Pharmaceutical Serialization: A Challenge for Developing Nations

For a long time, fake drugs have been a severe risk to public health in many developing countries, including India. People of these countries are either lack vital medications for serious illnesses or buy fake drugs from illegal or unreliable sources.

The majority of necessary medications are either highly expensive or available in illegal online stores. The medicines sold in online stores or on the dark web are potentially contaminated or produced with inferior quality. Ultimately, these medications don’t help patients’ conditions and sometimes actually make their diseases worse.
In a recent published chapter in the book “Novel Aspects on Pharmaceutical Research” Shambhu Sarkar, a pharmaceutical serialization expert, wrote that developing nations lack the capacity to supply and implement counterfeit detection technologies on a wide scale to prevent drug counterfeiting. On the other hand, developing countries like USA and Europe have successfully implemented drug counterfeiting prevention laws.

Shambhu Sarkar clearly articulated that why the healthcare sector in developing countries like India and other South Asian nations, mainly faces inadequate infrastructure and a lack of government funding for research and infrastructure improvements. They also have to deal with structural vulnerabilities like ongoing social and economic inequality, armed conflict, forced migration, dwindling public confidence in the government, the effects of climate change, and environmental fragility.

Developing countries face significant challenges when it comes to investing in public health. Existing pharmaceutical facilities struggle to meet international standards because they must make significant investments in new production and specialized packaging equipment to adopt serialization technologies for drug counterfeiting prevention. Pharmaceutical manufacturers are required to print the unique identifier on all packaging labels, grading systems, barcode printers, and vision systems and other materials to comply with the existing worldwide serialization rules.

To stop drug trafficking and counterfeiting, all supply chain participants must work together. Skilled resources were needed for the implementation and maintenance of the serialization system for drug traceability. Unfortunately, the level of technical literacy in developing nations is not encouraging. Southern Asia and Sub-Saharan Africa have the lowest rates of literacy, with most of those regions’ rates falling below 50%. Another issue for developing nations is the lack of technologically functional resources needed to implement and maintain an end-to-end serialization and drug traceability process.

Shambhu Sarkar published a similar research article in “Challenges for Implementing Digital Drug Traceability in Developing Countries. International Journal of Research Publications, 103(1), 760–766”, where he concluded that developing nations can use some best practices to prevent drug fraud until they implement a reliable drug traceability system. They can promote awareness programs, audio-visual advertisements, seminars, and door-to-door campaigns. The government should also invest in and set up a government-funded pharmacy and conduct regression audits on private drug suppliers in the supply chain. The risk to public health must be taken into consideration when regulatory authorities create regressive monitoring plans, enforce the law, and increase penalties for pharmaceutical counterfeiting.