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REGULATORY REQUIREMENTS FOR MANUFACTURING AND APPROVAL OF HERBAL PRODUCTS IN INDIA AND G-8 COUNTRIES
Y. Ratna Sindhu* and Sunkara Lakshmi Prasanna
ABSTRACT
In this study an attempt has been made to delve in the status of Herbal Regulations in G-8 Countries and to develop a strategy for initiating harmonization of Herbal Regulations in G-8 Countries. Further, recommendations are provided to strengthen the existing regulatory mechanism of Herbals in India. Though the regulatory harmonization of herbals is found to be an extraordinary challenge, it is today’s crying need to tackle the quality issues globally, as the survey report proposes in the study. The survey also exposed the fact that the share of the Patent and Proprietary ASU drugs for export purposes are negligible compared to domestic market. Difficulty in approval process, difference in regulation, lack of proper guidance and information are some of the reasons as reported by the participants. In order to promote export of ASU and herbal drugs from India, support of Pharmexcil is inevitable and its accessibility shall be made easier to industries through continuous awareness campaign. Irrespective of the traditional history, all herbal drugs shall be tested for its safety and efficacy using Keywords: Herbal, traditional, ASU, Phytopharmaceutical drugs, harmonization, pharmacopoeia. [Download Article] [Download Certifiate] |