Wednesday, December 6, 2023

BoMRA allays fears on deadly cold syrups

The Botswana Medicines Regulatory Authority (BoMRA) has issued a notice to its stakeholders and the public, that it has received a global rapid alert from the World Health Organisation (WHO) on cough and cold syrups manufactured by Maiden Pharmaceuticals Limited, Haryana, India

This comes in the wake of a story published exclusively in the Sunday Standard two weeks ago that (BoMRA) has licensed the Indian drug manufacturer believed to be exporting “toxic” medical products.

Maiden Pharmaceuticals which has been flagged by the World Health Organisation after its cough syrup  killed 66 children in Gambia lists Botswana among a half a dozen African countries that import its products.

According to a press statement from BoMRA “the products were first detected in the Gambia, where there were declared unfit for use by the (WHO) and allegedly responsible for the deaths of children reported in the same region.”

BoMRA has however allayed fears that the lethal cough syrup may be in Botswana. States a press release from Botswana’s medicines regulatory watchdog: “Upon receiving the alert, BoMRA immediately conducted due diligence on the matter, including checking the databases of all registered products and records of importation, including that of registered medicine distributors and retailers. The preliminary investigation has shown that none of the mentioned products appear on the BoMRA medicines register and there is no evidence that they are available in the Botswana market, based on any approval issued by the Authority.

BoMRA is mandated to ensure that all medical products used in Botswana meet the set standards of safety, quality, and efficacy, the Authority further reassures the nation that its post-marketing surveillance program has increased surveillance and diligence within the supply chains to detect and remove any such products if found.

The public is further requested to notify BoMRA of any suspicious products that may have been distributed through informal markets as well as report adverse drug reactions.

Botswana is one of six African countries which import drugs from Maiden Pharmaceuticals according to the drug company’s website. The other five are  Liberia, Burkina Faso, Sudan, Nigeria, and Sierra Leon.

Maiden Pharmaceuticals is also embroiled in a controversy in its home country as the Indian media questions why India’s  Central Drugs Standard Control Organisation (CDSCO) has not yet barred the company from operating in India when many of its medical products made for Indian use have also been found to be of substandard quality, often flagged by authorities.

It has emerged from media reports that the company has been flagged in many Indian states over the years after their medicines failed the quality and safety standards.

An investigation by India Todaynewspaper revealed that, “reports suggest that the company has been a serial offender on quality control standards in the past as many state governments, and authorities have flagged it. Dinesh thakur, a public health activist based in St Petersburg has published a long Tweet thread on the matter and has also raised questions over the functioning of the Central Drugs Standard Control Organisation (CDSCO) in India as well as the pre-qualification process of the WHO.

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