Apex Drug Regulator Identifies Sub-Standard and Spurious Medicines in Monthly Survey

The Central Drugs Standard Control Organisation (CDSCO) has identified 49 medicines as sub-standard and four as spurious in its latest monthly survey. This survey checks the quality of drugs available in the market. The list includes commonly used medications like metformin for diabetes, pantoprazole for acidity, and paracetamol for fever.

This exercise is routine for the drug regulator, involving random testing of medicines to ensure quality. Dr. Rajeev Singh Raghuvanshi, the Drug Controller General of India, stated, “There are no contaminated drugs; these are not of standard quality. These drugs have failed some quality tests. The four spurious drugs were not manufactured by the brands listed on their packaging.”

Each month, the CDSCO releases a list of drugs deemed not of standard quality (NSQ). Both central and state drug regulators randomly collect samples of various medicines from the market for testing. The monthly report details the names of the medicines that fail and the specific quality parameters they did not meet.

For example, metronidazole, an antibiotic, was named in the September list for failing the dissolution test. This means the medicine does not dissolve properly after consumption, hindering its effectiveness.

Dr. Raghuvanshi mentioned that around 3,000 samples are tested each month, with approximately 40 to 50 failing the tests.

Understanding Drug Quality Issues:

• Spurious Drugs: These are imitation products, often mimicking popular brands. They may or may not contain the actual active ingredient. For instance, Glenmark’s telmisartan and Sun Pharma’s pantoprazole were found not to be manufactured by their respective companies.
• NSQ Drugs: These drugs fail tests due to issues like incorrect descriptions, improper dissolution, or insufficient active ingredients. While they might not directly harm users, they can fail to provide the intended therapeutic effect.
• Adulterated Drugs: These contain harmful contaminants or adulterants. The drug regulator typically recalls any drugs found to be adulterated.

These monthly reports aim to inform the public, not to alarm them. If possible, avoid medicines from the specific batches mentioned by the CDSCO. Notices are issued to companies to take appropriate action regarding the affected products.