In a stringent move to safeguard public health, the Uttarakhand health regulator has implemented a ban on cough syrup production by manufacturers unable to conduct sample testing through gas chromatography, News18 has learned. This decision comes amid concerns about the quality and safety of cough syrups, following a spate of child deaths linked to contaminated products in Gambia, Uzbekistan, and Cameroon since mid-2023.
Gas chromatography is a sophisticated analytical technique that separates and identifies the chemical components of a mixture, revealing their presence, absence, and relative amounts. This technology is crucial for detecting harmful impurities, including the controversial diethylene glycol (DEG) and ethylene glycol (EG), which have been implicated in recent poisoning incidents.
Pharmaceutical companies lacking this “gold standard” of testing will be allowed to resume production only after fulfilling specific requirements. They must first demonstrate the purchase of gas chromatography equipment, followed by a physical inspection by the regulator. This strict measure underscores the gravity of the situation and the urgency of ensuring the safety of cough syrups.
The crackdown is further prompted by anticipation of increased cough syrup consumption during the winter months, when respiratory illnesses are more prevalent. A letter issued by Tajbeer Singh, the Uttarakhand drug controller, on December 21st and accessed by reporters, highlights this concern. It references recent quality issues with propylene glycol (PG), a common excipient in cough syrups, and emphasizes the need for manufacturers to adhere to strict quality standards to avoid contamination.
“Various critical excipients like propylene glycol, glycerine, sorbitol etc are used in the manufacture of cough syrups,” the letter states. “Manufacturers are required to ensure that these excipients meet the regulatory standards of quality so as to avoid any contamination in the formulations manufactured by using such excipients.”
The advisory concludes with a cautionary note about the potential for increased cough syrup use during winter. This proactive approach signifies the regulator’s commitment to prioritizing public safety and preventing future tragedies.