Standardization of Ayurvedic Medicines

Summary of AYUSH Medicines Standardization and Promotion

Regulatory Framework

• Drug and Cosmetic Act, 1940: Establishes separate regulatory provisions for AYUSH medicines.
• Drug Rules, 1945: Govern the standards and practices for manufacturing AYUSH medicines.

Quality Assurance Measures

• Compliance with Good Manufacturing Practices (GMP) is mandatory for manufacturers of Ayurveda, Siddha, Sowa-Rigpa, Unani, and Homeopathy medicines.
• Drug inspectors are responsible for collecting samples from manufacturing units and retail stores for quality testing.
• 34 drug testing laboratories across states/UTs are equipped for testing samples to ensure compliance with quality standards.

Standardization Efforts

• The Pharmacopoeia Commission for Indian Medicine and Homeopathy (PCIM&H) develops pharmacopoeial standards for AYUSH medicines.
• Regular capacity-building programs are conducted for stakeholders to strengthen quality assurance mechanisms.

Government Schemes

• AYUSH Medicine Quality and Production Enhancement Scheme (AOGUSY): Aims to assist AYUSH facilities in achieving WHO-GMP and NABL accreditation.
• International Cooperation Promotion for AYUSH: This scheme supports Indian AYUSH manufacturers and service providers in promoting exports and enhancing global reach.

Export Promotion Initiatives

• The AYUSH Quality Mark (AQM) initiative verifies quality certificates issued by competent authorities for export promotion.
• The AYUSH export value and major destinations for the last five years are provided, showcasing growth in international markets.

Economic Data on AYUSH Exports

• Export values in USD for AYUSH and herbal products from April 2020 to March 2026:
  • USA: $155.29 million (2020-21) to projected $151.57 million (2025-26)
  • Germany: $48.73 million (2020-21) to projected $64.32 million (2025-26)
  • Italy: $21.58 million (2020-21) to projected $36.08 million (2025-26)
  • UAE: $22.39 million (2020-21) to projected $32.43 million (2025-26)
  • Vietnam: $12.99 million (2020-21) to projected $24.57 million (2025-26)

International Agreements

• 27 MoUs at country-to-country level, 16 related to AYUSH chairs, and 57 institutional MoUs have been signed to enhance international collaboration on AYUSH practices.

Conclusion

The AYUSH Ministry is actively working towards standardizing and promoting AYUSH medicines through regulatory measures, quality assurance frameworks, and international collaborations aimed at enhancing exports and global reach. The economic data indicates a growing trend in AYUSH product exports, reflecting an increasing international demand for these traditional medicines.