2.3% of tested drugs found to be of sub-standard nature: DGCI

Drug Controller General of India (DCGI) found that 2.3% of all the drugs tested by it were of sub-standard nature. This was revealed by the surveillance which DGCI carried out since December 2012. The results of the surveillance was released by the DGCI on 19 March 2014.

During the surveillance, DGCI collected as many as 1123 samples were collected and tested. Samples were drawn from government hospitals, retailers and wholesalers between April and December 2013 by joint teams of central and state drug controller officials.

The test revealed that of 1123 samples tested, 26 drug samples failed to qualify the test. Moreover, the highest concentration of sub-standard drugs was found in Jammu & Kashmir followed by Himachal Pradesh.

The drugs which have been identified by DGCI as sub-standard are: (i) Cefden-O (Cefixime & Ofloxacin Tab); (ii) Fixin IR-200 DT (cefixime Tab); (iii) Rabed; (iv) Kindac-P (Aceclofenac & Paracetamol Tab); (v) Biodox Bolus; (vi) Ranodom (Omeprazole Magnesium & Domperidone Tab); (vii) Orymox-250 DT Tab; (vii) Diclogold-M (Paracetamol, Diclofenac Sodium & Mag. Trisilicate Tab); (viii) Coldgard (Paracetamol, Phenylephrine HCl, Chlorpheniramine Maleate, Caffeine Tab); and (ix) Pre-MR (Diclofenacv Pot., Paracetamol & Chlorzoxazone Tab)

Analysis

The results of the surveillance comes in the wake of regular ban on imports of Indian drugs by United States Food and Drug Administrators (USFDA). Recently, USFDA banned the import of drugs and drug ingredients from leading Indian manufacturers including Ranbaxy Laboratories and Wockhardt citing quality concerns.

The ban threatened the image and market share of 14 billion dollar of Indian pharmaceuticals sector in the United States. India is second only to Canada as a drug exporter to the United States, where it supplied about 40 percent of generic and over-the-counter drugs.

The DGCI conducted its last large-scale country-wide survey in 2009 for the period 2003-2008. It had collected over 24000 samples and tested them for genuineness amidst some allegations which termed India as a major source of fake drugs.

The study found that only 0.046% of the drugs in circulation were actually spurious and 6 to 7.5% of the drug samples tested failed quality standard tests annually.