CDSCO declares 37 drug samples as not of standard, one as misbranded in August

New Delhi, September 15, 2021:

The Central Drugs Standard Control Organisation (CDSCO) has declared 37 drug samples out of the 1,245 samples it tested during the month of August as not of standard quality. While there were no spurious drugs amongst the samples, there was one misbranded drug identified.

The medicine samples found as not of standard include a batch of antiviral drug Acivir -200 DT (aciclovir dispersible tablets) from Cipla Ltd, anti-viral drug Fluvir (oseltamivir phosphate oral suspension) from Hetero Healthcare Ltd, five batches of folic acid & ferrous sulphate tablets from Ahmedabad-based Deep Pharma, atenolol tablets IP 50 mg and ciprofloxacin tablets IP 500 mg from Vivek Pharmachem (India) Ltd, and others.

One sample in a plastic bottle without any label of the product or any details of the manufacturer, later tested as oxytocin collected by the Drug Control Department, Patna was identified as a colourless liquid/solution with black particles visible with bare eyes.

Life Plus hand sanitiser, manufactured by Life Plus Healthcare Pvt Ltd, was identified as misbranded. Of the 1,245 samples tested, 1,207 samples were declared as standard quality.

It may be noted that in July, the 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. In July also, a batch of Natural Sunshine hand sanitiser 100 ml, with chlorhexidine gluconate solution IP 2.5 percent and ethanol IP 70 percent 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.

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. PharmaBiz