Cough syrup deaths: Sample tested in Tamil Nadu found to be contaminated with DEG

New Delhi: A cough syrup sample tested in Tamil Nadu has been found to be contaminated with toxic diethylene glycol (DEG) beyond the permissible limits while test results on ten more drugs in Madhya Pradesh are expected in the next 24 hours, Union Health Ministry sources said on Saturday providing an update on kids deaths reportedly after consuming adulterated cough syrup.

At least 14 children – 11 in Madhya Pradesh and three in Rajasthan – died reportedly in the last one month after consuming adulterated medicines and three states – Kerala, Madhya Pradesh and Tamil Nadu – have banned the sales of Coldrif syrups in the wake of the reports about the deaths.

The ministry has been investigating children’s deaths allegedly after consuming two different cough syrup formulations.

Sources said 19 medicine samples including Coldrif cough syrup, Nextil antibiotics, painkillers, and antipyretic drugs were picked up by the authorities from Chhindwara district for testing. All these medicines were taken by the kids who died.

Of them nine samples – six tested by the Central Drug Standards Control Organisation and three by MP Food and Drugs Administration – have been found clean. “For rest of the samples, the results are expected by Sunday,” sources said.

“On the request of the MP government, Tamil Nadu FDA had taken samples of Coldrif cough syrup from the manufacturing premises of Sresan Pharma in Kanchipuram. The results of testing of these samples were shared with the Union Health Ministry on Friday evening. The samples are found to contain DEG beyond the permissible limit,” the Union Health Ministry said.

DEG, a toxic solvent used in industrial products, has been linked to fatal poisoning in several countries. It is not used for drug making and its adverse effects are known to the pharmaceutical industry. There have been at least five major cases of DEG poisoning in India since 1972.

Risk based inspections were initiated on Friday at the manufacturing premises of all the 19 drugs sampled, spread across six states - Himachal Pradesh, Tamil Nadu, Madhya Pradesh, Uttarakhand, Gujarat and Maharashtra.

The exercise aims to find gaps leading to quality failure of drug samples and suggest process improvement to avoid such incidents in future.

Fresh concerns on contaminated cough syrups arise nearly four years after India made syrups caused children’s death in Gambia and Uzbekistan, prompting the World Health Organisation to issue an alert. Since then more than 900 regulatory inspections of the manufacturing sites have been carried out by the authorities.

Meanwhile, the Rajasthan government has suspended the state drug controller and halted the distribution of medicines manufactured by Jaipur-based company Kaysons Pharma, whose dextromethorphan cough syrups are now under the scanner.

While the Medical and Health Department stopped the supply of all 19 medicines manufactured by Kaysons Pharma until further orders and distribution of all other cough syrups containing dextromethorphan has been suspended, Rajasthan officials said they didn't find any evidence of the three deceased kids consuming dextromethorphan syrups.