Express Pharma December 1-15, 2013 Part I

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CONTENTS Vol 9 No.3 DECEMBER 1-15, 2013

Chairman of the Board Viveck Goenka

POLICIES FOR SUCCESS

Editor Viveka Roychowdhury* BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bangalore Neelam M Kachhap Delhi Shalini Gupta DESIGN National Art Director Bivash Barua Deputy Art Director Surajit Patro

2013 has been all about long pending regulations finallyseeing the light of day…onlyto have them debated,dissected,modified and debated once again.What do industrystakeholders want from policymakers?

As a part of its IPC Special, Express Pharma invites industryexperts to share their thoughts

Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka

P36: COMPANY WATCH

Layout Rakesh Sharma

Anand Sharma meets Ireland’s Minister for Jobs, Enterprise and Innovation

Photo Editor Sandeep Patil

P49: INSIGHT

MARKETING Deputy General Manager Harit Mohanty Senior Manager Rajesh Bhatkal PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Rohan Thakkar CIRCULATION Circulation Team Mohan Varadkar

WEST BENGAL PHARMA REVIEW

Fixing India’s TB control policy

105

DESTINY OF PHARMA INDUSTRIES IN WEST BENGAL

P100: PROFILE

106

STADMED PHARMA: DIVERSIFYING PRESENCE

107

ALBERT DAVID TO LAUNCH MARKETING DIVISION

108

‘WE PLAN TO INCREASE OUR PRODUCTION CAPACITY BY STARTING A NEW PLANT’

Spaceage Aquatechs: A helping hand to conservation

P101: CLINICAL UPDATE Efficacy of PMBL to reduce infection risks in COPD patients by almost three-fold: Study

P112: PHARMA LIFE Alignment of human capital

IPC SPECIAL

20

CURRICULUM FOR CHANGE

26

65TH IPC LOC CONDUCTS SIXTH MEETING

27

‘CALL FOR QUALITY ASSURANCE IN EDUCATION’

28

SKY IS NOT THE LIMIT IN PHARMA INDUSTRY

30

VALUE ADDED AND SKILL-BASED EDUCATION IS NEED OF THE DAY

31

IPC 2013: REACHING NEW HEIGHTS

32

WHAT DO INDUSTRY STAKEHOLDERS WANT FROM POLICY MAKERS?

Express Pharma Reg. No.MH/MR/SOUTH-77/2013-15, RNI Regn. No.MAHENG/2005/21398. Printed for the proprietors, The Indian Express Limited by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright @ 2011. The Indian Express Ltd. All rights reserved throughout the world.

Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

EDITOR’S NOTE

Formulating policies for success

A

t a recent industry seminar, there was general consensus that slipups by individual pharma companies were dragging down the entire industry. Dr Claus-Dieter Boedecker, who heads Merck (India) as well as Merck Millipore India agreed that India is not alone at the receiving end of heightened regulatory vigil over non-compliance, but this year has seen an unusually high number of such ‘unpleasant surprises.’

Being tarred with the same brush is today a real concern but has not reduced global interest in India's market. Global PE firm KKR is reported to be close to buying a minority stake in Hyderabad-based Gland Pharma while US generics major Mylan, as well as two Indian companies, are said to be interested in buying out Chennai-based Bafna Pharmaceuticals. Both Gland Pharma and Bafna Pharma have focused on niche high value products and that's been their path for success.

Casting the US FDA or other regulators, overseas of domestics, as the big bad wolf is not the solution. Raising the bar and implementing stricter policies to ensure good manufacturing practices quality is the way forward. But many argue that we already stand the risk of strangulation by regulation.

How do we find the middle path, formulating policies for success, which will address both access and affordability as well as insure growth of a sector? As a part of its IPC Special, Express Pharma invited industry experts to share their thoughts. So while

10 EXPRESS PHARMA December 1-15, 2013

Many argue that we already stand the risk of strangulation by regulation

journalist-activist Bharathi Ghanashyam, co-founder of the blogsite/group, Journalists Against TB talks about the reforms needed in our TB control policy (page 49), legal eagle Kirit Javali highlights the need for policies to ensure affordability and availability of drugs (pg 50). With regards to clinical trials management, Dr Sauren Das comments that regulations must be implementable and practical (pg 51) and NGO head Harsha K Rajasimha (pg 52) urges the Government to provide direction and support to take on the urgent unmet needs of the 70+ million rare disease patients.

With this year’s 65th edition of the Indian Pharmaceutical Congress being hosted by the Indian Pharmacy Graduates Association, we focused on the theme: 'Curriculum for change' (pages 20-25) and got stalwarts like Dr B Suresh (pg 27), Dr Mahesh Burande (pg 28), Atul Kr Nasa, Vijay Bhalla (both on pg 32), Dr Roop Krishen Khar (pg 33), and SL Nasa (pg 34) to share their suggestions.

We round off this issue with Hay Group’s Global Managing Director – Life Sciences, Ian Wilcox, making the case that life sciences companies will ultimately rely on the strength of human capital initiatives to support the goal of showing value. A sound business strategy will underperform unless the human capital and cultural component of change is a top priority.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

cover )

IPC SPECIAL As industry and academia converge at the 65th Indian Pharmaceutical Congress, Express Pharma's IPC Special presents a preview of some of the hot topics which we hope will be debated at this much awaited event

20

pg

18

EXPRESS PHARMA December 1-15, 2013

26

pg CURRICULUM FOR CHANGE

65th IPC LOC CONDUCTS SIXTH MEETING

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27

pg

32

pg ‘CALL FOR QUALITY ASSURANCE IN EDUCATION’

THE MAIN FOCUS

WHAT DO INDUSTRY STAKEHOLDERS WANT FROM POLICY MAKERS?

19 EXPRESS PHARMA December 1-15, 2013

cover ) Curriculum for

change There are some issues associated with current pharma education system in India. More practical approach towards pharmacy education will help students become key growth partners for the pharma industry

BY SACHIN JAGDALE

Those with a DPharm degree find opportunities as pharmacists in hospitals or community pharmacies. The salaries offered are mostly lower than what nurses and diploma level engineers earn Dr Mukul Pore Director, Intox Laboratories

20 EXPRESS PHARMA December 1-15, 2013

T

here are many unsung heroes who have orchestrated the success story of the Indian pharmaceutical industry. Today, thousands of pharma professionals are working on different projects/positions in this industry. Pharma graduates and post graduates constitute a large proportion of this work force.

However, according to industry experts, outdated pharma curriculum that is being taught across many pharma colleges in India, is badly affecting the careers of pharma students.

Indian pharma industry, which is also one of the largest in the world, needs pharma students with more practical knowledge. Unfortunately, the current

format of pharma curriculum would make aspiring pharma professionals struggle to meet pharma industry's expectations.

Salary woes One of the problems plaguing the entry level Indian pharma industry professionals is their pay package. To the surprise of industry experts, with a few exceptions, pharma professionals have largely been deprived of modest pay packages. But, they also argue that if the pharma student is skilled enough then higher pay package will not be an issue for the job provider.

There are different job categories in the pharma industry and depending on the job profile, salary package also varies. Dr Mukul Pore, Director, Intox Laboratories, informs, “The average starting salary for a pharmacist is around ` 4,000, Research Scientists earn ` 10,000 - 40,000 per month, med-

ical representatives earn around ` 5,000 - 10,000 per month + incentives, manufacturing pharmacists take home ` 5,000 upwards, hospital pharmacists get around ` 3,0.00 - 5,000 per month, government jobs offer ` 1,500 - 2,500 per month (basic) along with contributory provident fund, daily allowances, insurance, medical reimbursement, and other allowances and benefits as per government rules. Freshers with B Pharm degree are taken as trainees with the average salary of about ` 5,000 to ` 10,000. After one year of experience professionals can draw higher salaries.”

He adds, “Those with a DPharm degree find opportunities as pharmacists in hospitals or community pharmacies.

The salaries offered are mostly lower than what nurses and diploma level engineers earn. Pharmacists who opt to work at chemist stores have been known to be exploited by owners and do not receive adequate pay.”

cover )

A good performer, in a time span of five to 10 years, can withdraw a salary of ` 5 to 10 lakhs per month with all facilities.

Dr Mahesh Burande Principal, CAYMET's Siddhant College of Pharmacy, Sudumbare, Pune. and President, Association of Pharmaceutical Teachers of India (APTI)

Faculty in most Indian universities and institutes are bogged down by teaching loads and the research component is consequently limited.

KV Subramaniam President and Chief Executive Officer, Reliance Life Sciences

22 EXPRESS PHARMA December 1-15, 2013

However, there are some contradictory views as well. Dr N Udupa, Director - Research, Manipal University and Professor, Department of Pharmacy Management, says, “It is a myth that BPharm or MPharm degree holder would get very less salary. To our knowledge the package (initial package) is decent and varies according to job description. It may be less in production and research when compared to marketing.

And there is an option of becoming an entrepreneur where sky is the limit.”

Skill and experience will earn you the money. Initial salary package may be less but as the pharma professional piles on experience his salary package also swells.

“You may not get a job of your choice, place of your choice, company of your choice, but you will get a job as per your knowledge, skill and atti-

tude to work at ground level,” opines Dr Mahesh Burande, Principal, CAYMET's Siddhant College of Pharmacy, Sudumbare, Pune. and President, Association of Pharmaceutical Teachers of India (APTI).

He adds, “In the pharmacy industry today, the starting salary may range from ` 8000 to ` 25000, depending upon companies' strength and students' professional skills. But once you start performing, you

can add many zeros to your salary. A good performer, in a time span of five to 10 years, can withdraw a salary of Rs 5 to 10 lakhs per month with all facilities. Initially, students should not look for salary but aim to get into the pharmacy profession, develop professional skills and think of performance.”

Burande asserts that performance is the only criteria in this world to achieve every dream and we should not com-

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cover ) pare ourself with other professionals. Comparison will always make us unhappy and we are in the business of making people healthy and happy by producing quality medicine and taking quality care, he states.

Outdated curriculum Colleges are perhaps the first halt where a student starts getting himself familiar with the pharma industry. However, pharma curriculum in India has very often been criticised for not keeping pace with the changing pharma scenario.

“Faculty in most Indian universities and institutes are bogged down by teaching loads and the research component is consequently limited. In interviews conducted by my colleagues and I, we find that conceptual learning is lacking and the orientation seems to be enrolling in a course to pass examinations, get a degree and an employment. Very rarely do you come across students genuinely interested in research and have a passion. There is an imperative to revamp the existing curriculae to make it industry-oriented, include action learning-based aspects and learning at a conceptual level,” says, KV Subramaniam, President and Chief Executive Officer, Reliance Life Sciences.

This is the reason Reliance Life Sciences started the Reliance Institute of Life Sciences (RILS), a not-for-profit organisation, in 2006, to focus on competency development through oneyear Young Professionals Programs and Advanced Diploma Programs in biotherapeutics, biopharmaceuticals manufacture, clinical research, quality management and marketing.

Pore says, “The number of pharmacy graduates, post graduates in the country is growing.

Although there is a quantitative growth, there is very little qualitative growth.”

He adds, “The fresh graduates have theoretical knowledge but are limited in exposure on

24 EXPRESS PHARMA December 1-15, 2013

Curriculum of a few pharmacy colleges is dynamic and suits the industry needs whereas a few pharmacy colleges do follow the outdated and obsolete curriculum

It is a myth that BPharm or MPharm degree holder would get very less salary. To our knowledge the package (initial package) is decent and varies according to job description.

Sreedhar D

Dr N Udupa

Associate Professor and Head , Department of Pharmacy Management, MCOPS, Manipal

Director - Research, Manipal University and Professor, Department of Pharmacy Management

the practical side due to very limited or virtually none handson lab experience. The lack of qualitative toxicology training opportunities is hurting the industry. Industry lack people able to design, carry out, and analyse in vivo experiments, and then build models to extrapolate data across species and into man.

Therefore, the graduates will need both sound theoretical grounding in concepts and guidance in applying these in practice from experienced industry experts.”

Though outdated curriculum is a worry for the pharma industry there are exceptions as well.

Some of the pharma colleges do keep themselves abreast with latest requirements of the pharma industry and update their curriculum accordingly.

“Curriculum of a few pharmacy colleges is dynamic and suits the industry needs whereas a few pharmacy colleges do follow the outdated and obsolete curriculum. It depends on the colleges and the regulatory body to prescribe the curriculum and also revise at least four years once for B Pharm and every two years for M Pharm. There should be inputs from pharma industry while designing/revising the curriculum. Apart from course work there should be inclusion of mini research projects and extra and co-curricular activities in the curriculum,” says Sreedhar D, Associate Professor and Head , Department of Pharmacy Management, MCOPS,

Manipal Pore warns that we are much behind of our Western counterparts as far as pharma curriculum is concerned. He also feels that our curriculum should be of international standards. “In order to demonstrate the requirements for pharmacists in India, it is necessary to undertake a pharmacy workforce study, to review pharmacy education programmes, and to compare them with the roles that have been accepted internationally. Pharmacy curriculum should be updated because we are much behind the Western countries in terms of research work that is carried out over there.”

“What is taught in the class room is never used in practice. A pharmacist is taught subjects like pharmacology, pharmacognosy, pharmaceutical jurisprudence, pharmaceutical chemistry, anatomy and physiology, pharmaceutics. Pharmacognosy, community pharmacy, pharmaceutical chemistry and pharmaceutical jurisprudence have no use in practice while other subjects have their own limitations,” opines Bhupendra Kumar, Secretary General, Indian Pharmacist Association (IPA).

Kumar feels that besides restructuring topics that are being currently taught in pharma colleges introduction of new subjects is also equally important.

Expectations from pharma institutes As the pharma institutes are

one of the sources from where the pharma industry would hire skilled professionals from, it is the prerogative of such institutes to nurture talents in such a way that it would stand to job giver's expectations.

Association of Pharmaceutical Teachers of India (APTI) is actively working towards making pharma institutes change the ways they conduct or frame their courses. Burande gives details about initiatives taken by APTI in this regard. He informs, “APTI has made a Academy – Industry Interaction cell and this cell will interact with industry continuously and discuss various new subjects, topics, practical skills required in pharmacy students before they pass out to take responsibilities.”

Subramaniam once again highlights the issues raised by many industry players. Giving industry perspective of this discussion, he says, “Educational institutions would need to re-orient towards industry-oriented courses. This would make them fairly employable after graduation.” Subramaniam expects changes not just at the levels of colleges, according to him, even universities have to take initiatives to make things more industry friendly.

“Universities can also make efforts to develop programmes aimed at developing students with specific competencies for the industry, such as manufacturing, validation, quality management and marketing. Here,

both academia and industry can work together on developing specific programmes to address the talent/competency requirements of industry,” feels Subramaniam.

Subramaniam insists that improvement is not only meant for the institutes. Students should also contribute in their own ways. Apart from the educational material available in the colleges there are so many information sources available through different channels that would help them know more about the industry. He explains, “Students, on their part, would need to look beyond their curriculum as well as develop a clear understanding of fundamental concepts. They would have to inculcate a habit of regular reading of scientific journals, periodicals and books in the domain, which sadly is lacking.

Practical experiments included in the university curriculum are important and students would do well to get as much hands-on experience as possible, along with internships in industry.”

Along with the infrastructure and quality of the education students also look for job assistance that these colleges would offer.

Colleges with good placement provisions do attract large number of students.

According to Burande, first of all pharma institutes should have a well-structured and functioning placement cell with a placement officer and a clerk. “It is very essential for any phar-

( macy institute as students would look at first placement while taking admission to any institute.

Placement officer should dedicate most of his working hours for the placements. He should be allowed to go around the companies advertising about the institute and bring in changes in the curriculum according to the needs of the industry. He should conduct training programmes for the outgoing students and make students employable. And he should negotiate a good package for students,� says Burande.

According to Kumar, phar-

Pharmacognosy, community pharmacy, pharmaceutical chemistry and pharmaceutical jurisprudence have no use in practice Bhupendra Kumar Secretary General, Indian Pharmacist Association (IPA).

macists are completely neglected in pharma industry.

BPharm degree holder finds it difficult to enter into the R & D space of a pharma company.

Modernisation of pharma curriculum will definitely address the issues highlighted by Kumar.

Forging the future path Till a few years ago pharma colleges were mainly seen in big metros. However, now this trend is slowly moving towards small metros as well. Many pharma colleges have been opened in remote parts of India from where a significant chunk of degree holders is passing out. But, these

25 EXPRESS PHARMA December 1-15, 2013

colleges might have their own limitations. Getting experienced faculties will be an issue. Lack of money leads to unavailability of good infrastructure and also the

equipment which are necessary to have industry-oriented practical experience. As already said by industry experts in this article, co-operation among educa-

THE MAIN FOCUS

tional institutes, pharma industry and government would help to overcome these limitations.

However, very few have paid heed to this call for co-operation

over the years. Unless somebody takes a decisive stand these issues would continue to prevail. sachin.jagdale@expressindia.com

cover ) 65 IPC LOC conducts sixth meeting th

Accident insurance coverage, job fair added as new attractions for prospective delegates

Usha Sharma New Delhi THE LOCAL organising committee (LOC) of the 65th Indian Pharmaceutical Congress (IPC) recently conducted its sixth meeting at FICCI House, New Delhi.

The meeting was attended

by Atul Kr Nasa, President, Indian Pharmaceutical Association; and other senior office bearers including Prof (Dr) Arun Garg, Organising Secretary; Vijay Bhalla, Treasurer; SL Sobti, Co-Chairperson; SL Nasa, Co-Chairperson; PP Sharma, Co-Chairperson- Protocol Committee; PK Jaggi, CoChairperson- Reception Committee; Dr Ajay Sachan, Associate Secretaries, KT Raghukumar, Associate Secretaries- Souvenir, Deepak Sharma, Associate Secretaries, Prof RK Khar, Chairperson – Inauguration Committee, Bhanu Dua, Chairperson –

26 EXPRESS PHARMA December 1-15, 2013

Venue Committee, Anil Kr Negi Chairperson – Hospitality Committee, P Arivazhagan, Chairperson - Entertainment Committee, Bharat Bhusan, Chairperson - Exhibition Committee, Kulbhushan Gupta, Chairperson - Press and Publicity, Saurabh Arora, Chairperson - Information and Public Relations, Shree Kumar, Chairperson - Sight Seeing, Naval Kishore Anand, Chairperson - Medical Services, Sunil Dhankar, Chairperson – Security and Surabhi Khanna Co-Ordinator. Each member put forward suggestions for the success of the event as per their designated roles.

Atul Nasa, President, 65th IPC Delhi welcomed all the members and informed them about activities related to the event, which will be held from December 20-22 at Amity University, Delhi NCR. He talked about the previously held meetings and gave details of the

progress on multiple fronts.

Following this, Garg explained each committee’s chairperson’s respective duties. He also shared details about budget allocation to respective committees as well as other resources required for the success of the 65th IPC. According to the registration committee, to date, 4000 delegates have registered. A breakup of the state wise numbers reveals that registrations from southern India currently outnumber the northern regions.

Revealing the core reason behind this imbalance, Bhalla informed the members that compared to past years, the number of students of M Pharma have decreased slightly. As a result, the number of vacant seats in most colleges have increased.

He also mentioned other issues which are contributing and restricting registrations. For instance, many students in Uttar

Pradesh will be busy with their semester exams during the event and hence unable to register.

To resolve this issue, Atul Nasa suggested that a letter should be presented to the examination authority so that the exam can be delayed and the students can be motivated to participate in the IPC. He has also informed that a team will be formed to brainstorm with the heads of departments of pharmacy colleges located near UP and in the NCR region and if required these students will be given a concessions for group registration.

For the first time in the history of IPC, a suggestion has also been made to provide insurance coverage of Rs 5 lakhs for all the delegates for all three days. The respective committee will be working on the same. Keeping in mind safety aspects, medical services, both emergency and regular, have

also been arranged.

To ensure that the attending students get the best out of the event and with a view to enhance their future prospects, the LOC is also planning to organise a job fair during the event. They are currently working with key pharma companies to ensure they send members from their human resource departments to identify and select resources for their companies.

The exhibition area for the 65th IPC is located on the Amity University campus and to date, 3,400 sq ft area has been already booked. The exhibition committee expects that the exhibition area will ultimately spread across 4,000 sq ft. Considering the large participation from students, the cultural committee has also arranged cultural programmes in the evenings. u.sharma@expressindia.com

(

THE MAIN FOCUS

I N T E R V I E W

‘Call for quality assurance in education’ Dr B Suresh, Vice Chancellor, JSS University, Mysore and President, Pharmacy Council of India briefs Usha Sharma on the changes needed in pharmacy education

What is the current state of Indian pharmacy education? Why is there less confidence in this field?

Indian pharmacy education is on the threshold of evolving and expanding its role in the healthcare delivery and emerging as one of the most relied source for the global health human resource. Moreover the newly developing areas in the pharma industry in pharmacovigilance, regulatory affairs, etc. The lack of confidence seen in the field is apparent. This is because the pharma industry has become knowledge intensive and expects the pharmacy graduates to be conscious of the advances and growth taking place in the industry. This calls for quality assurance in education, curriculum restructuring and experiential training.

In the last four to six months, there were a couple of protests and

27 EXPRESS PHARMA December 1-15, 2013

cover ) agitations across various parts of India for the betterment of the Indian pharmacists. Please share your opinion on the same?

The students' anxiety is only natural! This is predominantly because of the increase in the number of colleges and the consequent increase in the graduates passing out in the country.

This has resulted in quality issues in the industry and thereby decrease in the compensation being paid to graduates. Moreover the role of pharmacists in stores and hospitals is under utilised and the feeling particularly by the trade is that the pharmacist's presence is not essential, which is not true and explicitly wrong. There is not only a legal requirement for the presence of pharmacist in pharmacies but also a need to advise the patients and coordinate with the physicians on the challenges that arise because of newer medication and ever evolving new diseases.

Currently, what are the issues faced by the Indian pharmacists with regards to compensations? What regulations need to be

implemented in the system?

The compensation issue in the industry is both skill and knowledge based. However in the community pharmacy or drug stores even the minimum wages are not paid and compensation is not commensurate with the working hours and qualification acquired. The Pharmacy Act and the Drugs and Cosmetic Act clearly emphasise that the dispensing of medicine can only be made by a pharmacist. There is a strict need for regulatory authorities enforcing it!

Tell us about practising regulations and its importance in the society?

How will this cut the unethical practices which are prevalent in the society?

The proposed ' Pharmacy Practice regulations' emphasises on the roles and responsibilities in providing pharma care to patients and supporting the physicians in healthcare delivery. The regulations also provide for continuing education mandatory for reregistration with the council.

the scope and employability of the graduates passing out from such institutions.

DR B SURESH Vice Chancellor,JSS University, Mysore and President, Pharmacy Council of India

The regulations also define pharmacy as a practising profession and in lieu of the services rendered the pharmacist needs to be suitably compensated.

Being the president of the Pharmacy Council of India (PCI), what kind of partnerships do you think should take place between the industry and academia and how helpful will it be?

The Pharmacy Council of India advocates industry academia interaction and has also asked the institutions to appoint a placement coordinator at the institution level as well as organised a meeting for the same. A strong industry-academia relationship always enhances

Indian Pharmacopoeia is partnering with USP, WHO and other key regulatory authorities. What do you have to say on this?

This is essential if we are looking at harmonising with global pharmacopoeia standards.

Brief us about the dual regulations which prevail in India and inform us about the steps needed and its initiatives?

The acts that oversee pharmacy education are the Pharmacy Act 1948 and the AICTE Act. Dual regulations always have conflicting regulatory mechanisms which can be exploited by the providers of education, particularly if the leadership of such organisations and the acts are trying to regulate the same aspect and function. The need to set this right cannot be over emphasised here, particularly when the pharmacy education is facing challenges.

Tell us about professionals'

continuing pharmacist programme? How successful is this programme? Till now how many such programmes have been organised and where?

The PCI has provided guidance to councils that while re-registering the pharmacists they should take into consideration that the pharmacist should have undergone at least two continuing education programmes between the two registrations and with not more than a gap of five years. This is quite successful, though I am unable to provide the details or number of such programmes that have been organised, as these are organised at regional levels.

What modifications or changes would you like to suggest?

The various regulations that have been submitted to the Ministry of Health and Family Welfare need to passed. These will, I am sure, set right the problems being faced by the pharmacy profession in the country. u.sharma@expressindia.com

Sky is not the limit in pharma industry Dr Mahesh D Burande, Principal, CAYMET's Siddhant College of Pharmacy, Sudumbare, Pune and President, Association of Pharmaceutical Teachers of India, Chairman, Pharmacy Group, Maharashtra State board of Technical Education, Mumbai speaks to Usha Sharma about the gaps in India’s pharmacy education system

Today the pharmaceutical industry is facing a compensation issue in both skill and knowledge. What do you have to say on this?

The pharmaceutical industry in India is growing at

28 EXPRESS PHARMA December 1-15, 2013

15 per cent to 17 per cent every year by volume, but due to regulations, Drugs Price Control Order (DPCO) and promotion of generics, the profit margins are reducing.

The starting package in

pharma industry is always less as compared to the IT industry and expectations of B Pharm and M Pharm students are always high.

During the last 30 years, we have seen the industry

first test the person for his performance and then increase his package depending on the quality output from the employee. I believe once the person starts performing then the sky is not

the limit in pharma industry, as far as the package is concerned. Four active ingredients for success formula is application of knowledge, skill, hard work and most important positive

( at different locations with less packages.

The healthcare industry is also offering jobs in hospitals, clinical research,

DR MAHESH D BURANDE Principal,CAYMET's Siddhant College of Pharmacy,Sudumbare,Pune,President,Association of Pharmaceutical Teachers of India,Chairman,Pharmacy Group,Maharashtra State Board of Technical Education

attitude and passion towards the job and pharmacy profession. Compensation is always based on performance to give results, so a person who is joining the pharma industry should have patience for the first two years and start performing right from the first day.

Over the years, pharmacy graduates and the number of colleges have increased predominantly, but the job opportunity is much lesser.

Why is it so?

We have more than 1,000 pharmacy colleges in India and more than 70,000 students pass out every year.

Many of them, almost 20 per cent of the students are proceeding for post graduation which means 50,000 students are looking for jobs in the pharmacy profession and may be 15,000 post graduates are also looking for jobs in pharmacy profession. Presently, the size of the pharma industry is more than 20,000 in number which is providing almost 15 types of different job opportunities to the pharmacy students. Today 30 per cent jobs are available in pharma sales and marketing segment at any time in the growing pharma industry while jobs in production, quality control and quality assurance may be 20 per cent

29 EXPRESS PHARMA December 1-15, 2013

pharmacovigilance, regulatory, drug store, data management in IT companies and even in insurance companies. Post graduates

THE MAIN FOCUS

are required in R&D and teaching while MBAs in pharma marketing. You may not get a job of your choice, company of your choice, place

of your choice or package of your expectations but you will get a job any time anywhere in

Continued on Pg 30

cover ) Value added and skill-based education is need of the day Dr Madhusudan Saraf, Principal, Bombay College of Pharmacy highlights the grey areas in pharmacy education with Usha Sharma

Bombay College of Pharmacy (BCP) was established in 1957 and has seen various shades of the Indian Pharmaceutical Congress (IPC).

Please share your IPC experience in last 10-15 years.

BCP has been actively associated with Indian Pharmaceutical Congress in the past. The unique annual conference of the Indian Pharmaceutical Association along with Commonwealth Pharmaceutical Association was organised in the premises of BCP way back in 1977. I was fortunate to be associated in the capacity as a member of scientific services committee and as a Chairman/ CoChairman of the scientific session in several past conferences. It used to be a great memorable event to interact, learn and share our views and experiences during the scientific deliberations, besides meeting fellow colleagues and other professionals. It used to be a compact group of less than

2000-3000 delegates.

However, the number of delegates attending the Congess has swelled to enormous proportion.

Industry participation has been significantly reduced.

The charm of participation in the Congress is reduced due lack of focus and organisation of several conferences / conventions by different professional bodies during the year.

DR MADHUSUDAN SARAF Principal,Bombay College of Pharmacy

What reforms should you recommend to bridge the gap between industry and academia?

The gap between industry and academia will remain if they work in isolation. We at BCP have an excellent experience of working with the industry. We have a track record of successfully completing several projects in collaboration with the industry. The academic partners must establish confidence in the quality of the work carried out by them

and by submitting the report in the pre decided time.

There is always scope for increasing industry-institute interactions. The potential academic organisations can establish an industry institute partnership cell to undertake activities which will facilitate the industry to undertake programmes to update the knowledge and skills, utilise facilities available in the institutions and work on innovative

projects which will foster their growth through new avenues created. The academic institutions have to be accredited and obtain recognition to fulfill professional compliance anticipated. There should be periodic brain storming meetings to work on the technical problems faced by the industry and possible solutions that can be offered through the technical expertise available in the academic institutions. There is a need to address many health-related issues affecting Indian population. A meaningful dialogue between academia and industry can go a long way in resolving many issues.

Many students from your college are taking part at this year's IPC. What are your expectations?

The main problem faced by the pharmacy students is poor job prospects after their graduation. The large pool of

pharmacy graduate students passing number each year with paucity of knowledge and requisite skills seem to be the main reason for the problem. Imparting value added and skill based education besides conventional academic course coverage is the need of the day.

Where do you see the Indian pharma sector in the next two to three years?

I do see a potential growth of pharma sector in next two to three years. There are many challenges as well as opportunities. Innovative approaches need to be adopted by the industry and academic institutions.

Academic institutions should accept the challenges and work together with industry and government (tripartite arrangement encouraged by the government) to, provide novel products/devices. u.sharma@expressindia.com

Continued from Pg 29

Sky is not the... the pharma industry and with your experience and performance, you will rise in this profession where sky is no limit.

Do you think pharmacy graduates in India are well trained and can compete

30 EXPRESS PHARMA December 1-15, 2013

with their counterparts in the developed countries?

In the developed countries, PharmD students are well trained for healthcare practices and working in hospital and pharmacy (drug stores) is their profession which is most respected and

rewarded. We are working in this area and Pharmacy Council of India, by starting PharmD programme, will contribute in this regard and it will take some time to compete with skills of our counterparts in developed countries. Our B Pharm

students are well acquainted with manufacturing of drugs and formulations but skills which are required as per the needs of the pharma industry are still lacking. With their experience they develop the skill but that is why their initial package is not as high as

per their expectations. There is a need to develop pharmacy curriculum with importance to develop technical skills and soft skills while competing graduation which the industry is looking after. u.sharma@expressindia.com

(

THE MAIN FOCUS

IPC 2013: Reaching new heights THE INDIAN Pharmaceutical Congress is a scientific and professional annual meet, organised by the Indian Pharmaceutical Congress Association (IPCA) which is a federation of Indian Pharmaceutical Association – IPA; Indian Pharmacy Graduates Association – IPGA; Indian Hospital Pharmacists’ Association – IHPA; Association of Pharmaceutical Teachers of India – APTI and All India Drugs Control Officer’s Confederation – AIDCOC. The 65 th Indian Pharmaceutical Congress, 2013 is being hosted by the Indian Pharmacy Graduates Association at New Delhi. The theme of the Congress is Vision 2020: Empowering Pharmacist. It will be hosted from December 20 to 22, 2013 at Amity University Campus, Noida, Delh Prominent scientific personalities and intellectuals from the pharma industry, research and development, regulatory departments, quality control and quality assurance, hospital clinical and community pharmacy, academic, marketing, policy makers from government departments, pharma consultants, top officials of state and central agencies will participate in the IPC. About 10,000 delegates from various fields of pharma sciences are expected to attend, interact and benefit with the exchange of technical knowledge.

A scientific and professional memorial issue (Souvenir IPC 2013 ) will be released and distributed to delegates/participants on this momentous occasion.

Around 8,000 plus delegates are expected to attend the plenary sessions, scientific sessions and scientific poster paper presentations.

Around 80 speakers have confirmed participation including

31 EXPRESS PHARMA December 1-15, 2013

20 foreign speakers. There is a tremendous response from

the students of pharmacy and more than 1,800 papers have

been accepted for poster presentation in various scientific

sessions.

EP News Bureau-Mumbai

cover ) What do industry stakeholders want from policy makers?

A modern pharmacy education system, supported by rational regulations is the bedrock of any country's pharmaceutical industry. As a part of the IPC Special issue, Express Pharma invited stalwarts in pharmacy education to share suggestions to rationalise regulations, rejuvenate pharmacy education as well as attract and nurture fresh talent. Excerpts from their insights ...

'Rule 71 and 76 of Drugs and Cosmetics Acts 1940 should be deleted'

'Shortage of medicines, health at risk and benefits of NLEM are not passed on to the consumer'

TODAY WE have the option of better accessibility of drugs in the market, yet we are still juggling to get competent resources. For a single drug approval, pharmaceutical companies need to meet so many quality parameters and other associated approvals. But when it reaches the market and the end consumer, the stockist fails to maintain a supply chain.

The key reason behind this is Rules 71 and 76 of the Drugs and Cosmetics Acts 1940 as well as Rule 64. Rule 64 requires that a registered pharmacist needs to pass the matriculation examination or an equivalent examination from a recognised board having four year's experience in dealing with subjects related to drugs or hold a degree of a recognised university with one year experience in dealing with drugs.I feel Rule 71 and 76 should be deleted from the Drugs and Cosmetics Acts 1940 because they specify that that a graduate in science of a university established in India by law or has an equivalent qualification recognised and notified by the central government for such purpose.

If we amend these requirements then I strongly feel that entire pharmacist community of India will get employment if the said amendments come into action.

There will be no more scarcity of pharmacists and students will take active part in the profession

SHORTAGE OF essential medicines on retail shelves after the implementation of new pharma policy is a great cause of concern. The channel partners are duty bound to ensure abundant availability of all essential drugs across the country.

Supplies of widely used medicines such as vitamin –C (ascorbic acid), atorvastatin –an important medicine to lower elevated blood cholesterol levels, pyrazinamide- an essential drug for treatment of tuberculosis in intensive phase, Cetzine (cetrizine 10 mg) and Ceftum (cefuroxime) of GSK have been affected.

Channel partners seems to be following rules which suit their community purely from commercial perspective leaving behind the Government's national objectives of affordability and availability of essential medicines. The National Pharmaceutical Pricing Authority (NPPA), citing the Drug Price Control Order (DPCO) 2013, has communicated that no drug formulation can be sold to a consumer at a price exceeding the one notified by the Government or the one printed on the

32 EXPRESS PHARMA December 1-15, 2013

Atul Nasa Drugs Control Officer at Drugs Control Department New Delhi and President, Indian Pharmacy Graduates' Association

if they can be compensated in a systematic manner. The Rules were made during the 1940s, to cope with the scarcity of pharmacists in the country but today's scenario is completely different.

India has the highest number of pharmacists in the world. However, they are not willing to come into the profession as the industry is not rewarding them properly and hiring science graduates at a lower pay scale.

I strongly emphasise that qualifications for getting a wholesaler's license should be only given to registered pharmacists. If we work and resolve the above highlighted issues, then surely pharmacists will have a better future.

Vijay Bhalla Director, Lloyd School of Pharmacy of Greater Noida

medicine pack. Citing Para 28 of the DPCO 2013, the NPPA communication said that no manufacturer can refuse to sell a drug to a distributor while no distributor can withhold the sale of a drug to a retailer and no distributor or stockiest can decline a consumer planning to purchase the medicine. The DPCO 2013 stipulates a trade margin of 16 per cent to retailers while to wholesalers the industry offers a trade margin of eight per cent on price-controlled drugs, continuing with the earlier practice. For medi-

cines out of price control, trade channels continue to get margins of 10 per cent and 20 per cent as earlier.

Representation from the industry association and reports received indicate that there is a disruption in supplies of key medicines due to withholding sale of certain medicines by stockists and retailers protesting against the trade margins, the letter said. Since the implementation of the new pharma policy, a tussle has been on between pharma companies and trade channels over margins, with stockists reducing their orders leading to scarcity of widely prescribed medication like painkillers, anti-infectives, cardiac drugs and antibiotics. There may be a potential shortage of essential medicines on account of lower orders placed by distributors.

The drug pricing regulator, NPPA, in a strongly worded communication to pharma companies and distribution channels, has warned that the Essential Commodities Act may be invoked against those who disrupt the supply and distribution of essential medicines.

(

THE MAIN FOCUS

'Need to create a new generation of pharmacists, modernise the pharmacy profession' THERE HAS been haphazard and uncontrolled growth in pharma education in India, without proper rationale and actual needs as per manpower assessments. The private sector accounts for more than 70 per cent of pharmacy education. I suggest the following ‘five’ major steps.

levels and not be run in an ad hoc manner as is prevalent now 5. BPharm graduates should be considered for all competitive

exams including by UPSC, to increase placement potential.

In conclusion, we have to create a new generation of pharma-

cists and modernise the profession of pharmacy as per current needs of pharma industry and healthcare delivery. We have to

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Prof (Dr) Roop Krishen Khar (Kilam) Principal, BS Anangpuria Institute of Pharmacy, Faridabad

1. It is imperative that the profession of pharmacy has a single regulatory control and all powers be vested with Pharmacy Council of India (PCI).

2. Patient-oriented pharmacy is the backbone of this profession all over the world, where as in our country, we have not been able to nurture it and grow.

There is an urgent necessity to 'create space' for senior and qualified pharmacists in government hospitals and other institutions.

3. Pharmacy courses need to be outcome based at the unitary level of every subject in the curriculum, with more focus on development of skills, and direct application in practice/industry/market. There needs to be more clarity and preciseness at all levels and a clear cut focus emerging eventually at the end.

4. Institutions like NIPER need to keep up the standards and tradition in accordance with the mainstream profession.

They should be managed better by recruiting qualified staff at all

33 EXPRESS PHARMA December 1-15, 2013

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have a strong placement potential for talented students for which the Government has to take initiative and the onus.

cover ) 'Professional diplomas during graduation will bridge the industry-academics gap ' THERE ARE around 15 kinds of job opportunities in the pharmacy profession. You may not get a job, place, company or salary as per your expectations but you will get a job as per your knowledge, skill and attitude to work at the ground level. In the pharma industry today, a beginner's salary may range from Rs 8000 to Rs 25000, depending on companies' strength and students' professional skills. But, once you start performing in the pharma industry you can add several zeros to your salary.

A good performer, in five to ten years can take home a salary of Rs 5 to 10 lakhs per month, along with all other perks. Initially, students should not look for salary but aim to get inside in the pharmacy profession, develop professional skills and think of enhancing their performance. Performance is the only criteria in this world to achieve every dream. We should not compare ourself with other professionals because comparison will always make us unhappy and we are in the business of making people healthy and happy by producing quality medicine and providing quality care. Identify which job is suited to your personality, love that job, develop a passion for it and see how life becomes more beautiful with this attitude.

Ethics and professionalism are very important qualities that every pharmacist should have and can be developed. We, existing pharma professionals have to set an example, especially teachers in pharmacy colleges in front of their students, so that they learn from it. Professionalism starts with wearing a white apron, cap and gloves while doing practicals.

Documentation habit can be developed during practicals and completion of projects in a library. Students should be involved in doing professional presentations and behavioural skills should be demonstrated by conducting workshops. You

34 EXPRESS PHARMA December 1-15, 2013

should look and behave like a professional since we belong to the pharmacy profession.

Sincerity, regularity, time management must be imbibed during college days. Students with such exposure will work in the drug stores, hospitals and industry, demonstrating professionalism at every stage. To develop ethics, guest lectures on case studies in pharmaceuticals, successful stories of pharma professionals, programmes and workshops on positive attitude should be conducted. The behaviour of teachers such as avoiding partiality, showing transparency and standing for principles of life can accelerate the process of making students ethical and help inculcate passion and love for pharmacy in them.

Basically we are always attracted towards developed countries where they have excellent infrastructure, better lifestyle, and people are respected for their knowledge and skill. During our time also students were going abroad for further studies and getting jobs.

Nowadays admissions are easy because of loan facilities but getting a job abroad is becoming difficult in healthcare industry.

Jobs are available in pharmacovigilance and medical writing but not that many jobs are available in the pharma industry abroad. Jobs are also available in India with specific skills.

Pharmacy education in India is strengthening their standards by starting a Pharma D programme from Pharmacy Council of India but it will take some time to reach the global quality level. We should also think of our country and our industries' requirement first and match our core syllabus to develop competent pharmacists.

After independence our pharma industry was in development stage so our syllabus was developed to cater to the need of pharma industry in production, quality control and regulatory. We have not given im-

Dr Mahesh Burande President, Association of Pharmaceutical Teachers of India

portance to pharma care in hospital and community pharmacy.

Since now our pharma industry is in advanced stage with more than 182 plants approved by US FDA, we should think of developing pharma care which is the weak link in the pharmacy business.

Students of D Pharm and M Pharm Pharmacy Practice should start as professional pharmacists in hospital and medical stores with patient counselling, identifying drug â&#x20AC;&#x201C; drug interaction, reporting to doctor and create awareness of pharma care in patients and people. They should become owners to run drug store professionally and ethically.

Every hospital there should be a professional pharmacist and ownership of drug store should be handed over to pharmacist only. To continue the license as a pharmacist continuing pharmacy education should be compulsory and at each healthcare centre pharmacist should be compulsory with professional practice. Wholesale distribution license should be given to pharmacist only. So we have to change rules and regulations of pharmacy profession to bring this professionalism into practice. We should have passion and love for our profession as a pharmacist and we should not sell our profession by giving Reg. Pharmacist Certifi-

cate for Rs 3000/- or 5000/- to traders or non pharmacy owners, who brought this pharmacy profession down in minds of common people and society. All drug store should be air conditioned for stability of drugs and any Pharmacist should work in drug store for not more that eight hours and should wear a white apron with reg. pharmacist no. and every drug store should have a separate patient counselling section or room. No scheduled drug should be given without prescription. Change is the only stability and we have to bring this change to match the standard of global practice to serve humanity.

Presently, pharmacy education is unable to match the advancements in the pharma sciences because we do not have a real pharmacy academy â&#x20AC;&#x201C; industry cell at the national level to continuously interact on these fronts and suggest changes required every year to academic institutions.

As a President of APTI we are going to make this cell which will not only make suggestions on the syllabus but also orient teachers through professionals to teach theseeadvancements. Every two years we should send teachers to the pharma industry for two months of practical training to acquire new skills. Pharma industry should depute 10 per cent of their staff to teach and conduct practicals in pharmacy colleges for at least one month.

We should come out with specialisation at final year B. Pharm with six months theory and six months practical training to develop skills in pharmacy students. Doing professional diplomas during graduation will bridge the gap between academics and industry to make students competent to take responsibility in industry. Revolution can happen with change and change can be brought by people with authority to change the existing structure.

'PCI should be made an independent body' THE PROPOSED ONE year pharmacology course for non MBBS doctors will not serve the purpose of solvinghealth problems and will not be good for the Indian pharma industry. Pharmacist associations like Indian Hospital Pharmacists Association has maed representations to the Government that such type of

SL Nasa Registrar, Delhi Pharmacy Council

course may be conducted for those who are holding D.Pharm/B.Pharm and they will be ready to serve the rural areas. The Pharmacy Council of India (PCI) is producing more than 50,000 pharmacy graduates, 40,000 diploma holders 8000 post graduates in pharmacy, 2500 Ph.D in pharmacy and more than 4000 PharmD every year.

To attract the young talent in the pharmacy profession, we have to create a number of jobs in the Government and the corporate sector and in hospitals with a lot of incentives and good salary, according to the pay commissions notified by the Government of India. The private companies can be persuaded to give attractive salary packages after graduation or post graduation in pharmacy. Similarly Government hospitals can create more number of posts like store office, pharmacy man-

( ager, drug officer and may also focus on the clinical aspects of pharmacy. In this way, young talent can be attracted towards pharmacy profession.

There is no doubt that DPCO 2013 has reduced margins of profit for chemists and druggists but National Pharmaceutical Pricing Authority (NPPA) is looking at this aspect and the whole issue will be resolved by frequent meetings with chemists and druggists and the other agencies involved. As a result, patients may avail medicines at an af-

fordable rate.

The supply of anti-malarial and anaemic medicines to Government-run hospitals are not being dispensed by the pharmacists but are being distributed by orderlies or nurses and it is cannot certain that proper dosage of medicines are being given to the patients. The associations are in touch with the Government to create a number of posts for the pharmacists in these centres, so that the proper dosage of medicines or affordable medicines may be given to the patients.

The PCI has also framed pharmacy practice course and submitted to the Government for its implementation wherein the definition of a pharmacist, cadre post of pharmacist, duties of pharmacist have been mentioned.

The PCI has also suggested that the Government of India should upgrade the qualification for registration from DPharm to BPharm as the minimum registrable qualification in the Pharmacy Act, 1948 and for those who are holding DPharm qualification. The PCI has framed a

THE MAIN FOCUS

bridge course of two to three years duration to be run in various colleges notified by the it. As a result, degree holders will do proper justice to patients in terms of patient counselling, drug - drug reaction, drug food interaction and pharmacovigilance.

The success of policies depends upon the implementation of various schemes pending with the government and also involving PCI in framing such policies. Institutions of higher education like the NIPER's and fixing of prices of various bulk drugs and for-

mulated drugs are under the control of Ministry of Chemical and Fertilizers (Department of Pharmaceuticals), wherein the Ministry of Health and the PCI is not aware of such things. PCI should be made an independent body and there should be no dual control of AICTE as this not applicable in the Medical Council of India and Dental and Nurses Council of India.

(Compiled by Usha Sharma and Shalini Gupta)

35 EXPRESS PHARMA December 1-15, 2013

MARKET COMPANY WATCH

Anand Sharma meets Ireland’s Minister for Jobs,Enterprise and Innovation More Indian companies including medical device companies, scheduled to set up operations early next year ANAND SHARMA, Minister of Commerce & Industry, Government of India recently met Minister Richard Bruton TD, Minister for Jobs, Enterprise and Innovation, Ireland during his five-day visit to India this week. The two Ministers held talks on trade and commercial ties between the two countries and the deepening Indian-Ireland relationship as well as the EU- India FTA negotiations and other issues on international trade. They agreed to work together to further improve bilateral trade and commercial links.

Minister Bruton cited Bangalore-based Synowledge, a global provider of drug safety,

regulatory affairs, biometrics, clinical, and IT related solutions as one of two recent business wins bagged by IDA Ireland, Ireland’s government agency responsible for inward FDI. The second company, is another homegrown Bangalore-based company, Aditi Technologies, a cloud computing technology services company.

12 to 15 Indian companies already have operations in Ireland and the Minister indicated that they have a healthy pipeline with a few more Indian companies across various sectors, including financial services and medical devices, scheduled to join in early next year.

(L-R) Anand Sharma and Richard Bruton TD

The Irish delegation comprised more than 42 companies and Universities. This includes 25 Irish technology and international service companies, such

as TaxBack Group, PM Group, etc. and 17 higher education institutes and universities. Brian Conroy, Director, Asia Pacific, IDA Ireland and Terence

O’Rourke, Chairman, Enterprise Ireland were also a part of the delegation.

EP News Bureau – Mumbai

Biocon, Mylan receive DCGI nod for CANMAb Biosimilar Trastuzumab will help in the treatment of Her 2+ metastatic breast cancer BIOCON HAS received marketing authorization from the Drugs Controller General (India) (DCGI) for its biosimilar Trastuzumab being developed jointly with Mylan, for the treatment of Her 2+ metastatic breast cancer. The regulatory approval for biosimilar Trastuzumab in India is an important milestone for Biocon as it is the world’s first biosimilar version of Herceptin to be brought to the market. The biosimilar Trastuzumab will be marketed in India under the brand name of CANMAb by Bio-

36 EXPRESS PHARMA December 1-15, 2013

con and is expected to be available to Indian patients in Q4 FY14.

Kiran Mazumdar Shaw, Chairperson and Managing Director, Biocon, said, “This is a major milestone for both partners as it is the world’s first biosimilar Trastuzumab to be accorded regulatory approval.

We plan to make CANMAb available to Indian patients in Q4 FY14. The meticulous development of this important cancer drug has involved extensive product characterisation and clinical trials to demonstrate

comparability and similarity in PK (pharmacokinetic), safety, ef-

ficacy and immunogenicity against the innovator product.

We are committed to affordable cancer care and believe that biosimilar Trastuzumab will expand patient access to this life saving drug. The Indian approval is an encouraging milepost as we plan to leverage this data to support regulatory filings in several countries across the globe.” The global sales for Trastuzumab stood at ~$6.4 billion in 2012, while in India it recorded sales of ~$21 million.

Since 2009, Biocon and Mylan have been co-developing a

high value portfolio of Biosimilar monoclonal antibodies and complex biologics, comprising Trastuzumab, Pegfilgrastim, Bevacizumab, Adalimumab and Etanercept. The innovator product sales of these products in 2012 were pegged at ~ $34 billion.

The patent expiry of these products in regulated markets is expected from 2015 onwards. In 2013, this partnership was extended to co-development of Biosimilar insulin analogs for the global markets.

EP News Bureau – Mumbai

MARKET

Pfizer,Wyeth merger approved Initiates an important first step towards the creation of a single Pfizer brand in India THE BOARD of Directors of Pfizer (Pfizer India) and Wyeth (Wyeth India) have approved a proposal to merge Wyeth India with Pfizer India.

Aijaz Tobaccowalla, Managing Director, Pfizer India and Wyeth India, said, “I strongly believe that this merger will increase long-term value for all stakeholders. The combined entity would have an increased therapeutic presence and a derisked business profile. The merger process would require several approvals and we anticipate this will take approximately another nine months.”

The merger will be effected through a court approved Scheme of Amalgamation under Sections 391 to 394 and other applicable provisions of the Companies Act, 1956 (Scheme). As per the Scheme, the shareholders of Wyeth India will be issued shares of Pfizer India at a swap ratio which has been determined as seven shares of Pfizer India for every 10 shares held by the shareholders of Wyeth India.

The above swap ratio is based on the valuation carried out by independent accounting firms, after taking into account the payment of the interim dividend as set out above, and is on a post dividend basis. The recommended swap ratio has been reviewed by Merchant Bankers who have issued separate fairness opinions to the respective Board of Directors. Based on the proposed merger swap ratio, Pfizer India will issue approximately 15.9 million new equity shares to Wyeth India shareholders, as consideration for the merger.

The amalgamation meaningfully advances strategic priorities including: increase in the long-term value for the shareholders of Pfizer India and Wyeth India; creation of a single ‘Go to Market’ strategy and single company brand image leading to stronger market presence and higher confidence levels with all stakeholders; attracting

37 EXPRESS PHARMA December 1-15, 2013

best talent, increased employee confidence and morale under a single global Pfizer brand in In-

dia; greater financial strength; more focused operational efforts, realising operational syn-

ergies in terms of compliance and governance costs; increased share in therapeutic areas while

de-risking business profile.

EP News Bureau - Mumbai

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MARKET

Gilead attempts to secure patent on hepatitis C Is anticipated to receive market approval in the US on Dec 8 MÉDECINS SANS Frontières (MSF) supports the ‘patent opposition’ just filed at India’s Patent Office by the Initiative for Medicines, Access & Knowledge (I-MAK), which aims to prevent US pharmaceutical company Gilead/Pharmasset from gaining a patent in India on sofosbuvir, a drug for hepatitis C that is coming to market soon with an anticipated exorbitant price.

Gilead is expected to charge around $80,000 for one treatment course of sofosbuvir in the US. Even if offered at a fraction of this price in developing countries, this drug will be priced out of reach. The patent opposition, a form of citizen review allowed in many countries, offers technical grounds to show a drug does not merit patenting under India's Patents Act. This opposition was filed to ensure that affordable generic versions of sofosbuvir can be produced to help the millions of people infected with chronic hepatitis C in developing countries access the drug.

“Old science, known compound,” said Tahir Amin, Lawyer and Director, IMAK.org. “India’s patent law doesn’t give monopolies for old science or for compounds that are already in the public domain. We believe this patent on sofosbuvir does not deserve to be granted in India and have the legal grounds to prove it.” Sofosbuvir is the first of several oral hepatitis C drugs expected to come to market in the coming year. It cures hepatitis C in a much shorter time period than today’s available treatment, and for some forms of hepatitis C, eliminates the need to use the injectable drug pegylated in-

38 EXPRESS PHARMA December 1-15, 2013

terferon, which can be difficult to administer and causes many serious side effects.

Gilead is anticipated to receive marketing approval for sofosbuvir in the US on December 8.

MSF has started providing hepatitis C treatment for a small number of people co-infected with HIV in its clinic in Mumbai, but cost (as high as $5,000 per patient) and complexity of today’s available treatment means that patient numbers remain extremely low despite considerable needs. “In our projects, we need access to medicines like sofosbuvir that are easier for patients to take so we can expand treatment to more people. If the drug is unaffordable, the majority of the most vulnerable groups will remain untreated,” said Dr Simon Janes, Medical Coordinator with MSF in India. “We know from our experience providing HIV treatment over more than a decade in dozens of developing countries that treatment needs to be simple and affordable, preferably less than $500 to start with. An unaffordable price for this drug will have a chilling effect on funders and governments who need to start financing and providing treatment.”

“The world is waking up to a new crisis with hepatitis C,” said Olga Stefanishina of the Ukrainian Community Advisory Board. “More and more people are being diagnosed with chronic hepatitis C but are left to die because there’s no affordable treatment. With this patent opposition in India, we are starting the fight for better treatment that people can afford and governments can provide. We have no time to wait for charity or country-

by-country negotiations, low cost generic versions of the drug must be made available to all high-burden countries without discrimination.”

India has been called the ‘pharmacy of the developing world,’ because it produces many affordable generic versions of drugs patented elsewhere. More than 80 per cent of the HIV medicines used in developing countries come

from India, which is able to produce these medicines because its patent law sets the bar high for which medicines do and do not merit patenting, allowing generic manufacturers to compete for the market and drive prices down.

“The hepatitis C drugs coming out of the drug pipeline, including sofosbuvir, are compounds that are relatively simple and cheap to make,” said Dr Andrew Hill, a pharmacologist at Liverpool University who has published a study showing that sofosbuvir could be produced for as little as $62-$134 for a 12-week treatment course. “The profit projections for the oral hepatitis C drugs are staggering, and stand in no relation to what it costs to make these drugs.”

EP News Bureau – Mumbai

Axcellerate Pharma aims to become a market leader in life sciences industry Establishes CMO/ CRO and API manufacturing facility in New Jersey, US AXCELLERATE PHARMA has established CMO/CRO and API manufacturing facility in New Jersey, US. The focus will be on small molecule and biologics PR&D, innovative technology platforms, filling vial and bag operations, peptide synthesis, oligonucleotide production and related areas.

Axcellerate Pharma (Axcellerate) is a JV set up by TCG Lifesciences USA, an affiliate of TCG Lifesciences, a leading CRO engaged in drug development and clinical trial services; with Dilip Mehta, Founder and Chief Executive Officer, PANORAMA Consulting and Engineering, a leading developer of lab scale to GMP manufacturing facilities; and Alfagen Pharma, an affiliate of AlfaGene Bioscience, Inc, an innovative biotechnology company. The facility houses state-of-theart technology/equipment/ infrastructure and is supported by leading industry personnel from each of the partner firms.

“We will initially target specialised CMC and CMO activities that are time sensitive and high value in nature, that are desirable to be located geographically close to our clients. Axcellerate intends to leverage the strong scientific talent pool, end-toend capabilities and PR&D/intermediate production facilities of TCG Lifesciences in India to support its operations. This opportu-

nity represents another significant milestone for TCG Lifesciences’ continued expansion,” commented Swapan Bhattacharya, Managing Director, TCG Lifesciences, “as this strategic alliance will expand TCG Lifesciences’ geographic footprint and enable us to service clients in the US with a local presence while being supported globally.”

Dilip Mehta, Chief Executive Officer and Co-founder, Axcellerate commented, “We will engineer the facilities to provide the highest level of efficiency, technology and cost effectiveness to our customers, given PANORAMA’s broad involvement and experience in all facets of the pharma/biotech sector. We are pleased to join hands with TCG Lifesciences, who will bring in the scientific and technical know how and expertise in the cutting edge areas of drug discovery and development.”

“AlfaGene Bioscience has developed proprietary assay platforms in a range of therapeutic indications and has a scientific team with extensive experience in biologics and biomedical research. We also have a network of global relationships in the API arena to bring to bear for the success of Axcellerate,” remarked Mayur Doshi, President and Chief Executive Officer, AlfaGene Bioscience.

EP News Bureau – Mumbai

MARKET

Venus Remedies receives SFDA approval for meropenem Plans to launch the product in Saudi Arabia early next year VENUS REMEDIES has received approval for meropenem in the Gulf with marketing authorisation from the Saudi Food and Drug Authority (SFDA). The company is planning to launch this product in Saudi Arabia early next year. Meropenem is an off-patented antibacterial agent of the carbapenem class of antibiotics, which caters to diseases with a broad range of serious infections caused by single or multiple susceptible bacteria in both adults and children.

Pawan Chaudhary, Chairman and Managing Director, Venus Remedies said, “Venus has become the first generic drug manufacturer in the world to get marketing approval for this product from the Gulf Cooperation Council (GCC). The $35-million market for meropenem in Saudi Arabia offers a huge opportunity to us, and we are aiming at capturing a 25 per cent share in this market within the first year of the launch itself. Securing marketing authorisation from Saudi Arabia for meropenem is a significant and prestigious achievement for the company as the Saudi Arabian market is known across the world for its stringent quality control. This achievement is a hallmark of our regulatory team’s competence. Their hard work has been duly rewarded.”

Ashutosh Jain, Executive Director, Venus Remedies and Chief Executive Officer, Venus Pharma said, “The regulatory requirements of Saudi Arabia are stringent and expensive, due to which other generic pharma companies are unable to get the product registrations even after constant efforts. We are proud of our drug regulatory capabilities, which have enabled us to register the first generic formulation of meropenem injection in Saudi Arabia.”

EP News Bureau - Mumbai

39 EXPRESS PHARMA December 1-15, 2013

MARKET GROWTH TRACKER

IPM de-grew 1.7 per cent in October 2013 Valued at ` 6305 crores, with 10 therapies and 12 regions exceeding market growth rate THE INDIAN pharma market (IPM) is valued at ` 6,305 crores in October 2013. It has grown at -1.70 per cent in October 2013.

Zydus Cadila is the third biggest company in IPM versus fourth of last month but maintained fourth rank amongst corporates.

Amongst the top 10, Sun Pharma was at 15.1 per cent followed by Zydus at 2.7 per cent.

35 corporates have crossed the growth of IPM for the month of October 2013 amongst top 50.

Amongst the top 50 corporates, Corona Remedies has the highest growth of 69.4 per cent followed by Biocon at 55.4 per cent and Meyer at 27.4 per cent.

Amongst the 11-20 ranked companies, Glenmark has shown a high growth at 17.5 per cent followed by Torrent and Emcure at 13.3 per cent and USV at 10.9 per cent. Amongst upcoming corporates, Corona Remedies has grown at 69.4 per cent, Akument at 20.4 per cent and Eris at 18.3 per cent.

Amongst the top 50 in MNCs, Allergan grew the highest at 14.6 per cent, followed by Astra Zeneca at 7.6 per cent and MSD at 3.4 per cent. Novartis and Merck were better than IPM growths.

The DPCO 2013 containing molecules market was at -17.9 per cent whereas the non DPCO market grew by meagre 0.9 per cent resulting in an overall growth of -1.7 per cent for October 2013. The DPCO 2013 portfolio for GSK de-grew at 48.9 per cent and Ranbaxy de-grew by 31.9 per cent, whereas Sun Pharma had the least impact with its DPCO 2013 portfolio degrowing at four per cent.

The market has witnessed negative growths in the units as well in both the categories.

From therapy perspective , 10 therapies have outgrown the IPM growth. The anti-infective market has a de-growth of -15.1 per cent whereas respiratory market is at -3.8 per cent growth. The anti-diabetic

40 EXPRESS PHARMA December 1-15, 2013

With bonus units at full value Rank CORPORATE

MAT

MTH

IPM

(Val in Crs)

MAT Sep -13

Sep-13

Val (Cr)

MS%

GR%

Val (Cr)

MS%

GR%

72381

100.00

5.1

6305

100.00

-1.7

Abbott + Abbott HC + Novo

1

1

4815

6.65

0.8

413

6.54

-6.1

Sun Pharma

2

2

3821

5.28

17.2

346

5.49

15.1

Cipla

3

3

3658

5.05

4.6

320

5.08

0.4

Zydus + Biochem

4

4

3247

4.49

14.0

284

4.50

2.7

Glaxo

5

8

2941

4.06

-8.7

191

3.03

-35.5

Ranbaxy

6

5

2917

4.03

2.0

235

3.72

-14.5

Mankind

7

7

2605

3.60

7.2

228

3.62

-3.9

Alkem + Cachet + Indchemie

8

6

2532

3.50

8.1

233

3.70

0.4

Lupin

9

10

2179

3.01

6.4

188

2.98

-1.7

Pfizer + Wyeth

10

14

2100

2.90

-3.6

162

2.57

-22.3

Emcure + Zuventus

11

9

2022

2.79

14.6

190

3.01

13.3

Macleods

12

12

1860

2.57

7.5

164

2.61

-5.4

Intas

13

13

1837

2.54

12.8

163

2.58

7.5

Aristo

14

11

1707

2.36

6.0

166

2.64

1.7

Dr. Reddys

15

16

1612

2.23

8.6

138

2.18

3.3

Sanofi-Aventis + Universal

16

18

1532

2.12

1.4

126

1.99

-6.0

Glenmark

17

15

1512

2.09

13.6

146

2.32

17.5

market grew at 10.40 per cent and cardiac at 6.9 per cent in chronic business. Stomatologicals grew by 8.6 per cent, whereas derma market was at 6.4 per cent. Bonus in the anti-infective segment de-grew by 15.7 per cent, whereas in respiratory market it was -9.6 per cent.

From regional perspective 12 regions have outgrown the IPM growth. Kerala grows highest at seven per cent whereas Gujarat has registered 3.6 per cent.

Tamil Nadu de-grew at 6.2 per cent and Andhra Pradesh rest de-grew at 5.2 per cent. 12 regions have had negative growths in September 2013.

The biggest molecule Amoxycillin + Clavulanic degrew by 13.6 per cent, whereas Cefixime de-grew at 17.5 per cent. Paracetamol de-grew at 21.3 per cent and Azithromycin at 20.5 per cent. The markets of vitamin D grew by 50.1 per cent, Glimepiride + Metformin grew at 39.4 per cent, Rosuvastain by 19.3 per cent and Telmisartan grew by 17.4 per cent.

Super Group

MAT Oct 13

GR%

Mth Oct 13

GR%

IPM

72381

5.1

6305

-1.7

ANTI-INFECTIVES

12484

0.9

1080

-15.1

CARDIAC

8927

8.7

771

6.9

GASTRO INTESTINAL

8225

4.6

699

2.0

VITAMINS / MINERALS / NUTRIENTS

6393

3.6

555

-2.1

RESPIRATORY

5592

5.6

517

-3.8

PAIN / ANALGESICS

5226

3.0

457

-3.3

ANTI DIABETIC

5007

10.0

448

10.4

GYNAECOLOGICAL

4639

3.2

380

-3.3

NEURO / CNS

4494

8.5

388

4.4

DERMA

3882

7.6

349

6.4

OPHTHAL / OTOLOGICALS

1307

6.8

114

4.7

HORMONES

1241

6.5

107

-6.3

ANTI-NEOPLASTICS

973

24.3

88

27.9

OTHERS

935

3.7

81

0.5

Terminologies used

BLOOD RELATED

875

2.6

73

-1.9

VACCINES

841

-2.6

61

-13.3

ANTI MALARIALS

588

-5.2

74

-15.1

SEX STIMULANTS / REJUVENATORS

424

10.3

35

6.9

STOMATOLOGICALS

327

6.7

29

8.6

MAT – Moving Annual TotalMTH – MonthVal (Cr) – Value in CroresMS per cent – Market Share in PercentageGR per cent – Growth in percentage.

For more information, visit http://www.aiocd.net

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 joint venture with Trikaal Mediinfotech. AWACS (Advanced Working, Action & Correction System) reflects 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.

MARKET POST EVENTS

Conference highlights need for innovations in OTC Organisers CubeX, key speaker Nicholas Hall uncover little known aspects of pharma OTC

CUBEX, A DIVISION of Sorento Healthcare, recently organised a conference to highlight necessity of innovations in OTC sector. This conference was titled as ‘Innovation in OTC Business: From Concepts to Action.’

In the recent years, a lot has been said about innovation, however, for a long period innovation just remained a buzz word.

Things have been changing now and challenging market conditions are making companies to not just talk about but also to im-

plement innovations in their products and brand promotions.

Every session at the conference helped the audience to know many aspects of OTC business that were perhaps not known before. There were four sessions like ‘New thinking- new realities in the OTC industry,’ ‘Creating value added OTC business through innovation’, ‘Technology as a catalyst for innovation’ and ‘Stimulating innovation.’

Nicholas Hall, Chairman and

Chief Executive Officer, Nicholas Hall and Company and Susan Joshi, Managing Partner, Sorento Healthcare Communications provided an overview of

market trends and developments in the global and Indian OTC industry. Hall’s views on growth drivers for OTC business were appreciated by the at-

tendees. Joshi said that innovation and collaboration would decide the success of the OTC business. Collaboration allows to take advantage of the larger consumer healthcare opportunity.

Ameesh Masurekar, Founder Director, AIOCD Pharmasofttech, AWACS stressed that it was important to create competition among distributors at far higher trade margins. He largely spoke about unique business model in OTC business.

EP News Bureau-Mumbai

GOOD MANUFACTURING PRACTICES & QUALITY ASSURANCE 20th–24thJanuary 2014, Hotel Radisson, Greater Noida The Pharma Industry needs GMP Trained Professionals Attend an introductory & advanced GMP course that helps you adhere to regulatory guidelines & overcome non-compliance.

Designed for B.Pharm/ M.Pharm/ MSc / PhD in Life Science disciplines & working professionals in the Pharmaceutical Industry.

Get the SeerPharma ‘Confidence in Compliance’ SeerPharma is Asia-Pacific’s premier consultancy with solutions across QA, GMP & GxP compliance, training, risk management, validation, IT, productivity and automated quality management systems.

Training conducted by David Spaulding, Training Manager and Senior Consultant at SeerPharma with over 30 Years in the pharmaceutical and medical device industries including senior manufacturing and commercial roles at GSK Australia.

Course Fee: GMP Introductory Course (3 Days) – Rs.16,854/GMP Advanced Course (2 Days) – Rs.13,483/GMP Introductory & Advanced Course (5 Days) – Rs.28,090/(Inclusive of Service Tax @12.36%) Certificate will be awarded to all participants

For details and course content see: http://labnetworx.com/gmptraining http://www.seerpharma.com.au Phone: +91-85273-17888 Email: gmp@labnetworx.com

41 EXPRESS PHARMA December 1-15, 2013

MARKET

analytica Anacon India 2013 witnesses leading companies from instrumentation industry 4,022 trade visitors attended the event at Bombay Exhibition Centre

ADDRESSING THE challenges as well as the opportunities in the analytical instruments industry, the seventh edition of analytica Anacon India 2013, jointly organised by Messe München International (MMI) and the Indian Analytical Instruments Association (IAIA), ended with 4,022 trade visitors from the industry. The three-day event took place at the Bombay Exhibition Centre in Goregaon.

The analytica Anacon India Conference with the topic ‘Research & Regulations: Challenges for the Pharmaceutical, Life Science and Food Industries’ was presided by industry leaders as well as international speakers from the science, giving expert insights into the latest research developments in the analysis, chromatography, biotechnology and life-science sectors. The programme was organised by the IAIA and Prof Dr Oliver Schmitz (University Duisburg-Essen, Dept. Applied Analytical Chemistry).

Bhupinder Singh, Deputy Chief Executive Officer, Messe München International India, said, “analytica Anacon India 2013 has been successful in bringing a new momentum to research, business and technology of analytical instruments in India. The event has consistently showcased top manufacturers and suppliers of analytical instruments from all over the world. With a strong focus on innovation, this specialised event provided a platform for key professionals from around the world to link to the exciting Indian market.” analytica Anacon India attracted visitors from primary domains like pharmaceutical, chemical and petrochemical,

42 EXPRESS PHARMA December 1-15, 2013

food, medical laboratory, universities and research institutes. Offering potential to revolutionise other growing industries, the event had participation from a broad range of leading local, national and international analytical instrument manufacturers and distributors.

Speaking on the contribution of the Indian analytical industry to the overall growth of the economy, KV Venugopalan, President, Indian Analytical Instruments Association, said, “The Indian analytical instru-

analytica Anacon India attracted visitors from primary domains like pharmaceutical, chemical and petrochemical, food, medical laboratory, universities and research institutes

ment market including consumables and spares is estimated at around $1 billion with a growth rate of above 10 percent. This along with the rising demand and developments in food safety and pharma production will help the industry grow at a steady pace. There is a high dependence on import of technologies for research and at times they are not easily available for various commercial or legal reasons. The time has come to focus on developing cutting-edge technologies and instruments in India that will give us advantage in the coming decades.”

Pranaya Pradhan, Marketing Specialist, Millipore India,

Labwater, expressed, “The event is like a bridge between us and our customers. Since Millipore is a brand in the analytical instruments segment, we had a very good number of industry professionals coming to our stall for knowing the high-end technology used in our products. Many new customers visited our booth and we are hoping to get good business post the event.”

This edition of analytica Anacon India witnessed an impressive line-up of key players from the instrumentation industry like Agilient Technologies, Borosil, Bruker AXS Analytical Instruments, Cryogen Instruments, Eppendorf, GCE India, Genedirex, Inkarp Instruments, Labcon, LCGC Chrom Consumables, Marsap, Medispec Instruments, Merck

Millipore, Metrohm India, Phenomenex India, Skytech Systems, SV Scientific, TA Instruments, Vishva Protech, Waters India and many more.

Next to German Federal Ministry of Economics and Technology (BMWi) as well as the Association of the German Trade Fair Industry (AUMA) supporting German group participation, the trade fair also had international country pavilions from China and Japan.

Manu Grover, Product Manager, Waters, said, “The response that we are getting from the exhibition is really good.

Quality visitors from all segments, be it pharma or nonpharma, visited the stalls. All the big corporate names in pharma industry from across the state visited the show. On an

overall basis, the show is getting better year after year. The conference sessions also witnessed participation from high–end industry professionals.”

The trade fair also featured an international conference addressing various concerns in the instrumentations industry.

“The response from the visitors has been good. We witnessed a good number of walkins. A good volume of visitors from pharma, food and OEMs attended the event. All the prospects that we have got in terms of visitors were worthy enough. We even witnessed the footfall from the unexpected segments like oil and gas industry,” said Dr Ashes Ganguly, Managing Director, Cryogen Instruments India.

EP News Bureau-Mumbai

MARKET

EMPROVE seminar spotlights forthcoming regulatory changes

The excipients

that'll get you rolling

Features insights, solutions and tools to better cope with the challenges ahead

MERCK MILLIPORE, the life science division of Merck, organised the second edition of ‘EMPROVE Seminar Series’ in Mumbai. The seminar is an endeavour by Merck Millipore to offer the Indian pharmaceutical industry a platform for getting access to the latest trends and developments in the international regulatory arena. This year’s theme, ‘Stability in Turbulent Times’, addresses the challenges faced by the industry.

The seminar was inaugurated by Dr Claus-Dieter Boedecker, Managing Director, Merck [India] and Head – Merck Millipore [India] and Tapan Ray, Former President, – OPPI and Independent Pharmaceutical Industry Analyst & Consultant. Merck Millipore’s eminent panel of internationally reputed speakers equipped the pharma industry to successfully navigate the labyrinth of the global regulatory landscape.

The topics discussed ranged from potential solutions to challenges faced by exporters to regulated markets; stumbling blocks faced while making abbreviated new drug applications and how to overcome them; quality standards and certification available to grade pharma excipients in the current regulatory scenario.

Boedecker said, “Today the pharma industry in India is grappling with challenges owing to an uncertain and everchanging regulatory environment. It is imperative for our industry to understand, interpret and prepare to meet the challenges of tomorrow. Through the EMPROVE Seminar Series, our focus and commitment is to help customers understand the changing regulatory scenario and negotiate in such market dimensions. With EMPROVE, Merck Millipore establishes itself as leaders in quality and international regulatory compliance.”

Peter Salazar, Head of the Pharm Chemicals Solutions, Merck Millipore [India] and pioneer of the EMPROVE

Excipients for Direct Compression

Seminar Series remarked, “The 2013 edition of EMPROVE Seminar Series helps gain better insights into the rapidly evolving global regulatory scenario for improving stability of the pharma industry in such turbulent times.

Merck Millipore’s customer-friendly EMPROVE products and services, along with providing regulatory support, offers information on greater product safety, cost and time savings.”

Ray addressed the seminar on ‘Challenges in Pharmaceutical Exports for Regulated Markets and Potential Solutions’. He stated, “I am happy to be associated with the second edition of the EMPROVE Seminar Series. The setbacks on the regulatory front this year have adversely impacted advancements in drug manufacturing processes and technology. In such a scenario, pharma companies will need to focus their attention on appropriate corrective measures in this area sooner and the EMPROVE Seminar Series helps discuss and resolve regulatory challenges and provide solutions to the industry.”

At the seminar, Dr Najib Sehat, Head – Global Regulatory Management, Merck Millipore and Member – EXCiPACT Global Steering Committee spoke on pharmaceutical excipient quality standards and certification in the current regulatory environment.

Other experts who spoke at the seminar include Dhiraj Chopra, Associate Director, Dr Reddy’s Laboratories; Amit Bansal, Managing Partner, Resolute IP and Legal Solutions; Meena Kashyap-Shah, Sr Manager – Regulatory Affairs, JB Pharmaceuticals; and Dr Christian Dittrich, Global Marketing Manager – Bioavailability Enhancement, Merck Millipore.

Leading pharmaceutical companies attended the seminar and discussed the evolving regulatory scenario and tools to expedite the complex process.

Product name

Profil

Median Particle size

DI-CAFOS D 160

Dihydrate

160 μm

DI-CAFOS A 150

Anhydrous

150 μm

DI-CAFOS A 60

Anhydrous

60 μm

TRI-CAFOS 500

Spray dried

100 μm

Excipients for Granulation Product name

Profil

Median Particle size

DI-CAFOS D 14

Dihydrate

14 μm

DI-CAFOS D 9

Dihydrate

9 μm

DI-CAFOS A 12

Anhydrous

12 μm

DI-CAFOS A 7

Anhydrous

7 μm

TRI-CAFOS 250

Powder

5 μm

TRI-CAFOS 200-7

Powder fine

4 μm

Budenheim | Business Unit Performance Materials Increasing Performace – Improving Life

EP News Bureau-Mumbai

43 EXPRESS PHARMA

For inquiries contact: Budenheim India Pvt. Ltd. Phone: +91 (0) 11 49651 100 info.indiaoffice@budenheim.com

December 1-15, 2013

AZ_Produktrange_105x297.indd 1

20.04.2012 13:58:24

MARKET

DigiSights 2013 explores potential of digital & social media in pharma marketing Speakers highlight need for clarity on regulations in today’schanging environment. Express Pharma was the exclusive media partner DIGISIGHTS 2013, positioned as India’s first pharmaceutical and healthcare digital marketing conference was recently held in Mumbai. Organised by MediaMedic Communications in association with its GLOBALHealthPR partners, STweM and Webicina, the conference attracted participation from the pharma marketers and digital teams.

Express Pharma was the exclusive media partner for the conference.

In the keynote speech, Narayan Gad, Director, PharmaTechManagement, NMIMS shared how the pharma ecosystem evolved from the traditional telephone to smartphone. He divided the evolution into pharma 1.0 (1960-80), 2.0 (1980-2000) and 3.0 (2000 ahead). “Digital tools have crept into the ecosystem and doctors are now being controlled more by apps and technology,” he said.

He stressed upon social being the way forward and shared that “Pharma companies should not just focus on sales but on engagement.”

The healthcare practitioners practitioners (HCP)- industry panel had an experienced set of panelists. The session moderated by Amlesh Ranjan, Associate Director, Sanofi started by asking Dr Aniruddha Malpani, Medical Director @HELP on what change he observes in the industry. Malpani stressed that doctors should educate patients and the problem is trust deficit. “Patients don’t trust doctors and having a website will be the best thing but doctors don’t have time; this is where the pharma industry comes into picture”.

Dr Sushil Sabnis, senior or-

44 EXPRESS PHARMA December 1-15, 2013

Dinesh Chindarkar

HCP panel discussion (left to right): Dr Aniruddha Malpani, Dr Sushil Sabnis, Andrew Spong, Dr Ajit Dangi, Ashish Babtiwale and moderator Amlesh Ranjan

thopaedic surgeon said many patients are unable to access the internet. Moreover, the information may be unreliable.

Finally one-to-one interaction with a doctor is critical. Doctors would like to get relevant information at their own time rather than meet inefficient medical representatives.

Dr Ajit Dangi, President and Chief Executive Officer, Danssen Consulting, shared that he is quite excited by the medium and its quick reach.

However, pharma is a regulated industry so content placed on social media should have set guidelines otherwise things could go wrong. He even urged the MediaMedic Team to work with OPPI and related associations to help set clear social media guidelines which can go a long way.

Ashish Babtiwale, Director, Virchow Labs, was quite vocal about the speed of the digital world, how it helps reach HCPs faster. His perception is that digital kills the distance and the newer smartphones,

apps are the game changers of the industry.

Andrew Spong, Managing Director, STweM, and an authority on social health worldwide, shared his belief that patients have the right of participation in today’s world.

Smartphone penetration in India is the boon and industry should take advantage and weave their strategies around that.

Dr Bertalan Mesko, Managing Director, Webicina through a video, talked on how social media is changing the way for HCP’s, discussed about his recent book Social Media for Doctors which helps HCPs to adapt newer medias, kill their inhibition and set them on a platform of learning.

After the panel discussion, Dinesh Chindarkar, Cofounder and Director, MediaMedic, started with examples on how digital and social is changing the country. Emphasising that consumers are moving towards managing their own health, he said that

the movement of ‘Quantifiedself ’ has began. He further added that there is a shift in healthcare from doctor driven era to patient driven one; and hence the need to connect with consumers. He said, “It is not only about illness but about emotional connects; hence pharma should not just think about selling drugs but partnering for healthy outcomes.”

Spong shared his thoughts on the ‘Future of Digital Pharma Marketing’ about how about the consumers’ hunger for health information can be satisfied with digital channels’ untapped capability.

He said, “The world is shifting from dictated medicine to participative medicine, in other words, informed content to informed choice.” According to him the future of digital pharma marketing will be in building trust, maintaining an approachable outlook, informing and conversing with its customers and helping HCPs serve their patients

needs. He emphasised the need for pharma marketers in the digital age to adopt a customer-service mindset, goodwill creation and have the first-mover’s advantage to take this space. Having worked with many pharma and patient groups, he said that the biggest hindrance to adoption of digital by pharma is not regulations or ROI, but it’s own mindset.

Priti Mohile, Managing Director, MediaMedic Communications in her session on Social Media from Insighting to Category Building, focused on the role of integrated solutions covering branding, category building, digital and public relations. She gave insights on what can be learnt from consumer discussions on social media and offered a practical way forward. She emphasised, “Pharma should have an integrated approach that should emerge from the broader strategy of the category and brand rather than just opening up a Facebook

MARKET

Andrew Spong

Priti Mohile

page for the sake of it. Understanding the regulations within which we operate and responsible communication, can yield unmatched benefits to the industry.” She discussed how e-detailing on tablets should not just be digitised VAs, but interactive.

Kai Gait, Global Digital Director ,GSK shared his views via video on the changing pace of the world and how social media is transforming communication and changing patient’s behaviour with easy access to information. Selected digital case studies within pharma and healthcare were presented from GlobalHealthPR partners from the US, the UK, Argentina, Australia, and Portugal ranging from Gamification, mHealth, social media, integrated campaigns, content marketing etc.

The pharma marketers session rolled out with Salil Kallianpur, Commercial Head, GSK speaking on how digital can fill gaps in the health industry and its opportunities in India. He stressed on how to manage the huge data; and the need for industry to look into it as doctors don’t have time. He emphasised that the challenges in the industry such as ROI etc needs to be looked more broadly and strategically. Dr Salil Shinde from Pfizer focused on ‘Building Digital Communication’ and said that people come and engage with companies, but the industry will have to be honest and ready to solve problems. Going further he focused on how social channels and apps should be built.

Prateek Gupte, Application Spe-

cialist with MediaMedic explained how gamification and mHealth can be integrated for greater interest and fun. He said, “Gamification is not a marketing ploy but, an approach.” Milind Mangle, an independent consultant talked about elearning initiatives within Digital.

Mahesh Murthy, Founder, Pinstorm spoke on how the marketing world has changed. The shift has happened due to word of mouth and digital was powering it. He added, “Today it is about consumers first and then the product. Perception of doctors is changing, and they are being evaluated by consumers today.

So it is imperative for doctors to adopt this medium and listen while marketing forces of pharma companies can improve sales force by going digital.”

The interaction at DigiSights clearly indicated the need of clarity in this changing environ. DigiSights 2013 for the first time, provided a platform where the industry got together to explore the various possibilities that this newer media throws to the marketer. The companies that attended included Sanofi, GSK, Pfizer, Abbott, MSD, Sun, Merck, Alkem, UCB, Glenmark, Themis etc amongst others. Reflecting the changing India, the live tweets with the hashtag #DigiSights13 took this digital conference outside the room boundaries and had over 700+ tweets which made over 1.50 million impressions with active participation outside the room too.

EP News Bureau-Mumbai

45 EXPRESS PHARMA December 1-15, 2013

EVENT BRIEF DECEMBER - FEBRUARY 05

Healthcare Brand Summit

HEALTHCARE BRAND SUMMIT Date: December 5-6, 2013 Venue: Hilton Mumbai Summary: afaqs! is organising the Healthcare Brand Summit, that will bring together some of the most respected industry leaders, CEO’s and CMO’s from Rx, OTC, healthcare services, hospitals, diagnostics and device, wellness companies on a single platform, where they will discuss challenges and share their experiences.

Joining them will be healthcare communication experts from branding, social media, analytics, technology solution providers who will share their learning and experience in building brands in healthCare.

Contact details Samarjit Singh Vice President- Sales & Marketing B3, 1st Floor, Sector 4, Noida - 201301 Ph: +91-120-4077800 Mob: +91-9811436040 email: samarjit.singh@afaqs.com Web: www.afaqs.com

INDUSTRIAL GREEN CHEMISTRY CONVENTION & ECOSYSTEM (IGCW-2013) Date: December 6, 7 and 8, 2013 Venue: Renaissance Mumbai Convention Centre Hotel , Powai, Mumbai Summary: The Green ChemisTree Foundation along with its partners, supporters and associates, organise this international convention every alternate year in a bid to drive industry implementation of green chemistry and engineering based technologies.

IGCW, an industrial initiative, aims to bring to-

46 EXPRESS PHARMA December 1-15, 2013

06

IGCW 2013

gether chemistry-intensive chemical companies that deal in pharmaceuticals, fine and specialty chemicals, agro-based chemicals, dyes and pigment sectors, to collectively expand their awareness on environmentally benign manufacturing practices and technologies.

IGCW-2013 will offer an opportunity to over 300 chemical manufacturing companies for expanding their technical know-how on industrial green chemistry and engineering technologies as well as approaches. It would also offer the participating companies with a platform to share thoughts, exchange ideas and experiences, and hear successful case-studies from leading global experts on the subject.

The event is also expected to help bridge the gap between various chemical industry stakeholders and in turn assist in accelerating the implementation of green chemistry and engineering practices. It also aims to connect the participating companies with over 50 solutions and technology provider companies and organisations for addressing the immediate and pressing environmental, regulatory and resource challenges.

20

65th IPC, 2013

11th Edition of Bio Asia

Summary: Indian Pharmacy Graduates’ Association will host 65th IPC, 2013. Express Pharma has been chosen as the ‘Exclusive Official Media Partner’ for the 65th IPC, 2013. The event will be organised by Indian Pharmaceutical Congress Association. The academic partner for the event is Amity University, Noida.

Asst Director - Wellness and Nutraceuticals Federation Of Indian Chambers Of Commerce & Industry 33-B, Krishnamai Sir Pochkhanwala Road Worli, Mumbai - 400030.

Tel: (022) 2496 8000 Mob: 9869132887 Email: nandini.aggrwal@ficci.com

Contact details Dr Arun Garg General Secretary IPGA Director PDM College of Pharmacy Bahadurgarh, Haryana Mob: 09416056213

11TH EDITION OF BIOASIA

5TH FICCI-HADSA NUTRACEUTICAL CONFERENCE

65TH IPC, 2013

Date: January 17, 2014 Venue: Sci-Tech, Jogeshwari, Mumbai Summary: The objective of this conference is to enable nutraceuticals stakeholders to understand the'Business Dynamics of Nutraceuticals in India’. Discussions will be held on issues such as implications of regulations, product development, supply chain management, commercialisation and financial challenges.

The summit aims to provide an opportunity to the Indian nutraceutical / dietary supplements industry to network and interact with various representatives of government and semi-government institutions along, with other stakeholders from private sector, financial institutions, R&D to further resolve challenges being faced by this industry.

Date: December 20-22, 2013 Venue: Amity University, Noida

Contact details Nandini Aggrwal

Contact details Anuja Sawant Green ChemisTree Foundation C/o Newreka Green Synth Technologies Ph: +91-22-2879 1835/1275 http://greenchemistreefoundation.in http://industrialgreenchem.com/

17

Date: February 17 to 19, 2014 Venue: Hyderabad International Convention Centre Summary: The 11th edition of BioAsia is dedicated to the theme – ‘Innovate. Evolve’.

BioAsia’s focus on ‘Innovation in lifesciences’ will address the increasing disease burden, and the growing need for more efficacious and affordable healthcare solutions. Panel discussions hosting global industry leaders will deliberate on the path breaking solutions for the sector, from innovative products to models that reduce R&D cost while increasing efficiencies, and innovative financing models, that promote new business ideas.

The goal is to highlight innovation as the driver of the lifesciences economy in the coming years.

In addition, a parallel event AgBioAsia focusing on health and nutrition with the theme of ‘Harnessing the potential of the global nutraceutical market’ will be hosted by the Government of Andhra Pradesh in partnership with the International Crops Research Institute for the Semi Arid Tropics (ICRISAT) and the Federation of Asian Biotech Associations (FABA).

Contact details Paridhi Gupta Tel: 040 66446477

24

CPhI Quality

by Design

CPHI QUALITY BY DESIGN Date: February 24 – 26,2014 Venue: Kuala Lumpur, Malaysia Summary: CPhI – Quality by Design will focus on the drivers, regulatory framework, risks, principles and approach for QbD, and the benefits for the pharmaceutical industry in Asia to implement QbD to compete in the global arena. This event is a unique learning platform combining discussions, case studies and best practice to enhance knowledge sharing and networking; coupled with a practical training component to enhance applied and technical implementation know-how.

URL: http://www.qualitybydesignasia.com/?utm_campaign=EVENTLI STING&utm_medium=MEDIAPARTNERWEBSITE&utm_source=EXPRESSPHARMAONLINE&utm_content=URL&utm_term= Contact details Marcus Chan UBM Conferences ASEAN Tel: +603 2176 8712 Fax: +603 2176 8786 Email: marcus.chan@ubm.com

MANAGEMENT

POLICIES FOR SUCCESS 2013 has been all about long pending regulations finally seeing the light of day â&#x20AC;Ś only to have them debated, dissected, modified and debated once again. What do industry stakeholders want from policy makers?

Similarly, what's on the wish list of policy watch dogs like NGOs and patient support groups?

As a part of its IPC Special, Express Pharma invites industry experts to share their thoughts

48 EXPRESS PHARMA December 1-15, 2013

MANAGEMENT

INSIGHT

Fixing India’s TB control policy Despite having a focused TB control programme for over five decades, India faces the ignominy of having the largest number of TB cases in the world. Non-compliance, confusion and poor implementation of government policies mark the failure of the system, both private and public, in providing quality treatment for TB to those who need it. Who will clean up the mess in the TB sector, asks Bharathi Ghanashyam, Head - Communications,The Akshaya Patra Foundation and co-founder of the blogsite/group, Journalists Against TB

DUSK IS FALLING on a day that has seen intermittent rains.

Shanti Hospital in Bagalkot, Karnataka, is teeming with patients, many of who have travelled long distances to reach there. One of these is Mahboob Kushtagi (28). Married recently, he works as a supervisor in a granite company and earns about `4000 per month. He looks anxious and speaks haltingly; as if afraid that every word he utters will worsen his condition. “My travails began a year ago when I felt a swelling in my neck region which kept getting bigger,” he says. “Since then I have been to several doctors and have already spent Rs 20000/- on tests and medicines, not to count the work days I have lost. But I feel no better; in fact the swelling is much bigger now. I have lost weight and feel ill all the time.” Pointing to Dr Shafeeullahkhan Inamdar, a chest physician he has been directed to, he says tiredly, “I hope I get relief here. I don’t know where else to go for a cure.”

Dr Inamdar fills in the details, “His old records indicate that Mahboob was first treated for TB Lymphadenitis based on suspicion alone. The second doctor he went to conducted fine needle aspiration cytology (FNAC) on him. Though the results did not indicate evidence of it, he was again treated for the same condition. After a year he sought the opinion of an ayurvedic doctor who ran some

scans and decided it was more prudent to refer him to me. I will do an excision biopsy and treat him based on the diagnosis.”

If her weight was the only indication of her age Ratnamala Melnada (53) would be eight years old. She weighs only 28 kgs and is a very sick person.

Weakened to the extreme, she mumbles incoherently when asked questions. Her daughter replies on her behalf. Much of her past medical history is not clear; what is clear is that after recovering from an attack of TB more than 20 years ago, Ratnamala often took her old prescription to chemists and used anti-TB drugs to cure herself of normal coughs and colds. She is presently suffering from TB but is not responding to anti-TB medication. Her daughter swallows the lump in her throat and admits that if her mother were to die, she will be all alone in the world.

Mir Saheb (60) lives in an airless, dark, dank, two room tenement. His family of four other members including his one year old granddaughter lives with him. He sells ice cream and has to sometimes cycle 20 kms a day to make a decent living. He has recently been diagnosed with TB and put on the DOTS regimen. His granddaughter is very attached to him and he can be seen holding her and playing with her. But no family member has been counseled on the dangers that

BHARATHI GHANASHYAM Head - Communications, The Akshaya Patra Foundation and co-founder,Journalists Against TB

he poses to the little child. Nor has the child been put on prophylaxis treatment as recommended by the national TB control programme and in compliance with international standards of TB care If there is one thread that links these stories together, it is the failure of the system, both private and public in providing quality treatment for TB to those who need it. There are some tough questions that need immediate answers. Why was it so easy for Ratnamala to buy anti-TB drugs over the counter?

Why is Mir Saheb’s little granddaughter so vulnerable and unprotected? Will Mahboob finally get the right treatment?

This story was researched from Bangalore, Bagalkot and Badami in Karnataka. It was

difficult. While the latter two places at least provided answers, doctors and laboratories in Bangalore refused to take calls from this writer and in cases slammed phones on knowing who was calling.

Despite having a focused TB control programme for over five decades, India faces the ignominy of having the largest number of TB cases (26 per cent of the global total according to the Global TB Report 2013).

Drug resistant strains of TB are on the increase and as per the same report India is estimated to have 64000 cases of MDR TB. In the year 2012, two important measures were introduced by the Government of India which could regulate the TB sector – the ban on serological tests for detection of TB and mandatory notification of TB cases being treated in the private sector. Compliance to both is poor, in fact nearly non-existent in the places researched for this story. Additionally, efforts to buy anti-TB drugs over the counter proved easier than buying cough lozenges in all three places. The real life instances quoted above also point to multiple problem areas such as lack of standardised practices, lack of accountability and rampant flouting of rules and norms.

It is a known fact that over 65 per cent of those who need anti-TB treatment in India go to private healthcare facilities.

What quality of care do they re-

ceive? Dr Kiran Kalburgi who owns Kalburgi Nursing Home, Bagalkot says, “When I initiate a patient on anti-TB treatment, I have no mechanism to track whether s/he has completed the treatment. It is for the patient to complete the course of treatment. I have neither the inclination nor the time to follow-up on his/her progress.” Asked if he is not worried that the patient who drops out would be vulnerable to DR TB, he shrugs and is noncommittal.

Speaking about the mandatory notification order, Kalburgi says, “I have not received any information about this. Even if I did, I would not be interested in notifying the government if it meant mountains of paperwork.” Kalburgi was not alone in his ignorance of the order. Very few doctors this writer spoke to knew about it. Inamdaar gives the situation another perspective, “Doctors in the private sector very commonly treat patients on suspicion alone. How will they notify when they have no evidence that they are treating confirmed cases of TB? Besides I have not seen any efforts by the government to sensitise doctors to the need to notify.

The situation calls for much more than government orders (GOs) which remain on paper. It needs stricter enforcement.”

Pradeep Mane, Senior Treatment Supervisor, District Hospital, Bagalkot says, “We agree that the efforts to convey

49 EXPRESS PHARMA December 1-15, 2013

MANAGEMENT information about the mandatory notification have been inadequate. The response however is poor even in the few places we have conveyed the information.

Doctors are reluctant to give us details fearing that there will be too much of documentation.”

Dr Nalini Krishnan, Director, REACH (Resource Group for Education and Advocacy for Community Health) points out, “We have belatedly put in regulations when the challenge of MDR TB is grave. RNTCP approaches private healthcare providers with a take it or leave it attitude. Notification of cases has to be facilitated with due consideration given to patient identity and confidentiality issues.” Krishnan observes that all is not well with the government system too, “We know that there is 17-20 per cent MDR-TB in re-treatment cases within the

RNTCP itself which means that patients who have been on DOTS are coming back with drug resistance. This definitely raises questions about the quality of DOTS.” Abhay Kumar, President, Indian Pharmacist Association (IPA) admits, “We know it is not healthy practice to dispense Schedule H drugs across the counter. But pharmacies in India are completely unregulated.

We need stricter enforcement of the Drugs and Cosmetics Act. As per a survey we conducted in Mumbai, qualified pharmacists are almost never present in shops. There is almost always only a sales person dispensing drugs. The drug control department must be much more alert to such malpractices.”

Dr Gutta Suresh, National Coordinator for TB Control, IMA (Indian Medical Associa-

tion) says, “Private practitioners are important players in the healthcare sector in India. It is evident that if the public health system was robust, there would be no demand for our services.

We have supported mandatory notification, subject to certain conditions like protecting patient confidentiality. While it is early days yet, we know the weaknesses with regard to enforcement in India. The Drugs and Cosmetics Act which is more than 50 years old is yet to be enforced fully. So there are concerns about whether enforcement mechanisms are in place for this. Given the situation we need to be regarded as partners.”

So where does the buck stop? Who is to clean up the mess that the TB sector seems to be in? Most obviously the government. Madan Gopal I.A.S,

Principal Secretary, Department of Health and Family Welfare, Government of Karnataka however says it a little differently, “The private sector in India is weakly regulated with specific reference to compliance to the quality parameters and adherence to legal provisions. Public interest is required to deal with TB and similar communicable diseases. Professional bodies such as IMA should take a lead in this. Availability of drugs without prescriptions is an issue not only for TB drugs but also other drugs. This calls for responsible business practices by the owners of pharmacies, better consumer awareness and punitive measures against those violating norms.”

Authorities from RNTCP, despite several efforts to get responses, remained silent and did not respond at all. While the

debate goes on, point and counterpoints are raised, it is important to remember that Mahboob, Mir Saheb and Ratnamala are not ‘them’. They are ‘us’ and deserve better. Whether it takes coming together, punitive measures or any other, it is time now to get our act together. It might already be too late.

DISCLOSURES This story has been written under the aegis of the International Union Against Tuberculosis and Lung Disease (The Union)’s Media Fellowships for Reporting on TB. Akshaya Patra is an Indian NGO providing food for education to children in India while Journalists Against TB is a group of health journalists committed to increasing awareness about TB through their work. (http://journalistsagainsttb.wordpress.com)

POLICY WATCH

Time for reflection and implementation Kirit S Javali, Partner, Jafa & Javali highlights the need for policies to address concerns, while ensuring affordability and availability of drugs THE PHARMA regulatory environment across the world is getting more stringent. In order to compete in the global market, the Indian pharma market needs a strong and effective regulatory set-up.

The Indian pharma industry is currently undergoing a transition and is at cross roads trying to handle a number of issues like delays in clinical trial approvals, uncertainties over the FDI policy, the new pharma pricing policy, a uniform code for sales and marketing practices and compulsory licensing, and data protection, all of which need immediate attention and a direction.

India has been considered as an attractive destination for conducting clinical trials. This is mainly due to India’s genetic diversity; increasing and varied disease prevalence rates; availability of medical, pharmacy and

50 EXPRESS PHARMA December 1-15, 2013

science graduates, clinical infrastructure and comparative cost advantage.

However, the regulatory delays in the clinical trials are adversely affecting this possibility.

The delays and regulatory uncertainty have severely derailed the innovation curve as well as the growth of the clinical trial industry. Ineffective regulatory oversight, need for safeguards for informed consent for vulnerable populations and compensation guidelines for patients for trial related deaths have emerged as major concerns.

Hundred per cent FDI through the automatic route was possible in the pharma sector in India. The FDI policy, however, provides confusing signals. However, certain investments is allowed by the automatic route but after November 2011, some investments require the approval of the Foreign Investment

Promotion Board (FIPB) which often comes with conditions. We need a FDI policy which addresses these concerns while ensuring the affordability as well as the availability of drugs in India.

The pharma companies are feeling the effects of the price controls associated with the National Pharmaceutical Pricing Policy (NPPP) which will have a negative impact in due course.

However, with a well thought out strategies, a large part of this impact can be negated in the medium to long-term period.

While companies have accepted the reality of price controls, one issue which has adversely affected the industry is the timeline for the implementation of DPCO. The industry felt that the government did not provide sufficient time for implementing the new packaging and labelling with the revised prices. There was also lack of clarity about the

location where such packaging and labelling activities could be performed.

Another matter which is giving rise to some anxiety in our domestic pharma industry, especially in light of the recent spate of mergers and acquisitions is that as the threshold level for regulation is quite high, the Indian industry may become an easy target for MNCs for acquisition. This attracts the competition law regime to penalise and regulate such behaviour, and ensure that all players play by the rules of free and fair competition in the market. In India, we now have independent regulators i.e.

Competition Commission with appeal to the Competition Appellate Tribunal. With this significant move we need to sensitise members of the Competition Commission and the Tribunal to the techniques of modern competition analysis. Further, put-

ting the Competition Advocacy provision to extensive practice is therefore a must. We need to provide the right incentives for innovation which can move India forward on this path and encourage the development of drug products that meet the needs of Indian patients.

Thus, the pharma industry is in need of more regulation since there is no sector regulator and thus, the Competition law can fill in the essential gap. The relationship between IPR and Competition law must be further studied with specific emphasis on the pharma sector.

MANAGEMENT

Regulations must be implementable, practical Dr Sauren Das, Executive Director, Excel Life Sciences suggests that while framing regulations, regulators should handpick the bad apples rather than shunning the entire basket

CLINICAL RESEARCH enterprise was estimated to reach $1.6 billion by various marketing analysis firms like Frost & Sullivan, Ernst & Young etc.

But unfortunately all the estimates and analysis met an uninvited roadblock enforcing sharp dip in the research sector.

The decisions made by the Supreme Court, constitution of new laws and policies by Ministry of Health and Family Welfare to regulate research in India were more regarded as knee jerk reaction to the petition filed by non-profit group organisation. The laws were in place well before the whole fiasco burst and took the center-stage.

Having said that, amendments in regulations are necessary and most welcome – they bring in control and sanctity to any task that we perform.

However, these regulations must be implementable, practical and in sync with the global standards.

In the field of clinical research the rules and regulations have always existed. Any new ones must focus on the benefits to the end user – that is the patient. This patient can be one of us or one of our family members. The patient must be given the benefit of doubt and be given the best available treatment.

In the ever-evolving environment/scene of medicine, each day ushers in a new disease or a different type of an old disease and the physician must have access to a variety of treatment options to manage diseases of such diversity including new drugs that are still being tested as some times these are the last resort left to the doctor The inconvenience, social –cultural practice, pain, suffering and misery of a patient must be considered while framing or amending the rules. The

rules while controlling the process of management of the patient should not curb and tie the hands of the physician so tightly that he has no elbow room to treat his patient. A simple case of hypertension may be managed by one anti-hypertensive in one patient while it may require two or even three different such medications to manage the second similar patient. And, if we do not conduct trials of new medications we will not have access to those second and third medication.

Safety is definitely to be considered at any cost. There is no doubt about that. In fact, many of the anti-cancer drugs are like double-edged swords – cutting both sides. All of them have beneficial and adverse effects. In spite of that, they are still used because they do bring in relief and cure to the suffering patient while giving a handful of adverse events. The adverse events are managed and taken care of. The patient gets a longer life and a better quality of life too during that period. Majority of the new drugs which are currently used in the field of oncology are in the

Continued on Pg 53

51 EXPRESS PHARMA December 1-15, 2013

MANAGEMENT

Urgently require systematic investment in infrastructure enhancements The Government of India is in a perfect position to provide direction and support to meet the urgent unmet needs of the 70+ million rare disease patients, says Harsha K Rajasimha, Founder Member, Organisation for Rare Diseases India

A RARE OR orphan disease is any single disease or condition that affects less than 0.1 per cent of the population. The US and European Union (EU) have developed rare disease definitions based on their population size and structure. About 30 million patients are estimated to be suffering from rare diseases in the US and another 30 million in the EU. Considering the population of India, a disease affecting one in 10,000 is considered rare or orphan. This may seem like a

small number but it is important to note that when all rare diseases taken together, the number of patients affected is significantly large. About 7,000 to 8,000 different rare diseases affect over an estimated 80 million Indians. Some examples of rare diseases include Pompe, Hirschsprung disease, Gaucherâ&#x20AC;&#x2122;s disease, Cystic Fibrosis, Hemangiomas, and certain forms of muscular dystrophies.

Organization for Rare Diseases India (ORDI; www.or-

Whites Road, Royapettah, Chennai - 600 014 Tel: Board: 28543031/28543032/ 28543033/28543034. Fax: 28543035 E-mail: raghu.pillai@expressindia.com

HEAD OFFICE MUMBAI Rajesh Bhatkal The Indian Express Limited., Business Publications Division, 1st Floor, Express Towers, Nariman Point, Mumbai-400021. India Tel: 67440503 / 02 Fax: 022-22885831 Mobile: 98213 13017 E-mail : rajesh.bhatkal@expressindia.com Branch Offices NEW DELHI Ambuj Kumar The Indian Express Limited, Business Publications Division, Basement, Express Building, 9 & 10 Bahadur Shah Zafar Marg, New Delhi, 110 002 Direct Line: 011-2346 5727 Board Line: 011-2370 2100-107 Ext-727 Mobile: 09999070900 E-mail: ambuj.kumar@expressindia.com CHENNAI Dr Raghu Pillai The Indian Express Limited, Business Publications Division, New No.37/C (Old No.16/C) 2nd Floor,

52 EXPRESS PHARMA December 1-15, 2013

BANGALORE Khaja Ali The Indian Express Ltd. Business Publications Division, 5th Floor, Devatha Plaza 131, Residency Road, Bangalore - 560 025, INDIA Tel: 22231923/24/41/60 Fax: 22231925 Cell: 09741100008 E-mail: khaja.ali@expressindia.com HYDERABAD E. Mujahid The Indian Express Ltd. Business Publications Division, 6-3-885/7/B, Ground floor, V.V. Mansion, Somaji Guda, Hyderabad - 500082 Tel: 040 - 23418673/ 23418674/ 66631457 Telefax: 040 - 23418675 Mob: 09849039936 Email: e.mujahid@expressindia.com KOLKATA Ajanta Sengupta The Indian Express Limited Business Publications Division Express House NH-6 , Mouza - Prasastha &Ankurhati, PO - Salap

dindia.org) is a voluntary nonprofit organisation founded to represent the collective voice and needs of the rare disease patients and stakeholders in India.

ORDI aims to address the unmet needs and create opportunities that benefit rare disease patients in India. Based on our own experience and extensive feedback from the Indian rare disease community, we have identified several urgent action items for the benefit of Indian Rare Disease Patients:

New born screening for known rare diseases. This programme is running at select hospitals concentrated in New Delhi and there is compelling justification to scale up the new born screening program across India.

We recommend covering all metro cities in India immediately with strategy to cover smaller towns and villages eventually. Genetic testing based diagnostics facilities equipped for rare disease diagnoses have to become widespread. Genetic

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MANAGEMENT counselling should be offered at these centres and all maternity hospitals. In 2007, there were only 47 recognised genetic testing centres. This number has increased steadily over the years but given the population of India, there is a huge unmet need for uniform distribution of such facilities.

Not all rare diseases are curable or treatable. There are about 500 approved orphan drugs in the market.

Even when available, most patients cannot access and/or afford such treatments. The patients need accessibility to treatments when available either nationally or internationally. One example is Genzyme’s charitable access programme providing enzyme replacement therapy for Lysosomal Storage Disorders (LSDs) patients in India.

Since a large number of treatments and orphan drugs are under development, there are opportunities to enroll eligible patients into ongoing or upcoming clinical trials. A transparent enrollment process for Indian rare disease patients into global clinical trials is an urgent and important need because majority of rare diseases have no available treatments. ORDI aims to develop a rare disease patient registry would enable and facilitate such a transparent clinical trials enrollment process.

For certain undiagnosed debilitating rare disease patients with significant special needs, home-based or typical hospital care may not be possible.

Hence, special rehabilitation centres would need to be created to support such patients and their families.

All citizens, including those ~70 million rare disease patients, deserve access to all public amenities and services. Unfortunately, there is a significant lack of infrastructure to support disabled people at public service facilities such as government offices, banks, hospitals, educational institu-

tions, and post offices in India. A systematic investment in such infrastructure enhancements is urgently needed.

The Government of India is in a perfect position to provide the direction and support for these urgent unmet needs of the 70+ million rare disease patients. We urge the Government of India to take steps outlined below in this regard including: ● Setting up an exclusive department to deal with rare disease patients’ needs. Such a department should have appropriate budget to meet these above needs. A single window for clearance of import of orphan drugs and lifesaving drugs would be ideal. ● The medical education and training programmes have to be updated to include not only the most common diseases but help create the next generation of doctors trained in diagnosing and treating rare and genetic diseases.

These changes are aligned with the global medical community that is rapidly embracing the practice of 'personalised' medicine. ● Encourage the pharma research and development community to invest in discovery of novel diagnostic methods and orphan drug development by offering incentives. The US, Japan and other countries have enacted Orphan Drug Acts for this purpose in their respective countries since 1983, and the time is ripe for the most populous democracy to act now. ● ORDI aims to collaborate and formally engage with rare disease stakeholders in India including patient communities, physicians, biopharma industry, academic research community, and the state and national governments to facilitate a dialogue and catalyse progress to ultimately enable Indian rare disease patients to not only cope with their condition but also contribute to India’s growth.

Continued from Pg 51

Regulations must be implementable... market only after rigorous clinical research, many of these having Indian participation. Clinical trials conducted yesterday have given us better medicines today. And, to get better medicines for tomorrow we must conduct clinical trials today.

A research product today is a medicine tomorrow. A few bad apples in the basket must be handpicked and taken care of rather than tying the basket or shunning the entire basket.

Clinical trials today bring a ray of hope, not only in the face of the patient but also on the faces of many current and future patients. A plethora of allied and industries today support towards getting that better medicine for our people in India. You name it – the IT, data management, laboratories, logistics, courier, storage, and even translating agencies, are all actively contributing. We cannot curb and squeeze all of them at one go.

53 EXPRESS PHARMA December 1-15, 2013