HERBAL AND COSMETIC ANALYSIS- Unit3 .pptx

Dhanashree Kolhekar- BBAU, Lucknow
HERBAL AND COSMETIC ANALYSIS
PRESENTED BY-
DHANASHREE GIRIDHAR KOLHEKAR
M.PHARM 2ND
SEM
(PHARMACEUTICAL ANALYSIS)
BBAU, LUCKNOW

2
 Herbal remedies-
 Toxicity and Regulations: Herbals vs Conventional drugs,
 Efficacy of herbal medicine products,
 Validation of HerbalTherapies, Pharmacodynamic and Pharmacokinetic issues.
 Herbal drug standardization:WHO and AYUSH guidelines.
 Herbal drug-drug interaction:WHO and AYUSH guidelines for safety monitoring of
natural medicine,
 Spontaneous reporting schemes for bio drug adverse reactions,
 bio drug drug and bio drug-
 food interactions with suitable examples. Challenges in monitoring the safety of herbal
medicines.
Table of contents-

3 HERBAL REMEDIES
• Herbal remedies are natural substances derived from plants used to treat illnesses and
promote health.They have been an integral part of traditional medicine systems across
the world for centuries.
• Herbal remedies offer a natural and holistic approach to health.They often come with
fewer side effects compared to synthetic drugs and are commonly used in both
traditional and modern healthcare practices.

4 COMMON HERBAL REMEDIES
• • AloeVera: Known for soothing burns and skin irritation.
• Ginger: Helps relieve nausea and supports digestion.
• Turmeric: Contains curcumin, a powerful anti-inflammatory agent.
• Peppermint:Aids in digestion and relieves headaches.
• Garlic: Supports heart health and boosts the immune system.

5 FORMS OF HERBAL REMEDIES
• Herbs can be consumed or applied in various forms such as:
• Teas and infusions
• Capsules and tablets
• Tinctures and extracts
• Creams and ointments

6 SCIENTIFIC SUPPORT & RESEARCH
• Modern research is increasingly validating the efficacy of many herbal
remedies. Clinical trials and studies have shown that certain herbs have
significant therapeutic properties and can complement conventional
medicine.

7 SAFETY AND PRECAUTIONS
• While herbal remedies are natural, they are not always free from side
effects. It's important to:
• Be aware of possible interactions with medications
• Follow recommended dosages
• Consult with healthcare providers before use

8 CULTURAL AND TRADITIONAL USE
• Herbal medicine is deeply rooted in cultural traditions like Ayurveda from
India,Traditional Chinese Medicine, and indigenous healing practices.These
systems use herbs as part of a broader health philosophy.

9 THE FUTURE OF HERBAL MEDICINE
• With rising interest in natural health, herbal remedies are gaining
popularity.The focus is shifting toward:
• Sustainable harvesting
• Ethical sourcing
• Integrating herbal medicine with modern preventive healthcare

10 HERBAL REMEDIESVS. CONVENTIONAL DRUGS
• 1. Herbal Drugs: Derived from plants (leaves, roots, seeds, flowers).
• Conventional Drugs: Synthesized chemically or extracted and modified
from natural sources.
• 2. Composition Herbal: Complex mixture of natural compounds.
• Conventional: Often a single active ingredient for targeted action.

11
• 3. Mechanism of Action
• Herbal: Holistic action; may support multiple systems in the body
• .Conventional: Specific and targeted; designed to treat symptoms or kill pathogens.---
• 4. Effectiveness
• Herbal: Slower onset; effectiveness can vary based on preparation and individual
response.
• Conventional: Fast-acting; clinically tested and regulated.

12
• 5. Safety & Side Effects
• Herbal: Fewer side effects when used properly; risk of contamination or misidentification.
• Conventional:Well-studied side effects; may cause stronger adverse reactions.---
• 6. Regulation
• Herbal: Loosely regulated in many countries; quality can vary.
• Conventional: Strict regulation (FDA, EMA, etc.); consistent dosing and quality.

13 EFFICACY OF HERBAL MEDICAL PRODUCTS
• 1.What is Efficacy? Efficacy refers to how well a product produces the
desired therapeutic effect under ideal conditions (like clinical trials).---
• 2. Factors Influencing Efficacy of Herbal Products
• Plant source & quality (species, growing conditions)Part of plant used
(root, leaf, flower)Preparation method (tea, extract, powder)Dosage and
duration Individual differences (age, health, genetics)

14
• 3. Evidence-Based Examples---
• 4. Research ChallengesVariability in herbal product quality Small or poorly
designed studies Lack of standardization in doses and compounds Limited
funding compared to pharmaceuticals

15 THE EFFICACY OF HERBAL MEDICAL PRODUCTS
1. Understanding Efficacy in Herbal Medicine Herbal efficacy is not just
about symptom relief—it also includes long-term health benefits,
immune support, and disease prevention.
2. Some herbs work gradually, promoting balance and strengthening body
systems over time rather than offering quick symptom relief.

16
• 2. Scientific Evaluation of Herbal Products
• Randomized Controlled Trials (RCTs): Some herbal products have been
tested in clinical trials, showing promising results. For example: St. John’s
Wort has been shown in several studies to be as effective as standard
antidepressants for mild to moderate depression. Ginger is widely
supported for reducing nausea in pregnancy and chemotherapy patients.
Meta-analyses and systematic reviews are increasingly being done to
gather more reliable data across multiple studies.

17
• 3. Regulatory Recognition The World Health Organization (WHO)
recognizes the value of traditional medicine and supports research into its
efficacy.In countries like Germany, herbal products are regulated and
prescribed alongside conventional medicines under phytotherapy.---
• 4. Popular Herbs with Research-Backed Efficacy

18
• 5. Limitations & Risks Lack of standardization: Dosage, active compound concentration,
and extraction methods vary widely between products.Interactions with drugs: Some
herbs can interfere with medications (e.g., St. John’s Wort can reduce effectiveness of
birth control and antidepressants).Self-medication risks:Without professional guidance,
misuse can lead to poor outcomes or mask serious conditions.—
• -6.TheWay Forward Encourage integrative medicine approaches, combining herbal and
conventional treatments when appropriate.Support more clinical research to understand
how herbs work and in what doses they are most effective.Advocate for better
regulation and labeling standards for herbal products.

19 STANDARDIZATION OF HERBAL DRUGS:WHO &
AYUSH GUIDELINES
• 1. Introduction
• Herbal medicines play a vital role in traditional and modern healthcare
systems globally. However, due to their natural origin and complex
composition, herbal products often face challenges related to quality,
safety, and efficacy.To overcome this, international and national bodies like
the World Health Organization (WHO) and Ministry of AYUSH (India)
have developed standardization guidelines.

20
• 2.What is Standardization? Standardization is the process of ensuring
consistency in the quality, composition, and therapeutic effect of herbal
drugs. It involves setting defined criteria for: Raw material identity and
purity Manufacturing processes Finished product testing Packaging,
storage, and labeling Standardization helps eliminate variations in plant
species, environmental conditions, harvesting techniques, and processing
methods, all of which affect herbal drug qualit

21
• 3.WHO Guidelines for Standardization of Herbal MedicinesTheWorld Health Organization
(WHO) has published several documents and monographs to assist member countries in
regulating and ensuring the quality of herbal medicines.Key Components ofWHO
Standardization Framework:
• A. Raw Material Standards Correct botanical identification (scientific name, family, part
used)Follow Good Agricultural and Collection Practices (GACP)Ensure absence of
contamination (pesticides, heavy metals, microbes)
• B. Processing Standards Standard Operating Procedures (SOPs) for manufacturingUse of
validated extraction methodsIn-process controls to maintain consistency.

22
• C.Analytical Standards Physico-chemical tests (moisture, ash value, extractive
values)Chromatographic fingerprinting (TLC, HPTLC, HPLC)Quantification of
active/marker compounds
• D. Safety Testing Toxicology studies Microbial and heavy metal contamination limits
Pesticide residue analysis
• E. Pharmacovigilance Post-marketing surveillance of herbal drugs Collection and
assessment of adverse drug reactions (ADRs)F. Documentation Batch records,
certificates of analysis Labeling: plant name, part used, dosage, expiry date, warnings

23 4.AYUSH GUIDELINES FOR HERBAL DRUG
STANDARDIZATION
• The Ministry of AYUSH, Government of India, regulates herbal drugs from Ayurveda,
Siddha, Unani, and Homeopathy systems. It has established several regulatory frameworks
and reference standards.Key Bodies and Documents: Pharmacopoeia Commission for
Indian Medicine & Homoeopathy (PCIMH)Ayurvedic Pharmacopoeia of India (API)Unani
& Siddha Pharmacopoeias Good Manufacturing Practices (GMP) under ScheduleT of
Drugs & Cosmetics Act Main Focus Areas:
• A. Identification & AuthenticationBotanical verification of the correct speciesMicroscopic
and macroscopic studies

24 HERBAL DRUG INTERACTIONS
• 1. Introduction
• Herbal remedies are widely used for wellness and therapy, often alongside prescription drugs, creating a risk of herb-drug
interactions (HDIs).These interactions can lead to unwanted therapeutic failure or toxicity. Most patients do not report herbal
use to healthcare providers, increasing the risk of complications.---
• 2. Expanded Mechanisms of Interaction
• A. Pharmacokinetic Interactions (ADME changes)Absorption: Herbs may alter gastrointestinal motility or pH.Example: Psyllium
husk (fiber supplement) can bind to drugs like digoxin or carbamazepine, reducing absorption.
• Distribution: Competing for plasma protein binding sites.Example:Turmeric (curcumin) may displace warfarin from protein-
binding sites
• .Metabolism: Most common via Cytochrome P450 enzyme system.Inducers: St. John’s Wort reduces levels of oral
→
contraceptives, cyclosporine, warfarin.Inhibitors: Goldenseal inhibits CYP3A4, increasing drug levels and toxicity.Excretion:
Affects renal tubular secretion.Example: Dandelion has diuretic effects and may affect lithium clearance.

25
Pharmacodynamic InteractionsSynergistic: Enhances drug effectExample: Garlic + Warfarin →
excessive bleedingAntagonistic: Reduces drug effectExample: Ginseng may reduce effectiveness of
anticoagulants
3. Common Herb-Drug Interaction Examples-
Case 1:A patient on warfarin starts garlic supplements.Result: Internal bleeding due to increased
anticoagulant effect.Case
2:A woman on birth control uses St. John’sWort for depression.Result: Unplanned pregnancy due to
reduced contraceptive effectiveness.Case
3:A transplant patient on cyclosporine uses St. John’sWort.Result: Organ rejection due to reduced
drug levels.

26
• 5. Populations at Higher Risk Elderly (polypharmacy, slower metabolism)Pregnant or breastfeeding women
Patients with chronic illnesses (e.g., liver, kidney, heart conditions)Surgical patients (bleeding risk with herbs like
ginkgo, garlic, ginger)-
• 6. Regulatory and Safety Perspectives WHO Advocates for inclusion of herbal medicine data in
pharmacovigilance programs Promotes public education on herb-drug interactions FDA (USA)Considers herbal
supplements as dietary supplements, not drugs Requires labels to include a "consult your healthcare provider"
warning EMA (Europe)Issues monographs on herbs and potential drug interactions AYUSH (India)Encourages
integration with allopathic systems and monitoring interactions-
• 7. Prevention and Best Practices Patient Education:Always disclose herb/supplement use to your doctor Clinical
Tools: Use interaction checkers (Drugs.com, Medscape, etc.)Healthcare Provider Training: Include herb-drug
interaction awareness in clinical education se Standardized Products: Products with known concentrations of
active compounds reduce variability Avoid Herbs Before Surgery:At least 2 weeks before due to
bleeding/clotting risks

27 SAFETY MONITORING OF NATURAL MEDICINES:
WHO AND AYUSH GUIDELINES
• 1. Introduction
• Safety monitoring of natural medicines (herbal/traditional medicines) is essential
due to:Increased global use of herbal therapies Potential for adverse drug
reactions (ADRs) and interactions Lack of standardization and clinical testing
compared to allopathic drugs Despite being perceived as "natural" and "safe",
herbal medicines can cause toxicity, organ damage, or interactions with other
drugs if not monitored properly.

28
• 2.WHO Guidelines: Pharmacovigilance for Herbal MedicinesThe World Health Organization
(WHO) encourages all member states to integrate herbal medicine into national
pharmacovigilance programs (PvPs) and follow structured safety monitoring practices.
• A. Key WHO Recommendationsi. Inclusion in National Pharmacovigilance SystemsCountries
should register and report ADRs from herbal and traditional medicines just like synthetic
drugs.Herbal medicines should be part of the national PvP database.
• ii. Unique Challenges in Herbal PvPVariability in names and formulationsMultiple ingredients in
a single productMisidentification or adulterationLack of product labelingCultural differences in
usage

29 ADVERSE DRUG REACTION (ADR) REPORTING
• Healthcare workers, herbalists, and patients should report ADRs.Reporting forms should be modified
to include:Plant name (scientific + vernacular)Formulation details Source and manufacturerBatch
number, expiryRoute, dose, durationiv
• . Data Collection and AnalysisWHO recommends coding herbal products using theWHO Drug
Dictionary Enhanced (WHODDE).ADR data should be submitted to WHO-UMC (Uppsala
Monitoring Centre).v.Training and AwarenessTraining programs for doctors, pharmacists, herbalists,
and regulatory staff.Public awareness campaigns on the safe use of herbal products.vi. Collaboration
with Traditional HealersIn many regions, traditional healers are the primary users and distributors of
herbal medicine.WHO encourages their training and participation in safety surveillance.

30
• 3.AYUSH Guidelines: India’s System for Safety MonitoringIndia’s Ministry of AYUSH has
launched a Pharmacovigilance Program for Ayurveda, Siddha, Unani, and Homeopathy
(ASU&H) medicines since 2008, revised in 2017 to make it more robust.---A. Structure of
AYUSH Pharmacovigilance
• 1. Nodal Agency:Pharmacopoeia Commission for Indian Medicine & Homoeopathy
(PCIM&H)2.Three-Tier Network:National Coordinating Center (NCC):
PCIM&HIntermediary Pharmacovigilance Centers (IPvCs): Located at research councils and
national institutesPeripheral Reporting Centers (PvCs): Hospitals, colleges, dispensaries

31
• B. Key AYUSH Guidelines for Safety Monitoringi.
• Mandatory Reporting All ASU&H institutions, practitioners, and pharmacies are mandated to report ADRs.ii.
Data Collection Complete patient history, drug use history, diagnosis, treatment, adverse events, etc.Causality
assessment using WHO-UMC or Naranjo scaleiii.Analysis and ActionCentral database analysis to detect
patterns or clustersReports are sent to the Central Drugs Standard Control Organization (CDSCO) if
neededPotential regulatory action includes product recall or labeling updatesiv. Education and TrainingAYUSH
conducts workshops, CMEs (Continuing Medical Education), and training programs
for:PractitionersStudentsManufacturersv. Safety Evaluation of Proprietary MedicinesManufacturers must submit
safety data during licensingPost-marketing surveillance (PMS) is encouragedvi. Integration with Mainstream
PvPCollaboration with Indian Pharmacopoeia Commission (IPC) and CDSCO to merge ADR data.

32
• 4. Challenges in Herbal Pharmacovigilance
• Underreporting of ADRs due to cultural trust in herbal productsLack of unique identifiers
(e.g., barcodes, standard names)Multiple active ingredients in one productUse of non-
standardized herbal formulationsLimited documentation by traditional practitioners
• 5. Global Harmonization Efforts
• WHO promotes international harmonization of herbal pharmacovigilance:Encouraging
countries to include natural medicines in PvPSharing ADR data throughVigiBase (WHO-
UMC database)Publishing monographs and safety profiles of commonly used herbs

33 MONITORING THE SAFETY OF HERBAL MEDICINES
• Despite the increasing global use of herbal medicines, pharmacovigilance (PV) systems for
these products face multiple challenges due to the unique characteristics of herbal
therapies, compared to synthetic pharmaceuticals.
• 1. Complexity of Herbal Products Multi-component formulations: Herbal medicines often
contain multiple plant parts or combined formulas, making it difficult to attribute an
adverse event (AE) to a specific ingredient.Variation in composition: Factors like plant
species, part used, harvest time, geography, and preparation method can affect chemical
composition and potency.Example:The same herbal product from different manufacturers
may vary significantly in quality and effects.

34
• 2. Lack of Standardization
• Herbal products often lack uniform standards for identity, purity, potency, and
dosage.Absence of fixed dosages leads to inconsistent therapeutic and toxicological
outcomes.There may be no established monographs or reference materials for many
herbs, especially in traditional medicine systems.
• 3. Misidentification and AdulterationHerbal ingredients may be misidentified or
mislabeled, especially if local names are used instead of scientific names.Cases of
intentional adulteration with corticosteroids, NSAIDs, or allopathic drugs have been
reported.Example: Some slimming or sexual enhancement "herbal" products contain
sildenafil or ephedrine, increasing risk of adverse events.

35
• 4. Inadequate Regulatory OversightIn many countries, herbal products are sold as dietary
supplements or traditional remedies and are not subject to the same pre-market safety
testing as pharmaceuticals.Lack of post-marketing surveillance (PMS) for herbal
medicines contributes to underreporting of adverse effects.---5. Underreporting of
Adverse ReactionsCultural beliefs that “natural means safe” discourage patients and
practitioners from reporting ADRs.Many ADRs are not recognized or are attributed to
the patient’s condition rather than the herbal product.Healthcare professionals often
have limited awareness or training in herbal pharmacovigilance.

36
• 6. Challenges in Causality Assessment
• Difficulty linking a specific herbal product to an ADR due to:Complex mixturesLack of
batch traceability Missing information on dosage, duration, and preparationStandard
causality tools (e.g.,WHO-UMC, Naranjo scale) may not be fully applicable or validated
for herbals.---7. Herb–Drug and Herb–Herb InteractionsHerbal medicines are often used
in conjunction with conventional drugs, leading to interactions that may enhance toxicity
or reduce efficacy.
• Example:St. John’s Wort induces CYP3A4 enzymes, reducing levels of drugs like
cyclosporine or warfarin.Ginkgo biloba may increase bleeding risk when used with
anticoagulants.

37
• 8. Lack of Integration into Healthcare SystemsHerbal therapies are often practiced
outside formal healthcare systems, especially by traditional healers.These
practitioners may not be involved in pharmacovigilance networks or trained in ADR
reporting.
• 9.Variability in Global Guidelines While WHO and some countries like India
(AYUSH) have established herbal PV frameworks, many countries lack clear
guidelines.There is no global consensus on how herbal ADRs should be collected,
coded, and analyzed.
• 10. Limited Clinical Data and Research Most herbal products are not studied in
large-scale clinical trials for safety and efficacy.Toxicity data are often based on case
reports or traditional use, which may not reflect actual safety in diverse populations.

38
• 11. Difficulties in Reporting and Coding
• Existing pharmacovigilance software and dictionaries (e.g., MedDRA,WHODD)
are not always equipped to handle complex herbal names or multi-ingredient
formulations.Lack of standard coding for herbal names makes data entry and
analysis difficult.
• 12. Storage and Quality Issues
• Herbal products are often stored in non-standard conditions, leading to
contamination, mold growth, or degradation.This can contribute to toxic effects
or reduced efficacy that are hard to trace to the product’s original composition.

39 BIOLOGICAL DRUG AND FOOD INTERACTIONS
• 1.What are Biological Drugs? Biological drugs (biologics) are therapeutic products
derived from living organisms.These include:Monoclonal antibodies (mAbs) – e.g.,
infliximab, adalimumab Hormones – e.g., insulin, erythropoietin Cytokines – e.g.,
interferonsVaccinesGene therapies and cell therapiesUnlike conventional small-molecule
drugs, biologics are large, complex molecules and usually administered parenterally (IV,
SC, IM).
• 2. Bio-Drug and Food Interactions – General OverviewBiologics generally do not have
direct interactions with food the way oral drugs do, because they:Are not taken
orallyAre not absorbed via the GI tractDo not rely on metabolic enzymes like
CYP450However, indirect interactions can occur via nutrient-mediated immune or
metabolic modulation, or when supportive medications (e.g., corticosteroids,
immunosuppressants) are involved.

40
• 4. Examples of Biologic–Food Interactions
• A. Monoclonal AntibodiesInfliximab (Remicade) – used for Crohn’s disease, rheumatoid
arthritisInteraction: High-fat diets may worsen gut inflammation and reduce response to
infliximab.Recommendation:Anti-inflammatory diet (low processed food, rich in fiber)
may improve efficacy.Adalimumab (Humira) – TNF-alpha blockerInteraction: Obesity or
high sugar intake linked to reduced response due to increasedTNF expression.
• B. Insulin (Biologic Hormone)Interaction: Food has direct impact on insulin dosing.High
glycemic index (GI) foods raise blood sugar rapidly, needing more insulin.Alcohol can
cause hypoglycemia.Recommendation: Meal planning is essential; low-GI, balanced-carb
diets improve glycemic control.

41
• C. Erythropoietin (EPO)Interaction: Requires adequate iron, vitamin B12, and folate to
stimulate red blood cell production.Deficiency in these nutrients reduces EPO
efficacy.Recommendation: Iron-rich diet or supplementation often co-prescribed.
• D. Interferon TherapyUsed for hepatitis B/C, multiple sclerosisInteraction:High-fat diet
may worsen liver inflammation.Omega-3 fatty acids may reduce interferon-induced
depression (neuroprotective).Recommendation:Anti-inflammatory diet and fish oil
supplements may be beneficial.
• 5. Biologics and Nutritional SupplementsSome supplements or "functional foods" can
interact with biologics:Turmeric (Curcumin): May reduce inflammation but also alter
immune response.Probiotics: May influence the gut microbiome in inflammatory bowel
disease (IBD), affecting biologic response.St. John’s Wort: May interfere with metabolism
of immunosuppressive co-therapies (e.g., cyclosporine).

42 SPONTANEOUS REPORTING SCHEME (SRS) FOR
ADVERSE DRUG/BIOLOGICAL REACTIONS
• 1.What is the Spontaneous Reporting Scheme?The Spontaneous Reporting
Scheme (SRS) is a system used in pharmacovigilance to collect, assess, and
analyze reports of adverse drug reactions (ADRs) and adverse biological product
reactions that occur in the general population during routine clinical use of
medicines or vaccines.It involves voluntary or mandatory reporting by healthcare
professionals, manufacturers, and patients without active surveillance or
systematic data collection.
• 2. Purpose of SRSEarly detection of rare, serious, or unexpected
ADRsIdentification of safety signalsMonitoring benefit-risk balanceSupporting
regulatory actions (e.g., warnings, product withdrawal)Improving patient safety by
minimizing harm

43
• 3. Key Components of an SRS
• i. Reporting SourcesHealthcare professionals (physicians, pharmacists,
nurses)Manufacturers (as per regulatory requirement)Patients and
consumersClinical trial investigators (during post-marketing phase)
• ii. Reportable ProductsPrescription and over-the-counter (OTC) drugsHerbal
medicines and dietary supplementsBiologicals (e.g., vaccines, blood products,
monoclonal antibodies)Traditional medicinesiii.What to ReportSuspected
adverse reactions (mild to severe)Unexpected lack of efficacyDrug misuse,
overdose, medication errorsReactions from drug–drug, herb–drug, or vaccine–
drug interactions

44
• 4. Reporting Format andToolsMost national pharmacovigilance authorities provide
standardized ADR reporting forms, which typically include:Patient details (age, gender,
medical history)Suspected drug/biologic (name, dose, route, duration)Description of the
adverse event (onset, outcome, severity)Reporter details (name, qualification,
institution)Forms can be submitted via:Paper-based formsOnline portals or appsEmail or
telephone hotlines-
• 5. Reporting Workflow1.Adverse event occurs 2. Healthcare provider or patient submits
a report 3. Data entered into national ADR database 4. Causality assessment by
pharmacovigilance experts 5. If necessary, signals are sent to:Drug Regulatory
AuthorityWHO-Uppsala Monitoring Centre (UMC)

45
• 7.Advantages of SRSCost-effectiveCovers large populationHelps in identifying rare ADRs
not seen in clinical trialsEnables real-time safety updatesSupports post-marketing
surveillance (Phase IV studies)
• 8. Limitations of SRSUnderreporting is a major challenge (only 1-10% of ADRs are
reported)Incomplete or inaccurate reportsLack of denominator (cannot estimate
incidence rates)Reporter bias (more serious events likely to be reported)Cannot
establish definitive causality, only association
• 9. Improving SRS EffectivenessTraining healthcare professionals on the importance of
ADR reportingPatient awareness campaignsIntegration of SRS with Electronic Health
Records (EHRs)Feedback to reporters to encourage continued participationMaking
reporting anonymous and user-friendly.

46
• 10. SRS in Biological Products (Vaccines, Monoclonal Antibodies)Biological products are
more complex than small-molecule drugs, hence require:Separate tracking for batch
numbersSpecial attention to cold chain and storage issuesMonitoring for immunogenicity,
allergic reactions, cytokine storms, etc.In India,ADR reporting for vaccines is done via
the AEFI surveillance system (Adverse Events Following Immunization) coordinated by
MoHFW andWHO.
• 11. Role of WHO-UMC andVigiBaseWHO collaborates with over 130 countries to
collect global ADR dataReports are sent toVigiBase, maintained by the Uppsala
Monitoring Centre (Sweden)VigiBase enables global signal detection, trend analysis, and
alerts

47
THANKYOU

HERBAL AND COSMETIC ANALYSIS- Unit3 .pptx

More Related Content

What's hot

Similar to HERBAL AND COSMETIC ANALYSIS- Unit3 .pptx

More from DHANASHREE KOLHEKAR

Recently uploaded

HERBAL AND COSMETIC ANALYSIS- Unit3 .pptx