Earlier this week, a long-drawn legal battle over collusion by the Health Ministry with international non-governmental organisations to test experimental drugs on Indians landed before a Constitution Bench of the Supreme Court. In the last decade, on account of all clinical trials conducted by various pharmaceutical companies, nearly 2,800 patients are said to have died between 2005 and 2012 in India. A parliamentary panel report found all parties involved of gross ethical violations — the ministry, Drugs Controller General of India (DCGI), Indian Council of Medical Research (ICMR) and those who conducted the clinical trials.
However, because of a legal hurdle, the parliamentary report cannot even be looked at by the Supreme Court. This issue was referred to a Constitution Bench this week. The truth of the allegations is yet to be decided by the court.
In 2009, a prominent international NGO had launched a $3.6 million human papillomavirus (HPV) trial in India and tested two vaccines on 16,000 tribal girls in Andhra Pradesh and Gujarat, apparently without informed consent from the girls’ parents. After allegations were made that the girls had suffered adverse effects, the 72nd Parliamentary Standing Committee Report, in a scathing indictment of India’s then booming clinical trial industry, implicated the DCGI for licensing the vaccines without adequate research on safety and efficacy; the Health Ministry for not questioning violations in the licensing process; the ICMR for promoting a drug even before it was approved and the NGO for setting up a trial without following basic protocol. The parliamentary committee found commercial interests were influencing government policy, and that authorities were “overenthusiastic to act as willing facilitators to the machinations” of foreign institutions. The committee recommended that henceforth, trials ought to be conducted only in the 330 medical colleges that have emergency facilities. It also sought — among other things — an investigation into the illegal approval of drugs and of doctors who submitted “ghost” letters recommending drugs for approval.
The NGO, which cannot be named due to the pendency of the case in Supreme Court, and the drug companies involved have dismissed the allegations as baseless and oppose the court’s reliance on the report.
Indians as guinea pigs
In 2005, an important change in the Drugs and the Cosmetics Act allowed concomitant phase II trials — the stage where efficacy and safety of an experimental drug is tested — for the first time in India. It allowed drugs discovered abroad by multinational pharmaceutical companies to be tested on Indians, without the results coming in from the tests abroad. But clinical trials in India have been accompanied by large-scale criminality as doctors, officials and pharmaceutical companies understand well enough that India is a cesspool of corruption where clearances can be had for a pittance. While there have been many cases since, the underbelly of India’s clinical trial industry came to the spotlight in 2005 when 3,300 patients were subjected to 90 clinical trials that followed no protocols at a hospital in Indore, Madhya Pradesh. In American law, such violations automatically attract the criminal charge of battery. In India, the poor don’t count at all.
Clinical trials ought to be done under calibrated statutory regimes where — among other things — there is full disclosure to the patient undergoing the trial, the right to withdraw at any stage without any consequence, comprehensive medical insurance, meticulous monitoring after administration of the drug for serious adverse effects, and free access to the drug for the trial participants when it is cleared for commercial use. Despite several crimes of enormous proportion where the poor are tested as guinea pigs, nothing has ever been done. The patients continue to die or suffer severe adverse effects, monitoring is never done, compensation is seldom paid, medical treatment is seldom provided and prosecutions are the exceptions to the rule.
Colin Gonsalves is the founder of the Human Rights Law Network
