By Ajay Bhargava, Arvind Kumar Ray, Karan Gupta
In the recent case of Modi-Mundipharma Private Limited v Union of India & Ors., (Writ Petition (Civil) No. 11802 of 2016), the High Court of Delhi (Court) has clarified that incremental innovation or novel drug delivery systems like lipid / liposomal formulations, sustained release, controlled release, etc. should be treated as scheduled formulations under Drugs (Price Control) Order, 2013 (2013 DPCO) only if specifically specified in the list. The Court held that such differential forms should be considered different for the purposes of procurement, pricing, policy.
Modi-Mundipharma Private Limited (Petitioner) challenged the standing order dated 9 May 2016 (Standing Order) passed by the National Pharmaceutical Pricing Authority (NPPA) as it sought to include TRD Contin 100mg tablet CR 10 (Subject Formulation), within the scope of the ceiling price fixed for Tramadol tablet. The Petitioner being aggrieved by the Standing Order preferred a review under paragraph 31 of the 2013 DPCO, which was dismissed. The NPPA held that ceiling price of Tramadol 100mg tablet was fixed under Section 2.2.3 of the National List of Essential Medicines, 2015 (NLEM), which included all variants, including the Controlled Release (CR) and Sustained Release (SR) delivery systems.