Launched in July 2020, the PLI scheme seeks to bridge the manufacturing gap in medical devices within the country compared to other economies.
In a substantial leap towards promoting domestic manufacturing of medical devices, India's Production Linked Incentive (PLI) scheme has recorded an actual investment exceeding INR 879.42 Cr.
As of September 2023, the scheme has seen the initiation of 16 projects, contributing to the actual production of INR 3,251.76 Cr and employing 4,546 individuals during the period, according to the Department of Pharmaceuticals (DoP).
The PLI scheme launched through a notification in July 2020, aims to address the gap in the manufacturing of medical devices in the country compared to other manufacturing economies. It is designed to stimulate domestic manufacturing and attract substantial investments in the medical device sector.
This investment showcases tangible results in the production of high-end medical devices such as linear accelerators, MRI scans, CT scans, mammograms, C-Arms, MRI coils, and high-end X-ray tubes. The scheme has been instrumental in kickstarting domestic manufacturing in this critical sector.
The DoP invited applications from eligible companies in four rounds, receiving a total of 64 applications for the manufacturing of medical devices. Out of these, the department has approved 26 applications across different rounds, including 11 in the first round, eight in the second, five in the third, and two in the fourth.
With a total financial outlay of INR 3,420 Cr for the period 2020-21 to 2027-28, the PLI scheme invited applications under four distinct target segments:
1. Cancer care/radiotherapy medical devices
2. Radiology & imaging medical devices (both ionizing & non-ionizing radiation products) and nuclear imaging devices
3. Anaesthetics & cardio-respiratory medical devices, including catheters of the cardio-respiratory category & renal care medical devices
4. All implants, including implantable electronic devices
The scheme aims to support and encourage manufacturing in these crucial areas to enhance India's self-reliance in the production of medical devices.
The success of the PLI scheme has prompted the DoP to call for applications for the fifth round under Category B of the scheme. Additionally, guidelines have been modified to include more medical devices for support through the scheme.
Notably, the Category B applicants will see a significant expansion of eligible products. In the cancer care and radiotherapy medical devices category, the revised guidelines now include around 12 products, such as Cryoablation units, cryoprobes, and hyperthermic intravesical therapy, among others.
Similarly, the list of eligible products for radiology and imaging devices and nuclear imaging devices has expanded to include almost 26 products, ranging from collimators to 3T digital PET/MR.
In the category of anaesthetic and cardio-respiratory medical devices, the revised list mentions over 50 specific products, including laparoscopic surgery sets, non-invasive jugular oximetry monitors, and paediatric bronchoscope sets.
The segment covering all implants, including implantable electronic devices, now includes products such as Bi-Ventricular Pacemakers, expandable corpectomy devices, and MRI conditional automatic implantable cardioverter defibrillators.
For products not explicitly mentioned in the list, a technical committee will decide their eligibility under the target segment. Additionally, any product listed in Category A will not be considered under the 'other products' category in Category B.
This expansion of the PLI scheme, coupled with the increased support for diverse medical devices, is poised to further strengthen India's position in the medical manufacturing sector, fostering innovation and self-reliance in critical healthcare technologies.
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