Assessment of Global Regulatory Requirements for Non-Prescription Drugs in Comparison to Prescription Drugs for the Key Regulatory Regions: U.S., Europe and India

Abstract

There are two types of medicines. Prescription drugs and the non-prescription drugs. The non-prescription drugs commonly known as OTC drugs are found to be useful to both consumer as well as industry. The value of OTC drugs is increasing every year though OTC drug abuse is also found. The OTC drugs and the prescription drugs are regulated differently. The regulations for OTC drugs are different in different countries. The regulations in the countries like US and Europe are stringent while in many countries no specific regulations are present for OTC drugs. In US there are two pathways for OTC drug approval. The OTC monograph system and the Rx-to- OTC switch process. While in Europe and India there is no OTC monograph system. There are various differences in the prescription and non-prescription drugs. The challenges in the pathway for OTC drug approval varies from countries to countries since there are different regulations in different countries. In general globally common pathway is not available for OTC drug approval. The regulations for OTC drugs varies from country to country. Still more clear regulations are required globally.