The Central Drugs Standard Control Organization (CDSCO) has issued an advisory to all cough syrup manufacturers to ensure the use of quality excipients in the manufacture of cough syrups. This advisory was dated December 5, 2023.
The CDSCO reiterates that drug manufacturers must ensure adherence to the conditions of their manufacturing licences and prescribed Good Manufacturing Practices. This will ensure that the manufactured drugs are of quality standards and meet quality, safety and efficacy parameters.
In this regard, it is paramount that such formulations are manufactured in compliance with the prescribed standards. This extends not merely to API but also in respect of excipients used in manufacturing various formulations.
The CDSCO observes that during the winter season there may be an increase in the use of cough syrups. It thus enjoins cough manufacturers to greater caution in the use of excipients in their products.
The CDSCO particularly draws attention to the use of propylene glycol, glycerin, sorbitol, etc. in the manufacture of cough syrup. The CDSCO urges manufactures to ensure that these critical excipients that they procure are of standard quality so as to avoid contamination of their formulations.
Therefore, the manufacturers must use only pharma grade excipients from approved vendors/ dealers. They shall ensure that the procured excipients are of standard quality that meet regulatory requirements.
