Health ministry’s efforts to make registration of BA/BE studies mandatory with CTRI stuck in red-tapism
February 06, 2012, 0800 IST – Source : PharmaBizNews
The union health ministry’s efforts to make the registration of bioavailability and bioequivalance (BA/BE) studies mandatory with the Clinical Trial Registry of India (CTRI) are stuck in the bureaucratic red-tapism as different departments of the ministry are passing the buck on funding the project.
According to sources in the 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 NIMS could not take up the project so far as no funding has come from the ministry.
Though the then Drugs Controller General of India (DCGI) Dr Surinder Singh had asked the NIMS to get the funding for the project from Indian Council of Medical Research (ICMR), the ICMR is yet to the provide any funding to NIMS for the project. “We are waiting for funds. The moment we get the funding, we will start the project,” 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.
Hundreds of BA/BE studies are going on at any given time in the country at different clinical research centres. BA/BE studies which take about three months time, are conducted for finding the bioavailability and bioequivalance of a drug, especially the generic drugs and the combination drugs which are already in the market. For getting the license for a new combination drug or generic drug, it is mandatory to submit the BA/BE study results to the DCGI office.