Industry Seeks Role in Drafting Medical Device Bill


The new drugs, cosmetics and medical devices bill is expected to align with the 2017 Medical Devices Rules (MDR), experts say.

They note that an inclusive cadre of experts and industry representatives is needed and will help a holistic understanding of all issues and perspectives when developing the new law.

Speaking about the central government decision, the President of the Medical Technology Association of India, Pavan Choudary, said that medical devices are currently governed by MDR 2017, which has been meticulously developed by the Central Drugs Standard Control Organization (CDSCO). after extensive consultations with stakeholders.

“These rules also follow the World Health Organization’s regulatory framework for medical devices (including IVDs) and adhere to the step-by-step approach to regulate medical devices based on guidance documents developed by the Global Harmonization Task Force (GHTF) and international medical device regulators. Forum (IMDRF), ”said Mr. Choudary.

Mr Choudary added that the harmonized regulations also allow Indian manufacturers to achieve greater acceptability of their products in world markets, thus advancing the government’s Make in India goal and keeping India aligned with the chains of global supply.

“Therefore, it is imperative that any new law that is drafted complies with the MDR 2017,” he said.

Stating that it is imperative that the industry be included in the initial discussion to ensure a smooth transition to the new bill, Sanjay Bhutani, Country Director, Bausch and Lomb explained that the industry has worked hard with CDSCO. to strengthen the regulatory framework and would continue to do so to promote patient access to quality medical devices.

“An organized and broad legal architecture to regulate the activities of medical institutions, pharmaceutical companies, laboratories, clinical trials and medical equipment manufacturers will specify the roles, responsibility and accountability of players in the medical industry at the level micro, ”said Sudish Sharma, Executive Partner, Lakshmikumaran and Avocats Sridhariens.

“This will prevent non-compliance of regulatory frameworks by hospitals, pharmaceutical companies, laboratories and other medical institutions and lead to better corporate governance which will advance the healthcare sector in India,” he said. he adds.

The general manager of the German major of medical and pharmaceutical devices B Braun Medical (India), Indranil Mukherjee, said that over the past decade, and especially with the pandemic, regulators and policymakers have realized the need urgently to establish a well-defined and comprehensive framework for medical devices, diagnostics and equipment.

The current law and rules, although more specifically for pharmaceuticals, were archaic despite the amendments, Mukherjee said, adding that this led to the formulation of the new MDR, 2017, which was notified in 2020.

“It is encouraging to see that the Technical Advisory Group on Medical Devices (MDTAG), set up under the aegis of the Ministry of Health, is led by DCGI under CDSCO and is working on the development of a new law on medical devices. drugs, cosmetics and medical devices. An inclusive cadre of experts and industry representatives in this network of experts is needed and will help a holistic understanding of all issues and perspectives while framing the new law, ”he said.

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