The government easing the rules for clinical trials of drugs in the country is the shot in the arm that access to drugs in the country needed. The Drugs and Clinical Trials Rules 2019 do away with the necessity to conduct local trials for drugs that have been approved to be marketed in the US, the UK, the EU, Canada, Australia and Japan. This will mean these drugs can reach patients faster than before. Data generated in these countries will be deemed acceptable. Firms introducing a drug in India that is approved in any of the six jurisdictions will only need to carry out the Phase IV clinical trial, which is a post-marketing trial that involves study of long-term effects of the drug. Despite India’s high disease burden, the country hosts only 1.2% of the world’s clinical trials—this means morbidity and mortality could be actually higher than in a scenario where the newest and most advanced drugs globally are available in the Indian market. The regulator can now choose to exempt orphan drugs—medicines treating conditions affecting less than 5 lakh Indians—from Phase III and IV clinical trails. The changes mandate that ethics committees reviewing clinical trials at universities must be registered with the Department of Health Research; earlier, these ethics committees were just rubber-stamp bodies. This way, the rights and the safety of the patients will be ensured.
The new rules also provide regulatory clarity. India, after tightening clinical trial regulations in 2013 following allegations of rampant ethics violations, relaxed some of the rules in 2015 after clinical trials in the country took a beating. But the relaxations were done in a piecemeal manner, and there was little clarity for the pharmaceutical industry. Given just 88 of the over 1,400 deaths among participants in clinical trials of drugs in India between 2015 and 2018 were trial related, choking off trials did more harm than good. Junking the upfront compensation clause—paid pending determination of whether the death/disability was trial related—was also much needed. It had a chilling effect on drug-makers, more so because the upfront compensation didn’t need to be refunded if the death/disability was eventually proved to be unrelated to the trial. That said, the government needs to calibrate the easing of the rules for patient safety.
Oral vaccines, Nature reports, may show varying levels of efficacy between populations in high-income nations and low-/middle-income nations. The government must review the relaxation for oral vaccines and other such drugs, if need be. The new rules also reduce the time for the Drugs Controller General of India (DCGI) to decide on clinical trial application from 180 days to 90 days for drugs developed outside India and to 30 days for “discovery, research and manufacture” in India. If the DCGI fails to communicate its decision for drugs discovered in India within the stipulated 30 days, the permission to conduct trials will be deemed to have been granted. This will no doubt encourage the clinical trial industry, but the government needs to ensure that this doesn’t become a route for corruption and doesn’t prioritise speed over drug-safety. While a review by commercial ethics boards has been allowed in the new Rules—this was restricted to bioequivalence trials before—which can make drug approval much faster, there is a need to ensure that the boards don’t sacrifice scrutiny for profits.