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Drug regulator denies Dr. Reddy’s full marketing authorisation for remdesivir

The development comes even as the Recovery Trial, whose results were made public last month, showed that remdesivir had no significant benefit for Covid-19 patients. 

Published: 02nd November 2020 07:19 PM  |   Last Updated: 02nd November 2020 07:47 PM   |  A+A-

For representational purposes

Express News Service

NEW DELHI: India’s apex drug regulator has turned down a proposal by a pharmaceutical major for full marketing authorisation for remdesivir for Covid-19 patients but has said that the emergency use authorisation for the drug will continue. 

The development comes even as the Recovery Trial, led by the World Health Organisation, whose results were made public last month, showed that remdesivir, along with three other drugs tested, had no significant benefit for Covid-19 patients. 

As per the findings of the randomised clinical trial, among 2743 patients given ebola drug remdesivir, 301 died while 303 of the 2708 patients not given the medicine also succumbed to the infectious disease. 

The Covid-19 subject expert committee of the Central Drugs Standards Control Organisation, meanwhile, in response to an application by the Hyderabad based Dr. Reddy’s Laboratories, one of the four makers of the generic versions of remdesivir in India, maintained that the status quo will remain. 

“The firm presented the proposal along with clinical data for change in regulatory approval status for remdesivir injection from restricted emergency use to full marketing authorisation,” says the minute of the meeting held on October 29. 

“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,” it adds. 

The drug regulator, so far has not defined "restricted emergency use" approval in contrast to full marketing approval in spite of several requests by patients’ rights group All India Drug Action Network. 

Many doctors and researchers have also been questioning the permitted use of remdesivir for moderate to severe Covid-19 patients saying that it looks aimed at helping drug makers rather than patients. 

But despite the results from the Recovery Trial, the Union ministry of health and family welfare too, has also not amended its National Covid-19 Clinical Management Protocol which endorses the use of remdesivir and hydroxychloroquine under certain conditions.



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