The Drug Controller General of India (DCGI) granted a conditional permission for off-label use of bevacizumab injection (Roche’s Avastin) for ophthalmological problems and withdrew the alert notice issued against the drug on January 21 this year.

Bevacizumab injection is a drug that slows the growth of new blood vessels. It is approved by US FDA for certain metastatic cancers. But in India it was used as off-label by ophthalmological surgeons for treating eye ailments.

The CDSCO issued the Alert Notice in January cautioning the public and the healthcare community, including state and Union Territory regulatory authorities, that Roche’s Avastin (bevacizumab injection) was not approved in India for intravitreal use for ophthalmology purposes. Dr G N Singh had issued the notice in the light of the tragic incident occurred in a hospital in Gujarat where 15 patients’ vision was lost after this injection was taken. The notice explained that Roche’s Avastin had not been approved to treat any ophthalmic conditions and it could damage the eye sight.

Now DCGI has withdrawn the alert notice on the recommendations of the expert committee. The latest circular says that the committee examined and deliberated on the use of bevacizumab injection in ophthalmologic conditions as an off-label use and it was observed that the drug was not approved by global regulatory authorities for intravitreal use due to non-application by the Innovator for this purpose. However, WHO (April 2015) has recommended bevacizumab injection by including in the list of essential medicines prepared as anti-vascular endothelial growth factor in ophthalmic section based on recommendations of International Council of Ophthalmology (ICO). Further, regulatory agencies of France and Italy have allowed its off-label use as a Temporary Recommended Use (TRU).
 
Another observation of the expert committee is that the safety and efficacy of bevacizumab injection in intravitreal use is stated to be proven by various independent studies (over 2500 studies published) conducted globally. It was discussed that rate of endophthalmitis is significantly lower after the injection of this drug as compared to standard cataract surgery. Besides, it is 40 times cheaper than other available drug (ranibizumab injection) for same use and equally effective in India. This would put less financial burden on patients and prevent blindness of many.
 
Based on these facts, the expert committee requested the office of the DCGI to take necessary action to withdraw the alert notice issued on January 21 this year which was primarily issued as a precautionary measure in the light of the incidences of blindness reported in Gujarat. Further, it was proposed that All India Ophthalmological Society (AIOS) and Vitreo Retinal Society of India (VRSI) will formulate guidelines for safe and effective use of bevacizumab injection for ophthalmic purpose based on the written-informed consent as practiced globally for off-label use under appropriate environmental conditions by skilled ophthalmic surgeons based on risk-benefit analysis. They will further ensure that appropriate training and awareness may be imparted to its members, says the circular of the DCGI.
 
The national drug regulator has withdrawn his earlier alert notice because the ministry of health family welfare has accepted the recommendations of the expert committee.
 
Meanwhile, the writ petition filed by the Pharmaceutical Manufacturers Association in Tamil Nadu against DCGI for handling FDC control is coming for hearing in the last week of this month, sources informed.