Doctors advised to use Remdesivir on patients strictly under laid-down protocol

New Delhi: Doctors in state hospitals are being advised to use antiviral Remdesivir on COVID-19 patients strictly as per protocol amid some reports of liver damage in such patients treated with the drug, official sources said.
While the health ministry is reviewing the guidelines on the usage of the drug following the adverse reports, states and union territories are also being asked to orient doctors on the protocols of Remdesivir use and not to prescribe it indiscriminately.
To prevent black-marketing and overcharging of the drug, India’s drug regulator Drugs Controller General of India (DCGI) has asked manufacturers to set up a helpline where the patients or their family members can contact in case the drug is not available in the market and also put on their websites details of distributors and supply chain.
“AIIMS specialists tasked by the Centre to provide expert guidance are advising doctors in state hospitals to use the drug as mentioned in the protocols stating it has been approved for restricted emergency use purposes in moderate to severe cases of COVID-19 subject to a set of conditions under ‘investigational therapies’ and not as a mainstream treatment,” a source said.
Remdesivir has been included as an “investigational therapy” in the clinical management protocols for COVID-19 based on limited available evidence at present.
“The drug is being increasingly prescribed in the absence of any proven treatment leading to a rise in demand. But then the data derived from the studies so far suggest that its use can cut down the duration of the hospital stay and does not have any effect on the mortality,” an official explained.
Three companies, Hetero, Cipla and Mylan have been given permission by India’s drug regulator to manufacture and market the anti-viral drug remdesivir for “restricted emergency use” on hospitalised COVID-19 patients.
Written informed consent of each patient is required before the use of the drug while active post-marketing surveillance data and reporting of serious adverse events have to be submitted. (PTI)