New Delhi: Through a recent notice, the Government of India, the Ministry of Chemicals & Fertilizers, Department of Pharmaceuticals (DoP), has issued revised Guidelines for the Production Linked Incentive (PLI) Scheme to promoting domestic manufacturing of Medical Devices that indicate the differentiation of the eligible products into two categories and assigning incentives separately for them.
The guidelines for the scheme were first released on July 27, 2020, but were later replaced by updated guidelines that the department released on October 29, 2020. The updated PLI Medical Device Guidelines, dated 18.08.2022, have now been made available by the Department of Pharmaceuticals (DoP).
A committee, headed by the CEO, Andhra Pradesh MedTech Zone, constituted by the Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers has provided technical inputs to prepare the guidelines. These guidelines have been prepared after detailed consultations with the industry and other relevant stakeholders.
In accordance with the previous guideline, the PLI scheme's application period closed on November 30, 2022. However, the revised guideline includes measures to keep the application period open depending on notices made by the Department from time to time. The tenure of the Scheme is from Financial Year 2020-21 to Financial Year 2027-28.
According to the revised guidelines, on the basis of indicative eligible products, the medical devices are classified into two categories (A and B) under the scheme.
An amendment to the definition of applicant in the updated guideline designates those applying for products listed in Annexure 1 of the guideline as Category A applicants and those applying for products listed in Annexure 1A as Category B applicants. Based on this modification, changes are made to additional provisions and annexures.
The products listed in Annexure 1 include Rotational Cobalt Machine, Linear Accelerator (LINAC), CT Scan, MRI, Ultrasonography, X-ray equipment, C-arm, Gath-Lab, Positron Emission Tomography (PET) Systems, Single photon emission tomography (SPECT), Mammography, Collimator, Flat Panel Detector, Surgical X Ray C-Arm, Fixed LF and HF X Ray Products, X Ray Panels, MRI Coils and Monitors, Dialyzer, Anesthesia Unit Ventilators, Patient monitoring system, Anesthesia Workstation, Automated External Defibrillators (AEDs), ECG, Syringe Pump, Defibrillators, Stress Test System and Oxygen Concentrator, Dialysis Machine, Peritoneal Dialysis kits Fistula, Blood Line, Haemodialysis Catheter and Transducer Protector, Anaesthesia Unit Gas Scavengers, Anaesthesia Unit Vaporizers, Anaesthesia Unit Ventilators, Bi- Phasic Defibrillators, Infusion pumps - Syringe and Volumetric, Intensive Care Ventilators, Emergency Ventilators (Portable Ventilators), High Flow Oxygen Devices, Multiparameter Monitor, Suction Machine, Heart Valves, Stents, PTCA Balloon, Dilatation Catheter, Heart Occluders, PTCA Catheter, Hip Implants, Knee Implant and Trauma Implant, Drug Eluting Stents and Drug Eluting Balloons.
The products listed in Annexure 1A Brachytherapy Systems, Radiotherapy Simulation Systems, , Workstations- Radiotherapy Planning, Proton therapy system, Cyclotrons, Needles-Anesthesia, Syringes-Anesthesia, Anesthesia Kits, Masks -Anesthesia, Biopsy Kits- Renal, Dialyser reprocessing system, Lithotripters-Extracorporeal Renal,Cochlear Implants, Spinal and neuro-surgical implants, Urogynecologic Surgical Mesh Implants, Hernia Surgical Mesh Implants, Cerebral Spinal Fluid (CSF) Shunt Systems, Implanted Pacemakers, insulin pump, implaqted neuro-stimulated device like Deep Brain Stimulator, lntraocular lenses and others.
In addition, the notice stated that an applicant under Category A and Category B must meet the criteria of committed investment and minimum threshold sales for the year under consideration, as given in Annexure 2 (attached below) and Annexure 2A(attached below) of these guidelines respectively, to be eligible for disbursement of incentive for that year.
Furthermore, regarding the selection of applicants, the notice defined the evaluation criteria for "Category A" and 'Category B" .Applicant with higher scores will be selected.
The application form and the instructions to apply are explained clearly in the notice. It is said that the application can be done through the online portal, the URL of which is https://plimedicaldevices.ifciltd.com/.A non-refundable application fee of Rs. 1,00,000 (one lakh only) would be payable for each application. The application fee would be accepted electronically only.
Annexure 1 is a "Category A" applicant allowed to apply for the product target segments under the scheme.
Cancer care / Radiotherapy medical devices
Rotational Cobalt Machine, Linear Accelerator (LINAq
Radiology & Imaging medical devices (both ionizing & non-ionizing radiation products) and Nuclear Imaging Devices
CT Scan, MRI, Ultrasonography, X-ray eq.uipment, C-arm, Gath-Lab, Positron Emission Tomography (PET) Systems, Single photon em1ss1on tomography (SPECT), Mammography, Collimator, Flat Panel Detector, Surgical X Ray C-Arm, Fixed LF and HF X Ray Products, X Ray Panels, MRI Coils and Monitors
Anesthetics & CardioRespiratory medical devices including Catheters of Cardio Respiratory Category & Renal Care Medical Devices
Dialyzer, Anesthesia Unit Ventilators, Patient monitoring system, Anesthesia Workstation, Automated External Defibrillators (AEDs), ECG, Syringe Pump, Defibrillators, Stress Test System and Oxygen Concentrator, Dialysis Machine, Peritoneal Dialysis kits Fistula, Blood Line, Haemodialysis Catheter and Transducer Protector, Anaesthesia Unit Gas Scavengers, Anaesthesia Unit Vaporizers, Anaesthesia Unit Ventilators, Bi- Phasic Defibrillators, Infusion pumps - Syringe and Volumetric, Intensive Care Ventilators, Emergency Ventilators (Portable Ventilators), High Flow Oxygen Devices, Multiparameter Monitor, Suction Machine.
All Implants including implantable electronic devices
Heart Valves, Stents, PTCA Balloon, Dilatation Catheter, Heart Occluders, PTCA Catheter, Hip Implants, Knee Implant and Trauma Implant, Drug Eluting Stents and Drug Eluting Balloons.
Annexure 1A is "Category B" applicant allowed to apply for the product target segments under the scheme.
Cancer care I Radiotherapy medical devices
Brachytherapy Systems, Radiotherapy Simulation Systems, , Workstations- Radiotherapy Planning, Proton therapy system and other products* in this target segment.
Radiology & Imaging medical devices (both ionizing & non-ionizing radiation products) and Nuclear Imaging Devices
Cyclotrons and other products* in this target segment
Anesthetics & CardioRespiratory medical devices including Catheters of Cardio Respiratory Category & Renal Care Medical Devices
Needles-Anesthesia, Syringes-Anesthesia,, , Anesthesia Kits, Masks -Anesthesia, , Biopsy Kits- Renal, Dialyser reprocessing system, · Lithotripters-Extracorporeal -Renal and other products* in this target segment.
All Implants including implantable electronic devices
Cochlear Implants, Spinal and neuro-surgical implants, Urogynecologic Surgical Mesh Implants, Hernia Surgical Mesh Implants, Cerebral Spinal Fluid (CSF) Shunt Systems, Implanted Pacemakers, insulin pump, implaqted neuro-stimulated device like Deep Brain Stimulator, lntraocular lenses and other products* in this target segment.
Eliqibility Threshold Criteria for "Cateqory A" applicant
Rate of Incentive on Incremental Sales of Manufactured Goods for respective FY
Threshold Minimum Incremental Sales of Manufactured Goods
Maximum Incentive per applicant per target segment
segments of medical devices (detailed in Annexure 1)
FY 2022-23 - Rs.8 Crore Fv 2023-24 - Rs.17 Crore
FY 2024-25 - Rs. 27 Crore
Fx 202s-27 - Rs. 37 Crore
Total Maximum incentive — Rs. 121 crore
Eligibility Threshold Criteria for "Cateqory B" applicant
Incremental Sales of Manufactured Goods for respective FY
Incremental Sales of Manufactured Goods
For subsequent financial years i.e., from FY 2023-24 onwards, the threshold sales shall be computed at 10% growth over the minimum threshold incremental sale
To view the Guidelines for the Production Linked Incentive (PLI) Scheme for Promoting:Domestic Manufacturing of Medical Devices, click to the link below:
https://pharmaceuticals.gov.in/sites/default/files/Revised%20Guidelines%20of%20PLI%20Medical%20Devices%20dated%2018.08.2022.pdf