After several diabetic patients received a sham version of Roche's Avastin and lost their sight, the Drug Regulatory Authority of Pakistan (DRAP) is halting the sale or distribution of the drug until it can verify quality, the agency said in a release Sunday.
The affected patients received “altered/dispensed/diluted Avastin” to treat diabetic retinopathy, despite the drug only being approved in Pakistan to treat colorectal and other metastatic carcinomas, the regulator said.
Roche itself isn’t being blamed for the issue. Rather, DRAP singled out Genius Advanced Pharmaceutical Services, which it accused of altering, dispensing, diluting and selling unlicensed Avastin made under unhygienic and non-sterile conditions.
In response to Genius’ actions, Pakistan’s regulatory field force raided the company’s facility, according to the DRAP release.
“The premises have been sealed and legal proceedings have been initiated against the personnel involved,” DRAP said.
Roche “strongly condemns” the “criminal act of counterfeiting," the company said in an emailed statement. The company is doing “everything in its power to cooperate with the authorities to protect patients from counterfeits,” the company added.
“Avastin is not approved for any use in the eye,” Roche added. “Counterfeit medicines pose a health risk to patients because their content may be ineffective and contain harmful ingredients.”
Avastin is approved around the world to treat various cancers thanks to its ability to prevent the growth of new blood vessels that feed tumors.
This anti-VEGF mechanism has led many doctors to use the drug off-label to treat certain ophthalmic conditions, including diabetic retinopathy.