CDSCO declares 3.3 percent of drug samples tested in March as not of standard quality

New Delhi, April 29, 2022:

The Central Drugs Standard Control Organisation (CDSCO) has declared that around 3.3 per cent of the total drug samples it tested during the month of March, 2022, through various Central Drugs Laboratories in the country were not of standard quality. There were no spurious or misbranded drugs identified during the month, it added.

The drug regulator has tested a total of 1454 samples during the month, of which 48 were declared as not of standard quality. The rest of 1,406 samples were declared as of standard quality.

Out of the batches of drugs which were identified as not of standard quality, two samples were from public sector manufacturer Hindustan Antibiotics Ltd - doxycycline capsules IP 100 mg and calcium and vitamin D3 tablets IP (500 mg+250 IU) (calcium 500 mg and vitamin D3 250 IU) picked up by the CDSCO East Zone, Kolkata.

A batch of antibiotic Tinvista 300 (tinidazole tablets IP 300 mg) manufactured by Cadila Pharmaceuticals Ltd in Jammu & Kashmir, failed in disintegration test. A batch of anti-inflammatory drug Maycoxia-90 (etoricoxib tablets IP) and proton pump inhibitor (PPP) Rabeprazole tablets IP 20 mg manufactured Akums Drugs & Pharmaceuticals Ltd in Uttarakhand were also declared as not of standard quality for failing dissolution test.

The other drug samples which were declared not of standard quality, doxycycline hydrochloride capsules IP 100 mg manufactured by Super Formulations Pvt Ltd, Cetrizine tablets IP manufactured by Ciron Drugs & Pharmaceuticals, rolled bandage by Anamika Udyog, Telma H tablets containing telmisartan 40 mg and hydrochlorothiazide 12.5 mg Tablets IP from Dallas Drugs Pvt Ltd, Bio-D3 Plus Capsules containing calcitriol and calcium capsules manufactured by Macleods Pharmaceuticals, ofloxacin and ornidazole tablets IP from Coral Laboratories Ltd, among others. Sample of more than one drug has been declared as not of standard from some of the companies in the list.

A recent report quoting sources has said that the Central government is looking at keeping a tab on the companies which failed the quality tests more than twice in last year, with plans to conduct surprise inspections in their manufacturing units. This is part of the government’s efforts to wipe out the spurious and pure quality medicines from the country.

The instances of not-of-standard quality drugs among the total number of drugs tested by the CDSCO has been in the range of 2-3 per cent for the last several months, show the data.

In February, 39 out of 1,221 drug samples, medical devices and cosmetics, were declared by the drug regulator, which was around three per cent of the total drug samples tested during the month. This was a little over two per cent in January, at 27 out of 1,227 drug samples. 

This was around 2.4 per cent (33 samples) of the 1,385 total drug samples it has tested during the month of December, 2021. It has declared almost two per cent of the total drugs, medical devices and cosmetics products samples it has tested in the month of November, 2021, as not of standard quality. CDSCO, in the month of November, tested 1102 samples, out of which 22 were declared as not of standard quality. The rest of 1,080 samples were declared as having standard quality as per the requirements of the regulations.

In the month of October, almost 3.4 per cent of the drug samples the drug regulator drew from across the country were declared not of standard. Out of the 1061 samples tested during the month 36 turned out to be not of standard quality during the period.

In September, the CDSCO declared that it has tested 1,227 samples, of which 42 were not of standard quality, while in August, the total tested was 1,245 samples of which 37 were found not of standard quality.

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.

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