The Department of Pharmaceuticals (DoP) has quashed the ceiling price fixation of amlodipine 5 mg tablets by NPPA for deviation of DPCO, 2013, and has directed the NPPA to re-fix the ceiling price in accordance with the provisions of DPCO by considering the PTR of the 10 formulations with more than one per cent market share only.
Earlier, the NPPA had fixed the ceiling price of amlodipine 5 mg tablets vide its order No. S.O. 1686(E), dated 09.05.2016 under DPCO, 2013. Aggrieved by the order, Micro Labs Limited filed a review application against the price fixation.
In the review application, the petitioner contended that after perusal of the working sheet, it is observed that NPPA has also considered Almip 5 mg tablets 10’ pack “brand” of Cipla where SKU wise MAT value mentioned is 0.04 per cent (Sl.No.11), as one of the products (different “brand”) to calculate ceiling price of amlodipine tablets 5 mg even though their MAT value is less than 1 per cent which is contrary to para 4 of DPCO, 2013. They further submitted that the working sheet of calculation of ceiling price of amlodipine tablets 5 mg is erroneous and not based on the provisions as contemplated under Para 4 of DPCO, 2013.
The NPPA in its reply clarified each points raised by the petitioner.
During the detailed review of the case, the reviewing authority DoP noted that “It clearly mentions the medicines which are to be taken for calculation. In the instant case, the principles applied by NPPA go beyond what is mentioned in DPCO. Hence, NPPA may be directed to re-fix the ceiling price in accordance with the provisions of DPCO. The DPCO does not recognise a company for average PTR but only medicines/ formulations. Thus, only 10 formulations are to be considered having MAT value of more than one per cent each instead of 21 considered by NPPA in its calculation. Accordingly, NPPA may be directed to re-fix the ceiling price in accordance with the provisions of DPCO by considering the PTR of 10 formulations only. The DPCO does not recognise a company for average PTR but only medicines/formulations.
“The ceiling price fixation of amlodipine tablets by NPPA, vide S.O.No.1686(E), dated 09.05.2016, in deviation of DPCO, 2013, is hereby quashed and the NPPA is directed to refix the ceiling price in accordance with the provisions of DPCO by considering the PTR of the 10 formulations with more than 1 per cent market share only. The DPCO does not recognise a company for average PTR but only medicines / formulations,” the DoP order said.