Counterfeit Drugs : Problems and Solutions for the Indian Pharmaceutical Industry
Counterfeit Drugs
Problems and Solutions for the Indian Pharmaceutical Industry
Introduction
Counterfeit drugs have been around for much of the recent history of industrial-scale drug production in India and abroad. Although detailed data on counterfeit medicines are difficult to obtain by virtue of its very nature, a recent WHO report estimates the prevalence to be around 1% of sales in developed countries to over 10% in some developing countries1. The more important aspect of this global problem, according to the WHO report, is that while such estimates are only meant to provide insight into the problem, the occurrence of even one single case of counterfeit medicine is simply unacceptable to society. In addition to placing patients’ health at risk and undermining public confidence in medicines, the presence of counterfeit drugs exposes the vulnerability of the pharmaceutical supply chain and therefore jeopardizes the credibility of the entire industry.
The problem of counterfeit drugs in India is now well recognized by most pharmaceutical companies, government authorities, and the general public. The purpose of this article is to review extant information on this problem, discuss a number of critical issues, and explore the implications for the Indian pharmaceutical sector. However, a mere listing of a set of problems is unsatisfying without discussion of potential solutions. The second part of this article will review the options available to the pharmaceutical industry to combat this problem.
What are the problems?
1) National reputation — India is a major producer of counterfeit drugs
The production of counterfeit drugs in India has led to significant negative publicity around the world. A simple internet search yields many articles in the mainstream media about the abundance of counterfeit drug production in India and its harmful effects. Although much attention has been placed on specific examples where a particular counterfeit
Problems and Solutions for the Indian Pharmaceutical Industry
Introduction
Counterfeit drugs have been around for much of the recent history of industrial-scale drug production in India and abroad. Although detailed data on counterfeit medicines are difficult to obtain by virtue of its very nature, a recent WHO report estimates the prevalence to be around 1% of sales in developed countries to over 10% in some developing countries1. The more important aspect of this global problem, according to the WHO report, is that while such estimates are only meant to provide insight into the problem, the occurrence of even one single case of counterfeit medicine is simply unacceptable to society. In addition to placing patients’ health at risk and undermining public confidence in medicines, the presence of counterfeit drugs exposes the vulnerability of the pharmaceutical supply chain and therefore jeopardizes the credibility of the entire industry.
The problem of counterfeit drugs in India is now well recognized by most pharmaceutical companies, government authorities, and the general public. The purpose of this article is to review extant information on this problem, discuss a number of critical issues, and explore the implications for the Indian pharmaceutical sector. However, a mere listing of a set of problems is unsatisfying without discussion of potential solutions. The second part of this article will review the options available to the pharmaceutical industry to combat this problem.
What are the problems?
1) National reputation — India is a major producer of counterfeit drugs
The production of counterfeit drugs in India has led to significant negative publicity around the world. A simple internet search yields many articles in the mainstream media about the abundance of counterfeit drug production in India and its harmful effects. Although much attention has been placed on specific examples where a particular counterfeit
References: 1. WHO Report. International medical products anti-counterfeiting taskforce, 2006. 3. FDA News. FDA Announces New Measures to Protect Americans from Counterfeit Drugs. June 9, 2006. 4. Bernstein, I. Impact of the PDMA on the Pharmaceutical Supply Chain. US FDA, November 13, 2006. 5. Combating counterfeit medicines and protecting patients through a partnership approach. EFPIA Position Paper, 2006. 6. Hunt K. Are you reading me? The Globe and Mail, Toronto. April 11, 2007. 7. Mistry RD. e-Tagging is here with great promise. Pharmabiz. July 26, 2007.