The 5th Round of PLI Scheme Applications in Medical Devices

All implants, including implantable electronic devices, now enjoy broader representation in the PLI scheme.

December 22, 2023

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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.

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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.

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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.

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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.

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