New Delhi: The Supreme Court on October 27 sharply questioned the Centre and the Drugs Controller General of India (DCGI) over why action took about five years against companies accused of making and selling liposomal amphotericin B — the drug used to treat mucormycosis, or black fungus — on emergency permissions granted during Covid-19 that have since lapsed. A bench of Justices Vikram Nath, Sandeep Mehta and Aparesh Kumar Singh reserved its order on the public interest litigation.

Source: Hindustan Times, via NewsPlainly

"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?" the bench asked the government, as quoted by Hindustan Times. These were remarks made during the hearing, not findings in an order. The bench also said the government had moved only after the court stepped in: "You woke up only in February 2026 and started issuing notices after this court gave you a nudge," it said, according to the same report. The news agency ANI's report of the hearing gives the same account.

Source: ANI, via NewsPlainly

What the PIL alleges

The PIL, filed by Rajendra Prasad through advocate-on-record Tushar Giri, alleges — this is the petitioner's allegation, not a court finding — that several companies kept manufacturing and selling the drug on emergency approvals given under Section 26B of the Drugs and Cosmetics Act, 1940, after those approvals expired, without getting regular approvals. Section 26B lets the Centre, by a Gazette notification, regulate or restrict a drug it considers essential to meet an emergency caused by an epidemic or natural disaster. The petition asks the court to call for the records of the emergency permissions, quash them, halt production and sale, and have existing stocks recalled, seized and destroyed under safety rules. The court has not granted any of this yet.

Liposomal amphotericin B became critical in May 2021, when black fungus cases surged during Covid's second wave and the drug was in short supply. Business Today reported at the time that five more companies — Natco, Alembic, Gufic, Lyka and Emcure — were licensed to start making it, with imports planned to fill the gap.

27 October 2026Date of the hearing at which the bench reserved its order
February 2026When show-cause notices were issued to companies, as recorded in the court's April 2026 order
2021Year the Section 26B emergency permissions were granted during the second Covid wave

Which companies are in the case

Hindustan Times reported that Sun Pharmaceutical Industries, Emcure, Gufic Biosciences, Alembic, Lyka Labs, Natco Pharma and Intas are in the proceedings. Sun Pharma told the court on October 27 that it had not been granted emergency approvals; the court declined its request to be removed from the case because a show-cause notice had been issued to it. Cipla, Bharat Serums and Vaccines, BDR Pharmaceuticals International and Lifecare Innovations were removed as parties after it was shown their licences predated the pandemic and they had received no show-cause notice. Being named in the case does not mean a company has been found to have broken any rule — the court has not ruled.

Source: Health and Family (court proceedings summary)

What happens next

The bench said its directions would apply "across the board" to every company that got emergency licences during Covid, not only those named in the case, Hindustan Times reported. With the order reserved, the next step is the bench's written order; the reports read do not say when it will come. No order so far stops the sale of the drug, and the case record as reported does not allege that the medicine itself is contaminated or sub-potent — the dispute is over licensing and regulatory follow-up. (Sources: Hindustan Times and ANI reports of the October 27 hearing, via NewsPlainly; Health and Family; Inshorts)

Source: Inshorts (ANI/HT hearing report)