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Five Batches of Maiden Pharma Cough Syrup Flagged as ‘Spurious’ by CDSCO

Maiden Pharma came under fire after its cough syrups were linked to the death of over 66 children in the Gambia.

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Five samples of cough syrups produced by Maiden Pharmaceuticals have been declared 'not of standard quality', 'spurious', and 'misbranded', by India's drugs regulatory body, the Central Drugs Standards Control Organisation (CDSCO).

Why this matters: The CDSCO, reportedly, tested samples from five separate batches of the CSP Cough Syrup for Throat & Chesty manufactured by Maiden Pharmaceuticals in Himachal Pradesh, following a long-winding controversy surrounding cough syrups made by the company which were linked to the death of over 66 children in the Gambia in October.

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Breaking it down: The test reports, put out by the CDSCO in its list of drugs declared as 'spurious', 'adulterated,' released in December 2022, says the five samples failed assays (measuring presence of) of Diphenhydramine, Hydrochloride, Codeine, Phosphate, Sodium Citrate and Menthol in three of the samples; Assay of Codeine, Phosphate and Menthol in another sample; and an assay of Codeine, Phosphate, Sodium Citrate and Menthol in the last one.

This is not the first products manufactured by the company to fail drug safety tests. 21 batches of Albendazole tablets produced by Maiden Pharmaceuticals also failed the quality test, according to a report by the Tribune.

What happened in Gambia: In mid-2022, a slew of young children dying of acute renal injuries in the Gambia set off health authorities in the country. The investigation linked the death of at least 66 children to four cough syrups manufactured by Indian pharmaceutical company, Maiden Pharmaceuticals.

In October, a panel of experts at the Gambia National Assembly officially held the four cough syrups responsible for the deaths of the children.

The World Health Organization (WHO), in October, also released a statement saying diethylene glycol (DEG) has been found in four syrups produced by the company.

"Please DO NOT use them," said the WHO in the statement.

Action taken: Despite, the warning from WHO, and the call for ban by the Gambia health authorities, and despite the company being forced to stop production, Haryana Medical Services Corporation Limited (HMSCL) is yet to blacklist the firm, reported the Tribune.

India’s Drug Controller General Dr VG Somani, on 13 December, said that the cough syrups in question weren’t found to be contaminated when tested at an Indian government laboratory.

It must be noted, however, that the CDSCO in its December bulletin only mentions the samples failing assay. There is no mention of an impurity check, or DEG testing done on these samples.

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