Is Montair-LC banned in India?

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 legal nature of the April 2025 action is itself a direction rather than a Section 26A ban, and is flagged for verification in the content plan.

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.