JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objectives - Various procedures for approval of API and formulations for manufacture, sale,

export and import of drugs.

Course Outcome

The clear information about the regulations in India and abroad is gained by the

students.

UNIT - I

Introduction to Drug regulatory affairs, organisation structure of India, in central and state Division of drug controller of India and their function

UNIT - II

Procedure for obtaining manufacturing for basic drug and formulation, sale of drugs, import &export of drugs and their permission procedures.

UNIT - III

Application for procedures for approval for formulations and Active Pharmaceutical Ingredient.

UNIT - IV

USFDA & Europe, Japan guidelines for obtaining approval for API and formulations

UNIT - V

Salient features and principles of Quality by Design (QBD), ICH and WHO, obtaining for API and formulations approval

TEXT BOOKS

• 1. Laws of drugs in India, Hussain th
• 2. New drug approval process,5 edition, by Guarino nd
• 3. Commercial Manual on Drugs and Cosmetics 2004, 2 edition

REFERENCES

• 1. Good Manufacturing Practices for Pharmaceuticals, S.H. Wiling, Vol. 78, Marcel Decker.
• 2. fda.org, hc-sc.gc.ca,ich.org,cder.org