After launching a number of measures in the recent past to closely monitor the clinical trials in the country, the Drugs Controller General of India (DCGI) has asked all the zonal offices of Central Drugs Standard Control Organisation (CDSCO) to set up expert committees to mount regular inspections at the trial sites.
“It has been decided that the zonal offices of CDSCO should keep the records of the details of names, qualifications of investigators and clinical trial sites falling under their jurisdiction and also constitute expert committees to conduct clinical trial inspections,” DCGI Dr G N Singh instructed the zonal offices.
The expert committee along with drug inspectors shall visit the clinical trial sites at least once in a year to verify the compliance with Schedule Y, GCP guidelines and other applicable regulatory requirements, the DCGI said in a notice.
In the recent past, the authorities have taken a number of measures to streamline the clinical trial sector. Over 200 ethics committees secured registration after the CDSCO issued orders to make it mandatory for the clinical trial organisations to register the committees.
Apart from specifying norms on determining the quantum of compensation to the victims of trials, the DCGI had also set up three independent expert committees for examining the reports of serious adverse events of deaths during the clinical trials.
The Drugs & Cosmetics Rules have also been amended to include several pro-active measures in the sector. The norms for giving permission to the clinical trials, steps to ensure approved protocols and Schedule Y requirements, mandatory approval by the ethics committees, registration of trials with Clinical Trials Registry of India, filing of annual status report, report of adverse reactions, compensation for injury and death, etc. were in detail specified by amending the laws.
One of the key measures was to allow the authorities to conduct surprise checks in the sites of clinical trials and check all records, as deemed require, including in the offices of the employees, sponsors, agents, contractors, investigators etc. The present order asking the zonal offices of CDSCO to set up expert panels is a follow-up to this.