Govt releases guidelines for schemes to boost domestic manufacturing of bulk drugs, med devices

Source: The Economic Times, Jul 27, 2020

NEW DELHI: The government on Monday released guidelines for four schemes to boost domestic manufacturing of bulk drugs and medical devices as part of its drive to reduce dependency on imports for these critical products.

“In line with the vision of Prime Minister Narendra Modi, the schemes have been conceptualised for making India ‘atmanirbhar (self-reliant) in the pharma sector, chemicals and fertilisers minister D V Sadananda Gowda said.

The schemes—a production-linked incentive (PLI) scheme and industry park scheme each for bulk drugs and medical devices—seek to make India self-reliant in pharmaceuticals raw materials such as drug intermediates, active pharmaceutical ingredients (APIs) and key starting materials (KSMs), and medical devices.

Currently the country almost entirely depends on imports—mostly from China—for production/supply of 53 critical bulk drugs, while 86% of medical devices, too, are imported.

Bulk drug parks “will be based on plug and play model with prior regulatory approvals, state of art infrastructure, excellent connectivity, affordable land, competitive utility charges, and strong R&D ecosystem and so on”, Gowda said.

This will significantly reduce time and investment cost for setting up new manufacturing units. In addition, new units will be eligible for PLI scheme of the government, he said. “Eligible manufacturers will be selected for the PLI scheme on the basis of marks obtained in the evaluation criteria as per the guidelines.”
Ashok Madan, executive director of Indian Drugs Manufacturers’ Association (IDMA), said the industry has been waiting for detailed guidelines of the schemes notified last week.

“It’s for the first time that an impetus of Rs 10,000 crore is being given to augment API production in the country,” he said.

“Limiting the import content for production of listed 41 APIs/KSMs up to 30% is to encourage local manufacture with value addition for the production Linked Incentive,” Madan said.

The list of 41 products will enable domestic production of 53 key bulk drugs.

“Given the right implementation, India can aspire to be selfreliant in APIs/KSMs in 8-10 years,” Madan said.

The industry would like the government to support utilisation of idle capacities of medium API units with blanket environment approvals “subject to their complying with the overall pollution loads”, he said.

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