After World The Health Organization (WHO) has issued a medical product alert on four India-made cough syrups in connection with the recent deaths of children in The Gambia, with Karnataka’s drug regulator asking pharma companies to submit analysis of glycerin and propylene glycol within seven days. Has instructed, News18 has learned.
According to the WHO, laboratory analysis of cough syrups manufactured by Sonepat-based Maiden Pharmaceuticals confirmed “unacceptable” amounts of diethylene glycol and ethylene glycol, which can be toxic and cause acute kidney injury.
“Report of death due to cough mixture manufactured by Maiden Pharmaceuticals Ltd, Haryana, found to be contaminated with Ethylene Glycol and Diethylene Glycol”, reads the circular issued by the Drugs Control Department of Karnataka, accessed by News18.com. Therefore, the state government has directed all manufacturing units to “procure solvents such as glycerin and propylene glycol to comply with pharmacopoeial standards”.
It instructs to purchase only products of “pharmacopeial standards” because ethylene glycol is also a useful ingredient found in many consumer products such as hydraulic brake fluid, stamp pad inks, ballpoint pens, solvents, paints, plastics, films and cosmetics. Industrial compound. pharmaceutical manufacturing. It has a sweet taste but if eaten, it breaks down into toxic compounds in the body.
The October 10 circular reiterates that the WHO has said that the alleged faulty cough syrup has “unacceptable limits”. ethylene glycol and as diethylene glycol contaminants.
“Products containing such contaminated products should be treated as adulterated drugs in accordance with the provisions of the Drugs and Cosmetics Act and Rules,” the circular said.
“Therefore, all manufacturers are directed to purchase solvents such as glycerin and propylene glycol complying with pharmacopoeial standards directly from the manufacturers as required under Para 10 of Schedule M of the Drugs and Cosmetics Rules, 1945.”
The circular also asks manufacturers to choose “abundant precaution”.
“As a precaution, you are requested to sample and test or analyze all individual containers or packs of Glycerin and Propylene Glycol,” the circular said.
It also asked pharma companies to submit the certificate of analysis for glycerin and propylene glycol purchased in the last one year within seven days.
read all latest news of india And today’s fresh news Here