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Innovative Medical Devices under the Lens of Clinical Investigations – A Dormant Volcano Waiting to Erupt?

Introduction

Since the advancements in healthcare services and medicinal sciences, medical devices in India have become part and parcel of the existing healthcare delivery services framework.  Medical devices, in essence, are tools, instruments and even software which inter alia enable healthcare service providers to diagnose, monitor, mitigate and treat illnesses and health conditions.Continue Reading Innovative Medical Devices under the Lens of Clinical Investigations – A Dormant Volcano Waiting to Erupt?

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

Scrutinising India’s Organ Donation Laws and the Dilemmas of ‘Brain-Stem Death’

A significant demand-supply gap plagues the market for organ donation in India. The country has one of the lowest organ donation rates in the world, resulting in the death of innumerable patients in need of organ transplants.[1] While a part of this problem can be attributed to lack of awareness among potential donors, the issue is exacerbated by legislative ambiguity and regulatory shortcomings. The law on organ donation in India is primarily governed by the Transplantation of Human Organs and Tissues Act, 1994 (as amended in 2014) (“Act”), read with the Transplantation of Human Organs and Tissues Rules, 2014 (“Rules”).Continue Reading Beneath the Surface: Scrutinising India’s Organ Donation Laws and the Dilemmas of ‘Brain-Stem Death’

The Operation of e-Pharmacies and Data Privacy Risks

E-Pharmacies and operations thereof have been a contentious issue for long. While the issue remains static largely due to the delay in the notification of the E-Pharmacy Rules that were drafted in 2018, there is significant litigation that has ensued as well. The Government is contemplating whether e-pharmacies should be allowed to sell medicines online and, in this vein, the Drugs Controller General of India (“DCGI”) has issued show-cause notices to over 20 e-pharmacies to give them an opportunity to explain their operations and compliance with the regulations. As litigation ensues and rival contentions are presented before the courts[1], the Indian Government is currently seeking proper legal opinion on the regulation of e-pharmacies.Continue Reading The Operation of e-Pharmacies and Data Privacy Risks

Medical Devices Policy, 2023

                                                                                                                                               

In a bid to reduce import dependency and boost domestic production of medical devices, the Union Cabinet recently approved the National Medical Devices Policy, 2023 (“Policy”)[1]. The broad contours of the Policy were earlier notified vide a press release issued by the Press Information Bureau (“Press Release”).[2] The Policy aims to reduce India’s import reliance and has a stated goal to establish India as a global manufacturing hub for medical devices. This announcement comes at a time when the Government is actively promoting the ‘Atmanirbhar Bharat’ and ‘Make in India’ initiatives.Continue Reading Medical Devices Policy, 2023 – A Vision to Streamline Regulation, Incentivise Domestic Manufacturing and Facilitate R&D

Analysing Bharat Serums and Vaccines Limited v. Union of India & Ors. judgement

Price regulation of non-scheduled formulations has always been a contentious issue. While the Government can set prices of drug formulations that are listed on the National List of Essential Medicines (“NLEM”) – Scheduled Formulations, the Government can at best monitor prices of drug formulations that are not listed on the NLEM – Non-scheduled Formulations.

The Delhi High Court in its recent judgment in the matter of Bharat Serums and Vaccines Limited v. Union of India & Ors. provided much needed clarity on paragraph 20 Drugs (Price Control) Order, 2013 (“DPCO 2013”), which regulated the pricing of non-scheduled formulations and drugs, focusing on the legal implications ensuing from the breach thereof.Continue Reading Analysing Bharat Serums and Vaccines Limited v. Union of India & Ors. judgement

Introduction

There is no denying that India is one of the most significant players in the global pharmaceuticals space, especially in the generic and affordable vaccines segment. Emerging markets such as India are expected to become further crucial in the foreseeable future, given the global supply chain disruptions and discontinuities. Fifty percent of the global demand for various vaccines is met by the Indian pharmaceuticals industry and as per the Indian Economic Survey 2021, the domestic market is expected to grow 3x in the next decade. It is expected to develop at an annual rate of 11% over the next two years, possibly exceeding $60 billion in value.[1] India’s healthcare market is expected to reach $372 billion, driven by rising income, better health awareness and increasing access to insurance. India’s healthcare public expenditure stood at 2.1% of GDP in 2021-22 against 1.8% in 2020-21. Furthermore, in Union Budget 2022-23, Rs 86,200.65 crore ($11.28 billion) was allocated to the Ministry of Health and Family Welfare (MoHFW).Continue Reading Examining the Regulatory and Operational Issues Affecting M&A in Pharmaceuticals and Healthcare Industry

Digital Healthcare

The development in science and technology has scaled multiple heights and reached unprecedented levels of sophistication. Advanced methods are being used in all branches of research and technology, including medical diagnosis. Given that diagnosis is done either voluntarily or pursuant to a prescription, the field of medical testing is broad and encompasses a variety of situations. The process of diagnosis depends upon a range of variables, which includes diversified procedures, competent personnel, functional instruments, suitable facility or lab, reagent, etc. Each factor is as important as the other. Further, medical devices include a gamut of instruments ranging from a miniscule syringe used to collect blood samples, to sophisticated CT scanners. Both have the capacity to grossly impact a diagnosis. Hence, arises the need to minimise the variables and ensure uniformity in quality and standards. And, while the monitoring of medical devices, facilities and competent personnel are largely regulated, it is important to ensure that the diagnostic procedures are standardised.Continue Reading Evolving Landscape of Diagnostics’ Regulation in India & Digital Healthcare

Genetic Testing

Since the Covid-19 pandemic, people’s perception of healthcare has undergone a change. While the top 10 causes of death in India continue to be non-communicable diseases like diabetes, cardiac diseases, and respiratory diseases, these are easily preventable/ manageable if addressed at an early stage through vital screening and consultation at regular intervals. Furthermore, routine testing might reduce the severity of rare disorders, including auto-immune deficiencies, and also help lower cancer-induced mortality.Continue Reading Genetic Testing: A new doorway towards opportunities, challenges in preventive healthcare

Pharmaceutical and Healthcare

Since the inception of the ‘world wide web’, no other technology in the digital space has caught the attention of the world quite like ‘blockchain’. It has the potential to be a gamechanger with its promise of unmatched data security. Even though the implementation/ application of blockchain’s much-coveted underlying technology into various other industries has been a very recent phenomenon, the learned are already prophesising about  its ability  to shepherd us into a completely new way of network interactions and data storage. This future reality has been nick-named  ‘Web3’.Continue Reading Pharmaceutical and Healthcare Industry: A Case for Regulation Through Blockchain