The Central Drug Standards Control Organisation (CDSCO) has identified some batches of cough syrups as spurious. Apart from this, it has identified 112 other drugs and formulations that do not meet standard quality (NSQ) in its monthly drug alert for September this year, according to Livemint.
Central and state laboratories were responsible for identifying the failures, with 52 samples flunking tests at central facilities and 60 at state facilities. The affected batches cover highly common medications, including Telmisartan tablets for high blood pressure, diclofenac-based pain relievers, as well as paracetamol, pantoprazole, and multivitamin supplements.
The alert is particularly significant as it comes in the backdrop of deaths of at least 24 children caused by the consumption of the adulterated cough syrup "Coldrif" in Chhindwara, Madhya Pradesh. Coldrif was discovered to have large quantities of a toxic chemical called Diethylene Glycol (DEG). The admissible limit for this chemical is 0.1% in pharmaceutical products, but the cough syrup in question had 48.6%.
As per routine regulatory surveillance activity, the list of Not of Standard Quality (NSQ) and Spurious drugs is being displayed on the CDSCO portal on a monthly basis.
Identification of drug samples as NSQ is done based on failure of the drug sample in one or more specified quality parameters. 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 officials said.
Further, in September, one sample from the state of Chhattisgarh was identified as a spurious drug, which was made by an unauthorised manufacturer using a brand name owned by another company. The matter is under investigation, and action will be taken as per the Act and Rules.
This action of identifying NSQ and spurious medicines is taken on a regular basis in collaboration with state regulators to ensure that these drugs are identified and removed from the market.
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