Herbal Product Technology and Regulatory Science

By Dr. Swati Sanjay Patil, Dr. Galvina Pereira, Dr. Mandar Bhalchandra Mulik | Prin. K. M. Kundnani College of Pharmacy, Mumbai, Institute of Chemical Technology, Mumbai

Learners enrolled: 4266 | Exam registration: 1429

ABOUT THE COURSE:

This subject gives the student the knowledge of basic understanding of herbal drug industry, the properties of raw materials, guidelines for quality of herbal drugs, and excipients. The course also gives us knowledge about the application of herbs in traditional formulation as well as in cosmetics and nutraceuticals. It shed light on possible interactions of drugs with other medications. Students will gain knowledge about Intellectual property rights regarding natural products. The subject also emphasizes on Good Manufacturing Practices (GMP) and regulatory issues of herbal drugs inclusive of the Bioprospecting.

INTENDED AUDIENCE: Bachelors of Pharmacy, Technology and Health Science Courses

PREREQUISITES: Should have Completed Higher Secondary Certificate Examination from Science stream with Physics, Chemistry and Biology as core subject or Should have Completed Diploma in Pharmacy

INDUSTRY SUPPORT: Dr. Palep's Medical Research Foundation, Sandu Pharmaceuticals Ltd., CIRA Herbals LLP, Encube Ethicals Pvt Ltd.

Summary

Course Status :	Ongoing
Course Type :	Elective
Language for course content :	English
Duration :	12 weeks
Category :	Chemical Engineering
Credit Points :	3
Level :	Undergraduate
Start Date :	19 Jan 2026
End Date :	10 Apr 2026
Enrollment Ends :	02 Feb 2026
Exam Registration Ends :	20 Feb 2026
Exam Date :	25 Apr 2026 IST
NCrF Level	4.5 — 8.0

Note: This exam date is subject to change based on seat availability. You can check final exam date on your hall ticket.

Page Visits

Course layout

Dr. Swati Patil

Week 1:

Herbs as raw materials: Herbal drug preparation, Source of Herbs Selection
Identification and authentication of herbal materials.
Processing of herbal raw material
Adulteration of Herbal raw material
Ethnobotanical Foundations and GMP in Herbal Therapeutics

Week 2:

Indian Systems of Medicine: Basic principles involved in Ayurveda, Siddha, Unani and Homeopathy
Preparation of Ayurvedic formulations viz Aristas and Asavas,
Preparation of Gjutika and Bhasma
Standardisation of Asavas, Arishtas, Ghutika & Bhasma
Extraction & Phytochemical Screening of active constituents from herbs

Week 3:

Neutraceuticals: General aspects, Market, growth, scope
Nutraceutical products for Diabetes, cardiovascular diseases & Cancer
Nutraceuticals for Skin & hair
Nutraceuticals for oral hygiene
Mechanisms of Action and Bioavailability of Nutraceuticals in Disease Prevention and Wellness

Week 4:

Herbal Cosmetics and Excipients
Sources and classification of raw materials of herbal origin
Raw material such as fixed oils, waxes
Raw material as Gums & Colours
Raw materials as sweeteners, flavours & perfumes

Dr. Galvina Pereira

Week 5: Herb-Drug/Food/Herb Interactions:

General introduction to interaction and classification.
General introduction to interaction and role of ADME, Cytochrome p450 and P-gp in herb-Drug/Food/Herb interactions.
Study of following drugs and their possible side effects and interactions: Hypercium, Ginko biloba, Ginseng and Black Pepper, Licorice, Green tea with iron rich foods.
.Adverse reactions related to plants and foods such as allergy, intolerance, toxicity etc.

Week 6: Herbal formulations:

Herbal formulations: Conventional herbal formulations like syrups, mixtures, powders, capsules, tablets, creams and ointments
Novel dosage forms like phytosomes, liposomes, nano formulations, their composition,
preparation and characterization using standardized extracts and bio actives.

Week 7: Standardization of Herbs and Herbal Formulations

Standardization of Herbal drugs using Spectroscopic methods, such as UV-Vis, and chromatographic techniques such as HPTLC and HPLC analysis methods
TLC fingerprints of the following: Aqueous and hydro-alcoholic extracts of Ashwagandha, Licorice,and Haritaki, Alkaloid-rich fraction of Adulsa

Week 8: Quality Control Methods

WHO, AYUSH, and ICH guidelines on quality control, stability, and shelf-life studies of herbal medicines.
Role of Molecular Markers such as DNA
Fingerprinting rbcL, matK and SCAR marker in quality control of botanicals and formulations.
Herbal Pharmacopeias, Monographs and Books on Quality standards

Dr. Mandar Mulik

Week 9: Patenting aspects of Traditional Knowledge: Definition of the terms: Patent, IPR & Bioprospecting.

Week 10: Regulatory Issues - Regulations in India (ASU DTAB, ASU DCC), Regulation in US (DSHEA) and Regulation in Europe (EMA)

Week 11: General Introduction to Herbal Industry: A brief account of plant-based industries and institutions involved in work on medicinal and aromatic plants in India.

Week 12: Schedule T–Good Manufacturing Practice of Indian systems of medicine: Components of GMP (Schedule – T) and its objectives, Infrastructural requirements, machinery and equipment, documentation and records.

Books and references

1. Textbook of Pharmacognosy by Trease & Evans.

2. Textbook of Pharmacognosy by Tyler, Brady & Robber.

3. Pharmacognosy by Kokate, Purohit and Gokhale

4. Essential of Pharmacognosy by Dr.S.H.Ansari

5. Pharmacognosy & Phytochemistry by V.D.Rangari

6. Pharmacopoeal standards for Ayurvedic Formulation (Council of Research in Indian Medicine & Homeopathy)

7. Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to Evaluation of Botanicals. Business Horizons Publishers, New Delhi, India, 2002.

Instructor bio

Dr. Swati Sanjay Patil

Prin. K. M. Kundnani College of Pharmacy, Mumbai

Dr. Swati Patil is a distinguished researcher in Pharmacognosy and Herbal Drug Technology, specializing in the development of nutraceuticals, phytopharmaceuticals, and herbal cosmetics. Her work emphasizes the standardization of polyherbal formulations in accordance with WHO guidelines, blending traditional medicinal knowledge with modern scientific practices to ensure safety and efficacy. She has successfully led multiple industrial projects and overseen the technology transfer of herbal products, contributing to their commercial viability.

Her research also explores nanotechnology-based delivery systems to enhance the bioavailability of therapeutic phytoconstituents for diseases such as cancer, cardiovascular conditions, and PCOS. With numerous publications and presentations to her credit, Dr. Patil advocates for evidence-based validation of herbal medicines and sustainable innovations in integrative healthcare. She has mentored several Master’s and Ph.D. scholars, fostering academic excellence and interdisciplinary research.

Dr. Galvina Pereira

Institute of Chemical Technology, Mumbai

Dr. Galvina Pereira is currently an Assistant Professor at the Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, Mumbai. She has over 12 years of teaching experience in Pharmacognosy and Phytochemistry. Her areas of expertise include natural products, extraction, isolation technology development, preparation of semisynthetic derivatives, standardization of herbal formulations, analytical method development, forced degradation studies, and nutraceutical and cosmeceutical product development. She has contributed to the field through publications, presentations, podcast etc. She has Government and industry-sponsored projects in the domain of the extraction of phytochemicals from plant sources and developing cosmeceuticals.

Dr. Mandar Bhalchandra Mulik

Dr. Mandar Mulik: My research deals with an amalgamation of traditional complementary medicine and natural product-based drug discovery. It involves cost-effective generation of isolation technologies, development of herbal formulations using traditional approach along with a mechanistic understanding obtained by pharmacological evaluation, to evaluate (bioactivity) & standardize (with respect to phytoconstituents/marker compounds) Ethnobotanical& herbal formulations. Optimization of extraction parameters using RSM & QBD methodologies for process simplification of novel methods of extraction.

Course certificate

The course is free to enroll and learn from. But if you want a certificate, you have to register and write the proctored exam conducted by us in person at any of the designated exam centres.

The exam is optional for a fee of Rs 1000/- (Rupees one thousand only).

Date and Time of Exams: April 25, 2026 Morning session 9am to 12 noon; Afternoon Session 2pm to 5pm.

Registration url: Announcements will be made when the registration form is open for registrations.

The online registration form has to be filled and the certification exam fee needs to be paid. More details will be made available when the exam registration form is published. If there are any changes, it will be mentioned then.

Please check the form for more details on the cities where the exams will be held, the conditions you agree to when you fill the form etc.

CRITERIA TO GET A CERTIFICATE

Average assignment score = 25% of average of best 8 assignments out of the total 12 assignments given in the course.
Exam score = 75% of the proctored certification exam score out of 100

Final score = Average assignment score + Exam score

Please note that assignments encompass all types (including quizzes, programming tasks, and essay submissions) available in the specific week.

YOU WILL BE ELIGIBLE FOR A CERTIFICATE ONLY IF AVERAGE ASSIGNMENT SCORE >=10/25 AND EXAM SCORE >= 30/75. If one of the 2 criteria is not met, you will not get the certificate even if the Final score >= 40/100.

Certificate will have your name, photograph and the score in the final exam with the breakup.It will have the logos of NPTEL and IIT Bombay. It will be e-verifiable at nptel.ac.in/noc.

Only the e-certificate will be made available. Hard copies will not be dispatched.

Once again, thanks for your interest in our online courses and certification. Happy learning.

- NPTEL team