This is the September 2026 edition of a monthly compliance newsletter for industry stakeholders in India. It consolidates key regulatory notifications issued during August 2026 by CDSCO, FSSAI, and CPCB, along with compliance deadlines. The document is designed for manufacturers, importers, and compliance teams needing to track changes in drugs, medical devices, food safety, and environmental…
This is the September 2026 edition of a monthly compliance newsletter for industry stakeholders in India. It consolidates key regulatory notifications issued during August 2026 by CDSCO, FSSAI, and CPCB, along with compliance deadlines. The document is designed for manufacturers, importers, and compliance teams needing to track changes in drugs, medical devices, food safety, and environmental regulations.
The first section covers drug regulation by CDSCO and the Ministry of Health. It details a ban on fixed-dose combinations of Chlorpheniramine and Phenylephrine for children under four, a draft proposal to add four drugs to Schedule H1, and a clarification on filing Investigational New Drug applications for globally unapproved drugs tested on Indian subjects.
The second section addresses medical device rules. It explains new testing fees under a Ninth Schedule, requirements to print sterilisation site licence numbers on labels, and recognition of EU QMS certification for Class A devices. It also includes fee amounts and effective dates for these changes.
The third section covers FSSAI food safety updates. It proposes numeric thresholds for high fat, sugar, or salt foods in school canteens, and finalises plastic-free packaging rules for pan masala. The section includes comment windows and references to ICMR dietary guidelines.
The final section focuses on environmental compliance from CPCB. It highlights strict enforcement of the Common EPR Portal for plastic packaging, requiring registration of all entities, and extends the deadline for Waste Tyre EPR returns to 30 September 2026. It also notes upcoming changes to LED star-rating norms.