Current Regulations for Herbal Products
Herbal medicines make up an important component of the modern toward alternative medicine. Herbal medicine is becoming ever more popular in now a day’s world as people seek out natural remedies. Herbal medicines are widely used for treatment of human ailments in various systems of medicines like Ayurvedic, Homeopathic, Sidha, Unani and other regional systems of medicines. Herbal drug products classification vary from country to country, some categories include functional foods, dietary supplements and traditional medicines. A detailed literature survey for regulations of herbal drug products in Europe, US and India, Russia, Africa, south Korea was performed to identify recently introduced changes in regulations or newly introduced regulations compliance with the regulatory bodies. Committee for Herbal Medicinal Products (HMPC), Committee of European Medicines Agency (EMA) is developing guidelines for quality, nonclinical studies, clinical efficacy and safety. Traditional herbal medicines registration scheme(THMRS) has been recently introduced by Medicines and Healthcare Products Regulatory Agency (MHRA, UK). US FDA has issued draft guidance for Industry on “Complementary and Alternative Medicine Products and Their Regulation”. Drugs and Cosmetics Rules have been amended recently to control the quality, safety and efficacy of herbal drug products in India. This article provides an overview of herbal medicines and aimed to explain the regulations of various herbal medicines, standardization of herbal medicines, pharmacovigilance and marketing surveillance regulatory status of herbal medicines.
Published by: Chaduvu Ramkrishna, Jayachandra Reddy .P, Alagusundaram .M
Author: Chaduvu Ramkrishna
Paper ID: V3I3-1637
Paper Status: published
Published: June 29, 2017
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