Herbal Drug Development from Traditional Formulations: Refocusing Pharmaceutics and Posology for Accelerated Validation.
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Date
2014-06
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Abstract
Background: The World Health Organization (WHO) recommended that the toxicity data
of a traditional medicine (TM) product that has been in use for 20 years or more without
untoward effects should be determined, as the first step in its research and development (R&D). Such data in conjunction with efficacy data would be used to develop an
appropriate dosage form of the product. A key objective in researching such a product is to
validate the basis of the therapy, including the formula. Such validation, and any attempt to
modernize the product, should be guided by an understanding of the traditional know-how.
The Nigerian National Institute for Pharmaceutical Research and Development (NIPRD)
utilized this approach in developing Niprisan, an antisickling drug, based on a TM product
used since antiquity in Yoruba Medicine.
Aim: This article aimed to advocate the continuance and improvement of the WHO model
of herbal drug research and regulation (HDRR) as the most logical approach for adoption
by researchers and regulators.
Methodology: NIPRD’s adoption of the WHO model since 1989 was reviewed in parallel
with trends in herbal drug research worldwide; and within the contexts of regulatory
practices by Nigeria’s National Agency for Food and Drug Administration and Control
(NAFDAC) and the European Medicines Evaluation Agency (EMEA), with a view to
identifying more effective strategies within the WHO paradigm for HDRR.
Conclusion: Drug regulatory agencies (DRAs) like NAFDAC require effective laws,
policies and quality management systems (QMS) to execute their mandates effectively. On
the other hand, NIPRD’s output depends upon proper actions by a seasoned and
responsive DRA. Therefore, noting that NIPRD and NAFDAC were both created by military
decrees in 1989 and 1992 respectively, rather than by parliament acts, it is recommended
that in addition to instituting more effective laws and policies to regulate NAFDAC, both
NIPRD and NAFDAC need to adopt and implement suitable QMS for self-regulation, eg:
ISO 9001 for whole organizations; and ISO/IEC 17250 for the laboratories.
Description
Keywords
Traditional medicine (TM), product, toxicity data, dosage form, research, development, regulation, drug regulatory agency (DRA)
Citation
Ameh Sunday J, Toge Barnabas K, Ebeshi Benjamin U, Ambi Aminu A, Garba Magaji, Alfa John, Gamaniel Karniyus S. Herbal Drug Development from Traditional Formulations: Refocusing Pharmaceutics and Posology for Accelerated Validation. British Journal of Pharmaceutical Research. 2014 June; 4(12): 1451-1476.