Even after more than two years since it approved the proposal, the union health ministry's effort to make registration of bioavailability and bioequivalance (BA/BE) studies mandatory with the Clinical Trial Registry of India (CTRI) is still stuck in the bureaucratic red-tapism, thanks to the bickering between the two departments under the ministry over providing the required funds for the scheme.

According to sources in the National Institute of Medical Statistics (NIMS), which has been given the responsibility to make the necessary changes in its web network to incorporate the BA/BE features, the drugs controller general of India (DCGI)'s office (CDSCO) and the Indian Council of Medical Research (ICMR), both coming under the ministry of health, are passing the buck on the issue of providing the required funds for the project.

Earlier in 2011, after 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 NIMS to make the necessary changes in its web network to incorporate the BA/BE features.

The CDSCO asked the NIMS to get the required fund from ICMR. But the ICMR also rejected its proposal and directed the NIMS to approach the CDSCO for the required funds for the project. Sources said that the NIMS could not take up the project so far as no funding has come so far either from the ICMR or from the CDSCO.

By making registration of BA/BE studies mandatory, 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.