founders’ shares, representing approximately 77.5 per cent of the outstanding voting power in Taro. Upon completion of the merger, Taro will become a privately held company, will be wholly owned by affiliates of Sun Pharma, and its ordinary shares will no longer be traded on the New York Stock Exchange.

AARTI Drugs Ltd recently declared its financial results for the first quarter ended June 30, 2012. Continuing its healthy growth for yet another quarter, Aarti Drugs Ltd recorded a rise of 92.21 per cent in net profit to ` 8.88 crore for Q1 FY13, as compared to ` 4.62 crore in the corresponding quarter of last fiscal. Gross income from operations for the quarter ended June 30, 2012 stood at ` 203.96 crore, up 30 per cent, as compared to ` 156.89 crore in the same period last year. The jump in revenue was backed by expansion carried out over last two years. The company has achieved sales growth of 30 per cent in June quarter compare to corresponding previous quarter of June 2011. Thus, company has maintained growth, which was achieved in last year. Company has also achieved better growth in PBT and PAT level as compared to last year as company has started reaping the benefits of expansion,” said Prakash Patil, MD, Aarti Drugs Ltd.

across Europe encourage a substitution to generics when patents for the original products expire. An increasing number of patents will expire over the next few years, supporting continued strong market growth for generic pharma products. The Norwegian Medicines Agency estimates that the annual savings in selecting generic alternatives currently amount to more than NOK 2 billion in Norway alone. In addition to the three products now launched, Navamedic currently has 16 products under review by medicines authorities, progressing towards approval. Navamedic expects to launch several new generic products later in 2012.

Nidhi Saxena nominated as Business Woman of the Year 2012 NIDHI Saxena, Chairman & CEO, Karmic Lifesciences has yet another feather in her cap. The 38-year-old has been nominated under the category of Business Woman of the Year 2012 at Asia’s Pharmaceutical Business Leadership Awards 2012 organised by Pharmaleaders Group coinciding with the 5th Annual Pharmaceutical Leadership Summit 2012 under the theme ‘Brand India: Beyond Generics, Growth, Development & Opportunities’ to be held in Mumbai. She has been nominated under this category alongside

Saxena

the likes of Suneeta Reddy, Joint MD, Apollo Hospitals Enterprise Ltd; Anu Acharya, CEO, Ocimum Biosolutions; and Shenaz Khaleeli, Founder and CEO, PharmaLeaf India.

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Arvind Remedies Ltd revenues grew by 30 per cent to ` 140 crore ARVIND Remedies Ltd (ARL) a leading producer of branded and generic pharma product, recently announced its financial results for the first quarter ended June 30, 2012. The net sales for Q1FY13 stood at ` 140 crore a jump of 30 per cent as compared to in the corresponding period last year. The Earnings Before Interest, Taxes, Depreciation

and Amortization (EBITDA) grew by 83 per cent to ` 28.4 crore as against ` 15.5 crore in Q1FY12. Improvement in EBITDA is attributed to the increase in branded business. Net profit stood at ` 9.62 crore as against ` 8.25 crore in the corresponding period last year, registering a growth of 16.6 per cent. EPS stood at

` 1.89, as against ` 1.71 in Q1FY12. Dr Arvind B Shah, CEO and MD, said, “The performance of the company in the first quarter has been very encouraging. We have managed to perform well in these challenging times. We hope to step up the growth process in the forthcoming quarters and deliver value to all our stakeholders.”

Ranbaxy launches generic pioglitazone in the US RANBAXY Pharmaceuticals Inc has launched authorised generic pioglitazone hydrochloride tablets in the US market under an agreement with Takeda Pharmaceuticals US Inc. Bill Winter, Vice President, Trade Sales and Distribution,

North America, Ranbaxy, said, “Ranbaxy is making available the full range of generic pioglitazone in 15 mg, 30 mg and 45 mg tablets. The introduction of generic pioglitazone hydrochloride tablets is a significant and important

Mettler Toledo to host a webinar on USP changes METTLER Toledo recently announced an upcoming webinar with special guest presenter Gregory P Martin, President, Complectors Consulting and industry expert in pharma analytical chemistry. The United States Pharmacopeia (USP) has recently made revisions that will have a positive impact on the quality of current analytical sample preparation methods. The webinar will be hosted on September 18, 2012 at 11:00 EST (15:00 GMT). In this webinar, Gregory P Martin, Former Director, Pharmaceutical Analytical Chemistry, Merck Research Laboratories, who is also Chair of the USP expert panels on ‘Validation and

The United States Pharmacopeia (USP) has recently made revisions that will have a positive impact on the quality of current analytical sample preparation methods.

Verification’ and ‘Weights and Balances’, and Joanne Ratcliff, a weighing and sample preparation expert from Mettler Toledo, will explain how these USP updates will give the industry the opportunity to significantly improve the sample preparation process. The key learning objectives of this webinar include developing an understanding of how changes to the US Pharmacopeia will have a positive impact on the current sample preparation process; discovering why the US FFDA and USP would support gravimetric sample preparation methods; and learning how to incorporate gravimetric methods into an existing workflow to improve quality of results and minimize substance consumption in the laboratory.

addition to our portfolio of anti-diabetic products in the US. The launch further complements our resolve to bring high quality, affordable generic medicines as early as possible to the US healthcare system.”

In Brief iPads transforming how pharma sales forces interact with physicians and payers A recent study from Best Practices, LLC examines how the growth of iPad technology is rapidly transforming how field sales forces in the pharma industry interact with physicians and payers. The report, ‘Deploying the iPad to Sales & Managed Markets Teams: Training and Effectiveness Benchmark’, focusses on key challenges, lessons learned and best practices when deploying iPads or Android-based tablets to large customer-facing commercial groups within bio pharma and medical device organisations.

India, China might oppose EU regulation INDIA and China might jointly move to the World Trade Organization (WTO) to protect against the regulation on bulk drugs by European Union (EU), which may have an impact on the present exports of API’s from both the nations to European markets. The rules for importing APIs for medical products for human usage has been amended by the EU and the amended regulation will be effective from July 2013 making the procurement of cGMP compulsory from local authority for bulk export of drugs.

Drug molecule shows enhanced anti-HIV activity RESEARCHERS from Munich and Naples have shown that minimal modification of a synthetic peptide with anti-HIV activity results in a new compound with more than two orders of magnitude higher binding affinity to the chemokine receptor CXCR4 and greatly improved anti-HIV activity. This could be a step toward the design of new, more effective drugs against AIDS, inflammatory diseases, and some forms of cancer.

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Bosch inaugurates manufacturing facility at Goa BOSCH Packaging Technology India recently inaugurated its new manufacturing facility at Verna, Goa, built on 33,000 square metres land. The inauguration was presided over by Manahor Parrikar, Chief Minister, Goa and Mahadev Naik, Minister of Industries, Goa in the presence of V K Viswanathan, MD, Bosch Ltd and President, Bosch Group in India and Friedbert Klefenz, President, Bosch Packaging

Technology, Germany. Built with an investment of ` 34 crore the new plant will fulfill capacity expansion and meet the increasing demand of India’s fast growing packaging market as well as international markets. Viswanathan said, “Bosch sees India and the South Asia region as a high potential market for packaging technology particularly in the pharmaceuticals and foods segments. This facility will

meet the growing needs of the region through appropriate products and packaging solutions.” Klefenz said, “This new facility will bring our new global offerings to India and contribute in pursuing our future plans and consolidating our leadership position in the Indian and international markets. Hence, this is not just a milestone for the packaging technology division of Bosch in India, but a global one, too.”

In Brief GSK to divest majority of classic brands in Australia for £ 172 million GLAXOSMITHKLINE PLC has reached agreement to divest the majority of its ‘Classic Brands’ in Australia to Aspen Global Incorporated for approximately £ 172 million in cash. The divested brands include Valtrex, Lamictal, Timentin, Amoxil and Aropax and generated total sales of approximately £ 83 million in 2011 and approximately £ 31 million in the first half of 2012. Revenues for these products have gradually declined over recent years due to local market price reductions and generic competition. It is expected that the divestment will complete in Q4 2012, subject to regulatory approvals.

Plethico’s shares fall 50 per cent in a week

Novartis’ hearing of Glivec postponed NOVARTIS will have to wait longer in order to get a verdict on its legal challenge to the patent law of India after the country’s Supreme Court postponed the hearing of the case until September 11. The long-running dispute whose first legal salvoes were fired in 2005 primarily focusses on Novartis’ cancer drug Glivec (imatinib) but has far-reaching consequences for both the pharmaceutical industry and

patients. It has already been postponed by the Supreme Court several times. At the heart of Novartis’ challenge is a clause in India’s patent law known as Section 3(d), which does not allow a new form of a drug such as a new crystal structure to be patented unless it confers some form of improvement. Novartis maintains that the crystalline structure of the mesylate salt of imatinib, which

USP receives national recognition for employee benefits programme ILLUSTRATING its strong commitment to the long-term well-being of its employees, the US Pharmacopeial Convention has earned national acclaim for its benefits programme. An independent judging panel of employee benefits experts named USP as one of the 2012 winners of The Principal 10® Best Companies for Employee Financial Security. Judges selected USP because of its dedication to its employees through a focus on employee benefits, such as retirement and wellness programs, designed to improve both physical health and financial security. “USP and other Principal 10 Best winners continue to set the standard for improving employee financial security; they realise an investment in their employees constitutes an investment in their own future well being,” said Luke Vandermillen, VP, Principal Financial Group®. “Winning companies offer a number of ways to impact the long-term physical and financial health of their employees and understand the direct connection between well-rounded benefits, a healthier workforce and a better bottom line.” “We are proud and gratified to receive the tremendous honour of being named to Principal’s 10 Best list,” said Susan Bach, VP-HR, USP. “In keeping true to our mission of improving the health of people worldwide, we seek to provide the best-possible benefits to our own employees as they work to advance our mission. Our commitment to what we call a ‘total compensation philosophy’ that comprises competitive salaries, bonuses and extraordinary benefits is something that we live by as we evaluate our benefit offerings each year. This has been formalised at our board level, demonstrating our pledge to employees.”

is used in Glivec was a critical development for the product, improving its bioavailability and allowing it to be delivered effectively and safely in an oral dosage form. India’s Intellectual Property Appellate Board (IPAB) took a different interpretation, however, and in 2007 concluded that imatinib mesylate was a new form of a known substance and did not provide any significant advance over the older form.

SHARES in Plethico Pharmaceuticals extended their losses for a sixth day. The stock underperformed the BSE healthcare index, which traded flat in a weak market. The strong selling pressure in the counter was on account of concerns that promoters’ pledged shares might be invoked. The promoter stake in the company stands at 87 per cent, but 94 per cent of this has been pledged.

Rinac aims to capture 15 per cent refrigeration system in pharma sector RINAC India Ltd, an integrated engineering solutions company that currently hold 5 per cent share aims to capture 15 per cent share of the ` 500 crore worth of refrigeration system market in the next two years. To achieve this, the firm recently organised `Rinac Connect’, to create awareness on all aspects of refrigeration system in the pharma sector.

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In Brief European regulator charges Teva, Lupin and Unichem for blocking perindopril THE European Union anti-trust regulator charged Israel’s Teva Pharmaceuticals, India’s Lupin and Unichem Laboratories and three other drug companies for blocking the entry of a generic drug into the European market. Apart from Teva and Lupin, the European Commission (EC) has charged French drug company Servier Laboratories, US-based Mylan Laboratories and Slovenia-based Krka, d.d., Novo Mesto for blocking the entry of generic hypertension drug perindopril into the market.

Merck acquires cell culture media specialist Biochrom AG MERCK has entered into definitive agreements to acquire Biochrom AG located in Berlin, Germany. The acquisition will strengthen Merck Millipore’s Process Solutions business unit, which provides products, services and solutions that simplify production complexity for pharmaceutical and biopharmaceutical manufacturers. Biochrom’s cell culture media products are highly complementary and innovative, adding liquid cell culture media and buffers including serumfree products and disposable packaging solutions to the existing portfolio.

Abbott announces CE Mark and European launch of next-generation XIENCE ABBOTT announced that the XIENCE Xpedition™ Everolimus Eluting Coronary Stent System received CE Mark in Europe for the treatment of coronary artery disease. The company is launching the product immediately in CE Mark countries. XIENCE Xpedition is supported by the robust clinical evidence of the XIENCE family of stents, including data from more than 45,000 patients.

2nd Pharma Logistics China 2012 in October CPHI Conferences will launch the 2nd Pharma Logistics China 2012 during 23-25 October in Shanghai, China. The conference is the only gathering of heads from leading biotech/pharma companies, CROs and logistics solution providers, who will gather here to discuss key issues and share best experiences.

Green tea compound shows promise for tackling cancer UNIVERSITY of Strathclyde published a research stating that an extract known as epigallocatechin gallate has been known to have preventative anti-cancer properties but fails to reach tumours when delivered by conventional intravenous administration. Nearly two-thirds of the tumours it was delivered to either shrank or disappeared within one month and the treatment displayed no side effects to normal tissues. It is the first time that this type of treatment has made cancerous tumours shrink or vanish. In the tests, on two different types of skin cancer, 40 per cent of both types of tumour vanished, while 30 per cent of one and 20 per cent of another shrank. A further 10 per cent of one of the types were stabilised. Dr Christine Dufès, Senior Lecturer, Strathclyde Institute of Pharmacy and Biomedical Sciences, said, “These are very encouraging results which we hope could pave the way for new and effective cancer treatments. When we used our method, the green tea extract reduced the size of many of the tumours every day, in some cases removing them altogether but by contrast, the extract had no effect at all when it was delivered by other means and the tumours continued to grow.” The research paper has been published in the journal Nanomedicine.

FDA decision on approval of Lidoderm ENDO Health Solutions recently stated that the US FDA response to Endo’s Citizen Petition (CP) related to the approval requirements for generic versions of Lidoderm (lidocaine patch 5 per cent), a locally acting topical medication for the relief of pain associated with post-herpetic neuralgia. “We are disappointed in FDA’s decision to deny the citizen petition and approve a generic version of Lidoderm. The company believes that the approval of a generic version of Lidoderm without requiring clinical endpoint studies is inadequate to establish the safety and efficacy of this locally acting topical medication. The company anticipated the possibility of generic competition for Lidoderm in September of 2013 pursuant to its settlement agreement with Watson Pharmaceuticals and has been proactively preparing for the event.”

Wockhardt to launch generic Plavix® WOCKHARDT has received approval from the US FDA for marketing 75 mg tablets of clopidogrel bisulfate and a tentative approval for the tablets containing 300mg clopidogrel bisulfate, which are used to help reduce risk of heart attack or stroke. Clopidogrel is the generic name for the brand

Plavix®, marketed in the US by Bristol-Myers Squibb. “We have received two ANDA approvals over the period of three days,” said Dr Habil Khorakiwala, Founder Chairman & Group CEO, Wockhardt. “Wockhardt’s rapidly growing presence has been aided in large, by the

steady stream of new products,” he further added.Wockhardt will be manufacturing the clopidogrel bisulfate API in its facility at Ankleshwar, India and the tablets of clopidogrel at its facility in Aurangabad, India. The technology for the API and the tables were developed in house.

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Indegene Lifesystems launches Trialpedia 2.0 INDEGENE Inc, a leading global pharma and healthcare solutions provider, has launched TrialPedia 2.0 with ‘Advantage Insights’, an enhanced clinical trial analysis and decision support platform that hosts a real-time repository of clinical trial information with advanced search, data mining, and specialised service bureau services including custom research, analytics, and reporting. TrialPedia 2.0, a proprietary platform offered by Indegene, helps clinical development and operations, R&D, Competitive Intelligence (CI), BD & Licensing as well as strategic

marketing professionals effectively analyse clinical literature and trial data seamlessly, and benchmark competitive Clinical Development Programs (CDPs) across the industry. Apart from the most comprehensive list of trials and indications, TrialPedia 2.0 has many industry leading unique features including therapy area specific query parameters,

claim space prediction tools, trial feasibility and operations analysis and identification of competitive differentiators. Manish Gupta, CEO, Indegene, said, “With TrialPedia Advantage Insights, in addition to clients gaining access to this bestin-class platform, they can leverage our deep research and analytics expertise for all their reporting and analysis needs. We believe that the ‘Advantage Insights’ service bureau will help clients realise the true value of clinical trial analytics and help them navigate the business environment more effectively.”

Watson launches generic Xopenex® WATSON Pharmaceuticals, Inc an integrated global specialty pharmaceutical company engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialised branded pharmaceutical products

Waters and Nonlinear Dynamics to co-develop next generation research solutions WATERS Corporation and Nonlinear Dynamics Ltd have recently entered into an agreement to co-develop a new analytical solution that derives information from complex data sets generated by large-scale proteomics and metabolomics experiments. Used in small molecule research, protein characterisation, metabolite identification and bio-pharmaceutical applications, the Synapt HDMS system is still the only mass spectrometer to employ high efficiency ion-mobility based measurements and separations to enable the analysis of sample ions differentiated by size, shape and charge as well as mass. The added dimension of shape-selective separation increases the analytical specificity and sample definition so that scientists can extract more information from their samples, including the detection of components previously unseen by conventional mass spectrometers. “The complexity of biological samples is so great that the sensitivity and specificity of analytical techniques required for biological discovery presents scientists with significant challenges when it comes to managing experimental data,” said James Langridge, PhD, Director of Pharmaceutical & Life Sciences Discovery, Waters Division. “We believe that through our partnership with Nonlinear Dynamics we can address this situation and advance the pace of discovery.” “I am delighted to see this exciting partnership bring together the latest MS technology with world-renowned data analysis software,” said Will Dracup, Executive Chairman, Nonlinear Dynamics.

focused on urology and women’s health recently announced that it has launched an authorised generic version of Xopenex® (levalbuterol HCl) inhalation solution as part of an agreement with Sunovion Pharmaceuticals, Inc. Watson began

shipping the product. Xopenex inhalation solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.

Eppendorf expands tissue culture consumables range with Easypet® 3

EPPENDORF recently launched Easypet 3 electronic pipetting aid hat gives greater accuracy by controlling the speed conveniently and intuitively with the use of the operating buttons. In addition to tissue-culture treated plates, dishes and flasks, Eppendorf expands its range of tissue culture consumables by new launches. It boasts decreased battery charging time to 3 hours, allowing for increased cordless operation time. Vibrant backlit LEDs highlight the battery status. Being cordless, it enables flexibility in the laboratory allowing the user to freely move around the workplace.

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Elsevier integrates Reaxys with electronic laboratory notebook PERKINELMER has integrated its Electronic Laboratory Notebook (ELN) with Elsevier’s Reaxys, a web-based workflow solution designed for chemistry researchers in drug discovery, chemicals and academic research. Michael Stapleton, Informatics General Manager, PerkinElmer, said, “As chemists are turning to electronic laboratory notebooks to plan, execute and record their experiments, they also need ready access to complementary

pharmacological properties so that they can make better decisions. This integration also allows researchers to save valuable time by providing the ability to rapidly search and import external data while eliminating transcription errors.” The new integrated solution enables access to reaction and substance data directly from Reaxys into the ELN for enhanced productivity and streamlined workflows.

tools and data sources directly within the ELN interface. The interoperability of our ELN and Elsevier’s Reaxys provides researchers with access to extensive information on chemical compounds and related physical and

NeoGenomics unveils NeoType CLL assay THE cancer genetic testing services provider, NeoGenomics has launched the first molecular assay, NeoType CLL for clinical use in the US, which detects mutations in the SF3B1 gene (splicing factor 3b, subunit 1). The assay will offer stand-alone test in conjunction with a new comprehensive prognostic profiling panel for patients with Chronic Lymphocytic Leukaemia (CLL). The NeoType CLL profile is the

to be on the leading edge of cancer genetics testing with menu of services. Our new NeoTYPE cancer profile tests are designed to provide physicians with comprehensive information about the biology and potential clinical behaviour of specific cancers so patients can be offered the best quality personalised management and therapies that are targeted to their specific cancers.”

VanOort

company’s first hematology profiling test panel. Douglas VanOort, Chairman and CEO, NeoGenomics, said, “The offering is part of NeoGenomics commitment

NETZSCH introduces OMEGA NETZSCH grinding and dispersing business unit recently unveiled its newest machine-the OMEGA®economic dispersioniser. In several sectors of the industry, successful dispersing, which is the targeted separation of agglomerated particles, is still presenting a challenge. The OMEGA® achieves extraordinary energy OMEGA® efficiency through utilisation of turbulence, cavitation and shear forces, thus providing real energy and time-saving potential. In comparison to technologies currently in operation, OMEGA® dispersing unit is one of the most costeffective on the market. OMEGA® brings many technical benefits including efficient dispersion, small particle sizes, significantly reduced heat, reproducibility and easy cleaning/product changing. Applications for OMEGA® include printing inks, paints, pigment dispersions; cosmetic and skin care products, ointments, creams; cell disruption pharmaceutical products and more.

Bonfiglioli develops combination leak and particle tester the ASTM and is fully validated. Being equipped with cameras this machine is able to perform particle level and cosmetic inspection. The container is inserted in an airtight chamber where it is tested by applying vacuum. The PK-VVis combination is equipped with software based on the SCADA platform, through which the pressure pattern can be recorded, analysed and compared to a preset pattern, thus indicating if container is good or faulty.

QUALITY control is an essential operation in the pharma industry, especially when it concerns seal integrity and particle inspection. Bonfiglioli provides a solution that saves both time and space, making it one of the most cost-effective solutions in the market. The PK-V-Vis combination is a fully automatic leak tester and visual inspection machine for ampoules and vials. It may reach an output of 400 cpm and vial size can range between 2 ml and 100 ml. This leak testing method is according to

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In Convers

ation With

Apurv Group MD a Shah Veeda Clinic and Co-Founder, al Resear ch Pvt Ltd

Ranbaxy loss in Q2reports ` 586 crore 2012

13 Special

Focus

South East Asian count Next hub for outsou ries rcing?

Roundta

ble 18

Does India regulatory follow a string ent process for appro ving clinical trials?

Insight

& Outlook

Pharma co improve mpanies com m drug ac cess in it to India

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Mo de rn Ph a rm a •1 -15 S e pt e m be r 2 012

In Conversation With

Indian entrepreneurs need to adopt better work culture …says Shyam S Bhartia, CMD, Jubilant Life Sciences Ltd. In a candid conversation, Bhartia discloses the varied facets of success and the road map for Jubilant Life Sciences Ltd.

Chandreyee Bhaumik chandreyee.bhaumik@network18publishing.com

How was the transition from Vam Organic Chemicals to Jubilant Life Sciences? It has been an exciting journey. We started as Vam Organic Chemicals Ltd with a business model to build a chemical company that used alcohol as a raw material and setup the manufacturing facility in Gajraula (UP), close to sugar mills for easy accessibility of molasses. Almost a decade ago, we stepped onto the path of transformation from a chemical company to a diversified speciality chemicals and pharmaceutical company offering a wide range of products. Today, Jubilant Life Sciences has successfully transcended onto the next phase of evolution into an integrated pharma

Our business strategy consists of four key pillars of growth namely integrated operations, global outreach, innovation and sustainability.

and life sciences company. And considering the evolution that has transpired in the business lines, the company has classified its businesses into two verticals namely pharmaceuticals and life sciences ingredients. How have you capitalised on the opportunities that came your way? The company’s success so

far is an outcome of its strategic focus on the pharma and life sciences industry, moving up the value chain for products and services across geographies, constantly investing in various growth platforms and promoting a culture of innovation. What is your business strategy? Our business strategy consists of four key pillars of growth namely integrated operations, global outreach, innovation and sustainability. Integrated operations enable moving up the value chain into higher value-added products and services through vertical integration of various business lines. Over last few years, we have demonstrated our competitive advantage by vertically integrating advance intermediates to nutrition and crop science ingredients, Active Pharmaceutical Ingredients (APIs) to generic dosage formulations and collaborative drug discovery. Inter divisional transfers accounted for 11 per cent of our FY 2012 revenues, up from 6 per cent in FY 2011 growing at 118 per cent in the period. The key strategy of our geographical outreach is to increase penetration of our existing and new products with special emphasis on regulated markets and entry into new regions especially in emerging economies. Through innovation, we have introduced new products in the market and continuously improved our processes and multiple technologies resulting in increased revenues and improved margins. Revenue contribution from new products introduced in last 5 years is expected to move up

Quick bytes Three things that you would regard as must for work culture Working towards innovative solutions Care for the environment and safety Sharing knowledge and learning from each other Three non-tangential things important to you Love for my family Respect for my colleagues and peers Code of ethics Three qualities that you appreciate in your colleagues Honesty Ambition Purpose in life Success to you means... Economic and social growth of our stakeholders Your vision in life To attain and retain global leadership position in chosen businesses

from 8 per cent of sales to over 25 per cent in next 3 years. In order to create long term sustainability, we follow triple bottom line approach of economic, environment and social performance. Our company has been receiving highest possible rating, A+ by Global Reporting Initiative (GRI) since last 6 years consecutively. We have continuous programmes for sustainable reduction in energy usage and Greenhouse Gases (GHG) emissions with focus on revenue enhancement from green products.

by reducing our cost of production and investing in capacity and innovation. It is only in last 10 years that we decided to focus on pharma products and today, we have been ranked number 6 among the top 10 global contract manufacturing and

Challenges lay the foundation of success. How have challenges helped you? Jubilant Life Sciences has managed challenges through a collective team effort by everyone at all levels across the globe. When we started in 1978, there was Licence Raj in India and the markets were still protected. Even then, we were still leaders in some of the products we produced, though we started late in many of those products. When India opened up in 1990s we were thrown to intense competition, but we still managed to be profitable

services outsourcing players of the pharma industry, according to United Nations Conference on Trade and Development (UNCTAD). This transformation was achieved in a very short period of time.

In order to create long term sustainability, we follow triple bottom line approach of economic, environment and social performance.

How have you been able to maintain the quality standards at Jubilant? We aim at continuously achieving the quality of products and services that exceeds customer expectations across the globe through following measures.

We constantly explore the opportunity to upgrade our manufacturing technologies and quality standards to achieve and maintain quality leadership with thrust on ecofriendly processes. Further, we strive to create a cohesive and motivated team of international competence by providing continuous training to enhance knowledge and skills and ensure compliance to the national and international regulatory standards. What’s next? Jubilant Life Sciences is poised to build on the growth momentum for revenue and margins in coming times. We are on a strong trajectory to achieve a Compounded Annual Revenue Growth (CAGR) of over 20 per cent in next 3 years yielding into an even higher growth in operating profits due to operating leverage and efficiencies. Message to budding entrepreneurs There are no shortcuts for success and we must compete with the best in the world. Indian entrepreneurs need to adopt better work culture.

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Special Focus

Funding in biotechnology Shibani Shah shibani.shah@network18publishing.com

round the year 2000, the pharma industry laid eyes on the biotech sector and predicted its success and boon to unmatchable heights. The global biotech industry is currently estimated at $ 180 billion and has come a long way since the past decade. The Indian biotech industry from being about $ 0.5 billion in 2002-2003 reached almost $ 4 billion in 2010-2011 as per reports. A report by Frost & Sullivan predicts the global industry to reach $ 433 billion by 2015. India missed its $ 5 billion mark in 2010 but is hoping to reach $ 10 million in the next 3 years with 40 per cent year-on-year growth as per the report.

A wavering graph The biotech industry that was seen as a sunshine industry is now finding it difficult to sustain due to a financial downfall fuelled by lack of investment along with other factors such as lack of consistency, and not so promising results. We take a look at the factors that have caused the decline of this promising field after a decade of highs and lows.

Government lends the helping hand

From to now… At the beginning, the industry showcased itself as ‘the next big thing’. Bioagriculture, biofuels and biopharma were the three sectors wherein biotechnology promised tremendous growth. Biopharma sector turned out to be the golden goose and large pharma giants set up biotech divisions to take advantage of this upcoming market. Since then, tremendous growth has been observed in the biotech industry. The global biopharmaceutical market is estimated at $ 137 billion and expected to touch $ 319 billion by 2020. The Indian biopharmaceutical market contributes only about 1.4 per cent to the global industry but contributes a large chunk of 62 per cent to the Indian biotech industry. Biotech companies are high risk- and high innovationoriented companies. Investment is the key for

Government is taking efforts to promote the field but still it is more inclined towards pharma. Biotech is still not much at the forefront. Dr Ajay Kumar Sharma Associate Director - Pharma & Biotech, Healthcare Practice, Frost & Sullivan, South Asia & Middle East

Their prolonged research painted a picture of low success rate companies and this caused them to lose out on the investment. Panchapagesa Murali, President, ABLE, says, “Investors look out for good fundamentals in a company. They then consider the management and the track record of success. Once they are satisfied they will then look at the opportunity the company provides. Venture capitalists normally take a bit more risk than brick and mortar funding companies. However, today most are risk averse. Statistics from different agencies suggest that investments have actually not declined. However, investment into early stage companies is not just happening. May be late stage companies attract more funding because of lesser risk.”

the success for these R&Ddriven organisations. The biotech industry is now at cross roads. In 2009, the financial crisis caused majority of the companies to decrease their R&D spending but the cut backs caused the biotech companies to record higher profits. Although the companies have recovered from the 2009 crisis and grown at 10 per cent in 20102011, it still suffers due to the lack of sufficient investment. The major reason that has caused the biotech industry to take a back seat is its inability to launch new products due to the lack of funding. Dr Ajay Kumar Sharma, Associate Director - Pharma & Biotech, Healthcare Practice, Frost & Sullivan, South Asia & Middle East, explains, “When the biotech boom started it looked very promising. There was a large amount invested and the investors expected a great return. But the industry

did not pick up the way it was expected. The companies did not show convincing research. Almost 88-89 per cent of the projects did not materialise. There were projects that were successful but did not commercialise and the success rate was very low.”

Further, the biotech companies failed to launch products at regular intervals.

Deterring venture capitalists Biotech companies deter investors due to their delayed timelines. Also, their high risk oriented nature does not provide certainty on the successful commercialisation of the product. Dr Sharma believes, “Venture capitalists look out for Return of Investment (ROI) within duration of 5 years generally. In biotechnology companies that does not happen. For a biotech company, the research generally takes around 12-14 years and this delay may have caused these capitalists to shy away from investing.”

Venture capitalists normally take a bit more risk than brick and mortar funding companies. However, today most are risk averse. Panchapagesa Murali President, ABLE

The decline in the investment and the potential of the industry has encouraged the government to take initiatives and lend a helping hand to the biotech companies for start ups and the sustaining biotech companies. The Department of Biotechnology (DBT) formed the Biotechnology Industry Research & Development Assistance Council (BIRAC) to promote an environment for research and innovation in this sector. The DBT dedicates almost 30 per cent of its budget to private and public partnerships. The structure of BIRAC is designed to support start ups at every level. Murali comments, “Today, the Indian Government is the only source for venture funding. DBT in particular is doing everything that is possible to encourage biotech start ups. If the government also fosters a conducive climate for venture capitalists to proliferate and do business, the innovation sector will grow better than the rate at which it is growing today. BIRAC and efforts for setting up an innovation fund are commendable efforts on the part of the government.” On the other hand, Dr Sharma thinks, “Government is taking efforts to promote the field but still it is more inclined towards pharma. Biotech is still not much at the forefront.” The regulatory practices have been a hindrance to the successful execution of the company’s plans. Dr Sharma explains, “There is lack of synchronisation between government agencies. This has really been detrimental in the growth of the biotech industry in India. They do not have a standard process, or skilled manpower to scrutinise applications on a timely manner, experience of

Mo de rn Ph a rm a •1 -15 S e pt e m be r 2 012

Special Focus handling indigenous molecule applications etc.” But the government cannot be blamed entirely. To worsen the situation Dr Sharma explains, “There are cases when the company is not well versed with the formalities of application. This leads to a lot of delays.” The government is also encouraging academic start ups to a great extent. It might also save time since by then most of the fundamental ground level work will be accomplished at the academic level. Although not very prevalent in India now, but Dr Sharma believes this might happen by 2020. If the industry mentors the academic start ups, the established companies may be in the long run can take advantage of them. In the public and private partnership sector the government has made special policies that would help enhance the growth of the industry further. Dr Sharma explains, “There are initiatives taken by the government to create a separate fund for funding research for the biotechnology industry in form of grants or creating biotech clusters. Still the execution record of the government is something of a worry. If the government can use some form of Public – Private Partnerships (PPP) to disburse the funds, it can really speed up the process and also generate some meaningful steroid dose injunction for the industry.” In 2005, the Indian government opened the doors for 100 per cent Foreign Direct Investment (FDI) in the biotech sector. Biotech companies have benefitted greatly through FDI and it has driven the growth of the biotech industry greatly. As per the data released by the Department of Industrial Policy and Promotion (DIPP), the drugs and pharmaceuticals sector has attracted FDI worth $ 7.61 billion between 2000 and 2012. Murali highlights, “Biotech companies will prosper on account of matured venture capital investing from abroad. However, the issue is on how you regulate them and how they take the profits back to their country. The government can play a proactive role here in understanding the requirements and facilitating them. Biotech investors are different from an investor into real estate. Hence, there has to be some preferential policies here.”

The great paradox Experts from the industry say investors look out for innovative companies but for companies to carry out R&D you need high investments. To put this paradoxical

situation on one page, the biotech companies need to nurture their own growth. Rather than sticking to the fundamental model of ‘innovation with investment’ the companies should look to generate an alternate source of income to nurture their own growth rather than being dependent on investors and funds. Dr Sharma suggests, “Biotech companies cannot

The Indian biopharmaceutical market contributes only about 1.4 per cent to the global industry but contributes a large chunk of 62 per cent to the Indian biotech industry. wait for 12-14 years for the drugs to be successfully commercialised. They need to do a fair valuation to generate their funds to perform

research with low success rate molecules. Companies such as Biocon made a smart move by entering into the generics market along with their ongoing biotech research. Biotech companies should look at generating their own funds to survive in the long run.” Murali believes, “In the past, this approach has peacefully coexisted. All the major innovative companies have been born out of this model. Over a period of time, either a few funds have gone overboard that led to the collapse of this model or due to the conservative approach people have today are being overly cautious. Good matured venture capitalists still know the risk reward ratio and are doing pretty nicely.” While the financial help from the government supports these companies at every juncture the regulatory frame work worsens the situation. The Indian regulatory processes are very complex. There are cases of prolonged

delay observed in the approval of projects. These delays cause a great rise in the cost of R&D that further burdens the pocket of biotech companies. Dr Sharma explains, “It is not the governments’ fault entirely. There are cases when the company is not well versed with the formalities. Also, the government does not have qualified people and due to long duration of approvals sometimes there are cases of changes in policy and personnels that delay the process further.”

Will patent cliffs help? Biosimilars are expected to show a great potential in the contract research market. The patent cliffs are projected to bring the bio similar research market in India. The biotech companies can thrive on this opportunity to generate funds and expand their capabilities. But Dr Sharma explains how the biotech companies could advantage of the situation, “Ideally, the time has now

passed. It will take a drug at least 5 years to be out there in the market. The market is huge the companies could have taken advantage of this situation in 2008-2009.” Murali believes that blockbuster drugs will attract investment. He adds, “If this is not doing robust sales and new generation drugs have come into this space then people will not invest.” Bridging the gap between R&D and commercialisation will enhance the growth of this industry greatly. The decline in the investors seen in recent times has left the biotech companies at split ends. It will be interesting to see how they would change their own fate and how the government policies and support cause the sector to achieve its desired bench mark. The question still remains, has biotech companies reached the expected bench mark and will it ever reach the expected rise and boon expected at the start?

Mod er n P har m a•1 - 15 S ep t em b er 2 012

Special Focus

Technological advances in biotech Chandreyee Bhaumik chandreyee.bhaumik@network18publishing.com

iotechnology is a globally recognised field. This emerging and far-reaching field holds immense promise for food, health and environmental sustainability. According to the recently released report by Department Of Biotechnology, Ministry of Science & Technology, Government of India, today, there are a large number of therapeutic biotech drugs and vaccines that are currently being marketed, accounting for $ 40 billion market and benefitting over a hundred million people worldwide. In addition, several more are in clinical development. Further adding to these, there is a large number of agri-biotech and industrial biotech products that have enormously helped mankind.

BIG data a bigger concern? The rapid adoption of technology has made biotech companies competent. Without technology this industry would be handicap. With opportunities galore in the Indian biotech industry humongous amount of data will be generated and managing the same would be a task. Reviewing the advancements and the journey forward.

The significance Adoption of technology is an important aspect of biotech companies. As J Sairamkumar, Vice President, Life Sciences Practice, Cognizant, says “Globally, the distinction between pure-play pharma and biotechnology organisations has reduced dramatically. Today, all large organisations have a focus on both small molecules and biologics. One of the key technology trends driving the biopharma industry is the evolution of genetics and genomics technologies, which are enabling a much deeper understanding of diseases. Over the last decade, such technologies have evolved from various types of microarrays to next-generation sequencing. Next-generation sequencing provides an excellent

There is an increasing use of genetics and genomics technologies even in India with some local core facilities providing the infrastructure. J Sairamkumar Vice President, Life Sciences Practice, Cognizant

opportunity to change the way drug discovery and development happens in the industry.” Some of the key applications of genomics technologies are around identifying better gene candidates, increased understanding of disease level pathways, improved diagnostics, and targeted therapy. Elaborating on the advancements further, Sairamkumar adds, “Key advancement is the focus on translational research. It is now a fact that the era of blockbusters has come to an end. It is now increasingly important to identify the right patient population, and genomicsrelated technologies will be a key driver for this effort. The delivery of such drugs may be associated with diagnostics that will again need a strong understanding of disease biology.” The other key trend is the usage of predictive sciences across the spectrum of discovery and development. Increasingly, most organisations are utilising the pile of information that they have internally to guide their decision-making process and make it more informed. Seconding on the thought of high relevance of technology for biotech companies, Ajay Bharadwaj, CEO, Anthem BioSciences, says, “It is not possible for biotechnology companies to function without technological support. This is a fast changing world and in order to cater to this need technology is a must.”

Indian status quo India is a rapidly evolving market. And along with China, India is the most sought-after market for all the leading global biopharma organisations. Discussing the technology usage by biotech companies in India, Sairamkumar remarks, “There is an increasing use of genetics and genomics technologies even in India with some local core facilities providing the infrastructure. We would see a

Biopharma organisations are building integrated approaches to leverage the technology in different ways. rapid adoption of technologies in India very soon.” The use of technology has its advantages. Sairamkumar continues, “The genetics and genomics technology is changing the way traditional drug discovery and development happens. This has increased our understanding of biology across multiple species. Biopharma organisations are building integrated approaches to leverage the technology in different ways. The benefits are design of trials with the prior information on disease pathways; patient stratification based on genetic profiling; targeted therapy and focussed launch and new and advanced diagnostics.” In

other words, the technology is helping improve the chances of success of new programs, but more importantly, bringing better and safer drugs to patients. Explaining how India is developed in handling the technological advancements, Bharadwaj remarks, “India is equipped to handle the latest in technology but unfortunately we lack people to develop this technology. However, on a positive note we are spending more and with time things are getting better.” Comparing India with developed countries Bharadwaj comments, “In developed countries there are better universities and research institutes that make

In developed countries there are better universities and research institutes that make the process much easier. On the other hand, India lacks such efficient institutes. Ajay Bharadwaj CEO, Anthem BioSciences

the process much easier. On the other hand, India lacks such efficient institutes.”

Situation to improve? The key challenge in the use of technology is replicability and reliability. Sairamkumar says, “The genetic and genomics technology, such as nextgeneration sequencing, is still evolving and a recent study showed variations of results across vendor platforms for a given sample. There are several data-related challenges as well. Each run of NGS results in hundreds of gigabytes of data. This translates into challenges related to moving the data from core facility to the customer location, data storage, and highly intensive computations. Organisations are seriously evaluating cloud as a potential solution to address the data challenges with a focus on security.” Discussing the future path, Sairamkumar, says, “A set of evolving disruptive technologies— Social, Mobility, Analytics and Cloud (SMAC) IT stack, and Big Data—will again influence the way information is captured, knowledge generated, and decisions made.” He elaborates that the level of information being shared via social media makes it imperative to capture and analyse it for various actionable elements—identifying key opinion leaders, profiling investigators, capturing adverse events, targeting emerging markets, and so on. He emphasises, “We are seeing an increasing interest in the leading biopharma organisations to focus on these opportunities to build knowledge.” Big data is a reality in biopharma. The ability to manage and analyse big data is going to be a differentiator for organisations. The data is only going to grow over a period of time as digital media explode. The ability to capture all elements and make an informed decision is going to be crucial for success. According to Bharadwaj, with time more and more companies are going tech conversant. And thus, with time the usage is going rampant. As the younger generation of millennials comes to constitute a larger share of consumers and employees, mobility will play a key role. Thus, looking forward the ability to bring agility to business is also going to be a key driver for mobility.

Mo de rn Ph a rm a •1 -15 S e pt e m be r 2 012

Special Focus: Interface

Bioinformatics has a significant role to play in diagnostics and personalised medicine Shibani Shah shibani.shah@network18publishing.com

How would the genomic research industry shape up? In the last decade, the genomic research industry has grown in leaps and bounds with researchers from new domains seeking solutions in this space. The genomic approach towards technology development and the large-scale generation of community resource datasets has added an important new dimension to biological and biomedical research. The advancements in the interwoven processes of genetics, comparative genomics and high throughput bioinformatics allow us to cater to the needs of scientists with a range of upgraded modern research tools and analysis. Genomics will play a major part in integrating the clinical experience by combining diagnostics, genetics profile into personalising medicine. However, this will happen when costs reduce significantly and translational efforts in integrations are worthwhile. How the bioinformatics solutions would accelerate the drug discovery process and help pharma companies? To bring a drug to the market, it usually takes many years and involves labourious high-throughput screening process, which is demanding in terms of time and money. With our

powerful in-silico research tools and databases, the drug discovery process and healthcare research can become simpler and easier. Bioinformatics also has a significant role to play in diagnostics and personalised medicine and this can help in reducing overall healthcare costs and personalising treatment. Can you tell us the about ‘Research as a Service’ model developed by you? What started as a vision in 2009 has turned into reality and a platform for success today. ‘Research as a Service’ (RaaS) initially involved a cloud-based information system, a portal for sending samples, storing data, conducting analyses and reporting. Today, this has evolved into translational research solutions in various domains such as healthcare research and agriculture. Our distinct platform ‘Research as a Service’ (RaaS) allows complete outsourcing of genomics – from storing biological samples and performing on demand DNA- and RNA-based services to validating biomarkers using our proprietary databases and providing data and bioinformatic analysis. Our team is developing customised ‘research suites’ that make work easier for our clients. From sample management to analyses, executions, and reporting, everything is automated – making research more effective and efficient. Ocimum currently expanded in Malaysia to provide its services to

LIMS and bioinformatics software products. After establishing the base, Ocimum is expanding its BioIT consulting portfolio in the domain of next generation sequencing. With the positive market response to our BioIT product lines, we expect to see our sales grow by 50 per cent Compounded Annual Growth Rate (CAGR) after establishing a regional office in Malaysia. Already we have acquired three important customers in the agriculture space in Malaysia and Philippines and we see tremendous growth in this sector.

…says Anuradha Acharya, Founder and CEO, Ocimum Biosolutions. Here, she talks about genomics, bioinformatics, and their dream of becoming ‘the lab next door.’ the ASEAN markets, how much do you expect your sales to grow and are there any other markets that you plan to expand to? We have formed a Joint Venture (JV) with a Kuala Lumpur-based company to expand business and to provide products, solutions and services in the ASEAN region. Since two years we have been acquiring customers in Malaysia, primarily focussing on

Do you think the market would change with patent cliffs? Pharma sector thrives on innovation – there is always a demand for better and less expensive drugs. This requires an extensive amount of research. Pharma companies facing patent cliffs can tackle budgetary constraints by harnessing our research capabilities. Our products and research services give pharma companies an edge, especially where time and quality are of essence. Therefore, we believe that the market would only improve for us and for drug development. For example, we are providing gene optimisation tool for gene synthesis and optimisation tasks to a leading pharmaceutical group in the United States that was looking for new therapeutic options. Innovative models in Intellectual Property (IP) will help in creating the balance between patent cliffs and investments into IP by pharma companies.

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Automation Trends

utomation for the sake of automation is a sure recipe for disaster! The pharma plants are not show rooms. It is a commercial enterprise linked to the customer who expects quality and affordability; the regulatory who seeks assurance of quality and the organisation itself that must satisfy both in addition to the shareholders who seek returns on investment. This is where the Optimum Required Automation (ORA) become essential. Let us elaborate the concept further. We need to look at this issue in three parts. Need for automation. Automation necessary for compliance with a proper balance with the cost involved Cost of automation that is superfluous

Need for automation Automation may not necessarily be for regulatory compliance. It may be simply for enhancement of production efficiency as in the case of installation of high speed process equipment or automated material handling to eliminate manual labour. It could also be for achieving safe work practice as in usage of containment systems. In both the cases, though, automation will have some implication on regulatory compliance that will become a part of the review of such systems. For example, use of an isolator for an aseptic filling machine is necessary for the safety of the operator. However, since it must also provide the Grade A (Class 100) cover, the regulatory perspective is essential. The automation strictly for regulatory compliance is typically undertaken to control difficult to manage equipment or systems or processes. There can be many examples as follows: Automated generation, storage and distribution of clean utilities such as purified water, water for injection etc. Here, it is virtually impossible to keep a track of the parameters like pH and conductivity since it is a live system subject to different demands at different times. Automated Heating, Ventilation and Air Conditioning (HVAC) system with a Building Management System (BMS) for aseptic processes where the temperature, RH, differential pressures etc. are continuously monitored to provide high degree of assurance.

Compliance with a proper balance with the cost involved The two examples cited above fall in this category. In this case, the cost of non-

Plant automation

Reducing cost in regulatory compliance Regulatory non-compliance compliance can result in a huge cost compared red to the cost of automation. Here, the emphasis sis is on Optimum Required Automation (ORA) A) rather than automation as such. compliance could resultt in failure of the batch in an isolated case or rejection of the facility by the regulatory agency not if the failures cannot be explained and are too numerous. The analytical methods used today fall into automated systems since they cannot just be done manually like the HPLCs, GCs etc. If the pharmacopoeia specified a certain test, it has to be done irrespective of the cost involved. Cleaning in place (CIP) and Sterilisation in Place (SIP) are good examples of automation that are essential for regulatory compliance. With increasing focus on cross contamination avoidance and increase in the potency of molecules in use, the cleaning procedures have become more rigorous with time. Difficult to clean equipment recesses like the surfaces inside the reactors, fluid bed systems, isolation systems demand properly designed and fully automated recipe-driven CIP systems. These automated procedures, once validated for the worst case situations remove the fear of failure and simultaneously generate cogent data for the review by regulatory agencies. Similar is the case with many of the processes used in aseptic processing. With higher insistence on more reproducible results and higher degree of sterility assurance use of SIP systems has become mandatory. Terminal sterilisers as well as in situ sterilizations both need highly automated systems to provide that degree of assurance. One must be careful to understand that regulatory expectation is expressed in two ways namely standards and guidance. For example, the clean room standards as specified by Centre for Drug Evaluation and Research (CDER) for aseptic processing actually pits down numerical values of particle counts and viable counts for given class of area. There is no choice but to have a properly automated HVAC system to achieve this ‘standard’. Similarly, the pharmacopoeias specify many parametric controls over water, air and materials and products where automation

becomes necessary. Not having automation here and depending on manual methods may not be possible and even if it is, it may be fraught with danger. For example, manual stoppering of vials in an aseptic processing line is technically feasible but practically not advisable if a proper risk analysis is undertaken.

The user must pre define the automation requirements. A multi-functional team that has honest and accurate data on products, processes and requirements is an ideal solution. The possibility of a failure of a batch for sterility is a cost that is far higher from the perspective of loss of confidence than the cost of an automatic filling line. That is not the case with ‘guidance’ documents from the regulatory agencies. The agencies do understand that it is virtually impossible to prescribe uniform methods of manufacturing to the entire spectrum of products of different scale and history made globally to be covered by a single ‘standard’. This is where even the FDA and other agencies prescribe

guidance using he phrases like ‘appropriate’, ‘adequate’, ‘necessary’, ‘sufficient’ etc. Automation of such processes must be undertaken carefully since the achievement of the final quality is defined by the user and not by the regulator. It is, however, necessary to strike a right balance between the necessary automation and unnecessary specification. For example while the pressure differentials must be maintained between areas of successive grades like Grade B and C, for example, asking for too tight a specification like + or - 2 Pascal of pressure differential can be literally killing. Another example could be specifying tight norms for room temperature and humidity for a product that is stable to both these parameters just to prove the facility to be ‘high tech.’ The user must pre define the automation requirements. Typically, a multi-functional team that has honest and accurate data on products, processes and requirements is an ideal solution. This team must be provided with a task to develop a cost efficient system that provides higher degree of regulatory compliance. Such a team may start by asking some key questions as follows. Have we done a process audit to really list down all products, processes, parameters, acceptable norms etc?

Is this automation proposal relevant to the operations? (It is not uncommon to witness automation principles from automobile industry being forced on pharma units) Is the new technology tried, tested and proven? Is it a robust system? Will it reduce failures? Does it require highly trained manpower that is freely available at site? If not is such training available at reasonable cost? Is it possible to retain such trained manpower from poaching? (We must not lose sight of the fact that sudden disappearance of such manpower would lead to failures that the system was supposed to prevent) Are auxiliaries and support easily available? Does it cover all the needs of processes for products, parameters to be measures and controlled, documentation and validation needs? Are alternate systems possible to provide similar degree of regulatory compliance?

Cost of automation that is superfluous It may surprise many but a badly automated system can itself become a huge regulatory issue. It is not uncommon in many cases to find a highly automated HVAC system with full BMS where the system generated records are not offered for regulatory review but the manual records are! This happens since there are so many incursions as a result of wrong definitions that the system records would appear to be a list of errors. In a survey carried out in UK in 2000, it was found that 6-15 per cent of validation cost of direct impact systems in plants was unnecessary because the parameters and acceptance criteria were irrelevant to processes! The team of experts concluded that the validation cost as per cent of capital cost should be below 6 per cent (for simple product plants like orals) to 15 per cent (for high criticality plants such as oncology or BioSafety Level (BSL) 3 biotech plants). Anything above this is superfluous.

P K Kulkarni Managing Director Technolutions Projects Pvt Ltd pk.kulkarni@tppl.net.in

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Projects

Projects New projects and expansion activities are the barometers of industrial growth. These also present business opportunities to service providers like consultants, contractors, plant & equipment suppliers and others down the value chain. This feature will keep you updated with vital information regarding new projects and capacity expansions being planned by companies in the pharma/lifesceinces industry. Access to medicines Project type: Investigation Project news: The main aim of the proposed research is to investigate how the interplay of patent regimes, pharmaceutical regulation, availability of drug production facilities, healthcare infrastructure and service provision, and engagement by foreign donors influence appropriate, affordable access to medicines in South Asia and Sub-Saharan Africa. We aim to map patterns of production, distribution, supply and consumption of medicines within five healthcare areas HIV/AIDS, malaria, reproductive health, tuberculosis (TB) control and mental health.

Project location: Bhutan, Cambodia Project cost: 3905826 Implementation stage: Ongoing Contact details: The University Of Edinburghold College South Bridge, Edinburgh, United Kingdom, Tel: +44-1316509024 Fax: +44-1316509023 Attn: Angela NOBLE E-mail: university.centre@ed.ac.uk Drugs for neglected diseases Project type: Production Project news: The project’s ‘Drugs for Neglected Diseases’ initiative to support the development of

flubendazole as a macrofilaricidal drug candidate for treatment of onchocerciasis Loa loa coinfections Project location: United States Project cost: $ 5,787,659 Implementation stage: Ongoing Contact details: Bill And Melinda Gates Foundation PO Box: 23350 Seattle, WA 98102 USA Tel: (206) 709-3100 Novozymes enzymes RDI Project type: Research Project news: The project concerns the European-based part of the promoter’s corporate RDI programme in the period 20102011 related to discovery and development of innovative enzymes, novel pharmaceutical proteins and micro-organisms. The R&D investments focus on improving current products and processes as well as developing new business opportunities. Project location: Denmark

Project cost: 240 million Implementation stage: Ongoing Contact details: Novozymes A/SKrogshoejvej 36 2880 Bagsvaerd Denmark Tel: +45 44 46 00 00 Fax: +45 44 46 99 99 Rifampicin and isoniazid complexes formed with nanoparticles Project type: Research Project news: Project for rifampicin and isoniazid complexes formed with nanoparticles for inhibition of growth of multidrug resistant Mycobacterium tuberculosis; with the aim of lowering the current Minimum Inhibitory Concentration (MIC) as well as method of administration. Project location: India Project cost: ` 35 lakh Implementation stage: Ongoing Contact details: Defence Institute Of Advanced

Technology (Deemed University) Girinagar, Pune 411025 Maharashtra Attn: Dr Tejashree Bhave Tel: 020-24304021 Fax: 020-24389318, 24389411 E-mail: registrar@diat.ac.in Strengthening Pharmaceutical Systems (SPS) Project type: Pharmaceutical service Project news: SPS is a follow on to the Rational Pharmaceutical Management (RPM) Plus programme. The SPS programme provides a great opportunity for MSH and USAID to continue supporting developing countries in their quest to increase access to essential medicines. Project location: United States Project cost: $ 147.5 million Implementation stage: Ongoing Contact details: Management Sciences For Health INC784 Memorial Drive, Cambridge, Massachusetts 021394613 United States Tel: +1.617.250.9500

Information courtesy: www.tendersinfo.com 1, Arch Gold, Next to MTNL Exchange, Poisar, S V Road, Kandivali (W), Mumbai - 400 067, Maharashtra, India • Tel: 022 28666134 • Fax: 022 28013817 • Email: parmeet.d@tendersinfo.com

Latest Popular Tenders Brought to you by www.tendersinfo.com

Tenders

Inductively coupled plasma mass spectrometry Org : Directorate Of Forensic Science TRN : 12055400 Desc : Supply of inductively coupled plasma mass spectrometry. BOD : September 10, 2012 Loc : Gandhinagar, Gujarat BT : Domestic (NCB)

Mass spectrometer Org : Department of Atomic Energy TRN : 12100210 Desc : Supply of high performance gas chromatograph-mass spectrometer (GCMS) system required for heavy water plant (Baroda). BOD : September 10, 2012 Loc : Mumbai, Maharashtra BT : Domestic (NCB)

BOD : September 11, 2012 Loc : Medziphema, Nagaland BT : Domestic (NCB)

Ultracentrifuge Org : Indian Council of Agricultural Research TRN : 11927998 Desc : Supply of microprocessor controlled floor-standing ultracentrifuge with accessories. BOD : September 11, 2012 Loc : Medziphema, Nagaland BT : Domestic (NCB)

Drugs/Medicines Org TRN Desc BOD Loc BT

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Government of Rajasthan 12100230 Supply of tablets. September 11, 2012 Udaipur, Rajasthan Domestic (NCB)

Drugs/Medicines Org : Chandigarh State Aids Control Society TRN : 12053473 Desc : Supply of drugs to treat opportunistic infections and for post exposure prophylaxis of HIV/AIDS. BOD : September 10, 2012 Loc : Chandigarh BT : Domestic (NCB)

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Government of Rajasthan 12100229 Supply of injections. September 11, 2012 Udaipur, Rajasthan Domestic (NCB)

Automated microprocessor controlled media preparator sterilizer

High speed centrifuge Org : Indian Council of Agricultural Research TRN : 11928001 Desc : Supply of high speed centrifuge

Org

: National Institute of Pharmaceutical Education and Research (NIPER) TRN : 12004747

Desc : Supply of automated microprocessor controlled media preparator steriliser and dispenser complete with preparation and filling. BOD : September 12, 2012 Loc : Punjab BT : Domestic (NCB)

Thermal ionisation mass spectrometer Org : Department of Atomic Energy TRN : 12015465 Desc : Supply of thermal ionisation mass spectrometer system BOD : September 12, 2012 Loc : Mumbai, Maharashtra BT : Domestic (NCB)

Drugs/Medicines Org

: Vardhaman Mahavir Medical College and Safdarjang Hospital TRN : 11958912 Desc : Supply of antibiotic and identification discs. BOD : September 13, 2012 Loc : New Delhi BT : Domestic (NCB)

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All India Institute of Medical Sciences 11644056 Supply of drugs, medicines IV fluids. September 17, 2012 New Delhi Domestic (NCB)

Org: Organisation’s name; TRN: Tendersinfo Ref No; Desc: Description; DSLD: Doc Sale Last Date; BOD: Bid Opening Date; Loc: Location; BT: Bidding Type Information courtesy: www.tendersinfo.com

1, Arch Gold, Next to MTNL Exchange, Poisar, S.V. Road, Kandivali (W), Mumbai - 400067 Maharashtra, India Tel: +91 22 28666134 • Fax: +91-22-28013817 • Email: parmeet.d@tendersinfo.com

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Event List

N AT I O N A L E V E N T S India Stem Cell Conclave & Exhibition This event aims to be one of the biggest stem cell events in India and will cover the most cutting-edge content in stem cell research and commercial stem cell use. Industry experts across India and the world will converge to share papers on stem cell research, debate and discuss on how to overcome the challenges facing the stem cell industry in India and across the world, which can open new opportunities in the area of research, therapy and stem cell banking; September 1-2, 2012, Vivanta by Taj, Bengaluru For details contact: Asia Knowledge Associates Tel: +91-22-32951668 Email: prasanna@asiaknow.com Website: www.stemcellconclave.com

For details contact: IED Communications Pvt Ltd Tel: +91 22 22079567 Fax: +91 22 22074516 Email: arokiaswamy@ iedcommunications.com Website: www.iedcommunications.com

PUNE

CHENNAI

LUDHIANA

Gujarat, Oct 5-8, 2012

Maharashtra, Nov 2-5, 2012

Tamil Nadu, Nov 22-25, 2012

Punjab, Dec 21-24, 2012

INDORE

AURANGABAD

RUDRAPUR

HYDERABAD

Madhya Pradesh, Jan 11-14, 2013

Maharashtra, Feb 1-4, 2013

Uttarakhand, Feb 23-26, 2013

Andhra Pradesh, May 31- June 3, 2013

India’s premier industrial trade fair on products and technologies related to Machine Tools, Hydraulics & Pneumatics, Process Machinery & Equipment, Automation Instrumentation, Packaging & Auxiliaries, IT Products, Electrical & Electronics, Material Handling and Safety Equipment.

For details

Pharmac India It is a-three-day event that aims towards highlighting several issues of the industry. This will be large hub of reputed professionals from pharma formulation, herbal products, veterinary drug, medical & disposal, pharma machinery and many other sectors. There will be visitors from pharma company marketing/purchase/ export executive, marketing company & consultant, and international business representatives; September 8-10, 2012, Gujarat University Exhibition Hall, Ahmedabad.

Automation 2012 All leading companies in industry will showcase their latest products and help one find the solutions at the show. The show brings latest technologies from an interesting array of fields such as: factory automation, process automation and control systems, robotics & drives, field instrumentation & smart sensors bus technologies, software solutions, wireless technology, building automation, and hydraulic & pneumatic automation in renewable energy. From technocrats to solution providers, vendors and tech-buffs, the fair is all set to draw every one alike; September 7-10, 2012, NSE Complex, Mumbai

AHMEDABAD

For details contact: Orbitz Exhibitions Pvt Ltd Tel: +91-22-24102801 Fax: +91-22- 24102805 Email: ramesh.v@orbitexhibitions.com Website: www.orbitzexhibitions.com

Indian Pharma Expo 2012 Indian Pharma Expo 2012 is the perfect solution to meet the needs of the rapidly growing Indian pharma industry; to be able to network under one roof. There will be discussions on regulatory issues affecting the pharma market, commercial strategies and business models of key players, maximising revenue, overcoming challenges and

Network18 Media & Investments Ltd

Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028. • Tel: 022 3003 4651 • Fax: 022 3003 4499 • Email: engexpo@network18publishing.com

achieving growth and revaluating possible development scenarios; September 22-23, 2012, Pragati Maidan, New Delhi

Tel: +91 22 613 81800 Email: bhumika@kamikaze.co.in Website: /www.elscconclave.com/ pharma.html

For details contact: UBM India Pvt Ltd Tel: +91 22 6612 2600 Fax: +91 22 6612 2626-27 Email: info.india@ubm.com Website: www.ubmindia.in

Indian Lab Automation conference and exhibition

2nd Pharma Supply Chain Forum Now in its 2nd year, Pharma Supply Chain Forum is India’s premier pharma supply chain and logistics event in India covering a comprehensive range of supply chain topics including network optimisation, lean management, inventory management, security management, cold chain management, supplier-partner relationship management, packaging technology, forecasting & sourcing, and pedigree compliance; September 27, 2012, Taj Lands End, Mumbai For details contact: Kamikaze B2B Media

ILA 2012 will feature three technical conference tracks; ‘Drug Discovery and Development’, ‘Advances in Bioanalysis’ and ‘Advances in Genomics and Informatics.’ Each track will provide attendees with the opportunity to listen to presentations on cutting edge research in specific application areas, with an underlying theme of automating the technique, equipment or associated informatics; October 30-31, 2012, Renaissance Hotel & Convention Centre, Mumbai For details contact: Select Biosciences Ltd Tel: +44 1787 315110 Fax: +44 1787 315111 Email: enquiries@selectbiosciences.com Website: www.selectbiosciences.com

I N T E R N AT I O N A L E V E N T S JCBBB 2012 The 3rd Journal Conference on Bioscience, Biochemistry and Bioinformatics (JCBBB 2012) aims to provide a forum for researchers, practitioners, and professionals from the industry, academia and government to discourse on research and development, professional practice in bioscience, biochemistry and bioinformatics. This is one of the leading international conferences for presenting novel and fundamental advances in the fields of bioscience, biochemistry and bioinformatics. It also serves to foster communication among researchers and practitioners working in a wide variety of scientific areas with a common interest in improving bioscience, biochemistry and bioinformatics related techniques; September 1-2, 2012, Phuket, Thailand For details contact: International Journal of Bioscience, Biochemistry and Bioinformatics Tel: +91 422 2611146 Fax: +91 422 2611043 Email: ijbbb@vip.163.com Website: www.ijbbb.org

International Symposium on Pharmaceutical Reference Standards The event aims to discuss current topics and future approaches related to pharma reference standards. Pharmaceutical reference standards are essential for the quality control of

medicines. The symposium will bring together stakeholders involved in the production, characterisation and use of reference standards to exchange their views and opinions on the different issues related to the subject; September 3-4, 2012, EDQM Premises, Strasbourg, France For details contact: EDQM Public Relations Division & Documentation Tel: +33 0 3 88 41 31 50 Fax: +33 0 3 88 41 27 71 Email: beatrice.barth@edqm.eu Website: www.edqm.eu

NCCR 2012 The 6th National Conference for Clinical Research 2012 (NCCR 2012) aims to serve as a platform that aims to bring together clinical investigators, industry professionals, regulatory agencies and policy makers in order to address the issues and challenges of the industry. By gathering people from various research disciplines, the event aims to foster constructive and forward looking discussions, sharing of experiences, and mutual commitment towards the betterment of humanity; September 23-25, 2012, Sunway Pyramid Convention Centre, Malaysia For details contact: Association of Clinical Registries, Malaysia (ACRM) Tel: +603 4044 3060 Fax: +603 4044 3080 Email: contact@acrm.org.my Website: www.nccrconference.com

CSBio 2012 CSBio 2012 will also cover the engineering sciences related to the pharmaceutical industry, in both material and manufacturing sciences. This conference would like to gather like minded researchers and industrial counterparts who are involved in designing, developing and improving industrial processes and equipment for large-scale chemical and pharma manufacturing; planning and testing methods of manufacturing; developing methods for the treatment of bi-products; devising production processes that are safe, efficient, profitable and environmentally sound; October 3-5, 2012, Bangkok, Thailand For details contact: School of Information Technology Tel: +66 2470 9834 Fax: +66 2872 7145 Email: csbio2012@sit.kmutt.ac.th Website: www.csbio.org

CPhI Worldwide The event hosts over 1900 exhibitors and is the market leader for the global pharmaceutical ingredients industry. CPhI Worldwide has three co-located events: ICSE, P-MEC Europe and InnoPack. These events focus on specific sub-sectors of the pharma ingredients industry and provide visitors and exhibitors with additional capability to network and do business in dedicated areas; October 9-11, 2012, Feria de Madrid, Spain

For details contact: UBM India Pvt Ltd Tel: +91 22 6612 2600 Fax: +91 22 6612 2626-27 Email: info.india@ubm.com Website: www.ubmindia.in

2012 Nanotechnology Conference The event aims to bring together a panel of highly-accomplished nanotechnologists and well recognised authorities in various aspects of nanomedicine. This unique international conference offers an opportunity for pharma scientists, clinical researchers, physicians, therapists and industrial leaders to discuss the important international breakthrough developments in drug discovery, drug development, drug delivery, drug therapy and commerce to share their thoughts. The four-day conference will focus on the basic studies through translational efforts and clinical trials and address topics of novel issues concentrating more on recent advances, difficulties, and breakthroughs. This is how the event aims to reach out to the experts and decision makers of industry; October 31- November 3, 2012, Riviera Maya, Mexico For details contact: Zing Conferences Tel: +44 1223 750020 Fax: +44 1223 280270 Email: info@zingconferences.com Website: www.zingconferences.com

The information published in this section is as per the details furnished by the respective organiser. In any case, it does not represent the views of Modern Pharma.

Mod er n P har m a•1 - 15 S ep t em b er 2 012

Event Preview

Pharmac India 2012 Shibani Shah shibani.shah@network18publishing.com

ujarat houses a large number of pharma companies and contributes to 42 per cent to the total pharma turnover in India. To take a step further and bring together manufacturers and buyers of the pharma industry on a common platform Orbitz Exhibitions Pvt Ltd in co operation with Indian Drug Manufacturers Association will be organising Pharmac India 2012. Pharmac India, a pharma machinery, equipment and materials exhibition this year enters into its 3rd edition and will be held during 8-10th September at the Gujarat Exhibition Hall in Ahmedabad. In the previous edition, Pharmac India 2011, the exhibition drew more than 200 exhibitors and over 12,000 visitors.

From the organisers The organisers are excited and are expecting the event to be a grand success. Rupen Vikanmsey, MD, Orbitz Exhibitions Pvt Ltd, expresses, “It is a matter of immense pride that The Indian Drug Manufacturers’ Association has entrusted Orbitz Exhibitions

Visitor’s profile

A business platform for SMEs Pharmac India 2012 is scheduled to be held in Ahmedabad during September 8-10. This will provide a platform to the SMEs in pharma machinery, equipment and materials developers to showcase their products and also help in knowledge exchange, which will pave way for new business development. Pvt Ltd with organising Pharmac India 2012 an international exhibition on pharma machinery, pharma packaging and material industry, API’s, bulk drugs, and other allied segments. The exhibition is an opportunity for the SME’s to display their expertise and skills beyond geographical boundaries. We are quite confident that the 3rd edition of Pharmac India will be even more fruitful and beneficial for exhibitors and visitors.” Pharmac India is a SME centric one-of-its-kinds exhibitions in India. The visitors and exhibitors from around the globe define its international character.

Exhibitor’s profile Being hosted in the pharma capital of India, the exhibition attracts maximum visitors

The broad spectrum of exhibitors attracts a large numbers of visitors from various spheres of the industry. The visitors include export professionals, contract manufacturers, pharma distributors, biotech and pharma companies, etc. The previous edition had an impressive footfall of visitors not only from India but also abroad and this is expected to rise this year. This year Pharmac is expecting more than 15,000 visitors.

From first to third edition

In retrospective...

and exhibitors from the state of Gujarat. The exhibitors include companies dealing with pharma formulations, API for bulk drugs, pharma machinery, pharma packaging material, bio pharmaceuticals, nutraceuticals, consultants, CROs and other allied services. Vikanmsey adds,

“We are confident of 100 per cent exhibitor satisfaction. We present opportunities for pharma companies to display and demonstrate their products and services by providing very economical and competitive rate for exhibitors as compared to other similar events.”

Vikanmsey adds, “It has been an interesting journey since the first edition of Pharmac India. It has become the most popular event among pharma professionals in Gujarat and other states of India. We are very confident of taking Pharmac India to greater heights in the coming editions.” Pharmac provides a great platform and bridges the gap between manufacturers and materials and machinery providers. The exhibitors can not only take advantage by showcasing their products but also interact with the companies to know the changing demands and enhance their products and services accordingly.

Book Review

Editors: Dennis Douroumis Price:

` 10,500/-

Publisher: Wiley Distributor: Wisdom Book Distributors, Hornby Building, 1st Floor, 174, D N Road, Mumbai 400 001, Tel: 022 2207 4484/6631 8958, Telefax: 022-2203 4058 Email: thadam@vsnl.com

Sterile Product Facility Design and Project Management

Editor: Jeffery Odum

Every project team is under pressure to deliver a compliant facility in the stipulated time and budget. This calls for efficient project management and planning. The author has put together a project manager’s perspective of the entire process of facility project management. The initial chapters focus on the core concepts of project management. The chapters on project formation, project team, facility programming, and project control deal with each aspect in detail and simplify them with illustrations and flow diagrams. The book also looks at setting up a sterile manufacturing facility from the FDA’s Good Manufacturing Practices (GMP) regulations. The second half of the book deals with actual setting up of facilities and its various facets. Chapters dedicated to mechanical systems, architectural designs, construction, commissioning and quality control of the project describe in detail regulatory requirement and the trouble shooting tips for the same. The book concludes with chapters on establishment licensing, containment basics, multiproduct biological manufacturing facilities and future trends. The book uses a simple fluid language and its style of ‘problem solving’ delivery makes it a easy read. The book answers many theoretical issues related to facility design and management and also many practical problems relating to every step in the process. Essential read for every member of the project management industry, entrepreneurs and regulatory affairs department of every pharmaceutical industry.

Price:

` 3995/-

Publisher: CRC Press Distributor: Wisdom Book Distributors, Hornby Building, 1st Floor, 174, D N Road, Mumbai 400 001, Tel: 022 2207 4484/6631 8958, Telefax: 022-2203 4058 Email: thadam@vsnl.com

Hot – melt Extrusion: Pharmaceutical Applications Hot – Melt Extrusion technology (HME) is widely used in the plastic industry and is now being widely applied in the drug formulation processes as well. The technology is widely researched for producing better applications of the same to design newer drug delivery systems and biological implants. The editors have put together a comprehensive collection of chapters deciphering the basics and applications of this technology in the present day. The initial chapters describe in detail the mechanics of extruders, different types of extruders and the development of HME in pharmaceutical industry. HME components are further described in details in individual chapters on drug/polymer miscibility, plasticizers, use of poly(meth) acrylate, ethylcellulose, hypromellose and polyethylene oxide. The chapters describe the usage and applications of the above compounds in pharmaceutical products with the help of simple language, illustrations and pictures. The authors make use of actual products as examples to describe the applications of HME. Two chapters on polymeric films and taste masking discuss unique solutions provided by the HME processes with respect to drug delivery and drug compliance. The book concludes with chapters on scale up of HME in mainstream drug production, regulatory (FDA) perspective on HME technology and newer applications in implants and devices. A good collection of HME applications in one book making it a must read for anyone and everyone interested in HME processes.

Reviewer: Dr Mandar Kubal, Consultant - Infectious Diseases and HIV AIDS, Infectious Diseases and Pulmonary Care (IDPC) Pvt Ltd

Mo de rn Ph a rm a •1 -15 S e pt e m be r 2 012

Products Sysmac Automation Platform It is a new automation controller NJSeries that integrates motion, sequencing, networking, RFID tracking, and vision inspection. It comes with new software - sysmac studio - that includes configuration, programming, simulation and monitoring and a fast machine network - Ether CAT - to control motion, vision, sensors and actuators. The NJ-Series incorporates an Intel processor with fan-free operation. It delivers a true integrated development environment (IDE). Sysmac studio also offers an advanced 3D simulation environment to develop and test off-line motion profiles such as cams & complex kinematics. Intellectual property (IP) can be safely secured using 32-character passwords. Omron Automation Pvt Ltd Mumbai - Maharashtra Tel: 022-4228 8400 Email: in_enquiry@ap.omron.com Website: www.omron-ap.co.in

Laboratory chillers Polystat® Laboratory Chillers has quick rampup and cool-down with all operational and preventive maintenance accessed through the front panel. Designed to provide temperature control with the flexibility needed for demanding applications, they fit comfortably on a laboratory bench top. These chillers feature a temperature range of -10 to 80°C. The chillers allows the user to choose between five temperature set points. The air-cooled refrigeration system eliminates need for external water source and the small internal reservoir limits evaporation. With built-in energysaving mode, this series provides an environmentally friendly option for any laboratory. This mode activates a responsive control that will allow the chillers to operate with minimal energy consumption Cole-Parmer India Mumbai - Maharashtra Tel: 022-6716 2222 Email: vinita.singh@coleparmer.in Website: www.coleparmer.in

Adapplicator system developed by Braun, the spray alternative to needle injection, are few examples. Neejtech India Ahmedabad - Gujarat Tel: 079-26561312 Mob: 09825040231 Email: info@neejtech.com Website: www.neejtech.com

Steam boiler The fully automatic package steam boiler (IBR) has capacity ranging from 100 kg/hr to 2000 kg/hr with operating pressure of 10 kg/cm² g. Smoke tube & water tube version is also available. Coil is made from seamless tube of asthma 106 GR-B pipes. The unit is equipped with high efficiency oil/gas burner with air pre-heater arrangement which gives high thermal efficiency. Aero Therm Systems Pvt Ltd Ahmedabad - Gujarat Tel: 079-25890158 Email: contact@aerothermsystem.com Website: www.aerothermsystem.com

Pharma inspection machine The paper folding, shrink pack and pharma inspection machines are tested for CE marking, and thus fulfill one of the major statutory requirements of European Union. A range of customised solutions as per pharma industry requirements is also offered. Pharma inspection solutions include: pharmacode readers, leaflets and cartons. These have been specially designed for online checking of pharma codes printed on tubes, cartons, leaflets, labels, etc. Pratham Technologies Pvt Ltd Pune - Maharashtra Tel: 020-24352624 Mob: 09822047399 Email: enquiry@prathamtech.com Website: www.prathamtech.com

filtration, and environmental monitoring. Advantec’s range of filtration products fits comfortably within Cole-Parmer’s own product range. It offers customers an additional and valuable range of unique quality products that will enhance their processes and research. Cole-Parmer India Mumbai - Maharashtra Tel: 022-67162222 Email: vinita.singh@coleparmer.in Website: www.coleparmer.in

Capsule filling machine These automatic capsule filling machines also known as encapsulation equipment are compact, sturdy, covered with stainless steel panels, and hood covered with acrylic guard. The fill weight adjustment takes place within seconds. These machines are provided with tamping mechanism for powder filling, which enables capsules to be filled with a weight variation with ±2 per cent. Anchor Mark Pvt Ltd Mumbai – Maharashtra Tel: 022-28682001 Email: sales@anchormark.com Website: www.anchormark.com

Sieves

These are silicon moulded sifter sieves, fluid bed dryer (FBD) sieves and FBE dryer sieves. The silicon moulded sifter sieves are available in various sizes from 12” to 48” diameter. These are available in rivetted and special non-rivetted design. The mesh sizes vary from 4 mesh to 500 mesh with ASTM & BSS Standards. Atlanto Enterprises Mumbai – Maharashtra Tel: 022-23096098 Mob: 09819942853 Email: atlantoent@yahoo.co.in Website: www.atlanto.net

Filtration and separation products Rotary vane vacuum pump

Cleanroom moulds

Adapplicator, Alu cap, Snap cap, PE bottle pack cap, PE twin port cap are only some of many cleanroom moulds from Braunform. Highly sensitive packaging and measuring components, caps for use in dental and insulin fields, dialysis components, hygiene products and the

Advantec’s wide range of filtration solutions are used for laboratory, research and process applications. These products are used in a wide variety of scientific capacities and applications, such as microbiological analysis, air/gas

The Minivac SVL series of low vacuum pump is a sliding vane-type direct/ belt-driven vacuum pump mounted on common base frames. It is compact in size, vibration-free and hence can also be mounted inside the machine. The pump attains maximum vacuum levels up to 29” of Hg with capacities ranging

from 50-2000 lpm. Unique design of the lubrication system positively feeds minimum required oil to all rotating and frictional parts. The pump is useful in applications like capsule filling/ capsule printing machines and other pharmaceutical machineries, packaging/ labeling machines, screen printing/plate making, book binding/folding machines, vacuum chucking, etc. Shree Siddhivinayak Industries Dist Thane - Maharashtra Tel: 022-28458372 Email: minivac@rediffmail.com Website: www.minivacpumps.com

Metal analyser The 7700 series ICP-MS metal analyser is productive, simple-to-use, high sensitivity, low background, better interference removal, increased flexibility, easier to maintain and service. This workhorse 7700x is used for most applications, and in high-throughput commercial labs. It is designed specifically for semiconductor applications. The new 7700e offers a simplified and easy-to-use system for routine analysis. Featuring a new, configurable MassHunter software platform and a host of hardware developments, including a new frequency-matching RF generator and 3rd generation Octopole Reaction System (ORS3), all three 7700 series mainframes provide unrivalled levels of performance and ease-of-use. Agilent Technologies India Pvt Ltd New Delhi Tel: 011-51496664 Email: agilent@agilent.com Website: www.agilent.co.in

Walk-in humidity chamber The unit has doublewalled insulated PUF modular panels, which can be easily assembled at site. Interior is made of stainless steel and exterior is either made of mild steel finished with powder coating or stainless steel. The unit has full-length inner glass door and outside metal door with magnetic gasket and lock. It is provided with perforated stainless steel trays and has forced air circulation for uniform temperature. The intelligent controlling system has PLC base and PC communication. It has long lasting stainless steel tubular heaters with SS fins. Newtronic Equipment Company Pvt Ltd Mumbai - Maharashtra Tel: 022-28679326, Mob: 09821089932 Email: nmehta@newtronic.in Website: www.newtronic.in The information published in this section is as per the details furnished by the respective manufacturer/distributor. In any case, it does not represent the views of

Looking For A Specific Product? Searching and sourcing products were never so easy. Just type MPH (space) Product Name and send it to 51818 eg, MPH Laboratory software and send it to 51818

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Mo de rn Ph a rm a â&#x20AC;˘1 -15 S e pt e m be r 2 012

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30 List of Products & Advertisers Looking For A Specific Product? Searching and sourcing products were never so easy. Just type MPH (space) Product Name and send it to 51818 eg, MPH Laboratory software and send it to 51818 Product

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Emergency lighting.................................................. 21 Empower.................................................................BIC Evaporation .............................................................. 13 Filtration and separation products..................... 27 Fixtures...................................................................... 28 Flood lighting ........................................................... 21 Grip Pliers .............................................................. 28 Guided compact pneumatic cylinder...................BC Hand power operated label gumming machine ................................................................ 28 Heart valve frame ...................................................... 9 Heating Bath ............................................................ 19 High pressure homogenizer ................................... 19 High speed automatic big size lable over printing machine .................................................................. 28 High Speed automatic carton over printing machine .................................................................. 28 High speed automatic lable counting machine ... 28 High speed automatic lable over printing machine28 High speed automatic lid dispensing machine.... 28 High speed automatic wallet dispensing machine .................................................................. 28 High speed tablet presses........................................ 15 Horizontal handel clamp ........................................ 28 Hot plate ................................................................... 19 HPLC.......................................................................BIC Industrial lighting ................................................. 21 Informatics .............................................................BIC Inline disperser......................................................... 19 Inspection systems ................................................... 11 Jigs .......................................................................... 28 Kneading machine ................................................ 19 Labels ...................................................................... 29 Laboratory chillers ................................................... 27 Laboratory equipments........................................... 29 Laboratory reactor ................................................... 19 Laboratory software................................................. 19

Accent lighting ....................................................... 21 Advance foundry & CNC machine shop ............. 28 Agitators .................................................................... 19 Ambient air monitor-envirotrack & sampler ...... 29 Analytical instrumentation...................................BIC Aseptic liquid packaging system .............................. 6 Automatic carton over printing with embossing machine .................................................................. 28 Automatic lable gumming machine...................... 28 Barcode patient ID bands .................................... 29 Batch disperser ......................................................... 19 Bulk bag filler ........................................................... 28 Calorimeters........................................................... 19 Capsule filling machine .......................................... 27 Centrifugal monoblock........................................... 28 Chemical gas detectors............................................ 29 Chromatograohy instrument ................................. 29 Chromatography & mass Spectrometry ................. 3 Clamp ........................................................................ 28 Cleanlite - screwless cleanroom lumianaire (TOCR & BOCR) ................................................. 21 Cleanroom moulds.................................................. 27 Cod analyzer & digester .......................................... 29 Color masterbatches ................................................ 28 Coloumns & chemistries ......................................BIC Commercial lighting................................................ 21 Compact pneumatic cylinder................................BC Complete range of filling & crimping machines for aerosols ........................................... 29 Consumer lighting................................................... 21 Corton dispensing machine ................................... 28 Disperser................................................................. 19 Double sided rotary................................................. 15 Dry vacuum pump.................................................. 28 Electric actuator & gripper .................................BC Electronic gas monitors .......................................... 29

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Landscape lighting ................................................... 21 Liquid handling products ....................................... 29 Lonizer .....................................................................BC Magnetic stirrer ..................................................... 19 Material handling equipments............................... 28 Medium speed tablet presses.................................. 15 Metal analyser .......................................................... 27 Mill ........................................................................... 19 Mixing & drying ...................................................... 13 Monoblock high vacuum pump ........................... 28 Oil seal high vacuum pump................................. 28 Other process equipment ....................................... 15 Overhead stirrer ....................................................... 19 Pallets ...................................................................... 29 Peristaltic pumps ..................................................... 28 Persona - hospital bedlight..................................... 21 Pharma inspection machine .................................. 27 Pharma lighting ....................................................... 21 Pharmalux - cleanroom luminaire (TOCR & BOCR) ................................................. 21 Pilot / lab scale tablet presses ................................. 15 Pilot plant ................................................................. 19 Precision fabrication work...................................... 28 Printer ....................................................................... 29 Pull action................................................................. 28 Pump ......................................................................... 28 Rapid endotoxin detection system...................... 29 Refrigrated compressed air dryer .........................BC Road lighting ............................................................ 21 Roller compaction systems ..................................... 15 Roots vacuum pump............................................... 28 Rotary evaporator .................................................... 19 Rotary gear ............................................................... 28 Rotary lobe pump ................................................... 28 Rotary pump ............................................................ 28 Rotary tablet press ................................................... 15

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Rotary vane vacuum pump.................................... 27 Sanitary centrifugal............................................... 28 Screw pump.............................................................. 28 Selp priming monoblock ........................................ 28 Sensors......................................................................... 7 Shaker ........................................................................ 19 Sieves ......................................................................... 27 Single stage monoblock vacuum pump ............... 28 Single stage vacuum pump .................................... 28 Solid-Liquid Mixer .................................................. 19 Spectrophotometers................................................. 29 Spray systems-from the single machine to the complete filling line .............................................. 29 Steam boiler.............................................................. 27 Straight line Action.................................................. 28 Submersible .............................................................. 28 Sysmac Automation Platform ................................ 27 Tablet press machine............................................. 15 Thermostat & vaccum dryer / mixer .................... 19 Toggle action clamp ................................................ 28 Toggle press .............................................................. 28 Tooling & spares ...................................................... 15 Tpu masterbatches................................................... 28 Triplex plunger ......................................................... 28 Twin - screw co-rotating extruder........................... 9 Twin - screw element ................................................ 9 Twin - Sscrew extruder ............................................. 9 Two stage vacuum pump ....................................... 28 UPLC .....................................................................BIC Vacuum conveyor. ................................................. 28 Vacuum pump ......................................................... 28 Vertical handle clamp.............................................. 28 Vertical inline ........................................................... 28 Walk-in humidity chamber.................................. 27 Water analysis instrument ...................................... 29

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Advertiser’s Name & Contact Details Alok Masterbatches Ltd

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Advertiser’s Name & Contact Details Great Eastern Impex Pvt Ltd

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Advertiser’s Name & Contact Details Mack Pharmatech

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Advertiser’s Name & Contact Details Steer Engineering Pvt Ltd

T: +91-011-41612244

T: +91-011-2347431/32

T: +91-2551-230877

T: +91-80-23723309

E: sales@alokindustries.com

E: sales@geipl.com

E: sales@mackpharmatech.com

E: info@steerworld.com

W: www.mackpharmatech.com

W: www.steerworld.com

W: www.geipl.com

W: www.alokmasterbatches.com Cadmach Machinery Co Pvt Ltd

T: +91-79-25841491

T: +91-265-2517505 E: info@hapman.in

E: info@cadmach.com

W: www.hapman.in

W: www.cadmach.com Chamunda Equipments

Hapman India

Heattrans Equipments Pvt.Ltd

Sunjay Technologies T: +91- 22 6662 4330

E: Benjamin.margot@pamasol.com

E: info@sunjaytechnologies.com

W: www.pamasol.com

W: www.sunjaytechnologies.com

T: +91-079-2584015

Pierlite India Pvt Ltd

E: info@heattrans.com

T: +91-79-22782623

T: +91-79-25830742

E: clamp@chamundaequip.com

W: www.heattrans.com

E: pradeep@pierlite.co.in

E: info@technoind.com

W: www.chamundaequip.com

Hi-Mek Analytical

W: www.pierlite.co.in

W: www.tecnoind.com

Ika India Private Limited

E: india.customercare@crl.com

T: +91-80-26253900

W: www.criver.com

E: process@ika.in 7

T: +91-020-40147840

W: www.cognex.com 28

Thermo Fisher Scientific Sid Division T: +91-22-67429494

E: sales@ravelhiteks.com

E: analyze.in@thermofisher.com

W: www.ravelhiteks.com

W: www.thermoscientific.com BC

Uniphos Envirotronic Pvt Ltd

T: +91-149 3305400

T: +91-22-61233500

T: +91-79-25841814

E: india@reynders.com

E: gasdetection@uniphos.com

E: info@jacsonsengrs.com

W: www.reynders.com

W: www.uniphos-she.com

W: www.jacsonsengrs.com

T: +91-79-26403839

Joyam Engineers & Consultants Pvt Ltd

E: info@devpumps.com

T: +91-79-26569533

Salesworth India Pvt Ltd (Seidenader) 28

E: joyam@joyamvactech.com

W: www.devpumps.com

Techno Industries

T: +91-44-2496 3241/325

Reynders Label Printing India Pvt Ltd

W: www.ika.in Jacsons Engineers

E: sales.in@cognex.com

Dev Engineers

Ravel Hiteks Pvt Ltd

E: himek@vsnl.com

T: +91-80 - 25588175

Cognex Sensors India Pvt Ltd

T: +91 22 2533 1701

T: 41-55-417-4040

T: +91-79-27522437

Charles River

Pamasol Will Mader Ag

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Waters (India) Private Limited

T: +91-80-25274495

T: +91-80-28371900

E: mail@salesworth.com

E: waters_india@waters.com

W: www.seidenader.de

W: www.waters.com

BIC

W: www.joyamvactech.com Food & Pharma Specialities T: +91-0120-4236204 E: info@foodpharma.in W: www.foodpharma.in

Kamikaze B2B Media T: +91- 9969428590 E: bhumika@kamikaze.co.in W: www.elscconclave.com

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Sintex Industries Ltd

Weiler Engineering Inc

T: +91-2764-253500

T: +91-847-531-6733

E: pallets@sintex.co.in

E: solutions@weilerengineering.com

W: www.sintex-plastics.com

W: www.weilerengineering.com

Our consistent advertisers

RNI No: MAHENG / 2008 / 27125, Postal Regd No: G / NMD / 122 / 2011 - 13, Posted at P.C Stg. OfďŹ ce, GPO, Mumbai 400 001 On 19th & 20th Of Every Month, Date Of Publication: 16th Of Every Month