The Drugs Controller General of India (DCGI) has issued draft rules for the registration of clinical research organisations (CROs), as part of the regulator’s continued efforts to address concerns about lax oversight of the booming sector.

Rule 122 DAB on ‘Registration of clinical research organisations for conducting clinical trials’ will be incorporated into the Drugs & Cosmetics Act as Schedule Y-1. The proposed changes are subject to a 45-day consultation.

They set out the various requirements for CRO registration in India, which will be valid for five years from the date of issue unless suspended or cancelled during that period. Schedule Y-1 covers all organisations, individuals, institutions and companies with responsibility for initiating, managing or co-ordinating a clinical trial. It does not extend to clinical trial sites.

Among the criteria for registration are that the duties and functions assumed by the CRO should be specified in writing and properly quantified; quality assurance and control should be implemented in line with well-documented standard operating procedures; and education programmes should be in place to help investigators carry out the trial in accordance with the applicable guidelines.

Schedule Y-1 also imposes responsibilities for record-keeping and details the information required for registration, such as the CRO’s status as a legal entity and a copy of the contract between the organisation and its sponsor.

Last month a new rule took effect under which all studies conducted in India have to be logged in the clinical trials registry set up by the Indian Council of Medical Research.