All pharma-grade solvent manufacturers are required to obtain manufacturing licences through the ONDLS portal and upload real-time information about every batch produced
Following a series of incidents involving contaminated cough syrups, India’s apex health regulatory body has launched a digital monitoring system to oversee the production, movement, and quality of high-risk ingredients used in making these formulations, News18 has learnt.
The move, taken by the Central Drugs Standard Control Organisation (CDSCO)—communicated through a circular issued to all state and union territory drug controllers—directs regulators and manufacturers to use the Online National Drug Licensing System (ONDLS) portal for real-time monitoring of solvent batches.
The communication, dated October 22, seen by News18, mentions that the decision follows recent incidents of DEG contamination in syrups, which have raised serious safety concerns.
10 high-risk solvents
According to the document issued by the Central Drugs Standard Control Organisation (CDSCO), a list of 10 high-risk solvents has been identified, which includes glycerin, propylene glycol, sorbitol, maltitol, and ethyl alcohol—as key ingredients often used in syrups and other liquid medicines.
Signed by Dr Rajeev Singh Raghuvanshi, Drugs Controller General of India (DCGI), the document refers to a high-level meeting chaired by the union health secretary on October 5, where senior officials reviewed drug quality compliance and the rational use of cough syrups, especially in paediatric formulations.
The CDSCO had earlier asked all state regulators to ensure mandatory testing before the manufacture and release of any batch of cough syrups.
The latest move comes barely weeks after the deaths of several children in Madhya Pradesh were linked to allegedly contaminated cough syrups found to contain higher than permissible levels of diethylene glycol. Following the incident, the World Health Organization (WHO) issued a medical alert warning that the untracked distribution of such syrups through informal or localised channels could pose a risk to health.