The National Pharmaceutical Pricing Authority (NPPA) has exempted Biodeal Pharmaceuticals Limited’s indigenously developed Midazolam Nasal Spray 1.25% w/v from the provisions of the Drugs (Prices Control) Order (DPCO), 2013, for five years, allowing the company to fix its own prices for the formulation during this period.
Midazolam 1.25 per cent w/v nasal spray is a prescription rescue medicine used primarily for the emergency treatment of acute repetitive seizures and seizure clusters, as well as for pre-procedure sedation.
The exemption will be effective retrospectively from May 5, 2025, the date on which the Central Drugs Standard Control Organisation (CDSCO) granted marketing approval for the formulation.
In an order dated November 2, 2026, the NPPA said it considered the recommendations of its Multidisciplinary Committee (MDC) at its 153rd meeting held on October 29 before approving the exemption.
Biodeal claims to be the first company in India to receive permission from the Drugs Controller General of India (DCGI) for Midazolam Nasal Spray. According to the company, the DCGI also confirmed that no other strength of midazolam nasal spray had been approved in India before this grant.
The formulation has been developed indigenously through the company’s in-house research and development programme. Midazolam is an anti-epileptic drug used in the management of seizures. The nasal spray is intended to provide a non-invasive rescue option during seizure emergencies, particularly in situations where intravenous or intramuscular administration may not be immediately possible.
According to Biodeal, the spray has an onset of action within five minutes and uses a metered-dose delivery system to ensure consistency in drug administration. The company says its U-shaped bottle design is intended to deliver the full dose, including the last drop. The formulation comes in a 1.25 per cent w/v strength, with four metered doses in a 1.2 ml bottle.
Under the five-year exemption, Biodeal will be required to inform the NPPA of the Price to Retailer (PTR) and Maximum Retail Price (MRP) fixed by the company by submitting a price list in Form V under the DPCO, 2013.
Three months before the exemption expires, the company will have to comply with the applicable ceiling price or seek retail price approval for the formulation, as required.
The exemption applies only to Midazolam Nasal Spray 1.25% w/v and does not extend to the company’s other products.
Published on November 4, 2026
