47 ANNUAL REPORT 2012-13

th47 ANNUAL REPORT2012-13

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


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.



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)


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.


Source: IMS


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


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.



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


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.



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


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


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.


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.



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.


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:



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.


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


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.


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.



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


GOVERNANCE AND MANPOWER MANAGEMENT

* Resigned


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.



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


INNOVATION AND IPR

* Resigned


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.



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


STAKEHOLDER ENGAGEMENT AND PARTNERSHIPS

* Resigned


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.



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


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



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





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



31


ACCOUNTS & ADMINISTRATION AND FINANCE & TAXATION


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.



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


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.



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


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.



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


HUMAN RESOURCE DEVELOPMENT

* Resigned


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.



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


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.



* Resigned

LEGAL

MEMBERS


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


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



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


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.



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


MEDICAL, BIOTECH AND REGULATORY COMMITTEE


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



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


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


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


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


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


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

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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


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

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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


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

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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


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


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. 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


Pharmaceutical Policy /

DPCO

65



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



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


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



* Mr. Sameer Savkur

* Dr. Shashwati Pramanik

* Ms. Suja Subramaniam

* Dr. Garuva Arya


* Mr. Tapan Ray


Draft Guidelines of

Biotechnology Applications

National Pharmaceutical

Pricing Policy 2012




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


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


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


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


* Delegation comprising of

Members of the Medical,

Biotech & Regulatory

Committee

* Mr. Rajiv Shukla

Submission of data for

pricing of NLEM-2011

67


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


* 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


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


To present OPPI’s views /

suggestions on procedures

for Approval of FDCs

21. 25-26.04.13 * Mr. Dilsher Singh Kalha

Secretary, DoP



* Mr. R.K. Jain


* Mr. D.V. Prasad


* Mr. Satish Chandra

Joint Secretary & Legal Advisor

Department of Legal Affairs


* Dr. Sakthivel Selvraj

Senior Health Economist

Public Health Foundation of India

* Mr. Tapan Ray


(at meeting with

Mr. Selvraj)

Industry related issues





Secretary, DoP

* Mr. B.K. Singh, Director,

DoP & other officials from DoP

* Mr. Sameer Savkur

* Mr. Tapan Ray


Issues relating to Clinical

Trials

23. 08-09.05.13 * Mr. C.P. Singh, Chairman, NPPA

* Mr. Sanjay Kumar



* Mr. Shailendra Kumar

Director, MoHFW

* Dr. Biswajit Dhar

Director General

Research & Information Systems for

Developing Countries (RIS)

* Mr. Tapan Ray



DPCO 2013 / Regulatory &

Industry issues


Secretary, DoP

* FICCI Officials

* Mr. K.G. Ananthakrishnan

* Mr. Pheroze Khan

* Mr. Aijaz Tobaccowalla,

* Mr. Tapan Ray


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


Secretary, DoP

* Dr. A K Panda

Joint Secretary, MoHFW


* Dr. V.G. Somani


(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


69


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


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


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



PPI Scientists & Young


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


Indian Guidelines on

Similar Biologics:

regulatory Requirements

for Marketing Authorization

(Quality, Pre-Clinical and

Clinical Trial Requirements).




33. 01.08.2013 * Mr. Saurabh Chandra

Secretary

Department of Industrial Policy &

Promotion (DIPP)

* Mr. D.V. Prasad


* Mr. Dilsher Singh Kalha

Secretary

Department of Pharmaceuticals (DoP)



* Mr. B.K. Singh

Director, DoP

* Mr. C.P. Singh

Chairman, NPPA

* Mr. Sanjay Kumar


* Mr. Keshav Desiraju

Secretary


(MoHFW)

* Mr. R.K. Jain


* Dr. Jadgish Prasad

Director General of Health Services

(DGHS)

* Ms. Ranjana Smetacek

* Mr. Tabrez Ahmad


Issues related to the

Pharmaceutical Industry


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. Ajit Bendre

Interactive Meeting on

Implementation of

DPCO 2013


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


(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


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.


- 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


Secretary, DoP


Secretary, DoP

- Deputy Director (Formulations),

NPPA DoP

- Shri Raj Kumar



Secretary, DoP


Secretary, DoP

- Shri Chandra Prakash Singh

Chairman, NPPA


Secretary, DoP

- Shri Chandra Prakash Singh

Chairman, NPPA


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


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


2013 (DPCO 2013)

20.

21.

22.

24.

25.

26.

27.

28.

29.



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


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


Secretary, DoP

- Shri Raj Kumar


- The Director (MIS)

NPPA


Secretary, DoP

- The Deputy Director (MIS)

NPPA


Secretary, DoP

12.08.2013

30.08.2013


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


Secretary, DoP



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)


(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.


- 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


- The Secretary


- Dr. G.N. Singh


- 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


- Dr. G.N. Singh


- Dr. G.N. Singh


75


GSR 53(E) dated 30th January, 2013 on

Compensation in case of injury or death during

Clinical Trial

07.02.201311.


07.02.2013 Current Media Report on Compulsory Licensing12. - Shri Keshav Desiraju

Secretary


08.02.2013 Disruption of imports due to delayed renewal of

licences

13. - Dr. G.N. Singh


- Dr. Jagdish Prasad



- Shri Keshav Desiraju

Secretary


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


- Dr. A.K. Panda

Joint Secretary


08.04.2013 Interactive meeting with OPPI Delegation onth10 April, 2013 in New Delhi to discuss issues on

pharmaceuticals as well as biological products




Secretary, Health


- Dr. Jagdish Prasad



- Dr. V.M. Katoch

Secretary, Dept. of Health Research

Ministry of Health & Family Welfare &

Director General, ICMR

- Shri R.K. Jain

Additional Secretary – Health


- Dr. G.N. Singh







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



14.05.2013 Follow up of the OPPI meeting with DCGI onth10 April, 2013


- Drugs Controller General (India), CDSCO

28.05.2013 Permission to carry out changes to Product

labels – Correction of MRP at Depot / Stockist /

Dealer/Retailer



06.06.2013 OPPI Concerns on Implementation of Guidelines

on Similar Biologics: Regulatory Requirements

for Market Authorization in India



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.


Secretary, Health

- Dr. G.N. Singh


- 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


- 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


77


MINISTRY OF COMMERCE & INDUSTRY


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


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


- Shri Saurabh Chandra

Secretary


27.06.2013 thComments on DIPP Notification dated 5 May,

2013 on Draft ‘Patent (Amendments) Rules 2013

8. - Shri Saurabh Chandra

Secretary


02.07.2013 FDI Policy for the Pharmaceutical Sector of India9. - Shri Saurabh Chandra

Secretary


18.09.2012 National Pharmaceutical Pricing Policy1. - Shri Anand Sharma

Minister of Commerce & Industry



MINISTRY OF FINANCE


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


(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


MINISTRY OF LABOUR AND EMPLOYMENT


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


(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


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





OTHERS





(NPPP) 2011

3.


Deputy Chairman

Planning Commission

- Shri Srikant Jena





- Shri Sharad Pawar

Hon’ble Minister of Agriculture & Food

Processing Industries

- Shri Ashwani Kumar

Hon’ble Minister of Law & Justice


Deputy Chairman

Planning Commission


(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


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


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



“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


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”.


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


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.


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

Documents

47 ANNUAL REPORT 2012-13