My Clinical Trials Diary

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 DC

The most costly part of new drug discovery is the three phase clinical research lasting for three to four years involving thousands of human volunteers and investigators in multi locations. Any of these potential drug candidates can be abandoned during the trial period if their adverse drug events are beyond the acceptable limits.  It is certainly a high risk activity involving millions of dollars and pharmaceutical companies usually make sure that trial reports reaching the regulatory authorities are favourable. No new drug can be approved for marketing without submission of trial reports and their scrutiny by the regulatory authorities. Because of these reasons, the whole operation  of clinical research is highly secretive.  Apart from top MNCs like Pfizer, GSK, Novartis and Novo Nordisk, there are a large number of contract research organizations engaged in clinical trials in India for the last ten years.