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India is working to build an authentication ecosystem to battle counterfeits in pharma & medical devices, said Manoj Kochar, president, Authentication Solution Providers’ Association (ASPA).
Indian pharma has made rapid progress on one hand, but on the other hand there is the unfortunate struggle with spurious and substandard drugs. Pharmaceutical and medical devices have been for many years one of the key targets of counterfeiters, he added.
With the advent of globalisation and rising healthcare costs, the risk of counterfeiting has surged significantly. India, a major producer of approximately 20-22% of the world's generic drugs, faces a substantial threat due to counterfeiting, he noted.
There is a pressing need to establish an authentication and traceability ecosystem. While many countries importing pharmaceuticals from India prioritize serialization, a majority of Indian manufacturers need to update their packaging lines to implement this, hindering the adoption of serialization. Ensuring a robust end-to-end visibility and implementing a formidable track-and-trace system are crucial steps to safeguard the supply chain from counterfeit activities, Kochar told Pharmabiz.
Track-and-trace digital technologies offer actionable intelligence to brand owners through electronic means, enabling the identification of unauthorized sellers on the internet. Advocating for a multi-technology approach, encompassing overt, covert, digital, and analytical technologies, is essential to combat counterfeiting, tampering, and diversion through, authentication, and digital verification strategies, he said.
Overt technologies, designed to be easily recognisable but challenging to replicate, serve as the initial layer of protection against fraudulent product use. Some major pharma companies have implemented such overt features like holograms and security printing elements on their primary packaging. On the other hand, covert technologies, incorporating hidden features imperceptible to the human eye and detectable only with specialised equipment, offer a secondary level of certainty for field investigators engaged in the authentication process. Such covert features also employ optically variable diffractive and security printing technologies.
Counterfeit medical devices pose a dual threat by jeopardizing public health and eroding trust in the healthcare system. The utilisation of non-compliant and fake medical technology devices not only poses a significant risk to patient health but also poses a severe threat to the reputation, he said.
Absence of scrutiny by authorized entities in the Ministry of Health makes it impossible to assess the quality and safety of these unexamined devices. The dental industry faces susceptibility to counterfeits like X-ray machines, turbines, drills, and even falsified braces, where infections from substandard materials could endanger patients' lives. Counterfeit needles may lack sterility, putting users at risk of infections. - Secondly, counterfeit medical equipment can lead to inaccurate diagnoses.
For example, a blood glucose meter may fail to display accurate values for diabetics, and pregnancy tests may yield unreliable results. Counterfeit medical devices detrimentally affect the original registration holder who invested considerable resources in proving the preparation's safety and efficacy for registration with the Ministry of Health, he said.
Despite the non-bailable nature of most counterfeit offenses, it necessitates a more rigorous response from regulatory authorities, involving expedited mechanisms for identification and prosecution of counterfeiters, along with the imposition of heavier penalties.
Here ASPA is committed to partner the Indian pharmaceutical industry to eradicate the menace of counterfeit, which will further reinforce the Indian pharma industry’s pre-eminent status at the global stage, said Kochar.
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