The National Pharmaceutical Pricing Authority (NPPA) has approved separate pricing for Cipla Ltd.’s “Synchrobreathe Inhaler Device” when used with specific Budesonide and Formoterol formulations. This decision follows recommendations from a Multidisciplinary Committee of Experts and aims to promote incremental innovation in drug delivery.
Budesonide (100mcg and 200mcg) and Formoterol 6mcg + Budesonide 100mcg are scheduled formulations under the Drugs (Prices Control) Order, 2013 (DPCO 2013), and their ceiling prices are already fixed. Cipla Ltd. applied to the NPPA for separate pricing of their “Synchrobreathe Inhaler Device” when used with these formulations.
Expert Committee Recommendation and NPPA Approval
The Multidisciplinary Committee of Experts, in its 62nd meeting on September 25, 2024, recommended allowing a separate price for the device, set at 20% of the prevailing ceiling price of the respective formulations. This recommendation was based on the premise of promoting incremental innovation, supported by published literature.
The NPPA, in its 128th meeting on December 12, 2024, accepted the committee’s recommendation and approved the separate pricing under Paragraph 11(3) of DPCO 2013.
New Pricing for Synchrobreathe Inhaler Device
The following table outlines the approved prices (excluding GST) for the Synchrobreathe Inhaler Device when used with the specified formulations:
| S. No. | Formulation | Unit | Separate Ceiling Price of Synchrobreathe Inhaler (Rs.) |
|---|---|---|---|
| 1 | Synchrobreathe Inhaler for Budesonide Inhalation (MDI) 100 mcg/dose for 200 doses | 1 inhaler | 56.40 |
| 2 | Synchrobreathe Inhaler for Budesonide Inhalation (MDI) 200 mcg/dose for 200 doses | 1 inhaler | 41.20 |
| 3 | Synchrobreathe Inhaler for Budesonide 100mcg + Formoterol 6mcg for 120 doses | 1 inhaler | 50.88 |
These prices apply specifically to Cipla Ltd.’s Synchrobreathe Inhaler Device. Cipla can add the device’s price to the existing ceiling price of the corresponding formulation. GST can be added only if it is actually paid or payable to the government.
Retailers and dealers must display the price list prominently.
