Generic Drugs

“ GENERIC DRUGS” are the off patent drugs which are introduced into the market upon the expiry of the patent having the identical BIO-EQUIVALENCE”(Pharmaceutical equivalents whose rate and extent of absorption are not statistically different when administered to patients or subjects at the same molar dose under similar experimental conditions of the branded drug.)
They are boon and unequivocally Bane too.
BOON: They are safe and effective alternatives to brand name prescriptions
• Can help both consumers and the government reduce the cost of prescriptiondrugs
Factors Driving the Generics Growth:
Consumers becoming increasingly sensitive to pharmaceutical costs and aware of safety and efficacy standards for Generic products
Direct-to-consumer advertising is furthering the awareness and propensity towards generic substitution
Pressure to reduce healthcare costs, resulting in a push towards generic drug utilization (both from Government and Private Sector)
1. Ageing Population (at lower incomes) requiring increased medical attention à More Healthcare Costs
2. HMOs, Insurance Companies and Employers à under pressure to reduce healthcare spending à increased use of cost-containment measures
BANE: They reduce the amount of profits reaped by the original patent holders and handicaps their efforts.It also hampers the R&D sector in the nations particularly in INDIA and encorages them to continue thierr age old name as “COPY –CATS” .
The Quality of generic drugs is assured by:
• Bioequivalence for complicated products is discussed with
the same staff that reviewed the brand product.
• FDA has experience with the product
• Scientific literature published
• Product is known to be safe
.