The Health Ministry is finally planning to amend the Drugs and Cosmetic Rules to incorporate the already finalised guidelines and other aspects of clinical trials under Schedule Y1, after sitting on the proposal for over an year now.
Though the draft guidelines and requirements for registration of organization conducting clinical trials in the country had been developed and approved by Drug Technical Advisory Board (DTAB), it was yet to be incorporated in the rules. Sources said the government will now take steps to amend the rules by adding Schedule Y1 as planned. It will have all provisions related the trials including penalty provisions for defaults, on-site audits of trials, and registration of ethics committees.
From June 15, 2009 office of Drugs Controller General (India) has made mandatory to register all clinical trials permitted on or after the said date to be registered with Indian Council of Medical Research (ICMR) registry at www.ctri.in before enrolling first patient in the study. In order to streamline the trials, the CDSCO had taken many steps already, sources added.
Another proposal is to ask the trial companies to get the finger-prints of all volunteers in Phase III trials and share the data between the CROs. This will ensure that the same man is not going for another trial by another company, after being a subject in one trial. The number of trials that a principal investigator also will be limited for more effective end results, sources said.
The expert teams under the DCGI office are also holding on-site inspections of the trials for some time now. 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 GCP norms.
As per a report on 'The Glorious Metamorphosis Compelling Reasons for doing Clinical Research in India' published with a joint effort of FICCI and Ernst & Young Pvt. Ltd in 2009 the clinical trials market in India is sized at US$ 250 to US$ 275 million. India ranks as the second most preferred destination for trials in the world.