The Cosmeceuticals Grey Zone: When a Cosmetic Claim Risks Becoming a Drug Claim
“Cosmeceutical” is a popular marketing word. It suggests something more powerful than an ordinary Cosmetic — a product that treats skin condition, not just improves appearance. The problem is that Indian law does not recognize “Cosmeceutical” as a regulatory category at all. A product is either a Cosmetic or a […]
Read MoreSoftware as a Medical Device (SaMD) – India’s Regulatory Stance
Although software intended for Medical purposes has been regulated in India since the implementation of MDR, 2017 Rules. CDSCO’s Guidance Document on Medical Device Software (Doc No. CDSCO/MD/GD/MDSW/01/2026), issued on 21 July 2026, represents the first comprehensive regulatory guidance dedicated specifically to software-based medical technologies. Through Circular F. No. MED-16028/2/2025-office, […]
Read MoreThe Future of Biological Regulation in India: Biosimilars, CAR-T, AI & Advanced Therapies
India’s Biological Regulatory landscape is at an inflection point. The country that pioneered affordable Biosimilar access, built one of the world’s largest vaccine manufacturing ecosystems, and established the framework for recombinant Biological oversight is now navigating a new wave of regulatory complexity — driven by CAR-T cell therapies, personalised medicine, […]
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Ingredient Safety Dossiers: Building a Defensible Package for Novel Actives
Companies developing Cosmetics with new or unusual active ingredients face a higher regulatory bar in India than those using well-established formulations. Understanding what “new” means under the Cosmetics Rules, 2020, and what needs to go into a safety dossier, can save months of delay at the approval stage. Step One: Find Out If Your Ingredient Is Actually […]
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Recall Management for Medical Devices in India
A Recall is one of the few regulatory events where speed of response directly influences both patient safety outcomes and a company’s regulatory standing. Yet many manufacturers only consider their Recall process after a Recall becomes necessary — by which point, the absence of a pre-built protocol costs valuable time, […]
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How to Build an Indian Regulatory Strategy for Advanced Biologicals Before Entering the Market
The decision to enter the Indian market with an advanced Biological product should be made with a comprehensive regulatory strategy in place. India’s multi-authority regulatory environment, distinct clinical data requirements, unique quality expectations and complex commercial landscape reward companies that invest in strategic regulatory planning before beginning product development or […]
Read MoreRegulation/Guidelines
Cosmetic Claims Substantiation: What Counts as Evidence Under Indian Rules
Walk down any Cosmetics aisle and you will see claims like “clinically proven,” “dermatologist tested,” or “reduces fine lines in two weeks.” These claims sell products — but under the Cosmetics Rules, 2020, they also come with legal responsibility. Under Rule 36 of the Cosmetics Rules, 2020, a Cosmetic must […]
Regulation/Guidelines
AI/ML-Based Medical Devices — Emerging Regulatory Questions
Traditional Medical Device regulation assumes a fixed product: what’s approved is what ships, indefinitely, until a formal change is filed and reviewed. Adaptive AI and machine learning algorithms break that assumption by design — a model that continues learning after deployment is, in a meaningful sense, a different product than […]
Regulation/Guidelines
Post-Market Surveillance for Cosmetics in India: What CDSCO Expects After Launch
Getting a Cosmetic product registered and onto shelves in India is only half the job. Once a product is in the market, the Cosmetics Rules, 2020 place ongoing duties on manufacturers and Importers to keep watching it. This is called post-market surveillance, and it is becoming one of the areas […]