1. DRUG PREPARATION OF DISPENSING. KNOWLEDGE OF SHELF LIFE OF DRUGS. DR.JANARDAN PANDAY FORMER JOINT ADVISOR (AY) & ADDL.DRUG CONTROLLER DEPTT. OF AYUSH G.O.I

2. ELEMENTS AND PERFORMANCE CRITERIA OF DRUG PREPARATION FOR DISPENSING ELEMENT 1. RECOGNISE BASIC AYURVEDIC HERBS PERFORMANCE CRITERIA 1.1 IDENTIFY BASIC AYURVEDIC HERBS ARE IN THEIR NATURAL HABITAT 1.2 IDENTIFY BASIC HERBS IN THEIR DRIED FORM 3. ELEMENTS AND PERFORMANCE CRITERIA OF DRUG PREPARATION FOR DISPENSING ELEMENT 2. PREPARE THE MEDICINE PERFORMANCE CRITERIA 2.1 IDENTIFY AND PREPARE PHARMACEUTICAL INGREDIENTS AND EQUIPMENT 2.2 PREPARE MEDICINE ACCORDING TO AYURVEDIC GUIDELINES AND METHODOLOGY 2.3 PREPARE MEDICINE ACCORDING TO CLINIC GUIDELINES 2.4 TAKE CARE TO PREVENT CONTAMINATION OF OR BY THE HERBAL MEDICINE 4. ELEMENTS AND PERFORMANCE CRITERIA OF DRUG PREPARATION FOR DISPENSING ELEMENT 3. DISPENSE THE MEDICINE PERFORMANCE CRITERIA 3.1 IDENTIFY AND PREPARE DISPENSING INGREDIENTS AND EQUIPMENT 3.2 DISPENSE REQUIRED MEDICINE IN THE FORM AND QUANTITY STIPULATED BY THE PRESCRIPTION/ORDER 3.3 TAKE CARE TO PREVENT CONTAMINATION OF OR BY THE HERBAL MEDICINE 3.4 LABEL MEDICINE CORRECTLY 3.5 PROVIDE THE CLIENT WITH INSTRUCTIONS FOR TAKING THE MEDICINE 3.6 DISPENSE THE MEDICINE ACCORDING TO CLINIC GUIDELINES 5. ELEMENTS AND PERFORMANCE CRITERIA OF DRUG PREPARATION FOR DISPENSING ELEMENT 4. CONTROL STOCK PERFORMANCE CRITERIA 4.1 OBTAIN REQUIRED MATERIALS FROM ACCEPTABLE SOURCES 4.2 KEEP PHARMACY WELL STOCKED ACCORDING TO CLINIC GUIDELINES 4.3 IDENTIFY FACTORS WHICH HAVE AN EFFECT ON STORAGE 4.4 STORE MATERIALS ACCORDING TO CLINIC GUIDELINES 4.5 MAINTAIN AN REGISTER FOR THE ALCOHOL CONTAINING MEDICINES, ACCORDING TO STATE REGULATIONS 6. ELEMENTS AND PERFORMANCE CRITERIA OF DRUG PREPARATION FOR DISPENSING ELEMENT 5. COMPLETE DOCUMENTATION PERFORMANCE CRITERIA 5.1 RECORD WORKPLACE INFORMATION IN THE APPROPRIATE FORMAT 5.2 LABEL MATERIALS CORRECTLY 7. REQUIRED SKILLS AND KNOWLEDGE ESSENTIAL KNOWLEDGE: AYURVEDIC MEDICINE DISPENSING PRINCIPLES AND METHODS AYURVEDIC MEDICINE PHARMACY AYURVEDIC MEDICINE PREPARATION FROM SOURCE MATERIALS CHEMICAL AND PHYSICAL INCOMPATIBILITIES COMMON CAUSES OF VARIATION AND CORRECTIVE ACTION REQUIRED DISPENSING PROCEDURES EQUIPMENT AND INSTRUMENTATION COMPONENTS, PURPOSE AND OPERATION EXTERNAL THERAPY PRODUCTS, BOTH MEDICINAL AND DOMESTIC, BATHS, BATH OILS, CREAMS, DYES, FOMENTATIONS, OINTMENTS, POULTICES, SACHETS, SALVES, UBTANS, LEPAS, UPANAH FACTORS THAT AFFECT AYURVEDIC MEDICINES IN PREPARATION AND STORAGE 8. REQUIRED SKILLS AND KNOWLEDGE ESSENTIAL KNOWLEDGEHOW THE DISPENSING PROCESS AFFECTS THE END PRODUCT METHODS OF ADMINISTRATION FOR MEDICINES PREPARATIONS FOR INGESTION: RAW PLANTS, MEDICINAL PREPARATIONS:, COLD EXTRACTS, DECOCTIONS, ESSENCES, HONEYS, INFUSIONS, NUTRITIONAL SUPPLEMENTS, POWDERS, , SYRUPS, TAILA, GHRITAM, AVALEHA, ASAVA, ARISHTA, SAVARASAS, ARKA, KALKA, KSHEERAPAK PRESCRIPTION OF MEDICINES: LEGAL RESTRICTIONS, THERAPEUTIC GOODS ADMINISTRATION, HEALTH AND SAFETY, LABELLING REQUIREMENTS, RESTRICTED SUBSTANCES, PRINCIPLES OF MANUFACTURING, QUALITY CONTROL PROCEDURES PROCESS SPECIFICATIONS, PROCEDURES AND OPERATING PARAMETERS QUALITY CHARACTERISTICS TO BE ACHIEVED RECORDING REQUIREMENTS AND PROCEDURES SIGNIFICANCE AND METHODS OF MONITORING CONTROL POINTS WITHIN THE DISPENSING PROCESS THE NON-MEDICINAL INGREDIENTS USED IN THE PREPARATION OF AYURVEDIC MEDICINES 9. REQUIRED SKILLS AND KNOWLEDGE THE PREPARATION OF ANUPANAS THE PREPARATION OF DISPENSING MENSTRUUM(SOLVANTS) WASTE HANDLING REQUIREMENTS AND PROCEDURES 10. REQUIRED SKILLS AND KNOWLEDGE THIS INCLUDES THE ABILITY TO: ACCESS WORKPLACE INFORMATION TO IDENTIFY REQUIREMENTS FOR THE DISPENSING PROCESS APPLY KNOWLEDGE OF HYGIENE STANDARDS CONFIRM EQUIPMENT STATUS AND CONDITION CONFIRM SUPPLY OF NECESSARY MATERIALS AND SERVICES TO THE DISPENSING PROCESS CORRECTLY IDENTIFY EQUIPMENT AND INGREDIENTS FOR AYURVEDIC MEDICINE PREPARATION AND DISPENSING KNOLEDGE OF AYURVEDIC BOTANICAL KEYS KNOWLEDGE OF AYURVEDIC PLANT ANATOMY AND IDENTIFICATION 11. REQUIRED SKILLS AND KNOWLEDGE ESSENTIAL SKILLS AYURVEDIC PLANT CLASSIFICATIONS AND NOMENCLATURE DISPENSE AYURVEDIC MEDICINES IN ACCORDANCE WITH THE PRESCRIPTION IDENTIFY AYURVEDIC INGREDIENTS IN RAW AND DRIED FORMS MAINTAIN WORK AREA TO MEET HOUSEKEEPING STANDARDS MEASURE AND SEGREGATE MATERIALS 12. REQUIRED SKILLS AND KNOWLEDGE ESSENTIAL SKILLS MONITOR THE DISPENSING PROCESS AND EQUIPMENT OPERATION TO IDENTIFY OUT-OF-SPECIFICATION RESULTS OR NON-COMPLIANCE. THIS MAY INCLUDE: LABELLING STOCK FLOW/QUANTITY MEASURING DEVICES MATERIALS FAULTS EQUIPMENT FAULTS SERVICE FAULTS 13. REQUIRED SKILLS AND KNOWLEDGE ESSENTIAL SKILLS CLEAN AND SANITISE EQUIPMENT CARRY OUT ROUTINE MAINTENANCE PACK AND LABEL DISPENSED MATERIALS PREPARE AYURVEDIC MEDICINES FOR CLIENTS IN PHARMACEUTICAL FORMS (CAPSULES, EMULSIONS, CREAMS, OINTMENTS, SUPPOSITORIES, POWDERS ETC) PREPARE AYURVEDIC MEDICINES IN A RANGE OF DOSAGES PREPARE AYURVEDIC MEDICINES IN ACCORDANCE WITH OFFICIAL PRACTICE, CLINIC GUIDELINES AND RELEVANT LEGISLATION RECORD WORKPLACE INFORMATION 14. SKILLS AND KNOWLEDGE REQUIRED SORT, COLLECT, TREAT, RECYCLE OR DISPOSE OF WASTE, TAKING INTO ACCOUNT OPPORTUNITIES TO ADDRESS WASTE MINIMISATION, ENVIRONMENTAL RESPONSIBILITY AND SUSTAINABLE PRACTICE ISSUES TAKE CORRECTIVE ACTION IN RESPONSE TO OUT-OF- SPECIFICATION RESULTS OR NON-COMPLIANCE 15. RANGE OF KNOWLEDGE ESSENTIAL HERBS APIUM GRAVEOLENS, EMBLICA OFFICINALIS, ANGELICA SPP, FERULA ASAFOETIDA, WITHANIA SOMNIFERA,ABUTILON INDICUM, SIDA CORDIFOLIA, ECLIPTA ALBA, TERMINALIA BELERICA, CHRYSANTHEMUM INDICUM. EPHEDRA VULGARIS,POLYGONUM MULTIFLORUM, TRIBULIS TERRESTRIS, HYDROCOTYLE ASIATICA,COMMIPHORA MUKUL, TERMINALIA CHEBULA, JASMINUM GRANDIFLORA, NELUMBO MUCIFERA,SIDA RHOMBIFOLIA 16. RUBIA CORDIFOLIA,CYPERUS ROTUNDUS, AZADIRACTA INDICA,PIPER LONGUM, BOERHAAVIA DIFFUSA, ASPARAGUS RACEMOSUS, BAMBUSA ARUNDINACEAE,IPOMOEA DIGITATA, DIOSCOREA SPP,AMYGDALUS COMMUNIS, ALOE SPP, ANGELICA ARCHANGELICA, PIPPER NIGRUM, ACORUS CALAMUS, CINNAMOMUM CAMPHORA, ELETTARIA CARDAMOMUM, CINNAMOMUM ZEYLANICUM, EUGENIA CARYPHYLLATA, COCUS NUCIFERA,CORIANDRUM SATTIVUM,CUMINUM CYMINUM, TARAXACUM OFFICINALIS ECHINACEA AUGUSTIFOLIAEUCALYPTUS GLOBULIS, FOENICULUM VULGARE, TRIGONELLA FOENUMGRAECEUM, GENTIANA SPP, ZINGIBER OFFICINALE, GLYCYRRHIZA GLABRA, MYRISTICA FRAGRANS, BRASSICA ALBA, CITRUS AURANTUM,MENTHA PIPERITA,PUNICA GRANATUM, PLANTAGO PSYLLIUM,ROSA SPP, SANTALUM ALBUM, CASSIA ACUTIFOLIA, SESAMUM INDICUM, TAMARINDUS INDICA, CURCUMA LONGA, BACOPA MONIERA, BITTER MELON, GYMNEMA SYLVESTRAARJUNA, CHITRAK, KAESARI, NAGARKESAR, KAPI KACCHU JYOTISH MATI, GUDUCHI 17. KNOWLEDGE OF PHARMACEUTICAL INGREDIENTS AND EQUIPMENT VARIOUS RAW OR PREPARED HERBS/MEDICINES DIFFERENT MENSTRUUM/ANUPANA WHICH MAY INCLUDE:WATER, OIL, MILK,GHEE AND HERBAL JUICES MEASURING INSTRUMENTS, PERCOLATOR, PRESS AND BLENDER,CONTAINERS,SCOOPS,LABELLER, LABELS,PROTECTIVE CLOTHINGVARIOUS RAW OR PREPARED HERBS, 18. KNOWLEDGE OF AYURVEDIC GUIDELINES AND METHODOLOGY REFERS TO HEALTH AND SAFETY, LABELLING REQUIREMENTS LEGAL RESTRICTIONS PRINCIPLES OF MANUFACTURING MEDICINES SCHEDULED HERBS TESTING OF MEDICINES THERAPEUTIC GOODS ADMINISTRATION TRIDOSHAS THEORY 19. DISPENSING INGREDIENTS AND EQUIPMENT MAY INCLUDE BUT IS NOT LIMITED TO: CONTAINERS,DIFFERENT MENSTRUUM/ANUPANAS WHICH MAY INCLUDE: WATER, OIL, LABELLER, LABELS,MEASURING INSTRUMENTS, PROTECTIVE CLOTHING,SCOOPS VARIOUS RAW OR PREPARED HERBS/MEDICINES 20. THE FORM OF THE MEDICINE MAY INCLUDE BUT IS NOT LIMITED TO: ARISHTAS, ASAVAS, AVALEHA, BHASMAS, CAPSULES, CHURNAS, CREAMS, EMULSIONS, EXTRACTS, GHRITAS, GUTIS, KALPAS. KSHARA, OINTMENTS, PARPATI POWDERS, SUPPOSITORIES, WHOLE HERBS,SWARASA, TAILAS, VATIS,NETRA VINDU,KARNA VINDU 21. CARE IS TAKEN TO PREVENT CONTAMINATION MEANS MEDICINES ARE MADE AND PREPARED OVER AN IMPERVIOUS SURFACE MEDICINES WHICH COME INTO CONTACT WITH CONTAMINANTS ARE DISCARDED OBJECTS THAT COME IN TO CONTACT WITH THE MEDICINE ARE CLEANED AND DISCARDED THE WORK SPACE IS WELL VENTILATED 22. CLINIC GUIDELINES MAY INCLUDE: DISPENSING PROCEDURE HYGIENE AND WASTE GUIDELINES QUALITY SYSTEM GUIDELINES STOCK AND STORAGE PROCEDURES 23. INSTRUCTIONS FOR TAKING THE AYURVEDIC MEDICINE REFER TO FACTORS WHICH MAY INTERFERE WITH THE AYURVEDIC MEDICINE, E.G. CONSUMPTION OF FOOD, CONCURRENT USE OF ALLOPATHIC MEDICATIONS FREQUENCY OF ADMINISTRATION MODE OF ADMINISTRATION, E.G. EXTERNAL OR INTERNAL THE NEED TO REPORT INCIDENCES TO THE PRESCRIBING AYURVEDIC MEDICINE PRACTITIONER 24. ACCEPTABLE SOURCES INCLUDES COLLECTED AND PREPARED FROM NATURAL SOURCES AFTER ASCERTAINING THAT THE PLANT MATERIAL IS UNCONTAMINATED BY PESTICIDES OR OTHER CONTAMINANTS AYURVEDIC MEDICINE SUPPLIERS LISTED/REGISTERED IN THE RELAVANT ADMINISTRATION TRACK RECORD OF HISTORY OF SUPPLY 25. LABELLED CORRECTLY MEANS: ACCORDING TO LEGISLATIVE GUIDELINES ACCORDING TO CLINIC REQUIREMENTS 26. FACTORS WHICH MAY HAVE AN EFFECT ON THE STORAGE INCLUDE HEAT ABOVE 50OC PROLONGED EXPOSURE TO SUNLIGHT 27. WORKPLACE INFORMATION MAY INCLUDE: DETAILS OF PERSON(S) CONDUCTING PREPARATION AND DISPENSING DETAILS OF PREPARATION AND DISPENSING UNDERTAKEN DISPENSING INFORMATION FOR PRESCRIPTIONS STOCK DOCUMENTATION 28. TYPE OF PHARMACEUTICAL PROCESSINGS FRESH AS WELL AS DRIED PLANT MATERIAL IS USED FOR PROCESSING- DEPENDING ON AVAILABILITY AND NECESSITY. DIFFERENT PROCEDURES ARE ADOPTED TO PREPARE A DOSAGE FORM, WHICH IS STABLE FOR A LONGER PERIOD. THUS THE TYPE OF PHARMACEUTICAL PROCESSING DEPENDS ON FOLLOWING FACTORS: 29. BASIC PRINCIPLES OF DOSAGE FORMS 1. NATURE OF THE RAW MATERIAL: FRESH OR DRY 2. REQUIRED CONCENTRATION OF THE DOSAGE FORM 3. SOLUBILITY OF THERAPEUTICALLY USEFUL COMPONENT OF THE PLANT 4. HEAT STABILITY OF THERAPEUTICALLY USEFUL COMPONENT OF THE PLANT 5. ROUTE OF ADMINISTRATION 6. SHELF LIFE OF PREPARED DOSAGE FORM 30. BASIC RANGE OF FORMULATIONS THE AYURVEDIC FORMULATIONS RANGE WIDELY FROM FRESHLY EXTRACTED PLANT JUICE TO EYE DROPS, OINTMENTS, SURGICAL THREADS ETC. HOWEVER THERE ARE FIVE BASIC CLASSICAL FORMS TERMED AS PANCAVIDHA KASAAYA (SAARANGADHARA SAMHITAA - MADHYAMA KHANDA 1/1, 1983) FROM WHICH ALL OTHER DRUG FORMULATIONS OR FORMS ARE DERIVED OR DEVELOPED. THE FIVE BASIC FORMS ARE: SWARASA THE EXPRESSED JUICE, KALKA, A FINE PASTE OBTAINED BY GRINDING FRESH OR WET GRINDING DRIED PLANT MATERIAL, KWAATHA, THE DECOCTION, SHEETA OR HIMA, THE COLD WATER INFUSION AND FAANTA, THE HOT WATER INFUSION. THE FIRST TWO FORMS ARE PREPARED FROM FRESHLY COLLECTED PLANT MATERIAL AND ARE DIRECTLY PUT TO PATIENT USE, WHEREAS THE LAST THREE FORMS KWAATHA, SHEETA AND FAANTA ARE AQUEOUS EXTRACTS PREPARED FROM THE DRIED PLANT MATERIAL. 31. DOSAGE FORM AYURVEDIC THERAPEUTIC SYSTEM INCLUDES VARIOUS TYPES OF DOSAGE FORMS, DEPENDING UPON THE CONSISTENCY AND ITS SHELF LIFE, VIZ. VATI (TABLET),CHURNA (POWDER) AS SOLID DOSAGE FORMS; SWARASA (JUICE), KWATHA (DECOCTION), HIMA AND PHANTA (COLD AND HOT INFUSION, RESPECTIVELY), ASAVA AND ARISHTA (PREPARATION CONTAINING ALCOHOL) AS LIQUID DOSAGE FORMS WHERE AS SEMI-SOLID PREPARATION INCLUDES KALKA (PASTE) AND AVALEHA (ELECTUARY),ETC 32. UTILISATION OF DOSAGE FORM AMONGST OF THEM, BASIC DOSAGE FORMS LIKE SWARASA, KALKA, KWATHA, HIMA AND PHANTA ARE PRESCRIBED IN FRESH CONDITION BECAUSE OF HAVING SHORT SHELF LIFE; WHILE THE DERIVED FORMULATIONS LIKE ASAVA, ARISHTA AND AVALEHA, ETC. CAN BE USED THROUGHOUT YEAR OR MORE BECAUSE OF PROLONGED STABILITY 33. SHELF LIFE IN AYURVEDIC LITERATURES, SAVIRYATA AVADHI TERM IS MENTIONED IN CONTEXT OF THE TIME PERIOD DURING WHICH THE VIRYA (POTENCY) OF ANY DRUG REMAINS UNAFFECTED DUE TO ENVIRONMENTAL/MICROBIAL DETERIORATION; WHEREAS IN THE CONTEMPORARY SYSTEM, THE TERM SHELF LIFE IS USED TO INDICATE THE TIME PERIOD DURING WHICH AN API (ACTIVE PHARMACEUTICAL INGREDIENT) OR FPP (FINISHED PHARMACEUTICAL PRODUCT) IS EXPECTED TO REMAIN WITHIN THE APPROVED STABILITY SPECIFICATION, PROVIDED THAT IT IS STORED UNDER THE CONDITIONS DEFINED ON THE CONTAINER LABEL. 34. ANCIENT VIEW AS PER THE CITATION GIVEN IN THE RENOWNED AYURVEDIC TEXT SUSHRUTA SAMHITA, A DRUG WHETHER IT IS FRESH OR OLD, CAN BE UTILIZED FOR THERAPEUTIC PURPOSE UP TO WHICH ITS QUALITIES (APPEARANCE, TASTE, SMELL, ETC.) REMAINS INTACT CONDITION:- THESE CHARACTERISTICS ARE JUST THE SUBJECTIVE PARAMETERS OF THE PHYSIC-CHEMICAL PROPERTIES OF DRUG WHICH ARE GENERALLY UTILIZED AS THE QUALITY PARAMETERS OF TODAYS ERA ALSO AND NOT ON THE BASIS OF ATTAINEMENT OF THE PRODUCT UP TO SUB POTENT LEVEL ESTABLISHED ON SCIENTIFIC BASIS APART FROM DETERIORATION 35. ANCIENT VIEW CONTD. THE CONCEPT OF SAVIRYTA AVADHI (SHELF LIFE) FOR DIFFERENT AYURVEDIC DOSAGE FORMS ARE NOT SPECIFIED IN MAJOR CLASSICS LIKE CHARAKA, SUSHRUTA, ETC. BUT AFTER 13TH CENTURY, IT WAS CONSIDERED IN VARIOUS AUTHENTIC AYURVEDIC TEXTS LIKE VANGA SEN,SHRANGDHAR SAMHITA AND YOGARATNAKAR. ALONG WITH THE INDICATION OF BEST BEFORE USE DURATION, THE IMPORTANCE OF QUALITY OF PACKAGE AND STORAGE CONDITION IS ALSO EMPHASIZED IN CLASSICS. 36. CURRENT VIEW . NOWADAYS, DUE TO DEVELOPMENT AND ADAPTATION OF PACKAGING AND STORAGE TECHNOLOGY BY AYURVEDIC INDUSTRIES, A NEED ARISE TO RE-STUDY AND RE- ESTABLISH THE NEWER ONES CRITERIA. RECENTLY,GOVERNMENT OF INDIA HAS ALSO ISSUED A GAZETTE NOTIFICATION AND PROPOSED THE SHELF LIFE OF THE AYURVEDIC FORMULATIONS 37. ROLE OF TECHNOLOGY ON SHELF LIFE OF AYURVEDIC FORMULATIONS THERE IS NO ANY CLEAR IDEA ABOUT SHELF LIFE OF DIFFERENT AYURVEDIC FORMULATIONS IN THE CLASSICAL TEXTS BEFORE OF 11TH CENTURY AD. AFTER ABOUT 12TH AD, THE SCHOLARS HAVE PROVIDED A SPECIFIED SHELF LIFE/STABILITY PERIOD OF DIFFERENT DOSAGE FORMS . AS PER THESE TEXTS, THE KWATHA, KALKA AND SWARASA ARE REMAIN STABLE FOR UP TO ONE PRAHARA (3 HRS) WHILE CHURNA (POWDER) FORMULATION ARE HAVING ONLY 2-3 MONTHS OF STABILITY IN ITS POTENCY WHEREAS NOWADAYS, THE AIRTIGHT PACKED SPICES (TURMERIC, PEPPER, CORIANDER, ETC. POWDER) ARE USED COMPARATIVELY FOR LONGER PERIOD. ALSO THE STABILITY PERIOD OF THE VATI (PILLS) IS MENTIONED TO BE UP TO ONE YEAR WHICH SEEMS TO BE LESSER IN COMPARISON TO THE TABLETS OF ALLOPATHIC SYSTEM OF MEDICINE. AYURVEDIC FORMULARY OF INDIA (AFI) ALSO HAS SPECIFIED SOME TIME PERIOD DURING WHICH THE FORMULATION RETAINS ITS EFFICACY. THE LONGER STABILITY IN RECENT DOSAGE FORMS IS NATURALLY THE GIFT OF THE PRESENT PACKAGING TECHNOLOGY WHICH WAS NOT MUCH MORE DEVELOPED IN THE ANCIENT TIME. ALSO, THE MODERN SCIENCE HAS MADE SOME ADVANCES TO CONTROL AND REGULATE VARIOUS ASPECTS OF PHARMACEUTICAL PROCESSING 38. SAVIRYTA AVADHI OF DIFFERENT AYURVEDIC DOSAGE FORMS AS PER CLASSICS DOSAGE FORM SAVIRYA AVADHI VANGSEN SHARANGDHAR YOGRATNAKAR (1) KWATHA (DECOCTION) ---------- -------------- 03 HOURS (2) KALKA (PASTE) ----------- -------------- 03 HOURS (3) SWARASA (EXPRESSED JUICE) ---------- ------------- 03 HOURS (4) ANJANA (COLLYRIUM) ---------- --------------- 03 MONTHS (5) CHURNA (POWDER) --------- 02 MONTHS 03 MONTH (6) VATI (PILLS) ------------- 12 MONTHS ------- (7) GUDA/AVALEHA (ELECTUARY) 12MONTHS 12 MONTHS 06 MONTH (8) GHRITA & TAILA(0OL&FAT BASED) 06MONTHS 16MONTHS 12 MONTH (9) ASAVA (ALCOHOLIC PREPARATION) ------------ LONG TERM -------- - (10) DHATU (METALLIC PREPARATION) -------------- LONG TERM -------- (11) RASA (MERCURIAL PREPARATION) ------------- LONG TERM ------- 39. SHELF LIFE OR DATE OF EXPIRY FOR AYURVEDIC MEDICINES. GSR NO.764(E) DATED 15TH NOV.2009 U/R 161B OF D&C ACT Sl. No. Name of the Group of Ayurvedic Medicine. Shelf life and date of expiry with effect from the date of manufacture 1. Churna, Kwatha Churna 2 years 2. Gutika (Vati-Gutti, Pills, Tablets except Gutika with Rasa) 3 years 3. (i) Gutika Tablet containing Kasth aushadhi 3 years 4. Rasaushadhies No expiry date1 5. Asava Arista No expiry date1 40. CONTI Sl. No. Name of the Group of Ayurvedic Medicine. Shelf life and date of expiry with effect from the date of manufacture 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. Guggulu Mandura - Lauha Ghrita Taila Arka Dravaka, Lavana, KsaraLepa Churna Dant Manjan Powder Dunt Manjan Paste Lepa Guti Lepa Malahar (Ointment)/Liniment/ Gels/ 5 years 10 years 2 years 3 years 1 year 5 years 3 years 2 years 2 years 3 years 3 years 41. 18. 19. 20. 21. 22. 23. 24 Varti Ghana Vati Kupipakva Rasayan Parpati Sveta parpati Pisti and Bhasma Svarna, Rajata, Lauha, Mandura, Abhraka No expiry date1 bhasma, Godanti, Shankha Bhasma, etc 2 years (one time use) 3 years No expiry date1 No expiry date1 2 years No expiry date1 No expiry date1 42. 25. Naga Bhasma, Vanga Bhasma, Tamra Bhasma2 5 years 2 26 Capsules made of soft gelatin (depending upon the content material) for Kashtha aushadhi 3 years 27 capsules of hard gelatin (depending upon the content material) - containing Kasth aushdhi with Rasa, Bhasma, Parad- Gandhak 5 years2 43. 28. 29 . 30 . 31 . 32. Syrup/liquid oral (karna/nasa Bindu)Ear/Nass al Drop EyeDrop Khand/Granule/ pak Dhoopan/Inhale rs Pravahi Kwath(with preservatives) 3 years 2 years 1year 3year 2years 3years 44. TRAINING FOR DRUG PREPARATION OF DISPENSING(AS PER WHO) AYURVEDIC DISPENSER AND DISTRIBUTOR TRAINING HAS TO PROVIDE KNOWLEDGE AND SKILLS RELATING TO MECHANISMS, PROCEDURES AND TECHNIQUES FOR THE CLINICAL DISPENSING AND DISTRIBUTION OF AYURVEDIC MEDICINES. IT FORMS PART OF THE PRACTICE OF AYURVEDA AND IS SIGNIFICANTLY DIFFERENT FROM PHARMACY RELATING TO OTHER MEDICINES. THIS DIFFERENCE STRONGLY INFLUENCES THE ATTITUDE AND APPROACH TO HEALTH CARE OF DISPENSERS AND DISTRIBUTORS IN AYURVEDA 45. KEY ASPECT PERSONNEL TO PERFORM PROCESSING, PREPARATION, IDENTIFICATION, DISPENSING AND DISTRIBUTION UNDER THE GUIDANCE OF THE THEORIES OF AYURVEDA, SUCH AS PANCHABHAUTIK (FIVE BASIC ELEMENTS), TRIDOSHAS (HUMOURS), HOLISTIC APPROACHES, ETC. THUS, QUALITY CONTROL OF AYURVEDIC MEDICINES IS A KEY ASPECT OF DISPENSING AND DISTRIBUTION IN AYURVEDA 46. STANDERDISING OF PHARMACEUTICAL PROCESSIGS THE CHARAKA SAMHITA (1000 BC) AND SUSHRUTA SAMHITA (1000 BC) ARE THE ORIGINAL TEXTS OF AYURVEDA. ADDITIONAL, NEWER DOCUMENTS DESCRIBE IN DETAIL THE PROCESSING, MANUFACTURE, DISPENSING AND DISTRIBUTION OF AYURVEDIC MEDICINES IN VARIOUS WAYS. IN 1970, THE AYURVEDIC FORMULARY OF INDIA (1,2) WAS PUBLISHED IN TWO VOLUMES BY THE GOVERNMENT OF INDIA. IT CONTAINS OVER 600 COMPOUND AYURVEDIC FORMULATIONS. 47. IN 1999, PART I OF THE AYURVEDIC PHARMACOPOEIA OF INDIA WAS PUBLISHED BY THE GOVERNMENT OF INDIA. TO DATE, NINE VOLUMES HAVE BEEN PUBLISHED. 48. USE OF AYURVEDIC MEDICINES A MEDICINAL PLANT SHOULD NEVER BE COLLECTED FROM AN ANTHILL, A DIRTY OR MARSHY PLACE, GRAVELLY LAND, A GRAVEYARD OR A FOOTPATH. A PLANT INFECTED OR SPOILED BY FIRE, COLD, WATER OR ANY OTHER DAMAGE SHOULD NOT BE USED FOR PREPARING A MEDICINE. THE PRACTITIONER MUST CAREFULLY EXAMINE THE FOLLOWING FACTORS IN A PATIENT BEFORE DECIDING ON THE PATIENTS HUMORAL CONSTITUTION AND THE MEDICINE OR THERAPY TO BE ADMINISTERED: DUSHYA DOSHA BALA (PHYSICAL STRENGTH) KALA (TIME) ANALA (DIGESTION; FIRE) PRAKRITI (GENERAL CONSTITUTION) VAYA (AGE) SATVA (MENTAL STRENGTH) SATMYA (FAVOURABLE FACTORS) AHAR (DIET) AVASTHA (STAGE OF THE ILLNESS) 49. SAFE USE OF METALS, MINERALS AND POISONOUS SUBSTANCES METALS, MINERALS AND POISONOUS SUBSTANCES MUST BE PROPERLY PROCESSED IN ORDER TO BE USED AS A MEDICINE OR IN A MEDICAL FORMULATION, I.E. SHODHAN FOR POISONOUS SUBSTANCES AND SHODHAN AND MARAN (WHEREVER NECESSARY) FOR METALS AND MINERALS,AS IMPROPERLY PURIFIED SUBSTANCES ARE LIKELY TO CREATE TOXIC EFFECTS. 50. ADVERSE EFFECTS OF IMPROPERLY PROCESSED DRAVYA (BHASMA)METALS AND MINERALS FOR MARAN REQUIRE SPECIFIC PROCESSING IN ORDER TO DECREASE THE RISK OF ADVERSE EFFECTS. METALLIC AND MINERAL MEDICINE FORMULATIONS (BHASMAS) SHOULD ALSO BE SUBJECTED TO THE FOLLOWING TESTS FOR PURIFICATION BEFORE ADMINISTRATION: VARITARATWA SHOULD FLOAT ON WATER; REKHAPURNATWA SHOULD BE FINE ENOUGH TO FILL THE RIDGES ON THE SURFACE OF FINGERS NIRUTTHATWA THE METAL SHOULD NOT MAKE AN APPEARANCE IN ITS ORIGINAL FORM AFTER SUBJECTING THE BHASMA TO PROCESSING; NISHCHANDRATVA SHOULD BE LUSTRELESS; NISHKALANKA SPECIFICALLY FOR TAMRA (COPPER) BHASMA; NO GREEN COLOUR SHOULD APPEAR WHEN TAMRA BHASMA IS MIXED WITH CURD OR ANY SOUR SUBSTANCE. AYURVEDIC PRACTITIONERS SHOULD WARN PATIENTS WHEN METALS, MINERALS OR POISONOUS SUBSTANCES ARE INCLUDED IN THE PRESCRIPTION. INFORMATION 51. VIRUDDHA AHAR (INCOMPATIBLE DIETARY COMBINATIONS) FISH AND MILK, MEAT AND MILK SOUR SUBSTANCES AND MILK SALT AND MILK, FRUITS AND MILK, PEAS AND MILK LEAFY VEGETABLES AND MILK RADISH LEAVES AND JAGGERY BANANA WITH BUTTERMILK OR CURD CURD AND GHEE STORAGE OF GHEE IN BRASS CONTAINERS FOR MORE THAN 10 DAYS FRYING OF LONG PEPPER IN THE SAME OIL IN WHICH FISH HAS BEEN FRIED 52. ACCIDENTS AND ADVERSE REACTIONS ACCIDENTS AND ADVERSE REACTIONS MAY OCCUR IF: 1 PLANTS, ARE NOT PURIFIED BEFORE PREPARATION OF AYURVEDIC MEDICINE ; 2 METALS AND MINERALS ARE NOT PURIFIED DURING MANUFACTURE OF MEDICINE 3 PRECAUTIONS NECESSARY AT THE TIME OF COLLECTION OF VARIOUS PARTS OF PLANTS OVERLOOKED 4 THE PRACTITIONERS KNOWLEDGE OF POISONOUS SPECIES AND METAL- CONTAINING MEDICINES AND THEIR DOSAGE FORMS IS INADEQUATE; 5 SUBSTANDARD OR LOW-QUALITY MEDICINES ARE USED; 6 MEDICINES ARE USED FOR INDICATIONS THAT ARE NOT APPROVED; 7 MEDICINES ARE MISUSED; 8 MEDICINES INTERACT ADVERSELY WITH CHEMICALS, OTHER MEDICINES AND UNWHOLESOME FOOD; 9 THE PROVIDER LACKS SKILLED KNOWLEDGE OF CONSTITUENTS OF MINERAL ORIGIN, 53. CONTRAINDICATIONS IN THERAPY KNOWLEDGE OF CONTRAINDICATIONS IS JUST AS IMPORTANT WITH RESPECT TO THERAPEUTIC MEASURES AS IT IS WITH RESPECT TO MEDICINES. IT HELPS TO AVOID EXACERBATING DISORDERS AND MAY PREVENT ADVERSE EFFECTS. 54. PANCHAKARMA THERAPY PANCHAKARMA IS A GROUP OF FIVE THERAPEUTIC PROCEDURES: VAMAN (EMESIS), VIRECHAN (PURGATION), ANUVASAN AND ASTHAPAN BASTI (EVACUATION ENEMA), SHIROVIRECHAN (ERRHINE PROCEDURE INDUCING NASAL DISCHARGE) AND RAKTA MOKSHAN (BLOOD-LETTING) TO EVACUATE VITIATED DOSHAS FROM THE BODY.FOR EACH THERAPY CERTAIN CONTRAINDICATIONS HAVE BEEN NOTED WHICH NEED TO BE STRICTLY RESPECTED IF THE PATIENT IS TO HAVE BENEFICIAL RATHER THAN ADVERSE EFFECTS. 55. VAMANA SHOULD NOT BE PERFORMED ON AN ELDERLY PERSON OR PERSON WITH DEFECTIVE VISION, WASTING DUE TO CHEST INJURY, EMACIATION, PILES, FACIAL PARALYSIS, CONVULSIONS, RECENT PREGNANCY, INTERNAL HAEMORRHAGE DIRECTED UPWARDS, GASTROINTESTINAL WORMS, SEVERE CONSTIPATION, ROUGHNESS OF THE BODY INCLUDING SKIN, INTRA-ABDOMINAL SWELLING, ANAEMIA, ABDOMINAL DISORDERS, JAUNDICE OR OBESITY 56. VIRECHANA SHOULD NOT BE PERFORMED ON CHILDREN, WOMEN DURING PREGNANCY AND PUERPERIUM, ELDERLY INDIVIDUALS OR PERSONS SUFFERING FROM FATIGUE, FEAR, ACUTE FEVER, POOR DIGESTION, INTERNAL HAEMORRHAGE DIRECTED DOWNWARDS, RECTAL WOUNDS, DIARRHOEA, FOREIGN BODIES, CONSUMPTION, HARD BOWEL MOVEMENTS, THIRST, INDIGESTION, OR AFTER NONUNCTUOUS ENEMA OR EXCESSIVE UNCTION. 57. ASTHAPAN BASTI SHOULD NOT BE GIVEN TO A PERSON WHOSE BOWELS HAVE NOT BEEN EVACUATED (BY VAMANA OR VIRECHANA AFTER ADMINISTRATION OF ENEMA) AS OTHERWISE THE ACTIVE FRACTION OF THE MEDICINE WILL NOT CIRCULATE. 58. SHIROVIRECHANA SHOULD NOT BE PERFORMED BEFORE OR AFTER INTAKE OF WATER, WINE, POISON OR FATTY SUBSTANCES, AFTER TAKING MEALS, AFTER A HEADBATH, BEFORE A BATH, AFTER BLOOD-LETTING, AFTER EVACUATION AND ADMINISTRATION OF AN ENEMA, WHEN A PERSON IS SUFFERINGFROM ACUTE CORYZA (RHINITIS), DYSPNOEA OR COUGH, OR IN CLOUDY WEATHER OTHER THAN THE RAINY SEASON, EXCEPT IN CASES OF EMERGENCY. 59. RAKTAMOKSHANA SHOULD NOT BE PERFORMED IN PERSONS UNDER 16 OR OVER 70 YEARS OF AGE, WOMEN DURING PREGNANCY AND PUERPERIUM, NON-UNCTED PERSONS, AFTER BLOOD- LETTING, AFTER INTAKE OF SNEHA AND USE OF PANCHAKARMA, OR IN PERSONS SUFFERING FROM VATIKA DISORDERS, INDIGESTION, INTERNAL HAEMORRHAGE, DYSPNOEA, COUGH, DIARRHOEA, ABDOMINAL DISORDERS, VOMITING, ANAEMIA OR GENERAL ANASARCA (CONGESTION). 60. OTHER THERAPIES(SNEHANA) SHOULD NOT BE PERFORMED ON A WOMAN AFTER PREMATURE DELIVERY OR A PERSON HAVING VERY POOR OR INTENSE DIGESTION, OBESITY, DEBILITATION, DIARRHOEA, THROAT DISORDERS, POISONING, FAINTING, VOMITING, ANOREXIA, THIRST, ALCOHOLISM, KAPHA, AMADOSA OR URUSTAMBHA OR AFTER SNUFFING, ENEMA OR PURGATION. 61. SVEDANA SHOULD NOT BE PERFORMED ON A WOMAN DURING PREGNANCY, MENSTRUATION OR AFTER DELIVERY, OR ON AN EXCESSIVELY OBESE PERSON, DEBILITATION, FAINTING, WASTING DUE TO CHEST INJURY, POISONING, ALCOHOLISM, DEFECTIVE VISION, ABDOMINAL DISORDERS OR ERYSIPELAS, PROLAPSED RECTUM, MALAISE, ANGER, ANXIETY, FEAR, HUNGER, THIRST, JAUNDICE, ANAEMIA, CAUTERIZATION IN THE ANAL REGION, CONSUMPTION, PRAMEHA, KUSTHA AND VATARAKTA, AFTER INTAKE OF MILK, CURD, FATTY SUBSTANCES AND HONEY, OR AFTER PURGATION. 62. ANJANA SHOULD NOT BE USED ON A FEARFUL PERSON, AFTER EMESIS OR PURGATION, AFTER MEALS, WHILE FEELING NATURAL URGES OR ANGER, FEVER, EYESTRAIN, HEADACHE, CONSUMPTION, LOSS OF SLEEP, DAYTIME SLEEP, INDIGESTION OR THIRST, AFTER HEADBATH OR INTAKE OF SMOKE OR WINE, AFTER EXPOSURE TO FIRE AND SUN OR WHEN SUN IS NOT VISIBLE. 63. KSHARA KARMA KSHARA (CAUSTIC ALKALI) SHOULD NOT BE USED ON DEBILITATED, TIMID OR AGED PEOPLE, CHILDREN, PEOPLE SUFFERING FROM ANASARCA, ABDOMINAL ENLARGEMENT, INTERNAL HAEMORRHAGE, ADVANCED FEVER, PRAMEHA, IMPOTENCE OR DISPLACED TESTICLES, PREGNANT OR MENSTRUATING WOMEN OR WOMEN WITH UPWARDS DISPLACEMENT OF THE UTERUS 64. AGNIKARMA AGNIKARMA SHOULD NOT BE PERFORMED IN THE AUTUMN OR SUMMER, ON A PERSON OF PAITTIKA CONSTITUTION, A PATIENT WITH INTERNAL HAEMORRHAGE, RUPTURED VISCERA OR AN UNEXTRACTED FOREIGN BODY, DEBILITATED PERSON, CHILDREN, AGED PERSONS, TIMID PERSONS OR THOSE WITH MULTIPLE WOUNDS OR CONTRAINDICATED FOR SVEDANA. 65. USE OF METALS, MINERALS AND POISONOUS SUBSTANCES METALS, MINERALS AND POISONOUS SUBSTANCES MUST BE PROPERLY PROCESSED AS PRESCRIBED IN ORDER TO BE USED DIRECTLY AS A MEDICINE OR IN A MEDICAL FORMULATION, I.E. SHODHAN FOR POISONOUS SUBSTANCES AND SHODHAN AND MARAN (WHEREVER NECESSARY) FOR METALS AND MINERALS. DISPENSERS AND DISTRIBUTORS OF AYURVEDASHOULD BE ABLE TO UNDERSTAND THESE PRESCRIPTIONS AND BE ABLE TO VERIFY THAT THEY ARE CORRECT ACCORDING TO THE PRINCIPLES AND PRACTICE OF AYURVEDA. THE AYURVEDA DISPENSER OR DISTRIBUTOR SHOULD ALSO BE ABLE TO REFER BACK TO THE PRESCRIBER FOR CONFIRMATION OF THE PRESCRIPTION, WHEN APPROPRIATE 66. ADVERSE EFFECTS OF METALS, MINERALS AND POISONOUS SUBSTANCES BURNING SENSATION CONSTIPATION PAIN AND BURNING IN ABDOMEN RESTLESSNESS GIDDINESS AND SYNCOPE VOMITING LOSS OF STRENGTH, VIGOUR, LIBIDO POOR SHINE OF THE SKIN BRIGHTNESS OF THE EYES AND GENERAL HEALTH SKIN DISEASES AND OTHER CONDITIONS. 67. Dispensers and distributors of Ayurveda should warn patients when metals, minerals or poisonous substances are included in the prescription. Information regarding the use of these substances, signs of potential adverse effects and recommendations for the appropriate emergency response in the event of adverse effects, should be provided