Through a recent notification, National Pharmaceutical Pricing Authority (NPPA), Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India has set aside its notification of dated 11th May 2017 in which the regulator had fixed the ceiling price of the following formulations with immediate effect.
1. Erythromycin Estolate Tablet 250mg
2. Erythromycin Estolate Tablet 500mg
3. Erythromycin Estolate Syrup 125 mg / 5 ml
4. Chloroquine Phosphate Injection 40 mg / ml (64.5mg eq. to 40mg chloroquine)
On 11th May 2017, NPPA had fixed the prices of the Erythromycin Estolate Tablet 250mg at Rs 3.02 for 1 tablet, Erythromycin Estolate Tablet 500mg at Rs 5.86 for 1 tablet, Erythromycin Estolate Syrup 125 mg/5 ml at Rs 0.53 for 1ml, and Chloroquine Phosphate Injection 40 mg / ml (64.5mg eq. to 40mg chloroquine) at Rs 1.31 for 1ml.
However, challenging the said notification, Alembic Pharmaceuticals Limited filed a petition under paragraph 31 of the Drugs (Prices Control) Order, 2013
The petitioner contended that Erythromycin formulations namely Erythromycin Tablet 500mg, Erythromycin, Tablet 250mg and Erythromycin Syrup 125mg/5ml have been shifted to Non scheduled by the Government on 10th March 2016 and NPPA has been directed to regulate the Scheduled drugs shifted to Nonscheduled category as NON-SCHEDULED drugs under para 20 of DPCO, 2013.
Furthermore, the petitioner contended that NPPA had fixed 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.
After examination government had directed NPPA 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.
Following the notification of the government, NPPA re-examined and submitted the report to the government after that DoP stated that
“NPPA is hereby directed to set aside the SO 1526(E), dated 11.5.2017, as all the four formulations, i.e. Erythromycin Estolate Tablets 250 mg, Erythromycin Estolate 500mg, Erythromycin Estolate Syrup 125mg/5ml and Chloroquine Injection 40mg/ml, have been shifted to non-scheduled category vide SO 701(E), dated 10.3.2016.”
Below is the attachment for the same.
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