COVID-19 Pandemic: ICMR Denies Responsibility for “Informed Consent” and Patients Suffered or Died From Side-effects of Unproven Hydroxychloroquine (HCQ) Treatment

Despite most international medical studies found absolutely no evidence in support of using anti-malarial drug, Hydroxychloroquine (HCQ) to treat COVID-19, Indian Council of Medical Research (ICMR), top governmental organization to frame guidelines to fight the ongoing COVID pandemic in India, recommended that HCQ may be used to combat COVID-19 based on anecdotal evidence. The World Health Organization (WHO) had to prematurely terminate a multinational clinical trial (“Solidarity Trial”) to test the role of HCQ in COVID-19 because of major studies showing potential danger and no benefit of HCQ in COVID-19. India was also a participant country in The Who-initiated “Solidarity Trial” for HCQ. PBT also moved a PIL last April before the Supreme Court of India against such irrational use of HCQ that can cause serious harm and even death of COVID-19 patients due to adverse drug effects. The Apex Court disposed of the said PIL vide a final order/judgment on April 30, 2020 with specific direction that ICMR must review and respond to the concerns raised in PBT’s PIL.

In response to PBT’s specific concerns about reckless and indiscriminate use of HCQ in COVID-19 patients, ICMR’s assistant director general, Dr. R. Lakshminarayanan, sent a response via email yesterday (August 3) in which ICMR has made several astounding claims including:

1) That ICMR would abide by WHO’s decision to end HCQ “Solidarity Trial”. Ironically, the letter from ICMR stated that they WILL stop HCQ trial suggesting that COVID hospitals still continue to use HCQ even though WHO has stopped the trial last month and perhaps innocent COVID-19 patients continue to suffer or die due to continued treatment with HCQ.

2) That although ICMR declared that valid “informed consent” must be obtained from COVID-19 patients by doctors who plan to use “off-label” HCQ by explaining the potential dangers and side-effects of the drug before starting HCQ therapy, ICMR has claimed that they have no responsibility to assure that appropriate instructions for obtaining “informed consent” are sent to all doctors and hospitals who plan to use HCQ. ICMR has claimed that this responsibility lies with the Ministry of Health & Family Welfare. Ironically, Ministry of Health & Family Welfare has remained absolutely silent to repeated appeals from PBT about “informed consent”.

3) That ICMR has no knowledge how many COVID-19 patients may have suffered or died due to adverse reaction to the unproven HCQ therapy.

4) That ICMR has recommended HCQ only for the “treatment of mild COVID-19 in high-risk patients”. However, it is common knowledge today that unproven HCQ therapy is used widely by doctors across India to combat the spread of COVID-19. In fact, HCQ tablets are indiscriminately distributed to all unsuspecting railway passengers and devious political leaders are freely encouraging slum-dwellers to take HCQ in the most reckless and dangerous manner.

PBT has also written to other governmental authorities demanding details of the harm done to COVID-19 patients as a result of HCQ therapy and will move the appropriate court of law again if the authorities and COVID medical centers remain silent.