Drug Regulatory Authority of Pakistan has officially issued its Guidelines on GS1 DataMatrix Barcode and Serialisation of Pharmaceutical Products (1st Edition), effective 28 July 2026 - the operational layer beneath SRO 963(I)/2026.
In the same window, GS1 Healthcare published a position paper welcoming the SRO and inviting clarification in four areas: serial number requirements, expiry date interpretation, reporting alignment, and data carrier requirements for tertiary packaging.
Reading the two documents side by side is worth the time.
Where the Guidelines provide clarity
→ Serial numbers. Randomised, unique, hexadecimal (0–9, A–F), 12 to 20 characters. Annex I adds that "any subset" of the hexadecimal character set is acceptable ز
→ Tertiary packaging. The Guidelines now separate the two identification purposes explicitly: GS1 DataMatrix carries GTIN, expiry and batch to identify the trade item, while GS1-128 carries the SSCC to identify the logistics unit. Heterogeneous packs require SSCC only. This is the standards-aligned distinction GS1 asked to see stated.
→ Human-readable expiry. MM/YYYY remains acceptable for HRI where the Drugs (Labeling and Packing) Rules, 1986 permit it وno immediate artwork change forced on that count.
Where implementers will want to align early
The Guidelines specify that the expiry date encoded in the DataMatrix and submitted electronically to DRAP shall correspond to the actual approved expiry date assigned to the batch. GS1's paper proposed a different convention for markets using MM/YYYY on pack ,encoding the last day of the last full month before expiry.
Both approaches are defensible. They simply produce different values for the same batch. Manufacturers supplying multiple markets will want to confirm which convention applies in Pakistan before locking artwork, encoding logic and reporting mappings , because the three have to agree.
Timeline
Secondary packaging:*9 October 2026.
Tertiary packaging: phased, up to six years.
Primary packaging: exempt at this stage.
one side note the draft guidelines mentioned (allopathic drugs, including biologicals, for human and veterinary use) while the announced officially guidelines mention for registered pharmaceutical products in Pakistan.
We're tracking #Pakistan's rollout alongside 24+ national systems on TraceHub. Happy to compare notes with anyone working through the same questions.
Please visit #pakistan at TraceHub country tracker to check the published guildines and GS1 paper,and register to our awareness webinar on 29 of July for more insights regarding #Pakistan