India plans new bulk drug licence regime, supplier database to fix accountability
The plan for the licensing scheme is another step in the direction of regulating imports in the crucial sector. The government has already implemented a minimum import price (MIP) on certain bulk drugs, APIs and intermediates, including potassium clavulanate, Penicillin-G and Amoxicillin, to support domestic manufacturing and curb cheap imports, especially from China. Indian companies have also started manufacturing APIs under the government’s production-linked incentive (PLI) scheme launched in 2020 with a financial outlay of ₹6,940 crore for FY23 to FY29. According to the government, a total of 48 projects have been selected under the PLI scheme, of which 34 have been commissioned for 25 bulk drugs.
