Lax regulation exploited
Health campaigner Amulya Nidhi says the lack of strict regulations has prompted many pharmaceutical companies to look to India and other developing countries for the tests.
“In Europe and the US the laws are pretty strict. India, on the other hand, makes for a less restrictive destination for drug trials because the regulator lacks teeth,” said Nidhi, who works for the Swasthya Adhikaar Manch group.
Swasthya Adhikaar Manch, which is fighting on behalf of some of the trial victims, says most of them visited hospitals for routine treatment but were subjected to trials without their “informed consent.”
“In almost all the cases there is no genuine informed consent,” said campaigner Nidhi.
“The label on the medicines often does not specify that it is meant for trial, and vulnerable people end up being used as lab rats,” he said, showing one such drug sample to AFP in New Delhi.
Faced with widespread criticism, the government is amending the old Drugs and Cosmetics Act in order to fix greater responsibility on companies and ethics committees which are supposed to oversee the trials, although no timeframe for completion has been given.
As per the law, the subject of a trial or his family must be given copies of the patient information sheet, consent form and a clinical trial liability insurance policy.
Sonia Shah, author of The Body Hunters: Testing New Drugs on the World’s Poorest Patients, says it is imperative to find a way to balance the need for research with the full protection of patients.
“Under-financed hospitals and clinics gain expertise, funding, and often new equipment when they conduct clinical trials. Patients who lack access to regular care can get treatments otherwise not available to them,” she told AFP.
“The question is whether these benefits are in keeping with the health priorities of the country and whether they outweigh the risks,” she added.
The Indian state of Madhya Pradesh, home to the Pathaks, has been at the center of the trial scandal since 2004 when doctors were accused of using victims of the 1984 Bhopal gas disaster for trials without their consent.
The non-profit Bhopal Group for Information and Action, which fights for the rights of thousands left disabled by the world’s worst industrial disaster, said that 14 people died as a result of these trials.
The state was once again under the spotlight last year when a fine of just 5,000 rupees (US$92) was slapped on 12 doctors found to have conducted illegal trials on children and the mentally disabled.