Apollo Hospitals, AIIMS and Harvard University collaborate to improve the process of clinical trial regulations

The Apollo Hospitals Educational & Research Foundation (AHERF) along with Multi Regional Clinical Trials ( MRCT) Centre of Harvard University and the All India Institute of Medical Sciences (AIIMS) have joined to improve the process of evolving clinical trials regulations in India.

The group also discussed accreditation of sites, independent ethics committees (IECs) and investigators, process of informedconsentandissues related to compensation and legislation.

An Expert Committee was constituted by the Ministry of Health and Family Welfare to formulate policy, guidelines and standard operating procedures for approval of new drugs including biologicals, clinical trials and banning of drugs.

Union Minister of Health , Mr.GhulamNabi Azad recently stated ,’The committee set up under the chairmanship of Professor Ranjit Roy Chaudhury to formulate the policy , guidelines and standard operation procedures (SOP) for the approval of new drugs , clinical trials and banning of drugs has submitted its report. The government has examined the recommendations and finalized the action to be taken on various recommendations, the details of which have been posted on the CDSCO website””.

The initiative is mainly to set up a National Accreditation Council as soon as possible to accredit 3 entities – clinical trial investigators, clinical trial sites and the ethics committees and also add education of bio – medical ethics to the medical college curriculum. The initiative believes that GCP (Good Clinical Practices) training should be mandatory for all investigators during clinical trials andall sites doing clinical research should strictly adhere to the guidelines for doing so . The other recommendations would be that opportunitiesshould be given to new centres to get accredited ; all medical colleges ( new sites) be encouraged to do clinical trials ; Institutional ethics committees or sub – committees need to look into compensation issues and relook is required at some issues of video recording of informed consent.