NPPA panel fixes retail price of Zydus healthcare's Glycopyrrolate, Formoterol,Budesonide metered-dose inhaler

The retail price of Glycopyrrolate, Formoterol, and Budesonide metered-dose inhaler containing Glycopyrrolate IP 9 mcg, Formoterol Fumerate Dilhyderate IP equivalent to Formoterol Fumerate 4.8 mcg, and Budesonide IP 160 mcg has been set at Rs 8.63 per MDI excluding GST.

This recommendation came during the 40th meeting of the Multidisciplinary Committee of Experts, held on March 14, 2022, under the convenorship of Shri Manmohan Sachdeva, Advisor(cost), through video-conferencing, where the issue of retail price fixation of Glycopyrrolate, Formoterol, and Budesonide metered-dose inhaler containing Glycopyrrolate IP 9 mcg, Formoterol Fumerate Dilhyderate IP equivalent to Formoterol Fumerate 4.8 mcg and Budesonide IP 160 mcg, manufactured and marketed by Zydus Healthcare Limited under Para 5 of DPCO,2013 was analyzed.

Glycopyrrolate is an anticholinergic that works by relaxing muscles in the airways to improve breathing. It is used as an inhaled medication to prevent airflow obstruction or bronchospasm in people with COPD (chronic obstructive pulmonary disease), including bronchitis and emphysema.

Formoterol is a long-acting bronchodilator used as a long-term treatment to prevent or decrease wheezing and trouble breathing caused by asthma or ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema).

Budesonide is a corticosteroid that works by decreasing swelling and irritation in the airways to allow for easier breathing. It is used to help prevent the symptoms of asthma.

At a recent Multidisciplinary Committee of Experts' meeting, the panel observed that Glycopyrrolate injection 0.2 mg/ ml is a scheduled formulation. The panel further observed that the data of Glycopyrrolate 25 mcg respule is accessible in the Pharmatrac database.

The Committee deliberated upon the matter in detail and decided that since the application is for inhalation, the data of Glucopyrrolate respules would be appropriate to calculate the price of formulation under consideration since inhaler and repsules are similar type of formulations.

Accordingly, the committee recommended the retail price of Glycopyrrolate, Formoterol and Budesonide metered-dose inhaler containing Glycopyrrolate IP 9 mcg, Formoterol Fumerate Dilhyderate IP equivalent to Formoterol Fumerate 4.8 mcg, and Budesonide IP 160 mcg, manufactured and marketed by Zydus Healthcare Limited, at Rs 8.63 per MDI excluding GST as detailed below.