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1. The petitioner (hereafter „IRL‟) has filed the present petition impugning the notice dated 20.11.2017 (hereafter „the impugned notice‟) issued by the National Pharmaceutical Pricing Authority (hereafter „NPPA‟) demanding a sum of ₹2,93,57,006/- (₹2,00,95,630/- towards the overcharged amount plus ₹92,61,376/- towards interest at the rate of 15% p.a) for the amount overcharged by the petitioner and not complying with the ceiling price fixed under the Drugs (Price Control) Order, 2013 (hereafter „DPCO- 2013‟).

4. In the year 2011, the National List of Essential Medicines (hereafter „NLEM - 2011‟) was revised to include CETIRIZINE with the following strengths:-

 CETIRIZINE Tablets 10 mg and  CETIRIZINE Syrup 5 mg/ 5 ml

5. The DPCO-2013 was issued on 15.05.2013 with NLEM-2011 included as Schedule-I thereto. As noticed above, at the material time NLEM - 2011 included CETIRIZINE Tablets of the strength 10 mg and CETIRIZINE Syrup of the strength 5 mg/ml.

6. On 28.06.2013, NPPA issued a Price Notification Order fixing the ceiling price of CETIRIZINE syrup with strength 5mg/ml as ₹0.54/-. Subsequently, on 28.04.2014, NPPA issued another Price Notification Order fixing the ceiling price of CETIRIZINE tablets with strength 10 mg as ₹1.92/- per tablet and the ceiling price of CETIRIZINE Syrup-5mg/ml was revised to ₹0.57/-.

7. On 26.02.2015, NPPA issued another Price Notification Order revising the ceiling price of CETIRIZINE Syrup-5 mg/ml to ₹0.59/- and for CETIRIZINE tablet-10 mg to ₹1.94/-. Thereafter, on 02.03.2016, NPPA issued another Price Notification Order revising the ceiling price of CETIRIZINE Syrup-5mg/ml to ₹0.57/- and ceiling price of CETIRIZINE tablets-10mg to ₹1.94/- for 1 tablet.

8. On 16.04.2015, NPPA sent a notice to IRL, inter alia, stating that IRL had increased the Maximum Retail Price (MRP) of the formulation from ₹36.80 in December, 2013 to ₹40 in December 2014, which translated to an increase of 8.70% in the MRP of the Formulation. IRL was called upon to explain the reasons for such increase in the MRP and also furnish a consolidated price list of products manufactured or marketed by it.

13. Thereafter, on 07.04.2017, NPPA issued a Show Cause Notice, inter alia, rejecting IRL‟s contentions as not tenable. NPPA asserted that the ceiling price for the said formulation was first notified by a Price Notification Order dated 28.06.2013, whereby the ceiling price was fixed at ₹0.54 per ml (which worked out to ₹32.40 for 60 ml on pro-rata basis).

NPPA alleged that IRL had over charged to the extent of ₹1,92,86,598/- during the period from July, 2013 to May, 2016 and, accordingly, called upon IRL to show cause why action should not be taken for recovery of the over charged amount with interest. IRL responded to the aforesaid Show Cause Notice on 31.07.2017 stating that the Price Notification Order dated 28.06.2013 was inapplicable as it did not indicate the ceiling price for a formulation containing CETIRIZINE of the strength of 5 mg/5 ml. IRL claimed that since the strength of the Formulation did not match the one as was notified in DPCO-2013, the ceiling price as fixed was not applicable to the Formulation. IRL claims that, thereafter, it received a letter dated 10.10.2017 enclosing a letter dated 04.10.2016. In the said letter, it was stated that if IRL did not respond within a period of 15 days, it would be presumed that the petitioner had nothing to say and proper action would be taken under the provisions of DPCO-2013. IRL responded to the aforesaid notice reiterating its stand as noticed above. Thereafter, on 20.11.2017, NPPA issued the impugned notice.