New Delhi : The Department of Pharmaceuticals (DoP) has extended the deadline for submission of application for the production linked incentive (PLI) scheme for pharmaceuticals to August 15, 2021.
It has also changed the selection parameter for applicants, except in vitro diagnostics medical devices group, in which the weightage of 50 per cent for MSMEs would be based on the GMR from pharmaceutical goods in FY 2019-2020. In the operational guidelines issued on June 1, 2021, the 50 per cent weightage was on total investment committed by the applicant under the scheme, for MSMEs.
Global manufacturing revenue (GMR), according to the operational guideline, is the consolidated global revenues of the applicant and Group Company, if any, from the manufacturing of pharmaceutical goods and/or in vitro diagnostic medical devices. Revenues from any other source for instance R&D services, rental incomes, etc., shall be excluded for calculating the GMR.
The rest of the 50 per cent weightage will remain on the number of manufacturing plants in India owned by the applicant or group company and approved by foreign drug regulator with a compliance certification from a State Licensing Authority as on April 1, 2021.
“The application window shall be 75 days starting from June 2, 2021 to August 15, 2021 (inclusive),” says the government announcement. The previous application window was 60 days starting from June 2, 2021 to July 31, 2021, both dates inclusive
For applicants manufacturing only special empty capsules like HPMC, Pullulan, enteric etc., or complex excipients and not drugs, the selection parameter of number of Abbreviated New Drug Application/New Drug Application/Drug Master Filing/Certificate of Suitability (CEP) approvals is not relevant and the weightage for other relevant criteria will be increased prorata so that such applicants are not placed at a disadvantage, said the corrigendum.
Following the clause on the number of applicants to be selected, a new sub clause has been added stating that only one applicant, on behalf of its group companies (as defined in another clause of the guideline) shall be eligible for selection under the Scheme. The applicant and its group companies where the eligible products get manufactured will be considered collectively for the purpose of ascertaining threshold/committed investments, threshold/incremental sales and incentives under the scheme, it added.