New Delhi: The Government of India has extended the PLI Scheme for Medical Devices until 2035–36 and invited fresh applications to strengthen domestic manufacturing of medical devices, with a particular focus on critical component manufacturing.
The extended scheme has an available outlay of approximately ₹2,700 crore, which will be utilised to support eligible manufacturers. The online application portal is expected to become operational within the next 10 days.
The revised PLI Scheme for Medical Devices introduces several changes to its eligibility criteria and incentive-claiming procedures to make the programme more investor-friendly.
Key changes include discontinuing the minimum sales threshold requirement for claiming incentives and reducing the minimum investment requirement.
The government has also simplified the scheme guidelines to improve Ease of Doing Business (EoDB), while allowing applicants to submit multiple applications across different target segments.
PLI Scheme for Medical Devices: Over 60 High-End Products Manufactured Domestically
Launched in 2020–21, the Production Linked Incentive Scheme for Promoting Domestic Manufacturing of Medical Devices (PLI-MD) has supported the domestic manufacturing of more than 60 high-end medical devices and components.
These include X-ray tubes and detectors, 1.5T MRI machines, Linear Accelerators (LINAC), CT scanners, mammography machines, Cathlab equipment, orthopaedic and cardiac implants, and dialyzers, among other products.
The PLI Scheme for Medical Devices has contributed to domestic production valued at more than ₹16,000 crore to date.
Building on the experience and learnings from the first phase, the government has introduced changes to the scheme’s eligibility conditions and procedures for claiming incentives.
The revised framework is intended to encourage greater participation from manufacturers and attract investments into domestic medical device production.
Four Target Segments Under the Extended PLI Scheme
Under the extended PLI Scheme for Medical Devices, applicants will be allowed three years to establish their manufacturing facilities across any of the four identified Target Segments (TS).
The four target segments cover different categories of medical devices and manufacturing requirements.
These include:
- Target Segment 1 (TS1): Medical consumables, disposables and implants.
- Target Segment 2 (TS2): Critical components.
- Target Segment 3 (TS3): High-end medical devices where domestic manufacturing is currently at a nascent stage.
- Target Segment 4 (TS4): High-end medical devices that are currently only assembled in India.
The incentive rates will taper over the scheme period, with average rates of approximately 5% for TS1, 9% for TS2 and TS3, and 6% for TS4.
The government has outlined different manufacturing priorities across these segments.
For the consumables and disposables segment, the focus will be on developing manufacturing scale and achieving world-class quality standards.
For TS3 and TS4, priority will be given to value chain integration to improve the overall competitiveness and quality of Made in India medical devices.
A significant focus on critical component manufacturing under the PLI Scheme for Medical Devices is expected to support value chain integration and provide a boost to the micro, small and medium enterprises (MSME) sector.
Minimum Sales Threshold Removed; Investment Requirement Reduced
One of the key changes in the revised PLI Scheme for Medical Devices is the discontinuation of the minimum sales threshold requirement for manufacturers to claim incentives.
The government has also reduced the minimum investment requirement under the scheme, making it easier for companies to participate.
To improve Ease of Doing Business, the revised guidelines have been simplified and made more investor-friendly.
Applicants will be permitted to submit any number of applications across one or more target segments.
Additionally, the application window will remain continuously open over an extended period, providing manufacturers with greater flexibility to participate in the scheme.
The changes are based on the government’s assessment of the first phase and are aimed at addressing participation and implementation requirements under the programme.
PLI-MD 2.0 to Strengthen Critical Component Manufacturing and Indigenous Supply Chains
The extended PLI Scheme for Medical Devices, also referred to as PLI-MD 2.0, aims to advance the government’s Atmanirbhar Bharat and Make in India initiatives by strengthening domestic manufacturing capabilities.
The scheme is designed to develop indigenous supply chains, attract investments, generate employment, improve the quality of Made in India medical devices and reduce the prices of medical devices.
Another key objective is to enhance India’s global competitiveness in high-end medical technologies.
Under PLI-MD 2.0, the government is looking to promote deeper manufacturing capabilities rather than limiting domestic production to the assembly of finished medical equipment.
The programme will particularly encourage manufacturing of high-end medical equipment that is currently not manufactured in India.
Focus on 3T MRI, PET-CT and High-End Diagnostic Equipment
The PLI Scheme for Medical Devices will focus on developing domestic manufacturing capabilities for advanced medical equipment, including 3T MRI machines, PET-CT scanners, ultrasound probes and consoles, and high-throughput In Vitro Diagnostic (IVD) analysers.
These products represent areas where domestic manufacturing capabilities need to be strengthened.
By encouraging investment in high-end equipment and critical components, PLI-MD 2.0 aims to improve India’s domestic medical technology manufacturing ecosystem.
The focus on critical components is also intended to support the development of indigenous supply chains, improve value chain integration and create opportunities for MSMEs.
With an available outlay of approximately ₹2,700 crore and a longer implementation timeline extending up to 2035–36, the revised PLI Scheme for Medical Devices seeks to expand domestic production, strengthen manufacturing capabilities and reduce dependence on imported medical technologies.
