Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers has on 10th July, 2021 released a corrigendum/ addendum on the ‘Operational guidelines for the Production Linked Incentive (PLI) Scheme for Pharmaceuticals’ dated 1st June, 2021. The parameters for selection for the scheme shall include:
- For Group A / B: Gross manufacturing investment of applicant/group company in India in 10 years during FY 2010-11 to FY 2019-20 shall be 30%. Number of ANDA / NDA / DMF / CEP, as the case may be, of applicant/group company from either USFDA / EDQM/ EMA /BfArM/ UK MHRA / PMDA / Health Canada / TGA/ANVISA as on
01.04.2021 shall be 30%. R&D expenditure of applicant/group company as a % of GMR from pharmaceutical goods in FY 2017-18 to FY 2019-2020 shall be 40% - For Group C: Gross manufacturing investment of applicant/group company in India in 10 years during FY 2010-11 to FY 2019-20 shall be 30%. Number of ANDA / NDA / DMF/ CEP, as the case may be, of applicant/group company from either USFDA / EDQM/ EMA /BfArM/ UK MHRA / PMDA / Health Canada / TGA/ANVISA as on 01.04.2021 shall be 30%. GMR from pharmaceutical goods in FY 2019-2020 shall be 40%.
- For Group C (MSME): Number of manufacturing plants in India owned by applicant/group company and approved by USFDA / EDQM/ EMA /BfArM/ UK MHRA / PMDA / Health Canada / TGA/ANVISA or having WHOGMP compliance certification from a State Licensing Authority as on 01.04.2021 shall be 50%. Total Investment Committed by the applicant under the scheme shall be 50%.
