Cliorbit

Mumbai, India – October 10, 2025
In the aftermath of the devastating loss of at least 21 children due to contaminated cough syrup containing toxic diethylene glycol (DEG), healthcare safety advocates are urgently calling for comprehensive reforms in drug safety monitoring systems across India's pharmaceutical sector. The tragic deaths, primarily occurring in Madhya Pradesh after children consumed Coldrif syrup manufactured by Sresan Pharmaceuticals, have exposed critical vulnerabilities in the nation's drug safety infrastructure that demand immediate attention.
The contaminated syrup contained 48.6% diethylene glycol – a deadly industrial solvent – nearly 500 times above the acceptable limit of 0.1%. This represents one of the most severe pharmaceutical safety failures in recent Indian history, prompting nationwide soul-searching about how such tragedies can be prevented in the future.
The Human Cost of Safety Gaps
"When families trust a medicine to heal their children, the last thing they expect is for that very medicine to become a source of unimaginable grief," said Dr. Rajesh Kumar, a pediatric safety specialist at Mumbai's leading children's hospital. "These weren't isolated incidents – they represent systemic failures that could have been detected and prevented with proper safety monitoring systems."
The DEG contamination crisis follows a disturbing global pattern. Since 2022, the World Health Organization has linked contaminated cough syrups to over 300 child deaths worldwide, including 70 children in The Gambia and 68 in Uzbekistan. Each tragedy underscores the urgent need for robust, real-time pharmacovigilance systems that can detect contamination before it reaches vulnerable patients.
The Technology Gap That Costs Lives
Industry experts point to a critical disconnect between available safety technologies and their implementation in pharmaceutical manufacturing and distribution. While sophisticated pharmacovigilance systems exist that can monitor drug safety signals in real-time, many manufacturers – particularly smaller companies – lack access to affordable solutions.
"The technology to prevent these tragedies exists today," explains Dr. Priya Sharma, a pharmacovigilance researcher at the Indian Institute of Science. "Advanced monitoring systems can detect contamination signals, track adverse events, and identify safety patterns across multiple data sources. The challenge is making these life-saving technologies accessible and affordable for companies of all sizes."
Recent analysis suggests that comprehensive pharmacovigilance systems could have flagged the DEG contamination through multiple pathways:
•     Real-time monitoring of manufacturing processes
•     Early detection of adverse event clustering
•     Supply chain integrity tracking
•     Automated safety signal detection
Bridging the Affordability Gap
Recognizing this critical need, a new generation of healthcare technology companies is working to democratize access to pharmaceutical safety solutions. These initiatives focus on developing cost-effective, scalable platforms that small and medium pharmaceutical companies can implement without compromising their operational viability.
Cliorbit, a Mumbai-based pharmacovigilance services provider, represents this emerging approach to accessible drug safety. The company's platform integrates artificial intelligence and real-world data analytics to provide comprehensive safety monitoring at a fraction of traditional costs, specifically designed for the Indian pharmaceutical ecosystem.
"Our mission is simple – make life-saving safety technology accessible to every pharmaceutical company, regardless of size," said the company's safety director. "When children's lives are at stake, cost cannot be a barrier to implementing robust safety systems."
The company's approach includes:
•     Automated adverse event detection and reporting
•     Real-time contamination signal monitoring
•     Supply chain transparency tools
•     Regulatory compliance support
•     Cost-effective implementation for smaller manufacturers
Industry Response and Future Outlook
The pharmaceutical industry is beginning to recognize that safety cannot be treated as a luxury item available only to large corporations. Leading trade associations are calling for collaborative approaches that share safety infrastructure costs across multiple companies while maintaining competitive advantages.
"The DEG tragedy has served as a wake-up call for our entire industry," noted Amit Patel, secretary of the Indian Pharmaceutical Alliance. "We must move from reactive responses to proactive prevention. This means investing in technologies and partnerships that can detect problems before they claim lives.