After the World Health Organization (WHO) recently issued medical product alert on four India-made cough syrups in connection with children’s deaths in The Gambia, the drug regulator of Karnataka has directed pharma companies to submit the analysis of glycerin and propylene glycol within seven days, News18 has learnt.
According to the WHO, the laboratory analysis of the cough syrups manufactured by Sonipat-based Maiden Pharmaceuticals confirmed “unacceptable” amounts of diethylene glycol and ethylene glycol, which can be toxic and lead to acute kidney injury.
The circular issued by the drugs control department of Karnataka, accessed by News18.com, read “News reported on death due to cough mixtures manufactured by Maiden Pharmaceuticals Ltd, Haryana, found to be contaminated with Ethylene Glycol and Diethylene Glycol”. Therefore, the state government has directed all manufacturing units to “procure solvents like glycerin and propylene glycol complying with pharmacopoeial standards”.
It instructs to buy products only of “pharmacopoeial standards” because ethylene glycol is also a useful industrial compound found in many consumer products such as hydraulic brake fluids, stamp pad ink, ballpoint pens, solvents, paints, plastics, films, and cosmetics apart from drug manufacturing. It has a sweet taste but if ingested, it breaks down into toxic compounds in the body.
The circular dated October 10 reiterated that the WHO stated that the alleged faulty cough syrups contained “unacceptable limits of ethylene glycol and diethylene glycol as contaminates.”
“The products containing such contaminates are to be considered as adulterated drugs as per the provisions of Drugs & Cosmetics Act & Rules thereunder,” the circular had said.
“Therefore, all the manufacturers are herewith directed to procure solvents like glycerin and propylene glycol complying with pharmacopoeial standards, directly from the manufacturers as required under para 10 of Schedule M of Drugs & Cosmetics Rules 1945.”
The circular also asks the manufacturers to opt for “abundant precaution”.
“As an abundant precaution, you are requested to sample and test or analyse all individual containers or packs of glycerin and propylene glycol,” the circular said.
It also asked the pharma companies to submit the certificate of analysis of glycerin and propylene glycol procured in the last one year within seven days.
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