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.
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Key Responsibilities of CDSCO
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- 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.
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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.
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Purpose of the Quality Checks
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- 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.
- Types of Substandard Medicines
- Spurious Drugs: Fake products that imitate popular brands.
- They may or may not contain the correct active ingredient and are not made by the actual manufacturer.
- Example: Telmisartan (Glenmark) and Pantoprazole (Sun Pharma) were found to be fake.
- Poor Quality Drugs (NSQ): These may have faulty descriptions, may not dissolve properly, or have less active ingredients.
- They may not harm the patient but fail to treat the condition.
- Example: Metformin failed the dissolution test and would not work as intended once consumed.
- Adulterated Drugs: These contain harmful contaminants or adulterants. Such drugs are usually recalled to avoid causing harm.
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- 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.
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September 28, 2024
