The Central Drugs Standard Control Organisation (CDSCO) found one spurious and 220 not of standard quality (NSQ) drugs from a batch of samples tested randomly as part of August drug surveillance exercise, according to the drugs regulator’s NSQ alert issued on Tuesday.
The failed samples during routine regulatory surveillance included 29 samples tested by the central drugs laboratories and 191 identified by the state drugs testing laboratories.
NSQ drugs are those that fail to meet the quality standards or specifications, including those pertaining to labelling, dissolution, weight uniformity and sterility. Besides NSQs, some defective products related to quality are also categorised as adulterated or spurious drugs, which are considered to have the potential to cause serious adverse reactions and even death.
According to the report, one drug sample from the National Capital Territory (NCT) of Delhi was also identified as spurious.
The spurious drug was allegedly 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 Drugs and Cosmetics Act and Rules, according to the regulatory authority,” read the report.
CDSCO said the list of NSQ and spurious drugs is displayed on its portal every month as part of routine regulatory surveillance activity. The regulator clarified identification of a drug sample as NSQ is based on the failure of the particular sample in one or more specified quality parameters.
{{/usCountry}}CDSCO said the list of NSQ and spurious drugs is displayed on its portal every month as part of routine regulatory surveillance activity. The regulator clarified identification of a drug sample as NSQ is based on the failure of the particular sample in one or more specified quality parameters.
{{/usCountry}}In addition, CDSCO said that the finding is specific to the drug product of a particular batch tested by the government laboratory and does not warrant concerns regarding same drug products of a different batch available in the market.
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 only around 1.5% of the total drugs being sampled were found less efficacious in recent surveys.
The regulatory surveillance is conducted in collaboration with state drug regulators to identify NSQ and spurious medicines and facilitate their removal from the market.
CDSCO said the identification of NSQ and spurious medicines is part of its regular regulatory process aimed at ensuring that such medicines are identified and removed from the market.
“The matter concerning the spurious drug identified in Delhi remains under investigation, and further action will be taken in accordance with the applicable Act and Rules,” added the CDSCO report.
Meanwhile, Raghuvanshi warned against indiscriminate use of antibiotics and NSAIDS (non-steroidal anti-inflammatory drugs) as it could lead to chronic kidney disease.
NSAIDS are a class of drugs meant to reduce pain and lower temperature.
“It is mandatory to ensure that these drugs shall only be used when clinically indicated, in the appropriate dose and for the appropriate duration, and under the supervision of a registered medical practitioner,” said Raghuvanshi in his directive.
“Individuals, particularly those with pre-existing kidney disease or other risk factors for renal impairment, should inform their healthcare professional before using NSAIDs… The lowest effective dose for the shortest appropriate duration should be considered when prescribing NSAIDs, particularly in patients at increased risk of renal impairment… Hospitals and healthcare institutions are advised to strengthen systems for rational prescribing and monitoring of NSAIDs and antibiotics…,” read the DCGI’s note.