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Last Updated on January 6, 2025 by The Health Master
Compounding of offences
Government of India have amended Section 29, Section 30 and Section 32B of The Drugs and Cosmetics Act, 1940 for providing compounding of offences to enhance trust-based governance by decriminalization and rationalization of those offences through Jan Vishwas (Amendment of Provisions) Act, 2023.
Amendment
The Central Government has made amendment to Drugs and Cosmetics Act, 1940 effective from 31.12.2024 vide notification S.O. No. 1577(E) dated 28.3.2024 as required under provisions of Jan Vishwas (AOP) Act, 2023.
Draft Rules
Further, the Central Government has also issued draft rules of Drugs and Cosmetics (Compounding of Offences) Rules, 2023, vide notification GSR 374 (E) dated 10.07.2024, to provide procedure to followed during compounding.
Said rules also provide for the definitions for the authorities such as compounding authority and reporting authority.
It also provides a prescribed Form for making application for compounding offence.
Compounding authority
Under Rule 3 of the said draft Rules, the Central Government and State Government is required to appoint a person as compounding authority by notification in the official Gazette.
The Compounding Officer, Reporting Officer and the applicant need to follow the detailed procedure during the compounding of offences.
Ease of doing business
The efforts of Central Government for ease of doing business are yet to be available to the stakeholders regulated by Drugs and Cosmetics Act, 1940 and rules thereunder, as the said Draft Rule – Drugs and Cosmetics (Compounding of Offences) Rules, 2023 are yet to be finalized and notified.
Stakeholders are eager to avail the benefits and waiting for notification of final Rules for compounding and further notification of the Compounding Authorities by the Central Government and the respective State Governments.
1. What is the purpose of these amendments?
To increase the trust-based governance by decriminalizing and rationalizing certain offences under the Drugs and Cosmetics Act, 1940.
To improve the ease of living and doing business for stakeholders in the pharmaceutical sector.
2. Which sections of the The Drugs and Cosmetics Act, 1940 have been amended?
Sections 29, 30, and 32B of the Drugs and Cosmetics Act, 1940
3. When did the amendments come into effect?
From December 31, 2024.
4. What are the draft rules for compounding of offences?
The Drugs and Cosmetics (Compounding of Offences) Rules, 2023, were issued on July 10, 2024.
These rules outline the procedure for compounding offences, including definitions for authorities and a prescribed application form.
5. Who are the compounding authorities?
The Central Government and State Governments are required to appoint compounding authorities by notification in the official Gazette.
6. What is the current status of the compounding process?
The draft rules are still under consideration.
Stakeholders are awaiting the notification of the final rules and the appointment of compounding authorities by the Central and State Governments.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Disclaimer: This information is for general knowledge and informational purposes only and does not constitute legal or professional advice.
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