The Multidisciplinary Committee of Experts (MDC), which advises the National Pharmaceutical Pricing Authority (NPPA) on pricing issues, has sought official clarification from the Standing National Committee on Medicines (SNCM) and the Central Drugs Standard Control Organisation (CDSCO) regarding the inclusion of midazolam nasal spray in the National List of Essential Medicines (NLEM), 2022.
This move comes after Noida-based Biodeal Pharmaceuticals Ltd applied for exemption of its formulation — midazolam nasal spray 1.25 mg — from price control under Para 32(iii) of the Drugs Prices Control Order (DPCO), 2013. The company argued that its product represents a new drug delivery system developed through indigenous R&D, making it eligible for a five-year exemption from price regulation.
However, the situation became complex when CDSCO confirmed that it had granted new drug approval to Biodeal for the formulation on May 5, 2025, while also clarifying that no other strength of midazolam nasal spray had been approved so far. The MDC, on the other hand, observed that the formulation was already listed in NLEM 2022, suggesting that it should have been an already approved drug.
To resolve this discrepancy, the Committee has asked both SNCM—which oversees the revision of NLEM—and CDSCO to provide their views on the approval status and the inclusion process of the drug in the 2022 list.
According to records submitted by Biodeal, the Subject Expert Committee under CDSCO had earlier noted that while midazolam tablets and injection forms were previously approved, the intranasal route had not been authorized before Biodeal’s application—indicating that their formulation was indeed novel.
In August 2025, CDSCO reiterated its position that Biodeal’s midazolam nasal spray 1.25% w/v was the only approved formulation to date. A follow-up communication on September 11, 2025, confirmed this once again.
The MDC emphasized that as per NLEM 2022 criteria, any drug included in the list must already be approved and licensed in India. Moreover, NPPA has already fixed a ceiling price for midazolam nasal spray based on market data showing at least three companies manufacturing or marketing the formulation.
In its September 16, 2025, meeting, the Committee concluded that further clarity from both SNCM and CDSCO is essential before proceeding. Once their inputs are received, the matter will be reviewed again by the MDC.
Under Para 32(iii) of DPCO 2013, manufacturers introducing a new drug with a novel delivery system developed through indigenous research can seek exemption from price control for five years from the start of commercial marketing.
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