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Dr. Reddy’s Labs fails to get favourable ruling from DoP on review petition against pricing of omeprazole capsule

Ramesh Shankar, Mumbai
Thursday, December 07, 2017, 08:00 Hrs  [IST]

The Hyderabad-based pharma major Dr. Reddy’s Laboratories failed to get a favourable ruling from the Department of Pharmaceuticals (DoP) on its review petition against price fixation of “Omeprazole capsule 10mg” as the DoP noted that the company could not furnish any supporting documentary proof in support of its claim that the data of product omeprazole 10mg, manufactured by Zydus Cadila having MAT value of more than 1%, has not been considered for fixation of ceiling price of “Omeprazole capsule 10mg.

Earlier, Dr. Reddy’s had filed a review petition against price fixation of “Omeprazole capsule 10mg” by the NPPA through its order No. S.O. 248(E), dated 24.01.2017 issued under DPCO 2013.

In the review application, the petitioner contended that the worksheet for calculation of ceiling price of formulations notified vide S.O. 248 (E) dated 24th January, 2017 failed to consider all manufacturers of the aforesaid formulation having more than 1% market share and wrongly considered company’s formulation as a monopoly for omeprazole 10 mg capsules as listed in the first schedule of DPCO, 2013. The company submitted that “OCID CAPS 10 MG x 15” containing omeprazole 10 mg as manufactured by Zydus Cadila Ltd is also available in this category and has more than 1% market share and the price of this product should also be considered while fixing the ceiling price of formulations notified vide S.O. 248(E).

The petitioner further contended that independent data from IMS-ORG to certify that both the above mentioned formulations have Moving Annual Turnover (MAT) for the period ending August, 2015 of greater than 1% market share. And had NPPA correctly calculated the ceiling price of the aforesaid formulation as per the provisions of Para 4 of DPCO, 2013, after having taken into consideration “OCID CAPS 10 MG x 15”, there would have been a reduction in the average price to retailer and therefore the condition under Para 6(1)(a) is not satisfied. Accordingly Para 6 is not applicable in the instant calculation of ceiling price.

NPPA has calculated the price of omeprazole capsule 10 mg under the provisions of Para 6 of DPCO, 2013 without taking into consideration “OCID CAPS 10 MG x 15” containing omeprazole 10 Mg as manufactured by Zydus Cadila which also has more than 1% market share in this category, it further contended.

During the examination of the matter, the DoP noted that NPPA notified the ceiling price of omeprazole capsule 10mg vide SO 248(E), dated 24.01.2017, considering AIOCD-AWACS data for the month of August, 2015. The company, in its review application, stated that NPPA has not considered the market share of omeprazole 10mg manufactured by Zydus Cadila having more than 1% market share. In support of its claim, the company furnished only one sheet, containing IMS data of August, 2015, showing market share of 8.15% of formulation omeprazole 10mg manufactured by Zydus Cadila.

No other documentary proof is submitted by the company in support of its claim. The single sheet submitted by the company cannot be considered as an authenticated document. Therefore, the request of the petitioner company cannot be considered and the review petition may be rejected, the DoP noted.

 

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