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More than 100 pharma plants shut in India amid quality crackdown

The national drug regulator conducted inspections after cough syrup made in the country was linked to deaths of children

India’s drug regulator has carried out inspections at hundreds of pharmaceutical plants after cough syrup produced in the country and exported worldwide was linked to the deaths of dozens of children.

The Central Drugs Standard Control Organization (CDSCO) has conducted “risk-based inspections” at more than 400 pharmaceutical manufacturing units over the past year and a half, agency chief Rajeev Raghuvanshi revealed at an industry event on Thursday. Some 36% of these were closed down, he added.

“These [micro, small and medium enterprises] had to shut down as they realized that they cannot meet the expectations of the regulators,” said Raghuvanshi.

The Indian government is planning to implement several projects that would help the industry to improve the quality of the products, he added. 

“We cannot generalize [when it comes to Indian pharma],” Raghuvanshi told news channel Zee News on the sidelines of the event. “However, there are some defaulters and we are taking action against them.”

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Over 50 Indian cough-syrup makers fail quality test – report

India’s $41 billion pharmaceutical industry, one of the largest in the world, has been under intense scrutiny as cough syrups produced in the country have been linked to the deaths of dozens of children in Gambia, Uzbekistan, and Cameroon. Two toxins, diethylene glycol and ethylene glycol, which can cause acute kidney injury and death, were reportedly found in the medicines, Reuters has reported.

Last year, the regulatory body reported that more than 50 cough syrup manufacturers in India had failed quality tests that were made mandatory due to concerns over the quality of medicines that the country exports. Last year in May, the federal government made it mandatory for cough syrup manufacturers to get their products tested at government labs before exporting them.

In 2022, the World Health Organization (WHO) issued warnings in relation to four brands of cough syrup manufactured and exported by Indian drug maker Maiden Pharmaceuticals to Gambia.

According to Raghvanshi, New Delhi has not received any complaints from the WHO or any other agency since last July due to its ability to control the issues “from a quality point of view.”

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