DCGI Orders Strict Pharma Testing After Children Die from Contaminated Cough Syrup in India

Overview

The Drugs Controller General of India (DCGI) has issued a strong advisory to state and Union Territory drug controllers to ensure strict testing of pharmaceutical raw materials and finished medicines before they are released to the market. This follows tragic incidents where children died after consuming contaminated cough syrup.

What Happened?

• In Madhya Pradesh, 20 children died and five remain in critical condition due to kidney infections linked to cough syrup containing Diethylene Glycol and Ethylene Glycol.
• In Rajasthan, three children allegedly died after consuming similar cough syrup.
• Inspections revealed that manufacturers failed to test each batch of raw materials and active ingredients before production.

Why Is This Important?

These chemicals — Diethylene Glycol and Ethylene Glycol — are toxic and should never be present in medicines. Batch testing of raw materials and finished products is crucial to ensure safety and prevent tragedies.

DCGI Advisory Highlights

1. Drug controllers must ensure compliance with testing before market release.
2. Each batch of raw materials and final products must be tested in approved laboratories.
3. Manufacturers must keep proper records of all testing.
4. Only materials from reliable, approved vendors should be used.
5. Regular inspections must confirm adherence to these rules.

Frequently Asked Questions

What caused these children’s deaths?

Contamination of cough syrup with toxic chemicals Diethylene Glycol and Ethylene Glycol caused kidney infections, leading to fatalities.

What actions are being taken?

The DCGI has instructed state and UT drug controllers to enforce strict batch testing of raw materials and medicines, and ensure manufacturers follow proper safety protocols.

How can such incidents be prevented?

Manufacturers must conduct mandatory testing for every batch, maintain accurate records, and use only high-quality raw materials from approved vendors.

Conclusion

This tragedy highlights the urgent need for stricter pharmaceutical safety checks in India. The DCGI’s directive aims to prevent future incidents and safeguard public health.