This document provides an overview of the regulatory aspects of herbal medicines in India, Europe, and the United States. It discusses the key regulatory bodies and guidelines around herbal medicines in each region. In India, herbal medicines are regulated by the Ayush Ministry, ICMR, and Drugs and Cosmetics Act. In Europe, herbal medicines fall under European directives and are evaluated by the EMA and HMPC. In the US, herbal products are classified and regulated differently depending on if they are considered a dietary supplement, food, or drug.
the overall summary of regulation of herbal drugs in India and what document required for getting approval and summary of GMP, GCP guideline with labelling requirement.
REGULATORY ASPECTS OF FOOD & NUTRACEUTICALS A GLOBALKapilKumar198
This presentation contains detailed information about the regulatory aspects of food and nutraceuticals a global prospective, which includes WHO guidelines on nutrition and NSF International.
Regulatory requirements for herbal medicines: Herbal medicines are different from other types of medicines. The approval process is also different from other medicines. AYUSH Ministry given guidelines for approval of herbal medicines.
Query Solved
1. Regulatory requirements for herbal medicines
2. Herbal Medicines ke liye regulatory requirements
3. AYUSH ka important role in Herbal medicines launch
4. D and C act role in Herbal medicines
5. What are important steps to launch herbal medicines
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
the overall summary of regulation of herbal drugs in India and what document required for getting approval and summary of GMP, GCP guideline with labelling requirement.
REGULATORY ASPECTS OF FOOD & NUTRACEUTICALS A GLOBALKapilKumar198
This presentation contains detailed information about the regulatory aspects of food and nutraceuticals a global prospective, which includes WHO guidelines on nutrition and NSF International.
Regulatory requirements for herbal medicines: Herbal medicines are different from other types of medicines. The approval process is also different from other medicines. AYUSH Ministry given guidelines for approval of herbal medicines.
Query Solved
1. Regulatory requirements for herbal medicines
2. Herbal Medicines ke liye regulatory requirements
3. AYUSH ka important role in Herbal medicines launch
4. D and C act role in Herbal medicines
5. What are important steps to launch herbal medicines
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
FSSAI REGULATIONS FOR THE IMPORT, MANUFACTURE AND SALE OF NUTRACEUTICALS IN I...Swapnil Fernandes
- Nutraceutical market has shown steady increase in the last decade.
- The import, manufacture and marketing regulations for nutraceuticals in India have been streamlined with the updation of the FSSAI regulations 2016.
- RDA’s are a collection of values to express a person's nutrient need based on their life stage & gender.
- The RDA recommendations for the Indian population has been provided by the ICMR on the basis of scientific studies and subsequent data generated.
GMP Guidelines for Nutraceuticals - Indian And EuropeanVarshaJindaniya
This GMP Guidance Document covers the entire manufacturing process of Health Supplements/ Nutraceuticals in the form of Powders, Tablets, Capsules, Soft Gel Capsules and Liquids starting from procurement of raw materials to despatch of finished product.
Contact me: www.linkedin.com/in/varsha-jindaniya
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
FSSAI REGULATIONS FOR THE IMPORT, MANUFACTURE AND SALE OF NUTRACEUTICALS IN I...Swapnil Fernandes
- Nutraceutical market has shown steady increase in the last decade.
- The import, manufacture and marketing regulations for nutraceuticals in India have been streamlined with the updation of the FSSAI regulations 2016.
- RDA’s are a collection of values to express a person's nutrient need based on their life stage & gender.
- The RDA recommendations for the Indian population has been provided by the ICMR on the basis of scientific studies and subsequent data generated.
GMP Guidelines for Nutraceuticals - Indian And EuropeanVarshaJindaniya
This GMP Guidance Document covers the entire manufacturing process of Health Supplements/ Nutraceuticals in the form of Powders, Tablets, Capsules, Soft Gel Capsules and Liquids starting from procurement of raw materials to despatch of finished product.
Contact me: www.linkedin.com/in/varsha-jindaniya
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
Herbal drug regulations and standardisationRavish Yadav
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
Fundamentals of Food Production and Food Industries – Guires Food Research Labfoodresearch
Food Research Lab is one of the leading food industry consultants and offers various food production services. We provide food production and food manufacturing consultancy services to food, beverage and nutraceutical companies. Primary food production involves everything from food procurement, inventory control, quality checks to processing.
Regulatory authorities (US-FDA, WHO and ICH)Sagar Savale
To promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner.
With respect to such products, protect the public health by ensuring that the food are safe, Wholesome, sanitary, and properly labelled; human and veterinary drugs are safe and effective; there is reasonable assurance of the safety and effectiveness of devices intended for human use; cosmetics are safe and properly labelled, and public health and safety are protected from the electronic product radiation.
Participates through appropriate process with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
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3. HERBAL MEDICINES
It Include herbs, herbal materials, herbal
preparations and finished herbal products
that contain as active ingredients part of
plant, or other plant materials or
combinations.
3
4. Traditional/ Complementary
Medicine -WHO perspective
Traditional Medicine – Indigenous Medicine
existent in the region either recognised or
ethnic as in Chinese medicine, Indian
Ayurveda, Arabic Unani medicine, African
& Latin American practices.
Complementary / Alternative Medicine –
Added or used alternatively to dominant
health care system of allopathic medicine
as in US, Canada and Europe
4
5. Herbal drug products constitute a major
share of all the officially recognized
systems of health in India,like
Ayurveda, Yoga, Unani, Siddha, Homeopa
thy and Naturopathy.
Research Councils (ICMR and
CSIR), Department of AYUSH
(Ayurveda, Yoga &
Naturopathy, Unani, Siddha and
Homoeopathy) & Drugs and Cosmetics
Act 1940 (Amendment) regulates
herbal medicines in India.
Department of AYUSH, ICMR and CSIR
work together to achieve safe, effective
AYUSH products for the identified diseases
and to develop new drugs. 5
6. Indian Council of Medical
Research
Founded in 1911 as Indian Research Fund
Association
Renamed as ICMR in 1949
Apex organization to
formulate, conduct, coordinate and
promote biomedical research
6
7. ICMR’s Research on herbal
drugs
1911 onwards - ICMR
1964 – 70 : Composite Drug Research
Scheme
1983 – Disease oriented approach
2000 onwards - Collaboration between
ICMR & Dept. of AYUSH (earlier ISM & H)
Golden Triangle Partnership Program
2005 – ICMR – NIF Initiative
7
8. Quality Standards of Indian
Medicinal Plants
Standards set as per
WHO guidelines.
Use conventional and
modern scientific
approach.
Developed at 4 national
laboratories.
3 Volumes.
8
9. MAJOR ACTIVITIES
Status Report on propagation techniques
of Pterocarpus marsupium, Saraca
indica and Streblus asper – IHBT,
Palampur.
Agrotechnology of P. kurroa, IHBT,
Palampur
Clinical trial with Vijayasar (Pterocarpus
marsupium) in Chronic Diabetics
Survey of Medicinal plants of Western
Ghats
9
10. Spends on Traditional Medicine
Development
NCCAM, USA – USD
123.1 m in 2005
increase by 0.5 %
in 2006
WHO - <.1 % of
budget
India & China
spend more
10
11. 1980 ICMR Guidelines – “Policy Statement on
Ethical Considerations involved in research
on Human Subjects’’
Ethics Committee
Informed consent
Clinical trials
Research on children, mentally
disadvantaged,
those with diminished autonomy
Traditional Medicine
Publications
11
12. Revised ICMR Ethics Guidelines
Released in 2000
All institutions involved
in biomedical research
involving human beings
should follow these
guidelines to protect
safety and well being of
all individuals.
Guidelines on website -
http://www.icmr.nic.in
To be legislated - The
Biomedical Research on
Human Subjects
(Promotion and
Regulation) Bill, 2006
12
13. Research on herbal drugs –
Reverse Pharmacology
No toxicity study to be done for Phase II
trials…. if there are no toxicity reports when
use is for less than 3 months.
It should be necessary to undertake 4-6 weeks
toxicity study in 2 species of animal to be
used for > 3 months if there are reports
suggesting toxicity when a larger multicentric
Phase III trials are subsequently planned
based on the results of Phase II study.
Adverse Drug Reaction & drug-herb
interaction should be reported
13
14. Protocol
Group of experts should include experts from
traditional systems of medicine.
GCP compliant trial design
Biostatistician to be involved while designing
clinical trial protocol.
Pilot studies can be observational
Ideal to conduct a randomized, controlled trial to
validate
Monitoring must to detect toxicity as well as
efficacy
Statistical analysis should be presented in a
manner that is likely to facilitate the
interpretation of their clinical importance.
14
15. Monitoring
To be based on considerations such as objective,
purpose, design, complexity, blinding, size and
end points of the trial.
To be conducted and documented properly in
accordance with GCP.
Efficacy to be based on such defined endpoints as,
specific clinical symptoms or signs, or defined
prognostic laboratory markers.
Safety to be monitored on the basis of either
symptoms or signs,particularly to end points that
may signal anticipated toxicity.
Laboratory indicators of liver, kidney, cardiac or
haematological toxicity.
15
16. Special Concerns for Herbal
Remedies
1)For all researchers
GCP Guidelines also pertain to traditional drugs
Herbal remedies and medicinal plants to be
incorporated in modern system must follow DCGI’s
guidelines
Multidisciplinary Expert group for designing and
evaluating the study from concerned systems : ideal for
multicentric studies.
Association with physicians from the concerned system
shall be necessary as co-investigators / collaborators if
trial is in Modern Medicine Hospitals
2)Researchers from Indian Systems of Medicine
Guidelines not binding for evaluation of traditional
drugs for use in their own hospitals / clinics
16
17. QUALITY CONTROL AYURVEDIC
DRUGS (Drugs & Cosmetics
Act, 1940 & Rules, 1945)
Separate Chapter for Ayurveda, Siddha & Unani
medicines introduced in Chapter IV A.
33 C - Separate Drug Technical Advisory Board
under Drugs & Cosmetics Act, 1940 for Indian
Systems of Medicines to advise Government on all
aspects related to quality control and drug
standardization.
33 D - Separate Drugs Consultative Committee
comprising State Drugs Licensing Authorities set up
under the Act for securing uniformity in the
administration of the Act throughout India
33 E – misbranded drugs, 33 EE – adulterated
drugs, 33EEA – spurious drugs.
17
18. IMPORTANT PROVISIONS OF INDIAN DRUGS &
COSMETICS ACT, 1940 RELATING TO
AYURVEDA, SIDDHA AND UNANI DRUGS
33EEB - Regulation of manufacture for
sale of Ayurvedic drugs through drug
license system.
33EEC-Prohibitionof manufacture and sale
of certain drugs.
33EED –Power of Central Government to
prohibit manufacture etc., of drugs in
public interest.
33 F - Provision for Government Analysts.
33 G - Provision for Inspectors to visit
factory.
18
19. 33 H - Penalty for manufacture, sale
etc., of drugs in contravention of the Act.
33 J - Penalty for subsequent offences.
Prescribe qualifications and duties of the
Government analysts.
Prescribe methods of testing and analysis.
Establish Good Laboratories for Testing
and Analysis of drugs.
33 EEB – heavy metals within permissible
limits - Mandatory testing for heavy
metals (Arsenic, Lead, Mercury &
Cadmium) in export formulations.
19
20. Permissible Limit of Heavy Metals in
ASU Formulations with only Herbal
Ingredients
As per W.H.O & US F.D.A
Lead (Pb) 10 ppm
Cadmium (Cd) 0.30 ppm
Arsenic (As) 10 ppm
Mercury (Hg.) 1 ppm
20
21. List of Approved ASU Drug Testing
Laboratories
1)Under Rule -160 A to J of the Drugs and Cosmetics
Rule 1945 – 12 Labs
5 – Madhya Pradesh, 4 - Bangalore, 2 -
Hyderabad, Chennai, 1 – Haryana, New
Delhi, Jammu
2)GLP Compliant NABL Accredited Laboratories
a. International Institute of Bio-technology
(IIBT), Padappai, Tamil Nadu
b. Rallis Research
Centre, Peenaya, Bangalore, Karnataka
c. Jai Research Foundation, VAPI, Gujarat
d. Reddy’s Lab, Hyderabad, Andhra Pradesh 21
23. European Community
Directives
CD 2001/83(“basic” regulation)
CD 2003/63 of 25 June 2003 (Annex
I, criteria)
CD 2004/24 (Traditional herbal medicinal
products)
CD 2004/27 of 31 March 2004 (HMPC)
23
24. European Medicines Agency -
EMA
Central European Authority with specified
tasks.
• Committees and Working Parties
• Herbal Medicinal Products Committee –
HMPC
• Monographs and List Working Party - MLWP
• Coordination of National Competent
Authorities
• Guidance Documents (www.ema.europa.eu)
24
26. Herbal medicinal products fall within the
scope of the European Directive
2001/83/EC that foresees marketing of
each medicinal product and requires an ad
hoc authorisation to be granted on the basis
of results of tests and experimentations
concerning quality, safety and efficacy.
The main features of Directive 2001/EC
are traditional herbal medicine definition,
simplified registration procedure, provisions
for community herbal monographs and
community list of herbal substances and
preparations and establishment of the
Committee for Herbal Medicinal
Products(HMPC).
26
27. Most individual herbal medicinal products
are licensed nationally by member
states, the process for licensing and
information of herbal substances
and, preparations is harmonised across the
European Union. IN United Kingdom, to get a
product registered, companies have to
submit a dossier to the Medicines and
Healthcare products Regulatory Agency
(MHRA) demonstrating that it meets the
requirements of quality, safety and
patient information as per the Traditional
Herbal Registration Scheme.
The HMPC evaluates scientifically all
available information including non-clinical
and clinical data but also documented
long-standing use and experience in the
Community. 27
28. Community monographs are divided into
two columns: well-established use
(marketing authorisation) and traditional
use (simplified registration).
Well-established use section describes the
safety and efficacy data while traditional use
section is accepted on the basis of
sufficient safety data and plausible efficacy.
The Committee on Herbal Medicinal Products
(HMPC) has developed procedure to invite
the public to submit scientific data on
herbal substances and preparations.
The provided information may then be
used by the Committee in the
development of Community monographs and
to Community list entries.
28
29. The European Scientific
Cooperative on Phytotherapy
(ESCOP)
The European Scientific Cooperative on
Phytotherapy (ESCOP) was founded in 1989, the
main objectives being to establish harmonized
criteria for the assessment of phytomedicines, to
support scientific research and to contribute to
the acceptance of phytotherapy at a European
level.
In October 1990, the first five monographs were
presented at a symposium in Brussels and were
officially handed over to representatives of the
European Community. After a thorough
assessment, the Committee on Proprietary
Medicinal Products (CPMP) published four
monographs on anthraquinone laxatives in May
1994 29
31. In United States, the term
complementary/alternative medicines (CAM)
are most commonly used for traditional
medicine systems.
"Complementary medicine" refers to use of
CAM together with conventional medicine,
such as using acupuncture, in addition to
usual care to help lessen pain.
FDA in its draft guidance “Guidance for
industry on complementary and alternative
medicine products and regulation by the
food and drug administration” clarified
different categories of Complimentary
Alternative Medicines (CAM) products into
cosmetic; device; dietary supplement; drug,
as well as "new drug" and "new animal drug;"
food; and food additive.
31
32. FDA’s Center for Drug Evaluation and
Research (CDER) Guidance for Botanical Drug
Products differentiates between those
botanical drugs that could be marketed as
Over-The-Counter (OTC) and those that would
require New Drug Application (NDA).
The current state of herbal research in the
United States also contrasts with that of
China and Germany. The limited availability
of funds (mainly in the Office of Dietary
Supplements and the National Center for
Complementary and Alternative Medicine)
greatly restricts the volume of research
conducted; thus, in comparison with China
and Germany, there is less published US
scientific and medical literature regarding
herbal use.
32
33. Under DSHEA, the manufacturer or marketer of
dietary supplements containing new ingredients is
required to notify FDA 75 days before they are
marketed.
Under DSHEA, a 7-member Commission on
Dietary Supplements was formed to conduct
studies and make advisements on the
regulation of herbal label claims and
statements.
The Office of Dietary Supplements, an office
within the National Institutes of Health, was
established in 1995 to explore the potential role of
supplements for improving health care in the
United States.Along with herbs, supplements
also include vitamins, minerals, amino acids,
homeopathic remedies,concentrates,extracts,
and various combinations of these ingredients.
33
35. REFERENCES
1)International journal of herbal
medicine.(www.florajournal.com)
2)WHO Regional Office for the Western Pacific.
Guidelines for the Appropriate Use of Herbal
Medicines.Manila, Philippines: World Health
Organization; 1998.
3)US Food and Drug Administration, Center for
Food Safety and Applied Nutrition. Dietary
Supplement Health and Education Act of 1994.
December 1, 1995. Available
at:http://vm.cfsan.fda.gov/~dms/dietsupp.html.
Accessed August 14, 2009.
5)Guidelines for the Regulation of Herbal
Medicines in the South-East Asia Region.
35