Drug and medical device companies could get a wider route to settle certain offences without facing criminal prosecution under the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. The draft Bill proposes allowing certain categories of offences to be compounded, including specified violations involving not-of-standard-quality or misbranded drugs and certain regulatory breaches relating to clinical trials and medical devices.

The draft Bill has expanded the compounding route to reduce concerns among companies, including foreign drugmakers, about facing criminal prosecution for routine compliance failures. According to the draft Bill, six types of offences can be compounded, including certain offences involving not-of-standard-quality or misbranded drugs; failure to provide medical treatment or compensation to clinical trial participants; specified violations involving adulterated…