Biodeal Pharmaceuticals, an Indian contract development and manufacturing organisation (CDMO), has received New Drug Permission from the Central Drugs Standard Control Organisation (CDSCO) for its indigenously developed midazolam nasal spray 1.25percent w/v. This marks the first approval of the product at this strength in India.

In a further recognition of the product's 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. The recommendation recognises 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 for the rapid management of medical emergencies, particularly acute seizures. Traditionally administered through injections, the nasal formulation offers an alternative route of administration. It is designed to facilitate drug delivery in emergency and out-of-hospital settings, particularly when intravenous access is not readily available.

The product has been developed primarily at Biodeal Pharmaceuticals' Department of Scientific and Industrial Research (DSIR)-accredited research and development facility. Its development involved formulation science, device engineering, dosing precision and manufacturing expertise. The achievement reflects the company's increasing focus on developing differentiated pharmaceutical products and specialised drug-delivery systems.

Commenting on the development, Anurag Kumar, Chairman and Managing Director of Biodeal Pharmaceuticals, said the regulatory milestone demonstrated the company's capabilities in pharmaceutical research and innovation beyond its established manufacturing operations.

Kumar further noted that India's next phase of pharmaceutical industry growth would increasingly depend on developing differentiated products, specialised drug-delivery systems and domestic intellectual and technical capabilities. He emphasised that Indian CDMOs could play a greater role in this transition by expanding their capabilities beyond conventional pharmaceutical manufacturing.