Branded original drugs pass through years of research and development before reaching the market. The process starts with research on a disease and its potential cures. Once the drug discoverer derives a plausible theory that a certain active ingredient or ingredients can treat a disease, he proceeds to the next phase – laboratory testing on animals. If the drug proves safety and efficacy on animals, it moves to the next phase – controlled human trials. Still effective and safe? It then gets released under post marketing surveillance. If the drug causes problems, it will be pulled out on the market. Otherwise the new drug is patented with the Intellectual Property Office and the manufacturer gets 20years of exclusive rights to produce it.
The process of producing medicines takes about 15 years and involves millions of dollars. Some drug researches prove good in theory, only to fail in the development stages. When this happens, drug development may go back to square one, further prolonging the process and inflating costs. Expenses during development and production are factored into the market price of every newly developed drug.
Once the patient of an innovator drug expires, any manufacturer can copy and produce the same drug if they meet the requirements set by governments. Prices of generic drugs cover only production, packaging, marketing, distribution, and manufacturers’ profit.
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