Ongoing Sale of Covid-Era Liposomal Amphotericin B Challenged, SC Seeks Response from Top Pharma Firms, DCGI
New Delhi: The Supreme Court has sought responses from the Union of India, the Drug Controller General of India (DCGI), and several leading pharmaceutical companies, including Bharat Serum and Vaccines, Cipla, Sun Pharma, Emcure, and Natco Pharma, on a public interest litigation questioning the continued manufacture and sale of Liposomal Amphotericin B, a drug originally cleared for emergency use during the Covid-19 pandemic.
According to a LiveLaw report, a Bench of Justices Vikram Nath and Sandeep Mehta on Friday issued notice to the Centre on the plea, which also calls for the destruction of existing stocks of the drug, citing expired authorizations and potential safety risks.
A Bench of Justices Vikram Nath and Sandeep Mehta sought responses from the Union of India, the Drug Controller General of India (DCGI), and several pharmaceutical companies, including Bharat Serum and Vaccines Ltd., Cipla, Sun Pharma, Emcure, and Natco Pharma, among others.
The PIL, filed by Rajendra Prasad through Advocate-on-Record Tushar Giri, alleges that these companies continue to manufacture and distribute the antifungal medication on the strength of emergency approvals granted under Section 26B of the Drugs and Cosmetics Act, 1940, during the height of the Covid-19 crisis in 2021.
The petitioner claims that the authorizations have long expired and that there is currently “no regulatory oversight” ensuring the drug’s quality or safety.
The plea seeks multiple directions, including production of records related to the emergency approvals, quashing of all manufacturing permissions, and an immediate halt to production, sale, and distribution of Liposomal Amphotericin B by the respondent firms.
It also urges the Court to direct the Union government to recall, seize, and safely destroy existing stocks of the drug as per prescribed safety protocols.
