Modified PLI scheme to promote manufacturing of Bulk Drugs

Based on this, now there would be nine fermentation-based products with a total outlay of Rs. 900 crore instead of 10 products with an outlay of Rs. 1,000 crores.

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PLI Scheme

Last Updated on August 4, 2022 by The Health Master

With the modifications it has made in the guidelines of the production-linked incentive (PLI) scheme for the promotion of domestic manufacturing of bulk drugs in the country, the Department of Pharmaceuticals (DoP) will have nine products under the fermentation-based niche products and 24 products under the chemical synthesis route, as against 10 and 23 products, respectively.

Through a modification in the guidelines of the PLI scheme for the promotion of domestic manufacturing of critical key starting materials (KSMs)/drug intermediates (DIs) and active pharmaceutical ingredients (APIs) in the country, the DoP on July 26 moved vitamin B1 from the fermentation-based niche products to the chemical synthesis-based route.

Based on this, now there would be nine fermentation-based products with a total outlay of Rs. 900 crore instead of 10 products with an outlay of Rs. 1,000 crores.

Simultaneously, now there will be 24 chemical synthesis-based products with a total outlay of Rs. 1,480 crores, as against 23 products with an outlay of Rs. 1,380 crores according to the original guidelines issued on October 29, 2020.

The 10 percent incentive rate shall be applicable as applicable for APIs produced through chemical synthesis and the incentive ceiling for vitamin B1 will remain the same as per original guidelines, said a corrigendum for the guidelines issued by the DoP.

Under fermentation-based products, the rate of incentive for vitamin B1 was set at 20 percent from FY 2023-24 to FY 2026-27, 15 percent in FY 2027-28, and five percent in FY 2028-29. The rate of incentive under the chemical synthesis products will now be 10 percent flat from FY 2023–24 to FY 2027–28.

The maximum incentive per annum under the fermentation-based products was Rs 20 crore from FY 2023-24 to FY 2026-27, which will come down to Rs. 15 crores in FY 2027-28 and Rs. 5 crores in FY 2028. Under the chemical synthesis route, this will be Rs. 20 crores from FY 2023-24 to FY 2027-28.

Similarly, under the fermentation-based route, the maximum incentive for each selected applicant per annum was Rs. 10 crores from FY 2023-24 to FY 2026-27, Rs. 7.5 crore for FY 2027-28, and Rs. 2.5 crore for FY 2028-29.

Now, this has been changed to Rs. 10 crores from FY 2023-24 to FY 2027-28, according to the corrigendum. For the fresh applications invited, the year FY 2022-23 will be considered as the installation year.

According to a new invitation to the eligible active pharmaceutical ingredient manufacturers in the country to apply for the manufacturing of vitamin B1, through the chemical synthesis route, issued by the DoP on July 26, a maximum of two applications are to be selected to set up a minimum annual production capacity, as per scheme guidelines, of 200 MT, to mitigate a shortfall of 400 MT in minimum annual production capacity.

The incentive will be provided under the PLI scheme for the promotion of domestic manufacturing of critical key starting materials (KSMs)/drug intermediates and APIs in the country.

The decision was taken at a meeting of the Empowered Committee (EC) on June 3, 2022, to seek eligible candidates for the production of Vitamin B1 through the chemical synthesis route. Eligible applicants may apply online only.

The last date of filing the application is 30 days from the issuance of the notice, which said the notice was issued on July 26, 2022.

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