Regulations & Certifications of Herbal Drugs
Teacher
Dr G V Ramana
Category
Core Courses
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Regulations & Certifications of Herbal Drugs
Code(Credit) : CUTM1169(3-0-1)
Course Objectives
- This course emphasizes on the mandatory legal procedures which need to be implemented before manufacturing a drug.
To give the basic description of the organizations and authorities involved in the certification of organic products. To give knowledge on different certifications
Learning Outcomes
- Students will understand the role of Licensing authorities in enactment of the Good Manufacturing practices and surveillance of the clinical trials.
Students undertaking this elective course will have good knowledge of the organic certifiers and the process of obtaining relevant certificate for the validation of their products.
This course is particularly useful for students planning their career in organic farming sector as employees or self-entrepreneurs.
Course Syllabus
Theory
Module I (6 Sessions)
Licensing authorities, Licences for herbal products E.g.: Ayurveda, Proprietary medicine, consumer care etc., Drugs and cosmetic acts, Manufacturing licenses and its importance, Manufacturing practices and its importance.
Module II (10 Sessions)
FSSAI Rules and Regulations, Standards (BIS/EU/) & Clinical Trails:
FSSAI introduction, categories under FSSAI in detail, Ingredients (herbal and non-herbal) and its limits as per FSSAI, Licensing as per FSSAI, CDSCO and its role in clinical trials, Types of clinical trials, Claim substantiation and documentation. BIS , EU , Ref books, BIS web links, EU web link, EFSA Guidelines, AAFCO, National institute of Nutrition (web link)
Module III (8 Sessions)
HACCP/HALAL/Organic Certifications/Fair Trade
Organic certification- Purpose & Requirements-Global Organic regulatory bodies-National Organic Program (NOP)/USDA Organic-National Program for Organic Production (NPOP)-ECOCERT- COSMOS.
Module IV (6 sessions)
Non-GMO Project Product Verification Program-Kosher Certification-Hallal Certification-Hazard analysis and critical control points & ISO 22000. Fairtrade certification-Vegan Certification-Good Manufacturing Practice Certification (CGMP).
Suggested Reading
Drugs and cosmetic act 1945
Web : https://archive.fssai.gov.in/home/about-us/introduction.html
Objective Food Science and Safety standards ,by Prabodh Halde and sanjeev Sharma (Author)
https://cdsco.gov.in/opencms/opencms/en/Home/(web series)
Fundamentals of clinical trials
Design and Analysis of Clinical trials
A concise guide to clinical trials
A guide to Ayurvedic clinical practice by Dr.Vasant Patil, Chaukambha AyurvedicPratishtan
Objective Food Science and Safety standards ,by Prabodh Halde and sanjeev Sharma (Author)
https://cdsco.gov.in/opencms/opencms/en/Home/(web series)
Fundamentals of clinical trials
Design and Analysis of Clinical trials
A consise guide to clinical trials
A guide to Ayurvedic clinical practice by Dr.Vasant Patil, Chaukambha AyurvedicPratishtan
Essentials of Botanical Extraction-Principles and Applications: by Mandal SC et al., 2015, Elsevier Inc
Extraction technologies for medicinal and aromatic plants, International centre for science and high technology. Edited by Sukhdev Swami Handa, Suman Preet Singh Khanuja, Gennaro Longo, Dev Dutt Rakesh., 2008, ICS-UNIDO.
Session Plan
Session 1 (Theory)
Licensing authorities, Licences for herbal products
Licensing authorities, Licences for herbal products
https://www.youtube.com/results?search_query=Licensing+authorities%2C+Licences+for+herbal+products
Session 4 (Theory)
Drugs and cosmetic acts
https://www.youtube.com/results?search_query=Drugs+and+cosmetic+acts
Session 5 (Project)
Write a review report on herbal licensing authorities in India.
https://www.youtube.com/results?search_query=herbal+licensing+authorities+in+India
Session 6 (Theory)
Manufacturing licenses and its importance, Manufacturing practices and its importance
Good Practice in pharmaceutical industry 1Good Practices in Pharmaceutical Industry
Session 10-12 (Theory)
Licensing as per FSSAI, CDSCO and its role in clinical trials, Types of clinical trials, Claim substantiation and documentation.
Session 13 (Project)
Write a review report on CDSCO and its role in clinical trials, with recent case examples.
Session 14-16 (Theory)
BIS , EU , Ref books, BIS web links, EU web link, EFSA Guidelines, AAFCO, National institute of Nutrition
Session 17-18 (Theory)
HACCP/HALAL/Organic Certifications/Fair Trade
Session 19-20 (Theory)
Organic certification- Purpose & Requirements-Global Organic regulatory bodies
Session 21-22 (Theory)
Organic Program (NOP)/USDA Organic-National Program for Organic Production (NPOP)-ECOCERT- COSMOS
Session 23-24 (Project)
Prepare a regulatory compliance report for a herbal product of your choice.
Session 25-26 (Theory)
Non-GMO Project Product Verification Program
Session 27-29 (Theory)
Kosher Certification-Hallal Certification-Hazard analysis and critical control points & ISO 22000
Session 30-32 (Theory)
Fairtrade certification-Vegan Certification-Good Manufacturing Practice Certification (CGMP)
Session 33-34 (Project)
Write a detailed report on Hazard analysis and critical control points of a herbal product of your choice.
Case Studies
Case Studies
Our Main Teachers
Medicinal and Aromatic Plants, Pharmacognosy, Phytochemistry and Extraction technologies
Experienced regulatory affairs professional with 12+ years of experience in the pharmaceutical industry. Proven track record of success in managing and executing regulatory submissions to global regulatory agencies, including the US FDA, EMA, and MHRA. Expertise in all aspects of regulatory affairs, including product development, clinical trials, and post-market surveillance. Strong communication and interpersonal skills. […]