ISLAMABAD: Dec 15, 2022: After getting complaints of impurities containing toxic and lethal contents, the Drug Regulatory Authority of Pakistan (DRAP) has issued new guidelines for manufacturers/ importers of solvents used in manufacturing of sorbitol, glycerin, propylene glycol.
The DRAP initiative has come in context of rising complaints of impurities contained in solvents used in preparation of sorbitol, glycerin , propylene glycol which has high risk of deaths in the case if the products prepared from impure solvent is used by the patients.
In recent past, a number of deaths of infants have been reported in Indonesia and Gambia and it has raised alarms world over. The regulators are taking punitive actions to make sure that the solvents used in preparation of sorbitol , glycerin and propylene glycol do not contain any deadly impurities.
In its directive dated December 13, 2022, DRAP has advised to the manufacturers/ importers to have test at Central Drug Laboratory (CDL) Karachi of solvents glycerin, propylene Glycol and Sorbitol.
The DRAP notification advised to all stakeholders (pharmaceutical manufactures, regulators) are advised that while purchasing the listed solvents they should make sure that suppliers/ vendors of these solvents have performed the test for specific identity that includes limit test of DEG and EG of all the batches available in the consignment.
It added that the firms shall also be responsible of impurity test of the solvents like glycerin, sorbitol and propylene glycol on each and every batch either by acquiring in house facility or from CDL,DRAP Karachi . It said such test shall not render the firm for any regulatory action and shall be limited to present the use of adulterated solvent in the manufacturing .
The DRAP also advised to the drug inspectors to conduct risk based sampling of solvents for CDL Karachi for testing of any impurity.