27 samples out of 1,164 tested in April as not of standard quality

The Central Drugs Standard Control Organisation (CDSCO) has declared 27 samples it randomly collected during the previous month of April as not of standard quality, including various batches manufactured by major players like Abbott India, Alkem Health Science, Sun Pharma Laboratories, etc.

The Central Drugs Standard Control Organisation (CDSCO) tested a total of 1,164 random samples of drugs, medical devices, and cosmetics and declared that 1,137 were of standard quality. The pharma products reported as not of standard quality were around 2.32 percent of the total samples tested.

A sample from a random batch of Udilov 300 (ursodeoxycholic acid tablets IP 300 mg) from Abbott India; another from amoxicillin and potassium clavulanate tablets IP from Alekem Health Science, one from a unit of Alkem Laboratories; pantoprazole gastro-resistant and also from a domperidone prolonged-release capsules IP from Sun Pharma Laboratories are among those that failed the test.

The union government of India is keeping an eye on the companies that may have failed the quality tests more than twice in the last year only, intending to conduct surprise inspections in their manufacturing units.

The instances of not-of-standard quality pharma drugs among the total number of drugs tested by the Central Drugs Standard Control Organisation (CDSCO) have consistently been 2-3 percent for the last several months, showing the data.

The reader must note that around 3.3 percent of the total drug samples tested during March 2022 through the various Central Drugs Laboratories of the country were not of standard quality. There were; fortunately, no spurious or misbranded drugs identified during this period month, Central Drugs Standard Control Organisation (CDSCO)  added.

The drug regulator tested 1,454 samples during the month, of which 48 were declared as not of standard quality. The rest of the 1,406 samples were reported as of standard quality.

In February, 39 samples out of 1,221 tested drugs, medical devices, and cosmetics were declared by the Central Drugs Standard Control Organisation (CDSCO), around three percent of the total drug samples tested in the month. In January, this was a little over two percent at 27 out of 1,227 drug samples.

That was around 2.4 percent or 33 samples out of the 1,385 total drug samples the authority tested during December 2021. Central Drugs Standard Control Organisation (CDSCO) has declared almost two percent of the total drugs, medical devices, and cosmetics products samples tested in November 2021 as not of standard quality. Central Drugs Standard Control Organisation (CDSCO) tested 1,102 samples in November, and it found that 22 were declared as not of the standard quality. The rest of the 1,080 samples were reported as having standard quality as per the requirements of the regulations.

In October, almost 3.4 percent of the drug samples Central Drugs Standard Control Organisation (CDSCO) drew from across the country were declared not of standard. Out of the 1,061 samples tested during the month, 36 were not of standard quality during the period.

In September, the month of November declared that it had tested 1,227 samples and found 42 were not of standard quality, while in August, the total samples tested were 1,245, and the authority found 37 not of the standard quality.

The Central Drugs Standard Control Organisation (CDSCO) comes out with a list of drugs, medical devices, and cosmetics that are declared not of standard quality or spurious, adulterated, or misbranded every month.

The tested samples were drawn by the zonal and subzonal offices of n the month of November and tested in the drug testing laboratories based in Kolkata, Mumbai, Chandigarh, and Guwahati.