Why is the Supreme Court questioning Covid-era drug approvals?

The Supreme Court questioned the Centre and DCGI over expired emergency permissions for an antifungal drug. The case tests whether crisis-era drug approvals can continue after a public health emergency.The Supreme Court on Tuesday came down heavily on the Centre and the Drug Controller General of India (DCGI) over the alleged continued manufacture and sale of a critical antifungal drug under emergency permissions granted during the COVID-19 pandemic.The question before it was a basic one: can temporary approvals issued in a health crisis keep supporting commercial sales after they expire, when manufacturers have not met the regular regulatory conditions?The Court was troubled by the delay as much as the lapse. Regulators allegedly took years to act while the drug stayed on the market. The episode tests whether emergency relaxations are being allowed to stand in for regular scrutiny.The drug is liposomal amphotericin B, an injectable antifungal used for serious infections, including mucormycosis, commonly called black fungus. A CRISIS-ERA RELAXATIONIn the country’s devastating second COVID-19 wave in 2021, mucormycosis emerged as a serious complication, particularly among patients with diabetes or other risk factors. Cases surged, the drugs ran short, and the government came under pressure to raise supplies quickly.The Centre invoked Section 26B of the Drugs and Cosmetics Act, 1940, to make the medicine available through emergency permissions meant for an extraordinary situation. The dispute concerns companies allegedly continuing to make and sell the drugs on those permissions after they expired, without regular clearances or compliance with the applicable requirements.A public interest litigation (PIL) by Rajendra Prasad challenged the practice. It sought records of the emergency permissions, cancellation of the authorisations, a halt to manufacture and sale, and the recall and safe disposal of stocks in the market.DCGI UNDER FIREAt the 27 October hearing, a bench of Justices Vikram Nath, Sandeep Mehta and Aparesh Kumar Singh asked what officers had been doing for five years while the drug was allegedly sold on expired permissions. The judges asked whether officials had been sleeping or whether their palms had been greased.The bench noted that show-cause notices to non-compliant companies were issued only in February 2026, after the court intervened. The companies replied, but the matter stayed pending before the competent authorities.In April this year, the Court directed officials to decide the notices within two months.The DCGI heads India’s central drug regulatory system under the Central Drugs Standard Control Organisation (CDSCO).It oversees specified categories of drugs, including new drugs and clinical trials, while manufacturing licences and enforcement are shared with state drug authorities. The question before the Court was whether the system monitored the conditions attached to the emergency permissions, tracked their expiry, and ensured companies obtained approvals to continue.The difference between an emergency permission and a regular manufacturing licence was also noted.A relaxation granted to tackle a shortage cannot automatically become permanent authorisation, but – at the same time- selling a drug that entered through the emergency route does not make every seller a violator.Each manufacturer’s licence status has to be examined separately.Accordingly, the Court removed Cipla, Bharat Serums and Vaccines, BDR Pharmaceuticals International and Lifecare Innovations from the list of parties, since they held licences predating the pandemic and had received no show-cause notices.It rejected Sun Pharma's request for removal because a notice had been issued to it. Other companies named in the proceedings include Emcure Pharmaceuticals, Gufic Biosciences, Alembic Pharmaceuticals, Lyka Labs, Natco Pharmaceuticals and Intas Pharmaceuticals.NEXT STEPS NOWThe Court has reserved its order and said any directions will apply across the board to companies granted emergency licences without the requisite trials during COVID-19. The outcome could therefore reach beyond the manufacturers named in the case.The court has not ordered a blanket withdrawal of the drug, and it has not made a final finding on the legality of every company’s manufacture and sales.Experts underlined that the case has spotlighted the need for the country to move from emergency authorisation to routine oversight.“In a crisis, speed can prevent deaths. Once the emergency passes, regulators need to close out the relaxation: set an end date, check compliance and move manufacturers onto regular licences,” said a pharmacologist who has been with the CDSCO previously.- Ends