Price Cap Exemption Pending: NPPA Refers Biodeal Pharma's Midazolam Nasal Spray to CDSCO, SNCM for Review

The recommendation came during the 71st meeting of the Multidisciplinary Committee of Experts held on 16.09.2025, where the committee reviewed the application by Biodeal Pharmaceuticals Limited for exemption from the provisions of Drug Price Control Order 2013 under Para 32 (iii) for the formulation “Midazolam nasal spray 1.25 mg”.

The provisions of Drug Price Control Order 2013 under Para 32 (iii) states,

"The provisions of this order shall not apply to, if 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."

The Committee noted that the application submitted by Biodeal Pharmaceuticals Limited seeking exemption from the provisions of the DPCO, 2013 under Para 32(iii) for their product Midazolam Nasal Spray 1.25% w/v had been earlier deliberated during the 68th and 69th MDC meetings held on 03.06.2025 and 03.07.2025 respectively.

During the 69th meeting, the Committee directed the applicant to submit supporting documents to substantiate their claim regarding the novel drug delivery system developed through indigenous R&D.

In response, the company submitted, on 22.07.2025, the minutes of the SEC (Neurology & Psychiatry) meeting held on 18.04.2024. The company highlighted that while tablet and parenteral forms of Midazolam were previously approved, the intranasal route had not been approved by CDSCO until the permission granted to them, thereby establishing the novelty of their drug delivery system.

Subsequently, inputs were sought from the Office of CDSCO vide letter dated 28.07.2025. In response, the O/o CDSCO, through communication dated 01.08.2025, stated that “ Biodeal Pharmaceuticals Limited was granted New Drug permission by the Central Drugs Standard Control Organization (CDSCO) for the aforesaid formulation on 05-May-2025 and the earlier Midazolam Nasal spray 1.25% w/v was not approved by this office”.

The Committee in its 70th meeting held on 05.08.2025 deliberated on the same and directed to seek further clarification from the CDSCO and also directed that the applicant may be asked to appear before the Committee in the next meeting along with relevant product development documentation with respect to their claim under Para 32(iii).

During the meeting, the applicant made a presentation explaining therein the details of the indigenous development of the nasal spray formulation and its novel delivery mechanism. Also, the Committee deliberated upon the additional inputs provided by the O/o DCGI, vide letter dated 11.09.2025, reiterating therein that “Biodeal Pharmaceuticals Limited was granted New Drug Permission for the drug product - Midazolam Nasal Spray 1.25% w/v strength only—on 05.05.2025 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 National List of Essential Medicines (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 the ceiling price of the applied formulation based on the market data wherein 3 companies were appearing manufacturing/marketing the applied formulation.

In view of the above, 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.