Heparin Case Study - Pew Health

After Heparin:

Protecting Consumers from the Risks of Substandard and Counterfeit Drugs

pewtrusts.org/drugsupply

Pew HealtH GrouP

Table of Contents

executive Summary............................................................................................................ 7 Methodology ................................................................................................................... 11 Introduction and Background .......................................................................................... 13

SIdeBar 1: Components of a drug product ...........................................................16 CaSe Study 1: Adulteration of heparin ..................................................................16

Chapter 1: Pharmaceutical Manufacturing: Globalization and Quality Management ....... 21

1.1 Overview ..........................................................................................................................21 1.2 Globalization of manufacturing .......................................................................................21 1.2.1 Movement of U.S. drug manufacturing overseas ...................................................21 FoCuS: China .........................................................................................................24 FoCuS: India...........................................................................................................24 1.2.2 Globalization of medical device manufacturing .....................................................26 1.3 Gaps in ensuring quality and safety overseas..................................................................26 1.3.1 Manufacturing quality and regulation in India and China ......................................26 CaSe Study 2: Whistle-blower alert: Ranbaxy Laboratories Limited ......................28 1.3.2 Drug ingredient quality issues resulting from deceptive practices.........................29 CaSe Study 3: Gentamicin...