The Supreme Court on Wednesday said there was an approval by the Central government on use of Remdesivir and Fabiparivir 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 have been a matter of debate among medical experts.
A bench comprising Chief Justice S A Bobde and Justices A S Bopanna and V Ramasubramanian 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.
"You have not noticed this rule (New Drugs and Clinical Trials Rules) and filed this petition. We are adjourning this matter, you see the rules and then come back," the bench told lawyer M Sharma who has filed the PIL.
Adjourning the hearing by two weeks, the bench said, "There is approval by the Government of India for Remdesivir and Fabiparivir".
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.
"That respondent no.3 to 10 are Indian pharmaceutical company who have signed partnership agreements with foreign companies that are Gilead Science Inc -USA and Fujifilm Japan, to manufacture and sale impugned drug, Remdesivir and Avagin (Favipiravir) in India. Without having a licence, the are manufacturing and selling impugned drugs as a medicine for corona in India," the PIL alleged.
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, have issued licence to manufacture and sale 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).