Pharma Co-Vigilance
Since long, Ayurveda, Siddha , Unani and Homoeopathy (ASU &H) systems of medicine are being practised in India. In this era of globalization, concerns are being raised with regards to their clinical safety. There is a widespread misconception that all drugs of "Natural" origin are "Safe". There is also a common belief that long term use of a medicine based on tradition, assures both safety and efficacy.
These systems of medicines have thorough knowledge about essential characters of drugs that are to be used in the treatment to ensure safety and opine that right drug at the right dise by the right route at the right time for the right person provide beneficial effects. Non-complieance to the traditional regulations of the therapeutics will manifest in adverse events.
Pharmacovigilance in ASU & H system of Medicine
Pharmacovigilance is the science dedicatetd to reduce the risk of drug-related harms to patients. In India, National Pharmacovigilance Program under the control of Central Drug Standards Control Organization (CDSCO) has initiatied during 2003. WHO emphasizes that, traditional medicines are to be included into pharmacovigilance system and has published guidelines on safety monitoring of herbal medicines in pharmacovigilance system in 2004.
Considering the growing use of ASU & H products and medicines globally; inclusion of traditional medicines in Pharmacovigilance systems became equally important.
Pharmacovigilence is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems.
A nationwide program has been launched under central sector scheme funded by Ministry of AYUSH, New Delhi to establish and generate system wise database of adverse Drug Reactions (ADRs) and evolve evidence based reccomendations towards clinical safety of ASU & H Drugs.