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The Department of Pharmaceuticals (DoP) has invited applications from eligible manufacturers under the production linked incentive (PLI) scheme for bulk drugs for products which have not been applied for or are partially produced under the scheme, by the industry.
The Department will select a maximum of 25 applicants in this round, for six fermentation based niche key starting materials (KSMs) or drug intermediates (DIs) or active pharmaceutical ingredients (APIs), and five chemical synthesis based KSMs, DIs and APIs. The DoP has so far completed four rounds of selections of eligible candidates, under the scheme.
The notice inviting applications has been issued after a decision by the competent authority related to the "unsubscribed or partially subscribed eligible products," said the DoP.
The eligible fermentation-based products listed include erythromycin thiocyanate (TIOC) for which two applicants will be selected to have a minimum annual production capacity of 800 MT, to achieve a total available production capacity of 1,600 MT; neomycin for which two applicants will be selected for minimum annual production of 80 MT, to reach a total 160 MT; gentamicin for which two applicants will be selected for minimum production of 40 MT, for 80MT capacity; and clindamycin for which two applicants will be selected for minimum annual production of 60 MT for a total of 120 MT production capacity.
The other eligible fermentation-based products include streptomycin for which two applicants will be selected for minimum annual production of 50 MT, to have a total 100 MT capacity; and tetracycline for two applicants for minimum annual production capacity of 200 MT to have a total 400 MT eligible production capacity.
The DoP plans to select four applicants for Key chemical synthesis based product 2-methyl (5) nitro imidazole (2MNI) to produce 800 MT annually for a total of 3,200 MT; three applicants for dicyandiamide (DCDA) for minimum capacity of 8,000 MT for a total capacity of 24,000 MT; and one applicant for 1,1 cyclohexane diacetic acid (CDA) for minimum annual production of 1,500 MT.
Besides, it plans to select four applicants for other chemical synthesis product ciprofloxacin with minimum annual production capacity of 150 MT each; and one applicant for diclofenac sodium with minimum annual production capacity of 175 MT.
The eligible applicants were invited to apply through online mode from May 15 to June 14, 2025, with the last date of receipt of complete application being June 14.
"As per the decision taken, the conditions under the scheme, such as allocation according to available capacities, incentive ceiling in respect of products and limit of incentive up to the production tenure, i.e., up to FY 2027-28 for chemical synthesis products and up to FY 2028-29 for fermentation-based products, have to be complied with," said the DoP.
Applicants or their group companies, including subsidiaries who had applied earlier under the scheme for the said unsubscribed and partially subscribed products and were granted approval, but who subsequently withdrew from the scheme or whose approval was cancelled in line with the clauses of the scheme guidelines or owing to non-performance, are not eligible to apply for the same eligible product.
It may be noted that the DoP has received around 249 applications in four rounds since the launch of the PLI scheme for bulk drugs on March 20, 2020, out of which a total of 48 applications were approved till the end of December, 2024.
The ministry of chemicals and fertilisers has recently said that one of the significant achievements under the PLI scheme has been the surpassing of targeted investments. The scheme was announced with a total financial outlay of Rs 6,940 crore for the period from FY 2020-21 to FY 2029-30, with a main objective to promote domestic manufacturing of 41 identified bulk drugs to address their high import dependence.
"While the initial commitment was Rs. 3,938.57 crore, the actual realized investment has already reached Rs. 4,253.92 crore (as of December 2024)," said the Ministry. Out of the 48 projects, 34 projects have been commissioned for 25 bulk drugs.
Some of the notable projects under the scheme include Penicillin G Project in Kakinada, Andhra Pradesh, with an investment of Rs. 1,910 crore, which is expected to substitute imports of Rs. 2,700 crore per annum, and Clavulanic Acid Project in Nalagarh, Himachal Pradesh, with an investment of Rs. 450 crore, which is expected to substitute investment of Rs. 600 crore per annum.
The Department has earlier informed a Parliamentary Panel which looked into the budget for the DoP, that under the PLI scheme for Bulk Drugs, FY 2022-23 was the first year of performance for Chemical Synthesis products and FY 2023-24 was the first year of performance for Fermentation based products.
As of February 2025, an incentive amount of Rs. 20.32 crore have been disbursed to applicants, out of total financial allocation of Rs. 6,940 crore. The bulk drug projects are gradually scaled up because of consistency of quality and stability requirements. Further, fourteen more projects are under construction and expected to be commissioned in FY 2025-26. It is expected that as the projects mature, there would be an increase in sales and proportionately more incentive is expected to be disbursed in the future, it added.
The Department informed that under the scheme, sales worth Rs. 1,556.04 crore have been made including export sales worth Rs. 412.42 crore, as of December 2024. It is anticipated that 9,600 jobs will be created during the scheme's tenure. As per the Quarterly Review Report of December 2024, a total of 4,473 jobs have been generated by the selected applicants, it informed the Panel.
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