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SYLLABUS FOR THE COURSE

‘FELLOWSHIP IN STANDARDIZATION
OF ISM DRUGS’
SUBJECTS OF STUDY: 
 
Paper Subjects 

Paper -I STANDARDIZATION & QUALITY CONTROL OF ISM


DRUGS  
Paper –II BOTANICAL & CHEMICAL TESTING OF ISM DRUGS 
Paper -III BIOLOGICAL SCREENING OF ISM DRUGS 
Paper -IV PRACTICAL AND VIVA - VOCE 
Paper -V PROJECT AND VIVA-VOCE  
 

Paper I - STANDARDIZATION & QUALITY CONTROL


OF ISM DRUGS

Chapter I 
 
Introduction to Drug Standardization

Chapter II

General Methods of Processing of Herbs

• Definition, sources, identification and authentication of herbs.


• Different methods of processing of herbs like collection, harvesting,
garbling,
packing and storage conditions.
• Methods of drying – Natural and artificial drying methods with their merits
and demerits.
Chapter - III

Methods of Preparation of Extracts

• Principles of extraction and selection of suitable extraction method.


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• Different methods of extraction including maceration, percolation, hot
continuous extraction, pilot scale extraction and supercritical fluid extraction
with their merits and demerits.
• Purification and Recovery of Solvents. 
 
Chapter -IV

Standardization of Herbal Raw materials and Extracts

• Standardization of herbal raw materials including Pharmacognostical,


physical, chemical and biological methods with examples.
• Standardization of herbal extracts, physical, chemical and spectral analysis.
• Qualitative and Quantitative estimation of active principles from
standardized
extracts by HPTLC.
• Biological standardization -Pharmacological screening of herbal extracts
and
Microbiological evaluation of herbal extracts.
• Toxicity studies of herbal extracts

Chapter - V

GMP for the Production of ISM Drugs

• Primary processing of herbal products.


• Documentation required.
• Other guidelines for Quality Assurance of Herbal drugs.

Chapter -VI

Isolation and Estimation of Phytoconstituents

Different methods (including industrial) for isolation and estimation of


phytoconstituents from the following drugs (with special emphasis on HPLC
and HPTLC).

Chapter-VII

Global Regulatory Status on Herbal Medicines.

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Paper II - BOTANICAL & CHEMICAL TESTING OF ISM
DRUGS
Chapter-I

Introduction to Pharmacognosy

Chapter-II

Role of Pharmacognosy in the herbal industry.

Chapter-III

General aspects of cultivation ,collection and Processing of Herbal


durgs.
Good Agricultural Practice.

Chapter-IV

Plant growth regulators.

Chapter-V

Fermentation technology : Introduction, Production of secondary plant


metabolites by fermentation technology including design and operation of
industrial fermentors and Detailed study of production of Ergot
alkaloids(selected ISM Drugs)

Chapter-VI

Recent advances in Pharmacognosy.


Drug discovery from Medicinal plant sources.
High through put screening.

Chapter-VII

Phytochemical screening

1. Methods of extraction
2. Analysis of secondary Metabolites
3.Role of biomarkers in crude ISM drug analysis.
4. Isolation of Phyto Constitutes by using Chromotography
4. Identification of Phyto Constitutes by Septra studies

 
Paper -III - BIOLOGICAL SCREENING OF ISM DRUGS

Chapter - I

Toxilogical testing of herbal drugs

Use of animals for toxicology testing of ISM Drugs – acute, subacute and
chronic toxicology studies

Chapter - II

Pharmacological screening and review of literature for the


following group of
ISM drugs

In vivo and In Vitro methods of screening


a) Immunomodulatory drugs and its review.
b) Anticancer drugs and its review.
c) Antidiabetic drugs and its review.
d) Anti hepatotoxic drugs and its review
e) Hypolipidemic drugs and its review.
f) Antiinflammotory Drugs and its review.
g)Analgesic drugs and its review.
h) Anti Rheumatic Drugs and its review.
i) Antifertility screening in Female & Male
j) Anti Psychotic drugs and its review

Chapter -III

a) Anti bacterial studies of ISM Drugs


b)Antifungal studies of ISM Drugs
c)Antiviral studies studies of ISM Drugs

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Paper-IV- PRACTICAL & VIVA VOCE

I.Evaluation of crude drugs

1. Macroscopic and microscopic evaluation.


2. Determination of ash value.
3. Determination of extractive value.
4. Determination of moisture content.
5. Determination of foaming index.
6. Determination of swelling index.
7. Determination of microbial load.

II. Preliminary phytochemical screening of certain medicinal plants

Application of TLC and paper chromatography in phytochemical evaluation


of
crude drugs.

III. Isolation and estimation of phyto-constituents

1. Isolation of fixed oils from different sources and their


physical,physiochemical and chemical evaluation.

IV. Isolation of known marker compounds by column chromatography


(Demonstrative)

V.Systematic analysis of crude drugs from unknown origin.

Paper-V- PROJECT & VIVA VOCE

Any ISM drugs screened for Pharmacognosy & Phytochemical studies

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Scheme of Examination

Paper Subjects Internal Theory/Practical Viva 


Assessment (IA)
Paper -I Standardization & Max 50 min 25 Max100 min50 No Viva 
Quality control of ISM
Drugs
Paper -II Botanical & Chemical Max 50 min 25 Max100 min50 No Viva 
testing of ISM drugs
Paper-III Biological screening of Max 50 min 25 Max100 min50 No Viva 
ISM drugs
Paper-IV Practical and Viva - Max 50 min 25 Max100 min50 Max50
Voce min25 

Paper-V Project and viva-voce No IA Max100 min50 Max50


min25 
 

Result:

Note: A candidate must secure 50% for a pass in each component of the
examination .