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New requirement takes effect on 9 October
ISLAMABAD: The Drug Regulatory Authority of Pakistan has directed manufacturers and importers to comply with 2D Data Matrix barcoding and serialization requirements for registered pharmaceutical products manufactured locally or imported into Pakistan on or after 9 October 2026.
The direction appears in Circular F. No. 1-2/2026-CEO(DRAP), issued on 8 October 2026. It also clarifies that batches with a manufacturing date before 9 October remain exempt from the new requirement and may continue to be imported, distributed and sold.
The manufacturing-date exemption is important for imported stock. A batch manufactured before the cutoff is not brought within the new requirement merely because it enters Pakistan on or after 9 October. The circular expressly includes earlier-manufactured imported batches in its clarification.
Download the complete DRAP circular — PDF, 2 pages, or view it online.
Phase one covers locally manufactured and imported pharmaceutical products
DRAP describes the pharmaceutical Track and Trace System as a phased regulatory rollout. Phase one requires a unique 2D Data Matrix barcode and serialization for the pharmaceutical products within its scope.
The circular’s distribution list addresses manufacturers and importers of pharmaceutical and biological drugs and veterinary products. It also goes to the Pakistan Pharmaceutical Manufacturers’ Association and Pharma Bureau Pakistan for circulation to their members.
The document links the rollout to DRAP’s statutory mandate under the DRAP Act, 2012, and to amended labelling and packaging rules under S.R.O. 963(I)/2026. Manufacturers and importers are directed to meet the technical parameters in the relevant rules.
Earlier-manufactured batches can remain in circulation
Paragraph 4 draws the distinction between new production or imports subject to the requirement and batches protected by the manufacturing-date exemption. It states that locally manufactured or imported batches with a manufacturing date before 9 October 2026 remain permitted for import, distribution and sale.
That qualification means the circular does not announce a blanket ban on all existing medicine stock lacking the new barcode. The exemption concerns this particular requirement; it does not dispense with other registration, quality, expiry or sale requirements applicable to a product.
For example, an imported batch bearing a manufacturing date of 8 October falls within the circular’s stated earlier-date exemption. A locally manufactured batch dated 9 October falls on the new side of the cutoff. These examples explain the date distinction; they do not determine whether any particular product otherwise satisfies the law.
DRAP warns of legal action for non-compliance
The circular states that legal action under relevant legislation will be initiated in cases of non-compliance. It does not itself specify a fixed fine, prison term or automatic cancellation of a licence. Any enforcement report must identify the applicable legislation and the actual action taken rather than infer a particular penalty from this warning.
The document was signed by Atta-ur-Rehman, Director MIS, and states that it was issued with the approval of DRAP’s Chief Executive Officer. Copies were directed to federal and provincial health authorities and DRAP’s regional offices.
System is intended to support traceability and recalls
DRAP says the initiative is intended to curb spurious, falsified, counterfeit and unregistered medicines, support integrated product recalls and improve supply-chain transparency and integrity. These are the authority’s stated objectives, not findings that the rollout has already achieved those results.
The circular records consultations with industry bodies and importers, technical sessions and nationwide training. It also refers to published GS1 Data Matrix barcoding and serialization guidelines, video tutorials and assistance modules covering implementation and integration with DRAP’s e-Services portal.
Barcoding identifies a product or pack in a machine-readable form, while serialization distinguishes individual units through unique identifiers. The detailed technical standard remains governed by the applicable rules and DRAP guidance, rather than the general description in this report.
Source note: the circular contains an S.R.O. date inconsistency
Paragraph 2 identifies S.R.O. 963(I)/2026 as dated 9 June 2026, while paragraph 4 gives 9 July 2026 for the same number. The circular consistently gives 9 October 2026 as the implementation date. This report relies on that stated implementation date and identifies the S.R.O. by number without treating either conflicting issue date as conclusively verified.
The circular calls the underlying instrument the amended Drugs (Labelling & Packaging) Rules, 1978. That is the circular’s description; the Gazette instrument should be consulted for its exact legislative title and amendment text. The attached PDF reproduces the circular unchanged.
Primary material: DRAP’s official publication page and the official circular PDF.