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Wednesday, July 6, 2022

Home-made Molnupiravir antiviral drug likely to be approved for use

The Saigon Times

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HCMC – The Advisory Council for the Registration of Circulation of Drugs and Medicinal Ingredients under the Ministry of Health has proposed the ministry approve three locally produced Covid-19 antiviral drugs that contain the Molnupiravir active substance.

The proposal was made after the council considered approving the use of drugs containing the Molnupiravir active substance produced by a local drugmaker at a session on January 5.

The session took place after the National Assembly Standing Committee issued a resolution allowing implementing some Covid-19 response policies on December 30 last year, including approving new locally-produced drugs for Covid treatment.

These drugs must contain the same active substance or ingredient as those approved for use by the Stringent Regulatory Authorities (SRA).

The council carefully considered appraisals from experts on quality and clinical pharmacology, according to the ministry.

The council also presented some requirements for drugmakers to monitor the quality of the drugs after they are approved for use. Accordingly, producers must check the quality of ingredients before mass manufacturing the products.

In addition, the drugmakers must check the quality of the drugs each month, report their quality and shelf-life to the competent agencies and continue to study the stability of the drugs.

As for drugs that have yet to be approved for use, the council asked producers to continue supplementing relevant documents and submitting the results of the study on the quality and stability of the drugs.

The ministry also ordered the competent agencies to closely monitor the quality of the Covid antiviral and prices of these drugs in line with the Law on Pharmacy, the local media reported.

As of January 5, the Ministry of Health had allocated over 300,000 doses of Molnupiravir for the pilot program to treat Covid patients with mild symptoms. As many as 51 provinces and cities have participated in the program.

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