The Supreme Court Thursday sought the Centre's reply on a plea alleging that two medicines Remdesivir and Favipiravir, are being used for treatment of COVID-19 without approval. A bench headed by Chief Justice S A Bobde issued notice to the Centre on the plea and sought its response in four weeks.
Advocate M L Sharma petitioner in-person referred to the bench, also comprising Justices A S Bopanna and V Ramasubramanian, the World Health Organization (WHO) report of October 15 and said that nowhere these medicines are designated officially as medicines for coronavirus. The bench said it is only going to make the central government aware of it and therefore issuing notice.
On September 16, the top court had said that 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 registration of an FIR by the CBI against ten 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 have been permitted by the government for using in treatment of novel coronavirus patients.
Seeking CBI probe, Sharma had filed the PIL alleging that these two medicines have 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 that these medicines have not been certified as medicines for COVID-19 till date by any country. "They are under trial and no country, including India, has issued 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 Ltd, Hetero Labs Ltd and Zydus Cadila Healthcare Ltd as parties.
Stressing that there were no effective medicines for the pandemic, the plea said, "The Prime Minister have already initiated process with Russia to import COVID-19 vaccine to manufacture/distribute in India through PSU Bharat Immunologicals and Biologicals Corporation Limited (BIBCOL)."