PLI scheme for medical devices reopens with Rs 2,700 crore, runs to 2035-36; five earlier approvals named Visakhapatnam, Medak, Hyderabad

The Centre has reopened the PLI scheme for medical devices to new applicants and extended it to 2035-36, with about Rs 2,700 crore left to pay out, the Department of Pharmaceuticals said on Tuesday, 10 November. An online portal for applications is to open within 10 days of the announcement. Andhra Pradesh and Telangana already figure in the scheme: five entries in the department’s list of approvals dated 25 November 2024 named Visakhapatnam, Medak or Hyderabad as a place of manufacture.

A production-linked incentive pays a company a percentage of the additional sales of goods it makes in India. Since this one began in 2020-21, the department said, more than 60 high-end devices and components have gone into local production, among them CT scanners, 1.5-tesla MRI machines, cath labs, dialysers and cardiac implants, with output worth over Rs 16,000 crore. Its approved outlay is Rs 3,420 crore.

What changes for smaller makers

Guidelines issued the same day set up four segments: consumables, disposables and implants; critical components; high-end devices barely made in India; and those only assembled here. A firm with average annual turnover below Rs 150 crore over three years must invest at least Rs 50 crore in three of the segments. Larger firms and all component makers face no minimum investment, and the minimum sales needed before claiming money have been dropped.

Components share the highest rate with the third segment: 10% of eligible sales for three years, 8% in the fourth and 6% in the fifth, if the maker achieves the value-chain integration it commits to. On a product with no earlier sales, that is Rs 10 lakh for every Rs 1 crore sold in the first year. A maker that falls short gets 7%, or Rs 7 lakh. Consumables and implants earn 7% for two years and 3% in the final two.

Five approvals in the Telugu states

The 2024 list had 32 approvals. Three named Visakhapatnam, home of the Andhra Pradesh MedTech Zone: Trivitron Healthcare, whose approved products include CT scanners; Innvolution Healthcare, listed for stents and balloon catheters; and Varex Imaging Manufacturing India, for digital X-ray detectors. Two named Telangana: Sahajanand Medical Technologies, whose entry lists Medak along with Surat for stents, heart valves and heart occluders, and Majik Medical Solutions in Hyderabad for catheter tubing. The zone’s website counts more than 100 companies on its campus.

Applications reaching the portal before a month ends will be settled within 60 days. Each carries a non-refundable fee of Rs 1 lakh. Spending on land and buildings does not count as investment. An approved company gets up to three years to set up its plant and up to five years of incentive after that. The department will publish the method of applying on its website.