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Priyam Rajkumar

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Associate in the Pharmaceutical, Life-sciences and Healthcare practice at the Delhi NCR office of Cyril Amarchand Mangaldas. Priyam graduated from the University of Edinburgh, United Kingdom in 2019 and completed his Bridge Course from the National Law University, Delhi in 2020 and specializes in regulatory compliance, advisory work, tender matters and litigation pertaining to the pharmaceutical, medical devices, digital health, clinical trials and the life-sciences industry. He also has prior experience in technology, media and telecommunications (TMT) advisory, education matters and labour and employment matters. He can be reached at priyam.rajkumar@cyrilshroff.com

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

Encapsulating the Branded vs. Generics Debate: Pitfalls and Doctors’ Dilemma

The Ministry of Health and Family Welfare, on May 12, 2023, issued an Office Order directing heads of hospitals and polyclinics run by the Central Government, and CGHS wellness centres to ensure that all doctors (including residents) prescribe only generic medicines (“Order”). Additionally, this order contains an instruction to completely curtail the visits of medical representatives to hospital premises, with the caveat that information about new launches may be communicated by way of emails only.

On the face of it, there is little fault to be found in the Order and its dicta. In fact, it ties into the recent push to promote generic medications over expensive branded drugs. That said, it may be worthwhile to take a step back and look at the legal and policy implications of this course of action afresh, especially in light of the unintended consequences it may entail.Continue Reading Encapsulating the Branded vs. Generics Debate: Pitfalls and Doctors’ Dilemma

Introduction

In order to keep pace with the growing demand for quality goods and services while keeping competition at bay in this fiercely-contested sector, FMCG companies have constantly been on the lookout for effective and creative techniques to gain popularity and an edge over their rivals’ products. The marketing and sales teams of such companies, often armed with data, leave no stone unturned to outwit and outsell the products of competing companies. This comes as no surprise, as with the integration of innovative digital technologies and advancements in the possible venues for advertisements, companies have levelled up their consumer interaction experiences. For example, companies have now shifted their focus from hoardings and billboard advertisements to engaging social-media influencers to review and showcase their products. Some companies have even begun digitally interacting with customers and re-sharing posts (often with the company’s product prominently visible) of happy consumers on social media.Continue Reading What Does the Box Say? Exploring the legality of advertisement strategies commonly deployed by FMCG Companies

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

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

Advances in drug research over the years have resulted in the development of blockbuster drugs, which have increased the life expectancy of mankind. In the past decade, scores of patients across the globe suffering from rare or chronic ailments had limited treatment options due to unavailability / pending approval of life-saving drugs in their countries. From a legal standpoint, a drug is only permitted to be obtained and used by a patient once such drug has been granted the requisite approvals from the requisite drug regulatory authorities of such country after following proper clinical trial protocols that establish safety and efficacy of such drugs. With rising costs of drug trials, not every drug is submitted for approval in every country yet disease conditions that warrant use thereof still exist. Following representations from medical professionals and stakeholders to cater to such situations, drug regulators realized the need to ensure that such drugs are made available to those who need them irrespective of approval status. Currently, numerous expressions such as ‘usage on compassionate grounds’, ‘expanded access’ and ‘preapproval use’ exist to describe this concept and are used interchangeably[1].    Continue Reading Use of unapproved drugs in India on compassionate grounds- Unravelling the Regulatory Conundrum