2021-04-29 08:29:01
The above is news from Indian Express. Let us understand this holistically. First understand the terms:
1) A generic drug is a medication that has exactly the same
active ingredient as the brand name drug and yields the same therapeutic effect. It is the same in dosing, safety, strength, quality, the way it works, the way it is taken, and the way it should be used. Generic drugs do not need to contain the same
inactive ingredients as the brand name product, say colour or taste can be different.
However, a generic drug is generally marketed after the brand name drug's patent has expired, which may take up to 20 years. So, during the protection period of 20 years, the patent owner tries to recover its cost which it has spent on research and development and the drug is quite costly during this time as it is produced only by the patent owner under its brand name and others can’t manufacture and sell. After the protection period is over, any company can sell the generic versions of the drug and there is fierce competition which ultimately reduces the price of the drug.
But the (Indian Patent Act 1970) patent laws provide a remedy to the high price issue of branded drugs in the form of
licenses to the generic manufacturers even during the protection period of 20 years. This remedy is available in the form of
voluntary license (patent holder himself gives license to third party to manufacture the generic version and he decides the royalty/price etc.) and
compulsory licensing of the drug.
2) (Chemical) Reverse Engineering: It is the analysis of a product where a lab breaks down a material or product to determine the identity and quantity of its components. This process enables scientists to take a medication and discover the contents of its core and coatings. This is the method necessary to create
a generic version of a medication and requires various chemical processes to discover the exact contents of a formula.
3) Fixed Dose Combination (FDC) drugs are combinations of two or more active drugs in a single dosage form.
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