New Delhi : With the modifications it has made in the guidelines of production linked incentive (PLI) scheme for 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 chemicals synthesis route, as against 10 and 23 products respectively.

Through a modification in the guidelines of PLI scheme for 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 the vitamin B1 from fermentation based niche products to 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 crore. Simultaneously, now there will be 24 chemical synthesis based products with a total outlay of Rs. 1,480 crore, as against 23 products with an outlay of Rs. 1,380 crore according to the original guidelines issued on October 29, 2020.

“As per the decision taken, the 10 per cent 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 the Fermentation based products, the rate of incentive for vitamin B1 was at 20 per cent from FY 2023-24 to FY 2026-27, 15 per cent on FY 2027-28 and five per cent in the year FY 2028-29. Now, the rate of incentive under the chemical synthesis products will be 10 per cent 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 crore in FY 2027-28 and Rs. 5 crore in FY 2028. Under the chemical synthesis route, this will be Rs. 20 crore 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 crore 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 crore 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 the eligible active pharmaceutical ingredient manufacturers in the country to apply for manufacturing of vitamin B1, through 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 promotion of domestic manufacturing of critical key starting materials (KSMs)/drug intermediates and APIs in the country.

The decision was taken in a meeting of the Empowered Committee (EC) on June 3, 2022, to seek eligible candidates for production of Vitamin B1 through chemical synthesis route. The eligible applicants may apply online only. The last date of filing of the application is 30 days from the issuance of the notice, said the notice issued on July 26, 2022.