India is soon going to have its domestic production of anti-viral Remdesivir drug, which would have safety, efficacy, and stability for “restricted emergency use” on COVID-19 patients.
Recently, in the wake of the COVID-19 pandemic, the Drug Controller General of India has given the approval to Remdesivir for “restricted emergency use” on severely ill hospitalized coronavirus patients.
For this, the country’s top drug regulator is evaluating the application submitted by four domestic pharma giants who want to seek the approval to manufacture and sell Remdesivir in India.
“Their applications are being thoroughly studied and examined day and night. It had certain shortcomings for which the respective pharma companies are furnishing their report. The testing of the drug’s molecular compound will be done at our government laboratory. When it fulfills the safety parameters at the dose, India would soon have the benefit of its domestic product (Remdesivir) which has efficacy, stability, and safety for ‘restricted emergency use’ on COVID-19 patients,” a senior government official said.
“Remdesivir is a drug that is still under trial. Hence, looking at the COVID-19 situation in the country, it has been permitted for ‘restricted emergency use’ on COVID-19 patients. Doctors have to get the consent-form duly filled by the patient in a prescribed manner before using it,” he stated, adding that it is the first drug in India which has such strong control.
“The drug will be administered in the form of infection in five doses. On the first day, a patient will be given two doses followed by one dose for the next four days under the strict monitoring of doctors. The drug has to be given only to those severe COVID-19 patients with oxygen saturation level below 94 and respiratory rate more than 24,” the senior government official further said.
He informed that in other countries, patients are being administrated with 10 doses of Remdesivir.