The Department of Pharmaceuticals (DoP) has rejected Sanofi-Synthelabo (India) Pvt. Ltd's plea for withdrawal of NPPA's order fixing of ceiling price of amiodarone tablet 200 mg.

The NPPA had earlier fixed the ceiling price of “Amiodarone tablet 200 mg.” vide its order No. S.O. 1816(E) dated 18.05.2016 under Drugs (Prices Control) Order, 2013 (DPCO 2013). Aggrieved by the NPPA notification, Sanofi-Synthelabo (India) Pvt. Ltd filed a review application with the DoP, under paragraph 31 of DPCO, 2013.

The issue was examined by the DoP which is the reviewing authority. On examination, the DoP noted that the NPPA has revised the ceiling prices of these products as per provision of para 18(i), which states that: “The revision of ceiling prices on the basis of moving annual turnover value shall be carried out, (i) as and when the National List of Essential Medicines (NLEM) is revised by the Ministry of Health and Family Welfare or five years from the date of fixing the ceiling price under this Order, whichever is earlier.”

In this particular case, revision of ceiling price has been done by NPPA on the basis of revision of NLEM and consequent revision in Schedule I. NPPA is fully within its powers to revise the ceiling prices. As regards contention of the petitioner company that ceiling price of the formulation, i.e. amiodarone tablet 200 mg. ought not to have been fixed by reduction of WPI of 2.7105% as the same is not in accordance with provisions of Para 9(5), which reads as under:- “The market based data for fixing the ceiling price of a scheduled formulation due to a revision in the first schedule shall be the data available for the month ending immediately before six month of notification of revision in the first schedule.” It is submitted that para 13(3) of the DPCO, 2013 provides inter-alia as under: “Provided that in case of decline in wholesale price index, a corresponding reduction in the prices shall be made as per the provisions of sub- paragraph (4) of paragraph 16.”

From the above Para of DPCO, 2013, it may be seen that NPPA has correctly fixed the ceiling price of the aforesaid formulation under Para 4 of DPCO, 2013 taking into account of WPI reduction w.e.f. 1st April, 2016 @ minus 2.7105%.

After hearing both the parties, the DoP ordered, “In view of the above, the petition of the company with regard to withdrawal of notification of ceiling price of amiodarone tablet 200 mg. vide SO 1816(E) dated 18th May 2016 stands rejected”.