Since January 2023, approximately 1,174 drugs have been deemed NSQ and spurious, many from reputable pharmaceutical companies, highlighting concerns about their safety and efficacy
Published Oct 26, 2024 | 3:40 PM ⚊ Updated Oct 26, 2024 | 3:40 PM
71 medicines fail drug quality tests
Recent alerts from the Central Drugs Standard Control Organisation (CDSCO) revealed that 71 drugs failed quality tests, with common medications falling into the categories of “spurious” and “not of standard quality” (NSQ).
Among those flagged, was a popular gastric medication deemed spurious, while essential antibiotics were found to be NSQ. The report also highlighted issues with cough syrups, labour-induction medications, paracetamol, anti-inflammatory eye drops, calcium and vitamin D3 supplements, anti-diabetes pills, and blood pressure drugs.
Spurious drugs and NSQ drugs pose serious public health risks. Spurious drugs are counterfeit products that mimic genuine medications, often aiming to mislead consumers. NSQ drugs, on the other hand, are medications that fail to meet the quality standards set by regulatory authorities.
NSQ drugs can have quality issues, such as incorrect labelling, insufficient dissolution, or inconsistent active ingredient levels. For instance, a drug labelled to contain 100 mg of an active ingredient might have between 95 mg and 105 mg, resulting in its NSQ classification due to compromised effectiveness or safety.
A common gastric medication, a drug for treating non-cancerous prostate enlargement, a dietary supplement essential for bone health, and a medication used by women for anaemia and osteoporosis after menopause have been found to be spurious by the Central Drugs Standard Control Organisation (CDSCO) in the month of September 2024.
The spurious drugs identified include:
According to CDSCO, these medications were flagged as spurious after the manufacturers indicated they had not produced the implicated batches. A CDSCO representative commented, “The product is purported to be spurious; however, this is subject to the outcome of ongoing investigations.”
It should be noted that in this month’s alert, the spurious list does not include the names of original manufacturers, which were being used in previous months.
Apart from the detection of four spurious drugs, the CDSCO, and other state laboratories also identified 67 additional medications that were classified as Not of Standard Quality (NSQ) due to their failure to meet established quality standards or specifications.
NSQ drugs fall short of quality benchmarks set by regulatory bodies, making them potentially less effective or unsafe.
These drugs are:
The company with the highest number of drugs in the NSQ category, based on the data provided, is Zee Laboratories Ltd., with a total of four drugs listed:
These drugs failed on various quality tests, such as dissolution, assay, and particulate matter, according to the NSQ reports.
The top three laboratories with the most drugs identified as Not of Standard Quality (NSQ) in the reports are:
These laboratories have identified multiple NSQ drugs across various therapeutic categories, including antibiotics, diabetes medications, and antihypertensives.
Spurious drugs are counterfeit medications designed to mimic legitimate products, often with the intent to deceive consumers. For example, medications like Glenmark’s Telmisartan and Sun Pharma’s Pantoprazole were found to be spurious, lacking any manufacturing link to the original companies. Patients who believe they are receiving legitimate medications may unknowingly put their health at risk.
Spurious drugs typically imitate popular and trusted brands but may not contain any active ingredients or may contain incorrect dosages. This deception can lead to inadequate treatment or even exacerbation of medical conditions.
Patients who consume these medications may face immediate health risks, including adverse reactions, ineffective treatment, or progression of their illness due to a lack of therapeutic effect.
NSQ drugs refer to medications that fail to meet the quality standards established by regulatory authorities. While not outright counterfeit, these drugs can still pose significant health risks.
Although NSQ drugs may not be as immediately harmful as spurious drugs, they can lead to inadequate treatment outcomes, worsening a patient’s condition.
Commonly identified NSQ drugs, such as Paracetamol, Metformin, and Pantoprazole, have failed various quality checks conducted by the Central Drugs Standard Control Organisation (CDSCO), indicating the potential for ineffective management of conditions they are meant to treat.
Intent: Spurious drugs are intentionally deceptive, designed to mislead consumers. In contrast, NSQ drugs may result from manufacturing errors or quality control failures, often without any malicious intent.
Last month, the Central Drugs Standard Control Organisation (CDSCO) declared five specific drug samples as spurious. These drugs were reported by their actual manufacturers as not being produced by them. The identified spurious drugs include:
Central Laboratories NSQ List: A total of 48 drugs were reported with deficiencies noted by various central laboratories across India.
State Laboratories NSQ List: Eleven drugs were flagged, primarily from the Drugs Testing Laboratory in Thiruvananthapuram. Among the notable NSQ drugs were common medications such as:
These drugs failed various quality tests, including dissolution tests, which assess how well a drug dissolves in the body to be effective.
Several leading companies, including Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics, Karnataka Antibiotics and Pharmaceuticals, Pure and Cure Healthcare, and Meg Lifesciences, have been named as manufacturers of the flagged medicines.
Other companies, such as Sun Pharma and Torrent Pharma, contend that the medicines listed in the report are “counterfeits” and assert that their products conform to quality standards.
Since January 2023, more around 1174 drugs have been found to be NSQ, and spurious. Many of these drugs originate from well-known pharmaceutical companies, which raises concerns about their safety and efficacy. Monitoring these alerts is essential to protect consumers from potentially harmful medications.
For example, In August 2023, a CDSCO drug inspector in Chennai examined COLD OUT Syrup (Paracetamol 120 mg + Chlorpheniramine Maleate 2 mg/5 ml syrup) produced by Fourrts (India) Laboratories, which is intended for use in children. The analysis revealed that the syrup contained 2.23% w/v Ethylene Glycol and 0.17% w/v Diethylene Glycol.
The recommended maximum allowable level of Ethylene Glycol in liquid preparations for oral use is 0.1% (w/v). This level is considered adequate for screening raw materials and finished products to ensure safety for human consumption
Similarly, the maximum allowable concentration of Diethylene Glycol in liquid preparations for oral use is also set at 0.1% (w/v). This limit is established to prevent potential toxicity, especially in children, as even small amounts can be harmful
It is important to note that a cough syrup linked to the deaths of over 80 children in The Gambia contained unacceptable amounts of Diethylene Glycol and Ethylene Glycol, both of which are toxic to humans and can prove fatal when consumed.
Diethylene Glycol and Ethylene Glycol are commonly found in cold and cough syrups, especially those marketed for children.
So, regular updates and alerts promote consumer awareness regarding the medications they are using. Patients and caregivers can make informed decisions about their health, avoiding potentially dangerous drugs by staying informed about product recalls or safety notices.
(Edited by Ananya Rao)
