CDSCO calls for list of all Indian cough syrup makers, Pg16

Key Highlights:

• The CDSCO has requested State governments to provide a list of cough syrup manufacturers for a joint audit.
• Three contaminated cough syrups (Coldrif, Respifresh, and ReLife) linked to child deaths in India were identified by the CDSCO as containing diethylene glycol (DEG).
• The CDSCO has informed the WHO that the contaminated syrups were not exported from India and the manufacturers have ceased production.
• The WHO has offered support for investigating the incidents and highlighted a regulatory gap in screening for DEG/EG in domestically marketed medicines in India.

Detailed Insights:

• The identification of contaminated cough syrups and subsequent actions by the CDSCO highlight the importance of stringent quality control in pharmaceutical manufacturing.
• The presence of diethylene glycol (DEG) in cough syrups is a serious concern, as it is toxic and can cause kidney failure and death, especially in children.
• The WHO's concern over regulatory gaps in DEG/EG screening indicates a need for strengthening drug safety regulations and enforcement mechanisms in India.
• Joint audits of cough syrup manufacturers and improved screening processes are crucial steps to prevent future incidents and ensure the safety of pharmaceutical products.

Key Concepts Involved:

• CDSCO (Central Drugs Standard Control Organisation): National regulatory body for pharmaceuticals and medical devices in India.
• Diethylene Glycol (DEG): A toxic alcohol used in antifreeze and industrial solvent, can be fatal if ingested.
• Quality Control: System of maintaining standards in manufactured products by testing a sample of the output against specification.