Sector Snapshot:

The Indian Medical Devices industry is estimated at $11 Bn and is poised for significant growth in the next five years. Presently, India is counted amongst the top 20 global medical devices market in the world and is the 4th largest market in Asia after Japan, China, and South Korea. The Indian medical devices industry is identified as a ‘sunrise sector’ under the Make in India mandate of the Government of India.

India has become a leading destination for high-end diagnostic services and is a growing market for diagnostic kits, reagents, hand-held equipment, and stimulation for operation rooms. There are over 750–800 domestic Medical Devices manufacturers in India, with an average investment of $2.3–2.7 Mn and an average turnover of $6.2-6.9 Mn.

Starting from a time when ventilators & PPEs were not domestically manufactured at scale and testing kits were not available, India has now emerged as the forerunner in supplying COVID-19 related medical devices & diagnostics kits specifically ventilators, RT-PCR kits, IR Thermometers, PPE Kits, and N-95 masks to those in need, truly living by “Vasudhaiva Kutumbakam” (The World Is One Family).

Production Linked Incentive Scheme for Medical Devices (PLI 1.0): Laying the Foundation

With an objective to boost domestic manufacturing and attract large investment in Medical Device Sector, the Government of India had launched the Production Linked Incentive (PLI) Scheme for Promotion of Domestic Manufacturing of Medical Devices with a total financial outlay of Rs. 3,420 Crore ($ 455.2 Mn) for the period 2020-21 to 2027-28.

The PLI Scheme focusses on incentivizing domestic manufacturing under the following target segments of medical devices: -

• Cancer care/Radiotherapy medical devices,
• Radiology & Imaging medical devices (both ionizing & non-ionizing radiation products) and Nuclear Imaging Devices,
• Anaesthetics & Cardio-Respiratory medical devices including Catheters of Cardiorespiratory Category & Renal Care Medical Devices, and
• AII Implants including implantable electronic devices like Cochlear Implants and Pacemakers

Opened for applications in two rounds, the Production Linked Incentive Scheme received 28 applications & 14 applications respectively. In the first round, 13 applications were approved by the Government of India with a total committed investment of Rs.798.93 Crore ($ 106.3 Mn). In the second round, 8 have been approved with a total committed investment of Rs. 260.40 Crore ($34.66 Mn). Currently, 21 applicants have been approved with a total committed investment of Rs. 1,059.33 Crore ($141 Mn) for their respective projects under the four key target segments, the commissioning of which will seminally help in strengthening the domestic supply chains, provide adequate infrastructure for the healthcare sector, reduce the cost of manufacturing disability in the industry vis-a-vis competing economies, and focus on bolstering R&D and skill development within the sector.

The detailed analysis of applicants approved under the identified target segments of the Production Linked Incentive Scheme for Medical Devices is as follows:

With a laser eyed focus on providing an impetus to Aatmanirbharta, the Scheme envisions to lead to an incremental production of Rs. 68,437 Crore ($ 9.11 Bn) & generation of additional employment of 33,750 jobs over a period of five years starting from FY 2022-23.

Production Linked Incentive Scheme for Pharmaceuticals: Boosting in-vitro diagnostic devices

Approved by the Union Cabinet, chaired by the Hon’ble Prime Minister Shri Narendra Modi on February 24, 2021, the Production Linked Incentive Scheme (PLI) for Pharmaceuticals aims to enhance India’s manufacturing capabilities by increasing investment and production in the pharmaceuticals & medical devices sectors with a key intent to strengthen in-vitro diagnostic devices. With a total financial outlay of Rs. 15,000 Crore ($ 2 Bn), the Scheme intends to create global champions out of India who have the potential to grow and scale using innovative technology to penetrate the global value chains within a broad range of product segments for the period 2020-21 to 2028-29.

The PLI Scheme for Pharmaceuticals covers the following product categories: -

Category 1: Biopharmaceuticals; Complex generic drugs; Patented drugs or drugs nearing patent expiry; Cell based or gene therapy drugs; Orphan drugs; Special empty capsules like HPMC, Pullulan, enteric etc.; Complex excipients; Phyto-pharmaceuticals

Category 2: Active Pharmaceutical Ingredients / Key Starting materials / Drug Intermediates (except the Active Pharmaceutical Ingredients / Key Starting materials / Drug Intermediates covered under the earlier PLI scheme for APIs/KSMs and Dis)

Category 3: (Drugs not covered under Category 1 and Category 2): Repurposed drugs; Autoimmune drugs, anti-cancer drugs, anti-diabetic drugs, anti-infective drugs, cardiovascular drugs, psychotropic drugs, and anti-retroviral drugs; In vitro diagnostic devices; Other drugs not manufactured in India

The Scheme received 278 applications against which 55 (5 in-vitro diagnostic devices) applicants have been selected, leading to investments to the tune of Rs. 15,000 Crore ($ 2 Bn).The commissioning of the approved projects under the Scheme is projected to lead to generation of 100,000 employment opportunities & give impetus to innovation, R&D, and diversification of product profiles especially of high vale products across the Indian Pharmaceutical and Medical Devices industries.

The Scheme is also expected to contribute to product diversification of high value goods within Pharmaceuticals & Medical Devices, lead to incremental sales of Rs. 2,94,000 Crore ($39.13 Bn), and total incremental exports of Rs. 1,96,000 Crore ($ 26.09 Bn) from 2022-23 to 2027-28.

In Conclusion

The Production Linked Incentive Schemes for Medical Devices reflect India’s commitment to Aatmanirbharta in Medical Devices and will have positive spill-over effects on enhancing India’s manufacturing capabilities, boosting exports of medical devices, finished formulations, and patented drugs, and catalysing R&D within the sector.

Note: $ 1= INR 75.13 (as on today’s spot rate)