Karnataka drugs control department has seized around 31 drugs which are found to be not-of-standard-quality in the last one month between September 1 and September 30, 2012. These drugs were tested at random during an inspection drive undertaken by the  department’s enforcement team. All these drugs are manufactured by pharma companies across the country.

These drugs are lignocaine hydrochloride  injection IP manufactured by AstraZeneca Pharma India Limited in Bengaluru, Aceclofenac tablets manufactured by Rajdeesh Pharmaceutical Ahmedabad, Folifol Forte and Ferrous sulphate manufactured by Crest Laboratories in Madhya Pradesh, potassium and amodfene tablets manufactured by T&T Healthcare, Folic acid and Ferrous sulphate manufactured by Crest Laboratories in Madhya Pradesh, ofloxacin and andragel manufactured by SPB Pharma at Himachal Pradesh, Folic acid and  ferrous sulphate  tablets by Crest Laboratories in Madhya Pradesh, potassium clavulanate manufactured by Associated Biotech at  Nalagarh, District in Solan, Himachal Pradesh, diclofenac sodium, nimesulide by Wallace Helathcare in Kangra, Himachal Pradesh, bandage cloth by Anemik Industries in Meerut.

According to Dr. BR Jagashetty, drugs controller, government of Karnataka, the surprise inspections are mandated as frequent exercise. It is crucial  to make certain that products are of good quality. All the tests are being undertaken at the drug test labs at Bengaluru, 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  insufficient infrastructure, shortfall  of drugs inspectors, absence  of data bank and reliable  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.