India orders new drug manufacturing standards after deaths abroad

NEW DELHI:

Indian pharmaceutical companies must meet new production standards this year, according to a government announcement released on Saturday, although smaller companies have asked for a delay, citing their debt.

Shaken by a spate of deaths abroad linked to Indian-made drugs from 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 take responsibility for the quality of medicinal products to ensure that they are suitable for their intended use, comply with the requirements of the license and do not put patients at risk due to insufficient safety, quality or efficacy” , the notification dated December 28 said.

Companies must market a finished product only after receiving “satisfactory results” in ingredient tests and keep enough samples of intermediate and finished products to allow repeat testing or verification of a batch, he says.

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The health ministry said in August that inspections of 162 drug factories since December 2022 had found “absence of control of incoming raw materials”. He said less than a quarter of India’s 8,500 small drug factories met international drug production standards set by the World Health Organization (WHO).

The notification said these concerns must be addressed by large drug manufacturers within six months and small manufacturers within 12 months. Small companies had asked for an extension of the deadline, warning that the investments needed to meet the standards would shut down almost half of them because they are already over-indebted.

The WHO and other health authorities have linked Indian cough syrups to the deaths of at least 141 children in Gambia, Uzbekistan and Cameroon.