BENGALURU: The health department has flagged 26 medicines -- eight as spurious or fake and 18 as misbranded -- which are consumed for acidity, pain relief, cholesterol, iron deficiency, and nasal congestion.
It has stated that these medicines have been produced in violation of the Drugs and Cosmetics Act. Over a year, five pharmaceuticals have been convicted for violating safety standards. Twelve cases are in various stages of trial. Investigations are on to ascertain whether pharma companies used substandard chemicals in 26 medicines flagged by the department.
Of the 26 medicines, 10 used for nasal congestion relief were found to have violated the Act. Four medicines used for reducing eye inflammation and treating dry eyes, two to treat pain, inflammation and conditions such as arthritis and allergies have been labelled as spurious or misbranded.
The department found three samples of folic acid (iron supplements) and multivitamin medicines not meeting the set standards alongside other drugs used for treating glaucoma and high eye pressure as well as preventing nausea and vomiting caused by chemotherapy or surgery.
‘If labelling is misleading, medicines are marked as misbranded’
The department files cases against companies for misbranding drugs and if they are harmful. It may penalise them, but not file a case for mistakes such as labelling errors in cases where the medicine is safe. Also in cases where a company withdraws the product, the department issues a warning.
The alarming extent of counterfeit medicines in Karnataka came to light after Health Minister Dinesh Gundu Rao’s reply during the winter session in Belagavi.
Responding to a question by MLC CN Manjegowda, Gundu Rao outlined steps to curb such medicines, including regular sample testing from the supply chain by drug inspectors, investigations into complaints, and coordination with licensing authorities to take action against the violators.
Routine checks
Inspections conducted by drug inspectors often reveal whether a medicine is spurious or misbranded through rigorous sampling and laboratory testing.
An officer from the Drugs Control Department told TNIE that during routine checks at manufacturing units, pharmacies or distribution channels, inspectors collect samples of medicines, which are sent to government-approved laboratories for analysis.
“If a medicine fails to meet the prescribed quality standards set by regulatory authorities such as the Drugs Controller General of India (DCGI), contains incorrect or harmful ingredients, or is falsely labelled, it is classified as spurious. Similarly, if the labelling is inaccurate, misleading or fails to adhere to regulatory guidelines, the medicine is marked as misbranded. Once identified, the drugs are labelled accordingly, and immediate action is taken to prevent their distribution and sale,” the official said.
These medicines pose significant risks to public health as they can lead to ineffective treatment, adverse reactions and harm antibiotic resistance, the official said, adding that regulatory authorities, on a regular basis, detect spurious or misbranded medicines through inspections, testing, consumer complaints, and monitoring of manufacturing processes.