The Supreme Court on Tuesday came down hard on the Union government and the Drug Controller General of India (DCGI) for failing to act against pharmaceutical companies allegedly manufacturing and selling critical antifungal drug Liposomal Amphotericin B under expired emergency authorisations granted during the Covid-19 pandemic, asking what regulatory officials had been doing for five years while the drug was being sold without clinical trials and regulatory oversight.
During the 2021 crisis, the government invoked Section 26B to facilitate the availability of Liposomal Amphotericin B amid an acute shortage of the drug. In an order passed in April, the Supreme Court noted that show-cause notices had been issued in February 2026 to companies found not to have complied with the conditions of their licences. “What were your officers doing for five years when these drugs were being sold without clinical trials and other regulatory requirements? Were they sleeping or were their hands greased?” a bench of justices Vikram Nath, Sandeep Mehta and Aparesh Kumar Singh asked the government, expressing dismay over the delay in initiating regulatory action against companies accused of continuing to rely on temporary pandemic-era permissions. The bench, however, made it clear that any directions issued by it would not be confined to individual manufacturers. The petitioner has argued that the emergency permissions were intended to be temporary and that companies could not continue manufacturing and marketing the drug on the strength of lapsed authorisations. The proceedings have also brought the government’s delayed response under scrutiny. The notices had elicited replies, which were awaiting decisions by the competent authorities. The PIL, represented by advocate-on-record Tushar Giri, has sought accountability from the Centre and the drug regulator over the alleged continuation of manufacturing and sale under expired emergency permissions.
“You woke up only in February 2026 and started issuing notices after this court gave you a nudge,” it observed. “Whatever directions we issue will apply across the board for every company that were granted emergency licenses without proper trials during the Covid,” said the bench while reserving its order.
The bench pointed out that the government had moved against the companies only earlier this year after the Supreme Court intervened in the matter.
