India’s Central Drugs Standard Control Organization (CDSCO) has issued guidance for regulators and sponsors on clinical trial inspection procedures.
The document issued by CDSCO, part of the Directorate General of Health Services at India’s Ministry of Health and Family Welfare, sets out the objectives, scope and particulars of the government’s clinical trial inspection programme,
The inspection programme covers all sites and sponsor/contract research organisation (CRO) facilities involved in clinical studies of drugs, biologicals and medical devices regulated by India’s Drugs & Cosmetics Act.
The aims of the programme are to verify:
• compliance with Good Clinical Practice, so that the rights, safety and well-being of clinical trial participants can be protected;
• the credibility and integrity of the data generated in clinical trials;
• compliance with various other regulatory provisions, as laid out in the Drugs & Cosmetics regulations.
The guidance will give direction to inspectors/CDSCO officers on inspecting clinical trial sites, sponsor/CRO facilities and information supplied to investigators, the Organization said. It will also guide sponsors/CROs on the procedures applied in inspections and follow-up actions.
The document spans a wide range of issues, from planning for inspections to delegation of responsibilities, study protocols and record retention at clinical trial sites; and monitoring of investigators, quality assurance and data collection by sponsors/CROs.
The guidance is in line with wider government efforts to tighten up the regulatory framework for clinical research in India. The rapid growth of the sector in recent years has prompted concerns about lax oversight of clinical trials and CROs.
In July 2009, for example, the Drugs Controller General of India issued draft rules for the registration of clinical research organisations, while the previous month a new rule took effect under which all studies conducted in India had to be logged in the clinical trials registry set up by the Indian Council of Medical Research.
A programme of Good Clinical Practice (GCP) inspections and audits was launched in 2009. Earlier this year, there were press reports in India that trained inspectors from the Ministry of Health and Family Welfare would shortly be carrying out spot inspections of clinical trial sites to ensure compliance with GCP.