India aspires to become global leader in innovative drugs: Report

In a bid to become a global leader in innovative drugs, the Department of Pharmaceuticals will soon launch the Scheme for Promotion of Research and Innovation in the Pharma-MedTech Sector (PRIP) in September this year, official sources said. "The Union Cabinet has already approved the National Policy on Research and Development and Innovation in the Pharma-Med Tech Sector in India and also approved a new Scheme for Promotion of Research and Innovation in the Pharma-Med Tech Sector (PRIP) with a total outlay of Rs 5,000 crore for a period of five years, i.e., from 2023-24 to 2027-28," the Department of Pharmaceuticals said in a statement.

As per the Department, the Indian pharmaceutical industry is the third largest in the world by volume, with a current market size of around USD 50 billion, and is widely known as 'Pharmacy of the World'. Despite strong fundamentals, the sector faces various challenges, including a high degree of import dependence on Active Pharmaceutical Ingredients (API) and Key Starting Materials (KSMs); a relatively low pace of development of biologics, biosimilars, and other emerging products/ trends. A cogent policy was needed to shape the transformation of the experience of the COVID pandemic into a broader and more systematic approach for improving preparedness of the Indian Pharma MedTech sector to meet medical emergencies.

The Policy aims to strengthen the innovation ecosystem by focusing on key areas, such as drug discovery programmes to be built on National Health priorities based on the burden of disease, promoting discovery-based research to build a pipeline of new molecules, novel drug delivery systems, the development and standardisation of phyto-pharmaceuticals and evaluation of drugs for repurposing, and boosting core technologies in medical devices.Similarly, the PRIP scheme will help transform the Indian Pharma MedTech sector from cost based to innovation-based growth by strengthening the research infrastructure in the country. The scheme aims to promote industry-academia linkage for R & D in priority areas and to inculcate a culture of quality research, and nurture our pool of scientists. This will lead to a sustained global competitive advantage and contribute to quality employment generation in the country.

"The Scheme is designed to transform Indian Pharmaceuticals from a large global supplier of low-cost generic drugs to a position of global leadership based on innovation, with continued attention to patient safety and affordability of health products", the Department of Pharmaceuticals added.

The new Scheme is in pursuance of an announcement made in the Budget 2023-24, to take up a new programme to promote research and innovation in pharmaceuticals through Centres of Excellence and to encourage industry to invest in research and development in specific priority areas. The objective of the PRIP scheme is to transform the Indian Pharma MedTech sector from cost-based competitiveness to innovation-based growth by strengthening the research infrastructure in the country. The aim of the scheme is to promote industry-academia linkage for R & D in priority areas, inculcate a culture of quality research, and nurture our pool of scientists. This will lead to a sustained global competitive advantage and contribute to quality employment generation in the country.

The Scheme, which would be applicable for research and innovation for both human and animal health, will have two components:

One component includes Strengthening the Research Infrastructure through Centres of Excellence (CoEs) in the seven existing National Institutes of Pharmaceutical Education and Research (NIPERs), institutes of national importance under the aegis of the Department, at a tentative cost of Rs 700 crore (including recurring and non-recurring costs) over a period of five years.

Other component involves Promotion of Research in Pharma MedTech sector wherein financial assistance to the companies/ projects will be provided for both for in-house and academic R & D in six specified priority areas, viz.,New Chemical Entity (NCE), New Biological Entity (NBE), Phyto-pharmaceuticals (natural products), Complex generics and Biosimilars, Precision medicines, Medical devices, Orphan Drugs and Antimicrobial Resistance (AMR).

For implementation, a High-level Task Force chaired by the Minister for Chemicals and Fertilisers is proposed to provide oversight and guidance for the implementation of the Policy. The Task Force will draw upon resource persons from Departments and Organisations related to the implementation, as the success of the policy requires coordinated action by several agencies. An industry-led Advisory Committee would be set up for continuous feedback on the implementation of the Policy.An Empowered Committee under the chairmanship of the CEO, NITI Aayog, with Secretary level representation of Pharmaceuticals, Health, ICMR, DBT, CSIR, AYUSH, and DST will provide guidance for the implementation of this ambitious Scheme by the Department of Pharmaceuticals.