Herbal Drug Technology

1. HERBS AS RAW MATERIALS
     SELECTION, IDENTIFICATION AND AUTHENTICATION OF RAW MATERIAL
        (1) Selection methods
        (2) Identification and authentication of herbal plant material steps towards authentication
        (3) Processing of herbs for herbal raw materials
            3.1.1. Introduction : primary processing [Inspection and sorting,
            Washing/cleaning, Leaching, Drying-, Pre-treatments for drying of Herbs,
            Drying Methods (Shade, sun, artificial heat, heat-pump assisted, infrared,
            microwave, vacuum microwave, cooling and freeze drying)
        (4) Processing for herbal preparations
             4.1. Secondary processing (General Procedure)
             4.2. Secondary processing (Special processing)
             4.2.1 Detoxification and reduction of side effects
             4.2.2 Modification of therapeutic activity
             4.2.3 Boost in concentration of active ingredients
             4.2.4 The alteration in pharmacological properties
             4.2.5 Enhancing efficacy and therapeutical potential

2. BIODYNAMIC AGRICULTURE
     1. Definition, Biodynamic Principles
     2. GOOD AGRICULTURAL PRACTICES (GAP)
     3. ORGANIC FARMING; Introduction, 3. Concept, Agriculture techniques,
         Application in the production of medical/aromatic plan
     4. PEST MANAGEMENT/ PLANT PROTECTION;
         (1) Methods of Pest Management : Physical methods,
         (2) Cultural methods,(3) Genetic methods,
         (4) Biological methods : Predators, Parasitoids,
              Herbivores, & Significance of biological control
     5. Biopesticides/Bioinsecticide in pest management :
         Introduction, Advantages,
         Definition, Draw backs of synthetic pesticides
         Table 2-1 : Examples of Common Pests Attacking Medicinal
         Plants; 5.2. Types of bio-pesticides
         5.2.1. Microbial pesticides; 5.2.1.1. Bacterial bio-pesticides
         5.2.1.2. Fungicides, 5.2.1.3. Viruses, Bioherbicides,
          Table 2-2 Examples of few Bioherbicides.
         Phytochemical/Biochemical Pesticides—Examples :
         5.2.2.1. Pyrethrum; 5.2.2.2. Citrus oil
         5.2.2.3. Neem oil; 5.2.2.4. Rotenone
         5.2.2.5. Ryania; 5.2.2.6. Sabadilla,5.2.2.7 Garlic oil;
         5.2.2.8. Nirgundi; 5.2.2.9. Tuls
         5.3 Plant Incorporated Bio-pesticides/Protectants
     6. PHEROMONES AND OTHER ATTRACTANT

3. INDIAN SYSYTEM OF MEDICINE
     Introduction
     BASIC PRINCIPLES IN AYURVEDA, SIDDHA, UNANI AND HOMEOPATHY
     AYURVEDA, Introduction, Basic Principles in Ayurveda—
         1. Pancha Mahabhutas (55), 2. TriGuna
         3. TriDoshas (a) Vata (Ether and Air ),
            (b) Pitta (Fire and Water)
            (c) Kapha (Water and Earth)
         4. Sapta Dhatus (56), 5. TriDoshas Agni
         6. Tri Malas : Siddha System, Unani System, Homeopathy System
     Preparation and Standardization of Ayurvedic Formulations
          (1). Asava and Arishta a (1.2. Method of preparation,
          1.2.3. Characteristics of Asava & Arishta
          1.4. Standardization of Asava and arishta (68)
          1.4.1. Pharmacogenetic evaluations
          1.4.2. Pharmacological evaluations

         (2) Avaleha or Leha and Paka
          2.1. Definition, 2.2.Method of preparation,
          2.2.1. Test parameters

          (3) Churna and Kwatha Churna
               3.1. Definition, 3.2. Preparation of Churna
               3.2.1. Storage, 3.2.2. Characteristics
               3.3. Method to determine the particle size
               3.3.1. Test parameters of Churna

          (4) Gutika and Vati
               4.1. Definition, 4.2. General method of preparation,
               4.2.1. Storage, 4.2.2. Advantages,
               4.2.3. Test parameters,
               4.3. Modern analytical parameters for chemical constituents

         (5) Bhasma
              5.1. Definition, 5.2. Characters
              5.3. Method of preparation—
              5.3.1 Sodhana; 5.3.i. Types of Sodhna
              5.3.i.1. Samanya Sodhna; 5.3.ii.2. Visesa Sodhna
             (a) Bhavana, (b) Swedana, (c) Nirvana, (d) Mardana
              5.3.2 Marana (Incineration), 5.4.1. Quality parameters
              5.5. Amritkarana and Lohitikarana
              5.6.1. Storage, 5.6.2. Test parameters.

     Modern instrumental parameters for standardization

4. NUTRACEUTICALS
     Introduction; Definitions in respective countries :
     Canada, Japan, Korea,
     -European Union (EU) Australia,
     Russia, America & India
     Health potential of Nutraceuticals.
     1. Natural and organic foods (Traditional and Non-traditional)
         Categories based on classes; Categories based on for the purpose of nutritional business
     2. Dietary supplements— Introduction, Rules and Regulation,
         Ingredients [1. Nutrients: (Vitamins, Minerals, Antioxidants,
         Polyunsaturated fatty acids, Prebiotics, Probiotics,
          Synbiotics, Postbiotics,)
          2.Herbs (Cranberry, Soy-isoflavone, Black Cohosh, Milk thistle,
          St. John’s Wort, Echinacea,
          Ginkgo, Peppermint & Ginseng)]
          Vitamins as Diet Supplements
     3. Vitamins, 4. Macro/micro diet supplements
     5. PUFA diet supplement, 6. Antioxidant
     7. Prebiotics/Probiotics synbiotics herbs
          Table 4-1 Water Soluble Vitamins
          Table 4-2 Fat Soluble Vitamins as Diet Supplements
          Table 4-3 Macronutrients Diet Supplements
          Table 4-4 Micro/Trace Elements or Minerals
          Table 4-5 Vitamin like Compounds Diet Supplements
          Table 4-6 Examples of market PUFA Diet Supplement Products
          Table 4-7 Examples of prebiotics and their food source
          Table 4-8 Commercial products of probiotics.
3. FUNCTIONAL FOODS AND BEVERAGES
       3.1 Functional Food,
       Table 4-9 Examples of few functional foods in global market
       3.2. Functional beverages
       3.2.1 Dairy based beverages,
       Market size, Key players in
       dairy milk products Market products,
       Dairy based beverage market key players.
       Table 4-10 Dairy based Beverages Enriched
       with biologically active Compounds
       3.2.2 Vegetable and Fruit Beverages (Categories of
       fruit juice beverages, Market size, Key players
       Table 4-11 commercially available
       Enriched Fruit and vegetable
       Beverages Enriched with vitamins, minerals and probiotics
       3.3. Energy Drinks; Major ingredients:
       (Caffeine, Taurine, L-carnitine, Guarana, Inositol)
       3.4. Sport Drinks
       Table 4-12 Commercially Available branded Energy Drinks
       4. Natural Personal Care products
       4.1.2. Phytochemicals
       (Bioactive peptides, Polyphenols,
        Oligosaccharides, Marine algae,
       carotenoids, Polyunsaturated fatty acids (PUFA)
        4.2. Marketed Preparations and Global Key Players, & Market Growth.

     Market Growth and Scope of Nutraceuticals
     Health Benefits of Nutraceuticals

    ROLE OF NUTRACEUTICALS IN AILMENTS.
     Nutraceuticals in diabetes—[1. Dietary fibers,
     2. Antioxidant vitamins (Vitamin C, E, and Carotenoids),
     3. Polyphenols, 4. Polyunsaturated Fatty Acids(vii)(PUFA),
     5. Minerals, and 6. Herbs];
     Table 4-13 Medicinal plants having
     anti-diabetic properties like insulin
     Table 4-14 Medicinal plants having
     Anti-diabetic properties by
     Stimulation of pancreas for the release of insulin
     Table 4-15 Medicinal plants having anti-diabetic
     property by increasing the insulin secretion
     Table 4-16 Medicinal plants with anti-diabetic
     properties by reducing glucose absorption from GIT
     Table 4-17 Medicinal plants having anti-diabetic
     properties by inhibiting alpha glycosidase and alpha-amylase enzymes
     Table 4-18 Medicinal plants
     bioactive constituents with antioxidant activity
     (2) Nutraceuticals In Cancer
     2.1.1. Nutraceuticals in the Treatment of Human Cancers:
     Breast cancer, Prostate cancer, Lung cancer,
     Esophageal cancer, Colon and Colorectal cancer,
     Ovarian and endometrial cancer
     Table 4-19 List of nutrients having role
     in the prevention and management of cancer of different organs

     CARDIOVASCULAR DISEASES & NUTRACEUTICALS (CVD)
     3.1.1. Nutraceutical Ingredients: Antioxidants,
     Dietary fibers, Omega-3-fatty acids, Minerals, Herbs
     Table 4-20 Herbs useful in congestive heart failure
     Table 4-21 Herbs for hypertension
     Table 4-22 Herbs for angina pectoris
     Table 4-23 Herbs for the treatment of atherosclerosis
     Table 4-24 Herbs for cerebral and peripheral vascular disease
     Table 4-25 Herbs for use in Venous insufficiency
     Table 4-26 Herbs used for the prevention and treatment of arrhythmia
     4. Role of nutraceuticals in the management of obesity
     4.1. Nutraceuticals agent/herbs for obesity
     management-[Garlic, Bitter orange,
     Hadjod, Malabar tamarind, Gurmar,
     Indian lotus, Sweet leaf bush, Grape vine, and Ginger.
     5. Irritable Bowel Syndrome (IBS) diseases
     other g.i.t. diseases
     5.1.Role of nutraceuticals in the management of IBS
     5.1.1. Dietary fibers, 2. Prebiotics,
     3. Probiotics, 4. Dietary lipids,
     5. Fat soluble vitamins (Vitamin D, Vitamin K, Vitamin A) and
     6. Plant derived products
     Table 4-27 Plant derived products for IBS of other g.i.t. diseases.
     Study of some Herbs as Health Food—1. Alfalfa,
     2. Amla, 3. Ashwagandha, 4. Chicory, 5. Fenugreek,
     6. Garlic, 7. Ginger, 8. Ginseng, 9. Honey, 10. Spirulina

5. HERBAL-DRUG AND HERB-FOOD INTERACTIONS
     Study of Drugs and their Possible Side Effects and Interactions
     1. Introduction
     1.1. Types of mechanism involved in Drug and Food Interaction
     (1) Pharmacokinetic interaction, (2) Pharmacodynamics interaction,
     (3) Pharmaceutical interaction
     1.2 Classification of drug interaction
     (1) Drug-disease interactions: (Cardiac diseases, Digestive
     tract diseases Inflammatory bowel disease (IBD),
     Hepatic dysfunction, Hypothyroidism),
     (2) Drug-herb/s interaction
     Example of some clinically important drugs-herb interaction
     (I) Ginkgo, (ii) Aloe, (iii) Garlic,(iv) Ginger,
     (v) Ginseng, (vi) St. John’s Wort, (vii) Liquorice, (viii) Salvia,
     (ix) Rhubarb; (3) Drug-drug interaction(DDI)
     Some Examples: (i) Azithromycin and digoxin,
     (ii) Cimetidine with dexamethasone,(iii) Cimetidine with Warfarin,
     (iv) Furosemide and gentamycin, metronidazole and simvastatin,
     spironolactone and KCl,
     (v) Sulfamethoxazole and Warfarin
     (4) Drug-food interactions
     Examples of significant drug-food interaction
     Studies of few prominent Herbal drugs and
     their possible Side effects interactions—
     (1)Hypericum, (2) Kava-Kava
     (3) Pepper/Black pepper, (4) Ginkgo biloba
     (5) Ginseng, (6) Garlic, (7) Ephedra


6. HERBAL COSMETICS
     Introduction
     Advantages of Herbal Cosmetics v/s Synthetic cosmetics
     Composition of Herbal Cosmetics
     Types of Herbal Cosmetics—
     (i) Skin Care Herbal Products
     (ii) Hair Care Products
     (iii) Oral Hygiene Products
     RAW MATERIALS FOR HERBAL COSMETICS FROM NATURAL ORIGIN
     (1) Fixed Oils in Cosmetics—
     (A) Vegetable Oils:
     (1) Almond Oil, (2) Castor Oil, (3) Coconut Oil, (4) Olive Oil,
     (5) Jojoba Oil (229-33), (6) Sunflower oil (7) Soyabean oil, (8) Green Tea Oil
     (B) Nut oils:
     (Introduction,Cosmetics benefits)
     Examples: (i) Walnut Oil, (ii) Hazelnut Oil

     (2) Natural Gums in Cosmetics : (Introduction, Sources);
     Examples:(i) Acacia gum, (ii) Tragacanth gum,
     (iii) Guar gum, (iv) Locust/Carob bean gum,
     (v) Tara gum, (vi) Cassia gum, (vii) Xanthan gum;

     (3) Waxes in Cosmetics: (Introduction);
     Examples:(i) Spermaceti, (ii) Jojoba Oil (Liquid Wax),
     (iii) Carnauba Wax-, (iv) Candelilla Wax, (v) Beeswax

     (4) Protective Agents in Cosmetics
     (A) Natural, Sun Rays Blockers (Sun Screen)
     4.1. Peptides, (2) Sequalene, (3) Vitamin C
     4.2 Herbal Protectants:(1) Aloe Vera, (2) Amla,
     (3) Tomato (Lycopene), (4) Grape Fruits
     (5) Pomegranate, (6) Golden Roots,
     (7) Turmeric/Curcuma, (8) Red Ginseng, (9) Ginkgo

     (5) Antioxidants in Cosmetics products— Introduction
     5.1. Anti-oxidants in skin care products—Benefits:
     Antioxidant helps to prevent:
     (1) premature aging, (2) skin burn,
     (3) skin cancer, and (4) Repair and brighten the skin
     Table 6-2 Summary of some important herbs
     used in skin care products
     5.2. Antioxidants for Hair Care
     5.2.1. Vitamin C, (2) Vitamin A,
     (3) Vitamin E, (4) Resveratrol,
     (5) Zinc, (6) Iron,
     (7) Co-enzyme Q 10, (8) Flavonoids
     Table 6.3 Summary of some important Herbs
     for Hair Care products
     5.3. Antioxidants in Oral Hygiene Products
     5.3.1. Antioxidants used in the Oral Hygiene Products
     Polyphenols antioxidants:
     Introduction, Applications,
     Examples; 5.4.
     Summary of Herbs/Plant Constituents
     for Oral Hygiene Products
     5.4.1.Eucalyptus, (2) Green tea,
     (3) Myrrh, (4) Holy basil/Tulsi,
     (5) Chamomile, (6) Aloe vera,
     (7) Neem, (8) Miswak,
     (9) Turmeric, (10) Kantakari, (11) Clove oil

     (6) Perfumes in Cosmetics Products; Introduction
     of perfumes & fragrances
     6.1 Types of fragrances— (1) Warm scents, (2) Fresh,
     (3) Floral, (4) Oriental, (5) Woody.
     6.2 Types of cosmetics based on perfumes contents
     6.2.1 Fine fragrance, (2) Natural fragrance
     (3) Rosy floral scent (4) White floral fragrance
     (5) Spicy floral fragrance, (6) Oriental fragrance

     (7) Natural Colourant in Cosmetics
     Introduction, Classification of dyes,
     Significance & Disadvantages
     7.1 Plants Origin Colourant
     7.1.1. Annatto, (2) Curcumin,
     (3) Roselle colour, (4) Henna,
     (5) Carmine, (6) Caramel,
     (7) Chlorophyllium, (8) Dyers Rocket

     (8) Bleaching or Whitening Agents
     from Natural Origin
     Introduction; 8.1 Bleaching agents from plants
     8.1.1. Liquorice, (2) Oregano,
     (3) Chinese skill, (4) White mulberry,
     (5) Citrus species, (6) Marine products
     (7) Natural plants ext

7. HERBAL EXCIPIENTS
     Introduction;
     Significance of herbal excipients over the synthetic excipients
     Limitations of herbal excipients,
     Classification of herbal excipients
     Table 7.1 Categories of natural origin excipients
     (1)Natural Colourant—
     Introduction, Stability problem,
     Plant colourants on the basis of chemical structure
     [Indigo Dyes, Pyridine Based, Carotenoids, Quinonoid,
     Flavonoids, Betalains Pigments & Tannins
     Role of colourants in formulations
     1.2 Brief description of the
     source of some natural Colourant
     1.4.1. Annatto, (2) Burnt Sugar
     (3) Cochineal, (4) Turmeric
     (5) Carotene, (6) Tomato/Lycopene
     (7) Saffron, (8) Capsicum
     (9) Marigold, (10) Henna
     (11) Walnut, (12) Shikonin, (13) Beetroot
     (2) Natural Binders
     2.1 Introduction,
     Advantages and disadvantages,
     Synthetic binders and disadvantages
     2.2. Classification of binders
     2.3. Applications: Gums/Natural polymers, Mucilage’s,
     Starch paste, Cellulose solutions
     2.3.1. Application based,
     binders: Solution binder.
     2. Dry binders
     2.3.2 Source based binders—
     (1) Plant origin polymers
     (Tree exudates, Seed gums & Fruit pectin)
     (2) Marine source, (3) Animal source
     (4) Microbial source
     (3) Fillers/Diluents
     Definition, Application in dosage forms
     3.2 Classification
     3.2.1. Based on chemical nature:
     (Organic material, Inorganic material)
     3.2.2. Based on solubility:
     (Water insoluble diluents,Water soluble diluents)
     3.3. Description of the respective diluents:
     3.2.1. Cellulose,
     (2) Microcrystalline cellulose,
     (3) Dibasic Calcium Phosphate,
     (4) Sucrose, (5) Lactose (Milk sugar), (6) Mannitol
     3.2. Lubricants—Introduction,
     Mechanism of lubrication,
     Types of lubricants
     4.2. Description of Lubricants-:
     4.2.1. Stearic Acid,
     (2) Magnesium Stearate, (3) Talc
     (4) Hydrogenated Vegetable Oils
     (5) Sodium Lauryl Sulphate, (6) Mineral Oil
     (4) Coating Agents—Natural coating agents:
     (Gelatin, Guar gum, Gum Grewia)
     (5) Disintegrants, Introduction,Quality parameters
     Examples: (Fenugreek seed mucilage, Karaya gum,
     Soy polysaccharide, Psyllium/Ispaghula,
     Garden cress mucilage-, Locust bean gum, China rose mucilage
     (6) Viscosity Builders
     Introduction Quality parameters
     6.1.1. Natural viscosity builders—Tragacanth,
     Carrageenan, Gum Xanthan,
     Guar gum, Carob bean gum
     (7) Natural Perfumes and Flavouring Agents;
     Introduction, Significance, Other properties.
     Examples of Plant Derived Flavours
     8.3.1. Jasmine oil, (2) Lemon oil,
     (3) Rose oil, (4) Peppermint oil,
     (5) Raspberry, (6) Sandal wood oil,
     (7) Saffron, (8) Cardamom seed,
     (9) Cinamon oil/Cinnamon bark, (10) Clove/Clove oil
     Table 7.2 Summary of herbal drugs used as flavour & perfumes.
     (8) Preservatives:
     9.1. Introduction, Significance, Mechanism of action
     9.2. Herbs used as preservatives—
     Clove oil, Neem oil,
     Cumin seed oil, Citrus essential oil,
     and Plants/extracts/essential
     oils as Food Preservatives.
     Table 7.3 Summary of plants/herbs having
     Anti-bacterial, Anti-fungal
     (9) Natural Sweeteners—
     Introduction, types, significance
     9.1.1. Natural Sweeteners of Plant origin—Steviol glycoside,
     Monk fruit /Swingle fruit, Glycyrrhizin,
     Bitter orange, sweet prayer plant and
     Serendipity berry/Guinea potato
     Table 7.4 Summary of Sweeteners from Plants

8. HERBAL FORMULATION
     1. Definition
     2. Types of oral dosage forms
     2.1. Liquid dosage forms
     2.1.1. Herbal extracts, Herbal tinctures,
     Aromatic waters, Herbal syrups
     2.1.2. Mixtures
     Monophasic mixtures, & Biphasic mixtures
     (Emulsion & Suspensions).
     Herbal emulsions:Types,
     Advantages and disadvantages,
     formulation (emulsifying agents,
     preservatives, antioxidants),
     Preparation (wet gum method, dry gum method,
     mixing both the phases with heat,
     alternate edition of two emulsifying agents)
     2.1.3 Suspensions—Definition, Types,
     Significance of suspension, Formulation, Method of Preparation.
     Lotions (Definition, Examples, Method of preparations)
     2.2. Herbal Solid Dosage Forms
     2.2.1. Herbal tea bags,
     (2) Herbal powders, (3) Dry extract powders,
     (4) Granules, (5) Pills,
     (6) Herbal Capsules, (7) Herbal Tablets (compressed tablets,
     Molded tablets, and Herbal Lozenges)
     Compressed tablets (Sugar coated,
     film coated, enteric coated,
     press coated, controlled release,
     multipress, effervescent, and buccal tablets),
     significance-Preparation of
     tablets (compressed, Molded),
     methods (wet granulation, dry granulation, direct compressed method),
     significance, disadvantages
     2.2.2. Herbal Lozenges
     (Composition, Preparation of Lozenges,
     Examples—Significance, Disadvantages
     2.3. Semi Solid Dosage Forms—Definition,
     Ointments and creams, Medicated oils, Plasters and patches
     2.3.1. Ointments and Creams
     (Definitions, Table 8.1 Difference Between ointment
     and creams, Preparation of ointment and creams)
     2.3.2. Medicated oils/Herbal oils
     (Preparation of Medicated oils
     2.3.2.1 Plaster and Patches
     (Definition, Uses)
     2.3.3. Liniments, Herbal soaps
     2.4. Inhalations-Preparation of inhalations
     (Dry powder inhalation, Liquid inhalation.
     NOVEL DRUG DELIVERY SYSTEM(NDDS)—
     Introduction,
     Limitation of conventional dosage forms, advantages,
     1. Technology of NDDS:Micelle, vesicles, vesicular system,
     particulate system, and transdermal NDDS
     2.2.1. Vesicular system:
     Liposomes, Phytosomes, Emulsomes,
     Cubosomes, Pharmacosomes, Niosomes, Proniosomes, Aquasomes
     2.2.1. Liposomes; Formulation, classification, preparation,
     advantages, disadvantages, examples of herbal liposomes,
     application in cosmetics, Modification of liposomes
     (novasomes, invasomes, transfesomes,
     sphingosomes, and ethosomes),
     advantages of transfersomes
     2.2.2 Phytosomes—Introduction,
     advantages, preparation techniques
     (general, anti-solvent precipitation,
     rotary evaporation, solvent ether
     injection techniques),
     examples of marketed Phytosomes,
     difference between Phytosomes and liposomes.
     2.2.3 Emulsomes—Introduction,
     Uses, Method of preparation, Advantages
     2.2.4. Cubosomes—Introduction, Uses,
     Method of preparation
     2.2.5. Pharmacosomes: Introduction, Uses,
     Method of preparation
     2.2.6 Surfactant based Novel Drug Delivery System
     2.2.6.1 Niosomes—Introduction,
     Advantages, Examples, Uses
     2.2.6.2 Proniosomes
     2.2.6.3 Aquasomes
     2.3Particle Based Novel Drug Delivery System
     2.3.1 Nanoparticles:
     Introduction, advantages,
     advantages over liposomes,
     techniques to prepare nanoparticles
     loaded with herbal extract,
     Examples of herbal formulations
     2.3.2 Microparticles:
     Introduction, Method of preparation
     2.3.3 Microsphere: Introduction,
     Examples of herbal microspheres
     2.3.4 Microencapsulation—
     Introduction, Uses,
     Techniques of preparation, Applications,
     Examples of herbal formulations
     2.4 Transdermal Drug Delivery
     Systems (TDDS)— Introduction,
     General method of preparation,
     Preparation of Plaster and Patches,
     Basic principle of TDDS,
     Types of transdermal patches,
     advantages, disadvantages.


9. EVALUATION OF DRUGS
     Introduction
     EVALUATION OF DRUGS AS PER
     “ICH” AND “WHO” GUIDELINES—Objective, Benefits.
     1. ICH and its role in drugs assessment
     1.1.1. Aim, Objective of stability testing,
     Scope of ICH guidelines (QSEM),
     Quality guidelines, Safety guidelines, Efficacy guidelines,
     Multidisciplinary guidelines,
     Pharmacopoeias harmonization
     1.2. Evaluation of herbal drugs (ICH)
     2. WHO guidelines for the assessment of herbal drugs—
     Introduction, Definition of herbal drug
     2.1. WHO guidelines for the assessment
     of quality of herbal drugs
     2.1.1. Objectives,
     Definitions for herbal medicines (WHO)
     2.1.2. Quality assessment—
     (A) Pharmaceutical assessment
     (Crude plant material, Plant preparations, Finished products)
     2.1.2.1. Assessment of safety and efficacy
     3. WHO/ICH guidelines for stability
     testing of herbal drugs
     3.1.1. Guidelines—
     (1) Accelerated stability testing,
     (2) Mean kinetic temperature,
     (3) Real-time (long term) stability studies
     3.2. Stability testing—Stability
     assessment of herbal drugs/products
     Problems related to stability of herbal drugs/products
     3.3 Types of stability studies
     3.3.1. Real-time stability testing,
     (2) Accelerated stability, (3) Stress stability testing
     Table 9.1 Stability testing storage conditions
     Table 9.2 Stability testing storage
     conditions for products packaged
     in semipermeable containers
     3.4. Need for stability assessment
     3.5. Stability testing parameters
     Table 9.3 ICH Recommendations
     of stability testing parameters
     for different herbal dosage forms
     Table 9.4 WHO Recommendations of stability
     testing parameters For different herbal dosage forms
     3.6. Microbial contamination in general
     3.7. Main objectives and guidelines
     by ICH and WHO for the stability testing in the developing phase,
     3.7.2. For the registration dossier,
     3.7.3. In the post-registration period,
     3.7.4. Intended market
     Table 9.5Summary of main objective of stability testing
     Table 9.6 Climate zones for
     stability testing (ICH & WHO)
     3.8. Design of stability studies
     (protocol for stability testing)
     3.8.1. Test samples
     3.8.2. Test conditions for stability testing
     3.8.2.1. Accelerated studies, 2. Real-time studies
     3.8.3. Frequency of testing and
     evaluation of test results
     3.8.4. Analytical methods
     3.9. Presentation of evaluation report, Stability report
     3.10. Shelf-life and recommended storage conditions
     3.11. Recommended storage conditions for label.


10. PATENTING AND REGULATORY REQUIRE- MENTS OF NATURAL PRODUCTS
     (A) DEFINITIONS OF TERMS
     1. Intellectual Property Right (IPR)—
     Definition, Benefits,
     Brief history of IPR system,
     Types of IPR
     2. Patent—Definition, Brief history of patenting in India,
     Procedure for patent application and types
     3. Trademark, 4. Trade secret
     5. Industrial design, 6. Geographical indications
     7. Copy right, 8. Farmer’s right—Introduction,
     Protection of plant variety and
     farmer’s right (PPV & FR) Act, 2001,
     Objective of protection
     of plant variety and farmers rights,
     Farmers rights with respects to IPR
     9. Plant Breeder’s Right:
     Definition, Scope of rights
     10. Bio-prospecting—
     Introduction,
     Merits of Bio-prospecting,
     Demerits of bio-prospecting
     Table 10.1 Examples of Bio-discovery
     10.1 Acts for the Protection of bio-diversity in India—
     (i) PPV & FR Act, 2001,
     (ii) India, Biological Diversity Act,2002
     11. Bio-piracy—Definition, Types of bio-piracy.
     (B) PATENTING ASPECTS OF TRADITIONAL KNOWLEDGE (TK)
     AND NATURAL PRODUCTS
     Introduction, Patent,
     Defensive measure for protection (Traditional
     knowledge Digital Library (TKDL)
     (1) Patenting aspects of traditional knowledge
     1.1. Article 11, 1.1.2 Article 31,
     1.1.3 Disclosure requirement
     1.2. International Forums
     1.2.1. The Convention on Biological Diversity (CBD)
     1.4.1.1. Protocols of ‘Convention on Biological Diversity’(CBD)—
     (a) Nagoya protocol, (b) Cartagena protocol
     1.2.2. International Treaty on Plant
     Genetic Resources for Food and Agriculture,2001 (ITPGRFA)
     Patenting Aspects of Natural Products (As per WHO)—Definition,
     Patenting aspects of natural products,
     Eligibility criteria of natural products for patenting,
     Patenting aspects of various natural products
     (Traditional medicine)-dosage forms—
     (a) Extracts and formulations,
     (b) Combinations and preparations,
     (c) Preparation and extraction processes.
     (C) BIO-PIRACY OF TRADITIONAL KNOWLEDGE—
     Case study of Neem, and turmeric.


11. REGULATORY ISSUES OF ASU DRUGS
     Definition of ASU Drugs
     Regulations in India—
     (1) Quality standards for ASU herbal medicine,
     (2) Manufacture of ASU quality medicine,
     (3) Labelling & packaging of ASU medicine,
     (4) Labelling & packaging of export products of ASU medicine
     Need for ASU & H Drugs Regulations.
     Legal provisions for the manufacture of ASU drugs—
     (1) Drugs and Cosmetics Act,1940 related to ASU drugs,
     (2) Drugs & Cosmetics Rules 1945 related to ASU drugs,
     (3) Drugs & Magic Remedies (Objectionable advertisement Act), 1954 and Rules.
     ASU Drugs Related Provisions of Chapter IV-A—Table
     11.1 List of Drug Regulation Different
     Section according to the Drugs and Cosmetics Act,1940,
     Chapter IV A. Others Related Acts
     Applicable to AS U & H products—
     (i) Governing Bodies (ii) National Committees for ASU Drugs
     (iii) Institutional arrangement for development of quality standards.
     ASU DTAB Technical Advisory Board—
     Introduction, Composition of DTAB Table
     11.2 Composition of DTAB as per Drugs and Cosmetics Act,
     1940 Introduction to ASU DTAB
     Table 11.3 Composition of ASU DTAB.
     Sub-committees of ASU DTAB—Ayurveda,
     Siddha, Unani Drugs Consultative Committee (ASU-DCC).
     Regulations for Manufacture of ASU Drugs—
     (A) Standards of Ayurveda Siddha and Unani Drugs
     Table 11.4 Respective Pharmacopeia’s
     (B) Standard ASU Formulations—
     33E. Misbranded drugs, 33EE. Adulterated drugs, 33EEA. Spurious drugs
     (C) Permitted Excipients
     (D) License to manufacture the ASU Drugs under DC Act, 1940
     (E) Prohibition of manufacture and sale of Certain ASU Drugs
     (F) Penalty for manufacture, sale, etc.
     of ASU Drugs in contravention of this chapter.
     Relevant Schedules of Drugs and Cosmetics Rules,1945 related to ASU Drugs—
     Clinical Trials for ASU Drugs Good Clinical Practice Guidelines (GCP)
     for Clinical Trials of ASU Medicine Schedule Z
     Table 11.5 Revised Guidelines for Shelf life for ASU Formulations.


12. GENERAL INTRODUCTION TO HERBAL INDUSTRY
     PRESENT SCOPE AND FUTURE PROSPECTUS OF HERBAL INDUSTRY—
     Introduction,
     Scope of herbal drug industry,
     Future prospectus of herbal industry Ayurvedic Industry,
     Indian herbal industry:
     Bottlenecks for sector development,
     Major players of Ayurvedic industry, Threats and challenges,
     Future Growth: Segment wise Future Growth, Region wise growth.
     MEDICINAL PLANT BASED INDUSTRY—
     Plant based industry scenario:
     (1) Indian system of medicine industry,
     (2) Plant based food products industry
     (3) Plant based pharmaceutical industry Key market players:
     Table 12.1 Manufacturers of standard herbal extracts.
     1. Essential oils industry—Essential oil market size,
     Examples of oils in great demand,
     Market status of essential oils, Key players, Future scope,
     Essential oil industry in India
     2. Natural health products industries
     3.Medicinal Plants Based Industry in indigenous system of medicine.
     Challenges for Herbal Drug Industry of India—
     Introduction,
     Problems faced by Indian herbal drug industry:
     (i) Different regulatory requirements.
     Limited overseas market,
     (ii) Problems of standardization of raw material,
     (iii) Regulatory guidelines, Inadequate education.
     INSTITUTION INVOLVED IN WORK ON MEDICINAL PLANTS


13. SCHEDULE T : GOOD MANUFACTURING PRACTICE
     Introduction,
     Indian system of medicine, Definition & brief history
     Good Manufacturing Practice (GMP)—Introduction,
     Objective of GMP, Principles of Good Manufacturing Practice
     COMPONENTS OF GMP (SCHEDULE T).
     PART-I—Infrastructure requirements,
     Guidelines for the manufacturing of ASU drugs Infrastructural requirements
     Location & surrounding, Building, Health, clothing,
     sanitation and hygiene of workers,
     Machinery and Equipment, Quality control,
     Requirements for sterile products,
     Standard Operating Procedures (SOPs), Record of Analysis,
     Reprocessing and Recoveries, Documentation and Records,
     Master Formula Records, Quality assurance,
     Labels and other printed materials, and Site master files.
     PART-11(A) : Table 13.1 Schedule T – Area requirements.
     PART 11(B) : Table 13.2 List of machinery/equipment, minimum space
     for different category of medicine.
     PART 11(C) : List of equipment recommended for In-House Quality Control section wise.
     PART 11(D) : Supplementary guidelines for the manufacturing of Rasaushadhi
     (Herbo- mineral or metal or mineral formulations) of ASU medicines and Kushtajat
     Manufacture processing area—Quality control,
     Product quality control, Product recalls,
     medical examination of employee, Self-inspection Dosage form of Rasaushadhi,
     Table 13.3 Area specification/machinery
     equipment for different category of Rasaushadhi medicines.


   APPENDIX : References

Pharmacy