Pharma major Sun Pharmaceutical Industries has received favourable ruling form the Department of Pharmaceuticals (DoP) on its review petition against price fixation on “Volitra Enzo tablet” containing formulation trypsin 48 mg + bromelain 90 mg + rutoside trihydrate BP 100 mg + diclofenac sodium IP 50mg. The DoP has now directed the NPPA to to revise/refix the retail price of “Volitra Enzo tablet” by considering only those medicines/formulations having MAT value of more than 1% market share, as DPCO does not recognize a company for average PTR but only medicines/formulations.

Earlier, Sun Pharmaceuticals had filed a review application with the DoP against price fixation of “Volitra Enzo tablet” by the NPPA vide its order No. S.O. 4131(E), dated 22.12.2016 under DPCO 2013.

In the review application dated 17.01.2017, the petitioner contended that the working sheet uploaded on NPPA website dated 23.12.2016 suggested to have considered 15 packs in the retail price calculation. It is observed that 1 pack viz. TRYBR-D 48/100/90/50mg tablet 10 of Indoco Remedies has been captured in the calculation despite having market share less than 1%.

Further, the company referred to Notification S.O. 4131 (E), wherein two details are appearing ambiguous. Table title column No. 2 mentioned as Scheduled Formulation, and footnote (f) where its suggested to furnish quarterly return to NPPA in respect of production/import and sale of product in Form-III of Schedule-II of DPCO 2013. They submitted that the captioned formulation is a Non-Scheduled Formulation, and hence applicability of Form-III, Form IV does not stand appropriate in this case. Therefore, term Scheduled Formulation, and footnote (f) should be removed for transparent instruction and compliance.

On examination of the matter, DoP noted that it is seen from the calculation sheet that NPPA has clubbed the market share of two brands of Indoco Remedies.  DPCO does not recognize a company for average PTR but only medicines / formulations. Hence, NPPA has wrongly considered the PTR of TRYBR-D 48/100/90/50mg tablet 10’s pack, having only 0.74% share. Therefore, NPPA may be directed to consider only those medicines / formulations having MAT value of more than 1% market share.

Further, the DoP noted that as the product of the petitioner company is a ‘new drug’, and is not a scheduled formulation, the word ‘scheduled formulation’ should be removed from the column (2) of Table in SO No.4131(E), dated 22nd December, 2016. As per Schedule II of DPCO, 2013, Form III & Form IV are to be filled up for scheduled formulations only. Hence, Note (f) of the notification also needs to be removed.

“NPPA is hereby directed to revise/refix the retail price of “Volitra Enzo tablet” containing formulation trypsin 48 mg + bromelain 90 mg + rutoside trihydrate BP 100 mg + diclofenac sodium IP 50mg. by considering only those medicines/formulations having MAT value of more than 1% market share, as DPCO does not recognize a company for average PTR but only medicines / formulations.

“NPPA is further directed to remove the word ‘scheduled formulation’ in Column (2) of table and Note (f) of the notification for this product, since the subject product is a ‘new drug’”,the DoP in its order said.