The Avastin (bevacizumab) injection has emerged at the centre of the controversy surrounding five patients’ loss of vision in one eye each after being administered an infected injection at Sir Sunderlal Hospital here.
Avastin is not approved in India for use inside the eye (intra-vitrieal use for ophthalmology). The Drug Controller General (India) issued an alert on January 21 this year, asking the drug controllers in the states and union territories to monitor the movement of Avastin and its use in ophthalmology.
The alert notice has been signed by Dr GN Singh, Drug Controller General (India). The notice has been put on the website (www.cdsco.nic.in) of the Central Drugs Standard Control Organisation (CDSCO) which functions under the union ministry of health and family welfare.
The notice says, “Reports have appeared in the media (that) the drug Avastin (Bevacizumab Injection) 100 mg/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-vitreal route and this has led to loss of vision in certain patients at CH Nagri Eye Hospital Ahmedabad, Gujarat.”
It further states, “The drug is not approved in the country for intra-vitreal use for ophthalmology purposes. In view to safeguard the public health and as a precautionary measure, all concerned are hereby directed that drug is not used in ophthalmology and the states, union territories’ regulatory authorities may alert their inspectorate staff to monitor the movement of the said drug and its use in ophthalmology.” When asked, Uttar Pradesh drug licensing and controlling Authority AK Malhotra said, “We haven’t received any official communication from the Drugs Controller General (India) about any specific drug. Usually, we refer to their website to find out the latest development and decisions taken by the DCG.”
{{/usCountry}}It further states, “The drug is not approved in the country for intra-vitreal use for ophthalmology purposes. In view to safeguard the public health and as a precautionary measure, all concerned are hereby directed that drug is not used in ophthalmology and the states, union territories’ regulatory authorities may alert their inspectorate staff to monitor the movement of the said drug and its use in ophthalmology.” When asked, Uttar Pradesh drug licensing and controlling Authority AK Malhotra said, “We haven’t received any official communication from the Drugs Controller General (India) about any specific drug. Usually, we refer to their website to find out the latest development and decisions taken by the DCG.”
{{/usCountry}}DM orders probe
The Varanasi district magistrate on Monday ordered an inquiry into the incident in which five patients lost their sight in one eye due to the alleged use of an infected injection by doctors. There were reports that the injection given to the patients was the controversial Avastin.
Read: Infected injection affects eyesight of 5 patients in Varanasi