WHO issues product alert on three contaminated oral liquid medicines, Pg14

Key Highlights:

• The World Health Organization (WHO) issued a product alert on three contaminated oral liquid medicines reported from India on October 8.
• The medicines are specific batches of Coldrif, Respifresh TR, and ReLife, manufactured by Sresan Pharmaceutical, Rednex Pharmaceuticals, and Shape Pharma, respectively.
• Indian regulatory authorities have been advised to conduct targeted market surveillance, especially in informal supply chains.
• The Central Drugs Standard Control Organisation (CDSCO) stated that none of the contaminated medicines have been exported from India.
• The medicines were found to contain diethylene glycol, which is toxic and can be fatal if consumed.

Detailed Insights:

• The WHO considers the products substandard because they do not meet quality standards and specifications.
• The CDSCO reported the presence of diethylene glycol in the oral liquid medicines on October 8.
• The WHO is collaborating with Indian health authorities to monitor the situation and identify the contamination source.
• The contaminated products pose significant risks to patients and could cause life-threatening illnesses.
• The Indian regulatory authorities should evaluate the risks associated with oral liquid medicines produced since December 2024.

Key Concepts Involved:

• Diethylene Glycol: A toxic substance that is dangerous for human consumption and can be fatal.
• Substandard Products: Products that fail to meet established quality standards and specifications.
• Market Surveillance: The continuous monitoring of products in the market to ensure they meet required standards.