The shocking disclosure that at least 1,542 children have died in the past three years in the clinical trial of drugs carried out on them in India has emerged in a reply by the Central Drugs Standard Control Organisation (CDSCO) to a query filed under the Right to Information Act. It is clear that the children of the country are being used as guinea pigs by companies even as there is lack of regulation and the government has remained somnolent in spite of the recent rap on their knuckles by the Supreme Court which has taken cognisance of this issue. These are needless deaths which bring the focus once again on the unethical nature of much of this research as well as on the need for regulatory reform and stringent ethical safeguards to be put in place. In the last several years there has been a mushrooming of clinical trials in India largely owing to outsourcing by transnational corporations as well as an increase in the research by indigenous pharmaceutical and biotechnology companies. These companies find it attractive to conduct research in this country as it allows them faster and cheaper drug trials in the absence of a strict legal and regulatory regime. Poverty and the big population make a large pool of experimental subjects available even as there are issues of informed consent as poor and uneducated patients in government hospitals are lured into clinical trials with the promise of free medicines with many of them having little idea of what they were signing up for.
Corruption, the low cost of conducting the trial and collusion between drug companies and doctors has led to the rise in unethical drug trials in India. A parliamentary committee on health and family welfare has noted that there is sufficient evidence on record to conclude that there is a collusive nexus between drug manufacturers, some functionaries of the CDSCO and some medical experts. Even the existing regulatory framework is not complied with by the pharmaceutical companies because of lack of monitoring by the regulator which is short staffed and lacks expertise. The lack of transparency allows companies to get away with patently unethical and illegal drug trials. It is also true that a lot of this research is of dubious benefit or relevance to the health needs of this country. The government must therefore work to put in place urgently mechanisms to regulate such clinical drug trials so that ethics and human life can be preserved.