Cough Syrup Deaths: Are Over 700 Manufacturers Facing Scrutiny?
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Synopsis
In a shocking revelation, over 700 cough syrup manufacturers are facing scrutiny after tragic child deaths in Madhya Pradesh. Union Minister Anupriya Patel disclosed critical findings that could change the landscape of pediatric medication safety in India. This alarming situation has prompted urgent action and stricter regulations to protect vulnerable populations.
Key Takeaways
- Over 700 manufacturers under scrutiny following child deaths.
- The Coldrif syrup was linked to serious health issues.
- Testing for Diethylene Glycol now mandatory.
- Government taking criminal action against violators.
- Immediate bans on Coldrif syrup in affected regions.
New Delhi, Dec 2 (NationPress) - In light of tragic incidents involving pediatric fatalities in Madhya Pradesh, over 700 cough syrup manufacturers are currently undergoing rigorous examination, as stated by the Union Minister of State for Health, Anupriya Patel, during a parliamentary session on Tuesday.
A total of 26 children from Chhindwara, Pandhurna, and Betul districts, primarily aged under five, are reported to have lost their lives due to kidney failure linked to the consumption of Coldrif cough syrup.
“An extensive audit of more than 700 cough syrup manufacturers is being conducted in collaboration with state authorities. Enhanced market surveillance sampling of syrup formulations by both Central and State drug regulators has been initiated,” Patel noted in a written response to the Rajya Sabha.
Furthermore, the Indian Pharmacopoeia Commission, located in Ghaziabad, has implemented an amendment to the Indian Pharmacopoeia (IP) 2022, which now requires testing for Diethylene Glycol (DEG) and Ethylene Glycol (EG) in oral liquids at the finished product stage prior to market release, she added.
The Minister also revealed that a thorough investigation into the reported cases and deaths was carried out, which included collecting 19 drug samples from treating private practitioners and local retail stores.
The investigation traced the issue to the presence of DEG in Coldrif syrup produced by Sresan Pharmaceuticals based in Kancheepuram, Tamil Nadu.
The DEG concentration in the Coldrif syrup consumed by the deceased children was found to be 46.28 percent weight by volume (w/v), far exceeding the permissible threshold of 0.1 percent. Additionally, four samples were identified as Not of Standard Quality (NSQ).
As a result, the government conducted inspections at Sresan Pharmaceuticals, uncovering numerous critical and major Good Manufacturing Practices (GMP) violations, including unsanitary storage conditions.
The CDSCO, in conjunction with the Tamil Nadu government, has initiated criminal proceedings against the manufacturer and revoked their manufacturing license.
Subsequently, following the incident, Coldrif was promptly banned and recalled in Madhya Pradesh, Tamil Nadu, Odisha, and the Union Territory of Puducherry.
“A criminal case has been filed by the State of Madhya Pradesh, with stringent actions taken, including arrests of those involved,” Patel stated.
She also mentioned an advisory sent to all State/UT Health Departments and healthcare facilities to ensure the appropriate use of pediatric cough syrups.
The Drugs Controller has instructed all State/UT drug controllers to strictly adhere to testing mandates and maintain heightened vigilance against counterfeit and substandard drugs, taking swift action when necessary.
Point of View
Our commitment remains steadfast: to advocate for the safety and integrity of healthcare. The scrutiny of over 700 cough syrup manufacturers is a necessary step towards accountability and safeguarding public health. We must ensure that such tragic incidents are not repeated, and that our vulnerable populations are protected at all costs.
NationPress
02/12/2025
Frequently Asked Questions
What led to the scrutiny of cough syrup manufacturers?
The scrutiny was prompted by a series of child fatalities in Madhya Pradesh linked to contaminated cough syrups, specifically Coldrif, which contained harmful levels of Diethylene Glycol.
What actions are being taken against the manufacturers?
The government has initiated audits, inspections, and criminal proceedings against the manufacturers, including revoking licenses for those found violating Good Manufacturing Practices.
What is Diethylene Glycol and why is it concerning?
Diethylene Glycol is a toxic substance that can cause severe health issues, including kidney failure, especially in children. Its presence in cough syrups is strictly regulated.
How many children have died as a result of the contaminated syrups?
A total of 26 children from Madhya Pradesh have tragically lost their lives due to kidney failure attributed to the consumption of contaminated cough syrups.
What preventive measures are being implemented?
The government is enhancing market surveillance, enforcing stricter testing requirements for cough syrups, and providing advisories to health departments to ensure safe usage.
