India Pharma
Summit 2014-15
Policy Landscape Reforms for Strengthening
Indian Pharmaceutical Industry
“Focus on Critical Verticals to Foster Access to
Pharmaceuticals, Enhancing Production and Technology Adoption in
Pharmaceutical Enterprises & Medical Devices and Diagnostics”
rd
23 March 2015, Ramada Plaza Palm Grove, Mumbai
India Pharma
Summit 2014-15
Policy Landscape Reforms for Strengthening
Indian Pharmaceutical Industry
“Focus on Critical Verticals to Foster Access to
Pharmaceuticals, Enhancing Production and Technology Adoption in
Pharmaceutical Enterprises & Medical Devices and Diagnostics”
23rd March 2015, Ramada Plaza Palm Grove, Mumbai
The Department of Pharmaceuticals (DoP), Ministry of Chemicals & Fertilizers, Government of India in collaboration with
Federation of Indian Chambers of Commerce and Industry (FICCI) and the WHO Country Office for India is organizing the Sixth
India Pharma Summit 2014-15 on 23rd March 2015 at Mumbai.
Indian Pharmaceutical industry is estimated to be approx. USD $ 26 billion industry and is growing at an annual rate of 14%. The
industry has seen tremendous progress in terms of infrastructure development, technology base and the wide range of products
manufactured. To maintain continual access to affordable medicines and health products, it is necessary to augment the capacity of
the generic Indian pharmaceutical enterprises. This would further require efficient production and technology adoption measures to
ensure smooth access to the essential and good quality medicines.
The theme for this year's deliberations is “Policy Landscape Reforms for Strengthening Indian Pharmaceutical Industry” and critical
issues for the progress of the Indian pharmaceutical industry – various aspects of critical verticals to foster access to
pharmaceuticals at national and international levels, promoting production and technology adoption in Pharmaceutical Enterprises
for meeting national and global public health needs and the Regulatory issues and challenges for Medical Devices and Diagnostics.
This summit would provide a platform to various Departments of the Government in contributing to the vision for development of
policy framework reforms for strengthening Indian pharmaceutical industry.
Like last year, the summit would see a convergence of various stakeholders ranging from Indian and Global Pharmaceutical
Industry, Regulators and Policy Makers. Several international experts of repute are expected to participate and share best practices,
experiences & perspectives from across the globe.
Follow-up of the Past Summits
As an outcome of the previous Summits, Task Forces have been set up for R&D and Drug Discovery, Human Resources Development
(HRD) Capacity Building, and leadership in Clinical Research & Medical Devices. Additional taskforces for developing
manufacturing capabilities in each medical vertical in Pharma production, enabling the private sector and promotion of domestic
production of high end medical devices and pharma manufacturing equipment in the country have been set up by Government of
India.
Subsequent to the recommendations of the IPS 2014, two Regional Good Manufacturing Practices (GMP) Strengthening
Workshops for Indian Pharmaceutical Manufacturers and State Regulators focused on GMP in production of Active Pharmaceutical
Ingredients and Oral Solid Dosage Forms were organized at Mumbai and Chennai with the experts from WHO and MHRA. Three
more similar workshops are planned to be held in Bangalore, Gandhinagar and Goa in the month of April 2015.
Who Should Attend:
What to Expect:
• Decision-makers from: Think tanks/
Notified Bodies/Government
• Government Regulators
• Pharmaceutical and Biotech Industry
• CROs
• Public Health Organizations
• Venture Capital & Private Equity
• Academicians/ Research
• Institutions
• Deliberations on Critical Verticals to Foster Access to Pharmaceuticals at
National and International levels including focus areas for development of
manufacturing capabilities for the said critical verticals.
• Mechanisms to promote Production and Technology adoption in Pharmaceutical
Enterprises for Meeting National and Global Public Health Needs
• Understanding the Regulatory issues and challenges for Medical Devices and
Diagnostics in India including the issues of domestic production of high end
medical devices in India
• Strengthening the linkages of Indian Pharma industry with Pharmaceutical
research institutions like NIPERs etc
DRAFT PROGRAMME
08:30-09:30 Hrs: Registration
09:30-09:45 Hrs: Seating
9:45- 11:00Hrs Inaugural session
Session Moderator – Ms. Shobha Mishra Ghosh, Sr.
Director, FICCI
09:45-09:55Hrs Welcome Address
FICCI
09:55-10:05Hrs Opening Address
Dr Nata Menabde, WHO Representative to India
10:05–10:15 Hrs Special Address
Dr Habil Khorakiwala, Chairman FICCI Life
Sciences Council, Past President FICCI and
Chairman Wockhardt Group
10:15 -10:25Hrs Keynote Address
Dr. V K Subburaj, Secretary, Department of
Pharmaceuticals
10:25-10:35Hrs Inaugural Remarks
Shri Hansraj Gangaram Ahir, Hon’ble Union
Minister for State for Chemicals & Fertilizers
10:35- 10:50 Hrs Inaugural Address
Shri Ananth Kumar, Hon'ble Union Minister of
Chemicals & Fertilizers
10:50-10:53HRS Release of Position Paper
10:53–11:00 Hrs Concluding Remarks
*Mr Pankaj Patel, Vice President FICCI, Chairman
FICCI Pharmaceuticals Committee and Managing
Director, ZydusCadila
11:00-11:15 Hrs Tea Break
11:15-12:30 Hrs Session I
Critical Verticals to Foster Access to
Pharmaceuticals at National and International
levels
In this session we will focus on the policy
landscape reforms including ways of streamlining
the inter-ministerial and interdepartmental
coordination for the strengthening of the critical
verticals and the various challenges that should
jointly addressed by the industry and the
Government of India to create an enabling
environment for all key stakeholders – the
government, patients, pharma industry, and all
other stakeholders.
12:30-13:30 Hrs Lunch Break
13:30-14:50 Hrs Session II
The session would focus on promoting Production and
Technology adoption in Pharmaceutical Enterprises for
Meeting National and Global Public Health Needs.
Efficient production and technology adoption
measures are vital to ensure smooth access to the
essential and good quality medicines. This would
augment the capacity of Indian generic pharmaceutical
enterprises to meet the supply demands at National
and International levels. In this session, mapping the
landscape of pharmaceutical enterprises by
identification of measures needed to promote
production and technology adoption/transfer,
development of networks for promoting access to
medical products at national and global levels and
identification of mechanisms for the Indian
Government to perform a supporting role in transfer of
technology for production, including support to
national drug regulatory authorities would be
deliberated.
14:50-16:15 Hrs Session III
Regulatory issues and challenges for Medical Devices
and Diagnostics
In this session, the discussion would focus on the
present Indian medical device industry landscape
which is primarily import driven with imports
contributing close to 75% of the market. The domestic
market caters to low-value disposables and supplies
space, whereas importers dominate the expensive
high-end medical equipments with extensive service
networks. Along with the regulatory challenges for new
product development, the session would focus on
charting a road map for addressing the regulatory
issues for Medical Devices and Diagnostics in India
including the issues of domestic production of high end
medical devices.
16:15-16:30Hrs Tea Break
16:30-17:30 Hrs Valedictory session: Vision and Way Forward
This session will focus on the vision of various
Departments of the Government in contributing to the
policy framework reforms for strengthening the Indian
pharmaceutical industry, exploring mutually beneficial
synergies between the government, industry,
academia, medical profession and consumer groups to
usher the way for sustainable initiatives for improved
pharmaceutical access and identifying the various
ways of coordination between the various departments
of the Government.
About Organizers
The Department of Pharmaceuticals was created on 1st July 2008 to be a focused Department of Government of India for fostering growth of the
Indian Pharmaceutical Industry. The Department has been assigned several functions including inter-alia promotion of Research, Education and
Training, Public Private Partnership, international Cooperation, Inter- Sectoral cooperation, Industrial Cooperation, Environment and Hazard
Management and Pricing and Availability of Medicines. The Department of Pharmaceuticals discharges their functions through active consultations
with stakeholders to formulate new schemes/ proposals/ strategies for promoting growth of the Pharmaceutical Industry.
Established in 1927, FICCI is the largest and oldest apex business organisation in India. Its history is closely interwoven with India’s struggle for
independence, its industrialization, and its emergence as one of the most rapidly growing global economies. FICCI has contributed to this historical
process by encouraging debate, articulating the private sector’s views and influencing policy.
A non-government, not-for-profit organisation, FICCI is the voice of India’s business and industry.
FICCI draws its membership from the corporate sector, both private and public, including SMEs and MNCs; FICCI enjoys an indirect membership of
over 2,50,000 companies from various regional chambers of commerce.
FICCI provides a platform for sector specific consensus building and networking and as the first port of call for Indian industry and the
international business community.
Our Vision: To be the thought leader for industry, its voice for policy change and its guardian for effective implementation.
Our Mission: To carry forward our initiatives in support of rapid, inclusive and sustainable growth that encompass health, education, livelihood,
governance and skill development.
To enhance efficiency and global competitiveness of Indian industry and to expand business opportunities both in domestic and foreign markets
through a range of specialised services and global linkages.
World Health Organization is the United Nations' specialized technical agency for Health. It is an inter-governmental organization and works in
collaboration with its member states. WHO's objective is the attainment by all people of the highest possible level of health. Equitable access to
essential medicines for priority diseases is one of the requirements for fulfilling the fundamental right to health. WHO's Medicines' Strategy is
based on four key objectives: strengthening national medicines policy, improving access to essential medicines, the quality & safety of medicines,
and rational use of medicines.
WHO India Country Office collaborates with the Government of India and relevant stakeholders within the framework of the collaborative Country
Cooperation Strategy (CCS), to actively support the development and implementation of national health policies, strategies and plans in the area
of Essential Medicines & Pharmaceuticals, including access, quality and safety of medicines and impact of intellectual property rights on public
health.
For More Details Contact:
Mr. Raj Kumar
Under Secretary to the Government of India
Department of Pharmaceuticals
Ministry of Chemicals & Fertilisers
Shastri Bhawan, New Delhi
Email: [email protected]
Telephone:011-23071162
Mr. Kawaljeet Singh
Deputy Director
FICCI Federation House Tansen Marg,
New Delhi – 110001
Email: [email protected]
Telephone: 011-23487355
www.ficci.com
www.indiapharmasummit.in
Dr. Madhur Gupta
Technical Officer-Pharmaceuticals
WHO Country Office for India
RK Khanna Tennis Stadium,
Safdarjung Enclave
New Delhi – 110029
Email: [email protected]
Telephone: 011-66564800 (23274/23255)