Riemann Labs is one of three Indian drugmakers whose cough syrups have been linked to the deaths of at least 141 children in Gambia, Uzbekistan and Cameroon since the middle of last year.
That has cast a shadow on the quality of exports from India, often dubbed the “world’s pharmacy” due to its supply of life-saving drugs at low prices to countries that most need them.
The World Health Organization (WHO) said in July that a sample picked up from Cameroon of Naturcold syrup, whose maker India has identified as Riemann, contained as much 28.6% of the toxin of diethylene glycol, compared with an acceptable limit of no more than 0.10%.
An inspection at Riemann’s factory by state and federal regulators in June had found violations including improper ventilation, raising the risk of cross contamination, the sources said.
The other Indian cough syrup makers linked to the overseas deaths have also applied to reopen their factories, Reuters has reported.
India has made tests mandatory for cough syrup exports since June and has stepped up scrutiny of drugmakers, finding a string of deficiencies in recent inspections including poor documentation and a lack of self-assessment.
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