Modern Pharma - 16-31 December 2012 by Infomedia18

16-31 December 2012 I Vol 1 I N o 12 I `100

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In Conversation With 14

Special Focus 15

Interface 17

Policies & Regulations 19

Dr Swati Piramal Vice Chairperson, Piramal Enterprises Ltd

Higher pharmacy studies Is the grass greener on the ‘Western’ side?

Dr R S Gaud Dean, (SPPSPTM), SVKM’s NMIMS

Patent laws in pharma Why MNCs are shying away from Indian patenting policies?

FDI through FIPB may hamper investments in Indian pharma, FABA

Reacting to the government’s decision on all foreign investments in existing domestic pharma firms to be cleared by the FIPB on a compulsory basis, Shakthi M Nagappan, Executive Secretary, Federation of Asian Biotech Associations (FABA), the organisers of BioAsia 2013, said, “Decision to route all the FDIs in pharma sector through the FIBP may decelerate and reduce the investments into India, unless appropriate & transparent mechanisms and systems are deployed to scrutinise and process such applications without delays.”

Ind-Swift targets to achieve ` 1,500 crore revenue by 2015

Ind-Swift Laboratories, a drug firm is hoping to achieve ` 1,500-crore revenue by 2015 with overseas markets such as Japan, the European Union and the United States being the main growth drivers. At present, Ind-Swift Laboratories is witnessing 15 to 20 per cent growth. Company’s current revenues stand at over ` 1,000 crore. Primarily, the company will continue to focus on its core business, ie, API business.

Dr Reddy’s launches PamorelinÒ LA in India

Dr Reddy’s Laboratories Ltd recently announced that it has launched PamorelinÒ LA in India on December 3, 2012, under an exclusive marketing and sales agreement with Debiopharm GroupTM, Switzerland. PamorelinÒ LA is used for the treatment of locally advanced or metastatic, hormonedependent prostate cancer. PamorelinÒ LA will be imported in bulk from Debio Recherche Pharmaceutique (Debio RP). It will be made available primarily to urologists and oncologists across India.

Anacor Pharmaceuticals announces positive results from phase II trial

Anacor Pharmaceuticals recently announced positive results from a phase II safety, Pharmacokinetics (PK), and efficacy trial of its boronbased phosphodiesterase-4 (PDE-4) inhibitor, AN2728, in adolescents (ages 12 - 17) with mild-to-moderate atopic dermatitis, a chronic rash characterised by inflammation and itching. “Data from our first study of AN2728 in adolescents with atopic dermatitis are promising, with 35 per cent of patients achieving an ISGA score of ‘clear’ or ‘almost clear’ with a minimum 2-grade improvement,” said David Perry, CEO, Anacor.

Strides, Lilly in pact to expand delivery of cancer drugs Eli Lilly and Company and Strides Arcolab Ltd have collaborated to expand delivery of cancer medicines in emerging markets. As a part of this arrangement, Lilly will in-license a portfolio of high-quality, branded generic injectible and oral cancer medicines from Agila Specialties, the specialties division of Strides Arcolab Ltd, based in Bengaluru. Agila Specialties will manufacture cancer Kumar medicines, and Lilly will register and market these medications in multiple geographies across the emerging markets. In addition to the initial 10 medicines

included as part of the agreement, Lilly has the right to add additional high-quality branded generic oncology products to the portfolio in the future. “Cancer medicines of the highest quality continue to be an unmet need in many markets around the world. Building on our recent investment in a Lillybranded generics platform in China earlier this year, this agreement will help Lilly expand its portfolio and deliver high-quality cancer medicines to patients across emerging markets,” said Jacques Tapiero, Senior Vice President and President – Emerging Markets Division, Lilly.

Piramal’s subsidiary DRG acquires Abacus

Piramal Enterprises’ subsidiary Decision leading mobile communication tools.” Resources Group has acquired Abacus “We are excited to continue our International, a pioneer in evidence- growth as a Decision Resources Group based global market access solutions company,” said Simon Howard, CEO, for many of the world’s Abacus International. leading healthcare “We view this acquisition companies. The as a major step toward acquisition of UK-based becoming a fully The acquisition is Abacus by Burlington, part of DRG’s overall integrated global market Massachusetts-based access solutions provider. strategy to acquire and/ Our team of experienced Decision Resources Group will result in or build brands that can health economic and a significant global leverage each other’s market access specialists expansion of Decision forward to thought leadership look Resources Group’s incorporating the market market access capabilities. and payer research data Abacus will be part of the held by sister companies Market Access Business at Decision Resources Unit at Decision Resources Group, which Group to improve our payer insight and currently includes the brands: Fingertip value communications deliverables.” Formulary, HealthLeaders-InterStudy, The acquisition is part of Decision PharmaStrat and Pinsonault. Resources Group’s overall strategy “Abacus brings to the table a unique to acquire and/or build leading combination of technical excellence brands that can leverage each other’s and robust, evidence-based thought leadership to create analysis resulting in solutions meaningful products and that are well-designed to services for the healthcare address the needs of our industry. “Abacus is an healthcare clients,” said Jim important acquisition Lang, President - Market in Decision Resources Access Business Unit, Group’s overall strategy Decision Resources Group. to expand our market “Besides expanding our access capabilities and global market access services offer our clients the most and products, the acquisition innovative, high-value Howard also allows us to now offer advisory solutions,” said market access capabilities for the medical Peter Hoenigsberg, CEO, Decision device and diagnostic industry as well as Resources Group. Abacus International to significantly expand our commercial will remain headquartered in support capabilities, with industry- Bicester, England.

Arun Kumar, Founder & Group CEO, Strides Arcolab said, “We are delighted to partner with Lilly to expand its branded generics platform with high-quality oncology products that will benefit from Lilly’s strong global presence in key markets.” Commenting on the occasion, Melt Van Der Spuy, Managing Director, Eli Lilly and Company India, said, “This strategic partnership marks Lilly India’s entry into branded generics, reaffirming our commitment to reach more Indian patients. We believe this partnership will help us build a significant larger and more meaningful presence in the Indian cancer segment, and hence, enable us to better serve many more Indian patients suffering from various forms of cancer.”

AB SCIEX India opens new centre for analytical science in Delhi As part of its ongoing investment in India, AB SCIEX, a global leader in life science analytical technologies, has started a new $ 3 million facility in Delhi to give scientists and laboratory technicians Blair across India access to the latest innovations in analytical technologies. This state-of-the-art, scientific support centre is designed to help address some of India’s biggest analytical challenges, including food safety, environmental protection, vitamin D analysis, biomedical research, testing of banned drugs of abuse and the development of new therapeutics and generic drugs. “AB SCIEX continues to make significant investments in India as a strategic area of focus for us,” said Rainer Blair, President, AB SCIEX. “We are committed to responding to and meeting the growing needs of India’s research and applied analytical testing communities. We work relentlessly every day to be a trusted partner with Indian scientists and lab managers. Our new customer-centric facility in Gurgaon will allow us to take the lead with our customers to reshape analytical science in this amazingly forwardthinking region of the world.”

M o d e r n P harma•16-31 Dec em be r 2012

CONTENTS In Conversation With

Dr Swati Piramal Vice Chairperson, Piramal Enterprises Ltd

Special Focus

16 16

Pharma education and policies Higher pharmacy studies Is the grass greener on the ‘Western’ side? Lacunae in pharmacy education Need to refurbish the Indian system

Interface

Dr R S Gaud Dean, (SPPSPTM), SVKM’s NMIMS

Facility Visit Principal K M Kundnani College of Pharmacy In the quest to build bright futures

Insight & Outlook

15 16 17 18

www.modernpharma.in

Policies & Regulations Patent laws in pharma: Why MNCs are shying away from Indian patenting policies?

Tips & Tricks Mantras to retain employees: Knowing the right nuances

Event Preview

Med-Techno India 2013 Innovation and variety on offer

Event Report

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Mo de rn Ph a rm a •16 -31 D e ce m be r 2 012

Editorial

A timely booster dose!

Editorial Advisory Board Ajit Singh

Chairman, ACG Worldwide & Head, ISPE

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

Dr Gopakumar G Nair IPR Consultant & Advisor

Dilip G Shah

Chairman, IGPA & Secretary General, IPA

Daara Patel

Secretary General, IDMA

s this year comes to an end (and, not the whole world as prophesied by some doomsday sayers!), there is some definitive clarity at the policy level for foreign investments in the pharmaceutical sector. As per the latest government communiqué, all foreign investments in the existing pharmaceutical companies would be cleared by the Foreign Investment Promotion Board (FIPB). Apparently, this is intended to ensure availability of medicines at affordable prices, which prima facie appears to be a long shot into the ever expanding pharma horizon. A quick recap of its background will shed some more light here. After a string of recent buyouts involving leading Indian pharma companies and to make adequate provisions of affordable medicines for a burgeoning populace, a ministerial panel had, last year, modified the pre-existing policy of automatic clearances and put foreign investment in existing pharma companies on approval route. However, in the subsequent phase, several proposals for the pharmaceutical sector have reportedly been deferred by FIPB, primarily due to lack of clarity in the government policy. This, of course, did not send the right signals to the global investing community. In this backdrop, the government’s recent announcement should not only soothe the nerves of those waiting to financially leverage the healthy Indian pharmaceutical market but also boost the business sentiment in this domain across the country besides bringing the market to an order from the consumer’s perspective.

Guest Editorial

That said, the last mile is yet to be traversed in terms of bringing in due amendments in the Competition Act. This is being done to provide for an oversight of transactions in the pharma space involving foreign capital by the Competition Commission of India (CCI), the apex body primarily responsible for preventing activities that have an adverse effect on competition in the country. It means every proposal for foreign investment in existing Indian pharma companies will be referred to FIPB till the Competition Act is amended. At the same time, the government is reportedly exploring the possibility of incorporating sector-specific provisions in the run up to amending the Competition Act. This move, although aimed at bestowing powers to CCI to ensure that Indian companies after being acquired by MNCs continue to produce a specific quantity of essential medicines, also needs to look beyond the volume of production. Among others, technology transfer, R&D outlay and the threshold for foreign investment in brownfield projects (that would require CCI clearance) could be some engaging action points with the promise of holistic growth of Indian pharma.

Manas R Bastia manas@network18publishing.com

Pharma policy on the right tracks

ndia’s search for a universal formula to fix the prices of essential drugs is still eluding grasp, though marketbased pricing formula appears to be closest to reality, envisaged by the National Pharma Pricing Policy 2012 that covers three key principles - essentiality of drugs, control only on formulations and market-based pricing. The shift from cost-based pricing to market based has been long overdue, as it has been stunting the industry’s growth and forcing manufacturers to discontinue production of some controlled drugs, as it was proving highly unviable. The various drug policies all these years were broadly based on the principle of putting a ceiling on prices of essential drugs on a ‘lowest common denominator’ basis. The Indian economy is today largely market driven with prices determined by market conditions and market forces. None truer than the Indian pharma industry, which has matured and has a number of manufacturers with intense competition in the market for almost every medicine, ensuring their continued availability and keeping prices in check. A paradigm shift from costbased price control to market-based pricing was thus long overdue to ensure continuity in production and availability of controlled products. Patented drugs are, however, in a different category as monopoly products and need some ceiling/control on prices. The pharma industry is probably the only industry where not only the

input costs are controlled, but also the margins! Experience has also clearly proven that cost-based price controls are not in public interest. They hinder production, distribution, competition, technology and quality development, R&D, capital investments, exports and employment potential. Free market competition truly promotes these factors and is in the best public interest. Historically, products under severe price control, which gave no returns to the manufacturer, have been discontinued, leading to shortages and hardships to patients. Sharad Pawar and his Group of Ministers (GOM) agreed to try the market-based formula, which was basically envisaged by Dr Pronab Sen Committee way back in 2005 as they set about exploring options other than ceiling-based price control. The Department of Pharma has now drafted the National Pharmaceutical Pricing Policy 2012 and recommended that a simple average of all the products in a therapeutic category with at least 1 per cent marketshare is to be considered based on IMS data. The span of control is restricted to dosages and strengths listed in NLEM 2011 and would also include products under DPCO 1995 for a year, with increases allowed up to WPI. Formulations are to be priced only by fixing a ceiling price as per the dosage, which means manufacturers are free to fix any price up to or below the ceiling price. NDDS and indigenously patented products are allowed 5 year

holiday from price control. These proposals effectively mean that the span of control of the policy is expected to be around 30 per cent of the about ` 65,000-crore domestic pharma market. The government has now realised that keeping prices under strict control and artificially very low is neither going to benefit the patients, nor the industry. India is globally the 3rd largest producer of medicines by volume yet 14th in terms of value, due to the fact that our safe and quality medicines are also the lowest priced in the world! The policy is fairly well balanced with availability and affordability being taken care of by ensuring that there is control on essential medicines, at the same time allowing market forces to ensure that prices are affordable. It is a very rational attempt at achieving a fine balance between reasonable prices, uninterrupted availability, administrative feasibility and future growth & investment. The pharma industry needs to be provided some returns to invest in NDDS, newer and better therapies and drugs; otherwise patients will not benefit as they will not have access to the same. The National Pharma Pricing Policy, as presently drafted, appears to recognise this aspect and we await the day it becomes a reality! Daara B Patel

Secretary-General, Indian Drug Manufacturers’ Association

Mo de rn Ph a rm a •16 -31 D e ce m be r 2 012

News, Views & Analysis

Sanofi ranks third on 2012 Access to Medicine Index Sanofi has ranked third among twenty pharmaceutical companies on the 2012 Access to Medicine Index (ATM Index) created by the Access to Medicine Foundation, an international non-profit organisation dedicated to improving access to medicine to societies in need. “This third ranking on the 2012 Access to Medicine Index is a recognition of Sanofi’s efforts to act with all our partners to protect health and raise the hopes of patients,” said Gilles Lhernould, Senior Vice President - Corporate Social Responsibility, Sanofi. “The key challenge in the future will be to eliminate the north-south divide in access to healthcare. As a global healthcare leader, we are the right partner to achieve this goal.” The Access to Medicine Foundation particularly

welcomes the initiatives of Sanofi in the fields of multiresistant bacterial infections, malaria, tuberculosis and neglected tropical diseases, as well as the renewal of its partnership with the World

The key challenge in the future will be to eliminate the northsouth divide in access to healthcare. As a global healthcare leader, we are the right partner to achieve this goal.

Health Organization to fight those diseases, including Buruli ulcer, Human African

trypanosomiasis (sleeping sickness), Chagas disease and leishmaniasis. In its report, the Access to Medicine Foundation, creator of the ATM 2012 Index, highlights that Sanofi has significantly improved its approach to access to medicine in several areas and it leads the field in the area of public policy. It has continued to invest in R&D, targeting relevant diseases and has a broad range of molecules in its pipeline. The company has robust access management systems, interand intra-country tiered pricing, works with local governments to improve capability advancement and has initiatives in both donations and sustainable philanthropy, with two singledrug donation programmes.

India set to explore potential for pharma export to Iran India is all set to explore chances to export extra pharmaceutical products to Iran. The shortage of medicinal products owing to the latest sanctions established by the Security Council of United Nation. In light of this fact, the ministry of union commerce has issued directions to Pharmaceutical Export Promotion Council

of India (Pharmexcil) to send a business delegation to Tehran between December 17 and 19, 2012. The council anticipates success with this tour backed by the Indian embassy in Tehran. The Marketing Development Activity (MDA) scheme of the government too is planned to be implemented by the delegation. The MDA

is expected to gain the formal approval of the ministry very soon. The tremendous export potential vested in Iran owing to UN’s imposition of sanctions has led Pharmexcil to consider profits from the available opportunity and the council is inviting applications from members who wish to become a part of the delegation.

In Brief Prescription for OTC drug transfer hastened via MHRA process

Medicines and Healthcare products Regulatory Agency (MHRA) has launched a newly updated method to increase the speed of the process of transferring prescription-only medicines to the category of over-the-counter drugs. A new guideline present in the MHRA web page dealing with ‘How to change the legal classification of a medicine in the UK?’ has provided support to the new method. The innovative process outlined in the new guideline is able to slash the time from application to decision by a period equal to or greater than three months. According to the Group Manager of MHRA, “The UK has long been recognised for its leadership in increasing access to medicines by making prescription medicines available over the counter where it is safe to do so. The new process launched today, and guidance that underpins it, will speed and streamline the way medicines are made available safely, with benefits for the medicines users, the regulator and the industry.” The guideline is expected to come into effect from the present. The MHRA is responsible for developing the new guideline in collaboration with the industry of pharmaceuticals as part of Better Regulation of Medicines Initiative (BROMI) as well as its response to the Red Tape Challenge of the Government.

Ranbaxy issues voluntary recall of Atorvastatin due to quality issues

Ranbaxy Pharmaceuticals has issued a voluntary recall of certain lots of the company’s 10-mg, 20-mg, and 40-mg dosage strengths of atorvastatin tablets. The lots of atorvastatin, packaged in bottles of 90 and 500 tablets, are being recalled due to possible contamination with small glass particles (less than 1 mm in size). “Based on the information from Ranbaxy and from the FDA’s initial assessment, the possibility of adverse events related to the recalled product appear to be low, and if any adverse events are experienced, they would be temporary,” according to the FDA statement.

Unichem receives ANDA approval from USFDA for tizanidine tablets

Unichem laboratories Ltd has received ANDA approval from the USFDA for tizanidine tablets. Tizanidine tablets USP 2 mg and 4 mg are therapeutically equivalent to Zanaflex® tablets 2 mg and 4 mg from Acorda Therapeutics. The product will be commercialised from Unichem’s Goa plant, API ie, tizanidine hydrochloride used for this ANDA is also made in house at Roha plant.

Mo de rn Ph a rm a •16 -31 D e ce m be r 2 012

News, Views & Analysis

Nestle in pact with China’s Chi-Med In an attempt to go herbal and traditional, Nestle is shifting focus towards traditional Chinese medicine by joining forces with Chinese pharma group Chi-Med. The new body, called Nutrition Science Partners (NSP), will be equally owned by the two parties, Nestle said in a statement. They have not divulged any of the financials behind the deal. NSP will research, develop, make and sell nutritional and medicinal products derived from botanical plants, it said. The Joint Venture (JV) will also hand Nestle’s Health Science division, which is handling the deal, access to Chi-Med’s traditional Chinese medicine library, which with more than 50,000 extracts

from more than 1,200 different herbal plants is one of the world’s largest, the statement said.

Christian Hogg, Chief Executive, Chi-Med, said, “For Chi-Med, the deal, which is still subject to regulatory approvals, will bring a stream of novel botanical medicines and nutritional products to market and in so doing build significant value for patients and for our shareholders. Botanicals are in

the forefront in our view in the search for new medicines.” Initially, the product focus will be on gastro-intestinal health, a market worth up to $ 6 billion (4.6 billion euros) according to Chi-Med, but could in future expand into metabolic diseases and brain health, Nestle said. “Traditional Chinese plantbased medicines represented between 30 and 40 per cent of all pharma sales in China,” he added. “This JV provides Nestle Health Science with an opportunity to develop and commercialise truly innovative and scientifically validated botanical-based nutrition for personalised healthcare in gastrointestinal health,” said Cantarell, Head - Nestle Health Science.

Venus gets Phase III nod for its cancer detection NCE Pharmaceuticals major Venus Remedies Ltd recently said that it has received approval from the Drugs Controller General, India

(DCGI) to conduct PhaseIII clinical trials of its cancer detection New Chemical Entity (NCE). The molecule is for early cancer detection and this

ABLE India invites entries for Best Biotech Innovation Awards

Dr Murali

The Executive Council of the Association of Biotechnology Led Enterprises (ABLE), the apex body of the biotech sector in India has announced that entries for its prestigious Biotech (BT) innovation awards will be accepted till December 31, 2012 from Indian as well as global biotech innovators. The finalists for the best BT Innovations will be shortlisted in February and the winners will be awarded at the gala event being planned to commemorate 10 years of ABLE in March 2013. ABLE India plans to create a platform to recognise and award the best work by biotech professionals from India as well globally and instill the significance of biotech innovations by institutionalising ‘Best Biotech Innovations of the 21st Century (2001 – 2012)’. A Jury Panel comprising national and international experts will select the awardees. Dr P M Murali, President, ABLE India, said, “We are delighted to announce the first-of-itskind biotech innovation awards to recognise the work of professionals not just from India but also from abroad. The developing bio economy is not only about product and service innovations but also those in other enabling fields like investment /finance, education and policy initiatives of various governments.”

leap towards successful phase III will make Venus pioneers among the companies working and providing innovative solution for cancer detection.

Fresh National Pharmaceuticals Pricing Policy issued by government The National Pharmaceuticals Pricing Policy (NPPP) 2012 has been issued by the central government to implement a regulatory framework for labelling the price of drugs in order to ensure easy availability of muchneeded medicines at nominal rates. The policy presents considerable opportunity for completion and innovation to provide support to the development of the industry, thereby achieving the target of employment along with shared financial wellbeing.

As per the terms of the new policy, the regulation of price is going to be carried out taking into account the factor of ‘essentiality’ of the medicines as dictated by the ‘National List of Essential Medicines – 2011’ declared by the Health and Family Welfare Ministry, and amended often to suit the interests of the public under the Drug Price Control Order. The regulation of price will be applicable only for formulations instead of upstream drugs. The Span of Price Control will be determined according to the strengths and dosages listed in NLEM-2011.

Isis to get $25 million upfront in drug pact with AstraZeneca Carlsbad’s Isis Pharmaceuticals and British drug giant AstraZeneca recently announced that they have partnered to find drugs for cancer. Isis will get $ 25 million upfront from AstraZeneca. Isis will get an additional $ 6 million in the second quarter of 2013 if

the research programme is still ongoing. The agreement includes an Isis drug in a phase I for advanced lymphomas, called Isis Stat3Rx. Isis and AstraZeneca will work to take the drug through the rest of clinical trials and bring it to market.

Mod er n P har ma•16 -31 Dec emb er 2 012

News, Views & Analysis

GSK and Vodafone ink partnership agreement to accelerate kids’ vaccination GSK and Vodafone inked a partnership agreement for using mobile technology to accelerate kids’ vaccination programme for common infectious disorders in Africa. Despite several developments in form of vaccine availability and financial support, the basic vaccination programmes still not ensuring reaching about one fifth of total children across the world. The growing penetration of mobile phone devices in Africa provides an opportunity to develop novel and low-cost ways to enhance the outreach in remote areas. Initially, both companies would focus a tweleve month pilot vaccination program in Mozambique, which will be supported by the Mozambique Ministry of Health and Save the Children.

Cognitive behavioural therapy can reduce depression and improve quality of life Cognitive Behavioural Therapy (CBT) provided alongside drug treatment can help reduce the symptoms of depression and improve patients’ quality of life, according to new research. Depression is a common illness that has a major impact on a patient’s life. In the UK, between 5 and 10 per cent of the population has the illness at any one time. Globally WHO estimates around 350 million people suffer from the illness. The most commonly used treatment for depression is antidepressants, and although drug treatments can be effective, up to two thirds of patients do not respond fully

to them. Another treatment is CBT, a form of talking therapy that helps patients change their thinking and behaviour in response to their thoughts. Chris Williams, Professor Psychosocial Psychiatry, University of Glasgow, said, “This research is of great importance because it used a CBT intervention alongside treatment with antidepressants. It confirms how these approaches – the psychological and physical – can complement each other. It was also encouraging because we found the approach worked to good effect across a wide range of people of different ages and living in a variety of settings.”

In Brief Procurement of Ayurvedic drugs directed to be from licensed drug manufacturing units

Procurement of Ayurvedic drugs by state government hospitals, dispensaries and Central Government Health Scheme (CGHS) Ayurveda Medical Store Depot has been directed to be from licensed drug manufacturing units on the basis of quality analysis of medicines as per standards prescribed in the pharmacopoeia. In the case of Centrally Sponsored Scheme implemented by the Government, the procurement of Ayurvedic medicines by the states is required to be from Indian Medicines Pharmaceutical Corporation Ltd (a Government of India Enterprise) or from other public sector undertakings, pharmacies under state governments and co-operatives, who have their own arrangement for manufacturing medicines.

Theravance announces initiation of phase 2b study with its LAMA candidate, TD-4208

Theravance, Inc recently announced the initiation of a dose ranging phase 2b study with TD-4208 as a nebulised aqueous solution in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). TD-4208 is an investigational inhaled Long-Acting Muscarinic Antagonist (LAMA), discovered using Theravance’s multivalent approach to drug design. This compound is under development by Theravance for the treatment of COPD. “We are very pleased with the progression of TD-4208 into a phase 2b study in patients with COPD,” said Mathai Mammen, Senior Vice President - Research and Early Clinical Development, Theravance, Inc.

Survey ranks LifeCell as the most recommended stem cell bank A recent survey conducted by Nielsen India amongst gynecologists in the country shows that LifeCell International enjoys the highest brand equity in comparison to key industry players. According to the survey, out of the leading stem cell banks in the country LifeCell has the highest brand recall at 85 per cent with top of the mind position amongst gynaecologists. The study also shows that LifeCell is recommended by gynaecologists three times more than its closest competitor, making it the most recommended stem cell bank in India. From an industry point of view, the results reveal that over 99 per cent of the gynecologists interviewed were aware about stem cell banking and 90 per cent of them recommended the service to expectant parents. The first-of-its-kind industry research conducted by Nielsen amongst gynaecologists in India assesses the brand preferences in the stem cell banking industry. The survey was conducted across 8 leading metros covering Mumbai, Ahmedabad, Bangalore, Chennai, Delhi, Hyderabad, Kolkata and Pune. It involved personal discussions with over 300 gynecologists who have been actively practicing in the field for more than 3 years.

Sartorius launches Sartoguard NF prefilter series Sartorius Stedim Biotech (SSB), a leading international pharma supplier, has launched the Sartoguard NF prefilter series, completing its range of Sartoguard prefilters. These new prefilters feature a unique combination of high Performance Polyethersulfone (PES) membranes and highly innovative nanofleece technology. This is the first time that PES nanofleece material is being used for liquid prefiltration applications in biopharma manufacturing. The newly developed nanofleece technology provides an ultrafine fleece structure based on a small nanofiber diameter of 120-150 nm compared with the fibre diameter of conventional fleece materials of >500 nm. The resulting fleece structure offers enhanced clarification capabilities, even for extremely fine contaminants, along with a high-dirt holding capacity, fast flow rates and high total throughput performance. Sartoguard NF prefilters are the ideal choice for downstream protection of more expensive sterilising-grade and mycoplasma-retentive filters in challenging prefiltration applications for biopharmaceutical manufacturing.

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News, Views & Analysis Dr Dennis Gillings receives SCRIP Lifetime Achievement Award, Quintiles named CRO of the year Quintiles Founder Dr Dennis Gillings, CBE, has recently received the SCRIP Lifetime Achievement Award and the company he started has been named ‘CRO of the Year’ at the 2012 SCRIP Awards in London. The SCRIP awards acknowledge excellence in the biopharma Dr Gillings industry, based on judging by an independent panel of 16 life sciences experts. Being named CRO of the Year by SCRIP is a prestigious

honour for Quintiles, the world’s leading provider of biopharma services. It is one of the most competitive awards bestowed by SCRIP, and Quintiles’ has received it three times in the past 4 years. Likewise, Dr Dennis Gillings’ lifetime achievement award is equally celebrated. Mike Ward Chief Content Officer, Datamonitor Healthcare and Scrip Intelligence, said, “SCRIP’s Lifetime Achievement Award is reserved for an individual,

who has made an outstanding contribution to the pharma/ biotech industry. In founding Quintiles, Dr Dennis Gillings made an indelible impact on drug development by pioneering the clinical research organisation industry, revolutionising the field to the extent that clinical trials expertise now rests with these companies.” “I am honoured to receive this award,” said Dr Gillings. “It is humbling to be recognised by this prestigious panel, and I share this with Quintiles’ employees, past and present, around the world who make our company what it is today.”

Sanofi MS drug Aubagio gets second approval, in Australia Having already gained approval in the largest global pharma market, the USA, French drug major Sanofi’s says that its US biotech subsidiary Genzyme has received approval for its Aubagio

Indegene to acquire the multi-channel, e-detailing and physician marketing services of Canada-based Aptilon Indegene, a leading provider of R&D, commercial and marketing solutions to top global pharmaceutical and healthcare organisations, has recently announced a definitive agreement to acquire the multichannel, video and e-detailing, and physician marketing services business of Aptilon Holdings Inc, a wholly owned subsidiary of Aptilon Corporation. Aptilon, Gupta headquartered in Canada, is a pioneer and a leader in providing e-marketing solutions for several large pharmaceutical, biotech and healthcare clients in the United States, Canada and Europe. The need for intelligent, robust, and outcome-driven Multi-Channel Marketing (MCM) and Virtual/Inside Sales programmes is estimated to represent a $ 10 billion opportunity as companies continue to accelerate the transformation of their sales and marketing organisations over the next 4-5 years. Manish Gupta, CEO, Indegene, said, “By combining Indegene’s Virtual/Inside Sales and MCM capabilities with Aptilon’s technology platforms, significant physician reach, and multi-year data on physician behaviour in the North American and European market, clients can accelerate their physician engagement strategies and deploy true end-to-end worldclass programmes.” Denis Martineau, President, Aptilon Holdings Inc, added, “Aptilon has been a leading provider of world-class e-marketing, remote detailing and multi-channel marketing programs. Through this proposed transaction, our clients will gain access to an accelerated approach to drive integrated physician engagement programmes. In addition, our clients can leverage global expertise and infrastructure assets in the US, Europe and Emerging Markets to enhance productivity as well as effectiveness.”

(teriflunomide) from the Australian Therapeutic Goods Administration (TGA) as a new once-daily, oral treatment indicated for patients with relapsing forms of Multiple Sclerosis (MS).

BI signs manufacturing supply agreement with Apexigen Boehringer Ingelheim Biopharmaceuticals has signed a manufacturing agreement with Apexigen. Subsequent to the deal, Boehringer will offer cell line development support through high expression BI-HEX® system, complete method and process development apart from scale-up and clinical phase I supply comprising finish & fill development for APX005. APX005 is a humanised monoclonal antibody that targets CD40 to cure cancer patients. The drug candidate is

a robust CD40 agonist, which possess potent anti-tumour potential in preclinical studies. Speaking on the development, Simon Sturge, Senior Vice President - Biopharmaceuticals, Boehringer Ingelheim, said, “We are pleased to partner with Apexigen in the manufacturing of one of their pipeline antibodies. In particular, this is an exciting project for Boehringer Ingelheim. We are confident that our cutting-edge production process technologies will advance Apexigen’s robust clinical programme.”

Merck enters into phase II/III trials of MK-8931, for Alzheimer’s cure Merck entered into phase II/ III clinical trial of MK-8931 investigational BACE inhibitor for its efficacy and safety for mildto-moderate Alzheimer’s disease. MK-8931 is a novel investigational oral β-amyloid Precursor Protein Site-Cleaving Enzyme (BACE) inhibitor. The drug candidate

is subjected to EPOCH trial that comprise of 78-week, placebo-controlled, double-blind, randomized, parallel-group, phase II/III clinical study to evaluate one of three oral dosage forms (12, 40 or 60 mg) of MK-8931 that will be administered on a daily basis against placebo samples.

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News, Views & Analysis

Pharmexcil to represent India OPPI in pact with public and private players to reduce maternity mortality rate in India pavilion at Arab Health 2013 in Dubai The Organisation of Pharmaceutical Producers of India (OPPI) has joined hands with the Government of Maharashtra, Rotary Club of Mumbai, the Indian Medical Association and NGO Pragati Pratishthan to help reduce the maternity mortality ratio in the country. The project begins with a pilot study by conducting medical camps across the tribal areas of Thane district in Maharashtra. The medical causes of ‘Maternal Mortality’ include severe hemorrhage, infection, injury, anemia, raised blood pressure and injuries during childbirth. More importantly, delay in diagnosis of urgent and serious medical problems, Ray coupled with inadequate transport facilities with consequent delay in accessing expert care further contribute to the toll. Millennium Development Goal (MDG) 5A of the UN aims at three quarter reduction of Maternal Mortality Ratio (MMR) between 1990 and 2015. Slow progress in achieving the goal of MDG 5A, is partly due to programmes aimed at improvements through specific single areas of remedial

action such as training of professionals, building of infrastructure, or correction of deficient resources, some working at the grass root level. Major obstacles include lack of knowledge at the grass root level, about the benefits of modern medical practice and ways of accessing modern practice and resources – both medical and surgical. “This exercise will also help encouraging local women’s group to imbibe the principles of antenatal and postnatal care, family spacing, and child immunisation. Monitoring and evaluation against pre-agreed parameters will be the important components of this campaign,” said Tapan Ray, Director General, OPPI. In spite of focus on upgrading institutions to make Emergency Obstetric Care (EmOC) available, the proportion of institutional deliveries has shown a meagre increase, from 26 per cent to 39 per cent between 1990s to early 2000s. During the same period, skilled birth attendance increased marginally from 33 per cent to 47 per cent, while women receiving the

minimum three antenatal examinations rose from just 44 per cent to 51 per cent. As many as 61 per cent of women in India still continue to give birth at home , implying that the majority of Indian women deliver away from an EmOC institution increasing the risk of maternal morbidity/mortality. Ray said, “Subsequent to the permission from District Health Officer, an ANC camp was organised at a rural hospital in Mokhada village on 25th Oct 2012 with the support from the local MLA - Vangaji and the members of the ‘Gram Panchayat’. During last two months from the initiation of the project, the project team has conducted five ANC camps at tribal villages in Mokhada and Jawhar talukas of Thane district of Maharashtra. The member companies of OPPI have been supporting this health care objectives of the nation by donating medicines and providing volunteer support. This campaign aims at reducing maternal and new born child mortality through collaborative action along with imparting training at all levels from Basic Emergency Obstetrics and New Born Care (BEMONC) following the World Health Organisation (WHO) standards.”

The Pharmaceuticals Export Promotion Council of India (Pharmexcil) is confident in India’s pharmaceutical industry growth opportunities and is looking to continue strengthening its relationship with other countries for export, by preparing to Dr Appaji participate at Arab Health 2013. Arab Health, organised by Informa Life Sciences Exhibitions, will take place from January 28-31, 2013 at the Dubai International Convention and Exhibition Centre. With more than 3500 exhibiting companies from 32 countries, and 18 CME accredited medical conferences, Arab Health is a much anticipated addition to the 2013 medical event calendar in the Middle East and subcontinent region. There are about 3,000 pharmaceutical manufacturers, with over 10,500 units, the vast majority of which focus on generic drugs. India is home to 250 large manufacturers, and the domestic drug industry employs a workforce of approximately 460,000 people. Representing Pharmexcil at

Arab Health 2013, Dr P V Appaji, Director General, Pharmaceuticals Export Promotions Council of India, said, “Amid global economic concerns, the Indian pharma industry is bullish with a steep growth target. Within the pharma sector, India is one of the top five generic exporters of the world and maintains a positive trade balance. This is the seventh year for the council to take part at Arab Health. ” According to Simon Page, MD, Informa Life Sciences Exhibitions, “As a global exhibitions organiser, we are seeing very buoyant growth in emerging market territories where trade shows continue to be a major source of buyer and seller interaction. Multinationals are expected to expand extensively into the Indian pharma markets – by as high as 60 per cent by 2015 - through acquisitions, which will gradually enable the Indian companies to gain a foothold in the Western regulated markets. This year more than 200 new exhibitors will bring the total to almost 3500 from 63 countries across the globe.

Indonesian Pharmacopoeia to adopt and adapt USP–NF standards To promote harmonisation of standards for the quality of medicines and their ingredients, the United States Pharmacopeial Convention (USP) and Indonesia’s National Agency for Drug and Food Control (NADFC) have signed a letter of agreement that allows NADFC to translate, copy, adapt and incorporate materials contained in the United States Pharmacopeia and the National Formulary (USP–NF) into the Indonesian Pharmacopoeia.

USP is a scientific non-profit organisation that sets standards for the quality, identity, purity, and strength of medicines, food ingredients, and dietary supplements. USP’s standards are used in more than 140 countries. “The fact that the NADFC values the standards in USP– NF and wants to translate and adapt them for their Indonesian Pharmacopoeia shows the level of commitment to public health that USP seeks in its many international collaborations,” said

Roger L Williams, CEO, USP. its supplements to modernise “Efforts to harmonise the country’s standards support pharmacopoeia. people’s confidence in The NADFC is the common quality not allowed to of medicines across use the contents countries and regions, of USP–NF in and that aligns any publication with USP’s public other than the health mission.” Indonesian The agreement Pharmacopoeia. is valid for 5 years, “NADFC during which the Williams appreciates the NADFC may use information assistance from USP,” said Dr published in the USP–NF and A Retno Tyas Utami. “We will

adapt the content of USP–NF to suit our local needs in order to promote access to good quality medicines in the Republic of Indonesia. We recognise the USP–NF as a prime reference of science-based standards for pharmaceutical products.” Dr Utami works in the therapeutic product and narcotics, psychotropic and additive substance control group in NAFDC, which is responsible for publication of the Indonesian Pharmacopoeia.

Glenn Saldanha honoured with ‘Swiss Ambassador’s Award for Exceptional Innovation’ Swiss Ambassador Dr Linus von Castelmur honoured Glenn Saldanha, Chairman & Managing Director, Glenmark Pharmaceuticals Ltd with ‘Swiss Ambassador’s Award for Exceptional Innovation’ for his outstanding innovation-driven leadership on November 29, 2012 at an event organised at the Embassy of Switzerland in New Delhi. Acknowledging Saldanha’s contributions in the area of innovation Ambassador Dr Linus von Castelmur said, “Innovation has become the

new driving force of Indo-Swiss Partnership and Glenmark is a very good case in point. Glenmark Pharmaceuticals was the first Indian life science enterprise to establish a R&D facility outside India in 2006. Glenmark’s 3,000 sq m state-ofthe-art laboratory in La Chaux-de-Fonds Saldanha employs 60 highly qualified scientists.” Saldanha said, “I am deeply honoured to receive the Swiss

Ambassador’s Award for exceptional innovation. This award is even more meaningful because it is being presented by a country which is one of the leading innovation research destinations for the pharma industry, offering the best combination of infrastructure and talent for new drug discovery research. This has been demonstrated

by the success achieved by Glenmark in Switzerland.” Saldanha added, “Glenmark’s novel Biologics Research Centre at Neuchatel, Switzerland has been doing some cutting-edge research work in the area of novel biologics which resulted in our company signing a landmark agreement with Sanofi of France. Innovation leading to new drugs is critical to meeting the global unmet medical need and recognitions like these inspire us to continue our work in the area of innovation or drug discovery research.”

Earlier in his laudatory speech, Ranjit Shahani, President, Organisation of Pharmaceutical Producers of India, expressed that it has been Saldanha’s endeavour to serve people with low-cost medication. He has personally focussed his energies on research in therapeutic areas such as pain, inflammation and oncology. He remarked that Glenmark is one of the few Indian companies to have developed and licensed out six molecules to what is popularly known as Big Pharma.

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News, Views & Analysis

Mettler Toledo Thornton introduces dissolved ozone sensor with ISM™

StarDrop 5.3 offers intuitive virtual library design

Mettler Toledo Process Analytics Division recently announced the introduction of Thornton model 6510i dissolved ozone sensor with Intelligent Sensor Management (ISM) for continuous, fast and reliable monitoring of dissolved ozone in pharma waters. ISM features enable the user to maximise lifetime of the sensor and minimise downtime to perform routine maintenance. Typical applications include monitoring dissolved ozone in API, Water for Injection (WFI), Pure Water (PW), High Purity Water (HPW) and vaccines.

Optibrium™, developer of software solutions for drug discovery, recently announced a new version of its StarDrop platform. Version 5.3 introduces new features focussed on the design of virtual libraries, guided by StarDrop’s unique multi-parameter optimisation capabilities to prioritise compounds with the best balance of properties for synthesis and testing. Version 5.3 introduces its virtual library design capability as part of StarDrop’s Nova™ module, providing flexible and easy scaffold-based enumeration of a virtual library to allow drug discovery teams to rapidly explore new chemistry ideas. After drawing the scaffold on which the library will be based, users can select multiple functional groups, atoms or fragments to vary at each point of modification. These lists may be selected from a user-defined or centrally managed library, or sketched on an individual basis. A fully combinatorial library

According to Christie Martin, Product Manager, “Ozone is an effective sanitiser for pharma applications, and the new Thornton 6510i ozone sensor utilises the full spectrum of ISM capabilities to optimise ozone measurement.” A number of ISM’s benefits make the 6510i ozone sensor a particularly easy to use instrument. ‘The Dynamic Lifetime Indicator’ predicts when the sensor’s inner body and membrane will need to be replaced. To ensure the sensor’s measurement accuracy will always be high, the ‘adaptive

calibration timer informs operators as to when the sensor should be calibrated. The in-built sanitisation counter allows the limit of ozone concentration and duration of sanitization cycle to be defined by the user on the connected transmitter. The 6510i ozone sensor with ISM may be used with Thornton M300 ISM or M800 multi-parameter transmitters, which enable the use of two or four digital sensor inputs for continuous measurement of ozone, dissolved oxygen, conductivity, pH and total organic carbon.

Roche introduces new GS FLX+ software Roche recently announced the launch and immediate availability of a new software package that significantly improves long-read shotgun sequencing performance on its GS FLX+ System. This system is the first highthroughput sequencing platform to deliver one million reads with accuracy and length that are comparable to traditional Sanger-based methods. The improvements will allow researchers to discover more novel complex genetic variants and uncover the hidden biology in difficult-to-sequence regions

of genomes, transcriptomes and metagenomic samples. “This latest software release represents a major step forward in meeting the expectations of our customers on the long-read performance of the GS FLX+ System,” said Thomas Schinecker, President, Roche Sequencing Solutions. “Over 30 leading sequencing laboratories around the world are already implementing the latest improvements of our new software, and their feedback has been overwhelmingly positive.” Since the launch of the GS

FLX+ System, researchers have confirmed the value of extralong reads for more complete de novo assembly of whole genomes, superior full-length transcriptome analysis, and better characterisation of mixed metagenomic samples. “We have experienced excellent results in our laboratory using the latest GS FLX+ software. All sequencing metrics, including read length, have exceeded our expectations,” explained Hiroshi Tarui, RIKEN Omics Science Center and Yokohama City University KIHARA Institute for Biological Research.

may be generated for detailed investigation or, alternatively, a subset of compounds can be automatically selected based on a predicted property or StarDrop’s unique probabilistic scoring algorithm for multiparameter optimisation. These new capabilities are supported by further enhancements to StarDrop’s core features, including easyto-use tools for clustering, filtering based on substructure or properties and extensions to its interactive data visualisation. StarDrop offers a comprehensive desktop environment that saves time and reduces costs in drug discovery by guiding compound design and selection to quickly target high quality chemistry. Matt Segall, CEO, Optibrium, commented, “StarDrop offers a seamless workflow allowing our users to go from design and enumeration of a virtual library, through property prediction to prioritising the resulting compounds against the profile of properties they require for their project objective. Supported by interactive visualisations in StarDrop’s intuitive user interface, chemistry teams can quickly identify novel compounds with a high chance of success.”

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In Conversation With

Starting with R&D was a big adventure Arshia Khan arshia.khan@network18publishing.com

What difference does it make when a woman is at the helm of affairs of an organisation? Naturally a woman is more nurturing and is able to look at people in a different way because she is more family oriented. In my organisation I want to make people feel that it is more like a family rather than a place they would hate to come. One needs to make the place friendlier so that employees will feel safe and would love to come to work. How have you grown with Piramal Healthcare that has now become Piramal Enterprises? Starting with R&D was a big adventure. We started off as a very small company with a turnover of just ` 11 crore. In twenty years we grew to become one of the top five companies of India. And then we sold only 40 per cent of it for $ 3.8 billion. So, the acheivement is taking it from scratch to growing upto a level where we could achieve a good valuation for just half of our business. And the other half still exists, so we are growing. What ideas have you turned into reality at Piramal Enterprises? Getting drugs out to people. The one we did ten years ago – Rejoint for orthopaedic arthritis. It helped many people with arthritis. And our new cancer drug which is awaiting phase 3 trials will help millions of people. This should be commercialised within the next 2-3 years. Then we have the new molecular imaging portfolio. And one of our drugs Cargel has got EU registration. We will launch that by the

…says Dr Swati Piramal, Vice Chairperson, Piramal Enterprises Ltd. With her equanimous nature she has turned her research dreams into reality. Here, she details the journey when she started research for public health to the changes that the next gen can bring. end of this year. We have already spent ` 1,200 crore over the last decade in new drug development. What was the biggest challenge when you started Piramal? In a way, it was self-belief. To motivate people, to struggle through, to setting up research, often you have to direct the policy of the government, to help people believe that we can have innovation in India. It was a mountain to climb since such a belief did not exist. What according to you should an average entrepreneur do that will set him/her apart from others? I think you have to believe in yourself and have the enthusiasm. When I started R&D people said that any firstworld Indian did not know how to innovate, if they knew to innovate they did not know how to file a patent, if they filed a patent anything that they did during a clinical trial would not be accepted by the West. That any patent would not be accepted by any country was not novel. We knew how to copy, but we did not know to invent, so all those were myths, which we have burst today. We have 350 patents worldwide. We have R&D in five countries and clinical trial in four continents; and people are respecting us for our innovation. What has been the toughest business decision made by you? To go in for research; because everybody thought I was crazy

Off track Which book are you reading currently? I am very fond of poetries, so I read a lot of different kinds of poetries. Rabindranath Tagore is my favourite poet and I read his poems again and again, especially Gitanjali. He wrote a poem for scientists in Bengali, which I have re-written it in Hindi with Javed Akhtar and Pandit Jasraj sang it; and we call it the science anthem. It talks about how victory must come in the hands of those who try so hard, so that the main effort is to take away the darkness of ignorance and get the light of knowledge. He had written this for his friend Jagdish Bose at the opening of the Bose institute, in 1917; the same time he had written the National Anthem. What would be your earliest memory of childhood days? My dad used to love to make me read and learn Mathematics and my mother was very good at music, literature and loved cooking, which I have inherited and my daughter too; so it has gone over three generations.

and I was chucked out of the association of generics as they thought I was an idiot. But I really believed that Indian science has to prove itself. Honestly, it has been an uphill battle because the nature of this is so risky and complex that slowly improving the nature of work, people’s skill, your knowledge and trying to get the best in the world is not easy. What changes do you anticipate that the next gen (Nandini and Anand) might bring in? I think they are very systematic than we were. We were emotional and they are doing things with systems and processes. They use technology much better than we do. They look at data, measure every metric and they are very down to earth. We were struggling to survive and they are struggling to give back. In our times, things were not available, money was not available to grow, and the economy was not doing so well 30 years ago, you could not import anything the way you do today; you did not have knowledge about the Internet, so of course things then were tougher and slower; but today with the new world things are amazing.

We knew how to copy, but we did not know to invent, so all those were myths, which we have burst. A report by an IT firm highlights that companies are hiring more women and also allowing them to work from home when required. What is the scenario at Piramal Enterprises? At present, the total number of men employees is higher. But initially in some areas, like the R&D we used to have 5 per cent of women; today it is 50 per cent, and there are women at senior levels as well. So, the scenario has changed and is changing. The harder part to change is women on field, as they would like to be with their families. Having said that, I started a biotechnology division at Piramal 20 years ago and this had only females.

Tell us about your childhood days, college and now a business leader, how has the journey been? It has been a fascinating, rewarding and interesting journey. I started off as a young doctor and started to work on public health when I was 20. I started the no polio zone along with my friends. We succeeded in this area ten years later, by that time the national enrolment for polio had also started. Then we did other public health programmes for osteoporosis, epilepsy, chronic disease, diabetes, hypertension, etc. Everything we did had public health awareness and that is enriching because it touches thousands of lives. It was the first time I realised that you can make a change. You had a written a book on the verses of Bhagvad Gita, how did the idea come across and how often would you go back and refer to that? It started with my son when he was 17 years old. He was in Venice and was impressed with the architecture and history. He told his teacher that the most wonderful things were in Venice, and the teacher said no it is wrong and replied saying that the most oldest philosophy is in your own country. He felt so embarrassed that he did not know; so when he came back he wanted to study the Gita. We arranged for a teacher and we used to attend these classes and then we also became interested. They say that the child is the father of man so that is how it happened. We learnt about it and the important thing is the application. How does it work? Can we apply it in business, in life, etc. So the book gives examples of how we used the most important management lessons of the Gita.

What kinds of changes would you want to see in the Indian pharma industry? The biggest is the regulatory bottleneck. There are 65,000 new drug applications every year and we have only 150 full time people working in the DCGI’s office. So the queue is too long. We have to hire new skilled trained people. There is an IND committee that meets once a month and all senior people in the committee are not full time employees, as they are also teaching etc. Unlike the US FDA that has nearly 1,200 employees who work only for the FDA so their time to approve a clinical trial is only 28 days. Whereas in our country is above 6 months, and under the expert committee it is 8 months. So it takes too long. I call this as a very big regulatory bottleneck and unless we improve this we cannot really go forward as an innovative country. You also plan to bring out molecules from plants. What stage of development is that? These are unique molecules as they were derived from natural products, not all are from plants - some are microbes and some fungi. We have 19 compounds in the clinic and about 9 already being tested in human beings; they have finished the toxicology studies. What will be your strategy for growth at Piramal? Our dream has not changed - to get a drug to the market developed in India, to reduce the disease burden and we seek for a large impact. To do something outside the profits is a must, but there has to be a deeper meaning, a cause and a higher purpose in whatever you do.

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Special Focus

Higher pharmacy studies

Chandreyee Bhaumik chandreyee.bhaumik@network18publishing.com

raditional pharma graduate courses such as B Pharm & M Pharm are being pursued since a long time in the country. Over a period of time, new specialisations have entered the education syllabus to keep the education abreast of the latest happenings in the industry. But most of these higher courses are regular courses and there are several suggestions from many to upgrade and update the existing courses. With advancement in every field, the profession of pharmacy has also witnessed tremendous changes. Gone are the days when individuals from the industry were mere drug sellers. As a country, India has become a major R&D and clinical studies outsourcing hub. According to the Pharmacy Council of India (PCI), pharmacy as a profession is concerned with the art and science of preparing from natural and synthetic sources, suitable and convenient materials for distribution and use in the treatment and prevention of disease. Further, it embraces knowledge of the identification, preservation, combination, analysis and standardisation of drugs and medicines besides synthesis of new drug molecules, manufacturing of various dosage forms, (liquid orals, powders, tablets, capsules, ointments, injections, ophthalmic products, etc) quality control, clinical trials, bioavailability, research, side-effects, compatibility, in-compatibility, indications, contraindications, pharmacokinetics, pharmacodynamics, toxicology etc.

Pharma education in India

In 1860, the seed of pharma education was sown in India by Medical College, Chennai. Since then, there have been continuous efforts either to initiate new pharmacy classes or bring changes to the already existing ones. These courses are dedicated to provide pharma skills for the students. Talking about the present scenario of pharma education in India, Dr Saranjit Singh, Professor and Head, Department of Pharmaceutical Analysis and Dean, National Institute of Pharmaceutical Education and Research (NIPER), elaborates, “In developed countries, pharma education is oriented towards practice and clinic, while in India it is more focussed towards industry and research. The success and potential of Pharm D programme in India, which is a practice oriented course, is not clear yet.” It is beyond any doubt that currently there is a glaring gap existing between education and practice of pharmacy. Experts are of the opinion that majority of the academic institutions

Is the grass greener on the ‘Western’ side? The search for more and better has made several Indian students travel abroad for higher education in pharma. The pharma education in West is better equipped and research oriented, but at the same time Indian education is trying to keep pace with the latest industrial developments and market requirements.

providing pharma education are not in parallel with the industrial developments. Further, experts opine that the syllabus of the course in pharmacy education in India is extremely outdated and needs severe updating. While PCI is involved with the clinical subjects, All India Council for Technical Education (AICTE) takes care of the industrial orientation of the syllabus.

Fulfilling their Western dreams...

With passing time, it is noticed that there are several students who prefer going to the West to continue their pharma education.

In India, the education system is more theory oriented, whereas the West model is more practical oriented. Dr Saranjit Singh Professor and Head, Department of Pharmaceutical Analysis and Dean, National Institute of Pharmaceutical Education and Research (NIPER)

Discussing on the trend to move to the West, Dr Singh explains, “The pharma education in India got its direction with push of government after independence on self-sufficiency in manufacturing. I do not see any negativity in the same as the industry orientation of pharma education has helped the pharma industry in India to grow to the current strength, where it is recognised all over the world.” Continuing in this regard, he adds that the western model has its own strength as it is targeted towards quality care of the patient, the final recipient of pharma products. Since last decade, the pharma manufacturing has moved from West to East, so Indian industry is forced to meet stringent regulatory requirements of the West for exports. He affirms, “As a consequence, the academia is also changing and I see more and more institutions in the country modifying their curricula and teaching to orient it towards regulatory.” He says, “The West still continues to have the upper hand in cuttingedge research, apart from clinical orientation. The courses are designed accordingly. So, students from India are attracted towards taking education there.” It is true that quite a few students are moving towards the West but there is not any particular trend. Dr Singh avers, “I do not see much change in the trend. Previously, college numbers and student output was less in India and so a limited number and percentage of total output was leaving for West for higher education. With increased output of graduates in India, perhaps the

number of outgoing students has increased, though my assessment is that there is not much change in overall percentage from the past to present.” Commenting on the primary difference in pharma education between India and the western countries, Dr Singh says, “In India it is more theory oriented, whereas the West model is more practical oriented.”

Advantage: India

Talking about why students are moving out to the West to study further, Dr Debra Bevitt, Deputy Head - School of Biomedical Sciences, Newcastle

Studying in the West has a reputation on its own. A qualification from the West is celebrated everywhere. Dr Debra Bevitt Deputy Head School of Biomedical Sciences, Newcastle University, UK

University, UK, says “Studying in the West has a reputation on its own. A qualification from the West is celebrated everywhere. It is because of the advantage that the students will have they prefer studying abroad.” She adds, “In order to encourage students coming from abroad to university we have international scholarships, almost 80 in number. These are at the post-graduation levels. Several Indian students have been selected for this. They are worth £ 1500 each. Further, specific to India we have announced seven scholarships worth £ 2000 each. This is offered only on a merit basis. Again, there are facultybased scholarships (such as biosciences, engineering, computer sciences, etc). By and large the Indian students are so qualified that they get hold of the scholarships. There are also scholarships at the undergraduate levels” Highlighting the difference in pharma curriculum between India and other countries, Dr Bevitt says that it depends on the individual university and their curriculum.

Brain drain reversal?

Attempts should be made in order to ensure that there is a perfect pharma education culture in India. This would not only retain students or bring back the ones who are abroad but also create an interest among others to study here. Thus, higher authorities should take initiatives in promoting the education vigorously. Further, licenses should be granted as soon as the person finishes his diploma & degree. There should not be any delay in the entire procedure. Next, establishing premier institutes such as NIPER, in various parts of the country, will help in enhancing quality pharma education in India. Elaborating in this context, Dr Singh says, “Regarding reverse brain drain, again I do not feel there is percentage increase. As more numbers are leaving, higher number may be coming back. So percentage of past and present may be the same.” Discussing on why some of the students come back, Dr Bevitt says that there are ample reasons and cultural difference could be one significant consideration. Talking about what the situation will be in the next few years, Dr Singh opines, “I do not feel the situation is going to change largely in the next 5 years. Only there will be decrease in institutions because of dwindling number of students seeking admissions. Rest, higher education seekers in the West and those returning after acquiring degrees from abroad will remain at the same percentage levels as now.”

Modern Phar m a•16 -31 Dec emb er 2 012

Special Focus

Nikunj Sharma

Lacunae in pharmacy education

nikunj.kumar@network18publishing.com

harmacy education is basically meant to create technical workforce, vision and novel approach with respect to R&D, teaching and training of future healthcare providers in the field of pharmaceuticals and drugs. Unlike other education streams, pharmacy is directly related to the basic healthcare of people and hence deserves more emphasis on other aspects of this profession such as regulatory norms, ethics compliance, in-built entrepreneur skills and innovation-oriented educational environment.

Need to refurbish the Indian system

Experts opine

Firoz Khan, Head - Department of Hospital Administration, Teerthanker Mahaveer University, comments, “Globally, India ranks third in terms of manufacturing pharma products by volume and 14th by value, which is expected to reach among top 10 in the world. The Indian pharmaceuticals market will grow to $ 55 billion in 2020 and this fact guarantees employment opportunities in Indian pharmaceutical industry but still pharmacy students are not getting satisfactory placement. Who is responsible? Student who chose the profession or pharmaceutical industry!” Despite continuous evolution of pharmacy profession in several developing nations, the role of a pharmacist in the healthcare arena still needs to be recognised, and the situation is arisen due to the restricted public-pharmacists interaction. “No one is responsible but yes there is a need to understand the demand of current industry’s manpower requirement in term of technical knowledge and skills. Technological novelty and communication encroachment is the need of hour for the current pharmaceutical industry in terms of manpower requirements. That can be faucet by pharmaceutical educational universities and institutions. There are a few centres of excellence where students get all the facilities and are well placed after their graduation,” continues Khan. Anant P Hardas, Director, Indian Pharma Guidance Academy, says, “The syllabi is not modified periodically at par with the changing needs and demand, for industry and other institutions. The academic system also lacks in any industry representative with the management or faculty. In addition, options for elective subjects in final year of degree course are limited and refrained from core industry-oriented subjects

The origin of degree and diploma courses in pharmacy education in India dates back to 1937 and 1948, respectively. However, comparing the present pharmacy education scenario with other countries, our system has various drawbacks. The pharmacy councils and educational institutes need to upgrade the age-old system and recognise as well as induct the crucial role of a pharmacist in the healthcare arena. such as marketing-quality control-manufacturing-R&D, management and law procedures as well as community pharmacy for livelihood.” Shyamal Badani, VP Business Development, Oasis Test House Ltd, opines, “The Indian system of pharmacy education lacks focus on curriculum revision and improvement. The existing curriculum is old and not updated as per the current trends in the industry and marketplace. The lack of practical orientation and training makes it difficult for the students to keep pace with

Technological novelty and communication encroachment is the need of hour for the current pharmaceutical industry in terms of manpower requirements. Firoz Khan Head - Department of Hospital Administration, Teerthanker Mahaveer University

the changing trends of the industry. Practical education imparted in pharmacy colleges is limited only to a fixed number of laboratory experiments, most of which have little or no relevance to the current industry practices. There is a dire need to upgrade and modernise the curriculum, keeping in mind the latest developments in the pharmaceutical industry and practice.”

Changing perspective

In India, a pharmacist degree is viewed as a basic requirement to run a pharmacy store or assist in an established setup such as hospital, clinics, or pharmacy chains. However, in the US a pharmacist recommendation is mandatory to prescribe a specific drug. The practice of pharmacy has evolved to pharmaceutical care from its traditional role of focussing on drug dispensing to medication compounding. Indian Pharmceutical Association (IPA) and Pharmacy Council of India (PCI) and prominent pharmacy professional took many important initiatives such as launching of the Charter of Pharma Vision 2020 and roadmap document, which present several activities to build the future of pharmacy profession in the country through 2020. “There is an urgent need to introduce long in-plant practical training curriculum with some monetary benefits. In addition, state pharmacy councils do not conduct a recognised entrance exam or provide facility for continued

pharmacy education for registration to join the profession. On the other hand, the students-industryregulatory interaction is also not at par that give an insight to the pharmacy graduates, as they have direct role in consumer health. Pharma education sector also lacks in adequate sponsorships/scholarship programmes from the industry for the meritorious students. Also, newly graduated students lack in entrepreneur skills that hampers the innovation quotient, as these students are under psychological feeling of unemployment,” emphasises Hardas.

It is important for the education system to strengthen and upgrade as per the current industry requirements, incorporating elements of IT skills and industry practices, to generate a more competent workforce. Shyamal Badani VP - Business Development, Oasis Test House Ltd

A bright future ahead?

The future of pharmacy education in India is at the verge of saluting the advance curriculum and next-generation system of delivering quality education and exposure to the students. Government and educationists need to revamp the existing infrastructure and support the young brains by creating a world-class education curriculum that can build confidence among the students and drive the entire machinery on a right path. Badani further adds, “The students also need to be exposed to and taught about the latest regulatory systems, validations, clinical research, quality assurance, quality control and R&D-related activities. It is important for the education system to strengthen and upgrade as per the current industry requirements, incorporating elements of IT skills and industry practices, to generate a more competent workforce.” Pharmacy profession is known for its significant role as a healthcare provider in several developed nations, but in many developing countries the potential of pharmacists is not completely utilised. “In the next decade, pharmaceutical industries will scout for pharmacy graduates who are inclined to research. Now-a-days most of the M Pharm degree holders are doing jobs in production area (which until recently used to be a place for their graduate counterparts) and B Pharm graduates are doing marketing jobs, an area initially occupied mainly by science graduates. All these show that because of burgeoning students, now ball seems to be in the court of employer (though it had never been in the court of students) at the cost of degrees of the students,” says Khan. In developing nations, such as India, pharmacists are concerned about their existing role in the network of healthcare system. As Indian healthcare sector is witnessing robust growth, which hints for adequate reforms in current pharmacy education and profession to deliver trained taskforce matching the industry requirement. Indian pharmaceutical sector offers significant growth prospects in future and India is on a global map now. But, we need to ensure that our pharmaceutical educators are able to deliver globally competitive graduates that are well versed with the international standards and regulatory scenario. The issues describe above need to be addressed urgently to build a quality workforce of pharmacists that may participate in building the country’s healthy future.

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Special Focus: Interface

Education in India is being imparted in isolation without taking the pharma industry, the ultimate employer, into consideration Pallavi Mukhopadhyay pallavi.mukhopadhyay @network18publishing.com

Share some details about Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management (SPPSPTM). Established in 2006, SPPSPTM offers courses such as B Pharm + MBA (Pharma Tech), PG programmes in pharmaceutics, pharmacology, pharm chemistry, quality assurance, clinical pharmacy, pharmaceutical biotechnology along with dual degree MBA (pharma tech and healthcare management), Ph D and others. The university conducts an all India level NMAT-pharmacy examination followed by a personal interview for admission. We deliver the curriculum in consultation with pharmaceutical industry and academia of national repute so that students are updated with current practices and emerging technology. We emphasise on soft skills along with management education. Students get exposure in the industry as every course is embedded with industry project. We are actively involved in pharma research. About 1.75 crore revenue has been generated out of government grants. Students are also trained to be socially sensitive

and responsible individuals. Our social wing ‘Kshamta’ conducts disease awareness programmes and arranges annual medical check-up camps. Our school is involved in various international and national programmes for knowledge sharing. SPPSPTM has implemented several best practices to provide quality education with the help of excellent infrastructure. Your opinion on the current pharma education in India & the loopholes Education in India has not been based on reality. It is being imparted in isolation without taking the pharma industry, the ultimate employer, into consideration. The syllabus is not regularly updated. Educators are not serious about looking into the technical courses or revamping them. Teachers are not updated due to limited resources in the institution. There is no proper linkage between the universities/ colleges/teachers. Change in technologies need to be addressed in a timely manner and that is lacking today. Students are not well informed and face major problems when it comes to employment. What can be done to tackle this situation? Concerned stakeholder should decide what should be included in the new syllabus. Pharma colleges

…says Dr R S Gaud, Dean, Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management (SPPSPTM), SVKM’s NMIMS. Here, he shares insights on the Indian pharma education scenario.

must have liaison with industry and hospitals. Management should be revamped and the industry and academia should have a better platform for interaction. We must take China as an example of how population can be a blessing and work towards maximum utilisation of manpower and talent. Striving for better infrastructure and

providing better guidance to the students are areas we must prioritise. Genesis of Indian pharma education Formal pharmacy education leading to a degree began in 1937, with the introduction of a 3-year industry oriented Bachelor of Pharmacy course at Banaras

Hindu University. In 1947, there were 2-3 pharmacy colleges in India run by multinational organisations. Now, it has evolved into 4 year B Pharm and 2 year M Pharm courses. Every year nearly 75,000 students are coming out with pharmacy degree from around 1,500 institutes from different regions of India. Pharmacy programmes offered in India today are D Pharm, B Pharm, M Pharm and practice–based doctor of pharmacy Pharm D and Doctor of Philosophy in Pharmacy (PhD). The regulatory authorities are also encouraging the innovative idea to provide interdisciplinary skills and to create employable youth. Interdisciplinary education is the need of the day with dynamic curriculum and faculty who are thought leaders and innovative in their field of specialisation. How good are government grants? The government is very proactive in encouraging research and higher education in the field of pharmacy. Several government funding agencies such as DST, DBT, ICMR, CSIR and AICTE facilitate research activities by disbursing crores of rupees to academic institutions towards doctoral fellowships, travel grants, collaborative research facilities, grants for conducting seminars and symposiums, grants to set up sophisticated labs.

Mod er n P har ma•16 -31 Dec emb er 2 012

Facility Visit

Principal KM Kundnani College of Pharmacy (KMKCP), Mumbai

pallavi.mukhopadhyay @network18publishing.com

ounded by the Sindhi refugees in a bid to educate the Sindhi community, today Principal KM Kundnani College of Pharmacy (KMKCP) stands tall in the green bylanes of Cuffe Parade in Mumbai relentlessly working towards enriching pharma education in India. It was formed under the Hyderabad Sindh National College Board, which today runs various colleges all over Maharashtra. Walking along the corridors of the college invokes a sense of grace and peace coupled with zeal to explore further. Accredited by National Board of Accrediation, New Delhi and the University of Mumbai, this college, currently in its 41st year, is one of the few shining beacons of pharmacy education today. It is a recognised research centre for post-graduate studies.

Courses offered

Bachelors in pharmacy; Masters in pharmacy; PhD degree in 5 branches namely pharmaceutics, pharmaceutical chemistry, pharmaceutical analysis, pharmacology and pharmacongnosy & phytochemistry.

The associated faculty

Being associated with the college for 30 long years, Dr Mrs Priscilla D’Mello, Principal stresses that strength of the college is its faculty. She says, “The professors are constantly updated. We believe in academic monitoring and planning ahead of the year, assimilation of information and our focus remains on the ultimate placements of the students. We are continually strengthening our teaching and learning processes.” Kundanani College boasts of 18 professors in all, 13 post graduate guides out of which 10 are doctorate level guides and 5 professors who teach bachelors courses.

Bridging the gap

KMKCP has adopted various means of teaching for all round development of students. Today, the industry needs not just well educated students but

Research areas

Formulation department: New drug delivery system, nanotechnology, extended drug release, and prolonged drug release Analytical department: Development of analytical profile, impurity profiling Pharma chemistry department: Computer-assisted drug design using sophisticated software, synthesis of molecules at laboratory level Pharmacology department: Preclinical effects of several drugs tested on lower animals, toxicology Pharamacognosy & Phytochemistry department: Isolation of molecules from natural sources, bioenhancement studies

mature professionals with a drive for innovation and excellence. The college stresses on the outcome of the students in the long run over fulfilling short term commitments. In KMKCP, students and faculty attend research conferences, participate in oral and poster presentations nationally and internationally.

In the quest to build bright futures

In the wake of revamping education in India, KMKCP displays the elegance of forward thinking. With immense vigour to mould its students for a future to reckon with, this college tells a tale of both grit and humility. Principal, Dr Mrs Priscilla D’Mello takes us through its history and into its future… Students are encouraged to participate in student exchange programmes, visit international universities and understand research practices undertaken there. Students also go for factory visits and industrial training. Dr D’Mello adds, “We need to go beyond the syllabus and adapt different methods of quality building and strengthen student outreach activities.” Emphasis is given on personality development and ethics and social responsibility. The social responsibility activities include performing plays, undertaking road shows, tuberculosis awareness programmes, diabetes detection camps, and preparing and distributing pamphlets. Students visit old age homes and are involved in community and clinical pharmacy. Rotaract Club activities help students go beyond the syllabus. Guest lectures and workshops are organised and students are encouraged to give presentations and keep themselves updated at all times. The college calls attention to co-curricular and cultural activities. The syllabus is updated every 5 years because it sincerely believes that key to good learning is continuous education and upgradation.

Photograph: Nachiket Gujar

Pallavi Mukhopadhyay

is laid on continuous evaluation. The syllabus includes new developments in the areas of research and technology. Nanaotechnology, an upcoming research subject is added to the syllabus. Novel drug delivery systems, computerassisted drug design, molecular

Post-college scenario

Almost 25 per cent of the B Pharm graduates opt for jobs. Students are placed in marketing sectors, medico marketing sectors, insurance sectors, hospitals, clinical research areas, patent offices and regulatory affairs. Almost 10 per cent students go for research abroad, while the rest 65 per cent opt for management studies or research-based courses in India.

Available funding

The B Pharm course is a grant-in-aid course. About 90 per cent grant is received from the Maharashtra State Government. The college receives a grant of ` 30 lakh per year. The M Pharm course used to be partially funded by AICTE. The PhD courses are self-funded. However, students are encouraged to acquire grants from research organisations such as UGC, ICMR, DBT, AICTE, DST.

Evolution of pharma education

A few decades ago, pharma examinations were held annually. This gradually moved to the semester system. Currently, pharma colleges employ credit based syllabus, where emphasis

The expansive college library

Illustrious alumini

Glenn Saldanha, CEO, Glenmark Mehul Shah, CEO, Encube Ethicals Pvt Ltd Aditi Kare Panandikar, Director ± Business Development and HRD, Indoco Remedies Dr Geerish Gupchup, Dean ± School of Pharmacy, Southern Illinois University Madhu Uttam Singh, MD, Hemmo Pharma

“Institutes must conduct seminars and workshops to strengthen these upcoming areas.”

Infrastructure We believe in academic monitoring and planning ahead of the year, assimilation of information and our focus remains on the ultimate placements of the students. Dr Mrs Priscilla D’Mello Principal

modeling and pharma research is also being taught. There has been a surge in the importance on patent studies as well as pharmacotherapeutics and pharmacovigilance studies in the last 5 years. Newer teaching techniques such as presentations; use of molecular models, multimedia is being adopted in the institute today. Dr D’mello adds,

The instrumentation centre boasts of 6 HPLCs, 1 FTIR, 1 DAC, 1 HPTLC, 5 UV Visible spectrophotometers, mettler balances, spray dryers, fluidised bed dryers, coating equipment, rotary tablet machines for quality testing of formulations. The drug design laboratory is equipped with state-ofthe-art software assist for receptor binding of molecules, pharmacokinetic parameters, design newer molecules and study physiochemical parameters. The library, one of the main attractions of KMKCP, has 70 national and international electronic journals, 11,000 books, free Internet access for e-learning. Adding another feather to its cap, KCKMP has introduced language laboratories to enhance communication skills of vernacular medium students by introducing audio - video software for better spoken English. The drug information centre, which is in the process of development, has information about drug development and drug interaction, other learning CDs and multimedia. Besides, the college has a well equipped computer lab, 7 classrooms, and a multi-utility auditorium with sitting capacity 250 sponsored by Blue Cross Laboratories. Thus, education in KMKCP is a wholesome experience for every student that steps in. It is not just a knowledge sharing centre but a centre committed to each student’s all round development and growth.

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Insight & Outlook: Policies & Regulations

Patent laws in pharma

Why MNCs are shying away from Indian patenting policies? The global players continue to push the generics’ dominance in India by every possible means, whether in form of strict international export regulatory, quality factor or patent-related issues. A country has its own right to amend or change the policies as per the need of the hour as well as to protect its interests, so why pharma MNCs are shying away from the patent laws?

Nikunj Sharma nikunj.kumar@network18publishing.com

atent rights over original drug versions seem to be an never-ending issue between pharma MNCs and the Indian patent law office. On one side, the growing middle class makes India a lucrative market for the MNCs and their high cost drugs; the generic versions push the price constraints on major players.

Old game, new rules?

Dr Dhanalakshmi Iyer, Director, Lateral-I, comments, “Legal battles between pharma MNCs and India are on an ever increasing rise since the amendments that happened with regards to the Indian Patent Act 1970. The amended law in 2005 mainly focusses on the product patents being granted for new compounds but at the same time a law that strictly discourages new forms of the existing medicines. Now, whether this is done with a purpose to set high standards for patentability in India or is it a diplomatic move to encourage generics in India to prevent an innovators monopoly in the country?…is a thought-provoking question itself.” For poor and middle class income groups’ Indians, generics seem to be a boon to make the cost-effective versions of high-end drugs for chronic disorders available in the market.

Patent oppositions and Hatch-Waxman Act are the two powerful weapons that enable a generic competitor against a said innovator. Dr Dhanalakshmi Iyer Director, Lateral-Ia

“Patent oppositions and HatchWaxman Act are the two powerful weapons that enable a generic competitor against a said innovator to prevent the ever-greening of an MNC’s products. Also, the Indian system encourages incremental innovations known as generics, which is basically to boost a reduction in drug prices and a patent system that does not grant 20 years monopoly for such products. MNCs, considering their exorbitant investments and expenditures on sophisticated R&D, do not seem to be happy at all to accept this

India’s role in the supply of affordable generic medicines is key to scaling up treatment in developing countries. Leena Menghaney India Manager for the Access Campaign at Médecins Sans Frontières

legal approach that India relies on,” avers Dr Iyer. Leena Menghaney, India Manager for the Access Campaign at Médecins Sans Frontières, comments, “Multinational pharma companies have taken the Indian Government to court over the implementation of health safeguards in the patent law. The Novartis case - now pending a crucial decision from the Supreme Court - goes to the heart of what merits a patent. India’s role in the supply of affordable generic medicines is key to scaling up treatment in developing countries.

The outcomes of such legal battles will impact not only patients domestically but also patients living in developing nations that depend on cost-effective, quality generic drugs manufactured in India.” MNCs should consider the pricing in context with the demography and majority of consumer income slab, they are dealing with. The government policies should not be viewed as an effort to curb the growth prospects for a particular drug or company, as it is government’s duty and its citizen’s right to have access to affordable drug.

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Tips & Tricks

Mantras to retain employees

Knowing the right nuances

mployee retention is a major challenge for any organisation. Companies with low employee attrition rates provide a positive image to a prospective employee. A look at some of the innovative HR policies reveals how important retaining an employee can be. The pharmaceutical sector in India is no different. Comparisons become easier if companies are in clusters as in the Silicon Valley. Employees of different companies often get a chance to inter-mingle and assess the working conditions of their colleagues. In India, we have well-known hubs for the pharmaceutical industry such as Mumbai, Ahmedabad and Hyderabad where employees easily get to know industry benchmarks on most parameters, which help employees to rank their ‘preferred companies.’ Good pay-masters, swanky offices and canteens, perks, corporate culture and other goodies are often favourite topics of discussion among professionals during lunch time. Here are some tips and tricks to retain employees.

Tips& Tricks

Right selection: High attrition rates are often caused by wrong selections. This means a selected employee should not feel like a square peg in a round hole. If he does not have the right skills and aptitude, which are comparable with his departmental peers, he will soon start looking for an alternative employment. The word ‘right’ should also extend to a good ‘cultural’ fit.

Company culture: A high-handed approach is common among many interviewers of entry-level to middle management positions. A prospective Sales Manager or Production Manager is often told ‘You have to achieve your targets. Excuses for non-achievement are not acceptable in our company.’ This means the interviewer makes it clear that he wants a wizard with a magic wand so that no human factors can get into the way of performance.

Tips& Tricks

D G Rajarshi Managing Consultant, Pharma Resource

rajarshi@inpharmaresource.com

Promotional avenues: Many companies offer greater opportunities for promotion by closely tracking the strengths of each employee and finding or creating suitable positions to leverage these strengths for organisational needs. Periodic upgradation of staff members and assessment of potential for higher responsibilities is a great way to sustain employee motivation and ensure long-term retention.

Tips& Tricks

Work environment: This includes a variety of tangibles which an employee assesses during the initial months in the company. It includes the type of office ambience, the ergonomics, workstation, the cabin, the canteen, the systems, the management processes, the politics, the leadership, etc.

Tips& Tricks

Competence of boss: It is generally acceptable if bosses are tough task-masters. They are supposed to be. However, a boss who drives people crazy because of poor leadership and management abilities is often the cause of people attrition. A disciplined boss who is counted among ‘performers’ in an organisation are invariably those who are always supportive of his team’s efforts and gives them credit wherever and whenever due.

Tips& Tricks

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Projects

New projects and expansion activities are the barometers of industrial growth. These also present business opportunities to service providers like consultants, contractors, plant & equipment suppliers and others down the value chain. This feature will keep you updated with vital information regarding new projects and capacity expansions being planned by companies in the pharma/lifesceinces industry. Manufacturing of 2-Bromo-4-Fluoroacetanilide Project type: New facility Project news: Sajjan India Ltd is planning to set up a new pharmaceuticals project at Bharuch in Gujarat.

Manufacturing of ampoules Project type: New facility Project news: Caplin Point Laboratories Ltd is planning to set up a new pharmaceuticals project at Thiruvallur in Tamil Nadu. The project involves manufacturing of ampoules.

Project location: Bharuch, Gujarat Project cost: NA Implementation stage: Planning

Project location: Thiruvallur, Tamil Nadu Project cost: NA Implementation stage: Planning

Contact details: Sajjan India Ltd Matulya Centre, #2 Ground Floor, Senapati Bapat Marg, Lower Parel (W), Mumbai - 400 013 Tel : +91 22 2497 4400, 2497 4401 Fax : +91 22 2495 1098 Email: sil@sajjan.com, sajjan@bom2.vsnl.net.in Website: www.sajjan.com

Contact details: Caplin Point Laboratories Ltd Narbavi No.3, Lakshmanan Street, T. Nagar, Chennai, Tamil Nadu – 600017 Tel : +91 44 2815 6653, 2815 6905 Fax : +91 44 2815 4952 Email: jayapal@caplinpoint.net, vivek@caplinpoint.net Website: www.caplinpoint.net

Manufacturing of duloxetine-delayed release caps 60 mg Project type: New facility Project news: Cadila Healthcare Ltd is planning to set up a new pharmaceuticals project at Bharuch in Gujarat. Project location: Bharuch, Gujarat Project cost: NA Implementation stage: Planning Contact details: Cadila Healthcare Ltd Zydus Tower, Satellite Cross Roads, Sarkhej Gandhinagar Highway Ahmedabad - 380015 Gujarat Tel : 079-26868100 Fax : 079-26862365 079-26862366 Email: investor.grievance@zyduscadila.com Website: http://www.zyduscadila.com/ Manufacturing of liquid glucose Project type: New facility Project news: Blue Ocean Biotech Pvt Ltd is planning to set up a new pharmaceuticals project at East Godavari in Andhra Pradesh. The project involves manufacturing of liquid glucose. Project location: East Godavari, Andhra Pradesh

Project cost: NA Implementation stage: Planning Contact details: Blue Ocean Biotech Pvt Ltd 4-325, G. Ragampet, Peddapuram Mandal, East Godavari, Andhra Pradesh – 533440 Tel : +91 0884 2329 034 Fax : +91 0884 2329 035 Email: info@blueoceanbiotech.com Manufacturing of menthol BP/USP/EP/IP Project type: Dankaur, Uttar Pradesh Project news: Makevale Acrylics Pvt Ltd is planning to set up a new pharmaceuticals project at Vadodara in Gujarat. Project location: Vadodara, Gujarat Project cost: NA Implementation stage: Planning Contact details: K.V. Aromatics Pvt Ltd D-212 To 215, Epip, Site-V, Greater Noida, Dankaur, Gautambudha Nagar, Uttar Pradesh – 201306 Tel : +91 120 2341969 Fax : +91 120 2341793 Email: jobs@kvaromatics.com Website: www.kvaromatics.com

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Event List

N AT I O N A L E V E N T S IJCPPT-IOAJ

Pharma World Expo

The International Joint Conference on Pharmacology and Pharmaceutical Technology aims to recognises talents among the research scholars, by awarding them Trophies and Certificates of merits. In each track of the conference, there will be one best paper presentation award is being given to the scholars, based on the various criteria such as content of paper, originality of paper, PPT preparation, presentation style, and handling question & answer, January 6, 2013, India International Centre, New Delhi

Pharma Bio World Expo is one of the foremost shows for pharma and biotech industry in India. The show aims to be one of the largest exhibition and conference for chemical and pharma industry. There will be visitors and exhibitors from pharma processing, plants & equipments, pharma packaging machinery & materials, API, bulk drugs, additives, intermediates, analytical laboratory supplies (instruments, glassware, laboratory reagents / chemicals), environment control equipment & services, etc). This event aims to be a perfect meet for the entire industry; January 15-18, 2013, Bombay Exhibition Centre, Mumbai

For details contact: IJCPPT Tel: 09040051114 Email: ijcppt.india@gmail.com Website: www.interscience.in

Innovasia 2013 An excellent platform to build business, Innovasia 2013 falls under the umbrella of Vibrant Gujarat. The event aspires to highlight current technologies to combat current and future hurdles in fields of agriculture, production industries, infrastructure, energy, healthcare, IT, media and applied sciences; January 8-13, 2013; at Mahatma Mandir, Gandhinagar For details contact: Sunil Shah Global Innovation Center All Gujarat Innovation Society Ahmedabad Tel.: 9978904476 Email: support@gisindia.org.in Website: www.gisindia.org.in

For details contact: Chemtech Foundation Tel: +91 22 22874758 Fax: +91 22 22870502 Email: conferences@jasubhai.com Website: www.chemtech-online.com

Med Techno In this expo all kinds of healthcare products and services and different kinds of useful medical equipment and instruments will be given supreme importance. This expo will draw the attention of the leading experts related to medical and pharma industry. All kinds of healthcare techniques will also be highlighted in this expo. This aims to bring some useful and developmental changes in the medical industry and medical equipment & instruments manufacturing companies. These changes will be of great help for

LUDHIANA

Punjab, Dec 21-24, 2012

INDORE

Madhya Pradesh, Jan 11-14, 2013

AURANGABAD Maharashtra, Feb 1-4, 2013

RUDRAPUR

Uttarakhand, Feb 23-26, 2013

HYDERABAD

Andhra Pradesh, May 31- June 3, 2013

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

For details

Network18 Media & Investments Ltd

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

this industry to fulfill the requirements of their clients and patients. January 4-6 (Pune) and January 25-27, 2013 (Vijayawada); at Auto Cluster Exhibition Centre (Pune) and A Convention Center, Vijayawada, respectively For details contact: eyeball Media Pvt Ltd Tel: +91-44-45671150 Fax: +91-44-45671191 Email: santhosh@eyeballmedia.in Website: www.eyeballmedia.in

BioAsia 2013 This year, BioAsia is geared to carry forward the momentum with its tenth edition - BioAsia 2013. One can expect the best convergence at this much-awaited and most comprehensive lifesciences dynamic global forum. This time, through the succinct, cutting-edge theme of technologies, business, etc, BioAsia 2013 will explore a bio-future waiting to be shaped by the next big industry trends primarily biologics & biosimilars; January 28-30, 2013, HICC, Hyderabad For details contact: Federation of Biotech Association (FABA)

Tel: +91 (40) 66446577 Email: paridhi@bioasia.in Website: www.2013.bioasia.in

PHARMAbiotika PharmaBiotika 2013 is an exhibition with an in built buyer and seller meet which will help one in networking with 10000+ business visitors, 600 delegates and 400+ exhibitors, attending the global exhibition. There are around 30+ thought leaders from across the world sharing their valuable experiential learning in the 3 days conference which is going hand in hand with the exhibition. The event will help in meeting the potential customer requirements mapping for developing new trade leads and analyzing the exhibiting plan and help execute trade objectives, June 20-22, 2013, Mahatma Mandir Convention & Exhibition Center, Gandhinagar, Gujarat For details contact: Human Crayon Management Services Pvt Ltd Tel: +91- 120 – 6528801 Email: info@crayon4.com Website: www.pharmabiotika.com

I N T E R N AT I O N A L E V E N T S ICBMS’12 International Conference on Biological and Medical Sciences (ICBMS’12) aims at presenting the current research being carried out in that area. This conference is covered under International MultiConference on Chemical, Ecological and Biological Sciences (IMCEBS’12). The idea of the conference is for the scientists, scholars, engineers and students from the universities all around the world and the industry to present ongoing research activities, and hence to foster research relations between the universities and the industry. This conference provides opportunities for the delegates to exchange new ideas and application experiences face to face, to establish business or research relations and to find global partners for future collaboration; December 29-30, 2012, Grand Seasons Hotel, Kuala Lumpur, Malaysia For details contact: International Scientific Academy of Engineering & Technology Email: info@isaet.org Website: www.isaet.org

BIOSIGNALS 2013 The purpose of the international conference on Bio-inspired Systems and Signal Processing is to bring together researchers and practitioners from multiple areas of knowledge, including biology, medicine, engineering and other physical sciences, interested in studying and using models and techniques inspired from or applied to biological systems.

A diversity of signal types can be found in this area, including image, audio and other biological sources of information. The analysis and use of these signals is a multidisciplinary area including signal processing, pattern recognition and computational intelligence techniques, among others. With this vision in place the event aims to reach out to the industry professionals; February 11-14, 2013, Barcelo Sants Hotel, Barcelona, Spain For details contact: Biosignals Secretariat Tel.: +351 265 100 033 Fax: +44 203 014 5436 Email: biosignals.secretariat@insticc.org Website: www.biosignals.biostec.org

Bioinformatics 2013 The purpose of the international conference on bioinformatics models, methods and algorithms is to bring together researchers and practitioners interested in the application of computational systems and information technologies to the field of molecular biology, including for example the use of statistics and algorithms to understanding biological processes and systems, with a focus on new developments in genome bioinformatics and computational biology; February 13, 2013, Barcelona, Spain For details contact: Bioinformatics Secretariat Tel.: +351 265 100 033

Fax: +44 203 014 5436 Email: bioinformatics.secretariat@ insticc.org Website :www.bioinformatics.biostec.org

International Conference on Life Science & Biological Engineering The aim objective of LS&BE 2013 is to provide a platform for researchers, engineers, academicians as well as industrial professionals from all over the world to present their research results and development activities in networking and digital society. This conference provides opportunities for the delegates to exchange new ideas and application experiences face to face, to establish business or research relations and to find global partners for future collaboration; March 15-17, 2013, Tokyo, Japan For details contact: Kwansei Gakuin University Tel: +81 798 54 7394 Fax: +81 798 54 6082 Email: craig.mark@kwansei.ac.jp Website : www.lsbe.org

International Congress of Toxicology 2013 The theme for the conference is “From Basic Science to Clinical and Environmental Outcomes”. This conference encompasses novel approaches and technologies being used to properly assess the safety, toxicity, and risk for human health. The scientific programme will consist

of keynote/distinguished lectures, symposia, workshops, round table discussions, debate and poster sessions. This meeting will provide attendees with ample opportunities to exchange the ideas and to launch collaborations; June 30-July 4, 2013, Coex, Seoul, Korea For details contact: ICT XIII Secretariat Tel: +82-2-557-8422 Fax: +82-2-566-6084 Email: ict@ict2013seoul.org Website: www.ict2013seoul.org

Pharma Trials World Korea 2013 Pharma Trials World Korea 2013 is where pharma companies, trial sponsors, regional and international CROs and clinical trial sites gather to strategise in accelerating clinical development, accessing emerging markets, enhancing clinical operations through effective offshoring and outsourcing in Korea; July 8-11,2013, Korea For details contact: Terrapinn Pte Ltd Tel: +65 6222 8550 Fax: +65 6226 3264 Email:enquiry.sg@terrapinn.com Website: www.terrapinn.com

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

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Event Preview

Med-Techno India 2013

Innovation and variety on offer Chandreyee Bhaumik chandreyee.bhaumik@network18publishing.com

he goal of Med-Techno India is to ensure that the medical fraternity receives timely, accurate and help them be updated with latest technological innovations pertaining to healthcare and pharma industry. Being one of the most celebrated event in the industry, Med-Techno India provides a perfect platform for hospitals, medical equipment manufactures & exporters of India to explore the highly efficient Indian market. There are reasons for choosing the two places. A reasonable efficiency in healthcare, comparatively low treatment costs and state-of-the-art hospitals, hospitality and other feel-good factors have put Pune among the top destinations for medical tourism. And Vijayawada has centralised location for many medical cities such as Hyderabad, Vishakhapatnam, Guntur & Kakinada.

An ideal platform

The event aims to serve as an ideal platform for the medical equipment and instruments companies to showcase their latest developments to the industry. It aims in bringing

Ranging from product technology showcase to new product launch, business networking and business joint ventures, Med-Techno India 2013 will be offering several opportunities. The event, organised by eyeball Media Pvt Ltd will take place at Auto Cluster Exhibition Centre, Pune from January 4-6, 2013 and at A Convention Centre, Vijayawada from January 25-27, 2013. all the major products & series related to the industry under in one roof. The Indian healthcare industry is growing at the rate of 20 per cent per annum, creating high demand for medical instruments and equipment industry. Thus, with the increase in medical tourism in India, the Indian healthcare industry is attracting patient inflow from across the globe, leading to constant technological improvements. The need to provide affordable healthcare in India has resulted in hospitals investing heavily in new technological innovations, thus

Being one of the most celebrated event in the industry, Med-Techno India provides a perfect platform for hospitals, medical equipment manufactures & exporters of India to explore the highly efficient Indian market.

providing opportunity to extend cost benefits to patients. The Indian government has passed out a resolution to increase healthcare expenditure to 2.5 per cent of the Gross Domestic Product (GDP) from existing 1.4 per cent by end of 12 th Five Year Plan (2012-17), leading to overall positive outlook of healthcare in India.

Exhibitor’s forum

The event will be displaying hospital equipment, surgical equipment, rescue and emergency equipment, facility management & support services, hospital furniture, diagnostic/laboratory equipment, dental/ophthalmology equipment, medical disposables, hospital design and construction, IT provider for hospital, communication equipment, medical waste management systems, medical textiles, financial and health insurance services, office automation & equipment, accreditation agencies, etc. The event will be witnessing the presence of hospital owners, doctors/ specialists, purchase managers, hospital administrators,

dealers & distributors of medical equipment, physicians & surgeons, medical directors, medical and paramedical fraternity, R&D organisations, biomedical engineers, paramedical staff, health management & consultancies, public health services, government agencies, medical colleges & institutes and medical service provider. Talking about the expertise with which the events are conducted by the organiser, G Shakthivel, Eyeball Group, says, “Eyeball Media comes with an experience of over 15 years of providing down to earth, on ground practical brand solutions to clients. Our solutions have always been very simple yet very effective in connecting the brand to the target audience in a special way. All this is possible because of our team - the team that has been nurtured to excel in creating effective business platforms - be it exhibitions, conferences, seminars or business meetings.”

Mod er n P har ma•16 -31 Dec emb er 2 012

Event Report

P-MEC & CPhI India 2012

Reaching the benchmark and beyond...

mid global economic concerns, the Indian pharma industry is bullish with a steep growth target. In the pharma sector, India is one of the top five generic exporters of the world and maintains a positive trade balance, meeting over 90 per cent of the country’s medicinal requirements, explained Rajeev Kher, Additional Secretary, Department of Commerce, Ministry of Commerce and Industry, Government of India at CPhI and P-MEC India held in Mumbai. This is one of South Asia’s largest pharma events. Kher was the Guest of Honour at the inaugural session. Visitors from 118 countries across the globe are pre-registered for the threeday exhibition, held during November 21-23, 2012 at the Bombay Exhibition Centre, Goregaon.

Growth prospective

Elaborating on the growth prospective of the industry, Kher said, “Indian pharma exports are headed for a very healthy growth in generic and API exports and efforts are on to improve the foothold of traditional medicine exports. Pharma exports by the end of 2014-15 are expected to reach $ 25 billion. The Indian pharma industry is also covering a lot of ground in bio pharma at a rapid pace. Next, the market size of drugs losing patent protection was $ 270 billion in 2011 and is expected to go to $ 430 billion by 2016. It is but natural to view the Indian pharma industry among the top in the next decade.” He further added that the domestic industry is gearing up in a big way, with more people likely to be covered by various health benefit policies, be it insurance and with facilities offered by healthcare industry matching the best in the world. About improving the competitiveness, he said, “India has the largest pool of talented and trained personnel in the industry and is also backed with the lowest cost of operations. This along with positive policies facilitating growth would prepare the industry to meet future challenges. ” The challenges for the Indian pharma industry includes EU’s new directive for falsified medicines, USFDA’s increased cost of operations and China’s non-tariff barriers. To mitigate the same, the government will carry forward Brand India pharma campaign launched during CPhI Japan in March 2012. In other major exhibitions such as CPhI Southeast Asia and CPhI Worldwide in Madrid, Brand India pharma campaign was carried forward by showcasing the capabilities of the Indian pharma industry.

Event experience

A series of technical seminars were presented by exhibitors throughout the event. A CEO conclave with a panel discussion was held at the Westin Hotel, Goregaon, followed by the unveiling of the first CPhI India Pharma Awards. These awards were designed to appreciate and acknowledge the value of the Indian pharma industry and highlighted innovations in product development, environmental health and safety. A record 926 exhibitors from

CPhI awardees and guests along with UBM management

CPhI-P-MEC along with its co-located events can be considered as the largest and most comprehensive pharma industry events in South Asia. The event serves as a perfect meet with key decision makers in pharma industry from over 85 countries Read on to catch glimpses of this year’s event.

21 countries had gathered under the single roof of CPhI/P-MEC/ICSE/BioPh India three-day trade exhibition. The event provided an efficient platform for global pharma buyers to indentify business opportunities and meet with potential partners. Interestingly, to provide all vital information regarding the exhibition on real-time basis and make it easier for visitors to find exhibitors, a new mobile application was available in this event. The app

world. Overall, it has been a very good experience.” He also added that the company was receiving a tremendous response and a lot of positive reviews. Seconding the above thought, Dr Andreas Mattern, Business Unit Head – Pharma, Bosch, praised the number of visitors and even the quality of visitors. “We are very happy with the exhibition this year. The quality level of visitors is very high and very knowledgeable.”

made navigating the exhibition floor much easier and included details on the technical seminars, a comprehensive exhibitor list and floor plan with built-in networking and social media features. Talking about the event, Devashish Bakshi, MD, Tapasya Engineering Works Pvt Ltd, said, “This is the biggest and the best event till date. This event has shown that how Indian pharma industry has come on its own to become one of the largest markets in the

Mo de rn Ph a rm a •16 -31 D e ce m be r 2 012

Event Report

5th Banglore Nano

Opening windows to nanotech innovations Nikunj Sharma nikunj.kumar@network18publishing.com

ision Group on Nanotechnology in collaboration with The Department of IT, BT and S&T, Government of Karnataka organised 5th Banglore Nano between December 5 and 7, 2012 at Hotel Lalit Ashok, Bengaluru, India. C N R Rao, FRS, National Research Professor; Linus Pauling Research Professor; Honorary President, JNCASR, said, “The overwhelming response to Bangalore Nano reiterates the deep penetration that nanoscience and nanotechnology have made in India. There is a sharp rise is the number of scientists, research scholars and technocrats pursuing nanoscience and nanotechnology. We are at a stage wherein inventions are being transformed into innovative products for the good of common man. The NanoMission programme of Department of Science and Technology DST, Government of India has played a significant role in giving a boost to nanotechnology. And the central government and the Government of Karnataka have been proactive in supporting and funding science, especially nanotechnology.”

Dignataries releasing the compendium at the opening plenary of 5th Bangalore Nano

Encouraging the innovators

T Pradeep, Department of Chemistry, IIT Madras, received The India Nanotech Innovation Award for discovery of noble metal, nanoparticlebased drinking water purification methods. In addition, six budding researchers, from leading institutions in India, were presented Malhotra Weikfield Foundation - Bangalore Nano Young Scientist Award In the poster session, young researchers and scientists from 60 institutions such as JNCASR, IITs, International Universities and NCBS showcased various innovative ideas and concepts.

Highlighting the government’s initiative NanoMission to promote nanotechnology innovation in the

5th Banglore Nano added a new chapter to its success chart, proving to be a multiple view window to innovations taking place in the field of nanotechnology and nanoscience in India and global markets. Leading organisations and experts took part in the event to address delegates comprising academicians, industry people and researchers.

country, Dr T Ramasami, Secretary - Department of Science and Technology, informed, “NanoMission and initiatives such as Bangalore Nano has created great interest & enthusiasm among young people. India is among the top 5-6 nations in the world in terms of creation of knowledge in science and specifically nanoscience area. Bangalore Nano creates that ecosystem and we have a long way to go but we sure have begun well.” Speaking on the event’s popularity, Sir Richard Friend, Cavendish Professor of Physics, Cavendish Laboratory, Cambridge, UK, commented, “Bangalore Nano is a prized and valued event for the nano-community and the event has grown from strength to strength over the years.”

Widening exposure

5 th Banglore Nano offered a comprehensive platform for interaction to various stakeholders hailing from diverse arena and geographies. Delegates from Germany, France, USA, Japan, UK, Italy, Ireland, Saudi Arabia, and Czech Republic attended the conference. The event witnessed participation from 43 exhibitors from domestic and foreign markets that invited more than 2,000 visitors. Overall, the event remained successful with new concepts that engaged the participants, right from the students, academicians, industry and visitors. The knowledge initiative provided broader insight on almost each aspects of nanoscience horizon, from government, academic, research and business perspectives.

Mod er n P har ma•16 -31 Dec emb er 2 012

Book Review Essentials of Pharmaceutical Preformulation

Editors: Simon Gaisford, Mark Saunders

Preformulation is the very basic step in new drug development and research that will ultimately decide the fate of the experimental drug. Only one out of every five to 10,000 experimental molecules ever reaches the actual stage of human testing. Hence, it is very essential, economically, to select the right candidate for drug development through a vigorous preformulation process. The editors have brilliantly put together an 11 chapter monograph covering the major steps and processes in preformulation. The introduction chapter lays out the basic principles, analytical methods and technologies in a simple and lucid language. The dedicated chapters on ionisation, partition affinity, solubility, dissolution, salt selection, physical forms, stability and properties provide excellent details on basic concepts, basics of physical chemistry, analysis and implications. The summary box feature at the end of every major topic in a chapter is an excellent ready reckoner for brushing up on concepts. Each chapter is provided with easy to understand examples, illustrations, tables and graphs to drive home the principles of preformulation. This book can be considered as an excellent source for every pharmacy student and analytical chemists.

Price: ` 4,600

Editors: Catherine E Ulbricht, Ethan M Basch

Natural Standard Herb & Supplement Reference

Price: ` 2,995/-

The Natural Standard Research Collaboration is a group of respected and renowned experts in the field of integrative medicine, who have compiled an exhaustive reference on 98 herbs and their position in therapy and formulation. The majority of the book is a detailed reference guide on individual herbs arranged alphabetically. Each herb is described with specific reference to its clinical use, the evidence for its clinical use, safety, dosing and toxicology. Most important in each review is the emphasis on clinical evidence and studies with respect to the clinical conditions. The book also has an appendix of condition tables, where for a given clinical condition various herbs with their levels of evidence are grouped for easy use. An excellent must have reference text for every student, enthusiast, practioner, promoter and industry personnel associated with alternative and/or integrative medicine.

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

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

Reviewer: Dr Mandar Kubal, Director, Infectious Diseases & Pulmonary Care Pvt Ltd

invite that

rewards as well... Dear Reader, ‘Modern Pharma’ solicits original, well-written, application-oriented, unpublished articles that reflect your valuable experience and expertise in the pharmaceutical industry. You can send us Technical Articles, Case Studies and Product Write-ups. The length of the article should not exceed 1,200 words, while that of a product write-up should not exceed 100 words. The articles should preferably reach us in soft copy (either E-mail or a CD). The text should be in MS Word format and images in 300 DPI resolution & JPG format.

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In Conversa

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Anil Sharma MD, South Asia & Sub Saharan Dennison Material Africa, Avery s Group

FDA warne ‘defective’ s against some vaccines The death

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Pharma packag ing Automation to fuel growth

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Karl Vanden bussche MD, Reynder s Label Printing India Pvt Ltd

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Automation Trends 19 Optimal energy utilisati Thanks to automat on ion

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The sed of relevancost-based policy reveals l mechanism encourage Food ility and Control Order competition, of Drug Price its lack ce in current and Administratio and growth Drugs market conditi innovation, significant n (FDA) the 348 molecu (DPCO) 1995 and and help limitations all hospit has warned all on the harness the and adverse ons, export potent les will be als agains the disastr industry and ial. impact crippled by t the use medicines ous repress patient access. The of one, it has from that On the contra ions. shifted bulk For unders pharm aceuti cal batch. FDA has taken drug produc samples of out of India indust ry ry, the Weigh Average Price tion medici tands that access the alleged to countries faulty medic ted to essenti (WAP ly escalat such nes ) is of all brands as China, ed prices al to the centraines and sent them for select an effectiv a critical component l government’s e health system greater than , having of testing labora reduced the medicines, impera 1 drug per , and tive cent number of it tory at market share that good Uttarakhand industry players Kasau li, quality and is medicines . remain accessi safe , reduced recommende formula batch numbe “We have shared the innovation and afforda d by the Mark ble, availab in cost control rs GoM, will ble to le et-based pricin of these medici and manufacturer medici Market-based beneficiaries. s nes with all g new nes and limited over 20 per result in pricing will will encou They are hospitals. investm cent price introductions, encourage advised not rage reduction and safety. ent in quality and hence to until reports above all, in 60 investment failed to help from Kasaul use these patient This is of the NLEM per cent in whether the i determine medicines given the proble extremely import medicines. quality and reach patient medicines ant The hence m Further directi are at fault. of s plaguin located in Cham ber rural areas. g the countr counterfeit drugs patient safety ons will be spokesman the FDA y and the given by A drug price confidence said, “The . after lack of Order will in generic control said Amrut the report arrives policy must drug quality the medica severely ,” be carefully l community impact the in Commissione Nikha de, Assista calibra ted patients. availability and among nt r, FDA. to avoid This of essential st adverse medicines ensure contin new policy will trade-offs for patient also will be nearly uous availab 158 unauth in contro achiev ing s as it policy impossible ility of lled medici orised drug key drug for the industr to supply essenti objectives outlets sealed nes by prevenprice sale of striking medicines y betwee al from going ting a balance n ensurin In a memor medicines.” The Drugs in J&K off the market g quality account andum submit and reason P Chidam on ably priced , affordable enviro of an unviable manuf Organisation and Food Contro ted baram to , Finance and enablin l nment, which acturing (DFCO) has to patien ASSOCHAM Minister, unauthorised g ts case sealed happened said that of cost-based competition. industry growth drug sale outlets 158 in the Average the Weigh and Jammu and pricing. Price ted across Moreo (WAP Kashm The ASSOC ver, the to contro ) Satish Gupta, ir. HAM memo l the price mechanism said recommende new policy that given medicines randum d said, “In a series Controller, DFCO recommended of essential of the severe harness export by the GoM cost-based handicaps will will achieve potential different parts of raids carried out the govern and help in pricing policy pricing, a market-based ment achieve last few days, of the state during the would best $ 25 billion its target 158 unauth suit India’s of worth of sale outlets orised drug exports in pharmaceutic were sealed. the al sector. has been taken ” The step as per the The pharm of the High directions a industry Court, he the Union has urged High Court added. 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Liquid process filter cartridge

pH meter

L i q u i d process f i l t e r cartridge is available in depth, pleated, membrane a n d speciality types, ranging from 0.01 to 100 micron. It can be made available in 4 distinguishing sizes with variety of end connectors. These US grade filters are manufactured in ISO class 7 environment using FDA listed materials. It can be used in typical applications like pre filtration, pre RO, final filtration, clarification, particulate removal from non sterile formulations, filtration for pharmaceutical fermentations, filtration of water for injection, tank vent filtration, sterile filtration of active pharmaceutical ingredients and also for large and small volume parentals. They specialise in microbial removal, catalyst and steam recovery, particle and haze removal, solid contaminants removal, etc.

Advanced ph meter for research grade applications is a GLPcompliant meter with pH m e a s u re m e n t capability along with temperature. The pH range varies from -2.000 to 20.000 pH with accuracy of ± 0.002 pH. It features a new compact design that is over 40% smaller than other benchtop meters. The large display makes reading from distance possible. All measurements include temperature display. The meter includes autobuffer recognition for both USA and NIST pH buffer sets upto 5 points calibration. There is also a calibration due alarm function which skips out-dated calibrations issue. Water-resistant membrane keypad offers password protection for both set-up and calibration. Provisions for report generation is also present.

Thermax Ltd Pune - Maharashtra Tel: 020-66476356 Email: channelm@thermaxindia.com Website: www.thermaxindia.com

Cole-Parmer India Pvt Ltd Mumbai - Maharashtra Tel: 022-67162209 / 2222 Fax: 022-67162211 Email: response@coleparmer.in Website: www.coleparmer.in

Dynamic light scattering system Zetasizer Nano ZSP dynamic light scattering system is useful for highly sensitive measurement of the zeta potential, or electrophoretic mobility of proteins. The instrument delivers unique performance specifications for both size and zeta potential measurement, employing an approach to zeta potential measurement that accords with the latest industry guidance. It uses the company’s patented Diffusion Barrier

Technique which protects the sample by isolating it from the electrode. Consequently the applied voltage can be switched on for longer periods to generate more reliable measurement data. The method involves the use of a unique, disposable folded capillary cell which allows measurements to be conducted on samples as small as 20 microliter.

Malvern Aimil Instruments Pvt Ltd Mumbai - Maharashtra Tel: 022 - 39183596 Fax: 022 - 39183562 Mob: 09867368075 Email: soloni.gosalia@malvernaimil.com Website: www.malvernaimil.com

Pneumatic stirrer Pneumatic stirrer can be operated automatically as well as manually, depending on the requirement. They are designed as per client specification. The design is Current Good Manufacturing Practices (CGMP) compliant and product contact parts are AISI 316 and non contact parts are AISI 304 compliant. AC frequency variable drive is also present. Pneumatic stirrer is operated on pneumatic compressor air, for homogeneous mixing of paint, to avoid settling heavy particles, metallic particles, resin, pigmentation, etc. at the bottom of the container. Stirrer can be mounted on stand, PFT and container. Shefa Industries Mumbai – Maharashtra Tel: 022-25942473 Email: shefaindustries@yahoo.co.in Website: www.indiamart.com/shefaindustries

Mod er n P har ma•16 -31 Dec emb er 2 012

Products

In-line homogeniser system

In-line homogeniser system allows smooth changeover from laboratory to production plant. It allows the user to select from seven different mixing technologies using a variety of available mixing heads, all with programmable speed control to determine the best mixing function for the process. This laboratory machine offers a great variety of applications for many different mixing and particle size reduction processes. It eliminates the need to purchase separate mixers and operates as both a batch mixer and in-line mixer. The compact, tabletop design minimises space requirements. Cole-Parmer India Pvt Ltd Mumbai - Maharashtra Tel: 22-67162224 / 2222 Fax: 22-67162211 Email: response@coleparmer.in Website: www.coleparmer.in

Rotary tablet press Rotary tablet press with double-output and bi-layer tableting features the patented Exchangeable Compression Module (ECM) technology. It offers increase in productivity due to a very short change-over time, enhanced operator protection due to ECM, exceptional flexibility because same basic machine can be equipped with different ECMs. There is a zero-gap closed powder feeder to minimise crosscontamination between layers and to minimise powder loss, specially designed extraction nozzles and scraper fingers for optimal cleaning of the die table. It can undergo manual or fully automatic first-layer sampling. It also features the patented weight control system, which is exceptionally sensitive and accurate even at low compression forces. Its production capacity lies from 35,000 tablets/hour to 875,000 tablets/hour depending upon the model. Machine size and weight specifications are W = 2000 mm x D = 1500 mm x H = 2250 mm - 6000 kg. Shefa Industries Vadodara – Gujarat Tel: 265 – 3074270 Fax: 265 – 3074255 Email: pharma-india@gea.com Website: www.gea-ps.com

Barcode reader B a rco d e reader has an integrated advanced 2DMax+™ code reading software technology. Readers can now identify and decode severely damaged or poorly marked 2-D matrix codes using 2DMax technology which also makes the barcode reading unaffected by variations

in lighting, marking method, code quality or surface finish. Data matrix codes have built-in error correction but “no-reads” can still occur when codes are incomplete. It is exceptionally small with an industrial-rated housing measuring just 23 x 42 x 64mm and it also supports ethernet connectivity with a wide range of industrial protocols, for real-time part tracking, image archiving, data transfer and seamless integration with plant controllers and information networks. Cognex Sensors India Pvt Ltd Pune- India Tel: 020- 40147840, 9881466003 Fax: 020-66280011 Email: sisd.support.asia@cognex.com Website: www.cognex.com

Capsule manufacturing machine C a p s u l e manufacturing machine has production capacity of 1.5 million capsules per day. It has servo controlled dipping operation and is independent and easily programmable for cap and body sides. These machines are designed and built to last for decades. All operations are controlled by PLC with touchscreen user interface. Safety measurement in all critical areas is provided to prevent accidents. It complies with CGMP guidelines. Safrroys Machines Pvt Ltd Kolkata - West Bengal Tel: 033- 22897248, 22897341 Fax: 033-22897412 Email: safrroys@gmail.com Website: www.safrroys.com

Conductivity meter The

mhoCounter

CT-10 is a conductivity indicator and mhoCounter CT-11 is the meter with relay output option, which is programmable. Microprocessorbased electronics allow wide operating range and long term signal stability. Optional relays provide control for adjustment or alarms. These meters come with saddle mounting option or standard fittings to adopt to any process flow solution. Vatturkar Industrial Pune – Maharashtra Tel: 020-25380568, Mob: 09422320551 Email: response@vatsmeter.com Website: www.vatsmeter.com

Electronic panel timer The electronic panel timer is housed in small industrial grade plastic box. It gives 5 per cent setting accuracy and 1 per cent repeat accuracy. It is available in 415 V or 230 V with one changeover contact. Timing range is 30 sec, 60 sec, and 120 sec. Power and delay indications are provided on the front side of the timer. Potentiometer is provided to

set the required time. It measures 102 mm x 65 mm x 43 mm and weighs 250 gm approximately. Gelco Electronics Pvt Ltd Ahmedabad - Gujarat Tel: 079-22200902 Email: info@gelco-world.com Website: www.gelco-world.com

Disinfectant Preventol is a ready formulated disinfectant concentrate with cleaning power, highly effective in combating and eliminating a broad spectrum of microbial activity arising from bacteria, viruses, fungi and spores. This formulation combines the benefits of new generation phenolic active ingredients and stabilised aldehyde-based active ingredient to create a synergistic combination. It is proven to be effective where there is a high combination of blood and/ or protein and against naked viruses. It is perfectly suited for surface disinfection in hospitals, clinics, nursing homes, commercial establishments, manufacturing areas and animal houses. It is also ideal for protecting medical devices and instruments. Lanxess India Pvt Ltd Thane - Maharashtra Tel: 022- 25871000/25871540 Fax: 022-25826742 Email: sunder.rajan@lanxess.com Website: www.lanxess.com

Fluid bed dryer Fluid bed dryer is used for drying of wet material. It is equipped with air handling unit. The inlet air filtration is through pre, micro vee and hepa filter. It performs uniform and harmonious drying operation in a specified time. It has applications in tablet-granulation section of pharma industries. This dryer is compliant with CGMP under WHO and USFDA. Also offered is diversified novel advanced techno-upgraded qualitative model of fluid bed dryer like PLC operated, semi-automated and manually operated dryer with multi faceted and userfriendly features. Ratnakar Pharma Machinery Ahmedabad - Gujarat Tel: 079-22892614, Mob: 09427031284 Email: ratnapd@yahoo.co.in Website: www.ratnakarpharmamachinery.com

Magnetic drive centrifugal pump

are When it comes to buying equipment which on related to the pharma industry, one must rely les his/her required parameters as well as after-sa ts may suppor t because in the long run, the produc incur additional charges.

Mr. Arijit Chakraborty Market Research Analyst Ion Exchange (India) ltd

of the TMR series is that the pump can run dry for up to 15 mins without damage. The inlet/outlet for the pump is offered in threaded (BSP/NPT) or flanged (ISO/ANSI) connections. The TMR series is disassembled without disturbing the motor. Maximum flow rate that achieved is up to 30 m³/hr and heads up to 25 mWc. The strong magnetic coupling made up of rare earth materials and three versions of each model allow pumping of liquids of special gravities from 1.00 to 1.85. Shanbhag & Associates Mumbai - Maharashtra Tel: 022-28346604 Email: shanbhags@vsnl.com Website: www.shanbhags.com

Liquid-ring vacuum pump The single and doublestage liquidring vacuum pump is silent in operation. Design of the mechanical shaft seal ensures adequate protection to the shaft and provides for ease of maintenance. This leads to minimal time required for servicing thereby cutting down time to the barest minimum. The pump is rugged in design, reliable in performance and easy to maintain. Acmevac Sales Pvt Ltd Mumbai - Maharashtra Tel: 022-28375837, Mob: 09223388105 Email: acmevac@vsnl.com Website: www.acmevac.com

Gas monitor The range of this gas monitor is 0-5 ppm (V/V), resolution is 0.1 ppm, and the response time is typically less than 60 seconds. Detection principle is based on the sealed electromechanical sensor. The operating life of the sensor is expected to be of 1-year. The operating temperature ranges from 0 to 50°C. It has a LCD with battery indication.The alarm is both viewable and audible. Uniphos Envirotronic Pvt Ltd Valsad - Gujarat Tel: 0260-2730156 Email: cel@uniphos.com Website: www.uniphos-she.com

Lutz magnetic drive centrifugal pump is available in two series range AM and TMR. The materials are in glass-filled PP or carbon-filled ETFE. Unique feature

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

Modern Pharma

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Label Printin ds Optimal The death ’ vaccines India Pvt g energy utilisation Ltd old child of a two-and-aThanks to autom half-m after he ation some vaccin was admin onthASSOCHA e at istered Indira M appre Gandhi the governmen recent hend t-run Gove Supreme College that the result in and Hosp rnment Medi Court twin objec led to cal ruling ital (IGM a warni pharmaceut70 per cent will CH) has ng again of the industrial tives of publi medicines Indian st the inconsisten ical market c health grow from that and t and ineffi put under The Cham th. The particular use of price needs the Food contr ber cient cost-b batch. as it would existing Administr and Control ol mechanism cost-based further said that afford ased not only Drug of Drug of releva Order all hosp ation (FDA) policy revea the encou ability but (DPCO) nce the 348 has warn s Price itals again also availa improve ls its lack rage molecules significant in current mark 1995 and medicines ed bility and st the the disast and grow competition, et condi limita use of tions, has taken from that rous reprewill be crippled all on the indus tions and innov th and batch. adverse export On the by one, ssion samples help harne ation, try and FDA impact potential. faulty contrary, s. patien it has ss the medicines of the allege Average The out of Indiashifted bulk drugt access. For dly to the Price (WA the Weig and sent of all central hted understan phar mace utica production to count P) them brands, gover escalated testin g l indu ries such greater having medicines ds that acces labor atory nment’s drug prices than 1 s to essenstry Uttarakhan for select as China, per at Kasa market an effect is a critical medi reduced componen tial uli, share formcent batch numbd. “We have ive health the numb cines, impe recommend shared t of ula system, ers and rative indus er the of these try of medi ed by that good and it manufactu players, GoM, medicines is cines innovation reduced quality will resul the Marketrers They are with all and based prici over 20 and afford remain acces medicines in cost control sible, availasafe until repor advised not to hospitals. per cent t in able ng will to reduc price encourag beneficiari ble Market-ba tion in new introd and limited whether ts from Kasau use these 60 per cent es. e of the NLEM li determine investmen sed pricing investme the medi above all, uctions, and will encou Further t in quali nt in medicines safety. directions cines are at fault. rage quality The ty and hence medicines failed to help . This is the FDA and will be patient spokesman Cham ber reach given extremely after the given by located patient hence said Amru impo said, “The report in rural patients plagu the problem of Order safety. arrives,” areas. counterfei rtant ing the A drug Commissi t Nikh ade, will sever t drugs impact confidence country and Assis tant oner, FDA. policy mustprice control the availa ely of essen the medi in generic drug the lack of calib rated be carefully tial medi bility 158 unau cal comm quali cines will patients. ty in thorised to avoid unity and be nearly for patien adverse outlets seale This new drug sale impo amongst ts to suppl ensure polic achie ving trade-offs in y essen ssible for the indusas it policy conti The Drug d in J&K tial medi controlled nuous availa y will also try betwe objectives key drug In a cines.” Organisati s and Food bility of en ensur of striking a P Chid memorandum medicines medicines balan ing quali amba by preve price submitted and reaso unauthorison (DFCO) has Control ASSOCHA ram, Finan ty, afford ce account from going off nting sealed 158 ed drug Jammu ce Mini to and enabl nably priced the mark of able Average M said that and Kash sale outlets acros environme an unviable the Weig ster, competitio ing industry to patients manufactuet on mir. s nt, which Satish to contr Price (WAP) hted case of growth ring n. happened cost-b said, “In Gupta, Controller ol the mechanism and The ASSO medicines in the a price More over, ased pricing. CHAM said that different series of raids carrie, DFCO recommend of essen memorand recom parts of the new tial of given the d out in ed will last few the state um harne mended cost-based severe achieve polic y days, 158 by during hand the pricin ss expo pricing the sale outle icaps unauthoris GoM rt poten policy wouldg, a market-ba the ed drug tial and will has been ts were sealed sed $ government best suit .” The achieve help taken as 25 billio India’s step of the its targe per the High The pharm pharmaceutn worth of t of High Cour Court, he directions ical secto exports in the Unio a industry added. the r. The un-licensed t has direc has urged ted for withd n Ministry of Com that these sale outle and un-register that no rawing merce pharmaceut the t be allow ed drug logistical would bring in in the state, ical expo regulations ed to on this economic misba on rts. A issue has departmen he said addin function and The fresh lances in trade verdict Madras informatio . High Cour been pending coding no such t has been ensurg that the norms on sector is from establishm require under the n on packs that ing packs on all levels of the opposed t’s end. The pharm barfail ent is opera that stand to come ard sizes. of Com to the norm formulatio pharma a it tional. Drugs merce The Minis products. is n initia s statin has imple try g manu becoming a However, l phase in Assamworth a crore mented strain facturers for unde bar-c the for most seized r these to list The regulation oding products custo ms last all requi s since Guwahati red are year. However, depa rtme October the yet to be of tablet seized a large consi nt in implement further phase s Patie nts gnment s ed. containing worth over ` one battl diabetes pseud crore arrested and assoc ing two peoploephedrine and complicatio iated the drug. e for smug from new ns may benefit currently gling Sources are target key therapies that said 221 innov developing used abnormalit in maki the tablets patient of the medicines ative new were ies adherence which ng party pancreatic opportunit are very to help increase one cells, drug nearl of the the youth the great s, insulin ies to popular y 347 secretion witho ut among er value get better result best million patients consignme . Sources said s and from our system,” reducing signi fican tly the drug nt comp diabe tes, affected by tablets health said rised blood and care President John 1,174 kg have reduc sugar India, which inclu ding containing about 100 kg of and CEO, J Castellani, ed dosag , is by of powd minimise pseud is know as the e, er “We receiv oephedrin n stakeh no means an PhRMA. “This diabe damage painful nerve easy task, older of the world tes capital ed a tip-o e. consignme system – s throughout diabetic and prevent . the health but New Delhi nt was comi ff that a including These kidne companies care early resear y disease, if biopharma ng from . Our developmemedicines in godown officers ch research Castellani tackle this – must work (ware A repor pans out. either clinicnt – all in was made house) and raided a togeth shared objec of new the seizu Phar mace t relea sed al trials . The tive.” Examer to under packed re or diabe cutting-edge substance by the review ples in 58 Man ufact utica l Rese approaches tes in carto was official type 1 diabe FDA – includ by the arch informed. ns,” a custo daily medi the pipeline includ to fight (PhRMA) urers and e 32 of ms for diabe tes, 130 for e a oncetype 2 and for the prote cine that select tes-related biopharma revealed that Ame rica ively in assoc 64 metab “Many ceutical conditions. America’s iated with inhibits research olism, costs assocof the human and companies a medi gluco inhibit an enzym cine designed se avoided, iated with diabe economic neuro e linked to making tes to improvem can be type pathy and a medicine diabetic 2 diabe ent of once-week tes that may to treat ly dosin allow for g.

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