CDSCO's May 2026 surveillance identified 159 drug samples as 'Not of Standard Quality' and one as spurious. The Union Health Ministry also amended rules, ending the license exemption for cough syrup sales in villages with populations under 1,000.
CDSCO Flags 159 Drug Samples as Substandard in May 2026
As part of routine regulatory surveillance, the list of Not of Standard Quality (NSQ) and spurious drugs is being displayed on the Central Drugs Standard Control Organisation (CDSCO) 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.
Spurious Drug Case Under Investigation
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.
Health Ministry Tightens Rules for Cough Syrup Sales
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)
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