Abstract

REGULATORY CHALLENGES IN AYURVEDIC MEDICINES: CURRENT SCENARIO AND FUTURE PERSPECTIVES IN INDIA

Sumit Chaudhary*, Prerna Bhalla, Dr. Anil Kumar Sharma

Abstract

Background: Ayurvedic medicine, with a history exceeding 5,000 years, remains central to India's healthcare landscape. Despite a growing global herbal medicines market, the regulatory environment governing Ayurvedic medicines presents multifaceted challenges impeding quality assurance, clinical evidence generation, pharmacovigilance, and international market access. Objective: To critically examine the current regulatory framework for Ayurvedic medicines in India, delineate principal regulatory challenges, compare Indian provisions with those of the USFDA and EMA, and propose evidence-based recommendations for reform. Methods: A narrative review was conducted using peer-reviewed literature, regulatory documents, pharmacopoeial standards, and government policy documents. All 21 references are drawn exclusively from the uploaded source documents. Results: The regulatory architecture is anchored in the Drugs and Cosmetics Act 1940, Schedule T GMP, Ministry of AYUSH policies, and Ayurvedic Pharmacopoeial standards. Key challenges include: lack of standardization, quality control deficiencies, variable GMP compliance among MSMEs, insufficient clinical evidence, labelling non-compliance (45% of proprietary formulations lacking Schedule E1 caution warnings), and inadequate pharmacovigilance. Conclusion: Strengthening the regulatory framework requires coordinated action across standardization, GMP enforcement, evidence generation, pharmacovigilance, and international harmonization.

Keywords: Ayurvedic medicines, Drugs and Cosmetics Act, Schedule T, Good Manufacturing Practices, Ministry of AYUSH, pharmacovigilance.