New Drugs, Cosmetics and Medical Devices Bill should be in line with the Medical Device Rules 2017 and harmonized with global regulations- MTaI
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. The committee recently consulted with consumer
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. 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.
Pavan Choudary, Chairman & Director General, MTaI said, “Medical Devices are currently governed by The Medical Devices Rules 2017, which were meticulously developed by 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 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 Ministry of health.” Choudary added.