DCGI brings in stricter norms for tracking supply chain of high-risk solvents, Pg16

Key Highlights:

• DCGI mandates digital monitoring via ONDLS to track high-risk solvent supply chains.
• The order follows safety concerns after the death of over 20 children in Madhya Pradesh due to cough syrup contamination with diethylene glycol (DEG).
• ONDLS is a single-window digital platform for processing drug and cosmetic-related applications.
• All manufacturers of pharma grade solvents must obtain or register their manufacturing license through the ONDLS portal.

Detailed Insights:

• Diethylene glycol (DEG) is a toxic, colorless, and odorless liquid with a sweet taste, often used as an industrial solvent and linked to recent safety concerns.
• The Digital Monitoring System on the ONDLS portal will monitor the supply chain and quality of high-risk solvents, including Propylene Glycol.
• The order mandates that existing manufacturers must register on the ONDLS portal and submit data through Old Licence Management under ONDLS.
• This initiative aims to enhance the safety and quality control in the pharmaceutical industry by tracking the supply chain of high-risk solvents.

Key Concepts Involved:

• DCGI (Drugs Controller General (India)): The authority responsible for regulating pharmaceuticals and medical devices in India.
• ONDLS (Online National Drugs Licensing System): A digital platform for processing drug and cosmetic-related license applications.
• Diethylene Glycol (DEG): A toxic solvent, the presence of which in pharmaceuticals is a serious safety concern.