New Delhi : The Department of Pharmaceuticals (DoP) has extended the timeline for the medical devices industry to submit applications for the newly created Category B of the Production Linked Incentive (PLI) Scheme for Promoting Domestic Manufacturing of Medical Devices till November 21, 2022.
Eligible applicants for Category B were advised to apply through online mode from September 1 to October 31, 2022, according to an earlier notice. The Department, on August 18, revised the guidelines of the Scheme by creating a second category of medical devices by dividing the eligible products in the single category of medical devices it had in the initial guidelines issued in 2020.
The revised guideline had provisions to keep the application window open based on notice issued by the Department from time to time.
“It has been decided to extend the timeline for submission of applications under the ‘Production Linked Incentive (PLI) Scheme for Promoting Domestic Manufacturing of Medical Devices’ till November 21, 2022,” said the DoP in a latest notice.
With the revised guideline, the list of medical devices in the Annexure 1 of the guideline has been referred as Category A, while a newly bifurcated Annexure 1A has been referred to as Category B. Changes were 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 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 are in Category A and the rest of the products are in Category B.
Similar division has 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; and all implants including implantable electronic devices.
For instance, the cyclotrons and other products in the radiology and imaging segment, needles and syringes in anaesthetiser, anaesthesia kits, masks for anaesthesia, biopsy kits for renal, dialyser reprocessing system, lithotripters-extracorporeal-renal and other products in the target segment in the anesthetics and cardio-respiratory medical devices are in the Category B.
Cochlear implants, spinal and neuro-surgical implants, urogynaecologic surgical mesh implants, hernia surgical mesh implants, cerebral spinal fluid shunt systems, implanted pacemakers, insulin pump, implanted neuro-stimulated device like deep brain stimulator, 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, said that the eligibility threshold criteria and evaluation criteria shall be applicable as per the revised guidelines.
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 withdrawn or got rejected (if there are no applicants for 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.
According to the revised guideline, while the threshold criteria for the Category A stands the same, the threshold criteria for Category B applicant was added with the same rate of incentive on incremental sales of manufacturing goods applicable for each year. The category will also have a total maximum incentive of Rs. 40 crore for the five years.
The eligible applicants for Category A would be with Rs. 60 crore or above global medical devices manufacturing turnover company wise or groups company wise for the fiscal year 2018-19. For every additional Rs. 60 crore global manufacturing turnover, a score of five will be added.
Eligible applicant for Category B should have Rs. 20 crore or above global medical devices manufacturing turnover as a company or group company for the fiscal year 2019-19. For every additional Rs. 20 crore manufacturing turnover, a score of five would be added.
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 availability of outlay approved under the scheme.
The objective of the PLI scheme is to boost domestic manufacturing, attract large investment in the medical device sector, and to ensure a level playing field for the domestic manufacturers of medical devices with a total financial outlay of Rs. 3,420 crore 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 investment of Rs. 798.93 crore by the companies were approved with expected employment generation of around 3,812 persons. 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.