Ravenbhel’s Bilastine, Montelukast FDC Under Review, CDSCO Panel Seeks Pediatric Expert Opinion
New Delhi: In response to a proposal submitted by Ravenbhel Healthcare of the fixed dose combination (FDC) pulmonary drug Bilastine 10 mg plus Montelukast Sodium IP eq. to Montelukast 4 mg per 5 mL oral solution, the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has recommended inviting a pediatrician for a detailed discussion on the matter.
This came after the firm presented the proposal along with justification for BE and Phase III CT waiver before the committee.
Bilastine is an antihistamine medication used to treat hives (urticaria), allergic rhinitis and itchy inflamed eyes (allergic conjunctivitis) caused by an allergy. It is a second-generation antihistamine and takes effect by selectively inhibiting the histamine H1 receptor, preventing these allergic reactions.
Montelukast is in a class of medications called leukotriene receptor antagonists (LTRAs). It works by blocking the action of substances in the body that cause the symptoms of asthma and allergic rhinitis.
Montelukast is used to prevent wheezing, difficulty breathing, chest tightness, and coughing caused by asthma in adults and children 12 months of age and older. Montelukast is also used to prevent bronchospasm (breathing difficulties) during exercise in adults and children 6 years of age and older.
At the recent SEC meeting for Pulmonary held on the 7th August 2025, the expert panel reviewed the proposal along with justification for BE and Phase III CT waiver before the committee.
After detailed deliberation, the committee opined that Pediatrician may be invited in next meeting for wider discussion in the matter.
