New Drug Law in Parliament
The government is poised to introduce the Drugs, Medical Devices, and Cosmetics Bill, of 2023 during the current session of Parliament. This Bill aims to replace the 80-year-old Drugs and Cosmetics Act of 1940, consolidating and amending regulatory requirements for drugs, medical devices, and cosmetics across India.
Notably, the proposed legislation will encompass a distinct section dedicated to setting regulatory standards specifically for medical devices. This move will not only establish separate guidelines for these devices but also institute a dedicated team of regulatory officials equipped with specialized skills to oversee the approval and monitoring of all types of medical devices.
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Anticipated to bolster clinical trials for new drugs and investigations on investigational medical devices within the country, the new law also prioritizes the regulation of e-pharmacies.
Initially slated for introduction during the Monsoon session of Parliament, the Bill faced postponement due to opposition from medical device manufacturers. Concerns were raised by the Association of Indian Medical Device Industry (AIMED), contesting that the proposed legislation failed to introduce an independent regulatory framework for medical devices. Additionally, objections were made against the idea of establishing a single central medical device testing laboratory, citing practical challenges in conducting various types of testing for over 6,000 medical devices in one location.
The Bill envisions the establishment or designation of several key facilities such as the Central Drugs Laboratory, Central Medical Devices Testing Centre, State drugs laboratories, and State medical devices testing centres.
A ministry official reassured that the regulation of medical devices will be undertaken by a distinct team, governed by separate laws to address industry concerns. Emphasizing the Bill’s collaboration with policies encouraging startups and fostering research and development, the official highlighted its pivotal role in expanding India’s innovation ecosystem.
Also, read India’s Medical Technology Sector Projected to Surge to Rs. 2,177.9 Billion by 2026
As Operon Strategist, dedicated medical device regulatory consultants, we anticipate the proposed Drugs, Medical Devices, and Cosmetics Bill, 2023 to usher in a new era of regulatory clarity and advancement within India’s medical devices sector. Our commitment remains steadfast in supporting clients to navigate these evolving regulations, ensuring compliance, and fostering innovation for the benefit of the country’s burgeoning medical device industry. Contact us for consultancy services regarding medical devices.
