Karnataka drugs control department has seized 9 not of standard quality drugs. These drugs were tested by the Drug Testing Laboratory in Bengaluru and Hubli. The inspections were carried out between December 1-30, 2011.
The 9 drugs are Mannitol injection manufactured by Shree Krishna Keshav Laboratories in Ahmedabad, DREGO-D Rabeprazole Sodium Enteric Coated and Domperidone SR capsules manufactured by Hetero Drugs at Solan in Himachal Pradesh, Panzer-500 which contains ciprofloxacin hydrochloride tablets of MMC Healthcare Pvt. Ltd. at Solan in Himachal Pradesh, Zepent -40, which is Pantoprazole of Ultra Drugs at Solan in Himachal Pradesh, Rabetome-DM which contains Rabeprazole Domperidone tablets by Acacia Biotech at Uttarakhand, Pantador-D which is a combination of Pantoprazole and Domperidone manufactured by Staywell Formulation Pvt. Ltd. in Uttarakhand, Pole-40 which is a Pantoprazole tablet manufactured by Guru Cure located in Pudicherry, Ofrex which contains Ofloxacin and Tinidazole tablets manufactured by Acme Formulations in Solan in Himachal Pradesh and ANZ Suspension which contains Albendazole manufactured by HL Healthcare Pvt. Ltd. in Himachal Pradesh.
All the drugs were sized during the surprise inspections by the team of drug inspectors and the drugs were tested at the drug test lab at Bengaluru and Hubli. The department has now warned the pharmacy outlets, hospitals and doctors to refrain from stocking and prescribing these drugs, stated Dr BR Jagashetty, Karnataka drugs controller.
The department has now gone on to issues certificates to provide the details of the drugs seized and tested. It has also issued details of the drug inspector engaged in the picking up the medicine from the pharmacy outlets at random.
In addition, it has also provided details of tests and reasons for the declaring the samples not of standard quality. In the case of Mannitol injection manufactured by Shree Krishna Keshav Laboratories, the drug was declared not of standard quality because it appeared as a colourless liquid and all the containers had crystal deposits at the neck of the bottle indicating the leakage.
For DREGO-D Rabeprazole Sodium Enteric Coated and Domperidone SR capsules manufactured by Hetero Drugs, the label did not conform to the claim with respect to the assay of Domperidone.
In the case of Pantador-D, a combination of Pantoprazole and Domperidone manufactured by Staywell Formulation Pvt. Ltd, failed the disintegration test for tablets.
Pole-40 which is a pantoprazole tablet manufactured by Guru Cure located in Pudicherry, the sample was intact and tallied with the specimen seal but failed the disintegration test.
Ofrex which contains ofloxacin and tinidazole tablets manufactured by Acme Formulations in Solan in Himachal Pradesh, the drug did not pass the disintegration test and all the six tablets remained un-disintegrated even after 90 minutes of observation.
ANZ Suspension which contains albendazole manufactured by HL Healthcare Pvt. Ltd. drug was found to be not-of-standard quality with respect to the assay of albendazole.
With the regular and surprise inspections conducted by the team of inspectors, there is a constant awareness of the drugs failing tests in test labs. The drugs which were found faulty mainly were manufactured from Himachal Pradesh and Uttarakhand, stated the Karnataka Drugs Controller.