38 drug samples manufactured in state found substandard

As many as 38 drug samples manufactured in various drug clusters of the state failed quality parameters in the monthly alert issued by the central drug regulator today. They figure among 135 drugs samples declared not of standard quality from various states.

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Among these 38 samples, 16 figure in the Central Drugs Standard Control Organisation’s (CDSCO) list while the remaining 22 figure in the list of various states. They have been manufactured in 29 drug companies of Baddi, Barotiwala, Nalagarh, Paonta Sahib, Kala Amb, Solan, etc.

As part of the continuous regulatory surveillance, drug samples are picked from sales/distribution point, analysed and are displayed on CDSCO portal on monthly basis to create awareness among the stakeholders about such batches.

State Drugs Controller Manish Kapoor stated that drug batches figuring in the list will be immediately withdrawn from the market and the field staff will examine the units to detect laxities which led to quality parameters having failed in such drugs.

These drugs include cough syrups, six injections, anaesthetics gel as well as a mouthwash. Injections like Meropenem, two batches of Rabeprazole, Bortezomib used for upper respiratory allergies also figure in the list.

Injections were found to contain particulate matter which can be a serious health risk for patients. Lack of assay content, which hits its quality, was also found to be a reason for drugs lacking quality. Iron Sucrose injection used to treat iron-deficiency anaemia was bereft of adequate iron content. Dexamethasone injection used to treat severe allergic conditions, collagen diseases, pulmonary disorders, blood disorders, etc. lacked adequate assay.

Two samples of Divalproex extended release tablets meant for Jammu & Kashmir Medical Supplies Corporation Limited manufactured by a Nalagar-based company was declared not of standard quality due to lack of uniformity of weight.

Drugs listed in the alert are Manofex-180 tablet, two batches of Axbex Suspension, Noscapine, Chlorpheniramine Maleate, Guaiphenesin & Sodium Citrate syrup, Telmisartan tablets, Zovibact 800 mg tablet, Glimepiride tablet, Albendazole, Unipraz capsule, Paracetamol paediatric oral suspension and lignocaine hydrochloride gel is used as a local anaesthetics.

Other such drugs are Cghest-8 tablet, Okamet 500 tablet, Care zinc tablet, Amoxymoon CV-625 tablet, Panik-D tablet, Qupod200 tablet, Calcovit D3 tablet, Cipex-500 tablet, Terbicharge 250 mg tablet, Itraconazole capsules , Trubery LS oral drops, Sucrazum-O Suspension, Justkof-LS syrup, Retrazith-250 tablet, Brokuf-DM syrup and Cadcof-Lx Syrup,

They are used to treat common ailments like anti-allergy, a dietary supplement, hypertension, chickenpox, herpes, gastroesophageal reflux disease, pain, fever, inner ear disorder, type 2 diabetes mellitus, lung infections, malaria, asthma, bacterial infection, tonsillitis, sinusitis, calcium deficiency, lung infection, urinary tract infection, skin infection, and stomach infection, antifungal, cough, acidity, stomach ulcer, heartburn and cough.