NPPA Revises Ceiling Price of FDC Budesonide Plus Formoterol Inhalation

Written By :  Dr. Divya Colin
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2024-06-02 12:30 GMT   |   Update On 2024-06-02 12:30 GMT

New Delhi: Through a recent notice, the National Pharmaceutical Pricing Authority (NPPA), Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals has fixed and revised the ceiling price of the fixed-dose combination (FDC) the pulmonary drug Budesonide 400mcg plus Formoterol 6 mcg Inhalation (Dry powder inhalers) under the drugs (price control) order, 2013.

The ceiling price of the fixed-dose combination (FDC) of the pulmonary drug Budesonide +Formoterol has been revised from Rs 6.62 to Rs 6.95.

Budesonide is in a class of medications called corticosteroids. Budesonide (Uceris) is used to treat ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum).

Formoterol is in a class of medications called long-acting beta-agonists (LABAs). It works by relaxing and opening air passages in the lungs, making it easier to breathe.

Budesonide and formoterol combination is used to help control asthma symptoms and improve lung function. It is used when a patient's asthma has not been controlled sufficiently with other asthma medicines, or when a patient's condition is so severe that more than one medicine is needed every day

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Scheduled formulation means any formulation, included in the First Schedule whether referred to by generic versions or brand name (mainly products covered under the National List of Essential Medicines are Scheduled Formulation). In other words, all medicines covered in the National List of Essential Medicines, which are notified in Schedule 1, by the Govt. are scheduled formulation.

"Ceiling Price" refers to a price fixed by the Government for Scheduled Formulations in accordance with the provisions of the drugs (price control) order, 2013. Ceiling Price is the Maximum Price to the Retailer (excluding Taxes, if any)for the given product.

The notice stated that the National Pharmaceutical Pricing Authority's notification S.O. 938(E) dated 28.02.2024, further revised vide S.O. 1547(E), dated 26.03.2024 relating to fixation of ceiling price, published in the Gazette of India, Extraordinary, the Entry at Sl. No. 25 and 722 respectively of the Table, both in Hindi and English version, be read as follows:

Instead of

Sl. No.

Medicines

Dosage form & Strength

Unit

Ceiling Price

(Rs.)

(1)

(2)

(3)

(4)

(5)

25 of S.O.

938(E) dt

28.02.2024 and

722 of S.O. 1547(E) dt 26.03.2024

Budesonide (A)

+Formoterol (B)

Inhalation (DPI)

400mcg(A) +6 mcg (B)

1 Dose

6.62

Read as

Sl. No.

Medicines

Dosage form & Strength

Unit

Ceiling Price

(Rs.)

(1)

(2)

(3)

(4)

(5)

25 of S.O. 938(E) dt

28.02.2024 and

722 of S.O. 1547(E) dt 26.03.2024

Budesonide (A) +Formoterol (B)

Inhalation (DPI) 400mcg (A) + 6 mcg (B)

1 Dose

6.95

Further the notice added, "All the notes and other contents mentioned in the original order S.O. 938(E) dated 28.02.2024 and S.O. 1547(E), dated 26th March, 2024 shall remain same".

Also Read:NPPA Fixes Retail Prices of 69 Formulations, Details

To view the official notice, click the link below:

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