As part of the measures to tighten regulations in the clinical trials sector, the specially assigned Central Drugs Standard Control Organisation (CDSCO) teams will intensify the on-site inspections of trials after a number of recent inspections have exposed various good clinical practices violations.
Following the inspections by the expert teams from the CDSCO in the recent past, investigator, sponsors and monitors of the trials were issued warning letters in a few cases so far for violating the Good Clinical Practice (GCP) norms, sources said without identifying the names of Contract Research Organizations (CROs). In one case, the CRO had taken corrective measures while some trials are still under suspension.
"The clinical trial remained suspended at all the 12 sites of one CRO from November 6, 2008 to April 22. The inspection was held only one of their sites. The sponsor submitted various corrective actions taken to ensure GCP compliance. CDSCO scrutinized the same and decided to revoke the suspension on April 23 from all the sites except the inspected site. Further investigator of the inspected site also submitted details of corrective actions taken by them, based on which the suspension from the inspected site was also revoked on in June," a senior official said.
According to the Drugs Controller General of India (DCGI) office, the inspections would now be intensified across the country and special official teams including experts have been designated for the purpose in different CDSCO zones. Though only warning letters were issued in the cases so far to begin with and giving them chance to correct the faults, more stringent action including withdrawal of licences will be taken in case of future violations and serious lapses.
The CDSCO had taken a number of steps to streamline the sector and has prepared draft guidelines to be included as Schedule Y-1 which stipulates registration of CROs. The draft rule mandates that the CROs should undertake a declaration which reads, "We shall allow the licensing authority and/or any person authorised by him in that behalf to enter and inspect the premises and to examine the process/procedure and documents in respect of any clinical trial conducted by us for which the registration certificate has been made." The draft rules further clarifies that the licensing authority would suspend or cancel the license of the organisation if the latter fails to comply with the conditions of registration and the CRO has to appeal to the central government within 90 days of the receipt of the copy of the order.