Samples of 47 drugs made in Himachal not of standard quality

Popular blood pressure lowering drug, Telmisartan tablets, and Rabeprazole Sodium capsule, used for gastroesophageal reflux disease, figured among 47 drug samples that were declared substandard by the state and Central drug regulatory authorities in the drug alert issued on Friday.

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They figure in the list of 186 drug samples that have been declared substandard by the Central Drugs Standard Organisation (CDSCO) across the nation. Several Himachal-based firms have multiple batch failures of the same drug, thus reflecting consistent fall in the quality of the drugs. A majority of such erring firms have been figuring in the alert month after month and are based at industrial clusters of Baddi, Kala Amb, Paonta Sahib and Solan.

Multiple batches of Ofloxacin tablets, and Amoxycillin and Potassium Clavulanate, both used for treating bacterial infection figure in the list of drugs declared not of standard quality. Others comprise vitamin supplements, Aceclofenac and Paracetamol tablets, folic acid syrup, Cefixime powder, Rumiheal-D, Itraconazole Ofloxacin, Ornidazole & Clobetasol Propionate cream, etc.,

As part of the continuous regulatory surveillance, drugs, cosmetics and medical devices samples are picked from sales and distribution point, analysed and list of ‘Not of Standard Quality’ (NSQ) drugs are displayed on the CDSCO portal on a monthly basis to make stakeholders aware about the NSQ batches in the market.

Injections samples and cough syrups have also been found failing in quality parameters for issues such as lack of assay content, mislabelling, inappropriate pH, failing disintegration tests, etc., reflecting flaws in manufacturing.

These drugs are used to relieve common ailments such as acidity, pain, fever, stomach ulcers, heartburn as well as for conditions such as antibiotic treatment, gastroesophageal reflux disease, pain and inflammation, rheumatoid arthritis, musculoskeletal disorders as well as high blood pressure.

State Drugs Controller Manish Kapoor said, “All such batches figuring in the list will be immediately withdrawn and risk-based inspection of firms that repeatedly figure in these monthly lists would be conducted to identify the flaws and rectify the defects.”