38 drug samples from HP fail quality test
Thirty-eight drug samples, including 10 injections, manufactured by various pharmaceutical companies in the state, have failed to meet quality parameters, as per the monthly alert issued by the central drugs regulator today.
A total of 103 drugs from different states have been listed in the alert, while one has been declared spurious. Out of the 38 drugs from Himachal Pradesh failing quality test, 22 were tested by the central regulator and 16 by various states. Of the 22 drug samples tested by the central regulator, 10 were injections and one eye drops.
A large number of drug samples were found to be misbranded for various reasons such as not being labelled in the prescribed manner, false claims on the label or being coloured, coated, powdered or polished in ways that concealed damage or made the drug appear more effective than it actually is. “These defects are termed as minor, as per the Central Drugs Standard Control Organisation (CDSCO) guidelines, and the manufacturer is directed to rectify the same while ensuring that the said batch is withdrawn from the market. The field staff will be directed to enquire into the reasons for the drug samples failing quality parameters while the manufacturer will be issued a notice to explain his stand,” said State Drugs Controller Manish Kapoor.
Ten injection samples are on the list, namely injections comprising Haloperidol (mental), Rabeprazole Sodium (used for acidity and heartburn), Adrenaline Bitartrate (used to treat cardiac arrest), Aminophylline (used to prevent asthma), Bupivacaine Hydrochloride in Dextrose (used for spinal anaesthesia), Compound Sodium Lactate (used for intravenous fluid and electrolyte replacement), Phenytoin Sodium (used to control seizures), Polywin Vitamin B Complex and others. Serious defects, such as the presence of particulate matter that could pose a health risk were identified as the primary cause of the injections failing the quality test.
Other drugs that did not meet the quality standards include Calcium and Vitamin D3 tablets, Para 500, Xorcid-O Suspension, Amoxyheal-CV tablets, Rabicy-20 tablets, Aceclofenac and Paracetamol tablets, Glitel M1 tablets, Isosorbide Dinitrate tablets, Telmisartan and Hydrochlorothiazide tablets, Mi-6 capsules and Diclowin Plus.
These drugs are commonly used to relieve pain, fever, acidity, stomach ulcers, heartburn as well as for conditions like antibiotic treatment, gastroesophageal reflux disease, pain and inflammation, rheumatoid arthritis, musculoskeletal disorders, high blood pressure and to alleviate chest pain caused by heart disease.
As part of the continuous regulatory surveillance, drug samples are selected from sales/distribution points, analysed and the CDSCO publishes the list of Not of Standard Quality (NSQ) drugs to inform the stakeholders about the drug batches that have failed to meet the quality standards.
