CDSCO declares 41 samples out of 1,233 tested in May as not of standard quality

New Delhi, June 14, 2022:

The Central Drugs Standard Control Organisation (CDSCO) has declared 41 samples it collected during the month of May as not of standard quality, including batches manufactured by Dr Reddy's Laboratories, Cadila Pharmaceuticals, Synokem Pharmaceuticals, among others.

The drug regulatory authority has tested a total of 1,233 samples of drugs, medical devices and cosmetics and declared 1,192 of them are of standard quality. Those who h declared as not of standard quality is around 3.32 per cent of the total samples tested.

The sample of batches that failed the test include omeprazole (delayed-release) and domperidone (sustained-release) capsules from Dr Reddy’s Laboratories, in Baddi; Calnif Retard (nifedipine prolonged release tablets IP 20 mg) from Cadila Pharmaceuticals, in Jammu & Kashmir; rosuvastatin calcium tablets IP 10 mg manufactured by Synokem Pharmaceuticals Ltd, Uttarakhand, among others.

Two drugs from State-owned Karnataka Antibiotics and Pharmaceuticals Ltd - ciprofloxacin hydrochloride tablets IP 500 mg and fluconazole capsule IP 150 mg - were also among the samples which failed during the tests conducted by the CDSCO.

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.

However, some of the companies were frequently listed for manufacturing not of quality standard batches in several months over a period of time and the government, according to reports, are looking at keeping a tab on such companies for better quality standard compliance in future.

It may be noted that in April, 2022, the CDSCO has declared 27 samples out of the total of 1,164 samples it collected during the month, as not of standard quality including batches manufactured by Abbott India, Sun Pharma Laboratories and Alkem Health Science. Around 2.32 per cent of the total samples tested during the month were identified as not of quality standard.

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 these months.

The drug regulator has tested a total of 1,454 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.

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. 

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. PhamaBiz