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.
Responding to a question on whether Remdesivir will be dropped from COVID-19 treatment protocols after its negative impact on liver has been indicated, a senior Union Health Ministry official during a briefing on Thursday had said that they are aware of few studies which have indicated some adverse events.
"We are aware of this and within the ministry also there is a technical group of domain knowledge experts headed by DGHS that is looking into the evidence as it comes up.
"If there is a requirement to modify or refine our clinical treatment protocols we will definitely do it," Rajesh Bhushan, Officer on Special Duty in the Union Health Ministry, said.
He also said that the DCGI has written letters to companies manufacturing them with two specific suggestions to prevent the blackmarketing and overpricing of the drug.
"First suggestion was that these companies must put in place a 24x7 helpline where the patients or their family members could contact in case the drug is not available in the market or is being overcharged.
"Second suggestion given was that they must proactively put on their website the details of their distributors and their supply lines so that all confusion and anxiety in the market subside," Bhushan elaborated.
In addition, he said, the DCGI has also directed state governments to instruct drug inspectors to ensure that there is no black marketing of drugs which is being used in treatment of COVID-19 patients.
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.
In the letters, Bhushan mentioned, DCGI told these firms to upload the information on their websites regarding the distributors and supply chain details along with quantities where Remdesivir has been made available, so as to prevent black marketing and overcharging of the drug.
Considering the emergency and unmet medical need for COVID-19 disease, the drug controller said, the CDSCO has granted permission to companies to manufacture and market Remdesivir injectable formulation for restricted emergency use for the treatment of patients with severe COVID-19 infection subject to various conditions and restrictions.
"This office has received representation raising concerns regarding black-marketing and overcharging of the drug Remdesivir injectable formulation in the country," the DGCI wrote.