Alerts & Updates

Medical Devices, Pharma & Life Sciences – Court Update

| Jul 20, 2018

In a recent judgment (Modi-Mundipharma Pvt. Ltd. v. Uoi & Ors.; W.P. (C) 11802/2016), the Delhi High Court has recognised that incremental innovation or/and novel drug delivery systems deserve to be treated differently and cannot be painted with the same brush as conventional forms of the formulation. Even though the Core Committee which was formed to revise the NLEM in 2015 had deliberated and accepted that innovation in medicine must be encouraged and that formulations developed through incremental innovation/ novel drug delivery systems like inter-alia, lipid/liposomal, sustained release, controlled release formulations should be considered differently for purposes such as procurement policy, pricing etc., the intent of the Core Committee remains inadequately reflected in legislation and government action.

The judgment marks a welcome intervention in a domain which the Courts have of late shown reluctance to enter and have left to the discretion of the experts.

As the Government expands the scope of price control to medical devices, it is hoped that more issues relating to the inadequacies and ambiguities inherent in the DPCO-2013, when applied especially to medical devices, will be discussed, paving the way for changes.

We hope you will find the attached summary of the judgment useful.

We look forward to your comments, views and insights.

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