BackGlenmark’s covid spray fails to get panel nod
he Subject Expert Committee (SEC) of the Drugs Controller General of India (DCGI) has rejected Mumbai-based Glenmark’s nasal spray—FabiSpray— for covid, citing lack of strong evidence that it can prevent covid.
PremiumNEW DELHI : The Subject Expert Committee (SEC) of the Drugs Controller General of India (DCGI) has rejected Mumbai-based Glenmark’s nasal spray—FabiSpray— for covid, citing lack of strong evidence that it can prevent covid.
The expert panel said, “The committee did not recommend for approval of Nitric Oxide Nasal Spray due to lack of strong evidence for proposed indication," stated the Committee.
Queries sent to health ministry spokespeople did not elicit a response.
A Glenmark spokesperson said, “Glenmark received manufacturing and marketing approval from the Drugs Controller General of India for Nitric Oxide Nasal Spray (NONS) as part of the accelerated approval process in February 2022. Following this the company launched it in the country under the brand name FabiSpray, as a prescription drug for the treatment of covid-19 infection. The company later applied for an additional indication of ‘prevention of covid-19’ in line with global approvals which, the subject expert committee did not approve during its recent meeting. The company is studying the recommendations and will respond to the drug regulator or take steps as may be appropriate."
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