DCGI withdraws Alert on Bevacizumab Injection in Ophthalmologic conditions
The Office of the DCG(I) has been asked by the Ministry of Health to withdraw its alert regarding the use of Bevacizumab Injection in Ophthalmologic condition based on the recommendations of an Expert Committee meeting held on 08.02.2016 which emphasised on the safety and efficacy of Bevacizumab injection in intravitreal use and the affordability of the injection.
The DGC (I) had issued the alert notice issued vide letter no 12-52/2004-DC (Part- I) dated 21.01.2016 as a precautionary measure in the light of the incidences of blindness reported in Gujarat.
The committee's report was in continuation of the alert notice issued .
According to the DCG( I), the Committee's deliberation and observation report on the Bevacizumab injection in Ophthalmologic conditions as an off-label indication ran as follows:
1. Bevacizumab Injection is 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 recommendation of International Council of Ophthalmology (ICO), Further, regulatory agencies of France and Italy have allowed its off-label use a Temporary Recommended Use (TRU).
2.. 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 Bevacizumab Injection as compared to standard cataract surgery.
3. The Bevacizumab Injection 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.
The committee besides requesting a withdrawal of the notice by the DGC (I), also proposed that All India Ophthalmological Society (AIOS) and Vitreo Retinal Society of India (VRSI) formulate guidelines for safe and effective use of Bevacizumab Injection for ophthalmic purpose. This it wanted done based on the written and informed consent as practiced globally for off-label use, under appropriate environmental conditions by skilled ophthalmic surgeons based on risk-benefit analysis. It also recommended imposition of appropriate training and awareness to its members.
The Ministry of Health and Family Welfare, Government of India has accepted recommendation of the Committee.
The DGC (I) had issued the alert notice issued vide letter no 12-52/2004-DC (Part- I) dated 21.01.2016 as a precautionary measure in the light of the incidences of blindness reported in Gujarat.
The committee's report was in continuation of the alert notice issued .
According to the DCG( I), the Committee's deliberation and observation report on the Bevacizumab injection in Ophthalmologic conditions as an off-label indication ran as follows:
1. Bevacizumab Injection is 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 recommendation of International Council of Ophthalmology (ICO), Further, regulatory agencies of France and Italy have allowed its off-label use a Temporary Recommended Use (TRU).
2.. 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 Bevacizumab Injection as compared to standard cataract surgery.
3. The Bevacizumab Injection 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.
The committee besides requesting a withdrawal of the notice by the DGC (I), also proposed that All India Ophthalmological Society (AIOS) and Vitreo Retinal Society of India (VRSI) formulate guidelines for safe and effective use of Bevacizumab Injection for ophthalmic purpose. This it wanted done based on the written and informed consent as practiced globally for off-label use, under appropriate environmental conditions by skilled ophthalmic surgeons based on risk-benefit analysis. It also recommended imposition of appropriate training and awareness to its members.
The Ministry of Health and Family Welfare, Government of India has accepted recommendation of the Committee.
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