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Government gives nod to 11 bulk drug cos under PLI scheme

The government aims to reduce the import dependence on critical bulk drugs.

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By Ekta Batra  February 26, 2021, 1:00:30 PM IST (Updated)

Government gives nod to 11 bulk drug cos under PLI scheme
The government has approved the next set of companies under the Production Linked Scheme for bulk drugs. A total of 11 companies have been given the go-ahead to produce nine key starting materials (KSMs). Five companies have been approved to produce six fermentation-based niche key starting materials of KSMs or bulk drugs. Another six companies have got approval to produce three chemical synthesis KSMs or intermediates.


Key starting materials, intermediates and active pharma ingredients are basic raw materials or bulk drugs used in the manufacture of final formulations or drugs consumed. While India is a leading exporter of the final product, generic drugs, it heavily imports raw materials or bulk drugs, much of them from China. For some raw materials, the import dependence is as high as 80-100 percent.

By encouraging local production through the PLI scheme, the government aims to reduce the import dependence on critical bulk drugs. The scheme announced focuses on setting up greenfield plants in four different target segments at a cost of Rs 6940 crore. The government will also focus on setting up three bulk drug parks with an assistance of Rs 1000 crore per park.

The government kicked off the PLI in bulk drugs in January when it approved applications of three companies to manufacture four bulk drugs for a total investment of Rs 3761 crore.

Aurobindo got approval to manufacture Penicillin G, 7-ACA and Erythromycin Thiocyanate for an investment of Rs 3038 crore. Karnataka Antibiotics & Pharma was given the go-ahead to produce 7-ACA and Kinvan Private Ltd to manufacture Clavulanic acid. All these are key ingredients in antibiotics.

The latest list comprises two of the targeted segments – fermentation and chemical synthesis-based key starting materials. Under fermentation-based KSMs, those approved include includes Natural Capsules, a listed company, which is given the go-ahead to manufacture three steroids - Bethamethasone, Dexamethasone and Prednisolone, investing a little under Rs 100 crore. Other noticeable investments include Macleod Pharma, with the largest investment of Rs 198 crore amongst the list, has been given the approval to manufacture antibiotic Rifampicin. Others in the list are private companies Symbiotic Pharma, Optimus Drugs and Sudarshan Pharma approved to manufacture Prednisolone, Vitamin B and antibiotic Streptomycin.

The second list under target segment three includes Aarti Speciality Chemicals approved to produce chemical synthesis based KSM 2-Methyl-5Nitro Imidazole (2-MNI) at an investment of Rs 77 crore. Others include Meghmani LLP and Sadhna Nitro Chem to produce Para amino phenol with an investment Rs 55 crore and Rs 197 crore respectively. Three companies, Saraca Labs, Emmennar Pharma and Hindys Lab have been approved to produce intermediate CDA or 1,1 Cyclohexane Diacetic Acid for a total investment of Rs 109 crore.

The government, it seems, is speeding ahead when it comes to PLI in the pharma sector. It also approved the Pharma PLI scheme for formulations earlier this week. The Pharma PLI scheme has a total outlay of Rs 15,000 crore and aims to encourage manufacturing in complex generics, biotech drugs and other harder, less competitive drugs. The government had also given the go-ahead to the medical devices scheme which has a total outlay of a little less than Rs 3,500 crore and bulk drug parks worth Rs 400 crore with maximum assistance of Rs 100 crore each. The government has given its nod to a number of applications in the medical devices PLI with an investment amounting to Rs 729 crore.
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