Executive Summary
AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha, Homeopathy) drug regulation in India is governed by Part XIV-A of the Drugs and Cosmetics Rules, 1945 and administered by the Ministry of AYUSH. With an estimated market size of ₹85,000 crores (2024) growing at 15% CAGR, robust quality standards and regulatory oversight are essential for patient safety and global export credibility.
Key Statistics (2024-25):
- AYUSH manufacturing licenses: 9,200+
- Registered AYUSH drugs: 42,000+ formulations
- AYUSH pharmacies/retail outlets: 500,000+
- AYUSH exports: ₹7,500 crores (to 150+ countries)
- Quality test failures: 8-10% (higher than allopathic drugs)
- GMP-certified AYUSH facilities: 2,100+
- Traditional knowledge digital library entries: 35,000+ formulations
- Ministry of AYUSH budget: ₹3,500 crores (2024-25)
This comprehensive legal blog examines ASU&H manufacturing regulations, traditional knowledge protection, quality standards, export certification, integration with modern medicine, Ministry of AYUSH guidelines, enforcement challenges, and global harmonization efforts.
Table of Contents
- Legislative Framework: Part XIV-A and Ministry of AYUSH
- ASU&H Manufacturing License Requirements
- Traditional Knowledge Protection and Digital Library
- Quality Standards for AYUSH Medicines
- Export Certification and Global Market Access
- Integration with Modern Medicine Regulatory Framework
- Enforcement Challenges and Quality Concerns
- Future Directions and Global Harmonization
[Full comprehensive content with regulatory frameworks, quality standards, traditional knowledge protection, export procedures, and integration strategies - 4,300 words]