Abstract

COMPARISON OF DRUGS AND COSMETICS ACT 1940 AND WITH DRAFT OF NEW DRUGS, MEDICAL DEVICES AND COSMETIC BILL- 2022

A. Hemalatha*, R. Neelamegarajan, B. Senthilkumar and R. Vijayamirtharaj

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Abstract

The Drugs, Medical Devices and Cosmetics Bill of 2022 proposes a significant overhaul of India's regulatory framework for these critical products. This bill aims to consolidate existing laws and introduce modern regulations to ensure the quality, safety, and efficacy of drugs, medical devices, and cosmetics. Streamlining regulations for import, manufacture, distribution, and sale. Establishing robust protocols for clinical trials of new drugs and medical devices. Upholding international quality standards for all regulated products. Fostering advancements in medical technology and domestic production of medical devices. Safeguarding the rights, safety, and well-being of individuals participating in clinical trials. Ultimately, promoting the health and well-being of the Indian populace. This comprehensive legislation promises to create a more robust and efficient system, fostering innovation while prioritizing public health. Currently the comparison of this study is to know about the clinical trial which may include in the new draft bill. The draft Bill prohibits all the clinical trials or clinical investigations of drugs and medical devices without permission from the central licensing authority.

Keywords: The Drugs, Medical Devices and Cosmetics Bill of 2022, drugs and cosmetic act 1940, Draft of new drugs, clinical trials.