Express Pharma October 16-31, 2013 by Indian Express

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Market IT @ pharma: Spearheading progress Management Clinical trials in India: The churn continues Pharma Life OPPI awards at 47th AGM 16-31 OCTOBER 2013, ` 40

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VOL 8. NO. 24 OCTOBER 16-31, 2013

CONTENTS

Chairman of the Board Viveck Goenka

MANAGEMENT

Editor Viveka Roychowdhury*

Effect of BITs on patents PG 41 Regulatory transparency and integration key driver of future healthcare industry PG 43

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

RESEARCH

Bangalore Neelam M Kachhap

Novartis’ Gilenya reduces brain volume loss by one third in MS patients: Study PG 45 Technique allows direct functionalisation of alkenes without metallic reagents PG 46

Delhi Shalini Gupta MARKETING Deputy General Manager Harit Mohanty

PHARMA ALLY

Senior Manager Rajesh Bhatkal

‘We will continue to develop and offer new innovative products to meet industry demands’ PG 50 Clariant Chemicals (India) receives Responsible Care PG 51

PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Sr. Executive- Scheduling & Coordination Rohan Thakkar

PHARMA LIFE

Deputy Art Director Surajit Patro

OPPI awards at 47th AGM PG 80 Chandru Shahani: A man who won against all odds PG 82

Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka Photo Editor Sandeep Patil Layout Rakesh Sharma C I R C U L AT I O N Circulation Team Mohan Varadkar Express Pharma Reg. No.MH/MR/SOUTH-77/2013-15 RNI Regn. No.MAHENG/2005/21398 Printed for the proprietors,The Indian Express Limited by Ms.Vaidehi Thakar at The Indian Express Press, Plot No. EL-208,TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright @ 2011 The Indian Express Ltd. All rights reserved throughout the world. Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

October 16-31, 2013

MARKET

TURN TO PAGE 21 TO FIND SPECIAL DEALS

‘Access to pharma and healthcare remain a key issue in China’ PG 18 Bharat Biotech launches JENVAC

PG 20

Piramal Enterprise’s heritage brand ‘Saridon’ wins three Emvie Media Awards 21 Sanofi, IDF and PHFI partner to fight diabetes among children in India

PG 22

Sun Pharma and Intrexon form joint venture PG 24 Sept’03 sees significant volume dip in global pharma M&A: Medtrack PG 26 IGCW-2013 to drive implementation of green chemistry and engineering practices PG 27

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EDITOR’S NOTE Finding the new normal

THE GOVERNMENT'S CAUTIOUS STANCE ON FDI CURTAILS SUCH DEALS, TO THE DETRIMENT OF CORPORATES, GLOBAL AND LOCAL, AS WELL AS PATIENTS

Two global pharma CEOs, two years apart, making essentially the same sounds. That, in a nutshell, is the paradox presented by the India market. Tantalisingly huge to resist, but a tough one to crack. Andrew Witty, GSK's global CEO had exhorted his colleagues to "get the balance right" at OPPI's 45th AGM in 2011 (See report: 'We must get the balance right: Witty at OPPI AGM', Express Pharma Oct 16-31, 2011: http://pharma.financialexpress.com/ 20111031/market18.shtml) "Is the industry intelligent enough to contribute rather than conflict with the government?," he asked. "We have to think long term and recognise that many people are required for the solution," he said. And at this year's OPPI AGM, Sanofi CEO, Chris Viehbacher made essentially the same point on the perception of the global pharma industry when he said, "We have an obligation to go beyond other businesses and have to be an exemplar of ethics and compliance." Viehbacher's company does have a long history in India, and he pointed out to the acquisition of and investment in Shantha Biotech as proof that Sanofi does not have a "colonial" mindset towards India. He was making the point that the Government's cautious stance on foreign direct investment (FDI) curtails such deals, to the detriment of corporates, global and local, as well as

patients. Praising the achievements of Shantha Biotech’s founder, Dr Varaprasad Reddy, also seated in the audience, he said his company's interest was to realise Dr Reddy's vision of supplying affordable high quality vaccines to the children of India as well as the world. In essence, both global CEOs were underlining the natural symbiosis between global and local companies to serve patients at both levels. But issues like India's FDI policy and IP laws have both sides worried. "If in the long term we have to thrive, in the short term we must survive," stressed Viehbacher. He did go on to add that he would not evaluate a country on the short term and wouldn't make the mistake of betting against (India's) demography. Indeed, Sanofi is rumoured to be close to buying Elder Pharma's domestic formulation business. He seemed to advocate more efforts to change public perceptions, saying, "We must demonstrate that patents are not a block to greater access.” Arguments to increase FDI in Indian pharma, tone down IP laws or ease up on the clinical trials industry will continue. (See cover story in this issue: Clinical trials in India: The churn continues). The new price control regime is also a sore point with the industry. But given the Government’s stance so far, it looks like the industry will have to find a way to cope with the new normal. Viveka Roychowdhury viveka.r@expressindia.com

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12 EXPRESS PHARMA

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October 16-31, 2013

MARKET THE BUSINESS OF PHARMACEUTICALS

W H AT ’ S INSIDE

‘Access to pharma and healthcare remain a key issue in China’ PG 18 Bharat Biotech launches JENVAC PG 20 Piramal Enterprise’s heritage brand ‘Saridon’ wins three Emvie Media Awards PG 21 Sanofi, IDF and PHFI partner to fight diabetes among children in India PG 22 Suven Life secures three product patents from New Zealand, Singapore and South Korea PG 23 Sun Pharma and Intrexon form joint venture PG 24 IGCW-2013 to drive implementation of green chemistry and engineering practices PG 27 5th India Lab Expo to be held at Hitex Exhibition Centre, Hyderabad PG 28 65th IPC to be held in Delhi PG 29 2nd edition of Indian Pharma Expo achieves huge success PG 31

MANAGEMENT 35 RESEARCH 44 PACKAGING SPECIAL 49 PHARMA LIFE 80 October 16-31, 2013

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I Indian pharma sector's consistent progress is being further propelled by the growing implementation of IT services. Pharma players have come to realise that the use of IT services have indeed left a positive impact on their operational efficiency and in turn on their balance sheets.

IT services in pharma Dr Appaji PV, Director General, Pharmexcil says that IT plays a big role in the pharma sector, especially drug discovery, drug candidate designing, clinical research etc. It is also used for the submission of applications for overseas drug registrations in the common technical document (CTD) format. “IT has several applications in the drug standardisation/identification procedures as well,” he adds. According to Anagha Vyas, PaxPro Business Unit, Persistent Systems, India has been the preferred location for multinational drug manufacturers since the last few years. Now, they also look towards India for areas like discovery research, clinical trials and other administrative activities; and the use of IT would help to sustain this interest. PaxPro is a provider of Brand Lifecycle Management (BLM) solutions for the FDA regulated industries. She says, “IT services can largely be used in clinical and biotechnical research for drug development, medical devices, regulatory compliance management, supply chain management, data management, pharmacovigilance, business process outsourcing and IT infrastructure man-

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agement.” Realising the growth potential in the Indian pharma sector, IT solution providers are also introducing innovative and tailormade solutions to keep up the growth momentum. “The IT solutions today provide comprehensive services around acceleration of drug discovery, enhance clinical trial efficiencies, maximise manufacturing productivity, improve sales and marketing effectiveness, and manage the end-to-end product development. However most of the domestic pharma companies seek IT services for order planning, procurement, end-to-end sales cycle, better analysis of sales funnels, budgeting and resource allocation etc. Abstract enterprise applications that address sales and distribution, financial planning, supply chain, material management and warehousing solutions are also in demand in the Indian context,” informs Utkarsh Palnitkar, Head, Life Sciences, KPMG, India.

Pharma needs more IT IT is doing wonders for the pharma industry, but it is no where near sectors like financial services (banking, insurance, mutual funds), telecom, retail and the government who make up the key consumers of IT services in India. According to Palnitkar, these sectors command a lion’s share of current $10.2 billion domestic IT services. He informs, “As per the Datamonitor Global IT-BPO Services Forecast report, the Indian pharma IT services market is estimated to be at $ 443 million growing at 14 per www.expresspharmaonline.com

DR APPAJI PV

UTKARSH PALNITKAR

Director General, Pharmexcil

Head, Life Sciences, KPMG, India

IT plays a big role in the pharma sector, especially drug discovery, drug candidate designing, clinical research etc. It is also used for the submission of applications for overseas drug registrations in the common technical document (CTD) format

Abstract enterprise applications that address sales and distribution, financial planning, supply chain, material management and warehousing solutions are also in demand in the Indian context

cent year-on-year (YOY).” Palnitkar adds, “Though the life sciences industry is behind the top tier sectors, the mid level pharma companies are now fast realising the benefits of IT services so as to achieve cost efficiencies, streamline operations and more importantly meet the emerging stringent compliance guidelines. This would peg the addressable market size for IT service in pharma to be around 2X-3X times the current market size.” Thus, Indian pharma companies are slowly and steadily but definitely becoming more IT-savvy. However pharma MNCs, with their technology friendly attitude, are likely to constitute the major client base for IT solution providers, atleast for some more years to come.

able and operationally more efficient; a goal that cannot be achieved without the help of the requisite IT services. According to Vyas, pharma companies are vying with each other to explore new drugs. They are rapidly moving from clinical pilots to commercial scale manufacturing. She says, “A head start in launching a new product brings in significant return on investment (ROI). In this race to reduce the time to market, it is imperative to safeguard against errors that lead to recalls. The opportunity to leapfrog the competition is by adopting automation. We believe that pharma companies today need to automate or they will perish. High order of compliance and lengthy review cycles across multiple departments make the whole product development cycle longer and difficult to manage without automation.” She illustrates her point recounting how a Paxpro customer mentioned that they could triple their product releases with zero increase in headcount across departments just by implementing Paxpro. Spelling out the advantages, she says the customer now has better control of their entire process automation to

Market drivers Today, by volume Indian pharma industry is the third largest in the world. Almost every country in the world consumes some form of medicine manufactured in India. There is cut throat competition among Indian companies to gain a bigger share in the global market. Therefore, pharma companies have no option but to become more productive, internationally more accept-

October 16-31, 2013

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replace manual review and inspection tasks, greater collaboration through online tools, and one 'system of records' through integration with their other systems.

IT solutions for regulatory challenges Pharma regulatory requirements in overseas countries are always considered more stringent than in India. Use of IT services would perhaps play a major role in projecting Indian pharma industry as more quality conscious and serious about its business, a reason why pharma players in India have become more conscious of their IT deployment. Palnitkar says, “IT services have evolved over the past decade and today offer integrated solutions right from product development to post marketing surveillance. These services can be classified into research, compliance and post marketing activities. Discovery and preclinical solutions address lab automations (Laboratory

October 16-31, 2013

Information Management System (LIMS), Electronic Laboratory Notebook (ELN), Clinical Data Management System (CDMS), Scientific Data Management System (SDMS), compound registration systems), biomarker research, decision support systems as well as bio and chemo informatics areas. These solutions help achieve decreased clinical cycle times, optimise the work flow between various streams, standardise the process across trial locations and hence better present the metrics/data to regulators.” He adds, “Compliance services include audits that cover process adequacy, maturity, physical infrastructure, information security and IP protection. The solutions provide submissions management, labelling and digital asset management, application development and maintenance services that are fully 21 CFR 11 and CSV compliant etc. which expedite regulatory clearances by ensuring com-

ANAGHA VYAS PaxPro Business Unit, Persistent Systems

Automated environments have strict audit trails and security policies in place. These reduce the efforts needed to prove compliance to regulatory bodies enabling shorter approval cycles

SHYAMANTA PHUKON Project Manager, Enterprise IT Consulting, Blue Star Infotech

The relationship from vendor-client has transformed to a partnership model. There are already major IT service providers that have entered the pharma space and are playing key roles in the areas like medical writing, pharmacovigilance, bio stats etc

pliance. Finally, there are solutions for pharmacovigilance that help address the vigilance roadmap, maturity and gap analysis, product evaluation and vendor identification, signal detection, regulatory and business risks etc. that aid in compliance, faster reporting and corrective measures.” According to Vyas, the primary role of the regulatory teams is to ensure that products comply with the regulations and laws designed by the government to protect public health and she asserts, “Automation of the business processes forms a major part of this initiative to prevent errors due to mundane and repetitive work and improve quality. Automated environments have strict audit trails and security policies in place. These reduce the efforts needed to prove compliance to regulatory bodies enabling shorter approval cycles.” Continued on Page 25

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‘Access to pharma and healthcare remain a key issue in China’ MNC pharma is under scrutiny in China over claims of corruption and bribery. However, it remains a strategic market for pharma companies and collaborative partnerships are on the rise. Cher Boon Piang, Pharmaceuticals & Healthcare Analyst, at Business Monitor International reveals more details in an interview with Shalini Gupta

INTERVIEW

Stringent enablement requirements imposed in different State Intellectual Property Office (SIPO) guidelines remain a concern for big pharma companies. Compare this with the IP scenario in India. The Indian government has revoked and/or rejected patents and this is negative from a multinational pharma company's perspective. While there may be delays in getting patent approved, an issue not unique to China, we have yet to see a trend of such IP revocation/ rejection in China.

How much is the China pharmaceutical market worth in 2013 vis-a-vis that in 2008? What is the CAGR? How does this compare to India? Between 2007 and 2012, China's pharma market grew by a compound annual growth rate of 23.9 per cent in local currency terms (28.6 per cent in US dollar terms), higher than India (17.3 per cent in local currency, 11.4 per cent in US dollars terms). We expect this outperformance to continue over the coming decade. By 2022, we forecast that the Chinese pharma market will reach ($198 billion), far larger than India’s figure of ` 2,330 billion ($41 billion). China remains a dream market for MNC pharma, most of whom are already seeing double digit sales growth.Why? Compare this with India. A key reason for China's superior growth story is the government's commitment to healthcare. Latest data from the WHO showed that the proportion of government expenditure reached 55.9 per cent in 2011. In India, government health expenditure as a per cent of the total has remained rather consistent since 1995, with the highest proportion in 2011 at 31 per cent, significantly less than that of China. From a more macro perspective, government health expenditure as a percentage of GDP reached 2.9 per cent in 2011 for China, more than double the 1.2 per cent seen in India. The disparity in health commitment has far reaching effects, largely due to the interdependence of the phar-

China’s economic planning agency is also investigating the costs and prices of foreign drug makers, specially those on an approved list that are subsidised and purchased in bulk by local government with drugs such as Lantus by Sanofi added to the list in March. Which other drugs have made to the list? Note that China has two lists: National Essential Drug List (NEDL) and National Drug Reimbursement List (NDRL). Due to the more expensive nature of their drugs, MNCs' drugs are listed in NDRL. China has revised the NEDL in 2013, but the last revision of NDRL was in 2009. ma and healthcare sector. The attractiveness of the Chinese pharma market is also reflected in their revenues. In the case of AstraZeneca, the firm generated $431 million in Q2 2013 (quarter ending June 30, 2013) but in India, it only generated $22.3 million in the same quarter. Similarly for Merck & Co, revenues generated in China ($297 million) were eight times greater than those generated in India ($37 mil-

Snapshots of selected MNC dr ugs listed in NDRL Company

2004

2009

Drugs Removed From List

AstraZeneca

Pfizer

Bayer

Sanofi

Roche Novartis

18 39

20 46

Zelmac (tegaserod)

GlaxoSmithKline

Fraxiparine(nadroparin),Ridaura(auranofin)

Novo Nordisk

Merck & Co

Vioxx(rofecoxib),Crixivan(indinavir sulfate),Stocrin(efavirenz)

Johnson Johnson

Hismanal\(astemizole)

Cefobid(cefoperazone),Fragmin(dalteparin)

Source: Ministry of Human Resources and Social Security, China

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lion). For Novo Nordisk and AstraZeneca, meanwhile, sales in China represented 8.3 per cent and 6.9 per cent respectively of their total revenues in Q2 2013.

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In such an environment, do you see more MNCs follow suit with GSK and announce price cuts? What kind of marketing reforms and strategy would companies have, moving forward? We believe that such corruption is unlikely to be completely eradicated, unless the country offers a better operating environment for its hospitals (potentially at the expense of patients). More importantly, one of the GSK detainees publicly admitted that bribes were also offered to government officials in addition to hospitals, highlighting that systemic faults continue to exist in the government, despite the 2007 execution of the former director of the State Food and Drug Administration (SFDA), Zheng Xiaoyu, for his role in accepting bribes. Following the investigation, GSK announced that it will reduce its drug prices in the country. This was rather similar to the infant formula sector in which the government's investigation into the pricing and competitive practices of the country's leading infant formula producers prompted a wave of price cuts across the infant nutrition segment, involving companies like Mead Johnson, Nestle, Danone, Biostime and Meiji. Despite this similarity, we do not October 16-31, 2013

M|A|R|K|E|T believe that other MNC pharma firms will follow suit in lowering prices. The infant formula sector was largely investigated for a potential breach in antimonopoly law, a law which is difficult to prove in the pharma sector, owing to the highly varied products that the sector manufactures. In addition, there has not been much evidence that pointed to corrupted practices in other pharma firms. Therefore, by reducing their prices prematurely, these firms run the risk of being perceived as guilty of corruption. Nevertheless, we believe that government will increasingly use cost containment to reduce its financial burden in healthcare provision. Therefore, over the long-term price reductions of drug prices will be imminent. Over the short term, pharma MNCs will see a negative impact from these pricing investigations. With such uncertainties, we expect companies to cut back on sales visits to medical professionals or other marketing activities such as conferences. The lower numbers of outreach to the medical professionals may potentially lead to a slowdown in sales. Companies may also look into stepping up pharmacoeconomic studies to better justify the costs of their drugs should they be put under the spotlight, particularly for drugs that are listed on the National Reimbursement and/or

Essential Drug Lists. More importantly, longer-term optimism in the healthcare sector continues to exist in the country, therefore pulling out of the market will be detrimental to MNC pharma firms, some of which are facing slow or negative growth in developed markets due to various reasons including austerity measures and/or patent expirations. Access to pharma and healthcare remain as a key issue in the country, despite the government's consistent effort in weaving the world's largest universal health safety net, and pharma firms should therefore continue to market their products into lower tiered cities where there are larger unmet medical needs. China’s health spending is projected to rocket from $357 billion in 2011 to $1 trillion in 2020, according to a McKinsey report. Despite barriers and the continuing investigation, what opportunities currently exist for collaborations in the future? BMI notes that collaborative partnerships involving small biomedical companies/institutions from China and similar entities from developed states are increasingly common. More are expected to emerge, primarily due to the strong growth potential of the Chinese pharma market, which itself is being positively influenced by the country’s

12th Five-Year Plan over the period 2011-15. The Chinese government intends to boost innovation and development of the biological industry through various projects, such as building databases of genetic information and constructing research and development bases for biopharmaceuticals. The country’s plan to transform its biotechnology sector will mean better support for companies focusing on this high-growth sub-sector which will, over the long term, increase the sophistication of the biotechnology industry. The government is also encouraging Haigui 'sea turtles' (the Mandarin term for overseas-educated Chinese who return from abroad) to move back to China. The return of these scientists will mean the industry continues to attract R&D commitment from local companies, as they are equipped with skills learnt in developed countries as well as having knowledge of Chinese culture and the work ethics. Therefore, we continue to expect foreign firms to partner local firms in biomedical R&D, making use of the increasing local research expertise. Most 'sea turtles' come from the US and the majority of the recent partnerships are between US and Chinese firms. shalinig@expressindia.com

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"Calyx Chemicals and Pharmaceuticals Limited (the “Company”) is proposing to make, subject to receipt of requisite approvals, market conditions and other considerations, an Initial Public Offering of its equity shares (the “IPO") and has filed the Draft Red Herring Prospectus (the “DRHP”) with the Securities and Exchange Board of India (“SEBI”). The DRHP is available on the website of SEBI at www.sebi.gov.in, the website of the BRLMs, i.e. PL Capital Markets Private Limited at www.plindia.com and YES Bank Limited at www.yesbank.in and is also available on the website of the Company at www.calyx-pharma.com. Potential investors should note that investment in equity shares involves a degree of risk. For details, please refer to the DRHP, including the section titled “Risk Factors” of the DRHP. This publicity material does not constitute an offer of securities in any jurisdiction, including the United States of America (“USA”). Securities may not be offered or sold in the USA without registration under the U.S. Securities Act of 1933 as amended, or an exemption therefrom. The Company has not and does not intend to offer any securities to the public in the USA”.

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COMPANY WATCH

Bharat Biotech launches JENVAC The uniqueness of JENVAC is its excellent clinical data on safety and immunogenicity

enome Valley (Hyderabad)-based vaccine and bio-therapeutic innovator, Bharat Biotech recently launched its vero cell-derived purified inactivated JE vaccine ‘JENVAC’ which received manufacturing and marketing approvals from Drug Controller General (India) (DCGI). It is a fully indigenous vaccine commercialised using strain, identified, characterised, manufactured and tested in India. The uniqueness of JENVAC is its strength to provide increased immunogenicity and long-term protection as a result of unique manufacturing technologies. The virus strain for this vaccine was isolated in Kolar, Karnataka during the early 1980s and characterised by the National Institute of Virology, Pune and the strains were later transferred to Bharat Biotech for further vaccine development. The vaccine candidate strain was adapted to vero cell substrate and is manufactured using novel purification, inactivation techniques with advanced bioreactor technology. The most significant benefit JENVAC brings over live attenuated vaccines is that it can be administered during disease epidemics because it is a highly purified and inactivated vaccine. Dr VM Katoch, Secretary Department of Health Research, Government of India, said, “JENVAC not only represents a successful example of developing a totally Indian product of immense public health importance by publicprivate partnership but also will prove to be a good stimulus to Indian Council of Medical Research (ICMR) institutes and other institutions to move fast with their leads to fully developed products by following this route.” In clinical trials, JENVAC showed superior safety and immunogenicity, in head-to-head comparison with the live SA14-14-2 vaccine. JENVAC met all its primary and secondary endpoints, in the age group of one to 50 years, after one or two doses of vaccination. Phase III trials

showed 98.7 per cent sero-protection 28 days after the first dose and 99.8 per cent sero-protection 28 days after dose the second dose. The results proved that JENVAC can be administered as a single dose during epidemics for mass vaccination campaigns and also as a two dose schedule during routine immunisation as part of the national immunisation programme in endemic regions. The added benefit of JENVAC is its ability to provide long-term sero-protection. Dr Krishna M Ella, Chairman and Managing Director, Bharat Biotech, said ,“JENVAC is a product of years of committed R&D. It is yet another clone to clinic milestone for the Bharat Biotech team. JENVAC has the potential to reduce disease burden and reduce India’s import of JE vaccines. Bharat Biotech has a long history of developing novel healthcare solutions through public private partnerships, we hope to continue the same in years to come.” Japanese encephalitis is the most common cause of viral encephalitis in Asia-Pacific. It causes inflammation of the brain, symptoms include high fever, headache, sensitivity to light, stiff neck and back, vomiting, confusion and, in severe cases, seizures, paralysis and

coma. The disease which is transmitted via mosquitoes, with pigs and water birds acting as amplifying hosts for the virus, is the leading cause of viral encephalitis in Asia with ~50,000 clinical cases reported annually. The numbers of JE cases are vastly under-reported due to the lack of good surveillance infrastructure in affected countries. According to estimates, JE has infected approximately 10 million children globally, killing three million and causing long-term disability in four million children. JENVAC has the potential to prevent millions of infections, thereby saving lives and preventing longterm disability in millions, not just in India, but also in South East Asia, and Asia at large. According to a press release, Bharat Biotech will pursue a dual pricing strategy for JENVAC to cater to the needs of government agencies and those of the private market. The current manufacturing capacity of JENVAC is ~20 million doses, expandable to 60 million doses based on market requirements. The vaccine is available in both single dose and five dose presentations.”

Lupin launches generic Zymaxid ophthalmic solution in the US L Is indicated for the treatment of bacterial conjunctivitis

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upin has launched its generic Gatifloxacin ophthalmic solution, 0.5 per cent. Lupin had earlier received final approval from the United States Food and Drugs Administration (US FDA) to market a generic version of Allergan’s Zymaxid ophthalmic solution, 0.5 per cent.

Lupin’s Gatifloxacin ophthalmic solution 0.5 per cent is the generic equivalent of Zymaxid ophthalmic solution of Allergan and is indicated for the treatment of bacterial conjunctivitis. Zymaxid ophthalmic solution, 0.5 per cent, had annual US sales of approximately $62.3 million (IMS MAT Jun 2013). Lupin www.expresspharmaonline.com

was the first applicant to file an ANDA for Zymaxid ophthalmic solution and as such will be entitled to 180 days of marketing exclusivity. Commenting on the approval, Nilesh Gupta, Managing Director, Lupin said, “Having received approval earlier, we are happy to now launch this

EP News Bureau - Mumbai

product. The product is the first of the ophthalmic products that Lupin is bringing to the market and bears testimony to our continued commitment to serving our customers and patients by bringing high quality, affordable medicines.” EP News Bureau - Mumbai October 16-31, 2013

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Piramal Enterprise’s heritage brand ‘Saridon’ wins three Emvie Media Awards Receives gold award in both nominated categories for Best Media Strategy and Best Media Innovation on Radio

ing some of the movies that are dished out currently, consumers felt that at the end of the two-hour ordeal

they got nothing out except a headache. Saridon thus became an integral part of the conversation about a

movie review. We just converted this insight into a brand property. We are looking for more such win-

win partnerships to take this forward.” EP News Bureau -Mumbai

iramal Enterprise’s Saridon, India's headache analgesic, has won two Gold Emvie Media Awards 2013 for 'Best Media Strategy' and 'Best Media Innovation on Radio'. It is also honoured with 'The People’s Choice Award' for the top 10 advertisers in 2013 at The EMVIES 2013, instituted by the Advertising Club, India. Saridon’s 'Filmi Headache Meter' or the 'Saridon Movie Review' campaign was a big hit among the masses wherein the brand roped in the media agency Lodestar UM to use movie reviews along with other relevant headache properties to drive engagement with consumer in an entertaining yet relevant manner. Saridon was also positioned as 'The National Headache Reliever' as it looked at various headache situations in media. The best movie reviewers in the industry used the Saridon and headache association to ‘Saridon rate’ a movie. With a total of 9680 interventions during stressful content and more than 50,000 seconds of Saridon associations on media, Saridon received five stars for its performance in 2013. Kedar Rajadnye, President and Chief Operating Officer, Consumer Products, Piramal Enterprises said, “It is indeed a moment of pride for us to win these prestigious Emvie Media Awards. We may not have the big budgets of some of other brands but we make that up by being focussed to our brand core. Saridon’s 'Filmi Headache Meter' is an interesting way movie reviews are done. This property emerged from voice of our consumers. Movies have become a part and parcel of our lives now and the see-

October 16-31, 2013

www.expresspharmaonline.com

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Sanofi, IDF and PHFI partner to fight diabetes among children in India KiDS project aims to foster a school environment that creates a better understanding of diabetes and support children with this condition

(L-R) Sir Michael Hirst, President, IDF and Chris Viehbacher, Chief Executive Officer, Sanofi launch the KiDs initiative anofi, the International Diabetes Federation (IDF) and Public Health Foundation of India (PHFI) recently launched a joint public health initiative in India: Kids and Diabetes in Schools (KiDS). For children with type I diabetes, the project aims to encourage a safe and supportive school environment to manage their diabetes and avoid discrimination. In addition, the programme will raise awareness on diabetes (type I and type II) and benefits of healthy nutrition and exercise habits among school children. In India, diabetes is a major public health challenge and the country is today ranked at No. 2 globally. While type II diabetes has received considerable attention in interventions, it has not been so for Juvenile or type I diabetes, even though one out of five children with type I diabetes in the world would be an Indian (Ref.: International Diabetes Federation Diabetes Atlas. 5th ed. Brussels: IDF; 2011). The proposed schoolbased intervention will not

EXPRESS PHARMA

just focus on type I, but also type II diabetes since the prevalence of obesity is increasing and people are developing type II diabetes at a younger age. This will ensure overall benefit to school children of all age groups and their families. Launching the KiDS project at a media conference in Mumbai, Chris Viehbacher, Chief Executive Officer, Sanofi stated, “As a global leader in diabetes care, we focus on bringing real benefits to people with diabetes, not just providing a comprehensive portfolio of treatments and innovative patientfriendly devices, but also accompanying them in their daily life. With close support, we can really make a difference in patient outcomes so we are committed to partnering with key stakeholders to create the best patient support programmes possible. In India, through our alliance with IDF and PHFI, the KiDS project will help children with type I diabetes fight discrimination and manage their disease better. The project will also include health education www.expresspharmaonline.com

IN INDIA, DIABETES IS A MAJOR PUBLIC HEALTH CHALLENGE AND THE COUNTRY IS TODAY RANKED AT NO. 2 GLOBALLY for the school children to curb the increasing burden of type II diabetes.” “In a developing country like India, barriers to diabetes self-management at school are significant,” said Sir Michael Hirst, President, IDF. “By engaging with policy makers and education authorities, organising meetings in local communities and providing educational resources to schools, KiDS will raise awareness of diabetes, and the benefits of healthy nutrition and exercise habits among school-age children. IDF is delighted

that, in partnership with Sanofi and PHFI, KiDS will bring about a systemic change for children with diabetes in schools.” In a pre recorded message, Dr K Srinath Reddy, President, PHFI said, “The programme’s first step was a feasibility study to understand the status of diabetes management by reviewing current policies on diabetes in schools, existing school guidelines and initiatives, any best practices and identify gaps in the knowledge so that appropriate resources and dissemination routes can be developed. We found that there are no structured training programmes, plan or activity, implemented in the school settings that focus on diabetes management. Almost all the respondents emphasised the need for a comprehensive awareness/ educational programme in schools to sensitise students, teachers and parents on management of type I diabetes, and control of risk factors for type II diabetes.” EP News Bureau - Mumbai October 16-31, 2013

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Suven Life secures three product patents from New Zealand, Singapore and South Korea The patents are valid through 2029, 2030 and 2028 uven Life Sciences has secured three product patents one each from New Zealand (598505), Singapore (188212) and South Korea (10-1268654) corresponding to the New Chemical Entities (NCEs) for the treatment of disorders associated with neurodegenerative diseases. The patents are valid through 2029, 2030 and 2028 respectively. The granted claims of the patents include the class of selective 5-HT compounds discovered by Suven and are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer’s disease, Attention Deficient Hyperactivity Disorder (ADHD), Huntington’s disease, Parkinson disease and schizophrenia. With these new patents, Suven has a total of 17 granted patents from New Zealand, 16 granted patents from Singapore and 11 granted patents from South Korea. These granted patents are exclusive intellectual property of Suven and are achieved through the internal discovery research efforts. Products out of these inventions may be out-licensed at various phases of clinical development like at phase-I or phase-II. “We are pleased by the grant of these patents to Suven for our pipeline of molecules in CNS arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally,” says Venkat Jasti, Chief Executive Officer, Suven.

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EP News Bureau - Mumbai October 16-31, 2013

www.expresspharmaonline.com

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Sun Pharma and Intrexon form joint venture The joint venture will leverage Sun Pharma’s global capabilities and experience in developing and manufacturing complex dosage forms and specialty pharmaceuticals for niche therapy areas

un Pharmaceutical Industries through its subsidiary, and Intrexon Corporation, announced the formation of a joint venture to develop controllable genebased therapies for the treatment of ocular diseases that cause partial or total blindness in millions of people worldwide. Initial targets are dry age-related macular degeneration (AMD), glaucoma and retinitis pigmentosa. The joint venture will leverage Sun Pharma’s global capabilities and experience in developing and manufacturing complex dosage forms and specialty pharmaceuticals for niche therapy areas. Intrexon and Sun Pharma will share in both the financing of, and the revenues from, the joint venture. Through an Exclusive Channel Collaboration (ECC), the joint venture will have access to Intrexon’s full suite of proprietary synthetic biology technologies, including the RheoSwitch Therapeutic System (RTS) platform. RTS is a clinically validated method for controlling the location, concentration and timing of protein expression. RTS may

address a long-standing limitation of current approaches by enabling patients to receive a targeted biologic therapy without having to endure a lifetime of injections. The companies intend to further expand the future pipeline of targeted ocular diseases to potentially include wet AMD, macular edema, non-infectious uveitis and diabetic retinopathy. Samuel Broder, Senior Vice President, Intrexon’s Health Sector and Former Director of the National Cancer Institute noted that current treatments for major ocular disorders require frequent and often painful interventions that, at best, only slow the progression of the disease.

“Using our RTS platform, the goal is to engineer a genebased ocular treatment in which the concentration, location and timing of protein expression can be controlled with small molecule therapy,” Dr Broder said. “In combination with Sun Pharma’s tremendous development and manufacturing experience, we hope to produce a therapy that is minimally invasive as well as maximally effective in treating these debilitating diseases.” Dilip Shanghvi, Managing Director, Sun Pharma, said, “We believe Intrexon’s biotechnology capabilities will enable us to develop not one, but several highly effec-

THE COMPANIES INTEND TO FURTHER EXPAND THE FUTURE PIPELINE OF TARGETED OCULAR DISEASES TO POTENTIALLY INCLUDE WET AMD, MACULAR EDEMA, NON-INFECTIOUS UVEITIS AND DIABETIC RETINOPATHY

tive, novel treatments for multiple ocular disorders where there is currently an unmet need. Through this partnership it is our goal to provide relief for millions of people who today have very few treatment options and little hope of preserving their vision.” Randal J Kirk, Chairman and Chief Executive Officer, Intrexon, said the collaboration between Sun Pharma and Intrexon is a model relationship aligned to accelerate development and production of new bio-engineered therapies. Kirk said. “To address this immense unmet need, our innovative collaboration will unite Sun Pharma’s global capability to develop and manufacture complex pharmaceuticals with Intrexon’s proprietary cell and gene engineering technologies. We share Sun Pharma’s enthusiasm for the potential of our venture to produce a pipeline of product opportunities aimed at well-validated therapeutic targets.” EP News Bureau - Mumbai

Merck Serono and Ablynx strengthen collaboration Both partners will jointly select disease targets against which this group will develop nanobodies

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erck Serono, the biopharma division of Merck, and Ablynx have further expanded their relationship through a multiyear research alliance that could lead to several co-discovery and co-development collaborations. Under the terms of the agreement, Merck Serono will fund a dedicated discovery group at Ablynx. Both partners will jointly select disease targets against which this group will develop nanobodies, up to in vivo proof-of-principle. The dedicated group will focus on the discovery and development of nanobodies against a number of targets across multiple disease areas. The collaboration will span all of Merck Serono’s core research and development fields, including oncology, i m m u n o - o n c o l o g y, immunology and neurology. “We have established a trustful and productive partnership with Ablynx and a first compound has entered phase I at the beginning of

2013,” stated Dr Bernhard Kirschbaum, Executive Vice President, Head of Global Research and Early Development at Merck Serono and Member of the Merck Serono Executive Board. “Through our extensive collaboration history with Ablynx, both sides know how best to conceptually design programmes to ensure technology fit, differentiation potential, and a clear scientific rationale. Our common goal is to develop novel biologics with a high degree of differentiation for high-value therapeutic targets.” Dr Edwin Moses, Chairman and Chief Executive Officer, Ablynx commented, “This is an exciting expansion of our

partnership with Merck Serono, building on the success of our existing collaborations and allowing us to exploit the broad and powerful applicability of our Nanobody platform with a partner with whom we have successfully worked for over five years. The new alliance is an early stage discovery initiative, which allows the companies to rapidly explore the potential of novel targets across a range of therapeutic areas and to determine which programmes should be prioritised for later stage development. It is an interesting model that could create substantial value for both parties and one which we believe could be applicable for us in other

THE RESEARCH ALLIANCE WILL HAVE A TERM OF FOUR YEARS, WITH THE OPTION TO EXTEND BY TWO AND A HALF YEARS www.expresspharmaonline.com

partnerships.” The research alliance will have a term of four years, with the option to extend by two and a half years. Research funding from Merck Serono over the first four years will be over ¤ 25 million, including an initial payment of ¤ 11.5 million at signing, and will aim to ensure that the collaboration could deliver at least six programmes with proof-of-principle in a relevant animal model. In addition, depending on the successful achievement of in vivo proof-of-principle in sufficient programmes, Merck Serono will commit to taking at least four programmes forward with Ablynx in co-discovery and co-development arrangements. This co-development concept will extend the collaboration between both companies which started when they signed their first contract in 2008, followed by two additional agreements in 2010 and 2011. EP News Bureau - Mumbai October 16-31, 2013

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IT@ pharma: Spearheading the progress Continued from Page - 17

More to come Though Indian pharma firms lag behind their global counterparts as far as R&D is concerned, we are trying to catch up and launch more innovative products. A surge in R&D activity is bound to generate a lot of data. Managing this data without automation, will be an uphill task. Hence, this will open up more growth opportunities for the IT sector and R&D is just a fraction of operations that take place within the pharma industry. Vyas reveals more, “What we are seeing now is the next wave of technology investments by the pharma companies where they are trying to automate and connect the various lines of business such as packaging, graphics, R&D, regulatory affairs, finance, together to name a few onto a single platform. This is where business process automation (BPM) solutions come into the picture. BPM solutions that are custom developed for the pharma industry is something that the pharma CIO’s are looking for.” She adds, “Cloud and mobile services are becoming key enablers for pharma companies. Cloud today enables CIOs to quickly roll out solutions across business lines with zero IT investment. Similarly, mobile solutions enable shop-floor workers and the mobile workforce to be more productive and connected with the rest of the organisation, thus improving productivity and morale.” According to Shyamanta Phukon, Project Manager, Enterprise IT Consulting, Blue Star Infotech, IT services have been constantly evolving in delivering value to the pharma industry and played a strong role in business enablement. He says, “The relationship from vendor-client has transformed to a partnership model. There are already major IT service providers that have entered the pharma space and are playing key roles in the areas like medical writing, pharmacovigilance, bio stats etc.” October 16-31, 2013

He adds that a decade ago these would have been core areas for the pharma industry but now they are a part of the IT services offered. “The existing partnership saga would continue to evolve, and with fur-

ther innovation, there would be more areas in the drug development lifecycle that IT services would penetrate for enabling more business.” Thus, the current scenario offers synergistic

growth for both IT and pharma sectors. India is a cost-effective destination for drug manufacturing, a great lure for foreign players. Moreover, if the government does decide to relax FDI norms further,

with the requisite conditions, more MNCs could make India their base. It will be interesting to see how the IT sector responds to this development. sachin.jagdale@expressindia.com

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M|A|R|K|E|T DEAL TRACKER

Septâ&#x20AC;&#x2122;03 sees significant volume dip in global pharma M&A: Medtrack September saw no deals recorded in India

M&A (including private equity) trend analysis

3 5

11 16

1 4 3

& '

# $ ! % !

Source:

Top M&A deals (Sept 2013) Rank

Date

Target

Acquirer

Deal value ($m)

09/11/13

Adcock Ingram Limited (ZA)

CFR Pharmaceuticals S.A. (CL)

1,262.31

09/05/13

Astex Pharmaceuticals, Inc. (US)

Otsuka Pharmaceutical Co., Ltd. (JP)

866.00

09/16/13

Cornerstone Therapeutics, Inc. (US)

Chiesi Farmaceutici SpA (IT)

255.00

09/09/13

Laboratorios Casen Fleet S.L. (ES)

Recordati S.p.A. (IT)

122.60

09/20/13

Verenium Corporation (US)

BASF Corporation (US)

62.00

09/10/13

IGDRASOL (US)

Sorrento Therapeutics, Inc. (US)

28.20

09/12/13

Molecular Profiles (GB)

25.00

09/ 27/13

Inotek Pharmaceuticals Corporation (KR)

Columbia Laboratories, Inc. (US) Devon Park Bioventures; Rho Ventures; Care Capital LLC; MedImmune Ventures, Inc. ; Pitango Venture Capital

09/12/13

Egalet a/s (KR)

Index Ventures ; Undisclosed Investors

10.00

21.00

Source:

9 4

1 6 7

1 7 13

& '

1 5

3 7

Venture financing trend analysis

# $ ! % !

Source: Top venture financing deals (Sept 2013) Rank 1

Date

Target

Investors

Deal value ($m)

OrbiMed Advisors, LLC; Aperture Venture Partners, LLC; Osage Sep 4, 2013 Otonomy, Inc. (US) University Partners; Avalon Ventures; Domain Associates, L.L.C.; Novo Ventures; RiverVest Venture Partners; TPG Biotech Bay City Capital LLC; RA Capital Management, LLC; Alkermes plc; Sep 11, 2013 Civitas Therapeutics, Inc. (US) Canaan Partners; Fountain Healthcare Partners; Longitude Capital Management Co., LLC; Undisclosed Investors SR One; Kleiner Perkins Caufield & Byers; MPM Capital; Google Sep 4, 2013 iPierian, Inc. (US) Ventures; Mitsubishi UFJ Capital Co., Ltd.; ATEL Ventures, Inc.; Highland Capital Partners; FinTech Global Capital, LLC Ecotechnologies fund; Viveris Management; IRDI; Emertec; Demeter Sep 17, 2013 Fermentalg (FR) Partners; ACE Management; Picoty Algo Carburant; Sofiproteol

Sep 3, 2013

Tragara Pharmaceuticals, Inc. (US)

Domain Associates, L.L.C.; Mitsubishi International Corporation; Morgenthaler Ventures; ProQuest Investments; RusnanoMedInvest

45.90

38.00

30.00

16.03 12.00

Source:

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ergers & acquisitions (M&A) activity in the pharmaceutical sector recorded a downturn, in volume terms, across the globe. Asia-Pacific witnessed the highest fall in volume terms, recording no transactions in September 2013, a significant decrease of 100 per cent over the previous six monthâ&#x20AC;&#x2122;s average of 3.5 transactions. In one of the key deals announced during the month, Chile-based CFR Pharmaceuticals agreed to acquire Adcock Ingram, a South Africa-based pharma company, for approximately $1.2 billion. This transaction is consistent with CFRâ&#x20AC;&#x2122;s strategy of strengthening its position as one of the emerging market leaders in pharma. The combination of CFR and Adcock Ingram is anticipated to generate significant revenue and cost synergies, with an estimated net present value of at least $440 million. In another key deal, Japan-based Otsuka Pharmaceutical agreed to acquire Astex Pharmaceuticals, a US-based drug discovery company, focused on oncology, for approximately $866 million. The acquisition will strengthen Otsukaâ&#x20AC;&#x2122;s cancer portfolio and also its drug discovery research in the central nervous system therapy area, through Astexâ&#x20AC;&#x2122;s fragmentbased drug design technology. M&A activity in the pharma sector decreased in both volume and value terms, when compared to the average of the previous six months (March â&#x20AC;&#x201C; August 2013). According to Datamonitorâ&#x20AC;&#x2122;s Medtrack database, the pharma sector recorded 16 M&A transactions in September 2013, against the previous six monthsâ&#x20AC;&#x2122; average of 34 transactions. In value terms, the sector recorded deals worth $2.7 billion, against the previous six monthsâ&#x20AC;&#x2122; average of $8.9 billion. The Indian pharma sector witnessed no deals during September 2013, against the average of 0.1 deals over the previous six months.

Venture funding Companies in the pharma sector raised $175.9 million during September 2013, against the previous six monthsâ&#x20AC;&#x2122; average of $207.5 million. In terms of volume, the sector recorded 14 venture funded deals, when compared to the previous six monthsâ&#x20AC;&#x2122; average of 19.3 transactions.

Notes and Definitions Medtrack is a comprehensive, fully integrated, global biomedical database providing information on companies, products, patents, deals, venture financing, and epidemiology. It is a live database, constantly updated with news, milestones, trial information, etc. Medtrackâ&#x20AC;&#x2122;s unmatched coverage is supported by a userfriendly, highly dynamic set of decision support tools and analytics. In-house analysts and researchers add key insights and conclusions to provide you with the primary and secondary information you need. Key uses of the database include competitive intelligence, target identification, screen potential licensing and investment opportunities, patent assessments, product due diligence, royalty valuations, and developmental benchmarking.

Definitions 1.Deal value trend is based on transactions where associate values have been disclosed. 2.Trend analysis excludes rumored and terminated deals. 3.Value and volume analysis excludes private equity exits. For more information, visit us at www.medtrack.com

www.expresspharmaonline.com

October 16-31, 2013

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PRE EVENTS IGCW-2013 to drive implementation of green chemistry and engineering practices Event to be held in Mumbai on December 6, 7 and 8, 2013 he third Industrial Green Chemistry Convention & Ecosystem (IGCW-2013) will be held in Mumbai on December 6, 7 and 8, 2013. The Green ChemisTree Foundation along with its partners, supporters and associates, organise this international convention every alternate year in a bid to drive industry implementation of green chemistry and engineering based technologies. IGCW, an industrial initiative, aims to bring together chemistry-intensive chemical companies that deal in pharmaceuticals, fine and specialty chemicals, agrobased chemicals, dyes and pigment sectors, to collectively expand their awareness on environmentally benign manufacturing practices and technologies. IGCW-2013 will offer an opportunity to over 300 chemical manufacturing companies for expanding their technical know-how on industrial green chemistry and engineering technologies as well as approaches. It would also offer the participating companies with a platform to share thoughts, exchange ideas and experiences, and hear successful case-studies from leading global experts on the subject. The event is also expected to help bridge the gap between various chemical industry stakeholders and in turn assist in accelerating the implementation of green chemistry and engineering practices. It also aims to connect the participating companies with over 50 solutions and technology provider companies and organisations for addressing the immediate and pressing environmental, regulatory and resource challenges.

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EP News Bureau - Mumbai October 16-31, 2013

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M|A|R|K|E|T

5 India Lab Expo to be held at Hitex Exhibition Centre, Hyderabad T th

The event, slated to be to be held from November 21-23, 2013, will focus on latest trends and technology in lab & analytical instrumentation

he 5th India Lab Expo 2013 will be hosted at the Hitex Exhibition Centre, Hyderabad, India from November 21-23, 2013. The exhibition will showcase laboratory, analytical, biotechnology, life science, material testing, and laboratory consumable products and instruments. The expo organisers are expecting more than 50 foreign companies to participate directly and 400+ foreign principals through their channel partners in India. The foreign companies are likely to come from Germany, the US, the UK, Hungary, Switzerland, Italy, Canada, China, South Korea, Russia, Taiwan, Sweden, Neatherlands etc. 300+ exhibitors and 10000+ visitors representing diverse industries are expected to participate in the expo. The focus of the exhibition will be on the latest trends and technologies in the areas of laboratory and analytical instrumentation, chromatography and spectroscopy, biotechnology and life sciences, process control and reactors, medical and clinical diagnostics, clean room and sterilisation, quality control and environmental, educational labs, measurement and testing, liquid handling and filtration, laboratory consumables and allied products, laboratory furniture and construction.

The expo will comprise an exhibition and conference that will seek to bring suppliers and buyers of focal industries and institutions face-to-face for three days. Manufacturers and distributors from across the world will showcase their latest products and technology to buyers and users at a common platform in India. The exhibition will also provide an opportunity to the participants to connect with the global leaders, learn about cutting-edge technology, hear about vital research and appreciate the changes that the industry is going to witness in near future. The exhibiting companies will not only be able to present their innovations, products and services but also to meet key decision makers as well as find leads and confirmed orders. The organisers predicts that the attendees will have an unique opportunity to have

the entire spectrum of the laboratory industry in one place, at one time, providing them total solutions as well as an ideal platform to learn industry insights, connect with peers and grow professionally. India Lab Expo has become a big platform within a short span of time and is continuously growing at the rate of 25 per cent annually in terms of number of exhibitors and visitors. The purpose of shifting the exhibition venue from Delhi to Hyderabad providing better access to life science, pharma and biotechnology industries, research institutions and the educational sector which has witnessed 19 per cent growth in 2013 and is clustered and concentrated in Andhra Pradesh and nearby states. Andhra Pradesh is a pharma hub and produces one third of India's total bulk drugs, rank second in pro-

ducing value added food and beverages, premier technical and research institutions, large number of hospitals and diagnostic labs, etc. It has a vibrant ecosystem for chemical, life science and pharma industry consisting of large number of companies, institutions, support agencies and services along with a very strong community of professionals serving these industries. This generates regular sourcing of laboratory, analytical and biotechnology equipment and consumables by these labs and creation and dissemination of knowledge and skills specific to the industry. The organisers are also launching Pharma Mac Pac Expo – Focused Exhibition on Pharmaceutical & Packaging Machineries concurrently with India Lab Expo 2013 at same venue. EP News Bureau - Mumbai

PHARMA Pro&Pack Expo 2014 exhibition to be held in Mumbai Special pavilion for analytical instruments products and services

EXPRESS PHARMA

he 2nd international exhibition on pharma manufacturing technologies, PHARMA Pro&Pack Expo 2014, Mumbai is going to be held from April 24 to 26, 2014 at Mumbai Exhibition Centre, Mumbai. More than 54 per cent of the exhibit space has been confirmed and booked by the 2013 exhibiting companies at the exhibition venue on the last day of the PHARMA Pro&Pack Expo 2013, Mumbai Exhibition. Over a period of time, more and more companies have started joining the exhibition by confirming their exhibit space.

The successful exhibition has left a strong footprint in the Indian pharmal sector and has provided the best opportunity and the ideal platform to the industry to promote the Brand India concept. With the show being initiated, promoted and organised by the industry itself, it helps in providing a common platform to one and all, with a micro scaled entrepreneur sharing and exhibiting alongside the industry giants and promoting their skills and services. Various trade associations have extended their nonwww.expresspharmaonline.com

financial support to the exhibition. These include Federation of East African Pharmaceutical Manufacturers (FEAPM) and Confederation of Indian Pharmaceutical Industry (CIPI). A special pavilion has been allocated for the analytical instruments’ companies, especially for the member companies of the Indian Analytical Instrument Association (IAIA), one of the supporting associations of the exhibition. Rajesh Shah, Chairman, Maharshi Udyog and President, Indian Pharma

Machinery Manufacturers Association (IPMMA) informed, “PHARMA Pro&Pack Expo exhibition has been well recognised in its launch edition. Moreover, being the industry’s own show, PHARMA Pro&Pack Expo 2014 offers excellent branding and promotions opportunities for the entire industry in a cost effective manner. We are sure that we would be able to successfully deliver the show with overall manageable costing for every participant.” EP News Bureau - Mumbai October 16-31, 2013

M|A|R|K|E|T

65 IPC to be held in Delhi th

Around 8000 plus delegates are expected to attend the event he 65th Indian Pharmaceutical Congress will be held in Delhi NCR from December 20-22, 2013. The theme for this year's event is 'Pharma Vision 2020-Empowering Pharmacist'. The event will be hosted by Indian Pharmacy Graduates' Association, and will focus on bringing pharma experts across the globe to a single platform where pharmacy education and practices as well as their development shall be the main issues for debate and deliberation. Empowering pharmacists implies developing leaders in the sector from diverse backgrounds who shall provide their invaluable input in the growth of pharma as a profession and an industry. The first cut-off date for early registration is October 31, 2013 by when members/ delegates planning to attend may register by paying a nominal fee. Efforts have been made to invite the President/Prime Minister of India as the chief guests. The venue of the conference is Amity University Campus, Noida which is an international campus having all infrastructure for scientific sessions with state-of-the-art multi media facilities, spacious grounds for conducting exhibitions, hospitality, inaugural sessions and cultural events. The PHARMAceutical EXPO 2013, concurrent with the 65th IPC, will be organised by FICCI. Around 8000+ delegates are expected to attend the 65th IPC. There will be plenary sessions, scientific sessions and scientific poster paper presentations. For plenary and other scientific sessions, around 80 speakers are expected out of which around 30 will be foreign speakers. Students can present their research papers in various scientific sessions viz, pharma technology, medicinal chemistry, pharmacognosy, indigenous drugs, herbal formulations and phytochemistry, pharmacology and toxicology, clinical research and pharmacovigilance, biopharmaceutics, pharmacokinetics and

October 16-31, 2013

drug metabolism, pharmaceutical analysis and quality assurance, biotechnology and biotherapeutics, hospital, community and clinical pharmacy, pharma education and professional pharmacy, drug regulatory affairs, pharma

management, pharmacoeconomics and pharmacoepidemiology. Various scientific symposia will be held, which are: Presidents symposium on empowering pharmacists; Standardisation of biological

products; Advances in regulatory sciences and education; Pharma industry: From here to where; Role of community pharmacist in implementing public health policy; Molecular cardiovascular pharmacology; Pharma poli-

cies and export; Empowering pharma students through leadership development; Drug development regulations; and Strategies to strengthen practice services. EP News Bureau - Mumbai

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EVENT BRIEFS Tofflon seminar on ‘Challenges and solutions for lyophilised injectables in large scale and high efficiency manufacturing

Date: October 24-25, 2013

Date:October 18, 2013

Venue: Hotel Novotel, Juhu, Mumbai

Venue: The Westin Hyderabad Mindspace, Hyderabad

Summary: The Indian Pharmaceutical Association will organise the 6th Symposium on Nasal and Pulmonary Drug Delivery with the theme ‘Global Regulatory Trends’.This two-day scientific symposium is tailored specifically to nasal and pulmonary drug delivery and will welcome a panel of highly renowned scientists and technical experts for sharing knowledge about Orally Inhaled and Nasal Drug Products.

Summary: Tofflon Institute of Freeze Drying System will organise a seminar on ‘Challenges and Solutions for Lyophilised Injectables in large scale and high efficiency manufacturing.’ An international team of speakers from the US, Italy, Japan, Korea will offer their knowledge during the seminar as a valuable service to pharmaceutical and biotech industry. Contact details Chidananda R Marketing Executive Tofflon (India) (Subsidiary of Shanghai Tofflon Science and Technology Co) Tofflon Freeze Drying System Expertise in Pharmaceutical Industry 6th Main, 2nd Cross,Tayappa Garden Bilekehalli, Deverachikkana Halli Road Bangalore – 560076 Tel: (080) 41700254 Fax: (080) 41227584 Mob: 9945795502 Email: chidananda.r@tofflon.com / marketing.in@tofflon.com Website: www.tofflon.com

3rd International Fellowship on Health Technology Assessment Date: October 21-26, 2013 Venue: IIT Madras

IPA’s 6th Symposium on Nasal and Pulmonary Drug Delivery

Contact details SD Joag Indian Pharmaceutical Association Kalina, Santacruz (East) Mumbai - 400 098 Tel: (022) 26671072 Fax: (022) 26670744 Email: ipacentre@ipapharma.org Website: www.ipapharma.org

DIA’s 8th Annual Conference: The New Clinical Research Environment in India: Implications and Opportunities Date: October 24-26, 2013

Margi Memorial Lecture Date: November 9, 2013 Venue: Law College Complex at SVKM, Vile Parle, Mumbai Summary: The first Margi Memorial Lecture will be delivered by Dr Yusuf Hamied, Chairman and Managing Director, Cipla and an exponent of IPR in pharma. A commemorative publication of fond memories of Margi Patel Choksi through short articles and photographs will be published on the occasion. Announcement will be made about the proposed Margi Patel Choksi Memorial IPR Foundation, which will be a registered Public Trust (to be known as Margi Memorial Foundation). Contact details C/o. GNA Patent Gurukul 3rd Floor, Shivmangal Next to Big Bazaar, Akurli Road, Kandivli (East) Mumbai - 400101 Tel: (022) 28872058 / 40895454

Venue: NIMHANS Convention Centre, Bangalore, India

Summary: Doctors, nursing homes and hospitals, formulation organisations, API organisations, machinery and packaging, laboratory and analytical equipment, diagnostics, contract manufacturers and clinical research organisations will take part.The event will be co-located with IndiaLabExpo 2013. Contact details Atanu Bhattacharya Director Human Crayon Management Services C-28, Sector - 4,Noida - 201301, India Tel: (0120) 6528801 / (011) 65378800 Mob: 9810303916 (Delhi) / 9167280126 (Mumbai) Email: atanu@crayon4.com Website: www.pharmabiotika.com

Innovation in OTC Business: From Concepts to Action Date: November 22, 2013 Venue: The Westin Mumbai Garden City, Goregaon, Mumbai Summary: CubeX, in association with Nicholas Hall & Company will organise a one-day conference, Innovation in OTC Business: From Concepts to Action. Nicholas Hall will provide views on innovation as a significant growth driver for OTC industry. Delegates can also network with other expert speakers who have developed innovative strategies across various aspects such as business models, products, processes, marketing and channel management, into real-life action.

analytica Anacon India 2013 Summary: The conference will provide a forum for academia, industry, regulators and researchers to come together to discuss the new environment for health care product development in India, the challenges and the opportunities.

Summary: Healthcare Technology Innovation Centre (HTIC) will conduct the 3rd International Fellowship on Health Technology Assessment (HTA) at IIT Madras in collaboration with National Health System Resource Centre (NHSRC).The fellowship programme will feature international and national faculty giving lectures on various facets of HTA.

Contact details Manoj Trivedi, Senior Manager Marketing and Program Development, DIA India Cell: +91-98-1977-7493 Phone: +91-22-6765-3226 Email: Manoj.Trivedi@diaindia.org

Contact details Mohammad Ameel Consultant Biomedical Engineer Healthcare Technology Division (Medical Devices) National Health Systems Resource Centre Ministry of Health & Family Welfare, Govt of India NIHFW Campus, Munirka New Delhi - 110067 Tel: (011) 26108982/ 84/ 92/ 93 Fax: (011) 26108994/ 83 Mob: 9971234320 Email: Mohammad.Ameel @nhsrcindia.org Website: www.nhsrcindia.org

Date: October 24, 2013

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Marketing Lead, Information Mapping India, WTC Unit 2201A, Brigade Gateway Campus, Malleswaram West,Bangalore 560055 Tel: +91 (80) 6793 5328/29, Fax: +91 (80) 6793 5301 Mob: +91 (0)9916135360

Addressing Challenges in Pharmaceutical Research

Venue: Bandra Kurla Complex Trade Centre, Mumbai Summary: Information Mapping will organise a seminar on ‘Addressing Challenges in Pharmaceutical Research' through clear and effective documentation. It will address issues such as high level of competition; Lack of substantial returns on R&D investments; Slow time to market; Compliance Problems; High error rates Contact details Nidhi Raj Puri,

Date: November 12-14, 2013 Venue: Bombay Exhibition Centre, Mumbai Summary: The seventh international trade fair and conference for laboratory technology, analysis, biotechnology and diagnostics will have visitors from various domains like, pharmaceutical, chemical and petrochemical, healthcare, food, electrical engineering and electronics, medical laboratory, medicine, universities, research institutes and more. Contact details Anish Gangar Sr Manager - Marketing Communications MMI India 507/508, INIZIO Cardinal Gracias Road, Chakala, Andheri (East) Mumbai - 400 099 Mobile: 98205 82197 Email: anish.gangar@mmi-india.in

PHARMAbiotika 2013 Date: November 21-23, 2013 Venue: Hitex Exhibition Centre, Hyderabad

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Contact details CubeX (A Division of Sorento Healthcare Communications) Unit No. 12, Garodia Estate3/A Udyog Nagar, SV Road Goregaon (West) Mumbai - 400 064. Maharashtra. Tel: (022)4036 2008 Email: rshriyan@cubex.co.in

CPhI India Date: December 3-5, 2013 Venue: Bombay Exhibition Centre, Mumbai Summary: CPhI India will bring pharma professionals from all over the world to Mumbai and facilitates initiating and closing business deals.Take this opportunity to showcase your products and services while enhancing your brand at South Asia's leading pharma industry event. Contact details Chaitali Patil UBM India Times Square,Unit No 1 & 2, 'B' Wing, 5th Floor Andheri Kurla Road Marol, Andheri (East) Mumbai - 59 Tel: (022) 61727162 Fax: (022) 61727273 Email: chaitali.patil@ubm.com October 16-31, 2013

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POST EVENTS nd 2 edition of Indian Pharma Expo achieves huge success T The summit provided an ideal platform for business experts and stakeholders from the country’s top 20 pharma companies

October 16-31, 2013

he 2nd edition of ‘Indian Pharma Expo’ held at Pragati Maidan, New Delhi achieved a great success. Aimed at bringing together all pharma professionals under one roof, the exhibition

witnessed 66 exhibitors and more than 5300 plus visitors including many international visitors from countries like Australia, Malaysia, Philippines, Africa and Singapore. The opening ceremony of

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IPE-2013 were graced by Dr Monica Bhatia, Managing Director, UBM Medica India and the chief guest was Dr Shobha Vijender, Founder President, Sampurna, an NGO. The guests of honour were Atul Nasa, PresidentIndian Pharmacy Graduates’ Association (IPGA), Indian Pharmaceutical Congress Association (IPCA) and VicePresident, All India Drugs Control Officers Confederation (AIDCOC), also associated with Drug Control Department, Delhi; SL Nasa, President, The Indian Hospital Pharmacists' Association (IHPA), Registrar, Delhi Pharmacy Council and Kailash Gupta, President, AllIndia Chemists and Distributors Federation (AICDF) as well as Bhartiya Udyog Vayapar Mandal and eminent members of All

India Organisation of Chemists & Druggists (AIOCD) and RDCA. The event was supported by various associations, such as Confederation of Indian Pharmaceutical Industry, AIOCD, AICDF, Pharmaceutical Export Promotion Council of India, Mumbai Pharma Association, Navi Mumbai Retail Chemists and Wholesaler association. Express Pharma was a media partner to the event. The expo was conducted in association with Invision Medi Sciences (platinum partner), Biochemix (gold partner) & State Bank of India (banking partner), supported by DM Pharma, EPS Worldwide and Southern Travels/Hotel Southern were the logistics partner and travel partner respectively. EP News Bureau - Mumbai

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OPPI AGM focuses on improving access to advanced and affordable healthcare solutions Dr Shailesh Ayyangar, Managing Director India and Vice President - South Asia, - Sanofi India takes over as OPPI President

he pharmaceutical industry appreciates the concerns of the Government in expanding healthcare access to India’s 1.2 billion people, and believes that we must work together to find solutions that address the nation’s needs,” commented Christopher Viehbacher, President, EFPIA (European Federation of Pharmaceutical Industries and Associations) and Chief Executive Officer, Sanofi. He was giving his keynote address as the chief guest at the 47th AGM of the Organisation of Pharmaceuticals Producers of India (OPPI), which was held recently in Mumbai. Viehbacher said, “Access to innovative medicines can change the health of a nation. As an industry, we

“T

are committed to delivering innovative medicines that address the unmet medical needs of India. We urge the Government to offer greater IPR protection to pharma companies to encourage continued efforts towards drug discovery and development needed to combat diseases.” Viehbacher referred to the Millennium Development Goals (MDG) set by the UN for 2015 and said, “While India had made remarkable strides in reducing child mortality; what would further help India realise its vision for universal healthcare is an enabling environment and policy framework, with partnerships, open dialogue and transparency amongst public and private stakeholders.” Present at the meeting

were Dilsher Singh Kalha, Secretary Department of Pharmaceuticals (DOP) as the Guest of Honour and Managing Directors, chief executive officers and top executives of pharma companies, key opinion leaders, senior government officials, experts and media persons. Tapan Ray, Director General, OPPI announced the election of Dr Shailesh Ayyangar, Managing Director - India and Vice President South Asia, - Sanofi India as the new President of OPPI and Sudarshan Jain, Managing Director – Healthcare Solutions, Abbott Healthcare; Pheroze Khan, Managing Director, BristolMyers Squibb India; Aijaz Tobaccowalla, Managing Director, Pfizer and Lawrence Ganti, General Manager India,

Merck (Merck Serono) as the Vice Presidents. Ayyangar said, “I am honoured to have been nominated by my colleagues to be the President of OPPI for the year 2013-14. I assume this position from a stalwart, Ranjit Shahani who has served in this capacity for nearly a decade and has built great credibility for our industry. All of us in OPPI thank him for his extraordinary vision and contribution.” The programme included the presentation of OPPI Excellence Awards and the release of OPPI publications. Giving the vote of thanks, Ayyangar outlined his vision for OPPI’s agenda and future plans as president of this key industry association. EP News Bureau - Mumbai

Christopher Viehbacher, President, European Federation of Pharmaceutical Industries and Associations and Chief Executive Officer, Sanofi, addresses the 47th AGM of the OPPI

Guest of Honour Dilsher Singh Kalha, Secretary, Department of Pharmaceuticals Government of India makes a key point at the OPPI AGM

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October 16-31, 2013

VISIT

it’s all in the mix

pharma products, people & solutions

3-5 December 2013 Bombay Convention & Exhibition Centre Mumbai, India

Online Registrations Now Open !! WHY REGISTER ONLINE? • To get FREE ENTRY to the CPhI and P-MEC halls

Co-located with:

Organised by

• Get a FREE copy of the official show catalogue • To AVOID PAYING Rs. 500/- per person for ONSITE REGISTRATIONS

www.cphi-india.com

www.pmec-india.com

“India’s leading pharmaceutical event is ready for business”

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Industry experts discuss critical regulatory changes in pharma at PLCS The summit provided an ideal platform for business experts and stakeholders from the country’s top 20 pharma companies

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Usha Sharma – Mumbai ex Witness recently hosted the 2nd Annual Edition of Pharma Legal and Compliance Summit (PLCS) in Mumbai with an aim to gain better understanding of the recent regulatory reforms in the Indian pharmaceutical sector. The summit provided an ideal platform for business experts and stakeholders from the country’s top 20 pharma companies to come together and discuss the recent regulations, grey areas, business impact and implementation solutions. During the summit, experts discussed about the challenges which the Indian pharma companies are facing in an increasingly complex, demanding and fast changing logistics and regulatory environment. Traditional approaches are being challenged by shorter market cycles, outsourced production, and increasing government regulations. The day-long event also presented how multinational pharma companies are increasing efforts to strengthen their presence in India through research investment, licensing deals, co-marketing arrangements, acquisitions, or other partnerships. Today, nearly 25 per cent of proposals received by Foreign Investment Promotion Board are for pharma. On the other hand approval timelines and over restrictive regulations are giving thoughts for India- centric pharma organisation for establishing base in countries offering transparent regulations. Therefore, with increasing management expectations on business strategy formulation, especially in a complex regulatory environment, the 2nd Edition of Pharma Legal and Compliance Summit witnessed veteran speakers analysing, interpreting and strategising current and future response to legal, regulatory and compliance challenges. The summit was chaired by AS Kumar, General Counsel, Dr Reddy’s Laboratories, and the speak-

ers’ panel included Abhishek Malhotra, Partner, TMT Law Practice; Ajay Thomas, Registrar, LCIA India; Amitava Chakraborty, Associate Partner, TMT Law Practice; Arjun Vaidyanathan, Partner and Chief Operating Officer, Forensic KPMG; Darshini Bhatt, AGM IPR, Troikaa Pharmaceuticals; Debolina Partap, Associate Vice President and Head Legal, Wockhardt Group, India; Dr Nanda Kumar, Member, Advisory Board, Lex Witness; Dr Milind Antani, Head – Pharma and Life Sciences; Nishith Desai Associates; Gowree Gokhale, Partner, Nishith Desai Associates; KP Pradeep, Healthcare Compliance Officer, Johnson & Johnson, South Asia; Marshall Mendonza, Independent Legal Professional; MM Sharma, Head-Competition Law and Policy, Vaish Associates Advocates; Mukundan Bharathan, Senior Legal Counsel, GlaxoSmithKline Pharmaceuticals; Sanjay Sharma, CFE, CPP, Regional Security Manager, Asia Pacific – Japan, Global Security Group, MSD – Merck, Sharp & Dohme Corp; Sanjay Singh, Director, Corporate Finance KPMG India; Sofi Joseph, Head, www.expresspharmaonline.com

Regulatory Operations, Pfizer; Vivekananda N, Deputy Registrar and Head (South Asia), SIAC. Revealing the motive behind the holding the Summit, PBA Srinivasan, Editor-in-Chief, Lex Witness said, “Non-compliance related issues can cause irreparable reputational damage which can engulf the entire Indian pharma sector with loss of credibility in global markets. There are apprehensions of increased scrutiny following recent news of dodgy compliance, hence right now is the time to revise the legal and compliance strategies concerned so as to ensure sustenance and future growth.” During the panel discussion, Sharma briefed about the different competition challenges which are prevalent in the Indian pharma sector and how these competition issues are really affecting the pharma sector on a bigger scale to the Indian economy. Joseph predicted that in the near future we will be able to see much more such regulation reforms in the system. Antani informed, “The Drugs and Cosmetics (Amendment) Act, 2013 Bill, tabled in the Upper House of India’s Parliament, has pro-

posed criminal prosecution and fine for violation of any requirement specified under the Act or Rules or for violation of any condition prescribed in the permission to conduct clinical trials in India.” Before concluding the event the panelists also discussed hot topics like costbased and market-based price mechanism in the DPCO 2013, FDI in the pharma, clinical trial regulations, competitive competition and many more topics. Sharing the feedback of the summit, Partap said, “The Pharma Legal and Compliance Summit 2013 has been an excellent platform for all pharma legal, compliance and regulatory personnel to share their views and also the common challenges the industry is currently facing in India as well as globally. It also addressed very effectively the solutions, the do’s and don’ts which the pharma companies should ideally adopt to achieve the winning space in world scene. The summit further very illustriously deliberated upon the emerging trends and law in the patent and biologics spectrum. Overall it has been a very successful event.” EP News Bureau - Mumbai October 16-31, 2013

MANAGEMENT INSIGHT FOR MANAGING PHARMA

W H AT ’ S INSIDE

Effect of BITs on patents PG 41 Regulatory transparency and integration key driver of future healthcare industry PG 43

MARKET 15 RESEARCH 44 PHARMA ALLY 49 PHARMA LIFE 80 October 16-31, 2013

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T The Supreme Court (SC) of India order dated September 30, holding the approval of 162 trials in consideration until the next hearing on October 21, spread panic within the industry. Media reports based on court proceedings suggested that the SC’s directive was to not approve any trials on new drugs. However, the full text of the SC order made public a couple of days later revealed that the SC had held back these approvals for two weeks to enable the Additional Solicitor General to ‘place on record a recently released report of Prof Ranjit Roy Chaudhury and details of the existing regime which ensures safety to the subjects of clinical trials and avoid any serious adverse event by such clinical trials.’ Thus the full text of the SC order was quite different from the initial reports, reflecting both the heightened public awareness of clinical trials as well as the industry’s anxiety that more regulations can only mean more bad news.

Continuing regulatory reform … The clinical research industry in India has been in the throes of regulatory reform for the past year. The latest salvo is a compensation formula to determine the quantum of compensation in the cases of clinical trial related serious adverse events (SAEs) of deaths recommended by an expert committee set up by the Drug Controller General (India) (DCGI). And prior to the compensation formula, the DCGI had issued an order asking sponsors to provide details of agreements with investiga-

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APURVA SHAH

DR MILIND ANTANI

SUNEELA THATTE

Chairman, Association of Contract Research Organisations

Head, Pharma & Life Science Practice, Nishith Desai Associates

President, Indian Society for Clinical Research

There will not be any ambiguity in calculating the compensation. And the disclosure of CRO-investigator agreements is a good thought, the practical aspects of implementation must be viewed seriously

The publication of formula for compensation by the authority is a step in the right direction. It will help the sponsors and CROs to estimate the cost associated with conducting a clinical trial in India and plan the trial better

With regard to the compensation formula, we must apply the same approach in ensuring that participants in a clinical trial are not being coerced or induced into participating in a trial with the promise of large compensation

tors/institutions pertaining to payments for conducting trials and these aimed to bring better transparency in the system. Commenting on both these developments, Apurva Shah, Chairman, Association of Contract Research Organisations (ACRO) mentions, “There will not be any ambiguity in calculating the compensation. And while the disclosure of CRO-investigator agreements is a good thought, the practical aspects of implementation must be viewed seriously. Also, the intent of doing so must be transparently shared and communicated with all stakeholders including the industry, CROs and investigators. This will enable us to calculate the per subject compensation limit, hence better planning of study insurance and budget. And the insurance premium will be much higher now, as the compensation may go up to ` 4 - 73.6 lakhs.” Terming the DCGI's order related to disclosure of financial consideration of investigators at the time of applying

for permission to conduct the clinical trial in India as a welcome step, Dr Milind Antani – Head, Pharma & Life Science Practice, Nishith Desai Associates (NDA), a law firm, says, “It is indisputable that the common man views India’s clinical trial industry with suspicion today. Disclosure of financial interest of investigators will bring transparency to the process which in turn will help the industry in the long run. That said, we feel that the order will inconvenience the industry a lot.”

applications and we do not understand the rationale for a decision like this. Such delays are unwarranted at a time when the industry is looking at faster and more effective ways to bring drugs to market for the benefit of patients.” Dr Shoibal Mukherjee, Chief Medical Officer, Quintiles India & Head, Asia Medical Sciences Group states that disclosure of details of financial terms of agreements with investigators to the regulator might be a positive development. “However, it is not clear what the regulator intends to do with this information. There are currently no guidelines or regulations relating to research grants, so requirement for submission of this data is not a matter of checking on compliance. Release of this data to the public or press without adequate context and explanation, as has happened with adverse event data in the past, can lead to negative consequences,” he points out. Mukherjee suggests that the Government should per-

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… and their impact There is indeed no question that the industry is concerned about the impact of these notifications. Commenting on the adverse impact on approval timelines, Suneela Thatte, President, Indian Society for Clinical Research (ISCR) says, “Disclosure of CROinvestigator agreements being furnished at the time of clinical trial applications, will in our opinion, only add more delays and logistical challenges to the clinical trial

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haps make up its mind about what they want to do with the data before beginning to collect the information. As an alternative, he points out that submitting these to the regulator at any time prior to initiation of patient recruitment at the site should serve the purpose as the regulator can always put a hold on the study if it finds anything amiss. Explaining legal ramifications of this diktat, Anay Shukla, Member, Pharma Team, Nishith Desai Associates warns, “Owing to this order, the industry is now pondering whether sponsor/CRO is required to establish contractual relationships before applying for permission to conduct clinical trial. If it was the other way round, that is, if the contract was entered into before it received permission, and the permission did not come through, or came with prohibitory conditions, then it would result in loss of precious time, negotiations and paperwork for the sponsor/CRO.” Mukherjee concedes that while it may be appropriate to lay down some broad-based norms for payment of research grants, insisting that these agreements be signed before regulatory submission will delay trial initiation significantly and make the process more inefficient. Since these are tripartite agreements that take long to execute, sponsors often take advantage of the long regulatory review period to get these agreements in place but as he points out, they are always required to be executed before patient recruitment begins in a clinical trial. Shukla therefore recommends that the requirement of furnishing financial details should be inserted as a condition of permission given to conduct clinical trials in India. According to him, “The permission letter must clearly state that the perOctober 16-31, 2013

mission is contingent on furnishing financial details of the arrangement with investigators upon finalisation of the agreement, failing which the permission may be revoked at any time.” Hariani opines that while bringing in transparency in disclosure of financial details it is important to avoid manipulation in results or adoption of unethical practices. While the notification presently does not need amendment, he feels that the authorities should be open to make changes in the future, based on the experience gained in implementation. ISCR’s suggestion according to Thatte, is that if this information is required by the DCGI’s office, they should ask for it post approval and prior to initiation of a study at site. Also, given the clinical trial process, it does not sound feasible to reveal all the details before the trial begins. As Shah comments, “The details of CRO-investigator contracts isn’t operationally feasible before the onset of clinical trials as sites are finalised only after approval by expert committee (NDAC) appointed by DCGI. An important point that we must raise is that issuance of orders without discussion with various stakeholders, whose viewpoint, if considered as well, can make the implementation of guidelines and/or rules and regulations much more simpler for the authorities.” Raising more queries on the notifications, Dr SM Sapatnekar, Chief Executive Officer, Savishree Consultants asks, “What is the purpose of revealing the details of CROinvestigator contracts? How will the Government decide whether the amount is fair or hyper inflated? Can it refuse permission for recorded reasons if the compensation is too high?” www.expresspharmaonline.com

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AMEET HARIANI

Member, Pharma Team, Nishith Desai Associates

Managing Partner, Hariani & Co Advocates and Solicitors

There may be potential for misuse if the family has significantly more to gain monetarily from the patient’s death than by the patient staying alive

We recommended the order should be modified and requirement of furnishing financial details should be inserted as a condition of permission given to conduct clinical trial in India

I do not think that the compensation formula could be misused by subjects or their family members for their personal interest

any unethical practices.” Mukherjee feels that the formula adopted for the compensation is partially determined by its actual mechanism and points out that it is only one part of the ecosystem being created around clinical trials with a focus on monetary payments to patients or their relatives for “study-related injuries.” He says that while the intentions are laudable, many of those who are closely involved with clinical trials are still uncomfortable with the idea as “the practice of medicine is too complex to allow for easy adjudication of the cause of adverse events.” He informs that a caseby-case compensation formula is not adopted anywhere in the world as, “it is very easy to be biased, one way or another, in linking or not linking a trial to an individual instance of an adverse event. This is the very reason why clinical trials were devised as an unbiased way of determining the efficacy and safety of medicines. If it were so easy to judge whether a medicine was effective or not, and whether it caused serious side effects, we would not have to go through the elaborate process of a clinical trial and wait till its end to analyse the data and reach a conclusion regarding its efficacy and safety.”

of compensation was fixed at ` 8 lakhs with a view that this would ensure that the family received an amount equivalent to the minimum wages per month by way of interest. And it will not be wrong to anticipate that it might be misused by subjects or their family members, given the socio-economic realities of India. As Shah puts it, “Once the compensation values are seen to be so high it will induce people to participate in trials.” Sharing similar concerns, Mukherjee says, “There may be potential for misuse if the family has significantly more to gain monetarily from the patient’s death than by the patient staying alive, and the misuse potential would increase in direct proportion to the value of the payout in comparison to the actual monetary loss suffered by the family. In the present case, while the approach in ensuring that the family receives at least the minimum wages is sound, the mechanism chosen is flawed.” Antani, however, feels that there is little or no likelihood of it being misused by family members since the compensation is contingent upon proof that the SAE of death was related to clinical trial in ways prescribed in law. Moreover, he points out that a participant in the clinical trial is required under law to provide a written free informed consent for participation which negates the possibility of coercion by family members. His misgiv-

ing is that the high monetary compensation resulting from the formula decided by the expert committee may induce people to participate in clinical trial. Hariani points out that companies will have to take extra care while evaluating the subjects and recording their previous medical history before enrolling them in clinical trial as the new formula takes into consideration the age of the subject and the risk factor depending on the seriousness and duration of the disease at the time of enrolment in the clinical trial while deciding compensation. The base amount is defined as the compensation that would be paid to a 65year-old patient with a maximum of two years’ life expectancy. If the intention was to ensure that the family received the minimum wages every month for the expected duration of the patient’s life, then the amount of compensation should have been fixed at `1.85 lakhs (being minimum wages of ` 7,744 per month for 24 months), opines Mukherjee of Quintiles. Thus he points out that the base amount of compensation is fixed at a level disproportionate to the intention and logic of the argument. For younger patients, the compensation amount calculated by this formula will be higher and the mismatch even greater, he concludes. “We would suggest that compensation be calculated

DR SHOIBAL MUKHERJEE

The compensation formula saga Till 2012, compensation sums paid to victims of clinical trials in most instances, have been as low as ` 1.5 lakh to ` 3 lakh. Following public outcry at this data, the DCGI had constituted three independent expert committees on March 14 this year, chaired by Dr AK Agarwal, Maulana Azad Medical College. The committees were asked to examine the SAEs of deaths occurring during clinical trial and to recommend the cause of death, as well as determine the quantum of compensation to be paid by the sponsor or his representative. The compensation formula uploaded last month on the DCGI’s website was a fruit of these deliberations. Commenting on the formula Thatte opines, “A standardised compensation formula that is transparent, objective and all encompassing is something that all stakeholders of the clinical research process have been waiting for several months now. The issue of compensation has been a contentious one for a long while, largely because of the lack of clarity on what needed to be compensated and by how much. However, a compensation formula on its own will be ineffective until such time as we have more clarity on the compensation guidelines that were introduced on January 30, 2013.” Hariani informs, “Disclosure of information pertaining to financial support, fees, honorarium, payments in kind, etc., to be paid to the investigator as per contract entered into by the sponsor with the investigator or institution in clinical trials, would bring in transparency and ensure that unfair means are not adopted by companies to manipulate clinical trial data or engage in

ANAY SHUKLA

Then there is the other concern about the regulator’s capability to actually implement these rules. Does the DCGI’s office have the time and manpower to evaluate SAE reports, asks Sapatnekar. Further, what if the proposed trial is an investigator-initiated one? He concedes that seeking information can be understood; why does the Government want the entire contract? Is such information sought from any other profession?

Chief Medical Officer, Quintiles India & Head, Asia Medical Sciences Group

Cause for misuse The document released by the office of the DCGI states that the base amount www.expresspharmaonline.com

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simply by multiplying minimum wages with the number of months of expected earning life. A minimum amount may be fixed for those above the age of 65. This would provide substantial relief for families of younger healthy volunteers and patients with non-life-threatening diseases while reducing the potential for misuse,” suggests Mukherjee. Suggesting a solution, Thatte says, “With regard to the compensation formula, we must apply the same approach in ensuring that participants in a clinical trial are not being coerced or induced into participating in a trial with the promise of large compensation. This is a responsibility that both ethics committees and investigators in particular must take on and ensure.”

Impact on growth Industry observers point out that even though there is now a formula to compute compensation, it is silent on some issues. For instance, the compensation formula covers SAE of death only and no other adverse effects. Further, the provisional nature of the formula as well as the absence of a fixed formula for determining compensation for clinical trial related injury continues to cast a cloud of uncertainty over the issue of trial related compensation, forecasts Antani of NDA. Such uncertainty may slow down clinical trials in India. There are also signs that some stakeholders feel unfairly targeted by these regulations while alleging that others escape censure. Highlighting this concern, Dr Shubhangi Desai, Head,

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Will these two recent orders, coming after so many others in the same vein,clear the unfortunate perception that the clinical trial/ research industry is treating Indian patients/volunteers as ‘guinea pigs’? Clinical Operations, Asia Pacific, SIRO Clinpharm points out that the responsibilities of the two key stakeholders in a trial, i.e. the principal investigator (PI) and the patient, have not been considered while drafting the regulations. “This lacuna can be misused and can result in rampant false claims and may lead to increase in claims for medical management of adverse events (AEs) which might not be related to the investigational product. The onus for medical negligence must be on the PI and not on the legal applicant as this can lead to possibility of lack of oversight by the PI, leading to safety concerns for the clinical trial patients/participants,” she avers. Legal eagle Antani feels that the formula is in the right direction as it will help sponsors and CROs estimate costs associated with conducting a clinical trial in India and therefore plan the trial better. It would have had a much larger impact had the formula not been ‘provisionally final’. Expressing his concerns, Mukherjee says, “Given the

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strong potential for bias and the large monetary value of compensation payouts mandated by the recently introduced formula, it is likely that international sponsors may like to avoid India in their global clinical development programmes, and undertake trials in the country only when such trials are unavoidable for commercial entry into the Indian market. Local sponsors too may prefer to undertake trials outside their home country, as many of them have already started doing. This will take us back to the time when few doctors in the country had any experience of participating in the global drug development process.”

Steps under way An ISCR statement spells out the stand of CROs when it points out, “In the larger context of India’s requirements and the growing incidence of endemic diseases and emerging lifestyle diseases, clinical research is needed to develop new and effective medicines and vaccines to tackle our mammoth disease burden. India has 16 per cent of the world’s popu-

lation and 20 per cent of the global disease burden and yet, less than 1.5 per cent of global trials take place in India. It is only through clinical research that India will be able to find newer and better medicines to treat their population and reduce mortality rates for various diseases, including those unique to our part of the world.” Desai affirms, “We as a country have always had good laws and policies. What we have lacked is implementation and strong action against the violators within a specified time frame.” Media reports on unethical clinical trials have industry spokespersons refuting these charges. As the ISCR’s spokesperson, Thatte comments, “We would like to dispel the notion that there are 'many unethical clinical trials under way' in India. As in every profession and industry, there will always be players who operate at both ends of the spectrum and so while there may be a few in India who do not follow the requisite guidelines, we must acknowledge that

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there are several hundreds of clinical trials taking place in the country in utmost compliance with international and local guidelines.” Commenting on the regulatory reforms under way in the sector, Desai says, “Today, the Government has taken some positive steps like undertaking inspections, registration of the ethics committees (ECs), laying down compensation guidelines and so on. The next few months will be very critical as the various steps taken should be continued and action initiated against all parties where unethical trials are conducted.” Today, steps are being taken in the right direction for curbing unethical practices. However, implementation remains a challenge. Hariani is hopeful, considering the speed at which changes are being carried out, that the authorities will not leave any stone unturned to curb unethical trials. However, he comments that it is pretty shameful that the authorities have to be monitored by the Supreme Court. It clearly shows a Government without a will to act. Mukherjee is willing to concede that the regulations planned could have a positive impact. For instance, as he points out, “The recent orders would ensure that investigators are not vilified by activists and media for receiving a legitimate grant from commercial entities for the conduct of extramural research. Copies of financial agreements between sponsors and investigators submitted to the regulator can then be checked for compliance with these norms. Through this initiative, the government should encourage the use of publicly funded healthcare and research facilities for extramural research in a transparent manner as is done elsewhere in the world. This will help the cash-starved public healthcare and research-education sector attract private funding and improve their facilities without additional burden on the public exchequer while ensuring that there is no misuse of these facilities.”

Clearing the perceptions Will these two recent orders, coming after so many others in the same vein, clear the unfortunate perception that the clinical trial/research industry is treating Indian

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patients/volunteers as ‘guinea pigs’? Reacting to this Mukherjee opines, “This is a perception that is not supported by the facts and is one that we Indians have created and fuelled for ourselves. Only when we shed this perception will it change for others. We must ask this question to those among us who have nurtured this perception, but I suspect that deepseated insecurities that went into creating this perception will be hard to eradicate.” Though the clinical trial industry in India is at a relatively nascent stage compared to other global locations, it still needs to be compliant with global norms. The industry perspective voiced on various occasions is that volunteers who participate in a clinical trial receive a greater degree of medical care and attention than they would under regular treatment because of the high level of investigation and patient management that a clinical study protocol requires. So, there are already several checks and balances in place to safeguard the rights and privacy of patients in a clinical trial which is at times little understood by the public at large. Calling the use of such terms as as ‘misleading and unfortunate’ Thatte avers that it maligns the image of clinical trial participants as well as casts aspersions on the intent of those involved in the clinical research process. Desai feels these perceptions will change after implementation of Indian good clinical practice (GCP) strongly, i.e. by ensuring proper consenting at site, strict adherence to protocol and most importantly educating our people about clinical trials. Sapatnekar in fact points out that the term 'guinea pig' spreads a paranoia to the effect that 'all sponsors are out to exploit India' when in actual case, India did not have even two per cent of global clinical trials market.

Building a better future The industry provides the rationale that volunteers who participate in a clinical trial already have an underlying disease which could be mild or serious. They may participate in a clinical trial due to various reasons but their participation is guided by ICHGCP as well local GCP guidewww.expresspharmaonline.com

DR SM SAPATNEKAR

DR SHUBHANGI DESAI

Chief Executive Officer, Savishree Consultants

Head, Clinical Operations, Asia Pacific, SIRO Clinpharm

Wrong premises lead to wrong formula. Unless maximum amount of compensation is known, no insurer can name the premium

We as a country have had always good laws and policies. What we have lacked is implementation and strong action against the violators within a specified time frame

lines. These clearly indicate what a volunteer must understand prior to enrolling in a clinical trial. This process, called the informed consent process, is a crucial step in ensuring that the participant is informed about all aspects of the trial relevant to the subject’s decision to participate, points out Thatte. Highlighting the crucial role of the media to convey the right message to the public, she reasons that the term ‘guinea pigs’ will not disappear “until the media plays a more responsible role in reporting on clinical trials and educating the larger public about clinical research, while also highlighting the rights and responsibilities of patients.” There seems to be a general view that the introduction of the new formula would definitely see an uptick in the range of compensation. It would have a positive impact and would relatively increase the amount of compensation payable to the subject in the event of any clinical trial death/injury. It is also hoped that there would now be relative clarity on the amount of compensation that a person participating in the trial and suffering any injury/death, would obtain. But some issues still need to be ironed out. While commenting on the changes that need to be incorporated in the set compensation formula, Sapatnekar highlights some of these saying, “Unless maximum amount of compensation is known, no

insurer can name the premium. There is no way a genuine investigator initiated trial will start. If the procedure of claim settlement is ad infinitum, sponsor has many destinations other than India where the trials are faster, better and cheaper.” The industry also feels that there is a need to highlight the many benefits clinical research offers ordinary people in the long run. Desai avers, “People must be made aware about the importance of clinical research, the difference in the number of trials done in India vis-a-vis those done globally and about the guidelines followed in India, which are much more stringent than those used internationally. Since large swathes of India’s population have unmet medical needs, the government and the media should also highlight the advantages of participating in clinical trials. This notification alone cannot wipe out the perception.” ‘No gain without pain’ seems a trite summation of the industry's current situation but in this case, it fits the bill completely. In conclusion, as Hariani points out, while the apex court's observations on the subject has increased awareness, the notifications are only the first step towards changing the perception in the global market and prompting transparency. Both sides will have to take many more such steps in the same direction to reach the right balance. u.sharma@expressindia.com October 16-31, 2013

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LEGAL EAGLE

Effect of BITs on patents Manoj K Singh, Founding Partner, Singh & Associates, speaks about the effect of Bilateral Investment Treaties (BITs) on the intellectual property regime of the state

conomic reforms programmes in India were started in 1991, continued with the Bilateral Investment Promotion and Protection Agreements generally referred to as Bilateral Investment Treaties or BITs. These BITs seeks to provide favourable conditions for the investors of one country in the other country. The aim of the BITs is the stimulation of business initiatives and increase in prosperity. Government of India, so far, signed BITs with 82 countries out of which 72 are already in force.

What is an investment treaty? Before proceeding with the effect of the BITs on the intellectual property regime of the state, it is necessary to put some light on the investment treaty like BITs. A bilateral investment treaty is an agreement between two countries in which each country takes obligation for the investment in its country by the investors of the other country. The protections offered by BITs are only limited to ‘investors’ and their ‘investments’. Generally, ‘investment’ includes movable and immovable property, shares and other interests in companies, claims to performance under a contract having an economic value, and intellectual property

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rights. The obligations agreed upon in investment treaties are directly enforceable by the investors by way of international arbitration often before the international Centre for Settlement of Investment Disputes or a tribunal established under the Arbitration Rules of the United Nations Commission on International Trade Law (UNCTAD). There are 12 known treaty claims against India till date, the 11th highest number of claims in world. Further, there are 17 more claims that are estimated against India in the near future.

Position of pharmaceutical patents in India From the very inception patents remains a very sensitive issue in the context of pharmaceuticals. In favour of the pharma patents it is argued that stronger patent protection will incentivise the innovation while the opposition argues that strong patent regime will result in the monopoly over essential medicines and high prices and consequently exclusion of large section of society from essential medicines. This was balanced by the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) by introducing compulsory license on patented drugs.

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As a signatory of WTO, India has amended its patents laws in accordance with TRIPS and allowed pharma patents. However, the balance was made by prohibiting ever greening of patented drugs by prohibiting patents on ‘the mere discovery of a new form of a known substance’ and allowing grant of compulsory license.

BITs and patents In almost all the BITs India has signed, investments have been defined in a way that includes intellectual property rights such as patents, copyrights etc. This enables the investors to file claim under BITs for any action that directly or indi-

rectly affects their intellectual property, including patents. Indian BITs provides prohibition against expropriation. The term expropriation is defined as ‘taking of an asset by the government and all measures having the effect of taking the assets that deprive the investors of an asset its use.’ At times expropriation and nationalisation are considered as similar terms; however, expropriation is much broader than the former. Nationalisation means to bring under the control of or to make it the property of the nation, whereas expropriation means dispossession of property for the public use generally with compensation. The word ‘expropriate’ has a wider meaning than the word ‘nationalise’. The Indian BITs provides expropriation for the public use only, against the compensation in a non discriminatory manner. Conflict with BITs and patents arise when the Indian government takes the assets of the investors by way of compulsory license or by revoking patents in compulsory license. This step of the government triggers investors to invoke the expropriation clause in the BITs and to appoint arbitration tribunal to decide sovereign issues like whether the issuance of compulsory

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license is legal or not. Also, the investors are not bound to exhaust local remedies or approval of their government before bringing the claim under BITs. This is a situation where the gains acquired through the multilateral agreements like TRIPS on patents and public health may be lost bilaterally through BITs. In this context recent judgments of the Indian courts have signalled the possibility of the intervention of the BITs on the Indian IP regime. In March 2012, the Indian Patent Office on the claim of the Natco Pharma issued compulsory license for the making and selling of the Nexavar, a patented drug of Bayer Corporation. Later the decision of the Indian Patent Office was also affirmed by the Intellectual Property Appellate Board (IPAB). The compulsory license was mainly issued on the public grounds. Another case was of cancer drug Glivec. In April 2013, the Supreme Court of India held that the cancer

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drug glivec of Novartis is not a patentable subject matter under the Indian Patent Act, 1970. This judgment opens the doors for the generic manufacturers to manufacture the version of the glivec. The immediate reaction to these court and regulatory decisions was the losing companies discussing the option of dispute resolution under the BITs. While there is another option of WTO Dispute Resolution Mechanism under TRIPS, however, there is a large number of reasons to choose BITs. The potential impact of BITs proposed rights to the foreign investors can be seen from the case of Eli Lilly & Company Vs. Canada. Eli Lilly filed a notice of intent to arbitrate under North American Free Trade Agreement (NAFTA) claiming $500 million against Canada. The dispute arises due to the invalidation of the Eli Lillyâ&#x20AC;&#x2122;s patent on Strattera and Zyprexa by Canadaâ&#x20AC;&#x2122;s Federal Court of Appeal and subsequently

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dismissal of appeal by the Supreme Court of Canada. Eli Lilly states that the grounds taken by Canadian court i.e. promise doctrine and related disclosure requirement are well beyond the requirement in the US and European Union and also the same are not found in the Patent Cooperation Treaty (PCT). Challenging both the invalidations of its patents Eli Lilly claims violations of minimum standard of treatment, indirect expropriation, and national treatment norms. In essence, Eli Lilly claims that his expectations of profit were unjustly upset; the invalidation of patents is illegal from the international perspective and therefore constitute an expropriation. The decision in the case is pending. However, the above case clarifies the risks of including IP rights in investment treaties. Therefore as per the above Germanybased Bayer Corporation and Switzerland-based Novartis can bring claims against India for the granting of

compulsory license and invalidation of patent respectively under the BITs. BITs actually provide additional safeguards apart from WTO and TRIPS to foreign investors which they can seek in order to protect their investment unjustly. These treaties essentially provide regulatory powers to foreign investors and private arbitrators on one side and are restricting the sovereignty of the country to regulate business affairs on the other side. Further, little attention is given to the risk that the investment treaty poses against the access to the life saving medicines. Therefore in the present circumstances, BIT agreements are required to be reexamined in order to make sure that the benefits in public health sector conceded through multilateral agreements should not be lost in the light of bilateral agreements. (The author has been assisted by Kailash Choudhary)

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REPORT Regulatory transparency and integration key driver of future healthcare industry Industry experts forecast that regulatory transparency and integration along with ADCs and multi use facilities will be key drivers of tomorrow’s healthcare targets n early October, CPhI Worldwide and CPhI Pharma Evolution, part of UBM Live’s Pharmaceutical Portfolio, released the first section of its annual report, with forward looking article submissions from Piramal Enterprises, Fujifilm Diosynth Biotechnologies and Vision Consulting, examining the global implications of regulatory failure, single use technologies and the potential of antibody drug conjugates (ADC). The outlook for the next few years is particularly optimistic for the ADCs market where Vijay Shah, Executive Director and Chief Operating Officer, Piramal Enterprises envisages increased global investments and even the arrival of a new blockbuster drug to treat solid tumours. However, beyond the traditional cancer uses of ADCs he also forecasts this class of therapeutics will provide indications such as inflammation, demonstrating that ADCs are on the cusp of being the great break-through that many analysts have predicted. Unsurprisingly, in the short term the majority of ADCs will be for lymphoma treatment, but Investigational New Drug (IND) submissions for this class of drug will rise over 50 per cent in the next five years and ultimately the market will grow to $10 billion during the next 10 years. With such an increase in the prevalence of new targets, the report predicts that it’s really only a matter of time before we see ADCs providing therapeutic solutions to a range of conditions and this market is likely grow enormously over the next five, 10 and even 20 years. “In the past a major failing with ADCs has been that cytotoxic agents were simply not active enough to kill the target cell with such a small amount of payload, o.o1 per cent, however, new technologies that improve antibody and antigen conjugation could hold the key to really unlocking their potential. Over the next 10 years we will see ADCs with much higher penetration rates,” said Shah. Mark Carver, Senior Vice President of R&D and Innovation, Fujifilm Diosynth Biotechnologies

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warned however that unless we move towards a ‘health-based risk assessment’ approach to single use technologies innovation could be compromised- particularly for promising targets like ADCs that are often required to be manufactured in such facilities. The problem for biologics is that single use facilities are hugely increasing the costs of development and putting at risk promising targets that are deemed unviable before their true potential has been explored. With EMA guidelines likely to exacerbate this trend, many innovative targets are likely to struggle to make it into clinical trials. The solution to this problem is health-based approaches, such that even when there is only partial data on early phase development work and the likely doses they will be used at to support full PDE and MACO (Maximum Allowable Carryover Calculation) values there is still sufficient information to produce appropriate banding to evaluate risk. The cost reductions and increase in innovation will help accelerate the development of new biologics product classes and its now up to the regulators to implement these changes into the way assessment are conducted that maintain safety without compromising innovation. Similarly, Dilip Shah, Chief Executive Officer, Vision Consulting, has collectively examined the current regulatory environment and concludes that safety and compliance can be both increased by regulators simplifying and unifying their codes and working closer with industry. The problem, however, is that over the last few years and into the foreseeable future we are likely to see an increased number of deliberate infringements (FDA warning letters), particularly as analytical technologies increase. The resultant implication of these well publicised large pharma infringements is that there is a now a very real threat that increasingly restrictive regulations will prevent smaller more innovative players entering the market. The answer Dilip Shah believes will ultimately lie in producing a more transparent process – and crucially one that is unified across the globe – whereby regulators take a more active role in working industry to evaluate procedures in a transparent and consultative manner. EP News Bureau- Mumbai www.expresspharmaonline.com

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W H AT ’ S INSIDE

Novartis’ Gilenya reduces brain volume loss by one third in MS patients: Study PG 45 Technique allows direct functionalisation of alkenes without metallic reagents PG 46 Neutrons show accumulation of antidepressant in brain PG 47

RESEARCH CLINICAL UPDATES

Experts discuss and deliberate on diabetes at EASD 2013 Studies from across the globe trying to unravel various aspects of the silent killer were presented at this year’s EASD held in Barcelona, Spain he 49th Annual Meeting of European Association for the Study of Diabetes (EASD) was recently held at Fira Gran Via in Barcelona, Spain. The event saw attendance from the world’s leading international forum for diabetes research. A UK study presented at this event revealed that there have been considerable improvements in life expectancy of the population of Scotland, UK suffering from type I diabetes and recommended that this should now be reflected in life insurance and other relevant policies for those with the condition. The research has been done by professor Helen Colhoun and Shona Livingstone, University of Dundee, UK, and colleagues on behalf of the Scottish Diabetes Research Network. The study looked at people living with type I diabetes and aged 20 years or older anytime between 2008-2010 and revealed that the remaining life expectancy of type I diabetics aged 20-24 years was 45 years and 47 years for men and women respectively compared to estimates of 56 and 61 years respectively for the male and female general populations. The remaining life expectancy for those aged 65-69 years was estimated at 12 years for both men and women compared to 17 years and 19 years for the male and female general population. Another study on type I diabetes showed that having children lowers mortality in people with type 1 diabetes,

MARKET 15 MANAGEMENT 35 PACKAGING SPECIAL 49 PHARMA LIFE 80 44

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but for women more than men. The research was conducted by Dr Lena Sjöberg, University of Helsinki, Helsinki, Finland and National Institute for Health and Welfare, Helsinki, Finland, and colleagues. Sjöberg and team examined mortality and the causes of death among subjects with childhood-onset of type I diabetes as compared to control people, with a focus on mortality differences between childless people and those having had offspring. The effect of having offspring was looked at people in four categories: no children, one child, two children, three or more children. In general, the more children a person had, the lower mortality, but this trend was less pronounced in men than in women. Overall, all-cause mortality was half in persons who had offspring, among both people with diabetes and controls, and in both genders. Many research papers on type II diabetes were also presented at EASD. One research claimed that patients receiving sulfonylureas as first line treatment for type II diabetes have higher mortality than those receiving metformin. The researchers, led by professor Craig Currie, Cardiff University, UK, evaluated the comparative risk of all-cause

mortality for patients exposed to first-line diabetes monotherapy with either sulfonylureas or metformin and found that mortality is increased by 58 per cent when sulfonylureas is used as first-line therapy. Hence, Currie and colleagues opine that it may no longer be appropriate to offer first line treatment with sulfonylureas as a result of these findings. Yet another research looked at the ‘obesity paradox’ and surprisingly, found that older patients with type II diabetes who are obese have lower mortality than those with a lower bodymass index (BMI), a relationship not shown in younger patients. The findings could mean either of the two _ type II diabetes that develops due to obesity is different to that not related to obesity or that obesity offers metabolic protection from death in older people with type II diabetes. This study is by Dr Pierluigi Costanzo, Universities of Hull and York, UK, and colleagues. Another study presented at EASD 2013 also looked at obesity and its relation with diabetes. Exercise can chemically alter the genes associated with obesity or type II diabetes that are present in human adipose (fat) tissue, reveals a research by Dr Tina Rönn, Lund University,

MANY RESEARCH PAPERS ON TYPE II DIABETES WERE ALSO PRESENTED AT EASD. ONE RESEARCH CLAIMED THAT PATIENTS RECEIVING SULFONYLUREAS AS FIRST LINE TREATMENT FOR TYPE II DIABETES HAVE HIGHER MORTALITY THAN THOSE RECEIVING METFORMIN

Malmö, Sweden. In this study, Ronn and colleagues looked at how the DNA methylation pattern (how much the DNA had been chemically altered) in adipose tissue had changed in healthy men before and after a six months exercise intervention. The clinical and metabolic outcomes of the exercise intervention was a significant decrease in waist circumference, waist/hip ratio, diastolic blood pressure and resting heart rate, whereas a significant increase was seen for exercise capacity and ‘good’ cholesterol (HDL cholesterol). Professor Daniela Jakubowicz, Tel Aviv University, Israel, and Dr Hadas Rabinovitz, The Hebrew University of Jerusalem, Rehovot, Israel, and colleagues also presented a study in which a big breakfast rich in protein and fat appears to offer more benefits to people with type II diabetes than a smaller low calorie breakfast. In this study, the researchers analysed the effect of breakfast size and composition on blood glucose control and its association with hormone profile in adults with type II diabetes. In another study, an analysis of genetic variations known to be associated with type II diabetes shows that a ‘bad’ variant of KCNJ11 E23K polymorphism, also increases the risk of cardiovascular mortality by at least 20 per cent. Some 40 per cent of the type II diabetic population has this bad variant. The research is by Associate Professor Valeriya Lyssenko, Lund University, Malmö, Sweden, and Steno Diabetes Center, Gentofte, Denmark, and Dr Sami Alkayyali, Lund University, Malmö, Sweden. EP News Bureau - Mumbai

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Novartis’ Gilenya reduces brain volume loss by one third in MS patients: Study Confirms brain volume loss link with disability Basel ovartis announced new data indicating that continued treatment with Gilenya (fingolimod) led to a reduction in brain volume loss in patients with relapsing forms of multiple sclerosis (MS), and was associated with a higher proportion of patients remaining free of disability progression [1],[2]. These data were presented at the 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark. Brain volume loss is emerging as one of the best indicators of disability progression over the long-term in MS, and is a topic of much interest within the MS medical community[3]. Increasingly, research focus is on treatments that will reduce the rate of brain volume loss. Gilenya is the only oral treatment for MS that has shown early and consistent slowing of brain volume loss, and the new data presented at ECTRIMS add to the growing evidence base of Gilenya’s efficacy in MS and reinforce the correlation between brain volume loss and disability progression over the long-term[1]. "The data presented are very encouraging because they are from studies that took place over four years and show that Gilenya both reduces brain volume loss and slows the pace of disability progression for patients with MS," said Dr Timothy Wright, Global Head Development, Novartis Pharmaceuticals. "These are key treatment goals for patients with this chronic and debilitating illness.” The key findings Collective four-year results from the pivotal FREEDOMS and FREEDOMS extension studies showed that patients who were treated continuously with Gilenya 0.5 mg experienced up to one-third less brain

volume loss than patients who switched to Gilenya after receiving placebo for two years. Thus, delay in starting treatment with Gilenya by two years was associated with more brain volume loss[2]. ● Overall, patients who remained free of disease had consistently lower rates of brain volume loss compared to patients who experienced disease activity and MS progression. However, the benefit of Gilenya on brain volume loss was seen irrespective of whether patients were disease-free or had active disease[2]. (Disease activity was evaluated by assessing measures that give a broad evaluation of MS: disability progression, relapses and new brain lesions detected on magnetic resonance imaging scans.) ● A separate analysis of three key studies (FREEDOMS, FREEDOMS II and TRANFORMS) showed a correlation between disability progression and increased brain volume loss, and this correlation increased over time[1]. ● Higher baseline MRI lesion volume and baseline active lesions both predicted subsequent loss of brain volume during the studies but patients treated with Gilenya had less brain volume loss than those treated with placebo or IFN beta 1a IM, irrespective of baseline lesion volume and count[4]. MS patients with higher brain volume loss were more likely to experience disability progression[1]. Minimising disease progression in people with MS is a key treatment goal because MS can have a significant impact on the quality of life for patients, families and careers. Many patients may increasingly lose their independence due to diminished mobility, and some may lose their ability to walk or have problems with their sight. MS is also associated with a substantial economic burden, with studies in several European countries reporting annual costs equivalent to approximately ¤ 30,000-40,000 per patient[5].

References [1] Barkhof F, Cohen JA et al. Brain volume changes, on-study correlations and the link to disability in three fingolimod phase 3 studies. ECTRIMS 2013, Copenhagen, Denmark. [2] Radue E-W, de Stefano N et al. Brain atrophy and disease-free status over 4 years: analyses of the FREEDOMS core and extension trial data. ECTRIMS 2013,

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Copenhagen, Denmark. [3] Preventing brain atrophy should be the gold standard of effective therapy in multiple sclerosis (after the first year of treatment): Commentary. Controversies in Multiple Sclerosis. Multiple Sclerosis Journal19(8) 1007-1008. [4] Radue E-W, Cohen J et al. Baseline predictors of brain atro-

phy in phase 3 studies of fingolimod. ECTRIMS 2013, Copenhagen, Denmark. [5] Karampampa K et al. Treatment experience, burden and unmet needs (TRIBUNE) in MS study: results from five European countries. Mult Scler. 2012 Jun;18(2 Suppl):7-15.

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RESEARCH UPDATES Technique allows direct functionalisation of alkenes without metallic reagents The work demonstrates how substantial yields of highly functionalised compounds can be achieved from simple organic molecules in simple conditions with no metal catalyst

Kanazawa, Japan esearchers at Kanazawa University have demonstrated a technique that allows direct functionalisation of alkenes without the need for metallic reagents, photolysis or extreme reaction conditions. This research is also described in the inaugural June issue of the Kanazawa University Research Bulletin. The addition of functional groups to certain unsaturated hydrocarbons, known as alkenes, is a crucial stage in the synthesis of various compounds, including many plastics. For these functionalisation reactions to occur a carbon-hydrogen (C-H) bond must be activated, which is traditionally achieved using transition metal catalysts. However, use of these catalysts has both economical and environmental drawbacks. Now researchers at Kanazawa University have demonstrated a technique that allows direct functionalisation of alkenes without the need for metallic reagents, photolysis or extreme reaction conditions. Tsuyoshi Taniguchi and colleagues at Kanazawa University developed work where they had reported a reaction of alkenes using tert-butyl nitrite and molecular oxygen. They monitored the reaction products — γ-lactol and nitrate ester — using different solvents, and found that a high polarity aprotic (hydrogen-free) solvent gave the best yield, with γ-lactol as the major product. They then experimented with different alkenes and observed how the products

differed for branched and linear alkenes. Further reduction reactions demonstrated how the new synthesis technique could yield a range of useful derivatives, producing highly functionalised compounds from simple alkenes in only one or two steps. The researchers were also able to propose a possible reaction mechanism. While the exact pathway remains uncertain, they suggest that the key step is the cleavage of an oxygen-oxygen bond to form a highly reactive alkoxy radical a molecular component comprising an oxygen with single bonds either side to

hydrocarbon chains. The work demonstrates how substantial yields of highly functionalised compounds can be achieved from simple organic molecules in simple conditions with no metal catalyst. The authors conclude, “We believe that such ‘simple and advanced reactions’ are promising in the development of useful synthetic methods involving direct C–H functionalisation.” Source: Kanagawa University, Japan, Organization of Frontier Science and Innovation

Australian scientists develop world’s first cure for dengue fever A

98alive is a unique natural medicine containing Melaleuca alternifolia leaf concentrate that’s antiviral, antibacterial and immune boosting properties

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team of Queensland scientists led by microbiologist professor Max Reynolds have developed the world’s first cure for dengue fever by distilling Melaleuca alternifolia leaves from Australia’s native tea tree plant. Now available worldwide, 98alive is a unique natural medicine containing Melaleuca alternifolia leaf concentrate that’s antiviral, antibacterial and immune boosting properties have been scientifically proven to cure all four strains of dengue fever. Professor Reynolds states the product is a significant breakthrough in treating dengue fever, a disease transferred to

humans through A.aegypti mosquitoes which is estimated to effect 390 million people every year and is particularly prevalent throughout Asia. “Prior to 98alive there was no cure or vaccine against dengue fever which we felt needed to be addressed given that 40 per cent of the world’s population live in the dengue danger zone around the equator,” Reynolds said. “Adding to this, many of these at risk countries such as India and Indonesia also suffer high fatality rates due to current treatments not being affordable, effective or easily accessible. “98alive is taken in capsule form, so it is easy to administer,” Reynolds con-

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tinued. “It has been proven to commence elimination of the virus within ten minutes of being taken, which not only reduces the chance of the disease becoming life threatening but also prevents it from spreading.” Reynolds states, “The medicine’s immune boosting properties means it is also highly effective in preventing dengue fever. 98alive primarily strengthens the immune system and therefore the recipient’s ability to fight the viral infection. This means that travellers or people living in at risk areas can take 98alive as a means of preventing dengue fever and to build up a October 16-31, 2013

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THE INFECTION RATE OF DENGUE FEVER INCREASED 30 FOLD FROM 1960 TO 2010 AND HAS BEEN PROJECTED TO INCREASE EVEN FURTHER AS GLOBAL WARMING CAUSES THE HABITAT FOR MOSQUITOES TO EXPAND resistance to the disease.” This benefit of 98alive is particularly compelling given that the infection rate of dengue fever increased 30 fold from 1960 to 2010 and has been projected to increase even further as global warming causes the habitat for mosquitoes to expand. Reynolds states that 98alive’s unique make up of 98 active compounds is what makes it such an effective and fast acting treatment against the symptoms of dengue fever which include fever, headaches, muscle

pain and rashes. “Our unique process of distilling the Melaleuca alternifolia leaves ensures that the end result retains the plant’s highly beneficial antiviral, antibacterial, anti-inflammatory and antioxidant properties whilst removing the bulk of the potentially toxic monoterpene components that have, until now, prevented it from being consumed,” Reynolds said. “98alive is the only Melaleuca alternifolia-based medicine that is list-

ed on the Australian Register of Therapeutic Goods (Australian Licence 202131) and that is recognised by the United States’ Food and Drug Administration as safe for human consumption. Developed in Australia, which is known for its strict medical and product regulations, 98alive has undergone rigorous testing at world leading research facilities in Australia, the US and in Asia. EP News Bureau - Mumbai

Neutrons show accumulation of antidepressant in brain E A number of international studies have shown that a higher natural lithium content in drinking water leads to a lower suicide rate in the general population

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xperiments with neutrons at the Technische Universita¨t Mu¨nchen (TUM) show that the antidepressant lithium accumulates more strongly in white matter of the brain than in grey matter. This leads to the conclusion that it works differently from synthetic psychotropic drugs. The tissue samples were examined at the Research Neutron Source Heinz Maier-Leibnitz (FRM II) with the aim of developing a better understanding of the effects this substance has on the human psyche. At present lithium is most popular for its use in rechargeable batteries. But for decades now, lithium has also been used to treat various psychological diseases such as depressions, manias and bipolar disorders. But, the exact biological mode of action in certain brain regions has hardly been understood. It is well known that lithium lightens moods and reduces aggression potential. Because it is so hard to dose, doctors have been reluctant to prescribe this 'universal drug'. Nonetheless, a number of international studies have shown that a higher natural lithium content in drinking water leads to a lower suicide rate in the general population. Lithium accumulates in the brains of untreated people, too. This means that lithium, which has so far been regarded as unimportant, could be an essential trace element for humans. Josef Lichtinger is studying in his doctoral thesis at the Chair for Hadron

AT PRESENT LITHIUM IS MOST POPULAR FOR ITS USE IN RECHARGEABLE BATTERIES. BUT FOR DECADES NOW, LITHIUM HAS ALSO BEEN USED TO TREAT VARIOUS PSYCHOLOGICAL DISEASES

and Nuclear Physics (E12) at the Technische Universita¨t Mu¨nchen. From the Institute for Forensic Medicine at the Ludwig-Maximilians-Universita¨t Munich (LMU) he received tissue samples taken from patients treated with lithium, untreated patients and healthy test persons. The physicist exposed these to a focused cold neutron beam of greatest intensity at the measuring station for prompt gamma activation analysis at FRM II. Lithium reacts with neutrons in a very specific manner and decays to a helium and a tritium atom. Using a special detector developed by Josef Lichtinger, traces as low as 0.45 nanograms of lithium per gram of tissue can be measured. “It is impossible to make measure-

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ments as precise as those using the neutrons with any other method,” says Jutta Scho¨pfer, forensic scientist at the LMU in charge of several research projects on lithium distribution in the human body. Lichtinger’s results are surprising: Only in the samples of a depressive patient treated with lithium did he observe a higher accumulation of lithium in the so-called white matter. This is the area in the brain where nerve tracts run. The lithium content in the neighboring grey matter was three to four times lower. Lithium accumulation in white matter was not observed in a number of untreated depressive patients. This points to the fact that lithium does not work in the space between nerve cells, like other psychotropic drugs, but within the nerve tracts themselves. In a next step Josef Lichtinger plans to examine further tissue samples at TUM’s Research Neutron Source in order to confirm and expand his results. The goal is a space-resolved map showing lithium accumulation in the brain of a healthy and a depressive patient. This would allow the universal drug lithium to be prescribed for psychological disorders with greater precision and control. The project is funded by the German Research Foundation (DFG). Source: Technische Universita¨t Mu¨nchen (TUM) EXPRESS PHARMA

W H AT ’ S INSIDE

‘We will continue to develop and offer new innovative products to meet industry demands’ PG 50 Clariant Chemicals (India) receives Responsible Care PG 51 Quintiles advances new approach to speed biomarker-targeted therapies to cancer patients PG 52 GE Kaye LabWatch LT System offers wireless turnkey solution PG 53

PACKAGING S P E C I A L Bilcare starts field validation studies of its nonClonableID technology Developed in collaboration with CSIR, the system aims to secure the pharma supply chain as well as improve patient compliance

S September 1 marked the roll out of field validation studies of Bilcare’s novel nonClonableID technology which got approval under the Council of Scientific and Industrial Research (CSIR) under its New Millennium Indian Technology Leadership Initiative (NMITLI) Scheme last May. The nonClonableID technology is based on novel aspects of material science and utilises the law of randomness to create unique non-duplicable fingerprints. These fingerprints when processed, digitised and activated can function as unique identification tags.

Speaking to Express Pharma, Dr Praful Naik, Executive Director and Chief Scientific Officer, Bilcare who is the principal investigator for the project, said that, “Two leading brands of anti-diabetes and anti-TB medicines from leading MNCs have incorporated the nonClonableID technology into their packaging.” A total of 50 patients, (25 patients on each disease arm) will be enrolled by the 10 participating doctors. The study is expected to continue over five to six months and both arms will be monitored by a super specialist. The aim is to securitise the supply chain in the existing scenario, from the point of origin to the point of sale. The technology allows tracking of the medicines from the manufacturing facility to warehouses, then on to CNF agencies and stockists and finally to the retail level ie. the stockists and chemists. But what differentiates this technology is that it moves into the patient’s home as well. So the patient

MARKET 15 MANAGEMENT 35 RESEARCH 44 PHARMA LIFE 80 October 16-31, 2013

can scan the medicine strips, authenticating that the product is genuine. A second improvement over existing track and trace technologies is that it records consumption/non-consumption of doses and also alerts patients that their medicines are getting over allowing them to replenish their medicines in time so that no dose is missed. This attempt to monitor medicine usage and non-compliance was added based on feedback from medical practitioners who were consulted during the planning stages. For instance, if a patient delays consuming a dose at the prescribed time, he receives a reminder. If the medicine is still not consumed, the second reminder is sent to the patient as well as his doctor and caregiver (generally a family member). This signals a missed dose/non compliance to the doctor who can counsel the patient about the risk of developing drug resistance if the prescribed dosage regimen is not followed and

ensure that better compliance is maintained via the caregiver as well. Thus, Bilcare’s nonClonableID tags are useful not just to crack down on counterfeit medicines but also to reduce non-compliance leading to drug resistance. As Naik speaks of the problem of multi-drug resistant TB plaguing India, as well as the importance of diabetes patients taking their medication at the prescribed times, it is evident why these two disease conditions were chosen for the field validation study. The scanning device (reader) currently costs around `2000 to `2500 and Naik indicates that the price will reduce after commercial launch as more manufacturers start making the device. There is also a chance that the government might subsidise the cost in certain cases.The field validation study is expected to last five to six months, and will involve around 10 doctors (five in each arm) headed by a super specialist who will monitor both arms. The study size may be small (a total of 50 patients, 25 patients on each disease arm will be enrolled by doctors) but represents almost a year of extensive background work done by CSIR and Bilcare to create a completely scaled up system infrastructure for eventual nationwide implementation. Naik hopes the field validation it will go a long way towards demonstrating the utility of the nonClonableID tags in establishing product accountability through secured traceability from the point of origin to the point of dispensation, authenticity check and establishing epedigree as well as improving medication compliance by patients. EP News Bureau – Mumbai

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‘We will continue to develop and offer new innovative products to meet industry demands’ Shivaji Kamble, Commercial Director, Pharma, Nutritional and Functional Ingredients, Kerry Ingredients India shares details of the company’s journey and its future plans, in an interaction with Usha Sharma Tell us about Kerry Ingredients India's ongoing activities? Kerry Ingredients India manufactures and delivers technology-based ingredients, flavours and integrated solutions for the pharma as well as food and beverage (F&B) industry. Our unique, integrated approach to customer-specific innovation and product solutions is driven by our technology, market application, culinary and sensory expertise. What is the company's mission and vision? We aim to become the world leader in food ingredients and flavours serving for the pharma and F&B industry. Through our skills and wholehearted commitment of the employees, Kerry will be a leader in the selected market, excelling in product quality, technical and marketing creativity as well as service. Adulteration of food ingredients and dietary supplements is an ongoing issue. Does the company face similar issues in India, as well as in developed countries? Kerry has a total quality philosophy into its complete product life cycle. We have global systems and policies to ensure the highest quality and safety. International Pharmaceuti cal Excipients Council (IPEC) intends to open an office in Mumbai. What is your take on this? We are an active member of IPEC and our manufacturing processes are GMP compliant with IPEC guidelines. Having an IPEC India office will help to further align the industry globally regarding quality, safety, and functionality standards of excipients into the international marketplace. There are certain grey areas in Indian quality standards, including the ingredient

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INTERVIEW

segment. How difficult is it to conduct business in such a scenario? Kerry is committed to exceed the cGMP expectations of its pharma customer base with its extensive quality assurance programmes. We have global quality governance with regionally managed quality teams to ensure that all the standards are met. Entrepreneurs feel that operating business from India is slowly becoming tougher with severe competition. How do you handle this challenge and maintain your stronghold? We are building on 75 years of innovation, commitment and reliability as a world class excipient supplier. We have a good R&D and manufacturing expertise. No other company can provide the innovative and integrated cell nutrition and excipient solutions that we offer for greater manufacturing performance, improved reliability and cost savings. What services do you offer to the pharma industry? We have been a leading manufacturer of media supplements and excipients serving the biotech, pharma and nutrition markets. For cell culture and fermentation applications, we have a vast collection of media supplements including protein hydrolysates, yeast extracts, recombinant proteins, and complex systems that maximise yields and cell performance in biotechnological production systems. Our lactose, tabletting systems, www.expresspharmaonline.com

and coatings provide customers with business building solutions for improved tablet manufacturing. How effective and useful are these services? Kerry has a reputation of excellence in providing pharma grade film coatings, hydroxypropyl methylcellulose (HPMC), lactose, tabletting systems, and flavours for drug delivery systems. We have a history of leadership, product knowledge, industry expertise, and technologies to deliver the highest quality excipient solutions. Our new innovative products are focused on driving efficiencies in the direct compression tablet manufacturing process. These include superior products such as: ● The industries most extensive lactose product line of anhydrous, spray dried, crystalline and inhalation grades of lactose for all tabletting applications ● SheffCoat aqueous-based coating systems that are customised, ready-to-use, cost effective solutions ● SheffCel cellulose ethers are HPMC & MC multi-purpose excipients for pharma and nutritional supplement applications ● LubriTose self lubricating systems to simplify the tabletting process by eliminating the need for a separate lubricant. What regulatory compliances do your products adhere to? Each batch is produced in accordance within approved specifications and are GMP compliant with IPEC guidelines as well as regional requirements globally. Our products comply with the USP, EP and JP. How many pharma ingredients have been developed by your company and how many are in the pipeline? We are constantly researching and developing innovative solutions to solve current industry issues. Customers are coming to us for streamlining their supply chain because we can provide integrated excipient solutions that optimise their manufacturing, expedite the

overall development process, improve manufacturing efficiencies; and thus drive greater value for their business. Innovation has been our heritage, starting with anhydrous lactose and continuing today with products like LubriTose. We will continue to develop and offer new innovative products to meet the industry's demands. Tell us about Kerry Ingredients India’s strategic partnerships with pharma MNCs? Particularly in the pharma segment our Sheffield branded products are qualified in the top blockbuster biotech drugs and there are over 700 articles which refer to our products. We have also been awarded supplier of the year for our innovative products, excellent support and customer service by several MNCs. Are you looking to grow inorganically? Kerry strategically grows through organic and inorganic growth. How large is your presence globally? Are there any expansion plans? Kerry has over 100 manufacturing facilities in 24 countries supplying products to 140 countries. We will expand based on market demands. What is your manpower strength? Do you plan to scale it up in future? We have over 24,000 employees strong with global manufacturing, sales, technology, and application centres in 25 countries across the globe. We will expand our base as per the market demands. What are your corporate plans for the next two to three years? We are going to continue our investment in research and technologies in order to provide innovative, high quality solutions that will help our customers' drive greater product performance, improved reliability and optimised manufacturing efficiencies. u.sharma@expressindia.com October 16-31, 2013

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VENDOR NEWS Clariant Chemicals wins Responsible Care logo Responsible Care is a world-wide initiative developed by the chemical industry and is a voluntary commitment for continuous improvement in environment, safety and health performance

lariant Chemicals (India) has received the Responsible Care logo by the Indian Chemical Council (ICC). Dr Deepak Parikh, Vice-Chairman and Managing Director accepted the plaque from Yogesh Kothari, President, Indian Chemical Council (ICC). Parikh said, “We believe that sustainability among the specialty chemical companies is an important qualifier for continued long-term economic success. For us in Clariant we are convinced that Responsible Care is a combination of safer products, people, processes and environment. It is a vital programme that contributes to sustainable development. Incorporating responsible working attitude is a continuous journey for us. Environment, safety and occupational health are the pivots for any successful and responsible organisation. Our people and their commitment to ESHA is the key for us to keep the responsible care flag flying high going forward.” Kothari mentioned that he was happy that ICC is awarding this first logo to

Clariant, within the new ICC rules framework. “We urge multinational companies like Clariant to share their best practices with the ICC member companies and be a leader in propagating the importance and relevance of this initiative for other companies.” PA Murali, Head of Regional ESHA and PS, Clariant Chemicals (India), said, “Responsible Care is an important tool for us, to attain our ultimate vision of No Accident, No Injuries and No Harm to our environment. We are glad to be among the top 25 companies in India, who have now been awarded the Responsible Care logo.” ICC has set-up a two stage process to award the logo to member companies. The first stage involves submission of ESHA data, compliance status updates of each code and the Responsible Care commitment signed by the VC and MD. The

second stage involves audit at each site, within the first year of award of the Responsible Care Logo.” Clariant has given its support to the Responsible Care Global Charter with the signing of Responsible Care declaration by Dr Hariolf Kottmann, Chief Executive Officer, Clariant in May 2008. The Responsible Care principles are embodied in the sustainability policy which underlines the strong commitment to sustainable chemistry and the leadership role in our activities and business. In India, the Responsible Care programme is being driven by ICC which has a clear plan to promote Responsible Care awareness among member companies. ICC is a Responsible Care member of the International Council of Chemical Associations. Responsible Care is a world-wide initiative developed by the chemical indus-

try and is a voluntary commitment for continuous improvement in environment, safety and health performance. It is a commitment to build trust and confidence in the industry to improve living standards and the quality of life. Being part of this programme helps companies in many areas such as, identifying ESH requirements beyond regulatory compliance; diminishing the risks due to environmental, health and safety failures; optimising operational conditions and company performance; improving the image and reputation of the company towards the employees, authorities, customers and general public; and lastly, demonstrating an ongoing commitment to Corporate Social Responsibility (CSR). The Responsible Care programme has seven codes, each having a specific focus. They are process safety, employee health and safety, pollution prevention, emergency response, distribution, product stewardship and security. EP News Bureau – Mumbai

Malvern Instruments acquires NanoSight NanoSight has developed and commercialised a unique and patented technology, Nanoparticle Tracking Analysis

October 16-31, 2013

alvern Instruments has acquired nanoparticle characterisation company NanoSight (Amesbury, UK). NanoSight has developed and commercialised a unique and patented technology, Nanoparticle Tracking Analysis (NTA). The company’s instrumentation and software enable the rapid and simultaneous multi-parameter analysis and characterisation of many different types of nanoscale particles. With their ability to analyse particle size, concentration, zeta potential and aggregation, NanoSight systems are closely aligned with Malvern’s market-leading Zetasizer range, extending Malvern’s solutions for those working at the nanoscale. Currently the largest applications area for NTA is in life sciences, for the measurement of biological

nanoparticles, where one of the most exciting and rapidly expanding fields is exosomes. These are intercellular messengers whose quantity and biochemical composition reflect the disease status of an individual. NanoSight technology uniquely provides quantitative detection and characterisation capabilities to make exosomes a viable proposition as biomarkers for drug discovery, disease prognosis, diagnosis and monitoring, as well as personalised medicine. Paul Walker, Managing Director, Malvern Instruments, said, “NanoSight is a real entrepreneurial success story and I am delighted to be welcoming the NanoSight team to Malvern. NanoSight has grown every year since it was established in 2002 and has ambitious plans for the future. We will be providing the investment and support www.expresspharmaonline.com

needed to continue this drive forward and are absolutely committed to developing the NanoSight brand within the Malvern portfolio. “NanoSight’s unique technology has become accepted in laboratories around the world and is widely cited in research publications. With rapid advances in nanomaterials and the life sciences, in biopharmaceuticals especially, the demand for new technologies to answer continually evolving analytical challenges has never been greater. This is an exciting time and by bringing together complementary, leading edge technologies, Malvern continues to focus on delivering the analytical tools which laboratories so urgently need.” Jeremy Warren, Chief Executive Officer, NanoSight, said, “We have always seen Malvern as the

clear leader in our sector, and the exemplar of what we wish to become. The plans we have are ambitious and exciting, and the support and reach of the Malvern organisation will allow us to grow more rapidly than we could alone. I am sure that this change will bring opportunity to both our business and our colleagues. Malvern is our natural home.” NanoSight employs around 50 people worldwide and will continue to operate from its current facilities in Amesbury, Wiltshire, UK, under the existing management team. Malvern’s direct sales operations in key geographies and wider global presence will be used to make the NanoSight instruments and aftersales support even more accessible to a wider market. EP News Bureau – Mumbai EXPRESS PHARMA

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Quintiles advances new approach to speeden biomarker-targeted therapies for cancer patients Undertakes novel genomic ‘pre-profiling’ feasibility study to examine the promise of precision medicine in metastatic colorectal cancer patient

uintiles has announced plans to improve the development of biomarker-targeted therapies through a novel approach that promotes the genomic ‘pre-profiling’ of cancer patients. As a first step, Quintiles is undertaking a study with the participation of US Oncology Research, supported by McKesson Specialty Health and The US Oncology Network, to explore the operational feasibility and clinical benefits of an upfront approach to the genomic profiling of tumors from metastatic colorectal cancer (mCRC) patients. The study will investigate how pre-profiling and genomic sequencing data

may support physician treatment decisions, including the identification of appropriate clinical trials for patients. “Today, the industry’s approach to stratifying patients through genomic screening is sequential – testing for oncology biomarkers one at a time, and often only as part of screening for participation in a single clinical trial,” explained Jeffrey Spaeder, Chief Medical and Scientific Officer, Quintiles. “Early indications from this study suggest that we can provide physicians and patients with early visibility on potentially clinically actionable biomarkers within a rapid two-week timeframe.

This level and speed of analysis has promise to save valuable time in administering potentially life-saving therapies to patients, and reduce the development times of precision medicines.” As cancer research and care enter the era of precision medicine, Quintiles is actively transforming the model for testing new therapies. Preprofiling may accelerate early testing of new biomarker-targeted therapies by enabling biopharmaceutical companies to focus on molecules with high potential for safety and effectiveness. For cancer patients and physicians, preprofiling enables the efficient matching of the right patients

to the right clinical studies, and increases patient access to innovative therapies. “Our work is taking a critical step toward making precision medicine a reality,” continued Spaeder. “Quintiles’ end-to-end design and delivery model for connecting genomic testing with clinical trials supports the needs of patients, physicians and drug developers. Our goal is to provide oncology investigators and their patients with access to effective, cutting-edge therapies through a model built upon experience and high-quality cancer care.” EP News Bureau – Mumbai

Recipham to expand lyophilisation capacity with ¤ 32 million investment in Germany Construction of new production building with large scale freeze drying capability sets the company on a course to expand business from both new and existing customers

ecipharm has invested ¤ 32 million at its Wasserburg site located near Munich. The capital will be used to create a new building that will house a fourth production area adding to the three already in operation. This development will significantly increase the company’s lyophilisation capacity and will result in a brand new state-of-the-art facility equipped with the latest automatic loading and unloading technology. The building will also have the flexibility to accommodate further production lines. The number of employees will be increased from the current 282 to 320 and the new area is expected to be operational in 2016. The Wasserburg facility

has a long history of producing products in vials and ampoules for large, medium and small pharma companies and was established almost 40 years ago. It has emerged as a world leading specialist in aseptic filling and lyophilisation of injectable drugs supplying Europe, the US, Brazil and Asia Pacific. Armin Dallüge, General Manager, Recipharm in

Wasserburg said, “We are delighted with this decision to significantly expand our facility. We have been operating at full capacity for several years now and we see this investment as vital to maintain and increase our leadership in this field. Demand for lyophilisation is expected to increase in the coming years and we intend to be at the forefront of servicing this.”

THIS WILL RESULT IN A BRAND NEW STATE-OF-THE-ART FACILITY EQUIPPED WITH THE LATEST AUTOMATIC LOADING AND UNLOADING TECHNOLOGY

Thomas Eldered, Chief Executive Officer, Recipharm, commented, “Lyophilisation is a fast growing technology which we believe will become even more important. Recipharm is one of the few contract development and manufacturing organisations with the capability to make such a significant commitment to this dose form and our financial stability sets us apart from our competitors. Given the excellent track record of Wasserburg and in particular the highly skilled workforce, we are confident that this investment will help us to consolidate our position as one of the world’s leading CDMO’s.” EP News Bureau – Mumbai

Tofflon to organise seminar on lyophilised injectables An international team of speakers from the US, Italy, Japan, Korea will offer their knowledge during the seminar

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offlon Institute of Freeze Drying System will organise a seminar on ‘Challenges and Solutions for lyophilised injectables in large scale and high efficiency manufacturing.’ The event will be held in The Westin Hyderabad Mindspace, Hyderabad on October 18, 2013. An international team of speakers from the US, Italy, Japan, Korea will offer their knowledge during the semi-

nar as a valuable service to pharmaceutical and biotech industry. Tofflon has been growing up together with Indian lyophilised injectables industry for 10 years. The company has been working at more than hundred freeze dryer projects with Indian pharma and biotech industry. Tofflon freeze dryer has been working with all the global leading filling line brands: Bosch, Bausch+Stroebel, Groninger, www.expresspharmaonline.com

IMA, Inova, Steriline, etc. In the past five years, Tofflon is developing freeze drying system which serves for lyophilised injectables large-scale and high-efficiency manufacturing from emerging markets. The company focuses on critical aseptic process systematic integration from solution preparation and sterile filtration, sterile filing, freeze drying, auto loading systems, isolator to auto inspec-

tion with mechanical integration, as well as complete process automation. The added value are ‘aseptic risk control, high-efficiency, cost-effective’ under largescale manufacturing background so as to offer competitive solutions for your lyophilised injectables generics successfully stepping into regulated markets. EP News Bureau – Mumbai October 16-31, 2013

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PRODUCTS GE Kaye LabWatch LT System offers wireless turnkey solution T he GE Kaye LabWatch LT System, from GE Measurement & Control, offers a cost-effective solution to monitor environmental parameters within the biotechnology, medical and pharmaceutical sectors in compliance with regulatory requirements. It is a wireless system, featuring very simple hardware and software and is particularly suitable for small to medium size companies, which do not have the need or the budget to justify a fullscale SCADA system. “To comply with regulations such as FDA and GMP, it is essential that any monitoring system provides accurate and reliable monitoring of a wide range of parameters ranging from temperature, pressure and humidity to door switch relays and air flows,” explains Mark De Novellis, Global Product Manager at GE Measurement & Control. “Based on userdefined parameters, Kaye LabWatch will monitor and detect system excursions and can alert user-selected personnel wherever they are located. It will also create an audit trail of alarms and generate compliant reports. All this is carried out in real time by means of a user-friendly software platform, which is integrated with accurate wireless data loggers, seamlessly connected using GE’s highly reliable SmartMesh networking technology.” The primary inputs of the

October 16-31, 2013

new system are the extremely accurate, battery-operated, wireless RF ValProbe data loggers. These store and forward the real-time data form the parameter sensors at user-defined intervals to the RF Base Stations and can store up to 10,000 samples per sensor. Data is then transferred from the base stations to the local Ethernet network or USB2.0 and then accessed by the LabWatch LT system computer for processing and analysis. LabWatch LT is relatively simple to install and engineering costs have been minimised as the software is designed to be configured by a user with basic IT skills and the installation of the RF Logger hardware requires no wiring. Operator training is easy because of the system’s intuitive operation. LabWatch LT makes use of wireless sensors that adds lot of simplification while installation but before you choose any wireless you should always look for the points to get data reliability

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and data security, as in pharma industry data is very critical and loss of it not acceptable.

The wireless technology Redundant routing is a must have in a real world RF application. A full mesh topology with automatic node joining and healing lets the network maintain long-term reliability. It works without special-purpose routers. Its implementation in the Kaye product line allows up to 100 sensor nodes to be connected in a seamless, reliable and self forming mesh network. The mesh technology permits nodes to communicate with the base station and each other, correcting for weak RF links and automatically ad-justing to dynamic RF environment, e.g. a forklift truck driving into a warehouse blocking a signal. No special knowledge or expertise is required to install or operate the Kaye RF ValProbe. Smart-Mesh Network

Key features ●

Transmission reliability: RF

Mesh can provide up to 99.9 per cent transmission reliability. Redundancy introduced through datastorage elimi-nates risks of data loss. ● Dynamic network formation: No RF Site surveys required. System works out of the box and is fully validatable. ● Low energy consumption Data security: Immune to RF interference, snooping, insertion of invalid data.

Transmission reliability For the application in a GMP environment a wire-less sensor network needs to deliver wire-like transmission reliability. The Dust Networks SmartMesh is based on a time slotted channel hopping protocol (TSCH). The IEEE 802.15.4 provides 16 wireless transmission channels which are divided into different time slots. Each channel and each timeslot can be used for data packet transmission. Because of the manager coordinated network synchronisation each sensor nodes always listens, talks or goes into sleep mode in time

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and always uses the best possible available channel for data transmission avoiding any possible interference. Even pair wise channel hopping is possible enabling multiple simultaneous transmissions and further increasing reliability by increasing the available channels for each sensor node. Basically the time slotted channel hopping technique renders the transmission quite robust to interferences from other wireless device transmissions like cordless phones or WLAN connections and electric fields created by electric motors.

Low energy consumption In monitoring or mapping applications the possibility to place a sensor in a remote and difficult to reach location is a benefit of wireless sensor net-works. Often a power line is not available. For a wireless sensor node most power is required by the data transmission. Common wireless trans-

mission protocols require either a connection to the power line or frequent exchange of the batteries. In a Dust Networks SmartMesh the communication of the sensor nodes is reduced to a minimum using the time synchronised protocol advantages. In addition Dust Networks has developed a very low power consuming IEEE 802.15.4 compliant hardware. The combination of the low power optimised communication and the low power consuming hardware leads to sensor nodes that can run easily a year or longer on battery power while continuously monitoring the environment. The power consumption of the sensor node is monitored, too. Therefore the managing system can dynamically optimise the battery life by re-routing data transmission through neighbor sensor modes if available, and the system will report the end of lifetime for a battery for duly replacement.

Dynamic network formation The Dust Networks SmartMesh network is self-forming and self-optimising. Each of the nodes discover neighbours, measure RF signal strength, optimise signal pathways, dynamically optimise signal routing and route signal traffic from neighbours. A node may also join as an end node, become a routing node due to changing RF conditions and later revert back to an end node. The SmartMesh network manager performs a continuous optimisation of the transmission routing and changes the data pathways and allocate bandwidth in response of the dynamic changes in the RF environment. The extension of a SmartMesh sensor network is simple. The manager automatically discovers new sensor nodes and implement them into the existing network. Extending the network increases the optimisation possibilities and actually

improves reliability and data latency times.

Data security The Dust SmartMesh network provides full end to end data encryption (128bit XTEA) with pre-shared keys on RF level while checking data message integrity and authentication. Each sensor node is handled like an independent network device with a MAC address. The data inside the loggers and the basestation is encrypted and all files that are transferred to a PC is CFR 21 part 11 compliant hashed and digitally signed. All RF data is encrypted using a join key and a network key. These security features render the Dust Smart- Mesh network to one of the most secure networks available. Contact details Asif Gavandi Sales Manager-India & Bangladesh email: Asif.gavandi@ge.com

Cognex launches low cost vision sensors, Checker 4G 7 he Checker 4G series of vision sensors by Cognex offers unmatched performance and flexibility to solve even the most difficult applications. The Checker 4G series offers the same powerful and easy to use setup. Checker Vision Sensor is known for plus Ethernet networking for remote setup and monitoring, PLC communication through EtherNet/IP and PROFINET and the ability to save images of every inspection to an FTP server. The key features are: presence sensors verify that features are present; industry standard Ladder Logic editor allows for customisation of results and eliminates PLC programming; EtherNet/IP industrial protocol with RSLogix5000 Add-On-Profile; PROFINET industrial protocol support; image storage to FTP server; remote setup and display through your PC; encoder-based part tracking for variable speed lines; up to four discrete outputs; up to 32 job changes for maximum flexibility; coloured lens filters available. The applications of vision sensors are: Date code and MRP print presence/absence; detecting

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missing bottles; detecting missing caps and lot codes; verifying seal and cap presence absence; verifying label presence/absence and liquid fill level inspection. www.expresspharmaonline.com

Contact details Cognex Sensors India Regus, Level 6, Pentagon Towers, PII Magarpatta City, Hadapsar Pune â&#x20AC;&#x201C; 411028

Telephone: 020 40147840 Fax: 020 66280011 Email Id: lacroix.didier@cognex.com

October 16-31, 2013

Express Pharma Business Avenues

October 16-31, 2013

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Express Pharma Business Avenues

We care for your family . . .

Anti-Inflammatory Enzymes Serratiopeptidase Peptizyme (enteric coated serratiopeptidase granules) Trypsin Chymotrypsin mix ( 6:1)

Probiotics Saccharomyces boulardii Lactic acid basillus sporogenous

Circulatory Health Nattokinase

Bio Catalysts Immobilized Cal B

Digestive Aids Alpha amylase / fungal diastase / fungal amylase Alpha galactosidase Bacterial alpha amylase Bromelain Hemicellulase Lactase Lipase Ox bile

Papain Pepsin Pancreatin Protease ( acid / alkali)

Advanced Enzyme Technologies Limited Sun Magnetica, 'A' wing, 5th Floor, Accolade Galaxy, LIC Service Road, Louiswadi, Thane(W) - 400604, India Tel: +91 22 41703200, Fax: +91 22 25835159 • E-mail : info@enzymeindia.com • Website: www.enzymeindia.com

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Non-GMO ISO CERTIFICATION

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Products

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ROQUETTE, through its production units (in Europe, in Asia and in the United States) and its international distribution network, will assure a constant quality of products and services throughout the whole world.

www.roquettepharma.com For your local contact : Roquette India Pvt Ltd Email : pharmabiz.india@roquette.com - Tel : +91 22 2570 6775 Our local Distributor : Signet Chemical Corp. Pvt Ltd - Email : sales@signetchem.com

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Product Range Horizontal Plate Filter Press Plate & Frame Filter Press Bag Filter Cartridge Filter Single Plate Filter Holder Basket Filter Rotary Spray Ball Recess Plate Filter Press

Parksan Filters Pvt. Ltd.

103, Laxmi Industrial Estate, Navghar, Vasai Road (East), Dist. Thane - 401 210, India Tel : +91 250 239 1904 Mob : +91 98338 83114 Email : sales@parksanfilters.com Web : www.parksanfilters.com parksan@vsnl.net

CLEANING, SANITISING EQUIPMENTS CLEAN ROOM ACCESSORIES ASEPTIC PIPING , PW / WFI DISTRIBUTION LOOPS

Floor Drain Traps

Hand Sanitiser

Water Saver Cleaninng Nozzles(self-rotating) Nozzles

Shoe Cover Dispenser

Foot Sanitiser

Split Butterfly Valve

Pendents(Service Shafts) CIP/ SIP MODULE We also design & manufacture # IBC Washing/ Drying Modules # Containers/ Glass Ware Wash Modules # FBD Bag Washing/ Drying Modules # Cannisters Washing Modules # Drums Washing Modules

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8/B, Surat Singh Est ,SV Rd, Jogeshwari(W), Mumbai-400102 Tel; 022-26797941 Telefax:022-26798066 Cell: 9869231815 email: iewi@mtnl.net.in website : www.iewi.net

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Top Tank / Reactor Sampler

Flush Bottom valve October 16-31, 2013

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From Amsterdam to India

Pharmaceutical Consultancy Services (PCS) presents

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For More Information about the course and registration, please go to: http://www.pcs-nl.com/india PCS - Pharmaceutical Consultancy Services Pvt. Ltd. S.No. 5/3/7, Aditya Shagun Mall, Shop No. 63, Bawdhan, Pune 411021 +31 182 503 280 info@pcs-nl.com

PCS - Pharmaceutical Consultancy Services Veluwemeer 112 3446 JD - Woerden the Netherlands +31 182 503 280

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Express Pharma Business Avenues SILICONE TRANSPARENT TUBING FO R HI G H P UR I TY A P P LI C A T IO N S

DMF NO: 26710

1 1 1 1 1 1 1 1 1 1 1 1 1

US FDA regulations CFR 177.2600 for contact with food USP class VI requirements European Pharmacopoeia 3.1.9 Animal derivative free Imported state of the art machine ed Highly advanced auto-curing system rtifi e C Excellent heat resistance (-50째C to 250째C) m nroo Clea Odourless Completely nontoxic Repeatedly autoclavable No leaching of particles Does not support bacteria growth Retains elasticity even after prolonged use

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October 16-31, 2013

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Manufacturers of Pharmaceutical Machinery

39/2A, Purna Das Road, Kolkata - 700 029. Gram : Techpharma. Tel : 91 33 2464 4568 / 0457 7253 Fax : 91 33 2464 7254. Email : mails2neomachine@gmail.com, neocota@sify.com Website : www.neocota.com, www.neomachine.in Mumbai : 91 22 2261 4088, Chennai : 91 44 2432 2243 / 2432 8128, Delhi : 91 11 2546 0255

October 16-31, 2013

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Express Pharma Business Avenues ONE STOP SOLUTION FOR PHARMACEUTICAL RESEARCH

Innovation is our culture…

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!"#$%&%'($%)# )& +"'),-%#(#$ .+)$"%#/ (/ ."+ 012 31415.(6"7 8"/$"+# -9)$7 2".$%!" ,(..%#6: ;#(9</%/ )& .+)$"%# %,.=+%$%"/ %# +"'),-%#(#$ .+".(+($%)#/ >"#" ?=(#$%&%'($%)# -< @A52B@ C9"'$+).D)+"/%/ /</$",/ E)9"'=9(+ /%F" !"$"+,%#($%)# 31CB: B9%#%'(9 -%)'D",%/$+< (#(9</%/ G".(+%# 7C#)H(.(+%#7 G=,(# 1"+=, ;9-=,%# (#(9</%/

I%)9)6%'(9 ;'$%J%$< 3 K( (#! (: BD(.$"+ LMNOP: 2<+)6"# A"/$%#6 3BD(.$"+ LONOP: I('$"+%(9 C#!)$)H%#/ 3BD(.$"+ LMNP: 1$"+%9%$< A"/$%#6 3BD(.$"+ LQOP: E"$D)! R(9%!($%)# (/ ."+ BG ;EC1 A"/$ (/ ."+ SCB4 TQO 2+"/"+J($%J" C&&%'('< A"/$ 3BD(.$"+LNOP: I%)9)6%'(9 @"('$%J%$< &)+ 2('U%#6 E($"+%(9 (/ ."+ 3BD(.$"+LMQP7LMMP:

BIOSIMILAR TESTING

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ACCREDITATIONS USFDA registered cGMP control testing laboratory DSIR approved R & D Centre Drugs Controller General of India (DCGI) NABL accreditation for Chemical, Biological Medical Testing, Bioanalytical & Mechanical Recognized by Bureau of Indian Standards Drugs Control Administration (A.P) Department of Biotechnology approved Institutional Bio-Safety Committee (IBSC)

Formulation Development Microbiological Studies Biological Studies Pre Clinical Studies Analytical Research Bio-equivalence Studies Clinical Trials Dossier Preparation

4($( E(#(6","#$ .+('$%'"/ %# 1 2@; V;I1 (+" !"/%6#"! $) "#/=+" $)$(9 %#$"6+%$<7 /"'=+%$< (#! &(/$"/$ +"$+%"J(9 )& !($(W

SIPRA LABS LIMITED Industrial Estate, Sanathnagar, Hyderabad – 500 018. Tel: 040-23802000, Fax: 040-23802005 Email:sipra@sipralabs.com web: www.sipralabs.com October 16-31, 2013

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THE UNITED ENGINEERING COMPANY

UNITED “AFS-10” HI – SPEED AUTOMATIC AMPOULE FILLING AND SEALING MACHINE

UNITED “SAL” FULLY AUTOMATIC SELF ADHESIVE VERTICAL BOTTLE LABELING MACHINE FOR ROUND / OVAL / FLAT BOTTLE(SINGLE / BOTH SIDE LABELLING)

OUTPUT: 15000 to 18000 Ampoules/Hour RANGE : 1 ml. – 10 ml.

OUTPUT – 3000 to 12000 Bottles/Hour (Output depends on Bottle size & Label size)

Salient Features : n

Salient Features :

In feed of empty washed and sterilized ampoules with the help of conveyor or S.S.

Hopper and S.S. Tray.

Automatic collection of filled and sealed ampoules in erect position.

Vertical & Horizontal adjustment of label applicator and label position to handle

Both sides labelling machine is available for flat bottles.

Individual No Ampoule No Fill Arrangement.

S.S. 316 L syringe with rotary valve with a single volume adjuster.

Accurate Label Placement. Label dispensing with Servo Motor and Servo Drive for better accuracy. different size of bottles by means of Hand wheel.

A.C frequency drive & geared motor.

Same machine can handle round and flat bottles with minimum change parts.

Fully PLC controlled with touch screen & HMI.

Fully PLC controlled touch screen with HMI & AC Frequency Drive.

Machine body fabricated with Stainless Steel 304 quality.

Machine body is fabricated with S.S. 304 Structure & Cover.

Easy change over with minimum setting time for different size of ampoules.

Easy Change Over.

“UNITED” PROUDLY INTRODUCES MOST COMPACT HI-SPEED ONLINE VIAL WASHING MACHINE WITH ULTRASONIC WASH AND PLC SYSTEM MODEL – “OL-VW-12”

UNITED HI-PRO “ ARBW” AUTOMATIC ROTARY BOTTLE WASHING MACHINE

CAPACITY - 5ml. to 30ml. Round Vials. OUTPUT - 10000 to 14000 Round Vials/Hour

CAPACITY - 10ml. to 1000ml. Round Bottles. OUTPUT - 4800 to 8400 Bottles /Hour.

Salient Features : n

Salient Features : n Most Compact Design. No Bottle No Washing. n Machine supplied with 2 pumps for two different media of water fitted with filter and s. s. housing. n Conveyor driven by separate motor with AC Frequency Drive n The washing area is covered with acrylic sheet. n All pipes connected to water are as per GMP standard. n Machine can be used for air/water cleaning or even combine cleaning. n Versatile machine used for Glass/PET/HDPE bottles of different shape and size with additional change parts. n Easy change over with variable size. n Automatic loading and unloading of bottles. n After washing the bottles are directly fed to the filling machine without any hand touch. n Machine will stop automatically in case of bottle jammed at out feed. n

Most Compact Design.

PLC with HMI and AC Frequency Drive.

Minimum change parts.

Entire machine and contact parts with water & air are made of S.S. 316.

Alarms for Low Pressure of Recycled Water, DM, WFI & Compressed Air.

THE UNITED ENGINEERING COMPANY 132, Damji Shamji Industrial Estate, Mahakali Caves Road, Andheri (E), Mumbai 400 093. Phone : +91-22-2687 6919 ● Fax : +91-22-2687 6676 ● E-mail : uec.mum2@mtnl.net.in Head Office : 35A, Hazra Road, Kolkata-700 029 (INDIA) ● Phone : +91-33-2475 9744. Fax : +91-33-2475 7727 ● E-mail : uec@cal2.vsnl.net.in

October 16-31, 2013

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!" #

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AWARDS

OPPI awards th at 47 AGM Gives away awards in various categories rganisation of Pharmaceuticals Producers of India (OPPI) at its 47th annual general meeting in Mumbai announced a host of awards in various categories. With the aim of encouraging innovation in India, OPPI has instituted, as Public Private Partnership initiative along with NIPER and CSIR, OPPI Scientists and Young Scientists Awards. The awards were set up to encourage original research and innovation in the field of pharma sciences in India. The Best Scientist Award (CSIR) was bagged by Dr Gangadhar J Sanjayan, National Chemical Laboratory, Pune; Best Scientist Award (Academic Institute) was the winner of Dr Ellora Sen, National Brain Research Centre, Haryana

Dilsher Singh Kalha, Secretary, Department of Pharmaceuticals, Government of India presenting the OPPI Scientist Award to Dr Prabhu Dutt Mishra, Piramal Enterprises

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and the Best Scientist Award (Pharma Research Center) went to Dr Prabhu Dutt Mishra, Piramal Enterprises, Mumbai. Dr HR Nanji Memorial OPPI Marketing Excellence Awards 2013 were bagged by Boehringer Ingelheim India in the new products category and Novartis India in the existing products category. The OPPI Best Vendor Awards 2013 went to Medreich in contract manufacturing category and Leo Enterprises in Carrying & Forwarding Agents (CFAs) category. The OPPI Sales Force Excellence Awards 2013 was bagged by Eli Lilly and Company under the category Veeva – Empowerment for flawless execution. EP News Bureau-Mumbai

Dilsher Singh Kalha, Secretary, Department of Pharmaceuticals, Government of India presenting the OPPI Scientist Award to Dr Gangadhar J Sanjayan, National Chemical Laboratory, Pune www.expresspharmaonline.com

Piramal Enterprises bags rating from British Safety Council Award recognises the company’s adherence to world class safety and compliance with the best industry practices worldwide iramal Enterprises has achieved the British Safety Council (BSC) Five-Star Safety Award for the Digwal pharma solutions’ site, near Hyderabad. Piramal is the only Indian pharmaceutical company this year to achieve the rating. This award recognises the company’s adherence to world class safety and compliance with the best industry practices worldwide. Commenting on the appreciation, Vijay Shah, Executive Director and Chief Operating Officer, Piramal Enterprises said, “At Piramal, Environment, Health & Safety (EHS) is embedded in our very philosophy of business. The Digwal site underwent a stringent four-day audit from August 12-16, 2013 led by a delegate from British Safety Council (BSC), UK. I am happy to note that the audit results declared on September 10, 2013 scored Digwal site at a commendable 94.58 per cent The award is highly reputed and is awarded in recognition of world class safety prac-

tices. We are the only Indian pharma company this year to have received this prestigious award.” The British Safety Council audit is an internationally recognised system, used by leading organisations worldwide to benchmark their health, safety and environment (HSE) management systems against the best practices. The fivestar audit concentrates on five sections. They are safety organisation, management control system, fire control systems, measurement and control systems and workplace implementation. Piramal’s high score credits the site with a five-star rating (Grading of 92-100 per cent), which is a world-class benchmark standard.” Among many other areas of strength in Piramal’s safety management systems, the BSC auditor commended the management’s commitment and efforts to achieve excellence in occupational health and safety. EP News Bureau-Mumbai October 16-31, 2013

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

Transasia Bio-Medicals wins coveted ‘Global Business Excellence Award 2013’ Suresh Vazirani, Chairman and Managing Director, Transasia Bio-Medicals and Mala Vazirani, Executive Director, Transasia Bio-Medicals receive the award

ransasia Bio-Medicals has been conferred with the prestigious 'Global Business Excellence Award 2013’. The award was presented by Veerappa Moily, Senior Minister in Government of India. Suresh Vazirani, Chairman and Managing Director, Transasia BioMedicals and Mala Vazirani, Executive Director, Transasia Bio-Medicals received the award for Transasia BioMedicals Initiated this year, a survey of unlisted emerging companies who have been consistently contributing to their fields and delivering nothing short of the best was

conducted. The most deserving amongst them were then presented with awards in various categories under the 'Emerging Companies Excellence Survey and Awards'. As many as 526 companies from all across India were part of the

survey. Vazirani said, "We are thankful to all our customers and business associates for their continuous support and trust in us and for partnering in our progress. Transasia was set up to meet the need for reliable, affordable and

innovative medical diagnostic solutions. We remain committed to providing the highest quality products and services and will continue in our endeavour with the same zeal and passion.” EP News Bureau-Mumbai

CAMPUS BEAT IPA DB, Jamia Hamdard and DPR celebrate Pharmacist Day Initiatives for Consumers I Awareness on Safe Use of Medicines (iCASUM) was launched at Majedia Hospital

ndian Pharmaceutical Association's (IPA) Delhi branch (DB) at Faculty of Pharmacy, Jamia Hamdard in collaboration with Delhi Pharmaceutical Trust (DPT) recently celebrated Pharmacist Day. A number of activities were organised in the Hamdard campus. Initiatives for Consumers Awareness on Safe Use of Medicines (iCASUM) was launched at Majedia Hospital. It was followed by an e-essay

competition and e-poster competition and lectures by eminent pharmacists. The iCASUM booth at Majedia Hospital was inaugurated by Dr Firdaus Wani, Registrar, Jamia Hamdard along with Dr DB Ananthanarayana, Managing Trustee, DPT, Dr Farhan J Ahmad, President, IPA(DB), Kalhan Bazaz, Secretary, IPA (DB) and Ashish Das Gupta, Trustee, DPT. Farhan gave the welcome

address and briefed the gathering about the importance of Pharmacist Day and role of pharmacists in the society. Dr DB Ananthanarayana, Managing Trustee, DPT, delivered the presidential address on 'Good Storage Practices (GSP)'. He talked about the status of storage conditions in pharmacies across the country and briefed the students about good storage practices as well as how to educate

common men about the importance of GSP. An e-essay competition and an e-poster competition were organised on the topics 'Proud to be a Pharmacist' and 'Role of Pharmacist' respectively. A large number of entries were received by e-mail from various pharmacy colleges of NCR, Delhi. Prizes and momentoes were given to the winners. EP News Bureau-Mumbai

COURSE New modules added to Newcastle Univ’s e-learning courses 120 students registered N in 2012 from across the globe

October 16-31, 2013

ewcastle University, UK, which launched the MSc Oncology for the pharma industry, as a part of the MSc Oncology and Palliative Care e-learning programmes in 2012, will have two new modules in the new academic year: Health Economics, and Cancer Drugs and Technologies. 120 students were registered across the three e-learning programmes (MSc in Oncology, MSc in Palliative Care and MSc in Oncology for the

Pharmaceutical Industry) in 2012. Students from Australia, Canada, Greece, Malta, South Africa, India, Singapore, Saudi Arabia, the US, Ghana, Kenya, Egypt and New Zealand, enrolled for the courses. The programme has been designed to enable students to gain an insider’s look into the hospitals’ expectations from the pharma industry and the impact of regulatory procedures. It also focuses on the implications of www.expresspharmaonline.com

legislation and economic environment, and how pharmacists need to adapt to the changing sector by developing business skills. Ethical perspectives complement the scientific and business dimensions of the programme. Two new modules will be added to the programme for the new academic year: Health Economics, and Cancer Drugs and Technologies. Dr Charles Kelly, Degree Programme Director said,

“Students will gain knowledge that helps them build awareness of National Health Service (NHS) procedures. One of the main goals of the course is to help increase the understanding and cooperation between the pharma industry and NHS by helping students understand how decisions are made in adopting certain techniques, with the patient at the centre of the decision making process.” EP News Bureau-Mumbai EXPRESS PHARMA

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

OBITUARY Chandru Shahani: A man who won against all odds With the demise of Chandru Shahani (1936-2013), Founder, Klenzaids, India has lost a creative genius and a great entrepreneur, says Sachin Jagdale

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y first glimpse of Chandru Shahani was at a symposiaum on bio-contamination, organised by Klenzaids in Chennai. Though cancer had taken a toll on his health, the Klenzaids founder and entrepreneur attended the event on a wheelchair. Demonstrating his 'neversay-die spirit' which regular chemotherapy sessions had failed to dampen, he was instructing his colleagues to ensure the success of the event. “Only innovation can make India get noticed on the global platform,” he had told me then. A few minutes later, the Chief Guest of the event, India’s former President, Dr APJ Abdul Kalam, praised Shahani for the same ‘innovative attitude’. As Shahani’s 17 year long battle with cancer came to an end on September 25, the world lost an authority on designing microenvironment cleanrooms and containment systems. But more than that, we lost a creative genius and a great entrepreneur who will be remembered and revered by the global scientific and business community alike. Shahani's rise from a poverty-stricken partition-time refugee to a personality of national and international repute is a story that tells of his grit, determination and talent. Shahani started Klenzaids

where he pioneered methodologies based on his inventions. Many among those were related to aseptic technologies and bio-decontamination. He introduced submicronic filters and unidirectional laminar flow devices for semiconductor and microelectronics development and satellite integration. In parallel, he investigated the phenomena of 'chance positives' that led to random batch failures of injectibles. The seventies saw a renaissance in the

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Indian pharma industry despite the international technology apartheid stemming from Pokhran I. One of the key contributors to this upsurge was Klenzaids and the refugee behind it. Shahani was inspired by some extraordinary ideas that made him transcend all limitations to achieve success. While caring for the world he always made himself available to his family. “Aside from being a loving father to both his children, he

was an incredible grandfather to his four grandchildren. Everything that he did for society was in the name of his four grandchildren and he made them an integral part of such endeavors,” reveals an emotional Monisha Narke, Shahani's daughter. “He was also a father to the 400 people that worked in Klenzaids and their families. Several children in various villages and schools also considered him to be a father figure,” says Hamish, Shahani's son. Shahani’s dream was to see India as a self sufficient producer of pharmaceutical raw materials and medicines and he lived to see this coming true. He also dreamt of a strong India with a comprehensive space programme. Shahani was the ultimate organiser, meticulous to every detail. When he was diagnosed with cancer, he took it upon himself to focus on the long term management strategy of Klenzaids which has always been a professionally run company. ‘Vision to Mission’ is an anthology of views about the former President APJ Abdul Kalam, where as an editor, Shahani writes, "This is the story of one man, who gives of himself freely, leads fearlessly and wisely walks his talk." In my opinion, these words describe Shahani to the 'T' himself. sachin.jagdale@expressindia.com

October 16-31, 2013

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