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NEW DELHI: Drug makers and medical device firms facing minor regulatory violations can now avoid criminal prosecution and lengthy court battles, with the government rolling out a formal mechanism to settle eligible cases outside courts.The framework, laid out in the Drugs and Cosmetics (Compounding of Offences) Rules, 2025, allows certain offences under the Drugs and Cosmetics Act, 1940 to be resolved by paying a prescribed compounding amount, instead of facing prosecution, signalling a shift towards compliance-based regulation while retaining safeguards for public health.The Central Drugs Standard Control Organisation (CDSCO) has issued a detailed guidance document spelling out eligibility, timelines and procedures for compounding of offences, and the role of a designated Compounding Authority empowered to grant immunity from prosecution in approved cases.Under the rules, companies or individuals involved in the manufacture, import, sale or distribution of drugs, cosmetics or medical devices may apply for compounding either before or after prosecution is initiated. Applications will be examined after seeking reports from the relevant licensing and enforcement authorities, and the authority may allow or reject the request after review and, where required, a personal hearing. If compounding is permitted, the applicant must pay the compounding amount within the stipulated period, following which immunity from prosecution may be granted. The protection, however, is conditional and can be withdrawn if the authority later finds that material facts were concealed, false information was provided or conditions were violated.Officials said the mechanism is intended to reduce litigation over technical or procedural lapses, allowing regulators and courts to focus on serious violations that pose risks to public health, such as spurious or unsafe drugs.The guidance makes it clear that compounding is discretionary and not a matter of right, and that repeat or serious offenders may not qualify. The rules follow reforms under the Jan Vishwas framework aimed at decriminalising minor offences while maintaining regulatory oversight.