Side-effects of drug trials in India can often be fatal

▶ Poor and vulnerable often do not even realise they are enrolled in tests

Thousands of Indians have died in unethical clinical trials over the past decade and a lawsuit to improve regulation has dragged unresolved through the Supreme Court for six years.

Between January 2005 and November last year, 4,967 people died during the course of medicine trials and research, according to government data obtained by a non-profit – Swasthya Adhikar Manch (Sam).

Another 20,000-plus people have suffered adverse reactions.

Pharmaceutical companies have offered compensation to the families of the deceased only in 187 of these cases, said Amulya Nidhi, Sam’s founder.

At least 475 drugs have been tested in trials during this time, said Sanjay Parikh, the lawyer representing Sam in the lawsuit it filed against the government in 2012. The trials took advantage of loopholes in rules, lax oversight and India’s large population of poor people, who are often unaware of their rights as trial subjects, Mr Nidhi said.

The number of clinical trials in India rose after 2005, when testing laws were relaxed.

Drug companies began to recruit clinical research outsourcing companies to conduct trials in India, where costs are significantly lower. The annual revenue of these outsourcing firms has grown from $485 million (Dh1.78 billion) in 2010-2011 to more than $1bn today, according to research by Frost & Sullivan, a market consultancy.

India’s regulators have been unable to keep up with this explosion of testing.

“At one point, in Chandigarh, there were 257 trials going on, but only one ethics committee overseeing them,” Mr Nidhi said.

Trials take place under the radar as well, Mr Parikh said, sometimes by simply paying poor subjects about 500 rupees (Dh25) a day.

In 2013, after an interim order from the supreme court, the government made it mandatory for companies to seek written informed consent from each subject before a trial, and for the process of seeking this consent to be recorded on video.

But this rarely happens. What is more commonplace, Mr Nidhi said, is the kind of experience Pradeep Gehlot had. His story, as narrated to Sam, forms part of the non-profit’s case.

Mr Gehlot drives an auto rickshaw in the city of Indore, and when his father Srikrishna, a tailor, fell ill with breathlessness and chest pain, he admitted him to a government hospital.

In the hospital, Mr Gehlot was given a sheaf of papers to sign.

They were in English, which he could not read very well, but the doctors told him that his father would be treated free of charge with imported drugs. So Mr Gehlot went ahead and signed.

“Without his consent, Srikrishna was in a clinical trial for nearly two years,” Mr Nidhi said.

“His health started deteriorating and he died in 2012.”

When Sam heard about the case and sent a team to talk to Mr Gehlot, they confirmed from the documents that a trial had been conducted.

After Mr Gehlot complained, the doctor’s medical licence was suspended for three months.

Sam uncovered other cases of ethical breaches in a different Indore hospital and filed further complaints.

The state government, after investigating the hospital, found that 81 “serious adverse events” – including 32 deaths – occurred during clinical trials on more than 3,000 people. A third hospital enlisted 1,833 children and 233 mentally ill people in trials without their consent, the investigators’ report found.

The report also suggested that doctors and clinicians running these trials had frequently been sent on trips overseas, or had been paid out of process, by pharmaceutical companies.

Punitive measures are weak. After its inquiry, the government imposed fines of $100 apiece on 12 doctors for not co-operating with its investigations.

Two doctors were barred from conducting further trials for a period of six months.

But Chirag Trivedi, the president of the Indian Society for Clinical Research, which represents pharmaceutical researchers, said the country’s rules are actually too stringent.

One regulation, for example, calls for companies to also pay for the management of all medical problems during trials.

“There was a cardiovascular drug trial, which is for a heart ailment, where the company had to pay for tuberculosis treatment for nine months,” Mr Trivedi said.

“We all know that tuberculosis is caused by bacteria, not by any drug, and not by a clinical trial for a heart ailment.”

In every case that has warranted compensation, companies have paid out, he said.

But Mr Trivedi said that – “as in any industry” – there were companies that indulged in unethical trials as well.

At one point, in Chandigarh, there were 257 trials going on, but only one ethics committee overseeing them AMULYA NIDHI NGO founder