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The National Medical Devices Policy, 2023: A Closer Look at Strategy and Implementation

In an earlier blog post, we took a close look at the National Medical Devices Policy, 2023 (“Policy”), notified by the Department of Pharmaceuticals (“DoP”) on May 2, 2023[1]. We delved into the framework, objectives and core focus areas of the Policy. While the aim of the Policy was clearly to reduce import dependency and establish India as a global manufacturing hub for medical devices, little information was provided on the means to achieve these goals. To draw a holistic picture, we sought guidance from the Approach Paper to the National Medical Devices Policy, 2022 (“Approach Paper”)[2], which was based on similar principles and furthered the same goals as the present Policy. However, the DoP has recently also issued a strategy document on the Policy (“Strategy Document”)[3] to fine-tune and expand on its implementation strategies. In light of the same, this blog post analyses the Strategy Document, measures envisaged thereunder, enforcement priorities and focal points.Continue Reading The National Medical Devices Policy, 2023: A Closer Look at Strategy and Implementation

To Regulate or Not To Regulate DPCO 2013 and The Modi-Mundi Pharma Case

Drug price control has been a source of considerable agony to the pharmaceutical industry. Price caps on drugs, though flowing from a larger public interest perspective, has the power to throttle growth of the industry and limit availability of new life saving-drugs to the public at large. It is much to the chagrin of the major players and their business models. The Government has of course adopted the public comes first policy, which has also seen considerable support by the courts. Right or wrong depends on which side of the street one is on.

Price control as a measure has met with its fair share of challenges and is, as a policy issue, here to stay. Interpretation of price control regulations (DPCO) on the other hand is still a topic for many a contentious litigation before courts. The most recent one is a case where the Hon’ble Delhi High Court on July 17, 2018, passed a judgment in the case of Modi-MundiPharma Pvt. Ltd. v Union of India & Ors[1]. Here, the court opined that drugs developed through incremental innovation or a novel drug delivery system could only be included under the National List of Essential Medicines 2015 (NLEM) for the purpose of fixing the ceiling price, procurement etc. if they were explicitly listed. In other words, the court clarified on what kind of drugs are included.Continue Reading To Regulate or Not To Regulate: DPCO 2013 and The Modi-Mundi Pharma Case