Biodeal Told To Justify Novel Delivery Claim In NPPA Exemption Plea For Midazolam Nasal Spray
New Delhi: Biodeal Pharmaceuticals Limited has been directed by the National Pharmaceutical Pricing Authority (NPPA) to submit documents supporting its claim regarding a novel drug delivery system before a final decision can be made on its application for exemption under Para 32(iii) of the Drug Price Control Order (DPCO), 2013, for Midazolam Nasal Spray 1.25% w/v.
The recommendation came during the 69th Multidisciplinary Committee of Experts meeting held on July 3, 2025, where the NPPA reviewed the firm’s exemption request and noted that “the Committee directed that the applicant to provide the documents in support of their claim w.r.t. new delivery system.”
The company applied for price control exemption claiming the formulation was “developed in-house through indigenous research and development involving new drug delivery system.”
However, the committee noted that “Midazolam Nasal Spray 1.25mg/actuation is a scheduled formulation under NLEM 2022 mentioned at Sections 1.3.3 & 5.1.7 of Schedule I of DPCO, 2013.” The current ceiling price effective from April 1, 2025, is Rs. 220.59 per ml, notified via S.O. 1489(E) dated 27.03.2025.
This application was a follow-up to NPPA’s earlier direction in the 68th meeting on June 3, 2025, wherein the firm was asked to present a product demonstration. Complying with the direction, the representative of Biodeal demonstrated the product and submitted the following key points:
“The product has been approved by DCGI as new drug for new indication i.e. Seizure clusters, acute repetitive seizure.”
“The approved pack is for 1.2ml pack size and each actuation contains 1.25mg of the drug. The pack contains 12 actuations, out of which initial 4 sprays needs to be primed in the air, 4 sprays remain in the bottle undelivered. The artwork of the cartoon also claimed delivery of 4 actuation.”
“Applicant submitted that there is no comparator product in the market having same label claim i.e., 4 metered doses.”
“The company has also stated that Midazolam spray 1.25% w/v was never approved by DCG(I) earlier for sales and distribution in the country of India and Midazolam nasal spray is not available in the market.”
The committee, however, disputed this claim, stating:
“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.”
While the company submitted documentation to support its R&D claims, including a DSIR-accredited indigenous research facility, the panel expressed concern about whether the product truly qualifies as a “new delivery system” under Para 32(iii) of DPCO:
“The Committee inquired as how the applicant’s product is a new delivery system as other sprays are also there in the market for this formulation.”
Accordingly, the committee concluded that a decision could not yet be taken and directed the applicant to provide further supporting evidence:
“The Committee directed that the applicant to provide the documents in support of their claim w.r.t. new delivery system.”
