Pharmacy Law & Ethics

About this book

Pharmacy Law & Ethics is a broad, detail-heavy paper, and this textbook organises all of it clearly for the D.Pharma Second Year student. Written strictly as per the PCI Education Regulation 2020 (ER20-26T), it follows the official syllabus chapter by chapter, so what you study is exactly what your university examines.

It covers the general principles of law and the key Acts and rules — the Pharmacy Act 1948, the Drugs & Cosmetics Act 1940 and Rules 1945 (with schedules, licensing, sale and administration), the NDPS Act 1985, the Drugs & Magic Remedies Act 1954, the Prevention of Cruelty to Animals Act 1960, the Poisons Act 1919 and the FSSAI Act. It then covers drug pricing (NPPA, DPCO 2013, NLEM), the Code of Pharmaceutical Ethics and the pharmacist's oath, the Medical Termination of Pregnancy Act, the government pharma regulatory bodies (CDSCO, IPC), good regulatory practices, the BCS classification and clinical-trials framework (ANDA/NDA, New Drugs and Clinical Trials Rules 2019, patents and IPR), blood banks, the Clinical Establishment Act, the Biomedical Waste Management Rules 2016, bioethics and ICMR guidelines, the Consumer Protection Act, the Disaster Management Act and medical-device regulation.

Every Act is explained in simple, clear English with the objectives, definitions and salient features students are examined on, making a memory-heavy subject far easier to revise. At 150 pages it keeps the whole syllabus in one place.

Authored by Dr. Narendra Silawat (Ph.D, M.Pharm in Pharmacology; Professor, Oriental College of Pharmacy, Oriental University, Indore) and published by Shree Sai Prakashan, Meerut. Suitable for D.Pharma Second Year students at every PCI-approved institute across India.