Drug Testing Lab blacklists Brown & Burk's amoxycillin oral suspension
Brown & Burk of Micro Labs is in the eye of a storm following its drug, amoxycillin oral suspension, being blacklisted under 'not-of-standard quality' by the Drug Testing Laboratory of the Karnataka drugs control department.
In a communiqué, the Drug Testing Laboratory has warned the chemists and wholesalers not to stock or sell amoxycillin for oral suspension with batch number PDO10006, manufactured by the Bangalore-based Brown and Burke. The Laboratory has also included Forcin tablets and Ciprofloxacin tablets batch No. 403 manufactured by Prayas Pharmaceuticals apart from two other products amoxycillin and cloaxcillin capsules with batch number H 4001, manufactured by Himanshu Pharmaceuticals also categorised as being 'not-of-standard quality.' The note from the Drugs Testing Laboratory has warned the public not to purchase these drugs.
According to Brown and Burk officials, the product amoxycillin for oral suspension was manufactured at a state-of-the-art facility located at the Veerasandra Industrial Area in the outskirts of Bangalore, which was approved by Health Authorities of Canada and South Africa-MCC.
Sources from the company stated that they had asked the Drug Testing Laboratory to retest the drug as they were confident of its quality standards. The product is also for the export market but this particular consignment from which the drug was sent for testing is for the domestic market.
The company stated that they were open for any discussion as all data of the drug batches were available on hand and could be readily provided for any investigation.
Recently Brown & Burk bagged the IDMA (Indian Drug Manufacturers Associations) Quality Excellence Award and such an allegation for its popular drug amoxycillin oral suspension is not true, claimed the company.
A major point to be noted during the test is the storage factor of the drug prior to its analysis. As all amoxycillin preparations in oral suspension form calls for refrigerator storage, it is a known fact that the drugs testing lab could have not been able to do so as its cold storage facility is under repair.
Meanwhile officials from DTL asserted that the drug was found to be 'not- of-standard' quality and refused to comment any further.