49th Annual Report 2014-15

49th Annual Report 2014-15

OPPI 2015 Final AW 1st Part For Printing.indd 3 02/10/2015 3:59:38 PM

“I am proudthat together our

message of hopehas demonstrated

that one can gobeyond diabetes

and open thedoor to a life full

of possibilities.” Eshaan Shevate

(The youngest member of an international team of people

with Type 1 diabetes) participated in the Sanofi and

World Diabetes Tour’s ‘Type 1 Diabetes Challenge’ to

Machu Picchu, Peru in 2014.

SANOFI FOCUSED ON PATIENTS’ NEEDSSince 1956, Sanofi has aligned itself with India’s healthcare needs by building expertise, capability and capacity, through continued investments, strategic partnerships and a shared commitment towards patients.

www.sanofi.com www.sanofi.in www.sanofiindialtd.com

Through an integrated approach to diabetes

management - comprehensive portfolio, patient

support programme ‘Saath 7’; ‘Made in India’

reusable insulin pen AllStar™, public awareness

drives and ongoing scientific initiatives

- Sanofi endeavours to make a sustainable

difference to the diabetes ecosystem in India

- centered on patient needs.


Content

ANNUAL REPORT 2014-15

Executive Committee and Members 01

Message from President 03

Message from Director General 05

Pharmaceutical Landscape 07

Reports:

l Working Groups 15

l Committees 21

Looking Back 27

Project Jawhar 31

Awards 33

Meetings with Policy Makers and Government Authorities 36

Representations 53

Seminars and Knowledge Programmes 64

Past Presidents 68

“I am proudthat together our

message of hopehas demonstrated

that one can gobeyond diabetes

and open thedoor to a life full

of possibilities.” Eshaan Shevate

(The youngest member of an international team of people

with Type 1 diabetes) participated in the Sanofi and

World Diabetes Tour’s ‘Type 1 Diabetes Challenge’ to

Machu Picchu, Peru in 2014.

SANOFI FOCUSED ON PATIENTS’ NEEDSSince 1956, Sanofi has aligned itself with India’s healthcare needs by building expertise, capability and capacity, through continued investments, strategic partnerships and a shared commitment towards patients.

www.sanofi.com www.sanofi.in www.sanofiindialtd.com

Through an integrated approach to diabetes

management - comprehensive portfolio, patient

support programme ‘Saath 7’; ‘Made in India’

reusable insulin pen AllStar™, public awareness

drives and ongoing scientific initiatives

- Sanofi endeavours to make a sustainable

difference to the diabetes ecosystem in India

- centered on patient needs.


PRESIDENT

Dr Shailesh Ayyangar Sanofi India Ltd

VICE PRESIDENTS

Sudarshan Jain Abbott Healthcare Pvt Ltd

Sameer Savkur (up to 01.12.2014) Biogen Idec Biotech India Pvt Ltd

Aijaz Tobaccowalla Pfizer Ltd

K.G. Ananthakrishnan MSD Pharmaceuticals Pvt Ltd

Sharad Tyagi Boehringer Ingelheim India Pvt Ltd

MEMBERS

Raghu Kumar Allergan India Pvt Ltd

Sanjay Murdeshwar AstraZeneca Pharma India Ltd

Angel-Michael Evangelista Bayer Pharmaceuticals Pvt Ltd

Anish Bafna (up to 09.07.2015) Baxter India Ltd

Jitendra Tyagi Bristol-Myers Squibb India Pvt Ltd

K. Shivkumar (up to 31.03.2015) Eisai Pharmaceuticals India Pvt Ltd

Dr Sanjit Singh Lamba (w.e.f. 09.04.2015) Eisai Pharmaceuticals India Pvt Ltd

G. Sathya Narayanan Galderma India Pvt Ltd

Dr Hasit B. Joshipura (up to 31.07.2015) GlaxoSmithKline Pharmaceuticals Ltd

Sanjiv Navangul Johnson & Johnson Ltd

Ali Sleiman (w.e.f. 18.06.2015) Merck Ltd

Dr Ramesh Panchagnula Nektar Therapeutics (India) Pvt Ltd

Ranjit Shahani Novartis India Ltd

Melvin D’Souza Novo Nordisk India Pvt Ltd

Maturin Tchoumi Roche Products (India) Pvt Ltd

Aman Bajaaj Takeda Pharmaceuticals India Pvt Ltd

SPECIAL INVITEES

Annaswamy Vaidheesh (w.e.f. 20.08.2015) GlaxoSmithKline Pharmaceuticals Ltd

Arnaud Lefevre (w.e.f. 20.08.2015) UCB India Pvt Ltd

SECRETARIAT

MUMBAI Ranjana Smetacek Director General

Rajiv Shukla Director – Alliance Development

Vivek Padgaonkar Director – Project & Policy

Dr Ajaykumar Sharma Director – Research

Bhavna Singh Director – Communications

Ajit Bendre Director – Finance, Admn. & Association Secretary

Ashvin Muchhala Manager – Accounts & Administration

Cloti Baptista Sr. Executive Secretary

NEW DELHI Tabrez Ahmad Secretary General

Prem Singh Rawat Manager – Government Affairs

Executive Committee

01 ANNUAL REPORT 2014-15


ORDINARY MEMBERS:

• Abbott Healthcare Pvt Ltd • Allergan India Pvt Ltd • Amgen Technology Pvt Ltd • Astellas Pharma India Pvt

Ltd • AstraZeneca Pharma India Ltd • Bayer Pharmaceuticals Pvt Ltd • Bilcare Ltd • Boehringer Ingelheim

India Pvt Ltd • Bristol-Myers Squibb India Pvt Ltd • Dey’s Medical (U.P.) Pvt Ltd • Eisai Pharmaceuticals

India Pvt Ltd • Eli Lilly and Company (India) Pvt Ltd • Fresenius Kabi India Pvt Ltd • Galderma India Pvt Ltd

• GlaxoSmithKline Pharmaceuticals Ltd • GSI Pharma Pvt Ltd • Johnson & Johnson Ltd • Laboratoires Griffon

Ltd • Lundbeck India Pvt Ltd • Martin & Harris Pvt Ltd • Merck Ltd (Merck Serono) • MSD Pharmaceuticals Pvt

Ltd • Nektar Therapeutics (India) Pvt Ltd • Novartis India Ltd • Novo Nordisk India Pvt Ltd • Pfizer Ltd • Roche

Products (India) Pvt Ltd • Sanofi India Ltd • Serdia Pharmaceuticals (India) Pvt Ltd • Takeda Pharmaceuticals

India Pvt Ltd • UCB India Pvt Ltd

AFFILIATE MEMBERS:

• BMR & Associates LLP • Ernst & Young LLP • IMS Health Information & Consulting Services India Pvt Ltd

• KPMG in India • Quintiles Research (India) Ltd • Strategic Marketing Solutions and Research Centre Pvt Ltd

• Wolters Kluwer Health India Pvt Ltd • Yes Bank Ltd

ASSOCIATE MEMBERS:

• ACG Associated Capsules Pvt Ltd • SCHOTT Glass India Pvt Ltd

Members

1 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’ Chambers (IMC), Mumbai

6. International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), Geneva, Switzerland

OPPI’S MEMBERSHIP OF ASSOCIATIONS:

02


50 years ago India was just emerging from her past, striving to bring prosperity, progress and good health

to her people. The nascent pharmaceutical industry of India, at that time, became involved in building

manufacturing bases and quality systems to meet the growing need for medicines in the country. Half

a century ago, the formation of the Organisation of Pharmaceutical Producers of India (OPPI) signaled

the beginning of a golden era for the Indian Pharmaceutical Industry. Over these five decades we have

witnessed dramatic progress in our industry. Both domestic and multinational companies have played

a crucial role in creating a world-class image for our medicines – now being exported to every part of

the world. This industry stands tall alongside the Information Technology sector as the true ‘Pride of the

Nation’. The advancement in chemistry and process innovation in drug delivery systems has catapulted

India among the top exporting countries of quality medicines. OPPI salutes all the past colleagues in our

industry, who had the vision and courage to navigate through difficult times and the current workforce for

continuing to raise the bar!

Through the eventful 20th century, OPPI member companies helped create a strong industrial footprint in

India, which was reinforced by the visionaries of major domestic companies by creating their own industrial

facilities. As a result, India has attained near self-sufficiency in chemistry-based drug manufacturing and

has received international recognition as a leading exporter of quality finished formulations. It is a matter

of great pride that even today, some of the iconic brands prescribed by the medical fraternity in India have

come from the research platforms of OPPI member companies.

We have also witnessed major changes in the socio-economic milieu and in the demographic profile of

our country in the past 50 years. The disease pattern in India has been shifting. We have made good

progress in combating communicable diseases, albeit much still remains to be done, but the emergence of

Non-Communicable Diseases (NCDs) now poses a big challenge to the healthcare system. OPPI member

companies have played a leading role in bringing the fruits of years of research and development for the

benefit of Indian patients suffering from various NCDs. Today, as the world applauds the efforts made by

our Health Ministry in winning the war against Polio, it should be remembered with pride that OPPI member

companies have stood with the nation in making the Oral Polio Vaccine available to the children of India.

Our member companies are working with various state governments and the central government in the

DR SHAILESH AYYANGAR

President, OPPI



herculean task of enhancing awareness about NCDs, providing crucial lifesaving vaccines and engaging in

patient support programmes to help modify lifestyles.

Since its inception, OPPI has always stood for encouraging scientific quest, research and innovation. We

have steadfastly pursued this route against all odds and voices of dissent. We believe there can never be

any short-cuts in drug development as we deal with patients’ lives and safety. We cannot waiver from our

path of drug discovery research to find newer and safer medicines to help mankind. In the process, we

have helped the generic bio-pharmaceutical industry, because there would be few generics if there were

no research!

In hind sight, it would be fair to say that our successive Governments, during the past 50 years, should

have remained steadfast in allocating more resources for healthcare infrastructure capable of serving our

growing population. This has not happened for a variety of reasons and we remain among the lowest

ranked nations as far as public funding of the healthcare system is concerned. Almost seven decades post

independence, our public healthcare system remains unreliable and patchy in many states, and therefore

heavily dependent on private sector financing. Indeed, we have many challenges in our country but surely,

human health and dignity should have been the top priority! Having said this, much progress has been

made in recent years. Many healthcare indices look much better today as compared with 50 years ago. But

we have miles to go and much has to be done before we can achieve Health for All.

This past year, Government has taken some laudable steps, such as liberalising FDI in Brown field and

Green field pharmaceutical projects, developing a National Health Policy draft and stating their intention

to encourage R&D and implement IPR regulations in letter and spirit. The single window concept for

approvals of industrial sites in many states, the reopening of the Clinical Trials sector and the transparent

drug approval systems being put in place, are all very welcome moves. The Honourable Prime Minister,

Mr Narendra Modi, has often said that he would like to create an ecosystem of predictability and increase

ease of doing business in India. The industry is anticipating concrete actions in this regard, which will help

create more jobs, bring more investments in the sector and forge technological partnerships to leap-frog

in creating an inclusive healthcare system. I can say on behalf of OPPI member companies that we are

fully committed to working with our Government and all other stakeholders to ensure that healthcare for all

becomes a reality in the next decade.

On the eve of our Golden Jubilee anniversary, OPPI member companies rededicate themselves to the

task of achieving our national objective of Health for All. I thank all my fellow industry colleagues and all

stakeholders for their tremendous commitment and support over the past five decades.

04

Dr Shailesh AyyangarPresident, OPPIOctober 17, 2015 Mumbai


India has all the knowledge, technologies and interventions required for providing quality healthcare

to her people, for both disease prevention and treatment. On the face of it, much of the ill health,

disease, premature death and suffering we see around us is avoidable. To quote the draft National Health

Policy 2015, “The reality is straightforward. The power of existing interventions is not matched by the

power of health systems to deliver them to those in greatest need, in a comprehensive way, and on an

adequate scale”.

The long-term solution to India’s healthcare challenges will require a holistic approach and a critical

evaluation of our existing systems. We must have sustainable policy solutions to address healthcare

financing, infrastructure and human resource challenges. We remain hopeful that Government will accord

priority to healthcare, increase healthcare budgets and implement the promised Universal Health Assurance

programme. The pharmaceutical industry remains passionate and committed to fulfilling its role in helping

to address the nation’s healthcare challenges.

Medicines are a critical component of healthcare and there is no question that all people should have access

to all medicines. OPPI stands for a collaborative approach that will ensure patients access to innovative

medicines while supporting growth for India, through research, innovation and manufacturing. The creation

of a healthy India requires balancing the need for innovation with the necessity for more affordable medicines,

within a robust IP environment. Pro-innovation policies and increased access to medicines must go hand-

in-hand for the benefit of our patients. We will need to Make, Develop and Innovate in India if we are to truly

become a ‘Pharmacy to the World’.

RANJANA SMETACEK

Director General, OPPI



All of us have a collective responsibility towards all patients and we must guarantee to deliver responsible

healthcare. This is possible only when our entire healthcare system complies with global good manufacturing

practices and stringent ethics codes. To this end, Government’s formalising of the Uniform Code of

Pharmaceuticals Marketing Practices (UCPMP) this year, is a very welcome move.

As OPPI celebrates 50 years of being, I ask you to celebrate with us. As an industry, we have much to be

proud of: the Indian pharmaceutical industry is the third largest in the world by volume; it is the second

highest foreign exchange earner in the world; and it is a generics powerhouse.

Today, we can look back at a glorious past that has seen dramatic improvement in the quality of life,

unprecedented longevity and cures for diseases that were once incurable! We continue to aspire to make

a difference and strive towards a better tomorrow. We look forward to seeing a ‘Healthy India and an

Innovative India’.

I thank all my members and well-wishers for their continuous support, as we remain committed to fulfilling

our collective dream of extending healthcare to all people across India.

Ranjana Smetacek Director General, OPPI October 17, 2015 Mumbai

06


THE PHARMACEUTICAL LANDSCAPEIndia is the fifth fastest growing economy in the world (Source: Euromonitor) and is poised to become the third largest economy by 2040 (Source: PwC). A growing educated middle-class, rising income levels and increase in life expectancy are all indicators of a developing economy.

Unfortunately, rising affluence has also led to an increase in chronic and lifestyle-related diseases. However, growth in public expenditure on healthcare has not kept pace with the rapid growth of private and speciality hospitals, and the increased penetration of health insurance (which has a lot of space to grow even more).

Indian Pharmaceutical Industry India’s Life Sciences industry occupies a place of prominence globally. In pharmaceuticals, India is ranked eighth by value (USD 29 bn) and continues to enjoy high growth rates, between 15 per cent and 20 per cent, closely competing with China. Indian companies enjoy a strong presence in the US generics market, commanding a share of 19 per cent in 2014 as against 13 per cent in 20101.

Key Highlights of the Indian Pharmaceutical Industry2:

Domestic Pharmaceutical Formulation MarketThe domestic pharmaceutical formulation market has grown from USD 10.3 bn in 2010 to close to USD 15 bn in 2015. Historically, the Indian Pharmaceutical Market (IPM) has grown annually by twice the GDP growth percentage. It is now expected that the IPM will touch around USD 55 bn by 20204.

1 Indian Lifesciences 2030: Mckinsey-FICCI report | 2 IBEF Pharmaceuticals report 2015 | 3DIPP website | 4 IMS Institute Analysis


Leading pharmaceutical India’s pharmaceutical industry accounts for about 1.4 per cent producer of the global pharmaceutical industry in value terms, and 10 per cent by volume

One of the largest exporters India accounts for 20 per cent of global exports in generics

Among the fastest-growing The country’s pharmaceutical industry is expected to expand at industries a CAGR of 14.5 per cent over 2009-20, to $55 bn at the end of the period

Rapidly growing Healthcare, another fast-growing sector, is expected to grow at a healthcare sector CAGR of 17 per cent to $280 bn over 2011-20

Growing generics market The generic market is expected to grow to $26.1 bn by 2016 from $11.3 bn in 2011; India’s generics market has extraordinary potential for growth

Ranked 5th in terms of • Attracted 5 per cent of total FDI into India from attracting FDI April 2000 to June 20143

• Cumulative FDI inflows of $13.3 bn from April 2000 to June 20143


• With a 72 per cent market share (in terms of revenue), generic drugs form the largest segment of the IPM

• Generic drugs account for 20 per cent of global exports in terms of volume, making India the largest provider of generic medicines globally.

Performance of the Indian Pharmaceutical Industry (Domestic) over last five years6

57868

Value in INR Crores

73514

78828

90085

66977

Market progression- 5 years

15%

9%

7%

14%

08

5 IBEF Pharmaceuticals report 2015 | 6 AIOCD-AWACS analysis

pharmaceutical(in per cent)5


• Sales have increased continually year-on-year, demonstrating a typical pattern in movement. However, sales dipped in September 2013 for the first time, with negative sales growth.

• In FY 2014-15, industry revenue crossed the INR 7,000 crore mark for a single month in July 2014, the first month that this has ever happened. In the second half of that year, the market grew at 12.2 per cent, against 9.5 per cent the previous year, resulting in business improvement.

The key growth drivers in FY 2014-15 were new introductions in the non-NLEM category, price revisions and increased demand for existing products.

Snapshot of the Domestic Pharmaceutical Formulation market by Therapeutic Area, Multinational Companies (MNC) /Indian Split, Top Company Market Share and Brand Market Share over last four years7

7 AIOCD-AWACS analysis

Chronic-Acute Split

13%

10%

2012 2015

Acute

Chronic29 31

71 69

1.4x growth of chronic over acute therapy

2012 2015

Indian

MNC 24 22 8%

12%76 78

Indian-MNC Split

Domestic players account for more than 70% of the market and are growing aggressively

Share of top ten declined despite M&A

2012 2015

Top 10

11 to 30

30+ 13%

10%

12%

44.1 42.9

Top Company Market Share

32.7 33

23.1 24.1

Despite the challenging environment, top brands have exhibited leadership

2012 2015

Top 100

101 to 300

300+ 11%

13%

12%

16.6 17.5

Brand Market Share

14 14.3

69.4 68.2


In per cent

In per cent

In per cent

In per cent


Formulations Export8

• Acute therapy gives momentum while Chronic Therapy drives IPM

• The market shares of multinational companies have declined due to greater exposure to the National List of Essential Medicines (NLEM 2011)

• While the market share of the top 10 companies by revenue has declined, top brands continued to register growth

Value in INR Crores

Volume in Thousands

9%

5%

500,000

400,000

300,000

200,000

100,000

0

Value Volume

8 AIOCD-AWACS analysis | 9CRISIL database 2014-15

India’s pharmaceutical exports were USD 14 bn in FY 2014-15 and are expected to grow at a healthy 12-14 per cent CAGR over the next five years. Indian pharmaceutical companies continue to capitalise on export opportunities in regulated and semi-regulated markets. The Ministry of Commerce and Industry estimates that pharmaceutical exports will reach USD 25 bn by 2020. Indian drugs are exported to more than 200 countries in the world, with the Americas accounting for around 34 per cent, followed by Europe (26 per cent) and Asia (20 per cent)

Bulk Drugs (Active Pharmaceutical Ingredients)A high growth trend in demand of the international generic drug industry continues to fuel the growth of bulk drugs. Domestic formulation growth will continue to have a direct impact on active pharmaceutical ingredient (API) sales in India. Bulk drug exports from India are expected to reach about USD 12.5 bn by the end of 2015.

In India, 85 per cent of bulk drugs produced are exported. India’s API export to regulated markets constituted roughly 48 per cent of its total API exports as of March 2015. Of this, 29 per cent of exports were to generic formulators (who produce drugs for which patents have expired) and 19 per cent to on-patent innovator formulators9.

10


Position comparableto the US, achieved in just 10 years

Strong emergingpresence in areassuch as dermatology,topicals, etc.

Position primarily drivenby ARV’s significant potential to explore incremental innovation in other areas

Limited advancesmade so far, earlymovement seen forthe Indain market

52

22

10

5

11

India

US

Europe

Canada

Others

51

ANDA approvalsPer cent share, 2011-14

India 37

37

11

6

9

US

Europe

Israel

Others

ANDA approvalsPer cent share, 2011-14

US

Europe

India

Israel

Others

60

18

14

3

5

505(b)2 approvalsPer cent share, 2011-14

35

7

3

3

Europe

US

Japan

Canada

Others

NCE approvalsPer cent share, 2011-14

SpecialityGenerics

New therapeutic entities

New molecular entitiesGenerics

6 8

India is among the leaders for the Abbreviated New Drug Application (ANDA) approvals, but has a poor record when it comes to developing new therapeutic/molecular entities. The only success India has had so far is in development of anti- retrovirals.

Drug (Price Control) Order (DPCO) 2013 molecule basket vs Non-DPCOA recent study on ‘Assessing the Impact of price control measures on access to medicines in India’, released by IMS Health in 2015 shows a decline of 3 per cent in the volume share of DPCO molecules when compared to non-DPCO molecules. The report concludes that the primary beneficiaries of the DPCO 2013 price controls have been high income patient populations, rather than low-income target populations.

10 DoP presentation 2015 | 11 Indian Lifesciences 2030: Mckinsey-FICCI report

Research and Development (R&D) landscapeStatistics show that investments in R&D of the top 25 Indian companies have grown from INR 5060 crores (USD 1012 million ) in FY 2012-13 to INR 6103 crores ( USD 1110 million ) in FY 2013-14.

Yet India accounts for less than 1 per cent share of the US$ 142 bn in worldwide spending on pharmaceutical R&D during 2014. This is despite India’s unique strengths in this area: cost-competitive expertise in chemistry, availability of quality talent, a diverse patient pool and improving healthcare infrastructure. The Department of Pharmaceuticals (DoP) has envisaged developing India as a global drug discovery and pharmaceuticals innovation hub, capturing 15-20 per cent of the world’s R&D pipeline by 2020 leading to USD 70 bn in pharmaceuticals production10.

India currently has a nascent position in the innovation space, despite some initial small bets being placed11

ARV Combinations



Volume share

2007 2009 2011 2013 2015

22% 22% 25% 27% 30%

78% 78% 75% 73% 70%3 % decline in last 18 months

Non-DPCO DPCO

12

Clinical Trial Landscape

Clinical research is the only modality that will ensure newer lifesaving therapeutic options are made available for human use, particularly in domains of unmet medical needs. Without ethical clinical research, patient options are severely restricted.

The number of clinical trial applications received and permissions granted by the Central Drugs Standard Control Organization (CDSCO) during the last three years and in the current year are as below12:

Year No. of application received No. of permission granted*

2012 480 253

2013 207 73

2014 230 198

2015 87 137 (till 30/06/2015)

* Includes permissions granted for applications received during previous years.

A lot of uncertainty prevails around the future of clinical research in the country. Ironically, India accounts for around 17 per cent of the world’s population and 20 per cent of the global disease burden, with no clear clinical research agenda of our own to tackle this mammoth disease burden.

12 Q No. 2065: Raised in Lok Sabha in monsoon session

The graph depicts the volume share of DPCO Vs Non-DPCO molecules over 2007 - 2015


Actions that impact the pharmaceutical sector

• The Department of Pharmaceuticals (DoP) announced plans to re-launch the Jan Aushadhi scheme of

generic pharmacies from July 2015, expand selection of products included in the scheme to over 500,

and involve private retail pharmacies, in addition to specialised Jan Aushadhi stores.

• Prescribing in the public sector will be shaped largely by the National List of Essential Medicines (NLEM).

A Core Committee instituted by the Government has been tasked with the revision of the NLEM 2011.

A series of consultative meetings across the country have concluded and the list is awaited.

• Enforcement of the DPCO 2013 has increased the proportion of the market subject to price control.

Certain amendments to the DPCO 2013 are underway and pharmaceutical associations have submitted

their suggestions.

• A voluntary ‘Uniform Code of Pharmaceuticals Marketing Practices’ (UCPMP) was formalised from

January 01, 2015. Adoption and compliance was to be reviewed after six months. The revised time-line

for the review has been extended to August 31, 2015.

• An Integrated Pharmaceutical Database Management System (IPDMS) has been set up to facilitate the

online submission of information required under the DPCO 2013 by companies.

Recent pronouncements by officials appear to indicate a growing awareness of the importance of the

healthcare sector – and by extension the pharmaceutical industry – that goes beyond costs to the need

for leveraging India’s advantages in building an innovation culture. Associated with this awareness is also

recognition that having a robust Intellectual Property Rights (IPR) regime is important for the economy as a

whole. The government is currently reviewing a draft National IPR policy; in the coming year, public discourse

on the key issues of innovation, improving the IPR regime and the attendant benefits on access to healthcare

is likely to grow louder.

For more than 25 years, Gilead has worked to develop medicines that address areas of unmet medical need for people around the world.

Our portfolio of medicines and pipeline of investigational drugs include treatments for HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases and cardiovascular conditions.

Every day we strive to transform and simplify care for people with life-threatening illnesses.

Advancing Therapeutics,ImprovingLives.

For more information, please visit www.gilead.com.© 2015 Gilead Sciences, Inc.



For more than 25 years, Gilead has worked to develop medicines that address areas of unmet medical need for people around the world.

Our portfolio of medicines and pipeline of investigational drugs include treatments for HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases and cardiovascular conditions.

Every day we strive to transform and simplify care for people with life-threatening illnesses.

Advancing Therapeutics,ImprovingLives.

For more information, please visit www.gilead.com.© 2015 Gilead Sciences, Inc.


Working Groups (WG)Access and Affordability

Objectives:

l To support improvement in healthcare access and proactively engage in policy development

l Undertake research and studies to evaluate the impact of healthcare access and participate in the discourse on shaping policy

l To define OPPI’s position on enhancing access to healthcare and improving healthcare financing

l To bring together diverse stakeholders for a comprehensive dialogue on healthcare access issues

OPPI instituted a study with IMS Health on ‘Assessing the impact of price control measures on access to medicines in India’ in order to understand the effectiveness of price controls as a means to improve access. The study reviewed the DPCO 2013 and compared it with the DPCO 1995, to consider the relative impact of price controls on the entire healthcare ecosystem, predominantly on the true intended beneficiaries - the patients. The study identified certain critical levers which could help improve access to medicines in the country. The study concluded that India needs an all-encompassing healthcare model that will help achieve the objective of improving healthcare access in India, with the government in a lead role, supported by other stakeholders.

The WG worked on a paper on Healthcare Financing that analysed the merits of various financing and insurance approaches in addressing healthcare needs in emerging economies, while considering the learnings from developed economies. The paper outlined a role for regulatory and financing policy in expanding healthcare coverage and access.

The Fourth Healthcare Access Summit was held on August 7, 2015 in Mumbai. IMS was the principal partner at the summit. The event was supported by ASSOCHAM, AMCHAM, CII and FICCI. Leaders from the pharmaceutical industry, government officials, healthcare policy experts, medical practitioners and other distinguished professionals participated in an engaging discussion and presented solutions to make healthcare accessible.

The OPPI Healthcare Access Award 2015, supported by Abbott Healthcare and Johnson & Johnson, recognises the highest contribution made by an individual or institution toward improving access to healthcare with consideration for patient safety and adherence to quality. The jury to select the awardee comprised of Dr Srinath Reddy, Public Health Foundation of India; Dr Rajendra Gupta, Consultant; Gautam Kumra, McKinsey & Co; Dr Rajesh Upadhyay, APICON and Dr Shailesh Ayyangar, President, OPPI. Padma Bhushan Dr Devi Shetty, Chairman & Founder, Narayana Health, was declared the winner. Dr Shetty leads the way in providing affordable and world-class treatment for heart ailments.

OPPI has commissioned a study with KPMG on the Corporate Social Responsibility initiatives of its member companies that contribute to improved health outcomes in India.

CHAIRMAN: Sudarshan Jain (Abbott)

CO-CHAIRMAN: Sanjiv Navangul (Johnson & Johnson)

MEMBERS: Shirish Ghoge (Abbott ) • Pushpak Khare (Abbott) • Sanjeev Panchal (AstraZeneca) • Navin Sharma

(Baxter*) • Pooja Vatsyayan (Biogen Idec*) • Meenal Gauri (Boehringer Ingelheim) • Anil Kumar (Bristol-Myers



Squibb) • Edgard A. Olaizola (Eli Lilly) • Munish Malhotra* / Anant Garg (Eli Lilly) • S Raghavendra* (Galderma)

• Dr Rahul Bargaje (Gilead Science) • Sudheendra Kulkarni (Johnson & Johnson) • Priya Hingorani (Johnson &

Johnson) • Shilpa Arora (Merck Serono) • Ashis Mukherjee* / Vivek Kamath (MSD Pharmaceuticals) • Sanchit

Nanda (Novartis) • Vinay Ransiwal (Novo Nordisk) • Partha Ghosh (Pfizer) • Umang Chaturvedi (Ranbaxy*)

• V Simpson (Roche) • Sangita Topiwala (Sanofi) • M.K. Narayanaswamy (Sanofi) • Geeta Karnik (Serdia) • Mahesh

Kalsekar (Takeda) • K. Venkatesh (UCB) • Deep Bhandari (UCB) • Sudip Chakraborty (UCB)

SPECIAL INVITEES: Shrikant Ganduri (Yes Bank) • Amit Backliwal* / Nitin Goel / Amit Mookim / Kunal Khanna

(IMS Health)

*Resigned

16


Communications and Public Affairs

Objectives:

l To provide communications support to all WGs and Committees

l Prepare a communication tool kit for members

l Prepare OPPI position papers on identified industry issues

l To ensure consistent media engagement and balanced coverage in the press

l Increase the share of OPPI voice in media – to be consistently monitored

l Increase presence in social media

The WG identified and prioritised three focus areas for consistent communication: Innovation, Access to Healthcare and Ethics & Compliance. Based on these thrust areas, a tool kit with key messages was created for consistent and uniform messaging.

Ad Factors PR was appointed as OPPI’s new PR Agency to help enhance the image of OPPI and increase its visibility.

The WG was mandated to deliver on two specific initiatives; OPPI’s 50th year celebrations, and a Corporate Film. Special Task Forces (TFs) were formed to ensure smooth completion of these tasks.

The TF responsible for the corporate film was involved in the selection of the film-maker, the final storyboard and the entire making of the film. The film traces the 50 year journey of OPPI in India and, importantly, its role in transforming the healthcare landscape of the country. The film also showcases the work of the member companies in the field of innovation and drug research.

‘Healthy India. Innovative India.’ was selected as the theme for the 50th year celebrations. Another TF is supporting a year-long series of events around these celebrations, playing an active part in the specially constituted, high-level Steering Committee that is focused on this specific purpose.

Efforts were made by the WG to use the OPPI Blog, Twitter and Facebook to consistently engage with the public.

CHAIRMAN: Ranjit Shahani (Novartis)

CO-CHAIRPERSON: Ranjana Smetacek (OPPI)

MEMBERS: Varsha Chainani (Abbott) • Sridhar Ranganathan (Allergan) • Rajesh Mehra* / Varsha Das (AstraZeneca)

• Aloke Pradhan (Bayer) • Sophia Gonsalves (Bayer) • Neeti Khullar (Boehringer Ingelheim) • Kanchana

T.K. (Bristol-Myers Squibb) • Dr. Gaurav Arya* / Munish Malhotra* / Anant Garg (Eli Lilly) • Nandini Goswami* / Ransom

D’Souza (GSK Pharmaceuticals) • Ransom D’Souza* (Johnson & Johnson) • Rimmi Harindran (Merck Serono)

• Jyotsna Ghoshal (MSD Pharmaceuticals) • Neelima Dwivedi (MSD Pharmaceuticals) • Svetlana Pinto (Novartis)

• Sundeep Kumar (Novartis) • Anupama Rau (Novo Nordisk) • Sharad Goswami (Pfizer) • Umang Chaturvedi

(Ranbaxy*) • Shilpika Das (Roche) • Ranjita Sood (Roche) • Aparna Thomas (Sanofi) • Ruchita Mehra (Sanofi)

• James Fernandes (Serdia) • Ashish Ranjan (UCB)

*Resigned



Ethics & Compliance

Objectives:

l To build visibility and awareness for the OPPI Code of Conduct

l To work with Government to formalise the Uniform Code of Pharmaceuticals Marketing Practices (UCPMP)

For responsible healthcare to become the norm in India, and patients to be guaranteed safe care and quality medicines, the DoP formalised the UCPMP as a voluntary code, effective January 01, 2015. OPPI welcomed the efforts of the DoP in ensuring increased accountability with the highest ethical standards in manufacturing, marketing and prescribing.

The WG organised a series of interactions with healthcare professionals, patient organisations, hospital administrators and other stakeholders to discuss the UCPMP and the Medical Council of India (MCI) guidelines and understand their concerns, in order to make it effective and implementable.

OPPI has also had several rounds of consultations with the DoP and also met the Minister of Chemicals and Fertilizers and other government officials, in order to ensure that the entire industry is aligned with the marketing code. Where appropriate, the WG also sought clarifications on certain aspects of the UCPMP.

As requested by the DoP, the WG is currently working on the ‘best practices’ on complaint handling. For this, the WG invited the Advertising Standards Council of India (ASCI) to explain their methods of governance and regulation, reviewing them to explore if they could perhaps be adapted to the pharmaceutical industry.

The WG is also currently working on revising the OPPI Code of Conduct, based on the UCPMP and the updated IFPMA Code.

The WG organised the OPPI Ethics & Compliance Conclave with PwC and AZB as partners. There was active participation from the pharmaceutical industry, healthcare experts, patient organisations, government officials, regulatory authorities, pharmaceutical associations and the Indian Medical Association (IMA). An array of eminent speakers participated in the various panel discussions through the day. The Conclave was instrumental in bringing forth constructive suggestions on making the UCPMP robust and practical.

CHAIRMAN: K. G. Ananthakrishnan (MSD Pharmaceuticals)

CO-CHAIRMAN: Maturin Tchoumi (Roche)

MEMBERS: Swati Dalal (Abbott) • Vijayaprakash Devulapalli (Abbott) • Rajesh Sharma (Allergan) • Ramesh

Varadarajan (AstraZeneca) • Rajiv Wani (Bayer) • Raelene Antao Banerjee (Bayer) • Neha Kshirsagar (Bayer) • Rajiv

Malhotra (Biogen Idec*) • Santosh Mane (Boehringer Ingelheim) • Bratin Bag* (Bristol-Myers Squibb) • P. Srikanth

(Eisai) • Dr Simrat Sohal (Eli Lilly) • Madhusudan HK (Galderma) • Susheel Sule (Gilead Sciences) • Mohit Raina

(GSK Pharmaceuticals) • Jayashree Shetty (Johnson & Johnson) • Dr Rajesh Chitre (Merck Serono) • Sandeep

Seth (MSD Pharmaceuticals) • Girish Tekchandani (Novartis) • Dr. Ramesh Jagannathan (Novo Nordisk) • Samir

Kazi (Pfizer) • Ashish Vohra (Pfizer) • Dr Jejoe Karan Kumar (Ranbaxy*) • Ravindra Jain (Roche) • Dan Chellman

(Roche) • Parichay Mittal* / Arjun Thakkar (Sanofi) • Bratin Bag (Sanofi) • Dr Asmita Nimkar (Serdia) • Ashok

Bhattacharya (Takeda) • Dolcy Dsouza (Takeda) • Milind Kulkarni (UCB)

*Resigned

18


Innovation and Intellectual Property Rights IPR

Objectives:

l To help create a positive environment for (IPR) and encourage research and innovation

l To bring about a balance in discussions around Innovation and IPR

l To persuade key stakeholders that Innovation and IPR are good for the country

The WG developed a coordinated approach with stakeholders, aligning with PhRMA, IFPMA, EFPIA to build stronger advocacy. The group created position papers on critical topics: the Compulsory Licensing (CL) provision in the Indian Patent Act 1970, government control on patented medicines in India and on patentability. The shorter versions of these papers are available on the OPPI website.

The WG shared these OPPI positions with several government agencies and stakeholders. The group also prepared case studies and other reference materials for members to use when presenting the case for strong IPR in academic institutions or at public debates.

In December 2014, the IPR think tank set up by the Ministry of Commerce and Industry submitted the first draft of a National IPR policy, and called for comments on it. OPPI submitted recommendations to the think tank on the draft IPR Policy, followed by an interaction with them. Presently, the draft Policy is being circulated for inter-ministerial discussions. Finally, it will be reviewed by the Commerce Minister and then sent to the Cabinet for approval and announcement. Such a policy can provide a visionary national framework and act as a blue-print on how to utilise an IPR system, promote socio-economic and technological progress and development, and achieve international co-operation, trust and exchange.

CHAIRMAN: Aijaz Tobaccowalla (Pfizer)

CO-CHAIRPERSONS: Angel-Michael Evangelista (Bayer) • Jitendra Tyagi (Bristol-Myers Squibb) • K Shivkumar*

(Eisai)

MEMBERS: Shyamakant Giri (Abbott) • Pankaj Jain (AstraZeneca) • Dr. Ashish Gawde (Bayer) • Kedar

Suvarnapathaki (Boehringer Ingelheim) • Kanchana T.K. (Bristol-Myers Squibb) •Suresh Gupta (Bristol-Myers

Squibb) • Edgard A. Olaizola (Eli Lilly) • Kaizad Hazari (GSK Pharmaceuticals) • Ashish Srivastav (Johnson &

Johnson) • Nishant Berlia (Martin & Harris) • Prashant Laghate (Merck Serono) • Milind Thatte (Merck Serono)

• Vivek Kamath* / Anjan Sen (MSD Pharmaceuticals) • Swashraya Shah (MSD Pharmaceuticals) • Dinesh Charak

(Novartis) • Dr Ramesh Krishnamurti (Novo Nordisk) • Dr Srishyla (Novo Nordisk) • V Kumar (Pfizer) • Sharad

Goswami (Pfizer) • Shivprasad Laud (Roche) • Sujatha Subramaniam* / Rahul Vartak (Roche) • Yasmin Cama

(Sanofi) • Dr Mubarak Naqvi (Sanofi) • James Fernandes (Serdia) • Dr Sangeeta Madhok (UCB)

*Resigned



Medical and Regulatory

Objectives:

l To provide inputs for changes in policies affecting new drug approvals, biologics and vaccines, and other regulatory issues (like import registration).

A number of sub-groups were formed.

The Import Registration sub-group took up the specific issue of import registration of manufacturers’ sites. Presently, the CDSCO calls for registration of multiple sites involved in the manufacture of a single product. OPPI is in dialogue with regulators; the sub-group recommended removal of the three-month window for cancellation of the registration certificate in case there are changes in the constitution of the firm, or the address.

The New Drug Approval sub-group addressed the issue of clinical trial waiver for new drugs. The sub-group made a representation to the Minstry of Health and Family Welfare (MoHFW) and Drugs Controller General (India) seeking a waiver for local clinical trial data for medicines that treat life-threatening diseases. An indicative list was submitted along with a definition of what should be considered a ‘life-threatening condition’.

The Biologics and Vaccines sub-group focused on registration and import licenses, and is in dialogue with regulatory bodies to simplify the registration approval process for imported products.

The Clinical Trials sub-group led the discussion on issues related to AV recording and the restriction on number of studies per investigator. It has had meaningful meetings with the Directorate General of Health Services and the MoHFW on those issues. The sub-group also submitted a proposal for training and skill development for CDSCO inspectors, and another on Good Clinical Practices and Drug Development with Indian Society for Clinical Research. This group submitted inputs on the changes proposed in the Drugs and Cosmetics Amendment Act and Rules.

CHAIRMAN: Sameer Savkur (Biogen Idec*)

CO-CHAIRPERSONS: Anish Bafna (Baxter*) • Dr Suresh Menon (Novartis) • Suneela Thatte (Quintiles)

MEMBERS: Dr Balagopal Nair (Abbott ) • Arun Mishra* (Abbott) • Dr Paramjit Singh (Allergan) • Dr Thirumalai

Velu (Allergan) • Dr Veena Jaguste (Amgen) • Dr Shashwati Pramanik (Amgen) • Dr Pratik Shah (Astellas)

• Dr Bhavesh Kotak (AstraZeneca) • Dr Ashish Gawde (Bayer) • Girish Parhate (Bayer) • Meenu Batolar (Biogen

Idec*) • Dr Viraj Suvarna (Boehringer Ingelheim) • Dr Vinod Mattoo (Bristol-Myers Squibb) • Dr Ramakrishnan

Sundaram (Bristol-Myers Squibb) • Anilda D’souza (Bristol-Myers Squibb) • Dr Chandrashekhar Chavan (Eisai)

• Dr Anurita Majumdar* (Eli Lilly) • Rahul Chauhan (Eli Lilly) • Dr Sachin Rustagi (Galderma) • Dr Vrishali Desai

(GSK Pharmaceuticals) • Sukanya Choudhury (GSK Pharmaceuticals) • Dr Prashant Desai (Johnson & Johnson)

• Dr Vikram Singh (Johnson & Johnson) • Nishant Berlia (Martin & Harris) • Dr Qayum Mukaddam (Merck Serono)

• Dr Priya Chatterjee (Merck Serono) • Swarnaraj Jacob* / Rahul Luthra (MSD Pharmaceuticals) • Swashraya Shah

(MSD Pharmaceuticals) • Amita Bhave (Novartis) • Dr Ramesh Jagannathan (Novo Nordisk) • Dr Chandrashekhar

Potkar* / Sharad Goswami (Pfizer) • Dr Sonali Dighe* (Pfizer) • Dr Manish Paliwal* (Pfizer) • Sofi Joseph (Pfizer)

• Dr Anurita Majumdar (Pfizer) • Rajgopal Bhutada (Ranbaxy*) • Dr Anil Kukreja (Roche) • Seema Shimpi (Roche)

• Dr Mubarak Naqvi (Sanofi) • Yasmin Shenoy (Sanofi) • Dr Asmita Nimkar (Serdia) • Dr Santosh Jha (Takeda)

• Dr Sangeeta Madhok (UCB)

SPECIAL INVITEE: Shrikant Ganduri (Yes Bank)

*Resigned

20


Committees

Finance and Taxation

Objectives:

l To provide inputs for OPPI representations on Patented Product Pricing Policy and other pharmaceutical policy issues

l To work closely with IPA and IDMA to develop representations on the proposed amendments to the DPCO 2013 and revision of NLEM 2011

l To provide industry inputs for the Union Budget 2015-16

l To study the implementation challenges of the Goods and Services Tax (GST)

l To oversee OPPI Accounts and Administration

The inter-ministerial Committee on Patented Product Pricing Policy invited OPPI and other pharmaceutical associations to discuss the methodology in formulating a policy for the country. A cross-functional TF, with members from the IPR and Innovation WG along with a few members of the Finance and Taxation Committee, worked closely with PhRMA to develop a position paper on the subject.

A Core Committee formed by Government for revision of the NLEM 2011 held six consultative meetings across the country. These meetings were attended by experts from the OPPI member companies, who put forward industry concerns to be addressed while revising the NLEM 2011. OPPI also submitted suggestions to the chairman of the Core Committee.

OPPI highlighted operational issues affecting the effective implementation of the DPCO 2013 and provided inputs on proposed amendments. OPPI, in collaboration with IDMA and IPA, is working with Government to ensure access to medicines to patients in India.

With help from associate members, E&Y and KPMG, the Committee submitted OPPI’s Pre-Union Budget Memorandum to relevant ministries and departments. The memorandum was prepared in consultation with other associations such as IDMA, IPA, FICCI, CII & ASSOCHAM. The TF made several presentations to DoP/DoR on direct taxes, indirect taxes and transfer pricing elements affecting the pharmaceutical industry. Subsequently, post-budget recommendations, with inputs from industry bodies, were also submitted to Government.

The Committee made suggestions on augmenting OPPI’s Accounts and Administration and ensured statutory compliance of financial matters, as directed by Deloitte Haskins and Sells.

The Committee conducted a series of knowledge sessions: ‘Strategic Levers for Successful Drug Commercialisation in India’ by Varun Gupta, Novartis; ‘Union Budget 2015-16 Analysis - Inspiring Confidence and Empowering Change in India’ by Hitesh Gajaria, KPMG; ‘GST: impact, insight and way forward’ by Hitesh Sharma, E&Y, and a session on ‘Computation and Disclosure Standards (ICDS) for Computation of Taxable Income’ by Dinesh Jangid, KPMG.

CHAIRMAN: Aman Bajaaj (Takeda)

CO-CHAIRMAN: Melvin D’Souza (Novo Nordisk)

MEMBERS: Sachin Dharap (Abbott) • Shirish Ghoge (Abbott) • Rajesh Sharma (Allergan) • Dr Pratik Shah



(Astellas) • Rajesh Marwaha (AstraZeneca) • Sandeep Devgon (Baxter*) • N.V. Chalapathi Rao (Bayer) • Davendra

Singhvi (Biogen Idec*) • Thomas Wilmesmeier (Boehringer Ingelheim) • Mukesh Agarwal* (Bristol-Myers Squibb)

• Kanchana T.K.* (Bristol-Myers Squibb) • Raghavendra Agarwal (Bristol-Myers Squibb) • Vikram Arora (Eli Lilly)

• Kaushal Gupta (Fresenius Kabi) • Nimit Sanghvi (Galderma) • Sushil Khanna (GSK Pharmaceuticals) • Andrew

Aristidou (GSK Pharmaceuticals) • Manish Vora (Johnson & Johnson) • Kalpana Umakanth (Martin & Harris)

• Hemant Lad (Merck Serono) • Giri Giridhar (MSD Pharmaceuticals) • Milind Patil (Novartis) • Suhas Karambelkar

(Novo Nordisk) • S. Sridhar (Pfizer) • Sharad Goswami (Pfizer) • Sundeep Mehta (Ranbaxy*) • Patrick Watkins

(Roche) • M.K. Narayanaswamy (Sanofi) • Vaibhav Karandikar (Sanofi) • Geeta Karnik (Serdia) • Vinay Potdar

(Takeda) • Satish Joshi (UCB)

SPECIAL INVITEES: Hitesh Sharma (Ernst & Young) • Hitesh Gajaria (KPMG) • Shrikant Ganduri (Yes Bank)

*Resigned

22


Governance and Human Resources Management

Objectives:

l To conduct an industry benchmarking study for member companies - OPPI Field Force Compensation Study 2015

l To leverage relationships with other industry associations to jointly address industrial relations (IR) issues in the pharmaceutical industry

l To work closely with the Life Sciences Skill Development Council (LSSDC) and academia to make the pharmaceutical industry an employer of choice

l To organise knowledge sessions and the OPPI HR Summit 2015

OPPI has been engaging with the students and faculty of top management institutes through the OPPI Academia Programme. This is designed to initiate dialogue between the industry, the future workforce and academia. As part of this initiative, the Committee visited some management and research institutes across the country, including the National Institute of Pharmaceutical Education and Research (NIPERs). The objective was to gauge levels of interest among students towards the pharmaceutical industry and promote it as an industry of choice for young employees.

The Committee partnered with Aon Hewitt to conduct a study among member companies on compensation and benefits across various categories of Medical Representatives (MRs), and the sales and marketing functions. The study, which captures several aspects of compensation and benefits, will help member companies streamline remuneration in this area.

The Sales Promotion Employees (Conditions of Service) Act, 1976, was enacted by Parliament to regulate the services of sales promotion employees. However, given the different and specialised nature of their work, the Act has not prescribed work timings for MRs. OPPI, along with IDMA, has made several representations in various states against enforcing working hours for MRs.

OPPI’s HR Summit on ‘HR Imperatives & Organisational Sustainability’ was held on September 15, 2015 in Mumbai. Discussions at the summit covered diversity and inclusion, compliance and governance, and the Employee Value Proposition (EVP).

OPPI, along with other industry associations, supports the Life Sciences Sector Skill Development Council, which is focused on skill development in the pharmaceutical industry. OPPI has provided inputs on curriculum design, and in addition supported specific areas such as infrastructure and creation of a pool of Master Trainers and Assessors.

The Committee organised knowledge sessions: V. Srinivas, Illumine Knowledge Resources Pvt Ltd, conducted a programme on ‘Building Contributors in Organisations’. Ashish Ambasta, Towers Watson India, conducted a session on ‘2015 Asia-Pacific Market Trends/Insights for the Pharmaceuticals & Life Sciences Sector’ in which he shared recent trends in rewards in the pharmaceutical industry.

CHAIRMAN: K. Shivkumar* (Eisai) • Sharad Tyagi (Boehringer-Ingelheim)

MEMBERS: Ajay Bhatt * / Deepshikha Mukerji (Abbott) • Debashish Chatterjee (Allergan) • Kinnari Joshi (Astellas)

• Smita Saha (AstraZeneca) • K.S. Harish (Bayer) • Vikram Patki* (Bayer) • Garvita Bhandari (Biogen Idec*)

• Sanjay Srivastava (Boehringer-Ingelheim) • Shraddha Pradhan* / Deepa Shankar (Bristol-Myers Squibb) • Bhakti

Gokhale* / Preston Fernandes (Eisai) • Ranjit Singh Walia (Eli Lilly) • Tarkesh Gupta (Fresenius Kabi) • Abhigyan



Ghosh (Galderma) • Dr Rahul Bargaje (Gilead Sciences) • Ronald Sequeira (GSK Pharmaceuticals) • Anupam

Shrihari (Johnson & Johnson) • Cecilia M. Azavedo* / Milind Thatte (Merck Serono) • Vikram Patki (Merck Serono)

• Sameer Tamhane (MSD Pharmaceuticals) • Meenakshi Priyam (Novartis) • Malapaka SRKV Murthy* / Amit

Kumar Das (Novo Nordisk) • Dr Lakshmi Nadkarni* (Pfizer) • Ravi Subramanian (Pfizer) • Vikram Duggal (Ranbaxy*)

• Nilesh Kulkarni (Roche) • Gaurav Bahadur (Sanofi) • Rohit Kumar (Sanofi) • Jui Dabir (Serdia) • Deepa Misra

(Takeda) • Ashish Ranjan (UCB)

*Resigned

24


Legal

Objectives:

l To monitor and review changes in laws and policies affecting the pharmaceutical industry

l To act as an advisory and consultant on legal issues

l Review all IPR related cases impacting member companies

l Keep member fully aware of the changes relating to Company law, Patent law, Pricing and Competition law

l Identify key business issues facing member companies from a legal perspective and develop a common understanding and approach

l Defend the legal rights of the member companies to do business in India under Indian laws

l Support all WGs and Committees as and when needed.

NPPA’s use of Para 19 in the DPCO 2013 extended price control to several non-scheduled medicines. OPPI has challenged the constitutional validity of NPPA’s action in the Delhi High Court. Final arguments are being heard in this case.

NPPA has proposed amendments to the DPCO 2013. A cross-functional TF, with members from the Legal and Finance and Taxation Committees, prepared the OPPI position on this. The Committee also submitted a representation on the NPPA’s notification on change of definition of ‘non-schedule’ drug under Para 2 (v) of the DPCO 2013.

The Committee studied the legal interpretations of the UCPMP guidelines and provided inputs to the Ethics and Compliance WG.

A position paper on online sales of over-the counter (OTC) and prescription drugs by e-pharmacies is under preparation.

The Committee has been providing relevant data to government authorities and continues to provide regular inputs to the Medical and Regulatory WG and Finance and Taxation Committee for action items on relevant cases.

CHAIRMAN: G. Sathya Narayanan (Galderma)

CO-CHAIRMAN: Sanjay Murdeshwar (AstraZeneca)

MEMBERS: Kaiyomarz Marfatia (Abbott) • Anurag Sharma (Abbott) • Pankaj Jain (AstraZeneca) • Anuranjan Prasad

(Baxter*) • Rajiv Wani (Bayer) • Neha Kshirsagar (Bayer) • Santosh Mane (Boehringer-ingelheim) • Edgard A. Olaizola

(Eli Lilly) • Nilesh Pingle (Fresenius Kabi) • Kaizad Hazari (GSK Pharmaceuticals) • Sanjeev Shrivastav* / Tapan Pati

(Johnson & Johnson) • Vikas Gupta (Merck Serono) • Muralidhar Karnam (MSD Pharmaceuticals) • Dinesh Charak

(Novartis) • Kavery Madappa (Novo Nordisk) • Samir Kazi (Pfizer) • Akhilesh Nand (Ranbaxy*) • Shivprasad Laud

(Roche) • Yasmin Cama (Sanofi) • Partha Sil (Sanofi) • Geeta Karnik (Serdia) • Satish Joshi (UCB)

*Resigned



31 ANNUAL REPORT 2014-15 26

Technical and Supply Chain

Objectives:

lTo share knowledge on good practices and ensure compliance

lTo collaborate with DoP and National Institute of Pharmaceutical Education and Research (NIPERs)

lTo facilitate the creation of ‘Pharmazones’

lTo prepare a research paper on ‘Temperature controlled (cold chain) supply chain in India’

In February 2015, OPPI partnered with the Federation of Asian Biotech Association (FABA) in BioAsia 2015 held in Hyderabad. With participation from over 20 Asian countries, BioAisa 2015 created a global platform for discussions on the ‘New Era of Life Sciences - Opportunities in transition’. OPPI co-organised a seminar on Supply Chain and Logistics; participation from across the industry was a highlight of the seminar.

During the course of the year, the Committee organised knowledge sessions on ‘Electronic Stock and Sales System’ and ‘If Variable Barcodes are Made Mandatory’ by Ameesh Masurekar, AIOCD AWACS, and ‘Operational Efficiencies in the Supply Chain’ by Javin Bhinde, SynCore Consulting Group. As a member of the Academic Standards Committee of NIPER, OPPI provided regular inputs to NIPER on reducing current skill gaps in the industry. On request from the DoP, the Committee also provided inputs on the NIPER curriculm, suggestions on building industry and academia linkages and partnerships, and on strengthening Central Public Sector Enterprises.

A research paper on ‘Temperature Controlled (Cold Chain) Supply Chain’ prepared by OPPI examined the challenges in developing a temperature controlled supply chain and proposed recommendations for creating a best-practice compliant supply chain for pharmaceuticals in India. The Committee thanks DHL for providing significant inputs and allowing access to their data.

A TF led a site visit to Mezies Air Cargo Pvt Ltd’s terminal at Hyderabad Airport, and discussed issues on the infrastructure and logistics of pharmazones. A representation on these issues is being prepared, and will be submitted to Government soon.

Based on a TF-led visit to the Goa plants of Abbott, Merck Serono, Pfizer and Sanofi, representations were submitted on matters concerning FDA, DCGI, DCFT and implementation of Indian Pharmacopoeia 2014.

Annual Awards: The Committee managed the annual OPPI Scientist Awards and also supported the Best Vendor Award.

CHAIRMAN: Raghu Kumar (Allergan)

CO-CHAIRMAN: Dr Ramesh Panchagnula (Nektar)

MEMBERS: Shailendra Bobhate (Abbott) • Rajashekhar Akkaraju (Abbott) • K.T. Rajan (Allergan) • Devendra Mehta

(Astellas) • Robert Haxton* / Himanshu Saxena (AstraZeneca) • Vinay Phatak (Bayer) • Sanjay Manjrekar (Bayer)

• Raghavendra Agarwal* (Bristol-Myers Squibb) • Harsh Mehta (Bristol-Myers Squibb) • P. Thiyagarajan (Eli Lilly)

• Manas Sahoo (Fresenius Kabi) • Dr. Anand Dixit (Galderma) • Raju Krishnaswamy (GSK Pharmaceuticals) • Riju

Verma (Johnson & Johnson) • Aditya Berlia (Martin & Harris) • Rakesh Shah (Merck Serono) • Sanjay Bhatkhande

(MSD Pharmaceuticals) • Dharmesh Kharwar (MSD Pharmaceuticals) • Dr Firdosh Gardin (Novartis) • Suhas

Karambelkar (Novo Nordisk) • Vivek Dhariwal (Pfizer) • Sailesh Tekriwal (Ranbaxy*) • Arun Manjeshwar (Roche)

• Amit Nadkarni (Roche) • Krishna Parab (Sanofi) • Sadhana Mogre (Sanofi) • Santhosh Menon (Serdia) • Vinay

Potdar (Takeda) • Milind Kulkarni (UCB)

SPECIAL INVITEES: Ajit Singh (ACG) • Mohan Joshi (Consultant) • Ravind Mithe (KPMG) • Shrikant Ganduri (Yes Bank)

*Resigned

PROJECT JAWHAR:It takes between three and four hours to make the 128-km drive from Mumbai to Jawhar in Palghar district, a village in the tribal regions of rural Maharashtra. Once outside the city limits, it can be a lovely drive into the gentle slopes of the Western Ghats, with picturesque views of the countryside.

Three years ago, OPPI, in partnership with the government of Maharashtra, the Rotary Club, Mumbai, the Indian Medical Association and NGO Pragati Prathistan, launched Project Jawhar here, an initiative to lower the maternal mortality rate (MMR), a key global health indicator. Looking back at our work over these past years, there is reason to be proud.

The project’s goal is to promote awareness, reduce delays in emergency treatment, and encourage local women’s groups to understand and accept the importance of antenatal care, postnatal care, spacing children, and child immunisation. The project provides thousands of tribal women with access to healthcare and medicines that were severely lacking just a few years ago.

Project workers counsel the women about the risks of repeated pregnancies – stemming from the desire for a boy child; the physical and emotional trauma, and adverse effects on long-term health. Attention is paid to disseminating concepts of family planning and the importance of a nutritious diet during pregnancy and lactation.

Rekha, a young 24-year-old woman with a six-month-old baby girl, is grateful for the initiative. “Bringing the facilities to us and teaching us what to do has made our lives so much easier,” she tells a counselor. She brought her recently married and pregnant younger sister to one of the camps. “I tell all the women I know, about this camp.”

“I still remember the day we discussed this project with OPPI,” says Dr Bal Inamdar, former director general, Rotary Club, Mumbai. “They have been a strong pillar of support. OPPI member companies have provided medicines and also nutritional support to the women in the camps and have helped make a big difference.”

Over the last three years, thousands of women have participated in the antenatal and postnatal camps; they receive regular health checks and their newborns receive paediatric care as well. So today, there are close

Health checks organised in the camps

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32

to 7000 happy mothers – and probably an equal number of happy children – in Jawhar, Mokhada and Vikramgad, who came from as far as 40 kms away to the 53 health camps that were conducted as part of Project Jawhar.

Dr Bharat Mahale, a gynaecologist, at Cottage Hospital, Jawhar, has been associated with this project from its inception. “When we began, we faced two main challenges: low awareness of the risks of pregnancy among the women of Jawhar and nearby areas, and the shortage of medicines,” he recalls. “With every camp, we were able to slowly gain the trust and build confidence among the womenfolk. This has been largely due to the consistent supply of branded medicines from OPPI members companies and a strong word of mouth.”

There are many who express their gratitude to Government and to the counselors and workers of Project Jawhar as much as Rekha does, saying it is has made a real difference in their lives.

At Jawhar, we have helped build health literacy levels among sections of women who otherwise would not have access to information, besides providing the support and care they need during this phase in their lives.

“We believe that the outcomes achieved here go far beyond just improving maternal health,” says Lata one of Project Jawhar’s healthcare workers. “I think it has made a big difference to the quality of the families’ lives.”

Doctors report marked declines in the number of cases of severe anaemia, and equally notable improvements in Hb levels of several women. “Among all the women who attended the camps, not even one instance of maternal mortality has been reported,” says Dr Jayesh Lele, President Elect, IMA, Maharshtra State, who works at the camps. “That is a result we can be truly proud of.”

The outcomes are reflected in healthcare indicators too. In the UN’s Millennium Development Goals (MDGs), for example: the MMR target for India was 140 per hundred thousand births, to be achieved by 2015 (in 2012, it was 178). Government officials say that at the current compounded rate of decline, achieving the MDG target by the end of the year is possible.

The past three years have been very rewarding for all who participated in this initiative. There have been several learnings from Project Jawhar that have enhanced our knowledge and enriched our experience. In many parts of rural India, women are still denied basic access to healthcare. Perhaps the lessons from Jawhar can be leveraged in other, similar projects in the coming years.

A happy mother Women engrossed in a lecture in the camp

OPPI 2015 Final AW 3rd Part For Printing.indd 3 02/10/2015 4:06:13 PM



Meeting with Policy Makers and Government Authoritiesw.e.f August 16, 2014

Date Ministers / Officials Delegation Purpose

• Dr V.M. Katoch Director General, ICMR & Secretary, Department of Health Research

• Dr Y.K. Gupta Prof & Head, Department of Pharmacology, AIIMS

• Shri Rajeev Kher Secretary Commerce

• Shri Amitabh Kant Secretary, DIPP

• Ms Sujata Mehta Secretary, ER (MEA) Ministry of External Affairs

• Ms Aradhana Johri Secretary, DoP

• Shri K.L. Sharma Joint Secretary, Department of Health, MoH&FW

• Shri D.V. Prasad Joint Secretary, DIPP

• Shri Rajeev Arora Joint Secretary, (Com)

• Ms Chandni Raina Director, DIPP

• Ms Mugdha Sinha Director, Department of Commerce


• Sameer Savkur, Biogen Idec and Vice President, OPPI

• Shirish Ghoge, Abbott

• Dr Gaurav Arya, Eli Lilly

• Dr Ratnesh Lal, MSD

• Tarun Bhatnagar, Sanofi

• Tabrez Ahmad, OPPI






• Ranjit Shahani, Novartis and Immediate Past President, OPPI


• K G Ananthakrishnan, MSD and Vice President, OPPI

• Aijaz Tobaccowalla, Pfizer and Vice President, OPPI

• Ranjana Smetacek, OPPI



Discussion on Innovation and IPR

Discussion on Innovation and IPR

Discussion on challenges in the pharmaceutical industry

Discussions on the various issues related to the pharmaceutical industry

1 28.08.2014

2 09.09.2014

3 15.09.2014

4 15.09.2014

36



• Shri Injeti Srinivas Chairman, NPPA

• Officials from NPPA

• Shri K.L. Sharma Joint Secretary, Department of Health, MoHFW

• Shri Amit Khare Member Secretary, NPPA

• Dr M. Ariz Ahammed Joint Secretary, DoP


• Shri Sudhansh Pant Joint Secretary, DoP

Matters related to the DPCO 2013/ Pharmaceutical Policy issues

Industry related issues

Discussions on Guidelines dated August 20, 2014 issued by Odisha State Drug Control Department, for sale of drugs in Odisha

Courtesy call

Courtesy call

Matters related to New Drug Approval Process, Clinical Trials, Biosimilars and Import Regulation

Courtesy call

• Sameer Savkur, Biogen and Vice President, OPPI

• K.G. Ananthakrishnan, MSD and Vice President, OPPI





• Sudarshan Jain, Abbott and Vice President, OPPI





• Amitabh Baxi, Abbott

• Khomba Singh, Pfizer

• Prem Singh Rawat, OPPI



• Surbhi Chawla, BMS


• Dr Ratnesh Lal, MSD

• Sundeep Kumar, Novartis




• Navin Sharma, Baxter

• Surbhi Chawla, BMS

• Sharad Goswami, Pfizer




5 19.09.2014

6 30.09.2014

7 30.09.2014

8 01.10.2014

9 08.10.2014

10 10.10.2014

11 14.10.2014



• Shri Ali Raza Rizvi Joint Secretary, MoHFW

• Dr V.K. Subburaj Secretary, DoP

• Shri Shailendra Kumar Director - Health, MoHWF

• Shri Ajay Shankar Secretary, NMCC


• Officials from various ministries of Central Government

• Advisory Group Meeting CUTS International

• NLEM Core Committee






• Dr Jagdish Prasad Director General, DGHS

• Dr G.N. Singh DCGI

• Shri A.K. Pradhan Dy DCI

• Shri R. Chandrashekhar Dy DCI

• Shri Arvind Kukrety Dy DCI

• Officials from CDSCO



• Gaurav Arya, Eli Lilly









• Nominated Members from the OPPI Finance & Taxation Committee

• Dr Shailesh Ayyangar, Sanofi and President, OPPI






• Members of OPPI Medical & Regulatory Work Group

Courtesy call

Courtesy call

Regulatory issues, NLEM 2011, Clinical Trials

Discussions on the need for policies on New Drugs and the challenges on Make in India for the pharmaceutical industry

Business Responsibility Guidelines for the Pharmaceutical Sector

Participation in the National Consultation of NLEM 2011 revision

Issues related to pharmaceutical pricing and other challenges

Request to include OPPI in the Task Forces constituted by the DoP

Regulatory issues: PET Bottles and Clinical Trials approvals

12 15.10.2014

13 21.10.2014

14 29.10.2014

15 29.10.2014

16 30.10.2014

17 01.11.2014

18 03.11.2014

19 10.11.2014

20 12.11.2014

38


• Shri Jagdish Kumar Director, NPPA

• Shri S.S. Bisht Director, NIC


• Dr Ahmed Kamal Director, NIPER

• Dr Srinivasan Nanduri NIPER

• Dr Shraddha Choudhary NIPER

• Dr Satyanarayanan NIPER


• Shri Kaushal Shrivastav Chairman, CBEC

• Officials from CBEC Department of Revenue


• Officials from DoP



• Shri B.K. Singh Director, DoP

• Shri Ashish Banerjee Economic Officer, DIPP



• Vivek Padgaonkar, OPPI

• Dr Ramakrishnan Sundaram, BMS

• Amita Bhave, Novartis

• Yasmin Shenoy, Sanofi




• Manish Vora, J&J

• Gaurav Karnik, E&Y

• Anupam Jain, KPMG



• Meenu Batolar, Biogen Idec







• Gaurav Karnik, Ernst & Young LLP



NPPA meeting with industry bodies on the Integrated Pharmaceutical Database Management System (IPDMS)


Industry Academia interaction

Matters related to PET bottles; local phase III data waiver for new drugs, new indications and line extensions

Ministry of Finance Pre-Budget meeting for Union Budget 2015-16

Meeting on DoP Task Force on Medical Devices

Meetings of the Task Force on e-Samiksha

Matters related to the NPPA notifications & National Consultation by NLEM Committee

OPPI Budget Proposal 2015-16

21 13.11.2014

22 16.11.2014

23 21.11.2014

24 24.11.2014

25 26.11.2014

26 27.11.2014

27 10.12.2014

28 10.12.2014

29 12.12.2014







• Officials from DoP, Ministry of Commerce and CDSCO



• Officials from DoP Ministry of Commerce and CDSCO


• Officials from DoP Ministry of Commerce and CDSCO





• Shri Awadhesh K. Chaudhury Director, DoP

• Shri R Chandrashekhar Dy DCI

• Shri Raj Kumar Under Secretary, DoP

• Shri Awadhesh K. Chaudhury Director, DoP












• Shiv Prasad Laud, Roche








2nd meeting of DoP Task Force on Medical Devices

Meeting of DoP Task Force on development of manufacturing capabilities in each medical vertical in pharmaceutical production


Meeting of the Task Force on e-Samiksha

Meeting of the sub-group of DoP Task Force on Medical Devices

Odisha Drug Inspectors restricting sale of certain cough syrups, citing DPCO provisions

Presentation on Patented Drugs Pricing Policy to the Inter-Ministerial Committee on Prices of Patented Drugs

Discussion on the sub-group on NCD under Task Force on Critical Medical Verticals

30 13.12.2014

31 18.12.2014

32 22.12.2014

33 29.12.2014

34 02.01.2015

35 02.01.2015

36 07.01.2015

37 08.01.2015

38 09.01.2015

40



• Shri M. Zakaria Khan Yusufzai Sr. Development Officer, DIPP

• Officials from the Ministry of Commerce


• Officials from DoP and other Ministries

• Shri M. Zakaria Khan Yusufzai Sr. Development Officer, DIPP and other officials from the Ministry


• Members of IPR Think Tank

• Shri K.L. Sharma Joint Secretary, Department of Health, and officials from MoHFW

• Shri Sudhansh Pant Joint Secretary, DoP in Mumbai


• Prabhat Jain, Abbott






• Shilpa Arora, Merck Serono


• Tabrez Ahmad, OPPI • Sharad Tyagi, Boehringer Ingelheim and Vice President, OPPI

• Pravin Anand, Patent Attorney



• Meenu Batolar, Biogen Idec

• Dr Shailesh Ayyangar, Sanofi and President OPPI



• Bratin Bag, BMS

• Jayashree Shetty, J&J

• Ashish Vohra, Pfizer



• Meeting of the sub-group of the Task Force for e–Samiksha: Industry Government Linkages.

• Meeting of the sub-group on high-end medical devices and pharmaceuticals manufacturing equipment

Meeting of DoP Task Force on Medical Devices

Meeting of the sub -group on high-end medical devices and pharmaceuticals manufacturing equipment

Regulatory issues related to pharmaceutical industry

Draft National IPR Policy consultations

Matters on Drugs & Cosmetics Amendment Bill

Follow up on the UCPMP

39 18.01.2015

40 19.01.2015

41 29.01.2015

42 03.02.2015

43 03.02.2015

44 05.02.2015

45 05.02.2015

46 10.02.2015




• Other NPPA Officials


• Shri N.S. Kang Additional Secretary, Health & DG-CGHS


• Dr G.N. Singh DCGI • Senior officials from CDSCO


• Shri Atul Chaturvedi Joint Secretary, DIPP




• Shri Shailendra Kumar Director, Health, MoHFW



• Mehul Thakkar, J&J

• Vivek Dhariwal, Pfizer









• Neelima Dwivedi, MSD


• Ranjita Sood, Roche



• Dr Suresh Menon, Novartis












Issues related to the display of Distinguishing Mark and Ceiling Price/Unit in respect of Schedule Drugs under DPCO 2013

Odisha FDA’s restriction on sale of cough syrups under the provisions of DPCO 2013

Courtesy call


Meeting with the industry associations

DPCO 2013 & Pharmaceutical Policy

FDI in Pharmaceutical Industry

Regulatory issues

4th Meeting of the DoP Task Force on high-end Medical Devices and pharmaceutical manufacturing equipment

47 12.02.2015

48 13.02.2015

49 17.02.2015

50 18.02.2015

51 21.02.2015

52 24.02.2015

53 24.02.2015

54 24.02.2015

55 05.03.2015

42




• Angel-Michael Evangelista, Bayer and Member OPPI Executive Committee

• K. Shivkumar, Eisai and Member OPPI Executive Committee

• G. Sathya Narayanan, Galderma and Member OPPI Executive Committee

• Sanjiv Navangul, J&J and Member OPPI Executive Committee

• Dr Ramesh Panchagnula, Nektar and Member OPPI Executive Committee

• Aman Bajaaj, Takeda and Member OPPI Executive Committee




• Ajit Bendre, OPPI





• K. Shivkumar, Eisai and Member OPPI Executive Committee


• Sanjiv Navangul, J&J and Member OPPI Executive Committee




• Ajit Bendre, OPPI

Meeting of the OPPI Executive Committee members with NIPER

Meeting of the OPPI Executive Committee members with Government of Punjab at Invest Punjab, Chandigarh

56 11.03.2015

57 12.03.2015

• Prof K.K. Bhutani Director (Offg.), NIPER, Mohali, Punjab - Meetings organised at the behest of Punjab Government and facilitated by KPMG

• Shri Sukhbir Singh Badal Deputy Chief Minister of Punjab

• Dr Karan Avtar Singh Principal Secretary, Investment Promotion

• Shri Anirudh Tewari CEO, Invest Punjab

• Officials from Invest Punjab

• Utkarsh Palnitkar KPMG



• Shri Ananth Kumar Hon’ble Minister of Chemicals & Fertilizers



• Senior officials of the Ministry

• Dr Harshadeep Kamble Commissioner FDA, Maharashtra

• Shri Injeti Srinivas Chairman, NPPA in Mumbai

• Shri Injeti Srinivas Chairman, NPPA in Mumbai




• Shri R.K. Maggo Director, DoP


• Dr Harshadeep Kamble FDA Commissioner, Maharashtra




• Dharmesh Kharwar, MSD

• Sadhana Mogre, Sanofi

• Krishna Parab, Sanofi


• Rajiv Shukla, OPPI

• Dr Ajay Sharma, OPPI




• Jitendra Tyagi, BMS and Member OPPI Executive Committee



• Giri Giridhar, MSD

• Varun Gupta, Novartis



• Vishal Maheshwari, Abbott

• Manish Vora, J&J




• Other Industry Associations


• Ashish Jain, Abbott

• Suresh Nair, Ernst & Young LLP

• Krishan Parab, Sanofi

Launch of Jan Samadhan and release of NPPA Compendium – 2015

Industry interaction with new FDA Commissioner, Maharashtra

Issues of Implementation of DPCO 2013

Industry issues

To discuss proposals for amendment in DPCO 2013

Follow-up on meeting of March 17, 2015

58 12.03.2015

59 17.03.2015

60 18.03.2015

61 19.03.2015

62 25.03.2015

63 26.03.2015

44


• Dr V.M. Katoch former DG - ICMR & Secretary, Dept. of Health Research


• Dr Y.K. Gupta Head & Professor, Dept. of Pharmacology, AIIMS





• Shri Rajiv Aggarwal Joint Secretary, DIPP


• Shri R. Chandrashekhar Dy DCI


• Rajiv Shukla, OPPI




























• Ms Meenu Batolar, Biogen Idec

Matters related to NLEM and Access to Healthcare

Regulatory issues and PET bottles

Matters related to NLEM and Access to Healthcare

• Regulatory issues: D&C Bill, PET bottles ban

• NLEM 2011

Issues related to Pricing/DPCO 2013/NLEM 2011

To chalk out calender of events/programmes to be organised in partnership with DoP

Courtesy meeting

IPR issues

Discussion on e-Governance and

64 30.03.2015

65 30.03.2015

66 31.03.2015

67 31.03.2015

68 31.03.2015

69 01.04.2015

70 06.04.2015

71 06.04.2015

72 10.04.2015



• PHD Chamber Core Group Vision 2020 for Pharma & Medical Devices Sector


• Dr Eswara Reddy Joint DCI




• Dr. Sanjay Jaiswal MP of BJP


• Dr Subhash Bhamre BJP, MP


• Rishi Kapur, BMS

• Dr Lakhvinder Singh Batolar, J&J




• Ketan Kotadiya, Roche

• Gopinath Balaji, Quintiles

• Tabrez Ahmad, OPPI and Representatives of Indian Association of Dermatology, Leprology and Venerology


• Jayasree Menon, GSK


• Kedar Suvarnapathaki, Bohringer-Ingleheim

• Vinod Mattoo, BMS

• Rahul Chauhan, Eli Lilly



• Dr Shashwati Pramanik, Amgen

• Dr Ramakrishnan Sundaram, BMS






• Dr Veena Jaguste, Amgen

• Dr Viraj Suvarna, Boehringer Ingelheim



Digitisation of services at CDSCO

Discussion to formulate the vision for Pharma and Medical Devices Sector

Discussion on e-Governance and digitalisation of services at CDSCO

Discussion on Patient Safety

Proposals for amendment of DPCO 2013

• D&C Amendment Bill & Rules

• Clinical Trials waiver for life threatening diseases

• 3 trial site per investigator

• Clarity on Subject Expert Committee (SEC)

Discussion on healthcare policies

• Import related issues & Rule 37

• National Institute of Biologicals NIB Testing issue

73 10.04.2015

74 13.04.2015

75 24.04.2015

76 06.05.2015

77 06.05.2015

78 08.05.2015

79 12.05.2015

80 13.05.2015

46


• Shri Bhanu Pratap Sharma Secretary, Department of Health, MoHFW

• Shri Hansraj Gangaram Ahir Minister of State for Chemicals & Fertilizers


• Shri Arvind Kumar Principal Secretary to Government of Maharashtra


• Shri Rajiv Aggarwal Joint Secretary, DIPP

• Shri Ananth Kumar Minister for Chemicals & Fertilizers


• Senior officials of DoP

• Suneela Thatte, Quintiles



• Dr Veena Jaguste, Amgen

• Dr Viraj Suvarna, Boehringer Ingelheim






• Sharad Tyagi, Boheringer Ingelheim and Vice President OPPI

• K.G. Ananthakrishnan, MSD and Vice President OPPI

• Aman Bajaaj, Takeda and Member OPPI Executive Committee

• Pushpak Khare, Abbott

• N. V. Challapathi Rao, Bayer





• A joint industry delegation







• Clinical Trial waiver for life - threatening diseases

Drugs & Cosmetics Amendment Bill and Rules

Discussion on industry issues

NIPER Meeting at Guwhati

Issue of fixed working hours of the medical representatives

Discussions on issues related to IPR

Discussions on issues related to IPR

• NIPERs

• NLEM 2011

• DPCO 2013

81 13.05.2015

82 13.05.2015

83 19.05.2015

84 22.05.2015

85 26.05.2015

86 27.05.2015

87 30.05.2015




• Dr G.N. Singh, DCGI

• Shri A.K. Pradhan Dy Drugs Controller (I)

• Dr Ranjit Roy Chaudhury Chairman – Expert Committee to Formulate Policy Guidelines & SOPs for Approval of New Drugs, Clinical Trials & Banning of New Drugs



• Dr V.G. Somani Joint Drugs Controller (I)


• Shri Shailendra Kumar Director, Health, MoHFW



• Senior Officials


• Ms Shobha Mishra Ghosh FICCI

• Shri D Sengupta CII

• Shri Ombeer Tyagi ASSOCHAM

• Sharad Tyagi, Boehringer Ingelheim and Vice President, OPPI



• Members of OPPI Medical and Regulatory Work Group

• NGOs and other stakeholders

• Dhritiman Biswas, Abbott




• Dr Rishi Kapur, BMS


• Amit Mookim, IMS



• Anirban Roychowdhary, Merck






Regulatory issues

Related to Odisha Drugs Controller’s restriction on sale of cough syrups

Amendments to Drugs & Cosmetics Rules,1945, pertaining to drugs

Discussion on the Study - Access and Affordability in India - Assess the Impact of Price Control Measures

Amendments to Drugs & Cosmetics Rules, 1945, pertaining to clinical trials

Amendments suggested in DPCO-2013


88 30.05.2015

89 04.06.2015

90 05.06.2015

91 08.06.2015

92 08.06.2015

93 09.06.2015

94 09.06.2015

48


• Shri Sudhanshu Pandey Joint Secretary, Department of Commerce

• Shri Anurag Jain Joint Secretary, Prime Minister’s Office

• Dr K. Bangarurajan Dy Drugs Controller (India) DGHS, SDSCO, West Zone

• Dr Sharmila Mary Joseph Member Secretary, NPPA

• Senior officials of NPPA


• Senior officials of CDSCO

• Shri Manoj Jhalani Joint Secretary, MoHFW

• Shri Anshu Prakash Joint Secretary, MoHFW





• Shri Sudhansh Pant Joint Secretary








• Sachin Sable, MSD


• Sofia Braganza, Pfizer




• Meenu Batolar, Biogene Idec












Issue pertaining to Form 11 Export and Import NOCs and other related matters.

Discussions on the Odisha Drugs Controller’s restriction on sale of cough syrups.

Meeting on amendments to Drugs & Cosmetics Rules, 1945 pertaining to drugs

Regulatory and Healthcare issues

IP and FDI Issues

Launch of the Report of the Task Force on e-Samiksha

Launch of Pharma Price Data Bank (PPDB) – IPDMS

95 10.06.2015

96 10.06.2015

97 10.06.2015

98 11.06.2015

99 11.06.2015

100 12.06.2015

101 12.06.2015

102 22.06.2015

103 25.06.2015



• Shri V.K. Subburaj Secretary, DoP





• Dr Mohd. Shaukat Usta Dy DG, DGHS

• Dr Alka Sharma Department of Biotechnology




• Officials of NPPA


• Shri Sudhansh Pant Joint Secretary, DoP and officials from the Department


• Shri Sudhansh Pant Joint Secretary, DoP,

• Officials from the NPPA and CDSCO

• Shri Mohapatra Odisha Drugs Controller

• Shri V.K. Subburaj Secretary, DoP










• Sanchit Nanda, Novartis








• Dhritiman Biswas, Abbott




Meeting of the Task Force for development of manufacturing capabilities in each medical vertical in pharmaceutical production

Sub-group on NCDs under Task Force for development of manufacturing capabilities in each medical vertical in pharmaceutical production

Matters related to high margins in retail marketing of ‘traded generic medicines’


Meeting on amendments in DPCO 2013

Meeting to invite for the OPPI Fourth Healthcare Access Summit

Matters related to Codeine-based cough syrups issue with Odisha Drug Authorities

Meeting to invite for the OPPI Fourth Healthcare

104 01.07.2015

105 03.07.2015

106 14.07.2015

107 14.07.2015

108 15.07.2015

109 21.07.2015

110 21.07.2015

111 22.07.2015

50




• Shri Bibek Debroy Member, Niti Aayog




• Shri Sanjiv Kumar ADCI, CDSCO

• Ms Barnali Khastgir Under Secretary, DoP

















• Neelima Dwivedi, MSD




• Arun Mishra, Abbott

• Shripal Sharma, Bayer


• Representative from IPA







Access Summit

Sub-group on NCDs under Task Force for development of manufacturing capabilities in each medical vertical in pharmaceutical production

Meeting to invite for the OPPI Fourth Healthcare Access Summit

Meeting to invite for the OPPI Ethics and Compliance Conclave

Related to DPCO issues

Challenges faced in acceptance of GMP certificate

Related to Odisha FDA’s restrictions on sale of Codeine base formulations / SC Order

Meeting called by Hon’ble Minister of Chemicals & Fertilizers on the UCPMP

Task Force for development of manufacturing capabilities in each medical vertical in pharmaceutical production

112 22.07.2015

113 22.07.2015

114 22.07.2015

115 23.07.2015

116 24.07.2015

117 28.07.2015

118 29.07.2015

119 31.07.2015





• Dr V.G. Somani

Joint Drugs Controller (India)





















• Shrisih Ghoge, Abbott

• Shubhra Thakur, MSD















Matters related to the medical devices sector

Import issues in case of change of registration certificate

Discussion on the IPDMS and its functioning

Issues related to optimum capacity utilisation of Bulk Drugs/APIs

Trade Margins

India Pharma Awards

Regulatory issues

Regulatory issues

120 04.08.2015

121 07.08.2015

122 11.08.2015

123 11.08.2015

124 14.08.2015

125 26.08.2015

126 28.08.2015

127 28.08.2015

52


• Shri Jagdish Kumar Director (Monitoring), NPPA


• Ms Barnali Khastgir Under Secretary, DoP

• Shri Jagdish Kumar Director (M&E), NPPA

• Shri Jagdish Kumar Director (M&E), NPPA • Shri Injeti Srinivas Chairman, NPPA

Date Subject Addressed to

Ministry Representations

1 18.08.2014

2 03.09.2014

3 18.09.2014

4 24.09.2014

5 25.09.2014

Comments on the draft NPPA guidelines for discontinuation of Scheduled Formulations under Para 21(2) of DPCO, 2013

Pre-Budget Memorandum 2015-16

• Recommendations on the draft NPPA guidelines for discontinuation of Scheduled Formulations under Para 21(2) of DPCO, 2013

• Comments on the draft Internal Guidelines for dealing with cases of Price Revision under Para 19 of DPCO, 2013

Benefit of excise notification to be extended for Non-Scheduled Formulations covered under Para 19

Fixing of prices of products included in the Scheduled category under DPCO 1995 and DPCO 2013

1 Ministry of Chemicals & Fertilizers (DoP, NPPA) 31

2 Ministry of Health & Family Welfare / CDSCO / IPC / FDA 38

3 Ministry of Commerce & Industry 8

4 Ministry of Finance 12

5 Ministry of Labour & Employment 3

6 Others 5

Total: 97

Representations 2014-15w.e.f. August 16, 2014

Summary:

MINISTRY OF CHEMICALS & FERTILIZERS (Department of Pharmaceuticals – DoP and National Pharmaceutical Pricing Authority - NPPA)



• Shri A.K. Chaudhury Director, DoP








• Shri A.K. Chaudhury Director, DoP





• Shri Shyam Agrawal Assistant Director (M&E), NPPA


• Dr V.M. Katoch Chairman, Core Committee on Revision of NLEM 2011

6 17.10.2014

7 22.10.2014

8 22.10.2014

9 04.11.2014

10 05.11.2014

11 27.11.2014

12 28.11.2014

13 28.11.2014

14 28.11.2014

15 12.12.2014

16 19.12.2014

17 30.01.2015

18 12.02.2015

19 20.02.2015

Comments on detailed project report on Investment in Innovative Pharma: Establishing Pharma Funds

Integrated Pharmaceutical Database Management System (IPDMS)

Price reduction to be prospective instead of retrospective

Internal guidelines for soliciting representation to NPPA against price notification, without prejudice

OPPI’s inclusion in the newly constituted Task Forces of DoP

Comments on the draft proposal for display of distinguishing mark and ceiling price/unit in respect of Scheduled Drugs under DPCO 2013

Demand assessment for GLP compliant testing labs for pharmaceutical sector

Discrepancies noted/rectification proposed for National List of Essential Medicines (NLEM) 2011

Uniform Code of Pharmaceutical Marketing Practices (UCPMP)

Comments on public notice dated November 21, 2014 with respect to inclusion of certain anti-cancer drugs in NLEM 2011

OPPI’s partnership with DoP

Response to NPPA’s request for information on patented drugs from OPPI member companies

Suggestions on the UCPMP

Revision of the NLEM 2011

54



• Shri Shyam S Agrawal Asst. Director (M&E), NPPA


• Shri Ananth Kumar Hon’ble Minister for Chemicals & Fertilizers



• Shri Ananth Kumar Hon’ble Minister for Chemicals & Fertilizers








20 02.03.2015

21 06.04.2015

22 14.04.2015

23 29.05.2015

24 02.06.2015

25 04.06.2015

26 22.06.2015

27 26.06.2015

28 30.06.2015

29 10.08.2015

30 18.08.2015

31 28.08.2015

Information on patented drugs from OPPI member companies

DPCO 2013 Amendment – OPPI’s recommendations


DPCO 2013 – regarding notification S.O. 932(E) dated March 27, 2014

Amendment to DPCO 2013 - regarding notification S.O. 686(E) dated March 09, 2015


Amendment in the DPCO 2013

Comments / suggestions on the draft National Medical Device Policy 2015

OPPI comments on the Proposed Amendment in DPCO, 2013 from NPPA

Challenges while using the IPDMS

Comments on the suggestions from NPPA in respect of Proposed Amendment in DPCO, 2013

Comments on NPPA’s recommendations to the Government on trade margins



1 18.08.2014 Comments on proposal for creation of IT enabled system for Clinical Trials

MINISTRY OF HEALTH & FAMILY WELFARE (MoHFW) / CDSCO



• Dr A.K. Panda Additional Secretary, MoHFW

• Dr G.N. Singh Drugs Controller General (India)

• Shri K.L. Sharma Joint Secretary, MoHFW

• Shri Hrushikesh Mahapatra, Dy. Drugs Controller (Int) & D.C.(O) i/c, Office of the Directorate of Drugs Control Odisha

• Ms Arti Ahuja Commissioner cum Secretary (Health & FW) Department of Health & Family Welfare Government of Odisha





• Shri J.P. Nadda Hon’ble Minister of Health & Family Welfare

• Shri Deepak Kumar Principal Secretary, Ministry of Health Government of Bihar

• Prof Ranjit Roy Chaudhury Advisor, MoHFW

• Dr Shailendra Kumar Director (Drugs), MoHFW

• Ms Anita Tripathi Under Secretary, MoHFW

• Ms Anita Tripathi Under Secretary (Drugs), MOHFW

• Dr. G.N. Singh DCGI

3 27.08.214

4 23.09.2014

5 27.10.2014

6 04.11.2014

7 04.11.2014

8 10.11.2014

9 11.11.2014

10 14.11.2014

11 05.12.2014

12 22.12.2014

Suggestions on GSR 503(E) dated July 14, 2014 regarding amendment of Rule 105 of the Drugs & Cosmetics Rules, 1945

Guidelines dated August 20, 2014 passed by the Odisha State Drug Department in respect of sale of drugs in Odisha

Streamlining regulatory processes of the pharmaceutical industry

Draft notification GSR 701(E) dated September 29, 2014 regarding banning PET bottles in specific uses

Action against unethical practices in pharmaceutical marketing

Submission emphasising priorities to support the healthcare objectives and revitalise the pharmaceutical industry

To revoke the recent Order imposed on the sale of codeine-based cough syrups in Bihar

Draft notification GSR 701(E) dated September 29, 2014 regarding banning PET bottles in specific uses

Amendment in Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954

Comments on the strengthening of drug regulatory framework in India viz. (i) CDSCO and (ii) States’ drug regulatory system

• Shri Deepak Kumar Principal Secretary, Ministry of Health Government of Bihar

2 22.08.2014

To revoke the recent Order imposed on sale of codeine-based cough syrups in Bihar

56


• Ms Anita Tripathi Under Secretary (Drugs), MOHFW

• Shri Shailendra Kumar Director (Drugs), MoHFW

• Ms Anita Tripathi Under Secretary (Drugs), MoHFW


• Dr. G.N. Singh DCGI


• Shri J.P. Nadda, Hon’ble Minister of Health & Family Welfare

• Dr V.M. Katoch Former Secretary, Department of Health Research & Director General, ICMR

• Dr Y.K. Gupta Professor & Head, Department of Pharmacology, AIIMS


• Dr V.K. Subburaj, Secretary, DoP

• Shri K.L. Sharma, Joint Secretary, MoHFW

• Dr Mohd. Shaukat Usta Deputy Director General (NCD), DGHS, MoHFW

13 12.01.2015

14 16.01.2015

15 28.01.2015

16 02.02.2015

17 11.02.2015

18 02.04.2015

19 14.04.2015

20 23.04.2015

21 13.05.2015

22 18.05.2015

Constitution of a committee for examining and recommending amendment in the Drugs & Cosmetics Rules, 1945

Comments and suggestions on the draft Drugs & Cosmetics (Amendment) Bill, 2015

Comments and suggestions regarding amendment in the Drugs & Cosmetics Rules, 1945

Follow up on meeting of the sub-group on regulatory issues under the Task Force on promotion of domestic production of high-end medical devices and pharmaceutical manufacturing equipment in the country

CDSCO’s notice on pre-submission meetings – (regulatory pathways)

OPPI recommendations on Test Import License Validity (for drugs imported for use in Form 11 for examination/test/analysis)


Exemption of low priced drugs from price control

Position paper on the working of Genetic Engineering Appraisal Committee (GEAC)

Submission of the final report to sub-group on Non-Communicable Diseases (NCDs) under the Task Force ‘Development of Capabilities for Each Medical Vertical’



• Shri Bhanu Pratap Sharma Secretary, MoHFW


• Dr G.N. Singh, DCGI





• Shri R. Chandrashekhar Deputy Drugs Controller (India)

• The Under Secretary, MoHFW





• Shri Bhanu Pratap Sharma Secretary, MoHFW

23 18.05.2015

24 18.05.2015

25 21.05.2015

26 09.06.2015

27 24.06.2015

28 01.07.2015

29 02.07.2015

30 10.07.2015

31 17.07.2015

32 20.07.2015

33 21.07.2015

34 22.07.2015

35 05.08.2015

36 05.08.2015

Follow up on the May 13, 2015 interaction with the Medical & Regulatory WG

Follow up on the May 13, 2015 interaction with thre Medical & Regulatory WG

Follow up letter regarding regulatory issues

Follow up letter regarding regulatory issues

Position on consideration of local Clinical Trials (CTs) data waiver for life-threatening diseases

Training of CDSCO Inspectors

Import issues in case of change in Registration Certificate

Meeting on the Amendment in the Drugs & Cosmetics Rules, 1945 pertaining to drugs, held on June 11, 2015

Notification dated June 03, 2015 regarding draft rules to amend the Drugs and Cosmetics Rules, 1945, in Rule 96, in sub-rule (1) G.S.R. 449 (E) – F.No. 02/Misc./2010-DC/DFQC

Grievances of the clinical research fraternity on the restrictive limit on the number of CTs (not more than 3) that may be conducted by an investigator and proposal to amend the limit with justification

Position paper on the current DCGI practice of Registration of multiple site involved in a single imported product

CDSCO’s Notice dated June 04, 2015 - regulatory compliance of drugs imported into the country

Office notice dated July 22, 2015 DCG(I)/Misc.2015 (132) in context of permission obtained from DCGI for new drugs, CTs on bioavailability/bioequivalence studies

Imported Drugs: Implementation of physical verification and testing of all the

58


• Dr V.G. Somani Joint Drugs Controller (India)

• Shri Ali Rizvi Joint Secretary, Medical Education, MoHFW

37 11.08.2015

38 18.08.2015

drug products at Mumbai air and sea ports from July 2015

Import issues in case of change of Registration Certificate (follow up of interaction with Dr V.G. Somani)

Rational prescription of drugs and use of ‘Generic Names’

• Shri Rajeev Kher Secretary, Department of Commerce

• Shri Amitabh Kant Secretary, Department of Industrial Policy & Promotion (DIPP)

• Justice Prabha Sridevan Chairperson, IPR Think Tank


• Shri Ishtiyaque Ahmed Director, DIPP

• Smt Nirmala Sitharaman Hon’ble Minister of State for Commerce & Industry (Independent Charge)


• Shri Ishtiyaque Ahmed Director, DIPP

• Justice (Retd.) Prabha Sridevan Chairperson, IPR Think Tank

• Shri Narendra K. Sabharwal Convener Member, IPR Think Tank


1 17.09.2014

2 29.10.2014

3 28.11.2014

4 16.12.2014

5 18.12.2014

6 14.01.2015

7 30.01.2015

8 02.03.2015

Challenges faced by the research-based pharmaceutical industry in India

IPR Think Tank constituted by the DIPP

Public Notice dated November 13, 2014 seeking comments in respect of the proposed National IPR Policy

Mapping of the activities covered under Chapter VI of the consolidated Foreign Direct Investment (FDI) Policy, 2014 using NIC – 2008 codes

IPR Think Tank constituted by the DIPP

Views and suggestions on the consolidated FDI Policy circular 2015

Feedback on the draft National IPR Policy



MINISTRY OF COMMERCE & INDUSTRY



MINISTRY OF FINANCE (MoF)

• Shri S.K. Shrivastava Additional Chief Secretary Finance Department, Government of Maharashtra

• Secretary Department of Finance & Revenue, MoF

• Chairman Central Board of Excise & Customs

• Joint Secretary Tax Policy & Legislation (TPL), Central Board of Direct Taxes

• Joint Secretary (TRU-1)

• Shri Arun Jaitley Hon’ble Finance Minister

• Shri Sanjay Aggarwal Director, Public Procurement Division (PPD), Department of Expenditure, MoF

• Shri Jayant Sinha Hon’ble Minister of State for Finance

• Finance Secretary Department of Economic Affairs, MoF

• Secretary Department of Revenue, MoF

• The Commissioner (NC) Department of Revenue, MoF

• Director (Tax Policy & Legislation) Central Board of Direct Taxes

1 19.08.2014

2 03.09.2014

3 14.04.2015

4 15.04.2015

5 18.04.2015

6 29.04.2015

7 21.05.2015

8 29.05.2015

Recommendations on draft MVAT (Second Amendments) Rules, 2014 in relation to procedures/compliances for the issuance of e-waybill and transit pass

Pre-Budget Memorandum 2015-16


Suggestions/comments on Public Procurement Bill - stakeholders consultations Revision of the NLEM 2011

Recommendations : Post Union Budget 2015-16

Voluntary Code of Conduct (VCC) to NDPS (Regulation of Controlled Substance) Order, 2013

Comments on draft scheme of the Proposed Rules for computation of Arm Length Price (ALP) of an international transaction or specified domestic transaction


60


• Shri Prakash Manchhubhai Mehta Hon’ble Minister of Labour Government of Maharashtra

• Shri Vijay Sidramappa Deshmukh Hon’ble Minister of State for Labour, Government of Maharashtra

• Shri Baldev Singh Principal Secretary Department of Labour Government of Maharashtra

• The Chief Labour Office Department of Labour Government of Tripura

1 12.02.2015

2 03.06.2015

3 04.06.2015

Objection to notification G.N.No. SPE-2010/C.R. 143/Lab-3 dated January 15, 2014 issued by Labour Department, Maharashtra on the fixing working hours for the sales promotion employees

Meeting with the Industry delegation on May 22, 2015 regarding issues with fixing working hours for the sales promotion employees

Objection to the notification No. F.12(48)LAB/IR/2009/11607-21 dated September 06, 2014, Labour Directorate, Government of Tripura on fixing working hours for the sales promotion employees (Jointly by OPPI & IDMA)


MINISTRY OF LABOUR & EMPLOYMENT

• Shri Jayant Sinha Hon’ble Minister of State for Finance

• Ms Rashmi Verma Additional Secretary (Revenue) Department of Revenue, MoF

• Finance Secretary Department of Economic Affairs, MoF

• Revenue Secretary Department of Revenue, MoF

• Ms Rashmi Verma Additional Secretary (Revenue) Department of Revenue, MoF

9 01.06.2015

10 22.06.2015

11 05.08.2015

12 18.08.2015

FDI : Impact on the research-based pharmaceutical industry in India

Clarification on invitation of BIDs / proposals for production of concentrate of poppy straw & manufacture of Alkaloids

Suggestions on the Goods and Services Tax (GST)

Further clarification on invitation of BIDs / proposals for production of concentrate of poppy straw & manufacture of Alkaloids



Others

• Shri Nripendra Misra Principal Secretary to the Prime Minister of India



• Dr P.K. Mishra Additional Secretary to Prime Minister of India

• Shri K.A.P. Sinha Secretary to Government of Punjab

• Shri Rakesh Naithani Joint Director Rajya Sabha Secretariat

1 01.12.2014

2 07.04.2015

3 14.04.2015

4 03.06.2015

5 24.08.2015

Challenges facing the clinical research industry – over the last few years

OPPI position on the NLEM 2011


Comments on Policy for Bioscience Sector 2015

Suggestions on the ‘Ease of Doing Business’ to the Sub-Committee of DRSC on Commerce


62

With best compliments from



Nehru Centre, Mumbai

Palladium Hotel, Mumbai

St. Regis, Mumbai

OPPI, Mumbai

OPPI, Mumbai

OPPI, Mumbai

OPPI, Mumbai

OPPI, Mumbai

OPPI, Mumbai

Club Peninsula

Date Programme Venue


1 31.07.2015

2 07.08.2015

3 15.09.2015

Ethics & Compliance Conclave

Fourth Healthcare Access Summit

HR Summit: HR Imperatives for Organisational Sustainability

Interactive meeting: Ranjit Madan, Chief Executive Officer, Life Sciences Sector Skill Development Council (LSSSDC) with the Governance and Human Resource Management Committee

Presentation on New business models: operational efficiencies in the supply chain by Javin Bhinde, SynCore Consulting Group, to the Technical and Supply Chain Committee

Interaction of Healthcare Practitioners with the Ethics and Compliance WG

Presentation on Strategic levers for successful drug commercialization in India by Varun Gupta, Novartis, to the Finance and Taxation Committee

Presentation on the LSSSDC’s expectations from OPPI by KPMG, to the Governance and Human Resource Management Committee

Interactive meeting with KPMG on a study on the work done on CSR by OPPI members facilitated by the Access and Affordability WG

An interactive discussion between the E& Y Team led by Hitesh Sharma with the Finance and Taxation Committee on GST: impact, insight and way forward

Seminars and Knowledge Programmes

Seminars / Conferences

Knowledge Programmes

64

1 12.11.2014

2 27.11.2014

3 06.01.2015

4 08.01.2015

5 13.01.2015

6 14.01.2015

7 13.02.2015


OPPI, Mumbai

Club Peninsula

OPPI, Mumbai

OPPI, Mumbai

OPPI, Mumbai

OPPI, Mumbai

OPPI, Mumbai

OPPI, Mumbai

OPPI, Mumbai

OPPI, Mumbai

OPPI, Mumbai

OPPI, Mumbai

8 13.02.2015

9 02.03.2015

10 09.03.2015

11 10.03.2015

12 19.03.2015

13 31.03.2015

14 07.04.2015

15 10.04.2015

16 04.05.2015

17 12.05.2015

18 21.05.2015

20 19.06.2015

Presentation on Emergence of pan-India distributors and challenges to pharmaceutical companies by Ameesh Masurekar, Pharmatrack, AIOCD AWACS, to the Technical and Supply Chain Committee

Presentation on Union Budget by KPMG, to the OPPI members

Presentation on the Aarogya Bharat: India Healthcare Roadmap for 2025 by Bain & Company, to the Access and Affordability WG

Presentation on Building Contributors by V. Srinivas, Illumine Knowledge Resources, to the Governance and Human Resource Management Committee

Knowledge Session on the DPCO 2013 and the NPPP 2012 by Shirish Ghoge, Abbott Healthcare, conducted by the Finance and Taxation Committee

Interaction of NGOs with the Ethics and Compliance WG

Interactive session with Shweta Purandare, Secretary General, Advertising Standards Council of India (ASCI), organised by the Ethics and Compliance WG

Presentation on Electronic stock and sales system by Ameesh Masurekar, Pharmatrack, AIOCD AWACS, to the Technical and Supply Chain Committee

Interactive session with Shweta Purandare, Secretary General, ASCI, on the ASCI code and procedures on complaint handling, organised by Ethics and Compliance WG

Presentation on the various initiatives of LSSSDC by Ranjit Madan, CEO, LSSSDC, to the Governance and Human Resource Management Committee

Presentation on the Indian Accounting Standards converged with IFRS by Dinesh Jangid, KPMG, to the Finance and Taxation Committee

Presentation on If variable barcodes are made mandatory by Ameesh Masurekar, Pharmatrack, AIOCD AWACS, to the Technical and Supply Chain Committee



BioAsia 2015: New era of Life Sciences, organised by BioAsia, Faba

Reinventing business for global excellence, organised by Theory of Constraints International Certification Organisation (TOCICO)

Making a mega brand, organised by Brand Dialogue

Managing risks & liabilities in the pharmaceutical food & beverages sectors, organised by the Bombay Chamber of Commerce and Industry

Workshop on Future of Health, organised by Futureworlds

Knowledge Session on Conducting clinical trials in India by Amita Bhave, Novartis, conducted by the Legal Committee

Knowledge Session on 2015 Asia-Pacific market trends/insights for the pharmaceuticals & life sciences sector by Ashish Ambasta, Watson India, Governance and Human Resource Management Committee

Genome Valley, Hyderabad

Jaypee Golf Resorts & Spa, Greater Noida

Hyatt Regency, Mumbai

Vivanta by Taj President, Mumbai

Royal Bombay Yacht Club, Mumbai

OPPI, Mumbai

MSD Office, Mumbai


1 02.02.2015 03.02.2015 & 04.02.2015

2 18.04.2015 & 19.04.2015

3 08.05.2015

4 17.06.2015

5 28.07.2015

21 10.07.2015

22 21.08.2015

Events Supported by OPPI

66



Name Member company Year

Late Dr H.R. Nanji Pharmed 1966

Keith C. Roy Merck Sharp Dohme 1967 - 1969

Late Brig. B. S. Bhagat Rallis 1970 - 1973

S.V. Pillai Pfizer 1974 - 1975

Late Mr Sisir Mitra Cyanamid 1976 - 1978

Late Mr H.N. Dutt Gupta East India Pharmaceutical Works 1979

Late Dr S.K. Bhattacharya Sandoz 1980 - 1981

Late Mr George Daniel Hoechst 1982 - 1984

R.N. Langrana Abbott 1985

C.M. Hattangdi Parke - Davis 1986 - 1987

Dr S. Agarwala Rallis 1988 - 1990

D.K. Bose Burroughs Wellcome 1990 - 1992

H. Dhanrajgir Glaxo 1992 - 1994

Dr Anil S. Mehta Wyeth 1994 - 1996

D. Bhadury Hoechst Marion Roussel 1996 - 1998

H.R. Khusrokhan Glaxo 1998 - 2000

Late Mr P. Gupta Infar 2000 - 2001

Tapan Ray Abbott Sept. - Nov. 2001

Ranjit Shahani Novartis 2001 - 2007

Ranga Iyer Wyeth 2007 - 2009

Ranjit Shahani Novartis 2009 - 2013

OPPI Past Presidents

68



Organisation of Pharmaceutical Producers of IndiaMumbai: Peninsula Chambers, Ground Floor, Peninsula Corporate Park, Ganpatrao Kadam Marg,

Lower Parel, Mumbai 400 013. Tel: +91 22 2491 8123, +91 22 6662 7007 Delhi: Level 2, Elegance Building, Mathura Road, Jasola, New Delhi 110 025. Tel: +91 11 6635 1083

www.indiaoppi.com


Documents

49th Annual Report 2014-15