Last Updated on June 22, 2021 by The Health Master
The Department of Pharmaceuticals (DoP) has invited applications from eligible applicants to manufacture medical devices related to anaesthetics and catheters of cardio respiratory category and renal care under production linked incentive (PLI) scheme to boost domestic manufacturing.
References have been received by DoP as to whether applicants registered as Limited Liability Partnership (LLP) are eligible to apply under the PLI scheme for promoting domestic manufacturing of medical devices, as the LLP form of organization structure is not explicitly mentioned in the PLI Scheme Guidelines. The matter has been considered and it has been decided to allow the applicants falling under the category of LLP to apply for manufacturing of the eligible products under the PLI scheme for medical devices.
“Further, it is clarified that under Target Segment 3 of the PLI Scheme Guidelines dated October 29, 2020, ‘Oxygen Concentrators’ is included in the ‘Indicated Eligible Products’ in the Category – Anaesthetics and Cardio Respiratory Medical Devices including Catheters of Cardio Respiratory Category and Renal Care Medical Devices. Other terms and conditions of the Notice dated April 30, 2021 remain unchanged,” the notice further stated.
DoP had notified the PLI scheme for the medical device sector through a gazette notification dated July 21, 2020. DoP had issued guidelines for the PLI scheme for promoting domestic manufacturing of medical devices on October 29, 2020. Total financial outlay for the PLI scheme is Rs. 3,420 crore.
The PLI scheme is designed to attract investors in select 4 high technology target segments of medical devices where import dependence is very high.
Medical devices covered under the PLI scheme target segments include cancer care or radiotherapy medical devices, radiology and imaging medical devices, nuclear imaging devices, anaesthetics and cardio-respiratory medical devices including catheters of cardio respiratory category and renal care medical devices. Besides this, target segments also cover all implants including implantable electronic devices like cochlear implants and pacemakers.
PLI scheme stipulates that the medical device company should be registered in India. There should be a minimum Rs. 180 crore investment by one unit. Minimum net worth of the company should be Rs. 18 crore (30% of threshold investment of first year).
The eligible applicants can apply via online mode through https://plimedicaldevices.ifciltd.com/. The detailed guidelines of the scheme are available at https://plimedicaldevices.ifciltd.com/docs/Guidelines_Medical%20Devices.pdf.
The last date of receipt of complete applications is July 28, 2021.
Applicants can apply multiple products within one target segment. Application window is 120 days and approval thereafter within 60 days. Applications can be made through the online portal of the Project Management Agency (PMA) and the maximum number of applicants to be selected is 28.
The Government of India through its flagship “Make in India” initiative envisages to meet the rising demand of essential healthcare equipment for the country pushing the Indian medical devices sector to become self-reliant especially for essential 39 Covid-19 medical devices.
Under the PLI scheme, financial incentives shall be given to selected companies based on threshold investment and incremental sales (over Base Year) of medical devices covered under target segments. Under the Scheme, financial incentive shall be given to selected companies at the rate of 5% of incremental sales (over Base Year) of goods manufactured in India and covered under Target segments, for a period of five years i.e. from FY 2021-22 to FY 2025-26.
The scheme is applicable only for greenfield projects. Financial incentive under the scheme shall be provided only to companies engaged in manufacturing of goods covered under target segments in India. Eligibility shall be subject to thresholds of investment and incremental sales of manufactured goods (covered under Target Segments) over Base Year.
An applicant must meet all the threshold conditions to be eligible for disbursement of incentive. Eligibility under the PLI scheme shall not affect eligibility under any other scheme and vice-versa. The tenure of the scheme is from FY 2020-21 to FY 2026-27.