The government has issued a notification – effective June 1 – which also lists the names of the laboratories where the samples are to be tested. This includes the Indian Pharmacopoeia Commission-GhaziabadCentral Drugs Laboratory-Kolkata and Central Drugs Testing Laboratory-Chennai among others.
Recently, some cough syrups manufactured by pharmaceutical companies in India have come under scrutiny. The government has rightly decided to test all cough syrups destined for overseas. It goes without saying that similar standards should also apply to all cough syrups manufactured and sold in India.
The government’s decision follows medical product advisories issued by the World Health Organization on alleged contamination of cough syrups exported to the Gambia, Uzbekistan and the Marshall Islands and Micronesia by Indian pharmaceutical companies leading to morbidity and mortality.
“Our pharmaceutical products must meet global standards. The standards for pharmaceuticals are stricter”, Director General of Foreign Trade (DGFT) Santosh Sarangi She said.
THE Central organization for the control of drug standards (CDSCO), which reports to the ministry of health, argued that formulations based on cough syrup (cough syrups), due to the insolubility of the drugs used, require solvents such as propylene glycol and/or glycerin and /or sorbitol.
“There are commonly used adulterants with these solvents where mainly diethylene glycol and ethylene glycol are the most common. Adulterants are toxic to the kidneys and cause death when used in large quantities,” the drug regulatory body said.
Exporters will need to produce the “Certificate of Analysis” of the exported batch or batches from one of the above laboratories along with other documentation for export batch release, the CDSCO has proposed.
Clock Government tightens control over cough syrup
