In the forthcoming monsoon session starting Thursday, the Centre is set to present a new medical regulation. The New Drugs, Medical Devices, and Cosmetics Bill, 2023, along with 21 new bills and seven old bills for discussion, extending until 11th August.
The New Drugs, Medical Devices, and Cosmetics Bill, 2023, will supersede the 80-year-old Drugs and Cosmetics Act of 1940. This medical regulation implements updated and stringent norms for the pharmaceutical sector. The bill aims to govern the import, manufacturing, distribution, and sale of drugs, medical devices, and cosmetics while ensuring their utmost quality, safety, efficacy, and performance. Additionally, it addresses the need for clinical trials, investigations of investigational medical devices, and evaluations of new in vitro diagnostic medical devices, including AUSSH drugs, medical devices, and cosmetics, all within a transparent and strictly regulated framework. Furthermore, it intends to repeal the existing Drugs and Cosmetics Act, 1940, as confirmed by a government document reviewed by Mint.
The bill puts forth new definitions for various terms, including clinical trials, over-the-counter drugs, manufacturers, medical devices, new drugs, bioavailability study, investigational new drug, and imported spurious drugs, with the added objective of overseeing online pharmacy stores. Specifically, the draft bill prohibits the unlicensed sale, stocking, exhibition, offering for sale, or distribution of drugs via e-pharmacy, except under and in accordance with the prescribed license or permission.
The Centre’s proposal encompasses the establishment of distinct advisory boards, the Drugs Technical Advisory Board (DTAB) and Medical Devices Technical Advisory Board (MDTAB), to provide specialized guidance and counsel in their respective domains.
Moreover, the bill seeks to regulate traditional medicine practices, such as Ayurveda, Siddha, Sowa-Rigpa, Unani, and Homeopathy, by forming a dedicated Drug Technical Advisory Board for each of these areas.
In the past year, the health ministry invited inputs from stakeholders and the public regarding the proposed draft bill to garner valuable feedback and insights.
Amidst the bill’s presentation and ongoing discussions, Rajiv Nath, the forum coordinator for the Association of Indian Medical Device Industry, urged the government to address concerns by considering the implementation of a separate law to regulate medical devices, a practice adopted by numerous other countries like the EU, Saudi Arabia, Canada, Japan, and Brazil, which maintain separate regulations for devices compared to drugs.
As of now, the queries directed to the health ministry have not elicited any response. This leaves the draft of medical regulation’s status in question until further information is provided.