While disposing of the writ petition (PIL) filed by PBT challenging the “off-label” and unscientific use of anti-malarial drug, Hydroxychloroquine (HCQ), in COVID-19 patients, Hon’ble Apex Court passed an order on 30th April, 2020 directing the Solicitor General that the issues in this PIL may be placed before ICMR and ICMR should consider the points raised in this PIL. Almost two and half months later, ICMR has remained virtually silent and refused to provide specific answers to the important questions raised by PBT, such as whether “informed consent” is obtained from every COVID-19 patient before starting HCQ after full disclosure of the potentially life-threatening side-effects of HCQ. Last month, the World Health Organization (WHO) prematurely stopped the clinical trial (“Solidarity Trial”), a multinational clinical trial to test the role of HCQ against COVID-19. Many hospitals across India also participated in the “Solidarity Trial” to test the role of HCQ against COVID-19. But it widely reported that doctors across India are still using HCQ, as advised by ICMR, in patients infected with the coronavirus. PBT submitted a representation with ICMR and Ministry of Health & Family Welfare asking immediate response to the following 4 specific questions about the use of HCQ in COVID-19, in accordance to the order passed by the Hon’ble Supreme Court:
1) Is ICMR still recommending HCQ as treatment and/or prophylaxis for COVID-19 patients, hospitalized or at home, whether symptomatic or asymptomatic?
2) Has ICMR continued to participate in the HCQ arm of the “Solidarity Trial” in contrast to the WHO’s decision to stop?
3) Has ICMR issued necessary instructions to doctors/hospitals across India to obtain valid “informed consent” from COVID-19 patients before initiating HCQ therapy?
4) How many COVID-19 patients have died or suffered injuries due to adverse reactions to HCQ therapy?
PBT has given 7 days time to ICMR/MOHFW to answer the 4 questions and if they still remain silent, a “contempt” or other legal action may be taken against Indian government’s top agencies to control the COVID-19 pandemic.