Question

The First Schedule to the Drugs and Cosmetic Act, 1940 prescribes:

• A. Standards for cosmetics
• B. Standards for medical devices
• C. Authoritative books of Ayurvedic, Sidda and Unani systems
• D. Standards for drugs

Hint:

Don't confuse the main Schedules of the Act with the Rules: - First Schedule of Act $\implies$ Books of ASU - Second Schedule of Act $\implies$ Standards for manufactured/imported items - Schedules under Rules $\implies$ Alphabetical list (Schedule M = GMP, Schedule Y = Clinical Trials, etc.)

Answer 1

The Correct Option is C

Understanding the Concept: The Drugs and Cosmetics Act, 1940 contains two primary schedules within its main statutory framework, which are separate from the operational rules (Schedules A through Y):
• First Schedule: Lists the authoritative texts and books belonging to the traditional Indian systems of medicine, specifically Ayurvedic, Siddha, and Unani (ASU) systems. Any formulary or pharmacopoeia listed here dictates whether an ASU formulation is recognized as standard.
• Second Schedule: Outlines the official standards that must be met by drugs, biological products, and cosmetics imported into, or manufactured, stocked, and sold within India.

Step 1: Evaluate the purpose of the First Schedule.
The explicit mandate of the First Schedule is to list the approved reference texts (such as Charaka Samhita, Sushruta Samhita, and the Ayurvedic Pharmacopoeia of India). If a traditional product is prepared using methods outside these recognized books, it cannot legally be categorized under standard traditional medicine licensing pathways. This matches option (C).