Two of the major BRIC countries, Brazil and Russia, are increasing their efforts to ensure traceability and authentication of pharmaceutical products, according to Securing Industry.
Brazil’s proposed traceability system for medicines will be put through its paces in the coming weeks as pilot testing gets underway. The pilot of the long-awaited National Drug Control System (SNCM) is getting going more than eight years after medicines verification was first proposed.
The pilot will involve regulatory authority ANVISA and several pharmaceutical companies who will each put three batches of product through the system. It will effectively get underway in May when the database for the project is fully up and running, according to Brazilian pharma industry trade body Sindusfarma.
The SNCM requires the addition of 2D barcodes to individual medicine packs that, as a minimum, will include a unique randomised serial number, national registration number, lot number and expiry date. Towards the end of last year ANVISA published a draft implementation guide. Scanning the code will allow the packs to be tracked through the supply chain, with each supply chain member required to capture transaction data and communicate it to a central government repository.
The pilot is expected to take up to a year, with an eight-month review period, which will be followed by a three-year implementation window before the requirements become mandatory.
Meanwhile in Russia a new draft law will set an implementation date of January 1, 2020 for tracking and tracing of medicines – although some high priority drugs could see an earlier deadline. Marketing application holders for medicinal products must file registration information for the track-and-trace system with the Russian governing body by January 1, 2019.
A pilot programme has been running which involves 37 pharma manufacturers, eight distributors and more than 300 pharmacies and hospitals, which is testing data exchange processes for 50 drugs through the supply chain, according to a recent status update from Deloitte and Movilitas.
The key requirements are serialization (via a 2D data matrix code on secondary packaging) and aggregation of medicines (choice of three 2D code types) on shipping units such as boxes and palletsf or drugs produced in Russia and abroad, and reporting on each stage of medicines circulation from manufacturer to the sale to pharmacy/hospital or disposal.
Russian pharmaceutical sales are expected to swell from an estimated $21bn this year to $28.5bn in 2021, according to BMI Research data. But regulations are protecting domestic producers, such as Natsimbio, to help grow their market share from the current 27% to 50% by 2020.
SOURCE: AIPIA
