REGULATORY COMPLIANCE BULLETIN - October 2024

REGULATORY COMPLIANCE BULLETIN (Newsletter – October 2024)

Table of Contents

STQC  

Updates for STQC (Essential Requirements (ERs) under CRO)

Updates for STQC (Essential Requirements (ERs) under CRO)

On October 09, 2024, the Ministry of Electronics and Information Technology (MEITY) issued a notification in which the ministry confirmed that there is an extension of six months in timelines for the implementation of the “Electronics and Information Technology Goods (Requirement of Compulsory Registration) Order, 2021” for CCTV Camera. The new implementation date for the said order will be 09-04-2025. 

This extension is designed to facilitate a smoother transition and enhance the compliance process for all stakeholders involved. Also in an additional notification ministry announces Series Guidelines for CCTV Products Complying with Essential Requirements (ERs) under CRO. Please refer to the below points for the same. 

  • All products within a specific series must use the same System-on-Chip (SoC). 
  • The PCBA layout for all products in a series must remain identical. 
  • All products in the same series must use identical software/firmware versions with matching hash values. 
  • If multiple software versions are used, each version must be tested separately as an independent series. 
  • The hardware bill of materials (BoM) must be identical across the series. 
  • The software bill of materials (BoM) for each product in the series must include all the firmware components, operating system components, and database components as per the ER. 
  • The issued certificate must include key details such as a picture of the product or DUT (Design Under Test), model number, chipset information (including country of origin, make & model no.), firmware version, and hash value.  

For more information access the official notification from here.

For Series Addition notification: Series guidelines -CCTV ERs.pdf (meity.gov.in) 



BIS-CRS 

Guidelines for IS 18112: 2022 Implementation for TV 

Guidelines for IS 18112 2022 Implementation for TV

The Bureau of Indian Standards (BIS) mandates that all digital TV receivers for satellite broadcasts must comply with the IS 18112: 2022 standard for Free-To-Air (FTA) satellite TV and radio signals. Key points include: 

Certification Requirement: All TVs must be certified under IS 18112: 2022, in addition to safety standard IS 616: 2017. 

Implementation Deadline: Compliance is required by April 25, 2025.  

Requirement for Existing Licensee: All existing licensees need to apply Inclusion as per IS 18112 along with safety requirement following the existing series guideline of TV. if compliance is not followed by applicants, then the license will be cancelled. Application as per existing standard (IS 616 only) will be accepted one month before the deadline (25th March 2025). applications that are pending after the last date of implementation (25th April 2025) will be cancelled. 

Standard Mark: After getting approval with the latest requirement of IS 616 & IS 18112 BIS sticker is to be updated as below- 

Testing Lab: To date, test agencies are not accredited for the standard, as soon as the lab gets accreditation from BIS applicants can apply for compliance with IS 18112.  

You can refer to the below link for official notification from here. 


Updates to Indian Standard IS 302 (Part 1): 2024 for Household Electrical Appliance Safety 

The Bureau of Indian Standards (BIS) has updated the Indian Standard for household electrical appliances, IS 302 (Part 1): 2024, focusing on safety requirements for devices operating up to 250 V (single-phase) and 480 V (other applications, including DC and battery-powered appliances). 

This latest update aligns IS 302 with the most recent edition of the international standard IEC 60335-1, focusing on enhanced safety protocols. Key changes in the amendment include: 

  • Electrical and Mechanical:
  • Clarified PELV circuit requirements.
  • Revised power input and current measurement protocols for varying operating cycles.
  • Additional requirements for battery-operated appliances and metal-ion batteries, including new charging protocols.
  • Moisture Resistance and Durability:
  • Enhanced moisture resistance tests for automatic cord reel appliances and those with IP ratings.
  • Optical Radiation: Introduced safeguards for optical radiation hazards.
  • Symbol and Component Specifications:
  • Introduced a new Class III appliance symbol and specific battery charging and discharging requirements.
  • Updated requirements for humidity tests and electronic circuit checks.
  • Set component standards for telecommunication interfaces, thermal links, contactors and relays, lamps, and cord sets.

These changes are not yet mandatory in India but are anticipated to become compulsory after 23rd Feb 2025 as the existing standard stands withdrawn after this date. 



TEC (NCCS) 

Security Certification of IP Router and Wi-Fi CPE Products 

National Centre for Communication Security (NCCS) has recently announced that IP Router and Wi-Fi CPE products which is certified by TEC for their technical parameters and in use in the licensee’s (TSP) network, will be allowed to submit their application until October 31st, 2024.

The application must include: 

  • A self-declaration of compliance with the applicable ITSAR standards. 
  • An undertaking to remove any non-compliant products from the network. 

There are no application fees, and applicants will receive a “Pro Tem Certificate” valid for six months. This certificate ensures continuous supply until full certification.  

Remember, no further extensions will be given. 

The official notification can be accessed here. 



ISI  

Amendment issued on the Toys Quality Control Order, 2020

Amendment issued on the Toys Quality Control Order, 2020

In the interest of public safety and quality, the Central Government announced an amendment to the Toys Quality Control Order, 2020, on 30 September 2024, effective immediately upon publication in the Official Gazette. 

Key Amendment: 

Manufacturers certified by the Bureau of Indian Standards BIS, or those who have applied, can now import up to 300 toy samples max 5 of each type per financial year for Research & Development R&D purposes. 

Conditions to Note: 

  • Not for Commercial Sale: These imported items cannot be sold and must be disposed of as scrap.  
  • Record-Keeping Required: Manufacturers must maintain an annual record and submit a declaration to the Central Government. 

For further details, refer to the Toys Quality Control Amendment Order, 2024 from here.   


 BIS New Quality Control Order for Ropes and Cordages

BIS New Quality Control Order for Ropes and Cordages

The Central Government has announced the Ropes and Cordages Quality Control Order, 2024 which will come into force on 1st April 2025. For Small and Micro Enterprises producing domestically, it will take effect on 1st July 2025.  

  • Scope of Application: This order applies to specific goods as outlined in the Schedule but does not apply to items meant for export. 
  • Standard Mark Requirement: All specified goods must conform to the corresponding Indian Standards and bear the Standard ISI Mark, as licensed by the Bureau of Indian Standards. 
Good or Articles  Indian Standards 
Textiles – Manila Ropes  IS 1084: 2005 
Fiber ropes- Polyester 3-, 4-, 8- and 12- strand ropes   IS 11066: 2022 
Composite Synthetic Fiber Ropes  IS 14928: 2001 
Mixed Polyolefin Fiber Ropes  IS 14929: 2022 
Steel Wire Ropes  IS 1804: 2004 
Fiber ropes – Polyamide 3- 4- 8- and 12-Strand ropes   IS 4572: 2022 
Fibre ropes – Polypropylene split film, monofilament and multifilament (PP2) and

polypropylene high tenacity multifilament (PP3) – 3-, 4-, 8- and 12- strand ropes 

IS 5175: 2022 
Fibre ropes Polyethylene 3- and 4 -strand ropes   IS 8674: 2013 
Fibre ropes of polyester/polyolefin dual fibres  IS 17609: 2021 

This initiative aims to enhance product quality and safety standards in the ropes and cordages sector.  

For more details, refer to the official notification from here 


BIS Quality Control Order for Medical Textiles 

BIS Quality Control Order for Medical Textiles

According to the Bureau of Indian Standards Act, 2016, the Central Government has issued the Medical Textiles (Quality Control) Order, 2024 on 23 October 2024, which will take effect immediately after publication in the Official Gazette. 

Here are the key details:  

  • Scope of Application: The Order applies to the goods specified in the Schedules but does not cover items meant for export or those manufactured by self-help groups, which are defined as small informal groups promoting savings and resources for mutual benefit. 
  • Standard Mark Requirement: All specified goods must conform to the corresponding Indian Standards and bear the Standard ISI Mark.  
  • Certification and Enforcement: The Bureau of Indian Standards and the Textiles Committee, Ministry of Textiles, will serve as the certifying and enforcing authority for these goods. 

SCHEDULE A 

Sanitary Napkins  IS 5405: 2019 (Effective 1st January 2025) 
Baby Diapers   IS 17509:2021 
Reusable Sanitary Pads and Period Panties  IS 17514:2021 

 

SCHEDULE B 

Shoe Covers  IS 17349:2020 (Effective 1st April 2024) 
Dental Bibs/Napkins  IS 17354:2020 
Bed Sheets and Pillow Covers  IS 17630:2021 

 This initiative aims to enhance the quality and safety standards of medical textiles, ensuring better products for consumers. 

 For more details, refer to the official notification from here.   


 BIS Quality Control Order for Indutech

BIS Quality Control Order for Indutech

The Central Government has issued the Indutech (Quality Control) Order, 2024 which will come into force from 1st April 2025. For Small and Micro Enterprises (for domestic production only), as defined under the Micro, Small and Medium Enterprises Development Act, 2006, this Order will take effect on 1st July 2025.  

Below are the key highlights:  

  • Application: The order applies to the goods or articles specified in the Schedule but does not cover items intended for export.
  • Compulsory Use of Standard Mark: The goods mentioned below must conform to the corresponding Indian Standards and bear the Standard ISI Mark under a license from the Bureau of Indian Standards. 
Goods or article  Indian Standard 
Textiles – Flat woven webbing slings made of man-made fibres for general services   IS 15041: 2001 

Certification and Enforcement Authority: The Bureau of Indian Standards will serve as the certifying and enforcing authority for the specified goods. 

This order aims to ensure quality control in the Indutech sector, enhancing safety and compliance for consumers.  

For more details, refer to the official notification from here.   


 BIS Quality Control Order for Geotextiles 

BIS Quality Control Order for Geotextiles 

The Central Government has issued the Geotextiles (Quality Control) Order, 2024 and it will come into force on 1st April 2025. This order applies to the goods or articles specified in the Schedule but does not cover items intended for export.  

The goods mentioned in the Schedule must conform to the corresponding Indian Standards and bear the Standard ISI Mark under a license from the Bureau of Indian Standards.  

Goods or article  Indian Standard 
Geosynthetics — Synthetic Polymer Rope Gabions for Coastal and Waterways Protection  IS 17880: 2022 

 This order aims to ensure quality control in the geotextiles sector, contributing to public safety and enhanced compliance. 

 For more details, refer to the official notification from here


BIS Quality Control Order for Cookware, Utensils and Cans for Foods and Beverages

BIS Quality Control Order for Cookware, Utensils and Cans for Foods and Beverages

The Department for Promotion of Industry and Internal Trade has issued the Cookware, Utensils and Cans for Foods and Beverages (Quality Control) Order, 2024 which will come into force on the date of its publication in the official Gazette i.e. 11 October 2024.   

Goods or articles specified in the below table must conform to the corresponding Indian Standards and bear the Standard ISI Mark.    

Title of Indian Standard  Indian Standard 
Stainless Steel Utensils  IS 14756: 2022 
Wrought Aluminium Utensils  IS 1660: 2009 
Stainless Steel Sinks for Domestic Purposes  IS 13983: 1994 
Round Open Top Sanitary Cans for Foods and Drinks Tinplate  9396 (Part 1): 1987 
Aluminium cans for beverages  IS 14407: 1996 

 Exemptions:  

  • Products manufactured for export are exempt.
  • Enterprises with plant and machinery investment ≤ INR 25 lakh and turnover ≤ INR 2 crore for the previous financial year, as certified by a CA are also exempt. 
  • Products manufactured or imported before the implementation date can be sold for up to six months with appropriate declarations.
  • Goods filled with solid, liquid, or gas, when imported are exempted from this order. 
  • A maximum of 200 items per year is imported for R&D by manufacturers, provided these are not sold commercially and are scrapped after use, with records maintained are also exempt.  

Deadline to comply with this order:  

  • For General (other than micro and small enterprises): 1st April 2025 
  • Small enterprises: 1st July 2025  
  • Micro enterprises: 1st October 2025 

This order aims to ensure quality and safety in cookware and food-related products for the benefit of consumers and manufacturers alike.  

For more details, refer to the official notification from here.   


 BIS Quality Control Order for Electrical Appliances for Commercial Dispensing and Vending  

A new quality control order for Electrical Appliances for Commercial Dispensing and Vending is issued on 17 October 2024 supersedes the 2023 Quality Control Order for the same category, aiming to ensure public safety and quality control for specified electrical appliances.   

This order will come into effect on the date of publication in the Official Gazette.  

This order states that appliances listed in the below table must meet the corresponding Indian Standard and display the Standard ISI Mark under BIS licensing per Scheme-I of Schedule II in the BIS Conformity Assessment Regulations, 2018.   

Goods or articles   Indian Standards 
Electrical appliances for commercial dispensing and vending  302 (Part 2/Sec 75): 2018  

 Exemptions:  

  • Items manufactured solely for export. 
  • Up to 50 units are imported annually for R&D, not for sale, and disposed of as scrap after use. Manufacturers must keep records and provide them to the Government upon request.  

The date of implementation for general is 1st April 2025, for small enterprises is 1st July 2025 and for micro-enterprises is 1st October 2025.  

Violators of this order will face penalties under the Bureau of Indian Standards Act, 2016.  

For more details, refer to the official notification from here 


 BIS Quality Control Amendment Order for Bicycles – Retro Reflective Devices  

BIS Quality Control Amendment Order for Bicycles - Retro Reflective Devices

Issued by the Central Government under the Bureau of Indian Standards Act, 2016, this amendment revises the original 2023 Quality Control Order for retro-reflective devices on bicycles to introduce certain exemptions in the public interest.  

This order will take effect on the date of publication in the Official Gazette i.e. 17 October 2024.   

Amendments to the 2023 Order:  

  • Exemptions for Imports by export manufacturers.
  • Manufacturers importing retro-reflective devices solely for producing bicycles for export are exempt from this order.
  • The manufacturer must submit a self-declaration on official letterhead, signed by an authorized signatory, including details like invoice number and import consignment information. This declaration must state that the goods are for export production only and will not be used or sold in India’s domestic market.
  • Manufacturers must maintain import records for verification or audit by government authorities.  

Exemptions for Research and Development Imports:

Up to 200 units can be imported annually for R&D by manufacturers of bicycles or retro-reflective devices.  

  • Imported items must not be sold commercially and must be disposed of as scrap after use.
  • A year-wise record of these imports must be kept for potential government review. 

For more details, refer to the official notification from here. 


 BIS Quality Control Order for Solar Thermal Systems, Devices, and Components  

BIS Quality Control Order for Solar Thermal Systems, Devices, and Components

The Ministry of New and Renewable Energy has issued an order for Solar Thermal Systems, Devices, and Components to promote public interest and ensure quality compliance within the solar industry. This order will come into effect 180 days after its publication in the Official Gazette, i.e. April 2025  

Under this order, all the below listed solar thermal systems, devices, and components must bear the Standard Mark, obtained through a license as per Scheme-I of Schedule II of the BIS Conformity Assessment Regulations, 2018.   

Title of Indian Standard  Indian Standard  
Solar Flat Plate Collector – Specification Part 1 Requirement  IS 12933 (Part 1): 2003 
Solar Flat Plate Collector- Specification Part 2 Components  IS 12933 (Part 2): 2003 
All Glass Evacuated Tubes Solar Water Heating System  IS 16544: 2016  
Direct Insertion Type Storage Water Tank for All Glass Evacuated Tubes Solar Collector-Specification  IS 16542: 2016 

 Note: The Bureau of Indian Standards (BIS) and agencies notified by BIS, in coordination with the Ministry of New and Renewable Energy, will conduct market checks to ensure adherence to Indian Standards for all products bearing the Standard Mark.  

Any order violation will result in penalties as stipulated under sub-section (3) of Section 29 of the Bureau of Indian Standards Act, 2016.  

For more details, refer to the official notification from here 


Government Issues Amendments to Quality Control Orders for Various Acids 

Government Issues Amendments to Quality Control Orders for Various Acids

The Ministry of Chemicals and Fertilizers has issued amendments to multiple quality control orders concerning various acids and fatty acids. Each amendment specifies that the orders will take effect upon publication in the Official Gazette, with the enforcement date revised to April 24, 2025.   

The following quality control orders are impacted by the Second Amendment:  

  1. Lauric Acid  
  2. Acid Oil  
  3. Palm Fatty Acids  
  4. Rice Bran Fatty Acids  
  5. Coconut Fatty Acids  
  6. Hydrogenated Rice Bran Fatty Acids 

This extension provides relevant industries with sufficient time to comply with the updated standards.  

For more details, refer to the official notification from here.  



DGFT 

Expanding RoDTEP Benefits to More Products 

The Ministry of Commerce and Industry issued a notification on October 28, 2024, to align the RoDTEP Schedule with changes made to the First Schedule of the Customs Tariff Act. 

The notification makes the following changes to the RoDTEP Schedule: 

  • Adds 39 tariff lines at the 8-digit level 
  • Deletes 13 tariff lines at the 8-digit level 
  • Changes the descriptions of 2 tariff lines at the 8-digit level 

These changes are effective from October 1, 2024. 

For more details, refer to the official notification from here. 


Export Restrictions on Sesame Seeds to the USA 

The Indian government issued a notification on October 23, 2024, regarding the export of sesame seeds to the United States of America (USA). 

The notification introduces additional export policy conditions for sesame seeds, effective from November 16, 2024. These conditions are: 

For Sesame Seeds of Seed Quality (HS Code 12074010): 

Export to the USA is subject to the following conditions:   

  • The India Oilseeds & Produce Export Promotion Council (IOPEPC) is the designated authority to issue export certification.
  • The IOPEPC will issue export certification within two working days of receiving the request from the exporter, subject to a “Certificate of Analysis” by a NABL accredited laboratory.

For more details, refer to the official notification from here.  


Import Restrictions on Lighter Parts 

The Indian government issued a notification on October 13, 2024, regarding the import policy for parts of lighters. 

The revised policy condition is as follows: 

  • Import of parts of pocket lighters, gas-fueled, non-refillable or refillable (cigarette lighters) under HS code 96139000 is now restricted.

For more details, refer to the official notification from here. 



BEE 

Extension in Star label validity period for Refrigerators 

BEE has come up with a notification w.r.t Refrigerators, in which, the existing star label validity period has been extended for 1 year, for which details are given below, 

  • The revised sample label validity period will be from 1st January 2023 to 31st December 2025. 
  • The portal to apply for model continuation will be open from 21st October 2024. 
  • Model continuation applications will not be accepted beyond 31st December 2024. 

The official notification can be accessed from the link 



Waste Management

New Environmental Compensation (EC) Guidelines for E-Waste Management in India  

New Environmental Compensation (EC) Guidelines for E-Waste Management in India

The Ministry of Environment, Forest & Climate Change approved Environmental Compensation (EC) Guidelines under the E-Waste (Management) Rules 2022 on 9th September 2024.

In the E-waste industry, many informal collectors and recyclers operate. While they do recover valuable materials like gold, copper, aluminium, and iron from discarded electronics, their methods are often harmful to the environment which results in wasting lots of recoverable materials. EC helps redirect activities towards more sustainable practices. The document details the EC regime to be levied on the violators by the provision of the E-Waste (Management) Rules 2022. 

These will be applicable to entities involved in the manufacture, sale, transfer, purchase, refurbishing, dismantling, recycling and processing of e-waste or electrical and electronic equipment (EEE).  

Key Highlights:  

  • EPR credit cost will range between 30% To 100% of the EC cost (basis EEE category or recovered end product cost) as derived under EC regime 1.

EC is divided into 2 regimes:  

  • Regime 1: Penalize producers for the shortfall of end-product-wise EPR target.  
  • Regime 2: General Non-compliance with e-waste rules amongst the recyclers and refurbishers is covered along with penalties and license suspension in serious cases.  

EC Penal action for non-compliance 

  • Post 3rd Default, cancellation of registration provision is also included in the EC regime.  
  • EC will be levied for non-registration & dealing with unregistered entities.  
  • Informal e-waste storage, handling & other activities are also covered under the EC regime.   
  • EC is based on the environmental damage caused by non-compliance.   

This notification outlines the key provisions of the E-Waste (Management) Rules, 2022 and their amendments, for which Environmental Compensation (EC) may be levied in case of violations.  

For a detailed list of provisions, specific violations and the EC in terms of EEE item category and the corresponding lowest price of exchange of EPR Certificate please refer to the official notification link. 


Battery Waste Management  

Important Update on Battery Waste Management Guidelines 

The Ministry of Environment, Forest & Climate Change approved the notified Guidelines for the imposition of environmental compensation (EC) under the Battery Waste (Management) Rules, 2022. These EC guidelines issued on 10th September 2024, which aim is to streamline compensation procedures and enhance environmental accountability for producers, Recyclers, and Refurbishers.

In the Battery waste industry, many informal collectors and recyclers operate. While they do recover valuable material from discarded batteries, their methods are often harmful to the environment which results in wasting lots of recoverable materials.  

Environmental Compensation helps redirect activities towards more sustainable practices. The EC amount is calculated based on the type, quantity and toxicity of the battery.   

Key Highlights:   

  • EPR Credit Costs: These will range from 30% to 100% of the EC cost, based on lead acid, Lithium-ion, other batteries, or recovered end product cost under EC regime 1. 

EC Regimes 

  • Regime 1: Focuses on Producer falling metal-wise EPR target.  
  • Regime 2: General addresses Non-compliance with Battery Waste Management Rules, 2022 by any entity. The regime will also increase EC costs by 10% every year. 

EC Penalties for non-compliance 

  • The EC regime contains a provision for cancellation of registration. 
  • EC will be levied for non-registration & dealing with unregistered entities.  
  • The EC regime also includes informal battery waste storage, collection, segregation, and treatment-related activities. 
  • EC is based on the environmental damage caused by non-compliance.  

This notification outlines the key provisions of the Battery Waste (Management) Rules, 2022 and their amendments, for which Environmental Compensation (EC) may be levied in case of violations. For a detailed list of provisions, specific violations and the EC in terms of the battery item category and the corresponding lowest price of exchange of the EPR Certificate.

Please refer to the attached notification link.  



Voice Compliance 

New Rules Coming for Telemarketers to Reduce Spam

The Department of Telecommunications (DoT) is taking important steps to tackle the problem of annoying spam calls and messages. They plan to create new rules for telemarketers because many people are worried about these unwanted communications, especially since some are connected to financial scams.

To facilitate this the DoT has requested recommendations from the Telecom Regulatory Authority of India (TRAI) on how to create an authorization framework for regulating telemarketers effectively. The goal is to make telemarketers more accountable and help reduce the number of spam messages people receive. 

By introducing an authorization framework for telemarketers. These new rules will hold telemarketers responsible for their actions, helping to protect people from unwanted calls and potential scams. By introducing an authorization framework for telemarketers, the DoT aims to create a safer and more reliable experience for the end consumers.   



CDSCO 

CROs Must Register Before Starting Clinical Trials

Chapter VA requires Clinical Research Organizations (CROs) in India to register before conducting clinical trials or drug studies. CROs must submit Form CT-07B with fees and documents. The Central Licensing Authority (CLA) reviews applications within 45 days and can approve, request corrections, or reject them, with an option for appeal. Registration lasts five years and must be renewed before it expires. The CLA can inspect CROs anytime and can warn, suspend, or cancel registrations if rules aren’t followed. CROs can appeal if they disagree with CLA decisions. 



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