In Mumbai, the health authorities have been indiscriminately providing hydroxychloroquine (HCQ) to adults and children in order to control the spread of COVID-19. This has raised questions of medical ethics as the therapy lacks clinical evidence of efficacy in treating the disease of coronavirus.
This disclosure was made by the Directorate of Medical Education and Research (DMER) of Mumbai, which outlined its Covid-19 management protocol in an affidavit filed before the Bombay High Court. Jan Swasthya Abhiyan further submitted public interest litigation (PIL) which alleged that the authorities were conducting human tests to determine the efficacy of HCQ.
According to the DMER protocol, HCQ is a drug given to both asymptomatic and symptomatic patients with and without comorbidities, or other health conditions. In some cases, HCQ is given with HIV combination drugs lopinavir and ritonavir, and azithromycin. The dosage for children depends on their weight. However, Drug Controller General of India, VG Somani, agreed that some states have set their own protocol. He further added that these drugs should be administered under close medical supervision.
One of the main issues lies with the fact that the ICMR and health ministry guidelines do not clearly mention the precautions to be taken with off-label use such as the need for informed consent, screening for eligibility, close monitoring of side-effects and the need to get approvals from ethics committees, a public health expert stated to the media on the condition of anonymity. The lack of coordination between ICMR, the ministry of health and the states have posed to be a problem.
Health experts have further opined that as the government itself has not followed the guidelines for Monitored Emergency Use of Unregistered and Investigational Interventions, an ethical protocol should be developed to evaluate the potential use of experimental drugs like the HCQ in the event of public health emergencies.
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