The Ministry of Chemical and Fertilizers has notified the Production Linked Incentive (PLI) scheme for the Pharmaceutical Sector on November 26, 2021.
Key highlights:
- The scheme seeks to enhance India’s manufacturing capabilities by increasing investment and production in the sector and contributing to product diversification to high value goods in the pharmaceutical sector.
- The scheme shall provide financial incentives on the incremental sales (over Base Year) of pharmaceutical goods and in-vitro diagnostic medical devices to selected applicants based on pre-defined selection criteria. The incentives shall be paid for a maximum period of 6 years for each participant depending upon the threshold investments and sales criteria to be achieved by the applicant.
- The scheme covers three different product categories for which applicants have applied under the scheme:
-
- Category 1: Biopharmaceuticals, Complex generic drugs, Patented drugs, or drugs nearing patent expiry, Cell based or gene therapy drugs, Orphan drugs, Special empty capsules like HPMC, Pullulan, enteric etc., Complex excipients, Phyto-pharmaceuticals.
- Category 2: Active Pharmaceutical Ingredients / Key Starting materials / Drug Intermediates (except the Active Pharmaceutical Ingredients / Key Starting materials / Drug Intermediates covered under the earlier PLI scheme for APIs/KSMs and DIs being implemented by the Department)
- Category 3 (Drugs not covered under Category 1 and Category 2): Repurposed drugs; Auto immune drugs, anti-cancer drugs, anti-diabetic drugs, anti-infective drugs, cardiovascular drugs, psychotropic drugs, and anti-retroviral drugs; In vitro diagnostic devices; Other drugs not manufactured in India.
- A Technical Committee has been constituted, comprising of experts is assisting the Department in relation to the technical aspects of the scheme. SIDBI has put in place a digital mechanism for business processes being followed under the scheme. A vigorous monitoring framework shall also be put in place to track the progress of the scheme.