The government is ah set to introduce the New Drugs, Medical Devices, and Cosmetics Bill, 2023, during the ongoing Monsoon Session of Parliament to replace the existing 80-year-old Drugs and Cosmetic Act of 1940.
The pharmaceutical industry has welcomed the initiative of the government to regulate the sector and address the evolving needs and challenges but also has expressed the concern that public opinion should be considered to create a comprehensive framework.
The new bill seeks to regulate the import, manufacture, distribution and sale of drugs, medical devices, and cosmetics and ensure their quality, safety, and efficacy.
“Although the draft of the New Drugs, Medical Devices, and Cosmetics Bill, 2023, has not been shared with stakeholders
yet, we expect that it will incorporate several thoughtful provisions from the Medical Devices Rules, 2017.
“Currently, the regulation of medical devices operates under the Medical Devices Rules (MDR), 2017, and these rules are aligned with the WHO global model regulatory framework for medical devices and adopt a stepwise approach to regulation guided by the Global Harmonisation Task Force (GHTK) and the International Medical Device Regulators Forum (IMDRF),” Pavan Choudhary, the chairman of Medical Technology Association of India (MTal), told this newspaper.
He added that the industry be consulted and given an opportunity to submit their recommendations before the bill is finalised. The industry experts hailed the need for the new bill to regulate the industry and expect that the shortcomings of the old bill must be addressed in the new regulations.
