Pharma major Mylan gets nod to produce, market remdesivir

NEWDELHI: Pharmaceutical major Mylan was on Thursday given permission by India’s drug regulator to manufacture and market anti-viral drug remdesivir for coronavirus disease (Covid-19) under “emergency use authorization”. With this, three companies in India have the licence to manufacture and sell the experimental drug. The other two companies are Hetero and Cipla.

“Mylan has received the approval today [Thursday],” confirmed a Central Drugs Standard Control Organisation official, who did not wish to be identified.

“The approval, however, has been given under emergency use authorisation which means it is an experimental drug and all prorequires tocols for this category of drugs must be strictly adhered to before giving the drug to a patient.”

The protocol includes duly informing patients about the pros and cons of the drug. It requires the written consent of each patient after every minute detail has been explained and documented before the drug is given.

Those giving the drug have to maintain a comprehensive database on reactions in patients who were given it. It is part of active post-marketing surveillance that documentation and submission of details about serious adverse events to the drug controller’s office.

On June 21, Hetero and Cipla were given permission to manufacture and market the drug under the same emergency use authorisation.

The Union health ministry has in its Clinical Management Protocols recommended the use of the drug to treat Covid-19 patients with moderate stages of the illness. The drug has been included as an “investigational therapy” only for restricted emergency use purposes, with a need for medicines that work in saving lives.

It is not recommended for those with severe renal impairment, high level of liver enzymes, pregnant and lactating women, and those below 12.

WITH THE APPROVAL, THREE COMPANIES IN INDIA NOW HAVE THE LICENCE TO SELL THE EXPERIMENTAL DRUG