Anti-Covid drug manufacturers move to CDSCO for permission

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NEW DELHI: Hopes have risen for the approval of the first Covid-19 antiviral drug in India with two drug makers reaching the regulator, the Central Drugs Standard Control Organisation (CDSCO), with phase 3 clinical trial data of molnupiravir and seeking marketing authorisation for the pill.

Being called very promising in treating the coronavirus infection, the drug reportedly clears viral infection in about five days in mainly mild cases, preventing many people from progressing to a severe disease state.

“The Indian companies have submitted data from the phase 3 clinical trials of the drug and the subject expert committee on Covid19 is soon going to consider their applications,” a senior CDSCO official told this newspaper.

In India, five companies had entered into voluntary licensing agreements to produce generic versions of this drug.

The antiviral drug is also being evaluated by the USFDA for its effectiveness and safety and an advisory committee of the USFDA is set to meet next month to take up Merck and Ridgeback’s request for granting emergency use authorization for molnupiravir to treat mild to moderate Covid-19.

Merck, the original US-based developer of the oral broad spectrum antiviral drug, had reported this month that the drug halved the rate of hospitalizations and deaths in high-risk Covid patients who took it soon after infection in a large clinical trial.

Molnupiravir, like remdesivir, is a nucleoside analogue, which means it mimics some of the building blocks of RNA.

This antiviral gets incorporated into burgeoning RNA strands and, once inside, starts killing the virus.

Last month, the two drug makers independently testing generic molnupiravir in India, Natco Pharma and Hetero, in people with moderate Covid illness, however, had said they saw no “significant efficacy” for the experimental drug though they went ahead with the trials in people with mild illness.

But this, say virologists, is on expected lines as the sicker the patient, the less effective the drugs are at treating the illness.

“A pill would simply require a prescription. It will be a game changer as it will prevent people from landing up in hospitals,” said a virologist with the Indian Council of Medical Research (ICMR)

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