Karnataka drugs control department has seized 15 drugs which are found to be not-of-standard quality. These drugs were tested at random during a surprise inspection carried out by the department’s team of inspectors. All these drugs are manufactured by pharmaceutical companies located in the north and western parts of the country.

The inspections were carried out between August 1 and 30, 2012. The drugs included raberprazole manufactured by Crescent Pharma in Puducherry, Bandage cloth by Anamika Udyog in Meerut, ramipril tablets by a company in Roorkee, Calcirid by Elonva Pharma in Himachal Pradesh, Folyfol Forte which is a folic acid and ferrous sulphate tablet manufactured by Quest Laboratories at Indore, Ferrium X which is a ferrous ascorbate and folic acid suspension manufactured by Emcure Pharmaceuticals, Jammu, Folifol Forte which contains folic acid and ferrous sulphate tablet manufactured by Quest Laboratories in Indore, doxylamine succinate and peridoxine HCL tablets manufactured by Vilin Biomed at Uttarakhand, sodium ferridate, folic acid and vitamin B12 oral by Cosmos Pharmaceuticals in Solan in Himachal Pradesh, aceclofenac and paracetamol tablets manufactured by Pegasus Pharma at Uttarakhand, raberprazole sodium and domperidone sustained release capsules manufactured by Crescent Pharma, Puducherry, Festive-D eye/ear drops with ofloxacin manufactured by Laborate Pharmaceuticals at Himachal Pradesh, Surgical Spirit BP by Hychem Laboratories in Hyderabad  among others.

According to Dr BR Jagashetty, drugs controller, government of Karnataka, these inspections are part of the regular checks. It is vital to ensure that products are of good quality. All the tests are being undertaken at the drug test labs at Bangalore, Bellary and Hubli.

The drugs control department has now issued note of caution to all hospitals, pharmacy trade and the public to refrain from prescribing, stocking and taking these drugs.

According to a report dated May 8, 2012, by the department-related Parliamentary Standing committee on health and family welfare, a  drug can be categorized 'not of standard quality' for a variety of both major and minor technical reasons such as not stating the name of the pharmacopoeia correctly, problem with quality of bonding agent, colouring agent, dissolution time, etc. However, there are other more serious cases, where the active ingredient is significantly less in quantity that can harm patients. Therefore, this problem needs to be addressed with all the seriousness that it deserves both by more rigorous checks in procuring bulk drugs and by in-house quality control by manufacturers or solving the problem in transportation or storage at distribution/retail levels.

Only coordination with the state drug authorities can help sort out problems involved in the investigations of drugs manufactured in one state and declared ‘not of standard quality’ in another State. The drug authorities across the country are facing issues of inadequate infrastructure, shortage of drugs inspectors, non-existence of data bank and accurate information, non-uniformity of enforcement among the states and lack of pro-active interaction between the States particularly, in connection with investigations relating to drugs found not-of-standard quality,  stated the report.