PLI Scheme For Medical Devices Witnesses Rs. 879 Crore Investments Till September, 2023

New Delhi: The production linked incentive (PLI) scheme for promoting domestic manufacturing of medical devices has witnessed an actual investment of over Rs. 879 crore with a total of 16 projects commissioned from the initiation of the scheme, till September, 2023.

According to the Department of Pharmaceuticals (DoP), the scheme as on September, 2023, has seen an actual investment of Rs. 879.42 crore, resulting in actual production of Rs. 3,251.76 crore. It has also resulted in actual employment of 4,546 persons during the period. The Department added that with the implementation of the Scheme, domestic manufacturing of high-end medical devices has started which include Linear Accelerator, MRI Scan, CT-Scan, Mammogram, C-Arm, MRI Coils, high end X-ray tubes, etc.

The Department launched the project through a notification in July, 2020, with a view to address the disability in manufacturing of medical devices in the country, as against other manufacturing economies. The Scheme is intended to boost domestic manufacturing and attract large investments in the sector.

Applications from eligible companies were invited under the scheme and in four rounds, the Department received 64 applications for manufacturing of medical devices. Out of this, in four rounds, the department has approved 26 applications, including 11 in the first round, eight in second, five in third and two in the fourth round.

The Scheme, with a total financial outlay of Rs. 3,420 crore for the period 2020-21 to 2027-28, invited applications under four different target segments including 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 cardio-respiratory category & renal care medical devices and all implants including implantable electronic devices.

It may be noted that the DoP has recently called for applications from eligible candidates for the fifth round, under the Category B of the Scheme, along with modifications to the guidelines to add more medical devices to be supported through the scheme.

A significant revision has been made for the Category B applicants, under which several devices are added to the eligible products. Under the list of cancer care and radiotherapy medical devices, where there were four products were specifically named while including other products generally, the revised guideline has around 12 products including Cryoablation unit, cryoprobe, cryotherapy, HDR Brachytherapy, Holmium Laser system with MOSES technology, hyperthermic intra vesicular therapy, vacuum assisted breast biopsy machine among others listed.

Under the list of radiology and imaging devices (both ionising and non-ionising radiation products) and nuclear imaging devices, instead of four to five devices specified, the new list specifies almost 26 products including collimator, monitor, flat panel detector, 3T digital PET/MR, biplane DSA, cone beam computed tomography, CR system, dedicated solid-state cardiac SPECT camera, densitometer with computer, DEXA scan, DEXA scanner (BMD), ECHO and USG machine, among others are freshly added.

In the list of anesthetic and cardio respiratory medical devices including catheters of cardiorespiratory category and renal care medical devices, instead of around five products specifically listed, the new list has over 50 products specifically mentioned including kidney transporter with 05 sets of expendables with each equipment, laparoscopic surgery set with high-definition camera, minimally invasive cardiac instruments, non-invasive jugular oximetry monitor, paediatric bronchoscope set, paediatric cystoscope and resectoscope set/cystoscope and resectoscope, paediatric laparoscopy set, among others.

In the list of all implants including implantable electronic devices segment, products such as Bi-Ventricular Pacemaker with Quadripolar LV lead, expandable corpectomy device, MRI conditional automatic implantable cardioverter defibrillator, MRI conditional cardiac resynchronisation therapy – pacing and others were added.

For products not specifically mentioned in the list, the technical committee shall decide whether such products shall be considered eligible under the target segment. Any product which is listed in Category A will also not be considered under the ‘other products’ mentioned in Category B.

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