Following a distressing incident in which several diabetic patients were administered a counterfeit version of Roche’s Avastin, resulting in the loss of their vision, the Drug Regulatory Authority of Pakistan (DRAP) has taken decisive action by suspending the sale and distribution of the drug until its quality can be thoroughly verified. This move, announced by the agency on Sunday, reflects DRAP’s commitment to ensuring patient safety.
The affected patients were inadvertently given a “modified/altered/dispensed/diluted Avastin” as a treatment for diabetic retinopathy, despite the fact that Avastin is exclusively approved in Pakistan for treating colorectal and other metastatic carcinomas, as clarified by the regulatory body.
It’s important to note that Roche, the manufacturer of Avastin, is not at fault in this unfortunate situation. Instead, DRAP has singled out Genius Advanced Pharmaceutical Services, alleging that this entity engaged in the unauthorized alteration, dispensing, dilution, and sale of Avastin under unhygienic and non-sterile conditions.
In response to the actions of Genius, Pakistan’s regulatory field force conducted a raid on the company’s facility, as outlined in the DRAP’s official release. Consequently, the premises have been sealed, and legal proceedings have been initiated against those individuals involved, according to DRAP’s statement.
Roche has categorically condemned this incident of counterfeiting, characterizing it as a “criminal act.” The company has expressed its full commitment to cooperating with the authorities to safeguard patients from counterfeit medications, emphasizing that Avastin is not authorized for ocular use. Roche also underscored the significant health risks associated with counterfeit medicines, which may contain ineffective or harmful ingredients.
Avastin has earned global approval for its capacity to inhibit the growth of new blood vessels that nourish tumors, owing to its anti-VEGF mechanism. This unique property has led many healthcare professionals to employ the drug off-label for the treatment of specific ophthalmic conditions, including diabetic retinopathy.