Monthly Compliance Newsletter – September 2026

August 2026 was a busy month across India's regulatory landscape, with notable developments from CDSCO / Ministry of Health & Family Welfare, FSSAI, CPCB / MoEFCC, the Ministry of Power / BEE / BIS, MeitY, DGFT, and the Department of Telecommunications.

This edition covers a tightening of the rules around fixed-dose cold and cough combinations for young children, a proposal to bring four more medicines under stricter Schedule H1 control, new fee and labelling requirements for medical devices, a widened list of countries recognised for medical device quality checks, a clarification on where to file applications for globally unapproved new drugs, a proposed

Drugs & Cosmetics Regulation — CDSCO / Ministry of Health & Family Welfare

Government Bans Sale of Cold & Cough Combinations with Chlorpheniramine + Phenylephrine for Kids Under 4 — S.O. 4595(E), dated 18 August 2026

The Ministry of Health and Family Welfare has widened an existing restriction on a common cold-and-allergy combination. Back in April 2025, the government had already restricted the original combination

Four More Medicines Proposed for Schedule H1 Control — Draft G.S.R. 745(E), dated 19 August 2026

CDSCO has floated a draft amendment to bring four additional drugs under the stricter Schedule H1 category, which means tighter prescription, sale, and record-keeping controls once finalised. The four medicines proposed for addition are Flupentixol, Zopiclone, Gabapentin, and Carisoprodol.

Being a draft notification, this isn't final yet — it's open for public comments before the government finalises it.

Medical Devices (Second Amendment) Rules, 2026 — New Testing Fees & Sterilisation Site Labelling — G.S.R. 743(E), dated 14 August 2026

Second, if a device manufacturer outsources sterilisation to another licensed facility, the sterilisation site's licence number must now be printed on the device label — using the format "Sterilization sites Manufacturing License Number" or the short form "Ster. Mfg. Lic. No." / "S.M.L."

Medical Devices (Third Amendment) Rules, 2026 — EU Countries Added for Class A Device QMS Recognition — G.S.R. 744(E), dated 14 August 2026

This amendment does three things. It clarifies that testing laboratory requirements under Rule 19 also cover Quality Management System (QMS) standards, not just technical standards. It renames Rule 19's marginal heading to "Government Medical Device Testing Laboratories" for clarity. And most notably for importers, it expands Rule 63(1)'s proviso (iv) — which lists countries whose QMS certification is recognised for Class A non-sterile, non-measuring (NSNM) devices — to now include European Union countries, alongside the US, Australia, Canada, and Japan already covered.

CDSCO Clarifies Where to File Applications for Globally Unapproved New Drugs Tested on Indian Subjects — Circular dated 10 August 2026

CDSCO has clarified the filing route for a specific, fairly narrow category of drug applications: new drugs that aren't approved anywhere in the world yet, but where Phase III Global Clinical Trials (GCTs) involving Indian subjects are either ongoing or completed. CDSCO noted it had been receiving such applications through various channels, and after review by an internal technical committee, has now directed that all these cases — since they need a full evaluation of non-clinical and clinical data under the New Drugs and Clinical Trials Rules, 2019 — must be filed as Investigational New Drug (IND) applications and routed specifically to the IND Division at CDSCO headquarters, New Delhi.

Food Safety & Standards — Latest FSSAI Regulations, Notifications & Compliance Updates

FSSAI Proposes Clear Cut-Offs for "High Fat, Sugar or Salt" Foods in School Regulations — Draft Notification dated 7 August 2026

CPCB Issues Public Notice on Strict Enforcement of Common EPR Portal Registration for Plastic Packaging — dated 27 August 2026

The Central Pollution Control Board has put out a firm reminder that Producers, Importers, Brand Owners, Manufacturers (of compostable/biodegradable plastic items), Sellers, and Plastic Waste Processors must be registered on the Common EPR (CEPR) Portal before doing any business involving plastic packaging. CPCB says it has observed two recurring problems — entities that remain unregistered despite being covered under the rules, and registered entities continuing to record transactions with unregistered counterparties.

To fix this, CPCB is tightening the portal itself: going forward, the system will stop allowing

Waste Tyre EPR: Annual & Quarterly Return Deadline for FY 2025-26 Extended to 30 September 2026

Good news for entities registered on the Waste Tyre EPR Portal — the Ministry of Environment, Forest and Climate Change has extended the deadline for filing quarterly and annual returns for FY 2025-26 from 30 April 2026 to 30 September 2026. The extension came after CPCB flagged that producers and recyclers were facing operational and technical difficulties compiling and reconciling their compliance data on the centralised portal.

E-Waste EPR: Quarterly & Annual Return Deadline for FY 2025-26 Also Extended to 30 September 2026

The same relief has been granted to entities registered on the E-Waste EPR Portal. CPCB has informed all registered entities under the E-Waste (Management) Rules, 2022 that the deadline for filing quarterly and annual returns for FY 2025-26 has been extended from 30 April 2026 to 30 September 2026, in line with Rule 9A of the E-Waste (Management) Amendment Rules, 2024.

Battery Waste EPR: Annual Return Deadline for FY 2025-26 Extended to 30 November 2026

Producers registered under the Battery Waste Management Rules, 2022 have also been given more time. Following requests from producers about operational and technical challenges in compiling compliance data, the Ministry of Environment, Forest and Climate Change has extended the deadline for filing annual returns for FY 2025-26 from 30 June 2026 to 30 November 2026.

CPCB Opens Bulk Consumer Registration on the ELV EPR Portal

The Central Pollution Control Board has activated the Bulk Consumer registration category on its centralised End-of-Life Vehicles (ELV) EPR portal. Under the Environment (Protection) (End-of-Life Vehicles) Rules, 2025 — in force since 1 April 2025 — a "bulk consumer" is any entity owning more than 100 vehicles (this includes large fleet operators, corporates, and state transport undertakings). The portal itself went live in January 2026 for producer and Registered Vehicle Scrapping Facility (RVSF) registrations; the Bulk Consumer registration module is the latest addition, letting these entities now complete their registration online instead of through offline coordination with the SPCB.

Once registered, bulk consumers are required to deposit any vehicle that becomes an ELV at a designated

Mandatory Star Labelling for Induction Hobs Pushed Back to 1 January 2027

The Ministry of Power has postponed the mandatory star-rating requirement for countertop induction hobs by six months. The rating scheme was originally due to become mandatory from 1 July 2026, but the government has now moved that date to 1 January 2027.

BEE Revises Star Rating Norms for Self-Ballasted LED Lamps — Advisory dated 18 August 2026 (S.O. 2976(E) & S.O. 2977(E), Ministry of Power)

BEE has issued fresh instructions for all manufacturers and permittees of self-ballasted LED lamps under its Standards & Labelling programme. The existing star rating table has been upgraded by one full star level, and the new table will stay valid for two years, from 1 January 2027 to 31 December 2028. This follows a Ministry of Power notification that also pushes the earlier compliance deadline of 30 June 2026 (for meeting IS 16102 Part 2 requirements) to 31 December 2026, and adds a further, stricter table taking over from 2029 to 2031. Testing for flicker and stroboscopic effects specifically becomes mandatory only from 1 January 2027.

BEE Revises Star Rating Norms for Distribution Transformers — Advisory dated 18 August 2026 (S.O. 5967(E), Ministry of Power)

BEE has also revised the Star Rating Table for Distribution Transformers, with the new table valid for three years, from 1 January 2027 to 31 December 2029. The underlying Ministry of Power notification makes BIS certification and specific type-tests (short-circuit impedance, load loss, and no-load loss measurement per IS 2026 Part 1:2011) compulsory for every distribution transformer manufactured or sold in India, along with a detailed new loss table covering transformer ratings from 16 kVA to 2,500 kVA across all five star levels.

Standards & Labelling Programme for Tubular Fluorescent Lamps Discontinued — S.O. 2978(E), dated 10 June 2026

The Ministry of Power has formally withdrawn the mandatory Standards & Labelling scheme for Tubular Fluorescent Lamps, effective 1 July 2026. This phases out compulsory BEE star labelling for this lamp category — anything already done or pending from before the withdrawal date remains unaffected, but no new star-labelling obligation applies going forward.

BIS Extends Implementation Deadlines for LED Lamp and LED Luminaire Standards to 2 February 2027

The Bureau of Indian Standards has given manufacturers more time to comply with a whole set of revised LED standards. This covers self-ballasted LED lamps under IS 16102 (Part 1):2026, as well as seven categories of LED luminaires under the revised IS 10322 series — Fixed General Purpose LED Luminaires (and Fancy Lights), Recessed LED Luminaires, LED Luminaires for Road and Street Lighting, LED Flood Lights, LED Hand Lamps, LED Lighting Chains, and LED Luminaires for Emergency Lighting. For all of these, the last date up to which the old and revised standards can run in parallel has been pushed to 2 February 2027; all other terms of the original guidelines remain unchanged.

BIS Confirms Extended Implementation Date for Television Receiver Standard IS 18112 — 26 January 2027

BIS has issued updated guidelines confirming that the Ministry of Electronics and Information Technology (MeitY) has further extended the implementation date for mandatory BIS certification of Digital Television Receivers for Satellite Broadcast Transmission (IS 18112) under the Compulsory Registration Order. This aligns with MeitY's own gazette notification extending the deadline to 26 January 2027, covered in an earlier edition — this BIS circular simply confirms the same date for registration and testing purposes and updates the applicable implementation guidelines accordingly.

BIS Issues Registration Guidance for Wearable Glasses and Extended Reality Devices — dated 13 August 2026

BIS has issued a product-categorisation guide for companies applying for Compulsory Registration under the Electronics and IT Goods (CRS) Order, 2021, specifically for wearable glasses and extended reality (XR) devices — a fast-growing category that didn't have clear-cut filing guidance until now. Applicants must now file under specific categories: Audio Glasses (under Wireless Earphones & Headphones), Smart Glasses (under Digital or Video Camera, depending on whether they capture photos only or photos and video), and AR/MR Glasses (under Extended Reality Products). A separate table also breaks the Extended Reality Products category itself into AR Glasses, Other AR Devices, VR Headsets, MR Glasses, and Other MR Devices. Each distinct product name requires its own separate licence.

DGFT Widens QCO/BIS Exemption Scope for SEZ Imports — Notification No. 20/2026-27, dated 2 June 2026

The Directorate General of Foreign Trade has amended Para 2.03A(iii) of the Foreign Trade Policy, 2023 to widen the exemption from mandatory Quality Control Orders (QCOs) and BIS requirements for Special Economic Zone (SEZ) units and developers. Earlier, this exemption applied only to inputs imported for export production, with no clearance allowed into the Domestic Tariff Area (DTA). Under the revised provision, the exemption now covers all permissible goods imported for authorised SEZ operations — including raw materials, components, consumables, spares, and capital goods — aligning the FTP with the SEZ Act, 2005 and SEZ Rules, 2006.

Importantly, the exemption only covers use within the SEZ. Any removal, transfer, or clearance of such goods (or products made from them) into the DTA will still need to comply with the applicable QCOs,

DoT Extends Security Certification Exemption for Cloud-Based IP Routers and Wi-Fi CPEs to 31 December 2026

The National Centre for Communication Security (NCCS), under the Department of Telecommunications, has extended the exemption from mandatory security certification for cloud-implemented IP routers and Wi-Fi Customer Premises Equipment (CPE). The exemption — first granted in March 2026 and due to lapse on 31 August 2026 — has now been extended to 31 December 2026.