Govt-approved labs must test cough syrups before export | India News – Times of India
The government has issued a notification — effective June 1 — which also lists the names of labs where samples have to be tested. This includes the Indian Pharmacopoeia Commission-Ghaziabad, Central Drugs Laboratory-Kolkata and Central Drugs Testing Laboratory-Chennai, among others.
The government decision follows medical product alerts issued by the World Health Organisation on alleged contamination of cough syrups exported to Gambia, Uzbekistan and the Marshall Islands and Micronesia by Indian pharma companies which led to morbidity and mortality.
“Our pharma products have to meet global standards. The standards for pharma products are being more stringent,” director general of foreign trade (DGFT) Santosh Sarangi said.
The Central Drug Standards Control Organisation (CDSCO), which comes under the health ministry, submitted that syrup-based formulations of cough composition (cough syrups), because of insolubility of the drugs used, require solvents like propylene glycol and/or glycerine and/or sorbitol.
“There are adulterants commonly used with these solvents where mainly di-ethylene glycol and ethylene glycol are most common. The adulterants are toxic to the kidney and cause deaths if used in high quantities,” the drug regulatory body said.
Exporters will have to produce the ‘Certificate of Analysis’ of the batch or batches being exported from one of the above labs along with other documentation for the release of the consignment for export, the CDSCO proposed.
Watch Govt increases scrutiny of cough syrup
