Industry

Govt invites eligible Medical Devices Firms Category B of PLI scheme

Eligible applicants for Category B may apply through online mode from September 1, 2022 and the last date of receipt of complete application is October 31, 2022.

The Health Master

August 28, 2022

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Last Updated on October 6, 2024 by The Health Master

The Department of Pharmaceuticals (DoP) has called for applications from eligible medical device firms for the newly created Category B of the production-linked incentive (PLI) scheme for promoting domestic manufacturing of medical devices.

The Department, on August 18, revised the guidelines of the Scheme, creating a second category of medical devices by dividing the eligible products into the single category of medical devices that it had in the initial guidelines issued in 2020.

Eligible applicants for Category B may apply online mode from September 1, 2022, and the last date of receipt of a complete application is October 31, 2022.

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With the revised guideline, the list of medical devices in Annexure 1 of the guideline has been referred to as Category A, while a newly bifurcated Annexure 1A has been referred to as Category B. Changes have also been made in other clauses and annexures based on this revision.

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 machines,
Radiotherapy simulation systems,
Linear accelerators (LINAC),
Workstations-radiotherapy planning,
Proton therapy systems,
and other products.

Under the revised guidelines, rotational cobalt machines, and LINAC are in Category A and the rest of the products are in Category B.

A similar division has been applied in the other three segments—radiology & imaging medical devices (both ionizing and non-ionizing radiation products) and nuclear imaging devices; anesthetics and cardiorespiratory medical devices, including catheters and renal care medical devices; and all implants, including implantable electronic devices.

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For instance, the Cyclotrons and other products in the radiology and imaging segment, needles and syringes in anesthetizer, anesthesia kits, masks for anesthesia, biopsy kits for renal, dialyzer reprocessing system, lithotripters-extracorporeal-renal and other products in the target segment in anesthetics and cardio-respiratory medical devices are in Category B.

Cochlear implants, spinal and neuro-surgical implants, urogynecology surgical mesh implants, hernia surgical mesh implants, cerebral spinal fluid shunt systems, implanted pacemakers, insulin pumps, implanted neuro-stimulated devices like deep brain stimulators, intraocular lenses and other products are also in the Category B.

DoP, in its notice inviting eligible candidates for category B under the PLI scheme, DoP said that the eligibility threshold criteria and evaluation criteria shall be applicable as per the revised guidelines.

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The revised guideline said that if the selected applicants of Category A withdraw or get rejected with the approval of the Empowered Committee, the products applied by those applicants (if there are no applicants for the same products as approved in earlier rounds), shall automatically be included under Annexure 1A and may be made available for Category B applicants to apply.

In the previous guideline, the eligibility threshold criteria for the applicants were from the Fiscal Year 2022–23 to the Fiscal Year 2026–27 with a five percent rate of incentive on incremental sales of manufactured goods each year. The maximum incentive was Rs. 121 crores during the five years.

However, in the revised guidelines, while the threshold criteria for Category A remain the same, the threshold criteria for Category B applicants have been added with the same rate of incentive on incremental sales of manufacturing goods applicable each year.

The category will also have a total maximum incentive of Rs. 40 crores for the five years.

The eligible applicants for Category A would be those with a global medical device manufacturing turnover of Rs. 60 crores or above company-wise or group company-wise for the fiscal year 2018-19. For every additional Rs. 60 crore in global manufacturing turnover, a score of five will be added.

Eligible applicants for Category B should have a global medical device manufacturing turnover of Rs. 20 crores or more than the global medical device manufacturing turnover as a company or group company for the fiscal year 2019–19. For every additional Rs. 20 crore in manufacturing turnover, a score of five would be added.

The application window for the PLI scheme according to the previous guideline ended on November 30, 2022, but the revised guideline has provisions to keep the application window open based on notice issued by the Department from time to time.

The previous guideline fixed that a maximum of 28 applicants shall be selected under the scheme, with a maximum of 10 applicants under each target segment.

According to the revised guidelines, the number of applicants shall be selected under the scheme based on the availability of outlay approved under the scheme.

The department has earlier said that with an objective to boost domestic manufacturing, and attract large investment in the medical device sector, it has launched a production-linked incentive (PLI) scheme for the promotion of domestic manufacturing of medical devices to ensure a level playing field for the domestic manufacturers of medical devices with a total financial outlay of Rs. 3,420 crores for the period 2020–21 to 2027–28.

In the first round, 28 applications were received from 23 applicants under the scheme. Out of which, 13 applications with committed investments of Rs. 798.93 crores by the companies were approved, with an expected employment generation of around 3,812 people.

Since few slots remained unfilled for certain products, applications were invited again with the last date of submission as August 31, 2021, and a total of 14 applications were received.

It has approved eight plants in an EC meeting held on November 25, 2021. The DoP has recently released a list of 21 applications approved under the scheme till then.

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