Last Updated on January 6, 2024 by The Health Master
The Department of Pharmaceuticals (DoP) has extended an invitation to eligible active pharmaceutical ingredient (API) manufacturers in the country to apply for the manufacturing of vitamin B1, through the chemical synthesis route under the production linked incentive (PLI) scheme.
Prior to the announcement, the scheme had been supporting the 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 crores, respectively.
According to the latest notice, a maximum of two applications are to be selected to set up a minimum annual production capacity of 200 MT, as per scheme guidelines, 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 (KSM)/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.
As per the decision taken, the 10 percent 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 on January 27, 2022, has announced that it will select one applicant for the production of vitamin B1 under fermentation-based niche KSMs/DIs/and APIs, along with an invitation to apply for other products, 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 since the launch of the PLI scheme on October 29, 2020, but there were very few takers who could proceed with the projects considering the 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 the 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 it 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 have been approved to date.
In the first round of applications, 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.
Drug recall: Magnesium Citrate Oral Solution recalled due to this reason
USFDA gives nod for this generic high Blood Pressure drug
USFDA issues Form 483 for six observations to Granules Pharma
USFDA gives approval for this tablet to treat High BP
No extension in deadline for registration of Medical Devices
Drug recall: Sun Pharma, Glenmark recall products due to these manufacturing issues
Govt plans to reduce the prices of critical drugs on August 15
NMC directs State Medical Councils to take action against Quacks
FDA Haryana team raided, Codeine syrup recovered, FIR lodged
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
