JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objectives

To understand the Industrial and commercial potential of drugs of natural origin,

integrate traditional Indian systems of medicine with modern medicine and also to know regulatory and quality policy for the trade of herbals and drugs of natural origin.

Course Outcome

By the end of the course the student shall be able to know: The requirements for

setting up the herbal/natural drug industry. The guidelines for quality of herbal/natural medicines and regulatory issues. The patenting/IPR of herbals/natural drugs and trade of raw and finished materials.

UNIT - I

Herbal drug industry:

• a) Study of infrastructure, staff requirements, project profile, plant and equipment applicable to herbal drug industry. Plant design, layout and construction. Pilot plant scale –up techniques.
• b) GMP and GLP

UNIT - II

Regulatory requirements for setting herbal drug industry: Global marketing management. Regulatory requirements Export - Import (EXIM) policy. TRIPS Quality assurance in herbal/ natural drug products. Concepts of TQM, ISO-9000. Recent guidelines of DCGI on herbal formulations.

UNIT - III

• a) A brief account of companies making herbal drug formulations: List of formulations containing single herbal powder/extract, poly herbal powder/ extracts and their composition and uses.
• b) Monographs of herbal drugs: General parameters of monographs of herbal drugs in Ayurvedic Pharmacopoeia, Herbal Pharmacopoeia and American Pharmacopoeia.

UNIT - IV

• a) Testing of natural products and drugs: Herbal medicines - clinical laboratory testing.
• b) Stability testing of natural products: Indicative substances for quality assurance, GMP and HACCP in traditional system of medicine, methods of stabilization validation of analytical procedures.

UNIT - V

Patents: Patenting of herbal drugs: Benefits of patent protection, Patent application, drafting and filing an application. Indian and international patent laws, proposed amendments as applicable to herbal/natural products and process. Geographical indication, Copyright, Patentable subject maters, novelty, non-obviousness, utility, patent processing and grant of patents.

TEXT BOOKS:

• 1. Herbal drug industry by R.D. Choudhary (1996), Eastern Publisher, New Delhi.
• 2. Text book of Pharmacognosy and Phytochemistry by Vinod D. RangarI (2002), Part I & II, Career Publication, Nasik, India.
• 3. Quality control of herbal drugs by P.K. Mukherjee
• 4. Herbal Drug Technology by SS Agarwal and paridhavi
• 5. Pharmacognosy and Phytochemistry, A Comprehensive Approach 2nd Edition by S.L. Doore, S.S Khadabadi and B.A. Baviskar

REFERENCE BOOKS:

• 1. GMP for Botanicals - Regulatory and Quality issues on Phytomedicine by Pulok K Mukharjee
• (2003) 1st Edition, Business horizons Robert Verpoorte, New Delhi.
• 2. Quality control of herbal drugs by Pulok K Mukarjee (2002), Business Horizons Pharmaceutical Publisher, New Delhi.
• 3. PDR for Herbal Medicines (2000), Medicinal Economic Company, New Jersey.
• 4. Herbal Drugs Quality and Chemistry by D. D. Joshi M.Pharm I Year I Sem (PHARMACOGNOSY)