SC Slams Centre, DCGI Over Expired Liposomal Amphotericin B Emergency Approvals
New Delhi: The Supreme Court questioned the Union government and the Drug Controller General of India (DCGI) over an alleged delay of nearly five years in taking action against pharmaceutical companies accused of producing and selling Liposomal Amphotericin B using expired emergency permissions granted during the Covid-19 pandemic.
The court expressed concern that the critical antifungal medicine had allegedly remained on sale without the required clinical trials and regulatory oversight.
According to a recent media report by Hindustan Times, a bench comprising Justices Vikram Nath, Sandeep Mehta and Aparesh Kumar Singh demanded an explanation for the prolonged regulatory inaction.
“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, expressing dismay over the delay in proceeding against manufacturers allegedly relying on temporary pandemic-era authorisations.
The judges observed that the authorities had initiated action against the companies only earlier this year, following the Supreme Court’s intervention. “You woke up only in February 2026 and started issuing notices after this court gave you a nudge,” the bench remarked.
The hearing concerned a public interest litigation (PIL) brought by Rajendra Prasad, questioning the continued production and marketing of Liposomal Amphotericin B under emergency permissions issued during India’s devastating second Covid-19 wave in 2021. At the time, an acute shortage of the medicine had coincided with a surge in mucormycosis, commonly known as black fungus, a potentially fatal infection reported among Covid-19 patients.
To address the shortage and improve access to the antifungal drug, the government had invoked Section 26B of the Drugs and Cosmetics Act, 1940. The petitioner maintains that the resulting emergency permissions were limited in duration and could not authorise manufacturers to continue producing and marketing the medicine after those permissions expired.
Appearing for the petitioner, senior advocate S Muralidhar relied on the latest affidavit filed in the matter to highlight that several pharmaceutical companies had obtained emergency approvals, while effective follow-up by the regulatory authorities had allegedly been lacking. Senior advocate Amit Anand Tiwari, representing Sun Pharmaceutical Industries Ltd, submitted that the company had not been granted emergency approvals.
The court clarified that the scope of its forthcoming directions would extend beyond individual manufacturers to all companies falling within the relevant category. “Whatever directions we issue will apply across the board for every company that were granted emergency licenses without proper trials during the Covid,” the bench said before reserving its order.
Through the PIL, the petitioner has requested disclosure of the records concerning emergency manufacturing permissions issued to pharmaceutical companies under Section 26B of the Drugs and Cosmetics Act, 1940. The petition also seeks the cancellation of the licences or approvals concerned and directions prohibiting the companies covered by the plea from manufacturing, distributing and selling the drug.
The relief sought further includes recalling and seizing stocks already circulating in the market, followed by their destruction or disposal under appropriate safety protocols. The petitioner questions whether temporary relaxations introduced during an exceptional public-health crisis could lawfully support continued commercial production and sale after the emergency authorisations had lapsed, without the necessary regular clearances.
The authorities’ handling of the matter had also come under examination in an earlier Supreme Court order passed in April. In that order, the court recorded that show-cause notices were issued in February 2026 to companies that had failed to meet their licence conditions. Responses to those notices had been received, but decisions from the competent authorities were still awaited.
The bench had instructed the authorities to accelerate the proceedings and determine the show-cause notices within two months. It had also drawn a distinction between companies possessing regular manufacturing licences from before the pandemic and those operating under permissions originating from the emergency arrangements.
Cipla Ltd, Bharat Serums and Vaccines Ltd, BDR Pharmaceuticals International and Lifecare Innovations were subsequently deleted from the array of parties after the court was informed that their licences predated the pandemic and that no show-cause notices had been issued to them. However, Sun Pharma’s application to be removed from the case was declined because it had received a show-cause notice.
The proceedings also name Emcure Pharmaceuticals Ltd, Gufic Biosciences Ltd, Alembic Pharmaceuticals Ltd, Lyka Labs Ltd, Natco Pharma Ltd and Intas Pharmaceuticals Ltd.
HT reports that, the PIL, represented by advocate-on-record Tushar Giri, seeks to hold the Centre and the drug regulator accountable for the alleged continuation of manufacturing and sales under expired emergency authorisations. With the Supreme Court having reserved its order, the requests for cancellation of licences, stoppage of manufacture and sale, and recall and disposal of stocks remain reliefs sought by the petitioner.
