Brand check
Is Montair-LC banned in India?
Last checked 3 November 2026
Montair-LC, Montair-LC Kid and Montek-LC are not banned in India; the combination halted by the CDSCO on 11 Apr 2025 was levocetirizine + montelukast + ambroxol, a different three-drug product.
- Classification
- No ban or recall found in official records
- Decided by
- CDSCO / Ministry of Health and Family Welfare
- Reference
- No Section 26A notification for montelukast + levocetirizine; CDSCO direction of 11 Apr 2025 covers the ambroxol version
- Latest action
- 21 January 2026
- Last checked
- 3 November 2026
Montelukast 10 mg film-coated tablets. Photo: Montelukast Teva 10 mg.jpg by Ewave.one (CC BY-SA 4.0). Brand names and logos belong to their owners and are used here to identify the product this entry is about. All photo credits.
Business Today: India halts 35 drug combinations over health risks, full list
Our team has checked this record against the published reports, last on 3 November 2026. The government order itself is not published online, or we have not found it yet, so we link the best public report. If you have the order, send it to us and we will link it instead.
Scope. A record here does not by itself mean a product or company is unsafe or banned today. Regulatory actions can apply to one batch, one formulation, one period or one state. Always check the linked government document for the current position, and tell us if something is out of date. How we label records.
Below: Blacklisted's explanationWe explain what has been reported. The report above is the best source we hold.
Key facts
- Governing authority
- CDSCO, Ministry of Health and Family Welfare
- Ban notification
- None for montelukast + levocetirizine
- Halted product
- Levocetirizine + montelukast + ambroxol: CDSCO letter to state licensing authorities, 11 Apr 2025
- Manufacturers
- Cipla (Montair-LC); Sun Pharma (Montek-LC)
- NSQ note
- A levocetirizine + montelukast batch appeared in the Dec 2025 NSQ alert; batch-specific
Where the claim comes from
On 11 April 2025 the CDSCO directed state licensing authorities to halt 35 fixed-dose combinations approved at state level without central approval. One was levocetirizine + montelukast + ambroxol. Reports headlined 'montelukast-levocetirizine combination halted', and the leading two-drug brands, Montair-LC and Montek-LC, were assumed to be included.
Montair-LC (Cipla) and Montek-LC (Sun Pharma) combine montelukast, a leukotriene receptor antagonist, with levocetirizine, an antihistamine. They are among the most prescribed allergy products in India, including a paediatric "Kid" version. They are not banned.
The rumour comes from the CDSCO's action of 11 April 2025, when it wrote to state licensing authorities directing them to stop the manufacture, sale and distribution of 35 fixed-dose combinations that had been licensed at state level without the central approval required for new drugs. One of the 35 was levocetirizine + montelukast + ambroxol, a three-drug "allergy and cough" product. The two-drug montelukast + levocetirizine combination has central approval and was not on the list. The April 2025 action is a direction to state licensing authorities rather than a Section 26A ban.
Montelukast + levocetirizine was also absent from the 156-FDC ban of August 2024 and the 16-FDC ban of June 2026.
One more source of worry is the monthly quality alerts. The CDSCO's December 2025 alert, published in January 2026, listed a levocetirizine + montelukast batch as not of standard quality. Such findings apply to the batch named, from the manufacturer named, and not to the brand as a whole. Patients on Montair-LC or Montek-LC can continue as prescribed and check batch numbers if an alert names their product.
What this means for you
Keep taking it as prescribed
Montair-LC and Montek-LC remain licensed for allergic rhinitis and asthma.
Three-drug versions are different
A product that adds ambroxol was halted in 2025; check the label if you were given a 'cough' variant.
Batch reports are not bans
If a monthly alert names a batch, compare the number on your strip.
This is a record of official orders, not medical advice. Do not stop a prescribed medicine without asking your doctor or pharmacist.
Common questions
Is Montair LC banned in India?
No. Montelukast + levocetirizine is not in any ban list; only a three-drug version with ambroxol was halted in April 2025.
Is Montair-LC Kid banned?
No. The paediatric version is the same two-drug combination and is not banned.
Is Montek LC banned?
No. Montek-LC is montelukast + levocetirizine, the same legal two-drug combination.
Is montelukast banned in India?
No. Montelukast is not banned; the April 2025 halt named only levocetirizine + montelukast + ambroxol.
Batches flagged in CDSCO alerts
Products whose name matches this brand or molecule in CDSCO monthly NSQ alerts. A flagged batch is a single batch; the company's response, where reported, is noted on the page above.
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Montair LC Kid (Montelukast Sodium & Levocetirizne Hydrochloride Dispersible Tablets) | Batch AFB23W73Mfg Sep 2023 · Exp Aug 2025 | Pure & Cure Healthcare Pvt. LtdUttarakhand | Uniformity of Dispersion & Assay of Montelukast SodiumAssay | CDL KolkataCDSCO lab | Aug 2024 |
Ingredient records: Montelukast, Levocetirizine
Sources
- Business Today: India halts 35 drug combinations over health risks, full listNewsBusiness Today · 17 April 2025
- Business Standard: CDSCO halts manufacture, sale, distribution of 35 FDCs over safety concernsNewsBusiness Standard · 16 April 2025
- Business Standard: CDSCO flags 7 drugs as spurious, 167 fail quality tests in Dec 2025NewsBusiness Standard · 21 January 2026