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Reportedly in a move to uphold the manufacturing standards of cough syrups, the health regulator of uttarakhand has decided to ban the production of syrups by drug makers who cannot conduct sample testing through gas chromatography, News18 has learnt. Meanwhile gas chromatography is a method employed to segregate and identify the chemical constituents within a sample mixture, leading to the determination of their presence or absence, as well as their respective quantities. The method is used to detect the presence of harmful chemicals, including the controversial diethylene glycol (DEG) or ethylene glycol (EG).
Furthermore pharma companies that do not have the gold standard of testing will be allowed to open manufacturing lines only after submitting proof of buying the testing equipment followed by the physical inspection and the move comes after allegations of a severe outbreak of cough syrup-related poisoning, causing the deaths of children in Gambia, Uzbekistan, and cameroon since the middle of last year.
Moreover the regulator has made a move anticipating quality issues amid the increase in consumption due to the winter season. “Please refer to the quality concerns reported for Propylene Glycol (PG) supplied to cough syrup manufacturers. In this context, various measures have been taken to ensure the safety and efficacy of cough syrups marketing in domestic as well as export market,” said the letter written by Tajbeer Singh, drug controller of Uttarakhand. The letter written on december 21, accessed by reports was sent to all drug makers in the hill state.
“In case of manufacture of cough syrups, various critical excipients like propylene glycol, glycerine, sorbitol etc are used,” it said, adding that “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.” “During winter seasons, there may be an increase in the use of cough syrups in the country,” the advisory cautioned.