Question

Requirements of factory premises for the manufacture of cosmetics are mentioned in the Drugs and Cosmetics Rules, 1945 under:

• A. Schedule M
• B. Schedule M-1
• C. Schedule M-2
• D. Schedule M-3

Answer 1

The Correct Option is B

The question is about identifying the correct schedule in the Drugs and Cosmetics Rules, 1945, that outlines the requirements of factory premises for the manufacture of cosmetics. Understanding the context of the question is crucial here as it relates to the regulatory framework governing cosmetic manufacturing in India.

To arrive at the correct answer, let’s evaluate each option:

• Schedule M: Primarily pertains to the Good Manufacturing Practices (GMP) and requirements of premises, plant, and equipment for pharmaceutical products. It does not specifically cover cosmetics.
• Schedule M-1: This schedule specifically outlines the requirements for factory premises to manufacture cosmetics. It ensures that cosmetic products are manufactured in hygienic conditions, focusing on factors like cleanliness, layout, and proximity to pollution sources.
• Schedule M-2: Deals with the requirements for factory premises for the manufacture of medical devices, not cosmetics.
• Schedule M-3: Relates to special requirements for manufacture, control, and regulation of specific biologicals and not cosmetics.

Based on the explanation above, Schedule M-1 is the correct schedule that details the requirements for factory premises intended for the manufacture of cosmetics according to the Drugs and Cosmetics Rules, 1945.

Conclusion: The correct answer is Schedule M-1.