India’s first API fermentation unit in Nalagarh begins mass production

India’s first active pharmaceutical ingredient (API) fermentation unit at Plassra in Nalagarh has commenced large-scale production in the last few weeks. “Set up under the centrally-sponsored production linked incentive (PLI) scheme, this unit has achieved up to 6.5 per cent yield in the first few months. It is supplying API, a pharmaceutical raw material, to states like Gujarat and Uttarakhand initially,” said Vineet Kumar, member secretary, Industries Department, Nalagarh.

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Supply to Gujarat, Uttarakhand

• Will cater to 60 per cent of the domestic demand
• Plant starts production at Plassra in Nalagarh
• Supplied API to states like Gujarat and Uttarakhand in the initial trial period
• The domestic demand of API is pegged at 700 tonnes per annum

The unit will produce 400 tonnes of potassium clavulanate API annually once it achieves an optimum production level. Its domestic demand is pegged at 700 tonnes per annum.

Being a key API used in the production of several antibiotics, it will meet around 60 per cent demand of the domestic market. India is heavily dependent on China and Korea for this API requirement. As many as 309 people, including 252 Himachalis, have been employed in the unit. The state-level Single Window Clearance and Monitoring Authority had approved the project in its 17th meeting on July 7, 2021. The in-principal approval for setting up the plant was issued on July 28 the same year.

To give a boost to this unit, special incentives have been granted. These include 100 pc exemption on electricity duty for five years, 15 pc rebate on energy charges for five years, 100 pc exemption on stamp duty and registration fee, besides subsidised land at the rate of Re 1 per sq m. The centrally-funded PLI programme was launched for the promotion of domestic manufacturing of critical key starting materials (KSMs)/ drug intermediates and APIs in the country few years ago. It was launched after wide-ranging deliberations on India’s dependence on critical resources, a risk to supply chain bottlenecks after Covid pandemic disrupted supply chains. It also aims at enhancing pharma industry’s global competitiveness. The government had identified 48 critical APIs for local manufacturing in its first initiative.