NPPA fixes retail price of Budesonide, Dexamethasone, Details

New Delhi: Through a recent notice, the National Pharmaceutical Pricing Authority (NPPA), Ministry of Chemicals and Fertilizers, Government of India has fixed the retail price of  two pivotal drug in covid 19 therapy, Sun Pharma's Budesonide tablet and Cadila's Dexamethasone tablet under the Drugs (Prices Control) Order, 2013.

This came followed by the recommendation made by the National Pharmaceutical Pricing Authority (NPPA) Committee, which suggested the retail price of both Sun Pharma's Budesonide and Cadila's Dexamethasone tablet.

The Medical Dialogues Team had earlier reported that in the latest Multidisciplinary Committee meeting, after detailed deliberation, the NPPA panel had suggested the retail price of Budesonide IP 9 mg tablet for Sun Pharmaceutical Industries Ltd. (manufacturer and marketer) at Rs. 40.17 per tablet excluding GST and the retail price of each uncoated tablet containing Dexamethasone IP 6 mg for Cadila Healthcare Ltd (manufacturer) and Zydus Healthcare Ltd (marketers) at Rs. 3.36 per tablet excluding GST.

Budesonide 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.

Dexamethasone is a type of corticosteroid medication that has anti-inflammatory and immunosuppressant effects and is widely used in Rheumatic disorders, acute respiratory disorders, skin-related disorders, etc.

Dexamethasone is also recommended by the National Health Service in the UK and the National Institutes of Health (NIH) in the US for patients who are suffering from severe COVID-19 and need either mechanical ventilation or supplemental oxygen (without ventilation). Dexamethasone is otherwise not suggested.

As per the WHO recommendation, corticosteroids such as dexamethasone be given orally or intravenously for the treatment of patients with severe and critical COVID-19. Corticosteroids should not be used in the treatment of patients with non-severe COVID-19 unless the patient is already taking them for another condition, according to the WHO.

Now in the recently issued notice, in exercise of the powers conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated the 30th May, 2013 and S. O. 701(E) dated 10th March, 2016 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA), hereby fixes, the price as specified in column (6) of the table herein below as the retail price, exclusive of goods and services tax, if any, in relation to the formulation specified in the corresponding entry in column (2) of the said Table with the strength, unit and name of manufacturer & marketing company, as specified in the corresponding entries in columns (3), (4) and (5) thereof;

The notification further added;

(a) The manufacturer of above mentioned formulations i.e. "new drug" under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (6) of the table hereinabove.

(b) The manufacturer may add goods and services tax only if they have paid actually or it is payable to the Government on the retail price mentioned in column (6) of the above said table.

(c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (6) of the above table as per provisions contained in paragraph 11 of the DPCO, 2013. The manufacturer shall issue a price list in Form–V from date of Notification as per paragraph 24 of the DPCO, 2013 to NPPA through IPDMS and submit a copy to State Drug Controller and dealers.

(d) As per para 24(4) of DPCO 2013, every retailer and dealer shall display price list and the supplementary price list, if any, as furnished by the manufacturer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same.

(e) The above mentioned retail price is applicable only to the individual manufacturer / marketer as mentioned above i.e. who have applied for the same by submitting Form-I for price fixation / revision as stipulated under DPCO, 2013 and subject to fulfilment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturer/marketing companies.

(f) In case the retail price of any of the aforesaid formulations is not complied with, as per instant price notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955.

(g) Consequent to the issue of ceiling price of such formulation as specified in column (2) of the above table in this notification, the price order(s) fixing ceiling or retail price, if any, issued prior to the above said date of notification, stand(s) superseded.