To boost the production of bulk drugs, the department of pharmaceuticals (DoP) has invited fresh applications from the entities under the performance-linked incentive (PLI) scheme. Under the fifth round of the scheme, the DoP is seeking interest from the industry on 11 product categories to promote domestic manufacturing of active pharmaceutical ingredients (APIs), key starting materials (KSMs) and drug intermediates.
The notification said that the applicants or their group companies, including subsidiaries, who had applied earlier under the scheme but subsequently withdrew from the scheme or whose approval was cancelled owing to non-performance are not eligible to apply for the same eligible products.
Currently, India is heavily dependent on China for its bulk drug imports with nearly 72% (by value) of the country’s overall bulk drug imports in FY24 came from China. Over the past five years, the government has introduced a slew of programmes, including PLI scheme, revamped pharmaceutical technology upgradation assistance scheme (PTUAS), and setting up of bulk drug parks, to reduce the dependence on China to some extent.
Experts said that despite government initiatives, the reliance on China for bulk drugs remains high. As on September 2024, the total investments in the first four rounds of the bulk drugs-specific PLI scheme stood at Rs 4,025 crore across 32 commissioned projects. In total, the government received 249 applications under the scheme, and out of which 48 were approved.
Launched in FY21, PLI scheme for bulk drugs has an outlay of Rs 6,940 crore, and the production tenure from FY23 to FY29. Under the scheme, financial incentives is being given based on threshold investment and domestic sales made by selected applicant for the eligible products. In addition, there’s a separate PLI scheme for pharma manufacturing which has a financial outlay Rs 15,000 crore, and the production tenure from FY23 to FY28.
