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Shardul Nautiyal, Mumbai August 12 , 2025
In a significant regulatory development, the Pharmaceuticals Export Promotion Council of India (Pharmexcil) has urged exporters to implement Zambia’s new pre-shipment mandate to curb counterfeit medicines imports into Zambian market.

This is followed by an official notification from the Zambia Medicines Regulatory Authority (ZAMRA), announcing the mandatory 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.

This regulation, which will come into force from October 1, 2025, is being implemented to curb the entry of substandard and falsified medicines into the Zambian market and applies to all pharmaceutical products exported from India.

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 emphasized the seriousness of the compliance requirement and alerted its members to align with the new procedures to avoid trade disruptions.

“We wish to inform our members that the ZAMRA has officially communicated the implementation of pre-shipment mandate for all pharmaceutical consignments being exported to Zambia. Exporters have been 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,” said Raja Bhanu, director general, Pharmexcil.

India's pharmaceutical exports to Zambia reached USD 99.49 million during FY24. With India being one of the major suppliers of affordable and quality pharmaceuticals to African nations, including Zambia, this regulatory shift underscores the growing emphasis on drug quality, patient safety, and cross-border cooperation in medicine regulation.

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