Indian pharmaceutical corporations should meet new manufacturing requirements this yr, in accordance with a authorities notification launched on Saturday, though small corporations have requested for a delay, citing their debt load.
Jolted by a string of abroad deaths linked to Indian-made medicine since 2022, Prime Minister Narendra Modi’s authorities has stepped up scrutiny of pharmaceutical factories to wash up the picture of the $50 billion trade.
“The producer should assume accountability for the standard of the pharmaceutical merchandise to make sure that they’re match for his or her supposed use, adjust to the necessities of the licence and don’t place sufferers in danger as a consequence of insufficient security, high quality or efficacy,” stated the notification, dated Dec. 28.
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Firms should market a completed product solely after getting “passable outcomes” on checks of the elements and retain a enough amount of the samples of intermediate and ultimate merchandise to permit repeated testing or verification of a batch, it says.
The well being ministry stated in August that inspections of 162 drug factories since December 2022 discovered an “absence of testing of incoming uncooked supplies”. It stated fewer than 1 / 4 of India’s 8,500 small drug factories met worldwide drug manufacturing requirements set by the World Well being Group (WHO).
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The notification stated these considerations should be addressed by giant drugmakers inside six months and small producers in 12 months. Small corporations had requested for the deadline to be prolonged, warning that investments required to satisfy the requirements would shut down practically half of them as a result of they’re already closely indebted.
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The WHO and different well being authorities have linked Indian cough syrups to the deaths of at the very least 141 kids in Gambia, Uzbekistan and Cameroon.
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This story has been revealed from a wire company feed with out modifications to the textual content. Solely the headline has been modified.
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Printed: 06 Jan 2024, 02:00 PM IST
Supply: Live Mint