A medicine is a substance used for the diagnosis, prevention, treatment, or relief of disease. Medicines are broadly classified into branded and generic forms, where branded medicines are innovator products marketed under a trade name, and generic medicines are equivalent versions introduced after patent expiry with the same safety and efficacy.
Branded medicine
A branded medicine, also known as an innovator drug, is a medicinal product marketed under a proprietary trade name by the patent-holding company and is protected by intellectual property rights for a defined period.
Generic medicine
generic drug product is defined as one that is pharmaceutical product manufactured after patent expiry that is interchangeable with the innovator which is equivalent and bioequivalent to an innovator drug product.
Process of Development of Branded Medicines
Drug Discovery
↓
Pre-clinical Studies
(Lab & Animal testing)
↓
Clinical Trials
(Phase I → II → III)
↓
Patent Application
(20 years protection)
↓
Regulatory Approval
(CDSCO / FDA / EMA)
↓
Large-scale Manufacturing
↓
Brand Name Marketing
↓
BRANDED MEDICINE