New Delhi: The Modi government’s panel of experts has rejected a proposal by Hyderabad-based drug maker Dr Reddy’s Laboratories seeking change in regulatory approval status of antiviral drug Remdesivir.
Dr Reddy’s is one of the key companies manufacturing the investigational drug, which is also seen as one of the most popular and closely watched treatments for Covid.
Dr Reddy’s had in October submitted the proposal before the subject expert committee (SEC) along with clinical data, seeking to change the regulatory approval status for Remdesivir injection from “restricted emergency use” to “full marketing authorisation”.
The SEC advises apex regulator Drug Controller General of India (DCGI) on applications seeking approvals for new drugs, vaccines, and clinical trials for Covid.
“Restricted emergency use” status is given to the drugs which are still unapproved in the country but allowed due to an emergency situation, whereas giving “marketing authorisation” to any drug qualifies it as an approved drug by the regulator, which means its indications, effects and side-effects are mostly known.
However, “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,” according to the minutes of the meeting uploaded on the Central Drugs Standard Control Organisation’s (CDSCO) website — the health ministry arm that regulates the quality of drugs and vaccines in the country.
The decision was taken by the SEC in a meeting on 29 October.
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Remdesivir still under review
In June, the Ministry of Health and Family Welfare had updated the Clinical Management Protocol for Covid, in which Remdesivir was included as an investigational therapy only for “restricted emergency use” purposes.
During the emergency approval of the drug, originally manufactured by US-based Gilead Sciences, the health ministry had highlighted that the use of Remdesivir and other therapies such as Tocilizumab is based on “limited available evidence”.
The latest set of data from the interim findings of the World Health Organization’s Solidarity trial had revealed that none of the four repurposed drugs examined, including Remdesivir, had any benefits on Covid patients.
Remdesivir has been granted a full regulatory approval in the US, making it the first drug for Covid-19 to receive the Food and Drug Administration’s approval.
The National Task Force for Covid-19, set up by the Centre to advise on Covid-related research, is also reviewing the use of the drug based on the emerging evidence to decide whether Remdesivir should be continued or discontinued from the health ministry’s clinical management protocol.
Healthcare experts have also asked the DCGI to clarify the meaning of “restricted emergency use” in India.
“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 (All India Drug Action Network) over several months, 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,” said Malini Aisola, healthcare expert and co-convenor of AIDAN, a civil society group working towards a rational drug policy.
Also read: Approved by US, rejected by WHO — science of remdesivir & why it has turned controversial