
Top drug regulator DCGI flags 185 substandard, 4 spurious drugs in June 2025
These spurious drugs were reported from Bihar, one from New Delhi, and two from Telangana.
The monthly report, published by the CDSCO, highlights India's persistent challenge in maintaining drug integrity across the nation. Of the 185 NSQ drug samples, 55 were flagged by central drugs laboratories, and 130 by state labs.
A senior Delhi government official said that the Delhi drugs control department has down on the sale of fake anti-cholesterol medicines, primarily used for preventing serious cardiovascular conditions such as heart attacks and strokes.
The Union health ministry in a statement said that these drug samples failed one or more specified quality parameters, ranging from inadequate active ingredients to issues with dissolution, uniformity of weight, or sterility.
The failure is specific to the tested batch and does not necessarily indicate a broader concern for other drug products from the same manufacturer available in the market, the ministry said.
'Investigations revealed that these spurious drugs were manufactured by unauthorized entities using brand names owned by legitimate companies, highlighting the severity of the counterfeit drug problem. The matters are currently under investigation, and stringent action will be taken as per relevant acts and rules,' the ministry said.
This rigorous identification and removal of NSQ and spurious drugs from the market is a regular collaborative exercise between central and state regulators.
Meanwhile, the ministry of health has implemented several measures to combat the menace of spurious and substandard drugs in India.
As part of the plan, the government has strengthened the regulatory framework by making suitable amendments to the Drugs and Cosmetics Act, 1940. The government has introduced more stringent penalties for manufacturing spurious and adulterated drugs. Some offenses have also been made cognizable and non-bailable.
The government has also enhanced the testing infrastructure and made provision of licence suspension/cancellation which means that state drug regulators have the authority to suspend or cancel manufacturing licences of companies found to have produced NSQ drugs. Efforts are underway to ensure all the drug makers are following good manufacturing practice (GMP) at their units.
GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is a critical component of quality assurance in the pharmaceutical industry. It ensures patient safety, product consistency, prevention of contamination or errors etc.
In May, the apex drug regulator declared 186 drugs as substandard. Two samples were reported as spurious during the month.

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Mint
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The Wire
3 days ago
- The Wire
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'As part of the continuous regulatory surveillance, drug samples are picked from sales/distribution point and analysed, and the list of spurious [NSQ] drugs are displayed on the CDSCO portal on a monthly basis,' the CDSCO said. The purpose of displaying the list is to make stakeholders aware about the NSQ batches identified in the market, it added. The drugs that the CDSCO and state regulators most commonly found to be NSQ were mainly antibiotics, vitamin and calcium supplements, and anti-hypertensives (used for controlling blood pressure) in oral and injectable forms. The companies mentioned in this article are not the only ones whose products were found to be NSQ. We have only considered companies that made either multiple batches of a given drug that were found sub-par, or those that have manufactured various drugs that were found sub-par. It must be mentioned here that the CDSCO's and the states' labs only test a certain batch(es) of a particular medicine. If one batch of any drug has been red-flagged, it does not necessarily mean that all its batches would be substandard. Common 'errors' One of the most serious risks associated with NSQ drugs is improper sterility. This means that the drug contains harmful microorganisms that can lead to infection in a patient's body after ingestion. This could potentially cause extremely serious complications in patients, like sepsis or even death due to acute infection. The other common problem that some drugs have is that they contain 'particulate matter' – particles that inadvertently enter the drug during the manufacturing process. These particles can contaminate the drug. A 'description' error is one in which a drug's physical appearance does not match its prescribed appearance as per regulation. For example, if a tablet is described in regulation as having a white colour but a patient finds it to be orange, the tablet would have a description error. 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Two batches of Oscar Remedies's ciprofloxacin & dexamethasone eye/ear drops had 943.33% more ciprofloxacin than the labelled amount. The full lists of NSQ drugs made by the CDSCO and state regulators can be found here and here respectively. The Wire is now on WhatsApp. Follow our channel for sharp analysis and opinions on the latest developments.
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Business Standard
3 days ago
- Business Standard
CDSCO flags 4 drugs as spurious, 185 not of standard quality for June 2025
The Central Drug Standards Control Organisation (CDSCO) on Friday flagged select batches of four drugs as spurious and listed 185 other drugs and formulations as not of standard quality (NSQ) in its routine surveillance for June 2025. The drugs flagged as spurious in the apex regulatory body's recent monthly update for June 2025 include the antibiotic Taxim-O 200 and Rosuvas F10 and F20 tablets, used to lower cholesterol and reduce the risk of heart disease. The list also includes a sample of Thrombophob ointment, which is used to treat superficial inflammation or swelling of a vein due to a blood clot. While the CDSCO alert named the brands for which spurious samples were found, it did not identify the drugmakers involved. Taxim-O is originally marketed by Alkem Laboratories, whereas Rosuvas is a registered brand of Sun Pharma. The Union Health Ministry added that while two of the spurious drug samples were found in Telangana, one sample each was identified from Bihar and Delhi. A drug is generally considered spurious when it is manufactured by unauthorised manufacturers using brand names owned by other companies. 'The matter is under investigation and action will be taken according to the Act and rules,' a statement from the Union Health Ministry said. Officials familiar with the matter added that unauthorised manufacturers often produce counterfeit copies of many popular drugs, especially cardiovascular and hypertension medications. 'To counter this, rigorous identification and removal of NSQ and spurious drugs from the market is a regular collaborative exercise between central and state regulators,' they added. Of the 185 drugs found to be NSQ for June, 55 were identified at central drug laboratories in Kolkata, Mumbai, Hyderabad, Guwahati, and Chandigarh, while state drug testing laboratories identified the remaining 130. The identification of drug samples as NSQ is based on failure to meet one or more specified quality parameters, such as dissolution, uniformity of weight, and assay of active ingredients in the sample. However, the ministry stated that the failure is specific to the drug products of the batch tested by the government laboratories and does not warrant concerns about other drug products available in the market.