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Navigating Adverse Drug Reactions: Extent of Pharmacovigilance in India

    Introduction

    Pharmacovigilance, as defined by the World Health Organization (WHO), is the science and practice of detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems. Pharmacovigilance in essence aims to enhance patient safety by monitoring and evaluating the risks associated with pharmaceutical products. It is interesting to note that the significance of pharmacovigilance has grown over the years, especially with the increasing global integration of pharmaceutical supply chains and concerns over drug safety. With India being commonly referred to as the ‘pharmacy of the world’ due to it being a global supplier of affordable medicines, ensuring drug safety is critical for public health at large. This blog post outlines the pharmacovigilance system in India, including the existing framework, current challenges, and the future roadmap.

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    SEBI Proposes to Unlock Listed Debt Markets for Category II AIFs

    Introduction

    The Securities and Exchange Board of India (“SEBI”), as part of its ongoing regulatory reforms, released a consultation paper on February 7, 2025, seeking public comments to review Regulation 17(a) of the SEBI (Alternative Investment Funds) Regulations, 2012 (“AIF Regulations”). The objective is to enhance investment flexibility for Alternative Investment Funds (“AIFs”), particularly in debt securities, while addressing concerns arising from recent regulatory changes by way of allowing Category II AIFs to make up to 100% of their investment in certain listed debt securities as explained in detail below. As of now, Category II AIFs are allowed to make less than 50% of their investments in listed securities.

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    Proceedings seeking revocation of a Patent not same as those seeking a finding of Invalidity

    In  its recent judgment dated January 15, 2025, in C.O. (COMM.IPD-PAT) 38/2022 Macleod Pharmaceuticals Ltd. Vs The Controller of Patents and Anr., the Delhi High Court (“DHC”) tackled some rather tricky but interesting questions, which have surfaced time and again in heavily contested patent infringement and invalidation proceedings in recent years, particularly in the pharmaceutical space.

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    Removal of Managing Director: Legal Position and Practical Challenges

    Context

    A managing director (“MD”) is the principal executive officer of a company, serving on its Board in an executive capacity and is at the helm of its affairs. He is primarily responsible for managing the day-to-day affairs of the company under the overall ‘superintendence, control and direction’ of the Board.

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    IRDAI Regulatory Reform Series: Rural, Social Sector, and Motor Third-Party Obligations

    The Insurance Act, 1938 (“Insurance Act”), includes special provisions obligating insurers to mandatorily source a part of their business from persons residing in rural areas; workers in the unorganised or informal sector, or from economically vulnerable or backward classes of the society.[1] Insurers are also required to underwrite a minimum percentage of insurance business for third-party motor insurance policies, both under the Insurance Act[2] as well as the Motor Vehicles Act, 1988 (“MV Act”).[3] These requirements were, until recently, implemented through two distinct regulations issued by the Insurance Regulatory and Development Authority of India (“IRDAI”) – the IRDAI (Obligation of Insurer to Rural and Social sector) Regulations, 2015 (“RSO Regulations”), and the IRDAI (Obligation of Insurer in Respect of Motor Third Party Insurance Business) Regulations, 2015 (“MTP Regulations”).

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    Indranath Bishnu and Ayushi Agrawal

    Insurance Brokers Association of India projects insurance broking sector to capture a 45 per cent market share by 2030 following increased insurance penetration and the demand for insurance productsOver the past couple of years, the Indian insurance industry has seen a series of significant transformations and new developments. Modified regulations, liberalisation of commission regimes, and proposals for amendment of regulatory architecture have opened new avenues of growth for the insurance broking industry.

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    FIG Paper (No. 40 – VDA Series 4) Global Crypto Developments: Lessons for India’s Regulatory Regime in 2025.

    While reports indicate that India has the highest virtual digital asset (“VDA”) adoption across jurisdictions, we are yet to see any concrete movement on a corresponding regulatory framework to govern the sector and provide legal clarity.

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    FIG Paper (No. 40 – Data Law Series 6) Draft Digital Personal Data Protection Rules, 2025 - Key Implications for Financial Services Sector

    Background:

    1. India’s first dedicated data privacy law, the Digital Personal Data Protection Act, 2023 (“DPDP Act”)[1], was passed by both houses of Parliament, and received Presidential assent on August 11, 2023. 
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    Background and Introduction

    An “independent director” (“ID”) is defined as “an independent director referred to in sub-section (6) of section 149”,[1] where Section 149(6) of the Companies Act, 2013 (“Act”), clarifies that an ID is “a director other than a managing director or a whole-time director or a nominee director” of the company. To be appointed as an ID, a person must fulfil an elaborate set of objective and subjective criteria separated across equity unlisted and listed companies.

    Continue Reading Sufficiency of extant law to address governance concerns in relation to “independence” of an independent director in relation to subsequent directorships with the company
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    Public Takeovers in India: Flashback 2024

    The year 2024 saw 105 public takeovers implemented through the tender offer route under the Securities and Exchange Board of India (Substantial Acquisition of Shares and Takeovers) Regulations, 2011 (Takeover Regulations). The number of takeovers were 24% higher than the number of takeovers in CY23 (85 in all). The aggregate transaction size (i.e. the aggregate size of the underlying negotiated deal and tender offer) of the takeovers announced in CY24 was INR 705.89 billion, i.e. 158% higher than that of the takeovers announced in CY23 (i.e. INR 274.27 billion). Primarily, the deal activity in CY24 was driven by domestic strategic acquirers. Foreigners executed 11 deals in this space, which was substantially higher than in CY23 (being 3).

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