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CDSCO declares around 5% of drug samples tested in January as NSQs

CDSCO declares around 5% of drug samples tested in January as NSQs


Posted on March 1, 2024 Updated on February 26, 2024

The Central Drugs Standard Control Organisation (CDSCO) has declared almost 5 per cent of the total drug samples it tested during the month of January, 2024 as Not of Standard Quality (NSQ). The number of samples tested, however, has declined during the month compared to the previous months.

The CDSCO, in its monthly drug alert, said that during the month of January, it has tested a total of 932 samples out of which 46 were declared as NSQ, while no samples were declared as spurious or misbranded. The Organisation also said that a sample of Alkem Health Science’s Pan 40 (pantaprazole gastro-resistant tablet) declared as NSQ during the month of December, 2023 is purported to be spurious.

The drug samples tested as NSQ during the month of January, 2024 include Sun Pharma Laboratories’ epilepsy treatment drug Levipil 500 (levetiracetam tablets), manufactured in Sikkim in April, 2023 with expiry date of March, 2025. The sample picked up by CDSCO’s North Zone and tested in the Central Drugs Laboratory, Kolkata, failed in the dissolution test, it said.

Hetero Labs’ Pantosec (pantoprazole tablets 40 mg) manufactured in Himachal Pradesh also failed the tests related to dissolution in buffer stage, according to the regulator. The sample was collected by CDSCO, West Zone and tested in Central Drugs Testing Laboratory, Mumbai.

Four samples of surgical tape JMS Medi-tape from Japanese medical equipment and drugs manufacturer JMS Co Ltd has been declared as NSQ, as it failed in the standards related to length. The samples were picked up by CDSCO, West Zone and tested in Central Drugs Laboratory, Kolkata.

Anti-diabetic drug glimepiride 1 mg manufactured by Public Sector Undertaking Karnataka Antibiotics & Pharmaceuticals Ltd in Bengaluru also failed in a dissolution test. The sample was collected by CDSCO East Zone, Kolkata and tested by Central Drugs Laboratory, Kolkata.

Some of the other drugs which failed the standard quality test include trypsin, bromelain and rutoside trihydrate tablets from Pure & Cure Healthcare Pvt Ltd, moxifloxacin and prednisolone acetate eye drops (Moxizeep) frp, Zee Laboratories, and multiple drug samples from Jpee Drugs, Hygeia Pharmaceuticals, and others.

The drug regulator said that Alkem Health Science has informed the CDSCO that the batch of Pan-40 declared as NSQ in the month of December, 2023 has not been manufactured by them and that it is a spurious drug.

“Thus, the product is purported to be spurious, however, the same is subject to the outcome of further investigation,” it said.

It also said that cancer treatment drug Dacilon 0.5 (dactinomycin for injection 0.5 mg) manufactured by Celon Laboratories which was declared as NSQ in March, 2023, has been declared as standard quality in regard to the test for appearance and assay as per the form submitted by the CDL, Kolkata. The result is subject to the outcome of further investigation.

The CDSCO in December, 2023, declared 78 out of the 1008 drug samples tested during the month as NSQ, while the rest of the 930 samples are of standard quality.

As per ministry of health and family welfare, in Financial Year 2022-23, a total 89,729 number of drug samples were tested and out of this, 422 drug samples were declared spurious or adulterated. Another 2,921 drug samples were declared as NSQ, 642 prosecutions were launched and 262 persons were arrested related to the manufacturing, sale and distribution of spurious or adulterated drugs.

This is compared to 88,844 tests conducted in 2021-22, of which 2,545 samples were declared as NSQ, 379 samples as spurious or adulterated and 592 prosecutions were launched. During the fiscal year, 450 persons were arrested related to the manufacturing, sale and distribution of spurious or adulterated drugs, it added.

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