One spurious drug sample from Assam detected in May 2026; probe underway: CDSCO report
New Delhi, June 24
As part of routine regulatory surveillance, the list of Not of Standard Quality and spurious drugs is being displayed on the Central Drugs Standard Control Organisation portal every month, according to an official brief.
For the month of May 2026, Central Drugs Laboratories have identified 46 drug samples as Not of Standard Quality (NSQ), while State Drugs Testing Laboratories have identified 113 drug samples as NSQ. Identification of drug samples as NSQ is done based on failure of the drug sample in one or more specified quality parameters.
The brief clarified that the failure is specific to the drug products of the batch tested by the government laboratory and does not warrant any concern regarding other drug products available in the market.
Further, in May 2026, one drug sample from Assam was identified as spurious. The sample was found to have been manufactured by unauthorised manufacturers using a brand name owned by another company. The matter is currently under investigation, and action will be taken as per the provisions of the Act and Rules.
This action of identifying NSQ and spurious medicines is undertaken on a regular basis in collaboration with state regulators to ensure that such drugs are identified and removed from the market.
Earlier in June, in a major move to tighten regulatory control over the distribution of liquid medications, the Union Ministry of Health and Family Welfare amended the Drugs Rules, 1945, withdrawing the licensing exemption previously granted for the sale of cough syrups in small villages.
The amendment, notified via Gazette Notification G.S.R. 927 (E), omits the word "Syrup" from Schedule K, Serial No. 13, Entry 7, effectively ending an era where smaller habitations could retail these formulations without stringent oversight, the Ministry of Health and Family Welfare said in a statement.
Before this crucial regulatory intervention, Schedule K of the Drugs Rules allowed the sale of cough syrups in villages with a population of fewer than 1,000 individuals without requiring compliance with standard retail sale licensing provisions. With the new notification, any sale or dispensing of cough syrups in these rural pockets must strictly happen through duly licensed pharmacies.
The official statement from the Ministry of Health and Family Welfare highlighted the core objective behind the move, stating, "The amendment has been undertaken to strengthen regulatory oversight of syrup formulations and to align the exemption framework with contemporary public health and safety requirements."
— ANI
Reader Comments
"One spurious sample" sounds like a small number, but imagine how many people could have been affected if it wasn't caught. The problem is that these fakes often look identical to the real thing. Glad CDSCO is being transparent by putting the list online every month. But I wish state regulators were more proactive in smaller towns. No one should be taking fake medicines.
The cough syrup rule change is a step forward, but honestly? Many villages don't even have licensed pharmacies within 10 km. So where will people go now? The intention is good, but implementation needs to be practical. Also, 46 NSQ samples in central labs and 113 in state labs is scary. That's almost 160 batches of possibly harmful drugs. Need stricter penalties for manufacturers.
Good to see CDSCO working proactively. My family runs a small pharmacy in Kerala and we always check batch numbers for any alerts. The spurious sample from Assam using a brand name without permission is a serious crime. Hope the culprits get severe punishment, not just a slap on the wrist. Also appreciate that they clarified NSQ doesn't mean all products are bad.
One question: if they found 46 NSQ samples in central labs, how many more are still on the shelves? The system only works if we regularly test. The cough syrup amendment is good, but I hope they don't just stop there. What about eye drops, injections? All liquid formulations need better control. The more checks, the better for patient safety. 👍
A Ananya R Honestly, We welcome thoughtful discussions from our readers. Please keep comments respectful and on-topic.