CDSCO flags 2 drugs as spurious, another 111 fail quality test in Nov '24

While the CDSCO alert has named the brands for which they found spurious samples, the alert, however, does not name the drugmakers

The Central Drugs Standard Control Organisation (CDSCO) on Friday flagged select batches of two drugs as spurious and listed 111 other drugs and formulations as not of standard quality (NSQ).

 

The samples flagged as spurious in CDSCO’s recent monthly update for November 2024 include popular drugs Pan D and the antibiotic Augmentin 625 Duo, which are marketed by Alkem Laboratories and GlaxoSmithKline Pharma, respectively.

 

While the CDSCO alert has named the brands for which spurious samples were found, it does not name the drug manufacturers.

 

“The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. The product is purported to be spurious; however, the same is subject to the outcome of the investigation,” the replies state.

   

“These drugs have been made by unauthorised and unknown manufacturers using brand names owned by other companies. An investigation has been initiated in the matter,” the Union Health Ministry stated in a note.

 

The CDSCO alert added that as part of continuous regulatory surveillance, drug samples are picked from sales or distribution points, analysed, and a list of spurious drugs is displayed 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.

 

Of the 111 drugs found to be NSQ in November 2024, 41 were identified by central drug laboratories, whereas another 70 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 drugs include batches of fixed-dose combinations (FDCs), such as hypertension medication Ozomet PG2 tablets manufactured by Ozone Pharmaceuticals. The list also includes Cipla’s Tofajak tablets, used to treat rheumatoid arthritis, and Intas Pharma’s chest pain medication Monit SR30 tablets.

 

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

 

A ministry note on the drugs alert stated that November’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.