The Indian government has officially retracted its long-standing track-and-trace system for pharmaceutical exports, a directive that has been in place for nearly 14 years. This decision comes just before the latest extension that was supposed to last until February 1, 2025.
The move has raised eyebrows among industry observers, particularly in light of recent controversies involving cough syrup products linked to tragic incidents in Gambia and Uzbekistan that resulted in child fatalities. These incidents involved medications from two Indian companies, prompting concerns over the implications of the government’s withdrawal of the tracking system.
Representatives from the pharmaceutical industry have largely welcomed the announcement, arguing that the original mandate was poorly conceived. They pointed out that companies were already conforming to the regulations set forth by the countries importing their products.
The Union Commerce Ministry explained that the track-and-trace system, introduced in January 2011, required barcoding at various packaging levels. While secondary and tertiary packaging requirements were successfully established in 2011 and 2013, the implementation of primary-level barcoding faced significant operational hurdles and had to be deferred multiple times, culminating in the extension that was set to expire in 2025.
In its directive, the Directorate General of Foreign Trade (DGFT) noted its efforts to streamline export regulations in line with the evolving standards of the Union Health Ministry. The Ministry had recently introduced barcode and QR code requirements for 300 drug brands starting August 1, 2023, with plans for further expansion. The DGFT emphasized that most export destinations already have stringent serialisation practices that ensure product traceability without imposing extra domestic regulations.
A pharmaceutical exporter highlighted that countries like Nigeria have robust measures in place to combat counterfeit drug entry. According to him, the DGFT’s tracking mandate added an unnecessary layer of regulatory compliance for companies, as the requirements often differ significantly between nations.
R Uday Bhaskar, former Director-General of the Pharmaceuticals Export Promotion Council (Pharmexcil), expressed concern that this withdrawal could create confusion in international markets, where traceability is crucial for medications. He criticized the whole exercise as inconsistent, misguided, and unwise, noting the substantial investment of human resources and funding that had been dedicated to training the industry and implementing these measures.
The need for traceability emerged in 2010 as a means to combat counterfeit drugs, following an incident in Nigeria involving fake products purportedly traced back to India, although those products had never actually entered the country. Bhaskar noted that importing countries’ requirements have only tightened since that time.
A report commissioned by the Indian Pharmaceutical Alliance and the Indian Drug Manufacturers’ Association concluded that tackling drug falsification requires coordinated international efforts. It argued for the establishment of global coding standards and regulations to ensure success in this vital area. Such collaborative initiatives could facilitate the uniform deployment of technology worldwide, ultimately benefiting both manufacturers and vendors alike.
