Regulatory Focus™ > News Articles > How a Private Anti-Counterfeiting Initiative Could Pressure Regulators to Improve Drug Quality

How a Private Anti-Counterfeiting Initiative Could Pressure Regulators to Improve Drug Quality

Posted 19 February 2013 | By Alexander Gaffney, RAC

What happens when your local regulatory agency isn't known as being reliable or capable at overseeing the safety and quality of products in your country? In at least one country, consumers could soon have a private-sector solution to improve their ability to ensure their medicines are of sufficient quality and identity.

That initiative, run by the Partnership for Safe Medicines India Initiative (PSMII), is a side project of the Partnership for Safe Medicines-a coalition of industry and other healthcare groups that includes PhRMA, the Biotechnology Industry Association (BIO), and the Generic Pharmaceutical Association.

The combination is one of seemingly strange bedfellows. After all, there's little that branded and generic pharmaceutical groups agree on when it comes to patents, market exclusivity or the respective benefits of their products.

But one area in which they do agree is product quality and identity. "Counterfeit drugs are a serious patient safety problem," explains the group's mission statement. "The Partnership for Safe Medicines is working together to protect the safety of your prescription drugs."

Even in the US, the group has been active in calling attention to occasional breaches in the integrity of the supply chain, such as in the case of fake Avastin being found.

The US, however, has the benefit of having an established regulator, the US Food and Drug Administration (FDA), to help ensure and maintain high levels of quality throughout the industry. Other countries don't always have the benefit of the same standards of regulatory capacity.

Case in point: India. With over 1.2 billion people and an under-resourced regulator, the Central Drugs Standard Control Organization (CDSCO), the country has been seen by some as a haven for substandard and counterfeit medicines.

This isn't to say that's necessarily the fault of regulators. A recent paper by Roger Bate of the American Enterprise Institute (AEI) on counterfeit medicines found that drug products produced in India were actually disproportionately less likely to be counterfeit. However, due to the huge number of generic manufacturers that are based in the country, it can be difficult for consumers to determine which medicines are of proper quality and which are substandard. Fifty-one of 142 drugs sampled by Bate that came from India were substandard-better than regions like Asia and Africa, but still worse than the US and EU.

What Can be Done?

At issue for outside groups is an overarching question: How do you protect consumers from counterfeit and substandard products in resource-poor environments? Is there a way to improve product quality without the intervention of regulators?

One approach widely used by outside groups has been education. In 2010, the same India Initiative launched with a focus on educating India's burgeoning number of consumers on how to identify quality pharmaceutical products. A similar measure launched in China in 2012 is also supported by the PSM.

But now PSM is taking the India Initiative one step further, reports PharmaBiz. Under a new system, patients will be able to take pharmaceutical products to accredited, government-approved laboratories to make sure the product is truthful in its identity and adequate in its quality.

The initiative, PharmaBiz notes, will not be officially announced until later, and is currently circulating in draft form.

The pilot project could come to represent a private sector solution to some of the world's most pressing regulatory problems. Many consumers in these regions lack the resources to test the quality of medicines themselves. By being able to test the quality of medicines received, they may be able to identify certain distributors with poor supply chain safeguards or perhaps even double check if regulatory authorities are doing a proper job.

If, for example, consumers regularly find that approved medicines known to be manufactured by inspected companies are failing quality inspections, they may be able to pressure legislators and regulators to make improvements.

What remains to be seen are the details of the program, most notably its cost, duration, scope and locations. In such a massive country, it is likely that the program will be limited at first to some high-risk areas where funding might stand to make the greatest impact.

We've reached out to the PSM for more information and will update this piece if we hear back.

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