Ch.
Devilal College Of Ayurveda , Jagadhri (Haryana)
Departmant of Rasa PHARMACOVIGILANCE
Shastra & Bhaishajya FOR AYURVEDA DRUGS
kalpana
Submitted to- Submitted By-
Dr.Satakshi Sharma Deepanshu
M.D (Ayu.) Roll no. 26
PHARMACOVIGILANCE FOR
AYURVEDA DRUGS
INTRODUCTION
Pharmacovigilance
Pharmaco Vigilance
from Greek from latin
word word Vigilare
Pharmakon (means to
(means drug) keep watch)
Definition
Pharmacovigilance is the science and
branch which deals with the activities
such as collection, detection,
assessment, monitoring and
prevention of adverse effects with the
pharmaceutical products.
Adverse reactions (Integral part of drug
Pharmacology)
An unexpected or unwanted effect
caused by the administration of a
drug. There is popular or major
misconception among masses and
also a large population of
practitioners that Ayurveda drugs
are safe and do not have any
adverse reactions. There is no
such thing as a safe drug.
But आचार्य चरक describes all adverse reactions to medicines when they are
used inappropriately and also describe various factors which are to be
considered while choosing drugs:-
• प्रकृ ति (Patient / रोगी की)
• आयु (Age)
• विकृ ति (Diseased condition)
• सात्म्य (Tolerance)
• सत्व (Psychological state of मन)
• आहार-शक्ति(Digestion capacity)
आचार्य चरक says
• That even a strong
poison can become an
"योगादपि विषं तीक्ष्णमुत्तमं भेषजं भवेत् । भेषजं
excellent medicine if
चापि दुर्युक्तं तीक्ष्णं संपद्यते विषम् || तस्मान्न
administrated properly.
भिषजायुक्तं युक्तिबाह्येन भेषजम् | धीमता
• On the other hand, even
किञ्चिदादेयं जीवितारोग्यकाङ्क्षिणा ||
the most useful drug can
(च० सू० 1/127-128)
act like a poison if
handled carelessly.
यथा विषं यथाशस्त्रं यथाऽग्निरशनिर्यथा तथौषधमविज्ञातं
विज्ञानमामृतं तथा । " (च०सू० 1/125)
न जानी हुई (अविज्ञात) औषधि उसी प्रकार
प्राणघातिका होती है जिस प्रकार विष , शस्त्र , अग्नि
या इन्द्र का वज्र प्राण को हर लेते हैं। इनके विपरीत
जानी हुई औषधि अमृत के समान प्राणरक्षिका होती
है।
(च० सू० 1/126-127) के अनुसार-
गुण-धर्मों को जानने के बाद औषधियों को
मिलाने से तीक्ष्ण विष भी उत्तम औषध का
रूप धारण कर लेता है। जीवनोपयोगी
(प्रतिदिन सेवन करने योग्य) औषधि का भी
यदि दुरुपयोग अर्थात ठीक- ठीक सम्मिश्रण न
किया जाए तो वह तीक्ष्ण विष का रूप धारण
कर लेता है। इसलिए दीर्घ जीवन और आरोग्य
की कामना करने वाले बुद्धिमान मनुष्य को
चाहिए कि वह चिकित्सक द्वारा युक्ति बाह्य
सम्मिश्रित औषध का ग्रहण न करें।
Aim of Pharmacovigilance
i. To improve patient care
and safety.
ii. To promote rational and
safe use of medicines.
iii. To improve public health
and safety in relation to the
use of medicines.
iv. To contribute to the
assessment of benefit,
harm, effectiveness and
risk of medicines.
Responsibilities of Pharmacovigilance
(i) Timely Collection of data, recording and notification.
(ⅱ) Appropriate assessments.
(iii) Expedited and periodic reporting.
(iv) Creates appropriate structures for communications.
Need of Pharmacovigilance in Ayurveda
(i) To ensure safety of drugs, so as
to minimize adverse effects, if any.
(ii) To maintain efficacy of drug, so
as to provide maximum benefit to
the patient.
In ancient times, ayurvedic physicians
prepared medicines for their patients
themselves. Today, only a handful of
practitioners follow this practice and
production and sale of Ayurvedic drugs
has become formalised into a thriving
industry.
Two categories of medicines labelled as "Ayurvedic " are as available in the market:
(ⅰ) Classical as Ayurvedic formulations (which as per descriptions in आयुर्वेद संहिता ).
Example - कु टजारिष्ट, चन्द्रप्रभा वटी etc.
(ii) Patent and proprietary formulations made of herbs or extracts of herbs.
So, following needs are :-
(i) Humanitarian concern - Animal toxicology is often not a good predictor for human effects.
Evidence of safety from clinical trials is insufficient due to some limitations:
• Limited size
• Narrow population
• Narrow indications
• Short duration.
(ⅱ) Safe use of medicines.
(ⅲ) ADR's are expensive.
(iv) Promote rational use of medicines.
(ⅳ) Ensuring public confidence.
Difficulty in successful implementation of
Pharmacovigilance in Ayurveda
(i) Very low reporting of ADR’s .
(ii) Ignorance among physicians regarding
ADR’s .
(iⅱ) Inadequate methods and facilities of study
drug safety profile.
(iv) Too many products and multiple ingredient
formulations are difficult to monitor.
(v) False belief about the universal safety of
Ayurveda drugs.
Detection of adverse reactions to Ayurvedic medicines.
Ayurvedic drugs are safe , this is firm belief, detection of
adverse reactions to these medicines challenge, because :-
(i) In Ayurveda, methods to study drug safety problems have not
evolved adequately.
(ii) Although information related to the drugs safety mentioned
in the classical books is not easily accessible.
(iii) Lack of quality assurance and control in manufacture of
Ayurvedic medicine , which acts a confounding factor in
diagnosing the adverse reaction.
(iv) Signal detection is difficult because there is an inherent
belief about safety of ayurvedic medications. → leads to
• Lack of reporting
• lack of collection of reports relating to any formulations.
Assessment of adverse reactions to Ayurvedic medicines
Assessment of adverse reactions to Ayurvedic medicines is the greatest challenge for several
reasons, including:
(i) Information of adverse effects is scattered in Ayurvedic literature and not in electronic form,
hence making it is difficult to access.
(ii) There is confounding factor that the patient is often receiving allopathic medicines at the
same time.
(iii) Pharmacokinetics and toxicokinetics are very difficult and at this point of time, well-high
impossible making definite casuality, virtually impossible.
(iv) Dose related responses are rarely measured and reported.
(v) There is lack of expertise in performing casuality analysis with ayurvedic medicines.
Prevention of Adverse reactions to Ayurvedic medicines
(ⅰ) Unbiased drug information about
ayurvedic drugs including both classical and
proprietary formulations is not available
easily.
(ii) Education in ayurveda or modern does
not cover Pharmacovigilance of ayurvedic
medicines, thus never exposing the young
physicians to this concept.
(iii) There is not attempt at generating safety
data either before or after marketing of the
formulation.
Governing bodies
In India ;
(i) Indian Pharmacopoeia
Commission (IPC)
(ii) National coordination committee
(NCC) through the CDSCO (Central
drug standard control organisation)
cordially regulate the
pharmacovigilance activity.
Three tier structure of Pharmacovigilance network
• Peripheral centres- 43
• Regional centres- 12
• Zonal Pharmacovigilance Centres- 2
In addition to the NPC (National Pharmacovigilance centre) and NRAC
(National Pharmacovigilance advisory committee) based at the central
drug standard control organisation, New Delhi.
Peripheral
centres (43)
Ayurveda Siddha Homeopathy Unani centres-
centres-19 centres-11 centres-7 6
CONCL U S ION
The need of the hour is to educate the physicians and encourage them to analyse
and report any adverse effects that occur in a patient, no matter how petty or
irrelevant they may seem. Quality drugs are one of the main pillars of effective
therapy. The onus of providing quality drugs lies with the pharmaceutical houses .
The industry should take some concrete steps to generate confidence and reliability
for its products. The morality of manufacturing standard drugs can go a long way
in minimizing the adverse effects and generating confidence in therapeutic
efficacy. Further, this shall in long term lead to characterization of Ayurvedic drugs
as , OTC (over the counter) , prescription or scheduled drugs for better safety
stage, there also needs to be regulation of self- preparation and administration of
drugs by clinicians. This shall only be step towards global acceptance of Ayurvedic
drugs.
Thanks!
