Revision in terminologies and clarity in definitions required in draft New Drugs Bill-2022: MTaI

New Delhi, August 29, 2022:

Appreciating the efforts taken by the government to update the existing law in order to stay updated with global best practices and the ever-evolving field of medical technology through the draft New Drugs, Medical Devices and Cosmetics Bill, 2022, the Medical Technology Association of India (MTaI) has opined that some revision in terminologies and clarity in definitions are required in the Draft Bill.

The bill has provided clarity about the continuity of the licenses provided through Medical Device Rules 2017 which is a welcome move. The draft bill was released by the ministry of health and family welfare on July 8 and the industry was advised to submit their responses within a timeline of 45 days.

“MTaI appreciates the efforts taken by the government to update the existing law in order to stay updated with global best practices and the ever-evolving field of medical technology and believes that with the timely and necessary stakeholder engagements and by addressing the concerns raised, the new Bill will promote innovation and safety of medical devices in India,” said PavanChoudary, chairman and director general, MTaI.

However, some terminologies need revision especially with respect to categorisation of Medical devices as a misbranded, spurious and adulterated product. The definition and process of handling adverse events and post-market surveillance activities need to be aligned with global harmonized regulations

The bill must specify the causality assessment criteria before determining the penalties around an adverse event. It also has very severe penal provisions which might prove to be detrimental to the industry and ease of doing business in India, instead, in order to ensure compliance, the government should approach a graded punishment mechanism, added the Association.

“The bill also needs to clearly define the qualification, power, and responsibility of medical device officers to ensure their competency to handle such complex products and to safeguard the interest of the patient and the industry,” said Choudary.

The bill needs to address the different categories of medical devices and their specific requirements such as: In vitro diagnostics and software in and as medical device.

The ministry has released the draft bill as a comprehensive legislation with provisions to regulate medical devices, clinical trials and online pharmacy, among others in order to keep pace with changing needs, times, and technology as against the pre-independence legislation of the Drugs and Cosmetics Act, 1940.

The Bill proposes the constitution of Medical Devices Technical Advisory Board (MDTAB) to advise the Central Government and the State governments on technical matters pertaining to medical devices arising out of administration of the proposed Act.

A Drugs, Medical Devices and Cosmetics Consultative Committee (DMDCCC) shall also be constituted by the Centre to advise the Central Government, the State Governments, the DTAB and MDTAB on any matter tending to secure uniformity in the country in the administration of the proposed Act and the rules made thereunder. The DMDCCC will be headed by the Drugs Controller General, India and shall consist of members representing the Central government and the state government and shall meet at least once in six months.

The draft bill dedicates Chapter VI to import, manufacture, sale, distribution and clinical investigation of medical devices, which was earlier dealt in the Medical Devices Regulation, 2017. Pharmabiz