NewsStocksCDSCO Launches Nationwide Audit of Cough Syrup Manufacturers Following Child FatalitiesCDSCO Launches Nationwide Audit of Cough Syrup Manufacturers Following Child Fatalities
The Central Drugs Standard Control Organisation (CDSCO) has initiated a nationwide audit of all cough syrup manufacturers in India after 20 child deaths linked to contaminated cough syrup. Joint inspection teams will conduct audits based on quality standards, covering packaging, dosage guidelines, and raw materials. Recent developments include arrests, facility closures, and conflicting test results. Tamil Nadu's tests found diethylene glycol (DEG) in some syrups, with Coldrif containing 48.6% DEG, while CDSCO's tests found no traces in six samples.
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The Central Drugs Standard Control Organisation (CDSCO) has initiated a comprehensive nationwide drive to inspect and audit all cough syrup manufacturers in India. This action comes in the wake of 20 child fatalities linked to contaminated cough syrup, prompting urgent regulatory measures.
Key Points of the Nationwide Audit
- CDSCO has requested detailed lists of cough syrup manufacturers from all states and Union Territories for auditing purposes.
- Joint inspection teams comprising state FDA and CDSCO officials will conduct the audits.
- Audits will be based on 'Not of Standard Quality Ratings' for drugs failing quality standards.
- Inspections will cover:
- Packaging labels
- Dosage guidelines
- Prescription information
- Raw materials used in manufacturing
Recent Developments
Arrests and Facility Closure
- Madhya Pradesh Police arrested S Ranganathan, owner of Sresan Pharmaceutical, in connection with the banned cough syrup allegedly linked to the fatalities.
- Tamil Nadu government sealed a pharmaceutical unit and dispatched a police team for facility inspection.
Test Results
- Tamil Nadu's test report confirmed diethylene glycol (DEG) content in samples of Coldrif, Respifresh, and Refile syrups.
- Coldrif syrup was found to contain 48.6% DEG.
- CDSCO tested six samples of the banned cough syrup and found no traces of DEG.
Detailed Test Results
| Syrup Name | DEG Content | Action Taken |
|---|---|---|
| Coldrif | 48.60% | Banned |
| Respifresh | Presence confirmed (% not specified) | Under investigation |
| Refile | Presence confirmed (% not specified) | Under investigation |
This nationwide audit represents a significant step in ensuring the safety and quality of pharmaceutical products in India. The discrepancy between Tamil Nadu's test results and CDSCO's findings highlights the complexity of the situation and the need for thorough, coordinated investigations.
As the audit progresses, it is expected to bring about stricter quality control measures and enhanced regulatory oversight in the pharmaceutical industry, particularly in the manufacturing of cough syrups and other pediatric medications.
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