The Government of India has revealed the latest results of its Production Linked Incentive (PLI) Scheme for pharmaceuticals and medical devices — and the numbers point to a rapidly transforming domestic manufacturing ecosystem.
The first arm of the scheme targeting key starting materials (KSMs), drug intermediates (DIs), and active pharmaceutical ingredients (APIs) — was allocated ₹6,940 crore. As of September 2025, investments under this “Bulk Drugs” programme have reached ₹4,763.34 crore, in just over three-and-a-half years. This exceeds the earlier six-year commitment of ₹4,329.95 crore for greenfield projects.
Through these efforts, capacity has been established for 26 previously imported KSMs/DIs/APIs. On the sales front, cumulative domestic and export sales reached ₹2,315.44 crore, including ₹508.12 crore worth of exports — effectively replacing imports valued at ₹1,807.32 crore.
Under the broader PLI scheme for pharmaceuticals, aimed at scaling the country’s ability to produce higher value medicines, the original budgetary provision was ₹15,000 crore. However, actual investment as of September 2025 has surged to ₹40,890 crore. This investment covers both brownfield expansions and greenfield developments.
A total of 726 APIs/KSMs/DIs are now being manufactured under the scheme, of which 191 are being produced for the first time in India under this incentive structure. Domestic sales under this scheme alone till September 2025 have been recorded at ₹26,123 crore, significantly reducing dependency on imports.
The PLI facility also extends to medical devices, backed by a ₹3,420 crore allocation for a performance-linked incentive period running from FY 2022-23 to FY 2026-27. By September 2025, 22 greenfield projects have been commissioned and production has started on 55 high-end medical products — including imaging devices, radiotherapy equipment, anaesthesia machines, cardio-respiratory and critical care devices, and implantables.
These products include items on which India has historically been heavily import-dependent, such as linear accelerators, MRI and CT scan machines, C-arm X-ray machines, MRI coils, ultrasound machines and more. Cumulative eligible sales under this scheme stand at ₹12,344.37 crore, including ₹5,869.36 crore worth of exports.
In parallel, regulatory mechanisms overseen by National Pharmaceutical Pricing Authority (NPPA) continue to safeguard affordability of essential medicines. As of 26 November 2025, ceiling prices for 935 formulations listed under the national essential medicines list have been fixed. Additionally, retail prices for more than 3,500 “new drugs” — which are modified versions of existing essential medicines — have also been capped. NPPA rules limit price increases of such medicines to a maximum of 10% in any 12-month period.
On top of that, NPPA has applied price caps to a number of non-scheduled medicines: this includes 22 diabetes drugs and 84 cardiovascular medicines, delivering estimated annual savings of around ₹350 crore to patients. Prices and trade margins of 42 non-scheduled anti-cancer medicines have also been capped — covering roughly 526 brands — bringing down their cost by about 50% on average and yielding an estimated annual saving of ₹984 crore.
Prices of orthopaedic knee-implants have also been regulated, providing estimated annual savings of ₹1,500 crore. Previous efforts to cap trade margins on devices like oxygen concentrators, pulse oximeters, blood-pressure monitors, nebulisers, thermometers and glucometers (initiated in 2021) continue to benefit consumers — estimated annual savings from these measures stand at roughly ₹1,000 crore.
To support the long-term aims of boosting domestic drug and device production, the government has also approved the development of dedicated infrastructure: under the Bulk Drug Parks Scheme, three parks in Andhra Pradesh, Gujarat and Himachal Pradesh will bear common infrastructure such as utilities, effluent treatment, steam generation, warehouses and more — with total project costs surpassing ₹6,300 crore, backed by central assistance of ₹1,000 crore per park.
Firms manufacturing prioritized products under the PLI for bulk drugs get priority allotment of land. Under the Medical Device Parks Scheme, three parks have been approved in Greater Noida (UP), Ujjain (MP), and Kanchipuram (Tamil Nadu), with total cost approximated at ₹871.11 crore. As of November 2025, ₹180 crore out of an allocated ₹300 crore has been released. Civil construction is nearing completion, and so far 194 medical-device manufacturers have been allotted land over a 298.58-acre area; 34 units have already commenced building plants.
Beyond manufacturing expansion, the government is also working to regulate the sale of medicines and medical devices. The sale and distribution of drugs — including via online pharmacies — are governed under the Drugs and Cosmetics Act, 1940, enforced by state licensing authorities.
A draft update to the rules published in August 2018 proposed new provisions for registration and periodic inspection of e-pharmacies, mechanisms for complaint redressal, restrictions on advertising, and tighter monitoring to prevent overcharging or shortages. The government has underscored that, in cases where overcharging is found, appropriate action will be taken.
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