After Cough Syrup Deaths, India Launched “Online National Drug Licensing System (ONDLS)

In the wake of fatal incidents linked to contaminated cough syrups, India’s Central Drugs Standard Control Organisation (CDSCO) has rolled out a digital system to monitor the production and movement of high-risk pharmaceutical solvents. The move aims to prevent future cases of contamination that have caused severe health crises in several states.

New Oversight System for Drug Ingredients

The CDSCO has directed all state and union territory drug controllers to use the Online National Drug Licensing System (ONDLS) portal for real-time tracking of solvent batches. The circular, issued on October 22, mandates that all manufacturers of pharma-grade solvents obtain licences and upload detailed batch data, including certificate of analysis and buyer information. Regulators have been instructed to block any unverified batch from reaching the market.

Trigger: Recent Cough Syrup Deaths

The decision follows several child deaths in Madhya Pradesh linked to cough syrups contaminated with diethylene glycol (DEG), a toxic industrial solvent. Subsequent investigations revealed lapses in ingredient tracking and quality control. The World Health Organization (WHO) had issued a global alert warning that unregulated syrup distribution posed a serious health risk, particularly in paediatric formulations.

High-Risk Solvents Under Scrutiny

The CDSCO has identified ten solvents as high-risk, including glycerin, propylene glycol, sorbitol, maltitol, ethyl alcohol, and hydrogenated starch hydrolysate. These ingredients are essential in liquid medicines but prone to adulteration if sourced from unverified suppliers. The new directive, signed by Drugs Controller General of India Dr Rajeev Singh Raghuvanshi, follows a high-level meeting chaired by the Union Health Secretary on October 5 to review national drug quality standards.

Related GK Facts

• Diethylene glycol (DEG) contamination has caused mass poisoning in India since the 1970s, leading to multiple regulatory reforms.
• The CDSCO, under the Ministry of Health, is India’s apex authority for drug approval and quality control.
• The ONDLS portal was initially launched to digitise drug licensing and compliance processes nationwide.
• Propylene glycol and glycerin, though safe when pure, can become toxic if contaminated with industrial-grade chemicals.

Ensuring Traceability and Compliance

Under the upgraded ONDLS system, manufacturers must record every batch of solvents produced, ensuring end-to-end traceability. Those already licensed must register under a new “old licence management” module to maintain compliance. State regulators have been directed to conduct inspections, awareness drives, and training sessions to ensure that the system is uniformly implemented. The government expects this digital initiative to close regulatory loopholes and safeguard public health by ensuring pharmaceutical-grade purity at every stage of production.