Molnupiravir, the first oral anti-Covid drug, has major safety concerns, said the head of the Indian Council of Medical Research (ICMR) on Wednesday. The pill was approved for emergency use in the country by the Drugs Controller General of India (DCGI) in the last week of December.
Thirteen Indian pharmaceutical companies, including Cipla, Sun Pharma and Dr Reddy’s Laboratories, are manufacturing the drug, which is being developed by US-based biotechnology company Ridgeback Biotherapeutics in collaboration with American pharma giant Merck. The anti-viral, hailed by many as a “game changer”, introduces errors into the coronavirus’s genetic code, which prevents it from further replicating.
In a weekly press briefing, ICMR director-general Dr Balram Bhargava said that the drug can cause teratogenicity and mutagenicity.
Teratogenicity means the capability of a medicine to cause foetal abnormalities or disturb the formation of foetus or an embryo when taken by pregnant women, consciously or unconsciously. Mutagenicity means causing permanent changes in the genetic materials.
“Contraception has to be maintained for 3 months after taking the medicine, both for males and females. The child born with the influence of a teratogenic drug can be problematic. The drug can also cause damage to muscles and cartilage,” Bhargava added.
Cartilage is the slippery gel-like substance that coats our bones to help them in smooth movement without causing any friction resulting in acute pain.
“These are the reasons the drug is not yet included in the national treatment protocol. In fact, the World Health Organization and the United Kingdom have also not included it in national treatment guidelines, as of now. The US has approved the drug on the data of 1,433 patients showing 3% decrease in mild to moderate disease,” said the ICMR chief.
Bhargava clarified that while the panel has debated over the use of drugs twice and discussions continue, “we have concerns about the drug and its use during lactation, in children, soft-tissue injuries, reproductive age group”. He added that “we will debate on any possibility (over its inclusion in national treatment guidelines)”.
The DCGI has cleared the drug on thirteen conditions including the clause that the companies will conduct a post-marketing surveillance (PMS) study on the first 1,000 patients to assess the safety of the pill. It means all 13 companies will generate additional data on 13,000 people.
It also includes the condition that the drug cannot be authorised for use in patients less than 18 years of age or pregnant women. It also cautions the male and female of reproductive potential to use reliable methods of contraception during and after three months of treatment of molnupiravir.
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