The Indian Government has notified pharmaceutical companies that they must meet new manufacturing standards this year, after a string of deaths linked to Indian-made drugs since 2022.
The World Health Organisation and other health authorities have linked Indian cough syrups to the deaths of at least 141 children in Gambia, Uzbekistan and Cameroon.
Jolted by the tragedies, authorities have now intensified scrutiny of pharmaceutical factories to clean up the image of the $50bn industry, reports Reuters.
“The manufacturer must assume responsibility for the quality of the pharmaceutical products to ensure they are fit for their intended use, comply with the requirements of the licence, and do not place patients at risk due to inadequate safety, quality or efficacy,” said the notification.
Companies can market a finished product only after “satisfactory results” on tests of ingredients, and must retain a sufficient quantity of the samples of intermediate and final products to allow repeated testing or verification of a batch, it said.
The Health Ministry said in August last year that inspections of 162 drug factories since December 2022 had found an alarming “absence of testing of incoming raw materials”.
Fewer than a quarter of the 8 500 small drug factories met international drug manufacturing standards set by the WHO.
The notification said those concerns must be addressed by large companies within six months and small manufacturers in 12 months – the latter had asked for the deadline to be extended, warning that investments required to meet the standards would shut down nearly half of them because they are already heavily indebted.
Reuters article – India orders new drug-making standards after overseas deaths (Open access)
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