The Department of Pharmaceuticals (DoP) has rejected the review application of IPCA Laboratories Limited against price fixation of “paracetamol 500 mg. tablet”.

Earlier, the NPPA through an order No. S.O. 1351(E) [corrected SO No.1951(E)] dated 02.06.2016 had fixed ceiling price of “paracetamol 500 mg. tablet” under DPCO, 2013. Aggrieved by the NPPA order, IPCA Laboratories filed a review petition with the DoP.

In the review application, the petitioner contended that this is with reference to above mentioned Notification, in which based on the provisions of para 4, 10, 11, 14, 16, 17 and 18 Of the Drugs Price Control order 2013, the NPPA has decided to further reduce the prices of paracetamol tablets 500 mg to Rs.0.83 per tab from the Revision given on March 2, 2016, S O 644 (E) of Rs.1.01 per tab, giving effect to the Whole sale price index changes of -2.7105%. Neither the PTR nor the basket of producers have changed but the above reduction has been brought about without any assignable reasons NPPA as provided in paragraph 31 of DPCO, 2013.

The prices for Paracetamol Tablets of the said strength were changed on the following dates, and the following ceiling prices were announced:- June 14, 2013 Rs.0.94 per tab April, 28, 2014 (WPI @6.32%) Rs.1.00 per tab February 26, 2015 (WPI @3.849%) Rs.1.04 per tab April 2015 (adjusting for ED) Rs.1.036 per tab March 02, 2016 (WPI @-2.7105%) Rs.1.01 per tab June 2, 2016 Rs.0.83 per tab PTR cannot change overnight and in the instant case MAT values and brands taken into consideration do not reflect the correct position and NPPA is supposed to verify facts before working out prices.

In reply, the NPPA commented that it has fixed the ceiling price of Rs.0.84/tablet vide S.O. 1555(E) dated 14.6.2013 and the same was revised to Rs.1.00, Rs.1.04 & 1.0 per tablet vide S.O. 1156(E), 619(E) & 644(E) dated 28.4.2014, 26.02.2015 & 02.3.2016 respectively under NLEM 2011 and Rs.0.83/tablet vide S.O. 1351(E) dated 02.6.2016 under NLEM 2015. (ii) Company’s request to withdraw S.O. 1351(E) dated 02.6.2016 is not tenable as per para 18(1) of 2013. (iii) As per information available with M&E division (through IPDMS report), company is following ceiling price notified vide S.O. 1351(E) dated 02.6.2016 for above mentioned formulation. DOP is also requested to verify the same from the company by insisting on verified copies of the control sample of price revision and relevant invoices in support.

During examination of the case, the reviewing authority DoP noted that in the instant case, as regards the contention of the petitioner company that the price of paracetamol tablets 500 mg. was revised as Rs.1.01/tablet on 2.3.2016 and again fixed at Rs.0.83/tablet vide SO 1951(E), dated 2.6.2016, Para 18(i) of DPCO 2013 clearly states that the revision of ceiling prices on the basis of moving annual turnover value shall be carried out “as and when the National List of Essential Medicines is revised by the Ministry of Health and Family Welfare or five years from the date of fixing the ceiling price under this Order whichever is earlier.”

In view of this, NPPA has revised the ceiling prices of the formulations strictly as per the provision of DPCO 2013. WPI impact has to be taken care of while fixing the ceiling prices. Therefore, the petitioner company has no merit in this contention. As regards, considering different size of packs, para 4 of DPCO, 2013 clearly states that PTR of brands and generic versions of the medicines having market share more than or equal to one percent of total turnover on the basis of moving annual turnover is considered with fixing the ceiling price. There is no provision for considering different size of packs in DPCO, 2013. Hence, the contention of the petitioner company has got no merit. In view of the above, the hearing authority is of the view that the contentions of the petitioner company have no merit, hence the review petition may be rejected.

“In view of the above, the petition of the company with regard to withdrawal of notification of ceiling price of Paracetamol 500 mg. tablet vide SO 1351(E) [corrected SO No.1951(E)] dated 02.06.2016 stands rejected”, the DoP order said.