The findings indicated that the Drugs Controller General of India (DCGI) approved 33 drugs without any scientific evidence.
A group of doctors and activists, including Ranbaxy whistleblower Dinesh Thakur, have petitioned the ministry of health and family welfare to ensure greater transparency in regulation, especially over clinical trials, of the pharma industry. India recording over 2 million Covid-19 cases and over 40,000 deaths makes a strong case for urgent approval of pharmacological interventions. But, this can’t be done by junking required standards, risking lives and well-being. A 2012 parliamentary committee report on the functioning of the Central Drugs Standard Control Organization had highlighted serious lapses in India’s drug approval standards. The findings indicated that the Drugs Controller General of India (DCGI) approved 33 drugs without any scientific evidence. In some cases, despite these drugs being banned by foreign regulators, the Indian drug regulator approved sale in India. The Mahapatra committee, formed later to study the clinical trial process, reported more damning evidence of India’s poor drug-approval standards. For instance, in some cases, the DCGI never authenticated the results of clinical trials. Instead of appointing its own experts, the DCGI had asked the company to present expert testimony and gave approval based on that. Even though new rules for clinical trials have been in place since last year, things have hardly improved on the ground. Biocon’s itolizumab was approved without mandatory Phase III clinical trial. What’s worse is that the Phase II study was conducted on just 30 patients. Contrast this with the University of Oxford’s dexamethasone study having 2,100 test subjects in Phase III with 4,300 randomised control subjects, and Gilead’ s remdesivir trial with 397 patients, which was later expanded to 5,600. This could be an indicator of the inadequacy of India’s standards for drug approval. Moreover, while the findings of the dexamethasone and remdesivir trials were published in peer-reviewed journals, Biocon doesn’t seem to have published any such information on itolizumab so far. Even favipiravir and Coronil, it is alleged, have gotten approvals in similar fashion. In the case of favipiravir, the study involved 150 candidates.
The petitioners have suggested that clinical trial data be made public regardless of the success or failure of the trial. At present, while the Clinical Trials Registry of India lists ongoing and completed trials on its website, it does not disclose detailed results. Moreover, results of animal-trials are also not made public. Instead, the whole process, from approval to inspection, remains significantly non-transparent. Given how long the trial list could eventually get—India is also looking at indigenous vaccine candidates—the government would do well to make clinical trials more transparent at the earliest.