Course

Unit I

Herbs as raw materials

Definition of herb, herbal medicine, herbal medicinal product, herbal drug preparation Source of Herbs Selection, identification and authentication of herbal materials Processing of herbal raw material

Biodynamic Agriculture

Good agricultural practices in cultivation of medicinal plants including Organic farming.

Pest and Pest management in medicinal plants: Biopesticides/Bioinsecticides.

Indian Systems of Medicine

1. Basic principles involved in Ayurveda, Siddha, Unani and Homeopathy
2. Preparation and standardization of Ayurvedic formulations viz Aristas and Asawas, Ghutika,Chur- na, Lehya and Bhasma.

(11 Hours)

Unit II

Nutraceuticals

General aspects, Market, growth, scope and types of products available in the market. Health benefits and role of Nutraceuticals in ailments like Diabetes, CVS diseases, Cancer, Irritable bowel syndrome and vari- ous Gastro intestinal diseases.

Study of following herbs as health food: Alfaalfa, Chicory, Ginger, Fenugreek, Garlic, Honey, Amla, Gin- seng, Ashwagandha, Spirulina

Herbal-Drug and Herb-Food Interactions: General introduction to interaction and classification. Study of following drugs and their possible side effects and interactions:

Hypercium, kava-kava, Ginkobiloba, Ginseng, Garlic, Pepper & Ephedra.

(07 Hours)

Unit III

Herbal Cosmetics

Sources and description of raw materials of herbal origin used via, fixed oils, waxes, gums colours, perfumes, protective agents, bleaching agents, antioxidants in products such as skin care, hair care and oral hygiene products.

Herbal excipients:

Herbal Excipients – Significance of substances of natural origin as excipients – colorants, sweeteners, binders, diluents, viscosity builders, disintegrants, flavors & perfumes.

Herbal formulations :

Conventional herbal formulations like syrups, mixtures and tablets and Novel dosage forms like phytosomes

(10 Hours)

Unit IV

Evaluation of Drugs WHO & ICH guidelines for the assessment of herbal drugs Stability testing of herbal drugs.

Patenting and Regulatory requirements of natural products:

1. Definition of the terms: Patent, IPR, Farmers right, Breeder’s right, Bioprospecting and Biopiracy
2. Patenting aspects of Traditional Knowledge and Natural Products. Case study of Curcuma & Neem. Regulatory Issues – Regulations in India (ASU DTAB, ASU DCC), Regulation of manufacture of ASU drugs – Schedule Z of Drugs & Cosmetics Act for ASU drugs.

(10 Hours)

Unit V

General Introduction to Herbal Industry

Herbal drugs industry: Present scope and future prospects. A brief account of plant based industries and institutions involved in work on medicinal and aromatic plants in India.

Schedule T – GoodManufacturing Practice of Indian systems of medicine

Components of GMP (Schedule – T) and its objectives Infrastructural requirements, working space, stor- age area, machinery and equipments, standard operating procedures, health and hygiene, documentation and records

(07 Hours)

‘Herbal Drug Technology – Theory’ is a course offered in the sixth semester of B. Pharm program at School of Pharmacy, Health Sciences campus, Amrita Vishwa Vidyapeetham.

Course Duration: 45 Hours

Scope:

This subject gives the student the knowledge of basic understanding of herbal drug industry, the quality of raw material, guidelines for quality of herbal drugs, herbal cosmetics, natural sweeteners, nutra- ceutical etc. The subject also emphasizes on Good Manufacturing Practices (GMP), patenting and regula- tory issues of herbal drugs

Objectives:

Upon completion of this course the student should be able to:

1. Understand raw material as source of herbal drugs from cultivation to herbal drug product
2. Know the WHO and ICH guidelines for evaluation of herbal drugs
3. Know the herbal cosmetics, natural sweeteners, nutraceuticals
4. Appreciate patenting of herbal drugs, GMP.