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India all set to make Penicillin G after three decades on PLI push

Apr 02,2024

New Delhi: Two domestic drugmakers are set to start production of penicillin G and clavulanic acid this year, supported by the government’s production-linked-incentive (PLI) scheme, a development seen boosting India’s efforts to cut dependence on China for crucial drugs.

Industry executives told ET that the decks have been cleared for Hyderabad-based Aurobindo Pharma and Mumbai-headquartered Kinvan to begin production of the key starting materials (KSMs) penicillin G and clavulanic acid, respectively, and that their first batches will come this year. Penicillin G is used in making several antibiotics while clavulanic acid is used for manufacturing Amoxyclav, a combination drug whose most popular brand is Augmentin.

India stopped producing the two input drugs about three decades ago and since then it has relied on China for their supplies. “As of now, we are largely dependent on China. With the initiative of the production-linked-incentive scheme, companies like Aurobindo are coming up with fermentation-based products like PenG,” said Ravi Uday Bhaskar, director general, Pharmaceutical Export Promotion Council (Pharmexcil). “We will be in a better position in the coming few months.”

Aurobindo’s PenG plant is expected to start trial production this month and move into commercial production in a few months, the people cited earlier said.

The ₹2,400-crore plant has been commissioned in Andhra Pradesh. It has a production capacity of 15,000 tonnes per annum.

The government initiated the PLI scheme which is aimed at boosting domestic manufacturing of active pharmaceutical ingredients (APIs)/ KSMs, widening its scope to encourage export of these raw materials.

India’s pharmaceuticals industry is the third largest in the world, but is dependent on China for crucial raw materials. The PLI scheme seeks to reduce this dependency and ensure adequate domestic supply of bulk drugs and APIs. The focus on self-reliance became sharper following the disruptions in global supply due to COVID-19.

Dinesh Dua, former chairman of Pharmexcil, said that China is a major player in penicillin G and the initiative of starting its production in India will be a major victory for India.

“About 30,000 metric tonnes of penicillin is imported from China. China ensured closure of production in the entire world, including India, on account of huge government support in terms of subsidies, infrastructure support, ease of doing business (EODB) in regulatory landscape, cheap labour, etc.,” Dua said.

“This new initiative by India, however, is a major victory for India as it is going to compress demand from China.”

Source: Pharma

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