• Dr. Govind Baliram Yeole
• Dr. Sneha Suresh Mali
• Dr. Ravindra S. Kharat

The “World Health Organization (WHO) defines the pharmacovigilance (PV), as the pharmacological science relating to the detection, evaluation, understanding, and prevention of adverse effects, particularly long-term and short-term side effects of medicines”.1 PV in India was started back in 1986 when 12 regional centres were proposed. No activities were noted down for about a decade during this project. After this, India then joined the Uppsala, Sweden based WHO-adverse drug reaction (ADR) monitoring program in 1987. In beginning for ADR monitoring in the country, 8 regional centres were set up in Varanasi, Thiruvananthapuram, Guwahati, Jaipur, Bhopal, New Delhi, Bengaluru, and Chennai.2 The major goals of pharmacovigilance, namely to improve patient care and safety in relation to drug use, and thus promote rational drug use are recurrent themes of ayurvedic pharmacology (Dravyaguna Vigyan) and therapeutics (Chikitsa).3 Ayurveda, Siddha, Unani and Homeopathy (ASU & H) systems of medicines have their own principles and have their own pharmacopoeia, but at times even are practised in the country as Over the Counter (OTC) drugs without any authentic prescription. There is a wide spread 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. In this era of globalization, concerns are being raised with regards to their clinical safety. Considering the significance of this WHO emphasizes the provision of traditional medicine in pharmacovigilance system and has published guidelines on safety monitoring of herbal medicines in pharmacovigilance system in 2004.4 Ancient texts clearly mention that if a drug is used without the knowledge of its proper action, it would certainly act as a poison.5 Though it may seem to be a hypothesised statement, but its soul is vibrant with the concept of Pharmacovigilance. Moreover, if a drug is prepared according to its SOP and used clinically in the dose prescribed, then the adverse reactions can be minimized to a great extent. The decision-making regarding prescription of a drug also relies upon the yukti of the physician and his minute assessment of the roga and rogi bala, the time of administration of drug (kala), its place (desha), satwa, satmya, ahara shakti, vyayam shakti.6

pharmacovigilance, pharmacovigilance in ayurveda, need, difficulty and scope.

"Pharmacovigilance: Difficulty in Implementation, Need and Scope in Ayurveda", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.12, Issue 10, page no.c395-c405, October-2025, Available :http://www.jetir.org/papers/JETIR2510255.pdf

"Pharmacovigilance: Difficulty in Implementation, Need and Scope in Ayurveda", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.12, Issue 10, page no. ppc395-c405, October-2025, Available at : http://www.jetir.org/papers/JETIR2510255.pdf