Regulations & Certifications of Herbal Drugs

Teacher

Bhisma Narayan Ratha

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.
  • This course gives basic description of the organizations and authorities involved in the certification of organic products.
  • This course gives basic description of the authorities involved in the certification of organic products.
  • This course gives basic knowledge on different certifications.
  • This course provides knowledge on current good manufacturing practices related to herbal medicines.

Programming Outcomes

  • Students will understand the role of Licensing authorities in enactment of the Good Manufacturing practices. 
  • Students will understand the role of Licensing authorities in enactment of the surveillance of the clinical trials.
  • Students undertaking this elective course will have good knowledge of the organic certifiers.
  • Students undertaking this elective course will have good knowledge of the the process of obtaining relevant certificate for the validation of their products.
  • Students undertaking this elective course will find it particularly useful to plan their career in organic farming sector as employees or self-entrepreneurs.

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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

https://www.youtube.com/shorts/GydhpZlevbc

Session 2-3 (Theory)

Ayurveda, Proprietary medicine, consumer care

https://www.youtube.com/watch?v=2zqKZ6NuD7c

Session 4 (Theory)

Drugs and cosmetic acts

 

https://www.youtube.com/watch?v=hUsLu-i8buo

Session 5 (Project)

Write a review report on herbal licensing authorities in India.

Session 6 (Theory)

Manufacturing licenses and its importance, Manufacturing practices and its importance

https://www.youtube.com/watch?v=Ey4MqC7Kp7g

Session 7-9 (Theory)

FSSAI introduction, categories under FSSAI in detail, Ingredients (herbal and non-herbal) and its limits as per FSSAI.

 

https://www.youtube.com/watch?v=D6W-GvgG6Z4

Session 10-12 (Theory)

Licensing as per FSSAI, CDSCO and its role in clinical trials, Types of clinical trials, Claim substantiation and documentation.

https://www.youtube.com/watch?v=rZYQlx7yOb0

https://www.youtube.com/watch?v=Hv5Wq0JyWJI

https://www.youtube.com/watch?v=9RLTjbuXAS4

 

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

https://www.youtube.com/watch?v=lD4AlpkfdlE

https://www.youtube.com/watch?v=xFXpEgLEwoE

https://www.youtube.com/watch?v=jPkdYxwezGA

https://www.youtube.com/watch?v=uhz0xXd5hms

Session 19-20 (Theory)

Organic certification- Purpose & Requirements-Global Organic regulatory bodies

https://www.youtube.com/watch?v=uw4fQoX9wK0

https://www.youtube.com/watch?v=39j1mKKHAJU

Session 21-22 (Theory)

Organic Program (NOP)/USDA Organic-National Program for Organic Production (NPOP)-ECOCERT- COSMOS

https://www.youtube.com/watch?v=xgJOpXN9Fus

https://www.youtube.com/watch?v=lbnOE7qLeXc

https://www.youtube.com/watch?v=R_hQpsYkWSA&t=39s

https://www.youtube.com/watch?v=GCddRwkIhR0

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

https://www.youtube.com/watch?v=goNAxxo6hAQ

Session 30-32 (Theory)

Fairtrade certification-Vegan Certification-Good Manufacturing Practice Certification (CGMP)

https://www.youtube.com/shorts/Efp4f2khzpQ

https://www.youtube.com/watch?v=o4vTXb7RSBM

https://www.youtube.com/watch?v=mFwA2KTiPwI

Session 33-34 (Project)

Write a detailed report on Hazard analysis and critical control points of a herbal product of your choice.

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