Navigating Compliance: The Changing Regulatory Landscape of Ayurveda Products in India and Beyond - Tahminakhan123/healthpharma GitHub Wiki

Introduction

Ayurveda, the ancient Indian system of medicine, has transitioned from a traditional healing approach to a global wellness industry. With increasing global demand, the regulation of Ayurvedic products has become more complex, requiring harmonization between traditional practices and modern safety standards. This article explores the evolving regulatory landscape of Ayurvedic products, with a focus on India—the birthplace of Ayurveda—and its expanding international reach.

The Rise of Ayurvedic Products

Globally, the herbal medicine market is valued at over USD 150 billion, with Ayurveda-based formulations contributing significantly. Consumers are drawn to natural therapies for chronic conditions, lifestyle diseases, and preventive health, driving a surge in product availability—ranging from powders and tablets to oils and nutraceuticals.

Regulatory Framework in India

In India, Ayurvedic medicines are regulated under the Drugs and Cosmetics Act, 1940, and governed by the Ministry of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homeopathy).

Key highlights include:

Classifications: Ayurvedic medicines are classified into Classical formulations (based on ancient texts) and Patent/Proprietary medicines (new formulations using Ayurvedic ingredients).

Licensing: Manufacturers must obtain licenses from State Licensing Authorities (SLAs) under Schedule T of the Drugs and Cosmetics Rules.

GMP Standards: Mandatory adherence to Good Manufacturing Practices (GMP) under Schedule T.

Labeling Norms: Products must be labeled with batch number, manufacturing and expiry dates, and list of ingredients.

Pharmacopoeia Standards: Reference is made to the Ayurvedic Pharmacopoeia of India (API) and Ayurvedic Formulary of India (AFI) for quality benchmarks.

Post-Market Surveillance & Safety

Post-marketing surveillance remains a challenge. There is limited infrastructure for pharmacovigilance, though the Ministry of AYUSH has launched the Pharmacovigilance Program for ASU&H Drugs to improve monitoring of adverse effects.

Additionally, the Central Council of Indian Medicine (CCIM) and National Medicinal Plants Board (NMPB) play supporting roles in ensuring quality control and raw material standardization.

Global Regulatory Trends

Outside India, the Ayurvedic products regulatory landscape falls under complementary and alternative medicine (CAM) categories. Regulations differ:

United States: Ayurveda products are generally categorized as dietary supplements under the Dietary Supplement Health and Education Act (DSHEA). However, health claims must be substantiated, and FDA approval is required for disease-related claims.

European Union: The Traditional Herbal Medicinal Products Directive (THMPD) governs Ayurvedic products. Companies must submit safety and quality data for registration.

Canada: Regulated as Natural Health Products (NHPs) under Health Canada, requiring licenses, GMP compliance, and scientific evidence.

Gulf countries and Southeast Asia: Stringent registration and halal certification often apply.

Regulatory Challenges

Standardization: Ensuring consistent quality across herbal formulations is complex due to variability in raw materials.

Scientific Validation: Many formulations lack rigorous clinical trials, making global regulatory approvals challenging.

Global Recognition: Harmonizing Indian regulatory systems with international norms remains a work in progress.

Opportunities Ahead

The Indian government has initiated several steps to strengthen Ayurveda regulations:

Launch of the Ayushman Bharat Digital Mission (ABDM) to integrate AYUSH records.

Investment in Ayurveda research through the Central Council for Research in Ayurvedic Sciences (CCRAS).

Promotion of AYUSH industry exports via Pharma Export Promotion Council (Pharmexcil).

Conclusion

Ayurvedic products have earned global interest, but growth must be balanced with robust regulatory oversight. India’s regulatory framework provides a foundation, but adapting to global compliance standards is essential to promote Ayurveda as a safe and scientifically credible healthcare solution.