Key Points

The CDSCO is developing a comprehensive system to monitor cough syrup manufacturers following tragic child deaths. They've requested lists of all cough syrup companies from states to conduct thorough inspections and audits. This action comes after 22 children died in Madhya Pradesh from contaminated Coldrif syrup containing dangerous diethylene glycol. The World Health Organization is closely monitoring the situation and has expressed serious concern about these incidents.

Key Points: CDSCO Creates Robust System for Cough Syrup Safety After Deaths

  • CDSCO seeks complete list of cough syrup manufacturers from all states for comprehensive audit
  • 22 children died in Madhya Pradesh from contaminated Coldrif cough syrup
  • Sresan Pharmaceuticals violated 38 critical observations during joint inspection
  • WHO expresses deep concern and closely monitoring cough syrup-related deaths in India
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CDSCO to come up with robust system to keep check on cough syrup manufacturing companies: Sources

CDSCO launches nationwide audit of cough syrup manufacturers after 22 child deaths in Madhya Pradesh linked to contaminated Coldrif syrup with WHO monitoring situation

"We are discussing with experts for the best solution, and soon we will be coming up with a robust system - Official Sources"

By Shalini Bhardwaj, New Delhi, October 10

The Central Drugs Standard Control Organisation (CDSCO) sought a list of all cough manufacturing companies from all States. According to the sources, the CDSCO will conduct inspections, testing, and audits of all companies manufacturing cough syrup.

"We are discussing with experts for the best solution, and soon we will be coming up with a robust system. We will be doing an audit of the cough syrup manufacturing companies, and for this, states have been asked to provide the list of cough syrup manufacturing companies," official sources said.

The deaths linked to the contaminated cough syrup Coldrif have touched 22 children in Madhya Pradesh. The cough syrup manufacturing company Sresan Pharmaceuticals received a license from the State FDA in 2011 and renewed the license in 2016.

"Manufacturing site licensed in 2011 by the Tamil Nadu-FDA state," said sources.

During the inspection, the company was found to be in violation of 38 critical observations out of 364 total violations.

"The company was found violating 38 critical observations out of 364 violations during the joint inspection," sources said.

The Epicentre of deaths due to the presence of over 45 per cent of diethylene glycol in cough syrups at Madhya Pradesh's Chhindwara. But deaths reported in Rajasthan a cases of Acute respiratory syndrome or encephalitis.

"The deaths reported in Rajasthan are due to Acute respiratory syndrome or encephalitis, but not due to cough syrup," said sources.

In a reply to ANI over WHO concern regarding deaths in Madhya Pradesh due to cough syrup, WHO has shown concern and is closely monitoring the whole situation, "World Health Organisation (WHO) seeks clarification, closely monitoring and showing deep concern over deaths reported due to cough syrups in India... WHO recognises the gravity of these incidents and stands ready to support national authorities in investigating and responding to the tragic events.. CDSCO has confirmed that none of the products are exported to other countries."

- ANI

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Reader Comments

R
Rohit P
Good step by CDSCO. But why did it take so many deaths for authorities to wake up? The company had 38 critical violations! This shows our regulatory system needs complete overhaul, not just for cough syrups but all medicines.
A
Arjun K
As a parent, this news terrifies me. We trust these medicines for our children's health. 45% diethylene glycol? That's criminal! The manufacturers should face strict legal action. Hope the new system prevents such tragedies. 🙏
S
Sarah B
While I appreciate CDSCO's initiative, I'm concerned about implementation. State FDA gave license in 2011 and renewed in 2016 - how did they miss 364 violations? The problem is at ground level monitoring.
V
Vikram M
At least they're taking action now. The WHO concern shows this affects India's global reputation too. Glad no exports were involved. But we need transparency - public should know which companies are compliant.
K
Kavya N
This is heartbreaking. Each number represents a child with dreams. The system failed them completely. Hope the new measures include proper compensation for affected families and criminal charges for responsible officials.

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