As Indian regulators endorse controversial treatments for Covid-19, a group of high-profile physicians and activists is urging the government to bolster transparency surrounding all drug approvals, the release of clinical trial data, and licenses issued for pharmaceutical manufacturing.
Critics have long complained that Indian government oversight of its pharmaceutical industry is lax, but the issue has intensified in recent weeks over approvals for certain medicines to combat the new coronavirus. In one instance, a drug already used to treat psoriasis was granted emergency use for Covid-19 based on a mid-stage study of just 30 patients; late-stage study requirements were waived.
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If I recall, there was a small randomized study for Favipiravir, but I could be mistaken. To me, the big question, is “why has there not been a large randomized clinical study on Favipiravir? The drug is easy to manufacture. True, there are possible (probably?) teratogenic side effects and it would require a REMS, but why so few studies? The US is barely doing any research on Favi. It seems that it was prematurely approved in India, Russia, China, and a few other countries, based on small data. If it has promise, why are we ignoring Favi?