The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) on Friday granted conditional approval for Covid-19 treatment drug Molnupiravir and has said the drug should be prescribed with an insert, sources told CNBC-TV18.
“It is upon doctors now to prescribe the drug based on the conditions and it is the duty of the doctor to make the patient aware of the concerns with the drug,” the regulatory authority said.
The nod comes after ICMR Director-General Balram Bhargava said molnupiravir has major safety concerns and has not been included in the national protocol for the treatment of Coronavirus. During a press briefing earlier this week, he said the World Health Organization and the UK have not included it for treatment. Bhargava said the US has approved it based on only 1,433 patients in which three per cent reduction was observed in symptoms in patients with mild to moderate disease.
India’s drug regulator Central Drugs Standard Control Organisation on December 28 had approved Molnupiravir for the restricted use in emergency situations in patients with Covid-19.
Thirteen Indian pharmaceutical companies, including Cipla, Sun Pharma and Dr Reddy’s Laboratories, are manufacturing the drug, which is being developed by US-based biotechnology company Ridgeback Biotherapeutics in collaboration with American pharma giant Merck & Co Inc.
MSD Pharmaceuticals, a wholly-owned subsidiary of Merck said it is confident in the clinical profile of molnupiravir for the treatment of mild to moderate Covid-19 and no safety concerns were found during phase-3 trial.
In a statement, it said relevant information was provided to help the DCGI determine the most appropriate use of molnupiravir in India. “We are confident in the clinical profile of molnupiravir, which demonstrated a significant reduction in the risk of hospitalisation or death in our Phase-3 clinical trial with no observed safety concerns when compared to the placebo group,” MSD India said in a statement.
The CDSCO had received 22 applications for the manufacture and market of the drug Molnupiravir in the country.
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