At a press briefing on Tuesday afternoon, DGDA Director General Maj Gen Mahbubur Rahman said that the DGDA gave authorization to Beximco and Eskayef while eight others were waiting. COURTESY
The Directorate General of Drug Administration (DGDA) has granted Beximco, Square, Eskayef and Renata pharmaceutical companies approval for the production and marketing of molnupiravir, the first-ever Covid-19 pill developed by US drugmaker Merck & Co Inc and Ridgeback Biotherapeutics.
The US-based companies have jointly produced the experimental oral antiviral drug, which was originally developed to treat flu. The drug cuts the risk of hospitalization or death from Covid-19 by about half.
At a press briefing on Tuesday afternoon, DGDA Director General Maj Gen Mahbubur Rahman said that the DGDA gave authorization to Beximco and Eskayef while eight others were waiting.
Later in the evening, DGDA Deputy Director Salah Uddin and Renata Limited Company Secretary MdJubayerAlam confirmed to Dhaka Tribune that Square Pharmaceuticals Ltd and Renata were also given the green light following a meeting.
The meeting was held after the DGDA chief’s briefing.
Alam added that the name of their product is Lupravir and each pill will cost Tk50. He said they will need one week to go for production.
With the authorization, these companies will be able to produce the drug and supply it to both local and foreign markets.
According to the DGDA, Beximco Pharmaceuticals got the approval on Monday and Eskayef Pharmaceuticals Ltd on Tuesday.
The companies still waiting for authorization are General Pharmaceuticals Ltd, Beacon Pharmaceuticals Ltd, Incepta Pharmaceuticals Ltd, Acme Laboratories Ltd, Health Care Pharmaceuticals Ltd and Popular Pharmaceuticals Ltd.
Not for everyone
The pill will be used for the treatment of symptomatic or mild Covid-19. Patients will need to take eight pills a day (four in the morning and four in the afternoon) for five days.
DGDA chief Mahbubur said the pills would cost Tk50 each. The drug will only be available with a doctor’s prescription, and cannot be used by patients under the age of 18.
“Having the drug does not mean that the country will not need vaccination. Vaccination is a must, and we need to continue it to be safer. This medicine will only decrease the number of hospitalizations and deaths, it will not prevent the disease,” he warned.
In Bangladesh, the manufacturing plants of Eskayef, Square, Incepta, Renata and Acme have been approved by the UK’s drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).
Beximco in a statement said it began production of a generic version of the medicine on Tuesday. It will market the pill as Emorivir.
“The first launch of a generic version of molnupiravir is a great achievement for the company,” said Beximco Managing Director Nazmul Hasan.
Approved in Britain
Bangladesh on Tuesday became the second country in the world to approve the potentially game-changing Covid-19 antiviral pill while Britain became the first last week.
The MHRA recommended that the drug, which will be branded Lagevrio, be used as soon as possible following a positive Covid-19 test and within five days of the onset of symptoms.
UK Health Secretary SajidJavid said the treatment had raised hopes for the frail and immunosuppressed. Media reports said the UK had agreed to purchase 480,000 courses, with the first deliveries expected in November.
This is the first oral antiviral treatment for Covid-19 to get approved, with the green light coming ahead of potential US regulatory clearance. US advisers will meet this month to vote on whether molnupiravir should be authorized.
"An oral antiviral that can impact hospitalization risk to such a degree would be game-changing," said AmeshAdalja, senior scholar at the Johns Hopkins Center for Health Security.
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