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The Multidisciplinary Committee of Experts (MDC), which advices the National Pharmaceutical Pricing Authority (NPPA) on price related matters, recommended obtaining views from the Standing National Committee on Medicines (SNCM) and Central Drugs Standard Control Organisation (CDSCO) regarding the inclusion of anaesthetic drug midazolam nasal spray in the National List of Essential Medicines (NLEM), 2022 and the approval of the drug by the drug regulator.
The decision to seek views and inputs from the SNCM and the drug regulator follows a situation emerged following an application from Noida-based Biodeal Pharmaceuticals Ltd for exemption of its formulation midozalam nasal spray 1.25 mg from the provisions of the Drugs Prices Control Order (DPCO), 2013, under Para 32 (iii) of the Order.
While the CDSCO informed the Committee that it has issued a new drug permission for the formulation on May 5, 2025, and no other strength of midazolam nasal spray has been approved by the regulator till date, the MDC observed that midazolam nasal spray has been included in the NLEM, 2022, which means that the drug has already been approved.
The views and inputs from the SNCM, which reviews and revises the NLEM, and the CDSCO has been sought regarding the approval and the inclusion of the nasal spray in NLEM, 2022.
The company has earlier submitted the minutes of the Subject Expert Committee of the CDSCO highlighting that while the tablet and parenteral forms of midazolam were previously approved, the intranasal route had not been approved by CDSCO until the permission granted to them, in order to establish the novelty of their drug delivery system.
CDSCO, in August, informed that it has granted new drug permission to the said formulation, and earlier midazolam nasal spray 1.25% w/v was not approved by the office. Later, in response to further queries from the MDC, the drug regulator in a letter on September 11, 2025, reiterated that Biodeal was granted new drug permission for the nasal spray on May 5, and "no other strength of midazolam nasal spray has been approved by this office till date".
The Committee noted that midazolam nasal spray has been included in the NLEM, 2022.
As per NLEM 2022 report, one of the criteria for inclusion of a medicine in the NLEM was ‘The medicine should be approved/licensed in India.’ Also, NPPA has already notified ceiling price of the applied formulation based on the market data wherein 3 companies were appearing manufacturing/marketing the applied formulation.
"... the Committee recommended that views/inputs may be obtained from the Standing National Committee on Medicines (SNCM) and CDSCO regarding the approval and inclusion of midazolam nasal spray in NLEM 2022. The matter may again be placed before the Committee with inputs from SNCM and CDSCO," said the Committee in its meeting held on September 16, 2025.
Under Para 32 of the DPCO, 2013, the companies can apply for exemption from the drug price control measures for five years from the date of commencement of its commercial marketing by the manufacturer.
Para 32(iii) specifies that the price provisions under the DPCO shall not apply to a manufacturer producing a new drug involving a new delivery system developed through indigenous research and development for a period of five years from the date of its market approval in India.
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