The Health Ministry has sent samples of a drug to Central Drugs Laboratory in Kolkata following reports of around 30 patients at PGIMER, Chandigarh, complaining of infection and damage to vision after being injected with it.
"We have sent the samples to Central Drugs Laboratory in Kolkata for testing. Further course of action will be taken based on the reports," a senior health ministry official privy to the matter said.
According to reports, around 30 patients, who were injected with Avastin (manufactured by Swiss firm Roche) during treatment of retinopathy last week at the Post-graduate Institute of Medical Education and Research, Chandigarh, complained of infection and some of damage to their vision.
The Health Ministry has also sought a detailed report from PGIMER, Chandigarh, in this regard.
According to news reports, PGIMER suspects the problem was with a particular batch of the drug and has written to the state drug controller maintaining there were no lapse on its part.
Roche, meanwhile, said Avastin (popular brand name for bevacizumab) is an important cancer therapy and is approved for intravenous treatment of several types of advanced cancer.
"Avastin has not been approved for use in the eye by the US FDA, EMA or the Government of India. Furthermore, it is not developed and manufactured to meet intraocular (usage in the eye) standards.
"Adaptation of the product for use in this way is considered 'off label'," it said in a statement.
Noting that patient's safety is always its primary concern, it said the company is taking 'off label' use of Avastin in the eye "very seriously".
"Roche will co-operate fully with any investigation undertaken by the authorities," it said.
The company said when a physician makes a choice to use it 'off-label' in the eye, the original product is typically "partitioned or aliquoted" in a hospital or pharmacy, potentially for use in multiple patients.
"This process bears the risk of bacterial contamination and has already led to serious bacterial infections of the eye in other countries around the world," it said.
It said information regarding these events and the risks are also included in the prescribing information, which is inserted in each pack.
"We strongly recommend that Avastin should be used in line with the approved prescribing information and not for any eye indication," it said.
