Drug authority calls for overhaul of cough syrup testing protocols

In a bid to ensure patient safety and ensure manufacture of quality products, all cough manufacturers should have in-house facility of gas chromatography (GC) which can effectively detect presence of high risk components which often prove fatal.

A key recommendation in this regard has been made by the State Drugs Controller, Dr Manish Kapoor, to the Drug Controller General of India (DCGI) after slew of critical laxities have come to fore in various states in cases of toxic cough syrups. The issue assumes urgency after a recent case where consumption of toxic Coldrif cough syrup led to several mortalities in Madhya Pradesh.

Investigations conducted by the Tamil Nadu drug authorities, where the syrup was manufactured, reveal that the excipient propylene glycol (PG) was not tested for the presence of impurities like diethylene glycol (DEG) and ethylene glycol (EG) as the unit lacked such a facility.

Pharma experts informed that “Diethylene glycol and ethylene glycol are found as impurities in propylene glycol (PG) which is an excipient used to manufacture cough syrups. They are toxic substances used as industrial solvents and antifreeze agents that can be fatal if taken even in small amount, especially for children.”

As per the norms, a manufacturer is supposed to undertake pre-testing of the excipient to rule out the presence of contaminants and ensure quality drug manufacturing.

Pharmaceutical firms, which lack in-house testing facilities, rely on private labs as setting up an in-house lab entails an additional expenditure of Rs 1.5 crore. “A private lab takes about a week to test a sample of an excipient and each test is charged. In a bid to save time and costs, it has been observed that some pharmaceutical firms rely on the test reports provided by excipient traders, which at times are not accurate. Bypassing these key testing mandates has proved dear in several cases, where cough manufacturers end up producing toxic products which lead to severe health impact like renal failure,” informed a pharmaceutical raw material manufacturer.

Contrary to the mandate of providing safe and quality medicines, the tendency of callous cough syrup manufacturers to cut costs by bypassing quality parameters has been proving fatal time and again.

“Keeping in view the recent deaths of children in Madhya Pradesh, high risk components like diethylene glycol and ethylene glycol are required to be tested stringently. To ensure this all manufacturers, who use these components for manufacturing various products like cough syrups, should have in-house facility of GC and this norm should be implemented uniformally across all states,” stated Dr Kapoor.