After the World Health Organization flagged contamination in its cough syrups in the Mashall Islands and Micronesia in April, India suspended a drugmaker’s manufacturing license. The Indian regulators are inspecting drugmakers after cough syrups were linked to at least 89 child deaths in Gambia and Uzbekistan last year.
The WHO flagged contamination with unacceptable amounts of diethylene glycol and ethylene glycol, which are considered toxic to humans when consumed and can prove fatal, in samples taken from a batch of cough syrup made by QP Pharmachem Ltd, based in the northern Punjab state.
However, the company denied wrongdoing and told Reuters it planned to appeal against the suspension. Maiden Pharmaceuticals and Marion Biotech have also denied any wrongdoing.
Deputy Health Minister Bharati Pravin told the parliament, “Drug samples drawn from the manufacturing premises … were declared as ‘not of standard quality.”
The manufacturing licenses of QP Pharmachem Ltd and two other companies, whose products were linked to the child deaths – Maiden Pharmaceuticals and Marion Biotech Pvt. Ltd – have been suspended and their exports halted, Pawar added.
Sudhir Pathak, managing director of QP Pharmachem said production had been halted. He told Reuters that the company has planned to appeal against the suspension order with the government,
Pathak said he had tested the ingredients used in the cough syrup, named Guaifenesin TG, before starting its production. He also said he only exported the product to Cambodia and was unsure how it could have reached the Mashall Islands and Micronesia.
India has tightened its testing of cough syrup exports since June, making it mandatory for companies to obtain a certificate of analysis from a government laboratory before exporting products.
In June this year, the World Health Organisation in its probe related to the supply of contaminated cough syrups across the world, has flagged seven Made-in-India products.
It also flagged a total of twenty toxic medicines whose consumption led to the death of more than 200 deaths across the world. Rest of the medicine products in the list originated from Indonesia.
Haryana-based Maiden Pharmaceuticals, Marion biotech, and QP Pharma Chem are the main producer of these toxic syrups. Notably, WHO has earlier also issued alert for India-made contaminated drugs, but this time the list has come after the completion of a full investigation on the matter.
(With Reuters inputs)
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Updated: 26 Jul 2023, 07:37 AM IST