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Toxic Cough Syrup Case: CDSCO Orders License Cancellation After Tamil Nadu Confirms DEG Presence
The Union Health Ministry's response to the deaths of children in Madhya Pradesh and Rajasthan due to toxic cough syrup is under question. The ministry first issued an advisory and later advised states to investigate. The ministry initially gave the drugs a clean chit, but later confirmed the presence of toxic chemicals in Coldrif. Experts say the ministry cannot shirk its responsibility, as the central government is responsible for drug monitoring.
Due to toxic cough syrup, the Union Health Ministry's response to the deaths of 19 children in Madhya Pradesh and Rajasthan. After the deaths were reported, the Ministry initially issued an advisory advising caution when administering cough syrup to children.
Later, when the Tamil Nadu investigation report confirmed the presence of toxic chemicals in Coldrif brand cough syrup, Union Health Secretary Punya Salila Srivastava held an online meeting and advised states to increase drug testing and monitoring.
Ministry officials are attempting to distance themselves from the entire issue by citing health as a State subject. The Ministry of Health issued its first statement on the deaths of children due to toxic cough syrup on Friday. It stated that experts from the National Center for Disease Control (NCDC), the National Institute of Virology (NIV), and the Central Drugs Standard Control Organization (CDSCO) visited the affected areas and collected samples of several drugs.
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The Ministry claimed that none of the drug samples tested showed diethylene glycol (DEG), thus giving all cough syrups a clean chit. That same evening, the Ministry issued an advisory against giving cough syrup to children. The following day, on Saturday, the Ministry was shocked when an investigation in Tamil Nadu confirmed the presence of DEG in cold syrup.
A hastily issued press note again claimed that six cough syrup samples collected by the CDSCO from Madhya Pradesh did not contain DEG, and that three of the 13 samples collected by the Madhya Pradesh Drug Controller had tested negative for DEG.
The Ministry stated that only the samples collected from the cold syrup manufacturing unit containing DEG were found to contain DEG. The Ministry claimed that the manufacturing units of the 19 syrup samples collected had been under inspection since Friday. Following this, an online meeting was held between the Health Secretary and the states and union territories on Sunday. On Wednesday, the Ministry announced that the CDSCO had directed the Tamil Nadu drug regulator to cancel the license of the cold syrup manufacturing company.
A senior official who played a key role in the Ministry of Health during the COVID-19 pandemic clarified that the Union Health Ministry cannot shirk its responsibility by calling health a state subject. According to him, the CDSCO, the regulatory agency responsible for monitoring the quality of medicines, is under the Central Government. The regulatory agency is responsible for maintaining quality in collaboration with the states.
Under this authority, the CDSCO collects and tests drug samples from across the country and also monitors the investigations conducted by state drug regulators. He said that the deaths of children from toxic cough syrups represent a failure of the entire drug monitoring system, including the Union Health Ministry and its subordinate regulatory agencies.
