Abstract

PHARMACOVIGILANCE: AN APPROACH TOWARDS SAFETY OF AYUSH DRUGS

Adnan Mastan*, Ashutosh Tripathi, Sunil Kumar Rai, Vikram Pai and Lakshmanakumar Venkatachalam

ABSTRACT

Pharmacovigilance is essential for developing reliable information on the safety of AYUSH medicines. The system existed in India developed for synthetic medicines required some modification to address the specific requirements of medicinal herbs. In concurrence to this, Department of AYUSH, Ministry of Health & Family Welfare, Government of India, launched the National Pharmacovigilance Programme for reporting the adverse drug reaction for Ayurveda, Siddha and Unani (ASU) drugs, in the year 2008. Consequently, in collaboration with WHO, a Protocol of National Pharmacovigilance Programme for ASU (NPP-ASU) drugs published by Department of AYUSH to facilitate proper documentation, regulation, monitoring and control of the activities related to pharmacovigilance. This was followed by introduction of new scheme by Ministry of AYUSH in the year 2017-18, namely Central Sector Scheme for promoting pharmacovigilance of Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) Drugs. The principal goal of the scheme is to develop a culture of recording adverse effects and initiate safety monitoring of Ayurveda, Siddha, Unani and Homoeopathy drugs along with surveillance of misleading advertisements that appears in the print and electronic media. Pharmacovigilance remain a challenge in AYUSH systems of medicine, particularly given the increasing complexity of therapeutics, an ageing population and rising multi-morbidity. This article summarizes some of the key facts about pharmacovigilance with respect to AYUSH systems of medicine and explores aspects relating to prevention, diagnosis, reporting and management of adverse drug reaction in current clinical practice.

Keywords: Pharmacovigilance; Ayurveda; Yoga & Naturopathy; Unani; Siddha; Homoeopathy.