DoP accepts Sun Pharmas review petition on fixing price of Volitra Enzo Tablet

The Department of Pharmaceuticals (DoP) has accepted Sun Pharmaceutical’s review petition against price fixation of “Volitra Enzo Tablet” containing formulation Trypsin 48 mg + Bromelain 90 mg + Rutoside Trihydrate BP 100 mg + Diclofenac Sodium IP 50mg and has directed the NPPA to fix the 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 and also directed them to remove the word ‘scheduled formulation’ in Column (2) of Table, since the product is a ‘new drug’.

Sun Pharmaceutical Industries Limited had filed a review petition under paragraph 31 of the Drugs (Prices Control) Order, 2013 against notification S.O. No.4131(E), dated 22.12.2016 issued by the National Pharmaceutical Pricing Authority (NPPA) regarding fixing the ceiling price of Volitra Enzo Tablet containing formulation Trypsin48 mg + Bromelain 90 mg + Rutoside Trihydrate BP 100 mg + Diclofenac Sodium IP 50mg.

NPPA had fixed revise price Volitra Enzo tablet Rs. 14.44 per tablet which was challenged by the petitioner contending that NPPA has considered the PTR of TRYBR-D of M/s Indoco Remedies Ltd. despite having market share less than 1%.

At the time of examination of the case, the DoP noted that one pack, namely, TRYBR-D 48/100/90/50MG tablet 10’s pack of INDOCO REMEDIES LTD., which is having less than 1% market share and it was observed from the calculation sheet that NPPA has clubbed the market share of two Brands of Indoco Remedies Ltd. 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.

Further, it was also noted that the product of the petitioner company is a ‘new drug’, and is not a scheduled formulation.

Giving the decision, DoP stated, “NPPA is hereby directed to revise/refix the retail price of “Volitra Enzo Tablet” containing formulation Trypsin48 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’.