The Department of Pharmaceuticals (DoP) has directed the NPPA to revise the ceiling prices of “Paclitaxel injection, Carboplatin & Cisplatin” in the light of para 11(3) of DPCO, 2013 and strictly in accordance with para 4 of DPCO 2013.

Earlier, Fresenius Kabi India Private Ltd had filed three review applications dated 19.5.2016 under para 31 of DPCO against NPPA Notifications SO No.1560(E) dated 27.4.2016 and NPPA’s working sheet related to price notified on 27.4.2016 for price fixation of “Paclitaxel injection, Carboplatin & Cisplatin”.

Examining all the three review applications, the DoP noted that the said review petitions were filed against S.O. No.1560(E) dated 27.4.2016 for fixation of the ceiling prices under DPCO, 2013, due to amendment in Schedule-I of DPCO, 2013 on 10th March, 2016 using Para 17 & 18 of DPCO, 2013. In this regard, it is observed that the ceiling prices of all the three products were fixed on 5.11.2013, 28.6.2013 & 22.7.2013 after announcement of the DPCO, 2013. After that the ceiling price revised upward two times on 28.4.2014 & 26.2.2015 due to change of WPI as Para 16 of DPCO, 2013 and ceiling price revised downward one time on 2.3.2016 due to reduction in WPI. Hence, the issue raised by the petitioner company has no merit.

The base PTR price for all the three cases for all Division prices is old one, i.e. of May, 2012 and the ceiling price revised per pack and not per ML, but due to amendment in Schedule-I, the revision in the ceiling price is based on per ML basis and by considering the new PTR of all products (Aug, 2015), combined with all different pack sizes such as 5ml, 30ml, 50ml & 100ml etc., which is not correct. Company in its representations stated that the ceiling price for all the products should be fixed per ml for each pack size as per Para 11(3) of DPCO, 2013.

As regards company’s request for separate ceiling price for the formulations as per para 11(3) of DPCO, 2013, notified by SO 1152(E), dated 2.4.2016, the company representatives prayed that all packs of equal pack size and strength to be considered for ceiling price calculation and different price for different pack size as per para 11(3) of DPCO 2013 be granted. In this connection, para 11(3) of DPCO, 2013 may kindly be read as under:- “(3) Notwithstanding anything contained in sub-paragraph (1) and (2), the case of injections or inhalation or any other medicine for which dosage form or strength or both are not specified in the Schedule-I of the Drugs (Prices Control) Order, 2013, the Government may fix and notify separate ceiling price or retail price for such formulations with specific therapeutic rationale, considering the type of packaging or pack size or dosage compliance or content in the pack namely liquid, gaseous or any other form, in the unit dosage as the case may be, conforming to Indian Pharmacopoeia or other standards as specified in Page 7 of 7 the Drugs and Cosmetic Act, 1940 (23 of 1940) and the rules made thereunder for the same formulation.”

The NPPA representative, during the hearing, stated that company’s representation regarding ceiling price fixation for above said formulations under para 11(3) of DPCO, 2013 is under examination. After hearing the company as well as NPPA, hearing authority is of the opinion that NPPA may be directed to re-examine all the three cases and re-fix/revise the ceiling price under para 11(3) of DPCO, 2013, if considered necessary.

“NPPA is directed to revise the prices within one month of this order of all the three cases of the petitioner company in the light of para 11(3) of DPCO, 2013 and strictly in accordance with para 4 of DPCO 2013. The present review petition stands disposed off”, the DoP in its order dated September 19, 2016 said.