The Department of Pharmaceuticals (DoP), Ministry of Chemicals & Fertilizers, Government of India, in collaboration with the WHO Country Office for India and Federation of Indian Chambers of Commerce and Industry (FICCI) organised the 5th India Pharma Summit in 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.”
Aradhana Johri, Secretary, Department of Pharmaceuticals, highlighted that Indian pharma industry exports around $14 billion of pharma products, including vaccines, to most countries in the world. Pharma market in India is ranked third globally in terms of volume and 13th in terms of value, accounting for about 10 per cent of the world’s production by volume, including 80 per cent of global production of antiretroviral medicines manufactured in India.
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. There are various challenges being faced by the Indian pharma industry. Recently, Department of Pharmaceuticals had organised 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 and the ethical issues there-in.
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.
“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,” said Dr Nata Menabde, WHO Representative to India. She 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 international processes for convergence towards international standards and a need for self-reliance for domestic production of APIs in India to enable accessibility of affordable medicines. 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 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 global health and facilitate developing mechanisms for innovation for diseases prevalent in developing countries including India,” she added.
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 pharma 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, $2 million is being invested in R&D by the Indian pharma industry and the country has a capacity to become the global hub of R&D in the world. We have to create an ambience for research and need to streamline the landscape for clinical trials in India.”
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.
CP Singh, Chairman, National Pharmaceutical Pricing Authority added, “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.”
Dr Arbind Prasad, Director General, FICCI said Ïndian pharma industry exports to over 200 countries in the world and is growing at 14 per cent per annum. This is a unique opportunity for the industry and the government to partner for issues related to quality of pharmaceuticals, clinical trials and innovation agenda”.
“There is a need to foster the quality agenda in India including consideration of moving towards convergence towards international manufacturing standards, including PIC/S,” Pankaj Patel, Chairman, FICCI Pharmaceuticals Committee and Managing Director, Zydus Cadila said in his concluding remarks.
EP News Bureau – Mumbai