Intellectual Property Rights
Abstract
A novel drug's development necessitates extensive study in chemistry, production, controls, preclinical science, and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate drug development process, licensing, registration, manufacturing, marketing and labelling of pharmaceutical products. This article examines the drug clearance procedure in various nations, including the United States and India. A drug product must be examined for safety and efficacy in people before it can be licensed for import or production of a new medicine. A company's regulatory affairs department is critical in adhering to the laws, regulations, and standards established by many countries' regulatory agencies. The purpose of this article is to compare the drug approval processes in the United States, India, and all data on drug patents granted in the previous years and the current year.
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References
2. The Geographical Indications of Goods (registration and protection) Act, 1999 along with Geographical Indications of Goods (registration and protection) Rules 2002. India. New Delhi: Universal Law Publishing Co. Ltd; 2004.
3. The Patents Act, 1970 as amended by Patents (amendment) Act 2005. New Delhi: Commercial Law Publisher (India) Private Ltd; 2005.
4. Federal Trade Commission. Generic drug entry prior to patent expiration [Internet]. US:FTC; 2002 [cited 2008 Jun 14] Available from: http://www.ft c.gov
5. Eaton, Jonathan, Kortum S. Trade in ideas: Patenting and productivity in the OECD’, NBER Working Paper No. 5049, NBER: Boston and Washington, D.C; 1995.
6. Singh R. Law relating to intellectual property (A complete comprehensive material on intellectual property covering acts, rules, conventions, treaties, agreements, case-Law and much more). Edition 2, Vol. 1. New Delhi: Universal Law Publishing Co. Pvt. Ltd.; 2004
7. History of Patent System, India: Intellectual Property India, Ministry of Commerce and Industry; c2004-2008 [Internet]. India: ipindia; 2024 Mar 07 [cited 2008 Apr 02]. Available from: https://ipindia.gov.in/Patents/history_of_indian_patent_system
8. Lexchin J. Intellectual property rights and the Canadian pharmaceutical marketplace: Where do we go from here? Int J Health Serve.2005; 35:237-56.
9. Shivashankar M, Mani D, Mandal BK. An overview on intellectual property rights in pharmaceutical and biotechnology industries. J Chem Pharm Res. 2011; 3(2):753-61
10. Musungu SF, Villanueva S, Blasetti R. Utilizing TRIPS flexibilities for public health protection through South-South regional frameworks. Geneva: South Centre; 2004 Apr.
11. Edenshaw A. Asian perspectives on post-TRIPS issues in intellectual property. J World Intellect Prop. 2005; 8:211–2.
12. The Patents Act, 1970 as amended by Patents (amendment) Act 2005. New Delhi: Commercial Law Publisher (India) Private Ltd; 2005.
13. Central Drugs Standard Control Organization. List of Approved New Drugs [Internet]. India: CDSCO; 2025 [cited 2008 Apr 02]. Available from:
https://cdsco.gov.in/opencms/opencms/en/Approval_new/Approved-New-Drugs/
14. Correa C. Review of the TRIPS Agreement: Fostering the Transfer of Technology to Developing Countries, Third World Network 1999 [Internet]. twnside [cited 2008 Apr 02]. Available from: www.twnside.org.sg/title/foster.htm
15. IPO Intellectual property handbook. WIPO Publication no. 489 (E) ISBN 978-92-805-1291-5. Second Edition Reprinted. Geneva, Switzerland: World Intellectual Property Organization; 2004.
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