New Delhi: Activists have questioned the lack of transparency in the approval granted by Indian authorities for emergency use of remdesivir and favipiravir for treatment of Covid-19 patients in the country, while also raising their voice against the opaqueness in the functioning and membership of Covid-19 Subject Expert Committee (Covid-19 SEC).
It violates basic requirements of transparency from India’s drug regulator and is contrary to CDSCO’s own practices regarding the functioning of SECs, said All India Drug Action Network.
“We are deeply concerned that other than selective information available through media there is no other information in the public domain regarding the COVID-SEC, its deliberations, recommendations or any reservations that the committee may have had for large-scale sale of these drugs,” AIDAN said in a letter sent to VG Somani, Drug Controller General of India.
Earlier this month, Central Drugs Standard Control Organization (CDSCO) under the ministry of health and family welfare approved manufacture and sale of two drugs, favipiravir by Glenmark and also remdesivir by Hetero and Cipla. Hetero and Cipla will produce and market remdesivir in the country under licence from Gilead Sciences.
The network of activists, that is active in the field of increasing access of affordable medicines to people, criticised the government for not making the details of the members of the Covid-19 Subject Expert Committee that approves the medicines and method for treating Covid-19 patients in the country.
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,” said the activists.
Activists question the trial data submitted by companies
All India Drug Action Network (AIDAN) also questioned the approval of two drugs remdesivir and favipiravir for restricted use in emergency conditions.
“For remdesivir, it is unclear what trial data was submitted by Gilead, whether it included data published in peer-reviewed journals and whether the COVID-19 SEC also examined results of independent trials, (for example trials not conducted by the company),” AIDAN said.
Activists also questioned the authorities for not disclosing the relevant data provided by Indian companies that have been granted permission to manufacture and market two recently approved Covid-19 drugs in the country.
“It is not yet clear what data is provided by the companies in respect of stability data, impurity profile, assay etc. for the products produced in India,” said activists in its letter.
“In the case of favipiravir, no information is available about the studies and data submitted by Glenmark for marketing approval. It is so far unclear if Glenmark’s trials have been completed or whether the approval was based on initial or interim results.”
The group of activists said Favipiravir was still under trial in many countries and its efficacy in COVID-19 is yet to be proved.
“As treatments become increasingly available for COVID-19, emergency authorizations will continue to be granted; inevitably things are moving fast and several concessions and waivers in trials, data and approvals are also being granted,” said All India Drug Action Network.
Activists said these emergency authorizations make it even more critical for making the information public regarding the Covid-19 Subject Expert Committee (COVID-19 SEC), its composition and deliberations and the complete details of the recommendations.
Activists say the data used by the Covid-19 Expert Committee should be immediately made available to the public so that it can be scrutinized by public health experts, scientists, the medical community and patients.
“Making the details of the authorizations, experimental data etc. publicly available is crucial for patient safety,” said the activists.
Also Read: DCGI approves Favipiravir's manufacture & sale in India
