A curated reading list on nutrition policy, food and supplement regulation (including FSSAI), clinical trial rules (including CDSCO) and trial practice, with original sources for deeper reading.
NutritionAdvisory · India
FSSAI: ashwagandha leaves not permitted in health supplements
FSSAI reminded food businesses that only ashwagandha (Withania somnifera) root and root extracts are permitted under Schedule IV of the 2016 nutraceutical regulations. It cited safety concerns about reactive withanolides in the leaves, and the advisory followed a Ministry of Ayush direction issued the day before.
In practice: Check ingredient specifications and supplier certificates for plant part. The Karnataka High Court has granted an interim stay to the companies that petitioned it; the advisory still applies to everyone else.
CDSCO: NDCT (Amendment) Rules, 2026 introduce prior intimation for study material
Notified as G.S.R. 46(E), the amendment lets sponsors begin manufacturing new drugs and investigational products for clinical trials, BA/BE studies and testing once CDSCO acknowledges an online intimation on the SUGAM portal. Cytotoxic drugs, narcotics and psychotropics, sex hormones, beta-lactam antibiotics and biologics with live microorganisms still need prior permission, now with a 45-working-day review instead of 90.
In practice: Can shorten study start-up. Trial approval, ethics committee review and CTRI registration are unchanged, and material made under intimation may only be used in the study.
Good Clinical Practice: FDA issues ICH E6(R3) guidance
The revised guidance emphasizes quality by design, proportionate risk management and participant protection, while accommodating modern trial designs, data sources and technology.
In practice: A useful reference when reviewing sponsor responsibilities, study oversight and quality planning.
Under the NDCT (Amendment) Rules, 2024 (G.S.R. 581(E)), contract research organisations must be registered with the Central Licensing Authority, applying on Form CT-07B, before they conduct clinical trials or BA/BE studies of new or investigational drugs in people.
In practice: Confirm your CRO’s registration status when you qualify vendors for studies in India.
The FDA’s proposal describes a front-of-package Nutrition Info box showing saturated fat, sodium and added sugars as low, medium or high. Its May update extended the public comment period to 15 July 2025.
In practice: The proposal and supporting consumer research offer insight into how people interpret nutrition information. This item describes a proposal, not a final requirement.
Updated criteria for the “healthy” food label claim
The FDA announced revised criteria for the voluntary “healthy” claim. These combine qualifying food-group amounts with limits on added sugars, saturated fat and sodium.
In practice: A reference for nutrition product teams assessing formulation and label claims for the U.S. market.
Planning clinical trials with decentralized elements
FDA guidance addresses trial activities outside traditional study sites, including telehealth, in-home visits and visits with local healthcare providers.
In practice: A starting point for evaluating remote activities within a study’s participant experience and operational plan.
Manually curated. Dates refer to the source publication or update; this list is not a live news feed. These items cover developments in the United States and India; requirements in other markets differ. Follow the original sources for subsequent changes. Ask us how a change affects your product.