Last week the Drug Controller General of India suspended yet another drug trial in the country after the death of an infant. The victim was undergoing trial of an advanced pneumonia vaccine of Wyeth in a Bangalore hospital in violation of the country's weak clinical research rules. The child had a pre existing cardiac disorder and should not have been included in the trial. According to DCGI, the investigator of the vaccine did not adhere to inclusion-exclusion criteria, a standard protocol to be followed by pharmaceutical companies and CROs while conducting human trials. Wyeth was permitted to do trials only on healthy babies. The trial, began last year, was being conducted on 350 healthy babies who were between 42 and 72 days old. About 250 have already been tested and Wyeth is still allowed to collect the data. Only in last August, another instance of death of 49 infants reported while conducting clinical trials at All India Institute of Medical Sciences, New Delhi. The report was based on the facts provided in response to a Right To Information query raised by one of the Delhi based NGOs. AIIMS admitted that in all, 4142 babies were enrolled for clinical trials by the Institute's department of paediatrics since January 1, 2006 and out of that 2728 were below the age of one. As per the government records, as many as 700 human trials for various new drugs are going on in the country today. Out of this, 10 per cent are paediatric trials involving babies, infants and adolescents. Some senior investigators involved in the trials privately admit that over 80 per cent of children who undergo trials do not survive in India.
Such high rate of fatality in human trials is known only to the investigators, CROs and to the companies on whose behalf these trials are being conducted. Even DCGI and ICMR come to know about deaths and injuries during trials much later. In the case of paediatric trials, the parents of the children are usually poor and are kept in dark about the cause of death. They are made to believe that death is caused on account of some pre existing diseases of the child and not because of adverse reactions of the drug under trial. In the case of Wyeth trial, what has happened was the total neglect of the inclusion exclusion criteria by the investigator. The ethics committee was not aware of such violation at the site. The primary objective of having an ethics committee at a trial site is to monitor the trial and the subjects. As is the case with most of trial sites, the ethics committee at the Bangalore hospital also has been ineffective. Now, the issue before India's regulatory authorities is how to stop the recurrence of such violations or lapses of clinical research rules on the part of CROs and pharma companies. The whole process of recruitment of subjects, taking informed consents, compensation to subjects, etc. has to be made adequately transparent. The office of DCGI needs to be strengthened to detect such illegalities and take stringent and timely action against the offenders. Establishing a separate cell in the office of DCGI to monitor the functioning of ethics committees at trial sites could be one step.