Health ministry officials said on Thursday the decision to administer a combination of anti-HIV drugs -- lopinavir and ritonavir -- on a coronavirus-infected elderly Italian couple at a Jaipur hospital was "initially taken locally".
The hospital has been asked to inform the health ministry and the Indian Council of Medical Research (ICMR) before administering the drug combination on COVID-19 patients in future, officials said.
It was the first time that a combination of the two drugs was used to treat Covid-19 patients amid mounting coronavirus cases in India. The Italian couple are currently undergoing treatment at SMS Hospital in Jaipur.
"The decision to administer lopinavir and ritonavir combination initially was taken locally as they thought it was a severe disease and started the medicine. But we should not draw more conclusions from the same because single patient experiments do not reveal the truth more often. We need to have a structured study," Raman R Gangakhedkar, the head of the Epidemiology and Communicable Diseases-I at ICMR, said.
"Until we have a large data that come from such experiments we won't be able to infer more. But since the drug was administered we have pressed into a study mode where the samples are being regularly collected in order to see if the drug was efficacious," he said.
Dr S Meena, the medical superintendent of SMS Hospital, said the decision to administer the combination of lopinavir and ritonavir was taken after the Italian man and his wife had developed severe respiratory problems.
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The Italian man, who himself is a doctor, is in ICU and on oxygen support, Meena said, adding his condition is stable.
"Even before he acquired the infection, he had some respiratory issues. Also, he is a chronic smoker. His condition had deteriorated and he developed severe respiratory problems after getting the coronavirus infection and thus was given these drugs. his condition is stable.
"His wife who also had tested positive for coronavirus has recovered and has been shifted to a different hospital," Dr Meena said.
The Drug Controller General of India (DCGI) had approved the 'restricted' use of the combination of medications, lopinavir and ritonavir, which are second-line HIV drugs, before they were administered to the elderly couple. The DCGI had given the approval after the Indian Council of Medical Research (ICMR) had sought an emergency approval for using the drugs for treating COVID- 19.
The number of coronavirus patients in the country has risen to 74. The figure includes 17 foreigners -- 16 Italian tourists and a Canadian. It also includes three patients from Kerala who were discharged last month following recovery.