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Aimed & Regulatory Update

DoP invites eligible medical devices firms to apply for newly formed Category B of PLI scheme

The Department of Pharmaceuticals (DoP) has called for applications from eligible medical devices firms for the newly created Category B of the production linked incentive (PLI) scheme for promoting domestic manufacturing of medical devices.

The Department, on August 18, revised the guidelines of the Scheme creating a second category of medical devices by dividing the eligible products in the single category of medical devices it had in the initial guidelines issued in 2020. Eligible applicants for Category B may apply through online mode from September 1, 2022 and the last date of receipt of complete application is October 31, 2022.

With the revised guideline, the list of medical devices in the Annexure 1 of the guideline has been referred as Category A, while a newly bifurcated Annexure 1A has been referred to as Category B. Changes were also been made in other clauses and Annexures based on this revision.
The application window for the PLI scheme according to the previous guideline ended on November 30, 2022, but the revised guideline has provisions to keep the application window open based on notice issued by the Department from time to time.

The previous guideline fixed that a maximum of 28 applicants shall be selected under the scheme, with a maximum of 10 applicants under each target segment. According to the revised guidelines, the number of applicants shall be selected under the scheme based on availability of outlay approved under the scheme.

The department has earlier said that with an objective to boost domestic manufacturing, attract large investment in the medical device sector, it had launched a production linked incentive (PLI) scheme for promotion of domestic manufacturing of medical devices to ensure a level playing field for the domestic manufacturers of medical devices with a total financial outlay of Rs. 3,420 crore for the period 2020-21 to 2027-28.

In the first round, 28 applications were received from 23 applicants under the Scheme. Out of which, 13 applications with committed investment of Rs. 798.93 crore by the companies were approved with expected employment generation of around 3,812 persons. Since few slots remained unfilled for certain products, applications were invited again with the last date of submission as August 31, 2021 and a total of 14 applications were received. It has approved eight plants in an EC meeting held on November 25, 2021. The DoP has recently released a list of 21 applications approved under the scheme till then.

http://www.pharmabiz.com/NewsDetails.aspx?aid=152871&sid=1 ; August 27

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