Supreme Court censures Centre over lapsed Covid-era antifungal drug approvals

The Supreme Court of India on Tuesday expressed dismay at the continued regulatory inaction regarding pharmaceutical companies that have allegedly continued operations under expired Covid-era temporary approvals for an antifungal drug. The bench noted with concern the extended delays in initiating formal regulatory action against the firms in question, questioning the responsiveness of both the central government and the drugs regulator in addressing the matter.

The court's intervention highlights gaps in post-pandemic regulatory oversight, particularly regarding medications granted emergency approvals during the health crisis. Companies were permitted to manufacture and distribute certain drugs under time-bound temporary authorisations as containment measures, but these permissions were meant to expire once normal regulatory procedures resumed.

The apex court's criticism underscores growing judicial scrutiny of pharmaceutical regulation in India. The bench suggested that prolonged use of lapsed emergency provisions undermines the regulatory framework and poses potential risks to consumers who may be purchasing medications that lack current formal approval status.

The case reflects broader concerns about ensuring that temporary pandemic-era flexibilities do not become permanent workarounds for regulatory compliance. The court has directed authorities to expedite action and submit compliance reports, signalling its intent to enforce timely adherence to regulatory timelines in the pharmaceutical sector.