Gambia tightens rules for Indian drugs after cough syrup deaths

At least 70 children died in Gambia after ingesting Indian-made cough syrup last year. PHOTO: REUTERS

NEW DELHI – Gambia will make it mandatory from July 1 for all pharmaceutical products from India to be inspected and tested before being shipped out of the country.

These are the first known restrictions on exported goods after the deaths of dozens of children were linked to Indian-made cough syrups in 2022.

The new rules highlight how governments are reassessing their reliance on India’s US$42 billion (S$56.4 billion) pharmaceutical industry since the contamination came to light in 2022.

India supplies nearly half of the pharmaceuticals used in Africa.

In April, the Indian government said its officials had held meetings in Africa to ensure its drug exports did not suffer, following news that at least 70 children died in Gambia after ingesting the cough syrup last year.

Gambia’s latest move is to “address issues related to substandard and falsified (counterfeit) medicines entering the country”, said the executive director of the Gambian Medicines Control Agency (MCA) Markieu Janneh Kaira.

Ms Kaira, in a letter to India’s drug controller-general Rajeev Singh Raghuvanshi on June 15, said the MCA had appointed Quntrol Laboratories, an independent inspection and testing firm for pharmaceuticals in Mumbai, to issue a Clean Report of Inspection and Analysis report for all shipments from India.

The letter said: “Quntrol shall conduct document verification, physical inspection of the consignment and sampling, for laboratory testing for each shipment.

“If conformity is established at all levels, Quntrol shall issue the mandatory CRIA document. If conformity is not established with regards to the quality of the product, the shipment will be quarantined or seized by the MCA and the necessary regulatory actions shall be taken.”

Ms Kaira said the rule “applies to India only for now”. Since June 1, India has made tests mandatory for all cough syrups before they are exported.

Mr Raghuvanshi did not immediately respond to a request for comment.

With 2.5 million people, Gambia is one of Africa’s smallest and poorest countries. The World Bank is funding a testing laboratory in Gambia but it is not yet finished.

The letter said Quntrol would send samples for testing to “one of the analytical laboratories approved by MCA”. It did not say if the laboratory would be based in India or elsewhere.

In 2022, at least 70 children, most of them under the age of five, died in Gambia due to acute kidney injury that doctors have linked to adulterated cough syrups from India.

The World Health Organisation last year said the India-made cough syrups contained lethal toxins ethylene glycol and diethylene glycol – commonly used in car brake fluid and other products not fit for human consumption.

These ingredients can be used by unscrupulous actors as a substitute for propylene glycol, which is a key base of syrupy medicines – because they can cost less than half the price – manufacturing experts say. REUTERS

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