The Department of Pharmaceuticals (DoP) has ruled that there is no provision in DPCO to consider gelatin coating differently for fixing of ceiling prices of drugs. The DoP's ruling in this regard came while examining a grievance by Sanofi India that the price of formulation “Cetirizine 10 mg capsules” should not be considered being soft gelatin capsule and not covered in Schedule I of DPCO, 2013.

Earlier, Sanofi India filed a review application against the price fixation of “Cetirizine 10 mg capsules” by the NPPA through its order No. S.O. 247(E), dated 24.01.2017 issued under DPCO 2013.

In the review application, the petitioner contended that considering that there was an apparent error in the draft version of proposed price calculation sheet for the proposed ceiling price in respect of 'Cetirizine 10 mg capsules displayed on NPPA website which was uploaded on 6th December 2016, it made a detailed representation to NPPA vide  letter dated 7.12.2016 justifying that CETGEL 10 mg capsules manufactured by Universal Medicare Private Limited and marketed by Sanofi India Limited are soft-gelatin capsules as per the manufacturing license issued to the company by the concerned drug controller and these capsules are totally different than those listed in Section 3.2 of Schedule I to the DPCO 2013. However, NPPA has notified the ceiling price of 'Cetirizine 10 mg capsules as per S.O. 247(E) dated 24.1 2017 without considering the justifications furnished to NPPA.

During the examination of the case, the DoP noted that the petitioner company has challenged the NPPA Order S.O. 247(E), dated 24.01.2017 for price fixation of their formulation Cetirizine 10 mg capsules on the ground that NPPA has erred by considering their formulation “Cetirizine 10 mg capsules (CETGEL 10mg)”, manufactured by Universal Medicare and marketed by Sanofi, as the formulation is a soft gelatin capsule and is totally different than those listed in section 3.2 of NLEM 2015. The company claimed that Schedule I refers only to tablets, ceiling prices would not apply for Cetirizine soft-gelatin capsules.

The DoP further noted that in this connection the stand of NPPA is in order as Cetirizine 10 mg capsules is added/included under section 3 of NLEM 2015. NPPA has considered the PTR and MAT value of their formulation Cetirizine 10 mg capsules for working out the ceiling price of this formulation, which is in conformity with the provisions of explanation to note(1) of DPCO S.O. 701(E) dated 10.3.2016, which says that if a tablet is included, other dosage forms like conventional tablets and capsules are considered as included. Moreover, there is no provision in DPCO to consider gelatin coating differently.

“The grievance of  Sanofi India Limited that the price of formulation “Cetirizine 10 mg capsules” should not be considered being soft gelatin capsule and not covered in Schedule I of DPCO, 2013, cannot be acceded to as Cetirizine 10 mg capsules is included under section 3 of NLEM 2015 and there is no provision in DPCO to consider gelatin coating differently,” the DoP ordered.