Boosting Domestic Manufacturing Through the PLI Scheme
India has commenced domestic production of 44 advanced medical devices, including Linear Accelerators, MRI machines, and CT Scanners, under the Government of India’s Production Linked Incentive (PLI) Scheme for Promoting Domestic Manufacturing of Medical Devices. Launched in 2020, the PLI scheme aims to boost indigenous manufacturing capabilities with a total financial outlay of ₹3,420 crore and a production tenure spanning from FY 2022-23 to FY 2026-27. The scheme offers a 5% incentive on incremental sales of medical devices manufactured in India for five years, targeting four key segments.
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Milestones Achieved Under the PLI Scheme
As part of the initiative, 19 greenfield projects have been commissioned, resulting in the production of 44 high-end medical devices. These include Linear Accelerators, MRI machines, Mammograms, C-Arms, Ultrasound machines, and other previously imported devices. By September 2024, the cumulative sales of these products had reached ₹8,039.63 crore, with exports contributing ₹3,844.01 crore to this total.
Gujarat's Leading Role in the Initiative
Four greenfield projects have been established in Gujarat, further driving India’s self-reliance in medical device manufacturing.
Details of Greenfield Projects in Gujarat
S. No. | Name of Applicant | Products | Location |
1 | Envision Scientific Private Limited | Stents, PTCA Balloon Catheter | Surat, Gujarat |
2 | Meril Healthcare Private Limited | Hip Implants, Knee Implants, Trauma Implants | Vapi, Gujarat |
3 | Meril Life Sciences Private Limited | Heart Valves, Stents, PTCA Balloon Catheter | Vapi, Gujarat |
4 | Sahajanand Medical Technologies Private Limited | Heart Valves, Stents, PTCA Balloon Dilatation Catheter, Heart Occluders | Gujarat |
This initiative underscores India’s commitment to reducing import dependency and fostering innovation in medical technology, while bolstering exports and creating a robust manufacturing ecosystem.
About Operon Strategist
Operon Strategist, a prominent medical device regulatory consulting firm, has supported India’s medical device manufacturing under the PLI scheme. The company provides expert guidance on regulatory compliance, quality assurance, and certifications like ISO 13485, CE marking, and FDA approvals, enabling manufacturers to meet global standards.
By aiding in greenfield project planning, training programs, and export readiness, Operon Strategist has helped streamline the production of advanced medical devices such as MRI machines and CT Scanners. Their efforts contribute significantly to India’s goal of self-reliance, aligning with the “Make in India” vision and driving export growth in the sector.
Operon Strategist delivers complete solutions for obtaining regulatory approvals, including European CE Marking, FDA 510(k), Indian CDSCO Import Registration, SFDA, and UKCA compliance. We also support the establishment of manufacturing facilities by offering services such as facility layout design, cleanroom planning, machine validation, and ensuring facility adherence to global regulatory standards ensuring quality through ISO 13485, FDA QSR, and MDSAP compliance and all regulatory approvals.
