Pharmacovigilance Consideration for Ayurvedic Medicines in Pediatric Practice: Developing Protocols for Documenting Clinical Safety

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dc.contributor.authorSubramanian, DKen_US
dc.contributor.authorBalakrishnan, G.en_US
dc.date.accessioned2025-05-12T10:22:29Z
dc.date.available2025-05-12T10:22:29Z
dc.date.issued2024-12
dc.description.abstractBackground: The rising global trend of traditional medicine and complementary and alternative medicine use necessitates a structured approach to ensure patient safety and efficacy. Due to its unique theoretical framework, directly applying modern pharmacovigilance principles to Ayurveda may be insufficient. Purpose: This study aims to highlight the need for a collaborative approach that integrates traditional Ayurvedic knowledge with modern safety and efficacy evaluation methods. It critiques the limitations of current pharmacovigilance practices, espe- cially in the context of Ayurveda, and proposes improvements to better capture the complexities of traditional medicine. Methodology: An analysis of the “AyushSuraksha” program, a key initiative for the pharmacovigilance of Ayurveda, Siddha, Unani, and homoeopathy (ASU&H) medicines in India, was conducted. The program’s focus areas, including monitoring medications, specific materials, and procedure-based therapies, were reviewed in light of their efficacy and safety reporting mechanisms. Additionally, the applicability of current pharmacovigilance methodologies, particularly in the context of per- sonalized Ayurveda treatments, was evaluated through case studies and literature reviews. Results: The “AyushSuraksha” program, while focused on medication and therapy monitoring, overlooks the safety of food items used in Ayurveda. Current pharmacovigilance systems, designed for standardized medications, may be inadequate for Ayurveda, as demonstrated by positive outcomes in autism treatment despite the presence of microbiologically harmful products. Furthermore, existing pharmacovigilance proformas lack a distinction between physicians' and end-users perspec- tives, limiting the reporting scope. Conclusion: A transition to a holistic, evidence-based pharmacovigilance approach that incorporates Ayurvedic assess- ments and nonlinear herbal interactions is crucial. Separate proformas for physicians and end-users, along with disease- specific questions, are recommended to improve reporting accuracy. Expanding the scope of pharmacovigilance beyond standardized medication monitoring is essential for the evolution and refinement of Ayurvedic science.en_US
dc.identifier.affiliationsDepartment of Kaumarabhrithya, Vaidyaratnam P. S. Varrier Ayurveda College, Kottakkal, Kerala, Indiaen_US
dc.identifier.affiliationsAmrita Centre for Advanced Research in Ayurveda (ACARA), Amrita School of Ayurveda, Amrita Vishwa Vidyapeetham, Amritapuri, Kerala, Indiaen_US
dc.identifier.citationSubramanian DK, Balakrishnan G.. Pharmacovigilance Consideration for Ayurvedic Medicines in Pediatric Practice: Developing Protocols for Documenting Clinical Safety. Journal of Pharmacology and Pharmacotherapeutics. 2024 Dec; 15(4): 442-448en_US
dc.identifier.issn0976-500X
dc.identifier.issn0976-5018
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/247676
dc.languageenen_US
dc.publisherSage Publications India Pvt. Ltd.en_US
dc.relation.issuenumber4en_US
dc.relation.volume15en_US
dc.source.urihttps://doi.org/10.1177/0976500X241276311en_US
dc.subjectPharmacovigilanceen_US
dc.subjectAyurvedaen_US
dc.subjectpediatricen_US
dc.subjectadverse drug reactionen_US
dc.titlePharmacovigilance Consideration for Ayurvedic Medicines in Pediatric Practice: Developing Protocols for Documenting Clinical Safetyen_US
dc.typeJournal Articleen_US
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