The Central Drugs Standard Control Organisation (CDSCO) has listed at least 186 drugs and formulations as not of standard quality (NSQ) in May , after both central and state testing laboratories across the country flagged these samples, according to the national drugs regulator’s alert issued on Friday.
Two samples were found to be spurious.
Data accessed by HT for the year so far, showed that at least 561 samples were labelled as NSQ by the national drugs regulator while three 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 186 samples that failed the quality test, 128 were identified by various state drugs testing laboratories, while the central drugs laboratories identified 58 .
“As per routine regulatory surveillance activity, the list of Not of Standard Quality (NSQ) and Spurious drugs are being displayed… Identification of drug samples as NSQ is done based on failure of the drug sample in one or the other specified quality parameters. The failure is specific to the drug products of the batch tested by the Govt. Laboratory and it does not warrant any concerns on the other drug products available in the market,”CDSCO said in the statement.
“Two dug samples from the State of Bihar are identified as spurious drugs, which were manufactured by an unauthorized manufacturer using brand name owned by another company, the matter is under investigation and action will be taken as per Act & Rules.”
Last year, at least 900 samples were found to be of NSQ and 20 spurious from samples randomly lifted from across the country.
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 purpose of displaying the NSQ list is to make stakeholders aware about the batches of such drugs identified in the market.
The Drugs Controller General of India, Rajeev Singh Raghuvanshi, earlier 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.
“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,” read the statement.
