Data flags 19 spurious drug samples detected in 2024

The Central Drugs Standard Control Organisation (CDSCO) has listed at least 135 drugs and formulations as not of standard quality (NSQ) for December last year, after both central and state testing laboratories across the country flagged these samples, according to the drugs regulator’s alert issued on Friday.

Data accessed by HT for the entire 2024 showed that at least 858 samples were labelled as NSQ by the national drugs regulator while 19 samples were found to be spurious. NSQ drugs are those that fail to meet the quality standards or specifications, including those pertaining to labelling, dissolution, weight uniformity, and sterility.

According to a release issued by CDSCO, of the 135 samples that failed quality test, 84 were identified by various state drugs testing laboratories, while the central drugs laboratories have identified 51 samples.

The regulator in its release said that December’s NSQ reporting indicated increased participation of states in reporting NSQs to the central database. “Increased reporting of NSQs/Spurious identifications from states to central database will further help in improving availability of quality medicines in the country and beyond,” it added.

As part of the continuous regulatory surveillance, drug samples are picked from sales or distribution points and analysed after which the regulator displays a list of NSQ drugs on CDSCO portal on monthly basis, the release said. The purpose of displaying the NSQ list is to make stakeholders aware about the batches of such drugs identified in the market.

“It is a part of the campaign to arm the consumer with adequate information so that they are aware of the presence of such products in the market,” a senior official in the drugs regulatory department said, requesting anonymity.

In an earlier statement, the Drugs Controller General of India, Rajeev Singh Raghuvanshi, said that the CDSCO was taking all measures to drastically bring down the percentage of less efficacious drugs, noting that only around 1.5% of the total drugs being sampled were found less efficacious in recent surveys.

Identification of drug samples as NSQ is done based on the failure of the drug sample in one or the other specified quality parameters. The regulator said 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.

Besides NSQs, some defective products related to quality are also categorised as adulterated or spurious drugs, which are considered to have potential to cause serious adverse reactions and even death.

Of the 19 drugs labelled as spurious last year, five samples were lifted from Delhi, four from Bihar, and the others from east zone, Jharkhand, and Odisha.

The drugs found spurious include pantoprazole gastro-resistant tablets used for treating acid reflux, antibiotics such as amoxicillin & potassium clavulanate and cefixime, rosuvastatin used against high blood cholesterol, tamsulosin and dutasteride tablets meant to treat prostate-related issues, deflazacort used for treating rare genetic muscular disorder, as well as some calcium and vitamin D3 tablets.

According to the regulator’s statement, the manufacturers (as per label) of these fake drugs have claimed that the impugned products were not produced by them. An investigation is underway to know about the manufacturers of these fake medicines, people familiar with the matter said.

The drugs regulator conducts regular surveillance to check for the presence of NSQs and spurious drugs in market. Last month, a joint investigation was conducted by CDSCO east zone, and the drugs control directorate, West Bengal, at a wholesale premises in Kolkata and seized anti-cancer, anti-diabetic drugs worth ₹6.60 crore suspected to be spurious.

“This action of identifying NSQ and Spurious medicines is taken on regular basis in collaboration with state regulators to ensure that these drugs are identified and removed from the market,” the CDSCO statement read.