The Drugs Control Administration, Telangana on August 11, 2023, issued the advisory regarding the Procurement and testing of the raw materials Glycerin & Propylene Glycol by the Cough Syrup manufacturers.
The following has been stated regarding the procurement and testing of the raw materials "Glycerin" and "Propylene Glycol" before consuming the same for the production of formulations namely: -
• If Glycerin and Propylene Glycol are used as 'Pharmaceutical Aid/Excipient', they shall be procured directly from the manufacturers.
• Glycerin and Propylene Glycol must be tested for ‘Diethylene Glycol & Ethylene Glycol' (with a Limit: Not More Than 0.10%) as per the pharmacopoeial monographs of Glycerin & Propylene Glycol before consuming the same for the production of formulations
• All the individual containers/packs of Glycerin & Propylene Glycol on receipt of raw material are to be sampled and tested/analysed.
[Notification No. 09/DCA-Peshi/ 2023]
