MCQ
Drug Regulation MCQ - Practice Questions with Answers
Solve 3 Drug Regulation questions for RAS/RPSC preparation.
Practice questions
Q1Among the 16 banned Fixed-Dose Combination (FDC) drugs, match the active ingredient in List I with the ingredient it was combined with in List II: List I (Ingredient) List II (Combined with) A. Cefadroxyl 1. Probenecid B. Paracetamol 2. Lignocaine C. Gliclazide 3. Chromium Picolinate D. Acetyl Salicylic Acid 4. Ethoheptazine Select the correct answer using the codes given below:
Per the list of banned FDC drugs: Cefadroxyl was combined with Probenecid (A-1); Paracetamol with Lignocaine (B-2); Gliclazide with Chromium Picolinate (C-3); and Acetyl Salicylic Acid with Ethoheptazine (D-4). Hence the correct match is A-1 B-2 C-3 D-4, which is option B.
Q2With reference to the recent ban on Fixed-Dose Combination (FDC) drugs, consider the following statements: 1. The Centre banned the 16 FDC drugs under Section 26A of the Drugs and Cosmetics Act. 2. The ban was imposed without any review of clinical data by an expert committee. Which of the statements given above is/are correct?
Statement 1 is correct: the Ministry of Health and Family Welfare banned the 16 FDC drugs under Section 26A of the Drugs and Cosmetics Act. Statement 2 is incorrect: the Drugs Technical Advisory Board (DTAB) formed an expert committee that reviewed the clinical data and concluded the combinations offered no real therapeutic value. Hence only statement 1 is correct.
Q3With reference to the proposed acknowledgement-based Form 11 system for import of drugs for analytical and non-clinical testing, consider the following two statements: 1. The system, proposed through an amendment to the Drugs Rules, 1945, allows applicants to import small quantities of drugs on the basis of an acknowledgement received against a prior intimation form. 2. Sex hormones, cytotoxic drugs and narcotic and psychotropic substances are exempted from licensing and can be imported under the same acknowledgement-based system. Which of the statements given above is/are correct?
Statement 1 is correct; Statement 2 is incorrect, so the answer is "1 only". Statement 1 accurately describes the proposal: through an amendment to the Drugs Rules, 1945, applicants may import small quantities of drugs for examination, test or analysis on the basis of an acknowledgement received against a prior intimation form. Statement 2 is incorrect because sex hormones, cytotoxic drugs, beta-lactam drugs, biologicals containing live microorganisms, and narcotic and psychotropic substances are specifically EXCLUDED and continue to require a licence; they cannot be imported under the acknowledgement-based system.
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