New Rules Finalized for Compounding of Offences under India’s Drugs and Cosmetics Act

On 25 April 2025, the Indian Ministry of Health and Family Welfare published the official gazette of Drugs and Cosmetics (Compounding of Offences) Rules, 2024, introducing a structured framework for resolving specific offences under the Drugs and Cosmetics Act, 1940, through compounding.

Objective and Scope

These new regulations enable offenders to reach settlements without going through drawn-out legal proceedings. To supervise the compounding process, the Central Government will designate officers at the level of the Central Licensing Authority, Central License Approving Authority, or Central License Approving Authority. State Governments will designate officials at lower levels for the same purpose.

Application and Process

According to the regulations that specify the application procedure, companies or individuals engaged in the production, importation, sale, or distribution of pharmaceuticals and cosmetics may apply for compounding before or following the institution of prosecution. After receiving an application, the compounding authority may request a report from the reporting authority; this report must be submitted within a month, though the compounding authority may extend this deadline.

Payment and Immunity

The applicant must provide proof of payment and pay the compounding amount within 30 days of the offense being compounded. However, if the court denies immunity from prosecution the money paid will not be reimbursed. The regulations also make it clear that the authority has discretion over whether to grant immunity, so compounding does not guarantee immunity.

These clauses seek to ensure compliance with the regulations while expediting their enforcement.

Further details can be found in the official notification here.