CDSCO launches inspections after child deaths linked to contaminated cough syrup

New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has begun risk‑based inspections of pharmaceutical manufacturing units in six states following the collection of 19 drug samples — including cough syrups, antibiotics and antipyretics — amid reports of child deaths in Madhya Pradesh and Rajasthan allegedly tied to contaminated syrup.

The units under scrutiny are located in Himachal Pradesh, Uttarakhand, Gujarat, Tamil Nadu, Madhya Pradesh and Maharashtra. The inspections, started on Friday, aim to identify lapses in quality control that may have contributed to the crisis, and propose process improvements to prevent future failures.

A multidisciplinary committee drawn from bodies such as the Indian Council of Medical Research, National Institute of Virology, AIIMS‑Nagpur, CDSCO and the National Environmental Engineering Research Institute is analysing the collected samples to determine causes behind the deaths in Chhindwara, MP.

Six samples tested so far by CDSCO and three by the Madhya Pradesh FDA showed no evidence of contamination with Diethylene Glycol (DEG) or Ethylene Glycol (EG), known nephrotoxins. However, these were not samples of Coldrif, the cough syrup under suspicion — those tests remain pending.

At the request of the Madhya Pradesh government, Tamil Nadu’s FDA analysed Coldrif samples from the Sresan Pharma plant in Kanchipuram. “The samples had DEG beyond the permissible limit,” the ministry said. Consequently, Tamil Nadu has banned the syrup and begun removing it from the market, while inspection at the manufacturing facility continues.

Madhya Pradesh has also banned the sale of Coldrif. The state government says nine children have died from suspected renal failure since 7 September, and 13 others are under treatment. Chief Minister Mohan Yadav declared a crackdown: “The deaths … are extremely tragic. The sale of this syrup has been banned … The guilty will not be spared.”

In Kerala, the Drugs Control Department has suspended Coldrif sales, though a preliminary inquiry found that the flagged batch wasn’t sold in the state. Sample tests of Coldrif and other cough syrups are underway.

Meanwhile, officials say that in a Chennai‑based facility, cough‑syrup samples were found “adulterated” during inspection, prompting a production halt and demand for explanation from the manufacturer.

Rajasthan has suspended its state drug controller and halted distribution of 19 medicines from Kaysons Pharma — which produced Coldrif — after 40 of its products previously failed quality tests. Distribution of all other cough syrups containing Dextromethorphan is also suspended.

The Union Health Ministry has reiterated its advisory that cough syrups should not be prescribed to children under two years, and be used cautiously above that age, with strict supervision and minimal combinations.