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THE PHARMA REVIEW (FEBRUARY - MARCH, 2008)

An Overview of Legislation and Drug Regulatory Authorities

Sachdev Yadav

Abstract: The healthcare system counts on Drug Regulatory Affairs (DRA) for good, safe, and effective medicines and for fair rules and control on drug trade, information, and use. Regulatory authorities are continually challenged by the rapid development and sophistication of medicinal products, new technologies, and health care techniques. Any strategy to improve anything in the pharmaceutical area involves DRA. Similarly, any problem encountered in the area of pharmaceuticals has something to do with the DRA. Such developments pose a heavy demand on regulatory control systems. The specific interests, capabilities, and duties of regulatory authorities vary from country to country depending on the country’s specific needs.

Basic Functions of Drug Regulation

The basic functions performed by majority of regulatory authorities are more or less the same, which are as given under:

  • Licensing of manufacturers, importers, distributors, wholesale and retail outlets (premises, persons & practices).

  • Marketing authorization for drug products.

  • Quality control lab testing and application of sanctions.

  • Provision of drug information and monitoring of drug promotion and advertising.

  • Adverse drug reaction monitoring.

  • Authorization of clinical trials.

  • Monitoring of drug dispensing and prescribing practices.

  • Monitoring of drug utilization and promotion of rational drug use.

  • Price control may or may not be a part of the drug regulatory activities.

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