Abstract

DRUG REGULATORY AGENCIES IN INDIA AND U. S. A.

*Priya Dayanand Bhalke and Snehal Dhewale

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Abstract

Regulatory affairs in pharmaceutical industry aim at the protection of human health. People and government spent money on drugs because of the role they can play in saving lives, restoring health, preventing diseases and stopping epidemics. But, in order to do so, drug must be safe, effective and of good quality. since the purpose of drug is to diagnose, prevent or treat diseases or aliments in humans, they are products intimately linked with the advances in research and regulation. the pharmaceutical industry, while pursuing an international market is obliged to comply with national regulations. So, in this review article, an overview of few drugs regulatory agencies of four countries: India, USA, Europe & Japan is covered. Regulatory agencies and organizations play a vital role to meed the requirements of legal procedures related to drug development process in a country. Every country has its own regulatory autority, which is responsible to enforce the rules and regulatons and issue the guidelines to regulate the drugs development, licencing & registration.

Keywords: Regulatory affairs in pharmaceutical industry aim at the protection of human health.