PBT president, Dr. Kunal Saha appeared “in person” through “live” videoconferencing from USA to argue before a 3-judge Supreme Court bench of Justices R.V. Ramana, Sanjay Kishan Kaul and B.R. Gavai in the PIL filed by PBT seeking changes to the widespread recommended “treatment guidelines” for use of unapproved anti-malarial drug, Hydroxychloroquine (HCQ) and broad-spectrum antibiotic, Azithromycin (AZM) in COVID-19 patients. American Heart Association (AMA) and American College of Cardiology (ACC) as well as Canadian Medical Association Journal (CMAJ) have recently issued warnings that use of these drugs may cause serious adverse effects leading to heart failure and death, especially in patients with other cardiovascular conditions like high blood pressure or ischemia. The US Food & Drug Administration (FDA) also issued a drug “safety” warning last week about the “off-label” use of HCQ and AZM in COVID-19 patients. In this PIL, PBT has also sought that even if COVID-19 patients are given the experimental HCQ/AZM, they must be informed about the potential “adverse effects” of these drugs and doctors must obtain “informed consent” before using HCQ/AZM on COVID-19 patients.
After hearing Dr. Saha and the Solicitor General (SG) of India, Mr. Tushar Mehta, Apex Court based an order directing that PBT can email all necessary materials to the SG within 2 days and then SG will bring it to the Indian Council of Medical Research (ICMR) for investigation and necessary action in regard to the concerns raised by PBT. PBT has already filed all the relevant documents to the SG via email and hope that the ICMR will take appropriate precautionary measures, as advised by the international medical organizations, in regard to the use of HCQ/AZM to prevent injuries or death of the COVID-19 patients (see news below).