Indian Regulators Scrutinize Biodeal's Midazolam Nasal Spray Pricing Exemption Amid NLEM Inclusion Controversy
核心洞察
The Multidisciplinary Committee of Experts has sought clarification from regulatory bodies regarding the inclusion of midazolam nasal spray in India's National List of Essential Medicines 2022, following Biodeal Pharmaceuticals' application for price control exemption.
CDSCO granted new drug permission to Biodeal for midazolam nasal spray 1.25 mg on May 5, 2025, despite the formulation already being listed in NLEM 2022 with an established ceiling price of Rs. 220.59 per ml.
The committee has questioned Biodeal's claim of developing a "new delivery system" for seizure clusters (搜索), directing the company to provide additional documentation to justify its exemption request under DPCO provisions.
The National Pharmaceutical Pricing Authority (搜索)'s Multidisciplinary Committee of Experts has initiated a regulatory review regarding the inclusion of midazolam nasal spray in India's National List of Essential Medicines (NLEM) 2022, following a pricing exemption application from Noida-based Biodeal Pharmaceuticals Ltd (搜索).
The controversy emerged when Biodeal applied for exemption from the Drugs Prices Control Order (DPCO) 2013 under Para 32(iii), claiming its midazolam nasal spray 1.25 mg represents a novel delivery system developed through indigenous research and development. However, the committee discovered that midazolam nasal spray is already included in NLEM 2022, creating regulatory confusion about the drug's approval status.
Regulatory Timeline Discrepancy
The Central Drugs Standard Control Organisation (搜索) (CDSCO) informed the committee that it issued new drug permission for the formulation on May 5, 2025, stating that "no other strength of midazolam nasal spray has been approved by this office till date." This timeline conflicts with the drug's inclusion in NLEM 2022, as one of the criteria for NLEM inclusion requires that "the medicine should be approved/licensed in India."
The committee noted that NPPA has already notified a ceiling price of Rs. 220.59 per ml for the formulation, effective from April 1, 2025, based on market data showing three companies manufacturing or marketing the applied formulation.
Product Claims Under Scrutiny
During the 69th Multidisciplinary Committee meeting on July 3, 2025, Biodeal's representative demonstrated the product and submitted several key claims. The company stated that "the product has been approved by DCGI as new drug for new indication i.e. Seizure clusters (搜索), acute repetitive seizure (搜索)." The approved pack contains 1.2ml with each actuation delivering 1.25mg of the drug, providing 12 actuations total, though initial 4 sprays require priming and 4 sprays remain undelivered.
Biodeal also claimed that "there is no comparator product in the market having same label claim i.e., 4 metered doses" and that "Midazolam spray 1.25% w/v was never approved by DCG(I) earlier for sales and distribution in the country of India."
Committee Challenges Claims
The committee disputed these assertions, stating that "Midazolam spray 1.25% w/v is an essential drug under NLEM 2022 and hence has been approved by DCGI. Therefore, the contention that Midazolam spray 1.25% w/v was never approved by DCG(I) earlier for sales and distribution seems incorrect."
The panel expressed particular concern about the novelty claims, questioning "how the applicant's product is a new delivery system as other sprays are also there in the market for this formulation." The committee noted that midazolam nasal spray is listed under Sections 1.3.3 & 5.1.7 of Schedule I of DPCO 2013.
Regulatory Clarification Sought
Unable to resolve the discrepancies, the committee recommended obtaining views from both the Standing National Committee on Medicines (搜索) (SNCM), which reviews and revises the NLEM, and CDSCO regarding the approval and inclusion of midazolam nasal spray in NLEM 2022. The committee stated that "the matter may again be placed before the Committee with inputs from SNCM and CDSCO."
DPCO Exemption Framework
Under Para 32(iii) of DPCO 2013, manufacturers can seek exemption from price control provisions for new drugs involving novel delivery systems developed through indigenous research and development for five years from market approval. The committee has directed Biodeal to "provide the documents in support of their claim w.r.t. new delivery system" before making a final determination on the exemption request.