There was a time when no safety and quality of medicines were required to be submitted to the authorities. Manufacturers without any fear of being getting punished had freedom to prepare drugs. In fact, there was a law in USA and Europe that manufactures were allowed to prepare drugs as per their own specification.
This turned out to be disastrous in the first half of the 20th century as tragedies like Sulfanilamide Elixir Disaster (1937), Thalidomide Tragedy (1950-60s) took place. After such tragic incidents, voices were raised to make a proper regulatory body.
After 1960, the USA then decided to change its laws and the United States Food and Drug Administration (USFDA) was formulated. Every drugs manufacturer then had to take permission from the new body to get approval.
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On one hand, people were satisfied that the drugs they will get now will not be contaminated but on the other hand, the cost of creating drugs increased massively. Earlier, the preparation of medicines required much less cost but after the regulatory body was made, the cost got a huge jump.
Seeing US, many countries started following the same concept and several regulatory bodies were then established. But in 1984, US again changed its laws in order to ease some pressure from the manufacturers.
According to new laws, manufacturers were not required to repeat the expensive clinical tests to check the safety of drugs. However, when these rules started spreading in developing countries like India, it turned out to be horrible.
Poor laws were formed in developing countries which led to low quality and contaminated drugs. Generic manufacturing was boomed in 1980-90s due to slack laws. The successive governments were also responsible as they were not bothered about quality of drugs. The only thing that bothered them was how to reduce the cost.
India who ranks ranked 4th in the global generics market, leads the race in the global burden of counterfeit medicines. To everyone’s shock, 75 per cent of all counterfeit medicines traces its roots to India.