The three draft amendments released by CDSCO in 2025 — covering advanced biologics, Schedule H2 expansion, and debarment provisions — represent a significant tightening of India’s pharmaceutical regulatory framework. For any pharmaceutical law firm India or CDSCO legal consultant in India advising clients in the biotech and pharma space, these proposals demand immediate attention and […]

India’s regulatory framework for medical devices and in-vitro diagnostics (IVDs) has seen several important developments in late 2024 and early 2025. Key updates include an expansion of the list of notified medical devices (bringing items like surgical gloves, bandages, and syringes under regulation), revisions to risk-based device classification (with draft lists open for stakeholder feedback), […]

As part of our ongoing legal service India commitment, particularly in the domain of drug law, we bring you a detailed regulatory update on the recent government notifications prohibiting certain veterinary and food-chain drugs. Businesses and practitioners seeking compliance guidance may benefit from consulting a drug law firm India or a tech law partner well-versed […]

This chapter gives decision makers and compliance teams a clear, citable map of India’s drug regulatory framework — what laws and rules apply, how approvals work (including imports/exports), how clinical trials are governed, and how price control interacts with market access. For any pharmaceutical company legal advisory India or legal service professional in India advising […]

Compliance in the Indian healthcare sector operates at the intersection of public health protection, affordability, and industrial regulation. For pharmaceutical and medical device companies, regulatory compliance is no longer confined to licensing and quality assurance; it increasingly encompasses pricing controls, digital traceability, post-market surveillance, and platform-based distribution oversight. As regulatory intensity has grown during 2024–2025, […]

This chapter delves into the evolving regulatory landscape for biologics, biosimilars, biotechnology research, and emerging therapies in India. It highlights core legal frameworks, quality standards, approvals, ethical practices, and future policy directions. For any healthcare legal consultant india or legal service India professional advising life sciences clients, this framework represents one of the most complex […]

Introduction The rapid spread of sophisticated content manipulation, largely fueled by Artificial Intelligence (AI) and deep learning, has created an urgent need for new digital governance frameworks worldwide. The fundamental regulatory challenge is twofold: to effectively distinguish between harmless edited media and malicious deepfakes (realistic synthetic content created to deceive), and to balance the critical […]

Objective For any pharmaceutical company legal advisory india or healthcare legal consultant india, this section serves as an essential reference. Equip healthcare, pharma, and med tech stakeholders with a clear, citable map of India’s current framework for online drug sale (e pharmacy), telemedicine, digital health data protection, and platform/intermediary compliance—including what’s in force, what’s still […]

Introduction On 15 October 2025, the Food Safety and Standards Authority of India (FSSAI), issued an Order withdrawing all previous permissions for the use of the term “ORS” with any brand names [1]. Earlier orders dated 14 July 2022 [2] and 2 February 2024 [3] had permitted use of “ORS” as part of a trademark […]

The Union Ministry of Health and Family Welfare has issued a draft amendment to the Drugs Rules, 1945, introducing a key regulatory distinction under Schedule K between liquid antiseptics meant for household use and those intended for hospital or institutional use. The draft amendment has been notified as G.S.R. 759(E) in the Gazette dated 16 […]