Relevance: GS-II (Health), GS-III (Industry/Standards)

The news

Deaths of children abroad linked to contaminated cough syrups put a spotlight on India’s pharma exports and on the basics of quality by design.

What went wrong

A few batches used solvents and sweeteners (such as glycerin or propylene glycol) contaminated with diethylene glycol or ethylene glycol. These toxic glycols can cause acute kidney injury and death. In small firms, weak vendor checks, poor testing, and inadequate documentation let bad raw materials slip through.

How India responded

• Mandatory pre-shipment testing of cough syrups in government-notified laboratories; exporters need a certificate of analysis.
  
• Tightening of Good Manufacturing Practices (Schedule M) with risk-based inspections and digital batch records.
  
• Stricter standards for excipients to keep glycol contamination near zero; more scrutiny of import sources.
  
• Licence cancellations and prosecutions in egregious cases; advisories to importing countries and recalls.
  

What must happen next

• End-to-end traceability for excipients (from refinery to bottle).
  
• Qualified vendor lists, surprise audits, and stability studies in hot-humid conditions.
  
• Public batch-search portal so buyers and regulators can verify every exported lot.
  
• Stronger pharmacovigilance and swift, legally backed recalls.
  

Key terms
diethylene glycol • ethylene glycol • excipients • certificate of analysis • Good Manufacturing Practices (Schedule M) • pharmacovigilance • traceability • stability testing

Exam hook

Key takeaways

• The hazard is toxic glycols sneaking into syrups through contaminated excipients.
  
• India has moved to pre-shipment testing and upgraded Good Manufacturing Practices; enforcement must be uniform.
  
• Trust in exports depends on traceable supply chains and fast recalls.
  

UPSC Prelims question
Q. Consider the following statements:

1. Diethylene glycol and ethylene glycol contamination in medicines can cause acute kidney injury.
   
2. Pre-shipment testing of cough syrups in government-notified laboratories is required for export.
   
3. Schedule M in India relates to Good Manufacturing Practices for pharmaceuticals.
   Which of the statements given above is/are correct?
   

(a) 1 and 2 only 

(b) 2 only 

(c) 1 and 3 only 

(d) 1, 2 and 3
Answer: (d)

One-line wrap
For medicines, quality is a system, not a slogan—clean inputs, strict processes, and transparent recalls keep patients safe and exports credible.