Abstract
Indian pharmaceutical sector is rising very rapidly and there is a want of regulatory affairs professionals to provide the current needs of industries for the global competition. A regulatory affair is a somewhat new profession which has developed from the desire of governments to defend public health. The areas where government controlling the safety and efficacy of products are pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines. The pharmaceutical companies responsible for the discovery, testing, clinical trials, production, manufacture and marketing of these products also want to ensure that they supply products that are safe and make a worthwhile contribution to public health and welfare. Regulatory affairs professionals are the link between pharmaceutical industries and worldwide regulatory agencies. They are required to be well versed in the laws, regulations, guidelines and guidance of the regulatory agencies. There is a growing need to incorporate the current requirements of pharmaceutical industries in the standard curriculum of pharmacy colleges to prepare the students with the latest developments to serve the industries. The present article discusses the regulatory education and its need, learning resources, courses available, syllabus contents, and job opportunities in regulatory affairs.
References
Regulatory Affairs from Wikipedia, the free encyclopedia modified[online]7th April. Available from http://en.wikipedia.org/wiki/Regulatory_Affairs.
International regulatory affair updates [online] 2005. Available from http://www.iraup.com/about.php
“Douglas J Pisano and David S. Mantus” ‘Text book of FDA Regulatory Affairs A Guide for Prescription Drugs, Medical Devices, and Biologics’.2nd edition , August 2008
Topra brought by dimension associates [online] Available fromhttp://www.topra.org/careers/what-regulatory-affairs.
“Douglas J. Pisano and David S. Mantus” ‘Text book of FDA Regulatory Affairs A Guide for Prescription Drugs, Medical Devices, and Biologics’ Second Edition, August 2008
Science career brought by American association [online] 2011. Available at http://sciencecareers.sciencemag.org/ career_magazine/previous_issues/articles/1999_12_24/no DOI.12079275980051408699.
Topra brought by dimension associates [online] available from http://www.topra.org/careers/what-regulatory- affairs.
Training Needs in Regulatory Science for the Biopharmaceutical Industry,” Naturejobs Biotechnology, 2001;19(12):1187-1188
“Careers in Regulatory Affairs from Practitioner to professional,” Naturejobs Biotechnology, 2002;20(4): 409- 41:
Regulatory Affairs Management [online]. Avalible from: http://medind.nic.in/haa/t06/i1/haat07i1p51.
Recent Advancements [online]. Available from http://en.wikipedia.org/wiki/Regulatory_Affairs
Measurement of Quality [online]. Available from: http://www.pharmainfo.net/reviews/total-quality- management-pharmacy-education-potentials
Careers in regulatory affairs from practitioner to professional, nature jobs biotechnology, 2001;20(4): 409- 410
Available online: www.centrewatch.com
Training needs in regulatory sciences for the biopharmaceutical industry. 2001;19(12),1187-1189
Cutting, Thomas. "How to Survive an Audit". PM Hut. http://www.pmhut.com/how-to-survive-an-audit. 2008;2(4)13-21
Available online: http://en.wikipedia.org/wiki/Audit"
Available online: http://ezinearticles.com/?10-Steps-to- Maximize-Your-Energy-Audit&id=3633861
The Fourth Quadrant: A Map Of The Limits Of Statistics Nassim Nicholas Taleb An Edge Original Essay[online]. Available from http://www.fda.gov/RegulatoryInformation/ Guidances/ucm125067.htm#toc US FDA Compliance Program Guidance Manual
http://www.fda.gov/downloads/ICECI/ComplianceManuals /RegulatoryProceduresManual/UCM
Gehl Sampath, Padmashree. ‘India’s Pharmaceutical Sector in Emerging Strategies and Global and Local Implications for Access to Medicines’.2008
OPPI. 2008. Indian Pharmaceutical Industry: Vision 2015.
Singh, Seema. 2007. ‘Indian Pharma enters the global arena’. Cell. 128 March 9. Elsevier.
Das, Anjan & Kumar, Subodh. ‘Innovation, IPR and Public Good’. Express Pharma Pulse. 2008;3(7)16-31
FICCI. 2005. White Paper on ‘Clinical Trials in India’.
Srivastava DA. Country level report on the pharmaceutical sector in India’. Report commissioned by DFID, UK
Central Drugs Standards Control Organization. (Website: www.cdsco.nic.in).
http://www.medindia.net/indian_health_act/drugs-and- cosmetics-act-1940-introduction.htm
www.vakilno1.com/bareacts/drugsandcosmeticsact/drugsan dcosmeticsact.htm
http://www.dancewithshadows.com/pillscribe/cgmp- regulations-in-india-to-be-diluted/
http://www.prescriptiondrug-info.com/topics/drug-and- cosmetic-act/
N.K.Jain ,pharmaceutical product development” edition 3rd ,C.B.S publishers
P.P.Sharma “how to practice GMPs” 5th edition ,Vandana publication Pvt. Ltd Delhi
WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty- seventh Report. Geneva, World Health Organization, 2003 (WHO Technical Report Series, No. 908).
Guide to good storage practices for pharmaceuticals. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty- seventh Report. Geneva, World
Health Organization, 2003 (WHO Technical Report Series, No. 908, Annex 9).
WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-eighth Report. Geneva, World Health Organization, 2004 (Technical Report Series, No. 917).
Good trade and distribution practices for pharmaceutical starting materials. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty- eighth Report. Geneva, World Health Organization, 2004 (WHO Technical Report Series, No. 917, Annex 2).
Quality Assurance of Pharmaceuticals. A compendium of guidelines and related materials, Volume 1. Geneva, World Health Organization, 1997.
Quality Assurance of Pharmaceuticals. A compendium of guidelines and related materials. Good manufacturing practices and inspection, Volume 2 (updated version). Geneva, World Health Organization, 2004.
Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generic) Products – A Manual for a Drug Regulatory Authority. Geneva, World Health Organization, 1999 (Regulatory Support Series, No. 5, WHO/DMP/RGS/98.5).
A Model Quality Assurance System for Prequalification, Procurement, Storage and Distribution of Pharmaceutical Products. Geneva, World Health Organization, 2003 (unpublished draft).
Managing Drug Supply. The selection, procurement, distribution, and use of pharmaceuticals. Management Sciences for Health in collaboration with World Health Organization. 2nd Ed. Connecticut, USA. Kumarian Press, Inc., 1997.
Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C63/03). European Agency for Evaluation of Medicinal Products. Directive 92/25/EEC of 31 March 1992.
Australian Code of Good Wholesaling Practice for Therapeutic Goods for Human Use. Therapeutic Goods Administration, Australia. November 1991.
Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of drugs and Current Good Manufacturing Practice for Finished Pharmaceuticals. Code of Federal Regulations Parts 210 and 211. Food and Drug Administration, USA.
Principles and Guidelines of Good Manufacturing Practice for Medicinal Products for Human Use. Commission Directive 2003 794/356/EEC, 13 June 1991. European Agency for Evaluation of Medicinal Products.
Guidance Document: Good Manufacturing Practice for Medicine in South Africa. Medicines Control Council, South Africa, 2003.
Guide to Good Manufacturing Practices for Medicinal Products. Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme, July 2004.
Guide to Good Manufacturing Practices for Medicinal Products. Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme, July 2004.
Loan G. M., Wafai Z A., Qadrie Z L., Zargar S A., A review on “Therapeutic drug monitoring in psychiatry: an important step in clinical practice”, Int. J. Res. Dev. Pharm. L. Sci., 2012, 1(4), pp. 176-182.
How to cite this article:
Kumar S., Panwar R., Singh U., A review on “Regulatory affairs in the pharmacy curriculum ”, Int. J. Res. Dev. Pharm. L. Sci., 2013, 2(6), pp. 690-698.
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