The global regulatory push for serialization, which aims to decrease the incidence of drug-related criminal activity and secure the legitimate pharma supply chain, is good news for consumers. However, for most companies it can be a difficult, confusing, and expensive process, as different countries have different regulations that are constantly being amended and updated.
Here are some key facts regarding serialization in Asia and Latin America, two of the biggest markets in the global pharma industry.
China – The Chinese National Drug Administration made their first attempt at traceability and serialization in 2016, but the program was suspended soon after to make way for a new proposal. The new approach for traceability and serialization will be implemented by 2022. Under this new system, drug marketing authorization holders and manufacturers are responsible for building their own traceability system, which must conform to the standards outlined in the guidelines published by the Chinese National Medical Products Administration (NMPA).
India – Presently, serialization and tracking is only required on pharmaceutical products being exported out of India, but current trends indicate that an internal serialization is on the horizon. In 2018, the Drug Technical Advisory Board (DTAB) proposed the implementation of a tracking system for 300 major pharmaceutical brands on a voluntary basis. By 2019, the DTAB recommended implication of quick response codes (QR codes) on packaging of all API’s to track the origin and movement of these products.
Brazil – In 2019, Brazil began commercial implementation of their national drug control system, which is to be completed in 2022. By then, products must be serialized at the unit and case level with a 2D barcode that complies with Brazil’s unique coding format. Additionally, every member of the supply chain must track all product movement from manufacturing until dispensation to the patient.
Mexico – Mexico currently does not have and is not in the process of implementing national regulations for serialization and traceability or pharmaceutical products.
Many Asian and Latin American countries do not have a fully implemented pharma serialization programme. However, due to the increasing regulations regarding serialization around the world, compliance will likely be a requirement for participating in international trade in the future.