CDSCO flags cough syrup as spurious, 112 drugs fail quality tests

The central drug regulator found one spurious cough syrup and 112 substandard formulations during its September 2025 checks, triggering detailed scrutiny

The Central Drug Standards Control Organisation (CDSCO) has flagged select batches of one cough syrup as spurious, and listed 112 other drugs and formulations as not of standard quality (NSQ) in its routine surveillance for September 2025.

 

The central drug regulator said it had found a purported spurious sample of a cough syrup named Besto-Cof (Dry Cough Formula) from a state lab in Chhattisgarh as a part of its routing checks.

 

While the regulator has not disclosed the name of the manufacturer of the spurious syrup, it said that the actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been made by them, and that it is a spurious drug.

 

 

A drug is generally considered spurious when manufactured by unauthorised producers using brand names owned by other companies.

 

“The batch sampled for investigation was manufactured by an unauthorised manufacturer, using the brand name owned by another company. The matter is under investigation and action will be taken as per the Drugs and Cosmetics Act,” an official in the know said.

 

Besto-Cof is originally marketed by Delhi-based BestoChem Formulations, according to several e-pharmacy websites.

 

The development comes barely a month after the intake of contaminated cough syrup “Coldrif” led to the death of at least 24 children in Madhya Pradesh’s Chhindwara. The syrup was later found to contain 48.6 per cent Diethylene Glycol (DEG), a toxic solvent whose permissible limit in pharmacopoeial formulations is only 0.1 per cent.

 

In October, the drug regulator had flagged two more syrups — Respifresh TR, and ReLife — for having more DEG content than prescribed, though the formulations were not linked with Chhindwara deaths.

 

The CDSCO has also flagged samples of 112 drugs as NSQ, of which 52 were tested in central labs while 60 were tested in state labs. These include common medication formulations such as paracetamol, pantoprazole, and multivitamin supplements.

 

The list also includes several batches of Telmisartan tablets, which are prescribed to patients with high blood pressure or hypertension, and diclofenac-based medicines used as pain relievers.

 

Drug samples are categorised as NSQ when they fail to meet specified quality parameters such as dissolution, uniformity of weight, and assay of active ingredients.

 

“The failure is specific to the drug products of the batch tested by the government laboratory, and it does not warrant any concerns on the other drug products available in the market,” the Union health ministry said in a press note.

 

The ministry said rigorous identification and removal of NSQ and spurious drugs is a regular collaborative exercise between central and state regulators.

 

It also clarified that the failure is specific to the batches tested by government laboratories and does not raise concerns about other batches of the same drugs available in the market.