Regulation of ASU Drug Manufacture in India explains legal framework standards licensing and quality control of traditional medicines.
Regulation of ASU Drug Manufacture in India
- 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.
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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.
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Post-Licensing Compliance
- Manufacturers undergo periodic inspections to ensure ongoing GMP compliance.
- Any deviation from classical texts or pharmacopeial standards requires additional regulatory approval.
