Counterfeit Avastin in India: Punish the Criminals, Not the Patients.
OBJECTIVE
To report the recent controversy surrounding the intraocular use of bevacizumab in India and its relationship to the broader problems of off-label drug use, medication compounding, and drug counterfeiting.


METHODS
Perspective.


METHODS
Data for this perspective were obtained from several sources. Literature reviews for compounding-related endophthalmitis and drug counterfeiting were performed. Supplemental information was obtained through targeted Google searches for related published manuscripts. First-hand accounts of negotiations between representatives of the Vitreoretinal Society of India (VRSI) and India's Central Drugs Standards Control Organization (CDSCO) were provided by 2 of the authors (R.N., V.G.).


RESULTS
In December, 2015, 15 cases of intraocular inflammation following injections of counterfeit bevacizumab occurred in Gujarat, India. CDSCO reacted by prohibiting the use of intraocular bevacizumab throughout the country. Intense negotiations between the VRSI and CDSCO resulted in the permission to use bevacizumab in accordance with new safety guidelines. These include an enhanced informed consent process, the stamping of the Kezzler code on all bevacizumab vials, a real-time digital verification process between the end user and Roche Pharmaceuticals, and mandatory destruction of empty drug vials.


CONCLUSIONS
Counterfeit bevacizumab has caused outbreaks of sterile and infectious postinjection endophthalmitis in at least 3 countries during the past 5 years and has entered the supply chain in other countries. Physicians and compounding pharmacists need to be aware that international counterfeiters have targeted bevacizumab.
Department of Ophthalmology, Mayo School of Medicine, Jacksonville, Florida. Electronic address: stewart.michael@mayo.edu.
Michael W
MW
Stewart
LV Prasad Eye Institute, Hyderabad, India.
Raja
R
Narayanan
Institute of Medical Education and Research, Chandigarh, India.
Vishali
V
Gupta
Bascom Palmer Eye Institute, Miller School of Medicine, University of Miami, Miami, Florida.
Philip J
PJ
Rosenfeld
Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.
Daniel F
DF
Martin
Department of Ophthalmology, Queen's University of Belfast, Belfast, Northern Ireland.
Usha
U
Chakravarthy
D020533:Angiogenesis Inhibitors / Q000009:adverse effects*; D000068258:Bevacizumab / Q000009:adverse effects*; D058110:Counterfeit Drugs / Q000009:adverse effects* / Q000600:supply & distribution; D057237:Criminals / Q000331:legislation & jurisprudence*; D004339:Drug Compounding; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence; D009877:Endophthalmitis / Q000139:chemically induced* / Q000382:microbiology; D015818:Eye Infections, Bacterial / Q000139:chemically induced* / Q000382:microbiology; D005607:Fraud; D006801:Humans; D007194:India; D058449:Intravitreal Injections; D056687:Off-Label Use; D061214:Patient Safety / Q000331:legislation & jurisprudence*; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors
D020533:Angiogenesis Inhibitors; D058110:Counterfeit Drugs; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; D000068258:Bevacizumab