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Senior Associate in the Pharmaceutical, Life-sciences and Healthcare practice at the Delhi NCR office of Cyril Amarchand Mangaldas. Kartik graduated from National Law University, Delhi in 2018 and specializes in regulatory compliance, advisory work and litigation pertaining to the pharmaceutical and health-care industry. He also has experience in labour and employment matters, having worked in the Employment laws practice at the firm’s Delhi office. He can be reached at kartik.jain@cyrilshroff.com.

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

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

Consent in Healthcare

In Part 1 of this series (Consent in Healthcare: Outline, Gaps and Conundrum), we presented a brief regulatory background on informed consent in healthcare in India, as well as judicial pronouncements on the topic. We also focussed on specific methods of obtaining consent as prescribed by such regulations.

In this section, we’ll look at the practical implications of such legislations and rulings, particularly in the context of telemedicine and digital health, as well as instances in which the patient is unable to provide consent.Continue Reading Consent in Healthcare: Outline, Gaps and Conundrum (Part 2)

Consent in Healthcare

Informed consent is the bedrock of ethical medical practice. It is when a medical practitioner explains a medical treatment, irrespective of whether it is simple, sophisticated, fundamental, or specific, to a patient, before the patient agrees to it. It is crucial from a liability perspective as well. The Delhi High Court, in a recent order[1], noted with concern the absence of informed consent taken from a patient who underwent a hair transplant, which resulted in complications, leading to death of the said patient. The Court pointed out that hair transplantation, being an aesthetic surgery, needs to be performed by qualified dermatologists or trained surgeons with informed consent of the patient. While this matter relates to the limited aspect of informed consent in a cosmetic surgery setting, the issues raised in the case may have broader implications.Continue Reading Consent in Healthcare: Outline, Gaps and Conundrum (Part 1)

COVID-19 TEST KITS. A CHEAT SHEET

The COVID-19 pandemic has literally brought the world to a standstill. Large scale infections have resulted in lockdowns across the globe. At this critical juncture, testing continues to remain the most important step to get a grip over the situation. The situation in India is no different. With an upsurge in the number of COVID-19 cases in India, the need for largesse testing has become paramount. Low availability of test kits remains a cause of great concern to the government and healthcare practitioners. This is compounded by our massive populace, given the quantity that is required in the current scenario. This lack of availability of test kits is primarily because India does not have adequate indigenous manufacturing units of COVID-19 test kits and relies heavily on imported kits.

From a regulatory standpoint, such kits fall under the category of ‘in-vitro diagnostic’ kits under the Drugs and Cosmetics Act, 1940 (D&C Act) read with the Medical Devices Rules, 2017 (MD Rules) and are regulated as ‘medical devices’[1].
Continue Reading COVID-19 Test Kits. A Cheat Sheet