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CDSCO declares 48 out of 1,273 drug samples tested in June as NSQs
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Gireesh Babu, New Delhi
July 26 , 2023
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The Central Drugs Standard Control Organisation (CDSCO) has declared almost 3.7 per cent of the total drug samples it has tested during the month of June, 2023 as Not of Standard Quality (NSQ). One sample of anticoagulant drug Heparin injection, labelled as Flagorin, has been deemed as spurious by the drug regulator during the month.
According to the list of NSQs released by the drug regulator for the month of June, 48 were declared as NSQs out of a total number of 1,273 samples tested during the month. Out of the total, 1,225 samples were declared as of standard quality.
The sample of Heparin Injection IP 1000 IU/ml, labelled as Flagorin and has Gujarat-based Divine Laboratories mentioned as its manufacturer, failed in the test for identification and potency of Heparin. The sample is deemed to be spurious, said the drug regulator while announcing the results.
Out of the samples which failed the quality test, include drugs labelled as manufactured by some of the major pharmaceutical companies and public sector undertakings. This include Ranitidine tablets branded as Aciloc 150, manufactured by Cadila Pharmaceuticals, Pan 40 comprising pantoprazole gastro resistant tablets from Alkem Health Science, a unit of Alkem Laboratories Ltd, Acenomac-1 (nicoumalone tablets) from Macleods Pharmaceuticals, samples of ofloxacin and ornidazole tablets from PSU Karnataka Antibiotics and Pharmaceuticals Ltd, paracetamol tablets 650 mg and cetirizine tablets 10 mg from Hindustan Antibiotics, among others. Multiple drug samples of Maxclux 100 ml (flucloxacillin oral solution 125 mg/5 ml) labelled as manufactured by Maharashtra-based Maxheal Pharmaceuticals were also declared as NSQ.
It may be noted that the industry has recently come out with a request that the drug regulator should look at the various factors that go behind failing of a drug during a pharma company sample test before finalising the list of Not of Standard Quality (NSQ) samples. The regulator should also look at publishing the details of the drugs which successfully pass the quality test among other details in order to improve the drug alert process and before releasing the list, the association has sought the drug regulator to provide a fair chance to the industry for verifying the same, said Dr Rajesh Gupta, All India Head with Laghu Udyog Bharti Pharmaceutical Committee and State President of Himachal Drug Manufacturers Associations, Baddi.
“While the drug alert list is very much publishing the details of the NSQ products it only gives the total number of products which passed the test. That also was included after we made a request some years back. Our request is to release the list of products which passed the Standard Quality test also, like the NSQs, to create confidence in the manufacturing team and mass public,” said Gupta.
India’s varied geography and climatic conditions should also be taken into consideration when looking into the issue of NSQs. The stability of the product is highly dependent on the climatic condition of the logistics and storage area and there are several challenges in this.
He said that the regulator should also record the storage condition, including the day temperature of that location when the drug administrative official draws samples from a retailer or wholesaler. While drawing the samples, they should also examine whether the wholesaler or the retailer is fulfilling the licensing conditions instead of testing and publicising the NSQ details only with the names of the manufacturers.
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