Abstract

REGULATORY REQUIREMENT FOR SUBMISSION OF HERBAL DRUG PRODUCT IN INDIA, USA AND EUROPEAN MARKET

Mathew George*, Lincy Joseph, Mahendra Kuril, Kanaka V.S.

Abstract

The present work has been done to facilitate the registration and regulation of herbal medicines by establishing the foundation for a harmonized regulatory standard to meet the common demands of the region. It is obvious that there are some dossier and GMP requirements for the registration of herbal drugs, nutritional supplements and OTC drug products in the regulated market as well as in less regulated market. After comparing the regulatory status of India, USA and European market, it was found out to make some suggestions for India, based on regulated markets. In European countries there is a system with well defined guidelines for the herbal products but in case of India and USA these products are treated like other medicinal products. At last it was concluded that the system that is currently involved in India need to be further upgraded to require registration of individual drugs with specified quality control, safety and efficacy standards.

Keywords: GMP, WHO, OTC drug.