Approval accorded under PLI Scheme for Promotion of Domestic Manufacturing of critical Key Starting Materials (KSMs)/ Drug Intermediates and APIs in the country

With an objective to attain self-reliance and reduce import dependence in these critical Bulk Drugs – Key Starting Materials (KSMs)/ Drug Intermediates and Active Pharmaceutical Ingredients (APIs) in the country, the Department of Pharmaceuticals had launched a Production Linked Incentive (PLI) Scheme for promotion of their domestic manufacturing by setting up greenfield plants with minimum domestic value addition in four different Target Segments (In Two Fermentation based – at least 90% and in the Two Chemical Synthesis based – at least 70% ) with a total outlay of Rs. 6,940 cr. for the period 2020-21 to 2029-30.

The applications under four different Target Segments were invited with 30^th November, 2020 as the last date. In total, 215 applications have been received for the 36 products spread across the 4 Target Segments. The guidelines prescribed that the applications would be processed and decided within a period of 90 days, i.e., up to 28^th February, 2021. Five applications with a committed investment of Rs.3,761crore have already been approved under Target Segment I.

Eligible products under Target Segment II (Fermentation Based Niche KSMs/Drug Intermediates/APIs) were considered as per the decided evaluation and selection criteria. The applications of following companies, which have committed minimum/more than the minimum proposed annual production capacities and fulfil the prescribed criteria have been approved, as under:

Eligible products under Target Segment III (Key Chemical Synthesis Based KSMs/Drug Intermediates) were considered as per the decided evaluation and selection criteria. The applications of following companies, which have committed minimum/more than the minimum proposed annual production capacities and fulfil the prescribed criteria have been approved, as under:

*Subject to outcome of Writ Petition.

The setting up of these plants will lead to total committed investment of Rs 862.01crore by the companies and employment generation of about 1763. With this, a total of 19 applications with committed investment of Rs.4623.01 crore have been approved by the Government. The commercial production is projected to commence from 1^st April, 2023 onwards and the disbursal of production linked incentive by the Government over the six years period would be up to a maximum of Rs.4,870 cr. Setting of these plants will make the country self-reliant to a large extent in respect of these Bulk drugs. Further, applications under the Target Segment-IV are proposed to be taken up for approval before 28th February, 2021.

The Indian pharmaceutical industry is the 3^rd largest in the world by volume. It has high market presence in several advanced economies such as the US and EU. The industry is well known for its production of affordable medicines, particularly in the generics space. However the country is significantly dependent on the import of basic raw materials, viz., Bulk Drugs that are used to produce medicines. In some specific bulk drugs, the import dependence is 80 to 100%.