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Associate in the Pharmaceutical, Healthcare & Life Sciences Practice at the Delhi NCR office of Cyril Amarchand Mangaldas. Anshul graduated from the National Law School of India University, Bengaluru in 2022 and specializes in regulatory compliance, advisory work, tender matters and litigation pertaining to the pharmaceutical, medical devices, digital health, clinical trials and the life-sciences industry. He also has prior experience in arbitration, company law, contract law and insolvency litigation. He can be reached at anshul.butani@cyrilshroff.com

The National Medical Devices Policy, 2023: A Closer Look at Strategy and Implementation

In an earlier blog post, we took a close look at the National Medical Devices Policy, 2023 (“Policy”), notified by the Department of Pharmaceuticals (“DoP”) on May 2, 2023[1]. We delved into the framework, objectives and core focus areas of the Policy. While the aim of the Policy was clearly to reduce import dependency and establish India as a global manufacturing hub for medical devices, little information was provided on the means to achieve these goals. To draw a holistic picture, we sought guidance from the Approach Paper to the National Medical Devices Policy, 2022 (“Approach Paper”)[2], which was based on similar principles and furthered the same goals as the present Policy. However, the DoP has recently also issued a strategy document on the Policy (“Strategy Document”)[3] to fine-tune and expand on its implementation strategies. In light of the same, this blog post analyses the Strategy Document, measures envisaged thereunder, enforcement priorities and focal points.

Continue Reading The National Medical Devices Policy, 2023: A Closer Look at Strategy and Implementation

A Closer Look at India’s Pet Care Sector and Regulatory Grey Areas

In Part I of this series, titled ‘The (Pawsome) Pet Care Sector: Through a Legal Lens’, we provided a broad overview of the registration and compliance requirements for entities in the pet care industry. We also discussed factors like the entry options, the sector’s migration to the online mode, and relevant judicial pronouncements.

The legal framework for pet care in India is spread across a host of rules and legislations. The relevant regulatory duties are also divided between various regulators including the Food and Safety Standards Authority of India (“FSSAI”), the Central Drugs Standard Control Organisation (“CDSCO”), and the Animal Welfare Board of India, among others. Therefore, industry players will have to keep track of a wide range of legislations (along with relevant State rules and municipal laws) to ensure proper compliance.

Continue Reading Barking up the Right Tree: A Closer Look at India’s Pet Care Sector and Regulatory Grey Areas

The pet-care sector has seen a massive growth in India, particularly during the pandemic. The sector is estimated to touch INR 10,000 crore by 2025[1], with the number of pets increasing at a rate of 11% per annum[2]. Healthcare services, nutrition, drugs, and pet-grooming form the core of the overall pet care sector.

Alongside growth, the pet care sector has witnessed a noticeable increase in competition with the entrance of several established as well as nascent players. Large organisations (like Emami) view investment in the pet-care sector as a favorable avenue for corporate diversification[3]. Owing to the specialised nature of the sector, the market trend appears to be one of strategic collaborations between large industry players and smaller organisations with niche focus areas. There are also collaborations between smaller organisations which aim to increase their reach and market share in the pet care sector – an example is the recent acquisition of Capt Zack (specializing in pet accessories) by Wiggles (specializing in pet food).

Continue Reading The (Pawsome) Pet Care Sector: Legal Insights

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’

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

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