A seizure can strike anywhere — at home, on a bus, in a classroom — and in those minutes, an injection needs a vein, a hospital and a trained hand. Biodeal Pharmaceuticals, a Noida company that has spent two decades mastering the science of getting medicine through the nose, has built an answer that fits in a pocket: a midazolam nasal spray that India’s drug regulator has now approved for the first time, at a strength no Indian company had won permission for before.
The spray is Midazolam Nasal Spray 1.25% w/v, and the Central Drugs Standard Control Organisation (CDSCO) granted it New Drug Permission on 5 May 2025 — the first approval of this product and strength in India. The country’s drug pricing authority has since recognised it as a genuinely new, indigenously developed drug delivery system, exempting it from price control for five years. For families living with epilepsy, that approval turns a hospital procedure into something a caregiver can carry in a bag.
A rescue medicine, reimagined for the nose
Midazolam is an established medicine for the rapid management of emergency situations, used primarily for acute seizures — acute repetitive seizures and seizure clusters — as well as for pre-procedure sedation. Traditionally it is given by injection, which means finding a vein in the middle of a crisis. Delivered through the nose, the same medicine can reach a patient quickly in out-of-hospital settings where intravenous access may not be readily available.
Building that spray took more than filling a bottle. The product was developed at Biodeal’s Department of Scientific and Industrial Research (DSIR)-accredited R&D facility, and the work spanned formulation science, device engineering and dosing precision — the spray pattern, the plume geometry and the exact metered dose in every puff. The company says the development reflects its growing focus on differentiated pharmaceutical products and specialised drug delivery, and the regulators agreed: the Drugs Controller General of India confirmed that no other strength of midazolam nasal spray had been approved in India before this grant.
Two decades of nasal-spray craft
Biodeal Pharmaceuticals was founded in 2005 by Anurag Kumar, and it has grown into what the company describes as India’s leading nasal spray contract development and manufacturing organisation (CDMO). Its corporate office sits in Noida, with two manufacturing factories in Himachal Pradesh at Nalagarh and Paonta Sahib, and the numbers behind the operation are substantial: the company says it turns out 30 million nasal spray units a year, alongside 3 billion tablets and 650 million capsules, serving more than 1,000 clients across 80-plus countries with over 1,000 formulations and more than 100 global regulatory registrations.
The company’s nasal-spray platform was commissioned in 2011, and its manufacturing meets WHO-GMP, PIC/S and USFDA-compliant standards. It is trusted to manufacture Allegra Nasal for Sanofi, and the company says it secured three approvals from the Drugs Controller General of India in 2024–25 alone. That depth of inhalation and nasal-delivery expertise — aqueous, suspension and powder platforms, validated for global filings — is what made an indigenous midazolam spray possible.
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Why the regulators called it genuinely new
The second half of the story played out in November 2026, when the National Pharmaceutical Pricing Authority (NPPA) exempted the spray from the Drugs (Prices Control) Order for five years, effective from the date of its marketing approval. The authority’s Multidisciplinary Committee of Experts considered the case at its 153rd meeting on 29 October 2026 and recommended the exemption under Para 32(iii) of the order — the provision reserved for a new drug involving a new delivery system developed through indigenous research and development, rather than a reformulation of an existing medicine.
“This is a particularly meaningful milestone for Biodeal because it represents recognition of our ability to develop and innovate, beyond our established strengths in pharmaceutical manufacturing,” said Anurag Kumar, the company’s Chairman and Managing Director. “India has established a strong position in global pharmaceutical manufacturing. The next phase of growth will increasingly depend on our ability to develop differentiated products, build specialised delivery systems and create intellectual and technical capabilities within the country.”
From a factory floor in Himachal Pradesh to a spray that a parent can keep at home for the minutes that matter most, Biodeal’s midazolam nasal spray is a quiet landmark: an Indian CDMO stepping beyond manufacturing for others and into inventing for India — and proving that the country’s pharmaceutical strength can now reach all the way from the production line to the patient’s pocket.
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