Regulatory requirement sufficiency for registration of traditional herbal medicine based products in association of southeast asian nations regions: a model study with ashwagandha tablets
By: Ramadoss, Malathi Seshasayee Konda
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Contributor(s): Koumaravelou, K.
Publisher: Mumbai Indian Journal of Pharmaceutical Science 2022Edition: Vol.84(2), Mar-Apr.Description: 501-512p.Subject(s): PHARMACEUTICSOnline resources: Click here
In:
Indian journal of pharmaceutical sciencesSummary: In recent years, regulatory standards of traditional herbal medicines, is a topic of discussion. India is
pioneered in traditional herbal medicine and has the potential to benchmark standards. Association
of Southeast Asian nations region which is the second-largest consumer of herbal medicines with high
market potential is explored. The present research is focused to study the product registration process by
comparing the regulatory standards in India with the standards in association of Southeast Asian nations
regions. To understand the process better, the regulatory requirements, concerns and sufficiency to meet
up to the standards are explained using Ashwagandha tablets as a product model. The samples from the
Indian market are evaluated, the scope of regulatory sufficiency to the association of Southeast Asian
nation’s regulatory requirements is examined and the extent of its compliance with association of Southeast
Asian nation’s standards is evaluated. Additional requirement specific to the association of Southeast Asian
nations region apart from the standards already being followed is proposed to be included. This will help
the companies who wish to make a mark in the association of Southeast Asian nations regions.
| Item type | Current location | Call number | Status | Date due | Barcode | Item holds |
|---|---|---|---|---|---|---|
Articles Abstract Database
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School of Pharmacy Archieval Section | Not for loan | 2022-2211 |
In recent years, regulatory standards of traditional herbal medicines, is a topic of discussion. India is
pioneered in traditional herbal medicine and has the potential to benchmark standards. Association
of Southeast Asian nations region which is the second-largest consumer of herbal medicines with high
market potential is explored. The present research is focused to study the product registration process by
comparing the regulatory standards in India with the standards in association of Southeast Asian nations
regions. To understand the process better, the regulatory requirements, concerns and sufficiency to meet
up to the standards are explained using Ashwagandha tablets as a product model. The samples from the
Indian market are evaluated, the scope of regulatory sufficiency to the association of Southeast Asian
nation’s regulatory requirements is examined and the extent of its compliance with association of Southeast
Asian nation’s standards is evaluated. Additional requirement specific to the association of Southeast Asian
nations region apart from the standards already being followed is proposed to be included. This will help
the companies who wish to make a mark in the association of Southeast Asian nations regions.
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