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Indian pharmaceutical companies must meet new manufacturing standards this year, according to a government notification released on Saturday, although small companies have asked for a delay, citing their debt load.

Jolted by a string of overseas deaths linked to Indian-made drugs since 2022, Prime Minister Narendra Modi’s government has stepped up scrutiny of pharmaceutical factories to clean up the image of the $50 billion industry.

“The manufacturer must assume responsibility for the quality of the pharmaceutical products to ensure that 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, dated Dec. 28.

Companies must market a finished product only after getting “satisfactory results” on tests of the ingredients and retain a sufficient quantity of the samples of intermediate and final products to allow repeated testing or verification of a batch, it says.

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