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Sobre este libro
"Indian Pharmacy Laws: Foundations and Applications" is a seminal work that provides a unified and structured approach to understanding the intricate web of laws and regulations governing the pharmaceutical industry in India. The authors have carefully crafted each chapter to provide not only theoretical knowledge but also practical applications, using case studies, real-world examples, and detailed explanations to make the guide comprehensive and useful. The book covers a wide range of topics, including laws related to the manufacture, licensing, import, export, and sale of medicines, as well as emerging trends, global harmonization efforts, and the impact of evolving technologies and regulations on the industry. By bringing together all relevant topics under one roof, this book aims to empower its readers with the knowledge needed to succeed in the dynamic and highly regulated field of pharmaceuticals in India.
Table of Contents Overview:
Contents:
1. Pharmacy Council of India (PCI)
2. The Drugs, Cosmetics and Medical Devices Act
3. Central Drugs Standard Control Organization (CDSCO)
4. State Drug Regulatory Authorities
5. Indian Pharmacopoeia Commission (IPC)
6. Patents Act
7. E-Pharmacy
8. Regulatory Affairs
9. Health Insurance
10. Consumer Protection Laws
11. Imports and Exports
12. Food Safety and Standards Authority of India (FSSAI)
13. Goods and Services Tax (GST)
14. The Manufacture and Licensing of Medicinal Products
15. Pharmaceuticals Export Promotion Council of India (PHARMEXCIL)
About the Authors / Biographies:
About the Authors:
Muralidhar Rao Akkaladevi is the National Head for APP Pharmaceutical Technology and Development Division, Principal of St. Mary's College of Pharmacy and ex-President of Association of Pharmacy Professionals (APP) for Telangana State. With over 27 years of teaching experience, he has made significant contributions to pharmacy education and research. He holds a B.Pharm, M.Pharm, and Ph.D. from the prestigious Kakatiya University and secured an impressive All India Rank of 126 in GATE 1995. He has authored 15 books on various pharmacy topics and published numerous research papers. He is a Fellow of the Association of Pharmacy Professionals (APP) and the Indian Science Congress Association (ISCA). He is also a life member of several esteemed organizations, including the Association of Pharmaceutical Teachers of India (APTI), the Indian Pharmacy Graduates’ Association (IPGA), and the Indian Pharmacological Society (IPS). He is an eminent speaker who has shared his expertise at numerous national and international conferences, inspiring both professionals and students with his knowledge and experience. He is also a key resource person for Faculty Development Programs (FDPs) conducted nationwide. Prabhakar Reddy Veerareddy is an accomplished researcher, eminent teacher in Pharmaceutical Sciences. Currently he is serving as Head/Principal at University College of Pharmaceutical Sciences, Palamuru University, Mahabubnagar, Telangana State, India since November 2013. He did his B.Pharm from University College of Pharmaceutical Sciences (UCPS), Kakatiya University, Warangal; M.Pharm from University College of Pharmaceutical Sciences (UCPS), Andhra University, Visakhapatnam; Ph.D from University College of Pharmaceutical Sciences (UCPS), Kakatiya University, Warangal and Post-Doctoral Fellowship (PDF) from Butler University, Indianapolis, Indiana, United States of America (USA). In addition, he has also received his LLB from Kakatiya University, Warangal.
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