In the wake of at least 23 child deaths in Madhya Pradesh linked to cough syrups allegedly contaminated with Diethylene Glycol (DEG), the Central Drugs Standard Control Organisation (CDSCO) has introduced a digital system to monitor the supply chain and quality of high-risk pharmaceutical solvents.
The move comes amid increasing global scrutiny of India’s drug manufacturing standards, particularly from the World Health Organization (WHO), which has previously flagged quality lapses in DEG-contaminated medicines.
Digital Oversight Through ONDLS
In a circular issued by Dr. Rajeev Singh Raghuvanshi, Drugs Controller General of India (DCGI), all state and union territory drug controllers have been instructed to ensure that manufacturers of pharma-grade solvents secure manufacturing licences via the Online National Drugs Licensing System (ONDLS) portal.
The circular highlights that authorities have upgraded the ONDLS portal with a digital monitoring system to track both the supply chain and quality of high-risk solvents, including DEG — the chemical implicated in the Coldrif cough syrup produced by Chennai-based Sresan Pharmaceuticals.
List of High-Risk Solvents
The CDSCO has identified several solvents as high-risk, including:
- Glycerin
- Propylene glycol
- Maltitol and its solution
- Sorbitol and its solution
- Hydrogenated starch hydrolysate
- Polyethylene glycol (MW <1000)
- Diethylene glycol stearates
- Certain low-molecular-weight polyethylene glycol monomethyl ethers
- Polysorbates
- Ethyl alcohol
Under the new protocol, manufacturers must upload batch-wise details on the ONDLS portal, including production quantities, Certificates of Analysis (CoA), and the names of vendors purchasing the solvents. State regulators are tasked with ensuring that no batch reaches the market without complete documentation.
Moving Towards Traceability
As reported by thehindubusinessline.com, Sumant K. Tiwari, Joint Director, Drugs Control Department, Jharkhand, described the ONDLS integration for solvent tracking as a potential pilot blueprint. He noted that if successful, the system could evolve into a centralized national quality grid, enabling end-to-end traceability for drug licensing, inspections, and raw material oversight on a single platform.
