Pharmaceutical

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Double Check: Decoding India’s Dual Framework for Medical Device Labelling

Introduction

The medical devices sector in India is undergoing rapid transformation, driven by evolving regulations, technological advancements and growing healthcare demands. It is expected to grow to $20.51 billion by 2029. The demand for imported medical devices increased by 21% between November 2022 and October 2023, totalling medical device imports of INR 61,262.84 crore ($7.23 billion)[1]. The regulatory ambit governing medical devices in the country has seen significant reforms aimed at ensuring safety, quality and accessibility. For healthcare products, where precision and reliability are vital, stringent labelling regulations serve as a cornerstone for ensuring safety, quality, and consumer confidence. The regulatory framework for labelling of medical devices in India is governed by multiple legislative frameworks, each designed to uphold stringent standards.Continue Reading Double Check: Decoding India’s Dual Framework for Medical Device Labelling

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.Continue Reading Navigating Adverse Drug Reactions: Extent of Pharmacovigilance in India

    Impact of the Jan Vishwas Act, 2023 on the Pharmaceuticals Industry – Decriminalizing Minor Offences One Step at a Time

    Introduction

    The Jan Vishwas (Amendment of Provisions) Act, 2023 (“JV Act”) was introduced with the aim of conveying ease of doing business and to amend certain enactments for decriminalising and rationalising offences, thereby promoting trust-based governance. The impact of the JV Act has reverberated across various sectors, including the pharmaceuticals and cosmetics industry. A key area of interest in relation to the JV Act’s amendments is their impact on the Drugs and Cosmetics Act, 1940 (“D&C Act”), which governs the regulation of drugs and cosmetics in India.Continue Reading Impact of the Jan Vishwas Act, 2023 on the Pharmaceuticals Industry  – Decriminalizing Minor Offences One Step at a Time

    Rx for Referrals: Navigating the Ethical Considerations in India’s Medical Landscape

    Introduction

    In the intricate ecosystem of global healthcare, the trust between doctors and patients forms the bedrock of ethical practice. A growing number of Indian healthcare service providers are integrating digital health technologies into their business development initiatives and operational framework, leading to an unsettling trend. Several such healthcare providers now deploy offline and online resources to set up and maintain incentive-driven patient referral networks through collaboration and partnership arrangements with healthcare institutions and practicing doctors. These arrangements are designed to attract new patients through referrals from doctors, pharmacists, and healthcare workers, who are then adequately compensated with merchandise, coupons, gifts, travel facilities and grants. This intersection of medicine and commerce raises profound ethical and legal questions, challenging the integrity of the medical profession and the sanctity of patient care.Continue Reading Rx for Referrals: Navigating the Ethical Considerations in India’s Medical Landscape

    Pre-Clinical Testing on Claws and Paws: Decoding the Permissibility of Animal Experimentation

    Introduction

    The practice of experimenting on animals has long been a focal point of ethical and regulatory debates. Juxtaposed against the concerns for animal welfare, this complex landscape tries to strike a balance between the pursuit of scientific progress to advance human knowledge and safeguard the rights and well-being of fellow planet inhabitants. Notwithstanding the surge in global commitment to reduce the number of animals used in experimentation and research activities, reports indicate that more than 100 million animals are used globally for experimentation on an annual basis. Further, trend suggests that, currently, there is little to no decline in worldwide use of animals in research and lab work.Continue Reading Pre-Clinical Testing on Claws and Paws: Decoding the Permissibility of Animal Experimentation

    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