India regulates the use of hydroxychloroquine; concerns on its efficacy against novel coronavirus linger

March 27, 2020 0 By FM

As a measure to prevent the unregulated sale and possible misuse of hydroxychloroquine in the wake of the COVID-19 outbreak, the Union health ministry has brought the anti-malarial drug under Schedule H1.

Schedule H1 of the Drugs and Cosmetics Act, 1940 — the rule book governing the sale and distribution of pharmaceuticals and medical devices in India–stipulates that the drug can be sold only on prescription.

“…in exercise of the powers conferred by Section 26B of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby directs that sale by retail of any preparation containing the drug hydroxychloroquine shall be in accordance with the conditions for sale of drugs specified in Schedule H1 to the Drugs and Cosmetics Rules, 1945,” according to a gazette notification issued by the ministry.

The Indian government had banned the export of hydroxychloroquine and formulations made from the medication, two days ago.

Even as the government prohibits the exports and regulate the sale of drugs containing hydroxychloroquine, concerns about the efficacy of the anti-malarial against the new coronavirus remains a concern.

Efficacy data against COVID-19 yet to come

Hydroxychloroquine is among the medications that are being tested, as a potential treatment for patients with the disease.This use was largely based on a study published in 2005 that found that chloroquine prevented the replication of the SARS-CoV-1 virus that caused SARS in laboratory studies.

However, evidence from large-scale clinical trials supporting the safety and efficacy of the drug against the new coronavirus is still awaited. Besides treating malaria, hydroxyl-chloroquine is also used to treat lupus and chronic rheumatoid arthritis.

The drug has significant side effects, including gastrointestinal distress and potential permanent vision damage. Hydroxyl-chloroquine can also be deadly at a relatively low dose.

A Wuhan Institute of Virology study indicated it can cause deaths in adults at twice the daily recommended amount, which is only one gram. The drug can be even more dangerous for children.

A small clinical trial conducted by China’s Ministry of Sciences and Technology on 130 patients, showed that the drug decreased the severity of COVID-19 and increased the speed of viral clearance.

Chloroquine + azithromycin combo

A combination of hydroxyl-chloroquine and the antibiotic azithromycin, known as Z-Pak, has been studied in a small group of French patients suffering from COVID-19.

According to the trials data published in the International Journal of Antimicrobial Agents, the hydroxyl-chloroquine and the antibiotic azithromycin, showed a significant reduction of the viral carriage after six days of treatment and much lower average carrying duration compared to patients receiving other treatment. Six patients in the trial were asymptomatic and 22 had upper respiratory tract infection symptoms. Eight patients had lower respiratory tract infections. Twenty cases were treated in the study, with untreated patients acting as negative controls.

Experts urge caution

The US FDA is also evaluating the drugs but has not yet made recommendations.

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases of the US, is taking a more cautious, scientific approach. “As the Commissioner of US FDA and the president mentioned, we’re trying to strike a balance between making something with the potential of an effect available to the American people, at the same time that we do it under the auspices of a protocol that would give us information to determine if it’s truly safe and truly effective.

The National Task Force for COVID-19 constituted by Indian Council of Medical Research (ICMR) on March 23 suggested use of hydroxychloroquine for preventive treatment of asymptomatic healthcare workers and individuals in close contact of coronavirus patients. The drug may be also used in case of asymptomatic household contacts of confirmed COVID-19 patients.