Close on the heels of notifying the rules on giving compensation to the victims of clinical trials, the Union Health Ministry has now amended the Drugs and Cosmetics (D&C) Rules to set conditions for giving permissions to the trials and inspection of sites, looking to further streamline the sector.

Giving legal sanctity to the existing guidelines issued by the Drugs Controller General of India (DCGI) sometime back in this regard, the Government issued the notification to insert a fresh rule (122 DAC) which lists all conditions for granting permission to the trials.

The rules stipulate for adherence to the requirements of Schedule Y, good clinical practice guidelines and approval of ethics committee for initiating the study. It also makes the registration of trial mandatory with Clinical Trials Registry of India before enrolling the subjects.

“Annual status report of each clinical trial as to whether it is ongoing, completed or terminated shall be submitted to the licensing authority and in case of termination of any clinical trial, the detailed reasons for the same shall be communicated,” the rules say.

The notification also stipulates the reporting of serious adverse events during the trials, rules for medical management of the injury during the trials and reporting about the compensation given to the victims.

It also lays down rules relating to the inspection of the premises of sponsors, including their employees, subsidiaries, their agents, contractors, sub-contractors and trial sites by the officers authorized by the CDSCO any time with or without prior notice. The officers will also have powers to search and seize any record, data, document, books, investigational drugs related to the trials.

“The licensing authority may also impose any additional conditions for issuance of permission in respect of specific clinical trials, if considered necessary regarding the objective, design, subject population, subject eligibility, assessments, conduct and treatment of such clinical trial,” the notification said.

It has also specified on the actions that can be taken against the sponsors in the case of non-adherence to the rules. The licensing authority can repeal the permission, debar the investigator and sponsors after giving warning letters in case any discrepancy is found during the inspections, according to the notification.