Health ministry to rope in state governments to establish medical devices testing laboratories

The ministry of health and family welfare (MoHFW) is planning to rope in state governments also to establish or designate their existing laboratories as state medical devices testing laboratories and bring in enabling rules to support setting up of more testing laboratories for medical devices across the country as the sector is experiencing major regulatory paradigm shift including the introduction of a licensing regime.

The Union health ministry is looking at bringing in the support of state governments to actively participate in the testing activities, in order to ensure the quality of medical devices. It is amending the Medical Devices Rules, 2017, with introduction of sub-rules and changes in the existing ones relevant to bring in the desired regulatory framework.

A draft rule has been notified by the Ministry, under which it has proposed to insert a new sub-rule to the Rule 19, that the state government may, by notification, establish state medical devices testing laboratory for the purpose of testing and evaluation of medical devices or to carry out any other functions as may be specifically assigned to it.

The state government may also designate any laboratory having facility for carrying out and evaluation of medical devices as state medical devices testing laboratory for the purpose, with a condition that the laboratory should be accredited by the National Accreditation Body for Testing and Calibration Laboratories (NABL).

It has also added a definition to the state medical devices testing laboratory, stating that it means a laboratory established or designated by the state government under the Rule 19(3), which is the freshly proposed sub-rule. While the Rule 19 was specifically for Central medical devices testing laboratory, it has been proposed for amendment by omitting the word ‘Centre’, this emphasising that the laboratories could be established either by the Central or the state government.

The draft amendment is expected to be taken into consideration in seven days from the date of making the draft available to the public.

Industry experts have been raising concerns about the availability of proper medical devices testing laboratories for faster testing operations, considering that the licensing regime for a majority of the medical devices is expected to be in place soon.

The Central Drugs Standard Control Organisation (CDSCO), which regulates the drugs, medical devices and cosmetics industry in the country has been requesting the laboratories which have capacity for testing medical devices, with adequate quality accreditation to submit applications to strengthen the medical devices testing laboratories (MDTLs) network in the country.

As on November, 2022, around 28 laboratories were registered with the office for testing purposes. The Drugs Controller General (India) [DCGI’s] office is receiving the applications for registration under Medical Devices Rules (MDR), 2017 from various laboratories for testing of different medical devices, said the regulator in December, last year.

The medical device sector has remained largely unregulated till 2017 when Medical Device Rules, 2017 were framed by the MoHFW for comprehensive regulation of medical devices in a phased manner, especially on the quality, safety, and efficacy aspects, under the Drugs and Cosmetic Act, 1940

The sector is expected to grow in market size from the present 11 billion USD to 50 billion USD by 2025.

It may be noted that the Department of Pharmaceuticals, under the ministry of chemicals and fertilisers has released an approach paper on Draft National Medical Devices Policy, 2022, for consultation, which aims at addressing the core objectives of accessibility, affordability, safety and quality, focus on self-sustainability, innovation and growth in the Medical devices sector.

The Indian medical device market has a significant presence of multinational companies with about 80% of the sales by value generated from imported medical devices.

The policy envisions that by 2047, India will be having few National Institutes of Medical Devices Education and Research (NIMERs) on the lines of NIPERs; India will be home and originator to 25 high-end futuristic technologies in MedTech and will have a MedTech Industry of $100-300 billion size with 10-12% of global market share.

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