The Central Drug Standards Control Organisation (CDSCO) identified certain batches of a cough syrup as spurious and classified 112 other drugs and formulations as not meeting standard quality (NSQ) in its monthly drug alert for September this year.
Of these, 52 samples were analysed in central laboratories, while 60 were tested in state labs. According to multiple media reports, the list comprises widely used medications, including paracetamol, pantoprazole, and multivitamin supplements. It also features multiple batches of Telmisartan tablets, which are prescribed for high blood pressure, as well as diclofenac-based drugs used for pain relief.
This comes just a month after the consumption of the adulterated cough syrup “Coldrif” resulted in the deaths of at least 24 children in Chhindwara, Madhya Pradesh. Tests later revealed that the syrup contained 48.6% Diethylene Glycol (DEG), a toxic chemical, far exceeding the allowable limit of 0.1% in pharmaceutical products.
The central drug regulator said that, during routine checks, a sample of the cough syrup Besto-Cof (Dry Cough Formula) from a state lab in Chhattisgarh was found to be potentially spurious. Although the manufacturer’s name of the fake syrup has not been revealed, the genuine manufacturer stated that the disputed batch was not produced by them and confirmed it to be a counterfeit product.
‘Action will be taken as per Drugs and Cosmetic Act’
“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,” Business Standard quoted an official as saying.
Drug samples are deemed NSQ when they do not meet established quality standards, including dissolution, weight uniformity, and the assay of active ingredients.
The Union health ministry stated in a press release, “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 ministry added that the strict identification and removal of NSQ and spurious drugs is an ongoing joint effort between central and state regulators. It also emphasised that the issue is confined to the batches tested by government laboratories and does not affect other batches of the same drugs available in the market.
