Biodeal Pharmaceuticals receives CDSCO approval for Midazolam nasal spray

Biodeal Pharmaceuticals, an Indian Contract Development and Manufacturing Organisation (CDMO), announced a significant regulatory milestone for its indigenously developed Midazolam Nasal Spray 1.25% w/v, which has received New Drug Permission from India’s Central Drugs Standard Control Organisation (CDSCO). This is the first approval of this product and strength in India.

Further recognising its innovation, the National Pharmaceutical Pricing Authority’s (NPPA) Multidisciplinary Committee of Experts has recommended a five-year exemption under Para 32(iii) of the Drug Price Control Order (DPCO), 2013, recognising the product as a genuinely new, indigenously developed drug delivery system rather than a reformulation of an existing medicine.

Midazolam is an established medicine used in the rapid management of emergency situations, primarily acute seizures. Traditionally administered through injection, its nasal delivery offers a new well established delivery system innovated in the US, through the nasal route, particularly in emergency and out-of-hospital settings where intravenous access may not be readily available.

The product has been developed primarily at Biodeal’s Department of Scientific and Industrial Research (DSIR)-accredited R&D facility. The development involved formulation science, device engineering, dosing precision and manufacturing expertise, reflecting the company’s growing focus on differentiated pharmaceutical products and specialised drug delivery.

Commenting on the development, Anurag Kumar, Chairman & Managing Director, Biodeal Pharmaceuticals said, “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. Our teams have worked extensively on the formulation, device engineering and scientific development behind Midazolam Nasal Spray. The recognition by India’s drug regulatory and pricing authorities validates the investment we have made in building indigenous R&D capabilities over the years.

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. This milestone reinforces our belief that Indian CDMOs can play a much larger role in that transition.”

The development marks an important step in Biodeal’s broader evolution towards becoming a specialised, innovation-led CDMO. Building on more than two decades of expertise in nasal drug delivery, the company continues to strengthen its capabilities across complex formulations and specialised pharmaceutical manufacturing, with a focus on serving evolving healthcare requirements in India and international markets.