Zambia Tightens Rules on Indian Pharmaceutical Imports to Curb Fake Drugs

Starting October 1, 2025, all medicine shipments from India to Zambia must undergo inspection prior to leaving Indian ports. The policy, announced by the Zambia Medicines Regulatory Authority (ZAMRA), is designed to block the import of substandard or falsified pharmaceutical products.

Under the new system, consignments must pass a three-stage verification process—documentation review, physical inspection, and laboratory testing. Only shipments that meet Zambian quality standards will be issued a Clean Report of Inspection and Analysis (CRIA) certificate. Without this document, customs clearance in Zambia will be denied.

To implement the program, ZAMRA has authorized Quntrol Laboratories Pvt Ltd in India to conduct the inspections and testing. Exporters are being advised to coordinate with the approved facility well in advance to avoid shipping delays or rejection at the destination.

The measure follows heightened global scrutiny of pharmaceutical quality after contaminated Indian-made cough syrups were linked to child fatalities in Gambia and Uzbekistan. These incidents, though involving a small number of manufacturers, have raised broader questions about oversight and compliance in India’s vast pharmaceutical sector.

India is one of the world’s largest suppliers of generic drugs, exporting medicines worth $26.5 billion in FY24, with the total pharmaceutical industry valued at about $50 billion. While Zambia represents less than 1% of India’s pharmaceutical exports, the African nation’s decision reflects a growing global push for source-country quality certification—ensuring medicines are verified before leaving the exporting country.

India’s own regulator, the Central Drugs Standard Control Organization (CDSCO), has increased its monitoring efforts in recent years, issuing monthly alerts and mandating recalls or production halts for batches that fail quality tests. However, ZAMRA’s new requirement shifts part of the quality control burden directly to exporters.

Zambian officials stress that the move is not a targeted towards Indian manufacturers, but a public health safeguard intended to protect citizens from unsafe medicines. Industry observers note that if the measure proves effective, other importing countries could adopt similar policies, potentially reshaping the compliance landscape for pharmaceutical exporters worldwide.

(Rh/Eth/NS/MSM/SE)