Overview

The book covers key Indian pharmaceutical regulations in an easy-to-understand presentation, will be useful for Pharmacy and Life sciences graduates seeking to make a career in Pharmaceutical Industry. The book is also beneficial to key professionals in the pharmaceutical industries including those working in Product development, Quality Assurance, Regulatory Affairs, Finance, Marketing, Sales, senior executives including CEO's who should be familiar with these legislations to ensure compliance. Useful also for start-ups and those entrepreneurs planning to be a part of the Pharmaceutical industry as Manufacturer, Marketer or retail and wholesale medicines business through single or multiple outlets or set up Drug testing laboratories. The book covers salient features of Drugs and Cosmetics Rules and New Drugs and Clinical trial Rules. Pricing of drugs as prescribed in Drugs price control order is described. Nutraceutical related regulations are also included. It has a chapter on Marketing of drugs which covers the Uniform Code of Pharmaceuticals Marketing Practices . Regulations related to setting up of a Public testing laboratory is also included. The content is as under: Chapter 1 - Introduction 1.1 Global Pharmaceutical Industry1.2 Global Pharmaceutical Industry1.3Pharmaceutical Regulations1.4Expectations from stakeholders Chapter 2 - Regulatory Agencies Chapter 3 - Manufacture of drugs for Examination, Test, or Analysis 3.1 Introduction 3.2 License for examination, test, or analysis of drugs 3.3 Import of drugs for the purpose of examination, test, or analysis 3.4 Labelling of Medicines 3.5 Other labeling requirements 3.6 Standards for Ophthalmic preparations 3.7 Use of letter I.P. on the labels3.8 Packing of drugs 3.9 Use of Package inserts in product packs3.10 Quick Response code on the label of Active Pharmaceutical Ingredients3.11 Diseases which a drug may not purport to prevent or cure3.12 Shelf life of drugs3.13 Stability studies 3.14 Permitted Colours3.15 Standards of drugs 3.16 Schedule V and Vitamin Products3.17 Labels on packs of drugs for export Chapter 4 - Clinical Trials 4.1 Introduction4.2 constitution of ethics committee for clinical trials 4.3 Clinical trial of new drug or Investigational New Drug4.4 Academic clinical trial4.5 Inspection of clinical trial premises 4.6 Bioavailability or bioequivalence study of new drug or investigational new drug4.7 General Principles and practices of clinical trials (first schedule)4.8 Conduct of clinical trials 4.9 Compensation in case of injury or death in clinical trial or bioavailability or bioequivalence study of new drug or investigational new drug 4.10 Manufacture of new drugs or investigational new drugs for clinicalTrial, bioavailability or bioequivalence study or for examination, testand analysis 4.11Manner of labeling4.12 Import of new drugs and investigational new drugs for clinical trialor bioavailability or bioequivalence study or for Examination, test and analysis4.13 Permission to manufacture unapproved active pharmaceutical ingredient for development of formulation for test or analysis or clinical trial or bioavailability and bioequivalence Study Chapter 5 - Manufacture of Drug for sale or distribution Chapter 6 - Import or Manufacture of New drug for sale and distribution Chapter 7 - New Drug Application - similar biologics Chapter 8 - Import of drugs for sale or distribution storage, sale and distribution of drugs Chapter 9 - Storage, sale and distribution of drugs Chapter 10 - Narcotic and Psychotropic substances Chapter 11 - Drugs Price Control Order Chapter 12 Manufacture of Nutraceuticals Chapter 13 - Marketing of Drugs Chapter 14 - Public Testing Laboratories

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