A Review On Regulatory Requirements To Prevent Counterfeit Drugs In India

Abstract

Counterfeit drugs are a serious issue nowadays, which has been burdening for developing countries and has a significant impact on the health of people. The Indian drug regulatory agency has published the details of the counterfeited products found in recent years, the data indicates an alarming situation in the country to achieve a well-becoming level of attention between policymakers, researchers and the pharmaceutical industry. The present paper shows a thorough review of relevant and incidental literature from different agencies to reach the counterfeiting of drugs, its type, statistics, incidents and deficiency in Indian regulation. Different country regulations like U.S, Europe and Canada have also discussed in comparison with Indian regulation which shows that how India should adopt the technologies present in other countries to combat counterfeit medicine. Different technologies exist for prevention for counterfeitings of drugs like overt, covert and trace and track technologies; serialization and blockchain. In this article, the main focus is given on serialization and blockchain which will help from entering the counterfeit drugs into the supply chain because of unique code put on each box of drugs to trace them.