CDSCO flags select batches of 145 drugs for failing quality standards

Fifty-two drugs were identified by central drug laboratories, while another 93 were flagged by state drug testing labs

The Central Drugs Standard Control Organisation (CDSCO) has listed select batches of 145 drugs and formulations, including medications for hypertension, allergies and nausea, as not of standard quality (NSQ) for January 2025.

 

Of the 145 drugs found to be NSQ, 52 were identified by central drug laboratories, while another 93 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 include sample batches of Glenmark Pharma’s popular hypertension medication Telma AM, and Alkem Health Sciences’ Ondem-4 tablets, used to prevent nausea and vomiting. 

 

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, antibacterials and antibiotics used to treat bacterial infections such as tonsillitis, ear infections, throat infections, urinary tract infections (UTI) and bronchitis. 

 

Some combination medication samples include FDC tablets of montelukast sodium and levocetirizine hydrochloride, commonly prescribed to treat allergies.

 

Most drugs found NSQ by central labs this month were produced in units located in cities such as Ahmedabad and Vadodara in Gujarat, Himachal Pradesh’s Baddi, Maharashtra’s Tarapur, Puducherry, and Uttarakhand’s Haridwar and Roorkee.

 

January’s alert also marks the first time that the apex drug regulator has not listed any drugs as spurious for two consecutive months, a first since June 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 NSQ alert stated.

 

The ministry note added that January’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.