InvestorQ : Why has Reddy Labs application for marketing Remdesivir been rejected by the DSCO?
Archita Jajjoo made post

Why has Reddy Labs application for marketing Remdesivir been rejected by the DSCO?

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Niti Shenoi answered.
3 weeks ago
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Let me clarify that it is not a rejection. What the Central Drugs Standard Control Organisation has done is to reject proposal for a full approval for Remdesivir putting up by Reddy Labs. Instead they want it for restricted emergency use of the drug only. That is a fair argument as it is better to be reserved for special cases only.

The committee has taken the view that it would be premature to grant full marketing authorisation and opined that approval for Restricted Emergency use of the drug should continue. That was broadly what was expected.

It may be recollected that Reddy Labs is one of the 7 manufacturers in India with whom Gilead of the US has a licensing agreement for manufacturing and sell Remdesivir in India and other low income nations. The other companies include Cipla, Jubilant Life, Hetero Drugs, Mylan, Zydus Cadila and Syngene; which is a subsidiary of Biocon.

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