‘Were officers sleeping?’ SC raps Centre, drug regulator over expired Covid-era approvals

The Supreme Court criticised the Centre and the Drug Controller General of India for failing to act promptly against companies allegedly manufacturing and selling Liposomal Amphotericin B under expired emergency permissions. The court was concerned that the drug was sold without clinical trials and other regulatory requirements.

The bench said authorities acted only in February 2026, after the court intervened. It questioned what regulatory officers had been doing for five years while the alleged sales continued. Show-cause notices were issued, but decisions on companies’ replies were still pending.

The court also stressed that any directions would apply to every company granted emergency Covid-era permissions without proper trials, not just the manufacturers named in the case. It later directed authorities to decide the notices within two months. The court reserved its order, so the final consequences were not yet stated.

Liposomal Amphotericin B is a formulation of amphotericin B, an antifungal medicine used to treat serious fungal infections. The article identifies it as a critical drug whose availability became a major public-health concern during India’s second Covid-19 wave.

In 2021, India faced an acute shortage while mucormycosis, commonly called black fungus, was being reported among Covid-19 patients. The infection could be potentially life-threatening, so the government used emergency permissions to help make more of the medicine available. This created a rapid-access route during an exceptional crisis.

The dispute concerns what happened after that emergency period. The petitioner argues that companies could not keep manufacturing and marketing the drug using permissions that had lapsed. The Supreme Court is examining whether those temporary approvals were followed by regular clearances, clinical trials and continuing regulatory oversight.

The most striking timeline is the five-year gap highlighted by the Supreme Court. The bench asked what officials had been doing while the drug was allegedly sold without clinical trials and other regulatory requirements. It said authorities woke up only in February 2026, after the court gave them a nudge.

The proceedings involve several pharmaceutical companies that received emergency manufacturing permissions during the 2021 crisis. The article names Cipla, Bharat Serums and Vaccines, BDR Pharmaceuticals International and Lifecare Innovations among the companies named in the proceedings. Sun Pharmaceutical Industries also appeared through counsel, who said it had not received emergency approvals.

The article does not state the exact number of companies involved. It says the court’s eventual directions would apply across the board to every company granted emergency Covid-era licences without proper trials. That means the final impact could extend beyond the manufacturers specifically named in the petition.

Emergency manufacturing permissions were granted because India faced a severe shortage of Liposomal Amphotericin B during the second Covid-19 wave. The medicine was urgently needed as mucormycosis, or black fungus, was reported among Covid-19 patients. Section 26B was invoked to facilitate its availability.

These permissions addressed an extraordinary public-health emergency. They allowed companies to respond quickly while normal regulatory processes were being questioned in the litigation. The petitioner argues that such permissions were intended to be temporary and could not automatically support continued manufacture and sale after the emergency arrangements ended.

After the emergency permissions expired, companies allegedly needed requisite regular clearances and valid manufacturing licences. The Supreme Court distinguished companies that already had regular licences from those relying on emergency arrangements. The central issue is whether temporary pandemic permissions remained legally effective for commercial production once their conditions or validity period ended.

If companies are found to have sold Liposomal Amphotericin B without valid approvals, the drug stocks already in the market could face withdrawal. The PIL asks authorities to stop manufacture, distribution and sale by the companies concerned, then recall and seize existing stocks.

The plea also seeks destruction or disposal of those stocks under appropriate safety protocols. These measures would remove products whose approval status, manufacturing conditions or regulatory basis is disputed. They are intended to prevent continued circulation while authorities determine whether the companies complied with legal requirements.

The article does not say that the Supreme Court has already ordered a recall, seizure or destruction. Those are requests made in the PIL. The bench reserved its order after directing authorities to expedite decisions on show-cause notices. Any final action will depend on those regulatory decisions and the court’s eventual directions.

Medicines normally need clinical trials because laboratory promise alone cannot show how well a treatment works or what risks it creates in people. Trials provide evidence about benefits, side effects, dosage and appropriate use. This matters especially for drugs given to seriously ill patients.

Regular manufacturing licences address a different concern. They allow regulators to check whether a company, facility and process can consistently produce medicine to required standards. Continuing oversight can detect quality problems, changing risks, misleading claims or departures from approved conditions after sale begins.

The article highlights these safeguards because the companies allegedly continued selling Liposomal Amphotericin B under expired emergency permissions without clinical trials and other requirements. Emergency access can be vital during a crisis, but it does not automatically replace ordinary evidence and controls forever. Once the emergency basis ends, regulators must verify regular clearances and lawful manufacturing arrangements.

Section 26B of the Drugs and Cosmetics Act was invoked during the 2021 crisis to facilitate the availability of Liposomal Amphotericin B. In general terms, the provision gives the Central Government power to regulate, restrict or prohibit manufacture, sale or distribution of drugs in the public interest. The article focuses on its emergency use.

That power can help respond quickly when a critical medicine is scarce. But emergency permission should remain tied to the crisis and its conditions. Regulators should record which companies are covered, monitor production and quality, and require manufacturers to obtain regular clearances if commercial supply continues.

The case shows the danger of weak follow-up. The petitioner says temporary permissions continued after expiry, while the Supreme Court criticised the delayed regulatory response. A balanced approach would preserve rapid access during a health emergency, then promptly review safety, evidence, licensing and remaining stocks before allowing continued sale.