Drug Regulatory Affairs Detailed Syllabus for B.Tech third year first sem is covered here. This gives the details about credits, number of hours and other details along with reference books for the course.
The detailed syllabus for Drug Regulatory Affairs B.Tech 2016-2017 (R16) third year first sem is as follows.
B.Tech. III Year I Sem. L/T/P/C
Course Code:PS505 3/1/0/3
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.
TEXT BOOKS
- Laws of drugs in India, Hussain
- New drug approval process,5th edition, by Guarino
- Commercial Manual on Drugs and Cosmetics 2004, 2nd edition
REFERENCES
- Good Manufacturing Practices for Pharmaceuticals, S.H. Wiling, Vol. 78, Marcel Decker.
- fda.org, hc-sc.gc.ca,ich.org,cder.org
For all other B.Tech 3rd Year 1st Sem syllabus go to JNTUH B.Tech B. Pharm 3rd Year 1st Sem Course Structure for (R16) Batch.
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JNTUH B. Tech 2016-2017(R16) DETAILED SYLLABUS DRUG REGULATORY AFFAIRS WITH ANSWERS DOWNLOAD