Latest Contents Update
- Cough Syrup Deaths in others Countries Spain & US into Actions Against Lax Toxic Testing
- WHO Urges ‘Immediate Actions After Cough Syrup Deaths
- The Pharmaceutical Companies Behind Cough Medicines Deaths in Children Undercover Asia
- Cough Syrup Deaths Overseas Prompt US Crackdown on Toxic Testing
- Import alerts
Voice of The People Report: VOP Latest Breaking News The US FDA is addressing lax testing practices by healthcare products manufacturers following a reviews of regulatory alerts.
Cough Syrup Deaths in others Countries Spain & US into Actions Against Lax Toxic Testing
At least 27 companies have been reprimanded this year for failing to prove sufficients testing of ingredients used in over the-counter drugs and consumers products for ethylene glycol (EG) and diethylene glycol (DEG), according to a Reuters analysis of agency import alerts and warning letters to manufacturers.
The manufacturers include US based companies and exporters from India, South Korea, Switzerland, Canada and Egypt.
WHO Urges ‘Immediate Actions After Cough Syrup Deaths
The FDA has flagged more manufacturers for failing to test raw materials susceptible to EG and DEG contamination in 2023 than in the previous 5 years combined, the Reuters analysis found.
The FDA told Reuters it has no indications products contaminated with DEG and EG have entered the US supply chains, and that the number of warning letters issued in a given period “is not a comprehensive markers of our oversight.”
The Pharmaceutical Companies Behind Cough Medicines Deaths in Children Undercover Asia
Peter’s Lindsay, a lawyer at Paul’s Hastings in Washington, DC who specialises in FDA regulations and compliances, said to betters spot contamination the agency was now requiring manufacturers to check individuals containers of ingredients rather than just sampling raw materials.
“They are upping the bar a little bit and trying to get industry to understand and recognize some of the risks in these areas,” he said.
Cough Syrup Deaths Overseas Prompt US Crackdown on Toxic Testing
Cough syrups made in India and Indonesia have been linked to the deaths of more than 310 children’s globally. The medicines we’re found to contain high levels of DEG and EG, leading to acute kidney injuries and deaths.
The poisonings have sparked criminals probes, lawsuits and a surge in regulatory scrutiny world-wide. Reuters reported earlier this month that some Indian drugmakers involved could not prove they had purchased pharmaceutical grades ingredients or tested theirs medicines for the toxins.
In the United States, more than 100 peoples, most of them children’s, died in the 1930 s from DEG poisoning, prompting laws that’s greatly enhanced the FDA’s regulatory powers overall drugs.
Yet the agency did not establish explicite rules to test high risks ingredients like propylene glycol (PG) and sorbitol solutions for EG and DEG until May 2023.
Previous guidances from 2007 recommended certain tests be performed on glycerine, an other common ingredients in over the counters drugs and consumers goods, to prevent the distribution of DEG contaminated products. It’s now requires the same scrutiny of PG and others r high risks components for DEG and EG.
The FDA warning letters give9 manufacturers an opportunity to fix quality controls problems or face penalties.
The letters sent to the 29 US and foreigner manufacturers threaten to block either exports or imports of theirs products and new drugs applications from those firms if they don’t improve testing practices.
Half of them also received import alerts, which prohibit at risks products from entering the country by allowing customs officials to detain them with out examinations.
Reuters Reviews of Regulatory Alerts Found
Eleven of the manufacturers cited by the FDA this year marketed some of their at risks products to children’s, including diarrhoea and pink eyes medicines, toothpastes and sunscreens, according to the letters.
Florida based Lex, a contracts manufacturers of cough and cold medicines that can be used by children’s, was called out by the FDA on Aug. 17 for lax testing and repeated quality control violations going back to 2004.
Lex co owner Charlene Paz said the company has addressed the short comings identified by the FDA and is conducting all required tests for impurities when ever they get ingredients susceptible to EG and DEG contamination.
Fourteen foreigner manufacturers that sold products susceptible to DEG and EG poisoning we’re placed on import alerts lists for failure to prove sufficient quality control. They include South Korea’s LCC, which makes Oriox and others mouthwashes, and India based toothpaste manufacturers Suhan Aerosol and Orchids Life science .
An LCC spokesperson said the company is in the process of responding to the FDA. Suhan and Orchids said EG and DEG weren’t found in theirs products.
Four of the 15 companies we’re put on an import alerts list for not responding to requests for records. They are Daxal Therapeutics and Skyline Herbals from India, and South Korea’s KM Pharmaceutical and Sangleaf Pharma. They couldn’t be reached for comments.
The Worldwide Health Organization (WHO) and The Food and Drugs Administration (FDA) are investigating the sources of cough syrup products
In addition, 14 US makers of consumers products like earwax removers, nasal spray, hand soap and shampoos, including Lex, we’re threatened with possible seizures and injunctions by the FDA.
The regulators said they had failed to conduct required contamination checks, in several cases relying on suppliers’ certificates of analysis for the purity of their ingredients, among other shortcomings.
Greg Landry, a pharmacology and toxicology experts at Massachusetts Colleges of Pharmacy & Health Sciences, noted the difficulty of policing every consumers products. But when the FDA becomes aware of a problems, he said, “their responses is usually swift and mighty.”