There is a gradual revival in the number of clinical trials being done in India. From an all time low of 17 clinical trials approved by the Drug Controller General of India (DCGI) in 2013, the number has slowly increased to 97 in 2017, a more than 400% jump in five years.
Regulators and domain experts attribute the revival to introduction of scientific and balanced guidelines that suit all stakeholders. Activists, however, feel India is far from a watertight system when it comes to monitoring the trials.
But the jump in numbers is nowhere close to the pre-2013 period. For example, in 2012, the DCGI approved 253 trials, in 2011, the number stood at 283 and in 2010 at 529. “We are seeing some parity being restored,” said Suneela Thatte, board member of the Indian Society of Clinical Research, a clinical research professionals’ association.
In February 2012, a PIL plea filed by the Swasthya Adhikar Manch in the Supreme Court raised an alert over many irregularities in clinical trials, including lack of consent and compensation to the patients referred to as subjects. Around the same time, the 59th Parliamentary Committee report stated that there was a strong nexus between drug makers, doctors and some government regulators. In January 2013, a gazette notification by the Ministry of Health and Family Welfare determining the eligibility for compensation eventually led to many drug makers hunting for other locations for trials. “The clause of compensation was open to misuse and could act as an inducement for participation in the trial as it called for free medical management in terms of injury to the clinical trial subject. There was no distinction made between study related injury or non-related injury,” said Ms. Thatte, adding that approval time of clinical trials would also take extremely long.
According to DCGI Dr. S. Eswara Reddy there were many other clauses that were brought in: like investigators could not undertake more than three trials, to be conducted only in government hospitals, the site of trials should be 50-bed hospitals, etc. “Gradually, we have begun harmonizing the clinical trial environment as per international standards,” Dr. Reddy told The Hindu, adding that now 50% of the trials can be conducted in private hospitals, there is no restriction of three trials per investigator and a formula for calculating financial compensation has been derived.
However, the recent case of a clinical trial in Jaipur mired in a controversy where patients were allegedly deceived into participating in the trial. “The incident exposes the loopholes in government regulations,” said Amulya Nidhi, co-convenor of Swasthya Adhikar Manch. “Indians continue to be guinea pigs”, he said.
According to the Health Ministry, there were 436 serious adverse events (SAE) of deaths in clinical trials in 2012, 590 in 2013 and 443 in 2014. Of these, 16, 46 and 22 respectively were established to be related to clinical trials. In 2015 there were 162 deaths but data on those established due to clinical trials was unavailable. “If you check the government data, it will show many people were given compensation. But we keep asking them for the names of addresses which they refuse,” said Mr. Nidhi, adding that there are no drug inspectors for regular checks on trials and private hospitals don’t come under the Right To Information (RTI) Act. “No one knows what is exactly happening on the ground level. Violations continue to happen,” he said.