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New Drugs, Cosmetics and Medical Devices Bill should be aligned with MD Rules 2017 for effective regulation: Experts

The harmonized regulations also enable Indian manufacturers to get greater acceptability of their products in global markets.

medical device rules, MDR 2017, MTaI, CDSCO, DCGI, Global Harmonization Task Force, GHTF
In September 2021, the government constituted a high level committee for preparing of New Drugs, Cosmetics and Medical Devices Bill under the chairmanship of the Drugs Controller General of India (DCGI). The committee recently consulted with consumer associations for their suggestions.

Experts have advocated that the New Drugs, Cosmetics and Medical Devices Bill should be aligned with the Medical Device Rules (MDR) 2017 for effective regulation.

As per the government’s notification, the transition plan to implement the Medical Device Rules 2017 by the industry has been stipulated which includes registration and licensing process.  Therefore, Class A and B medical devices should comply with MDR, 2017 by August 2022 and Class C and D devices should comply with MDR, 2017 by August 2023.

According to Pavan  Choudary, Chairman & Director General, Medical Technology Association of India (MTaI), “Medical Devices are currently governed by MDR 2017, which were meticulously developed by Central Drugs Standard Control Organisation (CDSCO) after extensive consultations with stakeholders. These Rules also follow the WHO Global Model Regulatory Framework for Medical Devices (including IVDs) and adhere to the stepwise approach to regulating medical devices based on guidance documents developed by the Global Harmonization Task Force (GHTF) and the International Medical Device Regulators Forum (IMDRF).”

The harmonized regulations also enable Indian manufacturers to get greater acceptability of their products in global markets, furthering the Make in India objective of the government and keeping India aligned to global supply chains. Therefore it is imperative that any new laws that are framed are in line with the MDR2017.

MTaI is an association of research-based medical technology companies who have made remarkable investments by setting up a large number of R&D centres and manufacturing plants in India. MTaI represents a wide spectrum of the medical device and equipment industry with global experience in innovation and manufacturing.

In September 2021, the government constituted a high level committee for preparing of New Drugs, Cosmetics and Medical Devices Bill under the chairmanship of the Drugs Controller General of India (DCGI). The committee recently consulted with consumer associations for their suggestions.

As per the order issued by the Ministry of Health and Family welfare, dated August 27, the committee shall undertake pre-legislative consultations and examine the present Act, previously framed Drugs and Cosmetics Bills and submit a draft document for a de-novo Drugs, Cosmetics and Medical Devices bill. The committee is also allowed to co-opt members if it requires.

“MTaI believes that currently only CDSCO has the required expertise and experience to regulate the MedTech sector and welcomes that it has been made the custodian of any new regulations. As Medical Device is an intricate sector with a very broad product portfolio the committee must consider co-opting Industry Experts through the Medical Device Technical Advisory Group (MDTAG) which was constituted under the aegis of the union health ministry.” Choudary concluded.

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