The Drugs Controller General of India (DCGI)'s efforts to make registration of bioavailability and bioequivalance (BA/BE) studies mandatory with the Clinical Trial Registry of India (CTRI) may not become a reality in the immediate future as the National Institute of Medical Statistics (NIMS) has asked for more human resources to launch the project.
Sources in the union health ministry said that the NIMS, which has been asked by the DCGI office to make the necessary changes in its web network to incorporate the BA/BE features to launch the project, has expressed its inability to cope with the work pressure as the department does not have the required number of scientists to take up the new responsibility.
The NIMS has expressed its reservations in this regard to the senior officials in the health ministry at a meting held in May this year in this regard. However, the meeting, attended by senior health ministry officials including the DCGI, has given the in-principle approval to launch the project, sources said.
Sources said that for launching the project, the government has to appoint more staff in the department of Clinical Trial Registry of India. As the creation of staff in a government department takes its own time, the project may not be a reality in the immediate future as was earlier anticipated, sources added.
Another issue coming in the way of this project is funding. Though the then DCGI Dr Surinder Singh had asked the NIMS to get the necessary funding for the project from Indian Council of Medical Research (ICMR), the ICMR is yet to provide any funding to NIMS for the project. “Even after one year, we are waiting for funds from the ICMR,” a senior official said.
Earlier, after more than two years since the registration of clinical trials was made mandatory in the country, the health ministry had taken the decision in-principle to make the registration of BA/BE studies mandatory, on the same lines of the other clinical trials in the country. The then DCGI Dr Surinder Singh had directed the senior officials in the CTRI to make the necessary changes in its web network to incorporate the BA/BE features.
According to sources, the ministry wanted to streamline the BA/BE studies in the country. So far, registration of BA/BE studies with the CTRI was optional. Once it is made mandatory, all the BA/BE studies have to be registered with the CRTI without which the DCGI will not give permission to conduct BA/BE studies which are conducted on healthy volunteers.