The Department of Pharmaceuticals (DoP) has directed the National Pharmaceutical Pricing Authority (NPPA) to revalidate data on Famotidine tablet 20mg on a review application filed by Abbott Healthcare Pvt. Ltd. against fixation of ceiling prices of Famotidine tablet 20mg.

The NPPA vide its price fixation Order S.O. No.1016(E) dated 2.4.2014 had fixed the ceiling price of scheduled medicine Famotidine tablet 20mg under Drugs Prices Control Order, 2013 (DPCO, 2013).

Aggrieved by the NPPA notification, Abbott Healthcare had represented to the reviewing authority, DoP, against the price fixation.  After personal hearing on 18.7.2014, the DoP decided, “NPPA is directed to revalidate the data of the Petitioner as empowered under para 9 of DPCO, 2013. Whether Gelatin coated tablets are technologically different and deserve a different ceiling price the matter may be referred to Standing Technical Committee for advice. The Petitioner in the meantime is directed to maintain the ceiling price already notified by NPPA”.

In another case, the DoP rejected the review application filed by Fresenius Kabi India Pvt Ltd against fixation of ceiling prices of Ringer Lactate Injection. Earlier, the NPPA in its vide price fixation Order S.O. No.1156(E) dated 28.4.2014 had fixed ceiling price of Ringer Lactate Injection under DPCO, 2013.

Aggrieved by the NPPA notification Fresenius Kabi had represented to the reviewing authority, DoP, against the price fixation. Personal hearing was granted to the petitioner by the DoP on 01.7.2014. The petitioner was represented by Rakesh Sharma, director, Amol Kulkarni and Dr Sadanand Kulkarni. On behalf of the NPPA Naresh Arya, deputy director attended the hearing.

After hearing, the DoP decided, “the review application of the Petitioner is rejected on the ground that DPCO, 2013 does not provide for separate pricing for a separate packing material.  On the issue whether the variants available in the market have different therapeutic efficacy the cases pertaining to Baxter and B. Braun have already been referred to the Standing Technical Committee. As the ceiling prices are applicable across the board, any decision in the cases already referred to Standing Technical Committee will be applicable in this case also”.