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

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The Applications of following companies, which have committed more than the minimum proposed annual production capacities and fulfil the prescribed criteria have been approved under Production Linked Incentive (PLI) Scheme for Promotion of Domestic Manufacturing of critical Key Starting Materials (KSMs)/Drug Intermediates and Active Pharmaceutical Ingredients (APIs) in the country:

  S.No.  Name of approved Applicant  Name of Eligible ProductCommitted Production Capacity (in MT)C o m m i t t e d Investment (in Rs. crores)
1.M/s Aurobindo Pharma Limited (through LyfiusPharmaPvt. Ltd.)Penicillin G150001392
2.M/s Karnataka Antibiotics & Pharmaceuticals Ltd.      7 – ACA1000275
3.M/s Aurobindo Pharma Limited (through LyfiusPharmaPvt. Ltd.)2000813
  4.M/s Aurobindo Pharma Limited (through Qule Pharma Pvt. Ltd.)Erythromycin T h i o c y a n a t e (TIOC)  1600  834
5.M/s Kinvan Pvt. Ltd.Clavulanic Acid300447.17

The setting up of these plants will lead to total committed investment of Rs. 3,761 cr. by the companies and employment generation of about 3,825. The commercial production is projected to commence from 1st April, 2023 and the disbursal of production linked incentive by the Government over the six years period would be up to a maximum of Rs. 3,600 cr. Setting of these plants will make the country self-reliant to a large extent in respect of these Bulk drugs.

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 30th 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 28th February, 2021.

The Target Segment-I includes 4 Eligible Products, viz., Penicillin G; 7-ACA; Erythromycin Thiocyanate (TIOC) & Clavulanic Acid, in which the country is presently fully import dependent, were considered on priority as per the decided evaluation and selection criteria. Further, applications under the other three segments are proposed to be taken up for approval in the next 45 days. The Indian pharmaceutical industry is the 3 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.

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