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The Multi-Disciplinary Committee (MDC) of Experts, which advices the National Pharmaceutical Pricing Authority (NPPA) on various drug pricing related matters, has recommended price exemption for Biodeal Pharmaceuticals' antiepileptic drug Midazolam nasal spray 1.25 mg for five years.
The recommendation is on a request from the company seeking exemption of the formulation from the provisions under Para 32(iii) of Drugs Prices Control Order (DPCO), 2013 in respect of its formulation Midazolam nasal spray 1.25 mg, claiming that it is a new drug involving a new drug delivery system developed through indigenous research and development (R&D).
Midazolam nasal spray has already been included in the National List of Essential Medicines (NLEM), 2022.
The request and its merits were discussed by the Committee in several meetings from June, 2025. The Committee also sought inputs from the Standing National Committee on Medicines (SNCM) and the drug regulator regarding the inclusion of the drug in NLEM and its approval status.
The company was asked to furnish documentary evidence substantiating its claim of indigenous research & development in the development of the product. The company, in August, 2026, furnished a detailed justification of its indigenous R&D programme, including its scientific and quality-by-design approach, comparison with the reference product, scientific justification regarding the drug delivery system and pharmaceutical development data.
The documents included data relating to the container closure system, microbiological attributes, compatibility, device robustness, dosing orientation, profiling of sprays near container exhaustion, final trial batch results, volume remaining undelivered and data relating to content per actuation.
The Committee also received confirmation from the Central Drugs Standard Control Organisation (CDSCO), that it has granted new drug permission to the particular strength of the formulation in May, 2025 and the particular strength was not approved by the authority earlier.
The Committee further noted that the company's claim of indigenous development was supported by its Department of Scientific and Industrial Research (DSIR)-accredited in-house R&D facility and the detailed pharmaceutical development documentation subsequently furnished to NPPA.
"In view of the above, and particularly taking into consideration the regulatory opinion and confirmation furnished by the CDSCO regarding the New Drug Permission and the first approval of the Midazolam nasal spray, the Committee considered that the applicant's formulation meets the regulatory basis for consideration under Para 32(iii) of DPCO, 2013," said the Committee in its latest meeting.
In line with this, the Committee recommended grant of exemption to the company for the particular strength of the formulation for a period of five years from the date of its market approval in India under Para 32(iii) of DPCO, 2013.
Under Para 32(iii) of the DPCO, 2013, the provisions of the price control order are not applicable 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, provided that the provisions of the paragraph shall apply only when a document showing approval of such new drugs from the central drug regulator is produced before the government.
Noida-based Biodeal Pharmaceuticals, which is into developing and manufacturing pharmaceuticals, nutraceuticals, cosmeceuticals and herbaceuticals as a global contract development and manufacturing organisation (CDMO), specialises in intranasal drug delivery with a range of formats including metered dose, aqueous, herbal, saline, antihistamine, corticosteroid, and nasal sprays.
The company claims that it is the first in India to receive CDSCO's new drug permission for Midazolam nasal spray 1.25% w/v - indigenously developed through its own R&D programme. It claims that the drug, with novel intranasal delivery system ensures rapid seizure control with onset of action within five minutes, accurate metered dose ensuring therapeutic consistency. No injection is required for the drug delivery, with the U-shaped bottle design delivering full dose of the drug to the last drop.
"Seizure emergencies frequently occur in settings where intravenous or intramuscular administration is not immediately possible. A DCGI-approved, needle-free nasal spray with a 5-minute onset changes the options available in those critical moments," said the company in its social media page earlier.
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