India’s Central Drugs Standard Control Organization (CDSCO) has drawn up guidelines for regulators and sponsors to help tighten up clinical trial inspection procedures.
As a branch of India’s Ministry of Health and Family Welfare, the CDSCO has released the guidelines amidst wider government efforts to shore up the regulatory framework for clinical research in India.
The document outlines plans to protect the rights, safety and well-being of clinical trial volunteers, as well as ensuring better GCP compliance during clinical trial inspections.
The stricter guidelines also aim to increase the credibility and integrity of clinical trial data, helping increase compliance with drugs and cosmetics regulations.
The CDSCO claims a tighter framework will provide direction for inspectors and CDSCO officers when conducting inspections of sponsors, CROs (contract research organisations) and clinical trial sites.
Conversely, CROs will be provided with information concerning inspection procedures and any follow-up actions.
CDSCO headquarters say “inspection of clinical trial sites would generally be pre-announced,” but insist that spot-checks may occur “under some specific circumstances”. Inspection of the CRO or trial sponsor can still be conducted without prior notice.
All clinical trial sites and CRO/sponsor facilities involved in the clinical trial of drugs - including biological and medical devices covered by India’s Drugs & Cosmetics Act - will be included in the inspection programme.
Under the new guidelines, upon inspection comparisons will be made between data generated at the trial sites and documents held by sponsors.
Trial site inspection categories
Trial site inspection categories include documentation, study protocol, informed consent, case record forms, adverse events and ethics committees.
Inspection of the CRO or sponsor will place an emphasis on documentation, adverse event reporting and data collection and handling.
The CDSCO's tightening of the regulatory framework surrounding clinical trials comes during a time of rapid research growth in India, where the mandatory recording of study details only became law in June 2009.