Combating Counterfeit and Substandard Medicines in India: Legal Framework and the Way Ahead

Abstract

India has witnessed an exponential rise in markets of counterfeit medicines. Public health and well-being have suffered drastically due to these nefarious enterprises that are engaged in the trade of fake and substandard drugs for making illegal profits. As per WHO, the global market of fake drugs amount to 200 billion USD and 67% of these counterfeit drugs were categorized as dangerous to human health. Perpetrators have targeted Indian markets because it is a lucrative avenue for them and India doesn’t have a stringent regime or legal framework to tackle the menace of counterfeit drugs. India is the fourth largest export-import market for counterfeit and substandard medicines. In addition to people, ethical companies manufacturing genuine medicines have also endured heavy losses due to the booming counterfeit medicine market. Though India has certain administrative bodies in place to combat the challenge, criminals keep coming up with new methods to defraud the public as well as the government. The authors, in this article, have attempted to conduct a comprehensive analysis of the contemporary trends and challenges pertaining to counterfeit and substandard drugs racket. The author has also analyzed the legislative and policy framework and its efficacy against the menace of fake and substandard drugs.