Government revises PLI scheme guidelines to boost local production of bulk drugs, medical devices
Government revises PLI scheme guidelines to boost local production of bulk drugs, medical devices

The Department of Pharmaceuticals on Thursday revised guidelines of the Production Linked Incentive (PLI) schemes for promoting domestic manufacturing of bulk drugs and medical devices keeping in view the suggestions and comments received from the industry.

"Accordingly 'minimum threshold' investment requirement has been replaced by 'committed investment' taking into account availability of technology choices which varies from product to product," the Ministry of Chemicals and Fertilizers said in a statement.

The PLI schemes were approved by the Cabinet on March 20,2020, and detailed guidelines for the implementation of the schemes were issued by the Department of Pharmaceuticals on July 27, 2020, it added.

Post issuance of the detailed guidelines, the department received several suggestions and inputs from the pharmaceutical and medical device industry seeking certain amendments in the schemes to enable effective participation of the industry, the statement said.

The suggestions were examined by the respective Technical Committees formed under the schemes and their recommendations were placed before the Empowered Committees of the schemes chaired by the CEO of NITI Aayog.

After considering the recommendations the empowered committees approved the revision of the guidelines for both the schemes, it added.

The main changes in the revised guidelines for PLI scheme for promotion of domestic manufacturing of critical Key Starting Materials, Drug Intermediates and Active Pharmaceutical Ingredients in India are replacement of the criteria of 'minimum threshold' investment with 'committed investment' by the selected applicant, the statement said.

The change has been made to encourage efficient use of productive capital as the amount of investment required to achieve a particular level of production depends upon choice of technology and it also varies from product to product, it added.

The provision which restricts the sales of eligible products to domestic sales only for the purpose of eligibility of receiving incentives has been deleted, bringing the scheme in line with other PLI schemes and encouraging market diversification, the statement said.

A change has also been made in the minimum annual production capacity for 10 products and the last date for receiving applications under the scheme is now extended by a week to November 30, 2020 it added.

For the PLI scheme for promoting domestic manufacturing of Medical Devices there is replacement of the criteria of 'minimum threshold' investment with 'committed investment' by the selected applicant, the statement said.

There is also change in the eligibility criteria of minimum sales threshold in line with projected demand, technology trend and market development, for the purpose of availing incentive under the scheme, it added.

"The tenure of the scheme has been extended by one year keeping in view the capital expenditure expected to be done by the selected applicants in FY 2021-22. Accordingly, the sales for the purpose of availing incentives will be accounted for 5 years starting from FY 2022-2023 instead of FY 2021-2022," the statement said.

The last date for receiving applications under the scheme has also been extended by a week to November 30, 2020, it added.

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