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)
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