Pharma major Mylan gets nod to produce, market remdesivir

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 currently have the license 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 protocols 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 requires 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 considering the Covid-19 pandemic, and the need for medicines that work in saving lives.

On May 1, the US Food and Drugs Administration gave Gilead Sciences, which holds the patent for the drug, authorisation for its emergency use on Covid-19 patients.

The US Pharma major has announced it was in discussions with some of the world’s leading chemical and pharmaceutical manufacturing companies, including in India, to produce the drug that had shown anti-viral properties again Sars-Cov-2, the virus that causes Covid-19.

Gilead applied for import and marketing of remdesivir to the Indian drug regulatory authority on May 29, and the permission was given on June 1.

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

The 200 mg drug has to be administered in the form of injection on day one followed by 100 mg daily for five days. – Hindustan Times