Trade in substandard drugs has reached an alarming level in Rajasthan. Last month samples of 18 drugs manufactured by 12 companies including Sun Pharma, Aristo Pharmaceuticals, Cipla, Alkem Labs, Laborate Pharmaceuticals have been found to be substandard by the state Drugs Control Organization.
Other manufacturers whose drug samples were found to be not of standard quality (NSQ) included Accurate Pharma, Elfin Drugs, Affy Parenterals, Digital Vision, Yacca Life Sciences, Vivek Pharmachem, Care-Well Healthcare. The samples were tested by Rajasthan Drugs Control Organization from July 16-31, 2018. 50 per cent of 18 drugs tested NSQ are antibiotics, six drugs contained pantoprazole, one of the highest selling molecules in the country.
According to data prepared by Rajasthan FDA, among the drugs tested as NSQ is pantoprazole & domperidone tablets which is used to treat certain stomach and esophagus problems. The drug sample manufactured by Elfin Drugs bearing batch number 0527/480 and expiry date October 2018 did not contain domperidone.
Similarly, montelukast sodium & levocetirizine hydrochloride tablets manufactured by Cipla with batch number SA65947 and expiry date September 2018 was declared NSQ. The contents of the drug were found less than the claim made. The sample did not contain montelukast and levocetirizine hydrochloride was found 5.94 mg (i.e 118.8% of claim), said the FDA circular.
Aristo Pharmaceuticals’ Enteric coated pantoprazole sodium & domeridone SR capsules (Pantop-DSR) bearing batch number B452J037, expiry date August 2019 was tested as NSQ. The sample did not contain pantoprazole and failed to conform to the claim with respect to assay of domperidone which was just 36.87% of the claim. Omeprazole was found 20.32 mg per capsule, the circular stated.
Other drugs in the list of substandard drugs are Aristo Pharmaceuticals’ pantoprazole gastro resistant tablets (Pantop 40) (batch no. S171K017, expiry date March 2020) and cefpodoxime tablets 200 mg (Monocef 0-200) with two batches– B198H197 (expiry date July2019) and B198J017 (expiry date August 2019); Alkem Labs’ amoxicillin and potassium clavulanate tablets (batch no 7I70784, expiry date March 2019), cefixime tablets (batch no 7181490, expiry date August 2019), pantoprazole gastro resistant tablets (batch no 7133275, expiry date April 2020).
The list also included Laborate Pharmaceuticals’ calcium supplement with vitamin D3 chewable tablets (batch no GSMT-019, expiry date September 2018), Sun Pharma’s Enteric coated pantoprazole sodium and sustained release domperidone capsules (batch no EMS 2060, expiry date June 2019), Accurate Pharmaceuticals’ azithromycin tablets (batch no TNAP- 476, expiry date August 2018), Affy Parenterals’ glimepiride & metformin hydrochloride tablets (batch no AP6334, expiry date October 2018), Digital Vision’s telmisartan tablets 40 mg (batch no DVTC1672, expiry date August 2018), Yacca Life Sciences’ calcium carbonate, magnesium hydroxide zinc & cholecalciferol suspension (batch no YS- 7084, expiry date October 2018), Vivek Pharmachem’s diclofenac sodium tablet 50 mg (batch no DFT17013, expiry date August 2019) and hydrocoxtisone sodium succinate injection 100 mg (batch no HCL16048, expiry date July 2018), Care-Well Healthcare’s pantoprazole & domperidone tablet (batch no G-177 and expiry date August 2018).
The samples of Cipla, Alkem Labs, Vivek Pharmachem, Laborate Pharmaceuticals also failed in the National Drug Survey conducted by National Institute of Biologicals (NIB) across the country to check the proportion of drug samples failing in quality testing.
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