Parliamentary Panel asks DoP to expedite process of setting up National Standards for all medical devices
A Parliamentary Panel has asked the Department of Pharmaceuticals (DoP) and the Bureau of Indian Standards (BIS) to expedite the process of setting up National Standards for all types of medical devices and use of a ‘National Mark’ for all medical devices that comply with BIS/IEC standards.
The panel has observed that the absence of national standards for medical devices manufactured in India limits the opportunity for the domestic manufacturers to export Indian made devices.
The Department-related Parliamentary Standing Committee on Chemicals and Fertilisers in its 50th report on Promotion of Medical Device Industry also urged the DoP to take immediate necessary steps to expedite the creation of a Single Window System or Unified Application Portal for medical device industry so as to enhance the ease of doing business in this sector.
The recommendation for the national standards for domestically produced medical device comes in the backdrop of the Committee’s interaction with the industry representatives at Goa and Kochi in May, 2023.
The absence of national standards for all domestically produced medical devices is a matter of concern for the industry. While the BIS lays down the standards for medical devices and has published 1,540 Indian Standards for medical devices, the Committee noted that there are 6,000 plus medical devices in the market and are growing day by day.
The absence of National Standards for medical devices manufactured in India, domestic manufacturers are forced to follow the WHO/American/European standards, which also limits the export of Indian made medical devices in other countries, it observed. Further, a wide variety of testing standards are to be complied by the manufactures even for low risk class medical devices and procurement agencies also come with different standards which poses challenge to the manufacturer.
BIS has now prepared a 5-year Standards National Action Plan (SNAP) for the year 2022-2027 in which sector-wise priority areas (including medical devices and healthcare) for standardisation have been identified, which are being taken up and prioritized by the respective technical committees.
“The Committee, therefore, strongly urge the DoP/BIS to expedite the process of setting up National Standards for all types of medical devices to save the interest of domestic medical device manufacturers,” it said.
Further, it also urged the DoP to convince the Ministry of Health and Family Welfare or the Central Drugs Standard Control Organisation for using a ‘National Mark’ for all medical devices that comply with BIS/IEC standards to ease procurement related concerns and facilitate exports as well, it added.
“The Committee urge the Department to take immediate necessary steps to expedite the creation of a Single Window System/Unified Application Portal for medical device industry so as to enhance the ease of doing business in this sector,” added the Panel.
The medical device industry representatives also apprised that the presence of multiple-regulators have made the setting up of industry and manufacturing medical devices a time taking process which impairs investment, often causing delays in product launch.
Currently, the licensing framework for medical devices is spread across several legislations, guidelines and policies (including the Medical Devices Rules, 2017 and Drugs and Cosmetics Act, 1940), and is governed by a host of regulators, including the CDSCO, National Pharmaceutical Pricing Authority and State Licensing Authorities. Hence, the current regulatory landscape is complex, which inhibits business.
The Committee, however, observed that the National Medical Devices Policy, 2023 envisages to have Single Window Clearance System for the medical devices sector in line with the National Single Window System (NSWS) for medical devices sector, integrating all the regulators of the MedTech Sector.
The ministry of health & family welfare are in the process of integrating various departments/ministries concerned, like the BIS, Atomic Energy Regulatory Board (AERB), Ministry of Electronics and Information Technology (MeitY), Department of Animal Husbandry and Dairying, etc. with the Medical Device Portal.
The Committee said it is hopeful that the proposed system for the licensing of medical devices would minimise duplication of efforts and compliance burdens for licensing medical devices.
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