The Department of Pharmaceuticals (DoP) has rejected the review petition filed by Sun Pharmaceutical Industries against fixation of ceiling price of “Volini Duo (Acetaminophen 650 mg extended release tablets)”.

The petition was filed by the company with the reviewing authority, DoP, under paragraph 31 of the DPCO, 2013 against notification S.O. No.1253(E) dated 29.03.2016 and letter No. F.No.19(778)/2016/NPPA/Div.II, dated 23.5.2016 issued by the National Pharmaceutical Pricing Authority (NPPA) fixing the ceiling price of “Acetaminophen 650 mg tablet”.

The main grievance of the company was that as the captioned product is not included in NLEM 2015, instead of fixing a separate retail price for Volini Duo, NPPA directed the company to follow the ceiling price notified for paracetamol plain tablet 650 mg vide SO No.1253(E) dated 29.3.2016. Company has submitted further justifications for the need of fixing a separate retail price for Volini Duo on 26th May, 2016, referring to Explanation of No.2 of amended DPCO 2013, notified vide SO 701(E), dated 10th March, 2016. However, NPPA did not respond to the company’s submission and, therefore, company has filed a review application with Department of Pharmaceuticals on 22nd June, 2016.

In reply, the NPPA representative stated that NLEM 2015 does not mention different variants of paracetamol 650 mg tablet. Hence, all variants of Paracetamol 650 mg tablet has been taken into calculation while fixing its ceiling price. Accordingly, the company was directed to follow the ceiling price. While applying for price fixation of new drug in Form I the company submitted the PTR of 4 brands available having identical composition, which were already considered in the ceiling price fixation. The companies of those four brands did not file any representation/review against the ceiling price.  GSK also manufacturing and marketing Crocin Advance and following the ceiling price fixed by NPPA.

During examination, the DoP noted that the NLEM 2015 does not mention different variants of paracetamol 650 mg tablet. Hence, all variants of Paracetamol 650 mg tablet have been taken into calculation by NPPA while fixing its ceiling price. While applying for price fixation of new drug in Form I, the company submitted the PTR of 4 brands available having identical composition, which were already considered in the ceiling price fixation. The companies of those four brands did not file any representation / review against the ceiling price. GSK also manufacturing and marketing Crocin Advance and following the ceiling price fixed by NPPA. Hence, the Hearing Authority is of the opinion that the contention of the petitioner company has got no merit and the review petition may be rejected.

After due examination, the DoP ordered, “The points raised by the petitioner company in their review petition have got no merit and stand rejected.”