NPPA panel rejects Cipla application for special pricing of Ciphaler Inhaler Device

This came during the 35th meeting of the "Multidisciplinary Committee of Experts", held on 18.08.2021, where the drug maker, Cipla's application for a separate price/special price for the "Ciphaler Inhaler Device" was thoroughly discussed.

At the authority meeting, the panel noted that the document provided by Cipla Ltd in connection with the application for a different price/special price for the "Ciphaler Inhaler Device" falls under the provisions of DPCO 2013 para 11 (3).

According to para 11 (3) of DPCO 2013, in the case of injections or inhalation or any other medicine for which dosage form or strength or both are not specified in the Schedule-I of the Drugs (Prices Control) Order, 2013, the government may fix and notify a separate ceiling price or retail price for such formulations with a specified therapeutic rationale, considering the type of packaging or pack size or dosage compliance or content in the pack, namely liquid, gaseous or any other form, in the unit dosage as the case may be, conforming to Indian Pharmacopeia or other standards as specified in the Drugs and Cosmetics Act, 1940 (23 of 1940) and the rules made thereunder for the same formulation.

An inhaler is a medical device that uses a person's breathing to deliver drugs into their lungs. This permits medicines to be given to and absorbed in the lungs, allowing for more targeted medical therapy in this area of the body and a reduction in the negative effects of oral medications.

In respect to the Ciphaler Inhaler Device, the committee noted that the Ciphaler Inhaler Device presentation provided by Cipla specified the technical and other details of the product "Ciphaler Inhaler Device."

In addition, the Committee further observed that the claim of Cipla regarding the efficacy of the product is yet to be validated and the report as submitted by Cipla is not based on the product of Cipla.

Accordingly, after detailed deliberation, the Committee decided to reject the application of Cipla for grant of a separate price/special price for "Ciphaler Inhaler Device" under the provisions of Para 11 (3) of DPCO 2013.