Express Pharma December 1-15, 2012 Part -1 by Indian Express

I N D I A’ S F O R E M O S T P H A R M A & B I OT E C H P U B L I C AT I O N

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Pharma VOL 8. NO. 3 DECEMBER 1-15, 2012

Chairman of the Board Viveck Goenka

CONTENTS

Editor Viveka Roychowdhury*

MANAGEMENT Omkar Speciality Chemicals: Thinking big PAGE 33

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

IPC SPECIAL Quality human resource in pharmaceutical industry: Key for success PAGE 46 Pharma education: In need of a revamp PAGE 48

Bangalore Neelam M Kachhap Delhi Shalini Gupta MARKETING Deputy General Manager Harit Mohanty

Role of life sciences for growth of society PAGE 49

Senior Manager Rajesh Bhatkal PRODUCTION

WEST BENGAL PHARMA REVIEW

General Manager B R Tipnis Production Manager Bhadresh Valia

Drugs Control, West Bengal committed to healthy drugs regime PAGE 55

Asst. Manager - Scheduling & Coordination Arvind Mane Asst. Art Director Surajit Patro

RESEARCH

Chief Designer Pravin Temble

Alacris Theranostics enters agreement with GSK PAGE 109

Senior Graphic Designer Rushikesh Konka Photo Editor Sandeep Patil Layout Rakesh Sharma C I R C U L AT I O N Circulation Team Mohan Varadkar Express Pharma Reg. No.MH/MR/SOUTH-77/2010-12 RNI Regn. No.MAHENG/2005/21398 Printed for the proprietors,The Indian Express Limited by Ms.Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administra-tive Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright @ 2011 The Indian Express Ltd. All rights reserved throughout the world. Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

December 1-15, 2012

MARKET Vibrant Gujarat 2013 to focus on knowledge and networking Pharma sales in October shows 18.8 per cent growth

PAGE 21

PAGE 26

BioAsia 2013 to optimise immense business potential in biotechnology PAGE 27 CII to organise Life Science Conclave 2012

PAGE 28

www.expresspharmaonline.com

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EDITOR’S NOTE

Fixing pharma education The pharmaceutical industry used to be

factors like a slow down of exports to the EU as the

considered recession proof as compared to other

Eurozone crisis deepens, coupled with the slow but

sectors, but that myth has been roundly busted.

steady erosion of profit margins as we compete

India’s pharma peers thought they were in a sweet

with lower cost nations, we have to also look for

spot thanks to outsourcing of manufacturing and

reasons which are nearer home.

research and for some time, that was the case but

India does offers a value proposition for global

as 2012 draws to a close, India’s pharma industry is

pharma and a large part of that is not just the cost

also showing some troubling signs.

arbitrage but also the talent. But how deep is our

Consider this: the Naukri Job Speak index based

talent pool? Are our academia in sync with what

on job listings added to the Naukri.com site every

industry needs? And can they anticipate what

month, showed that hiring activity in the pharma

industry will need tomorrow?

sector dipped for three months in a row, with

As we put together our annual special issue for

September hires dipping a further six per cent from

the 64th Indian Pharmaceutical Congress, we asked

the previous month.

some of the most respected academia to take stock

Its true that the second half of the year

of pharma education in the country and more

generally does not see too much hiring, with major

importantly suggest solutions to fix the gaps. We

recruitment reserved for the first half of the year.

hope these issues will not just be discussed during

Indeed, pharma recruitments had been upbeat for

IPC but that the organising host, the Association of

the sector with in the early 2012, but that makes

Pharmaceutical Teachers of India, will be the

the dip all that deeper: hiring in September 2012 is

change agent and press for a transformative change.

10 per cent lower than in February. So what’s wrong? Besides macro-economic

10 EXPRESS PHARMA

www.expresspharmaonline.com

Viveka Roychowdhury viveka.r@expressindia.com

December 1-15, 2012

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THE BUSINESS OF PHARMACEUTICALS

Vibrant Gujarat 2013 to focus on knowledge and networking PG21 DCGI to be competent national authority to certify API exports to EU PG22 Pharma sales in October shows 18.8 per cent growth PG26 CII to organise Life Science Conclave 2012 PG28 Bangalore INDIA BIO 2013 to provide latest trends in biotech business opportunities PG29

MANAGEMENT 33 IPC 42 WEST BENGAL 55 RESEARCH 109 PHARMA ALLY 111 PHARMA LIFE 115

December 1-15, 2012

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After receiving the dubious and unpleasant tag of being diabetic capital of the world, India is on the verge of becoming the capital of obese people as well. In fact, rising incidence of diabetes in India is largely linked to the rising count of obese people in the country. On the other hand, though pharmaceutical companies and traditional medicine manufacturers were quick to offer remedies to tuck in Indian tummies, these sometimes came with worries attached.

India, the potential market Albert Einstein, the renowned German physicist who gave us E=mc2, had once said, “The devil has put a penalty on all things we enjoy in life. Either we suffer in health or we suffer in soul or we get fat.” And it seems India is not to be spared this fate. What’s more, we seem to favour a ‘quick-fix’ rather than the old fashioned diet and exercise routine to reverse the change. Why else would anti-obesity drug manufacturers sense a big market in India? Padmashri Shanmugaraj, Managing Partner, Prime Health Consultants explains this market buzz saying, “Considering the shift in our lifestyle over the last two decades, obesity and associated lifestyle diseases have become rampant and inevitable. Unhealthy foods have become the norm of the day due to their ease of availability coupled with the lack of time/means to cook healthy food. Adding to this, hectic work routines leave very little time for any physical activity. People, therefore, are looking for quicker, hassle-free ways to shed the extra kilos. This is precisely the reason for the surge in the use of fat-loss pills, liposuction and lipolysis procedures.” Deepak Desai, Director, Aurochem India, says, “Obesity

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has acquired epidemic proportions in the country with five per cent of the population suffering from it. According to the National Family Health Survey (NFHS), as many as 30 million Indians are obese. It was established that obesity raises the risk for several diseases and disorders such as type II diabetes, hypertension, and osteoarthritis. Obese women in particular are at high risk of breast cancer, uterus cancer, menstrual disorders and infertility. There is definitely a potential market for anti-obesity drug manufacturers considering number of obese people in India.” As far as India is concerned there is a considerable difference in obesity levels among the two genders. Ajit Mahadevan, Partner, Ernst and Young, gives the exact figures, “As per the NFHS, survey 2007, obesity (includes category of people who are overweight) in India is prevalent in 12 per cent of the male population and 16 per cent of the female population. Thus, there is a large potential for treatment of people that are overweight in India.” But anti-obesity drugs are not the obese patient’s only treatment option. Dr MN Parkar, laparoscopic surgeon, Kohinoor Hospital, contradicts claims of a booming anti-obesity drug market and opines, “Drug treatment has never been a favoured modality of treatment in obesity and with the availability of bariatric surgery and increase in the number of well trained bariatric surgeons, drug treatment can never be a preferred treatment in obesity. Therefore drug manufacturing may be on rise due to increase in awareness but India can’t be the next potential market as stated.”

market has been stagnant between 2010 and 2011 due to some of the drugs being banned in India because of their side effect profile. However, obesity tends to increase the risk of various diseases such as hypertension, blood pressure, and cardiac diseases, which is a much larger market. However, weight management through meal

PADMASHRI SHANMUGARAJ

ailments, obese people started looking for solutions to shed the extra fat. There might be some genuine products, however, the sudden rise in different types of suspicious obesity drugs was also witnessed. In India, there are an enormous number of online shops that offer drugs to curb obesity. With no credible study, such drugs can even be

DEEPAK DESAI Director, Aurochem India

Managing Partner, Prime Health Consultants

Considering the shift in our lifestyle over the last two decades overweight, obesity and associated lifestyle diseases have become rampant and inevitable

replacement options, supplements (herbal OTC) and other slimming products have seen an increase over the last few years and was forecast to reach almost ` 9.2 billion in 2011, as per an industry report from Euromonitor International 2012.” According to Desai, obesity is increasingly posing itself as a Market analysis Obesity is the grave problem Obesity has root cause of many in India, just a long history health ailments. It as in many in the European tends to increase the developed countries. risk of various diseases countries such Market for antisuch as hypertension, as the US and obesity drugs is blood pressure, UK. Though also phenomenal and cardiac India's obesity in this part of the diseases levels are low as world. Though India compared to the US is comparatively new to and UK, (approximately the obesity epidemic, with all eight per cent, comapred with market drivers properly placed, over 25 per cent in US and 15 India is already a favourite destination for the anti-obesity drug per cent in Europe), the concern is that the problem can soon manufacturers. Mahadevan provides market reach that magnitude if not adestatistics, “The obesity-related quately addressed. pharma drugs are ` 60-70 crore in 2011 that has grown at a Risks and rewards CAGR of 10 per cent over the As obesity turned out to be last three years. However, the the root cause of many health www.expresspharmaonline.com

Obesity has acquired epidemic proportion in the country with 5 per cent of the population suffering from it. According to the National Family Health Survey (NFHS), as many as 30 million Indians are obese

spurious and in the worst case scenario, life threatening as well. Shanmugaraj says, “Some anti-obesity drugs work by decreasing or even blocking fat digesting enzymes in the stomach, thus preventing its absorption. A few claim to work by increasing the metabolic rate so as to burn more calories, even at rest. The remaining work by reducing appetite, thereby preventing excess food intake.” She adds, “But then, the question is do these really work? The first type, the enzymeblocking drugs, have not been as effective as they seem to be on paper. In fact, the side effects (loose motions, oily spotting, frequent or hard-to-control bowel movements etc) far outweigh the benefits. The metabolic rate enhancers lead to raised heart rate and high blood pressure, which is not healthy at all. The appetite suppressants are known to cause unpleasant symptoms like insomnia, dizziness, palpitation, nausea, vomiting, flatulence, gas, bloating and diarrhoea.” She also points out that most of these drugs are recDecember 1-15, 2012

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ommended for short-term use only and unless these are taken along with a low-calorie diet and exercise programme, they don't work in the short term. According to Mahadevan, the overall anti-obesity segment has remained stagnant over the last couple of years, because some of key drugs such as sibutramine have been banned in countries across the globe including India. “The reason for this (ban) has been the limited benefits in long-term usage of these drugs versus the potential side effects. As a result not too many companies have focussed their R&D efforts on this segment. Typically not too many new anti-obesity drugs have been approved globally and it was only in 2012 after a gap of 13 years that the US FDA has approved new drugs to treat obesity – Belviq (lorcaserin) and Qsymia (phentermine/ topimarate). However, at the same time Qsymia has not been approved in EU due to the perceived risk with phetermine,” informs Mahadevan. Desai echoes Mahadevan's views and says, “A number of single drugs as well as fixed dose combinations have been banned for manufacture, marketing and distribution in India, which include combination of fenfluramine and phenteramine, Rimonabant and very recently Sibutramine. The only product that is doing well is Orlistat (generic Xenical). Other products are either herbal or proprietary ayurvedic preparations.”

Surgery, the last option? Recently, a leading politician in India underwent bariatric surgery. Within a few days after surgery the

AJIT MAHADEVAN

DR MN PARKAR

NICHOLAS GROGAN

Partner, Ernst and Young

Laparoscopic surgeon, Kohinoor Hospital Mumbai

Project Co-ordinator (Slim Asia), Unex Corporation Australia

The obesity-related pharma drugs are ` 60-70 crore in 2011 that has grown at a CAGR of 10 per cent over the last three years; however, the market has been stagnant between 2010 and 2011 due to some of the drugs being banned in India due to their side effect profile

Drug treatment has never been a favoured modality of treatment in obesity and with the availability of bariatric surgery and increase in the number of well trained bariatric surgeons drug treatment can never be a preferred treatment in obesity

Many people believe that drugs on obesity act as a shield against heart attack, stroke and even organ failure, which is a myth. In fact, a more proactive approach is to educate people about the risk of chronic disorders

drugs but it will take time to change the traditional aversion to surgery in a country like India, where it has always been considered as the last option for any health problems. Bariatric surgery may have to wait for acceptance. Mahadevan says, “As per the guidelines for bariatric surgery laid down by the US National Institute for Health; one of the criterion for bariatric surgery candidates are people with Body Mass Index (BMI) >= 40 kg/m2 or candidates with BMI greater than equal to 35kg/m2 with significant obesity related comorbidities. Bariatic surgeries have increased in India. In 2008, 3,44,221 surgeries were

(25,000), Mexico (13,500) and Australia (12,000). Only 1216 surgeries were performed in India in 2008. However, the number has been growing in India, as per the Metabolic/Bariatric Surgery Worldwide 2008, Henry Buchwald & Danette M Oien.” According to Shanmugaraj, reports show that patients typically lose more than 50 per cent of their excess weight after such surgeries. Obesity-related diseases improve markedly after bariatric surgery, decreasing cardiovascular risk and improving quality of life. However, she cautions, “Having said that, surgery need not be an option for moderately overweight or even slightly obese patients, but it may be a boon for morbidly obese patients. More so, if this obesity is accompanied with cardiovascular diseases and/or diabetes mellitus. Before opting for bariatric surgery, one must be aware of the possible side-effects like bleeding, wound infection, embolisms, and anastomotic strictures. Long-term complications may include ulcers, bowel obstruction, gallstones, and nutritional deficiencies. The US has seen a maximum number of patients opting for bariatric

surgeries but in the last couple of years, the number of surgeries performed has shown a plateau, which may be a good sign.” Over the last two decades, obesity has consistently shown an ascending graph in India across all age groups. If experts are to be believed, awareness would be the key to keep a check on rising epidemic of obesity in India. Nicholas Grogan, Project Co-ordinator (Slim Asia), Unex Corporation Australia, signs off, “With our experience in the industry, we have noticed that the sale of drugs is growing at the rate of 22.6 per cent per annum. Unfortunately people are unaware of solutions available to curb obesity. Many people believe that drugs on obesity act as a shield against heart attack, stroke and even organ failure, which is a myth. In fact, a more proactive approach is to educate people about the risk of chronic disorders can be reduced by losing five or six kgs of body weight. The same was even proved by recent clinical trials conducted on obese and diabetic patients for Slim Asia programme by UNEX Corporation Australia.”

OVER THE LAST TWO DECADES, OBESITY HAS CONSISTENTLY SHOWN AN ASCENDING GRAPH. IF EXPERTS ARE TO BE BELIEVED, AWARENESS WOULD BE THE KEY TO KEEP A CHECK ON THE RISING EPIDEMIC OF OBESITY IN INDIA entire nation saw his physically trimmed body. This incident threw the spotlight on bariatric surgery as an alternative to anti-obesity

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carried out world over, out of which US and Canada accounted for 2,20,000 surgeries amongst themselves. They were followed by Brazil www.expresspharmaonline.com

sachin.jagdale@expressindia.com December 1-15, 2012

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COMPANY WATCH

Vibrant Gujarat 2013 to focus on knowledge and networking Likely to sign MoU with UK MHRA

Usha Sharma Mumbai ith an aim to promote Indian pharma industry globally, Government of Gujarat will sign a memorandum of understanding (MOU) with UK MHRA, at the Vibrant Gujarat 2013 Summit, to be held from January 11-13, 2013. The state government is focussing on knowledge and networking rather than encouraging investment. Dr HG Koshia, Commissioner, Food & Drugs Control Administration, Gujarat said, “In Gujarat we

December 1-15, 2012

have enough investments and the Government is therefore looking beyond the investment peripheral. The government is encouraging knowledge and networking in the pharma sphere.” In a collaboration with UK MHRA, the Food & Drugs Control Administration (FDCA), Government of Gujarat will organise a seminar where discussions will be held on various regulatory requirements of EU and UK MHRA. During the seminar it will be addressing the issues related to the regulatory inspections and GMP requirements. The seminar is being sponsored by UK Trade

www.expresspharmaonline.com

VIBRANT GUJARAT 2013 SUMMIT, TO BE HELD FROM JANUARY 11-13, 2013 & Investment (UKTI) which is a trade promotion body of the UK MHRA. Around 100120 participants are going to take part in the seminar. Koshia continued, “To give an updated knowledge to the pharma industry in Gujarat, we are organising technical seminar in collabo-

ration with UK MHRA. Certainly, this will help pharma companies to know about updated regulatory requirements. We will be showcasing the e-governance developed by the FDCA and will be discussing this technologies in detail.” Speaking about the MoU, Koshia added, “This year in Gujarat, many global giants like Teva and Abbott have set up their ventures. A few more are in the pipeline as well. Considering this fact, we are expecting to close the MoU in similar lines of last Vibrant Gujarat.” u.sharma@expressindia.com

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DCGI to be competent national authority to certify API exports to EU Draft guidelines for certification as per Falsified Medicines Directive, to be finalised by Jan 2013 Usha Sharma & Viveka Roychowdhury Mumbai he Drug Controller General (India) will be the competent national authority to certify API exports to EU. As part of this role, the DCGI’s office will need to give a written qualification certifying that the exports meet EU GMP qualifications. It is expected that the Zonal offices of the Central Drugs Standard Control Organization (CDSCO) will also be part of this certifying process. This new level of responsibility has been necessitated to prepare for a new regulation scheduled to go into force in the European Union (EU) from July 2, 2013. Called the Falsified Medicines Directive (2011/62/EU), it mandates that all active pharmaceutical ingredients (APIs) imported into the European Union will need to be certi-

fied by a designated national authority of the exporting nation that they meet EU GMPs. The Directive was proposed to address the menace of counterfeit medicines entering the EU market and protect patient safety. Speaking on the sidelines of the ongoing industry meet, CPhI India, Rajeev Kher, Additional Secretary, Department of Commerce, indicated that he would be meeting the DCGI to iron out the details of how CDSCO will prepare for this certification process. As it is expected that the Zonal officers of the CDSCO will have to be operationally in tune with the specifications of the EU GMP in order to certify that the export consignments meet these norms, Kher indicated that CDSCO would be putting together a set of guidelines for its Zonal officers to enable this certification. Confirming his role, Dr GN Singh, DCGI, informed that his office would be drafting these guidelines in consultation with major industry players. These con-

sultations are already underway and the DCGI indicated that the draft guidelines will be finalised by January 2013. This is to ensure that Indian pharma exporters as well as the Indian regulators are well prepared for the scheduled July 2013 roll out of the EU Falsified Medicines Directive. Dr PV Appaji, Director General, Pharmexcil applauded this decision and pledged the support of the Council to DCGI/CDSCO. He revealed that Pharmexcil will be organising meetings in Mumbai and Hyderabad so that its members’ views can be channeled to the DCGI and incorporated into these guidelines as required. He expressed his hope that the drafting process will be completed within the next month. “Industry is anxiously awaiting these guidelines as they are crucial to pharma exports to the EU,” explained Appaji. The Directive was initially seen as a trade barrier and pharma exporters from India had concerns that exports to the EU would suffer badly. Singh sought to ally these

concerns saying, “We want to promote Indian pharma exports and to make this possible, the Centre and State regulators are working in close coordination with industry as well as with the Ministry of Commerce. My concern is that the regulator of the importing country should also be involved with the process to certify that the imported medicines do indeed meet their specifications.” Singh’s concerns seem to be reflected by industry associations like the European Fine Chemicals Group (EFCG) who have recently called for mandatory inspections of all global API manufacturing sites via mutual recognition agreements. The EFCG has also gone on record to criticise the Directive, stating that the measures do not adequately address the API quality issues associated and that in reality it does little to improve upon the present Directive (2001/83/EC) with regard to patient safety. viveka.r@expressindia.com / u.sharma@expressindia.com

Piramal Enterprises’ Healthcare in alliance with Fujifilm Diosynth Biotechnologies Will offer the seamless contract development and manufacture of antibody drug conjugates iramal Enterprises’ healthcare vertical has entered into a strategic alliance with Fujifilm Diosynth Biotechnologies, whereby the two parties will offer the seamless contract development and manufacture of antibody drug conjugates (ADCs), a growing niche in the development of biopharmaceuticals. The deal will allow customers to benefit from the experience and assets of both organisations, while simplifying the supply chain and vendor management relationships, leading to shorter time to clinic. Piramal is a world leader in antibody drug conjugation,

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whilst Fujifilm Diosynth Biotechnologies is one of the world’s leading providers of contract development and manufacturing services for biopharma products. The combined experience covers work on more than 150 bio-

malian-based biopharma. The company recently announced an expansion of its cGMP manufacturing facilities at both its RTP, US and Billingham, UK sites. Vijay Shah, Executive Director and COO, Piramal

THE DEAL WILL ALLOW CUSTOMERS TO BENEFIT FROM THE EXPERIENCE AND ASSETS OF BOTH ORGANISATIONS pharma and over 300 batches of ADCs spanning over more than 30 different NCEs, including the world’s only FDA-approved ADC. For Fujifilm Diosynth Biotechnologies, this is part of an ongoing programme to expand its offering in mamwww.expresspharmaonline.com

Enterprises said, "We are delighted to combine with Fujifilm Diosynth Biotechnologies to offer a seamless service to customers for the production of antibody conjugates. Fujifilm Diosynth Biotechnologies has a long track-record in delivering suc-

cessful biologics programmes, and this alliance will combine strengths from both companies for the benefit of our customers, and ultimately patients." Stephen Taylor, Commercial Vice President, Fujifilm Diosynth Biotechnologies said, "This strategic alliance with Piramal is an important step for us in bringing a new, high-technology offering to the market place. Our customers will benefit from high quality, consistent material, rapid service and shorter logistical chains, saving time on the critical path of drug development. Piramal is a recognised world-leader in this area and we are delighted to be partnering with them." EP News Bureau December 1-15, 2012

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Cipla Palliative Care Centre completes 15 years of caring for advanced stage cancer patients Announces another major price reduction on select cancer drugs n continuation with its commitment to make medicines affordable and accessible, particularly in

major anti-cancer drugs Sorafenib (SORANIB), Gefitinib (GEFTICIP) and Temozolomide (TEMOSIDE). Following the overwhelming response on the price cut received from the

â&#x20AC;&#x153;Continuing its contribution towards affordable and accessible treatment for patients, Cipla extends the work done in HIV/AIDS and Malaria to now include cancer, not only in India but globally,â&#x20AC;? announced Dr YK

through price reduction in three additional anti-cancer drugs Erlotinib (ERLOCIP), Docetaxel (DOCETAX) and Capecitabine (CAPEGARD). These drugs are for the treatment of lung and pancreatic cancer, breast

The revised prices for the selected products are stated below Indication

Molecule

Lung cancer (Metastatic non-small cell cancer)

Breast cancer, lung cancer (Non-small cell & small cell), head & neck cancer, gastric cancer, bladder cancer

Metastatic breast cancer, metastatic colorectal cancer, metastatic colon cancer anti-cancer medication, in May 2012, Cipla announced a dramatic price cut in three

Erlotinib

Docetaxel

Brand name

Current price (`) Revised price (`) Reduction (`s)

ERLOCIP 150 30 tablets

27,000

9,900

17,100

ERLOCIP 150 10 tablets

10,000

3,700

6,300

ERLOCIP 100 30 tablets

18,000

6,600

11,400

DOCETAX 20 mg

3,300

1,650

DOCETAX 80 mg

10,000

5,000

DOCETAX 120 mg

14,000

7,000

1,200

600

Capecitabine CAPEGARD 500 mg 10 tablets

patients and their families and doctors, Cipla is now announcing another break-

cancer, head & neck cancer, gastric cancer, bladder, colorectal and colon cancers.

Hamied, Chairman and Managing Director, Cipla. EP News Bureau

Panacea Biotec announces strategic alliance with Kremers Urban Alliance is for 11 High Barrier to Entry Generics and the launch of Tacrolimus Capsules in US anacea Biotec has entered into a strategic alliance with Kremers Urban (part of UCB Group) for 11 high barrier to entry generics, whose market size in US at the innovator level is around $ 4 billion. The first product in this portfolio to reach the market is Tacrolimus Capsules that is being launched in US in November 2012. Panacea Biotec was granted approval of the product from the US FDA in September 2012. Tacrolimus is used along with other medications to prevent rejection (attack of a transplanted organ by the immune system

EXPRESS PHARMA

of a person receiving the organ) in people who have received organ transplants. Tacrolimus is in a class of medications called immunosupressants. It works by decreasing the activity of the immune system to prevent it from attacking the transplanted organ. The total market size of Tacrolimus is approximately $892 million in US. Currently there are five generic players in the US; namely Sandoz, Dr Reddy's, Mylan, Watson and Accord Healthcare. The innovator brand Prograf(r) accounts for approximately 43 per cent of Tacrolimus sales in terms of units sold and generics account for the remaining 57 per cent. Commenting on the development, Dr Rajesh Jain, www.expresspharmaonline.com

Joint Managing Director, Panacea Biotec said, "Panacea Biotec's proven track record in building strong, collaborative working relationship is a key driver for this strategic alliance with Kremers Urban that will accelerate the company's growth plans in the US. Approval of Tacrolimus from US FDA is the first milestone achieved in Panacea Biotec's long term plan for US, the largest pharmaceutical market in the world. This would be followed by a series of high barrier to entry generic product launches that are being developed by the company. The commercialisation strength of Kremers Urban for high barrier to entry generics perfectly synergizes with Panacea Biotec's

research, development and manufacturing capabilities for such complex products forming a true win-win strategic alliance." Under the terms of the agreement Panacea Biotec would be responsible for research, development, registration and commercial supplies of the products while Kremers Urban would be responsible for marketing, sales and distribution. The business collaboration is based on long-term profit sharing by both companies. Submission of the first ANDA within this basket of 10 additional products was done in September 2012. The remaining nine ANDAs would be submitted over the next 16 months' time period. EP News Bureau December 1-15, 2012

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Lupin launches Generic Tricor tabs Had earlier received final approval for the same from US FDA upin announced that its subsidiary, Lupin Pharmaceuticals (collectively, Lupin) has launched its Fenofibrate tablets, 48 mg and 145 mg strengths in the US. Lupin had earlier received final approval for the same from the US Food and Drug Administration (FDA). Lupin’s Fenofibrate tablets are the AB rated generic equivalent of Abbott's Tricor

Senior UK MHRA team plans week long India trip To meet state and central regulators ed by the Chief Executive Officer of MHRA Prof Kent Woods and Dr Gerald Heddell, the head of Inspection and Vigilance, a senior delegation of UK regulators will be holding a series of seminars across four cities in India from December 3-10. The UK MHRA team is slated to engage in day long workshops/seminars with regulators at the state and central level in Mumbai (on December 3), Ahmedabad (December 5) and Hyderabad (December 7). In Delhi, the team is scheduled to have a closed door meeting with the Drug Controller General (India). The UK MHRA team is being supported by Pharmexcil and the UK Trade & Investment (UKTI) on this initiative. The day long workshops will serve to acquaint both the UK and Indian regulators with the responsibilities and procedures of the regulatory counterparts. UKTI representatives will also outline investment opportunities in the UK. EP News Bureau

December 1-15, 2012

tablets and are indicated for Primary Hypercholesterolemia

or Mixed Dyslipidemia and Severe Hypertriglyceridemia. Abbott’s Tricor tablets, 48 mg and 145 mg had sales of $1.26 billion as per IMS Health, June, 2012.

Commenting on the approval, Vinita Gupta, CEO, Lupin Pharmaceuticals and Group President, Lupin said, “We are happy to bring this product to market in the US.

Patients can be assured that they are receiving the same high quality product they have been accustomed to at a more affordable price.” EP News Bureau

33-year history of partnership with leading pharma companies

AZITHROMYCIN AZITHROMY CIN active pharmaceutical ingredients & its intermediates* Commercial scale Antitubercular Pyrazinamide# * Isoniazid # *

Antimalarial Artesunate Arteether Artemether# * Dihydroartemisinin Lumefantrine# * Piperaquine

Macrolides

Antihypertensive

Azithromycin Clarithromycin Erythromycin base # # Erythromycin estolate Erythromycin ethyl succinate+ Erythromycin oxime (intermediate) Erythromycin stearate #

Irbesartan # Losartan potassium Telmisartan Valsartan

Antihistaminic

Alendronate sodium Zoledronic acid

Sedative, Hypnotic Zopiclone

Antifungal Flucytosine

Cetirizine dihydrochloride # Hydroxyzine diydrochlorid + Meclizine diydrochlorid

Antiosteoporotic

Antiepileptic Valproic acid

Antidepressant Venlafaxine hydrochloride

Under Development Antiretroviral

Antidiabetic

Hypnotic

Antithrombotic

Ganciclovir Valaciclovir Valganciclovir Maraviroc

Linagliptin Vildagliptin

Eszopiclone

Clopidogrel bisulphate

* WHO APIMF

CEP / COS

*The Technical and Physical manufacturing capabilities exist with us for the above APIs and their intermediates. However these products will be offered only to the markets where any product or process patents are not infringing. During the validity of a patent the research quantities for developing products for regulatory submissions will only be offered to countries where such exemption exists (Hatch Waxman Act / Bolar exemption). While Calyx offers to work with the clients on Patent Status Verification, the final responsibility vests with the buyer. Recipients are requested to make their evaluation and determination as to the patent status prior to their use of the information or materials in their respective jurisdiction. Products under patent offered only for exempted research, clinical and development purposes. Only non-infringing products and processes are offered, subject to patent status verification by client.

Calyx Chemicals and Pharmaceuticals Limited Reg. Office: Unit No.110, Marwah's Complex, Krishanlal Marwah Marg, Off. Saki Vihar Road, Andheri (East), Mumbai – 400072, Maharashtra, India. Tel: +91-22-28571191, Fax: +91-22-66466416, Email: sales@calyxindia.com, crams@calyxindia.com USA Contact : 11728 E. Imperial Highway, Norwalk, CA 90650, Tel - 213-291-7773, Email: sales@calyxusa.com, crams@calyxusa.com Website : www.calyxindia.com "Calyx Chemicals and Pharmaceuticals Limited (the “Company”) is proposing to make, subject to receipt of requisite approvals, market conditions and other considerations, an Initial Public Offering of its equity shares (the “IPO") and has filed the Draft Red Herring Prospectus (the “DRHP”) with the Securities and Exchange Board of India (“SEBI”). The DRHP is available on the website of SEBI at www.sebi.gov.in, the website of the BRLMs, i.e. PL Capital Markets Private Limited at www.plindia.com and YES Bank Limited at www.yesbank.in and is also available on the website of the Company at www.calyx-pharma.com. Potential investors should note that investment in equity shares involves a degree of risk. For details, please refer to the DRHP, including the section titled “Risk Factors” of the DRHP. This publicity material does not constitute an offer of securities in any jurisdiction, including the United States of America (“USA”). Securities may not be offered or sold in the USA without registration under the U.S. Securities Act of 1933 as amended, or an exemption therefrom. The Company has not and does not intend to offer any securities to the public in the USA”.

www.expresspharmaonline.com

EXPRESS PHARMA

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GROWTH TRACKER Pharma sales in October shows 18.8 per cent growth The Indian pharmaceutical market (IPM) showed a growth of 18.8 per cent this October, as per AIOCD-AWACS' PharmaTrac, aided by a rebound in the anti-infective and anti-malarial therapy segments Highlights for October 2012

Company ranking in October 2012 with bonus units at full value Rank Company

MAT

10/01/2012

MTH

Oct-12

Val (Cr)

MS%

GR%

Val (Cr)

MS%

GR%

69087

100.00

17.0

6452

100.00

18.8

s per AIOCD-AWACS' PharmaTrac, the Indian pharmaceutical market (IPM) is valued at ` 6452 crores in October 2012. The Indian pharma market grew at a MAT (Moving Annual Total, sales for the 12-month period ending October) of 18.8 per cent for October 2012, compared to 16.7 per cent in the previous month. Among the

About PharmaTrac PharmaTrac is a the secondary sales data audit conducted by AIOCD Pharmasofttech AWACS, a pharmaceutical market research company formed by All Indian Origin Chemists & Distributors (AIOCD ) in a

Cipla

3496

5.06

13.3

319

4.95

14.8

Sun Pharma

3259

4.72

24.1

301

4.66

24.1

Glaxo

3229

4.67

20.3

297

4.60

17.4

Ranbaxy

2895

4.19

11.2

292

4.52

21.6

Abbott HC

2684

3.88

13.2

253

3.92

16.4

Super Group

MAT Oct 12

GR%

Mth Oct 12

GR%

Zydus Cadila

2656

3.84

18.9

262

4.06

32.6

IPM

69087

17.0

6452

18.8

36.7

ANTI-INFECTIVES

12476

14.9

1285

23.3

CARDIAC

8367

19.5

739

16.9

Mankind

2437

3.53

26.8

237

3.68

Alkem

2101

3.04

20.2

209

3.23

22.8

GASTRO INTESTINAL

7881

16.7

684

16.5

Lupin

2067

2.99

15.5

196

3.04

21.3

VITAMINS / MINERALS / NUTRIENTS

6079

19.5

554

20.1

27.9

RESPIRATORY

5244

14.1

537

20.1

PAIN / ANALGESICS

5129

12.6

471

10.0

GYNAECOLOGICAL

4518

13.2

396

13.9

ANTI DIABETIC

4502

27.2

399

22.6

NEURO / CNS

4153

15.0

370

15.4

Macleods

1734

2.51

32.6

174

2.70

Pfizer

1656

2.40

24.0

165

2.55

17.0

Intas

1627

2.36

20.0

151

2.34

27.2

Aristo

1613

2.33

16.1

164

2.54

30.2

DERMA

3638

19.0

330

16.4

Sanofi-Aventis

1423

2.06

17.7

126

1.95

10.8

HORMONES

1167

21.8

113

26.1

Dr. Reddys

1352

1.96

11.2

120

1.85

20.2

OPHTHAL / OTOLOGICALS

1149

16.5

102

18.6

OTHERS

1072

30.5

115

65.1

Glenmark

1334

1.93

29.0

125

1.94

23.3

VACCINES

875

11.4

16.5

Wockhardt

1326

1.92

17.8

119

1.84

8.6

BLOOD RELATED

859

18.8

13.1

ANTI MALARIALS

655

23.4

22.3

Micro Lab

1306

1.89

26.6

114

1.77

10.7

Ipca

1228

1.78

23.1

127

1.96

21.2

Torrent

1172

1.70

11.9

107

1.66

16.9

ANTI-NEOPLASTICS

644

6.1

3.7

SEX STIMULANTS / REJUVENATORS

374

19.9

16.2

STOMATOLOGICALS

304

15.2

17.3

top 10 companies, Mankind saw an impressive growth of 36.7 per cent and Zydus at 28.9 per cent. Three companies have crossed `300 crores for the month of October 2012. Without bonus Sun Pharma is ranked second. Corona Remedies has registered highest growth of 113.8 per cent with current rank among corporates at 55 and heading towards the top 50. From a therapy perspective the anti-infective market clocked a growth of 23.3 per cent whereas the respiratory segment has seen 20.1 per cent growth. The anti-diabetic market has grown at 22.6 per cent and cardiac at 16.9 per cent in chronic business.

Quarter on Quarter dynamics Analysing quarter on quar-

ter sales data, Q3 2012 (JulySeptember) showed a slightly higher growth of 13.9 per cent over 13. 5 per cent in the same period last year.

EXPRESS PHARMA

www.expresspharmaonline.com

joint venture with Trikaal Mediinfotech. AWACS in AIOCD AWACS stands for Advanced Working, Action & Correction System – reflecting the underlying philosophy behind AIOCD AWACS' research tools to reduce time to information by 50 per cent or more and to significantly improve on accuracy of information. Accurate and faster information flows from the market will help clients grow topline and bottom-line. For more information, visit http://www.aiocd.net Terminologies used MAT – Moving Annual Total MTH – Month Val (Cr) – Value in Crs, MS% - Market Share in Percentage GR% - Growth in percentage December 1-15, 2012

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PRE EVENTS BioAsia 2013 to optimise immense business potential in biotechnology Opens nomination process for annual awards, including BioAsia Innovation Award 2013 and BioAsia Young Minds Award 2013 ioAsia 2013 will be held at Genome Valley, Hyderabad from January 28 to 30, 2013. The event will seek to enhance, enrich and encourage newer innovations, path-breaking discoveries and effective solutions in the industry by offering a vibrant global platform for convergence of the key stakeholdersâ&#x20AC;&#x201D; biotech and biopharma companies, research institutions, investors, service providers, policy makers, regulators and analysts. BioAsia has opened the nomination process for its annual awards organised by Federation of Asian Biotech Associations (FABA) jointly with Center for Cellular and Molecular Biology (CCMB). The entry is open to all scientists, students and individuals from member countries of FABA who are interested or are pursuing research in the areas of biotechnology / life sciences or have created a product of value/utility or have made a significant contribution to the field of life sciences industry. The Award categories include BioAsia Innovation Award 2013 and BioAsia Young Minds Award 2013. The entries will undergo a short listing process and shortlisted proposals will be announced by end of December for exhibiting their presentation at the BioAsia Venue. The winner in each category will be selected by an expert team at the venue and the awards (` 1 lakh for innovation award and ` 50,000 for young minds award) will be given away at the Valedictory Ceremony of BioAsia 2013. With an objective of optimising the immense business potential of biotech, BioAsia enables an effective environment for fostering collaborations, joint ventures, M&As that has increasingly become an integral part of industry growth agenda. EP News Bureau

December 1-15, 2012

World Class Products Outstanding Service New

UV-2600 / 2700 UV-1800

BioSpec-nano

FTIR IRAffinity-1

DSC-60

GCMS-QP2010 Ultra AA-7000

GC-2010 Plus

Head Office : 103, S. J .House, 1st Floor, Sitaram Mills Compound, N. M .Joshi Marg, Lower Parel Mumbai - 400 011 T : 022 - 2301 5096 / 6450 7214 F : 022 - 2301 3592 E : info@toshvin.com W : www.toshvin.com Branches : Ahmedabad Bangalore Baroda

Chandigarh

www.expresspharmaonline.com

Chennai

Cochin Goa

Hyderabad Kolkata

New Delhi Pune EXPRESS PHARMA

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CII to organise Life Science Conclave 2012 onfederation of Indian Industry (CII) is organising the fifth edition of its annual flagship event ‘Life Science Conclave 2012’ on December 11-12, 2012 at New Delhi. The theme of the conclave is ‘Promoting Business Innovation to Drive Growth in Life Sciences.’ The conclave will have deliberations among the life science industry leaders, who would share their experiences and ideas to mitigate with the current market trends and challenges such as drying pipelines in R&D, ineffective business models to survive in the tough mar-

ket conditions. Further, growing need for increasing access and affordability of healthcare is adding a new challenge to the life science industry. We feel the deliberations at the conclave will provide adequate inputs to evolve recommendations to put the industry on the growth path. Special features: ● Participation of life sciences industry leaders, policy makers and regulators. ● Life science policy forum – To draw recommendations for the life sciences sector

●

to put the industry on growth track. Presentations by the representatives progressive state governments promoting life science industry, to provide information on the infrastructure and the fiscal incentives offered by state governments Networking opportunity with the industry, academia and research institutes. Life Sciences ExpoOpportunity to showcase products and services by life sciences companies to explore business opportunities.

Date and Venue Start Date: 11-12 December 2012 Venue: Stein Auditorium, India Habitat Center, New Delhi. Contact details: Ravikiran Veligeti, Executive Officer, CII 3rd Floor, IGSSS Building 28, Institutional Area, Lodi Road, New Delhi-110003, India, Tel: 91-11-45772007 Fax: 91-11-45772014 Email: ravikiran.v@cii.in EP News Bureau

Pharmexcil with Ministry of Commerce & Industry to organise iPHEX 2013 exhibition Event to be held at Bombay Exhibition Centre, Mumbai from April 24-26, 2013

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harmaceuticals Export Promotion Council of India (Pharmexcil) under support from Ministry of Commerce & Industry, Department of Commerce, Government of India, plans to invite 400 overseas buyers and regulators to visit India for sourcing various pharmaceutical products and services at forthcoming iPHEX 2013 exhibition. The event is scheduled at Bombay Exhibition Centre, Mumbai from April 24-26, 2013. Ministry of Commerce, has launched a series of initiatives to promote Brand India Pharma campaign and iPHEX 2013 will offer a perfect opportunity for international buyers to come to India and evaluate how well structured and regulated the Indian pharma industry is. iPHEX 2013 will showcase Indian pharma products and technologies to the global audience. The event will bring together drugs, pharma, healthcare industry, all under one roof. Co-located with Pharma Pro Pack 2013—a show for pharma machinery manufacturers, iPHEX 2013 will offer the industry majors from India and all across the world a great platform to connect and do business. iPHEX 2013 will be the largest industry event showcasing the diverse range of

L to R: Bhavin Mehta , iPHEX 2013 Committee Chief (Pharmexcil) with Rajeev Kher, Additional Secretary, Ministry of Commerce & Industry , Government of India

products in the following core sectors: APIs / formulations, ayush, biotechnology / biotechnology products, contract manufacturing / research / clinical trials (CROs), diagnostics / surgical dressings / medical devices, health services, medical tourism, R&D services, state pavilions and technologies and consultancy. The target visitors will be international buyers, large volume buyer seeking contract manufacturing, agents / distributors / dealers, government procurement agencies, hospitals and health service providers, private sector hospitals, clinics, day care centres and institutes, financial institutions, banks, private equity and venture capital funds, institutional agencies and development aid agencies. EP News Bureau

L to R: Nipun Jain, SME Panel Chief (Pharmexcil); Mridul Jain, Joint Secretary, Ministry of Commerce & Industry, Govt of India; Bhavin Mehta, iPHEX 2013 Committee Chief (Pharmexcil); Rajeev Kher, Additional Secretary, Ministry of Commerce & Industry, Government of India; Ashutosh Gupta, Vice Chairman (Pharmexcil); Dipak Desai, Committee Member (Pharmexcil); Abhay Sinha, Regional Director (Pharmexcil), Sooraj Dhawan, iPHEX 2013 Event Manager www.expresspharmaonline.com

December 1-15, 2012

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Bangalore INDIA BIO 2013 to provide latest trends in biotech business opportunities Event to be held in Bangalore from February 6-8, 2013

December 1-15, 2012

angalore INDIA BIO, an annual event organised by Department of Science & Technology (DST) Government of Karnataka, under the guidance of Vision Group of Biotechnology, will give an insight about the latest trends and biotech business opportunities in India. Since 2001, Bangalore INDIA BIO has been instrumental in promoting the inherent strengths of the Indian biotech industry to the outside world and is now acknowledged as the biggest and India’s national event on life sciences. Bangalore INDIA Bio 2013, to be held from February 6-8, will have multi-track conference, international trade show, biopartnering India, vision leadership series, CEO conclave, poster walkway of dis-

covery, Bio Excellence awards, bioquiz and workshops. Bangalore INDIA BIO 2013 will deliberate on issues related to the latest innovations in

economy. Exhibitors, conference delegates and 5,000 business visitors from across India and abroad will take part in the event. Discussions will be

WILL HAVE MULTI-TRACK CONFERENCE, INTERNATIONAL TRADE SHOW, BIOPARTNERING INDIA,VISION LEADERSHIP SERIES, CEO CONCLAVE, POSTER WALKWAY OF DISCOVERY, BIO EXCELLENCE AWARDS, BIOQUIZ AND WORKSHOPS biotechnology and focus on business opportunities that exist for companies in biopharmaceuticals, bio-industrial, bio-services, bioinformatics and agri-biotechnology in the light of the emerging bio

www.expresspharmaonline.com

held on issues such as collaborative and integrative business models as well as policy, regulation, and investment challenges for biotechnology in a global bio economy and will provide networking and

knowledge sharing platform for business leaders, policy makers, research heads and academia. International conference will focus on areas such as Deal Making Trends— Partnerships that take Innovation to Realisation; India and the Shifting Global Regulatory Environment; Potential demand for Biosimilars—Pioneering the Future; Strengthening the Clinical Research Ecosystem; Bioinformatics and Computational Biology; Medical Biotechnology and Biomedical Devices and Equipment; Vaccines and Health Trends; Cell Science and Stem Cell Therapy; Diagnostics and Targeted Therapeutics and Protection of Intellectual Property. EP News Bureau

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DIA India announces key events in early 2013 Workshop on e-CTD submission scheduled for February 2013

IA (Drug Information Association) India has very ambitious plans for first quarter of 2013. It will kick off its first activity with hands on workshop on e-CTD submission at Mumbai and Bangalore in February, Pharmacovigilance conference at Bangalore in March and 6th Regulatory conference at Ahmedabad in the month of April 2013. DIA (Drug Information Association) is the neutral global forum for knowledge exchange that fosters innovation to raise the level of health and well-being worldwide. It is headquartered at Horsham, PA, USA and has regional offices in India, Japan, China, Europe, Latin America and North America, with a membership base of 18,000 representing professionals from various facets of healthcare sector. DIA in India over the last four years has provided quality programs, publications, and knowledge resources to regulatory agencies, academia,

Chemistry, industry professionals, and Affairs, patient advocates across the Manufacture and Control (CMC), Pharmacovigilance country and Asian continent. Every year, DIA in India and the Annual Conference, conducts workshops and DIA has established itself as a platform where training programs in various neutral cities such as Ahmedabad, thought leaders from the Bangalore, Chandigarh, pharmaceutical, biotechnology, medical Chennai, Delhi, device, and Goa, Hyderabad related fields and Mumbai on exchange varied topics like ideas, neteCTD compilawork, and tion, Cardiac engage with Safety, Quality VISIT US AT 64th IPC, industry proManagement 07-09 DECEMBER 2012, fessionals Systems, Project CHENNAI, across the Management, STALL NO. 33 (HALL NO. A4) globe. Rapid Screening DIA India M e t h o d s , is very much Generic Drug engaged with Application academic using QbD, community Medical writing, Clinical research and in India. It has highly active Patenting to name a few. DIA Student chapters in Mumbai, conducts several workshops in Tamil Nadu, Karnataka and collaboration with Young Professional Chapter in Universities, Regulatory agen- Gujarat. There are various cies like US FDA, EDQM, opportunities available to students and faculty members to WHO and Pharmexcil. Through its five flagship benefit through DIA memberconferences and exhibitions ship by participating in held annually on Regulatory International conferences in

Europe and USA. The participation can be as a speaker, poster presenter and also as a volunteer in India as well as Global conferences. There is career Center section on web site www.diahome.org.This is sorted by region, interest area, job type or keyword, and then section for resume submission with confidentiality which may be of great interest to student community. There are special Interest Area Communities (SIAC) which allows members to exchange information, explore industry hot topics, and build a professional network through discipline-specific, global and regional SIACs. There is also online membership directory which allows one self to contact other DIA members easily and confidentially, and provide an online networking resource in addition to networking in person at through educational offerings. For more details contact Kaushik Desai, Director, DIA India at Kaushik.Desai@diaindia.org for further details.

EVENT BRIEF th

64 Indian Pharmaceutical Congress (IPC) Date: December 7-9, 2012 Venue: SRM Institution Campus, Chennai Summary: Association of Pharmaceutical Teachers of India will host the 64th Indian Pharmaceutical Congress. Contact details: Prof BG Shivananda Secretary-APTI Association Of Pharmaceutical Teachers of India HQ: Al-Ameen College of Pharmacy Opp Lalbagh Main gate, Hosur Main Road, Bangalore â&#x20AC;&#x201C; 560027 Email: aptienquiry@gmail.com

Seminar on Cleanroom design, Construction & Testing Date: December 8, 2012

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Venue: Hotel Parle International, BN Agarwal Market, Vile Parle (East), Mumbai 400 057 Summary: Contamination Control Society of India in association with ISHRAE Mumbai Chapter & ASHRAE will hold a seminar on cleanroom design, construction and testing. Contact details: Contamination Control Society of India C/O MeasureTest Corporation 94, Atlanta, Nariman Point Mumbai 400 021 Phone: (022) 22027982 Mobile: 90226 86802 Email: sheesh@mtnl.net.in

various states of India and other countries to cooperate and explore attractive business opportunities. One of the focus sectors to be covered will be pharmaceuticals and biotechnology. Contact details: Industrial Extension Bureau (A Govt of Gujarat Organisation) Phone : +91-79-2325 6009, +91-79-2325 0492 / 93

tions, investors, service providers, policy makers, regulators and analysts. Contact details: BioAsia Secretariat 204, Imperial Apartments Greenlands Circle, Ameerpet Hyderabad 500016 Andhra Pradesh, India Tel: +91 40-6644 6477 +91 40-6644 6577 Website: info@bioasia.in

BioAsia 2013 STEM 2013 Date: January 28-30, 2013 Date: January 31-February 1, 2013 Venue: Hyderabad

Vibrant Gujarat 2013 Summit Date: January 11-13, 2013 Venue: Mahatma Mandir, Gandhinagar, Gujarat Summary: The Vibrant Gujarat 2013 Summit is going to be transformational and revolutionary â&#x20AC;&#x201C; both in its coverage and scale. It will provide a platform for

Summary: Biotechnology being an emerging industry, game-changing strategies and relevant application of the knowledge-intelligence resource pool, drive the process of growth. BioAsia seeks to enhance, enrich and encourage newer innovations, pathbreaking discoveries and effective solutions in the industry by offering a vibrant global platform for convergence of the key stakeholders - Biotech & Biopharma companies, research institu-

www.expresspharmaonline.com

Venue: Fortune Park JP Celestial, Race Course Road, Bangalore Summary: STEM 2013 conference will focus on the latest trends in stem cell research and application, regenerative medicine and tissue engineering, inviting leading biotech and pharma companies, research organisations, scientists, companies into instrumentation and support systems, academic institutions, students, investment companies and law firms. December 1-15, 2012

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The conference will be organised by Society for Regenerative Medicine & Tissue Engineering. Contact details: Sankar Iyer Organizational Secretary SRMTE (Society for Regenerative Medicine and Tissue Engineering) 3, Lopez Apt, LM Road, Navagaon, Dahisar, Mumbai-400068 Tel: +91 22 2892 6657 Mob: +91 / 7838653861 / 93232 75711

Bangalore INDIA BIO 2013 Date: February 6-8, 2013 Venue: Bangalore, India Summary: Bangalore INDIA BIO is an annual event organised by Department of Science & Technology Government of Karnataka, under the guidance of Vision Group of Biotechnology. Since 2001, Bangalore INDIA BIO has been promoting the Indian biotech industry to the out-

side world and is one of the biggest event on life sciences. Bangalore INDIA BIO 2013 will be an opportunity to get insights about the latest trends and biotech business opportunities in India. It will also deliberate on issues related to the latest innovations in biotechnology and focus on business opportunities that exist for companies in biopharmaceuticals, bio-industrial, bioservices, bio-informatics and agri-biotechnology in the light of the emerging bio economy. It will also discuss about collaborative and integrative business models as well as policy, regulation, and investment challenges for biotechnology in a global bioeconomy and will provide networking and knowledge sharing platform for business leaders, policy makers, research heads and academia. Contact details: MM Activ #9, UNI Building, 1st Floor, Thimmaiah Road, Millers Tank Bed, Vasanthnagar, Bangalore - 560 052 Tel: +91 80 4113 1912 / 13 Fax: +91 80 4113 1914 Website: enquiry@bangaloreindiabio.in

PHARMA Pro&Pack 2013 Date: April 24—26, 2013 Venue: Mumbai Exhibition Centre, Goregaon Summary: PPPE 2013 is an initiative of the Indian Pharma Machinery Manufacturers’ Association (IPMMA), jointly with GPE Expo. The event will offer a single platform for more than 200 exhibiting companies from India and across the world to showcase their products. Contact details: Paresh Jhurmurwala GPE EXPO Global, Opp. Priyadarshini Tower, Near Judges’ Bungalows, Bodakdev, Ahmedabad 380015, Gujarat Tel: +91 79-2687 1390 +91 79-4000 8253 +91 79-4000 8233 Email: contact@pharmapropack.com

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December 1-15, 2012

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POST EVENT CPhI India sees record exhibitors, visitors Pharmexcil's ‘Brand India Pharma’ campaign takes centre stage Usha Sharma Mumbai he annual adda of the global pharmaceutical industry, the three-day global pharmaceutical expo, CPhI India, kicked off successively in Mumbai at Bombay Exhibition Centre. The event was organised in association with Pharmexcil and aimed to register large number of exhibitors and visitors throughout the event. This year’s event saw a record 926 exhibitors from 21 countries interacting under the single roof of CPhI India and its colocated events: P-MEC India, ICSE India, and Bio-Ph India trade exhibitions. The event is touted to be South Asia’s largest pharmaceutical extravaganza. Rajeev Kher, Additional Secretary, Ministry of Commerce and Industry inaugurated the show along with Dr PV Appaji, Director General, Pharmexcil, NR Munjal, Chairman, Pharmexcil, and Sanjeev Kher, Managing Director, UBM. Making his rounds of the various exhibitor halls and spending time with key exhibitors like ACG Worldwide, Shimadzu Analytical, Signet Chemicals, Calyx Chemicals and the like, Kher spoke about the Commerce Ministry’s plans to support all segments of the industry. Speaking on the sidelines of the meet, Kher said, “Our overall target exports for this financial year is $320 billion and to ensure that we reach this in the remaining five months, we are reviewing our position and strategy. One of these strategies is to diversify into different geographies. We are working on breaking into markets other than the US and EU like Africa, China, CIS countries, Russia, the Middle East and North America.” He also mentioned that besides additional markets, the Ministry is also considering other measures like special incentives and more market promotional activities to

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Dignitaries at the inaugural ceremony

Ribbon cutting ceremony at Pharmexcil pavilion boost pharma exports. He continued, “By the end of 2014-15, India’s pharma exports are expected to reach $25 billion. The Indian pharma industry is also covering a lot of ground in biopharmaceuticals at a rapid pace. Simultaneously the global generic market segment is growing faster than the branded drugs. The market size of drugs losing patent protection was $270 billion in 2011 and is expected to go up to $430 billion by 2016. Therefore it is but natural to view the Indian pharma industry among the top in the next decade. One of the major market promotional activities is the ‘Brand India Pharma’ campaign, a major branding initiative highlighting the three key proven characteristics of Indian pharma: presence across 230 countries, accessible due to affordable pricing and high quality. Kher emphasised that the www.expresspharmaonline.com

Ministry of Commerce will fully support Pharmexcil in its efforts to take the ‘Brand India Pharma campaign’ symbolised by a stylised Rx, to all countries and geographies. He further emphasised that the domestic pharma industry is gearing up in a big way, with more and 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. This year’s show had visitors from 118 countries across the globe, who had pre-registered for the threeday exhibition, which was held in seven exhibition halls spread over 55,000 sq. metres. P-MEC India had 45 new exhibiting companies and several new features like a new mobile app for easy real time navigation of the exhibition halls, which made its debut this year at CPhI

and P-MEC India. A series of Technical Seminars presented by exhibitors were held 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. On the first day of the show UBM announced that its next global CPhI destination would be Sri Lanka where it would be hosting the first ‘Sri Lanka Pharma Week’ from December 3-7, 2012. The event is expected to be one of the largest senior-level industry meets as the island nation gears itself up for some radical regulatory and operational changes. Thus ‘Sri Lanka Pharma Week’ will be all about building new relationships, cementing old ones and understanding how to successfully enter this burgeoning market. u.sharma@expressindia.com December 1-15, 2012

MANAGEMENT

W H AT ’ S INSIDE

THE BUSINESS OF PHARMACEUTICALS Violators of law... Drug Regulatory Authorities (DRAs) PG 36

December 1-15, 2012

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Many people believe that starting a business is a herculean task. They know they want to start a business, but they don’t know the initial steps to take. The same happened with Pravin S Herlekar, CMD, Omkar Speciality Chemicals (OSCL). While he was undergoing internship with Excel Industries in Mumbai during his final years in IIT-Bombay, he had an opportunity to meet KC Shroff, Managing Director, Excel Industries, who asked him piercing questions about his ambition in life after graduation. These questions from Shroff changed Herlekar’s life forever. Herlekar describes the scene, “As a trainee I had no clues then to strategise my abstract dream into entrepreneurship. I just replied naively to Shroff that I wished to opt for a decent career with some reputed brand or MNC. To which Shroff quipped and said, “So that’s all you want to do in life.” I was speechless and did not know what to say. Shroff who is a visionary then said, “You must start a business of your own and it should be something unique.” It was a pathbreaking suggestion for me from Shroff and the epicenter of my goal to start my own venture.” It turns out that many entrepreneurs started their businesses not because they had always had that dream, but because some event in their lives made it seem like the right thing to do at a certain time. “I always wanted to do something innovative in chemistry and had the courage to step out into the unknown and pursue a dream no matter what it takes,” says Herlekar. Armed with a Bachelor’s Degree in Chemical Engineering from the Indian Institute of Technology (IIT), Bombay and a Post Graduate in Management Studies from Mumbai University, Herlekar commenced a proprietary firm in 1983, with a working capital of meager ` 1 lakh, which he accumulated from provident

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fund during his seven years stint with Excel Group.

It all started in the kitchen...

changing market dynamics, which often requires newer technology adoption in production and this is one of the few challenges we face,” informs Herlekar.

Herlekar was aware of the fact that for any type of venture, be it big, small or home-based, startup Products funding is mandatory and defiOSCL started off in 1983 and nitely a stepping stone to success. primarily manufactured iodine “You will be surprised to learn that derivatives. It subsequently manumost of the multi-millionaires and factured selenium, molybdenum, billionaires of today just started bismuth and cobalt derivatives with great ideas and very less with capacity of mere six Metric funds. I did the same,” says Tones Per Annum (MTPA). Herlekar. Currently, OSCL manufactures He adds, “A bird doesn’t sing speciality chemicals and pharma because it has an answer, it sings intermediates, with a diversified because it has a song. With this portfolio of over 100 products, dogma, I tried to move out of con- consisting of niche organic, inorformity and search newer product ganic and organo inorganic interideas. Along the course of follow- mediates. Derivatives of molybdeing my own path, I have had many num, selenium, iodine, cobalt, bisdifferent experiences and have muth and tungsten are some of interacted with numerous individ- the inorganic intermediates, uals with very diverse back- besides organic intermediates, grounds. This such as resolving enabled me to agents and other explore, question, intermediates. TM re-think and finally Organo-inorganic give shape to my intermediates perspectives. include hyperva2 Finally, one that lent iodine comVISIT US AT 64th IPC, struck me was to pounds benzenemanufacture seleninic anhy07-09 DECEMBER 2012, import substitutes, dride, to name a CHENNAI, which did not have STALL NO. 33 (HALL NO. A4) few. All these much presence in products find India.” application in variIt was in the ous industries like 1980s, when there pharma, chemical, were stringent govglass, cosmetics, ernment norms ceramic pigments and restrictions on imports. With and cattle and poultry feeds. all his determination, Herlekar went ahead with the idea and Positive growth started developing a couple of OSCL has manufacturing facilimport substitutes and that too in ities, which can produce multiple his kitchen as he did not have any products using a combination of lab. processes. Currently, the company “It was in my kitchen that I has four units at MIDC, Badlapur developed some molybdenum and (East), Thane with a total capacity selenium derivatives, which were of 1,700 MTPA (as on June 2012). not manufactured in India and OSCL augmented its capacity from were completely imported. Hence, a mere six MTPA, when it started this marked the start of my career its business as a proprietary conas an entrepreneur. All my life, I cern in 1983 to manufacture selehave been doing only one thing nium and molybdenum derivaand that is to learn and apply. The tives. Since 2008, the capacity has major challenge I faced is in the increased nearly 4.5 times (as on

IT WAS IN THE 1980S,WHEN THERE WERE STRINGENT GOVERNMENT NORMS AND RESTRICTIONS ON IMPORTS.WITH ALL HIS DETERMINATION, HERLEKAR WENT AHEAD WITH THE IDEA AND STARTED DEVELOPING A COUPLE OF IMPORT SUBSTITUTES area Our that vate

of technology upgradation. business demands are such we constantly need to innoand grow according to the

June 2012). In April 2012, OSCL acquired Lasa Labs, which enabled it to add a portfolio of 10 Active

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Pharmaceutical Ingredients (APIs) like Albendazole, Closental and Flucanazole. Though most of the APIs are generic, it still offers incremental market opportunity for OSCl. For instance, Albendazole is estimated to have a global annual demand of about ` 1.7 billion. Currently, OSCL operates at the tail end of the pharma chain, as produces pharma intermediates, which finds application in the API manufacturing. Lasa’s acquisition enabled OSCL to spread out its presence across the value chain. OSCL manufactures some products, which are used in API manufactured by Lasa. OSCL acquired Urdhwa Chemicals, a sick unit in Chiplun, Ratnagiri District in FY12. Company set up a 2,800 MTPA facility for manufacturing organic chemicals, which commenced its operations in October 2012. It manufactures export-oriented APIs, which will further drive the export foothold. With the new launches in pipeline and timely ramp up of Urdhwa and Unit V facilities at Chiplun, OCSL’s export revenues is expected to improve significantly going forward. With a view to strengthen its research and development, OSCL acquired 99.82 per cent stake in Rishichem Research in May 2010. OSCL plans to consolidate its specialised research and development activities at Rishichem Research. OSCL is working to develop processes for manufacturing new high value added products and APIs. Once developed, it will scale up its operations with the help of facilities at Rishichem.

Ready for the competition OSCL does not have one specific competitor. However, the company does face some competition from different players having presence in some of the product categories similar to OSCL. Herlekar says, “The pharma intermediate and speciality chemicals industry are both highly fragmented. In pharma intermediates, OSCL’s key competitors include listed players like Sequent Scientific (competitor of Lasa Labs, which is into API manufacturing) and Vivimed Labs. Apart from pharma intermediates, Vivimed’s portfolio has a range of specialty chemicals (active ingredients) supplied to manufacturers of beauty care products like hair care, skin care, sun care and oral care products, and industrial care products, such as anti-microbial, anti-fouling agents and biocides. However, OSCL’s presence in this December 1-15, 2012

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end-user segment is very less.” He adds, “In the Iodinebased speciality chemicals, OSCL faces competition from listed player Samrat Pharmachem. Some other competitors in the price sensitive speciality chemicals segment include listed players like Camlin Fine Sciences, Vinati Organics, Sunshield Chemicals, Avon Organics and unlisted players like Maharashtra Organo Metallic Catalysts. OSCL also faces product specific competition from Chinese manufacturers in both its business segments.” However, OSCL is better placed compared to its competitors on the back of its R&D focus, operational flexibility because of product diversity and launch of newer products with Intellectual Property Rights (IPR) filing. OSCL’s credibility of meeting stringent quality requirements and dependably delivering high quality orders has garnered a loyal customer base in the domestic and international markets—resulting in repeat business, especially from global pharma players. All this has helped OSCL stay ahead of its competitors. According to Herlekar, some of the niche high-value added products (including pharma intermediates) manufactured by OSCL like resolving agents face less competition globally.

Passing on the baton Succession is quite significant for any family business. The choice of the ‘right’ successor plays an important role in ensuring smooth transition of family business and its future success. Herlekar informs, “In our

case, I have two strong inheritors, Omkar and Rishikesh, my two sons. Omkar is a PhD from UDCT, Mumbai and has already shouldered business responsibilities of the company as a whole time director. He spearheads the group’s R&D operations, besides

overseeing marketing, export and operations. Rishikesh is a BE Tech chemical engineer and he is currently growing up with the business with a strong interest in product development and marketing.” Speaking about the future

expectations, Herlekar says, “We expect to maintain our growth of 45-50 per cent yearon-year. We are also optimistic that it will resolutely take OSCL closer to the ` 500 crore turnover benchmark by 2015.” sachin.jagdale@expressindia.com

Pharma revenues Currently, OSCL manufactures speciality chemicals and pharma intermediates, with a diversified portfolio of over 100 products, consisting of niche organic, inorganic and organo-inorganic intermediates. Pharmaceutical intermediates and APIs contribute around 70 per cent of OSCL’s revenue, while the balance 30 per cent is contributed by speciality chemicals space (largely from cattle and poultry feed, glass industry, water treatment, chemicals user segment). Iodine and selenium derivatives are its key category of products, which account for about 77 per cent of OSCL’s total net sales (in FY12). Iodine derivatives like methyl iodide, trimethyl sulfoxonium iodide, potassium iodide and sodium metaperiodate are the top products, which account for about 45 per cent of OSCL’s total sales. December 1-15, 2012

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LEGAL EAGLE Violators of law... Drug Regulatory Authorities (DRAs) As pharmaceutical majors from developed markets are expected to outsource huge amount of manufacturing to low cost destinations in the the Asia-Pacific region, India will definitely benefit. But are the rules related to contract manufacturing being followed? Jagmohan Rai Agarwal, an industry veteran of over three decades, opines that since rules related to contract manufacturing models like loan licensing, thirdparty manufacturing and franchises are being blatantly and routinely flouted. It is high time that either the law is enforced in its true spirit or this provision be abolished evenue from contract manufacturing activity in the pharmaceutical sector is expected to hit $64 billion by 2016 and more than double between now and 2021, according to a report from Visiongain. Manufacturing of finished dosage forms will drive this growth, with expected compounded annual growth of 8.7 per cent between now and 2016. Production of active pharmaceutical ingredients (APIs) remained the largest sector for the contract manufacturing industry worldwide last year, accounting for 71 per cent of the total market. Similarly, a research report titled “Pharmaceutical Contract Manufacturing: A Global Strategic Business Report” released in March 2012 by Global Industry Analysts (GIA), points out that Pharmaceutical Contract Manufacturing (PCM) is emerging as a strategic option to an increasing number of pharma companies, owing to their ability to avail flexibility, quicker time-to-market, and lower scale-up costs. Outsourcing helps companies in cutting down on additional capacity in production networks. The GIA report points out that pharma majors from developed markets are expected to outsource huge amount of manufacturing in order to concentrate on the core tasks of research, development and marketing.

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Pharma companies face increasing pressure to expand their product pipeline, and seek enhanced revenues and profitability, along with growing cost pressures and rising penchant to externalising fixed costs are expected to skew drug manufacturing towards outsourcing. Besides, players in the pharma industry are also pressed by rising penetration of generics, which makes outsourcing a more compelling alternative to provide them with cost savings. In such a scenario, the role of contract manufacturing, as well as contract developing companies is expected to become much more significant in the resource and cost optimised pharma industry. These days ‘contract manufacturing’ in India, in the pharma sector has three options namely 1). Loan licensing, 2). Third-party manufacturing and 3). Franchise

Loan licensing other than Large Volume Parenterals (LVPs) It is vide Notification no. F.1-16/57, dated 15.6.1957 that the provision for loan licenses was inserted by GOI as Rule nos. 69A and 75A in the Drugs and Cosmetics Rules 1945. The explanation given in those rules reads as under: “For the purpose of this rule a loan license means a license which a licensing authority may issue to an applicant who does not have his own arrangements for manufacture but who www.expresspharmaonline.com

intends to avail himself of the manufacturing facilities owned by a licensee in form 25 or in form 28 as the case may be.” Today the market is flooded with products being manufactured on loan license system by those who have their own manufacturing facility at one or more than one places. As per CDSCO’s website hundreds of loan licences have been granted/renewed in favour of such companies who already have one or more than one facility of their own. This amounts to clear and gross violation of aforesaid provision of law and the violators are none other than State and Central Drug Regulatory officials. The author addressed a letter dated January 31, 2012 to the Drugs Controller General India I/C and to all the State Drug Regulatory Authorities on the subject drawing attention to this violation of the Drugs and Cosmetics Rules The letter observes ‘that almost all the State Licensing Authorities and even the Central Licensing Authority/Central Approving Authority in the country are engaged in violating provisions of Explanation to Rule 69-A (1), 75-A (1), 138-A (1), 153-A (i) and 76, (particularly in granting/renewing loan licences to manufacture for sale or for distribution of Large Volume Parenterals in form 28A of Rules).’ The letter reasons that ‘all the concerned authorities, whether sitting or retired, who have violated said rules, have rendered themselves liable for suitable criminal/civil legal action against all of them at appropriate forum. The ‘act’ of such officers cannot be termed as having done in ‘good faith’ and in fulfillment of their lawful duty.’ The author goes on to say, “It is expected that all such loan licences issued in violation of aforesaid rules, be cancelled within 30 days from receipt of this letter and

names of officers, whether sitting or retired, who have knowingly violated the Law, are recommended to the Lokayukta/CBI for suitable action against them.” It is surprising to note that far from replying, none of the State Drug Regulatory Authorities acknowledged the letter. The only reply received from Dr K Bangarurajan, Deputy Drugs Controller (I) of the office of the DCGI (File No. X11050/LVP/MISC/2012-D, Central Drugs Standard Control Organization, Directorate General of Health Services, (LVP Division)) addressed to all State Licensing Authorities mentioned the receipt of an application from the author and requested them to take appropriate action in the matter and inform the DCGI’s office as well. The letter addressed to DCGI/State Regulatory Authorities rose following two violations by all of them: 1. Grant / renewal of loan licences, other than LVPs in violation of rules. 2. Grant / renewal of licence to manufacture for sale of LVPs in absence of any provision in law. The answering officer in CDSCO very conveniently ignored first part of the letter and for the second part transferred the responsibility on state authorities. Out of the list almost every loan licencee has one or more than one facility of its own. The data also shows public sector undertakings as loan licencee in various states. As per CDSCO website information from Andhra Pradesh, Jharkhand, Orissa, Punjab, Karnataka and Uttarakhand were awaited, whereas information as regard to original licencee from Haryana and loan licencee from Bihar are awaited. The following minutes of the Drugs Consultative Committee (DCC) are relevant to be mentioned: Item 3(f)-21st DCC- 8December 1-15, 2012

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9.11.1979: Consideration of report of sub-committee appointed to study the problems created by the loan licensing system and suggest changes in the Drugs and Cosmetics Rules to remedy them. The consensus view of the committee was that loan licensing system should continue with certain restrictions. The committee unanimously agreed to the following restrictions being imposed on loan licensing system:1. Drugs and Cosmetics Rules should be suitably modified so as to require that after two renewals the loan licencee must set up facilities for manufacture of all categories of drugs covered by loan licence. 2. Not more than six units should be given loan licencee with a single manufacturer. 3. Not more than 10 items per unit should be allowed to be manufactured against a loan licence. 4. No loan licence should be granted to any unit on more than one parent firm. 5. That sub-committee has recommended that no loan licence should be granted for the manufacture of immunological products, surgical dressing, blood and its products, transfusion solutions, medicinal gases, disinfectants, cardiac glycosides, ecobolic preparations, antibiotic parenteral preparations, narcotic and psychotropic preparations, and also for repacking of drugs. The committee recommended that ophthalmic preparations and injections should also be included in the list of items not permitted to be manufactured against a loan licence. 6. Loan licensing system should not be exploited by manufacturers having facilities for manufacture to increase their production capacity. Loan licence is essentially meant for parties who do not have their own manufacturing facilities and have, therefore, to avail of the manufacturing facilities of other firms. Item no. 21: 21st DCC- 89.11.1979:- Consideration of the question of the grant of loan licence for sterile powders, whole human blood and blood products: The committee unanimously agreed that sterile December 1-15, 2012

products, whole human blood and blood products should not be licenced against loan licences. Item no. 27- 22nd DCC10th July 1981:- No new loan licences for injections should be issued and no strip packing should be allowed on loan licence.

The chairman stated that no exemption should be given in respect of ophthalmic sterile preparations and practice followed in respect of gamma radiation and sterilisation should continue. The chairman stated that whenever a decision has

been taken in the DCC, the same should be uniformly implemented. If any member has any difficulty, he should refer the matter to the chairman for clarification. Item No. 50- 29th DCC â&#x20AC;&#x201C; 6-7.01.1994: Consideration of framing uniform policy pending abolition of loan

licensing system with regard to manufacture of drugs in units other than the parent firm. DC, Orissa requested members to devise ways and means to curb the practice by which those manufacturers who did not have their own facilities but were still

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getting certain items manufactured from the companies who have adequate facilities to produce those drugs. Thus the parent manufacturer was mentioning on their label as if they were marketing the product manufactured on behalf of other units. The members joined with DC, Orissa in expressing the concern that this was another way of circumventing loan licensing system. Commissioner, FDA, Maharashtra informed that they were granting loan licenses as per the court directions. The fresh licenses or renewal of licenses were being granted subject to the clearance of court case or decision taken by Supreme Court or amendment, if any, made with regard to notification whichever was earlier. (Detail of court case referred by Commissioner, FDA, Maharashtra have not been quoted in the minutes). The chairman felt that no retrogrative steps should be taken for this matter specially with regard to grant of loan licences for LVPs and bulk drugs in view of the earlier decision reached by the DCC. Further, DC (AP) and FDC, Gujarat informed the chairman that loan

licenses relating to bulk drugs had been stayed by the courts in their State. (no detail of court cases are available in the minutes). After discussion the chairman requested Commissioner FDA, Maharashtra to give a write up on the manner of grant or renewal of loan licenses in his State so that the same could be circulated for information and necessary perusal by the other members. Another aspect related to availability of counterfeit/fake/spurious medicines is easily availability of printed packaging materials of the principal unit(s) either at the manufacturing site or at local vendor. Therefore, it is clear that the explanation attached to the above rules is being flouted / overlooked / violated knowingly. It is therefore high time that either the law be enforced in its true spirit or provision of loan license be abolished in the country.

Loan licensing of ‘LVPs’ It is vide GSR 119 (E) dated 11.3.1996, a licence to manufacture for sale or for distribution of drugs specified in Schedule C and C(1) other than LVP, sera and vac-

cines, drugs specified in Part X-B and Schedule X shall be issued in Form 28 and a licence to manufacture for sale or distribution of drugs specified under Schedule C and C(1) (other than LVP, sera and vaccines, drugs specified in Part X-B) and Schedule X shall be issued in Form 28B. A licence to manufacture for sale or distribution of large volume parenterals, sera and vaccines shall be issued in Form 28-D was inserted. It is worth evaluating that a licence in Form 28 is prescribed to be issued for drugs specified in Schedule C and C(1), other than large volume parenteral, sera and vaccines and a licence in Form 28-D is prescribed to be issued to manufacture for sale or distribution of large volume parenterals, sera and vaccines. An explanation, similar to Rule 69-A, is part of Rule 75-A for the purpose of issue of licence in Form 28-A (Rule 76-A) for drugs specified in Schedule C and C(1), excluding those specified in Part XB and Schedule X. Explanation: For the purpose of this rule, LVPs shall mean the sterile solutions intended for parenteral administration with a vol-

ume of 100 ml or more (and shall include anti-coagulant solutions) in one container of the finished dosage form intended for single use. It is interesting to note that there is no procedure and / or provision in any of the rules prescribing issuance of loan licence to manufacture for sale or distribution of large volume parenteral, sera and vaccines. The legislature has neither prescribed any fee nor the form for that purpose. As per the website of CDSCO one of the functions undertaken by Central Government i.e. CDSCO is: “To approve licences to manufacture certain categories of drugs as Central Licence Approving Authority (CLAA) i.e. for blood banks, LVPs, sera and vaccines.” The procedure for grant or renewal of licence to manufacture LVPs, sera and vaccines under Drugs and Cosmetics Rules 1945 is also available on the website of CDSCO. Here also there is no mention of procedure for issuance of loan licence to manufacture large volume parenterals. Now let us examine minutes of various meetings of Drugs Consultative

Compilation of original and loan licenses granted (Source: CDSCO web site, accessed between January/ February 2012)

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S. No

Name of state

No. of original licencee

No. of loan licencee

Assam

Bihar

224

Chhatisgarh

Delhi

Goa

157

Gujarat

806

767

Haryana

Himachal Pradesh

299

418

Jammu & Kashmir

Kerala

115

Madhya Pradesh

287

177

Maharashtra

565

956

Rajsthan

125

Sikkim

Tamil Nadu

446

119

Uttar Pradesh

483

TOTAL

3555

2956 (83.15%)

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Committee on the subject: 1. 34th DCC August 2000: Item no. 14: Consideration for the amendment to the concerned Rules under Drugs and Cosmetics Rules 1945 to make provision for the manufacture of LVPs under loan licence. “Considering the specific technical expertise and specialised facilities required for manufacturing quantity (quality) products which are to be formulated as LVPs, the DCC unanimously accepted the recommendation of the sub-committee for the amendment of the concerned Rules under the Drugs and Cosmetics Act so as to regularise the manufacturing of LVPs under loan licence till such time that loan licensing is an integral part of rules. It was agreed that there has been an omission in the forms pertains to CLAA in this regard and many drug formulation in large volume continue to be

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manufactured under loan licence arrangement as such skill may not be available with many industries. This correction however, needs limited to LVPs.” 2. 36th DCC June 2005: (a) Agenda no. 13: Documents to accompany with the licence for the grant/renewal sent for approval of CLAA to manufacture LVPs. “The large volume parentrals are sensitive products and therefore approving the grant of licence/renewal of the licence /permission for the manufacture of additional products requires detail information on facilities for manufacturing and testing.” “The LVPs, vaccines, blood products and recombinant products are sensitive products. Grant/renewal of the licence and permission for the manufacture of these products are to be duly approved by the CLAA. This requires that at the level of SLA, it should be ensured

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that all the documents are in order and are sent to CLAA.” (b) Agenda No. 40: Loan licensing of large volume parenterals: Loan licences for products specified for a Schedule C and C (1) are issued under Rules 75-A, 76-A and 78-A. Incidentally all large volume parenterals also fall under category of Schedule C drugs. Some states are issuing loan licences on Form 28-A without taking approval from Central Licence Approving Authority, which is mandatory under Rule 68-A. This has created a great confusion because in the case of host firm the licence is issued by licensing authority and finally approved by CLAA but for a Loanee firm who is enjoying facilities on the same host firm, no such approval is required from CLAA. Even in additional products, in case of the host firms are granted after approval of CLAA but for Loanee firm

they are sanctioned by SLA only. So this flaw in the law has to be rectified and if the loan licensing of LVPs is permissible then specific forms for applications and licence should be prescribed for the loanee firms also. At present, there seems to be no such provisions in rules and no forms have been prescribed for loan licence in respect of LVPs. DCG(I) explained the members that the loan licences which are granted for the purpose of utilising spare capacity of a licenced manufacturer and does not involve any manufacturing activity and the quality of product is taken care of by the principal manufacturer who is already approved by SLA or the CLAA as the case may be. Requests were received from many SLAs that the grant or renewal of loan licences for the manufacture of LVPs should be permitted by SLAs or separate provision should be created for processing such

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applications by CLAA even though it does not involve any establishment of a manufacturing activity. He added that CLAA undertakes the following activities before the approval of licence. 1. Verification of statements of the manufacturer in respect of manufacturing premises, technical staff, manufacturing facilities etc. 2. Inspection of the establishment. 3. Acceptance or rejection of the application on the basis of the report of the licensing authority. All these requirements are practically non existence in the case of loan licences. It was, therefore felt that a provision should be created in Rule 75-A and 78-A so as to facilitate SLAs for grant of loan licences for LVPs. After deliberations, DCC agreed to the proposal and recommended that Rule 75-A and 78-A may be suitably amended so that loan licences for LVPs could be granted by the State Licensing Authorities. However, it was agreed that a formal NOC would be obtained from CLAA before processing any application for loan licensing any CLAA item. 3. 37th DCC December 2006: CLAA Scheme: Abstract: CLAA scheme exists for more than 13 years. Major area of concern: 1. Non compliance but continue to be valid. 2. Loan licensing of CLAA product without CLAA approval. “As a principal decision was already taken to permit loan licensing for large volume parentrals, the DCC has agreed to process a loan licence application in 27-D and recommended in 28-D specifically mentioning that the application is for loan licence and mention the name of loan licensor and licencee pending creation of new form.” As per data available on CDSCO website numbers of loan licences to manufacture LVPs have been granted/renewed in various states under the nose and knowledge of CDSCO. It is not enough, as loan licences to manufacture LVPs have been issued to firms who have their own facility to

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manufacture LVPs either within or outside the state. Recent amendment: It is vide Gazette Notification GSR 574 (E) dated 17.7.2012 the Ministry of Health and Family Welfare, Government of India, the Drugs and Cosmetics Rules have been amended. 1. Rule 75 A (a), after sub-rule (1) sub-rule (1A) has been inserted, vide which form 27DA has been prescribed for application for grant or renewal of loan licence to manufacture for sale or distribution of drugs in large volume parenterals, sera and vaccine and Recombinant DNA (r-DNA) derived drugs. 2. Form 28DA has been prescribed for grant of loan licence to manufacture for sale LVPs, sera and vaccine and r-DNA derived drugs.

pressed about the Draft Rules vide GSR 557 (E) dated 21st July 2011, already published in the Gazette of India dated 21st July 2011. Thus it is evidently clear from above facts that state licensing authorities hand in gloves with Central Drugs Standard Control O r g a n i z a t i o n (CDSCO)/DCGI/DCC have jointly and severely violated the law of the land in granting/renewing loan licences to manufacture LVPs prior to amendment of rules. Where is the law, where are the law abiding people, where are the law enforcing authorities, where are our political leaders? (Exceptions are always there)

Third party Under this arrangement

AS PER DATA AVAILABLE ON CDSCO WEBSITE NUMBERS OF LOAN LICENCES TO MANUFACTURE LVPS HAVE BEEN GRANTED/RENEWED IN VARIOUS STATES UNDER THE NOSE AND KNOWLEDGE OF CDSCO 3. Form 26 J has been prescribed for renewal of loan licence for LVPs, sera and vaccine and r-DNA derived drugs. Above amendment has been incorporated in a hurry and without any valid reasoning. Further it is noticed that loan licences already granted and renewed from time to time prior to said amendment, had no legal sanctity. Even after above amendment the provision of ‘Explanation’ attached to relevant rules, reproduced below, is being violated. “For the purpose of this rule a loan license means a license which a licensing authority may issue to an applicant who does not have his own arrangements for manufacture but who intends to avail himself of the manufacturing facilities owned by a licensee in form 25 or in form 28 as the case may be.” It is also interesting to consider that while replying to authors letter on March 2, 2012, the office of CDSCO, New Delhi, knowingly supwww.expresspharmaonline.com

the firm/unit (A), normally renowned and brand leader, enters in to an MoU, with the manufacturing company (B), mostly an SME, where B agrees to manufacture generic/patent-proprietary products of A in the manufacturing facility belonging to B, at agreed terms. Firm ‘A’ purchases such manufactured products from ‘B’ on the basis of wholesale drug licence. ‘B’ obtains permission of those products in its license, if not already licensed. In the packaging material the logo and name of ‘A’ is printed more prominently than the name/address of ‘B’ for obvious reasons to cheat the public and medical profession as if the product is manufactured by ‘A’ the printed packaging materials and raw materials, is procured by ‘B’. ‘A’ makes such arrangement with number of companies thus the printed packaging material of ‘A’ is easily available at many places. There is, in most of the

cases, no account of such printed packaging material is maintained even after the third party arrangement is discontinued. There is no provision in law for this arrangement and is being adopted only to avail manufacture of products at a cheaper cost, to avoid legal responsibility under the Drugs and Cosmetics Act/Rules and also to save government revenue wherever possible. An SME like ‘B’ has been thrown out of open market and government business, has upgraded its unit to comply GMP norms under pressure investing huge sum to keep the licence / unit alive, who is under stress to meet monthly bills of the unit, arrange payment of interest and other dues of financial institutions/market, maintain the livelihood of staff/labour, keep the mouth shut of 32 government departments, and at last to maintain the average status of his family, in most of the cases such companies like ‘B’ are forced to become slave of units like ‘A’. If a detailed enquiry is conducted it will be revealed that every second product falls within above two categories. Glaring Judgment of Patna High Court between G l a xo S m i t h k l i n e Pharmaceuticals Ltd. & others Vs State of Bihar & another in Cr.Mis.No. 37985 of 2004 decided on 22nd February 2011 [2012(1) Drug Cases, 16]: A) Drugs and Cosmetics Act 1940 and Rules 1945sections 27(d), 18(a)(i), 18(a)(vi), 18(c) – cognizance taken for violation of the provisions of-appeal against- Rules 75A, 96, 97, section 17(b)- complaint filed against the accused persons including petitioners alleging that the seized drugs were manufactured by violating the provisions of loan licences and labeled by violating labeling rules 96 and 97 and logo and name of the intended purchaser (GlaxoSmithkline Pharmaceuticals Ltd- as a wholesaler), featured on the labels of the drugs and carton of drugs attract provision of misbranded drug-the fact not disputed that M/s G l a xo S m i t h k l i n e Pharmaceuticals Ltd. had December 1-15, 2012

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

purchased drugs from M/s Emcure Pharmaceuticals Ltd. as whole seller and as such there was no requirement to mention this fact on label of drugs in question that too in the letter bolder than the letters in respect of manufacturer over the label on the drug in question-no interference with the order of the cognizance- petition dismissed. B) Drugs and Cosmetics Rules 1945- no provisions in the Act under which the name and logo of the intended purchaser (Wholesaler), who purchases drugs from the manufacturer could appear on the labels of the drugs purchased. (Author is not aware whether appeal, if any, is filed and pending before Hon’ble Supreme Court against the aforesaid order/judgment.) Illegal practice, permitted by the regulatory, lead to production of 'As' medicines by unscrupulous persons.

the profession. Remember that the greatest crime is to compromise with injustice and wrong. Subhash Chandra Bose About the author Jagmohan Rai Agarwal, M.Pharm (1968), has nearly

37 years of industrial experience in the SSI sector and has been part of various industry fora Founder President of M.P.Pharmacy Graduates’ Association (MPPGA), M.P.Pharmaceutical Manufacturers’ Organisation

(MPPMO), M.P. Small Scale Drug Manufacturers’ Association (MPSDMA), Ex President Indian Pharmaceutical Association, M.P. State Branch, Indore (IPA), Ex Vice Chairman Confederation of Indian Pharmaceutical Industries

(SSI) (CIPI). He has recently submitted his Ph.D. thesis on the topic: “Enforcement of Drug Laws-Globalization vis-à-vis Indian Drug Laws”. The author can be contacted at sharda_jollo@yahoo.co.in

FRANCHISE: Manufacturing company ‘A’ enters in to product wise MOU for franchise with any person ‘B’, not necessarily a manufacturing unit. ‘B’ then negotiates with number of manufacturing units and gets the agreed products of ‘A’ manufactured and continues its marketing himself without any check or monitoring or control by the brand owner ‘A’. ‘B’ is authorised to print name and logo of ‘A’ as per its sweet will which normally is more prominently printed obviously to misguide the patient and medical profession as if the product is manufactured by ‘A’ in its own manufacturing unit. One can imagine the hazardous effect this system would bring in this noble profession. Number of advertisements can be seen either on internet or in print media where services either as third party arrangements and/or franchise are offered. And the regulatory (authority) is pretending unawareness of its serious consequences. It is an alarming situation and the present regulatory and governments much awake to check and forthwith stop such root cause of the problem being faced by December 1-15, 2012

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December 1-15, 2012

“The patients' demand for quick responses with antibiotics, analgesics, steroids, hormones etc. is a compelling reason. Our communities are not sufficiently aware of the strengths of Ayurveda, despite the long recorded use and safety. Not infrequently

vaidyas too lack confidence in total Ayurvedic management in the practice settings. The pharmacists have hardly any role in hospitals and medical colleges. I had proposed to IPC that we need pharmacistphysicians as bridge professionals to monitor and guide

oday, the cumulative number of doctors, across all systems of medicine in India, is more than 1.3 million. India has just six MBBS doctors per 10,000 people, while China has 14 per 10,000. The number of doctors registered with Medical Council of India (MCI) is approximately seven lakhs. It includes MBBS, specialists and super specialists. Approximately there are four lakh registered ayurvedic practitioners and 2.5 lakh homoeopathic practitioners in India. There is an acute shortage of doctors, the existing data reveals that India has a shortage of approximately 6-8 lakh doctors. Hence the Union Minister for Health and Family Welfare Ghulam Nabi Azad has called for bridging the gaps in healthcare with inherent strengths, holistic approach and wide range of remedies of Ayurveda, Unani, Siddha and Homeopathy (AYUSH). However, it has also been seen that the AYUSH practitioners are opting to prescribe allopathic medicines which in turn has triggered a massive ethical debate. Recently, there was a hue and cry whether AYUSH practitioners should be allowed to practice allopathy or not. While one part of the industry stresses that doing so is unethical and violating the law, the other side argues that the acute shortage of qualified doctors in India can be mitigated by allowing AYUSH practitioners to prescribe allopathy medicine if there is need. The reasons for practising allopathy by AYUSH practitioners are varied. Some of them are as follows: ● Fast relief Today, patients are not ready to wait to undergo a lengthy treatment as ayurvedic and homoeopathic treatment requires time to show an impact. Allopathic system of medicine gives fast relief compared to other systems, and hence patients prefer to opt for this method of treatment. Therefore BHMS (Bachelor of Homoeopathic Medicine and Surgery) and BAMS (Bachelor of Ayurvedic Medicine and Surgery) doctors are catering to the demands of patients. Ashok Vaidya, Research Director, ICMR Advanced Centre of Reverse Pharmacology Kasturba Health Society points out,

rational drug usage in India. Currently there are almost no dialogues between doctors and pharmacists. I suggested joint conference of IPA with API.” ● Lack of MBBS doctors in rural areas Today, while many MBBS

practitioners move for better prospects to urban areas or abroad, BHMS and BAMS doctors prescribe allopathic medicines in rural settings. Since BHMS and BAMS doctors have basic understanding and knowledge of anatomy, physiology and pharmacology they

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prescribe allopathic medicines. ● Non availability of traditional medicines The current availability of proprietary traditional medicines is not enough considering the size of patient pool and variety of diseases. Dr N Udupa, Principal, Manipal College of Pharmaceutical Sciences (MCOPS) highlights, “Today, the manufacturers of ayurvedic and homoeopathic medicines in the market are very few and there are serious issues with respect to availability of these products across the country. Even if a BHMS or BAMS doctor prescribes medicines related to their field, patients will not be able to receive the product. On the other hand, allopathic medicines are available at every retail chemist and it is not a problem even in rural places.”

Need for integrated cure Whatever the reasons, it is undeniable that India is in need of more integrated and skilled healthcare professionals and hence AYUSH practitioners are garnering a lot of attention these days. Vaidya informs that the 12th five-year plan has allocations for increasing the number of doctors in all systems of medicine. He also opines, “I hope that rather than creating more poor quality medical/Ayurvedic colleges we retrain and use all the personnel for integrated medical care. India does not need more doctors, we need intense school heath education/check ups, MCH care, nutrition, hygiene, and rural health care with accountability and lack of corruption.”

Revamping the AYUSH curriculum Recognising the need for the enhanced integration of AYUSH into the mainstream

healthcare delivery system, there has been some major changes in the AYUSH curriculum. While there are many common elements in the basic courses for MBBS and BAMS/BHMS, the new curriculum for Ayurveda degree includes several modern medicine domains. Udupa explains the difference between the course curricula and says, “The course tenure is similar for all courses that is five and a half years. However, in case of BHMS course, more focus is given on study of philosophy of homoeopathy and material medica. In case of BAMS course, more emphasis is given on principles of Ayurveda and treatment of diseases based on prakriti of patients i.e. vata, pitta or kafa. He furthers avers, “I feel the existing curricula should also emphasise on studying modern system of medicines as this has penetrated to more extent than Ayurveda or homoeopathy system in India. Also they should be taught about pharmacology of allopathic medicines as this would help not only them but also the patients as they would receive medicines prescribed by BAMS or BHMS based on informed decision.” He continues that the pharmacy profession in India now offers D Pharm degrees that is based on studying clinical aspects of medicines. If pharmacists are asked to work with BHMS and BAMS doctors, this would immensely benefit patients. As pharmacists would be having knowledge of clinical aspects of drugs, they can work in tandem with doctors and provide them with useful information related to medicine. Udupa is of the opinion that as all the systems of medicines work on different principles, it would be improper to

standardise curriculum, however the principles of each system of medicine i.e. allopathic, ayurvedic and homoeopathic should be included and taught for all systems of medicine. On

decided based on the requirements.” “Today no person would be satisfied with only MBBS degree. Doctors are moving towards specialisation and

ASHOK VAIDYA

DR N UDUPA

Research Director, ICMR Advanced Centre of Reverse Pharmacology Kasturba Health Society

Principal, Manipal College of Pharmaceutical Sciences

I feel the existing curriculum should also emphasise on studying modern system of medicines as this has penetrated to more extent than Ayurveda or homoeopathy system in India

What is needed is systemic efforts of all healthcare professionals with doctors including pharmacists and nurses should be encouraged that would help to strengthen healthcare system

the issue whether AYUSH practitioners should be allowed to practice allopathy or not he says, “The decision to permit BHMS, Diploma in Homoeopathic Medicine and Surgery (DHMS) and other practitioners to prescribe allopathic medicines rests with the government depending on need of society. If in a particular state the number of allopathic practitioners are sufficient per 1,000 population, government may not permit BHMS and BAMS to prescribe allopathic medicines whereas where need exist, it may be permitted. This may not have adverse effect on students opting as this is an issue to be

super specialisation. What is needed is systemic efforts of all healthcare professionals with doctors including pharmacists and nurses should be encouraged that would help to strengthen healthcare system. Also the role of physiotherpists, yoga practitioners should be emphasised so as to have a holistic approach towards healthcare profession, “ he adds. Vaidya states, “Ayurvedic doctors are trying to do their best for their patients. The Central Council of Ayurveda and Siddha’s Past President Late Sri Ram Sarmaji said that vaidyas can use drugs of other system, with adequate back-

207 Ayush Colleges/Institutes permitted to give admission in UG/PG courses during 2012-13 ◆ Under Section 13C/A of the IMCC Act, 207 Colleges/Institutes have been permitted by the Government of India for giving admission in Under Graduate and Post Graduate Courses of AYUSH during 2012-13. ◆ Of these, 169 colleges are Ayurvedic colleges, 31 colleges are Unani colleges and seven colleges are Siddha colleges. Out of 169 Ayurvedic colleges, 39 colleges are Govt. colleges, 130 colleges are private colleges. Of the 31 Unani colleges, eight are Govt. colleges and 23 are private Unani colleges. Of the seven Siddha colleges, three colleges are Govt. colleges, four colleges are private colleges. ◆ While the Government has allowed 8785 seats in Under Graduate Courses in Ayurveda, 1523 seats

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have been allowed in Post Graduate Courses. Of the 8785 seats in Under Graduate Courses, 1765 seats are in the Govt. Ayurvedic colleges, 7020 seats are in private Ayurvedic colleges. Of the 1523 Post Graduate seats, 404 seats are in Govt. Ayurvedic colleges and Institutes, 1119 seats are in private Ayurvedic colleges. ◆ 1154 seats have been permitted for admission in Under Graduate course in Unani during 2012-13. Of these, 276 seats are in eight Govt. colleges, 880 seats are in private colleges. Of the 86 seats in Post Graduate course, 63 seats are in Govt. colleges, 23 seats are in private colleges. ◆ 330 seats have been permitted in Under Graduate course in Siddha. Of these, 150 seats are in three

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Govt. colleges, 180 seats are in private colleges. Only three Govt. Siddha colleges have been permitted to admit 138 students in Post Graduate course. ◆ Maharashtra tops the list with 48 Ayurvedic colleges. In addition to this, there are four Unani colleges in the state. Karnataka has 34 Ayurvedic colleges, five Unani colleges in the state. ◆ Altogether 22 states are having AYUSH colleges/Institutes in the country. These states are – Andhra Pradesh, Assam, Bihar, Chhattisgarh, Delhi, Goa, Gujarat, Haryana, Himachal Pradesh, Jammu & Kashmir, Jharkhand, Karnataka, Kerala, Madhya Pradesh, Maharashtra, Orissa, Punjab, Rajasthan, Tamil Nadu, Uttar Pradesh, Uttarakhand and West Bengal.

December 1-15, 2012

ground knowledge, in the interest of their patients. It is rational to train all the doctors in the use of essential drugs, emergency medicines and CPR. The defensive stand of some IMA officials, calling vaidyas as quacks etc., and the restrictions on pluralistic drug usage have to be countered by awareness and education. Even MBBS doctors are often innocent of the state-ofthe art pharmacology. They learn more from the medical reps. They too need CMES in therapeutics.” He also informs, “Several courses have been started to teach modern pharmacology to vaidyas. I feel this integration will do good to enhance therapy.” However, he feels that a total switch to allopathic practice by vaidyas is to be discouraged.

Malaysia, Trinidad and Tobago, and South Africa has been initiated and is also under consideration with Nepal, Sri Lanka, Serbia and Mexico. Recently, the Department has approached WHO headquarters to extend its support and undertake col-

laborative activities for the development of traditional medicine with focused outcomes.

Future plans for AYUSH AYUSH has grown significantly over the Five Year Plans, many new initiatives

are proposed in the 12th fiveyear plan to shape the development of AYUSH, including flexi-funding for main streaming of AYUSH activities in the states like collocation of AYUSH facilities in PHCs, CHCs and district hospitals. Global trends indicate that

the natural medicine is going to be preferred resort of healthcare for chronic lifestyle and geriatric disorders and Indian systems of medicine can play a significant role in tackling emerging health problems. u.sharma@expressindia.com

Government's initiative Ghulam Nabi Azad, Union Minister for Health, announced that three more institutes, namely All India Institute of Ayurveda, North Eastern Institute of Ayurveda and Homeopathy and North Eastern Institute of Folk Medicine are expected to be functional in the current year. With regard to improving the standards of education and regulation of drugs, he said, in the last two years, some unprecedented steps have been taken to enforce the quality education norms and prevent the mushrooming of substandard colleges. For the first time, minimum standard requirements of ayurveda colleges and attached hospitals have been notified and relaxation given in certain eligibility conditions to facilitate objective inspection and reporting of college infrastructure and quality of teachingtraining facilities. Azad informed the members that the Department has also been strategic in bringing regulatory and quality control reforms and a proposal for creation of posts has been moved to the Department of Expenditure to set up AYUSH Drug Controller at central level. Regarding taking the Indian system of medicines to International forums, Azad mentioned that AYUSH Information Cells have already been set up in Malaysia, Trinidad and Tobago and Mexico for awareness building about AYUSH. International cooperation with China, December 1-15, 2012

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‘Opportunities are needed for professionals from academia and industry to connect, collaborate, and prosper’ APTI is hosting the 64th Indian Pharmaceutical Congress with a 'Vision 2020'. However, in the present scenario many changes need to happen faster and on a larger scale. In an interaction with Usha Sharma, Dr PG Yeole President, APTI suggests some solutions

As the host of the 64th IPC, what is APTI’s role? APTI was established 46 years ago by giant academicians of that time like Prof ML Shroff and Prof GP Shrivastava. It is an organisation whose heart beats and soul lives for the upgradation of profession and professionals in India. In today's India, teachers are multidimensional professionals, they are counsellors, motivators, guides, researchers, advisor, and consultants along with instructors. The association, by hosting this mega event, is providing an excellent platform for its members of academic field to bridge the gap and interact with industry professionals. The Congress’ theme is Vision 2020: Pharmacy Education: Innovation, Strategies and Globalisation. Why was this theme chosen? Globally, the pharmacy profession has matured and transformed from a product oriented to patient oriented one. So our education and its delivery needs an integrated and interdisciplinary approach with innovative training in nurturing next generation of professionals, thus the theme of the Congress is the most apt to ignite the minds for innovative strategies for global supremacy. Some of the key issues like present status of pharmacy education in India, globalisation of pharmacy education and streamlining quality of pharmacy education by uniform accreditation procedures would be discussed. Due to the increased demand in the high-tech pharma industry around the world, business and industry have potential for huge profits working globally. So in today’s world, globalisation is an important concept for students in pharmacy education to appreciate because of the demand in business and industry to hire people who can work with people of other nations and cultures. In addition, the world faces global challenges and will need interdisciplinary groups to solve them. We have to agree and be open to accepting the fact that pharmacy education in the country is in a crisis. The sur-

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vival of pharmacy institutions is questionable due to shortage of admissions. There are no takers for under graduate and even post graduate seats. Besides mushrooming growth other issues like declining employment opportunities, encroachment by industry people in academics, dichotomy in regulation, upgradation of diploma course, uniform curriculum at national level, establishment of pharmacy university needs attention. What are your views on the industry - academia gap? I agree there is a huge gap between the two. Academia is not meeting industry's demands. India has one of the most advanced academic communities as well as a productive industrial sector. Opportunities are needed for professionals from academia and industry to connect, collaborate, and prosper. Significant differences exist in the way research is developed and exploited but professional interaction will increase crossfertilisation of ideas. How can these gaps be filled? Education needs to be more skill oriented. The course content must be rewritten intermittently to stay updated and bridge the gaps between current technology and the institution. Industry, institute needs a dynamic and continuously evolving strategy, an innovative plan to renew the current strategy, to build sustainable bridges and remove unnecessary bumps that slows down innovation. What are the event’s highlights? This year IPC expects active deliberations of around 80 speakers, a president’ panel discussion, plenary lectures, symposia, debate and elocution competition. The most happening event of IPC is the poster session which is held in 12 different sections. What benefits will IPC provide to students considered the future of the industry? Students will get the best platform nationally for sharing and interacting, the chance to listen to active deliberations of www.expresspharmaonline.com

eminent personalities, an opportunity to visit grand techno-exhibition, opportunity to meet, interact, share and develop long lasting bond with fellow professionals. How many technical sessions will 64th IPC have? In 64th IPC around 80 renowned speakers will be actively deliberating on topics as diverse as ‘Challenges in manufacturing generics” to “Globalisation of Pharmacy Education” and the renowned speakers are top ranking Industrialist, pharmacy professionals from India and abroad, and the delegates will get an opportunity to listen and participate actively in deliberations. Please throw some light on the problems being faced by the students. It is believed that profession of pharmacy is recessionfree, but students are facing several problems and the root cause is the mushrooming of education centres across the country which in turn results in the imbalance of supply and demand ratio. Another problem is that the education today is interdisciplinary or multidisciplinary, so students have very poor knowledge of core subjects and this affects their future professional growth. Another problem that students are facing is non-uniformity of syllabus across the country. The total tenure for the doctorate degree has been increased by one year. Please comment on the adverse effects it will have on the students? I really think that by increasing the tenure by one year, students will face no adverse problems, I only want to suggest that we should follow the IIT pattern, instead of final viva, we should evaluate the students work every year and give grades and at the end calculate grade point average, in short continuous monitoring by expert committee will give some fruitful results at the end of tenure. Today, majority of the general practitioners are BHMS

and BAMS and still they practice allopathy. What is your view on this? Legally and ethically it is wrong. They are not supposed to prescribe allopathic medicines because they are not trained to do so. In India it happens only because of sheer negligence of authorities. According to you which curriculum urgently requires up-gradation and why? I sincerely feel that upgradation in pharmacy curriculum is urgently needed because present curriculum does not meet industry requirements. Also there is a need to harmonise the pharmacy curriculum. Being dean of faculty of medicine at RTM Nagpur University, we have upgraded the PG Syllabus, and changed it from annual to semester pattern. To date UG the syllabus is product oriented but we are determined to make it more patient-oriented, keeping in mind global trends. Which topics will be discussed at IPC 2012? Besides those already mentioned, other pertinent topics to be discussed at IPC include challenges for posed by the current global financial status, challenges in producing pharmaceuticals for international market, skills required as a global pharmacist of the 21st century, lessons learnt on the quality journey, intellectual property and launching new products, and up-gradation of student assessment in pharma education. Nanobiotech, herbals, targeting cancer stem cells, recent advances in manufacturing biotechnological products will also feature. Continuing education and upgradation of the quality for pharmacy teachers. What message would you like to provide on behalf of APTI for 64th IPC? Being the President of APTI, I want all delegates to actively enjoy every deliberation, upgrade their knowledge bank, enjoy the scenic beauty of Chennai and leave as happy individuals. u.sharma@expressindia.com December 1-15, 2012

Quality human resources in pharmaceutical industry: Key for success Dr Subhash C Mandal, Secretary, Regulatory Affairs Division, Indian Pharmaceutical Association, about pharma education system in India and how it has been designed to meet the needs of the industry

he Indian pharmaceutical industry started with a small turnover of ` 8 crores in the early forties, gradually growing at a fast pace, and reaching a total turnover of ` 104209 crores in the year of 2009-2010. This industry also exports a huge amount of drugs to the tune of ` 42154 crores. India is now a leading global player in the pharma manufacturing sector, and has been ranked third in terms of volume and 14th in terms of value of production. Presently, we have about 10563 manufacturing firms providing employment to 3,53,692 personnel, and have 5,50,000 retail outlets. The tremendous development was possible due to necessary protection provided by the Patent Act 1970. Pharma education in India started as a consequence of recommendations of a committee setup by the then British Government under the chairmanship of Col. RN Chopra. This committee made several recommendations for the development of pharma profession in India and starting of pharmacy education in India was one of such recommendations. As a result of it, B.Sc (Pharmacy) course was started at Banaras Hindu University in the year 1932. Thereafter Drugs and Cosmetic Act 1940 and Drugs and Cosmetics Rules 1945 have been enacted to regulate pharma industry. For regulation of pharmacy education and profession, the Pharmacy Act 1948 was framed and enacted. In the mean time, Licentiate in Pharmacy was started in Madras Medical College and in Jalpaiguri, West Bengal. This course has been renamed as

December 1-15, 2012

Diploma in Pharmacy. Gradually, B Pharm courses started in few universities during the fifties and later on. An upsurge in pharmacy colleges started since early eighties mostly under the private sector. The pharmacy education is a three-tier system in India, which are: Two-year Diploma: Diploma in Pharmacy (D Pharm) Four-year Graduate: Bachelor in Pharmacy (B Pharm) Two-year Post Graduate: Master in Pharmacy (M Pharm), Ph.D in Pharmacy and the newly introduced Pharm D Course Diploma in Pharmacy: It is a two-year course with a threemonth training in a health care institution approved by the Pharmacy Council of India. D Pharm personnel are generally engaged in community and hospital pharmacy though they also have scope in industry and marketing. Bachelor in Pharmacy: Graduate pharmacists are mostly engaged in industry in several capacities in manufacturing, quality control, sales and marketing, quality assurance, regulatory affairs and so on. Master of Pharmacy and Doctor of Pharmacy: These qualified pharmacists may opt for joining industry, research or teaching. Presently there are about 666 diploma and around 822 degree institutions producing about 26474 D Pharm, 53265 B Pharm, 21996 M Pharm and 38 Ph Ds per year. Pharmacy education is under dual control of Pharmacy Council of India (PCI) and All India Council for Technical Education (AICTE). Course curriculum of D Pharm is being prescribed by the PCI after approval of the Parliament. Presently D Pharm students are being taught the course curriculum framed in the year of 1991. Course curriculum framed 21 years back has actually lost its relevance in the present context. The need of the society has undergone a sea change due to Continued on Pg 54 www.expresspharmaonline.com

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Pharma education: In need of a revamp Prof Amal Kumar Bandyopadhyay, Division of Pharmaceutics, Department of Pharmaceutical Technology, Jadavpur University, Kolkata, opines that there is a need to evaluate and adopt a new approach to improve pharma education in India ducation is empowerment. It is a means to foster individual, social, professional and economic development and it shapes the difference between the world of today and that of tomorrow. The profession of pharmacy blends science, technical art and human relationship in a unique fashion. The issue of quality in education therefore becomes an essential concern, not only to those directly involved in the formal educational processes (such as students and educators), but also to society as a whole, policy-makers, professional bodies, parents and other stakeholders. In healthcare particularly, the need for professional interdependence has become increasingly apparent, as new priorities in public health and new demographic trends emerge, generating the necessity for multi-disciplinary approaches involving all healthcare providers as well as social scientists and practitioners. The evolution of medical sciences is from a naïve origin to a matured and advanced state, as we find it today. It has been an incredible journey and a great amount of work remains to be done in the future for further refinement of medical technology. It is said that in the pre-renaissance period, it took 400 years to develop two fold of science, but at present it has come down to four years. Computer, Internet, cable TV, mobile phone has changed life immensely. In science and technology, development is enormous. Pharma technology is not an exception. In earlier days extempore preparation of mixtures and powders were made in dispensaries. Then it developed to patented medicines. Tablet, capsules, injections were the conventional dosage forms

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and during that period presence of drug in a formulation was the only criteria. The concept of ‘bioavailability’ was not there, forget about ‘bioequivalence’. Repeat dosage form was the convention. Concept of sustained release (SR) dosage form did not prevail. Due to great developments in scientific research and the increasing (and changing) social demands in terms of healthcare, the profession of pharmacy has been forced to undergo a radical process of evolution with great shifts in its public mission in the last hundred years. Having changed firstly from formulation to dispensing of medicines, the role of pharmacists has recently evolved towards direct patient care and the assurance of therapeutic results. In this scenario, it becomes clear that quality pharmacy education needs to react to and even anticipate professional and social change. The relevance of quality of pharmacy practice is very significant in a developing and populous country like India, which has been facing problems like significant health and inappropriate medication usage. The professional pharmacy curriculum should be designed to produce pharmacists who have the abilities and skills that are necessary to achieve outcome related to, providing proper pharma care, drug information and education. Professions exist to serve the society and hence pharmacy, as a profession, must address the needs of society and individual patients throughout the world. It is important to reflect on the service that pharmacies provide while considering the content and therefore the mission of pharma education. The pharmacy profession plays a major role in the discovery, development, production and distribution of drug products and in the creation and dissemination of related knowledge. Quality pharmacy education is responsible for preparing students to enter into a www.expresspharmaonline.com

career in pharmacy and function as professionals and responsible citizens in changing healthcare systems. Students must be challenged to consider the broader relevance of their study. Pharmacy students must be comfortable and capable of communicating about health with nonexperts. Graduates must be able to fulfill their roles in society with an understanding of their ethical responsibility to patients. As pharmacists, they are increasingly called upon to deal with a growing level of complex ethical choices, hence students need formal training in ethical decision making. Due to liberalisation and globalisation many changes are bound to come. Hence there is a need to i) establish standards and criteria for the accreditation of professional degree programmes in pharmacy and continuing pharmacy education providers, ii) Promote continuous quality improvement within its accredited groups and itself, iii) Encourage innovation in pharmacy education, service and research, iv) Emphasise on learning outcomes in pharmacy education, v) Gather and analyse information and ideas from multiple sources and viewpoints as the basis for continuing policy development and decision making, vi) Optimise the effectiveness of human, financial and scientific resources. The objectives in the present scenario of pharmacy and life science education is to identify what is effective and ineffective in the current continuing education system and to reevaluate the current use of the continuing education unit in the contemporary vision for lifelong learning. To implement strategies to enhance the quality of continuing education providers and offerings, and to foster, through its accreditation activities, a philosophy of and commitment to lifelong learning is also essential. There is enormous change in healthcare and pharmacy profession. So

pharma education must prepare students to enter into the practice of pharmacy, in whatever areas are appropriate to the environment. The curriculum must be constantly assessed and evaluated to be in line with and even ahead of professional practice. They must be flexible enough to allow students to achieve a broad education in accordance with their interest. Special attention must be given to the sequence of courses and practice period that are found in the programme. The content of courses must be carefully considered, to ensure that they are relevant and up to date. Special consideration must be given to application of knowledge, communication, language and patient care skills, health system organisation, development of professional identity, critical thinking, and lifelong learning. However, currently the pharmacy and life science education in this country is not in a good shape. This might be due to wrong policies made by policy makers. The country needs enough pharma technologists, graduate engineers and other specialised life science personnel in terms of the total population of this country. But, we always compared the numbers with China. So, the authorities allowed starting colleges in rural areas, where there is no proper infrastructure and available faculties. As a result, colleges mushroomed without the assurance of quality education. The students could not get jobs because of insufficient industrialisation. As a result, every year several colleges closed down. In a college of 60 students, 90 post graduate seats were allotted with different disciplines which were not fulfilled. The colleges suffered much due to such policies. A total evaluation and new look approach is essential to come out from the present situation. The author can be contacted at akbju@yahoo.com December 1-15, 2012

Role of life sciences for growth of society Dr RS Gaud, Dean, SPP-SPTM, NMIMS, ponders whether the current curriculum in the life sciences sector preparing today's generation of professionals to meet the demands of tomorrow ducation in India has undergone phenomenal growth post independence, especially, during the past few years, as Indians realised that education is the ideal route for social, and economic growth of individual and society. Around the time of independence, education in India was primarily, philanthropic. After Independence, when the demand for educational opportunities increased, due to rising aspirations of the society and encouragement by the authorities, private institutions emerged on the scene to meet the demand. India is producing thousands of graduates, postgraduates and hundreds of doctorates every year, through its colleges and universities existing in public and private sectors. India boasts of best institutes in the world, like IIMs & IITs. Indian education is considered to be one of the best amongst the world education systems and Indian professionals are in great demand around the world, indicating the strength of the system. Today's technology-driven knowledge-based economy, requires qualified and skilled man power with higher education. Based on its talent pool, India is perceived to be one of the frontrunners in the global knowledge economy. Amongst the several disciplines that have shown tremendous growth and potential; science, engineering, technology and management fields are leading. In sciences, the contribution of life sciences to the growth of the society is remarkable which has influenced every walk of life. Its greatest impact is seen on the longevity and quality of human life. Life sciences are broadly covering, basic life sciences like botany, zoology, along with medical, biomedical, paramedical, pharmaceutical and other life and health-related areas. These

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sciences have seen an exponential growth in the past two decades. However, there are several challenges faced by education and training provided in these areas today, leaving much to be desired. Foremost among them is the quality and excellence in education. The goal of any education system is to empower the student with existing knowledge, capacity to think, analyse, inculcate problem solving approach, to enable the student to earn his livelihood while contributing to the economic growth and productivity of the society and be a responsible and socially sensitive citizen. This is a tall order to achieve which will lead to the creation of a progressive society. However, to achieve this, the key areas that are to be made available to the education system are: suitable curriculum, infrastructure, motivated faculty, inspired student community interested in excelling in the chosen area. Curriculum is the core of any programme which acts as the differentiator amongst many equals. The current curriculum is antiquated and is not in line with the rapidly emerging trends, especially in the life sciences area, like developments in medicines, emerging of diseases unknown earlier, development of newer diagnostic devices and medical procedures. If the curriculum and training system do not keep step, they may derail the growth process of the society. But curriculum, in the current Indian education system is not an area where all the stakeholders have a say in the matter. It is to be provided in a fixed frame work stipulated by the regulatory authorities and set in a point of time, covering all the bases available at that time. Some universities like SVKMâ&#x20AC;&#x2122;s NMIMS, BITs take feedback on curriculum from all the stakeholdersâ&#x20AC;&#x2122; viz. recruiters, professional from various industries as well as universities, parents and students and consider the suggestions for upgradation of curriculum. This approach might have www.expresspharmaonline.com

worked in the past but has become obsolete and is not futuristic. There can never be a common curriculum for the whole country or world as it has to change depending upon the regional needs, demands and the global requirement. While there is a need for certain basic skills which are commonly needed world over, which can form part of the curriculum, the rest of the curriculum needs to be dynamic in line with the emerging trends. Employability of the graduate coming out the set curriculum acts as an indicator of the strength of the curriculum. It is repeatedly mentioned at many fora by the recruiters that only around 10-20 per cent of the graduates coming out of the thousands of institutions are employable. Even they need orientation and induction training, which is a drain on the economy. This indicates the huge gap between the curriculum and the society/industry/employer requirements. This can be resolved by understanding the needs of the employer, which are changing by the day, and incorporating such changes into the curriculum as and when the need arises. In short, dynamic curriculum is the need of the hour. While considering the curriculum, all the stakeholders involved should be made to take an active part which includes the students, the faculty, the educationists, the policy makers, the employers and the end users namely doctors-patients or general public to provide inputs from their perspectives. There is a need for multi-level approach in the curricula as this can cater to the needs of society at various levels. It should enable certification, diploma and degree programmes with exit policy and scope for continuing education in future to allow flexible and lifelong learning. This enables the student to study and train at his convenience and contribute to society at various levels. It will also reduce the number of unemployable graduates and at the same time provide skilled man power in the para medical,

allied and other health areas. The current curriculum does not provide for this, even though government is thinking on these lines for the 12th plan. It is very clear that current curriculum does not meet the needs of today's society and industry, leave alone the future demands. Curriculum and pedagogy augment each other in training socially sensitive young professionals especially in the life sciences sector, as after training in this sector, they will be contributing to human growth and well being. It should encourage social inclusion to make it sustainable and progressive. A radical change in the curriculum and pedagogy is the solution to this problem. This is possible in the private sector of education which is empowered with autonomy in the areas like curriculum. Many private/deemed universities like SVKMâ&#x20AC;&#x2122;s NMIMS, BITS, Manipal, VIT and many more have taken advantage of this opportunity. Faculty and its quality has an enduring impact of the quality of education and the student minds. The faculty who deliver the curricula need to be upgraded on a regular basis to keep abreast with the changing curriculum and the latest trends, not only in theory but also application. The competence among staff needs to be constantly improved. The mindset of faculty that teaching includes lectures and practicals with no connect between learning and application has to be changed. There is a major responsibility on the shoulders of faculty to develop high quality individuals for the society. Traditional methods of assessment of students work well for certification and ranking purposes. Newer methods of teaching like case methodology, simulations, role plays, training at the place of future employment, understanding the end users' and societal issues, development of interpersonal and soft skills play a significant role in the development of a well rounded individual especially in the life sciences area which involves humans at the receiving end of all the educaEXPRESS PHARMA

tion and training. Practices like continuous evaluation, curriculum based on the requirement of industry, faculty – students exchange programme with international, as well as national linkages with universities and industry can contribute to this; which is successfully institutionalised by certain universities like Sikkim Manipal University, BITS, SVKM’s NMIMS and others. The mindset of the students that college is a place for edutainment, rote learning, memory recall test and certification should change. It should be inculcated in the students' mind that learning should be application oriented in real life, problem solving on day-to-day basis, being a socially sensitive individual contributing to the growth and well being of the society. Current generation of youth is endowed with better opportunities and exposure to the world and its changing trends, due to the improved communication system, world over. The time required to access, process and deliver information has reduced drastically, which converted the world into one global community with shared ideas, needs and development. Students who globe trot for acquisition of skills, employment have become the norm of the day. In such a scenario, college education plays a tremendous role in creating a quick impact on how the students deliver and contribute to the society. Curriculum in the college needs to be developed keeping all these factors in mind. The faculty should be able to encourage the students to find their calling in life and the curriculum should support them in achieving this. Multidisciplinary approach is not seen in the existing curriculum. Compartmentalisation of various disciplines, especially in the life sciences area is not acceptable anymore as every discipline has to intermingle with the other area to deliver a meaningful product/service/device/drug etc. This needs to be incorporated into the curricula immediately. Students should be provided with opportunities for horizontal and vertical movement in the curricula and flexibility to learn at their pace and with

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choice of subjects. There has to be credit-based system, with a number of prerequisite credits for the award of certificate, diploma and degree. This will allow choice of subjects to the students and encourage multidisciplinary learning depending upon the choice and requirement of the student. While infrastructure plays a great role in imparting the curriculum, teaching learning process and pedagogy are the deciding factors for the suc-

ducing employment seekers but not employment generators or leaders. There is a greater requirement for these skills in the life sciences area. This can be addressed by the curriculum which provides multidisciplinary skills including leadership, entrepreneurial and decision making skills. Indian mindset is genetically scientific in nature and also known for innovation for past many centuries. These skills need to be identified, honed and put to good

MULTIDISCIPLINARY APPROACH IS NOT SEEN IN THE EXISTING CURRICULUM. COMPARTMENTALISATION OF VARIOUS DISCIPLINES, ESPECIALLY IN THE LIFE SCIENCES AREA IS NOT ACCEPTABLE ANYMORE AS EVERY DISCIPLINE HAS TO INTERMINGLE WITH THE OTHER AREA TO DELIVER A MEANINGFUL PRODUCT/SERVICE/DEVICE/DRUG cess of any education system. Till date the curriculum is oriented towards input-based approach. It is changing towards outcome-based approach. The impact of the curriculum and training on the employability of the students and contribution to society is measured as an indicator of the strength of the curriculum. With the advent of knowledge-driven economy, intellectual property (IP) generation has taken the front seat in the education system where universities are seen as the places of growth and development of intellectual property. Curriculum should provide freedom of thinking for generation of IP to faculty and students, which can be converted into commercial applications for the benefit of society at large. This will in turn drive the growth of economy of the country and also improve the productivity and life style of people. Medical stents which increased the longevity of life and cellular smart phones which drastically changed the way the world communicates are only a few examples of the outcome of IP. The current curriculum is also lacking in training the students in developing innovation and entrepreneurial skills. It culminates in prowww.expresspharmaonline.com

use for the benefit of society, which can be done through innovative curriculum. The limited number of years of degree courses prior to certification may be inadequate in preparing the young professionals to meet the demands of tomorrow. This is because there are multidisciplinary skills required, especially in the life sciences area to cope up with the day to day demands of the work place. Today's youth is very techno savvy and very much into the technical gadgetry. E-tools like Internet, e-brary, e-journals, e-books available on their mobiles and other technical gadgets keep them updated with emerging trends. The multi-purpose use of social networking sites like facebook, twitter, linkedin has great impact on the some of the important outcomes, including the US presidential election. The delivery of curriculum should deploy these new technologies like cloud computing, social networks to improve the quality of higher education in the life sciences area. While these practices are part of infrastructure and teaching learning process at IITs, IIMs, NMIMS, BITS and some more educational institutions, it is not widespread in all the government and

private sector institutions. Very few universities like SVKM’s NMIMS has adopted blackboard technology to upload study material, updates related to knowledge areas for the students who can access the blackboard any time, any whether through Internet. Practical use and application of such technologies can positively contribute to the current curriculum in the life sciences sector and prepare young professionals to meet the demands of tomorrow. If the curriculum can provide the basic skills and inculcate the analytical and thinking capacity in students and enable the self study mode by providing them with the sources of learning and opportunities for continuous learning, the education system can prepare the youth to face the challenges of tomorrow of not only India but also the world. The above mentioned approaches are being used world over and SVKM’s NMIMS (Deemed to be University) has been using these techniques successfully since inception, which is the secret of the success of the students. SVKM’s NMIMS, is the first University to provide innovative inter-disciplinary dual degree courses in pharma-management, technologymanagement etc. meeting the requirements of the industry and providing industry ready youth, who are in great demand in the market and society. The curriculum is exemplary as all the stake holders including the students, faculty and the recruiters decide the curricula, adding the emerging areas and deleting the obsolete courses / subjects / topics. Also pure science have been brought in pharma interlink to produce interdisciplinary manpower to sever pharmamedical sector. Experiential learning is the core of the education system delivered which improves the confidence of the students to face real time issues and come up with solutions. This model can be replicated for the better growth of the graduates in particular and community in general. The author can be contacted at rsgaud@nmims.edu December 1-15, 2012

The importance and need for developing robust pharmacovigilance training programmes in India Robust training programmes will enable integration of good pharmacovigilance practice in the processes and procedures to help ensure regulatory compliance and enhance clinical trial safety and post marketing surveillance. Dr Pipasha Biswas, Chairperson, Special Interest Network Consultation Committee for Drug Safety & Pharmacovigilance, Faculty of Pharmaceutical Medicine, The Royal College of Physicians, London, UK and Director QPPV, Symogen, UK, gives an overview n increase in drug safety concerns in recent years with some high profile drug withdrawals have led to raising the bar by various stakeholders more importantly by the regulatory authorities. In Europe, there has been an extensive overhaul of the pharmacovigilance regulations and as of July 2012, pharmaceutical companies are busy adapting and implementing to the New EU Pharmacovigilance Regulations and to the Good Pharmacovigilance Practice Modules. Year-on-year, pharma companies have been reporting substantial increases in volume of Adverse Drug Reactions (ADRs) resulting in the demand for having trained resources, capable of handling and understanding pharmacovigilance to rapidly detect drug risks as well as to defend the product against an inappropriate removal. Proactive pharmacovigilance throughout the product life cycle is the way forward and the future direction for drug safety in this modern world. It is a challenge to codify and standardise the act of signal detection and risk management in the context of clinical trials and post-marketing pharmacovigilance. While major advancements of the discipline of pharmacovigilance have taken place in the West, not much has been achieved in India, and this has been mostly due to lack of proper trained personnel available in this highly disciplined and regulated field. However, with more pharmacovigilance activity being conducted in India, there is an immense need to train and build the expertise of personnel working in this area to

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western standards. For this to happen in India, a complete holistic training in the curriculum needs to be adapted and the mind set of people working in the field of clinical research and pharmacovigilance needs to be adapted. This article describes and discusses the various strategies and proposals to develop training programmes to build, maintain and implement a robust pharmacovigilance system for various stakeholders and increase the knowledge and competency skills to be at par with the western world.

Pharmacovigilance and its importance Pharmacovigilance is defined as the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long-term and short-term adverse effects of medicines. Pharmacovigilance is an important and integral part of clinical research and clinical drug development. Both clinical trials safety and post marketing pharmacovigilance are critical throughout the product life cycle. With a number of recent high-profile drug withdrawals, the pharmaceutical industry and regulatory agencies have raised the bar. Early detection of signals from both clinical trials and post marketing surveillance studies have now been adapted by major pharma companies in order to identify the risks associated with the medicinal product and effectively manage the risks by applying robust risk management plans throughout the life cycle of the product. Signal detection and risk management has added a www.expresspharmaonline.com

new dimension to the field of pharmacovigilance and as an evolving discipline; it requires ongoing refinement in order to increase its applicability and value to public health. Pharmacovigilance is still in its infancy in India and there exists very limited knowledge about the discipline. While major advancements of the discipline of pharmacovigilance have taken place in the western countries with several training programmes developed by various stakeholders in both academia and the pharma industry, not much has been achieved in India. However, robust training programmes in this discipline is required in India, which will enable integration of good pharmacovigilance practice in the processes and procedures to help ensure regulatory compliance and enhance clinical trial safety and post marketing surveillance. As the worldwide movement for the improvement of patient safety gains momentum, the subject of drug safety becomes even more prominent, thereby helping to reduce the risk of drug-related harms to patients. In India, as elsewhere in the world, the challenges and opportunities are substantial.

The enormity of the problem of ADRs Several studies conducted worldwide have demonstrated that ADRs significantly decrease the quality of life, increase hospitalisations, prolong hospital stay and

increase mortality. A landmark study by Lazarou in 1998 described ADRs to be the 4th -6th largest cause of death in the US and ADRs are estimated to cause 3-7 per cent of all hospital admissions. More than half of these ADRs are not recognised by the physicians on admission and ADRs may be responsible for death of 15 of 1,000 patients admitted. Furthermore, the financial cost of ADRs to the healthcare system is also huge. With more new medicines being approved for marketing more quickly without long-term safety studies by the regulatory authorities and switching of prescription-only medicines (POM) to over-thecounter (OTC) to be used more widely by patients for self-medication, the general public is at risk of exposing itself to ADRs. In the past, India's regulatory agencies and drug companies based their safety assessments on experiences derived from long-term drug use in the Western markets and there was no real urgency for the government to establish a strong pharmacovigilance system of its own. In recent years, however, the lag between when a drug is placed on the market and its subsequent availability in India has decreased considerably so that the much needed longer-term safety data is no longer available. In addition, India-based drug companies have increased their capacity to develop and launch new drugs through their own research efforts and this has EXPRESS PHARMA

heightened the importance of developing adequate internal pharmacovigilance standards to detect adverse drug events. However, what needs to be more important along with the funding is a focussed vision and effective strategy for developing robust pharmacovigilance training programmes which is lacking. Traditionally, pharmacovigilance was never done in India in pharma companies, be it Indian or MNCs, so there is an immense shortage of knowledgeable people who will be able to train and advice on this matter, as pharmacovigilance is a very complex subject, intertwined with regulations and complex systems. The need is therefore to engage trained pharmacovigilance experts having extensive and practical knowledge on pharmacovigilance, who can effectively train personnel to implement the systems and policies on pharmacovigilance. India is a vast country and there is a surfeit of drug brands â&#x20AC;&#x201D; more than 6,000 licensed drug manufacturers and over 60,000 branded formulations. India is the fourth largest producer of pharma in the world and is also emerging as a clinical trials hub. Many new drugs are being introduced in the country, so there is an immense need to improve the pharmacovigilance system to protect the Indian population from potential harm that may be caused by some of the new drugs. With more and more clinical trials and other clinical research activities being conducted in India, there is an immense need to understand the importance of pharmacovigilance and how it impacts the life cycle of the product. Given this situation at present, the Drug Controller General (India) (DCGI) should act quickly to improve pharmacovigilance so as to integrate Good Pharmacovigilance Practice into the processes and procedures to help ensure regulatory compliance and enhance clinical trial safety and post marketing surveillance.

The need for holistic pharmacovigilance training As organisations strive to compete in the global economy, differentiation on the basis of the skills, knowledge,

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and motivation of their workforce takes on increasing importance. According to a recent industry report by the American Society for Training and Development (ASTD), US organisations alone spend more than $126 billion annually on employee training and development. 'Training' refers to a systematic approach to learning and development to improve individual, team, and organisational effectiveness. Alternatively, development refers to activities leading to the acquisition of new knowledge or skills for purposes of personal growth. Training not only may affect declarative knowledge or procedural knowledge, but also may enhance strategic knowledge, defined as knowing when to apply a specific knowledge or skill. In addition, training may enable consistency in performance across conditions. Training is encompassing everything that is expected for the enhancement of organisational development and competencies. In order to

training programmes of professions such as clinical medicine, clinical pharmacy, clinical pharmacology or medical biology do not cover all the skills needed in pharmacovigilance. Very few universities in the world offer specific courses in pharmacovigilance. One reason might be that pharmacovigilance spans a wide range of subjects, e.g., pharmacology, epidemiology, clinical medicine, data management, drug legislation and communication, and they do not easily fit within the competence area of any of the existing academic departments. Unlike India, there are several robust taught face to face pharmacovigilance courses and training programmes in universities to help individuals gain knowledge and build expertise of this complex discipline. In the UK, the well known Post Graduate Programme for Training in Pharmacovigilance is conducted by the University of Hertfordshireâ&#x20AC;&#x2122;s MSc in

WITH THE ADVENT OF TECHNOLOGY, SEVERAL ORGANISATIONS HAVE OFFERED ONLINE TRAINING COURSES AND TRAINING PROGRAMMES IN PHARMACOVIGILANCE improve total performance, pharma organisations, service providers for pharmacovigilance and staff working at Central Drugs Standard Control Organisation (CDSCO) need to have trained and experienced people. The pharmacovigilance training programmes need to be purposive and meant to equip the employees with the necessary skills that are required for carrying out dayto-day pharmacovigilance activities smoothly. With the complexities of pharmacovigilance, emerge the importance of training and development programmes.

Training programmes in pharmacovigilance in western countries Pharmacovigilance is a relatively new and evolving science and is not a wellestablished academic specialism. Current curricula in the www.expresspharmaonline.com

Pharmacovigilance. This course trains professionals interested to pursue this discipline in a robust structured manner. A Post-Graduate Certificate Course in Pharmacovigilance and Pharmacoepidemiology is conducted by The London School of Hygiene and Tropical Medicine, University of london, is mostly for professionals working in the pharma industry wanting to advance their knowledge and expertise in this field. Similarly, the Drug Safety Research Unit (DSRU), based at Southampton, UK, is also a leading provider for several pharmacovigilance courses on various topics related to pharmacovigilance which are very popular. With the advent of technology, several organisations have offered online training courses and training programmes in pharmacovigi-

lance, which are self taught and can be done at ones leisure. The International Society of Pharmacovigilance (ISoP) is active in providing specialised ad hoc training courses in pharmacovigilance. Another organisation that does provide ad hoc training courses is the Drug Information Association (DIA) is yet another organisation that helps in building the expertise and knowledge of professionals working in this field.

Training programmes in pharmacovigilance in India With the globalisation of the pharma industry, and with off-shoring of pharmacovigilance activities to India, the need to maintain universal standards, as well as the demand for qualified and trained professionals to provide valuable inputs on Indian, European Union and American Regulatory, research and safety requirements in pharmacovigilance has propelled the need for a knowledge-packed training in this field. Pharma companies, Clinical Research Organizations (CROs), Business Process Organisations (BPOs) companies, regulatory agency i.e. DCGI office and CDSCO need professionals with good understanding of medical ethics, clinical research, pharmacoviiglance practices and patient safety, western regulations and effective communications. Keeping this in mind, and in response to this unmet need, Symogen, took the first initiative in conducting the first ever Certificate Course in Pharmacovigilance and Pharmacoepidemiology in India. This course was started in September 2007, in New Delhi and subsequently in Mumbai, taught by highly experienced and knowledgeable international faculty from the West for several years, covering all aspects of pharmacovigilance and drug safety management, endorsed by The Faculty of Pharmaceutical Medicine, The Royal College of Physicians, London (96 Credits), WHO Uppsala Monitoring Centre and the International Society of Pharmacovigilance. This course sensitised the students December 1-15, 2012

and equipped them with knowledge on pharmacovigilance practices worldwide and on the Indian scenario in detail. This course gave the young executives an opportunity to remain ahead of competitors in a very nascent yet competitive environment. This course is the first of its kind in India. With a growing demand for pharmacovigilance training in India, various private initiatives have been taken to meet this demand and profit from it. It is well known that there are a very few knowledgeable and experienced pharmacovigilance experts in India. Even if the existing experts spent all their time on pharmacovigilance teaching and training, they would still not be able to satisfy the need. Some providers of pharmacovigilance training might bring in pharmacovigilance experts from abroad or rely on a faculty of less-qualified and less-experienced tutors. However, bringing foreign experts to India contributes seriously to high tuition fees. It is therefore tempting for providers of pharmacovigilance training courses to include persons with limited pharmacovigilance expertise and experience in their faculty which has been happening in India. For professionals wanting pharmacovigilance training, it may become very important to critically assess the quality of the training being offered by various course providers. Since then, there has been mushrooming of organisations offering pharmacovigilance courses by Indian providers. However, these courses lacked both experienced trainers and content and did not provide the required skills set needed in this highly complex discipline. This has not only resulted in poorly trained pharmacovigilance staff in Indian organisations but has also affected the quality of the work tremendously that is been churned out from India.

The content in pharmacovigilance training Holistic training in pharmacovigilance needs to be adapted in accordance with the country specific keeping in mind the extent of pharmacovigilance knowledge of the trainees. Since there are many December 1-15, 2012

different stakeholders in society with a need for and an interest in pharmacovigilance, training has to be offered at different levels, with different content and given for different length of time. Health professionals working in hospitals, caring for patients in healthcare might need basic short course training for a week on ADR mechanisms, reporting requirements and patient management. Pharmacovigilance professionals involved in data collection, processing and analysis should have at more dedicated days to pharmacovigilance training. Apart from this, specific in-depth training in special sub-areas has to be provided. The 12module certificate course in pharmacovigilance and pharmacoepidemiology along with practicals associated with each modules, provided by Symogen provides a framework of topics that should be covered in a comprehensive pharmacovigilance training programme. Any pharmacovigilance programme being offered is like-

Drug Safety Data Module 8: Signal Detection Module 9: Benefit Risk Determinations Module 10: Communication In Pharmacovigilance Module 11: Setting up of Pharmacovigilance Department; Standard Operating Procedures used in Pharmacovigilance & Department links to Pharmacovigilance Module 12: Pharmacovigilance Compliance and Inspections Practicals to be covered in each Module ● Hands on experiences and discussions ● Projects and presentations ● Case studies where required (reporting of ADRs, causality, signal detection, benefit-risk etc) ● Discussions on risk management plans Training physicians; pharmacists and nurses on pharmacovigilance All postgraduate students of all disciplines in medicine, pharmacy and nursing in India should be taught phar-

SINCE THERE ARE MANY DIFFERENT STAKEHOLDERS IN SOCIETY WITH A NEED FOR AND AN INTEREST IN PHARMACOVIGILANCE,TRAINING HAS TO BE OFFERED AT DIFFERENT LEVELS,WITH DIFFERENT CONTENT ly to focus on a sub-set of these topics. It is very rare for any one individual to acquire full proficiency in all the aspects of pharmacovigilance and patient safety monitoring by only attending a training course and expertise needs to be built with continuous training on the job. Module 1: Principles of pharmacovigilance Module 2: Medical aspects of adverse drug reactions from various System Organ Class (SOCs) Module 3: Pharmacovigilance reporting systems and tools for management of reports Module 4: Global pharmacovigilance and safety standards Module 6: Methodologies in pharmacovigilance Module 7: Management of www.expresspharmaonline.com

macovigilance and have a thorough knowledge of pharmacovigilance. Since most medical colleges have a pharmacovigilance cell, post graduate trainees should spend considerable time developing themselves by attending to pharmacovigilance programmes in their medical colleges or teaching hospitals and should be made aware of pharmacovigilance, the need for and importance of reporting ADRs and the reporting procedure. They should be sensitised to ADR reporting during their residency training. To boost the reporting of ADRs and to encourage physicians serving throughout India, physicians and in particular general practitioners and specialists working both in urban and rural India

need to be trained in pharmacovigilance and encouraged to report ADRs to the pharmacovigilance programme. Pharma companies and CDSCO have an important role in creating awareness among physicians, pharmacists and nurses working in the community. Training programmes for physicians, pharmacists and nurses should cover practical aspects and carried out in small groups in a modular format so that they are able to recognise ADRs and develop a culture of reporting ADRs in the future. For those healthcare professionals in rural areas where the need to recognise ADRs is more important, continuous medical education (CMEs) programmes need to be conducted annually by the relevant professional councils. Newsletters developed by the DCGI in conjunction with the relevant councils should be distributed and mailed to doctors, nurses and pharmacists posted to the primary healthcare centres (PHCs). An awareness programme and a training schedule (both by distance education and face-to-face learning) covering all aspects of pharmacovigilance should be designed.

Conclusion With the ever increasing responsibilities and regulations to get to grips with, the role of pharmacovigilance grows increasingly complex. The science of pharmacovigilance is important for every country to ensure the safe use of medicines. Teaching and training pharmacovigilance to medical, pharmacy and nursing students will make them aware of their responsibility to report ADRs and increase and build expertise in pharmacovigilance. Pharmacovigilance is a demanding science offering great opportunities for reducing harm to patients and saving costs to healthcare systems. With holistic training and with the right knowledge and skills amongst professionals, pharmacovigilance can make an important contribution to the health of the nation. The author can be contacted at pipasha.biswas@gmail.com EXPRESS PHARMA

Quality human resources... Continued from Pg 47 socio-economic changes and due to the introduction of new drugs and new technologies. In case of B Pharm and M Pharm, AICTE formulated course is generally followed by most of the institutions except by few universities. Hence, B Pharm and M Pharm courses vary from one university to the other. Questions have been raised by experts that the course taught in colleges are more theoretical and not updated, which in general is failing to cater to the needs of the modern pharma industry. Doubts regarding the infrastructure and the quality of faculty members of some of the pharmacy colleges are not beyond questioning. Rationalisation of course curriculum, vigorous industryinstitute interaction and regular updating is highly needed to produce skilled technical manpower to compete in the global arena.

Continuing education Pharmaceutical Sciences & Technology is currently considered as a knowledge-based industry. A drug, which is deemed as life saving today, may be banned tomorrow due to surfacing of serious adverse effects/toxic effects or it may be outdated due to introduction of a better alternative. Pharmaceutical technology which is considered latest today, gets outdated tomorrow due to development of newer, more sophisticated high-end, effective technology. Even frequent changes in regulations lead to altering of many dimensions in the field of pharmacy. To cope with this situation, a pharmacist requires continuous updating of knowledge.

Teachers Pharmacists involved in teaching have several scopes for continuous education provided by University Grants Commission (UGC) and AICTE etc. They are also required to go through certain categories of training for promotion. AICTE has established centres for improving the quality of in-service teachers, for upgrading qualification as well as continuing education programmes. It also has some other programmes liketravel grant, seminar grant, career award for young teach-

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ers, emeritus professorship, visiting professorship, early induction programme, staff development programme etc. for encouraging teachers. AICTE also has a programme through which they provide financial grant to professional societies/bodies etc. for updating their members. There are also opportunities offered by Dept of Biotechnology (DBT), Indian Council for Medical Research (ICMR), Council for Scientific & Industrial Research (CSIR) etc.

Regulators Central Drugs Standards Control Organization (CDSCO) organises training for Drugs Control Officers in collaboration with World Health Organization (WHO). Recently, the said training is being conducted by National Institute of Pharmaceutical Education & Research (NIPER) at Mohali, Chandigarh. Homeopathic Pharmacopoeia Laboratory at Gaziabad organises trainings on different aspects of Homeopathic Medicines like, quality control, manufacturing, and GMP etc. Central Research Institute (CRI) conducts training for Drugs Control Officers and personnel engaged in Drug Testing Laboratory. National Aids Control Organization (NACO) organises training for Drugs Control officers on blood safety for effective monitoring of blood banks throughout the country. CDSCO recently launched the National Pharmacovigilance programme involving different health professionals including pharmacists to generate data on ADR and to educate all concerned about its significance.

Industry Generally the industries have their own training modules and concerted programmes for updating their employees, but sometimes, institutions like, CDSCO, NIPER, Central Research Institute (CRI) arrange trainings for industrial pharmacists. Different professional organisations like Indian Pharmaceutical Association (IPA) and industrial organisations like IDMA, OPPI etc., organise seminars, workshops on different emerging topics to educate and update the large pool of industrial pharmacists. In most cases those trainings are optional, www.expresspharmaonline.com

and are not linked with their career advancement. It is suggested that credit earning system for attending seminars, workshops/trainings like developed countries will be helpful for compulsory and continuous updating.

Hospital and community pharmacists There are rapid changes in the fields of hospital and community pharmacies with quick obsolescence of medicines. The expectations of patients are also in an upward mode, in tune with global changes. Pharma education in India was for a long time designed to meet the needs of the industry, but recently changes have been initiated to make it more patient-oriented. Several universities have already started postgraduate courses in Clinical Pharmacy, Pharmacy Practice etc., but the pharmacists need continuing education in the new fields like Pharmacoeconomics, Pharmacovigilance, Clinical Pharmacy, Rational Pharmaceutical Management, Rational Use of Medicines etc. Though such training courses are being arranged by a few professional associations, NGOs, and universities, no formal mechanisms exist for updating the practicing pharmacists. Recently PCI has floated a proposal that a registered pharmacist is required to go through some trainings for renewal of their registration. This may be the first mandatory training in this field. Ph.Ds: Higher research is generally conducted by the Ph.D Graduates in lifesciences including pharmacy. One recent publication in Nature reported that India produces 8,900 Ph.Ds in science, technology and engineering in 2011 which is quite low in comparison to the number of Ph.Ds produced in China (50,000 in 2009) and US (19,733 in 2009). Though there exists no definite breakup, it can be said with the help of existing data that India is generating very few number of Ph.Ds in life sciences. It is considered inadequate to match the population explosion and tremendous growth in the Indian economy. India has targeted to produce 20000 Ph.Ds by 2020. The problem is aggravated by an exodus of Ph.Ds to developed countries in search of better facilities and better

packages. Research in the emerging fields like â&#x20AC;&#x201C; genomics, metabolomics, nanobiotechnology etc require interdisciplinary approach, but unfortunately such culture has yet to be developed in India. Therefore it is envisaged, that a two-pronged approach is needed to produce more quality Ph.Ds and to provide them more conducive environment for conducting research.

Suggestions The following steps are being suggested for developing quality human resources in pharmacy: 1. A comprehensive programme requires to be put into place after judging the present societal need from the pharmacists. 2. A well thought out pharmacy course curriculum, to cater to the needs of the industry and the clinical establishment requires to be implemented throughout the country uniformly. 3. Industries should frame some sort of evaluation system, may be credit earning points like prevalent in other parts of the world. 4. AICTE and PCI need to be more vigilant to ensure required infrastructure and quality manpower of the educational institutions. 5. Pharmacy Council should impart training to pharmacists, or they must recognise training imparted by other organizations and allot credit points considering the effectiveness of the course curriculum/training module. 6. PCI should frame suitable legislation to make training mandatory for renewal of registration. 7. Pharmacy practice in our country is regulated by two major Acts, which are Drugs & Cosmetics Act and Pharmacy Act, but unfortunately there is no harmonisation between these Acts, resulting in ineffective control over the pharmacy practice. A co-ordination between the two are needed immediately. 8. Necessary steps require to be taken for proper utilisation of the potential of pharmacists in pharmacy practice. 9. Sufficient quality manpower needs to be created for advanced research in the field of pharmacy. The author can be contacted at subhash.mandaldr@gmail.com December 1-15, 2012

A Marketing Initiative

Drugs Control, West Bengal committed to healthy drugs regime edicines (i.e. drugs, diagnostics and vaccines) and healthcare services are essential goods and their universal accessibility is necessary to promote equitable, as well as efficient economic growth. According to a recent report on ‘Access to Medicines’, one-third of the world’s population does not have access to basic and essential drugs and this figure rises to one-half if the poorest parts of Africa and Asia are considered. Keeping in mind that medicines are important in curing and preventing diseases, the ultimate goal of 'Health for All' cannot be achieved if people do not have adequate access to medicines. Thus here the Government's role in creating access to medicines is crucial, particularly in developing countries like India, where a large part of the population still lives below the poverty line. India belongs to the group which is not only selfsufficient in production of medicines, but also exports substantial amount to developed and other developing countries. However, the healthcare system in this country is such that it supports availability of drugs in private retail market only, while affordability is seriously low. Under the current changing environment, the Indian pharma industry is mounting up the value chain. From being a pure reverse engineering industry focused on the domestic market, the industry is moving towards basic, research-driven, export-oriented, global presence providing a wide range of value added quality products and services, innovation, product lifecycle management and enlarging its market reach. In the immediate preindependence era (1940), the pharma industries of Bengal shared more than 80 per cent of the national drugs production that has gradually been reduced to less than eight per cent. The Government of West Bengal has its own drugs policy since 2004. The drug policy document not only mentions the policy statement, but also outlines the strategies and mechanism

December 1-15, 2012

Dr Chintamoni Ghosh towards implementations of policy mandates and commitments. The main aims and objectives of 'State Drug Policy — West Bengal 2004' are: ◆ To maximise essential medicines to people ◆ To promote rational use of medicines ◆ To facilitate rational pharma management in government health facilities ◆ To foster growth and sustainability of state level pharma industries ◆ To ensure compliance of drugs legislation/regulations and quality assurance (Hospital Efficiency in West Bengal, 2012) Agriculture is the backbone of West Bengal's state economy. Industrial and service sectors also contribute in the development of the state's economy. The pharma industry, mainly formulation units, require less land compared to other heavy industries and return on investment is fast. The prime objective of a regulatory agency is the availability of safe, effective and quality medicines at affordable price to the nation. Enforcement of the law depends on the degree of offence, which may vary from country to country but presence of Not of Standard Quality (NSQ) drugs and high price are mainly due to lack of proper enforcement of the regulatory law of the country. So the regulation is neither efficient nor effective if it is not implemented properly. Apart from conducting regular checking of unregistered pharma companies and www.expresspharmaonline.com

spurious drugs in the market, the state drugs control authority provides information about banned drugs, price notifications, attends to complaints related to the service of chemists and druggists, and addresses the adverse reaction caused by any drugs in the state. In addition to these functions, the drugs control administration is entitled to grant a renewal of drugs license for selling premises and manufacturing facility. A total of 175 blood banks, including non-government sector and 23 blood storage units are operating in West Bengal. They are regulated by this Directorate jointly with the Central Government. The authority also has joint responsibilities along with the central regulatory agency for approval of setting up of new Approved Drugs Testing Laboratory, Large Volume Parenterals (LVP), Medical Device and issue of WHO GMP certificates. Free sell certificate for export purpose, market standing certificate and production capacity certificate for participation of tender are also issued by this directorate. Apart from this, the state drugs control authority ensures the implementation of Drugs Price Control Order, 1995, The Drugs and Magic Remedies ( O b j e c t i o n a b l e Advertisement) Act 1954, The Narcotic and Psychotropic Substance Act 1986 and West Bengal Narcotic and Psychotropic Substance Act for the availability of morphine related products in the Palliative care unit, mainly for the cancer patients to protect and maintain safe and secure public health. The state drugs control is always concerned about the spurious and counterfeit drugs in the market. It has become a challenge to the state authority and will form a special task force for continuous vigilance to susceptive points. The state government is committed to the public in providing good healthcare services. One of the rules considered will be Public Private Partnership (PPP) initiative. The state government

is setting up a fair price shop, namely 'Salpa Mulyer Ousadher Dokan' in different medical colleges and hospital, which will be entered into the block level. The state drugs control authority is actively involved in implementation of this project for availability of essential medicine at competitive prices. Taking forward its initiatives, a special team of this directorate visited different chain pharmacies and pharmacy, situated in different corporate hospitals with various facilities in Kolkata and actions on the violations have been initiated with provision of the law. West Bengal is a potential market with a large target population in the Eastern and North Eastern states. It boasts of successful implementation of land reforms, with a developed rural economy resulting in an increase of purchasing power. Prime medical facility exists in Kolkata, Durgapur and Siliguri for patients from neighbouring countries, especially Bangladesh, Nepal and Bhutan. The pharmacy education in West Bengal was started 60 years back with the opening of Diploma Course in Jalpaiguri Pharmacy College. The Department of Pharmaceutical Technology is celebrating its 50 years of pharmacy course this year. Now the state has nine pharmacy colleges and also NIPER Campus in Kolkata. Even, educational institutes are showing interest to take part in the growth of pharma industries in the state. The Directorate of Drugs Control of the state too has extended a helping hand to pharma producers in meeting the global standards in stages. Since all surviving industries in West Bengal are GMP compliant, requirements of advanced tools and technology, validated and aseptic processing will no more be a problem. A strong motivation within the pharma industry is now required to regain its lost pride and position. (The author is Director of Drugs Control, Government of West Bengal) EXPRESS PHARMA

A Marketing Initiative

Parker Robinson: A leader in skin care now ventures into herbal medicine olkata-based Parker Robinson is one of the leading pharma company preparing mainly derma medicines in India. Skin disease is one of the most prevalent diseases in

developing countries, and ours is of no exception. The wide variation in climatic conditions, together with the socio-economic conditions of the people is the root of this discomfort. Keeping all

these factors in mind, Parker Robinson, now a GMP complaint company started its venture in early 80s. With a steady growth, it is one of the frontrunner in the industry today. It has a wide range

of dermatological preparations covering almost every skin ailments. But to cater to the varied needs of the sick, the company has expanded its product basket from skin to other

B K Sarkar, Managing Director, Parker Robinson products like antibiotics, expectorants, anti-oxidant vitamins with minerals, etc. Parker Robinson has set up a modern manufacturing unit in West Bengal, being managed by a group of experts, dedicated hardworking professionals to maintain the quality of the products in order to serve mankind in the best possible way. Besides, the company has recently set up a stateof-the-art R&D centre, approved by DSIR, Govt of India mainly for herbal research facilities and to develop several natural products to serve the society by tapping the vast natural resources. Herbal medicines make up a significant constituent of alternative medicine. Herbal medicine is becoming more and more popular in today's world as people seek out natural remedies. To compete in the growing pharma market, there is an need to use and scientifically authenticate more medicinally useful herbal products. WHO estimates that 80 per cent of the world population currently use herbal drugs for major healthcare ailments due to its advantages like potency and efficiency, more protection, fewer sideeffects, complete accessibility, recyclable and lower costs. Herbal drug is a chief constituent in traditional medicine and a common constituent in ayurvedic, homeopathic, naturopathic Continued on Pg 58

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December 1-15, 2012

A Marketing Initiative

Albert David launches new products, to enter new segments soon olkata-based pharma company Albert David, a unit of the Kothari group, has recently undertaken a range of initiatives for development of new products for increasing its market share in formulation segment to achieve sustained growth in the current fiscal year. “In the current fiscal, we have introduced new products and would be soon adding more brands to expand our product offerings,” said Kamal Prasad Mundhra, Executive Director, Albert David. Albert David, which makes pharma formulations, bulk drugs and injections, has three manufacturing plants — in Kolkata (for tablets and powder, small volume parenterals, oral liquids, bulk

drugs), Ghaziabad (for IV fluids in glass and polythene containers) and Mandideep (disposable syringes & needles). In the last fiscal, the company, touched a turnover of Rs 230 crore. The company has successfully launched UDCA and Silymarin combination, 'Actimarin' (75mg and 150 mg) /Actimarin Forte', Febuxostat – 'FBX', Dapoxetin – 'Amjoy', a drug for premature ejaculation and has also introduced products like 'Anaflam TH4 / TH 8' – a skeletal muscle relaxant, 'LArginine' Sachets, Isoxsuprine tablets and Alamin RG / RGX, which it feels will tilt the balance in its favour. Soon, it would launch

K P Mundhra, Executive Director, Albert David betahistine and domperidone combination, hormonal prepa-

rations and anti-asthmatic drugs. Commenting on its 55year old flagship product, 'Placentrex', Mundhra brushed aside any apprehension about the product. Earlier, the Government of India pursuant to the directives of the Hon'ble High Court of Delhi had revoked the ban on 'Placentrex Injection' for PID and Placentrex topical application for wound healing. This led to some confusion among the medical fraternity but the issue has been resolved and all out efforts have been made to restore the confidence of the doctors and revive the brand, he added. He said, “The company has given much thrust on its

Research & Development initiatives. The R&D wing is involved in the development of newer products with maximum therapeutic values, while at the same time focusing on improving the quality of its existing products.” In the coming days, the company plans to tap the international market in a bigger way. Exports will remain to be a key driver for growth of the company in the coming years, Mundhra added. He exulted confidence about the prospects of the pharma industry in the country and said, 'Albert David will continue to grow with the current strategies in place and is equipped to meet any future challenges.' EP Team - Kolkata

We value human life Albert David Limited has been in continuous pursuit of providing quality healthcare solutions. Applying its world class expertise to make high quality and affordable medicines. Our eternal passion is to work towards bettering human life.

Ursodiol 300mg & Silymarin 140 mg tablets

Isoxsuprine hydrochloride 10mg Tablets, 40mg SR Tablets, 5mg/ml IM / IV

15, Chittaranjan Avenue, Kolkata - 700 072, Phone: 2212-9700/9637/9592, Fax: 033-2225-8714/2212-9629, E-Mail: adidavid@cal.vsnl.net.in, E-Mail: adldavid@dataone.in, Website: www.albertdavidindia.com

December 1-15, 2012

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A Marketing Initiative

Continued from Pg 56 and other medicine systems. Herbs are usually considered as safe since they belong to natural sources. The use of herbal drugs due to toxicity and side-effects of allopathic medicines, has led to rapid increase in the number of

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herbal drug manufacturers. Herbal products have reached extensive adequacy as beneficial agents like antimicrobial, anti-diabetic, anti-fertility, anti-ageing, anti-arthritic, anti-HIV, sedative, anti-depressant, antianxiety, anti-spasmodic, analgesic, anti-inflammato-

ry, vasodilatory, hepatoprotective, treatment of cirrhosis, asthma, acne, impotence, meno-pause, migraine, gall stones, chronic fatigue, alzheimer's disease and memory enhancing activities. The company has launched their new finished

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products after an extensive research, experimentation and successful trials. It has brought to the market, more than 50 branded allopathic and 10 herbal finished formulations for human consumption targeted for dermatological, conventional, cosmeceuticals and nutri-

tional products. Some other formulations are undergoing research and trial. The major aim of Parker's R&D is its research in the field of natural products, encompassing the screening of medicinal plants for their pharmacological benefits, the identification of active principles, the development of extraction and purification systems for industrial application. It's R&D Centre is well equipped with sophisticated and imported scientific instruments and facilities to ensure and maintain the quality of health and safety, improved efficacy and increased productivity. A research team with skillful and energetic personnel has been employed for conducting research on phytochemistry, quality assurance and control, bio-assay, microbiology, stability testing and pharmacology. Additionally, to ensure sustainable supplies on its key products, herbal plants cultivation efforts has been successfully undertaken by the company and provides a platform for developing innovative natural products with scientific and clinical validation. Finally, it has been concluded that medicinal herbs as potential source of therapeutics aids has attained a significant role in healthcare system all over the world for human beings not only in the diseased condition but also as potential material for maintaining proper health. It is clear that the herbal industry can make great strides in the world. With the increased use of herbal products, the future worldwide labelling practice should adequately address quality aspects as well. Standardisation of methods and quality control data on safety and efficacy are required for understanding of the use of herbal drugs. A major factor impeding the development of the medicinal plant-based industries in developing countries has been the lack of information on the social and economic benefits that could be derived from the industrial utilisation of medicinal plants. Further research is required to exploit the compounds responsible for the observed biological activity. December 1-15, 2012