The Department of Pharmaceuticals (DoP) has rapped the National Pharmaceutical Pricing Authority (NPPA) for fixation of ceiling prices of non-scheduled formulations like “Erythromycin estolate tablets 250mg; erythromycin tablets 500mg and erythromycin estolate syrup 125mg./5ml” which is contrary to the provisions of DPCO, 2013.
The DoP has now clarified that “Erythromycin estolate tablets 250mg; erythromycin tablets 500mg and erythromycin estolate syrup 125mg./5ml” have been shifted to non-scheduled category of drugs under Schedule-I of NLEM, 2015. The DoP clarified in this regard while examining a review petition filed by Alembic Pharmaceuticals against price fixation of “Erythromycin estolate tablets 250mg; erythromycin tablets 500mg and erythromycin estolate syrup 125mg/5ml” by NPPA through its order No. S.O. 1526(E), dated 11.05.2017 issued under DPCO 2013.
In the review application, the petitioner contended that erythromycin formulations namely erythromycin tablet 500mg, erythromycin tablet 250mg and erythromycin syrup 125mg/5ml have been shifted to non-scheduled category vide government notification No. S.O. 701(E) dated 10.03.2016. In this connection the DoP has also issued an OM bearing No. F. No. 31026/31/2016-PI.I dated 20.04.2017, wherein NPPA has been directed to regulate the scheduled drugs shifted to non-scheduled category as non-scheduled drugs under para 20 of DPCO, 2013.
It further contended that the NPPA fixed vide its S.O. No. 1526 (E) dated 11.05.2017 the ceiling prices of above said non-scheduled formulations referring to the paras 4,10,11,14,16,17 and 18 of DPCO, 2013, which is inconsistent with provisions of DPCO, 2013. While issuing the impugned notification stated above, NPPA has also failed to appreciate its own OM No. F. No. 19 (119)/2014/Div-II/NPPA dated 01.05.2017 issued in respect of such scheduled formulations shifted non-scheduled category.
While examining the issue, the DoP noted that the ceiling prices of the formulations erythromycin estolate tablets 250mg, erythromycin tablets 500mg, erythromycin syrup 125mg/5ml and chloroquine phosphate injection 40mg/ml were fixed by NPPA vide SO 1526(E), dated 11.05.2017 to comply with the Review Order No.31015/20/2015-PI.I, issued by DoP on 30th August, 2016. The Review order was issued on the review petitions filed by IPCA Laboratories Ltd. in April, 2015 against SO No.834(E), dated 25.3.2015. At that time, the subject formulations were scheduled medicines in NLEM 2011. However, NLEM, 2015 came into force vide DoP notification SO 701(E), issued on 10th March, 2016, in which the formulations, erythromycin estolate tablets 250mg, erythromycin tablets 500mg and erythromycin syrup 125mg.5ml., were shifted to non-scheduled category.
The review order No. 31015/20/2015-PI.I, dated 30th August, 2016, was issued by DoP, to settle the grievances raised by M/s IPCA Laboratories Ltd. against the ceiling prices fixed for erythromycin estolate tablets 250mg, erythromycin tablets 500mg, erythromycin syrup 125mg.5ml. and chloroquine phosphate injection 40mg/ml by NPPA vide SO 834(E), dated 25.3.2015. At that time, the aforesaid formulations were scheduled medicines. However, by the time the Review Order was issued (on 30.8.2016), out of four medicines, three medicines, viz. erythromycin estolate tablets 250mg, erythromycin tablets 500mg and erythromycin syrup 125mg.5ml., have been shifted to non-scheduled category. Only one formulation Chloroquine Phosphate Injection 40mg/ml is left in the category of scheduled medicines (at 6.5.3.1 in Schedule-I of NLEM, 2015). Fixation of ceiling prices of non-scheduled formulations is contrary to the provisions of DPCO, 2013.
In view of this, NPPA may be directed to issue revised SO by excluding the formulations erythromycin estolate tablets 250mg, erythromycin tablets 500mg and erythromycin syrup 125mg.5ml., which have since been shifted to non-scheduled category under Schedule-I of NLEM, 2015, and revising the ceiling price of only one formulation, viz. chloroquine phosphate Injection 40mg/ml.
“NPPA is hereby directed to issue revised SO within one month by excluding the formulations erythromycin estolate tablets 250mg, erythromycin tablets 500mg and erythromycin syrup 125mg.5ml., which have since been shifted to non-scheduled category under Schedule-I of NLEM, 2015, and re-fixing the ceiling price of only one formulation, viz. chloroquine phosphate Injection 40mg/ml,” the DoP said in its order dated 24th of August, 2017.