TMDA allays fears over toxic syrups

THE Tanzania Medicines and Medical Devices Authority (TMDA) has allayed fears over presence of four types of syrups identified by the World Health Organisation (WHO) as potentially fatal to children.

TMDA Director General, Mr Adam Fimbo clarified on Friday in a statement that the products linked to an Indian company have not entered the local market.

“TMDA would like to assure the general public that these products are not available in our market and have never been registered for use in Tanzania,” he said.

Nonetheless, he stated that the Authority has increased its vigilance through its Post-Marketing Surveillance system (PMS) to detect any product that may cross borders.

“TMDA assures the public that there is no cause for concern because the cough preparations (syrups) and promethazine products in the Tanzanian market meet the authority’s market authorisation requirements on quality, safety and efficacy,” he said.

Mr Fimbo urged the public to notify TMDA if such products are discovered anywhere in the country via its headquarters or zone offices, or any nearby Regional and District Medical Officer’s offices, or any Police Station.

WHO flagged Promethazine Oral Solution (Manufactured by an Indian company), Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.

TMDA has also provided a toll-free number 0800110084 which Tanzanians can use to report drugs they suspect to be harmful.

Mr Fimbo stated that WHO notified the agency about four contaminated and substandard cough syrups manufactured by an Indian company, warning that they could be linked to the deaths of 66 children in The Gambia, a West African country.

“WHO is conducting further investigation with the company and regulatory authorities in India,” he noted.

The labels of all the products indicate that the same were manufactured by one company based in India by the name of Maiden Pharmaceuticals Limited.

All samples of the products tested indicate that they contain toxic excipients namely diethylene glycol and ethylene glycol which can cause severe and profound adverse drug reactions including death to users.

The UN health agency also cautioned that the contaminated medications may have been distributed outside of the West African country, with global exposure possible.

The WHO alert says all batches of these products should be considered unsafe until they can be analysed by the relevant national regulatory authorities, the WHO said.

“While these four products have been identified in The Gambia, it apprehended that they may have been distributed through informal markets to other countries or regions, and it is important to detect and remove these substandard products from circulation to prevent harm to patients,” the alert reads in part.

WHO requested increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these products. Increased surveillance of the informal/unregulated market is also advised, it added.

Delhi-based Maiden Pharmaceuticals Ltd, which allegedly exported faulty cough syrup to the Gambia has defaulted many times and had flouted rules before as well, a report in India Today stated.

The pharma company, as per the report, has been flagged in many Indian states over the years for their medicines failing the quality and safety parameters.

According to the extended licensing, Laboratory and Legal Node (XLN) database maintained by the government of India, Kerala and Gujarat state governments have repeatedly issued warnings against the company’s illegal practices. A Kerala drug inspector even filed a case in 2005, after which the company was fined in 2017.

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