Minor drug law violations can now be settled without court cases
New Delhi: Pharmaceutical and medical device companies facing certain minor regulatory violations may no longer be required to contest criminal cases in court, with the government introducing a formal framework that allows eligible offences to be settled through monetary penalties and corrective steps. The move follows amendments to the Drugs and Cosmetics (Compounding of Offences) Rules, 2025, notified under the Jan Vishwas Act, which seeks to decriminalise minor offences across multiple laws and improve ease of doing business, sources said on Monday.
The Drugs and Cosmetics Act, 1940, governs the safety, quality and efficacy of drugs, cosmetics and medical devices in India. Traditionally, even technical non-compliance under the Act could trigger prosecution. Officials said the revised framework is intended to address minor or procedural lapses without burdening courts, while retaining safeguards for public health.
“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 state. The new provisions allow certain offences to be resolved through a process known as compounding, under which companies or individuals can avoid prosecution by paying a prescribed amount and meeting specified conditions.
The Central Drugs Standard Control Organisation, which functions under the Union Health Ministry, has framed the Drugs and Cosmetics (Compounding of Offences) Rules, 2025, and issued detailed guidance outlining eligibility, timelines and procedures. While the rules establish the legal framework, they do not specify the offences eligible for compounding or the quantum of fines, leaving those decisions to the designated authority.
According to a document accessed by PTI, the additional director general of health services handling CDSCO matters has been appointed as the compounding authority. Applications can be submitted either before or after prosecution is initiated. The authority will seek reports from licensing and enforcement officials, examine the facts and may grant or reject the request. In some cases, applicants may also be given a personal hearing.
If compounding is approved, the applicant must pay the compounding amount within 30 days to secure immunity from prosecution. However, the protection is conditional. “The immunity from prosecution in certain cases shall stand withdrawn if a person fails to pay sum of specified order of compounding passed by the compounding authority,” the document said. Immunity can also be withdrawn if the authority finds that the applicant concealed material particulars or provided false evidence during the proceedings, in which case prosecution may follow.
Officials said the mechanism is discretionary and not a matter of right, and that repeat or serious offenders may not qualify. The intent, they added, is to reduce litigation over technical breaches and allow regulators and courts to focus on serious violations, such as spurious or unsafe drugs, that pose risks to public health.
with agency inputs
