Contaminated Cough Syrup Incident in Madhya Pradesh
In Madhya Pradesh's Chhindwara, at least 22 children tragically died due to contaminated cough syrup. This has prompted a potential major safety directive from the Centre, targeting the use of high-risk solvents in pharmaceuticals.
Drugs Consultative Committee (DCC) Meeting
- The DCC, part of the Central Drugs Standard Control Organisation (CDSCO), discussed the issue at its 67th meeting on November 17.
- The focus was on high-risk solvents, particularly in paediatric liquid formulations.
- The committee suggested consulting stakeholders to gather data on formulations using high-risk solvents.
High-risk Solvents
Propylene glycol is deemed safe in regulated amounts, but there is concern over the use of solvents like diethylene glycol (DEG).
- DEG is an industrial solvent found in products like brake fluid and paint.
- It is sometimes mistakenly or illegally used in medicines as a substitute for propylene glycol.
Findings and Consequences
- In Chhindwara, Coldrif cough syrup contained 48.6% DEG, far exceeding the prescribed 0.1% limit.
- Two more syrups from Gujarat, Respifresh TR and Relife, also had DEG above limits.
- Smaller pharma firms, especially unorganised ones, may use contaminants like DEG to cut costs due to low-regulation and competitive markets.
Financial Implications
- Substituting DEG can save approximately ₹100 to ₹200 per 100-litre batch, significantly increasing profits in a rural wholesale market with margins of 20-30%.
Conclusion
- The Central drug regulatory body's committee is raising alarms over the use of high-risk solvents in paediatric drugs.
- The CDSCO may take further action after consulting stakeholders and gathering details on drugs using these solvents.
