The government has approved a total of 33 applications with a committed investment of Rs 5,082.65 crore under the Production Linked Incentive scheme for Active Pharmaceutical Ingredients (API), the chemicals and fertilizers ministry has said. The disbursal of PLI by the government over six years will be up to a maximum of Rs 5,440 Crores.
Under the Aatmanirbhar Bharat campaign and with the aim to reduce import dependence on critical bulk drugs, the Department of Pharmaceuticals has launched a PLI scheme for the promotion of domestic manufacturing by setting up greenfield plants in four different target segments with a total outlay of Rs 6,940 crore for the period 2020-21 to 2029-30. The government will incentivize the producer firms by paying anywhere between five to ten percent of the yearly incremental output based on the category of a pharmaceutical product.
The Indian pharmaceutical industry is the third-largest in the world by volume. It has a high market presence in several advanced economies such as the US and other European nations. The industry is well known for the production of affordable medicines, particularly in the generics space. However, the country is significantly dependent on the import of basic raw materials (API), that are used to produce medicines. In some specific bulk drugs, the import dependence is 80 to 100 percent.
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In total, 215 applications have been received for the 36 products spread across the 4 target segments. Nineteen applications with a committed investment of Rs 4,623.01 crore have already been approved under Target Segment I, II, and III, the Ministry of Chemicals and Fertilizers said in the release.
Besides, 174 applications were received for 23 products under target segment IV — other chemical synthesis-based KSMs or drug intermediates or API. Out of 174 applications, 79 applications received for 11 eligible products were considered as per the decided evaluation and selection criteria by the Empowered Committee in its meeting held on February 27, 2021.
The applications of 12 companies that have committed minimum/more than the minimum proposed annual production capacities and fulfill the prescribed criteria have been approved, the ministry said.
Hetero Drugs Ltd and Rajasthan Antibiotics Ltd were among the 12 companies selected to produce 11 bulk drugs, making them eligible for production-linked incentives in lieu of investment commitments worth ₹459 crores, the government said in a statement.
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Hetero Drugs, as well as Dasami Labs Pvt Ltd, was selected to get incentives for manufacturing the anti-epilepsy drug oxcarbazepine, while Rajasthan Antibiotics, and also Anasia Lab Pvt Ltd, was selected for getting incentives for the production of the broad-spectrum antibiotic Meropenem. Dasami Labs was also selected for another anti-epilepsy drug carbamazepine, while Anasia also was chosen for the anti-hypertension drug olmesartan.
Other drugs for which companies were selected for getting incentives for production included anti-cancer drugs lopinavir and ritonavir, Vitamin B6, and aspirin, among others.
It has been further decided to take up the remaining 95 applications under the Target Segment-IV till March 31, 2021, for scrutiny and approval, as per the release.
The government on February 25 also approved a production-linked incentive (PLI) scheme for the pharmaceutical sector, entailing an outlay of Rs 15,000 crore.
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