NPPA Grants Biodeal's Midazolam Nasal Spray 5 Year Price Control Exemption

New Delhi: The National Pharmaceutical Pricing Authority (NPPA), under the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, has exempted Biodeal Pharmaceuticals Limited's Midazolam Nasal Spray 1.25 mg from the provisions of the Drugs (Prices Control) Order (DPCO),2013, for five years with effect from May 5, 2025 the date of its marketing approval by the Central Drugs Standard Control Organisation (CDSCO).

The exemption, notified, dated November 2, 2026, requires the company to report its Price to Retailer (PTR) and Maximum Retail Price (MRP) to NPPA through a Form V price list and follow the applicable ceiling price or seek retail price approval three months before the exemption expires.

Setting out its institutional background, the order states that NPPA was established through Government of India Resolution No. 33/7/97-PI.I, dated August 29, 1997, issued by the Ministry of Chemicals and Fertilizers. Its responsibilities include fixing prices and notifying changes in the prices of bulk drugs and formulations, monitoring the prices of non-scheduled drugs and formulations, and overseeing the implementation of DPCO provisions.

The Ministry, through S.O. 1394(E), dated May 30, 2013, issued in exercise of the powers conferred by Sections 3 and 5 of the Essential Commodities Act, 1955, delegated powers relating to specified paragraphs of DPCO, 2013, including paragraph 32, to NPPA for exercise on behalf of the Central Government.

Biodeal Pharmaceuticals Limited subsequently submitted an application seeking exemption under paragraph 32(iii) of DPCO, 2013, for Midazolam Nasal Spray 1.25 mg. According to the order, the formulation had been duly approved as a new drug by CDSCO under the Drugs and Cosmetics Act, 1940, and the rules framed thereunder.

NPPA considered the recommendations of the Multidisciplinary Committee (MDC) in detail at its 153rd meeting under DPCO, 2013, held on October 29, 2026. The authority approved that Biodeal’s formulation qualified for non-application of DPCO, 2013, provisions under paragraph 32(iii) for five years from the date of its market approval in India.

Accordingly, exercising the powers delegated under paragraph 32 of DPCO, 2013, through S.O. 1394(E), dated May 30, 2013, NPPA formally granted the company the exemption for the formulation for five years with effect from May 5, 2025, when CDSCO granted marketing approval.

The notice stated,

"In exercise of the powers delegated under para 32 of the Drugs (Prices Control) Order, 2013 vide S.O.1394(E) dated 30th May, 2013 issued by the Government of India in the Ministry of Chemicals and Fertilizers, M/s. Biodeal Pharmaceuticals Limited is exempted from the provisions of DPCO, 2013 under para 32(iii) of the said order in respect of the formulation “Midazolam Nasal Spray 1.25 mg” for a period of five years with effect from 05.05.2025, which is the date of grant of marketing approval by the Central Drugs Standard Control Organization."

As a condition of the exemption, Biodeal Pharmaceuticals Limited must inform NPPA of the PTR and MRP fixed by the company for the formulation by issuing a price list in Form V under DPCO, 2013.

The company must also follow the ceiling price or seek retail price approval, as applicable, for Midazolam Nasal Spray 1.25 mg three months before the expiry of the exemption granted under paragraph 32(iii) of DPCO, 2013.

To view the official notice, click the link below:

https://medicaldialogues.in/pdf_upload/2026/11/05/277621-482300.pdf