SC seeks Centre’s reply on plea alleging no approval for Remdesivir, Favipiravir to treat COVID-19

New Delhi, October 29

The Supreme Court on Thursday sought response from the Centre on a plea alleging that two medicines, Remdesivir and Favipiravir, are being used for the treatment of COVID-19 without approval.

A bench headed by Chief Justice SA Bobde issued notice to the Centre on the plea and sought its response in four weeks.

Advocate ML Sharma, petitioner in-person, referred to the Bench — also comprising Justices AS Bopanna and V Ramasubramanian — the World Health Organisation (WHO) report of October 15 and said nowhere these medicines were designated officially as medicines for coronavirus.

The bench said it was only going to make the Central Government aware of it and, therefore, was issuing a notice.

On September 16, the top court had said there was an approval by the Central Government on use of Remdesivir and Favipiravir as medicines to treat COVID-19.

The top court was hearing a plea seeking the registration of an FIR by the CBI against 10 Indian pharmaceutical firms for manufacturing and selling these two medicines for treating COVID-19 patients allegedly without valid licences.

Remdesivir and Favipiravir are antiviral drugs and their efficacy in treating COVID-19 patients has been a matter of debate among medical experts

On September 16, the top court had referred to the New Drugs and Clinical Trials Rules, 2018, and said these medicines had been permitted by the government for the treatment of novel coronavirus patients.

Seeking a CBI probe, Sharma had filed the PIL alleging that these two medicines had been wrongly manufactured and sold for treating COVID-19 patients without any valid licences from the Central Drugs Standard Control Organisation.

Sharma has sought prosecution of the Indian companies for offences of cheating and criminal conspiracy besides under the provisions of the Drug Act, 1940.

The PIL said these medicines had not been certified as medicines for COVID-19 to date by any country.

“They are under trial and no country, including India, has issued a licence to manufacture and sell them in the country…,” it said.

The companies are manufacturing and selling them at very high rates in India and people are paying that “due to the fear of COVID-19 infection” and are dying, it said.

More than 300 doctors have died in hospitals where these two medicines have been supplied and it amounted to “exploitation of public” due to the fear of death.

Remdesivir was introduced by Gilead Science Inc USA to treat Ebola Virus in Africa but it was not effective to treat Ebola virus as well, it said. Favipiravir was developed by Fujifilm Toyama Chemical and was actually approved to treat Influenza.

The PIL has made the Ministry of Health and Family Welfare and the Central Drugs Standard Control Organisation as parties.

It has also made 10 pharmaceutical companies including Cipla Ltd, Dr Reddy’s Laboratories Limited, Hetero Labs Limited and Zydus Cadila Healthcare Limited as parties.

Stressing that there were no effective medicines for the pandemic, the plea said: “The Prime Minister has already initiated the process with Russia to import COVID-19 vaccine to manufacture and distribute in India through PSU Bharat Immunologicals and Biologicals Corporation Limited (BIBCOL).” PTI