Antibiotic Killmed 625 LB Fails Quality Test, No Clavulanic Acid Found, Declared Seriously Substandard

New Delhi: A combination antibiotic tablet containing amoxycillin, potassium clavulanate, and lactic acid bacillus, marketed as 'Killmed 625 LB', has failed a quality test after being found to contain no clavulanic acid, one of its key active ingredients, prompting the state health department's Commissionerate of Food Safety and Drug Control (CFSDC) to issue an alert on Wednesday to drug control officers across the state.

According to the news reported by TOI, treating the issue with urgency, the state health department’s Commissionerate of Food Safety and Drug Control (CFSDC) on Wednesday issued an alert to drug control officers across the state.

Clavulanic acid plays a crucial role when combined with amoxicillin in treating bacterial infections such as ear infections, sinusitis, and respiratory tract illnesses. Its absence can severely compromise the therapeutic effectiveness of the medication.

Clavulanic acid acts as a β-lactamase inhibitor that protects amoxicillin from degradation by bacteria, significantly expanding its antibacterial spectrum. Many bacteria produce β-lactamase enzymes that break down the β-lactam ring of amoxicillin, rendering it ineffective. Clavulanic acid intercepts and inhibits these enzymes, protecting the antibiotic.

State Drug Controller Ajay Phatak confirmed that the drug has been classified as “seriously substandard” following a test report issued by the Government Analyst at the Drug Testing Laboratory in Jaipur, reports TOI.

In response, the CFSDC has instructed all drug control officers to enforce strict surveillance in their respective jurisdictions and initiate action under the Drugs and Cosmetics Act, 1940 and the Rules of 1945. Officials have also been directed to collect and test additional samples of medicines produced by the same manufacturer.

The drug ‘Killmed 625 LB’ was manufactured by VADSP Pharmaceuticals, based in Jharmajri, Baddi, Himachal Pradesh. Notably, the company had earlier come under scrutiny after one of its products, QCE POD 200 MG, a third-generation antibiotic, was also found to lack its active ingredient, Cefpodoxime.

A senior health department official stated that the failed sample indicates the drug would be ineffective in treating patients and assured that appropriate legal action will be taken against the manufacturer in accordance with existing regulations, as per the news reported by TOI.