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Kritika Asawa

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Associate in the Pharmaceutical, Healthcare & Life Sciences Practice at the Delhi NCR office of Cyril Amarchand Mangaldas. She can be reached at kritika.asawa@cyrilshroff.com

Designer Babies in India: Ethical Dilemma and Legal Roadblocks

Introduction

Imagine walking into a fertility clinic and choosing every detail of your future baby, including eye colour, height, intelligence, athletic ability, and even resistance to genetic diseases. Advancements in reproductive technology are pushing the boundaries of what is possible. In the United States, the demand for sperm and egg selection is soaring, with individuals spending thousands of dollars to “curate” their ideal baby. However, it is important to note that experts in the United States currently do not support the practice of creating designer babies through gene editing. Continue Reading Designer Babies in India: Ethical Dilemma and Legal Roadblocks

Beyond the Basket: Inside India’s Diverse E-Commerce Food Landscape – Part 2

Introduction

In our previous blog post, we provided insights into the regulatory framework governing E-Commerce Food Business Operators (“E-FBOs”)[1] that operate under the purview of the Food Safety and Standards Authority of India (“FSSAI”). The FSSAI, along with its state counterparts, is primarily empowered under the Food Safety and Standards Act, 2006 (“FSS Act”) and its accompanying rules, regulations, and guidelines to regulate the food industry and establish standards that ensure the safety and quality of food products. We also delved into the recent amendment to the FSS Licensing and Registration of Food Businesses Amendment Regulations, 2021 (“2021 Amendment Regulations”)[2], which were primarily introduced to regulate E-FBOs. We also analysed it in line with the key challenges and obstacles that E-FBOs might encounter, on their road to ensuring full compliance with the regulations.Continue Reading Beyond the Basket: Inside India’s Diverse E-Commerce Food Landscape – Part 2

Beyond the Basket: Analysing Underlying Challenges for India’s E-FBOs – Part 1

Introduction

India’s food industry is experiencing a digital revolution, with E-Commerce Food Business Operators[1] (“E-FBOs”) transforming the way food and related services/ products are being ordered, consumed and experienced. From local restaurants and cafes offering delivery through mobile applications, cloud kitchens serving gourmet meals, groceries delivered within minutes, the E-FBO landscape is brimming with innovation and opportunity. However, this digital transformation is not without regulatory challenges that E-FBOs must navigate to ensure compliance and maintain consumer trust.Continue Reading Beyond the Basket: Analysing Underlying Challenges for India’s E-FBOs – Part 1

From Farm to Fork: Demystifying India’s Food Safety Standards

Introduction

The Indian food industry thrives on innovation and dynamism, hence ensuring the safety of food products remains a top priority for the Indian authorities. The Food Safety and Standards Authority of India (“FSSAI”) serves as the guardian of public health, that introduced the Food Safety and Standards Act, 2006 (“FSS Act”). This legislation read with its compendium of regulations, rules, and guidelines meticulously outlines the framework for every step of the food supply chain from its origin to your table. While the FSS Act provides a foundational framework, the nuances of the regulatory framework are recorded in the regulations and guidelines, which have been established over time to encompass and regulate the expansive and ever-changing world of food products. This blog post delves into the legalities that govern the key aspects of the food industry; namely, production, distribution, import, advertising, labelling, and the safety testing standards.Continue Reading From Farm to Fork: Demystifying India’s Food Safety Standards

Innovative Medical Devices under the Lens of Clinical Investigations – A Dormant Volcano Waiting to Erupt?

Introduction

Since the advancements in healthcare services and medicinal sciences, medical devices in India have become part and parcel of the existing healthcare delivery services framework.  Medical devices, in essence, are tools, instruments and even software which inter alia enable healthcare service providers to diagnose, monitor, mitigate and treat illnesses and health conditions.Continue Reading Innovative Medical Devices under the Lens of Clinical Investigations – A Dormant Volcano Waiting to Erupt?

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

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