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Molnupiravir awaits NMRA approval despite Covid Committee green light

BY Buddhika Samaraweera

Even though Sri Lanka’s Covid-19 Technical Committee has granted approval for the use of the oral antiviral pill “Molnupiravir” no decision has yet been taken as to when and to whom it will be given in Sri Lanka, as National Medicines Regulatory Authority (NMRA) approval is pending.

“Nothing has been decided yet. Although certain committees may give their approval for the use of this, in the end, it should receive the NMRA’s approval. Either the NMRA should give permission for the emergency use of this medication without registration, or the NMRA should register it and give full clearance. Only then can this be used,” Ministry of Health Director of Communications and Deputy Director General of Public Health Services (DDGPHS) Dr. Hemantha Herath told The Morning yesterday (16).

He said this responding to The Morning’s query as to whether the Health Ministry had decided on a timeframe during which the said medication was expected to be given and the groups that would initially receive it.

Molnupiravir is an antiviral medication that inhibits the replication of certain RNA viruses and is used to treat Covid-19. Sri Lanka’s Covid-19 Technical Committee recently granted approval for the use of Molnupiravir, making it the first oral antiviral medication to be approved for the treatment of Covid-19 in Sri Lanka.

Dr. Herath also said that a final decision on the matter would be made after a lengthy process, adding that further evaluations were needed.

“This will take some more time. Especially if this is used in other countries, studies should be conducted to know the pros and cons of it. Otherwise, who is responsible if it is given all at once and side effects occur?” he questioned.

Meanwhile, when queried as to whether there are any plans to import this medication any time soon, State Ministry of Production, Supply, and Regulation of Pharmaceuticals Secretary Dr. S.K. Rathnayake said that no such plans are there as of now.

“The Covid-19 Technical Committee’s approval has been given for the use of this (Molnupiravir antiviral medication). The relevant process should be carried out and then we will take steps to import this, if necessary,” he added.

Developed by Ridgeback Biotherapeutics and Merck Sharp and Dohme Corporation, Molnupiravir works by interfering with the virus’s replication. This prevents it from multiplying, keeping virus levels low in the body and therefore reducing the severity of the disease. Based on clinical trial data, it is most effective when taken during the early stages of infection and therefore has been recommended for use as soon as possible, following a positive Covid-19 test and within five days of the onset of symptoms.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) had authorised Molnupiravir for use in people who have mild to moderate Covid-19 and at least one risk factor for developing severe Illness, such as obesity, old age, diabetes mellitus, or heart disease.