The Karnataka drugs control department has seized seven not of standard quality drugs in its recent surprise inspection conducted across pharmacy outlets in the state. The inspections were conducted in the end of December 2013 and the results were made available in early January, 2014. These drugs were found to be failing dissolution test, available for sale in the pharmacy outlets with faulty labels and noted for non conformance in the test of uniformity of weight of tablets.
The seven drugs are raberprazole sodium tablets, manufactured by three companies Rhydburg Pharma at Dehradun in Uttarkhand, Shervotec Pharmaceuticals in HPSIDC in Baddi district at Solan in Himachal Pradesh and Ultratech Pharmaceuticals in Village Tipra, Solan district in Himachal Pradesh. The drug for all the three companies was found not to conform to the Indian Pharmacopoeia (IP) standards and failed in the dissolution test, according to a communiqué from the Karnataka drugs controller Raghurama Bhandary.
Inmac Laboratories in Bangispura in Punjab manufactured the drug melopyrine or meloxicam injection which was declared to be not of standard quality because of its description and assay details on the carton box that was stated to be misleading.
Pro Laboratories which manufactured the drug Afenak Plus or aceclofenac in 100 mg with paracetamol 325 mg at its facility in Makkanpur in Roorkie district in Haridwar was found to fail the test in the uniformity of weight of tablets.
In the case of South East Pharmaceuticals in SIDCO Industrial Area in Chennai, its product Helmisol Powder or levamisole hydrochloride veterinary oral powder, which was seized by the state drug inspectors from Chitradurga was seen to be not of standard quality with regards to its description as its contained lumps and its content levamisole hydrochloride did not conform it its label claim.
Akums Drugs and Pharmaceuticals in Ranipur in Haridwar district which manufactured Hytide RD 20 was declared to be not of standard quality only because it did not conform with the label details related to the assay for omeprazole only.
“We will take appropriate action according to the guidelines. The available stocks of the drugs which were found to be not of standard quality will be recalled from the supply chain,” Bhandary told Pharmabiz.
These drugs were seized across Karnataka and the inspectors from state drugs control offices in the districts of Raichur, Chitradurga, Yadgir, Bengaluru, and Mysore carried out the surprise checks to pick up samples at random to test its content. These drugs were tested at the state drugs control department’s drug test labs at Bengaluru and Bellary.
The state drugs control department has been known for its regular and surprise inspections carried out every month.