Richard Nemesi, Global Vertical Manager for Pharmaceutical and Medical Devices, Videojet Technologies, opines that the main challenge is the sheer number of characters, which the printer needs to manage while coding in non-Latin language
In the last ten years, the development of the so-called pharmerging markets has provided Western drug companies with huge opportunities. Developing economies in countries like China, India, Russia, South Korea, Brazil and Mexico have become major consumers of pharmaceuticals. The IMS estimates that in 2014, pharmerging countries made up around a quarter of the total pharma market, and it’s estimated that by 2017, this will rise to a third. In Saudi Arabia alone, the market is worth around $4 billion, with 70 per cent of imports coming from Europe and 13.1 per cent from the US. Whilst in the Philippines, the pharma market has grown to $4.3 billion1, with foreign manufacturers supplying 75 per cent of the market2.
With the increased use of pharmaceuticals comes the increased risk of counterfeit medicine. In pharmerging countries, physicians’ concerns about poorly manufactured or counterfeit drugs mean they are more likely to write prescriptions for branded medicines rather than generics, with the brand acting as a guarantee of quality.3 The World Health Organization estimates that counterfeit medicines contributed approximately one per cent of the total drug supply in developed countries, however, up to 30–40 per cent in developing countries. Global serialisation of pharma products using coding is being put in place as the best way of counteracting this problem, enabling the pharma industry and regulators to track the products through manufacture, distribution and dispensing through the use of coding.
Challenges of coding in non-Latin languages
Data communication has now become an integral part of our everyday lives with the dominance of the Internet and devices like smartphones. In the world of electronic data handing, ASCII was the most used code in data communication until 2007. It was developed from telegraphic codes used in the early 1960s and is based on the English alphabet with Latin characters, with the capability to encode a total of 128 characters. At the time, standard printers were built to handle the ASCII protocol. With ongoing globalisation there was a need to expand beyond the ASCII limit of 128 characters, hence the development of UTF-8, which can encode over a million characters. It is currently used for more than 80 per cent of data communication because it incorporates all the extra characters, which are not included in Latin-based languages. UTF-8 is the standard system used to handle international characters contained in Arabic, Cyrillic and Asian languages.
Existing serialisation codes require human readable instructions to be in local languages and also machine readable symbols such as DataMatrix. In addition, there is detailed information required by national drug codes, which include a unique serial number for each item, plus packaging lot number and expiration date. As each saleable unit requires its own code and each code needs to be non-sequential, the demand for codes rises exponentially. The main challenge for pharma companies, when manufacturing for global markets using non-Latin languages such as Arabic, Cyrillic and Asian is the sheer number of characters the printer will need to manage. As a result, a specialised coding system with superior data handling is crucial for trading in these non-Latin language local markets.
Global serialisation timescales
Currently, many of the pharmerging markets do not have the capacity to meet their domestic pharma demand, representing export opportunities for large pharma companies. Serialisation regulations are being planned and many formalised in a number of these markets, presenting a complex landscape for navigation aspharma manufacturers or supply chain player. The following is an overview of some of the important pharmerging markets that use non-Latin languages domestically, what is required by their serialisation regulations and when the important milestones are:
In the past two years, China has been phasing in implementation of their track and trace regulations. With the final deadline on December 31, 2015, all of China’s pharma products will be covered under the country’s unique requirements, including serialisation and reporting. All levels of product will have to be serialised with a government-issued number. Pharma companies will be required to run a query on a Chinese government system in order to initiate and capture the serial numbers. Since 2013, the Essential Drug List (EDL) covers 502 products that currently require serialisation. The EDL requires that the Chinese National Drug Code (NDC) plus serial number to be printed on primary and secondary packaging.
Since the end of 2013, medicines sold in South Korea have been required to carry a 2D DataMatrix code containing the Global Trade Item Number (GTIN), lot number and expiry date. At the beginning of 2015, a new phased schedule for serialising medicines was introduced, and in 2016, there will be a requirement for a unique serial number to be incorporated into the code for almost one third of all pharma products sold in the country. South Korea’s Ministry of Health and Welfare also hopes the use of serial numbers will help manage medication records and reduce the occurrence of misprescribing.
Since March 23, 2015, the secondary packaging of prescription drug products sold in Saudi Arabia must contain both a human readable and a DataMatrix symbol encoded with GS1 GTIN to identify the item, the packaging lot number, expiration date and pack size. From March 12, 2017, every prescription drug item must contain a unique serial number with all the above information and the number must be encoded in the DataMatrix symbol.
In Jordan, after January 1, 2017, all prescription drug items must contain both human readable text, and a DataMatrix symbol encoded with GS1 GTIN to identify the product, the packaging lot number, expiration date and pack size.
Eastern Europe and Russia
Russia and Ukraine do have plans to introduce serialisation, though there are no confirmed time scales as yet. Russia has introduced the Pharma 2020 plan that requires international players to form partnerships with domestic manufacturers in order to gain a foothold in the market. Similar plans have been drawn up by Commonwealth, Latin American and African countries. It is also worth pointing out that Bulgaria also uses Cyrillic language. As the country is part of the European Union, serialisation and tracking compliance will be required by January 2, 2017.
The increase in serialisation of pharmaceuticals worldwide means there are huge gains to be made by companies who have systems in place to handle compliance in Arabic, Cyrillic and Asian speaking pharmerging markets. Part of addressing the challenge for production teams will be selecting the right coding equipment that can meet the functionality required by variable codes at the necessary speed and quality levels. Thankfully, significant innovation is happening across the industry, which is driving breakthrough changes in coding capability.
1. http://healthcare.globaldata.com/media-center/press-releases/ pharmaceuticals/ philippines-pharmaceutical-market-value-to-reach-8-billion-by-2020-says-globaldata
2. http:// www.pacificbridgemedical.com /publication/2014-philippines-pharmaceutical-market-update/
3. Pharmerging Markets: Picking a pathway to success. IMG Consulting Group, 2013. Pg 8