According to the new Draft Drugs, Medical Devices, and Cosmetic Bill, 2022, pharmaceutical firms will be held liable for injuries and damage caused to participants during a clinical trial. The draught bill proposes that any person who fails to provide required medical management or compensation should be punished with imprisonment, which may extend to one year, or with a fine that should not be less than twice the amount of compensation. While the existing act includes a provision to provide compensation to a relative of the deceased, the new draft proposes to compensate the legal heir of the patient, in case of death. The ministry is seeking opinions on the proposed law, over the next 45 days.

The draught bill has new regulations for drugs considered to be of substandard quality or fake. The penalty, which was originally set at 50,000, has been increased. According to the new draft, the firm will be punished with a penalization fine of not less than 10 lakh or three times the value of the drugs seized, whichever is greater, as well as imprisonment for a term not less than 10 years, which may extend to life imprisonment.

The government had already established a committee to draught new legislation for drugs, medical devices, and cosmetics to replace the existing Drugs and Cosmetics Act of 1940. Additionally, the draught law suggests creating medical device testing facilities similar to drug testing facilities at the state and federal levels. The proposal also contains a bill to establish a separate Drug Technical Advisor Board, which will have the chairperson of the director-general of health services and the member secretary of the Drug Controller General as members.