Sun Pharma plea against NPPA price fixation for Acetazolamide IP 500 mg rejected

The review application was filed by the drug maker on September 23, 2022 against the price fixed for its glaucoma drug formulation by the NPPA through an order issued on August 24, 2022.

Sun Pharma submitted that NPPA, while fixing the retail price of the formulation based on the ceiling price of acetazolamide 250 mg capsule at Rs. 4.53 per capsule fixed on March 25, 2021 instead of the ceiling price of Rs. 5.02 per capsule, which was filled in March 30, 2022. The Authority should have considered the order in March, 2022 for determining the retail price of the product at the said strength.

The retail price recommended by the Multi Disciplinary Committee (MDC) of Experts based on Pronab Sen Committee Report considering the ceiling price of acetazolamide 250 mg capsule fixed at Rs. 4.53 per capsule in March, 2021, was Rs. 8.15 per capsule, while it should have been Rs. 9.04 per capsule based on Rs. 5.02 per capsule ceiling price fixed on March, 2022.

The pharma firm argued; "By not considering the ceiling price already notified in March 2022 by NPPA, well before the date of the company application, the company is at a loss of Rs. 0.89 per capsule, which cannot be ignored."

It further alleged that the Authority, during its meeting, did not accept the drug maker's representation raising concern over the same.

Sun Pharma added that the data available for the month ending immediately before six months of receipt of application is considered for fixing the price for the new drugs already available in the market. However, the company’s retail price application for the new drug falls under another provision of the DPCO, 2013, which is for the new drug not available in the domestic market, since it is the first company to launch the product acetazolamide IP 500 mg capsule in the country.

Based on these arguments, the company requested the DoP to issue a directive to NPPA to revise or recalculate the retail price of the formulation.

On the other hand, NPPA clarified to the DoP that Sun Pharma filed the application on June 7, 2022 for retail price fixation of the extended release capsule and it was placed before the MDC since the market-based data was not available. The MDC in its 43rd meeting on July 4, 2022, recommended the retail price at Rs 8.15 per capsule excluding Goods and Services Tax (GST) by applying the formula as specified in the Pranab Sen Committee Report on the ceiling price of Acetazolamide 250 mg capsule, fixed on March 25, 2021, which is six months prior to the date of receipt of the application.

The Authority informed the Department;

“MDC adopted the same approach while recommending the retail price of other formulations. For instance, while recommending the retail price of “Human Coagulation Factor VIII 1000IU’ for Baxalta Bioscience in the same meeting, the Committee considered the ceiling price of ‘Human Coagulation factor VIII 250IU’ as applicable six month prior to the date of receipt of application.”

NPPA added that the use of formula of Pronab Sen Committee is one of the means/methods considered for pricing by MDC for arriving at a price of a new drug, the data of which was available in the market for the strength other than the applied strength of the new drug.

Subsequently, the Authority argued that in view of these arguments, the review application is not tenable and may be treated as closed.

Examining the issue, DoP observed that;

"The data of formulation available in market of the same drug but in a different strength (i.e. acetazolamide 250 mg capsule) was used. The same is used for reference pricing of the said new drug by MDC without altering the period of data to be used for pricing of new drug as contained in DPCO 2013, that is the data of six months preceding the month of receipt of application."

Considering both the arguments, the review authority under the DoP noted that the NPPA’s arguments on the fixation of the retail price based on the market data of the same drug but in a different strength, without altering the period of data to be used for pricing of new drug. It also noted that the MDC adopted the same approach while recommending the retail price of other formulations.

The review authority upheld the NPPA’s decision on fixing the retail price at Rs 8.15 per capsule for acetazolamide IP 500 mg as an extended release capsule, and rejected the review application. It held;

"The action of NPPA fixing the Retail prices of the formulation Acetazolamide IP 500 mg (as an Extended Release) Capsule of M/S Sun Pharma Laboratories. Limited vide S.C. No. 4002(E) dated 24.08.2022 is upheld and the review application under consideration is, accordingly, rejected."

To view the original order, click on the link below: