India Reopens PLI Applications for Critical Antibiotic and Antiviral Drug Manufacturing
核心洞察
India's Department of Pharmaceuticals (搜索) has reopened applications under the Production Linked Incentive scheme for domestic manufacturing of meropenem and ritonavir through March 12, 2026.
The initiative targets reducing India's 70% dependence on Chinese bulk drug imports by supporting domestic production of these critical active pharmaceutical ingredients.
Since launch, the PLI scheme has achieved cumulative sales of INR 19.62 billion with exports of INR 4.79 billion, creating domestic production capacity for 26 APIs across 48 approved projects.
India's Department of Pharmaceuticals (搜索) (DoP) has extended the application window for its Production Linked Incentive (PLI) scheme targeting domestic manufacturing of two critical pharmaceutical ingredients: meropenem, a broad-spectrum carbapenem antibiotic (搜索), and ritonavir, an essential antiretroviral drug (搜索). The reopened application period runs through March 12, 2026, following industry stakeholder requests for additional participation opportunities.
Strategic Focus on Critical Drug Dependencies
The renewed application cycle addresses India's significant pharmaceutical supply chain vulnerabilities, with the country importing over 70% of its bulk drug requirements from China according to central government estimates. The PLI scheme specifically targets meropenem and ritonavir production to strengthen domestic capacity for these essential medicines.
Under the current round, the DoP will select a maximum of four applicants for meropenem production, requiring minimum annual product capacity of 4 MT per applicant for a total capacity of 16 MT. For ritonavir, up to four applicants may be selected with minimum annual production capacity of 5 MT each, totaling 20 MT production capacity.
Scheme Performance and Investment Outcomes
The PLI Scheme for Bulk Drugs, launched on March 20, 2020, operates with a financial outlay of INR 69.40 billion through FY 2029-30. As of September 2025, the program has demonstrated substantial progress with committed investment of INR 43.29 billion and actual investment reaching INR 47.63 billion, exceeding initial targets.
The scheme has established domestic production capability for 26 APIs/KSMs/DIs across 48 approved projects involving 32 pharmaceutical firms. Cumulative sales have reached INR 23.15 billion, with exports totaling INR 5.08 billion and import substitution valued at INR 18.07 billion.
Manufacturing Requirements and Incentive Structure
Eligible applicants must comply with existing PLI scheme guidelines, including product-specific incentive ceilings and domestic value addition requirements. The scheme mandates minimum domestic value addition of 90% for fermentation-based products and 70% for chemical synthesis-based products. Financial incentives remain available only until FY 2027-28 for chemical synthesis products.
Companies that previously received approval but withdrew or had approvals cancelled for non-performance are not eligible to reapply for the same products. The scheme provides financial incentives on sales of 41 identified KSMs/DIs/APIs products manufactured through greenfield projects.
Infrastructure Development Through Bulk Drug Parks
Complementing the PLI initiatives, India is developing large-scale pharmaceutical infrastructure under the Scheme for Promotion of Bulk Drug Parks. The central government granted in-principle approval for three parks in Andhra Pradesh, Gujarat, and Himachal Pradesh on September 1, 2022, with a combined outlay exceeding INR 63.06 billion supported by up to INR 30 billion in central government incentives.
Broader Pharmaceutical Manufacturing Strategy
The bulk drug PLI scheme operates alongside the broader PLI Scheme for Pharmaceuticals, which targets advanced and high-value pharmaceutical products including biopharmaceuticals, complex generics, and patented drugs. This complementary program has achieved actual investment of INR 408.90 billion against a scheme outlay of INR 150 billion, with 726 APIs/KSMs/DIs being manufactured and 191 products produced in India for the first time.
The coordinated approach across both PLI schemes and bulk drug park infrastructure represents India's comprehensive strategy to achieve pharmaceutical self-reliance while positioning the country as a competitive player in the global pharmaceutical industry. The scheme continues through FY 2029-30, with applications for meropenem and ritonavir manufacturing available through the official portal at plibulkdrugs.ifciltd.com.