Karnataka Drugs Control department has seized a stock of Ofloxacin tablets valued at Rs 1,20,540. The stock tablets is found to be not-of-standard quality.
The seizure was carried out by a drugs inspector from the Bangalore Circle 4 of the department. The Ofloxacin tablets B No. LLT-9021, D/M:05/2009. D/E:04/2012 were found at Laksun Life Sciences in Bangalore. The drug was manufactured by Madhav Biotech Pvt Ltd at Solan in Himachal Pradesh.
Not-of-standard quality drugs are products with insufficient quantum of active ingredients, non-conformity with the requirement of sterility, disintegration, assay requirements, weight uniformity and presence of undesirable substances.
Ofloxacin is a second-generation fluoroquinolone antibiotic and is prescribed for chronic bacterial infections. It is also available as eye and ear drops, according to doctors at Victoria Hospital.
The not-of-standard quality of Ofloxacin tablets is a serious issue. As an antibiotic, the drug is to treat infection. The patients who take not-of-standard quality drugs will find no relief. There is also the issue of drug resistance, said doctors from Manipal Hospital which prescribes this drug commonly to control the infection.
Dr BR Jagashetty, drugs controller, said, “Government of Karnataka, the drugs manufactured from the former excise free zones are proving to be not-of-standard quality time and again. Our drug inspectors are constantly on the vigil to seize such samples which is detrimental to the health of patients.”
In an another surprise inspection drive, the State drugs inspectors managed to lay their hands on more such not-of-standard quality samples. These are Lopidus tablets containing Loperamide Hydrochloride manufactured by Lucent Biotech in Roorkee in Uttarakhand. Another drug, Lewon known as Levoflocacin tablets manufactured by Park Pharmaceuticals in Panchkula, Haryana was also found to be fail the stability studies. Levofloxacin is also an antibiotic to treat bacterial infections. It is in a class of antibiotics called fluoroquinolones which includes ciprofloxacin, Norfloxacin, ofloxacin and Trovafloxacin.
In addition, the government analyst drug testing laboratory at Chennai has declared two drugs Dicyclomine tablets prescribed for gastroenterology and Enalapril Maleate tablets for blood pressure manufactured by the Bangalore-based Embiotic Laboratories as not-of-standard quality. The drug was seized from the outlets in Tamil Nadu. The Karnataka drugs controller has warned the pharmacy trade and the healthcare providers not to hold any stock of the same.
As part of the good distribution practices, Dr Jagashetty is insisting on the withdrawal of the drug by the pharma companies from the wholesalers and check out its availability at the retail outlets to prevent harm to the consumer.