The Central Drug Standards Control Organization (CDSCO) has implemented a risk-based inspection initiative across six states following the tragic deaths of children linked to phlegm syrup in Madhya Pradesh and Rajasthan. According to sources within the Ministry of Health, the manufacturing units under scrutiny are located in Himachal Pradesh, Uttarakhand, Gujarat, Tamil Nadu, Madhya Pradesh, and Maharashtra. A total of 19 different medications, including cough syrups and antibiotics, have had their samples collected for examination.
PTI, New Delhi. In response to the alarming incidents of child fatalities connected to cough syrup, the Central Drug Standards Control Organization (CDSCO) has commenced a series of risk-based inspections across six states. These inspections were initiated following reports of the deaths in Madhya Pradesh and Rajasthan. Health Ministry officials have indicated that the manufacturing facilities involved are situated in Himachal Pradesh, Uttarakhand, Gujarat, Tamil Nadu, Madhya Pradesh, and Maharashtra, with samples from 19 drugs, including cough syrups and antibiotics, being tested for quality control.
CDSCO Launches Inspections on October 3
The Health Ministry revealed that the CDSCO officially began its inspection process on October 3. The focus of these inspections is to pinpoint deficiencies affecting the quality of pharmaceuticals. The overarching goal is to recommend improvements in manufacturing processes to prevent such tragedies from occurring in the future.
Investigating Causes of Fatalities
In addition to the inspections, a specialized team comprising experts from the National Institute of Virus Sciences, Indian Council of Medical Research, National Environment Engineering Research Institute, CDSCO, and AIIMS-Nagpur is currently evaluating various samples to determine the causes surrounding the deaths in Chhindwara, Madhya Pradesh, and its surrounding areas.
Meanwhile, a representative from the Food Safety and Drug Administration Department announced on Saturday that samples of cough syrup collected from a company in Chennai were found to be adulterated.
Production Halt Requested at Manufacturing Facility
Officials have demanded explanations from the company involved and have instructed them to cease production at their facility. Tamil Nadu’s Health and Family Welfare Minister, Ma. Subramanian, confirmed that the Drug Controller has initiated a comprehensive investigation into this incident.
This situation has prompted the Tamil Nadu government to prohibit the sale of the cough syrup known as ‘Coldrif’ and to withdraw this product from the market. This decision was made following concerns that the syrup may be linked to the recent child fatalities in Madhya Pradesh and Rajasthan.
Sale of Coldrif Syrup Banned in Kerala
On Saturday, Kerala’s Health Minister, Veena George, announced that the Kerala Drug Control Department has also placed a ban on the sale of Coldrif Cough Syrup within the state. Reports from various regions indicated potential issues with a specific batch of Coldrif Syrup. The minister stated that the Drug Control Department has conducted inspections throughout the state and collected samples of Coldrif syrup for further testing, while other cough syrup samples are also under investigation.
Telangana Issues ‘Public Alert’ Regarding Coldrif Syrup
In light of the reports concerning the syrup’s adulteration and the associated child fatalities in Madhya Pradesh and Rajasthan, the Telangana Drug Control Administration issued a public alert on Saturday. The warning advises citizens to discontinue the use of Coldrif Cough Syrup, specifically batch number SR-13, and to report any possession of the syrup to local medicine control authorities without delay.
All drug inspectors and assistant directors have been instructed to proactively notify retail and wholesale vendors, as well as hospitals, to “freeze” any stock of this specific product batch that may still be available in the market.
