From left to right: Ms Shoba Mishra Ghosh, Senior Director, FICCI; Mr Pankaj Patel, Chairman, FICCI Pharmaceuticals Committee and Managing Director, Zydus Cadila; Dr Nata Menabde, WHO Representative to India; Ms Aradhana Johri, Secretary, Department of Pharmaceuticals; Dr Habil Khorakiwala, Chairman FICCI Life Sciences Council and Chairman Wockhardt Group; Mr CP Singh, Chairman, National Pharmaceutical Pricing Authority; Dr Arbind Prasad, Director General, FICCI.
WHO Country Office for India in collaboration with the Department of Pharmaceuticals (DoP), Ministry of Chemicals & Fertilizers, Government of India and Federation of Indian Chambers of Commerce and Industry (FICCI) organized the Fifth India Pharma Summit on 20 March 2014 at Mumbai.
The theme for this year’s deliberations was: “Enhancing India’s Global Role in Supply of Generic Medicines - Focus on Strengthening Domestic Landscape of Active Pharmaceutical Ingredients (APIs), Regulation of Drug Trials and Fostering Innovation”.
Speaking at the summit, Dr Nata Menabde, WHO Representative to India said, “The issues of API’s quality, fostering R & D and innovation, and regulatory issues for clinical trials are key issues facing the pharmaceutical industry today.”
Dr Menabde highlighted the pivotal role being played by Indian manufacturers to the WHO Prequalification of Medicines Programme for increasing access to medicines in both developing and developed countries.
“There is a continued need to engage in the international processes for convergence towards international standards. In the clinical trials agenda, the regulatory landscape has undergone dynamic changes for ensuring efficacy, safety and quality of medicines. There is a however a need to further strengthen the Institutional Ethics Committees and capacity building of the stakeholders. India has been contributing to the agenda of the Global Plan of Action for Public Health, Innovation and Intellectual Property, and there is a need to ensure that there is a priority setting for the agenda of developing mechanisms for innovation for diseases prevalent in developing countries including India,” she added.
The summit witnessed a convergence of various stakeholders ranging from the Indian and global pharmaceutical industry, regulators and policy makers. Challenges and gaps for strengthening the domestic landscape of Active Pharmaceutical Ingredients (APIs) were extensively discussed.
Ms Aradhana Johri, Secretary, Department of Pharmaceuticals, highlighted that Indian Pharma Industry exports around US$14 billion of pharmaceutical products, including vaccines, to most countries in the world. She said, “At present, there is a significant dependence for intermediates of medicines, which needs to be reduced. There is a need to look at strengthening the development of the Bulk Drug Industry in India. Recently, Department of Pharmaceuticals had organized three GMP strengthening for manufacturers in Hyderabad, Ahmedabad, and Chandigarh in collaboration with WHO and FICCI. India has tremendous potential in R & D and research capabilities. The streamlining of the regulatory landscape of clinical trials is pivotal to create a balance between the growth of clinical trial industry as well as ethical issues.”
The deliberations focused on convergence towards international quality standards, streamlining the drug regulatory landscape for the conduct of clinical trials in India, fostering R & D and innovation by the pharmaceutical industry.
Habil Khorakiwala, Chairman FICCI Life Sciences Council, Past President FICCI and Chairman Wockhardt Group highlighted that Indian Pharma Industry has gone a major transformation over the past several years.
“India is expanding into the global markets to provide affordable medicines and have a broad base for manufacturing APIs and finished dosages. Presently, US$ 2 million is being invested in R & D by the Indian pharmaceutical industry and the country has a capacity to become the global hub of R & D in the world,” he added.
The summit provided a platform to engage at a policy level with stakeholders and chart a policy road map for enhancing India’s global role in supply of generic medicines.
Mr CP Singh, Chairman, National Pharmaceutical Pricing Authority said, “There is a need to strengthen the domestic landscape of APIs in India and develop appropriate mechanisms in this regard to meet the need of country specific regulatory requirements.”
‘’There is a need to foster the quality agenda in India including consideration of moving towards convergence towards international manufacturing standards, including PIC/S,” Mr Pankaj Patel, Chairman, FICCI Pharmaceuticals Committee and Managing Director, Zydus Cadila said in his concluding remarks.