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. The study was carried in across 405 hospitals in more than 30 countries, which measured the impact – or lack of – on factors like how often ventilation was required, how long hospitalised patients needed to stay in primary care, and the overall number of deaths.
Now, patient advocacy groups are seeking comprehensive data update related to COVID-related products from the Drug Controller General of (India) (DCGI). It has also requested to provide data on the type of approval, legal provisions for COVID – 19 related product regulatory approvals and mechanisms to build trust in the regulatory system.
Analysing the ongoing debate on whether remdesivir is effective for COVID-19 treatment or not, Bejon Misra, Founder Director, Patients Safety and Access Initiative commented, “It is a high time that robust decisions are taken based on science by experts, and then made public. Also, all treatments provided to COVID-19 patients are done by seeking consent from patients and making them aware of all the consequences. This will not only bring transparency in the process but will also build trust in the regulatory system existing in our country. Several reports contradicting each other is creating doubt and suspicion in the minds of the patients and caregivers. Therefore, we urge the authorities to build consensus before any kind of advisories and approvals are given to avoid such conflicting situations.”
On October 23, 2020, AIDAN had also written a letter to the DCGI requesting for a comprehensive and regularly updated list of COVID-related product regulatory approvals. As per the letter to the DCGI, it requested details of each case mention about the 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 (such as for restricted emergency use).
Malini Aisola, Co-Convenor, AIDAN said, “The CDSCO has till date not provided the meaning of “restricted emergency use” approval in contrast to full marketing approval. In spite of repeated requests by AIDAN over several months, the CDSCO has not provided the list of COVID-related regulatory approvals along with any conditions/restrictions attached to each approval and the legal provision under which it is granted.”
Another patient activist commented that analysing the present situation, the DCGI should make the data on remdesivir presented by the company (Dr Reddy’s) public, alongwith the reasons provided by the SEC for not granting the approval.
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