CDSCO Flags 220 Substandard Medicines: Key Facts for Pharma Manufacturers
A pharmaceutical product can look perfect on the shelf and still fail a laboratory quality test.
That is why the latest CDSCO alert on 220 substandard medicines deserves serious attention from pharmaceutical manufacturers, marketers, distributors, and quality professionals. During its August 2026 routine surveillance exercise, the Central Drugs Standard Control Organisation (CDSCO) identified 220 drug samples as Not of Standard Quality (NSQ). The findings included 29 samples identified through Central Drugs Laboratories and 191 through State Drugs Testing Laboratories. A separate drug sample from Delhi was also classified as spurious and remains under investigation.
The important takeaway isn't simply the number 220. The alert highlights the importance of consistent pharmaceutical quality control, reliable testing, documented processes, and strong GMP and pharmaceutical quality standards throughout the manufacturing lifecycle.
For manufacturers, the practical question is straightforward: What can be done to reduce the risk of quality failures?
Let's look at what the latest CDSCO alert means, and the checks manufacturers should prioritize.
What Are NSQ Medicines?
NSQ medicines are drug samples classified as Not of Standard Quality because they fail one or more applicable quality parameters during testing. An NSQ finding is specific to the tested sample or batch and should not automatically be interpreted as applying to every batch of the same medicine.
Quick Facts: What Happened in the Latest CDSCO Alert?
The August 2026 surveillance findings provide a useful snapshot of the regulator's ongoing market-monitoring activity.
Key Findings from CDSCO’s August 2026 Surveillance
- •220 NSQ Drug Samples Identified – CDSCO reported 220 medicines as Not of Standard Quality (NSQ) during the August 2026 surveillance exercise.
- •29 Samples from Central Laboratories – 29 NSQ samples were identified through Central Drugs Laboratories.
- •191 Samples from State Laboratories – 191 samples were reported through State Drugs Testing Laboratories.
- •1 Separate Spurious Sample – A separate spurious drug sample was reported from Delhi, distinct from the 220 NSQ samples.
- •Routine Regulatory Surveillance – The findings came from routine drug-quality surveillance and testing carried out through regulatory laboratories.
- •NSQ Means “Not of Standard Quality” – An NSQ finding indicates that a tested drug sample did not meet the applicable quality standard or specification.
The reported NSQ samples included medicines from commonly used categories such as paracetamol, metformin combinations, amoxicillin formulations, vitamin products, and cough syrups.
CDSCO has also clarified an important point: an NSQ identification is based on the failure of the particular tested sample or batch against one or more specified quality parameters. The finding should not automatically be interpreted as meaning that every batch of the same medicine is defective.
For pharmaceutical companies, this distinction matters.
The goal should not be to react to headlines alone. It should be to understand what quality systems can do to identify deviations before products reach the market.
Read also: CDMO vs Third-Party Manufacturing: Key Differences Explained
What Does “Not of Standard Quality” Actually Mean?
Not of Standard Quality (NSQ) is a regulatory classification used when a tested drug sample fails one or more applicable quality parameters or specifications.
Depending on the product, testing may involve parameters such as assay, dissolution, weight uniformity, sterility, labelling, or other prescribed requirements.
In simple terms, an NSQ finding means:
The tested sample did not meet the applicable quality requirement for the parameter examined.
This is also why the terms NSQ medicines, substandard medicines, and spurious medicines should not be casually used as synonyms.
NSQ vs. Spurious Medicines
NSQ / Substandard vs. Spurious Medicines
- •NSQ / Substandard Medicines – Refers to a drug sample that fails to meet one or more specified quality parameters during testing.
- •Spurious Medicines – Represents a separate regulatory classification, involving circumstances such as false identity, misleading information, or unauthorised manufacture, depending on the applicable law.
- •Laboratory Testing – NSQ findings are identified through laboratory testing against applicable quality specifications.
- •Different Regulatory Concerns – A spurious medicine finding may involve issues beyond routine quality-parameter failure and can lead to separate regulatory action.
- •Sample or Batch Specific – An NSQ result generally relates to the tested sample or batch and should be interpreted in the context of the specific test and report.
- •Routine Surveillance – NSQ findings can arise through routine drug-quality surveillance, while spurious cases may require a separate regulatory investigation.
In the current alert, CDSCO reported 220 NSQ samples and one separate spurious sample. The Delhi spurious case was reportedly under investigation.
Why Can a Medicine Become Substandard?
A quality problem does not necessarily begin at the final testing stage.
A finished pharmaceutical product is the result of multiple connected steps—from sourcing raw materials to manufacturing, testing, packaging, storage, and distribution. A weakness at any stage can potentially affect the final product.
This makes a controlled pharmaceutical manufacturing process essential.
1. Raw Material Quality
APIs, excipients, packaging materials, and other inputs need to meet their applicable specifications.
Effective raw material testing and supplier qualification help manufacturers establish that materials entering production meet the required quality criteria.
A strong system should cover:
- •Material specifications
- •Supplier qualification
- •Sampling procedures
- •Laboratory testing
- •Material approval and rejection
- •Traceability and documentation
2. Manufacturing Process Controls
Even high-quality raw materials cannot guarantee a high-quality finished product if manufacturing processes are poorly controlled.
Depending on the dosage form, processes such as blending, granulation, compression, coating, filling, drying, or sterilisation may require carefully defined controls.
This is where GMP compliance becomes particularly important.
Good Manufacturing Practices focus on controlled manufacturing environments, documented procedures, trained personnel, suitable facilities, equipment, quality systems, and consistent processes.
3. Finished Product Testing
Before a batch is released, appropriate testing should demonstrate that the finished product meets its specifications.
The exact tests depend on the dosage form and product requirements. They may include:
- •Assay
- •Dissolution
- •Uniformity
- •Microbial testing
- •Sterility
- •Physical characteristics
- •Other product-specific parameters
This is why drug quality testing is a core part of pharmaceutical manufacturing rather than an afterthought.
4. Packaging and Labelling
A product can meet formulation specifications and still face problems related to packaging or labelling.
Batch number, manufacturing date, expiry date, storage instructions, product information, and packaging components require appropriate control.
Strong pharmaceutical quality assurance therefore extends beyond the manufacturing floor.
5. Storage and Stability
Pharmaceutical quality also depends on appropriate storage and stability controls.
Temperature, humidity, light exposure, packaging integrity, and other environmental factors can influence product quality depending on the formulation.
What Does the 220-Drug Alert Mean for Pharma Manufacturers?
The latest CDSCO substandard medicines alert is best viewed as a reminder that quality needs to be managed throughout the product lifecycle.
For manufacturers, that means asking questions such as:
- •Are raw materials consistently tested?
- •Are suppliers properly qualified?
- •Are manufacturing processes controlled?
- •Are laboratory methods and records maintained appropriately?
- •Are finished products tested before release?
- •Are deviations investigated?
- •Are corrective and preventive actions documented?
- •Are storage and stability requirements being followed?
- •Are employees adequately trained?
These questions form the foundation of effective pharmaceutical quality control.
The same principle is important for companies that outsource production. If you're researching how to choose a medicine manufacturing company, don't evaluate a potential partner only on price or catalogue size.
Look at manufacturing infrastructure, quality systems, testing procedures, applicable certifications, documentation, product capabilities, and regulatory processes.
Fedley Healthcare, for example, publishes information about its WHO-GMP-certified pharmaceutical manufacturing, quality systems, product portfolio, and third-party manufacturing services.
5 Quality Checks Every Pharma Manufacturer Should Prioritize
Maintaining consistent product quality requires attention at every stage of manufacturing. These five checks can help pharmaceutical manufacturers strengthen their quality systems and reduce avoidable quality issues.
1. Check Every Raw Material Before Production
- •Verify APIs, excipients, and other materials against approved specifications.
- •Follow appropriate raw material testing procedures before use.
- •Maintain proper supplier qualification and material documentation.
- •Ensure only approved materials enter the pharmaceutical manufacturing process.
2. Control Every Step of the Manufacturing Process
- •Monitor critical manufacturing parameters consistently.
- •Follow approved SOPs and established production procedures.
- •Perform appropriate in-process quality checks.
- •Maintain GMP compliance throughout manufacturing.
- •Investigate significant deviations instead of overlooking them.
3. Verify Finished Products Before Batch Release
- •Test finished products against applicable specifications.
- •Check relevant parameters such as assay, dissolution, uniformity, or microbial quality where applicable.
- •Ensure laboratory results are properly documented and reviewed.
- •Use effective drug quality testing before releasing a batch.
4. Keep Complete and Traceable Batch Records
- •Record important manufacturing and testing activities accurately.
- •Maintain batch numbers, material details, test results, and relevant production information.
- •Ensure documentation allows a batch to be traced from materials to finished product.
- •Use proper records to support investigations when deviations occur.
- •Strong pharmaceutical quality control depends on reliable documentation.
5. Make Quality Assurance a Daily Practice
- •Don't treat quality assurance as something required only during inspections.
- •Regularly review quality systems, procedures, and manufacturing controls.
- •Train employees on applicable quality procedures and responsibilities.
- •Identify potential problems before they become larger compliance issues.
- •Build a strong culture of pharmaceutical quality assurance across the organization.
Consistent raw-material checks, controlled manufacturing, finished-product testing, accurate documentation, and active quality assurance can collectively strengthen pharmaceutical quality and support better GMP and pharmaceutical quality standards.
CDSCO & GMP Compliance Checklist
Manufacturers can use the following as a high-level internal review framework:
- •Raw Material Testing – Are APIs, excipients, and other materials tested against applicable specifications before use?
- •Supplier Qualification – Are raw-material suppliers properly qualified, evaluated, and monitored for consistent quality?
- •Pharmaceutical Manufacturing Process – Are manufacturing steps controlled, documented, and performed according to approved procedures?
- •In-Process Quality Control – Are critical parameters and relevant quality checks monitored during production?
- •Drug Quality Testing – Are finished products subjected to required quality tests before batch release?
- •Batch Documentation – Are manufacturing and testing records complete, accurate, and traceable for every batch?
- •Stability Testing – Are applicable stability studies and requirements properly addressed throughout the product lifecycle?
- •Pharmaceutical Quality Assurance – Are storage conditions, handling procedures, and quality systems consistently maintained?
CDSCO Compliance – Are applicable regulatory requirements, GMP standards, and CDSCO compliance obligations reviewed and updated regularly?
This is a practical checklist, not a replacement for applicable laws, licences, specifications, regulatory requirements, or professional compliance advice.
How to Choose a Reliable Pharma Manufacturer
For companies considering third-party pharmaceutical manufacturing, choosing the manufacturing partner is an important business decision.
A low manufacturing price may look attractive initially, but pharmaceutical manufacturing involves much more than production cost.
Before selecting a partner, examine:
Manufacturing Standards
Ask about the applicable GMP and pharmaceutical quality standards, manufacturing capabilities, quality systems, and certifications.
Quality Control
Understand how incoming materials, in-process products, and finished products are tested.
Product Capabilities
Check whether the manufacturer can consistently produce your required dosage forms and specifications.
Documentation
A reliable system should support appropriate batch records, testing documentation, specifications, and traceability.
Delivery & Supply Chain
Quality products are only useful to a business when they can be supplied consistently.
Regulatory Support
Understand what documentation and support are available for your particular product and business requirements.
Fedley Healthcare states that it provides third-party pharmaceutical manufacturing through WHO-GMP-certified facilities and offers quality-control and custom-formulation support.
Its published portfolio also covers pharmaceutical categories including tablets, capsules, syrups, injections, ointments, and other formulations.
Why WHO-GMP Manufacturing Matters
WHO-GMP is not simply a marketing phrase. Good Manufacturing Practices are intended to help ensure medicines are consistently produced and controlled according to appropriate quality standards.
For businesses outsourcing production, evaluating the manufacturer's quality infrastructure can therefore be an important part of due diligence.
Fedley Healthcare states that its manufacturing facilities are WHO-GMP certified and that it maintains quality-control systems covering manufacturing activities.
You can learn more about its manufacturing and company profile here:
WHO-GMP Certified Pharmaceutical Manufacturing – Fedley Healthcare
For companies specifically evaluating outsourced production:
Third-Party Pharmaceutical Manufacturing – Fedley Healthcare
And for product-related research:
Fedley Healthcare Pharmaceutical Products
What Should a Manufacturer Do After an NSQ Finding?
An NSQ finding should trigger a structured investigation rather than assumptions.
The appropriate response will depend on the product, batch, test parameter, regulatory requirements, and circumstances surrounding the finding.
A manufacturer may need to review:
- •The affected product and batch.
- •The laboratory test and reported parameter.
- •Raw material records.
- •Manufacturing and batch records.
- •Laboratory documentation.
- •Previous quality trends.
- •Potential root causes.
- •Corrective and preventive actions where appropriate.
- •Applicable regulatory communication or action.
Most importantly, manufacturers should avoid assuming that an NSQ result automatically applies to every batch of the same medicine.
CDSCO specifically stated that its NSQ identification relates to the particular drug product and batch tested by the government laboratory.
Final Takeaway
The latest CDSCO 220 substandard medicines alert is a useful reminder that pharmaceutical quality cannot depend on one final inspection or one laboratory test.
Quality is built step by step.
It starts with suitable raw materials, continues through a controlled pharmaceutical manufacturing process, depends on effective testing and documentation, and extends to packaging, storage, and distribution.
For pharma companies, the lesson is equally relevant when selecting a manufacturing partner. Whether you need pharmaceutical tablets and capsules, syrups, injectables, or other formulations, the manufacturer should be evaluated on quality systems and manufacturing capabilities—not simply on price.
Fedley Healthcare states that it offers WHO-GMP-certified manufacturing and third-party pharmaceutical manufacturing services, alongside a broad pharmaceutical product portfolio.
About Fedley Healthcare
Fedley Healthcare states that it has been operating since 2013 and provides pharmaceutical products and business services, including PCD Pharma Franchise and third-party manufacturing. Its website lists WHO-GMP, ISO 9001:2015, GLP, and DCGI-related credentials and says it has 1,000+ products and a presence across 29+ states.
Contact:
- •Plot No. 201, Ground Floor, HSIIDC, Alipur, Phase 1, Industrial Area, Barwala (PKL), Haryana – 134118
- •Email: fedleycare[@]gmail.com
- •Phone: +91-9855986633 | +91-9317692852 | +91-9888656719
Data Source: Verified Drug Quality Information
The information discussed in this article is based on official CDSCO drug-quality surveillance data and publicly reported regulatory updates concerning Not of Standard Quality (NSQ) medicines identified during routine testing.
For pharma manufacturers, these reports are more than just regulatory updates; they provide useful insight into recurring drug quality, batch testing, manufacturing controls, and GMP compliance concerns.
Readers and pharmaceutical businesses can refer to the CDSCO official NSQ drug database for the latest publicly available information on medicines reported as failing applicable quality standards.
This article interprets the available regulatory information from a pharmaceutical manufacturing and quality-control perspective. Manufacturers should always verify the latest official CDSCO notifications, testing results, and applicable regulatory requirements before taking compliance-related decisions.
Source: Central Drugs Standard Control Organisation (CDSCO) – NSQ Drug Alerts
View Official CDSCO NSQ Drug Alerts
Frequently Asked Questions
01. What does NSQ mean in pharmaceuticals?
NSQ means Not of Standard Quality. It refers to a drug sample that fails one or more applicable quality parameters or specifications during regulatory testing.
02. How many medicines were flagged by CDSCO in August 2026?
CDSCO identified 220 drug samples as NSQ during its August 2026 routine surveillance exercise—29 through Central Drugs Laboratories and 191 through State Drugs Testing Laboratories.
03. Is an NSQ medicine the same as a spurious medicine?
No. NSQ and spurious medicines are separate regulatory classifications. The August 2026 surveillance identified 220 NSQ samples and one separate spurious sample.
04. How can manufacturers reduce the risk of substandard medicines?
Manufacturers can strengthen pharmaceutical quality control, raw-material testing, supplier qualification, in-process controls, finished-product testing, documentation, stability programs, and GMP compliance.
05. Why is pharmaceutical quality assurance important?
Pharmaceutical quality assurance helps establish systems and processes intended to ensure that products are consistently manufactured and controlled according to applicable quality requirements.
06. What should companies check before choosing a medicine manufacturer?
Companies should assess manufacturing standards, quality-control systems, testing capabilities, applicable certifications, documentation, dosage-form capabilities, supply reliability, and regulatory support.
07. What is third-party pharmaceutical manufacturing?
Third-party pharmaceutical manufacturing involves a company outsourcing the manufacture of pharmaceutical products to a manufacturing partner under an agreed business and regulatory arrangement.
Disclaimer:
This article is intended for general pharmaceutical-industry information and educational purposes. It should not be treated as legal, regulatory, medical, quality-assurance, or compliance advice. Manufacturers and pharmaceutical businesses should verify applicable CDSCO requirements, licences, specifications, standards, and regulatory notices with qualified professionals and official authorities before taking action.