LUPIN LIMITED Vs. UNION OF INDIA

JUDGEMENT

(1.) The petitioner has filed the present petition, inter alia, impugning the notifications SO No. 1039 (E) dated April 01, 2017; SO No. 2058 ( E ) dated June 30, 2017 and; SO no. 1461 (E) dated April 02, 2018, issued by respondent no. 3 (National Pharmaceutical Pricing Authority hereafter "NPPA"), to the extent that they fix the ceiling prices of the formulations Budesonide (A) + Formoterol (B) and Tiotropium in Dry Powdered Inhalation (hereafter "DPI") dosage forms. The said notifications are hereafter referred to as the impugned notifications.

(2.) The controversy involved in the present petition relates to the manner in which the prices have been fixed for the subject formulations in DPI dosage form. There is no dispute that the subject formulations are included in Schedule 1 of the Drugs (Prices Control) Order, 2013 (hereafter "the DPCO") and, therefore, are scheduled formulations within the meaning of Clause (zb) of Section 2(1) of the DPCO. Thus, concededly, NPPA is empowered to fix the ceiling prices for the subject formulations under the DPCO. The petitioner claims that that the ceiling process of the DPI dosage forms, as notified under the impugned notifications, have not been computed in accordance with the provisions of the DPCO.

(3.) The petitioner is a pharmaceutical company and is, inter alia, engaged in the manufacture and sale of the subject formulations, namely, Budesonide (A) + Formoterol (B) Inhalation in the Dry Powdered Inhalation (DPI) Dosage Form and Tiotropium Inhalation in the Dry Powered Inhalation (DPI) Dosage form. The subject formulations are life saving drugs and are used for treating Chronic Obstructive Pulmonary Disease (COPD) and Asthma. The subject formulations are manufactured in four dosage forms. The dosage forms relevant to the controversy in this petition are Metered Dosage Inhalation (MDI) and Dry Powder Inhalation (DPI).