New Delhi, December 6, 2025 — The Department of Pharmaceuticals (DoP) has reopened the application window under the PLI Scheme for Bulk Drugs, inviting pharmaceutical companies to apply until 26 December 2025 for manufacturing critical active pharmaceutical ingredients (APIs) and drug intermediates domestically.
The Production Linked Incentive or PLI Scheme is a government program that provides financial incentives to companies for increasing domestic manufacturing. Under this scheme, companies receive incentives based on the value of goods they produce in India.
In the pharmaceutical sector, the PLI Scheme for Bulk Drugs focuses on boosting the local production of active pharmaceutical ingredients, drug intermediates, and key starting materials. These are the basic raw materials needed to make finished medicines. By encouraging companies to manufacture these ingredients within India, the government aims to reduce dependence on imports and strengthen the country’s medicine supply chain.
The scheme also works alongside government-supported bulk drug parks, which provide common infrastructure such as power, water, waste treatment, and testing facilities to reduce production costs for manufacturers.
In this sixth round of applications, DoP has identified two high-priority drugs: Meropenem, a broad-spectrum antibiotic, and Ritonavir, an antiretroviral medication. DoP has selected Meropenem and Ritonavir because both are essential medicines and India depends heavily on imports for their key raw materials.
Meropenem is a broad-spectrum antibiotic used to treat severe bacterial infections such as sepsis, pneumonia, and complicated abdominal infections. Hospitals use it for critically ill patients where timely treatment is essential.
Ritonavir is an antiretroviral medicine used in the treatment of HIV infection. It also boosts the action of other HIV drugs, which makes it a key part of many antiretroviral treatment combinations used in national HIV programs.
By supporting domestic production of these drug ingredients, the government aims to ensure uninterrupted supply, reduce vulnerability to global shortages, and strengthen India’s self-reliance in essential medicines.
For Meropenem, the scheme allows up to four companies — each with minimum annual production capacity of 4 metric tonnes (MT) — to be selected, with a total production capacity cap of 16 MT.
For Ritonavir, up to four firms may be selected, each producing at least 5 MT per year, with a combined cap of 20 MT.
Applications must be submitted online via the official PLI Bulk Drugs portal.
India currently depends heavily on imports for its bulk-drug requirements. Over 70 percent of bulk drugs used in the country are imported, making supply vulnerable to external disruptions.
The PLI Scheme for Bulk Drugs — launched in FY 2020–21 — aims to reduce this dependence by supporting domestic production of key starting materials (KSMs), drug intermediates (DIs), and APIs.
As of September 2025, the scheme has resulted in:
Domestic production capacity created for 26 KSMs/DIs/APIs that were earlier mainly imported
Investment of ₹4,763.34 crore against a committed ₹4,329.95 crore under greenfield projects
Domestic sales amounting to ₹2,315.44 crore and export sales worth ₹508.12 crore
Estimated import savings of ₹1,807.32 crore owing to the increased domestic production of APIs
In addition to production incentives, the government is supporting development of dedicated infrastructure through the Scheme for Promotion of Bulk Drug Parks. Three bulk-drug parks have been approved in the states of Andhra Pradesh, Gujarat and Himachal Pradesh.
The parks provide standard utilities such as power, water, effluent treatment, waste management, steam, warehouses, and regulatory-compliance infrastructure at subsidised rates to participating manufacturers.
State governments concerned have offered additional fiscal incentives such as capital subsidies, interest subsidies on loans, GST reimbursements, exemption from stamp duty and registration charges, and easier regulatory clearances to attract investment.
By boosting domestic manufacturing of key drug ingredients, the PLI scheme aims to ensure consistent availability of essential medicines such as broad-spectrum antibiotics and antiretrovirals through stable supply chains. Reduced reliance on imports may lead to lower production costs and potentially more affordable drugs for patients in India.
If companies successfully begin manufacturing Meropenem and Ritonavir domestically, the move could enhance the country’s drug security — especially in the face of global supply disruptions — and help safeguard public health.
Eligible pharmaceutical companies may submit their applications online until 26 December 2025. Selected firms will be required to comply with PLI scheme conditions, including production-capacity thresholds and incentive ceilings.
The DoP has clarified that firms or subsidiaries that had previously applied for the same products and either withdrew or had their approvals cancelled due to non-performance are not eligible to re-apply for the same products.
(Rh/MSM)
