CONCEPT OF DATA EXCLUSIVITY AND INDIA’S GROWTH AS GENERIC DRUG MANUFACTURER

DTAB’s decision to maintain the current data exclusivity equilibrium and instead concentrate on evaluating drug protection through bio-equivalence tests is a positive move.

The term “data exclusivity” refers to the protection of data (information) submitted to regulatory authorities or governmental agencies from third-party access. The data, in general, provides information for obtaining marketing clearances for application materials. For instance, a clinical trial report that discloses research trials conducted on people for the assessment of medical or behavioral intervention and is submitted to the government may be in support of a drug application. The information is normally needed to demonstrate the drug’s safety and efficacy.

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Article by Manisha Singh and Pankaj Musyuni, 1st published in The Legal Era

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