All India Drug Action Network (AIDAN) has written a letter to Drugs Controller of India and the Central Drugs Standard Control Organisation (CDSCO) highlighting the lack of transparency about the special Subject Expert Committee (SEC) that has been formed to evaluate COVID-19 drugs and health products (COVID-19 SEC) and the approval process for COVID-19 drugs.
The COVID-19 SEC has been involved in reviewing the applications for regulatory approval of drugs to treat COVID-19. In particular, the COVID-19 SEC had made recommendation in respect of remdesivir and favipiravir, which subsequently were granted marketing approval by the CDSCO.
“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-SEC, its deliberations, recommendations or any reservation that the committee may have had for large-scale sale of the these druge in 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,” the letter reads.
Here are the highlights of the letter:
1. Lack of transparency about the COVID-19 SEC: There is no information available about the composition of the SEC for COVID-19. While there are suggestions that the membership of the COVID-19 SEC overlaps with the Antimicrobial Antiparasitic, Antifungal a. Antiviral SEC and that relevant experts are also being co-opted based on the product being evaluated, the names of the committee members are not available in the public domain.
As a matter of usual practice, the minutes of meetings of various SECs are regularly published on the CDSCO website. It is therefore incomprehensible why the minutes of COVID-SEC meetings are not being shared. No information Ls available about the evidence submit by the companies as part of their applications for approval.
2. Lack of transparency on approved COVID.19 treatments: In March 2020, the CDSCO notified a regulatory pathway for approvals of COVID-19 drugs and vaccines. Since then, two drugs, remdesivir and favipiravir have received approvals for marketing for restricted emergency use, i.e., subject to certain conditions. No official information has been made available regarding the basis for the grant of these accelerated approvals or the conditions/restrictions that have been Imposed. There is, therefore, a complete lack of clarity on how the regulatory pathway for COVID-19 treatments is being implemented and the nature of approvals granted by the CDSCO.
3. Lack of publicly available data on COVID I9 treatments that have been approved: Information from trial data is crucial for healthcare workers to make decisions about who should get the medicines, when and how; particularly if there are possibility shortages. Adverse events/reaction data are also critical for healthcare workers to monitor patients. Finally, biases and gaps in trial design and implementation would also need to be scrutinised. Therefore, it is essential for trial data to be made public without delay and be available for scrutiny by public health experts, scientists, the medical community and patients.
