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The Maharashtra Food and Drugs Administration (FDA) has informed that the state FDA drug testing labs are fully equipped with advanced equipment like Gas Chromatography with Mass Spectrometry (GC-MS) to test toxic chemicals like diethylene glycol (DEG) in contaminated cough syrups.
DEG is a highly toxic chemical known to cause fatal poisoning in contaminated Coldrif cough syrups linked to child deaths recently in the country.
The Central Drugs Standard Control Organisation (CDSCO) has also directed all drug controllers in the States and Union Territories (UTs) to ensure testing of raw materials and excipients before manufacturing and release of the batch to the market.
A senior regulatory authority also highlighted that GC-MS is considered the gold standard for detecting DEG in medicines. The World Health Organization (WHO) and other health authorities have established methods based on GC-MS to ensure that levels of DEG in products are below safety thresholds.
He further added that though the equipment and test might be cost prohibitive for drug manufacturers, it is used by public testing labs and state FDA labs to detect DEG in industrial grade excipients widely used to make paints and as an anti-freeze agent. It has been learnt that drug manufacturers in India are known to rampantly use DEG as a cheaper substitute to pharmaceutical grade excipients such as glycerol, sorbitol and propylene glycol, mostly used as a viscosity enhancer or a thickening agent.
The Maharashtra FDA recently issued a 'Stop Use' notice in response to the test reports linking the deaths of several children in Madhya Pradesh and Rajasthan to a contaminated batch of Coldrif syrup (Batch No. SR-13) manufactured by Sresan Pharma of Tamil Nadu. The contaminated has tested positive for DEG. The contaminated product, Coldrif syrup (phenylephrine hydrochloride and chlorpheniramine maleate), carried the batch number SR-13, with a manufacturing date of May 2025 and expiry in April 2027.
As per a recent CDSCO statement, “Sresan Pharma manufacturing facility in Tamil Nadu was found to be grossly deficient in manufacturing practices, documentation practices and technically competent manpower, as well as in non-compliance with the GMP/GLP (good manufacturing practices and good laboratory practices) standards.”
While highlighting the significance of robust drug testing facilities in the state, a Maharashtra FDA official informed that the state FDA is today equipped with a drug testing infrastructure having state-of-the-art analytical instruments including GC-MS, high-performance liquid chromatography (HPLC), infrared (IR) spectroscopy, ultraviolet (UV) spectroscopy and liquid chromatography-mass spectrometry (LC-MS).
Currently, drug testing labs operate in Mumbai, Aurangabad and Nagpur. The Mumbai laboratory currently has the capacity to test 4,000 drug samples, Aurangabad laboratory has the capacity to test 2,500 samples and Nagpur lab has capacity to test 1,000 samples.
The Maharashtra FDA has also confirmed that particular batch of Coldrif syrup has not entered the drug retail supply chain in the state and measures for safety have been taken. The state drug regulator has also directed all license holders (retailers, wholesalers, hospitals, etc.) to halt the sale, distribution, and use of Coldrif syrup, Batch No. SR-13 without delay, if detected in the retail supply chain. Possession of the said batch should be reported immediately to local drug authorities or through the following channels: Toll-free number: 1800 222 365, Email: jchq.fda-mah@nic.in and Phone: 98928 32289.
The presence of DEG in any medicinal formulation can lead to serious health risks, including acute kidney failure and death, particularly among vulnerable populations like children.
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