Central drug regulator releases guidelines on compounding of offences

In a bid to make compliance easier, the Central Drugs Standard Control Organisation (CDSCO) has released guidelines and standard operating procedures (SOPs) related to the compounding of offences under the Drugs and Cosmetics (Compounding of Offences) Rules, 2025, which will be a guide to drug manufacturing companies and individuals on how to settle offences under the relevant provisions of the regulation under the Compounding Authority.

Released recently, the document prepared by the CDSCO will assist all stakeholders to understand and comply with the newly notified rules and aid in the ease of compliance.

“Any stakeholder desirous of applying for compounding of offences under the Rules may submit the application in the prescribed form in physical copy along with advance copy through email as specified under Rule 4 of the Drugs and Cosmetics (Compounding of Offences) Rules, 2025, to the Compounding Authority,” noted CDSCO.

A senior Health official explained that the new rules exempt pharma firms from appearing in court in case of “certain minor contraventions” and allow them to seek the provision of paying a monetary penalty instead, subject to conditions. They also must take “self-corrective actions”. The rules, however, do not mention the fine amounts or specify offences.

The change in guidelines follows amendments in the Drugs and Cosmetics (Compounding of Offences) Rules, 2025, introduced under the Jan Vishwas Act, which aims to promote the ease of doing business by decriminalising minor offences across various laws, including the Drugs and Cosmetics Act, 1940.

“Recognising the need to address minor and technical contraventions without overburdening the judicial system, Section 32B was introduced to allow for compounding of offences,” the rules said.

It added that immunity from prosecution in certain cases will be withdrawn if a person fails to pay the sum mentioned in the order passed by the compounding authority.

“The immunity granted to the applicant may be withdrawn by the compounding authority, if satisfied that such applicant had, in the course of compounding proceedings, concealed any particulars, material, or had given false evidence and thereupon, such a person may be tried for the offence,” the guidelines said.