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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’
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Significance of Providing Un-Relied Documents to Accused An Indicator of a Fair Trial

One of the key facets of the criminal law regime is that an individual/ entity should be given a fair and transparent trial. Sections 207 and 208 of the Code of Criminal Procedure, 1973 (“CrPC”) are in furtherance to the said principle, which relate to providing copies of police report and other documents to accused persons.

Continue Reading Significance of Providing Un-Relied Documents to Accused: An Indicator of a Fair Trial
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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.

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SEBI Adjudicates on Pledging of Securities held by Category I AIFs

Background

In a recent order[1] (“Order”), the Securities and Exchange Board of India (“SEBI”) held that a category I alternative investment fund registered with it (“Fund”); its investment manager (“Manager”); and its trustee (“Trustee”), were in violation of certain SEBI (Alternative Investment Funds) Regulations, 2012 (“AIF Regulations”). Specifically, these violations were with respect to provisions associated with (i) the code of conduct applicable to the Fund, Manager and Trustee; and (ii) provisions related to leverage and borrowings applicable to the Fund.

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SEBI’s MUTUAL FUND EXPENSE RATIO CONSULTATION PAPER

BACKGROUND

On May 18, 2023, the Securities and Exchange Board of India [“SEBI”] had placed a consultation paper related to the total expense ratio charged by Asset Management Companies [“AMC”] to unitholders of mutual funds. June 8, 2023 was set as the deadline for submission of public comments. The due date, however, was extended to June 8, 2023.

The proposal is aimed at curbing distributor practices such as unnecessary switching of schemes and pushing new fund offerings for higher commissions. SEBI in its consultation paper proposed to introduce performance fees for funds. It proposed two approaches, but also suggested testing the models under the Regulatory Sandbox.

Continue Reading FIG Paper (No. 21 – Series 1): SEBI’s Mutual Fund Expense Ratio Consultation Paper: Impact Analysis
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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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Context

The Prevention of Money Laundering Act, 2002 (“PMLA”), which came into force w.e.f. July 01, 2005, was enacted pursuant to India’s international obligations inter alia under the Vienna[1] and Palermo[2] Conventions, the Political Declaration and Global Programme of Action (1990)[3] adopted by the UN General Assembly, and to give effect to the recommendations made by the Financial Action Task Force (FATF) for combating money laundering (popularly known as the “Forty Recommendations”)[4].

Continue Reading Spotlight: Why PMLA Scheduled Offences need a fresh look?
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Highlights of the Master Circular on IRDAI (Registration of Indian Insurance Companies) Regulations, 2022

Introduction

Four months after the Insurance Regulatory and Development Authority of India (“IRDAI”) notified 2022 Regulations that streamline registration and share transfer requirements of Indian insurance companies, the IRDAI has issued a master circular titled ‘Master Circular on Registration of Indian Insurance Company, 2023’ dated April 24, 2023 (“Master Circular”) to supplement the procedural aspects of 2022 Regulations.

Continue Reading Highlights of the Master Circular on IRDAI (Registration of Indian Insurance Companies) Regulations, 2022
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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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FIG Paper

BACKGROUND

While the Reserve Bank of India (“RBI”) had in its August 10, 2022 press release stated that it is examining the First Loss Default Guarantee (“FLDG”) structures, the Digital Lending Guidelines issued by the RBI on September 2, 2022 neither permitted nor expressly prohibited loss sharing arrangements such as FLDGs, but recommended that provisions of paragraph 6(c) of the Reserve Bank of India (Securitisation of Standard Assets) Directions, 2021 dated September 24, 2021 (“Securitisation MD”) be adhered to for financial products involving contractual agreements such as FLDG. Paragraph 6(c) of Securitisation MD prohibits Regulated Entities (“RE”) from undertaking or assuming exposure under “synthetic securitisation” structures. This led to industry-wide confusion regarding the permissibility of loss sharing arrangements such as FLDG.

Continue Reading FIG Paper (No.18 – Series 2) RBI’s New Default Loss Guarantee Guidelines: Late but Not lost