Combating COVID-19: India to soon begin domestic production of Remdesivir drug
"Pharma companies have been directed to conduct Active-Post Marketing Surveillance of each case and prepare a report on the benefit or recovery of a patient and provide the data report to us," the official said, adding that these pharma companies have to submit a report to the government and also of a clinical trial being conducted anywhere in the world.;
New Delhi: 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 (DCGI) 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 have efficacy, stability and safety for 'restricted emergency use' on COVID-19 patients," a senior government official told ANI.
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