Drugs & Cosmetics (Compounding of Offences) Rules 2025

1. The Drugs & Cosmetics (Compounding of Offences) Rules, 2025 have been officially notified by the government.
2. These rules aim to streamline minor offence procedures under the Drugs & Cosmetics Act, 1940.
3. The core objective is to permit compounding of certain minor offences, allowing them to be settled by paying fines.
4. This eliminates the need for time-consuming criminal court proceedings for minor, non-serious violations.
5. The move is intended to decongest the judicial system and ensure faster resolution of cases under the Act.

Who do these rules apply to?

1. These compounding provisions are applicable to pharmaceutical companies.
2. They also cover individuals involved in the manufacture, import, sale, distribution, or any related activities regulated by the Act.
3. The rules are relevant for all stakeholders operating under the scope of the Drugs & Cosmetics Act.

What are the key conditions for compounding offences?

1. Only first-time offenders are eligible for compounding under these rules.
2. This ensures that repeat or habitual violators continue to face legal proceedings as per existing provisions.
3. The rules provide an opportunity for correction without litigation, specifically for minor and unintentional lapses.
4. Compounding will involve the payment of a specified monetary penalty, as per prescribed norms.

Why is this significant?

1. These rules bring in regulatory flexibility for minor offences in the pharmaceutical sector.
2. They support the government’s goal of promoting ease of doing business in the healthcare and pharma industries.
3. At the same time, the rules maintain a deterrent against repeat violations by limiting compounding to first-time offences only.
4. The initiative reflects a balanced approach—encouraging compliance without overburdening the legal system.