Q. Which one of the following is the definition of a “new drug” under the New Drugs and Clinical Trial (NDCT) Rules, 2019?
Red Book
Red Book

[A] A drug that has been used in India to a significant extent

[B] A drug that has not been used in India to any significant extent

[C] A drug that is only used for non-communicable diseases

[D] A drug that is only used for rare disorders

Answer: B
Notes:

Explanation – Under the New Drugs and Clinical Trial (NDCT) Rules, 2019, a “new drug” is defined as a drug that has not been used significantly in India. This means it is relatively new to the Indian market and lacks substantial usage data within the country.

Source: The Hindu

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