PG Certificate Program in

Technology & Management for AYUSH Pharmaceutical Industry

Detailed Syllabi.

The One Year Certificate Program comprises of 5 Modules, as below:

Module -1: Product Development including Clinical Trials for AYUSH Industry
Module -2: Good Manufacturing Practices in AYUSH industry
Module -3: Testing & QA in AYUSH drug manufacture
Module -4: Production & Marketing Management for AYUSH
Module -5: Standards and Regulatory aspects of AYUSH industry

Each Module would be of 4 weeks duration, and consisting of Lectures, Labs, Practical's, Demos, Visits etc. This will be followed by a Project or Internship of 4 weeks carried out in an Industry.

Detailed Syllabus, still being discussed and refined, of each of these modules is given below:

Module -1: Product Development including Clinical Trials (4 weeks)
  1. Methods of preparation and quality assessment of Arishtas, Asavas, Gulikas, Ghrithas, Satva, Tailas, Churnas, Lepas and Lehyas; Preparation of Siddha, Ayurveda and Unani formulations; New formulation and product development and large scale production; Production and Development of Fermented product development, Types of manufacturing systems - Mass production, Batch production and its maintenance.
  2. Industrial practices and manufacture of herbal drugs and cosmetics, production of Classical and proprietary medicines - Raw materials identification and processing for formulation- Process and product development of Herbal formulations, Monoherbal and polyherbal formulations.
  3. Pharmacognosy, Pharmacology & Toxicology

    Pharmacognosy: Definition, scope and applications in herbal medicine Classification and identification of drugs: Need for classification of drugs; classical (taxonomic, morphological, organoleptic, therapeutic); microscopy and modern (biogenetic) criteria for classification of powdered drug, methods for documentation of raw drugs.

  4. Drug administration in Indian systems of medicine: The holistic concept of drug administration; description of Sapta padarthas in Dravya guna; Single plant drugs and formulations in Ayurveda, Siddha and Unani; classical and modern means of drug administration
  5. Pharmacognosy of crude drugs: based on market survey including adulterants and substitutes. Toxicity analysis of ISM drugs: Introduction and importance of toxicity and dose assessment for ISM drugs, Types of assays and their uses - AMES test and MTT toxicity assays.
  6. Pharmacology & Toxicology
    Introduction about microbiology techniques required for ISM drug evaluation, types of assays - Toxicology assays -animal model studies- principle-cell based assays -culture - maintenance- assays-- antimicrobial- analgesic-anti-inflammatory-antidiabetic-alloepecia-liver-kidney functions-male potency-skin disorders-cancer-immuno modulatory-neuro disorders arthritis. etc..,
  7. Clinical Trials & Clinical Data Management:
    1. Introduction-Clinical Research-Pre-clinical and Clinical trials for Modern Drugs-Clinical trials for AYUSH drugs- Current Guidelines for AYUSH drugs-Definitions-Prerequisites for the study-Pre-Clinical supporting data-Study types- Protocol-Ethical Considerations- Study Design-Inclusion, Exclusion & Withdrawal of Subjects-Investigator's Brochure-Essential Documents-Assessment of Safety and Efficacy-Ethics Committee-responsibilities of stakeholders involved-Interim Review-Record Keeping-Informed Consent Process-Safety Information-Adverse Drug Reaction Reporting-Pharmacovigilance.
    2. Submission of Application-Statistics-Randomization and Blinding-Data handling and management-Quality control and quality assurance-Finance and Insurance-Compensation for Participation-Contract-SOP-Supply, storage and handling of ASU drug / Patent or Proprietary Medicines-Clinical study
    3. Study Reports-Monitoring-Electronic Data Processing-Clinical Data management-Good Clinical Practice Guidelines for Clinical trials in Ayurveda, Siddha, Unani (ASU) Medicines (2013).Ethical Issues (Ethical Guidelines for Biomedical Research Human Participants, Indian Council of Medical Research 2006).

References:

Harborne JB. Phytochemical Methods. New Delhi: Springer (India) Pvt. ltd., (2005). p.17.

General guidelines for methodologies on research and evaluation of traditional medicine (document WHO/EDM/TRM/2000.1). Geneva, World Health Organization, 2000.

WHO monographs on selected medicinal plants, Vol. 1. Geneva, World Health Organization, 1999.

Chen et al., 2008, S.T. Chen, J. Dou, R. Temple, R. Agarwal, K.M. Wu New therapies from old medicines , Nature Biotechnology, 26 (2008), pp. 1077-1083

Farnsworth, N. R. (1990) The role of ethnopharmacology in drug development, in Bioactive Compounds from Plants (Chadwick, D. J. and Marsh, J., eds.), John Wiley and Sons, New York, pp. 2-21.

Drummond, A. J. and Waigh, R. D. (2000) Recent Research Developments in Phytochemistry. vol. 4 (Pandalai, S. G., ed.) Research Signpost, India, pp. 143-152. 24 Sarker et al.

Ames B., McCann J., Yamasaki E.: Methods for detecting carcinogens and mutagens with the Salmonella/mammalian-microsome mutagenicity test; Mutation Research 31: 347-364 (1975).

Maron D. and Ames B.: Revised Methods for the Salmonella mutagenicity test; Mutation Research 113: 173-215 (1983)

Viletinck, A. J. and Apers, S. (2001) Biological screening methods in the search for pharmacologically active natural products, in Bioactive Compounds from Natural Sources (Tringali, C., ed.), Taylor and Francis, New York, USA, pp. 1-30.

Sarker S. D., Eynon E., Fok K., et al. (2003) Screening the extracts of the seeds of Achillea millefolium, Angelica sylvestris and Phleum pratense for antibacterial, antioxidant activities and general toxicity. Orient. Phar. Exp. Med. 33, 157-162.

Fundamentals of Clinical Trials, by Lawrence M. Friedman

Clinical Trials Handbook: Design and Conduct,Curtis L. Meinert

Clinical Research in Complementary Therapies,Principles, Problems and Solutions Edited by:George Lewith

Module -2: Good Manufacturing Practices (4 weeks)
  1. Principle and overview of the ISM- Pharmaceutical Quality System.-official directives of GMP- requirements of GMP- principles of Quality system- implementation of quality System
  2. Key personnel -Background and duties of the qualified person.-Duties of the Head of production department -Duties of the Head of quality control -Person releasing the batch - -Personnel training and hygiene.
  3. Premises & Equipment: Production area-Storage area-Quality control areas-Ancillary areas-Equipment.
  4. Documentation: Premises-Generation and control of documentation-Types of documents and specifications-Manufacturing formula and processing instructions-Packaging instructions-Procedures Consultants and records.
  5. Production: General principles-Prevention of cross-contamination in production-Guidelines for starting materials- Processing operations-Packaging materials and operations-Guidelines for finished products. Manufacturing technology - Process of formulations - packaging parameters -GMP regulations in AYUSH health care industry- process of AYUSH product registration-
  6. Processing of plant drugs: Methods of collection, process and storage of medicinal and aromatic plants; purification of raw drugs; factors causing drug contamination, methods of storage of drugs
  7. Quality control Principles-Tasks of QC- Technical transfer of protocol- Testing methods- GMP Guidelines related to complaints - Classification of defects-Product Recalls.

References:

WHO guidelines on good manufacturing practices (GMP) for herbal medicines. Geneva, World Health Organization, 2007

WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems. Geneva, World Health Organization, 2004

Module -3: Testing & QA in AYUSH drug manufacture (4 weeks)
  1. Instrumentation techniques involved in standardizing and validating the Indian systems of Medicine-TLC: (Thin Layer chromatography)-Basic principles-application-identification of phytochemicals using TLC (preliminary phyto chemical assay), quantification and validation of ISM drugs-HPLC (High performance liquid chromatography)-Basic principles- application- sample preparation- validation, quantification and marker compound identification, data acquisition, trouble shooting, pesticide residue and aflatoxins analysis using HPLC-HPTLC: (High performance Thin layer chromatography)-Basic principles- application- sample preparation- validation, quantification and marker compound identification, data acquisition, trouble shooting-Gas chromatography (GC): Basic principles- application- sample preparation- validation, quantification and marker compound identification, data acquisition, trouble shooting-ICP-MS-Basic principles, application, quantification of heavy and toxic metals in ISM drugs-UV- Spectrophotometer.
  2. Basic principles, application of Microbial techniques in ISM- Culture, identification and quantification techniques of microbial pathogens and handling of basic microbial cultures required for identification of microbial load on herbal products will be involved in hands on training. Basic microbiological studies, Preclinical in vitro and in vivo assays for claiming the ISM drugs.

References:

Wagner, H. and Bladt, S. (1996). Plant Drug Analysis-A Thin Layer Chromatography Atlas. Springer-Verlag, Berlin.

Merck Handbook (1980) Dyeing Reagents for Thin Layer and Paper Chromatography. E. Merck, Darmstadt, Germany.

Homans, A. L. and Fuchs, A. (1970) Direct bioautography on thin-layer chromatograms as a method for detecting fungitoxic substances. J.Chromatogr.51, 327-329.

Betina, V. (1973) Bioautography in paper and thin layer chromatography and its scope in the antibiotic field. J. Chromatogr. 78, 41-51.

Marquet P, Saint-Marcoux F, Gamble TN, Leblanc JCY. Comparison of a preliminary procedure for the general unknown screening of drugs and toxic compounds using a quadrupole-linear ion-trap mass spectrometer with a liquid chromatography-mass spectrometry reference technique. J Chromatogr B Analyt Technol Biomed Life Sci. 2003;789:9-18.

Module -4: Production & Marketing Management (4 weeks)
  1. Inventory Management: Purpose of inventory - Cost related to inventory - Basic EOQ model - variations in EOQ model - Finite Production, quantity discounts - ABC Analysis - MRP.
  2. Operations Management: Plant Location - Layout - Materials Handling - Method study - Time Study - Ergonomics - Aggregate Planning - Value Analysis.
  3. Production Management: Scheduling - Sequencing - Project Network Analysis - CPM - PERT - Time crashing.
  4. Optimization Techniques: Linear Programming - Graphical Method - Simplex Method - Transportation Problems- Assignment Problems.
  5. Operations Research (OR) methods: Game Theory - Replacement Theory - Queuing Theory - Simulation
  6. Concepts in Marketing: Definition, Marketing Process, Dynamics, Needs, Wants and Demands, Marketing Concepts, Environment, Mix, Types, Philosophies, Selling Vs Marketing, Consumer Goods, Industrial Goods.
  7. Buying behavior and Market Segmentation: Cultural, Demographic factors, Motives, Types, Buying Decisions, Segmentation factors, Demographic, Psycho graphic and Geographic Segmentation, Process, Patterns, Services marketing and Industrial Marketing
  8. Product, Price and Marketing Research: Product, Classifications of product, Product Hierarchy, Product Life Cycle, New Product development, Branding.
  9. Price: Objectives, Pricing Decisions and Pricing Methods, Pricing Management, Introduction, Uses, Process of Marketing Research
  10. Marketing Planning and Strategy Formulation: Components of a Marketing Plan, Strategy Formulation and the Marketing Process, Implementation, Portfolio Analysis, BCG, GEC Grids
  11. Advertising, Sales Promotion and distribution: Advertising - Characteristicscs, Impact, Goals, Types, Sales Promotion - Point of purchase, Unique Selling Propositions, Characteristics, Wholesaling, Retailing, Channel Design, Logistics, Modern Trends in Retailing, Modern Trends, e-Marketing

Text books:

  1. R. Kesavan, C. Elanchezian and T. Sundar Selwyn - Engineering Management - Eswar Press, 2005.
  2. R. Panneerselvam - Production and Operations Management - Prentice Hall of India, 2003
  3. Govindarajan. M, “Marketing Management - concepts, cases, challenges and trends", Prentice hall of India, second edition, 2007.
  4. Philip Kolter & Keller, “Marketing Management", Prentice Hall of India, XII edition, 2006

References:

  1. Koontz and Odonnel - Essentials of Management, Mc Graw Hill 1992.
  2. K.K. Ahuja - Personnel Management, Kalyane Publication, 1992.
  3. K. Panneerselvam - Production and Operations Management - Prentice Hall of India, 2003.
  4. Martand T. Telesand - Industrial and Business Management - S. Chand & Co., 2001.
  5. Donald S.Tull and Hawkins, “Marketing Research", Prentice Hall of India - 1997.
  6. Philip Kotler and Gary Armstrong “Principles of Marketing" Prentice Hall of India, XII Edn, 2000.
  7. Ramasamy and Nama Kumari, “Marketing Management: Planning, Implementation and Control,
  8. Macmillan and Company", 2002
  9. Czinkota & Kotabe, “Marketing Management", Thomson learning, Indian edition 2007
  10. Adrain palmer, “Introduction to marketing theory and practice", Oxford University press IE 2004
Module -5: Standards and Regulatory aspects (4 weeks)
  1. Business Laws and Regulatory Affairs: Drug and Cosmetics Act- Companies Act - 1956- The consumer protection act- The Foreign Exchange Management Act, 1999- The MRTP Act, 1969 and Competition Act, 2002.Regulatory environment - Regulatory Environment - Investigational new drug application (INDA) and new drug application (NDA); New drug development process; Pharmaceutical policy-2002; Analytical and bio-analytical-development and research IPR: Intellectual property right (IPR) and Indian Pharmaceutical Sector: Various treaties governing IPR; Biodiversity and bio- technological patents; New developments in IPR and regulatory aspects .
  2. National, International guidelines for ISM drugs, Management practices (GLP, GMP) , AYUSH protocol, guidelines, OECD guidelines, GLP and GMP practices for ISM drug formulations, License for ISM drugs etc.., Career opportunities in ISM Herbal Product Management.

References:

THE DRUGS AND COSMETICS ACT, 1940 , (23 OF 1940) Indian Pharmacopoeia 7th Edition, 2014. 4 Volume

WHO guidelines for assessing quality of herbal medicines with reference to contaminants and residues. Geneva, World Health Organization, 2007.

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