1. The document discusses the need for guidelines to practitioners and consumers for preventing adverse drug events from Ayurvedic, Siddha, Unani, and Homeopathic drugs. 2. It notes issues like compromises in quality, corruption, and advertisement anarchy that necessitate pharmacovigilance and regulatory guidelines. 3. The author proposes developing guidelines through an alert, advisory, and incentive-based approach and addresses concerns over their implementation and enforcement.

1. Need of Guidelines to Practitioners & Consumers for
Prevention of ADEs from ASU&H Drugs
Prof. Anand Chaudhary
Department of Rasa Shastra,
Faculty of Ayurveda, IMS
BHU, VARANASI

2. NEED OF GUIDELINES TO PRACTITIONERS & CONSUMERS FOR
PREVENTION OF ADES FROM ASU&H DRUGS
https://www.ncbi.nlm.nih.gov/pmc
/articles/PMC3117316/
http://apps.who.int/medicinedocs/
documents/s17085e/s17085e.pdf
https://aiia.gov.in/pharmacovigilance/
NCP Ayushsuraksha 2019 Jamnagar 10 Nov 2019

3.  ADE
 ADR
 Quality
 Safety
 Efficacy
https://www.who-
umc.org/media/1061/abbreviations
.pdf
2
Why PV/ PhV for AYUSH Drugs ?
NCP Ayushsuraksha 2019 Jamnagar 10 Nov 2019

4. Directly from
Nature
 Plant Derivatives
 Animal Derivatives
 Mineral Derivatives
 Metal Derivatives
Mercurial Derivatives
3
What is THAT Natural for AYUSH Drugs ?
NCP Ayushsuraksha 2019 Jamnagar 10 Nov 2019

5.  Yes ,This is an Essential Element
 Compromises
 Corruption
 Contemporary Techniques
 Confidence –Lower /Upper
 Advertisement Anarchy
4
So, PV is a Compulsory Component -
NCP Ayushsuraksha 2019 Jamnagar 10 Nov 2019

6. 5
 Alertness
 Advisory
 Motivation
 Incentive
 Accreditation
 Implementation
How it may be DONE ?
https://www.canada.ca/en/health-canada/services/drugs- health-products/reports-
publications/medeffect- canada/health-product-vigilance-framework-health-canada-
2012.html
NCP Ayushsuraksha 2019 Jamnagar 10 Nov 2019

7. • Probably YES
• Probably NO
• Immunity of Officials
• Arrogance of Manufacturers
• Egotism of Physicians
• Ignorance of Consumers
6
Are Regulatory Guidelines may Facilitate THE PURPOSE ?
NCP Ayushsuraksha 2019 Jamnagar 10 Nov 2019

8. 7
https://www1.nyc.gov/assets/doh/downloads/pdf/han/advisor
y/201 9/elevaNteCdP-Alyeuvsheslusr-aoksfh-ale2a0d1-9mJaemrcnaugrayr-an1d0-
aNrosve2n0i1c9.pdf
Regulatory Requirements
NCP Ayushsuraksha 2019 Jamnagar 10 Nov 2019

9. 8
A caring and knowledgeable clinician,
acutely aware of his/her limitations,
employs his ayurvedic knowledge
after adequate safety- netting in
order to deliver the best possible
patient care. Such well- meaning
clinicians whose approach to ancient
medical classics is seasoned by
scientific thinking, though a minority,
constitute the very cream of the
crop.
Finally, the funny but dangerous group
of gimmick mongers. From pulse
reading to medical astrology
https://www.thehindu.com/opinion/open-page/one-
system-four-practices/article29813865.ece
For Physicians
NCP Ayushsuraksha 2019 Jamnagar 10 Nov 2019

10. NCP Ayushsuraksha 2019 Jamnagar 10 Nov 2019
 Consumer Guidelines for Appropriate use of
Ayurvedic Medicines
 Developing observatory powers about effects of
Ayurvedic Medicines
 Legal proection
 Consumer Care
9
For Consumers

11.  Developing a sense of responsibilities
 Assurance of Quality ,Safety and Efficacy
 Certification Processes
 Penalty Provision ,if found guilty
10
For Manufacturers
NCP Ayushsuraksha 2019 Jamnagar 10 Nov 2019

12. https://health.gov/hcq/pdfs/ADE-Action-Plan-
508c.pdf
Path Way for Legal Guidelines
NCP Ayushsuraksha 2019 Jamnagar 10 Nov 2019

13. http://apps.who.int/medicinedocs/documents/s21625en/s2162
5en.pdf
12
Progressive Proposals for PV
NCP Ayushsuraksha 2019 Jamnagar 10 Nov 2019

14. https://www.fda.gov/media/71878/downlo
ad
13
Progressive Proposals for PhV
NCP Ayushsuraksha 2019 Jamnagar

15.  Doctrine
 Drug
 Dose
 Duration
Herbal Hype Duty Demand
14
Milestone Measures
NCP Ayushsuraksha 2019 Jamnagar

16. Chinese Curve Official Overview
https://www.ncbi.nlm.nih.gov/pubmed/2237
4080
https://link.springer.com/article/10.1007/s40264-018-
0762-z
15
Established Examples
NCP Ayushsuraksha 2019 Jamnagar

17. 1.local health systems must identifythe
group of patients for whom they are
accountable.
2.Second, effective health systems are
increasingly grounded in high-quality
community-based care.
3.Third, and in part due to the evolution
toward community-based care, health
systems around the world are starting to
“meet patients where they are,” both
physically and in terms of their health
trajectory.
4.The fourth principle common to
convergent health systems is using data to
guide care delivery and driveimprovement. https://hbr.org/2019/10/4-principles-for-
improving- health-care-around-the-
world
ImpressivePrincipled Guidelines
NCP Ayushsuraksha 2019 Jamnagar

18. Ideal Document Initiative Detail
https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-
mps/alt_formats/pdf/pubs/medeff/fs-if/2012- hpvf-cvps/dhpvf-
ecvps-eng.pdf
Proposed Guidelines to Prevent ADE
NCP Ayushsuraksha 2019 Jamnagar

19.  True Science
 Ethical Science
 Effective Science
 Beneficial Science
Market Magnum Sagacious Science
https://www.nature.com/articles/d41586-019-
03172-5
Precautionary Platform
NCP Ayushsuraksha 2019 Jamnagar

20. Physician
s Patients
Attendant
s
Medicines
Quality
Safety
Efficacy
Advertisements http://apps.who.int/medicinedocs/documents/s21625en/s21625en.pdf
Before Final Words -
NCP Ayushsuraksha 2019 Jamnagar

21. Yes , There is Need of Guidelines to Practitioners &
Consumers for Prevention of ADEs from ASU&H
Drugs which may be prepared and be NOTIFIED by
Licensing Authorities with provision of penal
actions ,if not followed properly .
20
CONCLUSION