Cipla moves against NPPA for price fixation of asthma drugs; DOP junks plea

New Delhi: Mumbai-based drugmaker, Cipla Limited's review petition against the Government regulatory agency, National Pharmaceutical Pricing Authority (NPPA) for fixing the price of its formulations Budesonide Inhalation (DPI) 200mcg/dose, Budesonide (A) + Formoterol (B) Inhalation (DPI) 100mcg (A)/200 mcg(A)/400 mcg(A) + 6 mcg (B) and Tiotropium Inhalation (DPI) 18 mcg/dose, Budesonide Inhalation (MDI) 200mcg/dose and Tiotropium Inhalation (MDI) 9 mcg/dose has recently been disposed of by the Department of Pharmaceuticals (DoP).

The said formulations include Tiotropium which is used to treat lung diseases such as asthma and COPD (bronchitis, emphysema) while Budesonide is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma.

The move comes following a petition filed by the drugmaker earlier this year under paragraph 31 of the Drugs Prices Control Order (DPCO), 2013.

However, DoP rejected the petition observing that the company has not implemented the ceiling prices notification of the formulations before filing the review applications.

Challenging DoP, Cipla had stated that the review applications of Glenmark and Lupin for review of the price of Metered Dose Inhalers (MDI)/Dry Powder Inhalers (DPI) were earlier considered by the authority even though the applicants had not implemented the notified prices.

In response to this, DoP said that the hearings were given to Glenmark and Lupin on the ground that NPPA had not earlier fixed the ceiling price of DPI formulations and wrongfully inserted it in notification giving an impact of Wholesale Price Index.

"Considering the merit of their cases, the Department of Pharmaceuticals had granted hearing to those companies at that time," states DoP.

According to DoP, in the instant matter, NPPA has fixed the ceiling price of DPI formulations, and therefore this case is not similar to the cases referred to by the applicant.

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

Nothing the same, DoP has rejected the review applications filed by Cipla.

Also Read: DOP rejects Review Petition of Lupin against ceiling price fixation for its combinations