All stakeholders involved in the conduct of clinical trials in India will now be subject to detailed inspection by the drug authorities in the country. This includes sponsored pharmaceutical companies, clinical research organizations (CRO), investigators and independent ethics committees.
The Central Drugs Standard Control Organization (CDSCO) and the Drug Controller General of India (DCGI) have recently issued guidelines for the inspection of clinical trials conducted in India under the clinical trial inspection programme. The main objective of the programme is to verify good clinical practice compliance, the safety and well being of the subjects involved in clinical trials, the credibility and integrity of clinical trial data generated and compliance with the Drugs and Cosmetics Rules.
The programme will cover all sites and facilities which are involved in the clinical trial of drugs, including biological and medical devices identified under the Drugs and Cosmetics Act, 1940.
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