In response to PBT’s PIL and direction from the Supreme Court of India about “off-label” use of unproven anti-malarial drug, Hydroxychloroquine (HCQ) and antibiotic Azithromycin (AZM), assistant director of the Indian Council of Medical Research (ICMR), highest authority to regulate treatment of COVID-19 in India, sent a letter dated 16th May, 2020 to answer PBT’s concerns for widespread use of HCQ and/or AZM in COVID-19 patients that many recent scientific studies have shown that it can cause serious adverse effects resulting increase in heart failure and sudden death (see ICMR letter below). In its PIL before the Apex Court, PBT had sought that based on the recent reports about HCQ/AZM, treatment guidelines issued by ICMR must include essential precautionary measures to protect the vulnerable COVID-19 patients and doctors must obtain valid “Inform Consent” from the patient/patient’s family before starting the experimental HCQ/AZM therapy after full disclosure of the potential dangers of these drugs to the patient/patient’s family.
Although ICMR appears to have agreed that consent from the COVID-19 patients may be necessary before putting them on with “off-label” HCQ/AZM, ICMR has made an astonishing claim that all COVID-19 patients have automatically given an “Implied Consent” when they are treated in Indian hospitals following the published “Treatment Guidelines” because somewhere in these guidelines a generic statement exists to “Communicate early with patient and family”. Supreme Court of India has defined “Informed Consent” in numerous decisions including the landmark judgment in Samira Kholi vs. Dr. Prabha Manchanda & And. (2008 SCC 2, 1) in which the Apex Court has categorically held that doctors must obtain “informed consent” before any treatment or surgery after explaining full details about all pros and cons, especially risks involved and other treatment options available, in regard to the new therapy. It is astounding that the highest medical body in India (ICMR) feels that all COVID-19 patients have automatically given “Implied Consent” to be subjected to any experimental therapy without their knowledge about the risks involved in the experimental drugs. PBT has already submitted a rebuttal-response to ICMR’s outlandish letter and demanded immediate clarification and appropriate action in regard to the experimental and potentially dangerous treatment with “off-label” HCQ/AZM.