No Relief: DOP rejects review petition by CIPLA challenging NPPA price fixation

New Delhi: Holding that drugmaker, Cipla did not comply with the mandatory implementation of the retail price of the formulation before filing the review petition, the Department of Pharmaceuticals (DoP) has rejected the review petition filed by the drugmaker against the apex drug price regulator, National Pharmaceutical Pricing Authority (NPPA) for fixing the retail price of their formulation “Formoteraol Fumarate Dihydrate 6mcg + Beclomethasone Dipropionate IP 100MCG Inhaler (MDI)”.

Medical Dialogues had earlier reported that NPPA had fixed the retail price of 10 drug formulations under the Drugs Prices Control Order (DPCO), 2013, exclusive of goods and services tax (GST) including Cipla's said formulation at Rs 1.46 for per metered dose.

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Thereafter, Cipla moved an application to review the price of its Inhaler fixed by NPPA. However, it was noted by the DoP that the company has launched the product without complying with the notified price.

As per Para 31 of DPCO, 2013, it is mandatory for the applicant company to implement the ceiling/retail price of the formulation before filing the review petition. Para 31 of DPCO, 2013 states ;

“……pending a decision by the Government on the application submitted under the above paragraph, no manufacturer shall sell a scheduled formulation or a new drug, as the case may be, at a price exceeding the ceiling price or retail price, as the case may be, fixed by the Government of which a review has been applied for.”

Noting the same, the Department held;

"The product Formoterol Fumarate Dihydrate 6mcg + Beclomethasone Dipropionate 100 mcg inhaler (MDI) has been launched by the company without complying with the price notified vide SO 2944(E), dated 14.08.2019. Hence, as per provisions contained in para 31 of DPCO, the review application dated 11.09.2019 stands rejected."

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