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DoP directs NPPA to re-fix retail price of teneligliptin 20 mg plus metformin 1000 mg ER tablets

DoP directs NPPA to re-fix retail price of teneligliptin 20 mg plus metformin 1000 mg ER tablets


Mumbai, February, 2017

The Department of Pharmaceuticals (DoP) has directed the National Pharmaceutical Pricing Authority (NPPA) to examine the data/information once again and to re-fix the retail price of teneligliptin 20 mg + metformin 1000 mg ER tablets as it has been found by the DoP that the NPPA has erred in taking the correct data while fixing the retail price of these formulations.

 

Earlier, the NPPA had fixed the ceiling price of teneligliptin 20 mg + metformin 1000 mg ER tablets vide its order No. S.O. 2570(E) dated 29/07/2016 under Drugs (Prices Control) Order, 2013 (DPCO 2013). Aggrieved by the order, the Glenmark Pharmaceuticals filed a review application against price fixation by the NPPA.

 

In the review application, the petitioner contended that the NPPA has not properly worked out the average price, which according to them should be MRP Rs.10.83 per tablet of teneligliptin 20 mg.

 

In reply, NPPA commented that on scrutinizing the representation, it is observed that PTR and MAT value in respect of X-MET 500 mg tablet used in working sheet is correct and hence the representation of the company is not tenable.

 

During examination, the reviewing authority, DoP, noted that the company aggrieved with the price, requested for providing the calculation sheet. NPPA fixed the price based on the principles of Pharmaeconomics as per para 15(3) of DPCO, 2013, in the 6th Meeting of Standing Committee of Experts held on 20.7.2016. The Standing Committee of Experts considered the data of Glenmark Pharmaceuticals & Ajanta Pharma and marketed by various companies. The said companies claimed retail price ranging from Rs.13.52 to Rs.22.00 per tablet. The formulation is DCG(I) approved. The committee observed that although as per paragraph 9(4) of DPCO, 2013, the market based data for fixing the retail price of new drug available in the market, shall be the data available for the month ending immediately before six months of receipt of application for fixing the price of the new drug.

 

However, the committee observed that since teneligliptin is a new molecule which has been launched recently by different companies, for computation, the data of teneligliptin tablet 20 mg based on current data of Pharma Trac June, 2016 may be considered. Accordingly, NPPA fixed the retail price of composition teneligliptin 20 mg. + metformin 1000 mg ER tablets at Rs.11.65. The company submitted its own calculation and based on Pharma Trac June 2016 data for plain teneligliptin, the average Price to Retailer (PTR) comes out to be Rs.8.31 per tablet of teneligliptin 20 mg. Consequently, the Retail Price (RP) works out to Rs.9.64 per tablet after adding 16% Retailer’s Margin as provided under DPCO. Post that, if one were to add the ceiling price for metformin 1000 mg which Rs.3.38 per tablet of metformin 1000 mg, the total Retail Price for teneligliptin 20 mg + metformin 1000 mg ER tablets comes to Rs.13.02 per tablet as against Rs.11.65 declared by NPPA. The company provided with the Working Sheet of Pharma Trac data of June, 2016 of teneligliptin 20 mg. tablets, and on perusal it is noted that the data of following two companies, viz. Wockhardt and Alembic, having more than 1% market share, were missing. It was also noted that the wrong PTR data of one company, i.e. Intas, was taken while fixing the retail price.

 

In view of the above, it is observed that NPPA has erred in taking the correct data while fixing the retail price of the subject formulations. Hearing Authority is of the view that NPPA may be directed to examine the data/information submitted by the company, on merit, and to re-fix the retail price of the subject formulation within a period of one month from the date of Order by the Reviewing Authority.

 

“NPPA is hereby directed to examine the data/information submitted by the company, and to re-fix the retail price of teneligliptin 20 mg + metformin 1000 mg ER tablets, on merit, within a period of one month from the date of issue of this Order,” the DoP said.