Pharmaceutical major Mylan has received permission from India's drug regulator to manufacture as well as market Remdesivir- an antiviral drug used in the treatment of the novel Coronavirus.
Pharmaceutical major Mylan has received permission from India’s drug regulator to manufacture as well as market Remdesivir- an antiviral drug used in the treatment of the novel Coronavirus. The nod has been given to produce Remdesivir for hospitalised patients and some restricted usage, news agency PTI reported on Thursday. The approval has come from the Central Drugs Standard Control Organisation(CDSCO), the report said citing an official.
It is to note that before using the drug, a written informed consent of each patient is needed and a report of post-marketing surveillance data along with details on serious adverse events will have to be submitted, the report said.
The pharmaceutical giant has already signed a non-exclusive licensing agreement with the US pharmaceutical company Gilead Sciences (company that holds the patent for antiviral drug Remdesivir). Gilead Sciences on May 29 had applied to CDSCO to get approval for importing and marketing of Remdesivir in India.
Drugmakers Hetero and Cipla were given permission on June 21 after which they can manufacture and market Remdesivir in the country. The permission from the Indian drug controller had come after due deliberations and all the companies are only allowed to manufacture the antiviral drug for emergency use. Apart from Cipla and Hetero, some other drug manufacturers like Jubliant, Dr Reddy’s Labs and BDR have applied for permissions and their approval is still pending with CDSCO.
Meanwhile, the Ministry of Health and Family Welfare within its ‘Clinical Management Protocols for COVID-19’ has recommended the use of Remdesivir for patients who are at a moderate stage (need oxygen support) of Coronavirus infection. As the drug is considered as a part of the investigational therapy, only restricted use is permitted.
The Health ministry had further clarified that those who are suffering from severe renal problems or have a high level of liver enzymes are not permitted to use the antiviral drug. It is also not recommended for pregnant or lactating women as well as children below 12 years of age. If given in the form of injection, a 200 mg dose should be given on the first day and 100 mg dose daily for 5 days.