Why Experts Are Worried About the Hype Around India’s Latest COVID-19 Drug

On June 20, an Indian drug company announced the launch of a new antiviral drug to treat “mild to moderate” COVID-19 patients.

Glenmark Pharmaceuticals, based out of Mumbai, became the first Indian pharmaceutical company to introduce an oral COVID-19 medicine. The antiviral drug called Favipiravir will be sold under Glenmark’s brand name FabiFlu for Rs 103 (US$1.35) per tablet.

In a statement, Glenmark called the introduction of the drug a “landmark development.” Local news headlines called it “India’s first COVID-19 drug," while others hailed it as “Good News!”

“FabiFlu has the potential to be a game changer,” a Glenmark spokesperson told VICE News in an email interview. “This will take off tremendous pressure from India’s healthcare system.”

The hype is palpable in a country with 425,282 confirmed cases, the fourth highest in the world. Even though the last few weeks had seen the approval of two other drugs, Covifor and Cipremi—administered via injections—FabiFlu claimed to break new ground as the country’s first oral COVID-19 treatment. Glenmark’s shares surged 35 percent at the Bombay Stock Exchange in just two days.

But government officials caution that Fabiflu is still an experimental drug. “It is not for blanket use,” Dr Rakesh Varma, Additional Director General of Health Services, told Indian news channel NDTV.

“The decision to use or not use the medicine is not based on the patient. It has to be taken by the treating physician,” Varma said, adding that the medicine will be administered only once the patient signs a consent form.

The hype is already adding to the pressure on the medical community. On June 22, doctors in the south Indian city of Hyderabad told local media that they feel compelled to prescribe the drug to their COVID-19 patients.

“However, [the hype] is unwarranted given the scanty clinical evidence favouring Favipiravir (FabiFlu),” Malini Aisola, the co-convenor of watchdog organisation All India Drug Action Network (AIDAN), told VICE News.

Favipiravir is the generic version of Avigan, which was developed by Toyama Chemical, a subsidiary of Japan’s imaging and biotechnology giant, Fujifilm Holdings Corporation. It was approved for use in the country in 2014 for the treatment of new strains of influenza.

Favipiravir has been approved as an experimental treatment for COVID-19 in China and Russia. Indonesia allowed favipiravir therapy for moderate and severe COVID-19 patients last month. The drug is reportedly the subject of at least 16 clinical trials around the world.

Japanese Prime Minister Shinzo Abe, who had initially talked up the drug, maintained that there is no solid evidence yet that Favipiravir is effective against COVID-19.

In India, the scramble for COVID-19 medication comes as the healthcare system crumbles with its ill-equipped facilities, limited testing, and problematic handling of cases.

In the recent past, reckless endorsement of drugs like hydroxychloroquine not only led to stockpiling, but also concerns over side effects. The World Health Organisation has since halted the use of the drug for global trials.

Glenmark has stated that its clinical trials were held on 150 positive patients. A Glenmark representative told VICE News that the testing group is small “given the urgency for medication in a pandemic.” “Our study findings are consistent with several global published studies that prove Favipiravir’s efficacy against COVID-19,” they stated.

“The data from Glenmark's phase 3 trials has not been peer-reviewed and published, a basic step of data transparency,” Leena Menghaney, a Delhi-based lawyer who works on medicines law and policy, told VICE News.

Phase-3 clinical trials usually involve testing of the efficacy of drugs through trials on a few hundred to 3,000 humans to determine if people getting tested are statistically better off than those who don’t. They’re also designed to figure out side-effects.

Glenmark stated that they did not observe any side effects in their human studies in India. However, the drug is not recommended for patients with severe renal or hepatic impairments, or pregnant and lactating women. Glenmark also cautioned against its use for patients below age 20.

Activists are also flagging the role of the Indian government’s drug regulatory body, Central Drugs Standard Control Organisation (CDSCO).

FabiFlu received “emergency use authorisation” from the CDSCO. “[It] grants accelerated approval for new drugs taking into account the disease severity, rarity, and the availability or lack of alternative treatment,” said the Glenmark spokesperson.

In India, however, emergency provisions are not clear-cut in the Drugs and Cosmetics Act, 1940. In March, the CDSCO came out with a “high priority” regulatory pathway for approvals of COVID-19 drugs and vaccines.

Aisola said the drug regulatory body did not publish details of the approval process for COVID-19 experimental drugs, including FabiFlu. “No information is available about the evidence submitted by the companies as part of their applications for approval, details of the technical evaluation, the basis for grant of approval or any conditions attached to the emergency authorisation," she told VICE News.

For now, Glenmark has cited four studies, two from China, and one each from Russia and Japan, to highlight the promise of the drug. Indian doctors are concerned that this proof is not enough. In one “proof”—a Chinese study involving 35 people with mild disease—the study did not produce “objective improvement in clinically relevant parameters.”

“Rapidly conducted trials would give us at least workable evidence to go on,” Dr Sahaj Rathi, a hepatologist and researcher, and Dr SP Kalantri, a professor of medicine and medical superintendent, told Indian web media The Quint. “The argument that trials cannot occur during a pandemic is invalid, as is clearly shown by the many trials published from across the world.”

“Information needs to be shared with the public due to implications for the use of these therapies, and because patients are particularly vulnerable in being administered experimental treatments," said Aisola.

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