Remdesivir use may be managed by government


MUMBAI: The subject expert committee of the Drug Controller of India has suggested that drugmaker Gilead’s experimental drug remdesivir should be administered under a ‘compassionate use’ programme and not sold directly to private hospitals, considering that the drug is still under trial.

This essentially means that the companies which have got the licence to manufacture the drug will have to sell it to government institutions, ET has learnt from officials aware of the development.

The recommendations come as four Indian drug companies, Cipla, Hetero, Mylan and Jubilant, gear up to get an approval for the drug in the treatment of Covid-19.

Remdesivir received an emergency authorisation approval in countries like US and Japan, and in US its distribution is controlled.

The US Food and Drug Administration (FDA), while giving its emergency approval, has restricted supply where it said that distribution of the drug will be controlled by the US government.

The US FDA directed that Gilead will supply the drug to authorised distributors, or directly to a US government agency, who will then distribute to hospitals and other healthcare facilities as directed by the government, in collaboration with the state as well as local government authorities.

“Since most patients who are currently being treated for Covid-19 are in public hospitals and since the efficacy is still not known, this seems to be the thinking,” said an official who was aware of the development and did not wish to be quoted due to the sensitivity of the issue.

In case of remdesivir, Indian companies have asked for a trial waiver.

READ  ECR earns Rs 1,588 cr in Aug, emerges top revenue zone

“In India, if the Indian health ministry introduced the drug out of clinical trials, it should ensure that the guidelines are in place for informed consent and monitored emergency use of remdesvir, the results of which are documented and shared in a timely manner with the wider medical and scientific community,” said Leena Menghaney, who is a lawyer with Doctors Without Borders.





READ SOURCE

LEAVE A REPLY

Please enter your comment!
Please enter your name here