Last Updated on August 14, 2025 by The Health Master
Compounding Authority
The Ministry of Health and Family Welfare has announced the appointment of the Additional Director General of Health Services, who oversees the Central Drugs Standard Control Organization (CDSCO), as the new compounding authority.
This appointment is made in accordance with sub-rule (1) of rule 3 of the Drugs and Cosmetics (Compounding of Offences) Rules, 2025.
This compounding authority will be responsible for exercising the powers and functions of the Central Government concerning the compounding of offenses and addressing matters that arise from these rules.
The appointment of the compounding authority has been issued by the notification, vide No. S.O. 3551(E), dated 01-08-2025, and was published in The Gazette of India and came into effect on the same day.
Importance of the compounding authority:
The appointment of the Additional Director General of Health Services as the compounding authority is an important development in the regulatory compliances for drugs and cosmetics in India.
This appointment is aiming for the smooth process of handling offenses under the new Drugs and Cosmetics (Compounding of Offences) Rules, 2025.
By the appointment of this central authority within the CDSCO, the government aims to increase the efficiency, transparency, and consistent approach in the regulatory compliance with respect to the compounding of offenses.
The official will now have the specific powers and functions to address and compound offenses, which is crucial for maintaining the integrity of the pharmaceutical and cosmetic industries.
What is the compounding of offenses?
Compounding of offenses is a legal process in which someone accused of a minor, non-serious, or less severe offense can avoid prosecution by paying a penalty in accordance with the law.
The compounding of offense is typically applied to less critical violations and helps to reduce the burden on the judicial system and to spare the accused the lengthy process of prosecution.
With this new appointment, the Additional Director General of Health Services is now empowered to facilitate this process for offenses related to drugs and cosmetics.
Q: What is the Central Drugs Standard Control Organization (CDSCO)?
The CDSCO is the national regulatory body of India. It is responsible for ensuring the quality, safety, and efficacy of drugs, cosmetics, and medical devices.
Q: What is the purpose of the Drugs and Cosmetics (Compounding of Offences) Rules, 2025?
The purpose of these rules is to provide a regulatory compliance for the compounding of offenses related to the Drugs and Cosmetics Act, allowing the accused to avoid a lengthy prosecution process by paying a penalty as per the law.
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.
Drugs and Cosmetics (Compounding of Offences) Rules, 2025: Gist
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