New drugs, cosmetics and medical devices bill should align with MDR 2017, says MTaI
A high-level government committee was constituted back in September 2021 to draft the New Drugs, Cosmetics and Medical Devices Bill which will be used for governance in the healthcare sector. The bill will be prepared
A high-level government committee was constituted back in September 2021 to draft the New Drugs, Cosmetics and Medical Devices Bill which will be used for governance in the healthcare sector. The bill will be prepared under the chairmanship of the Drugs Controller General of India with the committee having the freedom to co-opt members if required.
As per the order issued by the Ministry of Health and Family welfare dated August 27, the committee shall undertake pre-legislative consultations, 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.
Speaking on the importance of aligning the new bill with existing Medical Devices Rules 2017, Pavan Choudary, Chairman & Director General, MTaI said, “Medical Devices are currently governed by The Medical Devices Rules (MDR) 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,” he added.
He further suggested opting for industry experts through the Medical Device Technical Advisory Group which was constituted under the aegis of Ministry of health so as to ensure right regulation for the intricate sector of medical devices.