Registration of clinical research organizations which conduct human studies on drugs, cosmetics and medical devices would soon be made mandatory in India.
Central Drug Standard Control Organisation (CDSCO), the apex body regulation drugs in India, has already published the draft rules and guidelines for the registration of CROs seeking comments from the stakeholders of the industry.
The new set of guidelines mandating the registration of all organization conducting human research comes in the wake of looming controversies that large drug companies are making a killing using Indian patients guinea pigs and on the ethical nature of clinical research being practiced in the country.
The draft rules termed as Schedule Y 1 have already been approved by Drug Technical Advisory Board (DTAB), the expert committee that advises the drug regulator on technical aspects. Schedule Y of the Drug and Cosmetics Act of India –the rule book of regulation for drugs and cosmetics –stipulates the broader guidelines for clinical research.
The set of guidelines mandates strict adherence of standard operating practices as pre-requisite for obtaining registration for clinical research organizations (CROs).
Licences will be granted with five years of validity. But the regulator will have the power to suspend or cancel the licence within the term if the CRO is found not complying with or violating the stated guidelines.
Once the licence is suspended or cancelled, the CRO can appeal the Central Government within ninety days.
Schedule Y1 requires that all CROs to be “under the charge of a person who is responsible for the overall activities of the organization,’’ and the person in charge
should be thoroughly familiar with the investigational product(s), the protocol, written informed consent forms or other information provided to the subjects, the standard operative procedures by the sponsors, Good Clinical Practice Guidelines (GCP) guidelines and other rules applicable to the conduct of clinical trials.
CROs are mandated to implement and document all SOPs designed for quality control and quality assurance, besides training the staff – including the investigators – to update their skills. Training will include protocol adherence, seeking a free and fair informed consent and responding to concerns of research participants during the study.
CROs should also check the accuracy and completeness of the data/documents and keep all the records (written documents, electronic, magnetic or optical records, scans,
etc.) such as protocols, approvals from the CDSCO & ethics committee,
investigator(s) particulars, consent forms, monitor reports, audit certificates,
relevant letters, reference ranges, completed and the final reports for further verification.
The draft guidelines also seeks an undertaking from the CROs that they will have no objection to “allow the licensing authority and/or any person authorized by him in that behalf to enter and inspect the premises and to examine the process/procedure and documents in respect of any clinical trial conducted for which the registration certificate has been made.’’
CRO sector in India is one of the fastest growing sectors in the pharma outsourcing industry. Almost all globally operating CROs have either set up own offices in India or linked up with Indian CROs.
India’s drug naïve and genetically diverse patient pool, faster recruitment potential, low cost operations and easy availability skilled professionals are often considered facilitating the rapid growth of the industry.