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DCGI took strict measures on opthalmic drug Avastin

 

Clinical courses

 

Clinical courses

Drugs Controller General India (DCGI) took strict measures on Roche's Avastin (Bevacizumab Injection) after some reports on loss of visions. It is noted that opthalmic injection of Avastin leads to blindness in some patients which is not approved for intra-vitrieal use in India as per DCGI.

There are some reports has appeared that the drug Avastin (Bevacizumab Injection) 100mg/4ml/ 400 mg/16ml vials manufactured and marketed by M/s Roche Product (India) Pvt. Ltd., have been used in the treatment of eye ailments through intra-vitrieal route and this has lead to loss of vision in certain patients at M/s C. H. Nagri Eye Hospital, Ahmadabad, Gujarat.

The drug is not approved in the country for intra-vitrieal use for ophthalmology purposes.

Therefore DCGI directed to regulatory authorities that the drug is not used in ophthalmology to safeguard the public health and as a precautionary measure asked State / UT regulatory authorities to alert their inspectorate staff to monitor the movement of the Avastin and its use in ophthalmology.

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