The PIL filed by People for Better Treatment (PBT) through its President Dr. Kunal Saha, said the use of HCQ and AZM were recommended for the most serious COVID-19 patients by the Health Ministry based primarily on anecdotal evidence and not as a specific therapy.
The petition has also sought directions to take necessary steps for immediate implementation of all the specific preventive measures recommended in hospitals across India to protect the lives of COVID-19 patients who are being treated with HCQ and AZM.
It said the Ministry of Health & Family Welfare published comprehensive 'Revised Guidelines on Clinical Management of COVID-19' on their website on March 31, 2020 that included detailed description of how to test, diagnose and treat COVID-19 patients.
"Ministry of Health has specifically advised that although no specific anti-viral medicines are available against COVID-19, a combination of HCQ and AZM may be administered as an 'off-label' use to the most seriously ill COVID-19 patients who are in ICU," it said.
Many doctors have started using HCQ and AZM to treat their most critically ill COVID-19 ICU patients in hospitals across India following the published treatment guidelines put forward by the Health Ministry, it said.
"Off-label use of HCQ and AZM in acutely ill COVID-19 patients has been highly controversial from the very beginning. However, both HCQ and AZM were studied extensively prior to FDA approval for their use in indicated medical conditions and both drugs are known for occasional and serious adverse reactions,particularly on the cardiovascular system in humans," the plea said.
It said an extraordinary joint bulletin issued on April 8 by leading American cardiology societies have cautioned that use of HCQ and AZM in COVID-19 patients can pose serious dangers due to its inherent adverse effects.
Canadian Medical Association Journal published a very similar warning for using HCQ and AZM to patients with COVID-19, the plea said, adding that they also increased the risks of heart failure and cardiac mortality.
"The petitioner-organization submitted an urgent written representation to Ministry of Health intimating it about the serious and potentially life-threatening dangers for using HCQ and AZM in COVID-19 patients and urging it to immediately adopt the precautionary measures.
"Unfortunately, even after several reminders by your Petitioner via telephone/email considering the extremely urgent situation, Ministry of Health has remained absolutely silent and did not respond or shown any interest to adopt any precautionary measures to mitigate the obvious risks including heart failure and death involved with the acutely sick ICU patients with COVID-19 receiving treatment with HCQ and AZM," the plea said.
It has also sought directions to the Union Health Ministry to obtain "informedconsent" from all COVID-19 patients for treatment with HCQ and AZM by bringing necessary changes in the treatment guidelines. PKS ANB RDMRDM