DCGI brings in stricter norms for tracking supply chain of high-risk solvents

The Drugs Controller General (India) has directed digital monitoring on the Online National Drugs Licensing System (ONDLS) for tracking the supply chain of high-risk solvents.

The order, issued earlier this week, comes following serious safety concerns after the alleged death of over 20 children under the age of five years due to contamination of cough syrups with Diethylene glycol (DEG) recently in Madhya Pradesh. DEG is a toxic, colourless, and odourless liquid with a sweet taste, often used as an industrial solvent.

ONDLS is a single-window digital platform in India for processing drug- and cosmetic-related applications for manufacturing and sales licences, and various certificates. Developed by the Centre for Development of Advanced Computing (CDAC) in collaboration with the Central Drugs Standard Control Organisation (CDSCO), it aims to streamline and standardise the process across the country.

In his letter, DCGI head Rajeev Singh Raghuvanshi noted, “It has been decided that a Digital Monitoring System on the ONDLS portal needs to be established for monitoring the supply chain as well as the quality of the high-risk solvents, including the Propylene Glycol. Accordingly, ONDLS portal has been upgraded and made live by this Directorate for addressing this issue.’’

Also read: CDSCO calls for list of all cough syrup manufacturers in India, initiates joint audit

Earlier, all the States/ Union Territories were asked to review compliance with drug quality norms and promote the rational use of cough syrups, especially in paediatric populations. Additionally, they were asked to take measures to ensure testing before the manufacture and release of the batch to the market by way of monitoring during inspections, sensitising the manufacturers through circulars, etc.

Dr. Raghuvanshi said that as per the latest order, all the manufacturers of pharma grade solvents should obtain manufacturing licence through the ONDLS portal. The letter noted that in case the manufacturer already holds the manufacturing licence, he must register on the ONDLS portal and submit the data through Old Licence Management under ONDLS.

Further, the solvent manufacturers should also upload details on the ONDLS portal regarding each batch manufactured with quantity etc and details of the vendors to whom the solvents are sold from time to time.

“You are also requested to ensure that no batch is available in the market without complying to above direction,’’ the DCGI has directed.