Government proposes compensation for trial injuries
July 11, 2022:
Pharmaceutical firms will be liable to pay compensation for injuries and damage caused to participants during a clinical trial, according to the new draft Drugs, Medical Devices, and Cosmetics Bill, 2022.
The draft bill proposes that any person (sponsor, clinical research organisation or any other organisation or investigator) who fails to provide required medical management or compensation shall be punishable with imprisonment, which may extend to one year, or with a fine which shall not be less than twice the amount of compensation.
It also says that in case of death, the company should provide compensation to the legal heir of the participant. The existing Act provides compensation to a relative of the deceased. The ministry has sought comments on the draft bill over the next 45 days.
According to the draft bill, a drug deemed not to be of standard quality or spurious shall be punishable with imprisonment for a term not less than 10years but which may extend to imprisonment for life and shall also be liable to fine of not less than ₹10 lakh or three times the value of drugs confiscated, whichever is more. The fine has been revised from ₹50,000 in the existing law.
The government had earlier set up a committee to frame new laws for medicines, medical devices and cosmetics in order to replace the existing Drugs and Cosmetics Act, which was formed in 1940. At present there is no distinction between the regulatory treatment of drugs and medical devices.
The draft bill also proposes medical device testing centres on the lines of drug laboratories in states and at the central level.
The bill proposes to form a separate Drugs Technical Advisory Board (DTAB) and Medical Devices Technical Advisory Board (MDTAB) that will advise the Centre and state governments on technical matters pertaining to drugs and cosmetics related to implementing the amended law, among other functions.
The board will include the chairperson of director general of health services and member secretary of Drugs Controller General. A similar proposal has been drafted for MDTAB. The draft bill also includes a separate chapter for AYUSH drugs, which proposes to regulate Sowa-Rigpa and homeopathy, whereas the existing act only regulates Ayurveda, Unani and Siddha drugs and cosmetics.
The bill proposes establishing a scientific research board in a bid to support the regulatory authority on the advances used for developing innovative drugs of Ayurveda, Siddha, Sowa-Rigpa, Unani and homoeopathy, their safety and efficacy, making devices and other related matters. ET Health