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25-02-2023, 06:03 PM
Penny MacRae
Published: 2:00pm, 25 Feb, 2023
India-made eyedrops linked to a “superbug” outbreak in the United States have put the country’s flagship pharmaceutical industry under an unwelcome spotlight over possible quality safety lapses.
The US Food and Drug Administration (FDA) this month warned against using the eyedrops that have been potentially tied to a “rare, extensively drug-resistant” bacteria causing infections, blindness and one death in 55 people in the country.
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India’s drug industry has also been in the news over the kidney-failure deaths of 90 children – 20 in Uzbekistan and 70 in Gambia – that the World Health Organization (WHO) has linked to Indian-made cough syrups.
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In India, ...... three years ago, 12 children’s deaths were blamed on contaminated syrup made by a company whose products had failed regulatory tests 35 times in a decade.
......
India’s patchwork of state and federal regulations creates oversight problems. Domestic inspections can be sporadic and Indian drugs are not always standard quality. Regulation is complicated by the fact there are 3,000 Indian companies running 10,500 generic manufacturing plants and a shortage of drug inspectors.
......
The US FDA, which inspects Indian plants exporting to the US, has uncovered fudged test and manufacturing data, adulteration, impurities, substandard quality, faulty equipment, and hygiene issues with troubling regularity.
......
India’s Central Drugs Standard Control Organisation approves new medicines. But the licensing of facilities and manufacturing quality checks rest with India’s 28 states.
Drugs failing quality tests in one state can continue to be sold in others as there is no binding nationwide recall mechanism and little information-sharing. Some offences are not prosecuted when firms can persuade officials to look the other way. Other offences receive only minor penalties.
https://www.scmp.com/week-asia/people/ar...g-outbreak
Published: 2:00pm, 25 Feb, 2023
India-made eyedrops linked to a “superbug” outbreak in the United States have put the country’s flagship pharmaceutical industry under an unwelcome spotlight over possible quality safety lapses.
The US Food and Drug Administration (FDA) this month warned against using the eyedrops that have been potentially tied to a “rare, extensively drug-resistant” bacteria causing infections, blindness and one death in 55 people in the country.
......
India’s drug industry has also been in the news over the kidney-failure deaths of 90 children – 20 in Uzbekistan and 70 in Gambia – that the World Health Organization (WHO) has linked to Indian-made cough syrups.
......
In India, ...... three years ago, 12 children’s deaths were blamed on contaminated syrup made by a company whose products had failed regulatory tests 35 times in a decade.
......
India’s patchwork of state and federal regulations creates oversight problems. Domestic inspections can be sporadic and Indian drugs are not always standard quality. Regulation is complicated by the fact there are 3,000 Indian companies running 10,500 generic manufacturing plants and a shortage of drug inspectors.
......
The US FDA, which inspects Indian plants exporting to the US, has uncovered fudged test and manufacturing data, adulteration, impurities, substandard quality, faulty equipment, and hygiene issues with troubling regularity.
......
India’s Central Drugs Standard Control Organisation approves new medicines. But the licensing of facilities and manufacturing quality checks rest with India’s 28 states.
Drugs failing quality tests in one state can continue to be sold in others as there is no binding nationwide recall mechanism and little information-sharing. Some offences are not prosecuted when firms can persuade officials to look the other way. Other offences receive only minor penalties.
https://www.scmp.com/week-asia/people/ar...g-outbreak
