After more than two years since the registration of clinical trials was made mandatory in the country, the Union health ministry will soon make the registration of bioavailability and bioequivalance (BA/BE) studies mandatory with the Clinical Trial Registry of India (CTRI).
According to sources, the Union health ministry has already 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 drugs controller general of India (DCGI) Dr Surinder Singh has already directed the senior officials in the CTRI to make the necessary changes in its web network to incorporate the BA/BE features, sources said.
According to sources, just like the clinical trials, the DCGI wanted to streamline the BA/BE studies in the country. So far, registration of BA/BE studies with the CTRI was optional. Once the DCGI makes it 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.
The CTRI was set up by the National Institute of Medical Statistics (NIMS) which is an arm of Indian Council of Medical Research (ICMR) and is funded by the Department of Science and Technology (DST) through ICMR. It also receives financial and technical support through the WHO, WHO-SEARO, and the WHO India Country office.
The main objective of the CTRI is to ensure that every clinical trial conducted in the region is prospectively registered with full disclosure of the 20-item WHO ICTRP dataset, as well all items of the CTRI dataset, in order to improve transparency and accountability; improve the internal validity (details of the methods of the trial that produce reliable results, primarily the method of random sequence generation, concealment of allocation, blinding of participants and investigators, and inclusion of all participants results) of trials right from the design,through conduct and reporting; conform to accepted ethical standards; and lead to reporting of all relevant results of all clinical trials in India and the region.