 "CDSCO flags 135 drugs for failing quality standards for December 2024")
The Central Drugs Standard Control Organisation (CDSCO) on Friday listed select batches of 135 drugs and formulations as not of standard quality (NSQ) for December 2024.
Of the 135 drugs found to be NSQ this month, 51 were identified by central drug laboratories, while another 84 were flagged by state drug testing labs. NSQ drugs are those that do not meet the quality standards set by national or international authorities.
These samples include Macleods Pharma’s popular thyroid medication Thyrox 25, Cipla’s Okamet tablets used to treat Type 2 diabetes, and Cadila’s antibacterial medication Ciprodac 500 tablets.
A note by the health ministry on the drugs alert stated that the failure is specific to the drug products of the batch tested by the government laboratories and does not warrant any concerns about other drug products available in the market.
The NSQ list also includes batches of fixed-dose combinations (FDCs), such as cough syrups and medications used to prevent cardiovascular events such as heart attack and stroke. Some combination medications include FDC capsules of rosuvastatin, aspirin, and clopidogrel, used to prevent heart attacks.
Most drugs found NSQ by central labs this month were produced in units located in cities such as Ahmedabad, Vadodara, Himachal Pradesh’s Baddi, Puducherry, and Uttarakhand’s Haridwar and Roorkee.
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The apex drug regulator has not listed any drugs as spurious in December's alert, a first since July last year.
As part of continuous regulatory surveillance, the CDSCO picks up drug samples from sales or distribution points, analyses them, and displays a list of spurious drugs on the CDSCO portal on a monthly basis.
“The purpose of displaying the spurious drugs list is to make stakeholders aware of the spurious drug batches identified in the market,” the alert stated.
The ministry note added that December’s NSQ reporting indicated increased participation of states in reporting NSQs to the central database.
“Increased reporting of NSQs and spurious identifications from states to central databases will further help in improving the availability of quality medicines in the country and beyond,” it said.