CDSCO declares 44 drug samples as not of standard, one as misbranded in July
New Delhi, August 23, 2021:
The Central Drugs Standard Control Organisation (CDSCO) has declared 44 drug samples out of 1028 it has tested as not of standard quality, during the month of July, 2021. Of the samples tested, 983 were declared as of standard quality.
Apart from the 44 samples which were identified by the authority as not of standard, one drug sample was declared as misbranded. A batch of Natural Sunshine Hand Sanitiser 100 ml, with chlorhexidine gluconate solution IP 2.5 percent and ethanol IP 70 per cent from Jharkhand-based Shree Enterprises, manufactured in March 2020, was found to have no mentioning of the manufacturing license number on the label, making it misbranded product.
This sample was drawn by the Drug Control Department of Jharkhand and tested in Regional Drug Testing Lab in Guwahati.
The samples which were tested as not of standard include a batch of Supradyn multivitamin tablets with minerals and trace elements from Piramal Enterprises Ltd (failed due to disintegration), a batch of ramipril tablets IP from Ortin Laboratories Ltd (failed on Assay), albendazole tablets IP 400 mg from Syncom Healthcare Ltd (dissolution), a batch of calcium carbonate, magnesium oxide, manganese sulphate, zinc and vitamin D3 tablet from Mascot Health Series Pvt Ltd (failed for Assay of vitamin D3) among others.
The number of samples tested has gone up significantly, as the regulator has declared that 39 samples out of a total of 681 drug samples tested, came out as not of standard quality during the month of June, 2021.
None of the samples were identified as spurious during the month of July. The drug regulator comes out with the list of drugs, medical devices and cosmetics which are declared not of standard quality/spurious/adulterated or misbranded, every month.
In comparison, during the month of May, 2021, the authority has tested 627 samples, out of which 625 samples were tested as of standard quality. The number of samples declared as not of standard quality included 22, of which 21 were legal.
During the month of April, 2021, the CDSCO has conducted tests on 931 samples, of which 908 were declared as of standard quality, while 23, including 22 legal, were declared as not of standard.
The test samples were drawn by the zonal and sub zonal offices of CDSCO, and tested in the drug testing laboratories in Kolkata, Mumbai, Chandigarh, and Guwahati. Phrambiz