The pharmaceutical industry in India ranks 3rd in the world in terms of volume and 14th in terms of value according to Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers. Indian drugs are exported to more than 200 countries in the world, with the U.S. as the key market. Generic drugs account for 20% of global exports in terms of volume, making the country the largest provider of generic medicines globally and expected to expand even further in coming years.

Pharmaceutical companies operate in one of the most dynamic and heavily regulated environments. Changes in regulations in terms of stringent quality aspects by leading drug regulatory bodies such as U.S. Food and Drug Administration (USFDA), Therapeutic Goods Administration (TGA, Australia) and the European Medicines Agency (EMEA) have increased the significance of regulatory compliance management for drug manufacturers and suppliers. Pharma companies across the globe are obliged to alter their compliance practices to conform to changes in regulations and stringent
CGMP compliances.

India enjoys an important position in the global pharmaceuticals sector. The country also has a large pool of scientists and engineers who have the potential to steer the industry ahead to an even higher level.

Pharma and Lifesciences Industry - Certain Tax, Regulatory and Governance Aspects, in which we have discussed the following aspects relating to pharma industries:

  • FDA regulations
  • Various tax and legal compliances
  • Enterprise Risk Management
  • Direct as well as Indirect taxes provisions
  • Good Manufacturing Practices
  • Good Clinical Practice (GCP Guidelines)
  • Various International Laws
Following is the table of content of the e book

Table of Contents
Sr no. Topics Page No.
1 Chapter 1 Background 1
2 Chapter 2 Compliance Calender 9
3 Chapter 3 Direct and Indirect Tax 16
4 Chapter 4 Enterprise Risk Management 64
5 Chapter 5 Compliances Required From an Indian Pharmaceutical Company 85
6 Chapter 6 Good Manufacturing Practice (Schedule M to Drugs and Cosmetics Act, 1940) 99
7 Chapter 7 Good Clinical Practice (GCP Guidelines) 119
8 Chapter 8 Various International Laws
9 1. WHO Medicines 123
10 2. WHO Sites 129
11 3. The Organisation For Economic Co-operation And Development (OECD) 130
12 4. Therapeutic Goods Administration (TGA) 130
13 Chapter 9 International Council on Harmonization 131
14 Chapter 10 European Medicines Agency (EMEA) 137
15 Chapter 11 Code of Federal Regulations- Title 21 – USFDA 140
16 Annexure 1 DTAA Rate Chart 150
17 Annexure 2 TDS Rate Chart for Financial Year 2018-19 155
18 Abbreviations 164

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