Bangalore: Drug Controller General of India (DCGI) has scrutinised clinical trial data of the advanced pneumonia vaccine developed by the USbased pharmaceutical firm Wyeth that caused the death of an Indian infant during trials.

The phase-III of the clinical trial, which is the final stage before launching a medicine in the market, was undertaken on infants in Bangalore. The clinical trial audit is being done for the first time in the country by the drug regulator.“The audit report is expected by next week,” DCGI Dr Surinder Singh said. The drug regulator will also probe other clinical trials undertaken in the country. It plans to conduct at least three such audits of clinical trials in a quarter in different zones. ET first reported in October that the regulator will conduct random audits of clinical trials.

 Source: Economic Times (more…)