Zambia mandates pre-export checks of all Indian medicines to curb entry of substandard, fake drugs

New Delhi: Zambia has for the first time mandated pre-export checks of all Indian medicines destined for the African nation in a bid to curb the entry of substandard, adulterated and fake drugs.

Starting 1 October, every medicine consignment must undergo document checks, physical inspection and quality testing by a laboratory appointed by the Zambia Medicines Regulatory Authority (ZAMRA). Only after a Clean Report of Inspection and Analysis (CRIA) certificate is issued will these medicine consignments be cleared by Zambian customs.

“This regulation 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,” the Pharmaceuticals Export Promotion Council of India (Pharmexcil) said in a circular on its website dated 6 August. The council, with over 4,000 member-companies, said ZAMRA officially communicated the implementation of the new mandatory requirement for all pharmaceutical consignments exported to Zambia.

According to the circular, all shipments with a bill of lading dated on or after 1 October 2025 must be accompanied by the CRIA. This document certifies that the products meet the required quality standards.

“Every country has the right to make quality control checks. This measure is a direct response to concerns about substandard and falsified medicines entering the Zambian market,” said an official in the know of the matter. “Right now, a product is registered, then the customer places the order and the manufacturers start selling. Now, with Zambia’s new regulatory provision, the products will be verified by them and then it will be cleared for exports to Zambia.”

Zambia accounted for less than 1% of India’s pharmaceutical exports in FY24. The measure comes in the backdrop of poor-quality Indian-made cough syrups that have been linked to the deaths of 84 children in Gambia and Uzbekistan since 2022.

Authorized agency

According to the circular, ZAMRA has designated Quntrol Laboratories Pvt Ltd as the authorized agency in India to conduct the verifications, inspections and testing, and to issue the CRIA.

“Exporters are requested to ensure strict compliance with this requirement to avoid any clearance issues at the Zambian border,” Pharmexcil stated.

India’s pharmaceutical industry, the world’s third largest by volume, is a global powerhouse with a diverse product base including generic drugs, vaccines and biologics. The industry’s strong global presence and significant export value highlight its importance in providing accessible and affordable medicines worldwide.

In FY24, the market was valued at $50 billion, with exports accounting for $26.5 billion. India’s pharmaceutical exports to Zambia reached $99.49 million during this period.

Manufacturing or selling substandard, adulterated or fake drugs is a punishable offence in India. To ensure public safety, the Central Drugs Standard Control Organization puts out monthly “Drug Alerts” that list medicines that fail quality checks.

When a drug is found to be not of standard quality, the manufacturer is immediately required to recall the product and halt further distribution. Based on investigations, the licensing authorities can suspend or cancel permits and issue stop-production orders.