Karnataka drugs control department has declared six drug samples as being not of standard quality. The drugs were tested from drug test labs not only in the state but also at Chennai and Jaipur. The samples include a product of GlaxoSmithKline and two from the Bangalore based Embiotic Laboratories. The inspections were carried out during January 1 to 30 at the pharmacy outlets across the country where the samples were picked up at random.
The drugs are declared as being not of standard quality because of inadequate quantum of active ingredients, non compliance with the requirement of sterility, disintegration, assay requirements, weight uniformity and presence of undesirable substances. Companies need to maintain the highest quality of manufacture and have to ensure re-checks at every stage to avoid getting into this situation, stated Dr BR Jagashetty, Karnataka drugs controller.
The drug test lab at Bangalore has stated that three drugs as being not of standard quality. These are X-CV Dry Syrup, which contains amoxycillin and potassium Clavulanate oral suspension manufactured by Bonn Schertering Bio Sciences, Puducherry, Himoxona injection which contains Dexamethasone sodium phosphate manufactured by Hindustan Medical Products in Bihar and Mefenamic Acid with Paracetamol tablets manufactured by Pramukh Swami Pharma at Gandhinagar in Gujarat. Orders have been issued to pull out these drugs off the pharmacy shelves, he said..
The drug test lab in Chennai has issued a warning is to Bangalore-based Embiotic Laboratories for two products Dicyclomine and Alprazolam tablets which have shown to be not of standard quality. The drug test lab at Jaipur has found that GSK’s Cetrizine Hydrochloride syrup is not of standard quality.
According to experts, at times drugs are found not of standard quality because of the storage practices followed by pharmacy outlets. The drug as such could have been produced by the company adhering to good manufacturing practices, but during transit and storage in harsh temperature conditions, the contents of the formulation are known to deteriorate.
In July 2009, Delhi Pharmacy Trust had recommended that to put up with the issue of unscheduled power cuts, all pharmacy outlets would need to go in for solar energy to operate the refrigerators and freezers to maintain the drugs at the right temperature. This would help drugs retain the quality, said Dr DBA Narayana, managing trustee, Delhi Pharmaceutical Trust. The main objective was to prevent the deterioration of contents and retain the strength of the contents, he added.
According to Dr Jagashetty, at times drugs could be of the right quality when tested in Bangalore, but the same drug would fail the test at labs in located in cities which are warmer. This is where good storage practices comes to play, he added.