Medical Plastic Data Service Magazine



Our 30th Year of Publication
Page  2 of 4

Cover Story

Indian Medical Device Manufacturing Industry: Evolving Ecosystem


Mr. Rajiv Nath
Managing Director, Hindustan Syringes & Medical Devices Ltd. & Forum Coordinator,
Association Of Indian Medical Device Industry (AiMeD)

This September has been a most eventful month with come September bringing in the formal announcement of the creation of Medical Devices Export Promotion Council and shortly followed up with the reconstituted Medical Devices Promotion Councilís first meeting under the chairmanship of the Secretary Dept. Of Pharmaceuticals.

BIS sought a meeting with Stakeholders and for discussing the SNAP (Standards National Action Plan) for the next 5 years and sought AiMeDís inputs for domestic industry needs and the deadline for compulsory licensing of October 1st for all low-risk medical devices loomed.

The Parliamentary Standing Committee on Health & Family Welfare headed by BJP MP Prof Ram Gopal Yadav presented its report on ďMedical Devices Regulation & ControlĒ to the Rajya Sabha on 12 th Sep. which will help the manufacturing of medical devices to thrive if most of these recommendations are implemented.

All Medical Devices have still to come under Regulations and are still under a transitional stage.

The Draft Notification for Resellers of Medical Devices was released for public comment by MoH&FW in Feb 2022 and now released on September 30th. Itís now a simple registration process and not as cumbersome as is for Resellers of Drugs which had more stringent storage and warehousing conditions and needed a pharmacist - in case of Medical Devices this will be related to nature of products and on basis of guidance of manufacturers whose products are being resold for any specific temperature / storage condition, if any.



Since there are now no conditions like keeping a refrigerator etc. to seek a Wholesale Drug License a Reseller of ventilator or any oxygen therapy equipment is free to store the goods anywhere if no special environment conditions are prescribed in the IFU (instructions for use) or as a specific condition under a Distribution Sales Agreement with a Manufacturer.


Also, on 30th September vide Circular of CDSCO the time to get a Manufacturing License from CDSCO for a Class B Medical Device like a moderate risk oxygen therapy equipment has been extended by 6 months if the Manufacturer has already registered his product or applied for the Manufacturing License. For Class C Medical Devices, one has time till Oct 2023 to get a Manufacturing License for making ventilators or other Class C high moderate risk oxygen therapy equipment as detailed in CDSCO Classification List. Similar is the case for Class D high risk medical devices.


By default, this 6-month reprieve for Class A & B manufacturers and importers gets extended to even resellers of Class A&B Medical Devices (other than for the 37 Medical Devices that were already Notified as Drugs prior to February 2020) and they need to apply to their State Licensing Authority on hard copy if online registration system not launched by them.


For Non-Sterile, Non-Measuring Medical Devices items like nonsterile surgical instruments, orthopedic support & rehabilitation devices, spectacle frames more diluted requirements are being Notified vide Draft Notification Dt: 20th September 2022 which now no more seek an audit for compliance to Schedule V Quality Management System requirements that are along the lines ofISO13485 and will provide relief to a number of affected micro & small manufacturers.


Indian medical devices manufacturing Ecosystem is evolving for the better


The Eco System of medical devices manufacturing is evolving for the better with the Parliamentary Committee on Health making the following recommendation that will come as a delight for manufacturers of Medical Devices and related shareholders. Key Excerpts are reproduced below:


The Committee recommends that instead of drafting a combined legislation for Drugs, Medical Devices and Cosmetics, the Ministry should appreciate the potential of the Medical Device industry and formulate a separate legislation for Medical Devices.


The Committee recommends that the new legislation should set up a new set of regulators at different levels for regulating the Medical Devices industry. Unlike the present structure, the proposed regulator should license the manufacturing of all classes of medical devices i.e., Class A, B, C, and D. This would help harmonize the regulation process throughout the country as it would do away with different regulating procedures employed by different States. The Committee feels that in the new legislation regulatory controls need to be shared between Centre, State and Conformity Assessment Notified Bodies in Law. There should be no duplication of State and Central Government regulations. There needs to be accountability fixed on State Regulator to the Central Licensing Authority (or a National Regulator) to ensure harmonious enforcement.


The Committee believes that with industry growing by leaps & bounds, the government should not afford regulation of medical devices by pharma experts and its time that at ground level the medical device regulations are dispensed with by qualified and well-trained Medical Device Officers to give a fillip to the Medical Device industry in the country.


The Committee recommends the Ministry to introduce standards and certification process (particularly for Class C&D products) comparable to global standards. The Ministry, along with compulsory compliance to Quality Management System as per schedule 5 of the MDR, 2017, should also allow cognizance to 3rd party assurance schemes like ICMED 13485.


The Committee is of the considered view that to encourage indigenous manufacturing, the Government should provide incentives or encourage preferential purchase for domestically manufactured products in Government procurement. In this regard, the Department should ensure that in all public procurement, the preference must be given to Indian manufactured medical devices having domestic content of at least 50%. Given the size of Government's (both Central and State) purchase, the Preferential Purchase Agreement would have a significant pull for several medical devices companies to manufacture medical devices in India. Also, the PLI scheme should be broad based, and all the medical devices should be covered under the scheme. Additionally, the Committee recommends that PLI scheme should be expanded to cover raw material and component manufacturing as well so that India can become a hub for raw material for the world.


To invigorate the culture of research and development in medical devices in institutions like IITs, NITs and other academic institutions the Committee recommends the Department to start Research Linked Incentive (RLI) Scheme in Line with PLI scheme. The Department should facilitate academia- industry partnership for undertaking research projects on industry challenges and incentivize the successful outcomes.


The Committee expresses concern over the fact that the highly technical medical devices industry, having no synergy with the Ministry of Chemicals & Fertilizers is being promoted by them instead of Ministry of Health and Family Welfare. The Committee, therefore, recommends that since the Ministry of Health and Family Welfare is the key stakeholder and the medical devices' being very diverse in range with respect to technology and material sciences, inter-ministry co-ordination is required between various departments, which should be done by the Ministry of Health and Family Welfare only. The Committee, accordingly, recommends that to nurture the nascent medical devices industry, the government should consider creation of a separate Department of Medical Devices for playing the role of a policy maker, facilitator as well as regulator.


The Dept of Pharma & Honourable Minister Shri Mansukh Mandaviya announced it is organising a large-scale India MedTech Expo 2022 event on Medical Devices sector form 09-11th December 2022 at Pragati Maidan, New Delhi with the focus to showcase Indiaís journey and opportunities in the sector.


The event will create opportunities to network and explore collaborations both for the sectorís growth in India and its potential contribution globally, duly bringing together all the stakeholders such as PLI Participants, Start-ups, MSMEs, Innovative Entrepreneurs, R&D Facilities, Incubators, Public and Private Hospitals, etc.


The event will bring together industry, academia, research institutions, investors, state governments, MedTech parks and the Government bureaucrats for taking the sector on a forward growth trajectory. The Prime Minister is expected to inaugurate the Expo and this will provide further impetus to this sector which we hope one day will become one of the ToP5 manufacturing hubs of Medical Devices worldwide.

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