Clinical trials in India are governed by rules defined in Schedule Y of the Drug and Cosmetics Rules, 1945. During the revision of Drugs and Cosmetics Rules, 2005, the Schedule Y was comprehensively amended to take the Indian regulations on par with globally acknowledged definitions and measures. Schedule Y describes the pre-requisites and guidelines for import and/or manufacture of novel drugs for trade or for clinical trials.
The Recent updates to Schedule Y will implicitly convey a strong commitment of Indian government for the conduct of trials in India with strict GCP compliance and in safeguarding the interests of human subjects. The new regulatory guidelines pertaining to informed consent, serious adverse events (SAEs) reporting, compensation in case of injury or death for bioequivalence studies are same as in clinical studies.
Freshly there have been three amendments in Schedule Y of the Drugs and Cosmetics Act. The first amendment is introduction of Rule122 DAB which signifies procedures to examine the reports of SAEs taking place during clinical trials and disbursement of compensation in case of trial connected injury or death as per laid timelines. The detailed procedure is defined by addition of Appendix XII in Schedule Y. The reporting timeline for all serious and unexpected adverse events by principal investigator is currently within 24 hours of incidence of event to the sponsor, Licensing Authority and the EC; but, earlier to this amendment, the 24 hours reporting was restricted to sponsor by the investigator.
The second amendment in recent updates to Schedule Y being inclusion of Rule 122 DAC which states circumstances under which application for conduct of trials shall be approved by licensing authority, which includes a very critical point that the sponsors, their auxiliaries, representatives, sub-contractors, and trial sites shall permit inspectors endorsed by CDSCO to scrutinize their premises.
The third amendment is related to obligatory registration of the Ethics Committees (EC) in the Drug and Cosmetic act vide G.S.R. 72(E) dated February 08, 2013 with addition of Rule 122 DD. This rule states that prior registration of ECs with DCGI is compulsory to review and accord its consent to a clinical study protocol.
With recent updates to Schedule Y, currently, the entire clinical research industry in India, including the BA/BE centers are experiencing a tough time due mounting doubts surrounding the calculation of compensations for victims, how to arrive at the definition of injury and reasons in clinical trial related injury.
*G.S.R stands for General statutory rules.