Apex drug regulator seeks list of cough syrup makers from states, Pg9.

Key Highlights:

• The apex drug regulator has requested states to provide a list of cough syrup manufacturers to audit their units.
• This action follows the death of at least 14 children in Madhya Pradesh due to contaminated cough syrup.
• Sresan Pharmaceuticals in Tamil Nadu was found to have 48.6% diethylene glycol (DEG) in its syrup, exceeding the permissible limit of 0.1%.
• Redmex Pharmaceuticals in Gujarat had 1.3% DEG in its RespiFresh syrup; both companies received stop production orders.

Detailed Insights:

• The Central Drugs and Standard Control Organisation (CDSCO) was unaware of Sresan Pharmaceuticals' existence, highlighting regulatory gaps.
• Before 2017, joint inspections by state and central teams were not mandatory for new manufacturing licenses.
• Sresan Pharmaceuticals did not test raw materials or finished products, violating established regulations.
• Regulators cannot test every batch of medicine, placing the responsibility for testing on the manufacturing companies.

Key Concepts Involved:

• Diethylene Glycol (DEG): A toxic contaminant, with a permissible limit of 0.1% in syrups.
• NSQ (Not of Standard Quality): Indicates products that do not meet the required quality standards.
• CDSCO (Central Drugs Standard Control Organisation): National regulatory body for pharmaceuticals and medical devices.