After multiple deadlines and extensions, the Centre has withdrawn its track-and-trace system that had been mandated for pharmaceutical exports, about 14 years ago.
In fact, the Centre’s directive withdrawing the tracking system for pharma exports came just ahead of the last extension that was valid up to February 1, 2025.
But this has some industry-watchers concerned on the confusing signals it could send internationally – given the cough syrup incidents in Gambia and Uzbekistan (2022), where products from two companies in India were potentially linked to deaths reported among children.
Pharma industry representative are welcoming the directive saying, it was “ill-conceived” in the first place, as companies were complying with the requirements of importing countries.
Barcoding
In its recent directive, the Union Commerce Ministry explained, the track-and-trace system, introduced in January 2011, had mandated barcoding at various packaging levels. “While tertiary and secondary packaging requirements were successfully implemented in 2011 and 2013, primary-level barcoding and parent-child data uploading faced operational challenges and were repeatedly deferred, with the last extension valid until February 1, 2025.”
The Directorate General of Foreign Trade (DGFT) was streamlining export regulations by aligning with the evolving regulatory framework of the Union Health Ministry, the directive said, pointing to the latter’s barcode/QR code requirements for 300 drug brands, effective from August 1, 2023, and with plans for expansion. “Most export destinations have their own serialisation requirements, ensuring product traceability without additional domestic regulations,” it said.
A pharmaceutical exporter said, countries like Nigeria have stringent methods to prevent counterfeit products from entering their region. The DGFT’s tracking mandate for pharma exports added to the regulatory compliance on companies, he said, as often the requirements across countries were not aligned.
Confusing signals
R Uday Bhaskar, former Director-General, Pharmaceuticals Export Promotion Council (Pharmexcil), observed that the withdrawal could send out confusing signals in the international markets, as traceability is important when it comes to medicines. The exercise has been “inconsistent, mindless and unwise,” he said, adding that a lot of human resource and funds had been put into training the industry and implementing these measures.
Traceability came up in 2010 as an anti-counterfeit measure, when a fake product in Nigeria, that was said to have originated from India, had in fact not touched Indian shores, Bhaskar recalled. Much has changed since, he said, as importing countries further tighten requirements on incoming products.
In fact, a PwC authored-report on the issue for the Indian Pharmaceutical Alliance and the Indian Drug Manufacturers’ Association, concludes: “Countries must work together to combat drug falsification because it is a global issue. It is imperative that global coding standards and regulations be established. Initiatives cannot be carried out in isolation and require cross-border synergy to succeed. Such collaborative initiatives would facilitate consistent technology deployment worldwide, benefiting not only manufacturers but also vendors.”