Supreme Court chastises Indian government for letting expired Covid-era antifungal approvals linger

In a sharp rebuke, a three-judge Supreme Court bench asked the Union government and the Drug Controller General of India what they had done for five years while Liposomal Amphotericin B was sold without required trials. The hearing stemmed from a public-interest litigation by Rajendra Prasad, which points to emergency authorisations issued under Section 26B during the 2021 black-fungus surge that have since expired. Senior counsel S Muralidhar cited affidavits showing multiple manufacturers continued production, while Sun Pharma’s lawyer denied receiving any emergency licence.

The court observed that the government only began issuing show-cause notices in February 2026 after judicial prompting and warned that any directives will cover all companies that used the lapsed permissions. The petition seeks cancellation of the licences, seizure of existing stocks and destruction of the drug, arguing that temporary pandemic relaxations cannot justify ongoing commercial sales. The bench reserved its order pending further submissions.