Center publishes rules for second PLI plan for pharmaceuticals worth 15,000
The government said on Tuesday it would offer 55 drugmakers a total of ₹15,000 crore of production-related incentives for six years through FY29 to boost the manufacture of drugs, in vitro diagnostics and their raw materials in India.
The incentives, similar to cash back rewards, would be granted to drugmakers in proportion to incremental sales, in addition to the revenue generated by the product in fiscal year 2019-2020.
The Pharmaceuticals Department (DoP), which formulated the program, has divided the products, which include formulations, biopharmaceuticals, bulk drugs, and in vitro diagnostic medical devices, among others, into three categories. The first and second categories would attract a 10% incentive on additional sales, and the third category would attract a 5% incentive.
The government has allocated ₹11,000 crore for the first category, which includes biopharmaceuticals, complex generic drugs, patented or expiring drugs, gene therapy drugs, orphan drugs and herbal pharmaceuticals, between other. He put aside ₹2,250 crore for the second category, which includes bulk drugs that are not among the 41 products included in the first PLI program announced in July 2020.
The third category would get a total of ₹1,750 crore and would include reused drugs, autoimmune, anti-cancer and anti-diabetic drugs, as well as drugs not made in India and in vitro diagnostics.
A company that has made or plans to make investments as of April 1, 2020 will be considered eligible for the program, the DoP said in its press release.
The DoP, through a selection committee, will select a maximum of 55 applicants under the program, who will be allowed to apply for more than one product in any of the three categories through a single application, to provided that they meet the criteria for each category.
To be eligible, the company must make investments with a value between ₹50 lakh and ₹50 crore, depending on the category of the drug and the financial capacity of the company. The investment includes the cost of new plant and machinery, associated equipment and utilities, research and development, technology transfer, product registration and expenses incurred for the building where they are installed. installations and machinery.
The government’s announcement comes a day after it said four candidates for the first PLI program withdrew and were replaced by four other companies. The first program aimed to increase the production of 41 bulk drugs, for which India is heavily dependent on imports, especially from China.
Industry officials said the withdrawal is a sign of problems with the first program because instead of two or three participants to produce each drug in bulk, the government panel selected one for many of the bulk drugs in the industry. first program.
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