India: Clinical Trial Sponsors Can Be Inspected Any Time

December 1, 2010
Sponsors and clinical research organizations (CROs) involved in trials in India should be prepared for an inspection at any time and without prior notice, a new guidance says. Inspections can be conducted before or during a trial or after it has been completed, according to the guidance issued by India’s Central Drugs Standard Control Organization (CDSCO) last month. The inspection program applies to all sponsors/CROs and sites involved in trials of drugs and devices covered by the country’s Drugs & Cosmetics Act. CDSCO will conduct both routine and for-cause inspections.
Clinical Trials Advisor