DoP invites applications to produce vitamin B1 through chemical synthesis route under PLI scheme

New Delhi, July 27, 2022 :

The Department of Pharmaceuticals (DoP) has extended an invitation to eligible active pharmaceutical ingredient (API) manufacturers in the country to apply for manufacturing of vitamin B1, through chemical synthesis route under the production linked incentive (PLI) scheme.

Prior to the announcement, the scheme had been supporting manufacturing of vitamin B1 through the fermentation process. The DoP has earlier approved applications from Optimus Drugs and Sudarshan Pharma Industries to produce 200 MT of vitamin B1 each, with a committee investment of Rs. 35 crore and Rs. 57 crore respectively.

According to the latest notice, 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. As per the decision taken, the 10 per cent incentive rate shall be applicable as applicable for APIs produced through chemical synthesis.

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.

The Department, in an earlier notice in January 27, 2022, has announced that it will select one applicant for production of vitamin B1 under fermentation based niche KSMs/DIs/and APIs, along with invitation of application for other products ion including neomycin, gentamycin, clindamycin base, streptomycin and tetracycline through the fermentation based route.

The DoP has been pitching the PLI scheme for fermentation based products from the launch of the PLI scheme in October 29, 2020, but there were very few takers who could proceed with the projects considering various constraints in setting up fermentation-based facilities successfully, owing to the strong competition from China and the requirements for power and water at a manageable cost along with proper technology to manufacture the products at a competitive rate.

The government has recently amended the environmental regulations to suit the requirements of the manufacturers. However, the industry feels that there needs further push from the government for the industry to start production of fermentation based products on a competitive scale.

According to the DoP, a total of 49 applications were approved for the PLI scheme for bulk drugs, till the last meeting held on June 3, 2022, in two rounds. Out of the 215 applications received for the first round, 41 were approved, while out of the 24 applications in the second round, eight were approved by the Department.

Under the PLI scheme for Pharmaceuticals out of a total of 278 applications, 55 are approved till date. Under the PLI scheme for medical devices, in the first round out of 28 applications, 13 were approved, and in the second round, out of 14 applications, eight were approved. The last EC meeting on medical devices was held on June 3, 2022. Pharmabiz