Question

Which schedule of the Drugs and Cosmetics Act covers Good Manufacturing Practices (GMP)?

• A. Schedule H
• B. Schedule M
• C. Schedule K
• D. Schedule X

Hint:

Important schedules in the Drugs and Cosmetics Act:

• \textbf{Schedule M} $\rightarrow$ Good Manufacturing Practices (GMP)
• \textbf{Schedule H} $\rightarrow$ Prescription drugs
• \textbf{Schedule X} $\rightarrow$ Narcotic and psychotropic drugs
• \textbf{Schedule K} $\rightarrow$ Drugs exempted from certain provisions

Remember: \textbf{GMP = Schedule M}.

Answer 1

The Correct Option is B

Step 1: Understanding the Concept:
The Drugs and Cosmetics Act, 1940, and its associated rules contain various schedules that regulate the import, manufacture, distribution, and sale of drugs in India.
Each schedule dictates specific legal guidelines for different categories of drugs and manufacturing practices.
Step 2: Key Approach:
Identify the specific lettered schedule that outlines the requirements for Good Manufacturing Practices (GMP).
Step 3: Detailed Explanation:
Schedule H contains a list of prescription drugs that cannot be sold without the prescription of a registered medical practitioner.
Schedule M details the Good Manufacturing Practices (GMP) and requirements of premises, plant, and equipment for pharmaceutical products.
Schedule K lists drugs that are exempted from certain provisions related to manufacture and sale.
Schedule X covers narcotic drugs and psychotropic substances that require special licenses for sale and storage.
Therefore, Schedule M is the correct answer.
Step 4: Final Answer:
Schedule M covers Good Manufacturing Practices (GMP).