Comprehensive Pharmacovigilance for Ayurveda Drugs: Safety, Monitoring, and Regulatory Framework

TOPIC 26 · Dr. Kiran Sures h Edayath
Pharmacovigilance for
Ayurveda Drugs
Department of Rasashastra evam Bhaishajya Kalpana (RSBK)
Future Institute of Ayurvedic Medical Sciences (FIAMS), Future University, Bareilly
AyUG-RB Dr.Kiran S Edayath · Topic 26 · Pharmacovigilance for Ayurveda Drugs 1

6 Learning Objectives
1 Describe the term Pharmacovigilance & its importance for Ayurvedic drugs. CO2 CO4 CO5
2 Explain the status & central sector scheme of PV for ASU&H drugs. CO4 CO5
3 Define Adverse Drug Reactions (ADR) and its types. CO4 CO5
4 Identify and monitor ADRs. CO2 CO4 CO5
5 Discuss the safe & efficacious use of Ayurvedic drugs. CO2 CO4
6 Debate on ADR of ASU drugs. CO4 CO5

SECTION 1 OF 6
Meaning & Importance of Pharmacovigilance
Learning Objective 1 · CO2, CO4, CO5

1.1 WHAT DOES THE TERM MEAN?
Pharmaco-Vigilance — “Watching Over Drugs”
PHARMAKON
Greek · “drug” + VIGILARE
Latin · “to keep watch”
AyUG-RB Dr.Kiran S Edayath · Topic 26· Pharmacovigilance for Ayurveda Drugs 4

1.1 WHAT DOES THE TERM MEAN?
Pharmaco-Vigilance — “Watching Over Drugs”
PHARMAKON
Greek · “drug” + VIGILARE
Latin · “to keep watch”
PHARMACOVIGILANCE
WHO Definition
The science and activities relating to detection, assessment, understanding, and prevention of adverse effects
or any drug-related problem.

1.3 & 1.6
Why Pharmacovigilance Matters
WHY PV IS NEEDED (in general)
Trials use small, short-duration samples — rare ADRs surface only after wide
use.
Provides continuous benefit–risk assessment of marketed medicines.
Protects public health via early safety signals.
WHY IT MATTERS SPECIFICALLY FOR AYURVEDA
“Safe-by-default” is a false assumption — suppresses ADR detection.
Poly-herbal / herbo-mineral formulations = complex causality tracing.
100,000+ formulations demand a systematic approach
Builds global credibility & regulator trust for Ayurvedic medicine.
Classical Acknowledgment of Risk — Charaka Samhita
A medicine correctly used acts like nectar; wrongly used, it can act like poison, a weapon, fire, or a thunderbolt. Ayurveda never claimed medicines to be inherently risk-
free.

SECTION 2 OF 6
Status & Central Sector Scheme for ASU&H PV
Learning Objective 2 · CO4, CO5

2.1 HOW WE GOT HERE
Evolution of ASU&H Pharmacovigilance (2003–2025)
2003
CDSCO's National PV
Programme begins
(allopathic drugs)
2007
Jamnagar workshop → PV
Cell + Ayurveda ADR form
2010
PvPI launched by CDSCO
(NCC later at IPC, Ghaziabad)
2017–18
AYUSH Central Sector Scheme
→ three-tier network
2018
PvP-ASU&H launched,
coordinated by NCC, IPC
2025
Upgraded AyushSuraksha
Portal (Supreme Court-
directed)

2.2 THE ESCALATION CHAIN
The Three-Tier PV Network for ASU&H
TIER 3 · FRONTLINE
Peripheral Pharmacovigilance Centres (PPvCs)
97 ASU&H teaching institutions / hospitals nationwide

TIER 3 · FRONTLINE
TIER 2 · INTERMEDIARY
Intermediary Pharmacovigilance Centres (IPvCs)
5 institutes — NIA Jaipur, ITRA Jamnagar, NIUM Bengaluru, NIS Chennai, NIH Kolkata

TIER 3 · FRONTLINE
TIER 2 · INTERMEDIARY
Intermediary Pharmacovigilance Centres (IPvCs)
5 institutes — NIA Jaipur, ITRA Jamnagar, NIUM Bengaluru, NIS Chennai, NIH Kolkata
TIER 1 · APEX
National PV Coordination Centre (NPvCC)
All India Institute of Ayurveda (AIIA), New Delhi → informs Ministry of AYUSH for regulatory action

2.3 & 2.5
PvP-ASU&H Programme & the AyushSuraksha Portal
Network of PPvCs at ASU&H teaching institutions & hospitals nationwide
Builds scientific ADR/AE reporting culture among practitioners, teachers, students
Targets heavy-metal content in Rasa aushadhis, poly-herbal interactions & quality issues
Embeds PV training into BAMS/BUMS/BSMS/BHMS curricula under NCISM's CBME
30 May 2025 — AyushSuraksha Portal
Supreme Court–directed (WP Civil 645/2022): a real-time, centralised dashboard tracking ADRs and misleading ads, letting State Licensing Authorities log complaints
— and opening direct ADR reporting to consumers and the public for the first time.

SECTION 3 OF 6
Adverse Drug Reaction (ADR) — Definition &
Types

3.1 DEFINITION
What Counts as an Adverse Drug Reaction?
“A response to a drug that is noxious and unintended, occurring at doses normally used for prophylaxis, diagnosis, or
therapy of disease, or for modification of physiological function.”
— World Health Organization (WHO)
By Severity
Mild · Moderate · Severe · Lethal
By Onset
Acute (<60 min) · Sub-acute (1–24 hrs) · Latent (>2
days)
By Organ System
WHO-ART or MedDRA classification

3.2 RAWLINS–THOMPSON SYSTEM
The A–F Classification of ADRs
A — Augmented
Dose-dependent, predictable; common, low mortality
e.g. Hypoglycaemia with insulin
B — Bizarre
Dose-independent, unpredictable, immunological
e.g. Anaphylaxis with penicillin
C — Chronic
Related to cumulative dose, long-term therapy
e.g. Analgesic nephropathy

3.2 RAWLINS–THOMPSON SYSTEM
The A–F Classification of ADRs
A — Augmented
Dose-dependent, predictable; common, low mortality
e.g. Hypoglycaemia with insulin
B — Bizarre
Dose-independent, unpredictable, immunological
e.g. Anaphylaxis with penicillin
C — Chronic
Related to cumulative dose, long-term therapy
e.g. Analgesic nephropathy
D — Delayed
Manifests after some time, even post-stop
e.g. Teratogenicity, carcinogenesis
E — End of use
Occurs on abrupt withdrawal
e.g. Benzodiazepine withdrawal seizures
F — Failure
Unexpected therapeutic failure
e.g. OCP failure with enzyme inducers
Mnemonic: A-B-C-D-E-F = Augmented · Bizarre · Chronic · Delayed · End-of-use · Failure

3.4 A RELATED CONCEPT
Drug Interactions — Drug-Drug, Herb-Drug, Herb-Herb
A drug interaction occurs when the effect of one substance is altered by the presence of another — a drug, food, or herb.
Pharmacokinetic
Affects absorption, distribution, metabolism, or
excretion.
Pharmacodynamic
Additive, synergistic, or antagonistic effect at the
site of action.
Example
NSAIDs + anticoagulants → increased bleeding risk.
ASU&H Significance
Since many patients take Ayurvedic medicines alongside allopathic treatment, herb-drug interaction monitoring is a critical part of ASU&H pharmacovigilance.

SECTION 4 OF 6
Identification & Monitoring of ADRs
Learning Objective 4 · CO2, CO4, CO5

4.1 DETECTION TOOLKIT
Methods of ADR Detection & Monitoring
Spontaneous Reporting
Voluntary reports by professionals/patients — backbone
of PvPI/PvP-ASU&H
Intensive Hospital Monitoring
Records all ADRs in a defined hospital population
Cohort Event Monitoring
Prospective study following a defined patient cohort
Case-Control Studies
Compares drug exposure with/without a reaction
Record Linkage
Cross-links prescription & outcome databases
Meta-analysis & Data Mining
Statistical signal detection across large databases

4.3 FROM BEDSIDE TO REGULATOR
The ADR Reporting Workflow
WHAT TO REPORT
• All suspected ADRs, alone or in combination
• Hospitalisation, death, life-threat, disability, congenital anomaly
• Even minor / common reactions

WHAT TO REPORT
WHO / WHERE
• Any healthcare professional can report
• Standard form → nearest PPvC / IPvC
• AyushSuraksha Portal (2025): direct public reporting too

WHAT TO REPORT
WHO / WHERE
• Any healthcare professional can report
• Standard form → nearest PPvC / IPvC
• AyushSuraksha Portal (2025): direct public reporting too
PROCESSING FLOW
PPvC
receives
IPvC
causality (WHO-UMC)
NPvCC / AIIA
aggregates nationally
Ministry of AYUSH
regulatory action

4.4 JUDGING THE LINK
Causality Assessment & Severity Grading
Certain Probable Possible Unlikely Conditional Unassessable
WHO-UMC Scale — from most to least likely the drug caused the event
Naranjo Algorithm (1981)
10-question scored tool:
Score ≥9 Definite · 5–8 Probable · 1–4 Possible · ≤0 Doubtful
Severity (Hartwig & Siegel, 7 levels)
Mild (1–2) → Moderate (3–4b) → Severe (5–7)
Severe = intensive care, permanent harm, or death.
Every ADR record documents 4 dimensions: Causality + Severity + Seriousness + Preventability

SECTION 5 OF 6
Safe & Efficacious Use of Ayurvedic Drugs

5.1 THE CLASSICAL SAFETY FRAMEWORK
What Classical text Says About Safe Use
“A medicine correctly understood and used acts like nectar; wrongly used, it can act like poison, a weapon, fire, or a thunderbolt.” — Charaka Samhita,
Sutrasthana Ch. 1
Drug-Related Factors
Prakriti · Guna · Karma/Prabhava · Desha · Ritu
Grahitam (harvesting) · Nihitam (storage) · Upaskritam (processing)
Patient-Related Factors
Prakriti (constitution) · Vayas (age) · Vikriti (disease state)
Satmya · Satva · Ahara-shakti · Vyayama-shakti · Sara · Sanhanan · Bala
Rasashastra Safeguard: Bhasmas & herbo-mineral formulas require strict Shodhana (purification) & Marana (incineration) — deviation was recognised even in
antiquity as a cause of toxicity.

SECTION 6 OF 6
Debate on ADR of ASU Drugs

6.1 DEBATE PREP
Present Challenges in Ayurvedic Pharmacovigilance
(i) DETECTION
• ‘Inherently safe’ belief delays ADR recognition
• Little ADR coverage in curriculum
• Safety data not organised for retrieval
• Multi-system use complicates causality

6.1 DEBATE PREP
(i) DETECTION
(ii) ASSESSMENT
• Data scattered, non-digitised
• Multi-ingredient — hard to isolate cause
• PK/toxicokinetic data largely unavailable
• Few trained in both Ayurveda + PV

6.1 DEBATE PREP
(i) DETECTION
(ii) ASSESSMENT
• Data scattered, non-digitised
• Multi-ingredient — hard to isolate cause
• PK/toxicokinetic data largely unavailable
• Few trained in both Ayurveda + PV
(iii) PREVENTION
• 100,000+ formulations, informal sector
• Conventional–traditional communication gap
• Patients don't disclose Ayurvedic use
• Limited UG/PG attention; low industry incentive

6.2 & 6.3 WAY FORWARD
Strengthening PV — National Level & Future Scope
Embed PV formally into BAMS/PG curricula (NCISM competency-based) Mandate ADR reporting with clear regulatory backing
Develop Ayurveda-specific causality tools for poly-herbal complexity Leverage technology — apps, crowdsourced monitoring, digital records
Build a centralised PV research repository; run patient-awareness drives Pursue international collaboration to align with global PV standards
Pharmacovigilance completes the Quality – Safety – Efficacy triad essential for the scientific credibility and global acceptance of Ayurvedic
pharmaceutical science.

Thank You
Department of RSBK, FIAMS · Future University, Bareilly · AyUG-RB Dr.Kiran S Edayath, III BAMS

Comprehensive Pharmacovigilance for Ayurveda Drugs: Safety, Monitoring, and Regulatory Framework

More Related Content

Similar to Comprehensive Pharmacovigilance for Ayurveda Drugs: Safety, Monitoring, and Regulatory Framework

Recently uploaded