Intra vitreal use of Avastin is back
After the Drug Controller General India (DCGI) issued an alert / ban against the intravitreal use of Avastin, a core committee was formed by the leadership of All India Ophthalmological Society (AIOS) and the Vitreo-Retinal Society of India (VRSI) to resolve this issue. The team led by Dr D Ramamurthy, President-Elect, AIOS met the union Health Secretary on 2nd February. Detailed dossiers were also sent to the PMO, Health Minister and the DCGI. The DCGI called for a meeting of an expert committee from various leading ophthalmic institutions and representatives of AIOS-VRSI yesterday on 8th Feb. The meeting was also attended by the top representatives of Roche, which manufactures Avastin. The main outcomes of the meeting were as follows: • A rejoinder will be issued by the DCGI allowing the intra vitreal use of Avastin, after getting an informed consent from the patients and mentioning it is an off-label usage. • Roche has been instructed to reinstate the Kezzler code on every individual vial, which they had withdrawn a few years back. Kezzler code is a 16-digit alphanumeric serial used to instantly authenticate each and every vial by sending an SMS to Roche. This should help to prevent spurious drugs from entering the market. • A list of authorized dealers across India will be made available and it is better to procure the medicine from them only ensuring the preservation of cold chain. • AIOS-VRSI will prepare a set of guidelines for the usage/injection of intra vitreals. A standard consent form will also be circulated. The use of Avastin should be commenced only after the rejoinder is issued by DCGI. Use of this drug continues to remain off label. It should be used only after obtaining an informed consent. The challenge of fractionation and maintaining sterility needs to be addressed.
After the Drug Controller General India (DCGI) issued an alert / ban against the intravitreal use of Avastin, a core committee was formed by the leadership of All India Ophthalmological Society (AIOS) and the Vitreo-Retinal Society of India (VRSI) to resolve this issue. The team led by Dr D Ramamurthy, President-Elect, AIOS met the union Health Secretary on 2nd February. Detailed dossiers were also sent to the PMO, Health Minister and the DCGI. The DCGI called for a meeting of an expert committee from various leading ophthalmic institutions and representatives of AIOS-VRSI yesterday on 8th Feb. The meeting was also attended by the top representatives of Roche, which manufactures Avastin. The main outcomes of the meeting were as follows: • A rejoinder will be issued by the DCGI allowing the intra vitreal use of Avastin, after getting an informed consent from the patients and mentioning it is an off-label usage. • Roche has been instructed to reinstate the Kezzler code on every individual vial, which they had withdrawn a few years back. Kezzler code is a 16-digit alphanumeric serial used to instantly authenticate each and every vial by sending an SMS to Roche. This should help to prevent spurious drugs from entering the market. • A list of authorized dealers across India will be made available and it is better to procure the medicine from them only ensuring the preservation of cold chain. • AIOS-VRSI will prepare a set of guidelines for the usage/injection of intra vitreals. A standard consent form will also be circulated. The use of Avastin should be commenced only after the rejoinder is issued by DCGI. Use of this drug continues to remain off label. It should be used only after obtaining an informed consent. The challenge of fractionation and maintaining sterility needs to be addressed.
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