When regulators become violators, who is to regulate them? That perplexing question is what arises from the damning report of the Parliamentary Standing Committee that investigated alleged irregularities in the conduct of the human papilloma virus vaccine trial on nearly 23,500 girls in the 10-14 age group in Vadodara, Gujarat and Khammam, Andhra Pradesh. But more importantly, the report provides a rare glimpse into the murky ways in which certain policy decisions that affect a large number of people are taken by nodal agencies with utter disregard to propriety. The vaccine given to young girls for preventing cervical cancer was approved for use in India in October 2008. But an MoU was signed as early as February 2007 by the Indian Council of Medical Research and an American agency, Programme for Appropriate Technology in Health, wherein the regulator committed itself to “promote the drug [vaccine] for inclusion in the universal immunisation programme” well before the “utility and rationale” of inclusion was studied. Incidentally, the ICMR is not the body that takes a call on introducing a vaccine in the immunisation programme. Thus, by entering into an agreement, the ICMR abdicated its responsibilities of being a watchdog and instead became a “willing facilitator [that] acted at the behest of PATH in promoting the interests of the [vaccine] manufacturer.” The Drug Controller General of India is equally culpable for being a mute spectator when clinical trial rules were “flagrantly violated.”
If the nodal agencies bending over backwards to facilitate the introduction of the vaccine is shocking, the Union Health Ministry’s role in scuttling the truth-seeking process is alarming. The ministry has made a mockery of the trial subjects by choosing people with well-established conflicts of interest to be a part of the inquiry committee to look into the irregularities. The DCGI, on its part, ensured that “no accountability was fixed” on the erring officials and no definite steps were taken to improve the trial process. The collusion of the agencies and the ministry turns the spotlight on the government’s intent in removing the obstacles for multinational drug companies to undertake human clinical trials. The conduct and investigation of one of the country’s notorious trials clearly demonstrates that the government showed no interest in protecting its people, choosing instead to abet the criminal acts of private companies and safeguard itself. If the very design of a trial that involved ICMR could be faulty, one is left wondering what the status of other trials would be. How safe are people who knowingly or unknowingly volunteer for trials in India?