The manufacturing of Ayurveda, Siddha, and Unani (ASU) drugs in India is governed by:
Drugs and Cosmetics Act, 1940
Drugs and Cosmetics Rules, 1945 (with amendments specific to ASU drugs)
Licensing Requirements
Manufacturers must obtain a manufacturing license from the State Licensing Authority (usually the State AYUSH department).
Compliance with Good Manufacturing Practices (GMP) as per Schedule T is mandatory.
Good Manufacturing Practices (GMP) - Schedule T
GMP guidelines include:
Location & Premises: Proper layout, ventilation, and cleanliness to prevent contamination.
Equipment: Well-maintained and calibrated machinery.
Quality Control: In-house or external accredited labs for raw material and product testing.
Documentation: Batch records, SOPs, and raw material specifications
Quality Standards & Testing
Raw materials must meet standards in recognized Pharmacopoeias (Ayurvedic, Siddha, Unani).
Testing includes identity, purity, strength, and safety (heavy metals, microbial load, pesticide residues).
Labeling Requirements
Labels must include:
Drug name, manufacturing license number, batch number.
Manufacturing & expiry/best-before date.
Dosage form and instructions.
Warnings/cautions (if applicable).
Classical formulations should reference authoritative texts.
Post-Licensing Compliance
Manufacturers undergo periodic inspections to ensure ongoing GMP compliance.
Any deviation from classical texts or pharmacopeial standards requires additional regulatory approval.
