DoP asks NPPA to reconsider retail price fixation on Abbotts nutritional supplement Nervup Forte Plus

New Delhi, October 31, 2022:

 

The Department of Pharmaceuticals (DoP) has sent the review application from Abbott Healthcare Pvt Ltd related to the retail price fixation of its nutritional supplement Nervup Forte Plus, back to the National Pharmaceutical Pricing Authority (NPPA) for reconsideration.

NPPA, through a notification on August 19, 2021, fixed the retail price of Nervup Forte Plus - Alpha Lipoic Acid USP 100 mg + vitamin D3 IP 1000 IU + pyridoxine hydrochloride IP 3 mg + methylcobalamin 1500 mcg + folic acid IP 1.5 mg tablet, for Abbott at Rs. 10.97 per tablet excluding Goods and Services Tax (GST).

The company raised its objection against the price fixation through a review application on September 17, 2021 through a review application. The DoP took up the matter and examined the argument from both the sides, before arriving at a decision to remand the review petition to the NPPA.

Abbott, in its review application said that the NPPA fixed the retail price for the formulation based on recommendations of the Multi Disciplinary Committee (MDC) of Experts, using the average of Form V price data submission of two companies to derive the retail price of Rs. 10.97 excluding GST.

However, the company argued that the data from market data firm Pharmatrac for the month of January 2021, showcases 15 brands with the same composition contributing to more than 1 per cent market share. Thus, the retail price derived from the averaging the same would be approximately around Rs. 14.24 excluding GST, per tablet.

NPPA, on the other hand, initially argued that it received the company’s application on June 22, 2021 and data of November, 2020 was looked into. The date of the said formulation was not available in Pharmatrac database for the month and the Authority informed the MDC of Experts in line with Para 5(2) (i) of DPCO, 2013, which state that the price to retailer of a new drug, not available in domestic market, shall be fixed by the Government on the principles of pharmacoeconomics of the new drug, on recommendation of a Standing Committee of Experts.

The MDC, considered the matter and fixed the retail price, including the 16 per cent retailer margin, at Rs. 10.97 per tablet.

During the examination by DoP, the company submitted the data of the subject formulation from Pharmatrac for the period of November 2020, which had prices of four formulations available. NPPA said that only one stock keeping unit is similar to that provided by Abbott and the other data said to be provided by Pharmatrac to the company is different from the data provided by Pharmatrac to NPPA.

NPPA admitted that the data about the formulation of at least one manufacturer was available for the relevant month. The DoP observed that based on this, according to Para 5(1) of DPCO, 2013, the retail price of a new drug for existing manufacturers of scheduled formulations available in domestic market shall be calculated based on the average Price to Retailer of the brands of same strength and dosage with at least one per cent market share and adding 16 per cent retailer margin to it, while the Para 5(2) prescribes methods to fix retail price of new drug not available in domestic market.

It further noted that the DPCO by way of Para 6 has provisions for calculations of ceiling price in case there is no reduction in price in absence of competition, but no such mechanism exists in case of retail price fixation.

“As such, in case of data of even one manufacturer will imply fixation of retail price as per provisions of Para 5(1) of DPCO, 2013,” observed the DoP, while remanding the review application back to NPPA to reconsider the same strictly as per provisions of DPCO, 2013.

According to online drug store 1mg.com, the Nervup Forte Capsule is a prescription medicine used to treat nutritional deficiencies. It helps formation of red blood cells and enhances the absorption of iron in body, helping improvement in level of haemoglobin and thus reducing the risk of anemia. It also helps in proper functioning of the brain and nervous system, it says.Pharmabiz