Herbal Drug Technology B.Pharm Sixth Sem
UNIT- IV 10 HOURS
4.1 Evaluation of Drugs
4.1.1 ICH guidelines for the assessment of herbal drugs
4.1.2 WHO guidelines for the assessment of herbal drugs
4.2 Stability testing of herbal drugs.
4.3 Patenting and Regulatory requirements of natural products:
4.3.1 Definition of the terms: Patent, IPR
4.3.2 Patenting aspects of Traditional Knowledge and Natural Products.
4.3.3 Bioprospecting and Biopiracy
4.3.4 Case study of Curcuma & Neem
4.3.5. Farmers right
4.3.6 Breeder‘s right
4.4 Regulatory Issues
4.4.1 Regulations in India (ASU DTAB, ASU DCC)
4.4.2 Regulation of manufacture of ASU drugs and Schedule Z of Drugs & Cosmetics
Act for ASU drugs
==================================================================
4.1 Evaluation of Drugs
4.1.1 ICH guidelines for the assessment of herbal drugs
Introduction
The International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use (ICH) is unique in bringing together the
regulatory authorities and pharmaceutical industry to discuss scientific and
technical aspects of drug registration. Since its inception in 1990, ICH has
gradually evolved, to respond to the increasingly global face of drug
development. ICH's mission is to achieve greater harmonisation worldwide to
ensure that safe, effective, and high quality medicines are developed and
registered in the most resource-efficient manner.
In November 2005, the ICH Steering Committee adopted a new
codification system for ICH Guidelines. The purpose of this new codification
is to ensure that the numbering / coding of ICH Guidelines is more logical,
consistent and clear. Because the new system applies to existing as well as
new ICH Guidelines a history box has been added to the beginning of all
Guidelines to explain how the Guideline was developed and what is the
latest version.
,Herbal Drug Technology B.Pharm Sixth Sem
With the new codification revisions to an ICH Guideline are shown as (R1),
(R2), (R3) depending on the number of revisions. Annexes or Addenda to
Guidelines have now been incorporated into the core Guidelines and are
indicated as revisions to the core Guideline (Example- R1).
The ICH topics are divided into four categories and ICH topic codes are
assigned according to these categories.
Q- Quality Guidelines
Harmonisation achievements in the Quality area include pivotal
milestones such as the conduct of stability studies, defining relevant
thresholds for impurities testing and a more flexible approach to
pharmaceutical quality based on Good Manufacturing Practice (GMP)
risk management.
Q1A - Q1F Stability
Q2 Analytical Validation
Q3A - Q3D Impurities
Q4 - Q4B Pharmacopoeias
Q5A - Q5E Quality of Biotechnological Products
Q6A- Q6B Specifications
Q7 Good Manufacturing Practice
Q8 Pharmaceutical Development
Q9 Quality Risk Management
Q10 Pharmaceutical Quality System
Q11 Development and Manufacture of Drug Substances
Q12 Lifecycle Management
S-Safety Guidelines
ICH has produced a comprehensive set of safety Guidelines to uncover
potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent
breakthrough has been a non-clinical testing strategy for assessing the
QT interval prolongation liability: the single most important cause of drug
withdrawals in recent years.
S1A - S1C Carcinogenicity Studies
S2 Genotoxicity Studies
S3A - S3B Toxicokinetics and Pharmacokinetics
,Herbal Drug Technology B.Pharm Sixth Sem
S4 Toxicity Testing
S5 Reproductive Toxicology
S6 Biotechnological Products
S7A - S7B Pharmacology Studies
S8 Immunotoxicology Studies
S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
S10 Photosafety Evaluation
S11 Nonclinical Safety Testing
E- Efficacy Guidelines
The work carried out by ICH under the Efficacy heading is concerned
with the design, conduct, safety and reporting of clinical trials. It also
covers novel types of medicines derived from biotechnological processes
and the use of pharmacogenetics/genomics techniques to produce better
targeted medicines.
E1 Clinical Safety for Drugs used in Long-Term Treatment
E2A - E2F Pharmacovigilance
E3 Clinical Study Reports
E4 Dose-Response Studies
E5 Ethnic Factors
E6 Good Clinical Practice
E7 Clinical Trials in Geriatric Population
E8 General Considerations for Clinical Trials
E9 Statistical Principles for Clinical Trials
E10 Choice of Control Group in Clinical Trials
E11 Clinical Trials in Pediatric Population
E12 Clinical Evaluation by Therapeutic Category
E14 Clinical Evaluation of QT
E15 Definitions in Pharmacogenetics / Pharmacogenomics
E16 Qualification of Genomic Biomarkers
E17 Multi-Regional Clinical Trials
E18 Genomic Sampling
M-Multidisciplinary Guidelines
, Herbal Drug Technology B.Pharm Sixth Sem
Those are the cross-cutting topics which do not fit uniquely into one of
the Quality, Safety and Efficacy categories. It includes the ICH medical
terminology (MedDRA), the Common Technical Document (CTD) and the
development of Electronic Standards for the Transfer of Regulatory
Information (ESTRI).
M1 MedDRA Terminology
M2 Electronic Standards
M3 Nonclinical Safety Studies
M4 Common Technical Document
M5 Data Elements and Standards for Drug Dictionaries
M6 Gene Therapy
M7 Genotoxic Impurities
M8 Electronic Common Technical Document (eCTD)
M9 Biopharmaceutics Classification System-based Biowaivers
M10 Bioanalytical Method Validation
4.1.2 WHO guidelines for the Assessment of Herbal Drugs
4.1.2.1Introduction
Herbal medicines means: Finished, labelled medicinal products that contain as active
ingredients, aerial or underground parts of plants, or other plant material, or combinations
thereof, whether in the crude state or as plant preparations.
Plant material includes juices, gums, fatty oils, essential oils, and any other substances of this
nature. Herbal medicines may contain excipients in addition to the active ingredients.
Medicines containing plant material combined with chemically defined active substances,
including chemically defined, isolated constituents of plants, are not considered to be herbal
medicines.
Exceptionally, in some countries herbal medicines may also contain, by tradition, natural
organic or inorganic active ingredients which are not of plant origin.
The past decade has seen a significant increase in the use of herbal medicines. The objective
of these guidelines is to define basic criteria for the evaluation of quality, safety and efficacy
of herbal medicines and thereby to assist national regulatory authorities, scientific
organizations and manufacturers to undertake an assessment of the
documentation/submissions/dossiers in respect of such products.
As a general rule in this assessment, traditional experience means that long-term use as well
as the medical, historical and ethnological background of those products shall be taken into
account.
UNIT- IV 10 HOURS
4.1 Evaluation of Drugs
4.1.1 ICH guidelines for the assessment of herbal drugs
4.1.2 WHO guidelines for the assessment of herbal drugs
4.2 Stability testing of herbal drugs.
4.3 Patenting and Regulatory requirements of natural products:
4.3.1 Definition of the terms: Patent, IPR
4.3.2 Patenting aspects of Traditional Knowledge and Natural Products.
4.3.3 Bioprospecting and Biopiracy
4.3.4 Case study of Curcuma & Neem
4.3.5. Farmers right
4.3.6 Breeder‘s right
4.4 Regulatory Issues
4.4.1 Regulations in India (ASU DTAB, ASU DCC)
4.4.2 Regulation of manufacture of ASU drugs and Schedule Z of Drugs & Cosmetics
Act for ASU drugs
==================================================================
4.1 Evaluation of Drugs
4.1.1 ICH guidelines for the assessment of herbal drugs
Introduction
The International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use (ICH) is unique in bringing together the
regulatory authorities and pharmaceutical industry to discuss scientific and
technical aspects of drug registration. Since its inception in 1990, ICH has
gradually evolved, to respond to the increasingly global face of drug
development. ICH's mission is to achieve greater harmonisation worldwide to
ensure that safe, effective, and high quality medicines are developed and
registered in the most resource-efficient manner.
In November 2005, the ICH Steering Committee adopted a new
codification system for ICH Guidelines. The purpose of this new codification
is to ensure that the numbering / coding of ICH Guidelines is more logical,
consistent and clear. Because the new system applies to existing as well as
new ICH Guidelines a history box has been added to the beginning of all
Guidelines to explain how the Guideline was developed and what is the
latest version.
,Herbal Drug Technology B.Pharm Sixth Sem
With the new codification revisions to an ICH Guideline are shown as (R1),
(R2), (R3) depending on the number of revisions. Annexes or Addenda to
Guidelines have now been incorporated into the core Guidelines and are
indicated as revisions to the core Guideline (Example- R1).
The ICH topics are divided into four categories and ICH topic codes are
assigned according to these categories.
Q- Quality Guidelines
Harmonisation achievements in the Quality area include pivotal
milestones such as the conduct of stability studies, defining relevant
thresholds for impurities testing and a more flexible approach to
pharmaceutical quality based on Good Manufacturing Practice (GMP)
risk management.
Q1A - Q1F Stability
Q2 Analytical Validation
Q3A - Q3D Impurities
Q4 - Q4B Pharmacopoeias
Q5A - Q5E Quality of Biotechnological Products
Q6A- Q6B Specifications
Q7 Good Manufacturing Practice
Q8 Pharmaceutical Development
Q9 Quality Risk Management
Q10 Pharmaceutical Quality System
Q11 Development and Manufacture of Drug Substances
Q12 Lifecycle Management
S-Safety Guidelines
ICH has produced a comprehensive set of safety Guidelines to uncover
potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent
breakthrough has been a non-clinical testing strategy for assessing the
QT interval prolongation liability: the single most important cause of drug
withdrawals in recent years.
S1A - S1C Carcinogenicity Studies
S2 Genotoxicity Studies
S3A - S3B Toxicokinetics and Pharmacokinetics
,Herbal Drug Technology B.Pharm Sixth Sem
S4 Toxicity Testing
S5 Reproductive Toxicology
S6 Biotechnological Products
S7A - S7B Pharmacology Studies
S8 Immunotoxicology Studies
S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
S10 Photosafety Evaluation
S11 Nonclinical Safety Testing
E- Efficacy Guidelines
The work carried out by ICH under the Efficacy heading is concerned
with the design, conduct, safety and reporting of clinical trials. It also
covers novel types of medicines derived from biotechnological processes
and the use of pharmacogenetics/genomics techniques to produce better
targeted medicines.
E1 Clinical Safety for Drugs used in Long-Term Treatment
E2A - E2F Pharmacovigilance
E3 Clinical Study Reports
E4 Dose-Response Studies
E5 Ethnic Factors
E6 Good Clinical Practice
E7 Clinical Trials in Geriatric Population
E8 General Considerations for Clinical Trials
E9 Statistical Principles for Clinical Trials
E10 Choice of Control Group in Clinical Trials
E11 Clinical Trials in Pediatric Population
E12 Clinical Evaluation by Therapeutic Category
E14 Clinical Evaluation of QT
E15 Definitions in Pharmacogenetics / Pharmacogenomics
E16 Qualification of Genomic Biomarkers
E17 Multi-Regional Clinical Trials
E18 Genomic Sampling
M-Multidisciplinary Guidelines
, Herbal Drug Technology B.Pharm Sixth Sem
Those are the cross-cutting topics which do not fit uniquely into one of
the Quality, Safety and Efficacy categories. It includes the ICH medical
terminology (MedDRA), the Common Technical Document (CTD) and the
development of Electronic Standards for the Transfer of Regulatory
Information (ESTRI).
M1 MedDRA Terminology
M2 Electronic Standards
M3 Nonclinical Safety Studies
M4 Common Technical Document
M5 Data Elements and Standards for Drug Dictionaries
M6 Gene Therapy
M7 Genotoxic Impurities
M8 Electronic Common Technical Document (eCTD)
M9 Biopharmaceutics Classification System-based Biowaivers
M10 Bioanalytical Method Validation
4.1.2 WHO guidelines for the Assessment of Herbal Drugs
4.1.2.1Introduction
Herbal medicines means: Finished, labelled medicinal products that contain as active
ingredients, aerial or underground parts of plants, or other plant material, or combinations
thereof, whether in the crude state or as plant preparations.
Plant material includes juices, gums, fatty oils, essential oils, and any other substances of this
nature. Herbal medicines may contain excipients in addition to the active ingredients.
Medicines containing plant material combined with chemically defined active substances,
including chemically defined, isolated constituents of plants, are not considered to be herbal
medicines.
Exceptionally, in some countries herbal medicines may also contain, by tradition, natural
organic or inorganic active ingredients which are not of plant origin.
The past decade has seen a significant increase in the use of herbal medicines. The objective
of these guidelines is to define basic criteria for the evaluation of quality, safety and efficacy
of herbal medicines and thereby to assist national regulatory authorities, scientific
organizations and manufacturers to undertake an assessment of the
documentation/submissions/dossiers in respect of such products.
As a general rule in this assessment, traditional experience means that long-term use as well
as the medical, historical and ethnological background of those products shall be taken into
account.
