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MCQ

Drug Regulation and Drugs Rules 1945 MCQ - Practice Questions with Answers

Solve 1 Drug Regulation and Drugs Rules 1945 questions for RAS/RPSC preparation.

Practice questions

Q1With 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?

A 1 only
B 2 only
C Both 1 and 2
D Neither 1 nor 2
Explanation

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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