The All India Drug Control Officers’ Confederation (AIDCOC) has demanded that the functioning of the Clinical Research Organizations (CROs) conducting clinical trials/BA & BE studies should be brought under the purview of the state and the central regulatory authorities, like those of blood banks, vaccine sera etc.
The national committee of the Confederation which held a meeting in New Delhi last week passed a resolution in this regard. The issue has been drawing the attention of drug control officers, media and the general public for some years now.
AIDCOC will submit a copy of the resolution to the union health minister next week, sources from the Confederation told this reporter. The drug control officers have passed the resolution following serious violations of trial rules by CROs in the last few years in various parts of the country.
Licence for a CRO is given by the Central Licensing Authority, but after that nobody knows what is happening in the organizations or their mode of operations. In the case of blood banks, the CDSCO and the state drug control departments have some powers to monitor and control their activities. But there is no specific rule empowering the state authorities to intervene in the activities of the CROs. Therefore, suitable amendment to the Drugs & Cosmetics Act (D&C Act) is called for, said Ravi Uday Bhaskar, national secretary of AIDCOC.
According to official reports, currently 1868 clinical trials are going on as per the Clinical Trial Registry of India maintained by the office of the Drug Controller General of India. Many of the drugs being tested are not even of specific relevance to the country and could have been tested anywhere. There should be a proper procedure and specific rule to control the organizations, said M Dhilip Kumar, Treasurer of AIDCOC.
Recently the states of Andhra Pradesh and Gujarat witnessed controversy over deaths during clinical trials, and in 2008 there was the reported news of death of 49 children during their clinical trials at the All India Institute of Medical Sciences in New Delhi. According to sources there is no record available with the CDSCO about the number of clinical trials conducted in government or private hospitals prior to November 17, 2008, as the registration of clinical trial was voluntary then.
From June 15, 2009, it has been made mandatory to register all clinical trials permitted at the ICMR clinical trial registry. Recently the union government has admitted that 1725 persons have lost their lives to drug trials in the last four years.