FDA-approved inspectors plan short-notice audit of trials

NEW DELHI: Drug Controller General of India (DCGI) is planning random audit of clinical trial sites across the country on a regular basis by this

June and will suspend any human experiment if the research organisation is found violating the guidelines. The move comes in the wake of successful audits over the last few months that enabled the drug regulator to efficiently monitor the human trials, a health ministry official said. Under the scheme, a team of drug inspectors will walk into clinical trial centres at short notice and audit the internal processes and the clinical trials data. “The audit programmes that we had run in last few months have been very successful. The team of US Food and Drug Authority (USFDA) that trained our drug inspectors through workshops for conducting audit are also very satisfied with the process. Now, we plan to do such audits on a regular basis in each zone—North, South, East and West,” DCGI Dr Surinder Singh said. The USFDA had trained 24 officials from the health ministry to conduct such audits. These people then trained state drug inspectors. The trained state drug inspectors will now do regular audits in each zone and hence keep a tab on human experiments going on across the country. While the first phase of the training was funded by the USFDA itself, the second phase of training state drug inspectors was funded by the World Health Organisation, an official said. According to Dr Singh, the audits will be conducted at a short notice and if required, we may suspend the clinical trials as well. The drug regulator had earlier suspended clinical trial for a vaccine by US drug maker Wyeth, following the death of an infant. The DCGI had also ordered a first ever audit of the trial sites. While recently the DCGI decided to allow the company to go ahead with the trial, the drug regulator removed the ban only from 11 hospitals out of 12 where the trials were being carried out. “The ban continues to be there on the trials at Bangalore’s St. John’s Hospital,” the official said. The idea is to keep a check on unethical experiments on human beings as well as to improve the tarnished image of the country in regulating human experiments. It is believed that Indians are treated like guinea pigs in clinical trials due to lack of expertise and adequate infrastructure to conduct trials. Experts also say that very few pathology laboratories in India follow good laboratory practices and the data generated by several pathology labs are often fake. According to estimates of ministry of health and family welfare, clinical research market in India is more than $389 million and is expected to be around $ 1 billion by 2010.