Post on 17-Aug-2015
Challenges for Generic Companies on Grounds of Quality, Efficacy and Safety
M. Faisal Shahid
University of Karachi
Generic Drug
A drug formulation, equivalent to an innovator brand standard in terms of efficacy, therapeutic effect with same strength, dosage and formulation
Quality Issues
Commoditization, and vast reforms in regulated and unregulated markets
Increased competition on prices
Complex product portfolios
Safety
Top Five Major Issues for Deviations:
Air Monitoring and Ventilation Issues Essential Equipment Failures Set Point Instrument Drifts/Maintenance Design Checks and Plant Operations/Scale ups Failures due to Flow Induced Vibrations
Efficacy
Bio-availibility deviations in formulations Factors:
Process scale up problems Lack of compliance API sources Product closure/storage parameters
Biologics
Sero-Rico, but uncertain results Hot cake in regulated markets High risk, high gains High technical and analytical requirements Will account for 8/10 of top drugs by 2016
Conclusions
Generic sector market share shall increase in coming decade
Biologics and Bio-similars will dominate regulated markets
With increasing regulatory support and framework, generic sector would flourish in third world states