It was way back in 1963 that the US FDA finalised the first version of Good Manufacturing Practices (GMPs) for finished pharmaceuticals. There have been periodic revisions to keep up with technology as well as increasing global trade of pharma products. Similar versions of the US FDA’s GMPs have been since adopted in other countries, keeping in mind their unique challenges. In time, regulators of most countries agreed to work towards harmonising their standards to avoid discrepancies.
The global serialisation initiative, started half a century later and is still barely out of its first decade. Thus in comparison, serialisation/ track and trace is at a relatively nascent stage. The first important legislation aimed at securing the pharma supply chain was the US Drug Quality and Security Act in November 2013. The US was and still is the largest pharma market, so this Act impacted all exporters to the US. In spite of the tremendous capital expenditure involved, they had to move to change their systems or lose lucrative export revenue. The move to establish national and then international electronic systems to identify each medicine, and then track and trace each pharma product, from the time it leaves the manufacturer’s facility, to wholesalers, distributors, and finally chemists, the point of sale to the patient, is a good step towards patient safety but is daunting in terms of operational feasibility.
Ironically, though serialisation started as a move to standardise one aspect of a pharma product’s packaging to detect substandard/ counterfeits, different countries chose their own standards. Thus India, as the pharmacy of the world, with a vast export footprint, contends with multiple serialisation requirements.
To further complicate matters, pharma manufacturers in India have different specifications for the domestic market. The serialisation initiative is today at the stage of harmonisation, with key export country mandates, like the US and the EU, rolling out by November 2017 and 2019 respectively. (To know more, read the story, Making sense of serialisation, in the August 16-31, 2017 issue, pages 52-56)
Most big pharma companies are well placed to meet the serialisation deadlines and are today looking at serialisation as a strategic business tool. For instance, at the chemist level, in fact, across the retail trade, spanning stockists, wholesalers and distributors, the data generated can be used as an inventory management tool.
For the manufacturers too, it helps better inventory management as the barcodes include data on the origin, shelf life and batch number of the product. Much like every supermarket can access the expiry dates and sources of all products on their shelves.
From food and garment retail, to the aerospace industry, the pharma sector has many precedents when it comes to serialisation. While the ultimate goal is common, countries have chosen their own paths which is adding to the confusion and will ultimately lead to loss of legitimate business. Differing standards could also create gaps in the supply chain which could be exploited. Let’s hope that these are resolved sooner rather than later.