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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
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Cosmetics Regulation in India

Customised cosmetics have recently grown in popularity, with customers increasingly appreciating the value of personalised rather than off-the-shelf products. Customers often prefer to pick ingredients which suit their skin/ hair characteristics, and associate such unique products with greater effectiveness and functionality. Several cosmetics manufacturers and retailers are already in the race to capture this growing demand in India. However, little attention has been paid to the legal implications and regulatory risks which arise from the import, production, storage, mixing and/ or retail of such customised cosmetics. It is therefore essential for players in this emerging market to be mindful of certain important legal questions and considerations to ensure proper compliance. This is especially in light of the new regulatory landscape, which has been laid down through the Cosmetics Rules, 2020 (“Cosmetics Rules” / “Rules”) and has been rapidly evolving over the past few years.

Continue Reading Concept to Compliance: Unveiling the Untapped Realm of Customised Cosmetics Regulation in India
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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
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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
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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
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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
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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

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)