NPPA panel suggests MRP of Sun Pharma Budesonide 9 mg ER tablet

The recommendation has been made by the Multidisciplinary Committee of Experts at its 30th meeting, held on 19.04.2021. The issue of the retail price fixation of each film-coated extended-release tablet containing Budesonide IP 9 mg manufactured and marketed by Sun Pharma under Para 5 of the DPCO, 2013 was addressed during the meeting.

Budesonide belongs to the corticosteroid category of medicines which acts directly in the lungs to reduce inflammation and swelling of the airways, making breathing easier. Budesonide is a medication that is used to treat and avoid asthma symptoms such as wheezing and shortness of breath.

Further, Budesonide, an inhaled glucocorticoid, seems to be an effective treatment for COVID-19 infection in its early stages, which may be beneficial in global healthcare systems.

The Medical dialogue team had earlier reported that in a recent study, researchers had reported that early administration of inhaled budesonide can reduce the likelihood of needing urgent medical care and reduce time to recovery after early COVID-19. The study findings were published in THE LANCET Respiratory Medicine on April 09, 2021.

In the latest Multidisciplinary Committee meeting, the committee noted the reply received from the Office of the Central Drugs Standard Control Organisation (C DSCO) regarding the retail price fixation under Para 5 of DPCO, 2013 for each film-coated extended-release tablet containing Budesonide IP 9 mg manufactured and marketed by Sun Pharma.

The Committee further noted that the data for Budesonide 3 mg capsule was available. Accordingly, the derived price of Budesonide 9 mg capsule was attempted based on the data of Budesonide 3 mg capsule and applying the recommendation of Pronab Sen Committee and it came to Rs. 41.34 per capsule excluding GST, as detailed below:

Derived price as per recommendation of Pronab Sen Committee P (s) = P*.[1+a.{(s-s")/s*}]

Where. P(s) = Price ceiling of the strength s,

P* = price ceiling for reference strength s* s = strength in terms of API content

s* = reference strength

a= 0.8 for tablet / capsule and 0.7 for injectibles

Price of Budesonide 3 mg capsule as per Para 4 of DPCO 2013 based on the data for the month of July 2020 = Rs. 15.90 per capsule excluding GST

Therefore, the derived price of Budesonide 9 mg capsule is Rs. 15.90 [1+0.8 {(9-3)/3}] = Rs. 41.34 per capsule excluding GST.

The Committee further decided that since the price of a capsule is comparatively costlier than a tablet, Rs.0.10 be deducted from the derived price of Budesonide 9 mg capsule, i.e. Rs. 41.34 per capsule excluding GST so as to arrive at the derived price of Budesonide 9 mg tablet. Accordingly, the derived price of Budesonide 9 mg tablet came to Rs. 41.24 per tablet excluding GST. The Committee also noted that Mls Sun Pharma Laboratories Ltd had claimed the retail price of Budesonide Extended-Release tablet at Rs. 40.17 per tablet excluding GST.

After detailed deliberation, the committee recommended the retail price of Budesonide IP 9 mg for Mls Sun Pharmaceutical Industries Ltd. (manufacturer) and Mls Sun Pharma Laboratories Ltd. (marketer) at Rs. 40.17 per tablet excluding GST as detailed below: