THE Union Health Ministry is working on a proposal to provide accreditation to clinical trial centres, investigators and ethics committees — all of which will kept be out of the purview of Central Drugs and Standards Control Organisation, the country’s highest drug regulatory body. Thus, the role of CDSCO will be limited only to granting permission for testing new pharmaceutical products.
Clinical trial permissions have been stalled for months after the Supreme Court last year rescinded the regulator’s nod for 157 clinical trials. Based on the recommendations of the Professor Ranjit Roychowdhury Committee, the new regulatory model would take several aspects of clinical trials away from the CDSCO.
An expert working for streamlining clinical trials said, “The idea is to introduce a foolproof and transparent accreditation process at all levels right from the investigator who conducts the trials, the centre where it is done and the ethics committee that clears it. Accreditation cannot be misused because the individuals or institutions would then stand to lose their accreditation. The CDSCO that will continue to give permissions for clinical trials will not be involved directly in the accreditation process to avoid conflict of interest.”
While recognition to ethics committees in some form has been debated, given the important role it plays in ensuring a clean and ethical trial, in all those discussions the CDSCO or the drug controller’s office has always been the principal player. Taking that out of its purview would bring in accountability and transparency at multiple levels, the ministry suggested.
Though, the accreditation agencies have not been finalised yet, one of the institutions that are being looked at as possible options is the Quality Council of India. The Roychowdhury panel had advocated constitution of a body for the accreditation of centres.