Experts seek data on remdesivir and COVID-19 treatment-related products
Ask for details of specific indications for which approval has been granted, any conditions or restrictions attached to the approval as well as the type of approval and legal provisions under which the approval has been granted
Recently, Dr Reddy’s Laboratories’ plea to change the regulatory approval status of remdesivir injection, COVID-19 treatment drug, from restricted emergency use to full marketing authorisation was rejected by COVID-19 subject expert committee (SEC) of the Central Drugs Standards Control Organisation (CDSCO).
“After detailed deliberation, the committee did not recommend for grant of full marketing authorisation and opined that approval for Restricted Emergency use of the drug should continue,” stated the minutes of the SEC meeting, held on October 29.
This follows the World Health Organisation’s report which indicates that some of the drugs used in COVID-19 treatment, like Remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon regimens appeared to have little or no effect in the treatment of COVID-19