New Delhi: The Supreme Court directed the health ministry to monitor and regulate all clinical trials of experimental drugs in the country until further notice and observed that unregulated trials have caused “havoc”.
The apex court order on Thursday revoked the power of the Central Drugs Standard Control Organization under the Drugs Controller General of India (DCGI), which has so far been the nodal agency for monitoring clinical trials in India. The Supreme Court was hearing a lawsuit filed by non-profit Swasthya Adhikar Manch in February, which had alleged that participants in such clinical trials faced health problems and had even died because of the practice.
“Uncontrolled clinical trials are causing havoc to human life. There are so many legal and ethical issues involved with clinical trials and the government has not done anything so far,” justice R.M. Lodha said while hearing the petition. The court has directed the health secretary to file an admissible affidavit within four weeks after it refused to accept one filed by deputy drugs controllers as it failed to comply with the court’s order passed in October.
In October, the apex court had said it may bar clinical trials in the country unless the health ministry provided information within a month regarding deaths during such programmes, besides compensation and general practices when new drugs are tested on Indians.
DCGI had submitted in court on Thursday that 475 human clinical trials for “new chemical entities not approved as drugs for human use anywhere in the world” were approved by the Indian drug regulator between January 2005 and 30 June 2012. Out of the 475 experimental drugs, 17 have been given approval for marketing, according to court records.
During the period, 11,972 serious adverse events, excluding deaths, were reported, out of which 506 have been attributed to clinical trials. None of the victims has been compensated. A total of 57,303 subjects were enrolled in these clinical trials and 39,022 of them have completed the trials.
“The magnitude of the problem is now emerging with the government admitting that no laws were in place between 2005 and 2012 for new chemical entities and yet the government was approving trials so casually,” said Amulya Nidhi, an activist with Swasthya Adhikar Manch. “Our whole plea has been to stop testing for experimental drugs unless there is a regulation in place for it. Besides, there is no mention of rules regarding compensation in the Drug and Cosmetics Act. We hope to strengthen our campaign for relevant amendments in the Act.”
In response to interim applications seeking information on experimental drugs being tested in India, between January 2005 and 30 June 2012, the Union government said there were no records for trials conducted between 2005 and 2007. Since 2008, government records showed that 80 deaths can directly be attributed to clinical trials and 40 of these victims have been compensated.
This is the first time that state governments have been asked to put comprehensive data on clinical trials in the public domain, according to Chinmay Mishra, one of the petitioners.
According to conservative estimates by Swasthya Adhikar Manch, there have been 2,374 reported deaths during clinical trials since 2007.
India’s clinical trial industry has been mushrooming since the introduction of patent protection laws in 2005, drawing multinational companies because of its ethnically diverse pool of patients with low entitlement literacy and huge regulatory void, according to Mishra.
Conducting clinical trials in India can bring down research and development costs by nearly 60% for big pharmaceutical companies, according to industry estimates.
“For the first time, due to the court’s intervention, the horrifying human rights violations in clinical trials are under judicial scrutiny. We hope this will be taken to its logical conclusion,” said Colin Gonsalves, a Supreme Court lawyer.
“We don’t know what exactly the court has expressed by revocation of DCGI’s power. The department of health is the authority which makes the policy for clinical trials,” said Arun Bhatt, president of Clininvent Research Pvt. Ltd, one of the country’s top clinical research organizations.
“DCGI is just the enforcement arm of this department. Just revoking the power of DCGI will not resolve the issue as the department will need to again depend on another officer and his team to do the work,” he said.
C.H. Unnikrishnan in Mumbai contributed to this story.