Central Drugs Standard Control Organisation (CDSCO)

Recently, The Central Drugs Standard Control Organisation (CDSCO) released its monthly list of drugs that fail quality tests.

More on the news

• Around 50 medicines like paracetamol (fever), metformin (diabetes), and pantoprazole (acidity) were found to be either spurious or not of standard quality (NSQ).
• The findings were part of routine random sampling.   

About CDSCO

• CDSCO is India’s National Regulatory Authority (NRA) under the Directorate General of Health Services, Ministry of Health & Family Welfare.
• Headquarters: New Delhi. 

Enroll now for UPSC Online Course

• Key Responsibilities of CDSCO

• • Safety and Quality: Ensures transparency, accountability, and uniformity in services to maintain the safety, effectiveness, and quality of medical products.
  • Approval of New Drugs: Approves new drugs and oversees clinical trials.
  • Standards for Drugs: Establishes standards for drugs and controls the quality of imported drugs.

• Collaboration with State Regulators

  • Licensing: Along with state authorities, CDSCO grants licenses for critical drugs like blood products, vaccines, IV fluids, and sera.
  • Expert Advice: Provides guidance to ensure uniform enforcement of the Drugs and Cosmetics Act across the country.

What is CDSCO’s NSQ Alert?

• CDSCO releases a monthly list of medicines that fail quality tests, highlighting the drugs that do not meet standards.
• Central and state regulators collect samples from the market and test them randomly.
• The list includes medicines and the specific parameters on which they failed.

Check Out UPSC Modules From PW Store

• Purpose of the Quality Checks

• • These monthly alerts inform the public, healthcare departments, and state regulators about medicines that may not be of high quality.
  • It also ensures that pharmaceutical companies know their products are under constant monitoring.

• Examples of NSQ Drugs
  • Metformin failed the dissolution test, meaning it wouldn’t dissolve properly and wouldn’t work as intended.
  • The list also includes other medicines that fail to meet specific quality parameters.

Enroll now for UPSC Online Classes