Law & Justice

Supreme Court Criticises Government for Delayed Action on Expired Covid‑Era Drug Approvals

By Utkarsh Anand

The Supreme Court on Tuesday criticised the Union government and the Drug Controller General of India (DCGI) for failing to act against pharmaceutical companies that allegedly continued to manufacture and sell the antifungal drug Liposomal Amphotericin B under temporary Covid‑era approvals that had expired. The bench, consisting of Justices Vikram Nath, Sandeep Mehta and Aparesh Kumar Singh, asked the government what its officers had been doing for five years while the drug was being sold without clinical trials or regulatory oversight. "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 justices asked.

The court noted that the government had only begun to issue notices in February 2026 after the Supreme Court had intervened, and observed that the authorities had "woken up only in February 2026 and started issuing notices after this court gave you a nudge." The reprimand came during the hearing of a public interest litigation (PIL) filed by Rajendra Prasad, which challenges the continuation of manufacturing and sale of Liposomal Amphotericin B under emergency permissions granted during the severe shortage of the drug in the second Covid‑19 wave in 2021.

Senior advocate S. Muralidhar, appearing for the petitioner, referred to the latest affidavit filed in the case to show that emergency approvals had been granted to several companies but that there had been no effective follow‑up by regulatory authorities. Senior advocate Amit Anand Tiwari, appearing for Sun Pharmaceutical Industries Ltd, told the court that the company had not been granted emergency approvals. The bench clarified that any directions issued would apply across the board to every company that had been granted emergency licences without proper trials during the Covid‑19 pandemic.

The PIL seeks the production of records relating to the emergency manufacturing permissions granted under Section 26B of the Drugs and Cosmetics Act, 1940, and the quashing of such licences or approvals. It also seeks directions to stop the manufacture, distribution and sale of the drug by the companies concerned, to recall and seize stocks already in the market, and to dispose of them in accordance with appropriate safety protocols. The petition questions whether temporary regulatory relaxations granted to address an extraordinary public‑health emergency can continue to serve as the basis for commercial production and sale after the emergency permissions have expired.

In an earlier order in April, the Supreme Court noted that show‑cause notices had been issued in February 2026 to companies that had not complied with the conditions of their licences. The notices had elicited replies, which were awaiting decisions by the competent authorities. The bench directed the authorities to expedite the process and decide the show‑cause notices within two months. The court distinguished between companies that had obtained regular manufacturing licences before the pandemic and those whose permissions arose from the emergency arrangements.

Companies named in the proceedings include Cipla Ltd, Bharat Serums and Vaccines Ltd, BDR Pharmaceuticals International and Lifecare Innovations, which were removed from the list of parties after it was pointed out that they held licences predating the pandemic and faced no show‑cause notices. Sun Pharma’s plea to be removed from the case was rejected because a show‑cause notice had been issued to it. Other companies named in the proceedings include Emcure Pharmaceuticals Ltd, Gufic Biosciences Ltd, Alembic Pharmaceuticals Ltd, Lyka Labs Ltd, Natco Pharma Ltd and Intas Pharmaceuticals Ltd.

The PIL, represented by advocate‑on‑record Tushar Giri, seeks accountability from the Centre and the drug regulator over the alleged continuation of manufacturing and sale under expired emergency permissions.