Ministry notifies Production Linked Incentive (PLI) scheme for the Pharmaceutical Sector

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:

1. 1. 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.
   2. 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)
   3. 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.

*Tanvi Singh, Editorial Assistant has reported this brief.