Indian drug association questions approval of drugs for COVID-19 treatment

The All India Drug Action Network wrote a letter to the Drugs Controller General of India questioning how certain drugs were being approved for COVID-19 treatment.
Indian drug association questions approval of drugs for COVID-19 treatment
Indian drug association questions approval of drugs for COVID-19 treatment
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Several antiviral drugs — Remdesivir, Dexamethasone and Favipiravir — have been marketed as “game changers” to the battle against COVID-19. However, the reality is that these drugs have been available in the market for long, and are not necessarily ‘new’ discoveries.

Questioning the manner in which these drugs are approved for treating individuals diagnosed with COVID-19, the All India Drug Action Network (AIDAN) has written a letter to the Drugs Controller General (India), stating that lack of transparency in approving these drugs is akin to withholding important information about their use. AIDAN is an independent network of various non-governmental organisations that work towards making quality health care and essential medicines affordable to all.

According to AIDAN, the COVID-19 Special Expert Committee (SEC), formed by the Central Drugs Standard Control Organisation (CDSCO), has not provided enough information regarding the approval of various drugs in the treatment of COVID-19.

“We are deeply concerned that other than selective information available through the media, there is no other information in the public domain regarding the COVID-19 SEC, its deliberations, recommendations or any reservations that the committee may have had for large-scale sale of these drugs in the absence of relevant data. This violates basic requirements of transparency and the right to information from India’s drug regulator and is contrary to CDSCO’s own practices regarding the functioning of SECs,” read the letter.

AIDAN also pointed out that the drugs currently approved for treatment do not have proper scientific evidence to support the claims pertaining to the treatment of COVID-19. It points out there it is unclear whether the trial data provided by Gilead Sciences, the manufacturer of the drug Remdesivir, was peer-reviewed and whether the SEC examined the results of independent trials, which were not conducted by the company itself. Similarly, according to AIDAN, the Favipiravir drug, which is produced by the company Glenmark, also does not have clear published data.

The AIDAN further requested that CDSCO provide more details about the COVID-19 SEC on its website along with a list of CDSCO-approved treatments for COVID-19.

“Immediately publish the list of CDSCO approvals for COVID-19 treatment along with: the details of the type of approval granted; legal provisions under which the approval has been granted; any conditions/restrictions attached to the approval; details of the clinical data submitted by the companies in support of their application for approval, including any published and unpublished studies; and data on the adverse events and reactions associated with the approved treatment,” the letter stated.

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