1 CENTRAL SECTOR SCHEME FOR PROMOTION OF INFORMATION, EDUCATION, AND COMMUNICATION (IEC) IN AYUSH

2 CENTRAL SECTOR SCHEME FOR PROMOTION OF INTERNATIONAL CO-OPERATION (IC) IN AYUSH

3 CENTRAL SECTOR SCHEME FOR SUPPORTING RE-ORIENTATION TRAINING, CONTINUING MEDICAL EDUCATION AND EXPOSURE PROGRAMS OF AYUSH. There is an urgent need for re-orienting and upgrading their professional competence & skills. Emerging trends of health care and scientific outcomes necessitate time to time enhancement of professional knowledge of teachers, practitioners and researchers. Many issues of the profession can not be covered through stereotyped course curricula and need augmentation & clarification through direct interaction with the resource persons and domain experts. Good ClinicalPractices and Good Teaching Practices are the two areas where AYUSH practitioners and teachers need to be regularly updated to keep up the standards of health delivery and adequate training of students respectively in accordance with the emerging demands.

4 CENTRALLY SPONSORED SCHEME OF NATIONAL MISSION ON MEDICINAL PLANTS OPERATIONAL GUIDELINES of NATIONAL MEDICINAL PLANTS BOARD

5 CENTRALLY SPONSORED SCHEME FOR “DEVELOPMENT OF AYUSH INSTITUTIONS” ContainsEligibility Criteria for A&B:Funds to Govt./Govt.- aided AYUSH Institutions:Eligibility Criteria for model institutions/center of advanced studiesEligibility Criteria for new institution/university:Pattern of assistance under the Scheme.Guidelines for submission of application and implementation of Scheme:Programme Management UnitPROFORMA OF APPLICATION

6 CENTRALLY SPONSORED SCHEME OF QUALITY CONTROL OF AYURVEDA, SIDDHA, UNANI AND HOMEOPATHY DRUGS
SCHEME NO. 1 RELEASE OF BALANCE INSTALLMENT OF FINANCIAL ASSISTANCE SANCTIONED FOR ESTABLISHMENT / STRENGTHENING OF DRUG TESTING LABORATORIES AND PHARMACIES DURING THE 10TH PLAN.
SCHEME NO. 2 REIMBURSEMENT OF EXPENDITURE INCURRED BY STATE DIRECTORATE OF ISM&H/STATE LICENSING AUTHORITIES FOR TESTING OF AYURVEDA, SIDDHA, UNANI AND HOMOEOPATHY DRUGS SAMPLES THROUGH NABL ACCREDITED/ OTHER APPROVED LABORATORIES FOR TESTING OF HEAVY METALS/PESTICIDE RESIDUE/ MICROBIAL LOAD/ IDENTIFICATION OF INGREDIENTS ETC.
SCHEME NO. 3 REIMBURSEMENT OF EXPENDITURE INCURRED BY STATES FOR STRENGTHENING OF ENFORCEMENT MECHANISM OF AYURVEDA, SIDDHA AND UNANI DRUGS AT THE STATE LEVEL AND EXPENDITURE INCURRED IN TESTING OF ASU&H MEDICINES BY FUNCTIONAL ACCREDITED LABORATORIES.SCHEME NO. 4 ASSISTANCE TO AYURVEDA, SIDDHA & UNANI (ASU) DRUG MANUFACTURING UNITS TO ESTABLISH AN IN-HOUSE QUALITY CONTROL LABORATORY FOR THE PURPOSE OF QUALITY CONTROL TESTING OF ALL RAW MATERIALS/FINISHED PRODUCTS AS PER PHARMACOPOEIAL PARAMETERS INCLUDING TESTING OF INGREDIENTS/HEAVY METALS/PESTICIDE RESIDUE/MICROBIAL LOAD ETC.
SCHEME NO. 5 ASSISTANCE TO ASU MANUFACTURING UNITS HAVING A TURNOVER OF UPTO RS.20.00 CRORES FOR ACQUIRING US FDA/EU GOOD MANUFACTURING PRACTICES CERTIFICATION FOR THEIR UNITS.

7 CPCSEA GUIDELINES FOR LABORATORY ANIMAL FACILITY CPCSEA Committee for the Purpose of Control and Supervision on Experiments onAnimals

8 CURRENT GOOD LABORATORY PRACTICES GUIDELINES FOR ISM & HOMOEOPATHIC DRUG TESTING LABORATORIES DEPARTMENT OF INDIAN SYSTEMS OF MEDICINE &HOMOEOPATHY; INISTRY OF HEALTH AND FAMILY WELFAREGOVERNMENT OF INDIA

9 ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTS INDIAN COUNCIL OF MEDICAL RESEARCH NEW DELHI

10 GOOD AGRICULTURAL PRACTICES FOR MEDICINAL PLANTS National Medicinal Plant Board; Department of AYUSHMinistry of Health and Family Welfare, ;Government of IndiaIn collaboration with World Health Organization (WHO)

11 GOOD DISTRIBUTION PRACTICES (GDP) FOR PHARMACEUTICAL PRODUCTS WORLD HEALTH ORGANIZATION

12 GOOD LABORATORY PRACTICES (GLP)

13 GUIDE TO GOOD STORAGE PRACTICES FOR PHARMACEUTICALS This guidance has been prepared in close collaboration with the International Pharmaceutical Federation (FIP).

14 GUIDELINES FOR CARE AND USE OF ANIMALS IN SCIENTIFIC RESEARCH INDIAN NATIONAL SCIENCE ACADEMYThis report was submitted by the Expert Committee Constituted by the IndianNational Science Academy, New Delhi

15 GUIDELINES ON GOOD FIELD COLLECTION PRACTICES FOR INDIAN MEDICINAL PLANTS National Medicinal Plants Board, Department of AYUSH,Ministry of Health and Family Welfare, Govt. of IndiaIn collaboration withWHO Country Office for India, New Delhi

16 GUIDELINES FOR PREPARING STANDARD OPERATING PROCEDURES (SOP) FOR INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH Indian Council of Medical Research

17 HEALTH AWARENESS/ TREATMENT CAMPS OF ISM&H IN THE NORTH-EASTERN STATES AND SIKKIM Objectives of the scheme are :(i) To instill health awareness in general public especially among women and children(ii) To educate them about the easily available ISM&H remedies for primary health care(iii) To provide medicare cum guidance in select areas of ailments for which treatment is availablein different Indian Systems of Medicine and Homoeopathy.

18 NATIONAL MEDICINAL PLANTS BOARD (Deptt. of AYUSH)Ministry of Health & Family WelfarePROMOTIONAL AND COMMERCIAL SCHEMES

19 OPERATIONAL GUIDELINES FOR THE CENTRAL SECTOR SCHEME FOR CONSERVATION, DEVELOPMENT AND SUSTAINABLE MANAGEMENT OF MEDICINAL PLANTS NATIONAL MEDICINAL PLANTS BOARD

20 PHASES OF CLINICAL TRIALS

21 QUALITY CONTROL METHODS FOR MEDICINAL PLANT MATERIALS World Health Organization Geneva

22 Schedule TGood manufacturing practices for Ayurveda and siddha and unani medicine

23 SCHEDULE Y REQUIREMENTS AND GUIDELINES FOR PERMISSION TO IMPORT AND / OR MANUFACTURE OF NEW DRUGS FOR SALE OR TO UNDERTAKE CLINICAL TRIALS In the Drugs and Cosmetics Rules, 1945 (hereinafter referred to as said rules), in Part X-A, after rule 122-DA, the following shall be inserted, namely:-,

24 SCHEME FOR ACQUISITION, CATALOGING, DIGITIZATION AND PUBLICATION OF TEXT BOOK & MANUSCRIPTS There are estimated to be around a 100,000 medical manuscripts in differentlanguages and scripts in Public and private collections in India and abroad. An extremely small fraction (less than 1%) of these manuscripts are actually published. There is no comprehensive catalogue of the medical manuscripts of India with their locations. It is only recently, that NMM has initiated work in the country for digitization of the manuscripts. Enormous work is involved in cataloging and digitization and in the translation and preparation of critical editions of prioritized manuscripts. Given NMM’s expertise in the cataloging and digitization of manuscripts, the AYUSH department has decided to implement the scheme in coordination with National Manuscripts Mission, Department of Culture, Government of India. A large body of AYUSH knowledge exists in the country in the form of classical text material, manuscripts, scientific outcomes, personal experiences, folklore, local health practices, ethno-medicine, tribal medicine etc. This information needs to be properly catalogued and digitized in user-friendly manner and make it easily accessible as well as protected. Similarly, flow of information of statistical importance from the field to the State headquarters and from States to Center needs to be streamlined and electronic networking of institutions facilitated. Objectives of the schemeEligibilityFunding Pattern Structure of proposalsStaff requirementProject appraisalApproval of projects Selection process: Submission of applications

25 SCHEME FOR DEVELOPMENT OF AYUSH CLUSTERSObjectives of the scheme:(a) To fill in the critical gaps in the sector especially related to standardization, quality assurance and control, productivity, marketing, infrastructure and capacity building through a cluster based approach (b) To encourage the level of organization in the sector thereby creating social capital for sustainability of collective initiatives

26. SCHEME FOR DEVELOPMENT OF INSTITUTIONS OF INDIAN SYSTEMS OF MEDICINE & HOMOEOPATHY Development of ISM&H Under Graduate Colleges. Assistance to Post Graduate Medical Education Re-orientation Training Programme for ISM&H personnel Renovation and Strengthening of ISM&H Teaching Hospitals Establishment of Computer Laboratory in ISM&H collegesUpgradation of academic institutes to the status of StateModel Institute of Ayurved/ Siddha/ Unani/ Homoeopathy

27. SCHEME FOR EXTRA MURAL RESEARCH (EMR) IN AYURVEDA, YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY (AYUSH) Aims and Objects:-1) To develop evidence based support on the efficacy of AYUSH drugs and therapies;2) To generate data on safety, standardization and quality control for AYUSH products and practices;3) To facilitate the validation of relevant and promising practices and skills of traditional health practitioners and to further develop their utility for public benefit;4) To retrieve and revive the rare classical literature and historical aspects of AYUSH;5) To investigate the fundamental principles of Indian Systems of Medicine;6) To generate a data base on various aspects of AYUSH practices;7) To generate data on Heavy metals, Pesticide residues, microbial load, Safety/Toxicity etc. in the raw drugs & finished ASU & H drugs;8) To utilize appropriate technologies for development of single and Ply-herbal/herbo-mineral products to make it globally acceptable;9) To develop the products those have IPR potentials to attract national/multinational pharmaceutical companies;10) Human Resource Development especially to inculcate Scientific aptitude and expertise relating to AYUSH systems.

28. SCHEME FOR GRANT-IN-AID TO NON-GOVERNMENTAL ORGANISATIONS FOR PROMOTION OF INDIAN SYSTEMS OF MEDICINE & HOMOEOPATHY ContainsObjectivesEligibility Funding patternPattern for financial assistanceHow to apply

29. SCHEME FOR GRANT-IN-AID TO NON-PROFIT/NON-GOVERNMENTALAYUSH ORGANISATIONS/INSTITUTIONS FOR REVITALIZATION OFLOCAL HEALTH TRADITIONS, MIDWIFERY PRACTICES ETC IN ORDERTO ENHANCE HEALTH SECURITY OF RURAL COMMUNITY.

30. SCHEME FOR GRANT-IN-AID TO NON-PROFIT/NON-GOVERNMENTALAYUSH ORGANISATIONS/INSTITUTIONS FOR UPGRADATION TOCENTRES OF EXCELLENCE

31. SCHEME FOR PROVIDING CENTRAL ASSISTANCE FOR DEVELOPMENT AND CULTIVATION OF MEDICINAL PLANTS USED IN INDIAN SYSTEMS OF MEDICINE & HOMOEOPATHY It contains details of scheme Headings are . Objectives and main Activities under the Scheme:Institution/Bodies Eligible for Assistance:Commencement of the Scheme and its Implementation: Quantum of Assistance:Conditions for grant-in-aid :Release of Assistance:Incurring of Expenditure:Procedure for Submission of Applications :List Of Medicinal Plants/Trees Suggested for Development And CultivationPROFORMA OF APPLICATION

32. SCHEME OF GRANT-IN-AID FOR PROMOTION OF AYUSH INTERVENTION IN PUBLIC HEALTH INITIATIVES. This scheme is meant to support coordinated programs for public healthintervention of AYUSH.

33. WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS
The WHO Expert Committee on Specifications for Pharmaceutical Preparations met in Geneva from 24 to 28 October 2005. The Contents1. Introduction 2. General Policy 2.1 Cross-cutting pharmaceuticals — quality assurance issues 2.1.1 Quality assurance 2.1.2 Policy, Access and Rational Use 2.1.3 Malaria 2.1.4 Biologicals/Vaccines2.1.5 Production of oral rehydration salts 2.1.6 Other clusters and departments 2.1.7 International collaboration 2.1.8 Follow-up report to the Expert Committee 2.2 Pharmacopoeial Discussion Group 2.3 International Conference on Harmonisation 2.4 International Conference of Drug Regulatory Authorities 2.5 Counterfeit drugs 3. Quality control — specifi cations and tests 3.1 The International Pharmacopoeia (Fourth Edition) 3.1.1 Dissolution test requirements 3.2 Pharmacopoeial monographs on antiretrovirals 3.3 Quality specifi cations for antimalarials 3.4 Quality specifi cations for antituberculosis drugs 3.5 Specifi cations for other medicines 3.5.1 Revision of published monograph on oral rehydration salts 3.5.2 Monograph on oral powders 3.5.3 Monographs for excipients 3.5.4 Specifi cations on herbal medicines 3.6 Basic and screening tests 4. Quality control — International Reference Materials 4.1 International Chemical Reference Substances 4.2 New International Chemical Reference Substances for antiretrovirals 4.3 Guidelines for secondary reference substances 5. Quality control — national laboratories 5.1 External quality assurance assessment scheme 6. Quality assurance — Good Manufacturing Practices 6.1 Heating, ventilation and air-conditioning 6.2 Manufacture of herbal medicines 6.3 Validation 7. Quality assurance — inspection 7.1 Training modules for inspectors 8. Quality assurance — distribution 8.1 Good distribution practices for pharmaceutical products 9. Quality assurance — risk analysis 9.1 New approach to inspections and manufacture 10. Quality assurance — stability 10.1 Stability testing conditions 11. Prequalifi cation 11.1 Prequalifi cation of priority medicines 11.2 Quality assurance for assessment of procurementagencies — Model Quality Assurance System 11.3 Prequalifi cation of quality control laboratories 11.4 Procedure for prequalifi cation — manufacturersof active pharmaceutical ingredients 12. Regulatory guidance on interchangeabilityfor multisource (generic) pharmaceutical products 12.1 Guidelines on registration requirementsto establish interchangeability 12.2 Revision/update of the guidance on the selection ofcomparator pharmaceutical products for equivalence assessment 12.3 List of comparator products for prequalifi cation 12.4 Proposal to waive in vivo bioequivalence requirementsfor the WHO Model List of Essential Medicines, immediate release, solid oral dosage forms 12.5 Additional guidelines for organizations performingin vivo bioequivalence studies 13. Donations of medicines 13.1 Quality of medicines donated (directly from the manufacturer) 14. Regulatory guidance on post-approval changes 14.1 Guidance on variations to a prequalifi ed dossier 15. Nomenclature and computerized systems 15.1 International Nonproprietary Names 15.2 WHO nomenclature used in quality assurance 16. Summary and recommendations 16.1 New standards and guidelines adopted and recommended for use 16.2 Activities that should be pursued and progress reportedat the next meeting of the Expert Committee 16.3 New areas of work suggested
Acknowledgements
Annex 1List of available International Chemical Reference Substancesand International Infrared Reference Spectra
Annex 2Supplementary guidelines on good manufacturing practicesfor heating, ventilation and air-conditioning systems for non-sterilepharmaceutical dosage forms
Annex 3Supplementary guidelines on good manufacturing practicesfor the manufacture of herbal medicines
Annex 4Supplementary guidelines on good manufacturing practices: validation
Annex 5Good distribution practices for pharmaceutical products
Annex 6A model quality assurance system for procurement agencies(Recommendations for quality assurance systems focusing onprequalifi cation of products and manufacturers, purchasing, storageand distribution of pharmaceutical products)
Annex 7Multisource (generic) pharmaceutical products: guidelineson registration requirements to establish interchangeability
Annex 8Proposal to waive in vivo bioequivalence requirements forWHO Model List of Essential Medicines immediate-release,solid oral dosage forms
Annex 9Additional guidance for organizations performing in vivobioequivalence studies

34. WHO guidelines on good agricultural and collection practices(GACP) for medicinal plants