ALL medicines entering Bahrain will be soon scanned for their authenticity, as the country works to finalise a state-of-the-art system for tracking and tracing pharmaceutical products … in the latest move to prevent fake pills and syrups reaching the market.
From June 1 onwards, stakeholders such as the Customs Directorate, agents, distributors, import pharmacies and dispensers will be required to scan the 2D barcode of drugs from the port until they reach the patient.
This is part of the pharmaceutical track and trace system’s third and final step, the ‘Aggregation and Blockchain Validation’ phase. “Once these are done and the customs update the system, we will go fully live with the track-and-trace system by 2023,” said National Health Regulatory Authority (NHRA) chief executive Dr Mariam Al Jalahma.
Dr Al Jalahma is confident the system will aid in the prevention of counterfeit medicines. She was speaking to the GDN from the sidelines of the Gulf Forum for Medicine Regulation in Dubai – a three-day forum concluding today which has gathered stake-holders, decision-makers and pharma companies discussing on latest regulations in the field.
The GDN reported earlier that the medicine track-and-trace system allows authorities to document the journey of medications from an overseas manufacturer to individual patients within the country.
The new ability to track medicines from warehouses to patients will supplement the efforts of the Supreme Council for Health (SCH), which is already tracking medicines from their origin to Bahrain’s drug storage facilities.
“The focus of the discussion at the forum was on medication tracking and tracing, which is currently being implemented in the UAE, Bahrain and Saudi Arabia,” said Dr Al Jalahma.
“The topic is important because it primarily aims to prevent counterfeit medications from reaching patients and to find ways to track them.
“The annual summit also discussed e-labelling – the future trend to have a leaflet in the medication packages with an electronic code that can scanned by the patients for relevant information of the medication.
“We also discussed issues related to regulating the pharmaceutical products in different countries.
“Bahrain presented its update on track-and-trace as well as information on listed drugs.”
As part of its phase-wise implementation of the system, NHRA had set up its Medical Value Chain (MVC) Traceability Hub track-and-trace system for Bahrain in November.
“The end-to-end traceability of medicines comes with some inventory management challenges for customs, agents, distributors, import pharmacies, clinics and hospitals,” explained Dr Al Jalahma.
“For this we have been on a phased approach to tracking serial numbers, allowing these groups to utilise the aggregated information related to shipments when scanning their deliveries.”
The first phase was serialising the medicine shipments through the Marketing Authorisation Holder (MAH – a non-profit organisation which allows the holder to market a specific medicinal product) which will forward it to the NHRA-MVC hub, done in December. The second phase initiated with the call to all manufacturers to aggregate all medicines, no later than May 1, which is ongoing.
“The third phase known as the ‘Aggregation and Blockchain Validation’ phase, addresses customs, agents, distributors and import pharmacies, as well as dispensers,” added Dr Al Jalahma.
“By June 1, the Customs Directorate will scan the 2D barcode of the aggregated shipments to authenticate medicine shipments arriving in Bahrain.
“At the same time, agents, distributors and import pharmacies will scan the 2D barcode on each medicine pallet label shipment received and will send that data to the NHRA-MVC hub for validation.
“The dispensers – pharmacies, clinics and hospitals – from the same day in 2022 will also do the same on all deliveries they receive and will further do the same when dispensing medications.”
The NHRA has issued training guides on how to carry out the scanning and has also conducted a test run last month.
The is a global battle against criminal drug networks which are mass-producing fake pills and falsely marketing them as legitimate prescription pills to deceive the public.
In many countries counterfeit medicines are made to look like prescription pills and can be deadly.
raji@gdn.com.bh
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