Plea In Supreme Court To Stop Sale Of “Liposomal Amphotericin B” Medicine Made Using Emergency Approval Granted During Covid Time

The Supreme Court today issued notice on a public interest litigation seeking quashing of approvals or licenses granted for manufacturing of 'Liposomal Amphotericin B' for emergency use during the Covid-19 pandemic.

The PIL, filed by one Rajendra Prasad, also seeks stoppage of distribution and destruction of existing stock of the said medication, in accordance with appropriate safety protocols. 

A bench of Justices Vikram Nath and Sandeep Mehta passed the order, calling for the response of the Union of India, the Drug Controller General of India and pharmaceutical companies including Bharat Serum and Vaccines Ltd., Cipla, Sun Pharma, Emcure, NATCO Pharma, etc.

As per the petitioner, the medication continues to be manufactured by the respondent-companies on expired emergency authorizations which were granted in 2021 at the time of Covid-19 outbreak. There is no regulatory oversight in place, the petitioner claims.

The specific reliefs sought are as follows:

- Direction to Union of India and DCGI to produce the records pertaining to approval/licensing granted to various manufacturers including respondent-companies to manufacture Liposomal Amphotericin B under Section 26B of the Drugs and Cosmetics Act in case of emergency;

- Quashing of the manufacturing license/permissions/approvals granted to respondent-companies under Section 26B;

- Stoppage of manufacturing, distribution and sale of Liposomal Amphotericin B by the respondent-companies.

- Direction to Union of India to recall and seize the stocks of Liposomal Amphotericin B manufactured by the respondent-companies from the market and destruction/disposal of the stock in accordance with the appropriate safety protocols. 

The petition has been filed through AoR Tushar Giri.

Case Title: RAJENDRA PRASAD Versus UNION OF INDIA AND ORS., W.P.(C) No. 953/2025