PLI Scheme for Medical Devices Reopened: ₹2,700 Crore Second Phase Runs Till 2035-36
The Department of Pharmaceuticals (under the Ministry of Chemicals and Fertilizers) invited fresh applications under the Production Linked Incentive (PLI) scheme for medical devices. About ₹2,700 crore is available, and the scheme now runs till 2035-36. This new round is called PLI-MD 2.0.
The rules are easier now. There is no minimum sales threshold for claiming incentives anymore, and the minimum investment manufacturers must commit has been reduced.
Selected companies get three years to set up factories. Applications will be filed on an online portal, expected to open within about 10 days.
The scheme covers four target segments: (1) consumables, disposables and implants, (2) critical components, (3) high-end devices that India has only just started making, and (4) high-end devices that are only assembled in India today.
The first phase (from 2020-21) led to Indian manufacturing of over 60 high-end devices and components, such as CT scanners, 1.5 tesla MRI machines, LINACs (cancer radiation machines), cath labs and heart implants, with production worth over ₹16,000 crore.
The new phase targets machines still mostly imported, such as 3 tesla MRI, PET-CT scanners, ultrasound probes and high-throughput lab analysers. It also aims to bring more small firms (MSMEs) into component making.
PLI Scheme for Medical Devices
The PLI Scheme for Medical Devices is a Government of India scheme that pays companies a cash reward for making medical machines and implants in India. The reward is a percentage of the extra sales a company makes from devices produced in its Indian factories. The aim is simple: make India less dependent on imported medical equipment, and make good hospital equipment cheaper and easier to get. It is run by the Department of Pharmaceuticals in the Ministry of Chemicals and Fertilizers.
The government has reopened this scheme as PLI-MD 2.0 with about ₹2,700 crore and a tenure till 2035-36. The easier rules and higher rewards for critical components are meant to bring in smaller firms and move India from assembling machines to truly making them.
Production Linked Incentive (PLI) Scheme
The PLI Scheme is a government plan that gives companies a cash reward for producing more in India. The reward is a percentage of the extra sales of goods made in Indian factories, compared to a base year. So the more a company produces and sells, the more it earns. It started in 2020 and now covers 14 sectors.
The medical devices scheme was one of the very first PLI schemes. Its reopening with simpler rules shows the government adjusting PLI design based on lessons from the first phase.
Medical Device Regulation in India
A medical device is any instrument, machine, implant or material used to find, prevent or treat a disease, where it works mainly in a physical way rather than as a medicine. In India, devices are regulated as "drugs" under the Drugs and Cosmetics Act, 1940, through the Medical Devices Rules, 2017. The regulator is the Central Drugs Standard Control Organisation (CDSCO), headed by the Drugs Controller General of India.
Devices made under PLI-MD 2.0 must still get licences under the Medical Devices Rules, 2017 before sale. High-end devices like MRI and CT scanners fall in higher risk classes, so they need central approval.
- PLI-MD 2.0 announced: 10 November 2026 by the Department of Pharmaceuticals
- Outlay: about ₹2,700 crore; tenure extended to 2035-36
- Minimum sales threshold removed; baseline investment requirement reduced; three years to set up facilities
- Four segments: consumables/disposables/implants; critical components; nascent high-end devices; assembled high-end devices
- First phase: approved 21 March 2020; ₹3,420 crore; 5% incentive on incremental sales over 2019-20
- First phase output: over 60 high-end devices and components; production over ₹16,000 crore
- New targets: 3T MRI, PET-CT, ultrasound probes and consoles, high-throughput IVD analysers
- Medical Device Parks: ₹400 crore for four parks (HP, MP, TN, UP)
- Medical Devices Rules, 2017: four risk classes A to D