BATTLE AGAINST COUNTERFEIT MEDICAL DEVICES

India's laws to administer medical devices are cryptic, giving enough room for counterfeit products to outwit regulations and corrupt the economy. Experts reveal ways by which India can succeed in its battle against counterfeits medical products

- Raelene Kambli

Attention healthcare providers!

Did you know that globally around 8-10 percent of all medical devices are of fake origin?

Did you know that it is important for manufacturers to have a Unique Device Identification (UDI) to ensure traceability of their products?

And did you know that is important for healthcare providers to to check the identification and clinical examinations of medical products while procuring them?

Sadly, ill awareness about counterfeit products amongst healthcare providers is one of the chief reasons for such products to circumvent regulations and corrupt the economy.

The impact of counterfeit medical devices harm patient rights, damage brand equity and cause losses to original equipment manufacturers. According to Aarthi Sivanandh(Partner) and Bhargavi Ravi (Associate) of J Sagar Associates, globally approximately 8 percent of all medical devices are counterfeit and only 20 percent of countries in the world have established regulations to counter their spread. Most commonly counterfeit devices include surgical devices such as clip cartridges, mesh, plates and screws.

Dr Milind Antani, Lead Pharma & Healthcare, Medical Device & Med-Tech Practice, Social Sector Practice, Nishith Desai Associates informs, “Counterfeit medical devices are not only a threat to public health but also reduce the level of public trust in the healthcare system. Usually, medical devices are required to undergo comprehensive clinical investigations to establish their safety before they can be marketed to the general public. For counterfeit medical devices, no such tests are carried out. Prevalence of counterfeit medical devices in the market also makes it tougher for manufacturers of generic devices to establish their presence in the market as patients are not as comfortable purchasing medical devices manufactured by less prominent companies.