New Delhi: An expert committee of the Narendra Modi government has rejected a proposal by Mumbai-based drugmaker Macleods Pharmaceuticals Ltd to manufacture chewable tablets of the drug Favipiravir for Covid-19 patients.
Favipiravir, an antiviral medication developed in Japan, has been the subject of several trials across the world as a potential treatment for Covid-19, and has been approved for restricted emergency use in India.
At a meeting on 6 November, the Subject Expert Committee (SEC) — which advises the Drug Controller General of India on applications seeking approvals for new drugs, vaccines, and clinical trials — found that the justification submitted by Macleods Pharmaceuticals to manufacture and market chewable Favipiravir tablets was “inadequate”.
This was revealed in the minutes of the meeting uploaded on the Central Drugs Standard Control Organisation’s (CDSCO) website. CDSCO is a health ministry arm that regulates the quality of drugs and vaccines in the country.
Chewable tablets are deemed beneficial for factors such as palatability, stability, precise dosing, portability, and ease of delivery. However, such tablets are generally explored for medicines made for children or as supplements.
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Mylan proposes to test Favipiravir in three drug combos
The SEC is, however, considering another proposal by US-based Mylan Pharmaceuticals to test Favipiravir with three different drug combinations.
According to the proposal submitted by Mylan, the antiviral drug will be tested with Bromhexine, Colchicine USP tablet and Nitazoxanide tablet in three different arms of a clinical trial, which will also have a fourth arm known as the ‘standard of care’ treatment.
In a clinical trial, arms signify a group of people who receive the same intervention. Clinical studies may have two or more research arms.
While Bromhexine is used in the treatment of respiratory tract disorders associated with mucus, Colchicine USP tablet is used to cure a form of arthritis where patients suffer from pain and inflammation due to deposition of uric acid in the joints. Nitazoxanide, an antiparasitic medication, is used in the treatment of diarrhoea and worm infections.
The expert panel has asked Mylan to submit more details on the proposal, including the “scientific justification for having four arms with different drugs in the proposed study”, according to the minutes of the meeting.
“In the proposed trial of 4 arms, Favipiravir with 3 different drugs is proposed to be compared with Standard of Care (SOC). Justification for comparing the combination therapy versus SOC instead of comparing the combination therapy with Favipiravir plus SOC should be submitted,” the panel further noted.
Treatments based on SOC are known as symptomatic treatments, where a doctor gives medicines to manage the symptoms shown by patients, along with usual care.
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