India has withdrawn an alert on off-label use of Roche's ($RHBBY) approved oncology drug Avastin to treat age-related macular degeneration after an expert committee advised the country's drug regulator the treatment is beneficial.
Earlier this year, the Indian states of Telangana and Gujarat blocked sales of Avastin (bevacizumab) after reports that 15 patients who had it injected into their eyes for related treatment partially lost sight.
Roche has stated it does not approve the use of Avastin for anything other than cancer treatments and raised concerns of bacterial infections if injected into the eye.
However, according to the Business Standard newspaper, the Drug Controller General of India (DCGI) accepted an expert committee report that safety and efficacy use for eye injections was demonstrated in "over 2,500 independent studies published globally and that it is 40 times cheaper than the other available drug for the same use."
According to the Business Standard, the expert committee suggested the All India Ophthalmological Society (AIOS) and Vitreo Retinal Society of India (VRSI) formulate guidelines for ophthalmic use of Avastin.
"The AIOS, in tune with the recommendation, has already formulated guidelines and communicated it with its members along with details of the consent format," D. Ramamurthy, AIOS president, told the Business Standard.
Ramamurthy said that in India a vial of Avastin costs INR25,000 ($372.65) to INR27,000 ($402.46) and could cover 15 patients. He added that the other therapies used such as Lucentis (ranibizumab) remain more expensive, though prices have dropped.
- here's the story from Business Standard