New Delhi: The Central government will likely put up the New Drugs, Medical Devices & Cosmetics Bill, 2023, in the Parliament in the monsoon session that begins tomorrow, Thursday, July 20
This eagerly anticipated bill aims to modernize and strengthen the regulatory framework governing the pharmaceutical sector. Alongside several other bills, it will be discussed in Parliament until August 11.
The proposed New Drugs, Medical Devices, and Cosmetics Bill of 2023 aims to replace the outdated Drugs and Cosmetic Act of 1940, which has been in effect for over 80 years. The new bill will establish updated laws and more stringent regulatory norms to ensure the quality, safety, efficacy, and performance of drugs, medical devices, and cosmetics.
Reviewing a government document, Mint has gained insights into the bill's core objectives. It seeks to regulate various aspects such as the import, manufacture, distribution, and sale of drugs, medical devices, and cosmetics. Furthermore, it places significant emphasis on ensuring the highest possible regulatory standards, transparent regulatory processes, and the repeal of the existing Drugs and Cosmetics Act of 1940.
The bill introduces new definitions for critical terms like clinical trials, over-the-counter drugs, manufacturers, medical devices, new drugs, bioavailability study, investigational new drug, and imported spurious drugs. An important aspect of the bill is its aim to regulate online pharmacy stores, prohibiting the sale or distribution of drugs through e-pharmacy without the appropriate license or permission.
To strengthen the regulatory structure, the government has proposed the establishment of two separate advisory boards. The Drugs Technical Advisory Board (DTAB) and the Medical Devices Technical Advisory Board (MDTAB) will provide valuable guidance and expertise in their respective domains.
In a noteworthy move, the bill also addresses the regulation of traditional medicine practices such as Ayurveda, Siddha, Sowa-Rigpa, Unani, and Homeopathy. It outlines the formation of a dedicated Drug Technical Advisory Board to oversee these fields, ensuring their compliance with regulatory standards.
As the monsoon session commences, the introduction of the New Drugs, Medical Devices, and Cosmetics Bill, 2023, represents a significant step forward in strengthening the regulatory framework for the pharmaceutical sector and ensuring the well-being of the public.
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