India's draft policy aims to encourage R&D in pharma, promote innovation

Eager to create an ecosystem for innovation, a draft policy document prepared by India's Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers has proposed to cut down the time taken for regulatory approvals for innovative products by at least 50% within the next two years. The policy aims to catalyze R&D in the pharma and medtech sector, and to propel India to become a leader in drug discovery through incubating an entrepreneurial environment, reports The Pharma Letter’s India correspondent.

Acknowledging the need for greater emphasis on encouraging R&D through indigenously developed cutting-edge products and technologies across the value chain, the proposal talks about laying down a Common Specific Procedure Pathway (CSPP) for each class of product, on the lines of the US Food and Drug Administration. The CSPP would include checklists, prescribed timelines, parallel processing, joint inspections, automatic approvals, and sharing of data across regulators.

The policy postulates three main focus areas - the first will create a regulatory environment that facilitates innovation and research in product development, expanding the traditional regulatory objectives of safety and quality. The second focus area would be to incentivize private and public investment in innovation through a mix of fiscal and non-fiscal measures, thereby matching risks with remunerative financing options. The third area of focus will be to build an enabling ecosystem designed to support innovation and cross sectoral research as a strong institutional foundation for sustainable growth in the sector.