Pakistan is moving forward with plans to introduce 2D barcodes to all pharmaceutical products in a bid to eradicate falsified medicines.
All registered drugs manufactured after 15 December 2017 will be required to emboss a 2D barcode data matrix on the packaging, the Daily Times reported.
“A step-wise approach has been adopted while taking stakeholders on board,” the Drug Regulatory Authority Pakistan (DRAP) said. “In the second phase, barcoding will also be mandatory for primary and tertiary packaging of drugs. In the third phase, each pack will contain a unique serialisation code along with the 2D data matrix. All these steps will be very helpful to eradicate the menace of spurious, substandard, falsified and counterfeit drugs from the market of Pakistan.”
The anti-counterfeiting move follows amendments to Pakistan’s drugs labelling and packaging rules that were issued in June this year.
Under the amendments, the machine-readable 2D barcodes must be based on standards of the GS1 embedding Product Identification Code, otherwise known as the Global Trade Item Number (GTIN), which is a unique identification key comprising 14 characters that includes a GS1 company prefix, item reference and check digit. The 2D barcode must also include information on the expiry date, batch number, product identification information (including drug name, dose and pack size) and serial number.
The barcode is to be printed on the primary and secondary drug packaging (the packaging in direct contact with the active ingredient and the packaging containing the primary packs respectively), while the expiry date, batch number and price will be carried on the secondary packaging of drugs.
GS1 is an international organisation dedicated to design and implementation of global standards and solutions.
The new rules apply to all conventional drugs imported, exported or manufactured domestically, including biologics for human and veterinary use. It does not currently apply to alternate medicines, health and over-the-counter non-drug products, nutraceuticals, medical devices, medical gases or radiopharmaceuticals.
Pharmaceutical manufacturers are required to submit product and company information directly to an online database co-ordinated by DRAP known as DRIS (Drug Regulatory Information System). Companies are also required to maintain their own database of product barcoding information. Meanwhile, DRAP is also working on developing a complete track and trace system as per international practices.
The barcode aims to help facilitate identification, as well as a means to track and trace the product. The measure, which the Pakistan Government had been discussing for several years, should allow patients and healthcare professionals to verify medicines through the use of a free smartphone app that reads the barcode.
The anti-counterfeiting move was welcomed by the Federal Minister for National Health Services Saira Afzal Tarar, who said it would give a “major boost” to eradicating spurious and counterfeit drugs.
Training sessions, conducted by DRAP, are being held for pharmaceutical companies and their associations. Concerns had previously been raised by the industry that the deadline for implementation was too short and did not give companies enough time to get the technologies in place.
The new regulations are one of a number of moves the Pakistan Government has employed to crackdown on counterfeit drugs.
In August, DRAP in collaboration with the Ministry of National Health Services, Regulations and Coordination, launched a three-month campaign against fake drugs. The initiative included market surveillance through inspections and drug sampling. There were also efforts to improve co-ordination between enforcement agencies, and also media engagement to improve public awareness on fake drugs.
This followed a similar earlier three-month campaign that was deemed effective, resulting in the closure of hundreds of sales outlets and illegal and non-compliant manufacturing units, and the arrests of a number of individuals.