Will Gilead sciences get marketing authorization in India?
Gilead sciences seeks Indian marketing authorization
The US pharma giant Gilead sciences applied for the marketing authorization of its antiviral drug remdesivir in India in which the drug is considered as a potential treatment. The company applied for the authorization to CDSCO ( Central Drugs Standard Control Organization) which will examine the effectiveness of the drug. The company holds the data of the pre and post clinical studies for the drug.
Among all the countries the US is in the great emergency situation due to COVID. So the country has given emergency use authorization (EUA) for the drug. The Japanese Ministry of Health approved the drug under an exceptional pathway. A new development source stated that on the basis of USFDA approvals and other authorized approvals India can issue an authorization to the drug according to 2019 Drug and clinical trial rules.
This will also be a backdrop of two pharmaceutical giants in India Cipla and Hetero labs in which they have applied for the permit to manufacture remdesivir. An official said that the companies have got the green signal for clinical trial waiver but their applications are still pending.
Gilead science has made up a non-exclusive license agreement for the manufacture and distribution of remdesivir with Cipla, Junliant life sciences, and hetero. The Indian Council of Medical Research stated earlier that remdesivir was used during the Ebola outbreak and it can control SARS-CoV-2 replication.
A recent study by The New England journal of medicine says that two of the three patients administered with remdesivir was cured. Any new drug has to go through the trials before getting authorization for marketing in India. But according to the 2019 Drug and clinical trial rules, there are certain clauses in Phase 3 clinical trials in which the drug can be marketed in situations such as medical emergency.
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