Volume : 13, Issue : 09, September – 2026
Title:
REGULATORY HURDLES IN THE APPROVAL OF HERBAL MEDICINES AND TRADITIONAL FORMULATION IN INDIA.
Authors :
G. Nandini*, G. Kamal Yadav
Abstract :
The global resurgence of interest in herbal medicines and traditional formulations has positioned India—home to Ayurveda, Siddha, and Unani systems of medicine—as a potential leader in the herbal drug market. However, despite the country’s vast ethnopharmacological heritage, the regulatory landscape governing the approval of herbal medicines remains complex and fragmented. This study critically examines the regulatory hurdles faced in the approval process of herbal and traditional formulations in India under the frameworks of the Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945, and the National AYUSH Mission guidelines. Key challenges include the lack of standardized evaluation parameters, inadequate clinical validation requirements, ambiguity in categorization between classical and proprietary formulations, and limited harmonization with international guidelines such as those of the WHO and ICH. Additionally, insufficient pharmacovigilance data, variability in raw material quality, and absence of comprehensive safety and efficacy dossiers contribute to delays and rejections during regulatory review.
Through comparative analysis with regulatory frameworks in developed markets such as the European Union, United States, and Japan, this research highlights the gaps in India’s approval mechanisms and proposes strategies for regulatory reform. Strengthening scientific validation, establishing Good Agricultural and Collection Practices (GACP), and integrating modern analytical tools for standardization are identified as critical steps toward ensuring global acceptance of Indian herbal drugs. The study concludes that a balanced regulatory approach—respecting traditional knowledge while ensuring scientific rigor—will be pivotal in promoting innovation, consumer safety, and international competitiveness of India’s herbal medicine sector.
Keywords: Herbal medicines, Traditional formulations, Regulatory hurdles, AYUSH, Standardization, Drugs and Cosmetics Act, Pharmacovigilance, India
Cite This Article:
Please cite this article in press G Nandini et al., Regulatory Hurdles In The Approval Of Herbal Medicines And Traditional Formulation In India..,. Indo Am. J. P. Sci, 2026; 13(09).
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