How to read a record
What our labels mean
Every record has two layers. On top, one of five plain labels, so you can tell at a glance what kind of action it is. Underneath, the exact legal term the regulator used, with the document it comes from. The document is the authority; we organise and explain it.
The five labels
Number of records on the site with each label today. Most "failed a lab test" records are single batches from CDSCO's monthly alerts.
Banned or prohibited
Banned or prohibitedA regulator or court has stopped the making, sale or import of this product or combination in India.
- Prohibited under Section 26A
- The Central Government has banned the manufacture, sale and distribution of a drug or fixed-dose combination (FDC) by a Gazette notification. Applies across India from the date in the notification.
- Prohibited under food law
- An FSSAI regulation or order does not permit a substance (for example a colour or additive) in food, or bans a practice such as ripening fruit with calcium carbide.
Recalled or suspended
Recalled or suspendedStock was ordered off the market, or a licence was suspended. Usually limited to specific batches, products or a period of time.
- Recall ordered
- The regulator or the company withdrew specific products or batches from sale. Other batches and products from the same brand are usually unaffected.
- Licence suspended or BIS licence action
- A manufacturing or BIS certification licence was suspended or cancelled, so the maker may not sell under it until it is restored.
Failed a lab test
Failed a lab testA sample failed a quality test, most often one batch rather than every pack. The record says whether a government lab or an independent tester did the test.
- Not of Standard Quality (NSQ)
- A government drug-testing laboratory found that a sample from one batch did not meet its standard (for example the amount of active ingredient, dissolution or sterility). It is listed in CDSCO's monthly drug alert.
- Spurious
- The sample was fake or wrongly labelled: made by someone other than the company named on the label, or passed off as another product. The named company is often a victim, not the source.
- Independent lab test finding
- A private testing company or a published study found a problem (for example protein below the label claim). No regulator has acted on it, and the brand may dispute it.
Regulatory notice
Regulatory noticeA regulator issued a notice, restriction, warning or direction, or a ban is stayed or under review. It is not a ban.
- Restricted
- Allowed, but with a condition: a dose limit, an age limit, a warning on the label or a limit on how it is sold.
- Stayed
- A court has paused a ban while a case is heard. The product can be sold until the court decides.
- Halted
- A regulator told licensing authorities to stop approving or making something. It is a direction, not a Section 26A ban.
- Under examination
- The regulator or an expert committee (such as the DTAB) is reviewing the product. Nothing has been decided.
- Notice or advisory
- A regulator issued a warning, show-cause notice, advisory or direction. It is not a ban or a recall.
No current action
No current actionNot banned, cleared, or an earlier action was quashed or withdrawn. It does not certify that a product is safe.
- Not banned
- We checked the official lists and found no ban or recall. This is the answer to a common "is it banned?" question, not a safety certificate.
- Cleared
- The product was reviewed or tested and passed, or the regulator closed the matter.
- Quashed or revoked
- A court struck down a ban, or the government withdrew it. There is still a record, but no ban is in force.
- Withdrawn
- An earlier notice, advisory or certificate was withdrawn or has lapsed.
How we rank sources
Each record shows the strongest source we have, and says which tier it is. We only call something banned, recalled or failed when a Tier 1 document says so. Where the best we have is a news report, the record says so plainly until we find the document.
Tier 1: government primary source
The order, gazette notification, alert, recall or court judgment itself, published by the authority that issued it.
7,706 records
Tier 2: government-linked source
A government press release, a government lab report or a state health department statement that reports the action.
2 records
Tier 3: news report
A news report of the action. Used only where the original document is not public, and marked as such.
103 records
Tier 4: independent test or study
A published study or a private testing company. No regulator has acted on it.
180 records
Batch, product, brand and company are different things
Batch
One production run, printed on the pack as "B. No." or "Lot". NSQ and most recalls apply to a batch. Other batches of the same product are not affected unless the record says so.
Product or formulation
A specific medicine or food, such as a combination of two drugs in a tablet. Section 26A bans apply to the formulation, whatever the brand name.
Brand
The name on the pack. One brand can include many products and strengths. A record about one product is not a record about the whole brand.
Manufacturer
The company named after "Mfd. by". Our manufacturer pages count records linked to a company. A count is not a finding that the company's products are unsafe.
Every exact status we use
See the methodology for how records are made and checked, and corrections to report a mistake.