Do Generic Medicines Need To Obtain License?

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A generic medicine is something that directly affects the general public. It is a topic that comes under the concurrent list. You will find several generic medicine store franchises in India, but people aren’t much aware of their existence.

Let’s see the licensing policy related to generic medicines,

License for generic medicines

Generic drugs are approved only after a rigorous review by the FDA and after a set period that the brand product has been on the market exclusively. This is because new drugs, like other new products, are usually protected by patents prohibiting others from making and selling copies of the same drug.

In India, the generic medicines are approved jointly by Drugs Inspectors of Central Government and State Governments to verify compliance with the conditions of the license and the provisions of the Drugs & Cosmetics Act and Rules for not less than once in three years or as needed as per risk-based approach.


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