PM5021: Regulatory Issues in Pharmaceutical Industry Syllabus for Pharma Tech 5th Sem 2019 Regulation Anna University (Professional Elective-I)

Regulatory Issues in Pharmaceutical Industry detailed syllabus for Pharmaceutical Technology (Pharma Tech) for 2019 regulation curriculum has been taken from the Anna Universities official website and presented for the Pharma Tech students. For course code, course name, number of credits for a course and other scheme related information, do visit full semester subjects post given below.

For Pharmaceutical Technology 5th Sem scheme and its subjects, do visit Pharma Tech 5th Sem 2019 regulation scheme. For Professional Elective-I scheme and its subjects refer to Pharma Tech Professional Elective-I syllabus scheme. The detailed syllabus of regulatory issues in pharmaceutical industry is as follows.

Course Objective:

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Unit I

Indian Drug Regulatory Aspects
Drug regulatory bodies in India,Drugs and Cosmetics Act 1940 and its rules 1945,Drug regulatory bodies in India -CDSCO, MHFW, IPC, ICMR, NPPA,TheThe Drugs (Prices Controls) Order, 1955. The Indian Patents and Designs, Act 1970, Magic Remedies and Objectionable advertisements Act,Prevention of Food Adulteration Act 1954 ],Intellectual property rights,Patent act- Patent, TradeMark Regn, TRIPS.

Unit II

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Unit III

Cgmps& Drug Dossiers
Good manufacturing practices for active pharmaceutical ingredients (bulk drug substances), pharmaceutical excipients, pharmaceutical products, sterile pharmaceutical products, biological products, manufacture of herbal medicines and radiopharmaceutical products .documentation, good laboratory practices (GLPs), good clinical practices (GCPs) Drug dossier contents – CTD (CMC section) and data

Unit IV

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Unit V

Regulatory and Ethical Issues in Health and Disease
Animal experimentation: concerns of welfare, Justification of use of animals in research; use of alternatives; Human experimentation-Nuremberg code and Helsinki declaration; Assisted Reproductive Technologies, Pre-implantation genetic diagnosis, Surrogacy, Use of Embryos; Therapeutic and Reproductive Cloning-Ethical, Legal and Social Issues; genetic testing and Genetic Screening, Types of Testing, Clinical Utility and Validity of Tests, Testing processes, Social stigma, discrimination, misuse of data; HGP and ELSI, case study; Somatic and Germline gene therapy; Organ transplantation and Xenotransplantation;Biosafety and biodiversity: Classification of microorganisms based on safety, Biosafety levels, Risk groups, Risk Assessment and Management, Spill Protocols, Biosafety Containment guidelines; Biodiversity – Need and Methods for Protection; Convention for preservation of biodiversity and farmer”s rights; patenting of biodiversity: ethical issues

Course Outcome:

For the complete syllabus, results, class timetable, and many other features kindly download the iStudy App
It is a lightweight, easy to use, no images, and no pdfs platform to make students’s lives easier.
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Text Books:

1. C.V.Subbrahmanyam and J.Thimmasetty, “Pharmaceutical regulatory affairs”, 1stEdn., vallabh Prakashan, New Delhi, 2012.
2. Willig, H., Tuckeman, M.M. and Hitchings, W.S., “Good Manufacturing Practices for Pharmaceuticals”, 5th Edition, Marcel Dekker Drugs and the Pharmaceutical Sciences, by CRC Press, New York, 2000.
3. N Udupa, Krishnamurthy Bhat, “A Concise Textbook of Drug Regulatory Affairs”, Manipal University Press (MUP); First Edition, 2015.
4. Malik, Vijay “Drugs and Cosmetics Act – 1940”, 11th Edition, Eastern Book Co., 1998.
5. “Quality Assurance of Pharmaceuticals : A Compendium of Guidelines and Related Materials”, Vol.I and Vol.II. Good Manufacturing Practices and Inspection”, WHO / Pharma Book Syndicate, 2002.

References:

1. Ira R. Berry, The Pharmaceutical Regulatory Process, marcel dekker Series: Drugs and the Pharmaceutical Sciences, by CRC Press, Newyork, 2004.
2. Mindy J. Allport-Settle, Current Good Manufacturing Practices: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference, Pharmalogika Inc., USA, 2009.
3. Sharma, P.P., “How to Practice GMPs”, 3rd Edition, Vandana Publications, 2006.
4. Abraham, John and Smith, Helen Lawton, “Regulation of the Pharmaceutical Industry”, Palgrave / Macmillan, 2003.
5. Weinberg, Sandy “Good Laboratory Practice Regulations”, 3rd Rev. Edition, Marcel Dekker Inc., 2003.
6. Gad. Shayne C. “Drug Safety Evaluation”, John Wiley Intersciences, 2002.
7. Thomas, J.A. and Fuchs, R.L. “Biotechnology and Safety Assessment”, 3rd Edition, Academic Press, 2002

For detailed syllabus of all the other subjects of Pharmaceutical Technology 5th Sem, visit Pharma Tech 5th Sem subject syllabuses for 2019 regulation.

For all Pharmaceutical Technology results, visit Anna University Pharma Tech all semester results direct link.