Once upon a time (before the 1960s), the world was a lot simpler and medicines were too. The medicines available in the market then were all branded and each manufacturer of medicine had their own way to prepare a certain drug. The law at the time in USA and Europe required that medicines should maintain the manufacturing process as per the manufacturer’s specification. No safety, efficacy or quality data were required to be submitted to the authorities by the manufacturer prior to marketing the drug.
The Sulfanilamide Elixir Disaster (1937), Thalidomide Tragedy (1950–60s) as well as contamination of various vaccines in the first half of the 20th century brought focus on the need for safety, effectiveness and cost-benefit analysis of using powerful drugs in various diseases. This concern ran parallel to the exponential rise in the development of new drugs especially new antibiotics. In…
