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The Zambia Medicines Regulatory Authority (ZAMRA) has announced the postponement of pre-shipment inspection implementation by the Indian pharma exporters until further notice. “An updated implementation timeline will be issued at the appropriate time,” a Notification from ZAMRA stated.
The mandate of pre-shipment inspection implementation by the Indian pharma exporters, which was scheduled to come into force from October 1, 2025, was being implemented to curb the entry of substandard and falsified medicines into the Zambian market. This mandate applied to all pharmaceutical products exported from India.
ZAMRA had on August 06, 2025 officially communicated to India about the implementation of pre-shipment mandate for all pharmaceutical consignments being exported to Zambia through a Circular.
As per the regulation, ZAMRA aimed at mandating the implementation of pre-shipment document verification, physical inspection, quality control testing, and the issuance of a Clean Report of Inspection and Analysis (CRIA) for all pharmaceutical consignments entering Zambia from India.
The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has urged all member companies exporting pharmaceuticals to Zambia to take note and act accordingly. Pharmexcil had earlier urged exporters to implement Zambia’s new pre-shipment mandate to curb counterfeit medicines imports into Zambian market.
ZAMRA Circular had earlier stated, “From October 1 onwards, all shipments bearing a Bill of Lading must be accompanied by a CRIA to facilitate customs clearance at Zambian ports of entry. Quntrol Laboratories Private Limited has been designated by ZAMRA as the authorized agency to carry out the verification, inspection, testing, and CRIA issuance in India.”
Pharmexcil had emphasized the seriousness of the compliance requirement and alerted its members to align with the new procedures to avoid trade disruptions. Exporters were strongly urged to initiate coordination with Quntrol Laboratories well in advance of the deadline to ensure timely processing and to prevent any shipping delays or port clearance issues.
India is one of the major suppliers of affordable and quality pharmaceuticals to African nations, including Zambia. India's pharmaceutical exports to Zambia reached USD 99.49 million during FY24.
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