Question

Schedule T of Drugs and Cosmetics Rules, 1945 deals with:

• A. GMP for ASU drugs
• B. GLP and requirement of premises and equipments
• C. GMP for Homeopathy medicine
• D. GMP for Pharmaceutical product

Answer 1

The Correct Option is A

The correct option is (A): GMP for ASU drugs.

Answer 2

The question asks what Schedule T of the Drugs and Cosmetics Rules, 1945 specifically covers. Let's check each option against what that schedule was actually written to regulate.

1. GMP for ASU drugs: Schedule T was added to the Rules specifically to lay down good manufacturing practices for Ayurvedic, Siddha, and Unani manufacturing units, covering their infrastructure, raw material quality, manufacturing process, and quality control requirements.
2. GLP and requirement of premises and equipments: Good laboratory practice requirements along with general premises and equipment conditions for licensing are dealt with under other schedules of the Rules, not under Schedule T, which is specific to ASU manufacture.
3. GMP for Homeopathy medicine: Homeopathic drug manufacturing standards are covered separately under Schedule M-I of the Rules, a schedule distinct from Schedule T.
4. GMP for Pharmaceutical product: Good manufacturing practice requirements for conventional allopathic pharmaceutical products are laid out in Schedule M, while Schedule T deals only with the traditional ASU category.

Only the ASU option matches the specific traditional medicine manufacturing scope that Schedule T was written for.

The correct answer is GMP for ASU drugs.