47 annual report 2012-13
TRANSCRIPT
About OPPI The Organisation of Pharmaceutical Producers of India (OPPI), established in 1965,
represents the research-driven pharmaceutical companies in India. OPPI is committed to
supporting the nation’s healthcare objectives and facilitating industry and stakeholder
partnerships, while striving to create and sustain an environment conducive to
innovation.
OPPI Members Follow:
Good Manufacturing Practices (GMP)
OPPI Code of Pharmaceutical Practices
OPPI's position on Intellectual Property Rights (IPR)
OPPI functions mainly on the following areas:
Continuous dialogue with the stakeholders
Actively engage in knowledge creation & knowledge sharing with value addition
Engage in ̀ Corporate Academia' Interaction
OPPI identifies itself with the country’s national healthcare objectives and encouraging its
members to make substantial contributions to social causes and actively promotes
Corporate Social Responsibility (CSR).
OPPI is an active member of International Federation of Pharmaceutical Manufacturers &
Associations (IFPMA), Geneva.
ANNUAL REPORT2012-13
Organisation of Pharmaceutical Producers of IndiaPeninsula Chambers, Ground Floor, Peninsula Corporate Park,
Ganpatrao Kadam Marg, Lower Parel, Mumbai 400 013.Telephone: +91 22 2491 8123, 2491 2486, 6662 7007 Fax: +91 22 2491 5168
Email: [email protected] Website: www.indiaoppi.com
IndexMessage 1
Introduction 3
Discussion and Analysis 5
Organisation and Objectives 17
Reports 20
Working Groups:
• Access and Affordability
• Governance and Manpower Management
• Innovation and IPR
• Stakeholder Engagement and Partnerships
Special Committees:
• Accounts & Administration and Finance & Taxation
• Communications (Internal & External) and Government Affairs
• Human Resource Development
• Legal
• Marketing Code, Ethics and Compliance
• Medical, Biotechnology and Regulatory
OPPI in Pictures 47
Membership of Associations / Publications 64
Meetings with Policy Makers / Government Authorities 65
OPPI Representations 72
Seminars and Knowledge / Academia Programmes 82
Members 84
Past Presidents 85
th47 ANNUAL REPORT2012-13
Organisation of Pharmaceutical Producers of India
Executive Committee : 2012-13
PRESIDENT Mr. Ranjit Shahani Novartis India Ltd.
VICE PRESIDENTS Dr. Shailesh Ayyangar Sanofi India Ltd.
Dr. Hasit B. Joshipura GlaxoSmithKline Pharmaceuticals Ltd.
Mr. Sudarshan Jain Abbott Healthcare Pvt. Ltd.
Mr. K.G. Ananthakrishnan MSD Pharmaceuticals Pvt. Ltd.
MEMBERS Mr. Ajit Singh* (upto 31.3.2013) ACG Associated Capsules Pvt. Ltd.
Mr. Raghu Kumar Allergan India (P) Ltd.
Mr. Anandh Balasundaram* (upto 1.9.2012) AstraZeneca Pharma India Ltd.
Mr. Anish Bafna Baxter India Pvt. Ltd.*
Mr. Angel-Michael Evangelista Bayer Pharmaceuticals Pvt. Ltd.
Mr. Sameer Savkur Biogen Idec Biotech India Pvt. Ltd.
Mr. Sharad Tyagi Boehringer Ingelheim India Pvt. Ltd.
Mr. Pheroze Khan Bristol-Myers Squibb India Pvt. Ltd.
Mr. Rajiv Chopra (upto 21.3.2013) DSM Nutritional Products India Pvt. Ltd.*
Mr. K. Shivkumar Eisai Pharmaceuticals India Pvt. Ltd.
Mr. Rakesh Bhargava* (upto18.7.2013) Fresenius Kabi Oncology Ltd.
Mr. G. Sathya Narayanan Galderma India Pvt. Ltd.
Mr. Rajan S. Tejuja* (upto 12.4.2013) Johnson & Johnson Ltd.
Mr. Lawrence Ganti Merck Ltd.
Mr. Melvin D’Souza Novo Nordisk India Pvt. Ltd.
Mr. Aijaz Tobaccowalla Pfizer Ltd.
Ms. Meeta Gulyani Roche Products (India) Pvt. Ltd.
Dr. Safia Rizvi UCB India Pvt. Ltd.
SPECIAL INVITEES Mr. Rehan Khan (upto 20.6.2013) Abbott India Ltd.*
Mr. Jonathan Hunt (upto 18.4.2013) AstraZeneca Pharma India Ltd.
Mr. Sanjay Murdeshwar (w.e.f.16.5.2013) AstraZeneca Pharma India Ltd.
Mr. Melt van der Spuy (upto 30.8.2013) Eli Lilly & Company (India) Pvt. Ltd.
Mr. Swami Raote (upto 14.8.2013) Johnson & Johnson Ltd.
Mr. Sanjiv Navangul (w.e.f. 14.8.2013) Johnson & Johnson Ltd.
WORKING GROUPS CHAIRMAN CO-CHAIRMAN
Access and Affordability Mr. Sudarshan Jain Mr. Raghu Kumar
Governance and Manpower Management Dr. Shailesh Ayyangar Mr. Sharad Tyagi
Innovation and IPR Dr. Hasit Joshipura Mr. Angel-Michael Evangelista
Stakeholder Engagement and Partnerships Mr. K.G. Ananthakrishnan Mr. Rehan Khan*
SPECIAL COMMITTEES CHAIRMAN CO-CHAIRMAN / CO-CHAIRPERSON
Accounts & Administration and Finance Mr. Rajan Tejuja* (upto 12.4.2013) Mr. Ajit Singh (upto 31.3.2013)*
& Taxation
Communications (Internal & External) Mr. Aijaz Tobaccowalla Ms. Meeta Gulyani
and Government Affairs
Human Resource Development Mr. Lawrence Ganti Mr. K. Shivkumar
Legal Mr. G. Sathya Narayanan Mr. Rakesh Bhargava (upto 18.7.2013)*
Marketing Code, Ethics and Compliance Mr. Pheroze Khan Dr. Safia Rizvi
Medical, Biotech & Regulatory Mr. Sameer Savkur Mr. Melvin D’Souza
* Resigned
Organisation of Pharmaceutical Producers of India
SECRETARIAT
MUMBAI Mr. Tapan Ray Director General
Ms. Ranjana Smetacek (w.e.f.3.6.2013) Director General (Designate)
Mr. Rajiv Shukla Director – Alliance Development
Mr. Vivek Padgaonkar Director – Project & Policy
Mr. Santosh Zokarkar (w.e.f. 25.7.2013) Director – Communications
Dr. Ajaykumar Sharma (w.e.f. 15.7.2013) Director – Research
Mr. Ajit Bendre Associate Director – Finance,
Admn. & Association Secretary
Mr. Ashvin Muchhala Manager – Accounts & Administration
NEW DELHI Mr. Tabrez Ahmad (w.e.f. 15.7.2013) Secretary General
Mr. Prem Singh Rawat Manager – Government Affairs
Mr. Ranjit ShahaniVice Chairman & Managing Director,
Novartis India Ltd.
1
Message
The last 12 months have been eventful for
the pharmaceutical industry in India,
particularly in the areas of pricing and
intellectual property. The Organisation of
Pharmaceutical Producers of India (OPPI)
acknowledges the supportive role played
by Government in steering the Indian
pharmaceutical industry, which is
emerging as a significant player in the
global arena. While Government’s
unstinting support has helped the Indian
pharmaceutical industry become a critical
global generics player, there is still work to
be done when it comes to incentivising
industry to invest in research.
The present IP environment poses a
serious challenge for the future climate of
innovation in our sector. Today, it is very
difficult to obtain patents on valuable
pharma inventions. If a patent is granted,
effective enforcement is impossible and a
patent-holder can very easily be deprived
of any proprietary right conferred by the
patent. Even 67 years after independence,
we are yet to see a molecule “invented in India”. With our Prime Minister declaring this the decade of innovation, we would really like
to see the Indian Government and all the other stakeholders play a role in supporting this vision.
A technology-intensive industry like ours needs to continuously innovate, if it wishes to grow and compete globally. India has the
opportunity to become a hub of innovation for the pharmaceutical industry, provided we put in place an ecosystem that fosters
innovation.
OPPI is of the firm belief that an innovation-led pharmaceutical industry and a generics pharmaceutical industry can, and must, co-
exist in India. The innovation pipeline contributes to the generics pipeline. If there are no innovative drugs, there will be no generics
drugs. Every single generic drug started as an innovative medicine. Today, if we are living healthier and longer lives, it is in no small
measure because of the research-based pharmaceutical industry. Respect, support and protection for innovation will eventually
contribute to the benefit of the patient.
At the same time, there continues to be much uncertainty around FDI investment in brownfield and greenfield ventures, in the
Indian pharmaceutical industry. India needs to upgrade her pharmaceutical skills and FDI should be viewed in this context. Foreign
investment will help add significantly to India’s scientific capabilities and allow our top scientists to benchmark themselves against
the best, all to the long term benefit of India and the patient.
Organisation of Pharmaceutical Producers of India2
In addition to Fiscal and Current Account deficits, India unfortunately suffers from another set of twin deficits - investment and
technology. Free flow of FDI in Pharmaceuticals will go a long way in meeting both these deficits. FDI in any sector delivers value to
a nation. Employment is assured and the taxes resulting from more successful businesses benefit the country. Apart from this, FDI
helps introduce global best practices in the pharmaceutical sector, resulting in optimal resource utilisation and increased
productivity.
While the pharmaceutical industry in India has indeed made significant progress, the time has come to upgrade our skills to the next
level, in areas such as product innovation and new molecule search among others. Capacity building and sustained drug discovery
programmes, even within the domestic industry, should be seen in the longer time horizon. Foreign investment, apart from bringing
in much needed funding to India, will also greatly add to India’s technological capabilities and expose India’s finest scientific talent
to world-class practices and processes, helping them mature and reach the next level of capability.
India’s post liberalisation experience - in line with the experience of the rest of the world - has proved that competition never harmed
any Industry or country. On the one hand, global competition has enabled Indian companies to change and compete globally; on
the other, in each Industry where FDI has been allowed, MNCs have benefited India. They have focused not only on meeting India’s
market needs but also helped upgrade skills and add to the exports prowess of the country. There is no reason to believe, either
empirically or based on facts thus far, that the case would be any different for the pharmaceutical industry.
OPPI believes that unrestricted FDI in Pharma - both brownfield and greenfield - is in the best interests of the country and will help
India in the short, medium and long terms. We are keen to engage with all relevant stakeholders to understand their concerns and
make sure we arrive at conclusions that are best for India. There are several areas in which MNCs and Indian pharmaceutical
companies already collaborate, including clinical trials, co-marketing and manufacturing. There is every reason to believe that this
collaboration can extend to other areas, particularly with some incentivisation by the government.
OPPI and all our members reiterate their commitment to achieving healthcare for all. We remain committed to collaborating with the
Indian Government, and other stakeholders, to find sustainable solutions that balance the need for innovation with the necessity for
more accessible medicines. We believe that a long-term solution to India’s healthcare challenges requires a holistic approach and
a critical evaluation of our existing systems. We support the Indian government’s quest for more accessible and affordable
healthcare. We welcome a more comprehensive dialogue between all stakeholders. We look forward to working in collaboration
and partnership towards a common goal. Together we can make it happen!
Ranjit Shahani,
President OPPI,
September 30, 2013
Mumbai.
3
Introduction
One of the path breaking recent developments is Drugs Price
Control Order 2013 (DPCO 2013). It has been notified after an
agonizing wait of about 17 years, bringing all 652 formulations of
348 essential drugs covering 27 therapeutic segments of the
National List of Essential Medicines 2011 under price control.
However, the question still remains, have the successive DPCOs
since 70’s been able to achieve the desired objectives?
Be that as it may, the new policy differs from the previous one in the
methodology of price control. The cost based pricing mechanism
has been replaced with a market-based one, where simple average
price of all brands with a market share above 1% in their respective
segments will be considered.
Companies selling medicines above the new Ceiling Prices (CP), as
will be notified by the National Pharmaceutical Pricing Authority
would have to slash prices to conform to the CP level. However,
those selling these scheduled drugs below the CP will not be allowed to raise prices, resulting in significant price reduction of most
essential drugs with price increases in none. Prices of all these formulations will be frozen for a year. Although a silver lining is that
manufacturers will be permitted an annual increase in the retail price in line with the Wholesale Price Index (WPI).
The span of control with DPCO 2013 will cover approximately 18% of the ` 72,000 Crore pharmaceutical market. However, the
total coverage will increase to around 30% after coupling it with existing medicines already under price control.
DPCO 2013 continues with the provision of DPCO 1995 fixing margin for the Retailers at 16% of Ceiling Price, excluding Taxes.
Indian patients will undoubtedly be the biggest beneficiaries of the new DPCO, as ceiling prices will now be based on roughly 91%
of the pharmaceutical market by value, resulting over 20% price reduction in 60% of the NLEM medicines. The prices of some
drugs will fall by even upto 70%.
In the short-term, industry profitability would decline. However, despite initial adverse impact, higher volume growth over the next
few years may help the companies to recover and pick-up growth momentum.
Moreover, the shift in the methodology of price control from virtually opaque and highly discretionary cost based system to
relatively more transparent market based one, appears to be directionally right and more prudent. Even WHO in its feedback to the
Department of Pharmaceuticals welcomed the intent to move away from cost-based pricing as it has been abandoned elsewhere.
Thus, DPCO 2013 should achieve the objectives of the Government in ensuring essential medicines are available to those who
need them most by managing prices in the retail market and balancing industry growth on a longer term perspective.
I believe, DPCO 2013 will be implemented in such a way as to achieve the declared objectives of NPPP 2012.
Mr. Tapan RayDirector General
OPPI
Organisation of Pharmaceutical Producers of India4
That said, coming back to the point where I started from, price control of medicines since the last four decades have certainly been
able to make the drug prices in India one of the lowest in the world coupled with intense cut throat market competition.
Unfortunately, this solitary measure has failed to improve desirable access to modern medicines for the common man due to
various other critical reasons, which we hardly discuss and deliberate upon with as much passion as price control.
Otherwise, why despite so many DPCOs and rigorous price control over the last four decades, 47% of hospitalization in rural area
and 31% of the same in urban areas are still financed by private loans and selling of assets by individuals?
OPPI supports the healthcare goals of the country and has been actively contributing to building a sustainable healthcare system
for improved access to medicines in the country through longstanding patient assistance programs, immunization programs and
training of healthcare workers… and of course, research on new medicines to treat unmet medical needs of the population of the
country.
Many other important issues of the industry are still in ‘work in progress’ stage. You will get to know some of those areas during the thopen session of our 47 Annual General Meeting (AGM). As I step down from OPPI after the AGM to pursue other interests, I thank
all of you for your kind support always and pray for your good health, happiness and success in all your endeavor.
Tapan Ray
Director General
OPPI
Discussion and Analysis
5
Source: www.tradingeconomics.com/The World Bank Group
2004 2012201020082006
2000
1800
1600
1400
1200
1000
800
600
400
200
0
599.46
810.15
1242.431380.64
1847.98
India GDPUSD Billion
thThe 47 Annual Report of OPPI outlines various initiatives undertaken and highlights major events of the year 2012-13. It also
captures the concerns and challenges of the pharmaceutical industry in general and the member companies of OPPI, in particular,
by analyzing implications of various industry-related issues.
Indian Economy
The Indian economy has almost quadrupled in size since 1991. The Gross Domestic Product (GDP) in India was worth USD 1848
bn in 2011, which represents 2.98% of the world economy. As per the International Monetary Fund (IMF) report India's GDP growth
is likely to be 5.7% during the calendar year 2013 and further improve to 6.2% a year after.
One of the highlights of the India story is its savings rate. After touching 37% of GDP at one point, it has come down to 30%, which is
still among the highest in the world. With the GDP now touching almost USD two trillion, this translates into savings of almost USD
600 bn.
Discussion and Analysis
Organisation of Pharmaceutical Producers of India6
World Pharmaceutical Market: 2012
No. Country USD Bn. % Share Val Gr
Global Pharma Market 961 100 5
1. USA 329 38 -1
2. Japan 112 13 0
3. China 82 10 24
4. Germany 42 5 -6
5. France 37 4 -8
6. Brazil 29 3 6
7. Italy 27 3 -8
13. India 14 1 11
Source : IMS Knowledge Link Global Sales 2012
Patent expiries have had an impact on the growth rates of the global pharmaceutical market. Research pipelines are struggling to
deliver new drugs capable of matching revenues previously generated by patent-expired brands. Pharmaceutical cost-
containment measures by various governments have also begun to limit market growth.
Based on IMS Global Prognosis Report 2012, markets in Europe are expected to be among the most subdued, with sales expected
to register a CAGR of just 0.7%. Low growth is also likely be the order of the day in North America (CAGR forecast of 2.4%) and
Japan (CAGR of 2.6%). By contrast, markets in South-East and East Asia, the Indian sub-continent and Latin America are forecast
to register double-digit growth. China, Brazil, India and Russia will all rank among the world’s 10 biggest pharmaceutical markets by
2016.
The gap between growth rates in developed and major emerging markets is expected to widen further over the next five years.
Total Indian Pharmaceutical Market
India represents one of the fastest growing healthcare markets globally. From a market of USD 13.62 bn in 2007, it is expected to
reach USD 31 bn by 2015. In terms of volume, India ranks third with 10% share of the global pharmaceutical market. However, in
terms of value, it occupies thirteenth position, accounting for 1.5% of the total pharmaceutical production across the globe.
Emerging markets’ share in the global pharmaceutical industry is expected to touch 28% by 2015 from current 18%. India
constitutes 8% of this segment currently (1.44% of the total market), and is projected to grow to 10% (2.8% of the total) by 2015.
(Source: DoP-E&Y Report)
Domestic Formulation Market
Domestic pharmaceutical formulation market has grown from USD 11.4 bn in 2010 to close to USD 14 bn in 2012; registering a
growth of 11% and is expected to record a CAGR of 15.7% for the period of 2010-2015, as per the IMS Prognosis Report 2012.
Historically, growth of the Indian Pharmaceutical Market (IPM) has been about double GDP growth. It is now expected that IPM
turnover will reach around USD 55 bn by 2020. (Source: IMS)
Retail Sector
In 2012, the Indian pharmaceuticals retail market recorded a turnover of ̀ 547 bn, growing at 14% CAGR over the last five years.
(Source: IMS SSA, MAT Dec 2012)
Discussion and Analysis
7
The key growth drivers have been a large number of new introductions, price revisions, increased demand of the existing products
and market penetration beyond the traditional core markets.Years 2010 and 2011 have witnessed many M&As, altering the market
dynamics. This has resulted in changes in ranking as well as therapy leadership.
The value contribution from companies with a turnover of more than ` 10 bn has increased from 52% to 60%, whereas the value
contribution from companies with turnover between ̀ 3 – 10 bn has decreased to 18% from 25% over last year.
The expansion of price control to all products on the NLEM 2011 in DPCO 2013 will put a constraint on price growth.
Hospital Sector
In 2012, the Indian hospital market for pharmaceuticals registered a turnover of ̀ 65.5 bn.
Performance of IPM (Retail) Over Last Five Years
Source: IMS Market Prognosis Report 2013
Source: IMS SSA, MAT Dec 2012
Performance of IPM (Hospital) Over Last Five Years
2008
2008
2009
2009
2010
2010
2011
2011
2012
2012
312.94
25.99
17%
32%
17%
28%
15%
30%
11%
14%
547.49
65.5
492.93
57.54
427.85
44.21
366.79
34.32
10%
16%
` Billion
(Figures inside column indicate value growth)
` Billion
(Figures inside column indicate value growth)
2009 2010 2011 2012
(14%)
(9%)
(8%)
(in %
)
Extra-urban Markets
18 19 20
20 19 19
32 31 31
Rural Class II to IV Class I Metros
18
20
33
29 30 31 30
Most of the leading corporate hospital groups have announced expansion plans, pursuing a broader geographical presence and
establishing hospitals in smaller cities; while many plan to broaden their businesses beyond the hospital sector into specialist
primary care segments. Increase in private health insurance, which remains largely focused on inpatient coverage, will also
contribute to growth.
Overall, the market is estimated to grow at ~18% over the next five years to reach ̀ 150 bn in 2017. (Source: IMS Health)
Vaccines Market
According to GBI Research Report, the overall global vaccines market was valued at USD 28 bn in 2010 and is expected to reach
USD 56.7 bn by 2017 with a CAGR of 11.5%. The key future growth driver for this segment will be the introduction of newer
vaccines, which are currently either in the regulatory filing stage or in the late stages of clinical development.
McKinsey in its report titled India Pharma 2020: Propelling Access and Acceptance, Realizing True Potential stated that at 2%
penetration, the vaccines market of India is significantly under-penetrated with an estimated turnover of around USD 250 mn,
where the private segment accounts for two-thirds of the total. McKinsey expects the market to grow to USD 1.7 bn by 2020.
Consumer Healthcare Market
Indian Consumer Healthcare segment for pharmaceuticals is currently estimated at over USD three bn comprising mainly Rx-to-
OTC and ‘pure-play’ OTC segments. This segment is expected to grow at 14-16% to become a USD 14-18 bn market by 2020.
(Source: Indian Pharma 2020, McKinsey)
Extra-urban Markets
The pharmaceutical industry has started to see gains from the extra-urban markets. This will be a key driver of the next wave of
growth for pharmaceutical companies. The market outside India’s major metros has vast untapped potential. Already local
manufacturers have spearheaded moves to broaden geographical coverage of the market, targeting extra-urban and rural areas
over the past five years.
The contribution from these markets is expected to take a significant leap with increasing government spend on National Rural
Health Mission (NRHM), Rashtriya Swasthya Bima Yojana (RSBY), and the thrust on Jan-Aushadhi.
Organisation of Pharmaceutical Producers of India8
Source: IMS
Discussion and Analysis
Formulations Export
The Ministry of Commerce has targeted Indian pharma sector exports at USD 25 bn by 2014, at an annual growth rate of 25%. The
industry registered exports of USD 13 bn with a growth rate of 30%, in the last year (Source: Pharmexcil). The Government has also
planned a ‘Pharma India’ brand promotion action plan spanning over a three-year period to give an impetus to generic exports.
Indian companies export off-patent generic drugs to over 200 countries and India is often referred to as ‘The Pharmacy of the World’
(Source: Pharmexcil). Biosimilar drugs, already an emerging segment in some markets, are expected to gain popularity as the
regulatory pathways are put in place even in the highly regulated markets like US and Europe.
Generics Market
On the basis of the international growth trends for generics, the global generics market is expected to grow to USD 142 bn by 2015.
(Source: OPPI-Yes Bank Report)
Bulk Drugs (Active Pharmaceutical Ingredients)
Growth of the international generic drug industry will continue to fuel the growth of the bulk drug industry worldwide. Domestic
formulation growth will continue to have a direct impact on the API sales in India.
Indian companies have received a higher number of USFDA approvals for 178 ANDAs during 2012 as compared to 144 in the
previous year and filed 417 DMFs during the year 2012 with USFDA as against 404 DMFs in the previous year despite stringent
approval norms (Source: Pharmabiz). Bulk drug exports from India is expected to reach around USD 12.5 bn by 2015. (Source:
OPPI-Yes Bank Report)
Contract Research and Manufacturing Services (CRAMS)
Ballooning costs for research and development and low productivity have prompted the research-based global pharmaceutical
companies to outsource part of their research and manufacturing activities to lower-cost developing nations like India and China.
Over the last five years CRAMS industry has been contributing close to 8% of the total Indian pharmaceutical business. A spurt in
activities on the outsourcing front is likely to take the CRAMS sector to around USD 7.6 bn by the end of 2013. Factors like a vast
expanse of speciality hospitals with state-of-the-art facilities, diverse population and gene pool, increasing number of chronic
diseases and a combination of diseases, characteristics of developing and the developed countries, are expected to propel the
CRAMS industry growth at a CAGR of over 42.2% (2007-2012). (Source: PharmaBiz)
However, the South East Asian markets are now emerging as a hub for sourcing generics and branded formulations.
Medical Devices Market
The Indian medical devices market, which was valued at USD 2.5 bn in 2012, will have a CAGR of nearly 23.2% for the period of
2009-13 (Source: KPMG). The medical equipment segment accounts for 55% of the total medical devices market, which is
followed by medical implants and disposable segments accounting approximately 25% and 20% (Source: Cygnus). The market for
medical supplies and disposables is dominated by the domestic manufacturers, whereas importers dominate the high-end medical
equipments. There are some 700 medical device makers in India. However, almost 75% of medical devices are currently imported
by India. The medical device consumer base will be 268 mn by 2015 growing at 17% per year. (Source: KPMG)
The industry has a large number of overseas players who have set up manufacturing facilities in India, or are operating by tying up
with Indian distributors. Simultaneously, the domestic players are also increasing their manufacturing capacities and diversifying
their product portfolio.
9
Discussion and Analysis
Medical Tourism
India has experienced increased popularity in medical tourism, as patients in developed nations become increasingly discouraged
with local healthcare facilities, higher costly procedures and long waiting times. Affordability of treatment is a big pull factor since
treatment in India costs just 10-20 % of what it costs abroad.
According to a report published by RNCOS, titled Booming Medical Tourism in India, India’s share in the global medical tourism
industry will reach around 3% by the end of 2013; generating revenue of around USD three bn by 2013 with a CAGR of around 26%.
The number of medical tourists is expected to grow at a CAGR of over 19% during the forecast period to reach 1.3 mn by 2013.
Health Insurance
The Indian healthcare insurance industry is worth ` 604.97 bn growing at a CAGR of approximately 42.3% between 2008 and
2015. The market penetration will be three - fold higher in 2015 (Source: IRDA). According to World Bank Report, 99% of Indians
will face a financial crunch in case of any critical illness.
The market drivers are likely to be increasing awareness of health insurance, rising healthcare costs, supporting demographic
profiles (prospering Middle Class, increasing disease state, population), detariffing of the general insurance industry (which has
increased emphasis and efforts by insurance companies towards health insurance and other personal lines of business), and
rationalisation of premium rates (e.g. trend of upward revision in respect of Group Health Policies).
With the health insurance portability in place, the sector has seen a range of innovative products. Companies have started offering
better features while keeping a check on prices. This sector is expected to get a boost when the government increases the FDI cap
for the insurance industry in general.
Research and Development (R&D)
India spends only 0.8% of its total GDP on R&D, which is much lower as compared to developed nations like, USA (2.8%), Japan
(3.1%), Germany (2.5%) and France (2.2%). (Source: Taking Wings, OPPI-E&Y)
In order to capture a share of 15-20% of the world’s R&D pipeline, India needs to adopt an aggressive approach towards drug
discovery and innovation. However, with an average success rate of 0.2-0.3%, India should be able to develop around 4-6 new
drugs by 2020 out of the pool of 2,250-3,000 drug candidates, generating around USD 6 – 8 bn value.(Source: DoP-E&Y)
To achieve this, India needs to focus on various elements of drug discovery:
• Create an innovation friendly ecosystem and strengthen R&D infrastructure
• Foster private industry participation in new drug discovery and innovation activities
• Encourage a conducive environment for private players to scale up their R&D acitivity
• Strengthen industry-academia linkage to enable knowledge and technology transfer
• Effect speedy redressal of IP related disputes
OPPI on the Task Force: India as a Drug Discovery and Pharma Innovation Hub 2020
The Department of Pharmaceuticals (DoP) engaged M/s. Ernst & Young (E&Y) to prepare a Detailed Project Report for Developing
India, as a Drug Discovery and Pharma Innovation Hub 2020. In order to arrive at a broad consensus on the recommendations
made by E&Y in the Project Report and to promote growth and development of the pharmaceutical Industry, the DoP organised a
series of meetings and a workshop with all major stakeholders: Industry, Academia and the Government.
OPPI is an important constituent of this Project.
Organisation of Pharmaceutical Producers of India10
Discussion and Analysis
Incremental Innovation in India
Incremental innovations are indeed very important for the country and have been benefitting patients immensely over decades,
across the world. A report titled The Value of Incremental Pharmaceutical Innovation highlighted as follows:
• As per the National Knowledge Commission, while 37.3% of Indian companies introduced breakthrough innovations in
recent years, no fewer than 76.4% introduced incremental innovations.
• 60% of the drugs on the World Health Organization’s essential drug list reflect incremental improvements over older drugs.
The report indicates some of the benefits of ‘Incremental Pharmaceutical Innovation’ for India as follows:
1. Improved quality of drug products, including products that are better suited to India’s climate.
2. Development of treatments for diseases that are prevalent in India for which new drug discovery is currently limited or
otherwise inadequate.
3. Increasing likelihood that for every therapeutic class, there is a treatment to which an Indian patient will respond.
4. Development of the R&D capacity and expertise of Indian pharmaceutical companies.
5. Reduction of healthcare and other social costs in India through improved drug quality and selection.
6. Increased access to medicine as a result of price competition.
There are numerous examples that can ably demonstrate that ‘incremental innovation’ of the pharmaceutical innovators helps
significantly in improving the efficacy and safety of existing drugs. OPPI believes that all such innovations should in no way be
considered frivolous as they have substantial and positive impact in improving conditions for ailing patients.
Foreign Direct Investment (FDI) in Pharma Sector
The Pharmaceutical Sector was opened up for 100% FDI through automatic route only in 2002 as part of the financial reforms
process, positioning India as an attractive investment destination. This reforms process demands stability as, by partnering with
MNCs, Domestic pharma companies have begun to gain access to international expertise, technology, resources, good
manufacturing practices and markets.
Since then, the pharmaceutical industry has become one of the top 10 contributors for inward FDI as published in the Fact Sheet on
FDI of DIPP. This could happen mainly due to predictability of the FDI policy for the Pharmaceuticals Sector of the country.
The consolidated FDI policy 2012, in the Pharmaceuticals Sector, is as under:
(i) FDI, upto 100% under the automatic route, is permitted for greenfield investments.
(ii) FDI, upto 100%, under the Government approval route, is permitted for investments in existing companies.
For any merger or acquisition in the Pharmaceutical Sector, the overseas investor will have to seek permission from the Foreign
Investment Promotion Board (FIPB) and after six months, CCI will vet such deals. However, 100% FDI under automatic route
continues to be allowed in new projects.
OPPI believes that opening-up FDI in pharmaceuticals, as the required safety measures are now in place, has the potential to
catapult Indian pharma onto the global business map expeditiously. It will reinforce India as the preferred investment destination
of the world. Liberal Policy on FDI in Pharmaceuticals will strengthen the process of creating innovation capabilities, developing
cost effective R&D and establishing a manufacturing base to bring in high tech products to contribute to the economic growth of the
nation.
11
Discussion and Analysis
Drug Price Control Order (DPCO) 2013
In recent years, following a series of protracted judicial and executive activities, the New National Pharmaceutical Pricing Policy
2012 (NPPP 2012) came into effect on December 7, 2012. In the new policy, the span of price control was changed to all drugs
falling under the National List of Essential Medicines 2011 (NLEM 2011). Even the price control methodology was modified from
cost-based to market-based. Accordingly, the new Drug Price Control Order (DPCO 2013) was notified on May 15, 2013, after a
long wait of 18 years; bringing all 348 drugs and 652 formulations in 27 therapeutic segments of the NLEM, under price control. As
prescribed in the NPPP 2012, in the new DPCO the cost based pricing mechanism has been replaced with a market-based one,
where simple average price of all brands with a market share above 1% in their respective segments will be considered. However,
the matter is still sub judice.
Companies selling medicines above the new Ceiling Prices (CP), as will be notified by the National Pharmaceutical Pricing
Authority (NPPA), will have to slash prices to conform to the new CP level. However, those selling these scheduled drugs below the
ceiling price will not be allowed to raise prices, resulting in significant price reduction of most essential drugs with price increases in
none. Prices of all these formulations will be frozen for a year. However the manufacturers will be permitted an annual increase in
the CPs in line with the Wholesale Price Index (WPI).
The span of DPCO 2013 will cover approximately 18% of the USD 13.6 bn domestic pharmaceutical market. However, the total
coverage will be around 30%, for a year, after being coupled with existing price controlled medicines, as these will continue with the
current prices for a year. DPCO 2013 continues with the provision for the trade of DPCO 1995, fixing margin for the Retailers at 16%
of Ceiling Price, excluding Taxes.
Indian consumers will undoubtedly be the biggest beneficiaries of the new DPCO as ceiling prices will now be based on roughly
91% of the pharmaceutical market by value, resulting in upto 20% price reduction in 60% of the NLEM medicines. The prices of
some drugs will fall up to 70%. (Source: IMS / AIOCD AWACS)
In the short-term, Domestic Pharma Market may shrink by around 2-3% on implementation of the new policy (Source: AIOCD
AWACS). The impact could be more pronounced for OPPI member companies.
OPPI feels that the shift in the methodology of price control from a virtually opaque and highly discretionary cost-based system to a
relatively more transparent market-based one, is directionally right and more prudent.
Pricing Policy for Patented Products
The government is preparing a policy for the pricing of patented medicines. The committee recommended three specific price
setting approaches.
• Drugs with no therapeutic equivalent would be reference priced and discounted based on purchasing power parity per capita
Gross National Income (GNI)
• Drugs with therapeutic equivalent in India would be also reference priced as in previous but then adjusted so price is not much
higher than locally available therapeutic equivalent
• Drugs launched first in India will be priced based on cost, risk factors, and any other relevant factor
In the current situation where prices in the Indian market are already much lower compared to the reference countries, the policy
may make the business proposition of supporting innovation unviable. It may lead to an environment in India that does not support
innovation. OPPI has already submitted its proposal on the subject to the Department of Pharmaceuticals for its consideration.
Organisation of Pharmaceutical Producers of India12
Discussion and Analysis
Government initiatives
National Health Mission (NHM)
thPublic health financing in India is abysmally small. It will rise from 1.05% to 1.85% of GDP during the 12 Five Year Plan. While still
not adequate, the increased amount should be used to strengthen the public health care system and provide financial protection to
those burdened by high out-of-pocket expenditure (78% of all health care).
The National Rural Health Mission (NRHM) is now to be expanded with addition of the National Urban Health Mission (NUHM),
recognising the urban poor. The National Health Mission (NHM), which unifies the two, receives 64% of the total budget of the
health ministry, rising from the 57% received by NRHM alone till last year. The NHM also provides for progressive integration of
many vertical health programmes, influencing the determinants like water, sanitation, nutrition and environment.
While NRHM has markedly increased the health care indicators, the quality of public health facilities needs to be improved. This
demands more and better trained professionals, improved infrastructure and drug supply, and measures of accountability
assessed through social and technical audits.
Universal Health Coverage
The Prime Minister has declared that health would be accorded the highest priority with the government intent to raise the public thfinancing of health to 2.5% of India’s GDP, during the course of the 12 Five Year Plan.
The High Level Expert Group (HLEG) on UHC was constituted by the Planning Commission of India, with the mandate of
developing a framework for providing easily accessible and affordable health care to all Indians. While financial protection was the
principal objective of this initiative, it was recognised that the delivery of UHC also requires the availability of adequate healthcare
infrastructure, a skilled health workforce and access to affordable drugs and technologies to ensure the entitled level and quality of
care for every citizen.
The HLEG undertook a situation analysis of each of the key elements of the existing health system. It has made recommendations
for reconfiguring and strengthening the health system to align it with the objectives of UHC; bridging the presently identified gaps
and meeting the projected health needs of the people of India over the next decade.
For UHC to succeed in India, political and financial commitments are required from the central as well as state governments.
On the issue of improving affordability and availability of essential medicines, OPPI believes that an ongoing dialogue and Public
Private Partnership initiatives would result in a holistic approach to address the challenge. However, it is pertinent to note that the
socio-economic imbalance in the context of affordability of medicines is misunderstood. India has amongst the lowest prices in the
world. It is very unfortunate that due to lack of UHC significant expenditure on healthcare, including medicines, is out-of-pocket.
Free Essential Medicines at Public Health Facilities
Supporting its drive to improve access to healthcare, the government announced a significant increase in financial allocation thearmarking ̀ three trillion for health under the 12 Five Year Plan (2012-2017), with the provision of free essential medicines and
the development of NHM. As part of the initiatives, the government had announced a plan to provide free access to essential
generic medicines at all public healthcare facilities, to be rolled out over the next five years. Under the plan, drugs for inclusion
would be chosen by each state from the 348 medicines on the NLEM. The government envisages that the plan would extend
access to public healthcare to around 52% of the population by 2017, from 22% at present. Two states, Rajasthan and Tamil Nadu,
have already begun to supply free essential generic medicines at public health facilities and both are being regarded as potential
pilots for other states for a nationwide scheme.
13
Discussion and Analysis
Key Healthcare Indicators : Progress
As per the World Health Statistics 2012,
Report total expenditure on health as a
percentage of GDP was around 4.2%. While
this is comparable to some of the other
developing countries, India still has one of the
lowest per capita total expenditure on health
and unlike other developing countries a large
part of this expenditure is private and out-of-
pocket .
Life expectancy at birth has more than
doubled, Infant Mortality Rate (IMR) has
reduced to one-third and Maternal Mortality
Ratio has reduced to almost one-tenth.
India's health financing system is a big factor
among the challenges of health inequity, inadequate availability and reach, unequal access, and poor and costly health-care
services. Low per person spend on health and insufficient public expenditure resulted in the high proportions of private out-of-
pocket expenses. Citizens receive poor value for money in the public and the private sectors. Financial protection for medical
expenditures is far from universal with only 10% of the population covered by medical insurance.
However, this progress, though significant, is not adequate. Apart from missing its own goals for healthcare outcomes, India now
needs to catch up with other developing countries on the key healthcare indicators.
Market Forecast
The Indian pharmaceutical market is expected to grow at a CAGR of 15.1% in the period 2012-2016. (Source: IMS Market
Prognosis 2012-16)
Source : IMS Market Prognosis (2012-2016) - (` bn)
Hospital Sector Unaudited Sector Retail Sector
2011 2012 2013 2014 2015 2016
530
6090
600
70
100
680
90
120
780
110
140
880
130
160
1000
160
190
India Pharmaceutical Market Forecast
Organisation of Pharmaceutical Producers of India14
Type Brazil Russia India China
Exp. on Health (% of GDP) 8.8 5.6 4.2 5.1
Govt. Exp. on Health (% of Total Exp. on Health) 43.6 63.4 30.3 52.5
Pvt. Exp. on Health (% of Total Exp. on Health) 56.4 36.6 69.7 47.5
Govt. Exp. on Health (% of Total Govt. Exp.) 5.9 8.5 3.7 12.1
Social Security Exp. on Health (% of General Govt. Exp. on Health)
- 38.7 17.4 64.7
Health Expenditure Vs Indicators (BRIC)
INDICATORS
EXPENDITURE
Type Brazil Russia India China
Life Expectancy at birth 73 68 65 74
Neonatal Mortality Rate (Per 1000) 12 06 32 11
Infant Mortality Rate MDG 4 (Per 1000) 17 9 48 17
Maternal Mortality Ratio MDG 5
(Per 1,00,000 Birth)56 34 200 37
Source: World Health Statistics 2012
It is possible that this trend may continue for some time with the fast-increasing incidences of Non-infectious Chronic Diseases
(NCDs) and increasing rural market penetration of pharmaceuticals in the country.
Discussion and Analysis
15
Key OPPI Projects
A. Improving Healthcare Access in India
In this rapidly evolving environment, OPPI undertook the project with the goals of:
• Assessing the challenges in bridging access gaps.
• Building a landscape of initiatives that improve healthcare access.
Research findings point to four key dimensions to good healthcare access:
• Proximity / Location
• Availability / Capacity
• Quality / Functionality
• Affordability
Difficulties faced by an individual seeking healthcare with respect to physical reach, availability, quality or affordability
constitutes a Healthcare Access Gap.
OPPI believes any long-term solution to India’s healthcare challenges will require a holistic approach and a critical
evaluation of our existing systems.
B. Reduction of Maternal Mortality – an important Millennium Development Goal
As per United Nation Developmental Plan (UNDP), the eight Millennium Development Goals (MDGs) around poverty,
hunger, illiteracy and disease have been divided into 18 quantifiable targets and will be evaluated against 48 indicators.
MDG-5 is to improve Maternal Mortality Ratio (MMR). Though the MMR in India has declined from 398 per 100,000 live
births to the current level of 200; the country still needs to achieve 109 by 2015.
As collaborative approach, by participating in a Pilot Project in various PHCs at Tribal villages around Jawhar in Thane
district of Maharashtra, OPPI has shown its commitment in the joint endeavour for reduction of maternal mortality in the
target population in India.
As part of the initiative, a vocational training team travelled to the target areas; offering hands-on training to improve
required skill sets, assisting with a time bound plan for building resources, creating awareness of important actions in
emergency treatment, encouraging local women’s group to accept principles of antenatal care, postnatal care, family
spacing and child immunisation. OPPI member companies have made significant contribution by providing free medicines
and volunteer support at these camps.
C. Collaboration with NIPER/CSIR
OPPI is continuing its engagement with premier research institutions of the country such as CSIR, NIPER and academia to
recognise and reward young scientists engaged in pharmaceutical research.
Discussion and Analysis
Organisation of Pharmaceutical Producers of India16
Concerns and Challenges
a. Access to Healthcare
• High out-of-pocket expenses for Healthcare
• Sub-optimal access to medicines
b. Innovation and IP
• Lack of an innovation-friendly ecosystem in the country
• Compulsory Licensing
• Patentability, Patent Linkage, Patent Enforcement, Patented Product Pricing
• Regulatory Data Protection
• Lack of mechanism for fast-track and speedy disposal of IP cases
OPPI remains committed to collaborating with the Indian Government, and other stakeholders to find sustainable solutions that
balance the need for innovation with the necessity for more accessible medicines, within a robust IP environment.
OPPI supports the Indian government’s quest for more accessible and affordable medicines and welcomes a more comprehensive
dialogue between all stakeholders.
Discussion and Analysis
Executive Committee
As per the provisions of Articles of Association of OPPI, 18 members were elected. In addition, five members were co-opted on the
Executive Committee (EC) for the year 2012-13. During the year, following six EC members resigned from their positions:
1. Mr. Ajit Singh ACG Associated Capsules Pvt. Ltd.
2. Mr. Anandh Balasundaram AstraZeneca Pharma India Ltd.
3. Mr. Anish Bafna Baxter (India) Pvt. Ltd.
4. Mr. Rajiv Chopra DSM Nutritional Products India Pvt. Ltd.
5. Mr. Rakesh Bhargava Fresenius Kabi Oncology Ltd.
6. Mr. Rajan S. Tejuja Johnson & Johnson Ltd.
OPPI thanked them and placed on record its appreciation of the contributions made by all of them during their tenure.
Membership
OPPI’s membership comprised 60 members (43 Ordinary, 11 Affiliate, six Associate) as of March 2013 and 51 members
(36 Ordinary, nine Affiliate, six Associate) as of September 2013.
Guiding Principles
The guiding principles give direction for the achievement of the strategic goals, define character that drives the Organisation. The
four Guiding Principles are:
• Address Healthcare challenges by shaping policies
• Trusted Resource and Partner
• Foster the development of a strong R&D based Pharma Industry
• Thought Leadership
It is expected that the behaviour of the member companies of OPPI should be consistent with the guiding principles.
Key Priorities
• To create positive environment to shape the implementation of IPR (Intellectual Property Rights) to encourage research
and innovation.
• Advocacy for improving access to healthcare and proactively engage in access policy development.
• Support development of healthcare regulatory policies through dissemination of global best practices and standards.
• Create a balanced and fair view of the industry through collaborative pan industry effort.
• Build manpower capabilities and governance structure of OPPI to ensure effective implementation of the strategic goals.
Key Objectives
1. Participate and Drive Policy Shaping and their Implementation
2. Advocacy for Disease Awareness and Access to Healthcare
3. Engage Stakeholders to Facilitate Effective Partnerships and Collaboration
4. Ensure Effective Governance of OPPI with Appropriate Capability
5. Driving Effective Communication Strategy
Organisation and Objectives
17
This year, Working Groups were constituted in order to drive the cross-functional implementation of these objectives. Each
Working Group is chaired by a Vice President and Co-chaired by an Executive Committee Member. The members of the Working
Groups comprise functional heads from OPPI Member Companies as well as non-functional heads who are experts in the area.
The Working Groups and the mandate given by the Executive Committee to each of these are as follows:
1. Access and Affordability
• Develop a 2-3 year strategy on Access aligned with National priorities.
• Roll out the IMS Access study and Outcome Analysis.
• Implement focused approach to reduce MMR – a key millennium development goal.
• Strengthen organisational capabilities with focus on key issues to be addressed.
2. Governance and Manpower Management
• Recruit new professionals to drive the effective operations of OPPI.
• Re-deploy and train existing manpower.
• Remodel performance evaluation system.
• Establish Measurable KPIs to track strategic goals.
• Establish OPPI governance structure and norms.
3. Innovation and IPR
• Influence and shape the IP climate for fostering Research and Innovation
• Prepare OPPI Position Paper on Innovation for the growth of the Pharmaceutical Industry.
4. Stakeholder Engagement and Partnerships
• Develop, update and map key stakeholders and define key focus areas with lead persons and deliverables
• Collaborate and partner with key stakeholders through initiatives such as PPP
• Engage OPPI Members
- Drive awareness and collaboration
- Knowledge Sharing, Engagement and Awards
• Alliance building with IPA / IDMA and other associations
Six Special Committees were consituted to foster knowledge sharing, internal engagement and operational hygiene factors. Each
Committee is chaired and co-chaired by the Executive Committee Member. Members comprise other Executive Committee
Members, Heads of Member Companies, Functional Heads and non-functional heads who were deemed as experts nominated by
CEOs/Heads of OPPI Member Companies. The Committees and the mandate given by the Executive Committee to each of these
are as follows:
Organisation of Pharmaceutical Producers of India18
Organisation and Objectives
Special Committees Mandate
Communications (Internal & External) andGovernment Affairs
Accounts & Administration andFinance & Taxation
• Provide oversight and reviews of internal OPPI accounts and administration issues.
• Review and provide input into finance and taxation matters impacting the industry.
• Develop clear communication objectives, strategy, and implementation plan inclusive of priority stakeholders and media engagement.
• Establish Communication metrics for stakeholder engagement.
• Communicate OPPI objectives to internal stakeholders to proactively position OPPI.
• Implement communication strategy to advocating for sustainable health policies.
Organisation and Objectives
19
Special Committees Mandate
Marketing Code, Ethics & Compliance • Review Ethics and Compliance in Pharmaceutical business.
• Encourage Companies to train people on ‘OPPI Code of Pharmaceutical Practices 2012’ and its periodic review.
• Suggest interactions with Department of Pharmaceuticals on Uniform Code of Pharmaceutical Marketing Practices (UCPMP).
• Suggest measures to enhance image of the pharmaceutical industry with ethical practices and compliance.
Human Resource Development
Legal
Medical, Biotech & Regulatory
• Provide input and governance to OPPI manpower management.
• Coordinates best practice sharing on industrial relations (IR) and build alliance with Industry Associations to address IR issues.
• Conduct industry benchmarking to be shared with member companies.
• Monitor and review changes to shape–up the legal environment for pharma
• Organise Knowledge Programmes promoting good corporate governance, including Competition Commission laws for members.
• Provide input to changes in policies effecting Medical, Biotech and Regulatory issues.
• Continuous dialogue with DCGI and other stakeholders.
• Provide inputs in shaping the Clinical Trials Regulations in India.
Knowledge Creation and Knowledge Sharing
To serve the collective interests of its Members and enable industry professionals to excel in the competitive business environment,
OPPI has been organising a series of interactive learning programmes for knowledge creation and knowledge sharing.
OPPI Seminar on "Access to Healthcare: Challenges and the Way Forward"
A seminar on `Access to Healthcare – Challenges and the Way Forward’ was held on August 23, 2013 in Mumbai. The seminar
examined the recent ground-breaking study “Understanding Healthcare Access in India – What is the Current State?” by the IMS
Institute. The event brought together distinguished professionals, acclaimed experts, policy makers and other stakeholders from
the Indian healthcare industry and allied sectors to share their vision and key insights about how the overall status of healthcare
access can be improved in the country. The discussions among diverse stakeholders pointed to the fact that Healthcare Access is a
complex challenge. Any long-term solution to India’s healthcare challenges will require a holistic approach through stakeholder
dialogue and partnership.
Industry e-Updates
As an on-going initiative to enable members stay connected with the happenings in the Pharmaceutical Industry, OPPI continues
the following activities on a regular basis, to update the member companies of OPPI on industry related media reports at domestic
and international level.
< OPPI Daily Press Review – A daily e-newsletter containing important press clips of the day, derived from national and international media reports.
< OPPI Pharma Spectrum – A monthly e-magazine containing national and international reports / articles / editorials covering important issues of the Industry, including OPPI related news.
The soft copy of the “Pharma Spectrum” is made available to members at its website:www.indiaoppi.com
< OPPI Monthly Activity Highlights – A monthly e-newsletter capturing the key initiatives, addressing the concerns of the members and leading to the achievement of OPPI's core objectives, undertaken during the month.
Top 10 News of 2012
To help Members review important media reports of the year at a glance, OPPI has, for the first time, posted “Top 10 News of
2012” in “Members’ Area” on its website: www.indiaoppi.com
Organisation of Pharmaceutical Producers of India20
Working Groups and Special Committees
ACCESS AND AFFORDABILITY
* Resigned
CHAIRMAN CO-CHAIRMAN
Mr. Sudarshan Jain Abbott Mr. Raghu Kumar Allergan
SPECIAL INVITEES
Mr. Ranga Iyer Consultant Dr. Gaurav Arya Eli Lilly
Mr. Hitesh Sharma Ernst & Young Mr. Muralidharan Nair Ernst & Young
Mr. Amardeep Udeshi IMS Health
MEMBERS
Mr. Shirish Ghoge Abbott Mr. Pushpak Khare Abbott
Mr. Vinay Phatak Bayer Ms. Pooja Vatsyayan Biogen Idec
Ms. Radhika Bhalla Boehringer Ingelheim Mr. Jitendra Tyagi Bristol Myers Squibb
Mr. Dibakar Bhattacharya Eli Lilly Mr. Himanshu Buch GlaxoSmithKline Pharma
Dr. Narendra Vutla GlaxoSmithKline Consumer Mr. Sudheendra Kulkarni Johnson & Johnson
Ms. Shilpa Arora Merck Serono Mr. Rajesh Marwaha* MSD Pharmaceuticals
Mr. Giridhar Sanjeevi MSD Pharmaceuticals Mr. Amitabh Dube Novartis
Mr. Vinay Ransiwal Novo Nordisk Mr. Rajindrra Patkar RPG Life Sciences*
Mr. G.K. Raman Roche Ms. Sangita Topiwala Sanofi
Mr. M.K. Narayanaswamy Sanofi Dr. Jan-Frederic Kesselhut* Serdia
Dr. Asmita Nimkar Serdia Mr. Saameer Khedkar UCB
While progress has been made in India over the past decade from both public and private sector initiatives, but significant
challenges still persist in providing quality healthcare on an equitable, accessible and affordable basis across all regions and
communities. A 40-45% reduction in out-of-pocket expenditures for both outpatient and inpatient treatments can be attained
through a holistic approach addressing critical, interrelated dimensions of healthcare access.
A research study on, ‘Understanding Healthcare Access in India: What is the Current State?’ was conducted by IMS Health India.
The objectives of this research study were to map the current healthcare status comprehensively, prioritise the challenges or gaps
based on the relative impact on access, and provide a roadmap to guide future improvements. It is the most comprehensive
assessment of healthcare access undertaken since 2004 and is based on an extensive survey of nearly 15,000 households
covering all socio-economic groups in rural and urban areas across 12 states. Information was gathered on more than 30,000
healthcare system interactions, supplemented by interviews with over 1,000 doctors and experts. The survey, analysis and report
preparation were conducted independently.
Following are the key findings of this research study:
The provision of healthcare services in India is skewed toward urban centers and the private sector. Urban
residents, who make up 28% of India’s population, have access to 66% of the country’s available hospital beds, while the
remaining 72% who live in rural areas have access to just one-third of the beds. Similarly, the distribution of healthcare
workers, including doctors, nurses and pharmacists, is highly concentrated in urban areas and the private sector.
Working Groups and Special Committees
21
Physical reach of any healthcare facility is a challenge in rural areas, particularly for patients with chronic ailments.
Patients in rural areas must travel more than five kilometers to access an inpatient facility 63% of the time. Difficulty in
accessing transportation options and the loss of earnings as a result of travel time lead to treatment being deferred, or
facilities selected that may be closer but are not cost-effective or best suited to patient needs. This is especially true for
patients suffering from chronic ailments.
Private healthcare facilities are being used by an increasing proportion of patients due to gaps in quality and
availability of public facilities. Over the past 25 years, both rural and urban patients have increased their use of private
service providers over public options. In 2012, 61% of rural patients and 69% of urban patients chose private in-patient
service providers, up from 40% reported in a 1986/87 government survey. Long waiting times and the absence of diagnostic
equipment in public facilities were cited as key reasons by more than 40% of those surveyed. Better quality of treatment in
private, in-patient centers was cited as an additional reason by 38% of survey respondents.
Availability of doctors is a key reason for selecting private facility outpatient treatments. Across both urban and rural
sectors, and among the poor and affording populations, at least 60% of those surveyed considered doctor availability as a
significant reason for selecting private facilities for outpatient treatment. Absenteeism is typically higher in the less
economically developed states of India.
Patients using private facilities face greater affordability challenges. The cost of treatment at private healthcare
facilities is between two and nine times higher than at public facilities. For example, poor patients receiving outpatient care
for chronic conditions at a private facility spent, on average, 44% of their monthly household expenditure per treatment,
compared to 23% for those using a public facility.
Medicine costs as a proportion of out-of-pocket healthcare expenses remain high but stable. On average, across
public and private facilities, medicines account for more than 60% of patients’ total out-of-pocket expenses for outpatient
treatments, and 43% for inpatient treatments. This share of expenditures for medicines has not increased since 2004 for
inpatient treatments, and has decreased for outpatient treatments. Low insurance penetration – and current insurance plans
that do not cover drug costs – make the total cost of medicines a continuing, significant burden for a majority of the
population.
Improving the quality and availability of public healthcare facilities would drive the greatest reduction in patient
out-of-pocket costs. The report assessed the relative impact of improvements across each of the four components that
contribute to healthcare access. Enhancing the quality and availability of public healthcare facilities would curb the diversion
of patients to private channels – enabling more patients to utilize lower-cost facilities and reduce their out-of-pocket costs.
The report released in July 2013 is available at http://www.imshealth.com / deployedfiles / imshealth / Global / Content / Corporate /
IMS%20Institute / India / Understanding_Healthcare_Access_in_India.pdf
The Working Group Chaired by Mr. Sudarshan Jain, Managing Director – Healthcare Solutions, Abbott Healthcare Pvt. Ltd. and Co-
chaired by Mr. Raghu Kumar, Managing Director, Allergan India Pvt. Ltd. took the following initiatives, during the year –
OPPI Access Seminar
OPPI MMR Project
Round-table on Rural Access in Healthcare
White Paper on Access to Healthcare
OPPI Access Seminar
Access to healthcare is a subject of high importance in India. The importance of developing adequate healthcare infrastructure,
backed by efficient delivery systems for medical supplies and the creation of a talent pool of healthcare professionals is necessary
to ensure access to healthcare.
Organisation of Pharmaceutical Producers of India22
Working Groups and Special Committees
A recent study by IMS Institute, ‘Understanding Healthcare Access in India – What is the current state?’ recommends the following
three priorities for healthcare access –
1. Improve availability of Healthcare Services
2. Raise performance of service quality in Healthcare Delivery Organisations
3. Expand & Accelerate Affordability of Healthcare.
As a roll out the IMS Access Study, OPPI organised a Seminar on, ‘Access to Healthcare – Challenges & Way Forward’ on August
23, 2013, bringing together distinguished experts, government officials and other important stakeholders for sharing their views on
ways to improve the overall status of healthcare access for the nation.
OPPI Maternal Mortality Ratio (MMR) Project
Millennium Development Goal 5 (MDG 5) is to improve Maternal Mortality Ratio (MMR). Though the national MMR in India has
declined from 398 per 100,000 live births to current level of 200, the country still needs to achieve 109 by 2015. As collaborative
approach, OPPI participated in a Pilot Project in various PHCs at Tribal villages around Jawhar in Thane district of Maharashtra,
towards the joint endeavour for reduction of maternal mortality. A vocational training team travelled to the target areas, offering
hands-on training to improve required skill sets, assistance with a time bound plan for correction of deficient resources, promoting
awareness of the importance of actions in reducing delays in emergency treatment, encouraging local women’s group to accept
principles of antenatal care, postnatal care, family spacing and child immunisation.
OPPI member companies have made significant contributions by providing free medicines and volunteer support at the diagnostic
camps.
Round-table on Rural Access in Healthcare
OPPI supported the Round-table on “Rural Access in Healthcare” organised by Rural Marketing Association of India (RMAI) held
on August 30, 2013 in India International Center, New Delhi.
This Round-table was attended by an array of distinguished speakers, executives from Pharmaceutical Industry, government
officials and other stakeholders, who shared their views on Rural Access in Health Care.
White Paper on Access to Healthcare
The Group is preparing a Whit Paper, which will provide a roadmap to all stakeholders for improving access to healthcare in India.
The White Paper will be released in the forthcoming OPPI AGM.
23
Working Groups and Special Committees
GOVERNANCE AND MANPOWER MANAGEMENT
* Resigned
CHAIRMAN CO-CHAIRMAN
Dr. Shailesh Ayyangar Sanofi Mr. Sharad Tyagi Boehringer Ingelheim
SPECIAL INVITEES
Mr. Vivek Dwivedi* KPMG
MEMBERS
Mr. Shirish Ghoge Abbott Ms. Nagina Singh Abbott
Mr. Shashin Bodawala Boehringer Ingelheim Ms. Shraddha Pradhan Bristol-Myers Squibb
Ms. Tejashree Talpade Eisai Mr. Ronald Sequeira GlaxoSmithKline Pharma
Ms. Cecilia M. Azavedo Merck Serono Mr. Sameer Tamhane MSD Pharmaceuticals
Ms. Monaz Noble Novartis Mr. Saibal Bhattacharya RPG Life Sciences*
Mr. Pradeep Vaishnav* Sanofi Mr. Gaurav Bahadur Sanofi
Mrs. Jui Dabir Serdia Mr. K. Venkatesh UCB
In the overall revamping process of OPPI especially in the areas of Governance and Manpower selection and with the mandate -
“Build manpower capabilities and governance and structure of OPPI to ensure effective implementation of organization’s goals”,
the Working Group under the strategic direction of Chairman, Dr. Shailesh Ayyangar, Managing Director, India & Vice President,
South Asia, Sanofi India Ltd. and Co-Chairman, Mr. Sharad Tyagi, Managing Director, Boehringer Ingelheim India Pvt. Ltd.,
decided the following projects for the year.
Capacity Building
Performance Appraisal System
OPPI Governance
Accordingly, the project teams were formed for each of the projects, the action plans were drawn and progress reviewed and the
way forward decided in each of the meetings.
Capacity Building
The members of the Working Group facilitated the recruitment process. As per plan all positions at OPPI are filled up and OPPI
Secretariat is gearing up to meet the strategic objectives of OPPI for 2013.
Using the resource pool of OPPI member companies, the members of the Working Group will be planning the developmental
programmes to the OPPI staff based on their training needs as a part of the capacity building exercise at OPPI.
The training capsule was conducted by Mr. Ronald Sequeira and Ms. Cecilia Azavedo for the entire staff of OPPI. The committee
complimented the team for their efforts and time.
Organisation of Pharmaceutical Producers of India24
Working Groups and Special Committees
Performance Appraisal System
The Working Group reviewed the current Performance Appraisal System, had a special interactive session with every employee of
the OPPI secretariat to understand various areas of operation. Based on the initial findings, the team conducted the PDP for the
OPPI staff through resources from the member companies with measurable KPIs to track the strategic goals of OPPI. The
elements covered under Performance Appraisal System are as follows:
Purpose of Performance Management
The Performance Management Process (PMP)
Goal-Setting
Mid-Year Review
Year-End Appraisal
Performance Management Template
Assessing Performance and Assigning Ratings
Final Performance Rating
Subsequently, the committee conducted a training capsule which covered goal setting, Mid-term review and year-end appraisal for
the entire OPPI staff on OPPI Strategic Goals 2013-14 and suggested the way forward. Based on the need gap analysis the
committee will be planning training programme with the expertise from the OPPI member companies, for each of the OPPI
employees of the Secretariat.
OPPI Governance
The Working Group reviewed the current governance, organisational structure, studied the current Articles of Association with the
intention to ensure that all the activities are performed accordingly.
Election of OPPI office bearers
In line with the Articles of Association of OPPI, the Working Group has developed a new proposal for the election of the President
and the office bearers of OPPI which was placed before the EC and approval obtained.
25
Working Groups and Special Committees
INNOVATION AND IPR
* Resigned
CHAIRMAN CO-CHAIRMAN
Dr. Hasit B. Joshipura GlaxoSmithKline Pharma Mr. Angel-Michael Evangelista Bayer
MEMBERS
Dr. Shripad Jathar Abbott Mr. Shyamakant Giri Abbott
Mr. Kaiyomarz Marfatia Abbott Dr. Ashish Gawde Bayer
Dr. Viraj Suvarna Boehringer Ingelheim Mr. Kedar Suvarnapathaki Boehringer Ingelheim
Mr. Bhavik Desai Bristol-Myers Squibb Mr. K. Shivkumar Eisai
Dr. Gaurav Arya Eli Lilly Dr. Rahul Sawakhande Galderma
Mr. Kaizad A. Hazari GlaxoSmithKline Pharma Mr. Rachit Garg Johnson & Johnson
Mr. S. Varadarajan Merck Serono Mr. Jaspreet Singh Chandhok MSD Pharmaceuticals
Dr. Raman Shetty Novo Nordisk Mr. Shivprasad Laud Roche
Ms. Sujatha Subramaniam Roche Dr. Uday Bapat RPG Life Sciences*
Ms. Yasmin J. Cama Sanofi Dr. Jan-Frederic Kesselhut* Serdia
Dr. Asmita Nimkar Serdia Mr. Milind Kulkarni UCB
Innovations are indeed very important for the country and have been benefiting the patients immensely over decades, across the
world. Impact of Innovation measured by healthcare outcomes thus establishing its value while addressing misconceptions that
are likely to exist in the minds of the stakeholders is very significant for the pharma industry.
As per the National Knowledge Commission, while 37.3% of Indian companies introduced breakthrough innovations in recent
years, no fewer than 76.4% introduced incremental innovations. Development of the R&D capacity and expertise of
pharmaceutical innovators help significantly improving the efficacy and safety of existing drugs.
To create positive environment for shaping the implementation of IPR (Intellectual Property Rights) to encourage research and
innovation the Working Group - Innovation and IPR led by Dr. Hasit Joshipura, Senior Vice President, South Asia & Managing
Director, India, GlaxoSmithKline Pharmaceuticals Ltd. and Mr. Angel-Michael Evangelista, Country Division Head – India, Head –
South Asia (India & Pakistan), Bayer Pharmaceuticals Pvt. Ltd. set the following objectives for the year.
Influence and shape the IP climate for fostering Research and Innovation
White Paper on Innovation for the growth of the Pharmaceutical Industry
Review OPPI Position Papers
Drive implementation of fast-track bench for speedy resolution of IP litigations
Influence and Shape the IP climate for fostering Research and Innovation
To influence and shape IP climate, the committee feels that OPPI needs to actively continue efforts to demonstrate to all the
stakeholders that IPR are not a barrier to access to medicines in the developing world and that the Industry is actively engaged in
exploring the use of various tools to improve access considerably but in a manner consistent with respect to IPR.
In order to disseminate right knowledge, roundtable discussion with various stakeholders such as, Head of National Innovation
Council, Senior officials from MoHFW, and Ministry of Commerce & Industry (DIPP), CSIR; Secy., DoP, the Opinion Leaders,
IMA, CEOs/IPR Legal Heads, R&D Heads is planned.
Organisation of Pharmaceutical Producers of India26
Working Groups and Special Committees
White Paper on Innovation for the growth of the Pharmaceutical Industry
A joint meeting of the Working Group – Innovation & IPR and Communications (Internal & External) & Government Affairs
Committee was planned to develop OPPI Working Paper on Current IP Situation and Patent Infringement Issues. The objective
was to make it known to the Government officials that Research and Development driven pharma companies in India are
seriously concerned about the patent protection, since the current environment for innovation is uncertain and inconsistent.
The committee is finalising the white paper covering challenges to innovation like pre and post grant opposition, Compulsory
Licensing (CL), state licenses, implications on OPPI member companies and expectations.
Prepare and Review OPPI Position Papers
OPPI Position Papers on the Compulsory Licensing, IPR, Regulatory Data Protection are available at the following web link:
http://www.indiaoppi.com/OPPIpositionDataProtection.pdf
The committee is in the process of reviewing all these papers at the back drop of recent court judgments on patent related issues in
the country.
OPPI/PhRMA actions on IP-related Issues
India does not provide mechanisms for resolution of patent disputes prior to marketing approval. Such mechanisms are needed to
prevent the marketing of patent infringing products. The loophole that allows state-level FDAs to grant Marketing Authorization for a
product after four years even if a patent still exists, need to be plugged appropriately.
The OPPI / PhRMA IP experts group is working together to provide inputs on IP related issues at the government level to close the
loophole.
27
Working Groups and Special Committees
STAKEHOLDER ENGAGEMENT AND PARTNERSHIPS
* Resigned
CHAIRMAN CO-CHAIRMAN
Mr. K.G. Ananthakrishnan MSD Pharmaceuticals Mr. Rehan Khan Abbott India*
SPECIAL INVITEES
Mr. Ranga Iyer Consultant Mr. Muralidharan Nair Ernst & Young
Mr. Mohan Joshi Schott Glass
MEMBERS
Mr. Amitabh Baxi Abbott Mr. Sambit Sathapathy Abbott
Mr. Nilesh Nayak Bayer Ms. Vaibhavi Choksi Boehringer-Ingelheim
Ms. Kanchana. T K Bristol-Myers Squibb Mr. P.M. Srikanth Eisai
Mr. Bhushan Akshikar GlaxoSmithKline Pharma Ms. Rimmi Harindran Merck Serono
Dr. Vijay Salgaonkar MSD Dr. Swashraya Shah MSD Pharmaceuticals
Dr. Ramesh Panchagnula Nektar Mr. Ravi Limaye Novartis
Mr. Vinay Ransiwal Novo Nordisk Ms. Ranjita Sood Roche
Mr. Atul Balel RPG Life Sciences* Mr. Anthony Jones Sanofi
Dr. Stephan Barth Sanofi Dr. Jan-Frederic Kesselhut Serdia
Strategic alliances between business, government and civil society are a growing feature of both developed and emerging
economies. Such multi-stakeholder partnerships are necessary because it is becoming increasingly clear that no one sector in
society can deliver the complexities of sustainable development alone.
Realising the need, the Working Group Chaired by Mr. K.G. Ananthakrishnan, Vice President & Managing Director, MSD
Pharmaceuticals Pvt. Ltd., took the following initiatives during the year:
Mapping of Key Stakeholders
Pharma CEOs' Forum
Corporate Social Responsibility
OPPI Awards
Mapping of Key Stakeholders
Penn Schen Berland (PSB) conducted a study to assess the opinion and outlook of a core group of stakeholders. The team
interviewed some Executive Committee members of OPPI for an in-depth understanding of issues related to the pharmaceutical
industry and interacted with the public sector and government regulators, including bureaucrats responsible for Healthcare in India.
Representatives from Hospital Administration, Insurance Companies, HCPs, Media personnel and Patient Support Groups were
also interviewed. The study also considered major healthcare policies and OPPI Position on each, and prepared a report which
mapped all key stakeholders and their perception of the Industry and OPPI. Action plans are being developed to address some of
the challenges that were highlighted as a result of the study.
Pharma CEOs' Forum
The Working Group has developed a proposal for a platform - Pharma CEOs’ Forum, as a knowledge exchange platform wherein
leaders will be able to gain ideas, information, opinions and solutions to various challenges from other successful CEOs and
thought leaders. This forum is aimed to provide an opportunity to collaborate amongst the peer group, learn from diverse topics and
evaluate unified action for key challenges facing the Pharmaceutical Industry.
Organisation of Pharmaceutical Producers of India28
Working Groups and Special Committees
The overall objective of the forum is to help create a balanced and fair view of the pharma industry through collaborative, pan
industry effort by forming an alliance with CEOs of OPPI and non-OPPI member companies on issues of common interest,
such as:
Improving access to healthcare
Contributing meaningfully in policy dialogues for addressing Healthcare Challenges
Encouraging Research and Innovation
Disseminating knowledge and sharing best practices
Corporate Social Responsibility
OPPI member companies have a long history of contributing to improved health outcomes in India by improving access to
medicines, providing patient education, building health system capacity and by investing in research into new medicines for unmet
needs.
An analysis by the Hudson Institute identifies an estimated USD 94.8 bn in pharmaceutical industry contributions to developing
countries over a 12 year period from 2000 through 2011.
The report of the study is available at –
http://www.indiaoppi.com/OPPI%20Member%20Companies%20Contributions%20in%20Improving%20Access%20to%20Healt
hcare%20in%20India.pdf
OPPI Awards 2013
OPPI Scientists and Young Scientists Awards
In continuation with the Public-Private Partnership (PPP) initiative in the area of Pharmaceutical Research and Development
(R&D) and to encourage innovations in India, OPPI has collaborated with two premier R&D focused institutions, NIPER and CSIR,
by instituting Scientists and Young Scientists Awards at both the institutes.
Besides the above Partnership, OPPI Scientists Awards and Young Scientists Awards are also extended to other Pharmaceutical
Research Centres and Academic Institutions.
Awards are being given in the following areas of research:
Pharmaceutical Chemistry
Pharmaceutics : Novel and Improved Drug Delivery System
Pharmacology : New models for evaluating drugs
Pharmaceutical Biotechnology / Nanotechnology
Pharmacognosy & Phytochemistry : Evaluation of plants and plant products for treatment of unmet medical needs
These awards are supported by:
AstraZeneca Pharma India Ltd.
Bayer Pharmaceuticals Pvt. Ltd.
Eli Lilly and Company (India) Pvt. Ltd
Johnson & Johnson Ltd.
Martin & Harris Pvt. Ltd.
MSD Pharmaceuticals Pvt. Ltd.
Pfizer Ltd.
Sanofi India Ltd.
29
Working Groups and Special Committees
The following were the panel of jury for the award this year:
Dr. Ahmed Kamal, Project Director, National Institute of Pharmaceutical Education & Research, (NIPER), Hyderabad
Dr. Samir K. Brahmachari, Director General, CSIR
Prof. K.G. Akamanchi, Pharmaceutical Division UICT, Mumbai
The winners of these Awards, selected by a panel of independent jury, will be awarded a Cash Prize of ̀ 100,000 each, along with a
Citation and Trophy during the forthcoming Annual General Meeting of OPPI.
Dr. H. R. Nanji Memorial Marketing Excellence Awards
The OPPI Marketing Excellence Awards have become a gold standard for Pharmaceutical Companies in India. These awards are
for the best marketing initiatives in “Existing Products Category” and “New Products Category” and dedicated in memory of Dr. H.R.
Nanji, the founder and the first President of OPPI.
A panel of eminent personalities evaluated the entries from various member companies of OPPI. The assessment criteria were
Innovativeness, Brand Strategy and Brand Performance.
The following were the Panel of Juries for the awards this year –
Dr. Balkrishna Inamdar, Past President, Indian Medical Association
Dr. Jayesh Lele, Hon. State Secretary, Indian Medical Association
Dr. Madhav Welling, Pro Vice Chancellor, NMIMS University
Mr. Kumar Hinduja, Sr. Director, Strategy Planning & Business Development, IMS Health Information & Consulting
Services India P. Ltd.
Mr. Tapan Ray, Director General, OPPI
The winners of these Awards, selected by a panel of independent jury, will be awarded a Cash Prize of ̀ 100,000 each, along with a
Citation and Trophy during the forthcoming Annual General Meeting of OPPI.
OPPI Best Vendor Awards
For creating Commercial Excellence in Pharmaceutical Industry and promoting a culture of ethical and professional approach,
OPPI has instituted the “OPPI Best Vendor Awards” in the following areas since the past few years:
Contract Manufacturing
Carrying & Forwarding Agents (CFAs)
The Award for Contract Manufacturing category was supported by M/s. Abbott Healthcare.
A panel of eminent personalities evaluated the vendors in each category. The following were the panel of juries for the Award this
year:
Mr. Pratin Vete, Associate Director for Business Advisory Services, Ernst & Young Pvt. Ltd.
Dr. Rakesh Singh, Chairman, Indian Society of Supply Chain Management
Dr. Bomi Gagrat, Consultant
Mr. Tapan Ray, Director General, OPPI
The winners of these Awards, selected by a panel of independent jury, will be awarded a Cash Prize of ̀ 100,000 each, along with a
Citation and Trophy during the forthcoming Annual General Meeting of OPPI.
Organisation of Pharmaceutical Producers of India30
Working Groups and Special Committees
OPPI Sales Force Excellence Award
Excellence of Sales Force is gaining increasing importance in the Pharmaceutical Business in India. Companies are adopting
innovative practices to enhance effectiveness of their respective sales team and make them more productive. To promote
excellence in pharmaceutical selling, OPPI has instituted the OPPI - Sales Force Excellence Award to recognize and honor the
Best SFE Practice within OPPI Member Companies.
The following panel of eminent personalities evaluated the entries from OPPI Member Companies –
Mr. Rahul Guha, Principal, The Boston Consulting Group
Mr. Surjya Roy, Director, CR Client Service, Nielsen (India) Private Ltd.
Mr. Neeraj Vashisht, Sr. Principal, Management Consulting, IMS Health Information & Consulting Services India P. Ltd.
Mr. Kaustubh Chakraborty, Associate Partner, McKinsey & Company
Tapan Ray, Director General, OPPI
The winners of these Awards, selected by a panel of independent jury, will be awarded a Cash Prize of ̀ 100,000 each, along with a
Citation and Trophy during the forthcoming Annual General Meeting of OPPI.
31
Working Groups and Special Committees
ACCOUNTS & ADMINISTRATION AND FINANCE & TAXATION
CHAIRMAN CO-CHAIRMAN
Mr. Rajan S. Tejuja* Johnson & Johnson Mr. Ajit Singh ACG Associated Capsules*
Mr. Sachin Dharap Abbott Mr. Shirish Ghoge Abbott
Mr. Rajesh Sharma Allergan Mr. Lokesh Godbole* Astellas
Mr. Himanshu Agarwal AstraZeneca Mr. N.V. Chalapathi Rao Bayer
Mr. Davendra Singhvi Biogen Idec Biotech India Mr. Mukesh Agarwal Bristol-Myers Squibb
Mr. Girish Hingorani Eisai Mr. Vikram Arora Eli Lilly
Mr. Dewang Smart Galderma Mr. Mehernosh B. Kapadia GlaxoSmithKline Pharma
Mr. Manish Vora Johnson & Johnson Ms. Kalpana Umakanth Martin & Harris
Ms. Chinmaya Parekh Merck Serono Mr. Rajesh Marwaha* MSD Pharmaceuticals
Mr. Rajiv Sharda* MSD Pharmaceuticals Mr. Giridhar Sanjeevi MSD Pharmaceuticals
Mr. Raman Akella Nektar Therapeutics Mr. Pramod Gupta Novartis
Mr. Sanchit Nanda Novartis Mr. Suhas Karambelkar Novo Nordisk
Mr. S. Sridhar Pfizer Mr. Sundeep Mehta Ranbaxy
Mr. S.G. Vaidyanathan Roche Mr. Sachin Raole RPG Life Sciences*
Mr. M.K. Narayanaswamy Sanofi Ms.Geeta Karnik Serdia
Mr. Vinay Potdar Takeda Mr. Satish Joshi UCB
MEMBERS
SPECIAL INVITEE
Mr. Hitesh Sharma Ernst & Young Mr. Hitesh Gajaria KPMGMr. Mohan Joshi SCHOTT Glass
* Resigned
To provide oversight and reviews of internal OPPI accounts and administration issues, the subcommittee from AAFT was formed
which met during the year to review the financial affairs of the OPPI.
Members:
Mr. M.K. Narayanaswamy, Sr. Director- Accounting & Taxation, Sanofi India Ltd.
Mr. Satish Joshi, Director – Finance, UCB India Ltd.
Mrs. Kalpana Umakanth, Director - Finance, Martin & Harris Pvt. Ltd.
Based on the deliberations, the Secretariat continued to implement OPPI’s various core objective related initiatives by way of
organising and supporting knowledge-based Seminars, Conferences and Academia Programmes. Accordingly, OPPI Budget
Proposals for 2013-14 were prepared, discussed and recommended for approval by the Executive Committee.
Organisation of Pharmaceutical Producers of India32
Working Groups and Special Committees
FINANCE & TAXATION
To review and provide input to finance and taxation matters impacting the members of OPPI Accounts & Administration, and
Finance and Taxation committee worked quite extensively during the year led by Mr. Rajan Tejuja,* President & Executive Director,
Johnson & Johnson Ltd. (Chairman) and Mr. Ajit Singh, Managing Director, ACG Associated Capsules Pvt. Ltd.* (Co-Chairman).
Subsequently, Mr. Shirish Ghoge, Director, Government Affairs, Abbott Healthcare Pvt. Ltd. took initiative to drive the Committee in
the interest of the operational issues of member companies of OPPI.
Government Spend on Healthcare
In most of the countries, around 80% of expenses towards healthcare, including medicines are reimbursed either by the
Government or through health insurance or similar mechanisms. However, in India, about 80% of overall healthcare costs including
medicines are borne out-of-pocket by the individuals.
A distinct change is now noticeable within the healthcare financing system in India. Slow but gradual emergence of healthcare
providers with medical insurance and other related products, patient advocacy groups, standard treatment guidelines, etc. are
expected to bring in a radical change the way current healthcare financing is managed.
Interaction with Stakeholders
As an ongoing process, several interactive meetings of the Committee members with key stakeholders like Ministry of Health and
Family Welfare, Ministry of Chemicals and Fertilizers, Ministry of Finance, Ministry of Corporate Affairs, Department of
Pharmaceuticals (DoP), National Pharmaceutical Pricing Authority (NPPA) and Planning Commission were held during the year.
The objective of National Pharmaceutical Policy is to put in place a regulatory framework for affordability and availability of
required medicines – “essential medicines” – while providing sufficient opportunity for innovation and competition to support the
growth of industry.
Narcotic Drugs & Psychotropic Substances (Regulation of Controlled Substances)
Order, 2011
The Committee suggested amendments to the Proposed Enactment of the Narcotic Drugs & Psychotropic Substances
(Regulation of Controlled Substances) Order, 2011 to Department of Revenue to consider the recommendations of the Standing
Committee on Finance in the current Amendment Bill, covering inadvertent non-compliances or procedural lapses, undue
harassment faced by legally authorised manufacturers, dealers traders, etc. of Narcotic, Psychotropic and Controlled Substances
during investigations and enforcement of laws/rules pertaining to the substances.
CC, PC, PM and PL Norms for the Year 2012
NPPA is required to revise / fix the norms for Conversion Cost (CC), Packing Charges (PC), Process Loss (PL) and Packing
Material (PM) every year under DPCO, 1995 and has decided to initiate a study for revision of the said norms for the year 2012. The
Members of the committee actively participated in the meetings convened by the NPPA on the subject.
Knowledge Dissemination
A Post Budget interactive discussion was arranged for OPPI Members. The Ernst & Young team led by Mr. Hitesh Sharma made a
presentation on “Key Features of India’s Union Budget 2013-2014” pertaining to the Life Science Industry.
33
Working Groups and Special Committees
UNION BUDGET 2013-2014
In its Pre-Budget Memorandum, OPPI proposed budget/fiscal measures and support in the following key areas:
A. Infrastructure building
B. Improving access to medicines
C. Reduction in transaction costs
D. Incentivizing R&D
E. Reduction in tax burden and other measures
Unfortunately, there were no significant amendment in this budget for the healthcare sector, as such. However, OPPI appreciates
the following announcements of the Finance Minister in his budget speech:
A. Increased budgetary allocation for National Rural and Urban Health Mission may improve access. However, a planned
allocation on ‘Universal Health Coverage’ initiative was highly expected.
B. The scope of Rashtriya Swasthya Bima Yojna (RSBY) has been expanded to widen its coverage, which is also expected to
have an impact in improving access to healthcare for the marginalized section of the society.
Following other proposals of the Finance Minister are also laudable and could benefit the Industry in the longer term:
Increased budgetary allocation for Medical Studies
Expansion of medical care facilities for women and differently abled people
Increased allocation for geriatric care
Setting up of Indian Institute of Biotechnology
Allocation of fund for products based on science and technology innovations
The Industry also expected that Government would take measures to make all imported life-saving drugs more affordable to the
patients by eliminating the import duty. Unfortunately, this has not happened. In OPPI’s view, the healthcare concerns of the country
have not been given adequate importance in the Union Budget 2013-14 to help improving the healthcare needs of the nation.
Patented Product Pricing
The Indian government is preparing a policy for the pricing of patented medicines. The committee set up by the government
recommended three specific price setting approaches, which can be seen in Discussion and Analysis part of the report.
Rapid increase in the number of healthcare providers and other related stakeholders with attractive schemes for various strata of
the civil society, will herald the emergence of very powerful groups of negotiators for products’ price and other healthcare related
services. These groups will be capable of influencing doctors’ prescriptions and other treatment choices.
Task Force on the Patented Product Pricing responded to the report of DoP on the subject, keeping in mind the interest of OPPI
member companies to encourage innovation and R&D, in the country.
National Pharmaceutical Pricing Policy 2012
The Pharmaceutical Industry in India, has been contributing significantly to drive growth of the Indian economy over a period of time
and delivers a promise to contribute even more to the nation, if it is nurtured well and allowed to flourish continuously meeting the
unmet needs of ailing patients.
Organisation of Pharmaceutical Producers of India34
Working Groups and Special Committees
The DoP had prepared a draft National Pharmaceutical Pricing Policy, 2011 (NPPP-2011) based on the criteria of essentiality under
National List of Essential Medicines-2011 (348 drugs with specified dosage and strengths), as stipulated by the MoHFW which was
placed before the Group of Ministers (GoM). Based on the recommendations of the GoM, National Pharmaceutical Pricing Policy
2012 (NPPP-2012) was formulated and placed before the Cabinet, which approved the same with certain modifications.
The new policy decided to adopt the SAP (Simple Average Price) of all brands formula (where market share of the brand
(on basis of MAT) is >=1%)
Annual price increase of NLEM medicines will be allowed as per the Wholesale Price Index
Although Individual brand cap of NLEM medicines does not exist, restriction of competition in combinations of NLEM is
enforced
Prices of medicines under DPCO 1995 but not under NLEM 2011 would be frozen for one year after which a maximum
increase of 10% p.a., as in case of other non-NLEM drugs would be allowed
The Ceiling Price of drugs in the NLEM can be revised as a consequence of significant change in market dynamics
Any drug can be added to the NLEM on the recommendation of MoHFW
DoP to ensure that production levels of NLEM drugs are maintained by an appropriate mechanism
Manufacturer of a NLEM drug with dosages and strengths as specified in NLEM to be required to seek a price approval
from the government if it wishes to launch a new drug by combining the NLEM drug with another non NLEM drug or by
changing the strengths and dosages of the same NLEM drug
MoHFW to consider making the prescription of drugs by generic names mandatory
Being an important stakeholder, OPPI was invited to make the presentations on several occasions to different ministries and
government officials who have a significant role in the policy making.
Subsequently representations were made to the concerned government departments like Ministry of Health and Family Welfare,
National Pharmaceutical Pricing Authority (NPPA) and Department of Pharmaceuticals for the comments, giving suggestions and
even seeking clarifications on the new NPPP 2012 and finally for effective implementation of NPPP 2012.
The Committee reiterated full understanding of the challenges that the government is facing to extend adequate and appropriate
healthcare facilities to a vast majority of population of India.
Seminar - Clarifying Issues : DPCO 2013 Implementation
In the light of the recently notified DPCO 2013 and its implementation, a lot of anxiousness has spread across the member
companies of OPPI. In order to address the concerns of our members and discuss the critical issues, OPPI Accounts &
Administration and Finance & Taxation Committee organized a Seminar at Club Peninsula, Peninsula Corporate Park, Lower
Parel, Mumbai.
35
Working Groups and Special Committees
CHAIRMAN CO-CHAIRPERSON
Mr. Aijaz Tobaccowalla Pfizer Ms. Meeta Gulyani Roche
* Resigned
Ms. Varsha Chainani Abbott Mr. K.T. Rajan Allergan
Mr. Shashank Shanbhag* AstraZeneca Mr. Aloke Pradhan Bayer
Mr. Anand Kadkol Boehringer Ingelheim Mr. Kanchana T.K. Bristol-Myers Squibb
Mr. Vineet Gupta Eli Lilly Dr. Rahul Sawakhande Galderma
Ms. Jayasree Menon GlaxoSmithKline Pharma Ms. Nandini Goswami GlaxoSmithKline Pharma
Mr. Aditya Berlia Martin & Harris Ms. Rimmi Harindran Merck Serono
Ms. Jyotsna Ghoshal MSD Pharmaceuticals Ms. Neelima Dwivedi MSD Pharmaceuticals
Ms. Svetlana Pinto Novartis Mr. Sundeep Kumar Novartis
Mr. Vinay Ransiwal Novo Nordisk Ms. Sarita Bahl Pfizer
Ms. Amita Burmen* Pfizer Ms. Ranjita Sood Roche
Mr. Rajesh Shirambekar RPG Life Sciences* Ms. Aparna Thomas Sanofi
Mr. Tarun Bhatnagar Sanofi Dr. Jan-Frederic Kesselhut* Serdia
Dr. Asmita Nimkar Serdia
MEMBERS
COMMUNICATIONS (INTERNAL & EXTERNAL) AND GOVERNMENT AFFAIRS
Communicating key messages, impact fully, to the stakeholders through the right medium is an important aspect of any business
situation. The operational issues faced by the member companies need to be taken up with appropriate government authorities
for a smooth functioning on a day to day basis.
Under the leadership of Mr. Aijaz Tobaccowalla, Managing Director, Pfizer (Chairman) and Ms Meeta Gulyani, Managing Director
& Head – Indian Management Center, Roche (Co-Chairperson) the CGA Committee comprising the functional heads and other
members nominated by Heads of Member Companies have taken the following projects under the mandate given to them.
Working closely with Working Group: Innovation & IPR
OPPI – IMS study on access to healthcare roll out plan
Patented Product Pricing Report of DoP
Media Engagement Programme on OPPI Position on Clinical Trials
Since crafting right message to the right target audience is the fundamental role of this Committee, on each of the above projects
project teams from the CGA Committee were formed which worked very closely with the appropriate Working Groups or the
Committees as the case may be.
Working closely with Working Group – Innovation and IPR
As per the EC decision, a joint meeting of the Working Group – Innovation and IPR and CGA Committee was planned to develop
OPPI Working Paper on Current IP Situation and Patent Infringement Issues. The objective was to make it known to the
Government officials that Research and Development driven pharma companies in India are seriously concerned about the patent
protection, since the current environment for innovation is uncertain and inconsistent.
Organisation of Pharmaceutical Producers of India36
Working Groups and Special Committees
OPPI – IMS study on access to healthcare roll out plan
Access to healthcare comprises not just medicines but more importantly the healthcare infrastructure viz. doctors, paramedics,
diagnostics, and health centers/hospitals. In India the demand for these services has outstripped supply. As government seeks to
expand healthcare spread, it must select a strategy that gives highest ‘healthcare access’ benefit to the Indian population.
A recent study of IMS Institute, ‘Understanding Healthcare Access in India – has made the relevant recommendations to enhance
the healthcare access in the country.
After the kick-start on the “Access to Healthcare – Challenges and the Way Forward” Seminar, the Committee will be evolving a roll
out plan of this important initiative of OPPI, which is very much aligned with the healthcare goals of the nation.
Patented Product Pricing Report of DoP
The government is preparing a policy for the pricing of patented medicines. The Government appointed committee recommended
three specific price setting approaches which we have seen in the Discussion and Analysis part of the report. OPPI CGA
Committee has worked extensively with the TF from the Working Group – Innovation & IPR and Accounts & Administration and
Finance & Taxation for OPPI Position on the Patented Product Pricing report of DoP.
The CGA Committee contributed for the OPPI representation to DoP on the subject.
Media Engagement Programme on OPPI Position on Clinical Trials (CTs)
Patient Compensation will now include injury or death, even if those are not related to the drugs being tested in the CT. It is worth
mentioning that these guidelines have been reportedly worked out after due consideration of around 300 comments received from
the stakeholders on the draft proposal circulated by the MoHFW with the members of the civil society, expert groups and pharma
companies. The CT sites will be authorized by the local licensing and the inspection authorities of the Central Drugs Standard
Control Organization (CDSCO).
After a series of meetings with DCGI and Expert Committee to formulate policy guidelines headed by Prof Ranjit Roy Chaudhury,
OPPI Medical, Biotechnology & Regulatory Committee and CGA Committee are planning media engagement programme.
37
Working Groups and Special Committees
HUMAN RESOURCE DEVELOPMENT
* Resigned
CHAIRMAN CO-CHAIRMAN
Mr. Lawrence Ganti Merck Serono Mr. K. Shivkumar Eisai
MEMBERS
Mr. Shrikrishna Bhave* Abbott Mr. Ajay Bhatt Abbott
Ms. Nagina Singh Abbott Mr. Debashish Chatterjee Allergan
Ms. Kinnari Joshi Astellas Ms. Smita Saha AstraZeneca
Mr. K.S. Harish Bayer Mr. Prachi Sharma Biogen Idec
Ms. Neha Poddar Boehringer Ingelheim Ms. Shraddha Pradhan Bristol Myers Squibb
Mr. Sameer Bhariok Eli Lilly Ms. Tejashree Talpade Eisai
Mr. Tarkesh Gupta Fresenius Kabi Mr. V.P. Shenil Fresenius Kabi
Mr. Vishal Vadakeri Galderma Mr. Ronald Sequeira GlaxoSmithKline Pharma
Mr. Abhishek Mathur Johnson & Johnson Mr. Nishant Berlia Martin & Harris
Ms. Cecilia M. Azavedo Merck Serono Mr. Sameer Tamhane MSD Pharmaceuticals
Ms. Chetana Gargava* Novartis Mr. M.V. Chandrashekar* Novartis
Mr. Rajesh Bhola* Novo Nordisk Mr. Malapaka SRKV Murthy Novo Nordisk
Mr. Vinod Shetty* Pfizer Dr. Lakshmi Nadkarni Pfizer
Mr. Vikram Duggal Ranbaxy Mr. Nilesh Kulkarni Roche
Mr. Saibal Bhattacharya RPG Life Sciences* Mr. Pradeep Vaishnav* Sanofi
Mr. Gaurav Bahadur Sanofi Ms. Jui Dabir Serdia
Ms. Deepa Misra Takeda Mr. Atul Bagal UCB
A company’s growth is dependent on the strength of its employees. The first step in developing a strong employee base starts with
identifying and recruiting the correct human resource. However, it does not end there. The ongoing goals for human resources are
talent development, employee retention and conflict management. These form the core of human resource development.
The Committee Chaired by Mr. Lawrence Ganti, Country Manager - Merck Serono and Co-chaired by Mr. K. Shivkumar, Managing
Director, Eisai Pharmaceuticals India Pvt. Ltd. took following initiates during the year –
Industrial Relations
Employee Compensation Survey
OPPI Academia Programme
HR Leadership and Capability Enhancement Programme
Knowledge Dissemination Programmes
Industrial Relations
Pharmaceutical Industry in India is recognized by our Government as a knowledge-based industry, with a turnover of over
` 1200 bn and growing at about 15%, it is one of the most developed industries. The Industry employs over three million employees
(direct one million and indirect two million). It has contributed significantly in improving the health indicators, such as life
expectancy, infant mortality, birth rate etc by making available high quality affordable medicines. The key factor for this
achievement has been the availability of many alternatives and choices to the doctors and hospital administrators in making
informed decisions for prescribing the correct medicines.
Organisation of Pharmaceutical Producers of India38
Working Groups and Special Committees
Medical Representative professionally is the backbone of any pharmaceutical company, and the first link in scientifically informing
and clinically updating the medical profession about the latest advances and the breakthroughs on a variety of drugs and
disseminate knowledge about the drugs.
The Pharmaceutical Industry is looking forward to a period of sustained growth driven by India’s strong economic fundamentals,
and at the same time the nation’s global outlook. Government’s prompt and timely action to address IR issues of the
Pharmaceutical Industry will reinforce the confidence and improve the performance of the industry. In turn, this could facilitate the
Government in achieving its target of ‘Health for All’ by providing quality affordable medicines, and ensuring easy access.
Employee Compensation Survey
Increases in the remuneration package for the Indian Pharmaceutical sector with the growing attrition rates is a real challenge for
retaining talent.
OPPI partnered with Mercer for the compensation and benefits study across the various categories of employees of the Sales and
Marketing functions. This Research Study is aimed to capture the various aspects of Compensation & Benefits prevalent in India,
which will facilitate OPPI Member Companies to streamline their remuneration in these areas.
The findings of this study will be released in November 2013.
OPPI Academia Programme
To strengthen the collaboration with leading Academic Institutions of India, the HRD Committee has planned OPPI Academia
Programme. The programme is aimed to convey the latest know-how on the emerging challenges and the opportunities of the
pharmaceutical companies and at the same time seeking concerns, suggestions and expectations of the students from the
industry.
Members from Executive and HRD Committees will interact with the students of the leading management institutions of India
during the year.
HR Leadership and Capability Enhancement Programme
Seminar
The HRD Committee has planned a Seminar in November 2013 on, ‘HR Trends – Challenges, Opportunities & Way Forward’
The seminar is aimed to bring in learning’s in following areas in relation to the HR function:
Developing Employee relations capability in HR in current business scenario
Change Management and HR – developing capabilities
HR as an Influencer in Business Decision making – required competencies
Being an equal partner while working with Powerful CEOs and Business Leaders– what it takes.
Is there really a 'One HR' concept? – Seamless working across the silos/verticals created
39
Working Groups and Special Committees
Knowledge Dissemination Programmes
The Committee organized the following knowledge dissemination programmes during the year -
Mr. Dietmar Eidens, Executive Vice-President and Global Head of Merck Serono Human Resources addressed the
members of the HRD Committee covering following areas,
• HR as a Business Partner
• Emerging Markets (In context to the role of HR)
• HR as Project Management.
Ms. Githanjali Pannikar, Director, Corporate Executive Board (CEB) made a presentation to the HRD Committee on
‘Building HR Capability to Drive Business Impact’
Mr. Saibal Bhattacharya, RPG made presentation on ‘IR situations in Pharma: A broad perspective’ to the members.
Organisation of Pharmaceutical Producers of India40
Working Groups and Special Committees
* Resigned
LEGAL
MEMBERS
CHAIRMAN CO-CHAIRMAN
Mr. G. Sathya Narayanan Galderma Mr. Rakesh Bhargava* Fresenius Kabi
Mr. Ravi Kiran Abbott Mr. Kaiyomarz Marfatia Abbott
Ms. Kinnari Joshi Astellas Mr. Pawan Singhal AstraZeneca
Mr. Rajiv Wani Bayer Mr. Bhavik Desai Bristol-Myers Squibb
Mr. Nikhil Kulshreshtha Fresenius Kabi Mr. Kaizad Hazari GlaxoSmithKline Pharma
Ms. Sharmistha Basu Johnson & Johnson Mr. Vikas Gupta Merck Serono
Dr. Rajesh Chitre Merck Serono Mr. Jaspreet Chandhok MSD Pharmaceuticals
Mr. Dinesh Charak Novartis Mr. Suhas Karambelkar Novo Nordisk
Mr. Samir Kazi Pfizer Ms. Neha Kshirsagar Ranbaxy
Mr. Shivprasad Laud Roche Mr. Rajesh Shirambekar RPG Life Sciences*
Ms. Yasmin Cama Sanofi Ms. Geeta Karnik* Serdia
Dr. Jan-Frederic Kesselhut Serdia
Legal Committee Chaired by Mr. G. Sathya Narayanan, Managing Director, Galderma India Pvt. Ltd. and Co-chaired by Mr.
Rakesh Bhargava, Chairman, Fresenius Kabi Oncology Limited played an active role through various advisory and consultative
practices for shaping up the Legal issues during the year,
National Pharmaceutical Pricing Policy of India 2012 / DPCO 2013
Compulsory Licensing
Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954
Knowledge Dissemination Programme
NPPP 2012 / DPCO 2013
To address legal issues arising out of NPPP 2012 and DPCO 2013, a Joint Task Force was formed which had a series of meetings
during the course of the year. Several representations were made to DoP, NPPA to address the pressing issues impeding the
implementation of DPCO 2013 by member companies of OPPI. During an interactive meeting with NPPA / DoP officials at Mumbai
the members of the committee highlighted the bariers in the execution of DPCO 2013 and the representation were made as follow
up of the discussion.
Compulsory Licensing
OPPI does not believe that Compulsory Licensing of patented inventions is a sustainable or viable course of action to address
India’s healthcare challenges.
A well documented Position Paper on Compulsory Licensing was prepared to give a proper understanding of using this provision
under the Patents Act, which essentially is meant to be used sparingly and only in special circumstances and conditions.
41
Working Groups and Special Committees
Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954
The Drugs & Magic Remedies (Prevention of Objectionable Advertisements) Act, 1954 (DMR Act) was enacted to deal with the
issues of false publication and advertisements for treatment of certain diseases like Cancer, Diabetes etc and to prohibit the
advertisements of certain drugs claiming magic qualities. The Act was mainly intended against illegal practices concerning
advertisements making totally false claims of preventing or curing certain diseases.
OPPI recommends a comprehensive review of DMR Act in the current environment of advanced Medical Science. Keeping in mind
the intent of the Act, necessary changes may be needed in the following areas -
1. Scope of definition of drugs should be restricted to very specific drugs which are prescription medicines for the specific
diseases and should not include other substances like dietary supplements etc.
2. Category of diseases stated in the Schedule need to be relooked for relevant communication can be shared on diagnosis
and treatment to educate all stakeholders.
3. Scope of communication with the Registered Medical Practitioners should be expanded to include even electronic and
digital communication.
4. Communication to other healthcare service providers like nurses, paramedic staff, community health workers etc should
be permitted to equip them with the basic & relevant information.
5. Compounding of offences should be introduced to protect genuine manufactures in cases of inadvertent errors.
Knowledge Dissemination Programme
To bring in learnings for the members, the Committee organised the following Knowledge Dissemination Programme:
‘e-Compliance Framework’ by Fresenius Kabi Team
‘Companies Bill 2012’ by Mr. Shivprasad Laud, Roche
‘Competition Law’ by Economic Laws Practice
Organisation of Pharmaceutical Producers of India42
Working Groups and Special Committees
MARKETING CODE, ETHICS AND COMPLIANCE
CHAIRMAN CO-CHAIRPERSON
Mr. Pheroze Khan Bristol-Myers Squibb Dr. Safia Rizvi UCB
SPECIAL INVITEES
Mr. Shashank Karnad KPMG Mr. Ravi Limaye NovartisMrs. Vidya Rajarao PwC* Mr. Darshan Patel PwC*
Mr. Rajendra T. Chalse Abbott Mr. Shrihari Shidhaye Abbott
Mr. Sridhar Ranganathan Allergan Dr. Rajesh Naik* Astellas
Mr. Ramesh Varadarajan AstraZeneca Mr. Pradnesh Kamat Bayer
Mr. Rajiv Malhotra Biogen Idec Ms. Vaibhavi Choksi Boehringer Ingelheim
Dr. Viraj Suvarna Boehringer Ingelheim Ms. Anuradha Gupta Boehringer Ingelheim
Mr. Bratin Bag Bristol-Myers Squibb Mr. P. Achuthan Eisai
Dr. Simrat Sohal Eli Lilly Mr. Sanjay Deshpande Fresenius Kabi
Mr. Amol Laxman Kulkarni Fresenius Kabi Mr. S. Raghavendra Galderma
Mr. H.K. Madhusudhan Galderma Mr. Mohit Raina GalxoSmithkline Pharma
Ms. Jayashree Shetty Johnson & Johnson Mr. Nishant Berlia Martin & Harris
Mr. Piyush Kant Merck Serono Dr. Rajesh Chitre Merck Serono
Mr. Sandeep Seth MSD Pharmaceuticals Mr. Girish Tekchandani Novartis
Mr. Venkat Kalyan* Novo Nordisk Mr. Omar Sherief Mohammad Novo Nordisk
Mr. Suresh Subramanian Pfizer Ms. Anamika Gupta Pfizer
Dr. Navneet Wadhwa* Ranbaxy Mr. G.K. Raman Roche
Mr. Rajindrra Patkar RPG Life Sciences* Mr. Virendra Lamba Sanofi
Mr. James Fernandes Serdia Mr. Ashok Kumar Bhattacharya Takeda
MEMBERS
* Resigned
The business dealings of OPPI member companies are governed by local as well as international laws, regulations and
conventions. They have internal Ethics and Compliance, Codes and Charters which enshrine the ethical principles governing the
activities and are committed to uphold the highest corporate ethics and strive for excellence. As the industry touches new heights
of growth with advanced medical knowledge and access to medicine, functioning ethically is very important.
In interactions with the medical community, following ethical promotional practices is important. Integrity, accuracy and clarity are
essential in such interactions and exchanges with the healthcare professionals and patients. Most importantly, there must always
be confidence that prescription decisions are made on an ethical and patient-focussed basis.
Mr. Pheroze Khan, Managing Director, Bristol-Myers Squibb India Pvt. Ltd. (Chairman) and Dr. Safia Rizvi, Managing Director,
UCB India Pvt. Ltd. (Co-Chairperson), gave direction to the members of the committee under the broad mandate described in the
earlier part of the report.
The Committee decided to take the following four projects:
Uniform Practices with reference to OPPI Code of Pharmaceutical Practices 2012
Uniform Code of Pharmaceutical Marketing Practices (UCPMP) – Interactions with DoP
Image of the Pharmaceutical Industry with reference to Ethics and Compliance
Concerns and Regulations with reference to Ethics and Compliance
43
Working Groups and Special Committees
Accordingly, four project teams were formed and in each of the committee meetings progress on the action plan was discussed,
reviewed and way forward decided.
Uniform Practices with reference to OPPI Code of Pharmaceutical Practices 2012
The OPPI Code of Pharmaceutical Practices 2012 is based on the model IFPMA Code and sets out principles considered basic to
ethical behaviour in pharmaceutical marketing. Its implementation can be meaningful only with the coordinated and coherent
efforts of member companies with cooperation from the medical community.
The Committee discussed the issues revolving around OPPI Code Clauses 7.1.5; 7.5.1; 7.5.3 and Q/A – covering elements such
as Consultant Agreements, Promotional Aids, Gifts/Brand Reminders; Patient Assistance Programmes, Third Party Sponsorship
etc., so as to ensure the conformity to the implementation of the Code.
Uniform Code of Pharmaceutical Marketing Practices - Interactions with DoP
The DoP reviewed its draft of Uniform Code of Pharmaceuticals Marketing Practices (UCPMP), encompassing recent MCI
Regulation and other current issues. This is a voluntary code of Marketing Industry for the present and its implementation six
months from the date of its issue. Implemented effectively by the Pharma Association would consider making it a statutory code.
OPPI has welcomed the updated draft UCPMP which sets a high standard for Ethical Marketing and brings in a level playing field
for all the stakeholders. On the updated draft UCPMP, OPPI had made a comprehensive representation giving its comments and
suggestions to meet the global standards of Ethical Marketing Practices.
The members of the committee have studied the document well and will be seeking clarification on few grey matters with DoP
during the planned interaction. The Committee is waiting for the final version of UCPMP from DoP, so that for efficacious
implementation, a dialogue can be set with DoP.
Image of the Pharmaceutical Industry with reference to Ethics and Compliance
Ethics, propriety and business value standards of big pharma, besides various types of legal compliance, are coming under
increasing stakeholders’ scrutiny, especially in the developed markets of the world. Very frequently media reports from across the
world, highlight serious indictments of the Government and even judiciary for bribery, corrupt business practices and other
unbecoming conduct, aimed at the global mascot for healthcare. In the process, affecting the image of the pharmaceutical industry.
Even the Parliamentary Standing committee on Health reportedly expressed concern that the “evil practice” of inducement of
doctors by the pharma players, the practice still continues.
Based on the Penn Scholan Berland (PSB) findings on the perception of OPPI in the eyes of various stakeholders, the Committee
is evolving plans to enhance the image of the pharmaceutical industry with reference to ethics and compliance aspect.
Concerns and Regulations with reference to Ethics and Compliance
The Committee studied the country specific phamaceutical industry codes with reference to the complaint handling procedures
such as -The Prescription Medicines Code of Practice Authority (Britain)(ABPI); FARMINDUSTRIA; Regulatory Bodies and
Procedures implementing the Code of Professional Conduct (Italy); Code of Pharmaceutical Marketing Practices (Hongkong
Association of the Pharmaceutical Industry) HKAPI (Hongkong); Australia; Canada etc on the aspects of complaints and
sanctions. The recommendations made on the potential penalties and consequent need for these studies and consensus, building
for the actions to be taken against those who violate the Code.
Organisation of Pharmaceutical Producers of India44
Working Groups and Special Committees
Knowledge session
A special session was arranged with Mr. Darshan Patel, Executive Director, PricewaterhouseCoopers (PwC) on ethics and
compliance related area in pharmaceuticals. He made a comparative study of OPPI Code, MCI Guidelines, Draft UCPMP and
made suggestions on the elements and sections of the Code for consistent implementation by OPPI member companies.
Meeting with MCI officials
MCI has issued the notification with reference to Code of Conduct for doctors and professional association of doctors in their
relationship with pharmaceutical and allied health sector industry on Gifts, Travel Facilities, Hospitality and Medical Research. In
order to get clarifications on certain grey areas from MCI Guidelines with regard to interactions with Health Care Professionals
(HCPs) and Promotion to HCPs, few members of the committee along with the chairman had an elaborate meeting with MCI
officials at Delhi. MCI is very concerned of the ethics amongst its members and their relationship with the pharma industry. MCI is
open to work with OPPI and other associations, and the DoP, to put in place a uniform code for doctors and industry.
45
Working Groups and Special Committees
MEDICAL, BIOTECH AND REGULATORY COMMITTEE
CHAIRMAN CO-CHAIRMAN
Mr. Sameer Savkur Biogen Idec Mr. Melvin D’Souza Novo Nordisk
SPECIAL INVITEE
Ms. Suneela Thatte Quintiles
Dr. Qayum Mukaddam Abbott Dr. Rashmi Hegde Abbott
Dr. Paramjit Singh Allergan Dr. Thirumalai Velu Allergan
Dr. Veena Jaguste Amgen Dr. Shashwati Pramanik Amgen
Dr. Pratik Shah Astellas Dr. Rajesh Naik* Astellas
Dr. Ammar Raza* AstraZeneca Dr. Bhavesh Kotak AstraZeneca
Dr. Premnath Shenoy AstraZeneca Dr. Ashish Gawde Bayer
Dr. Anjali Nagpal Biogen Idec Dr. Ritika Bajaj Biogen Idec
Ms. Meenu Batolar Biogen Idec Dr. Viraj Suvarna Boehringer Ingelheim
Mr. Kedar Suvarnapathaki Boehringer Ingelheim Dr. Vinod Mattoo Bristol-Myers Squibb
Dr. Ramakrishnan Sundaram Bristol-Myers Squibb Dr. Amitabh Dash Eisai
Ms. Gauri Ojha * Eisai Dr. Anurita Majumdar Eli Lilly
Mr. Rahul Chauhan Eli Lilly Mr. Ramkrishna Khawale Fresenius Kabi
Dr. Rahul Sawakhande Galderma Dr. Sadhna Joglekar GlaxoSmithKline Pharma
Ms. Sukanya Choudhury GlaxoSmithKline Pharma Dr. Jeroze Dalal GlaxoSmithKline Pharma
Dr. Narendra Vutla GlaxoSmithKline Consumer Dr. Prashant Desai Johnson & Johnson
Dr. Priya Chatterjee Merck Serono Dr. Swashraya Shah* MSD Pharmaceuticals
Mr. Swarnaraj Jacob MSD Pharmaceuticals Dr. Anirban Roy Chowdhury MSD Pharmaceuticals
Dr. Viraj Salgaonkar MSD Pharmaceuticals Dr. Suresh Menon Novartis
Ms. Amita Bhave Novartis Dr. Kamala Rai* Novartis
Dr. Raman Shetty Novo Nordisk Dr. Chandrashekhar Potkar Pfizer
Dr. Manish Paliwal Pfizer Dr. Murtuza Bughediwala Pfizer
Mr. Rajgopal Bhutada Ranbaxy Dr. Veena Venkatesh RPG Life Sciences*
Dr. Anil Kukreja Roche Dr. Pravin Chopra Sanofi
Ms. Yasmin Shenoy Sanofi Dr. Jan-Frederic Kesselhut* Serdia
Dr. Manjusha Rajarshi* Serdia Dr. Asmita Nimkar Serdia
Dr. Santosh Jha Takeda Dr. Manish Hathial UCB
MEMBERS
* Resigned
Medical, Biotech and Regulatory Committee Chaired by Mr. Sameer Savkur, Managing Director, Biogen Idec Biotech India Pvt.
Ltd. and Co-chaired by Mr. Melvin D’Souza, Managing Director, Novo Nordisk India Pvt. Ltd., extended its support on following
issues during the year -
Clinical Trials
Regulatory
Biosimilars
Organisation of Pharmaceutical Producers of India46
Working Groups and Special Committees
Clinical Trials
OPPI remains committed to sponsoring Clinical Trials that fully comply with legal and regulatory requirements laid down in the
Drugs & Cosmetics Act 1940 and Rules made there under. The Committee has developed a voluntary Code for its members in line
with the global “Principles on Conduct of Clinical Trials”. OPPI Member Companies are committed to follow the principles laid down
in this document, in conformance to all applicable International and Indian regulations, guidelines and ethical principles.
OPPI believes in a robust and transparent process for the conduct of Clinical Trials to obtain regulatory approval for all new drugs.
This process should be in the interest of patients, while supporting the Government’s initiative to create a framework for
compensation in case of Clinical Trial related injury or death.
The committee made representations on the notification [GSR 53(E) dated 30th January, 2013] related to this issue to the Expert
Committee and officials of Ministry of Health (MoH) in this matter. A delegation comprising Mr. Ranjit Shahani, President, OPPI; Mr.
Tapan Ray, Director General, OPPI; Dr. Shailesh Ayyangar, Vice President, OPPI; Mr. Melt van der Spuy, a member of Executive
Committee, OPPI; Mr. Sameer Savkur, Chairman OPPI Medical, Biotechnology & Regulatory Committee; and select members of
Medical, Biotechnology & Regulatory Committee met the MoH officials for presenting OPPI’s proposal for amendment of this
notification.
Regulatory
On an ongoing basis, the committee made recommendations on various regulatory issues during the year and had series of
interactive meetings with the Drugs Controller General of India (DCGI), and other officials for resolving the issues impacting the
members of OPPI.
The committee presented its views in the following areas -
Amendment of the Drugs & Cosmetics Rules for making a provision of approval of drug formulation containing single active
ingredient in generic name only.
Cancellation of Permission / License in Case an Applicant / Manufacturer who Fails to Launch their Product for Marketing in
the Country Within a Period of Six Months from Obtaining the Permission / License from CDSCO
Guidelines on Good Distribution Practices for Pharmaceutical Products
Disruption of Imports due to Delayed Renewal of Licenses
Schedule H1 Drugs
Joint Representation with other Industry Associations (IDMA, IPA, FOPE) on Fixed Dose Combinations (FDCs)
Biosimilars
Biosimilar is not identical to an already registered reference biological medicinal product in terms of quality, safety, and efficacy.
These products rely, in part, for licensing on prior information obtained from the innovator product and a demonstration of similarity
based upon detailed and comprehensive product characterization. To ensure the safety and efficacy of biosimilars, OPPI believes
that these products should only be approved following the submission of appropriate data generated with the biosimilar drug, which
should include pre-clinical tests and controlled clinical trials with a significantly relevant number of patients addressing all the issue
in their respective study designs.
OPPI supports the CDSCO / DBT Guidelines on Indian Guidelines on Similar Biologics: Regulatory Requirements for Marketing
Authorization (Quality, Pre-Clinical studies and Clinical Trials requirements). Mr. Sameer Savkur, Chairman OPPI Medical, Biotech
& Regulatory Committee and select members of the Committee met the Drugs Controller General of India (DCGI) to discuss issues
related to Biosimilars and for ensuring adherence to the Guidelines by all stakeholders.
OPPI in Pictures
47
thOPPI 46 Statutory AGM on September 14, 2012 at Club Peninsula, Mumbai. Seated from left Mr. Ajit Bendre, Associate Director, Finance, Admn. and Association Secretary, OPPI; Mr. Tapan Ray, Director General, OPPI; Mr. Ranjit Shahani, President, OPPI and Mr. Joe Pretto, Partner, Deloitte Haskins & Sells, Auditors for OPPI .
thMr. Tapan Ray, Director General, OPPI addressing at the OPPI 46 AGM on September 15, 2012 at The Taj Mahal Palace, Mumbai.
OPPI in Pictures
Organisation of Pharmaceutical Producers of India48
thMr. Ranjit Shahani, President, OPPI addressing at the OPPI 46 AGM on September 15, 2012 at The Taj Mahal Palace, Mumbai.
thA view of the distinguished audience at the OPPI 46 AGM on September 15, 2012 at The Taj Mahal Palace, Mumbai.
OPPI in Pictures
49
Mr. Tapan Ray, Director General, OPPI presenting bouquet to Guest of Honour Dr. Sam Pitroda, Advisor to the Prime Minister of thIndia at the OPPI 46 AGM on September 15, 2012 at The Taj Mahal Palace, Mumbai.
thMr. C.P. Singh, Chairman, NPPA addressing at the OPPI 46 AGM on September 15, 2012 at The Taj Mahal Palace, Mumbai.
OPPI in Pictures
Organisation of Pharmaceutical Producers of India50
thChief Guest Mr. D.S. Kalha, Secretary, Department of Pharmaceuticals addressing at the OPPI 46 AGM on September 15, 2012 at The Taj Mahal Palace, Mumbai.
Mr. Tapan Ray, Director General, OPPI, Dr. Sam Pitroda, Advisor to the Prime Minister of India, Mr. D.S. Kalha, Secretary, thDepartment of Pharmaceuticals, Mr. Ranjit Shahani, President, OPPI and Mr. C.P. Singh, Chairman, NPPA at the OPPI 46 AGM
on September 15, 2012 at The Taj Mahal Palace, Mumbai.
OPPI in Pictures
51
Dr. Sam Pitroda, Advisor to the Prime Minister of India Presenting Scientist Award to Dr. Shyam Sunder Sharma, NIPER, Mohali, at ththe OPPI 46 AGM on September 15, 2012 at The Taj Mahal Palace, Mumbai.
Dr. Sam Pitroda, Advisor to the Prime Minister of India Presenting Young Scientist Award to Dr. Akkattu T. Biju, NCL, Pune, CSIR at ththe OPPI 46 AGM on September 15, 2012 at The Taj Mahal Palace, Mumbai.
OPPI in Pictures
Organisation of Pharmaceutical Producers of India52
Mr. D.S. Kalha, Secretary, Department of Pharmaceuticals Presenting Dr. H.R. Nanji Memorial OPPI Marketing Excellence Award thto GlaxoSmithKline Pharmaceuticals Ltd., for the Brand –‘CCM’ in the Category of ‘Existing Products’ at the OPPI 46 AGM on
September 15, 2012 at The Taj Mahal Palace, Mumbai.
Mr. D.S. Kalha, Secretary, Department of Pharmaceuticals Presenting Dr. H.R. Nanji Memorial OPPI Marketing Excellence Award thto MSD Pharmaceuticals Pvt. Ltd. for the Brand – ‘Rota Teq®’ in the Category of ‘New Products’ at the OPPI 46 AGM on
September 15, 2012 at The Taj Mahal Palace, Mumbai.
OPPI in Pictures
53
Mr. D.S. Kalha, Secretary, Department of Pharmaceuticals Presenting OPPI Sales Force Excellence Award 2012 to Mr. Anil Matai, CEO Pharmaceutical Division, Novartis India Ltd. for the outstanding Sales Force Excellence Project, ‘Transform to accelerate’ at
ththe OPPI 46 AGM on September 15, 2012 at The Taj Mahal Palace, Mumbai.
Mr. C.P. Singh, Chairman, NPPA Presenting Best Vendor Award in the category of Contract Manufacturing to Dr Amit Rangnekar thDirector, Centaur Pharmaceuticals Pvt. Ltd. at the OPPI 46 AGM on September 15, 2012 at The Taj Mahal Palace, Mumbai.
OPPI in Pictures
Organisation of Pharmaceutical Producers of India54
Mr. C.P. Singh, Chairman, NPPA Presenting Best Vendor Award in the category of Carrying and Forwarding Agents (CFAs) to Mr. thVaijanath Jagushte, Managing Director, AIOCD Ltd., and his team at the OPPI 46 AGM on September 15, 2012 at The Taj Mahal
Palace, Mumbai.
thKeynote Speaker Dr. Sam Pitroda, Advisor to the Prime Minister of India addressing at the OPPI 46 AGM on September 15, 2012 at The Taj Mahal Palace, Mumbai.
OPPI in Pictures
55
thMr. D.S. Kalha, Secretary, Department of Pharmaceuticals, releasing OPPI 46 Annual Report 2011-12 L-R Mr. Ajit Bendre, Associate Director - Finance, Admn. and Association Secretary, Mr. Rajiv Shukla, Director, OPPI, Mr. Tapan Ray, Director General, OPPI, Mr. C.P. Singh, Chairman, NPPA, Mr. D.S. Kalha, Secretary, Department of Pharmaceuticals, Dr. Sam Pitroda, Advisor to the
thPrime Minister of India, Mr. Ranjit Shahani, President, OPPI, Mr. Vivek Padgaonkar, Director, OPPI at the OPPI 46 AGM on September 15, 2012 at The Taj Mahal Palace, Mumbai.
Shri. Dilsher Singh Kalha releasing OPPI Compendium of Case Studies on Ethics & Compliance. L-R, Mr. Rajiv Shukla, Director, OPPI, Mr. Tapan Ray, Director General OPPI, Mr. C.P. Singh, Chairman, NPPA, Shri. Dilsher Singh Kalha, Secretary, Department of Pharmaceuticals, Dr. Shailesh Ayyanger, Chairman, OPPI Ethics & Compliance Committee, Dr. Sam Pitroda, Advisor to the
thPrime Minister of India and Mr. Ranjit Shahani, President, OPPI, at the OPPI 46 AGM on September 15, 2012 at The Taj Mahal Palace, Mumbai.
OPPI in Pictures
Organisation of Pharmaceutical Producers of India56
Dr. Sam Pitroda releasing a Joint Report by OPPI & McKinsey titled ‘Transforming India’s Vaccine Market’. L-R, Mr. Rajiv Shukla, Director, OPPI, Mr. Tapan Ray, Director General, OPPI, Mr. C.P. Singh, Chairman NPPA, Shri. Dilsher Singh Kalha, Secretary Department of Pharmecuticals, Dr. Sam Pitroda, Advisor to the P.M. of India, Mr. Masood Alam, Chairman, OPPI Vaccines
thCommittee, Mr. Palash Mitra, Director, McKinsey & Company and Mr. Ranjit Shahani, President, OPPI, at the OPPI 46 AGM on September 15, 2012 at The Taj Mahal Palace, Mumbai.
Dr. Sam Pitroda releasing Research Report prepared by OPPI and Ernst & Young titled, ‘Unlocking the Potential of the Pharma Distribution Channel’. L-R , Mr. Tapan Ray, Director General, OPPI, Mr. C.P. Singh, Chairman, NPPA, Shri. Dilsher Singh Kalha, Secretary, Department of Pharmaceuticals, Dr. Sam Pitroda, Advisor to the Prime Minister of India, Mr. Sudarshan Jain, Chairman – OPPI Materials Management Committee, Mr. Ranjit Shahani, President, OPPI, Mr. Vivek Padgaonkar, Director, OPPI and Mr.
thMurali Nair, Partner, E&Y at the OPPI 46 AGM on September 15, 2012 at The Taj Mahal Palace, Mumbai.
OPPI in Pictures
57
Shri C. P. Singh releasing ‘OPPI Quality Assurance Guide – Vol. II’. L-R , Mr. K. G. Ananthakrishnan, Chairman, Technical Committee, OPPI, Mr. Tapan Ray, Director General, OPPI, Mr. C.P. Singh, Chairman, NPPA, Shri. Dilsher Singh Kalha, Secretary, Department of Pharmaceuticals, Dr. Sam Pitroda, Advisor to the Prime Minister of India, Mr. Ranjit Shahani, President, OPPI, Mr.
thVivek Padgaonkar, Director, OPPI at the OPPI 46 AGM on September 15, 2012 at The Taj Mahal Palace, Mumbai.
Shri C. P. Singh releasing OPPI Commemorative Publication on ‘Improving Access, Innovation & Reach of Healthcare in India’. L-R Mr. Ryan Albuquerque, Partner and Founder Director, Universal Consulting India Pvt. Ltd., Mr. Tapan Ray, Director General, OPPI, Mr. C.P. Singh, Chairman, NPPA, Shri. Dilsher Singh Kalha, Secretary, Department of Pharmaceuticals Dr. Sam Pitroda, Advisor to
ththe Prime Minister of India, Mr. Ranjit Shahani, President, OPPI at the OPPI 46 AGM on September 15, 2012 at The Taj Mahal Palace, Mumbai.
OPPI in Pictures
Organisation of Pharmaceutical Producers of India58
thSmt. Jaya Row, Founder, Vedanta Vision addressing at the OPPI 46 AGM on September 15, 2012 at The Taj Mahal Palace, Mumbai.
Dr. Avijit Lahiri, Cardiologist and Director Clinical Imaging & Research Centre, Wellington Hospital, London, (UK), with the audience of his address on “The New Scourge of the World – Diabetes & Heart Diseases” on October 15, 2012 at Club Peninsula, Peninsula Corporate Park, Lower Parel, Mumbai.
OPPI in Pictures
59
Release of “OPPI Code of Pharmaceutical Practices 2012” by Mr. Ranjit Shahani, President and the Executive Committee of OPPI on December 20, 2012 at OPPI Conference Room Mumbai.
Mr. Hitesh Sharma, Partner, E&Y and his team with the audience at the presentation on “Key Features of India’s Union Budget 2013-14” on March 4, 2013, at Club Peninsula, Peninsula Corporate Park, Lower Parel, Mumbai.
OPPI in Pictures
Organisation of Pharmaceutical Producers of India60
Mr. Dietmar Eidens, Executive Vice President and Global Head, Merck Serono Human Resources, Mr. Lawrence Ganti, General Manager, India, Merck Serono and Chairman, OPPI HRD Committee along with Mr. K. Shivkumar, Managing Director, Eisai Pharmaceuticals India Pvt. Ltd., and Co- Chairman, OPPI HRD Committee with the audience at a presentation on “Building HR Capability to Drive Business Impact” on April 29, 2013 at Merck Sereno office at Mumbai.
ndMr. Tapan Ray, Director General, OPPI Addressing at the 2 Asia Partnership Conference of Pharmaceutical Associations (APAC) April 11 & 12, 2013 - Tokyo.
OPPI in Pictures
61
Mr. Shirish Ghoge, Member of OPPI Accounts & Administration and Finance & Taxation Committee addressing at OPPI Seminar on “Clarifying Issues : DPCO 2013 Implementation” organised on July 16, 2013 for the Members of the Working Group on Stakeholder Engagement & Partnerships, Accounts & Administration and Finance & Taxation Committee, Legal Committee at Club Peninsula, Peninsula Corporate Park, Lower Parel, Mumbai.
An interactive meeting of OPPI Executive Committee members with Ms. Neena Shenai, a U.S. Congressional Staffer and Trade Counsel of the U.S. House of Representatives Ways & Means Committee, the U.S.-India bilateral trade issues along with other delegates from the U.S. Consulate, in the OPPI Conference Room, Mumbai on May 3, 2013.
Mr. Tapan Ray, Director General, OPPI addressing at the Interactive meeting of the OPPI Members to discuss issues relating to the implementation of the DPCO 2013 and other pressing issues of the industry with Mr. Dilsher Singh Kalha, Secretary, DoP,Mr. Shambhu Kallolikar, Joint Secretary, DoP, Mr. B.K. Singh, Director and Mr. C.P. Singh, Chairman, NPPA on August 22, 2013 at Mumbai.
Mr. Sudarshan Jain, Chairman, OPPI Working Group on Access and the Affordability addressing at the Seminar on ‘Access to Healthcare – Challenges and the Way Forward’ on August 23, 2013 at Shangri-La Hotel, Mumbai.
OPPI in Pictures
Organisation of Pharmaceutical Producers of India62
OPPI in Pictures
63
Panel Discussion: Seminar on ‘Access to Healthcare – Challenges and the Way Forward’ moderated by Mr. Ranga Iyer, Consultant, from Left to Right Dr. C.A.K. Yesudian, Dean, School of Health Systems Studies, Tata Institute of Social Sciences,Dr. Shashank Joshi, Consultant Endocrine & Metabolic Physician, Lilavati Hospital and President Elect, APICON, Mr. D. G.Shah, Secretary General, IPA, Mr. Manish U. Doshi, President, IDMA, Mr. Muralidharan Nair, Partner, Ernst & Young and Mr. Amit Backliwal, Managing Director, IMS Health Information & Consulting Services, on August 23, 2013 at Shangri-La Hotel, Mumbai.
L - R, Mr. Sanjay Kumar, Member Secretary, NPPA, Dr. Shailesh Ayyangar, Vice President, OPPI, Mr. B. K. Singh, Director, DoP, Mr. Shailendra Kumar, Director - Drugs, Ministry of Health, at OPPI Seminar on ̀ Access to Healthcare - Challenges and the Way Forward' on August 23, 2013 at Shangri-La Hotel, Mumbai.
Publications
OPPI's Membership of Associations1. The Associated Chambers of Commerce & Industry of India (ASSOCHAM), New Delhi
2. Confederation of Indian Industry (CII), New Delhi
3. Employers’ Federation of India (EFI), Mumbai
4. Federation of Indian Chambers of Commerce and Industry (FICCI), New Delhi
5. Indian Merchants’ Chamber (IMC), Mumbai
6. International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), Geneva, Switzerland
th OPPI 46 Annual Report - 2011 - 12
OPPI Ethics & Compliance – A Compendium of Case Studies
OPPI Commemorative Publication – Improving Access Innovation & Reach of Healthcare in India
OPPI – McKinsey Report – Transforming India’s Vaccine Market
OPPI – E&Y Report – Unlocking the Potential of the Pharma Distribution Channel
OPPI Code of Pharmaceutical Practices – 2012
India Emerging – Pharma’s Evolving Business Models (OPPI & E&Y Report)
Transforming Life Sciences Logistics in India (OPPI & DHL Report)
The Evolution of Sales Models in the Indian Pharma Industry (OPPI & IMS Report)
Lean Implementation - Indian pharmaceutical industry (OPPI & PwC Report)
Achieving Growth with Responsibility (OPPI & NMIMS Report)
Successful Partnerships (OPPI and E&Y Report)
Corporate Social Responsibility Update – 2010 Caring for Society
OPPI – Ernst & Young Report 2009: ‘Taking Wings’
OPPI Guidelines on Cold Chain Pharmaceutical Products
OPPI Code on Conduct of Clinical Trials
OPPI - Yes Bank Report, “Pharmaceutical Industry: Vision 2015”
OPPI - Guide to Road Safety
OPPI IPR Symposium Proceedings
Outsourcing Opportunities in Indian Pharmaceutical Industry
Corporate Social Responsibility of Pharmaceutical Companies in India : Practices, Perspectives and Way Forward
OPPI Guidelines on Good Laboratory Practices (GLP)
OPPI Anti-Counterfeiting Guidelines
Organisation of Pharmaceutical Producers of India64
Meetings with Policy Makers / Government Authorities
Sr. No. Date Ministers / Officials Delegation Purpose
1.
2.
3.
03.10.2012
04.10.2012
09.10.2012
* Dr. Raja Sekhar Vundru
Joint Secretary
Department of Pharmaceuticals (DoP)
& other officials from the DoP
* Mr. C.P. Singh
Chairman
National Pharmaceutical Pricing
Authority (NPPA) & Senior Officials of
NPPA
* Mr. Dilsher Singh Kalha
Secretary, DoP
* Dr. Raja Sekhar Vundru
Joint Secretary, DoP
* Mr. C.P. Singh, Chairman, NPPA
* Mr. B.K. Singh, Director, DoP
* Mr. Prem Singh Rawat
* Mr. S. Sridhar
* Mr. Navin Sharma
* Mr. Prem Singh Rawat
* Mr. Tapan Ray
Meeting of the Core
Committee of Pharma
Biotech World Expo 2012
Allowance of MAPE on the
revision of prices of
Scheduled Formulations
under the DPCO 1995
Issues relating to
Pharmaceutical Industry
4. 10.10.2013 * Officials from the Department of
Revenue, Ministry of Finance
* Mr. Shirish Ghoge
* Mr. Amitabh Baxi
* Ms. Anamika Gupta
Issues related to Narcotic
Drugs & Psychotropic
Substances (Amendment)
Bill 2011
5. 23.11.2012 * Mr. Dilsher Singh Kalha
Secretary, DoP
* Mr. B.K. Singh
Director, DoP
* Mr. D.V. Prasad
Joint Secretary
Department of Industrial Policy &
Promotion (DIPP)
* Mr. S. Raghavan
Joint Secretary
Department of Biotechnology
* Dr. G.N. Singh
Drugs Controller General of India
(DCGI)
* Mr. Tapan Ray
* Mr. Tapan Ray
* Mr. Prem Singh Rawat
Pharmaceutical Policy /
DPCO
65
Meetings with Policy Makers / Government Authorities
Sr. No. Date Ministers / Officials Delegation Purpose
6. 23-24.01.13 * Mr. Dilsher Singh Kalha
Secretary, DoP
* Mr. B.K. Singh
Director, DoP
* Mr. R.K. Jain
Additional Secretary
Ministry of Health & Family Welfare
(MoHFW)
* Dr. Jagdish Prasad
Director General Health Services
(DGHS)
* Mr. D.V. Prasad
Joint Secretary, DIPP
* Mr. Tapan Ray
* Mr. Prem Singh Rawat
Pharmaceutical Policy /
DPCO and Regulatory and
IPR related issues
7. 06.02.2013 * Mr. C.P. Singh, Chairman, NPPA
* Mr. Sanjay Kumar
Member Secretary, NPPA &
Senior Officials of NPP
* Mr. Shirish Ghoge
* Mr. M.K. Narayanaswamy
* Mr. Tarun Bhatnagar
* Mr. Prem Singh Rawat
Implementation of National
Pharmaceutical Pricing
Policy 2012
8. 06.02.2013 * Mr. G. Mohan Kumar
Special Secretary
Ministry of Water Resources &
Senior Officials of the Ministry
* Mr. Prem Singh Rawat Enhancing Water Use
Efficiency in Industries
9. 11.02.2013 * Dr. G.N. Singh, DCGI
* Dr. V.G. Somani
Dy. Drugs Controller (India),
CDSCO (West Zone)
* Mr. Sameer Savkur
Members of the Medical,
Biotech & Regulatory
Committee
* Mr. Rajiv Shukla
Discussion regarding the
Notification on
Compensation in Case of
Injury or Death during
Clinical Trial [GSR53(E)
dated January 30, 2013]
10.
11.
22.02.2013
26.02.2013
* Mr. Chaitanya Prasad
Controller General of Patents,
Designs & Trade Marks
* Mr. Shambhu Kallolikar
Joint Secretary, DoP
* Mr. B.K. Singh, Director, DoP
* Mr. Sameer Savkur
* Dr. Shashwati Pramanik
* Ms. Suja Subramaniam
* Dr. Garuva Arya
* Mr. Prem Singh Rawat
* Mr. Tapan Ray
* Mr. Prem Singh Rawat
Draft Guidelines of
Biotechnology Applications
National Pharmaceutical
Pricing Policy 2012
Organisation of Pharmaceutical Producers of India66
Meetings with Policy Makers / Government Authorities
Sr. No. Date Ministers / Officials Delegation Purpose
12. 26.02.2013 * Dr. V. M Katoch
Secretary,
Dept. of Health Research &
Director General
Indian Council of Medical Research
(ICMR)
* Dr. Jagdish Prasad, DGHS
* Mr. Tapan Ray
* Mr. Sameer Savkur
* Mr. Melt van der Spuy
* Dr. Sadanand Kulkarni
* Dr. Raman Shetty
* Dr. Anil Kukreja
* Dr. Pravin Chopra
Notification GSR 53(E)
dated January 30, 2013
on Compensation in case
of injury or death during
Clinical Trial
13. 27.02.2013 * Mr. Keshav Desiraju
Secretary, MoHFW
* Dr. Jagdish Prasad, DGHS
* Mr. R.K. Jain
Additional Secretary, MoHFW
* Dr. A.K. Panda
Joint Secretary, MoHFW
* Dr. G.N. Singh, DCGI
* Mr. A.K. Pradhan
Deputy Drugs Controller (India)
* Mr. Ranjit Shahani
* Mr. Tapan Ray
* Dr. Shailesh Ayyangar
* Mr. Sameer Savkur
* Dr. Veena Jaguste
* Dr. Sadanand Kulkarni
* Dr. Raman Shetty
* Dr. Anil Kukreja
* Dr. Pravin Chopra
* Ms. Suja Subramaniam
* Mr. Prem Singh Rawat
Notification GSR 53(E)
dated January 30, 2013 on
Compensation in case of
injury or death during
Clinical Trial
14. 07.03.2013 * Mr. Ishtiyaq Ahmad
Director, DIPP
* Mr. Amitabh Baxi
* Mr. Prem Singh Rawat
Discussion on the
Consolidated Foreign
Direct Investment Policy
Circular - Sixth Edition
15. 08.03.2013 * Health Minister of Timor Leste
* Dr. G.N. Singh,
DCGI & Senior Officials from CDSCO
* Mr. Sameer Savkur
* Mr. Prem Singh Rawat
Discussion on issues
relating to Public Health,
Medical Education &
PPP in Health Sector
16.
17.
11.03.2013
03.04.2013
* Mr. Sanjay Kumar
Member Secretary, NPPA
* Mr. A.K. Gautam, Advisor, NPPA
* Mr. Asokan, Director, NPPA &
Senior Officials of NPPA
* Prof. Ranjit Roy Chaudhury
Chairman, Expert Committee to
Formulate Guidelines and SOPs for
Approval of New Drugs, Clinical Trials
and Banning of Drugs
* Members of the Expert Committee
* Dr. V.G. Somani
Dy. Drugs Controller (India)
* Mr. A.K. Pradhan
Deputy Drugs Controller (India)
* Mr. Gaurav Kumar, ADC(I),
CDSCO, HQ
* Mr. S. Sridhar
* Mr. Amitabh Baxi
* Mr. Navin Sharma
* Mr. Prem Singh Rawat
* Delegation comprising of
Members of the Medical,
Biotech & Regulatory
Committee
* Mr. Rajiv Shukla
Submission of data for
pricing of NLEM-2011
67
Sr. No. Date Ministers / Officials Delegation Purpose
18. 04.04.2013 * Workshop organised by the
Department of Pharmaceuticals
* Mr. Vivek Padgaonkar Workshop on “Developing
India as a Drug Discovery
& Pharma Innovation
Hub 2020”
19. 10.04.2013 * Dr. G.N. Singh
DCGI
* Mr. A.K. Pradhan,
Deputy Drugs Controller India
* Mr. S.P. Shani
Deputy Drugs Controller India
* Mr. Sameer Savkur
* Dr. Sadhna Joglekar
* Ms. Meenu Batolar
* Dr. Ramakrishnan
Sundaram
* Dr. Viraj Suvarna
* Mr. Rahul Chauhan
* Mr. Manmoy Parida
* Ms. Sukanya Chaudhury
* Ms. Seema Shimpi
* Ms. Priya Chatterjee
* Ms. Amita Bhave
* Mr. Abhinav Shrivastav
* Ms. Yasmin Shenoy
* Mr. Rajiv Shukla
* Mr. Prem Singh Rawat
Regulatory issues relating
to Imports Registration,
FDCs and Biologics
20. 15.04.2013 * Prof. C.K. Kokate,
Chairman & the Members of Expert
Committee to Formulate Policy
Guidelines and Procedures for
Approval of Fixed Dose Combinations
* Ms. Yasmin Shenoy
* Mr. M.V. Sheshagiri
* Dr. Qayum Mukkadam
* Ms. Sukanya Chaudhury
* Mr. Swarnaraj Jacob
* Dr. Asmita Nimkar
* Dr. Manjusha Rajarshi
* Mr. Prem Singh Rawat
To present OPPI’s views /
suggestions on procedures
for Approval of FDCs
21. 25-26.04.13 * Mr. Dilsher Singh Kalha
Secretary, DoP
* Mr. Shambhu Kallolikar
Joint Secretary, DoP
* Mr. R.K. Jain
Additional Secretary, MoHFW
* Mr. D.V. Prasad
Joint Secretary, DIPP
* Mr. Satish Chandra
Joint Secretary & Legal Advisor
Department of Legal Affairs
* Dr. G.N. Singh, DCGI
* Dr. Sakthivel Selvraj
Senior Health Economist
Public Health Foundation of India
* Mr. Tapan Ray
* Mr. Prem Singh Rawat
(at meeting with
Mr. Selvraj)
Industry related issues
Meetings with Policy Makers / Government Authorities
Organisation of Pharmaceutical Producers of India68
Sr. No. Date Ministers / Officials Delegation Purpose
22. 08.05.2013 * Mr. Dilsher Singh Kalha
Secretary, DoP
* Mr. B.K. Singh, Director,
DoP & other officials from DoP
* Mr. Sameer Savkur
* Mr. Tapan Ray
* Mr. Prem Singh Rawat
Issues relating to Clinical
Trials
23. 08-09.05.13 * Mr. C.P. Singh, Chairman, NPPA
* Mr. Sanjay Kumar
Member Secretary, NPPA
* Mr. B.K. Singh, Director, DoP
* Mr. Shailendra Kumar
Director, MoHFW
* Dr. Biswajit Dhar
Director General
Research & Information Systems for
Developing Countries (RIS)
* Mr. Tapan Ray
* Mr. Prem Singh Rawat
Pharmaceutical Policy /
DPCO 2013 / Regulatory &
Industry issues
24. 17.06.2013 * Mr. Dilsher Singh Kalha
Secretary, DoP
* FICCI Officials
* Mr. K.G. Ananthakrishnan
* Mr. Pheroze Khan
* Mr. Aijaz Tobaccowalla,
* Mr. Tapan Ray
* Mr. Prem Singh Rawat
Roundtable discussion on
“Draft Report of the
Committee on Price
Negotiations for Patented
Drugs
25. 24-25.06.13 * CDSCO Workshop * Ms. Meenu Batolar
* Dr. Jayasheel B.G.
Two-day Workshop for
Harmonization of Schedule
Y Indian GCP and Ethical
Guidelines for Biomedical
Research on Human
Participants”
26. 25.06.2013 * Mr. Mahesh Zagade
Commissioner
Food & Drug Administration
(Maharashtra State) & his team of
Officers
* Mr. Bhagwat Singh Deora
* Mr. Dewang Smart
* Mr. Sanjay Sabnis
* Ms. Sharmistha Basu
* Mr. Rajiv Sharda
* Mr. Sanjay Bhatkande
* Mr. Sanchit Nanda
* Mr. S.G. Vaidyanathan
* Mr. Rajiv Shukla
27. 26.06.2013 * Mr. Dilsher Singh Kalha
Secretary, DoP
* Dr. A K Panda
Joint Secretary, MoHFW
* Dr. G.N. Singh, DCGI
* Dr. V.G. Somani
Deputy Drugs Controller India
(West Zone)
* Mr. Tapan Ray
Issue of Availability of
Medicines for the People
in Maharashtra State
Issues relating to DPCO
2013 and the Way Forward
Meetings with Policy Makers / Government Authorities
69
Sr. No. Date Ministers / Officials Delegation Purpose
28. 26.06.2013 * Dr. A.A. Natu
Professor
Indian Institute of Science,
Education & Research
* Dr. Sourav Pal
Director, CSIR – National Chemical
Laboratory, Pune
* Mr. Satyen Amin OPPI Scientists & Young
Scientists Awards 2013
29. 01.07.2013 * Dr. M. Lakshmi Kantam
Director
CSIR – Indian Institute of Chemical
Technology (IICT)
* Dr. Ahmed Kamal
Scientists & Head – Medicinal
Chemistry & Pharmacology
CSIR – IICT
* Prof. N. Satyanarayana
Registrar, NIPER
* Dr. Ramesh Panchagnula
* Ms. Sadhana Mogre
* Dr. Prasad Kanitkar
* Mr. Vivek Padgaonkar
OPPI Scientists & Young
Scientists Awards 2013
30. 19.07.2013 * Dr. P. Prasannaraj
Additional Secretary (Responsible for *
Professional Conduct, Etiquette and
Ethics)
Medical Council of India
* Mr. Pheroze Khan
* Mr. Rajiv Malhotra
* Mr. Bratin Bag
* Mr. Tabrez Ahmad
* Mr. Vivek Padgaonkar
MCI Guidelines with
regards to interactions
with HCPs and Promotion
to HCPs
31. 19.07.2013 * Dr. Zakir Thomas
Project Director
Open Source Drug Discovery (OSDD)
& Head, DG’s Technical Cell, CSIR
* Dr. Ratnesh Lal
* Mr. Vivek Dhariwal
* Mr. Vivek Padgaonkar
* Mr. Prem Singh Rawat
PPI Scientists & Young
Scientists Awards 2013
32. 24.07.2013 * Dr. G.N. Singh, DCGI
* Mr. A.K. Pradhan
Deputy Drugs ControlIer India
* Mr. S.P. Shani
* Mr. Sameer Savkur
* Dr. Ramkrishnan
Sundaram
* Ms. Meenu Batolar
* Mr. Rahul Chauhan
* Dr. Manish Paliwal
* Dr. Anil Kukreja
* Dr. Mubarak Naqvi
* Mr. Tabrez Ahmad
* Mr. Prem Singh Rawat
Indian Guidelines on
Similar Biologics:
regulatory Requirements
for Marketing Authorization
(Quality, Pre-Clinical and
Clinical Trial Requirements).
Meetings with Policy Makers / Government Authorities
Organisation of Pharmaceutical Producers of India70
Sr. No. Date Ministers / Officials Delegation Purpose
33. 01.08.2013 * Mr. Saurabh Chandra
Secretary
Department of Industrial Policy &
Promotion (DIPP)
* Mr. D.V. Prasad
Joint Secretary, DIPP
* Mr. Dilsher Singh Kalha
Secretary
Department of Pharmaceuticals (DoP)
* Mr. Shambhu Kallolikar
Joint Secretary, DoP
* Mr. B.K. Singh
Director, DoP
* Mr. C.P. Singh
Chairman, NPPA
* Mr. Sanjay Kumar
Member Secretary, NPPA
* Mr. Keshav Desiraju
Secretary
Ministry of Health & Family Welfare
(MoHFW)
* Mr. R.K. Jain
Additional Secretary, MoHFW
* Dr. Jadgish Prasad
Director General of Health Services
(DGHS)
* Ms. Ranjana Smetacek
* Mr. Tabrez Ahmad
* Mr. Prem Singh Rawat
Issues related to the
Pharmaceutical Industry
34. 22.08.2013 * Mr. Dilsher Singh Kalha
Secretary, DoP
* Mr. Shambhu Kallolikar
Joint Secretary, DoP
* Mr. B.K. Singh
Director, DoP
* Mr. C.P. Singh
Chairman, NPPA
* Members of the
Executive Committee
* Members of the Working
Group on Stakeholder
Engagement &
Partnerships, Finance &
Taxation and Legal
Committees
* Mr. Tapan Ray
* Ms. Ranjana Smetacek
* Mr. Vivek Padgaonkar
* Mr. Ajit Bendre
Interactive Meeting on
Implementation of
DPCO 2013
Meetings with Policy Makers / Government Authorities
71
OPPI Representations
Summary
Sr. No. Representations
Sr. No. Date Subject Addressed to
1. 18.09.2012 National Pharmaceutical Pricing Policy - Shri M.K. Alagiri
Minister for Chemicals & Fertilizers
2.
3.
4.
5.
6.
20.09.2012
15.10.2012
25.10.2012
15.11.2012
15.11.2012
Review of Curriculum at NIPER from Pharma
Industry Perspective
Allowance of 100% MAPE on Revision of Prices
of Scheduled Formulation under DPCO, 1995
Pre-Budget Memorandum – 2013-14
Draft National Pharmaceutical Pricing Policy
(NPPP) 2011
Draft National Pharmaceutical Pricing Policy
(NPPP) 2011
- The Secretary
DoP
- The Secretary
DoP
- The Secretary
DoP
- Shri Srikant Jena
Hon’ble Minister of State (Independent
Charge) for Statistics & Programme
Implementation & Minister of State for
Chemicals & Fertilisers
- Shri M.K. Alagiri
Hon’ble Minister of Chemicals & Fertilisers
MINISTRY OF CHEMICALS & FERTILIZERS (DoP, NPPA)
Illustrative List
1.
2.
3.
4.
5.
6.
31
27
9
4
5
4
80
Ministry of Chemicals & Fertilizers (DoP, NPPA)
Ministry of Health & Family Welfare (CDSCO / IPC / FDA)
Ministry of Commerce & Industry
Ministry of Finance
Ministry of Labour & Employment
Others
Total
Ministry
Organisation of Pharmaceutical Producers of India72
18.12.2012
14.01.2013
15.01.2013
22.01.2013
31.01.2013
04.02.2013
07.02.2013
07.02.2013
13.02.2013
01.03.2013
19.03.2013
28.03.2013
Uniform Code of Pharmaceutical Marketing
Practices (UCPMP)
Illegal activities paying cash amount for pre-
scribing medicines by Abbott Healthcare Solutions
Seeking clarifications on New National
Pharmaceutical Pricing Policy of India 2012
OPPI Code of Pharmaceutical Practices 2012
Implementation of National Pharmaceutical
Pricing Policy - 2012
Illegal activities paying cash amount for pre-
scribing medicines by Abbott Healthcare Solutions
GSR 53 (E) dated January 30, 2013 on
Compensation in Case of Injury or Death during
Clinical Trial
Current Media Report on Compulsory Licensing
Implementation of National Pharmaceutical
Pricing Policy 2012 (NPPP 2012)
Extension of deadline to provide feedback on
Report of Committee on Price Negotiation for
Patented Drugs
Price Revision for Scheduled Formulations
28.03.2013 OPPI feedback on Report of the
Committee on Price Negotiations for Patented
Drugs
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
Sr. No. Date Subject Addressed to
- Shri Dilsher Singh Kalha
Secretary, DoP
- Shri Raj Kumar
Under Secretary, DoP
- Shri B.K. Singh
Director, DoP
- Shri Raj Kumar
Under Secretary to Govt. of India, DoP
- Shri Dilsher Singh Kalha
Secretary, DoP
- Shri Dilsher Singh Kalha
Secretary, DoP
- Deputy Director (Formulations),
NPPA DoP
- Shri Raj Kumar
Under Secretary to Govt. of India, DoP
- Shri Dilsher Singh Kalha
Secretary, DoP
- Shri Dilsher Singh Kalha
Secretary, DoP
- Shri Chandra Prakash Singh
Chairman, NPPA
- Shri Dilsher Singh Kalha
Secretary, DoP
- Shri Chandra Prakash Singh
Chairman, NPPA
- Shri Dilsher Singh Kalha
Secretary, DoP
- Shri Raj Kumar
Under Secretary, DoP
01.04.2013 Developing India as a Drug Discovery & PharmathInnovation Hub 2020 – Workshop on 4 April,
2013 in New Delhi
19. - Shri S.C. Sharma
Director, DoP
OPPI Representations
73
04.04.2013
25.04.2013
03.05.2013
03.05.2013
07.05.2013
16.05.2013
03.06.2013
22.07.2013
25.07.2013
OPPI Post-Budget Recommendations
th Addendum – GSR 53(E) dated 30 January,
2013 on Compensation in case of injury or death
during Clinical Trial
OPPI alternative proposal to the Report of the
Committee on Price Negotiation for Patented
Drugs
Implementation of Drugs Prices Control Order,
2013 (DPCO 2013 – OPPI suggestions)
Clinical Trials Encompassing Pharma and
Biotech
Submission of data for pricing of NLEM-2011
drugs under National Pharmaceutical Pricing
Policy 2012 (NPPP-2012)
OPPI suggestions - Implementation of Drugs
Prices Control Order, 2013 (DPCO 2013)
Price Fixation of Formulations specified in
Schedule I of the DPCO 2013
Implementation of Drugs Prices Control Order,
2013 (DPCO 2013)
20.
21.
22.
24.
25.
26.
27.
28.
29.
Sr. No. Date Subject Addressed to
- Shri Dilsher Singh Kalha
Secretary, DoP
- Professor Ranjit Roy Chaudhury
Chairman – Expert Committee to Formulate
Policy Guidelines & SOPs for approval of new
drugs, clinical trials & banning of new drugs
(AHERF), New Delhi
- Shri Dilsher Singh Kalha
Secretary, DoP
31.01.2013 Addendum – OPPI suggestions for smooth and
globally aligned process for Safety Reporting
during Clinical Trials
23. - Professor Ranjit Roy Chaudhury
Chairman – Expert Committee to Formulate
Policy Guidelines & SOPs for approval of new
drugs, clinical trials & banning of new drugs
(AHERF), New Delhi
- Shri Dilsher Singh Kalha
Secretary, DoP
- Shri Raj Kumar
Under Secretary to Govt. of India, DoP
- The Director (MIS)
NPPA
- Shri Dilsher Singh Kalha
Secretary, DoP
- The Deputy Director (MIS)
NPPA
- Shri Dilsher Singh Kalha
Secretary, DoP
12.08.2013
30.08.2013
Implementation of Drugs Prices Control Order,
2013 (DPCO 2013) - Clarifications
Implementation of DPCO 2013 – Interactive
Discussion with OPPI Members held on
August 22, 2013 in Mumbai
30.
31.
- Shri S.C. Sharma
Director, DoP
- Shri Dilsher Singh Kalha
Secretary, DoP
OPPI Representations
Organisation of Pharmaceutical Producers of India74
MINISTRY OF HEALTH AND FAMILY WELFARE
18.09.2012
25.10.2012
26.10.2012
05.11.2012
15.11.2012
18.01.2013
31.01.2013
National Pharmaceutical Pricing Policy
Testing of Biological Samples at National Institute
of Biologicals (NIB), Noida
Comments on Draft Rules – Drugs andth Cosmetics (6 Amendment) Rules, 2012
Guidelines on Recall and Rapid Alert System for
Drugs (including Biologicals & Vaccines)
Draft National Pharmaceutical Pricing Policy
(NPPP) 2011
Cancellation of permission/license in case an
applicant/manufacturer who fails to launch their
product for marketing in the country within a
period of 6 months from obtaining the
permission/license from CDSCO
OPPI’s comments on Draft Guidelines on Good
Distribution Practices for Pharmaceutical
Products
1.
4.
5.
6.
7.
9.
10.
Sr. No. Date Subject Addressed to
- Shri Ghulam Nabi Azad
Minister of Health & Family Welfare
28.09.2012
12.10.2012
Draft Guidelines on Good Distribution Practices
for Biological Products
Comments on Draft IPC Monographs on
Interferon Alpha 2b Injection
2.
3.
- Dr. G.N. Singh
Drugs Controller General (India), CDSCO
- Ms.M. Kalaivani
Pharmacopoeial Associate Indian
Pharmacopoeia Commission Ministry of
Health & Family Welfare
- Dr. G.N. Singh
Drugs Controller General (India), CDSCO
- The Secretary
Ministry of Health & Family Welfare
- Dr. G.N. Singh
Drugs Controller General (India), CDSCO
- Shri Ghulam Nabi Azad
Minister of Health & Family Welfare
20.12.2012 Draft Rules (Gazette Notification GSR 748 (E)t hdated 5 October, 2012 regarding the
amendment of the Drugs & Cosmetics Rules for
making a provision of approval of drug
formulation containing single active ingredient in
generic name only
8. - Dr. G.N. Singh
Drugs Controller General (India), CDSCO
- Dr. G.N. Singh
Drugs Controller General (India), CDSCO
- Dr. G.N. Singh
Drugs Controller General (India), CDSCO
75
OPPI Representations
GSR 53(E) dated 30th January, 2013 on
Compensation in case of injury or death during
Clinical Trial
07.02.201311.
Sr. No. Date Subject Addressed to
07.02.2013 Current Media Report on Compulsory Licensing12. - Shri Keshav Desiraju
Secretary
Ministry of Health & Family Welfare
08.02.2013 Disruption of imports due to delayed renewal of
licences
13. - Dr. G.N. Singh
Drugs Controller General (India), CDSCO
- Dr. Jagdish Prasad
Director General of Health Services
Ministry of Health & Family Welfare
- Shri Keshav Desiraju
Secretary
Ministry of Health & Family Welfare
08.02.2013
25.03.2013
Interactive meeting with DCGI – OPPI Delegationthon 11 February, 2013 in CDSCO office, Mumbai
Ethics Committee Registration GazettethNotification GSR 72(E) dated 8 February, 2013
– Drugs and Cosmetics (Third Amendment)
Rules 2013 [Rule 122 DD – Registration of
Ethics Committee]
14.
15.
- Dr. G.N. Singh
Drugs Controller General (India), CDSCO
- Dr. A.K. Panda
Joint Secretary
Ministry of Health & Family Welfare
08.04.2013 Interactive meeting with OPPI Delegation onth10 April, 2013 in New Delhi to discuss issues on
pharmaceuticals as well as biological products
16. - Dr. G.N. Singh
Drugs Controller General (India), CDSCO
- Shri Keshav Desiraju
Secretary, Health
Ministry of Health & Family Welfare
- Dr. Jagdish Prasad
Director General of Health Services
Ministry of Health & Family Welfare
- Dr. V.M. Katoch
Secretary, Dept. of Health Research
Ministry of Health & Family Welfare &
Director General, ICMR
- Shri R.K. Jain
Additional Secretary – Health
Ministry of Health & Family Welfare
- Dr. G.N. Singh
Drugs Controller General (India), CDSCO
MINISTRY OF HEALTH AND FAMILY WELFARE
Organisation of Pharmaceutical Producers of India76
OPPI Representations
MINISTRY OF HEALTH AND FAMILY WELFARE
Sr. No. Date Subject Addressed to
09.05.2013 Additional comments / suggestions on GazettethNotification GSR 228(E) dated 20 March, 2012
– Draft Rules to amend the Drugs & Cosmetics
Rules, 1945 regarding Schedule H1 Drugs
18. - Dr. G.N. Singh
Drugs Controller General (India), CDSCO
14.05.2013 Follow up of the OPPI meeting with DCGI onth10 April, 2013
19. - Dr. G.N. Singh
- Drugs Controller General (India), CDSCO
28.05.2013 Permission to carry out changes to Product
labels – Correction of MRP at Depot / Stockist /
Dealer/Retailer
20. - Dr. G.N. Singh
Drugs Controller General (India), CDSCO
06.06.2013 OPPI Concerns on Implementation of Guidelines
on Similar Biologics: Regulatory Requirements
for Market Authorization in India
21. - Dr. G.N. Singh
Drugs Controller General (India), CDSCO
06.06.2013
06.06.2013
20.06.2013
Approval of New Clinical Trial Application
Representation of OPPI in Task Force on
regulation of Similar Biologics
Anticipated Shortage of Medicines
22.
23.
24.
- Shri Keshav Desiraju
Secretary, Health
- Dr. G.N. Singh
Drugs Controller General (India), CDSCO
- Hon’ble Chief Minister of Maharashtra
- Hon’ble Minister of Public Health,
Family Welfare & Protocol
Government of Maharashtra
16.07.2013
03.09.2013
03.09.2013
Joint IDMA, IPA, FOPE and OPPI Representation
on Approval SLA-Approved Fixed Dose
Combinations) FDCs) pre-October 2012
permitted for manufacturing for sale in the
country based on Safety & Efficacy
GSR 364(E) dated June 7, 2013 – Draft Rules to
Amend D&C Rules 1945, in Schedule Y pertaining
to Clinical Trial
GSR 520(E) dated July 31, 2013, regarding
Package Insert and Promotional Literature in Bold
Red Letters for Preparations Containing Pioglitazone
25.
26.
27.
- Dr. G.N. Singh
Drugs Controller General (India), CDSCO
- Dr. A.K. Panda
Joint Secretary, Health
- Dr. A.K. Panda
Joint Secretary, Health
08.05.2013 Comments / suggestions on Gazette NotificationthGSR 228(E) dated 20 March, 2012 – Draft
Rules to amend the Drugs & Cosmetics Rules,
1945 regarding Schedule H Drugs
17. - The Secretary
Ministry of Health & Family Welfare
77
OPPI Representations
MINISTRY OF COMMERCE & INDUSTRY
Sr. No. Date Subject Addressed to
22.10.2012 OPPI Views and Suggestions on Draft National
IPR Strategy prepared by the Sectoral Innovation
Council on IPR
2. - Shri D.V. Prasad
Joint Secretary
Dept. of Industrial Policy & Promotion
26.10.2012 OPPI Views and Suggestions on Draft National
IPR Strategy prepared by the Sectoral Innovation
Council on IPR (Revised)
3. - Shri D.V. Prasad
Joint Secretary
Dept. of Industrial Policy & Promotion
15.11.2012 Draft National Pharmaceutical Pricing Policy
(NPPP) 2011
4. - Shri Anand Sharma
Hon’ble Minister of Commerce & Industry
& Minister of Textiles
15.01.2013 OPPI Comments on the Draft “Guidelines for
Examination of Biotechnology Applications”
5. - Shri Chaitanya Prasad IAS
Controller General of Patents, Designs and
Trademarks
25.01.2013 Consolidated FDI Policy Circular –
Issue of Sixth Edition of the Circular
6. - Smt. Anjali Prasad
Joint Secretary
Dept. Industrial Policy & Promotion
- Shri Deepak Narain
Director
Dept. Industrial Policy & Promotion
07.02.2013 Current Media Reports on Compulsory Licensing7. - Shri D.V. Prasad
Joint Secretary
Dept. of Industrial Policy & Promotion
- Shri Saurabh Chandra
Secretary
Dept. of Industrial Policy & Promotion
27.06.2013 thComments on DIPP Notification dated 5 May,
2013 on Draft ‘Patent (Amendments) Rules 2013
8. - Shri Saurabh Chandra
Secretary
Dept. of Industrial Policy & Promotion
02.07.2013 FDI Policy for the Pharmaceutical Sector of India9. - Shri Saurabh Chandra
Secretary
Dept. of Industrial Policy & Promotion
18.09.2012 National Pharmaceutical Pricing Policy1. - Shri Anand Sharma
Minister of Commerce & Industry
Organisation of Pharmaceutical Producers of India78
OPPI Representations
MINISTRY OF FINANCE
Sr. No. Date Subject Addressed to
15.11.2012 Amendment to the NDPS (Regulations of
Controlled Substances) Order 1993 with regard
to controls over import and export of precursor
chemicals (F.No.11012/3/2010-NC II)
2. - Mr. S.N. Dash
Under Secretary, NC – II, Dept. of Revenue
- Mr. T.G. Parate
Section Officer, NC-II, Dept. of Revenue
- Mr. Rajesh Nandan Srivastava
Director (NC), Dept. of Revenue
15.11.2012 Draft National Pharmaceutical Pricing Policy
(NPPP) 2011
3. - Shri P. Chidambaram
Honourable Finance Minister
04.04.2013 OPPI Post-Budget Recommendations – 2013-144. - The Secretary
Dept. of Finance & Revenue
- The Chairman
Central Board of Excise & Customs
- Mr. Ashutosh Dikshit
Joint Secretary, Tax Policy and Legislation
(TPL), Central Board of Excise & Customs
- Mr. Vivek Johri
Joint Secretary (TRU-1)
Dept. of Revenue, Ministry of Finance
25.10.2012 OPPI Pre-Budget Memorandum – 2013-141. - The Secretary
Dept. of Finance & Revenue
- The Chairman
Central Board of Excise & Customs
- Mr. Ashutosh Dikshit
Joint Secretary, Tax Policy and Legislation
(TPL), Central Board of Excise & Customs
- Mr. Vivek Johri
Joint Secretary (TRU-1)
Dept. of Revenue, Ministry of Finance
79
OPPI Representations
MINISTRY OF LABOUR AND EMPLOYMENT
Sr. No. Date Subject Addressed to
15.11.2012 Industry’s Concern on proposed 8 Hours Working
Regulation for Medical Representatives
2. - Shri Prithviraj Chavan
Hon’ble Chief Minister of Maharashtra
20.11.2012 Draft National Pharmaceutical Pricing Policy
(NPPP) 2011
3. - Shri Montek Singh Ahluwalia
Deputy Chairman
Planning Commission
24.05.2013 Joint IDMA and OPPI Representation on
‘The Representation of Rajasthan Medical and
Sales Representatives’ Union’
4. - Shri Dhan Raj Sharma
Addl. Labour Commissioner (IR)
Government of Rajasthan
Opp. NBC Factory, Shanti Nagar
Hasanpura,Jaipur 302 006, Rajasthan
21.06.2013 Joint IDMA and OPPI Representation on
‘The Representation of Rajasthan Medical and
Sales Representatives’ Union’
5. - Shri Dhan Raj Sharma
Addl. Labour Commissioner (IR)
Government of Rajasthan
Opp. NBC Factory, Shanti Nagar
Hasanpura,Jaipur 302 006, Rajasthan
18.09.2012 National Pharmaceutical Pricing Policy1. - Shri Kapil Sibal
Minister of Human Resource Development
and Minister of Communications and
Information Technology
Sr. No. Date Subject Addressed to
18.09.2012 National Pharmaceutical Pricing Policy1. - Shri Sharad Pawar
Minister of Agriculture and Food Processing
Industries
- Shri Montek Singh Ahluwalia
Deputy Chairman
Planning Commission
- Shri Salman Khurshid
Honourable Minister of Law & Justice and
Minority Affairs
- Shri Srikant Jena
Hon’ble Minister of State (Independent
Charge) for Statistics & Programme
Implementation & Minister of State for
Chemicals & Fertilisers
OTHERS
Organisation of Pharmaceutical Producers of India80
OPPI Representations
Sr. No. Date Subject Addressed to
20.11.2012 Draft National Pharmaceutical Pricing Policy
(NPPP) 2011
3.
- Shri Montek Singh Ahluwalia
Deputy Chairman
Planning Commission
- Shri Srikant Jena
Hon’ble Minister of State (Independent
Charge) for Statistics & Programme
Implementation & Minister of State for
Chemicals & Fertilisers
- Shri Sharad Pawar
Hon’ble Minister of Agriculture & Food
Processing Industries
- Shri Ashwani Kumar
Hon’ble Minister of Law & Justice
- Shri Montek Singh Ahluwalia
Deputy Chairman
Planning Commission
15.11.2012 Draft National Pharmaceutical Pricing Policy
(NPPP) 2011
2.
13.02.2013 GSR 53(E) dated 30th January, 2013 on
Compensation in case of injury or death during
Clinical Trial
4. - Prof. Ranjit Roy Chaudhury
Chairman
Expert Committee to Formulate Policy
Guidelines & SOPs for Approval of New
Drugs, Clinical Trials & Banning of New Drugs
- Dr. Lalit Kumar
Professor, Medical Oncology, AIIMS
- Dr. Nikhil Tandon
Professor, Endocrinology, AIIMS
- Dr. Sudha Prasad
Director & Professor
Obstetrics & Gynaecology
Maulana Azad Medical College
81
OPPI Representations
Seminars and Knowledge / AcademiaProgrammes
Organised by OPPISeminars / Conferences
Date Programme Venue
July 16, 2013 Seminar – Clarifying Issues: DPCO 2013 Implementation Club Peninsula, Mumbai
August 23, 2013 Seminar “Access to Healthcare – Challenges and the Way Forward” Shangri-La Hotel, Mumbai
Knowledge Programmes
Date Programme Venue
October 15, 2012 Dr. Avijit Lahiri, renowned cardiologist and Director, Clinical Imaging &
Research Centre, Wellington Hospital, London, U.K. made a
presentation on “The New Scourge of the World – Diabetes &
Heart Disease”
Club Peninsula, Mumbai
January 17, 2013
March 04, 2013
Club Peninsula, Mumbai
Club Peninsula, Mumbai
“Messaging Workshop” organised by OPPI Communications (Internal
& External) & Government Affairs Committee. EC Members
participated in the programme. Presentation was made by Mr. Aman
Gupta, CEO, Imprimis Life PR Pvt. Ltd., and his team.
Key Features of India’s Union Budget 2013-2014
- by Mr. Hitesh Sharma and his team Ernst & Young
March 22, 2013 OPPI, MumbaiReport on IMS Study on “Improving Access to Healthcare in India” -
- by Mr. Amardeep Udeshi, IMS Health Information & Consulting
Services India Pvt. Ltd.
March 26, 2013 OPPI, MumbaiKnowledge Session on “e-Compliance Framework”
- by Mr. Nikhil Kulshreshtha and his team
Fresenius Kabi Oncology Ltd.
December 21, 2012 Club Peninsula, MumbaiConsequent to launch of new “OPPI Code of Pharmaceutical
Practices 2012” an interactive meeting with Heads of Marketing,
Medical, Legal and Ethics Compliance functions of OPPI Member
Companies along with EC Members to explain key features of the Code
Organisation of Pharmaceutical Producers of India82
August 13, 2013
August 22, 2013
OPPI, Mumbai
Mayfair Banquets, Mumbai
Mr. Sushil Nathani, Economic Laws Practice made a presentation
on issues related to the competition laws.
Interactive Meeting with DoP Officials – DPCO 2013 Implementation
June 14, 2013 OPPI, MumbaiKnowledge Session was organised for Members of Marketing Code,
Ethics & Compliance Committee wherein Mr. Darshan Patel,
Executive Director, PricewaterhouseCoopers Pvt. Ltd., made a
presentation on “Industry Practices with reference to OPPI Code”.
Date Programme Venue
OPPI, MumbaiJune 5, 2013 Knowledge Session was organised for Members of Legal Committee
wherein Mr.Shivprasad Laud, Company Secretary & Director,
Roche Products (India) Pvt. Ltd. made a presentation on
“New Companies Bill 2012”
Supported by OPPI
Date Programme Venue
October 20-21, 2012
November 5, 2012
November 6, 2012
November 27, 2012
December 11-12, 2012
December 18-19, 2012
February 12, 2013
“Emerging Challenges and Opportunities in Pharmaceutical
Management” organised by Indian Institute of Health Management
Research (IIHMR)
IIHMR Jaipur
Courtyard by Marriott, Ahmedabad
Sci-Tech Centre, Mumbai
Hotel The Grand,New Delhi
Stein Auditorium IndianHabitat Centre, New Delhi
Hotel The Lalit BarakhambaRoad, New Delhi
Taj President, Cuffe ParadeMumbai
th“10 Pharma Summit & EXPO 2012”
– Organised by CII
FICCI-HADSA 4th International Nutraceuticals Conference
“National Conference on Cold Chain Management 2012” organised by
PHD Chamber of Commerce & Industry
“Life Science Conclave 2012” for ‘Promoting Business Innovation to
Drive Growth in Life Sciences’ organised by CII
th“9 India Health Summit” - organised by CII
“Changing Landscapes of Risks & Liabilities in the Pharmaceutical &
FMCG Sectors” - organised by Bombay Chamber of Commerce and Industry
April 24, 2013 OPPI, MumbaiSpecial Session was organised for Members of HRD Committee
- by Mr. Lawrence Ganti,General Manager, India, Merck Serono Global
Operations and Chairman, OPPI HRD Committee.
Mr. Dietmar Eldens, Merck Serono made a presentation on
“Trends in Human Resources” and Ms. Stella Zhang,
Merck Serono participated in this Session.
Knowledge Session on “Building HR Capability to
Drive Business Impact”
- by Ms. Gitanjali Pannikar, Director, CEB
Seminar and Knowledge /Academia Programmes
83
MembersOrdinary
1. Abbott Healthcare Pvt. Ltd.
2. Allergan India (Pvt.) Ltd.
3. Amgen Technology Pvt. Ltd.
4. Anglo French Drugs & Industries Ltd.
5. Astellas Pharma India Pvt. Ltd.
6. AstraZeneca Pharma India Ltd.
7 Bausch & Lomb Eyecare (India) Pvt. Ltd.
8. Bayer Pharmaceuticals Pvt. Ltd.
9. Bilcare Ltd.
10. Biogen Idec Biotech India Pvt. Ltd.
11. Boehringer Ingelheim India Pvt. Ltd.
12. Bristol Myers Squibb India Pvt. Ltd.
13. Dey’s Medical (U.P.) Pvt. Ltd.
14. Eisai Pharmaceuticals India Pvt. Ltd.
15. Eli Lilly and Company (India) Pvt. Ltd.
16. Fresenius Kabi India Pvt. Ltd.
17. Galderma India Pvt. Ltd.
18. GlaxoSmithKline Consumer Healthcare Ltd.
Affiliate
Associate
1. BMR & Associates, LLP
2. C Marc (India) Pvt. Ltd.
3. Ernst & Young Pvt. Ltd.
4. KPMG India Pvt. Ltd.
5. IMS Health Information & Consulting
Services India Pvt. Ltd.
1. ACG Associated Capsules Pvt. Ltd.
2. Colorcon Asia Pvt. Ltd.
1. Johnson & Johnson Medical
2. Becton Dickinson India Pvt. Ltd.
3. Schott Glass India Pvt. Ltd.
3. Quest Diagnostics India Pvt. Ltd.
Associate – Medical Diagnostics and Devices
19. GlaxoSmithKline Pharmaceuticals Ltd.
20. Johnson & Johnson Ltd.
21. Laboratoires Griffon Pvt. Ltd.
22. Lundbeck India Pvt. Ltd.
23. Martin & Harris Pvt. Ltd.
24. Merck Ltd. (Merck Serono)
25. MSD Pharmaceuticals Pvt. Ltd.
26. Nektar Therapeutics (India) Pvt. Ltd.
27. Novartis India Ltd.
28. Novo Nordisk India Pvt. Ltd.
29. Pfizer Ltd.
30. Ranbaxy Laboratories Ltd.
31. Roche Products (India) Pvt. Ltd.
32. Sangfroid Industries Ltd.
33. Sanofi India Ltd.
34. Serdia Pharmaceuticals (India) Pvt. Ltd.
35. Takeda Pharmaceuticals India Pvt. Ltd.
36. UCB India Pvt. Ltd.
6. Quintiles Research (India) Ltd.
7. Strategic Marketing Solutions and
Research Centre Pvt. Ltd.
8. Wolters Kluwer Health India Pvt. Ltd.
9. Yes Bank Ltd.
Organisation of Pharmaceutical Producers of India84
Past Presidents
Sr. No. Name Member Company Year
1. Late Dr. H.R. Nanji Pharmed 1966
2. Mr. Keith C. Roy Merck Sharp & Dohme 1967-1969
3. Late Brig. B. S. Bhagat Rallis 1970-1973
4. Mr. S.V. Pillai Pfizer 1974-1975
5. Late Mr. Sisir Mitra Cyanamid 1976-1978
6. Late Mr. H.N. Dutta Gupta East India Pharmaceutical Works 1979
7. Late Dr. S.K. Bhattacharya Sandoz 1980-1981
8. Late Mr. George Daniel Hoechst 1982-1984
9. Mr. R.N. Langrana Abbott 1985
10. Mr. C.M. Hattangdi Parke-Davis 1986-1987
11. Dr. S. Agarwala Rallis 1988-1990
12. Mr. D.K. Bose Burroughs Wellcome 1990-1992
13. Mr. H. Dhanrajgir Glaxo 1992-1994
14. Dr. Anil S. Mehta Wyeth 1994-1996
15. Mr. D. Bhadury Hoechst Marion Roussel 1996-1998
16. Mr. H.R. Khusrokhan Glaxo 1998-2000
17. Late Mr. P. Gupta Infar 2000-2001
18. Mr. Tapan Ray Abbott Sept.-Nov. 2001
19. Mr. Ranjit Shahani Novartis 2001 – 2007
20. Mr. Ranga Iyer Wyeth 2007 – 2009
85
OPPI MISSION
To make continuing contribution towards achieving
healthcare objectives of the nation while professionally
addressing the collective interests of its members
and encouraging innovation for inclusive growth.
VisionOPPI is an organisation of research and innovation driven pharmaceutical companies, committed to addressing India's healthcare needs by:
Facilitating greater access to quality healthcare solutions
Encouraging research and innovation
Disseminating knowledge and sharing best practices
Contributing meaningfully in policy dialogues
Mumbai OfcePeninsula Corporate Park,Peninsula Chambers, Ground Floor,Ganpatrao Kadam Marg,Lower Parel, Mumbai 400 013INDIA
Tel. : +91 22 2491 8123 +91 22 2491 2486 +91 22 6662 7007Fax : +91 22 2491 5168 E-mail : [email protected]
Delhi OfceLevel 2, Elegance Building,Mathura Road, Jasola,New Delhi 110 025INDIATel. : +91 11 4060 1428 : +91 11 4060 1080Fax : +91 11 4060 1235E-mail : [email protected]
Website : www.indiaoppi.com