COVID-19: Centre doesn’t clarify basis for CDSCO authorising remdesivir

Government also does not provide clarity about whether remdesivir should be given to only severe patients

By Banjot Kaur
Published: Tuesday 02 June 2020
The US FDA has already provided emergency authorisation for remdesivir to treat COVID-19 patients. Photo: Flickr__

The Central Drug Standard Control Organisation (CDSCO) has granted approval for the emergency use of ‘remdesivir’ to treat novel coronavirus disease (COVID-19) patients. However, the Union Ministry of Health and Family Welfare (MoHFW), in a conference on June 2, 2020, could not share details of the evidence on the basis of which this authorisation was granted. 

“There was a certain protocol that was followed,” Lav Agarwal, a secretary in MoHFW, said in response to a Down To Earth (DTE) query.

“The permission is granted on the basis of available evidence that is produced by the organisation. However, its details — what was the evidence presented to the government or in what dose it would be administered — is not available with me at the moment,” he added. 

Hence, what evidence the ‘organisation’, the company that holds the patent for the drug —Gilead Inc or the Indian firms that have been granted licence for manufacturing by Gilead (Cipla and Hetero Labs) — presented was not immediately clear.

The government also did not provide clarity about whether remdesivir should be given to only severe patients.

News agency PTI quoted a source as saying that since the drug is to be administered intravenously, it can only be given to hospitalised patients. 

DTE also reached out to the Drug Controller General of India (DCGI) V G Somani, seeking these details. However, neither was the phone call answered nor was the mail replied to. This story would be updated if either MoHFW or DCGI respond.

The Indian Council of Medical Research (ICMR) is a participating agency in the ‘Solidarity Trial’— a global trial anchored by the World Health Organization — for this drug. The trial is ongoing. 

The US Food and Drug Administration (US FDA) had granted an emergency use authorisation for remdesivir to be used for treating COVID-19 patients. This was granted on the basis of a randomised control trial (RCT) conducted by US-based National Institute of Disease and Infectious Diseases (NIAID) and an observational study by Gilead Inc itself.

The NIAID trial, that was conducted on 1,093 patients, suggested that the time of recovery was 11 days as against 15 days in case of those who did not receive the drug. 

However, another RCT conducted on 237 severe patients in Hubei (an erstwhile epicentre of the outbreak) found no significant clinical benefit in patients who were administered the drug as compared to those who were not.

An important limitation of this trial was that it was underpowered. That is, it fell short of enrolling patients for the trial as originally designed. 

The US FDA advises a dosage of 200 milligrams (mg) on day 1, followed by 100 mg for another nine days, infused intravenously, in adults. It can be extended for another five days if required. What dosage Indian patients would be administered is not clear. 

Community transmission?

Organisations like the Indian Association of Epidemiologists and several other experts have said for quite some time now that India is witnessing community transmission.

However, the government has officially denied this so far. “We are conducting seroprevalence studies. By the end of this week or the beginning of next week, the results would be out in the public domain,” Nivedita Gupta, a senior scientist with ICMR told the press. 

Gupta also said India’s peak was still far away and the country did not need to worry about it as enough measures were being taken to contain the spread.

However, if the peak is not near, it means India is in for a long haul because the epicurve of the virus in any given setting does not bend without reaching the peak. 

Though the government has not clarified it so far, many studies suggest India will reach its peak in June-July.

India’s low fatality rate has also been talked about but equally, concerns have been raised about deaths being under-reported.

“It is wrong to say every death is due to COVID-19. A causality assessment is to be done…,” Gupta said responding to a query as to why those who were brought dead to hospitals with respiratory illness were not being tested for COVID-19 in several instances.

This is a violation of ICMR guidelines according to which, a nasal swab has to be taken for all suspected deaths. Gupta did not respond to a query on why ICMR guidelines were not being allegedly followed. 

The Delhi government flagged the idea of closing its borders so that COVID dedicated beds could be used only by Delhi residents. “The guidelines that the central government has issued are only normative. If a state government feels that it needs to take additional steps, it is free to do that,” Agarwal said responding to a query about the Centre’s stance on this. 

When asked if there was a lack of coordination between the states, Agarwal said, “By asking these questions you try to create a gap. We are all working in unison.” 

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