Gambia will import pharmaceutical products from India only after they are independently tested, the first such restriction since child deaths last year in Gambia and Uzbekistan, linked to Indian-made cough syrups, stirred concerns about the quality of drugs from India.

The Gambian Medicines Control Agency (MCA) has told Indian authorities that it has introduced a regulation that will require all imported pharmaceutical products from July 1 to be inspected and sampled for testing to ensure conformity to quality standards “prior to shipment from India”.

The regulation for inspection, quality-control testing and a Clean Report of Inspection and Analysis (CRIA) from an independent lab seeks to address issues related to substandard and falsified medicines entering the country, the MCA’s executive director, Markieu Janneh Kaira, said in a June 15 letter to Rajeev Raghuvanshi, the head of India’s drug regulatory authority.

The MCA has appointed Quntrol Laboratories, a Mumbai-based private inspection and testing company, to carry out the process and issue the CRIA for all shipments. Kaira has requested Raghuvanshi to share this information with pharmaceutical exporters, industry associations and state authorities.

The MCA letter has surprised sections of the domestic industry and clinical pharmacologists, some of whom have interpreted the Gambian demand for independent testing as a signal of a lack of confidence in the Indian government’s own pre-export testing protocols and regulations.

The directorate-general of foreign trade, a Union commerce ministry department, had last month directed that all cough syrups produced in India and intended for export should be sample-tested in government-accredited labs.

Experts had viewed the DGFT order as part of the Centre’s efforts to restore India’s image as a source of reliable medicines, dented after Gambian and Uzbek authorities found contaminated Indian-made cough syrups last year and US authorities this year detected contaminated eye drops from India.

“India’s pharma industry is exporting medicines to nearly 200 countries — and no other country has a rule that Gambia now wants to introduce,” said an industry executive who requested not to be named. “But Gambia of course has the right to do this.”

Raghuvanshi, the drugs controller-general of India and the head of the Central Drugs Standard Control Organisation, was not immediately available for comments on the letter from the MCA.

Santanu Tripathi, a clinical pharmacologist who has no association with the CDSCO but has seen the MCA’s letter, said the Gambian decision was “disappointing” because it appeared to disregard the testing regulations imposed by the Indian government in favour of independent testing.

“The requirement for independent testing indicates Gambian authorities are not ready to accept the testing protocols and pre-export requirements that Indian government regulators have imposed on drug exporters,” said Tripathi, former head of clinical pharmacology at the Calcutta School of Tropical Medicine. “This is not good for our regulators’ image. I hope the Indian government will take this up to resolve it.”