Ensure testing of raw materials, finished drugs: CDSCO to states, Pg12.

Key Highlights:

• CDSCO directed state drug regulators to ensure drug manufacturers test raw materials and finished products before market release.
• The directive follows reports of child deaths in Madhya Pradesh linked to contaminated cough syrup.
• CDSCO observed manufacturers were not testing each batch of excipients, APIs for compliance.
• State regulators are urged to ensure manufacturers have a vendor qualification system for raw materials.

Detailed Insights:

• The CDSCO's directive aims to strengthen quality control in pharmaceutical manufacturing.
• A vendor qualification system ensures raw materials are sourced from reliable companies, enhancing drug safety.
• The lack of testing excipients and APIs can lead to substandard drugs and adverse health outcomes.
• This measure aligns with ongoing efforts to improve drug regulation and prevent future tragedies.

Key Concepts Involved:

• Excipients: Inactive substances that serve as the vehicle or medium for a drug.
• API (Active Pharmaceutical Ingredient): The part of a drug that produces its intended effects.
• Vendor Qualification System: A process to assess and approve suppliers of raw materials.