. 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 The protection, however, is conditional and can be withdrawn if the authority later finds that material facts were concealed, false information was provided or conditions were violated.Officials said the mechanism is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.About the AuthorAnuja JaiswalAnuja Jaiswal is a Senior Assistant Editor at The Times of India, with an impressive 18-year career in narrative journalism. She specializes in health and heritage reporting, expertly simplifying complex health information to make it engaging and understandable for readers. Her deep dives into heritage topics are well-researched, resulting in captivating narratives that resonate with her audience. Over the years, she has worked in Chandigarh, Chhattisgarh and West UP, gaining diverse on-ground experience that shapes her storytelling.Read MoreEnd of ArticleFollow Us On Social MediaVideos”US Has No Jurisdiction in Venezuela” Ex-UN Envoy Dilip Sinha Slams US Action In VenezuelaAfter T20 World Cup Move, Bangladesh Now Bans IPL 2026 Broadcast Amid Mustafizur Rahman RowSC Rejects Bail Plea Of Umar Khalid, Sharjeel Imam; Grants Bail To 5 Others In Delhi Riots CaseRajnath Singh Commissions ICG’s Pollution Control Vessel ‘Samudra Pratap’, Hails Make-In-IndiaShashi Tharoor, Manish Tewari & Salman Khurshid Raise Concerns Over US Attack In Venezuela’Whole Of Jammu And Kashmir Should Be Reunited With India’: British MP Bob Blackman’Can Raise Tariffs Very Quickly’: Trump Warns India Over Russian Oil Imports, Praises PM Modi’Indian Firms Have Long Experience In Dealing With Venezuela Oil’: Expert On Opportunity For India”Sport Should Be Kept Apart From Politics” Tharoor On Mustafizur RowProbe Reveals Red Fort Blast Module Used ‘Ghost’ SIM Cards For Encrypted Chats123PhotostoriesParing beans with this one staple can give you complete protein5 trending kaleera designs every modern Indian bride is obsessed with right nowKrystle D’Souza, Ayesha Khan to Tamannaah Bhatia: When Bollywood actresses turned special songs into iconic moments9 Arabian desserts that are a must-try in Dubai5 worst foods for your skin, top plastic surgeon revealsRestoring Chennai’s Crown: The Bharat Insurance Building’s Towers, Spires, and Glory RevealedWhy Sadhguru says parents must work on themselves before correcting children5 cold-proof animals that freeze and restart life after winterModern Bus Hub for Chennai: 75-year-old Broadway Redeveloped with 73 Bays; Rs 800-Crore Multi-Modal to Ease TravelA Road Beneath The Mountains: How A 7-Km Tunnel Will Reshape Travel To Kedarnath123Hot PicksUS strikes VenezuelaVande Bharat Sleeper TrainPublic holidays January 2026Gold rate todayUmar Khalid BailCigarette tax hikeBank Holidays JanuaryTop TrendingSan Francisco 49ersBrittany MahomesNoah Lyles and Junelle Bromfield Net WorthWayne Gretzky Daughter Net WorthSidney Crosby LifestyleLeBron James vs Stephen Curry Net WorthTom BradyLeBron James WifeCam ThomasCharlie Kirk
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.
