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The Central government is in the process of imposing Minimum Import Price (MIP) on certain active pharmaceutical ingredients (APIs) and intermediates, including those used for manufacturing of antibiotics, aiming at providing further support to manufacturing of these raw materials in the country.
According to sources, the Department of Pharmaceuticals (DoP) has initiated the process with detailed proposals on at least one product - potassium clavulanate and its intermediate - used for production of antibacterial formulations to treat various infections.
The aim is to impose an MIP to discourage large-scale import of these raw materials, largely from China, which may impact the sustainability of domestic producers.
This is expected to help the Indian firms which are setting up and producing these bulk drugs under the production linked incentive (PLI) scheme for promotion of domestic manufacturing of critical key starting materials (KSMs)/drug intermediates (DIs) and active pharmaceutical ingredients (APIs) in India, implemented to improve self-reliance and reduce import dependence on these raw materials.
DoP has been in consultation with the Prime Minister's Office (PMO), and various Ministries linked to the industry, including the ministry of health and family welfare, ministry of finance, and the ministry of commerce and Industry, and others for introduction of an MIP on such imports.
It is learnt that the Department has now approached various stakeholders with detailed proposal to impose the MIP, seeking their inputs and objections related to the imposition.
For instance, the DoP has prepared a detailed proposal regarding imposition of MIP on potassium clavulanate and tertiary butyl amine salt, used as an intermediate for production of the bulk drug.
The fermentation-based product has been approved to be manufactured by Himachal Pradesh-based Kinvan Pvt Ltd, promoted by Khilari Infrastructure Private Limited and DPB Antibiotics.
Some of the other fermentation-based products approved under the scheme are penicillin G by Aurobindo Pharma through Lyfius Pharma, and 7-ACA (7-aminocephalosporanic acid) by Karnataka Antibiotics and Pharmaceuticals and Orchid Bio-Pharma Ltd.
Kinvan, which has already set-up its manufacturing facility in Nalagarh, Himachal Pradesh with a capacity of 400 MTPA KgA, is expected to meet almost 40% of the country's demand through the facility, according to the company website.
Union minister of state for chemicals and fertilizers Anupriya Patel, in the Rajya Sabha in July, 2025 said that under the PLI scheme for promotion of domestic manufacturing of bulk drugs, which has a total financial outlay of Rs. 6,940 crore, 32 companies/pharmaceutical entities have been selected for greenfield production through 48 projects involving 33 APIs/DIs/KSMs.
Out of the 6-year production tenure of the scheme, till June 2025, over three years of implementation stand completed for chemical-synthesis-based products and over two years for fermentation-based products.
"Already, against committed investment of Rs. 3,938.5 crore, cumulative investment for the projects approved under the scheme has substantially exceeded the target, reaching Rs. 4,709 crore," she added.
Domestic production capacity, with minimum domestic value addition of 90% in fermentation-based products and 70% in chemical-synthesis-based products, has been created in respect of 26 APIs/KSMs/DIs.
Cumulative sales of Rs. 1,962 crore have been reported over the period from FY 2022-23 onwards, including exports of Rs. 479 crore, thereby avoiding imports worth Rs. 1,483 crore, she said.
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