The Department of Pharmaceuticals (DoP) has rejected the review application filed by FDC Ltd against price fixation of “Metformin (1000 mg), flunarizine, ramipril etc.”
The NPPA had earlier fixed the ceiling prices of “Metformin (1000 mg), flunarizine, ramipril etc” vide its order No. S.O. 1253(E) dated 29.03.2016 and SO 1405(E) dated 12.4.2016 under Drugs (Prices Control) Order, 2013 (DPCO 2013). Aggrieved by the NPPA notification, FDC Ltd filed a review application against the price fixation.
In the review application, the petitioner contended that separate notifications should be issued for existing scheduled medicines & others for which prices are notified for the first time. In para 4 of DPCO, 2013, there is no provision to add or subtract ceiling price due to increase or decrease in WPI index. As mostly ceiling prices have been fixed for the first time, WPI index linked reduction is not applicable. In Notification No. 1253, certain existing scheduled medicines have been included such as atorvastatin 10 mg, metoprolol 25 mg and metoprolol 50 mg. For such medicines, price reduction linked to WPI index is proper. However, in rest of cases where ceiling price is notified for the first time under para 4, reducing ceiling price linked to WPI index is uncalled for and is in contravention of DPCO provisions (particularly para 4 and para 16).
It further contended that majority of 173 medicines (103+70) covered under Notifications 1253(E) and 1405(E) dated 29/03/2016 and 12/04/2016 respectively are medicines which were hitherto non-scheduled and by virtue of Notification no. S.O. 701 (E) dated 10/03/2016 (NLEM 2015) have become DPCO Schedule I drugs. In all these cases, WPI linked price reduction cannot be made.
In reply, NPPA commented that DPCO, 2013 came into existence w.e.f. 15/05/2013 & NPPA has fixed that ceiling price for Betaxolol hydrochloride drops 0.5% vide S.O No. 1677(E) dated 14/06/2013. The benefit of WPI was admissible after the expiry of one year. As regards points No.5 to 11 of the review application dated 19.4.2016 of the company, NPPA submitted that Para 4, 10, 11, 14, 16, 17 & 18 of DPCO, 2013 to be referred. DPCO, 2013 has been issued under Section 3 of Essential Commodities Act, 1955. NPPA is mandated to fix fair, reasonable and affordable prices for all scheduled medicines under DPCO, 2013. Therefore, company’s requests cannot be considered, as they do not seem to have merit.
During examination, the reviewing authority DoP stated that the grievance of the company is examined under the provisions of DPCO, 2013, and it is seen that para 13(3) provides 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. Since the subject formulations of the petitioner company became scheduled formulation by virtue of Notification No.SO 701(E), dated 10.3.2016 (NLEM 2015), the NPPA has rightly applied the WPI impact in respect of products of FDC to pass on the benefits to the consumers. As regards, SO 1405(E), dated 12.4.2016, while notifying the said SO, NPPA has not taken into account the WPI impact. In view of the above, NPPA has fixed the ceiling prices strictly as per the provisions of DPCO, 2013, and the grievances raised by petitioner company has no merit and the review application may be rejected.
“NPPA has fixed the ceiling prices strictly as per the provisions of DPCO, 2013, and the grievances raised by petitioner company have no merit and the review application stands rejected,” the DoP ordered.