Infrastructure Regulatory Aspect of Ayurvedic, Siddha Unani Indian Traditional Medicines in India

10. Registration of Practitioners

11. Course contents of Degree Courses of Ayurveda (5.5 years)

30.   Ayurvedic Products Herbal Products 1. Based on sound fundamental 1. Imperical and principles, well documented Experimental base 2. Time tested on human beings 2. Products based on in-vivo for safety & efficacy and in-vitro trials 3. Based on wholesome 3. Isolated or extracted ingredients material is used 4. Simple procedures of 4. Sophisticated procedures processing and for new molecules manufacturing 5. Holistic and comprehensive 5. Generalized or impirical use approach of use for health Contd�

31.   Ayurvedic Products Vs. Herbal Products 6. The product is developed and 6. The product is developed tested in the manner and tested on the it is used basis of analytical parameters 7. Psychophysical 7. No such consideration, characteristics of fragmented approach patients are taken of treatment into consideration, hence holistic approach

32.   1. Official - name of the drug - (Sanskrit/Tamil/Arabic) 2. General Introduction: 3. Synonyms e.g., Regional names etc. 4. Description : (a) Macroscopic, description (b) Microscopic (Pharmacognostic), description - Root - Stem - Leaf - Flower - Fruit - Seed 5. Powder - diagnostic features 6. Chemical constituents �..Contd��

33.   Standards of Identity, Purity and Strength Foreign matter - not more than % Total Ash - not more than % Acid insoluble ash - not more than % Alcohol soluble extraction- not less than % T.L.C. (IDENTITY TEST) (with method & description) Properties and Action: (i) Rasa (Taste) (ii) Guna (Properties) (iii) Virya (Predominant action) (iv) Vipaka (Metabolic action) (v) Karma (Pharmacological action)

34.   Pharmacopoeial Standards of ASU Drugs Reference : Pharmacopoeia of India(API) Monograph �..contd. Important Formulations: ---- Therapeutic Uses: ---- Dose: ---- Authentic/Textual Refences ----

35. Pharmacopoeial Standards of ASU DrugsRef. : Ayurveda Pharmacopoeia of India(API)Monograph �..contd. Additional Quality Standards Microbial load Heavy metals Pesticide residue Safety profile ( Toxicity) Efficacy

36.   DOSAGE FORMS OF ASU FORMULATIONS

37.   DOSAGE FORMS OF ASU FORMULATIONS

38.   DOSAGE FORMS OF ASU FORMULATIONS (multiple ingredients) (Contd��.) Sl.No. Dosage Form No. of ingredients Single dose 21. Bhasma - (Calcinated ash); 1-3 50-100 mg. (i) Mineral based ash; (ii)Metal based ash 22. Lauh & Mandora - 5-20 1gm. (Iron ash based formulations); 23. Ras Yoga - (i) Kupipakva 2-5 50-100 mg. Rasayan & Parpati - Meallic compounds 2-5 30-60 mg. (ii) Rasayoga - Herbo-mineral 5-20 125-250 mg. -metalic formulations

39.   Published Pharmacopoeial standards of A.S.U. drugs Enforcement of GMP Schedule �E� of the Drugs and Cosmetics Act provides list of poisonous materials Licensing for drug manufacturers Ayurvedic Formulary of drugs published Essential Drug Lists published Punitive action provided in the Act for misbranded, adulterated and spurious drugs - Schemes to provide financial assistance for strengthening of infrastructure, functional capacity of pharmacies & drug testing laboratories implemented