ASPA report highlights trends in pharma crime

The menace of substandard and falsified (SF) medical products is not new. Unfortunately, however, the issue is still undervalued and undertreated. Counterfeiting and illicit trade plague all industries, but pharmaceuticals and healthcare are among the most prominent victims, especially when there is a matter of life and death.

01 Apr 2022 | By Rahul Kumar

The report welcomes the government's decision to make QR codes mandatory on APIs

The Authentication Solutions Providers' Association (ASPA) has studied the major counterfeit incident noticed during the Covid-19 period and its impact in the country and released its latest report. 

Titled ‘Substandard and falsified medical products, learning from Covid-19 pandemic and technological tools to ensure medicines and patient safety’, the report highlights the trends on pharmaceutical crime and incidents of SF medical products that happened during Covid-19 and recommendations to combat it. 

The report also welcomes the government of India’s decision to make QR codes mandatory on active pharmaceutical ingredients (APIs). However, it suggested a comprehensive approach towards building an authentication ecosystem in the country. 

The study found that fueled by the Covid-19 pandemic, incidents of substandard and falsified (SF) medical products increased by almost 47% from 2020 to 2021. The noticed incidents were mostly related to Covid-19 related medical products, including vaccines, medicines, Covid test kits, antibiotics, face masks and sanitisers. During the peak of Covid-19, incidents of SF medical were observed in 23 out of 29 states and seven union territories.

On the other hand, SF products are impacting every product sector, and the incidents of counterfeiting in India have risen with a 20% growth from January 2018 to December 2020. Globally too, pharmaceutical SF incidents rose 111% over the past ten years, derailing global efforts to fight life-threatening disease and to achieve its sustainability goals.

Nakul Pasricha, president, Authentication Solution Providers’ Association (ASPA), said, “Criminals have seen the pandemic crisis as an opportunity to sell more and more substandard and falsified medical products, taking advantage of the vulnerability of the people in need. The adverse impact of the huge increase in circulation of spurious medicine and medical essentials on the fight against the Covid-19 pandemic has almost gone unnoticed. It is unfortunate as criminals produce ineffective or harmful products in packaging that appear identical to genuine products to make them difficult to detect. The circulation and use of these SF medical products violate the right to health and slows down the pace of providing quality health services that people deserve. It is high time for firm action to curb this menace. If preventive steps are taken now, we will be better positioned to deliver effective healthcare to patients.”

Despite guidelines, the circulation of SF medical products has been an under-addressed/ under-tackled issue. The recent decision to make QR codes mandatory on active pharmaceutical ingredients (APIs) is a significant step towards initiating a positive change in the ecosystem. APIs are the primary raw materials used in making medicines – capsules, tablets, syrups & others. Enforcing the mandate on APIs is the right starting point. The consumer will be the ultimate winner because of this step as it will have a significant impact in making the supply chain more secure and protecting the quality of medicines. This step will be instrumental in distinguishing spurious and original drugs and make the ecosystem less vulnerable to substandard and falsified products. 

National authentication and traceability projects have been trending internationally for the last few years, with China, Brazil, Turkey, the USA, and the EU pioneers in this area. It has helped these countries reduce the shadow market in various industries, improved tax collection, and significantly reduced losses incurred by businesses from counterfeit products and illegal trade. India should also implement these measures in other sectors to join the league of advanced digital economies.