Last Updated on October 6, 2024 by The Health Master
PLI Scheme
The Department of Pharmaceuticals (DoP) has opened the gateway for the fifth round of applications under the Category B of the production linked incentive scheme (PLI Scheme).
This initiative aims to foster the domestic manufacturing of medical devices.
Recent revisions in guidelines have expanded the scope, incorporating a plethora of medical devices eligible for government support.
Let’s delve into the key changes and their implications.
Revised Guidelines:
1. Corrigendum Issued on December 19
The DoP, in response to emerging needs, released a corrigendum to the guidelines on December 19.
This update was sanctioned with the approval of the competent authority.
2. Changes in Category A Eligibility
The indicative eligible products for Category A applicants witnessed amendments.
Notably, collimator and flat panel detector, along with MRI monitors, were removed from the radiology and imaging medical devices list.
3. Significant Expansion in Category B Eligibility
Category B applicants experienced a substantial overhaul in the list of eligible products.
In the cancer care and radiotherapy medical devices segment, the revised guidelines now encompass a diverse array of devices, including Cryoablation units, cryoprobes, and HDR Brachytherapy.
4. Augmented List of Radiology and Imaging Devices
The list of radiology and imaging devices saw a remarkable augmentation.
Instead of a handful of specified devices, the revised list now includes approximately 26 products, ranging from collimators to 3T digital PET/MR.
5. Anesthetic and Cardio Respiratory Devices
The guidelines for anesthetic and cardio respiratory medical devices witnessed an extensive expansion.
Over 50 products were specifically mentioned, ranging from kidney transporters to minimally invasive cardiac instruments.
6. Incorporation of Implants
All implants, including implantable electronic devices, now enjoy broader representation in the PLI scheme.
Products like Bi-Ventricular Pacemakers and MRI conditional cardiac resynchronization therapy devices have been added.
7. Role of the Technical Committee
For products not explicitly mentioned, the technical committee will determine their eligibility under the target segment.
Any product listed in Category A will not be considered under Category B’s ‘other products.’
8. Focus on Key Components
Major components constituting a significant part of the finished medical device, with distinct HS codes, are considered included in the corresponding target segment.
Application Process and Timeline
The DoP is actively inviting applications from eligible Category B applicants for medical devices based on the revised guidelines as of February 25, 2023.
The deadline for online applications is January 18, 2024. Investments made after April 1, 2021, will be considered for eligibility, aligning with the scheme guidelines.
Recent Changes in Investment Criteria
The Department, in its continuous efforts to refine the PLI scheme, made significant changes in investment criteria.
For this round, investments incurred towards clinical trials of eligible products in India will be considered as part of the investment determining eligibility, capped at a maximum of 10 per cent of committed investment.
Evolution of Guidelines
The journey of PLI scheme guidelines has seen several milestones.
From the initial guidelines issued on October 29, 2020, to the amendments on August 18, 2022, the Department has diligently divided eligible products into two categories, allocating incentives separately for each.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
Procedure to obtain license for manufacturing of Medical Devices
Procedure for registration of Medical Devices: CDSCO
Registration for sale of Medical Devices: Procedure and conditions
Latest Notifications: Medical Devices
Classifications of Medical Devices under the provisions of MDR 2017
Notified Bodies for Medical Devices
Updated list of Notified Bodies for Medical Devices
Updated list of Medical Device Testing Laboratories (MDTLs)
Forms: All types of Medical Devices
Schedules: All types of Medical Devices
International Drug Racket busted, Rs 3 Crore Worth of Medicines Seized
USFDA approval granted for this Kidney Disease Drug
3 PLI Schemes: Transforming India’s Pharma Industry
Unlocking Opportunities: Pharmexcil Urges Exporters to Embrace DGFT Amnesty Scheme
Drug alert: 2921 out of 89729 samples declared as NSQ in 2022-23
CDSCO to restrict Common Cold and Flu Medicine
USFDA issues EIR For APL Healthcare of Aurobindo
EMA: European Medicines Agency prepare for AI in regulation
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
