Q. Consider the following statements:
1.A fixed-dose combination (FDC) medicine refers to a pharmaceutical product that contains a single active ingredient formulated in different strengths.
2.In India, FDCs can only be approved by the central government.
Which of the statement(s) given above is/are correct?
Answer: B
Notes:
Explanation –
Statement 1 is incorrect. A fixed-dose combination (FDC) medicine refers to a pharmaceutical product that includes two or more active ingredients combined in a single dosage form, such as a pill or capsule.
Statement 2 is correct. In India, fixed-dose combinations (FDCs) are considered new drugs and require approval from the central drug regulatory authority, which is the Central Drugs Standard Control Organization (CDSCO).
Source: The Hindu
