It is not the first time that the products of Maiden Pharmaceuticals Ltd — whose cough syrups allegedly caused the death of 66 Gambian children — have come under the scanner. Its tablets for diabetics have earlier been declared “substandard” by states like Bihar, Jammu & Kashmir, Kerala and Gujarat.
In 2015, authorities in Gujarat reported that samples of Maiden-manufactured Macipro, a drug containing the popular antibiotic ciprofloxacin, had failed the dissolution test. In 2021 and early 2022, Kerala authorities found Maiden’s products to be of substandard quality by at least five times.
Two sets of tablets of metformin – used to treat type-2 diabetes – from a hospital in Palakkad in March 2022 and from a primary health centre in Ernakulam in September 2022 had failed the dissolution test, according to a news agency report.
The Central Drugs Standard Control Organisation (CDSCO) has sent the samples of the same batch of the four Maiden Pharmaceuticals Ltd-manufactured cough syrups, on which the WHO issued alert, for testing. The Union Health Ministry has said that the further course of action in the matter will depend on the CDSCO probe outcome.
"The samples (controlled samples of the same batch manufactured by M/s. Maiden Pharmaceuticals Ltd for all the four drugs in question) have been taken and sent for testing to Regional Drug Testing Lab, Chandigarh, by the CDSCO, the results of which will guide further course of action as well as bring clarity on the inputs received, to be received from WHO," said the Ministry in a statement here.
The CDSCO in its preliminary report has said that it has been found that Maiden Pharmaceuticals is a manufacturer licensed by the State Drug Controller for products Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup, and MaGrip n Cold Syrup under reference, and holds manufacturing permission for these products for export only. The company has manufactured and exported these products only to The Gambia. As per the tentative results received by WHO, out of the 23 samples of the products under reference which were tested, 4 samples have been found to contain Diethylene Glycol/ Ethylene Glycol.
It has also been informed by the WHO that the certificate of analysis will be made available to the WHO in near future and it will share it with the Indian regulator. The exact one to one causal relation of death has not yet been provided by the WHO to the CDSCO, the ministry added.
Maiden Pharmaceuticals exports its products to countries in Asia, Africa and Latin America. Medical officers in The Gambia first raised the alarm in July after dozens of children were diagnosed with serious kidney problems.