Newsletter — Monthly Compliance – August 2026
DRUGS & COSMETICS REGULATION — CDSCO / MINISTRY OF HEALTH & FAMILY WELFARE
Drugs (Tenth Amendment) Rules, 2026 — G.S.R. 607(E) dated 8 July 2026: New Restriction on High-Alcohol Oral Formulations
The Ministry of Health and Family Welfare has notified the Drugs (Tenth Amendment) Rules, 2026 via G.S.R. 607(E), published in the Gazette of India on 8 July 2026. The amendment tightens the regulatory treatment of oral liquid medicines with a high alcohol content, closing a long-standing exemption gap.
Until now, Schedule K of the Drugs Rules, 1945 exempted certain categories from full compliance with the Act and its rules. This amendment carves out an exception within that exemption: all oral formulations containing more than 12% alcohol v/v (ethyl alcohol), when packed and sold in packings or bottles larger than 30 ml, will no longer enjoy the Schedule K exemption. In parallel, these same high-alcohol oral formulations have been added as a new entry (Sl. No. 52) under Schedule H1, placing them in the same tightly monitored category as habit-forming and commonly misused drugs — meaning stricter record-keeping, prescription, and dispensing controls will now apply.
This move follows growing regulatory concern over misuse of over-the-counter cough syrups and tonics with high alcohol content, particularly in larger pack sizes.
Statutory Reference: G.S.R. 607(E), F. No. X.11014/07/2025-DR-Part(3), MoHFW — Gazette of India, 8 July 2026
Effective Date: 6 months after publication in the Official Gazette (i.e., on or around 8 January 2027)
Issued by: Harsh Mangla, Joint Secretary
Action for Industry: Manufacturers and marketers of oral liquid formulations should audit their portfolio for products exceeding 12% alcohol v/v in packs above 30 ml; such products will need to move to Schedule H1 compliance (restricted sale, prescription-linked dispensing, and enhanced record-keeping) before the effective date.
CDSCO Circular — Vigilance on Imported Cosmetics Sold Without Valid Import Registration (22 July 2026)
The Central Drugs Standard Control Organization has issued a circular directing tighter surveillance on imported cosmetics being sold in the domestic market without a valid Import Registration Certificate. The circular, signed by Drugs Controller General (I) Dr. Rajeev Singh Raghuvanshi, is a reminder that under Rule 12(1) of the Cosmetics Rules, 2020, no cosmetic can be imported into India unless it has been registered by the Central Licensing Authority or a delegated officer.
CDSCO has observed that imported cosmetics are entering the market without valid registration, prompting this enforcement push.
What's Changing: State Licensing Authorities and Zonal heads of CDSCO have been asked to direct their inspections toward enhanced surveillance of imported cosmetics.
Port-Level Action: All port officers have been directed to keep strict vigil to prevent entry of unregistered cosmetics into India.
Statutory Basis: Cosmetics Rules, 2020 (notified 15 December 2020) under the Drugs and Cosmetics Act, 1940, Rule 12(1)
Issued by: Dr. Rajeev Singh Raghuvanshi, Drugs Controller General (I), CDSCO
Action for Industry: Importers and distributors of cosmetics should verify that every imported cosmetic product carries a valid Import Registration Certificate before it is placed in the domestic market; expect increased inspection activity at ports and in retail/distribution channels.
CDSCO Notice — Stakeholder Comments Invited on Restricting Brand Name Extensions by Pharma Firms (dated 6 July 2026)
The Central Drugs Standard Control Organization (Enforcement Division) has issued a notice inviting public comments on a proposal to regulate the practice of pharmaceutical companies marketing multiple drug formulations under the same established brand name with different extensions.
The issue stems from representations received alleging that a pharmaceutical company was selling several drug formulations — each with different active ingredients — under one common brand name, differentiated only by suffixes. The Drugs Consultative Committee (DCC), in its 67th meeting on 17 November 2025, flagged this as a consumer safety concern: using an identical brand name across products with different active ingredients can mislead consumers and cause confusion about the actual therapeutic use of the medicine.
Rather than issuing a binding rule outright, DCC has recommended a stakeholder consultation before any formal change is proposed.
Statutory Reference: Notice No. Enforc-11021(11)/106/2024-eoffice, CDSCO Enforcement Division, dated 6 July 2026
Comment Deadline: 17 July 2026
Comments To: enforcecell.div@cdsco.nic.in
Issued by: Dr. Rajeev Singh Raghuvanshi, Drugs Controller General (India)
Action for Industry: Pharmaceutical companies using brand-name-extension strategies (i.e., a single brand name spanning products with different active ingredients) should review the DCC recommendations on the CDSCO website and consider submitting comments before the deadline, as any eventual restriction would directly affect existing branding and labelling strategies.
BIS Extends Compliance Deadline for Eight Product Categories Under Quality Control Order — Corrigendum Dated 6 July 2026
What happened: The Bureau of Indian Standards has given manufacturers an extra six months to meet BIS certification requirements for eight product categories, through a corrigendum issued on 6 July 2026.
Background: This corrigendum amends an earlier BIS notification (Ref. HQ-PUB013/1/2020-PUB-BIS (1420), dated 3 February 2026) that had set compliance deadlines for a range of product categories under its schedule.
What's changed: For Serial Numbers 02, 03, 04, 06, 07, 08, 09, and 11 of that schedule, the compliance date in Column (5) has been pushed back:
| Old Deadline |
2 August 2026 |
| New Deadline |
2 February 2027 |
That's a six-month extension for the affected categories.
The BIS corrigendum dated 6 July 2026 extends the implementation deadline only for Serial Numbers 02, 03, 04, 06, 07, 08, 09, and 11 of Notification HQ-PUB013/1/2020-PUB-BIS (1420). These correspond to the following product categories:
| Sl. No. |
Indian Standard |
Product Category |
| 02 |
IS 10322 (Part 5/Sec 1): 2026 |
Fixed General Purpose Luminaires |
| 03 |
IS 10322 (Part 5/Sec 2): 2026 |
Recessed Luminaires |
| 04 |
IS 10322 (Part 5/Sec 3): 2026 |
Road & Street Lighting Luminaires |
| 06 |
IS 10322 (Part 5/Sec 5): 2026 |
Floodlights |
| 07 |
IS 10322 (Part 5/Sec 6): 2026 |
Handlamps |
| 08 |
IS 10322 (Part 5/Sec 7): 2026 |
Lighting Chains (Decorative/String Lights) |
| 09 |
IS 10322 (Part 5/Sec 8): 2026 |
Emergency Lighting Luminaires |
| 11 |
IS 16102 (Part 1): 2026 |
Self-Ballasted LED Lamps for General Lighting Services (Safety Requirements) |
Statutory Reference: HQ-PUB-BIS (1568), dated 6 July 2026, amending HQ-PUB013/1/2020-PUB-BIS (1420) dated 3 February 2026
Issued by: S. K. Verma, Scientist F & Deputy Director General (HMD), BIS
Action for Industry: If your product falls under Sl. No. 02, 03, 04, 06, 07, 08, 09, or 11 of the referenced schedule, update your compliance calendar to the new date. The extra runway is useful, but it's best spent completing testing and certification early rather than treated as a reason to slow down.
Temporary Suspension of n-Butyl Acrylate QCO Enforcement Extended to 31 July 2026
The Ministry of Chemicals and Fertilizers (Department of Chemicals and Petrochemicals) has further extended the temporary suspension of the n-Butyl Acrylate (Quality Control) Order, 2021. This is a rolling relaxation the government has been renewing in response to ongoing global supply chain disruption affecting availability of n-Butyl Acrylate.
The amendment simply pushes the operative date in the proviso to Paragraph 2 of the 2021 Order — the earlier cut-off of 10 July 2026 has now been replaced with 31 July 2026, meaning mandatory BIS certification requirements under the QCO remain suspended until the new date.
Statutory Reference: S.O. 3729(E), F. No. PC-II 46016/6/2020-Tech.CPC (Part 2), Ministry of Chemicals and Fertilizers, 9 July 2026
Background: Principal Order — S.O. 5438(E), 24 December 2021; previously extended via S.O. 1854(E), 10 April 2026
Revised Suspension End Date: 31 July 2026
Issued by: Dr. G. Venkatesh, Joint Secretary
Action for Industry: Importers and manufacturers of n-Butyl Acrylate can continue operating without BIS certification under this QCO through 31 July 2026; keep an eye out for further extensions or a reinstatement date, since this has already been renewed once before.
MeitY Extends Compulsory Registration Timeline for Television Sets to 26 January 2027
The Ministry of Electronics and Information Technology has extended, for the ninth time, the implementation timeline for compulsory BIS registration of Television Sets under the Electronics and Information Technology Goods (Compulsory Registration) Order, 2021.
Television Sets were added at Sl. No. 64 of the CRO schedule via S.O. 1929(E) on 26 April 2023, requiring compliance with IS 18112:2022. The order was originally due to take effect on 26 July 2026 — the very date this extension was issued, effectively granting a last-minute reprieve. The implementation date now stands extended to 26 January 2027.
This is part of a long pattern of extensions for this product category — the principal order has been amended eleven times since March 2021
Statutory Reference: S.O. 4182(E), F. No. W-47/7/2023-IPHW, MeitY, 26 July 2026
New Implementation Date: 26 January 2027 (previously 26 July 2026)
Issued by: Asha Nangia, Group Coordinator & Scientist 'G'
Action for Industry: Television manufacturers and importers get another six months before mandatory IS 18112:2022 registration kicks in — use this window to complete testing and registration rather than assume a further extension is guaranteed.
MoEFCC Removes "Brine Sludge" from Hazardous Waste List for Chlor-Alkali Industry
What happened: The Ministry of Environment, Forest and Climate Change has notified the Hazardous and Other Wastes (Management and Transboundary Movement) Amendment Rules, 2026, with immediate effect from its date of publication.
Worth noting: This amendment skipped the usual public notice-and-comment process. The Central Government invoked its public-interest override under Rule 5(4) of the Environment (Protection) Rules, 1986 to dispense with prior notice — meaning this change went straight into force without a consultation window.
What's changed: The substance of the amendment is narrow but directly relevant to the chlor-alkali industry. In Schedule I of the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016, under the process "Production of caustic soda and chlorine" (S. No. 16), the entry "16.3 Brine sludge" has been removed from the list of hazardous waste categories requiring management under these Rules.
Statutory Reference: G.S.R. 636(E), F. No. 23/151/2022-HSM, MoEFCC — Gazette of India, 16 July 2026
Effective Date: 16 July 2026 (date of publication)
Issued by: Uday Chaudhary, Joint Secretary
Action for Industry: Caustic soda and chlorine manufacturers should update their hazardous waste inventories and compliance filings to reflect that brine sludge no longer falls under this entry. Check with your environmental compliance team on whether this changes disposal or reporting obligations at your facility — the exemption from this specific entry doesn't necessarily mean the waste stream is free of other regulatory requirements.
Goa Launches Deposit Refund Scheme for Liquor Packaging — Registration Deadline 31 July 2026
What happened: The Goa Deposit Refund Scheme Authority has notified Phase I of its Deposit Refund Scheme (DRS), covering liquor and liquor-based commodities packed in DRS-eligible materials. This is a state-level extended producer responsibility measure aimed at the packaging sector in Goa.
Phase I Scope: The scheme covers glass, plastic, and metal packaging used for liquor and liquor-based products, along with any other DRS products — including multi-layered packaging and liquid packaging boards — that the Authority may specify going forward.
Why it matters now: Registration isn't optional groundwork for later — it's a hard precondition. Without it, PIBOs won't be able to place liquor products in the Goa market once the scheme takes effect.
Statutory Reference: Notification No. 3-1-2026-27/GDRS/Notification/01, dated 30 June 2026, Goa Official Gazette Series I No. 14
Registration Deadline: 31 July 2026 — mandatory for all Producers, Importers and Brand Owners (PIBOs) dealing in liquor products
Effective Date: 1 September 2026
Issued by: Sachin S. Desai, Member Convenor, Goa Deposit Refund Scheme Authority
Action for Industry: Liquor brand owners, importers, and producers selling into Goa should register under the DRS well ahead of the 31 July 2026 cut-off. Given the deadline falls before this newsletter reaches most readers' desks, this needs immediate attention rather than routine follow-up — missing it risks disruption to market placement from September onward.
Common EPR (CEPR) Portal Now Active — Single Platform for All EPR Waste Streams
The Central Pollution Control Board (CPCB) has launched the Common Extended Producer Responsibility (CEPR) Portal, a unified platform bringing together registration and compliance management for all EPR waste streams — including Plastic Waste, E-Waste, Battery Waste, Tyre Waste, Used Oil, Scrap of Non-Ferrous Metals, and Construction & Demolition Waste — under one login.
What's New on the Portal:
A refreshed, more user-friendly interface with improved navigation.
Existing registered users can log in directly using their CEPR credentials.
Circulars, SOPs, Rules, and other compliance documents are now consolidated in one place instead of being scattered across waste-stream-specific portals.
Migration has begun for Plastic Waste applications — entities already registered on the standalone Plastic Waste Portal can link their application to the Common EPR Portal, after which their existing details are fetched and verified. Note: some portal features are still under development, so a few action items may not be fully functional yet.
All new registrations for Plastic Waste entities must now go through the Common EPR (SSO) Portal — the earlier standalone portal route is being phased out.
What Registered Entities Should Do Next:
Log in to the new Common EPR Portal.
Link your existing registration(s), wherever applicable.
Verify your registration details once linked.
Report any discrepancies observed during verification.
Complete pending registrations and compliance activities through the new portal.
Issuing Authority: Central Pollution Control Board (CPCB)
Status: Active as of July 2026; migration for Plastic Waste applications currently in progress
Action for Industry: If you're a Producer, Importer, or Brand Owner (PIBO), or a Plastic Waste Processor (PWP) registered on any of the earlier EPR portals — for any waste stream — this is the right time to move to the new Common Portal, link and verify your registration, and complete any pending compliance activity there instead of on the legacy portal.
Standard Pack Sizes Now Prescribed for Edible Oils & Fats — Advisory Dated 5 June 2026
What happened: The Department of Consumer Affairs (Weights and Measures Unit) has issued an advisory amending the Standard Operating Procedure dated 29 December 2023 for determination of net quantity and standard pack sizes for edible oils and fats. It follows industry representations flagging a proliferation of inconsistent package sizes in the market, and aims to make prices easier for consumers to compare across brands.
Standard Pack Sizes for Major Edible Oils (palm oil/palmolein, soybean, sunflower, mustard/rapeseed, groundnut, sesame, rice bran, cottonseed, corn oil, and their blends):
| Category |
Package Size |
Applicability |
| (a) |
Below 200 g or 200 ml |
No restriction |
| (b) |
200 g, 500 g, 1 kg, 2 kg,3 kg,4 kg, 5 kg, 15 kg, 20 kg (or the equivalent in ml/litres) |
Standard packaging applies; net quantity must also be declared by weight, in matching font size, if declared by volume |
A few other things to know:
Minor edible oils (outside the major categories above) remain exempt from the standard pack size requirement, but must still comply with Unit Sale Price declaration norms under the LMPC Rules, 2011.
Wherever quantity is declared by volume, the pack must also show the equivalent weight, per the Fourth Schedule of the LMPC Rules.
The requirement applies equally to domestically manufactured and imported edible oils — no carve-out for importers.
Statutory Reference: Advisory No. I-10/11/2024-W&M (E-35106), Department of Consumer Affairs, dated 5 June 2026
Transition Period: 3 months from the date of issue
Issued by: Ashutosh Agarwal, Director (Legal Metrology)
Action for Industry: Edible oil manufacturers, packers, and importers should align packaging lines to the prescribed standard sizes within the 3-month transition window, and make sure dual weight/volume declarations are in place wherever quantity is shown by volume.
New SOP: Simplified Recognition/Endorsement Process for Already-Approved Weighing & Measuring Instrument Models (dated 9 June 2026)
The Department of Consumer Affairs (Weights and Measures Unit) has introduced a Standard Operating Procedure to cut down duplicate model-approval filings for imported weights and measures. Currently, every model of weight or measure must undergo model approval before manufacture or import — even when an identical model, made by the same manufacturer, has already been approved in India for a different importer.
The new SOP lets a second importer of an identical model skip the full model-approval process and instead apply for an Endorsement/Recognition Certificate referencing the existing Certificate of Approval, provided identity and compliance can be verified.
Key features:
Applies only where the model is identical in every respect — no variation in principle, design, specifications, software/firmware, sealing arrangement, material, or metrological characteristics.
Importers must hold valid authorisation from the manufacturer/brand owner and produce the original Certificate of Approval for the same model.
A full documentation set is required, including OIML-CS certificate, sealing diagrams, instruction manuals, and (where applicable) circuit diagrams, PCB layout, and software/firmware version details.
Where identity is clearly established, no fresh testing is needed; BIS/the Director can still call for additional documents or limited verification in case of doubt.
The endorsement is linked to the original approval and issued electronically via the portal — but a fresh model approval number is generated for the new importer.
This is purely a procedural simplification — it does not dilute any statutory requirement under the Legal Metrology Act, 2009.
Statutory Reference: O.M. No. I-9/11/2026-W&M (E-39647), Department of Consumer Affairs, dated 9 June 2026, issued under Section 22 of the Legal Metrology Act, 2009
Applications To: Director, Legal Metrology, Department of Consumer Affairs, Krishi Bhawan, New Delhi (dirwm-ca\@nic.in)
Issued by: Ashutosh Agarwal, Director (Legal Metrology)
Action for Industry: Importers bringing in weighing/measuring instrument models that are already approved in India under a different importer's name can now apply for the streamlined endorsement route instead of restarting model approval from scratch — this should meaningfully cut approval timelines for such cases.
DoT Suspends Processing of DPL/NDPL and Manufacturing & Testing Licence Applications (O.M. dated 2 July 2026)
The Wireless Planning and Coordination Wing of the Department of Telecommunications has directed that acceptance and processing of applications — including renewals — under the current Dealer Possession Licence (DPL), Non-Dealer Possession Licence (NDPL), and Manufacturing & Testing Licences issued under the Indian Wireless Telegraphy Act, 1933 be suspended with immediate effect.
This follows notification S.O. 3368(E) dated 23 June 2026, which brought sub-sections (1) and (6) of Section 3 of the Telecommunications Act, 2023 into force from that date — effectively superseding the licensing framework these applications were being processed under.
What Happens to Existing Applications: Applications already in the pipeline will now be processed under the new provisions of the Telecommunications Act, 2023 and rules made thereunder, with appropriate fee adjustments for amounts already paid.
Statutory Reference: O.M. No. R-11018/13/2026-PP, DoT, dated 2 July 2026, issued pursuant to S.O. 3368(E) dated 23 June 2026
Effective Date: Immediate (2 July 2026)
Issued by: T. Hari Babu, Sr. Deputy Wireless Advisor
Action for Industry: Businesses relying on DPL/NDPL or Manufacturing & Testing Licences should not submit fresh applications or renewals under the old framework; track DoT/Saral Sanchar Portal and NSWS portal updates for the new application process under the Telecommunications Act, 2023, and be prepared for revised fee structures.
TEC Extends Test-Report Exemptions for PON Broadband Equipment Parameters till 31 December 2026
The Telecommunication Engineering Centre (Telecom Certification Division) has issued an update on exemptions available for select parameters of the Essential Requirements (ER) governing PON (Passive Optical Network) family of broadband equipment under MTCTE.
Protocol Test for any PON interface: Exempted from submission of test reports till 31 December 2026.
Automatic Laser Shut-Down (ALS) / Automatic Power Shut-Down (APSD) (per ITU-T G.664 / IEC 60825 Annex-A1): Self-Declaration of Conformity by the applicant/OEM is acceptable till 31 December 2026, in lieu of a test report.
Statutory Reference: No. 5-5/2024-TC/TEC, TEC, DoT, dated 1 July 2026 (in continuation of earlier letter dated 29 December 2025)
Validity: Till 31 December 2026
Issued by: Rakesh Goyal, Director (TC-II)
Action for Industry: PON equipment manufacturers/OEMs can rely on self-declaration for ALS/APSD compliance and skip protocol test report submission for PON interfaces through end-2026 — update your MTCTE application checklist accordingly.
TEC Grants Wide-Ranging Generic Exemptions from Test Reports Across Multiple MTCTE Product Categories (dated 1 July 2026)
In a significant relief for telecom equipment makers, TEC has extended/granted a broad set of exemptions from test-report submission for numerous parameters and interfaces across MTCTE Essential Requirements, valid till 31 December 2026 or until further orders. This builds on an earlier exemption letter dated 29 December 2025 and an addendum dated 18 February 2026.
Product categories covered include (selected highlights):
Mobile Radio Trunking System (MRTS) — frequency band, RF power output, and conformance to multiple ETSI standards
Repeaters for Cellular Networks — GSM, WCDMA and LTE repeater station parameters and operating frequencies
Precision Timing Protocol (PTP) Grand Master Equipment — voltage, pulse shape/width, and timing/frequency synchronisation profiles
VHF/UHF Radio System Equipment and PTP-PMP Microwave Fixed Radio Systems
ADSLx and VDSLx interfaces — bit rate, PSD, loop resistance, and related parameters
Optical Fibre (Single Mode) and Optical Fibre Cable — mechanical, electrical, and fire-safety characteristics
HF Radio Systems, GSO/NGSO satellite terminals and gateways, and satellite communication equipment transmit power
5G NR (FR1/FR2) interworking parameters, SHDSL interface parameters, and 2.5GE/5GE/10GE link speed tests
128G Fibre Channel — exempted along with a Self-Declaration of Conformity (proforma enclosed with the letter)
Base Station 5G NR Type 1-H and Hybrid Active Antenna System — OTA sensitivity and radiated transmit power parameters (newly added to the exemption list)
Where 128G Fibre Channel is involved, applicants must additionally submit a Self-Declaration of Conformity on their letterhead, following the proforma enclosed with the letter, declaring in-house test compliance for each relevant parameter.
Statutory Reference: No. 5-5/2024-TC/TEC, TEC, DoT, dated 1 July 2026 (in continuation of letter dated 29 December 2025 and addendum dated 18 February 2026)
Validity: Till 31 December 2026 or until further orders
Issued by: Rakesh Goyal, Director (TC-II)
Action for Industry: Telecom equipment manufacturers and OEMs should cross-check their specific product/ER variant against this exemption list — many routine test-report submissions can now be skipped or replaced with self-declaration, which should meaningfully speed up MTCTE certification for the covered categories. This update needs to be reflected on the MTCTE Portal against each relevant parameter.
Action Checklist
Review oral liquid drug portfolios for alcohol content above 12% v/v in packs over 30 ml — these now fall under Schedule H1 controls, effective \~January 2027.
Verify Import Registration Certificates are valid for all imported cosmetics before market placement; expect stepped-up port and inspectorate vigilance.
If covered under BIS Sl. No. 02, 03, 04, 06, 07, 08, 09 or 11 (Ref. HQ-PUB013/1/2020-PUB-BIS), plan compliance toward the revised 2 February 2027 deadline.
Chlor-alkali manufacturers: update hazardous waste classifications following removal of the "Brine sludge" (16.3) entry.
Liquor brand owners/importers selling in Goa: register under the Deposit Refund Scheme by 31 July 2026.
Edible oil manufacturers/packers: transition to standard pack sizes within the 3-month window from 5 June 2026.
Telecom equipment dealers/manufacturers: do not file new DPL/NDPL or Manufacturing & Testing Licence applications under the old framework; await DoT's updated process under the Telecommunications Act, 2023.
Pharma companies using shared brand names across formulations with different active ingredients should review CDSCO's DCC recommendations and submit comments by 17 July 2026.
n-Butyl Acrylate importers/manufacturers: BIS certification under the QCO remains suspended till 31 July 2026 — track for further extension.
Television manufacturers/importers: new compulsory registration deadline under IS 18112:2022 is 26 January 2027.
Importers of weighing/measuring instruments with an already-approved identical model: use the new Endorsement/Recognition SOP to bypass duplicate model approval.
PON broadband equipment OEMs: protocol test and ALS/APSD test-report exemptions apply till 31 December 2026.
Telecom OEMs across MRTS, repeaters, PTP equipment, DSL, optical fibre, satellite, 5G NR, and 128G Fibre Channel categories: check the generic MTCTE exemption list (valid till 31 December 2026 or further orders) to streamline certification; note the Self-Declaration of Conformity requirement for 128G Fibre Channel.
