India's contribution to clinical trials has been remarkably low—1.2 per cent, which, experts say, is inadequate for a country that has the second highest population (17 per cent) and the highest disease burden in the world (20 per cent ).
However, with the new rules regulating clinical trials likely to come into effect in the next month, this scenario is set to change. “According to the new rules, if an Indian company does not hear from the drug regulator on their proposal for clinical trials and research in 30 days, the proposal is considered approved. Earlier, the approval process would take anywhere from three to six months,” Dr Easwara Reddy, Drug Controller General of India told THE WEEK.
In case of a multi-national, the window for approval would be 90 days, according to an expert from the Indian Society of Clinical Research (ISCR).
“This is a major decision. We want to encourage ethical and scientific research. As a country we are perceived to be low on innovation, and all about generics. The new rules will encourage Indian companies [as opposed to their multi-national counterparts] to innovate,” Reddy said. In the past, however, a section of experts have raised a concern on this clause, citing issues such as a lost application, and demanding that the regulator inform the applicant anyway.
Reddy said that the new rules also tackle the contentious subject of informed consent for participants in a clinical trial. “The form for informed consent has to be published in a regional language. Besides, the subjects also have to define their educational qualification and profession. This will prevent unethical practices,” he said.
The new rules will come into effect in the backdrop of a huge dip, and then, a small rise in the number of clinical trials in India. In 2010, the number stood at 500, in 2013, it came down to 17. This happened in the wake of two PILs in the Supreme Court over the issue of allegedly illegal clinical trials, and consequently, tightening of the rules governing clinical trials.
In 2014, however, the number increased to 37, and last year, the number stood at 100, according to ISCR. “We are the only country to have audio-visual recording for informed consent. Companies are also liable to provide medical management for patients who participate in the trials. In the case of death because of participation in a clinical trial, the compensation has to be provided in the range of Rs 4 lakhs -75 lakhs,” said Dr Chirag Trivedi, president, Indian Society for Clinical Research.
However, it remains to be seen how the Centre has resolved the issue of different rules for “academic trials” and “clinical trials”, even though the risks for human participants remained the same in both the cases.
India, rue experts, has had a “conducive” environment for clinical research given the cost advantage—more than 50 per cent during phase I studies, and more than 60 per cent during phase II and III studies as compared to developed nations. The country also has a large ethnically and genetically diverse population, suffering from various ailments. It is also home to six out of seven genetic varieties of human race who are largely “treatment naive” and looking for a cure and better treatment.
“We need to encourage research on our patients to ensure that we have drugs that work for our population. For instance, the dosage of atorvastatin [medicine used to lower cholesterol] is much lower for our population. Such insights can only be gleaned if the drug is tested on our population,” said Dr Sanjay Mittal, senior director, clinical cardiology and head of research, Medanta-The Medicity. “In another instance, a drug that is now the gold standard for treatment in heart failure [a combination of salbutamol and valsartan] came much later to India because of the time it took to have a trial in India,” said Mittal.