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Pain Management 2018
Internal Medicine 2018
International Journal of Anesthesiology & Pain Medicine
ISSN: 2471-982X
Page 74
March 26-28, 2018
Vienna, Austria
JOINT EVENT
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E d i t i o n o f I n t e r n a t i o n a l C o n f e r e n c e o n
Internal Medicine and Patient Care
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E d i t i o n o f I n t e r n a t i o n a l C o n f e r e n c e o n
Pain Management
Volume 4
T
he process of pharmacovigilance (PV) of herbals in India has
come a long way since initiation. PV practices are helping
in establishing and maintaining rational age of drugs within the
ambit of Pharmacotherapy. ADR’s (adverse drug reaction) from
herbal medicines are least reported, many herbal preparations
without following any drug safety requirements are marketed
without its pharmacovigilance. Due to the lack of clinical trials of
most herbal preparations, post marketing vigilance becomes a
critical source of safety and information. Widely reported issues
as ADR’s associated with Ephedra and Aristolochia have shown
herbal medicines can show high levels of toxicity in humans. The
most common adverse drug effects reported are hepatic and
renal problems. The WHO has database of over 16000 suspected
herbal case reports. Central Drug Standards Control Organization
and AYUSH are the major government organizations working to
monitor ADR related to herbal ingredients. The number of reports
related to herbals/traditional/alternative medicines is abysmally
low. The current challenges in pharmacovigilance of herbal
medicines includes ADR terminology not covered in Ayurvedic
curriculum, drug safety problems, signal detection, lack of quality
assurance/quality control, lack of information about active
principles and with regard to the mechanism of action of herbal
active principles. Some countries accept traditional, experience-
based evidence while others consider herbal remedies as
dangerous or of questionable value. Monitoring the safety of
herbal medicinal products in the market or in the pipeline, will go
a long way in restoring the confidence of their safety.
arormahek35@yahoo.co.inChallenges and issues in pharmacovigilance of herbal
medicines in India
Mahek Arora
Amity University, Noida, India
Int J Anesth Pain Med 2018, Volume 4
DOI: 10.21767/2471-982X-C1-003