Last Updated on December 31, 2023 by The Health Master
The Department of Pharmaceuticals (DoP) has approved the applications of five medical devices companies under the production linked incentive (PLI) scheme for promoting domestic manufacturing of medical devices, in the category it has added through an amendment of guidelines in August, 2022.
According to a latest list from the DoP, it has approved the applications of five companies in Category B, comprising radiology and imaging medical devices (both ionising and non-ionising radiation products) and nuclear imaging devices.
This will support domestic manufacturing of 87 products or product components in the near future, said the officials.
Samvardhana Motherson Maadhyam International Ltd has received the approval under the scheme for products including Housing Diamond Emerald Metric 90 DEG, Housing/Center section Sapphire, Anode Outer Sealing Ring, Ring Sealing Cathode Inner, Sealing Ring, Shield, Cathode, among others.
Indovasive Pvt Ltd’s received the approval for incentives to manufacture:
- Biopsy Kits-Renal,
- Dialyser Reprocessing System,
- PCN Catheter/Kit (Abscess Drainage Catheter/Kit),
- Ureteral Catheter Malecot Catheter/Kit,
- Re Entry Malecot Catheter/Kit,
- Suprapubic Catheter/Kit,
- Dual Lumen Ureteral Catheter,
- IUI Catheter/Kit,
- Braided Shaft Catheter (Ureteral Access Sheath),
- Cysto Catheter/Kit,
- Urethral Stent,
- Double J Stent/Kit (Long Term),
- Double J Stent/Kit (Short Term).
Omron Healthcare Manufacturing India Pvt Ltd has received the approval to get the incentive on manufacturing of automatic blood pressure monitor.
Meril Endo Surgery Pvt Ltd has been awarded with approval for incentive to manufacture:
- Hernia Surgical Mesh Implants,
- Endocuter,
- Linear Stapler,
- Linear Cutter,
- Trocar,
- Litigation Clip,
- Hemostats.
For Neurovasive Pvt Ltd, the PLI Scheme will be applicable for:
- Cerebrospinal fluid shunt system (CSF),
- Flow diverter implants, e
- Embolic liquid,
- Peripheral stent,
- Carotid stent,
- Intracranial stent,
- Intrasaccular device.
It may be noted that the DoP has earlier approved 21 applications from medical devices firms to support manufacturing of various devices under the scheme.
With approval of these five products now, the total number of projects approved has been 26, with a committee investment of Rs.1,206 crore.
Out of this, so far, an investment of Rs. 714 crore has been achieved, said the ministry of chemicals and fertilisers.
Under the PLI scheme, a total of 14 projects producing 37 products have been commissioned and 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.
Remaining 12 products will be commissioned in near future,” said the Ministry while announcing the Cabinet approval for the National Medical Devices Policy, 2023.
The DoP revised the guidelines for the PLI scheme dividing the eligible products into two categories and allocating incentives separately in August, 2022.
While in the previous guidelines issued on October 29, 2020, the indicative eligible products for:
- The cancer care/radiotherapy medical devices segment were listed as Brachytherapy Systems,
- Rotational Cobalt Machine,
- Radiotherapy Simulation Systems,
- Linear Accelerator (LINAC),
- Workstations – Radiotherapy planning,
Proton therapy system and other products, under the revised guideline, Rotational Cobalt Machine and LINAC were in Category A and the rest of the products were listed in Category B.
Similar division had been applied in the other three segments:
- Radiology & imaging medical devices (both ionising and non-ionising radiation products) and nuclear imaging devices;
- Anesthetics and cardio respiratory medical devices including catheters and renal care medical devices;
- All implants including implantable electronic devices.
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