Someone brings a box of chloroquine hydroxy tablets in Seattle, Washington, March 31, 2020. Photo: Reuters / Lindsey Wasson.
On March 23, 2020, the Ministry of Health and Family Welfare (MoHFW), released a advisor directing health care workers and household contacts of COVID-19 patients to start using hydroxychloroquine (HCQ) as prophylaxis. This is based on recommendations from the National Task Force for COVID-19 and the Indian Medical Research Council (ICMR).
During the ongoing pandemic, HCQ has made news on several occasions, including during a semi-tense dispute when US President Donald Trump forced Prime Minister Narendra Modi to Share it HCQ India stock with US. Recently, Trump even was announced at a press conference that he had started giving one HCQ pill every night.
HCQ is an anti-malaria drug and is considered safe to use when prescribed for indications that have been approved. However, it has not been tested or approved anywhere in the world for use against COVID-19. The US Food and Drug Administration (FDA) has cleared the use of HCQ under the Emergency Use Authorization procedure, in adults who have been hospitalized with COVID-19. But the body has discouraged use of the drug under any other circumstances due to HCQ side effects.
On March 23, the day before India’s national lockdown began, the Ministry of Health and ICMR recommended the use of HCQ as prophylaxis even though they have not been able to reliably verify their safety and efficacy claims. In the two months since, the joint monitoring group under the Ministry of Health, chaired by the Director General of Health Services, together with the National Task Force for COVID-19, has reviewed the use of HCQ as prophylaxis and issued revised advisor on the 22nd of May.
Data used by the Ministry of Health were used from a study of 1,323 health workers, of which 214 reported adverse effects. The ICMR conducted a retrospective analysis and found an association between “the number of prophylactic doses taken and the frequency of SARS-CoV-2 infections in symptomatic healthcare workers”. The advisor also reported investigations at three government hospitals in Delhi and at AIIMS that found health services using HCQ as prophylaxis were prone to contracting COVID-19.
Behind this data, the Ministry of Health revised its previous advisors and expanded its scope, advising health workers in all hospitals and blocks that have a COVID-19 ward to consume drugs as prophylactic subjects for contraindications such as retinopathy and existing cardiomyopathy. The revised advisor also recommended the use of HCQ as prophylaxis for surveillance workers in the detention zone and the police and paramilitary personnel assigned to activities related to COVID-19. Finally, the advisor continues to apply to household contacts of COVID-19 patients, as before.
This represents a major change in the number of people affected, so it is important for the Ministry of Health to make sure this step is safe and effective, given that HCQ side effects can be serious – and because it is important to maintain commitment to the evidence during a pandemic.
In India, drugs such as HCQ are regulated under the 1940 Medicines and Cosmetics Act and the 1945 Medicines and Cosmetics Regulations. All drugs – including those approved for one use case but which have since been reused for those who others – must be tested in stages. before it can be marketed. So if HCQ, approved to be used to treat patients with lupus and rheumatoid inflammation and (in some cases) malaria, is proposed to prevent or treat COVID-19, it must be tested again based on the laws and regulations first.
Under the Drug Regulations, all drugs must be tested on animals and then humans before being approved. These tests check their physical and chemical properties, mode of operation, metabolism, dose response, movement through the body and side effects of the patient. Every test step must be approved by the Indian General Medicines Supervisor before the next step can begin.
In an emergency situation such as an ongoing pandemic, the Drug Regulations allow researchers to import the results of animal toxicology studies and human trials conducted abroad. Tests for product characterization and animal pharmacology still need to be done in India.
However, there is no evidence that animal pharmacological studies are carried out for HCQ-as-prophylaxis in India – nor is there evidence of human trials conducted abroad that ICMR and the Ministry of Health can then be used to recommend HCQ to important workers and the frontline of India, etc. .
The rigorous testing procedures described by the Narcotics and Narcotics Act share the same fundamental goals as those throughout the world: efficacy and safety. That is, the drug must be proven effective and safe before being approved. When dealing with a pandemic, a third goal emerges: speed. This means that safe and effective drugs must be available to patients and health care workers as soon as possible.
However, the government must ensure that its need to provide a solution quickly does not violate the first two objectives. Safety is of particular concern when dealing with drugs such as HCQ, viz known to have dangerous side effects.
Thus, the Ministry of Health has not followed the applicable legal framework before prescribing HCQ.
There is no research in the world that shows HCQ is safe or effective. In fact, some have found mixed results. A small sample study done in Wuhan in February found that HCQ could significantly shorten recovery time. On the other hand, large-scale studies done in a New York hospital in early May found that patients taking HCQ had the same risk of death as those who did not.
Most recently, based on controversial study published in Lancet that’s a lot criticized for his method, WHO it depends multinational clinical trial for HCQ as a treatment for COVID-19. The hospital also advises doctors and medical associations around the world to avoid giving HCQ to COVID-19 patients until enough evidence is available.
On May 29, ICMR write to WHO who opposed the suspension of the trial and subsequent WHO advisors because the prescribed dose for Indian health workers was 25% of the amount given in the trial. The letter added that ‘Indian research’ had found evidence of the efficacy of HCQ in treating COVID-19.
However, the ICMR correspondence spoke of HCQ as a treatment while the research he claimed had explored HCQ as prophylaxis. More importantly, ICMR research itself is not a clinical trial, because both require the Narcotics Act and the Narcotics Regulations. This is a retrospective study and does not meet the rigors of clinical trials established in law.
Furthermore, US law governing the FDA providesEmergency use authorization‘, Which the FDA can use to permit treatments that have not been tested during emergencies, when there are no approved alternatives. MoHFW is not empowered by such laws. However, the ICMR did draft guidelines in 2017 to ensure that untested drugs are used in a way that minimizes ethical violations. But then ICMR avoid them – even when the Ministry of Health has made decisions on the basis of ad hoc executive fiat without the necessary warnings.
If HCQ is marketed as prophylaxis for COVID-19, HCQ must be rigorously tested first, according to existing law. The studies that the Ministry of Health and ICMR used to make their decisions do not meet these criteria. It is true that tests take time – but they need this time to minimize risk and to maximize patient safety, and to make sure the medication is truly functioning. And when patients are frontline health workers themselves, it becomes more important to make sure the drugs are safe.
Tanmay Singh is an advocate based in Delhi. He tweeted @TanmayPratapS.
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