Abstract

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.