In a bid to tighten the reins on cough syrup quality control, the Uttarakhand health regulator has imposed a stringent new requirement: drug manufacturers must possess gas chromatography equipment for sample testing, or face a production ban. This move comes after reports of child deaths in Gambia, Uzbekistan, and Cameroon linked to contaminated cough syrups, and amid concerns about potential quality issues during the winter season, when syrup consumption typically rises.
Gas chromatography, a sophisticated analytical technique, separates and identifies individual chemical components in a mixture, allowing for precise quality control. This technology can accurately detect harmful contaminants like diethylene glycol (DEG) and ethylene glycol (EG), which have been implicated in recent syrup-related tragedies.
Previously, manufacturers without gas chromatography technology could still operate. Under the new regulations, however, such companies can only open new production lines if they provide verifiable proof of purchasing the necessary equipment. Subsequently, physical inspections will be conducted to ensure compliance before permitting operation.
This decisive action stems from a letter authored by Uttarakhand’s drug controller, Tajbeer Singh, on December 21st. Circulated to all drug manufacturers in the state, the letter highlights quality concerns with propylene glycol (PG), a common cough syrup excipient, urging manufacturers to adhere to strict quality standards for all excipients to prevent contamination.
“In case of manufacture of cough syrups, various critical excipients like propylene glycol, glycerine, sorbitol etc are used,” the letter states. “The 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.”
Furthermore, the advisory acknowledges the potential for increased cough syrup use during winter months, emphasizing the need for stringent quality control measures.
Uttarakhand’s proactive stance sets a strong precedent for ensuring cough syrup safety across India. By mandating gas chromatography testing and tightening regulations on excipient quality, the state aims to safeguard public health and prevent further tragedies.
