TEC (MTCTE)
Amendment of clauses in MTCTE Procedure
TEC has recently announced several amendments to the official MTCTE procedure. The same has been outlined below:
The MTCTE Procedure clause 5.4 previously stated:
“Only complete-in-itself, standalone, independent equipment are tested and certified under MTCTE. Equipment modules/components are not covered by MTCTE. Further, combinations of independent equipment made to form systems are not certified under MTCTE; instead, each independent piece of equipment should be certified separately”
The updated clause 5.4 now reads:
“Combinations of independent equipment made to form systems are not certified under MTCTE; instead, each independent equipment should be certified separately”
Similarly, the item (I) of Table A.2 of Annexure-A previously stated:
“Spare Cards or Chassis/ Components/ Modules/ Transceivers such as SFPs/ Patch Cords” are the items that will not be covered under MTCTE.
The revised item (I) of Table A.2 of Annexure-A now reads that:
“Spare Cards or Chassis” are the items that will not be covered under MTCTE.
Official Notification from the regulator can be accessed here.
NCCS (COMSEC)
COMSEC (Security) Certification for EoS and EoL Products
The National Centre for Communication Security (NCCS) has recently announced the security certification procedure for products listed as End of Sale (EoS) or End of Life (EOL) by the manufacturer.
No security certification is required for products that have been classified as EoS before the mandatory date of certification. For such EoS products, manufacturers should have no plans of further support in terms of software or hardware modifications.
If any modifications are made to these EoS products, the manufacturer must apply for a Security Certificate that will be valid until the product reaches EoL and submit internal test reports demonstrating compliance with the ITSAR.
Security certifications are also not required for products that are declared EoL before the mandatory date of certification and no further modifications are proposed to be made by the OEM.
The official notification can be accessed here.
WPC
Another Step Towards Ease of Doing Business: Issuance of Equipment Type Approval (ETA) for License-Exempt Wireless Equipment Devices
DOT released a notification regarding the WPC ETA certification for products operating in wireless License-exempt bands.
In a recent update notified by DoT, it is concluded that all Equipment Type Approval (ETA) for products exempted from licensing requirements (i.e. operating in de-licensed frequency bands) will be processed on a self-declaration basis.
Previously, application for ETA for wireless products categories restricted to Import used to take a significant amount of time compared to ETA-SD (applicable for products categorized under to import category). This change will significantly reduce the approval timelines. However, the imports of products under the restricted Import category are expected to comply with other requirements like an import license from DGFT before import.
Official Notification can be accessed here.
Additional Guidelines for Issuing Experimental and Demonstration Licenses
The Department of Telecommunications (DoT) has recently simplified the approval process for experimental and demonstration licenses. Here are the key points:
- Fixed Timelines: For experimental licenses (radiating category), if no decision is conveyed within 30 days for applications not requiring inter-ministerial consultation, the license will be deemed issued.
For those requiring consultation, comments will be sought within seven days, and a provisional license will be granted after 60 days if no comments are received. This provisional license will convert to a regular one after 90 days, provided there are no adverse comments.
- For demonstration licenses (radiating category), licenses without inter-ministerial consultation will be deemed granted after 15 days. For those requiring consultation, licenses will be deemed granted after 45 days once comments are sought from relevant authorities.
These changes aim to reduce delays and simplify regulatory requirements, enhancing the ease of doing business in the telecom sector.
Official Notification can be accessed here.
DGFT
Changes Ahead: New Import Rules for Laptops and Tablets from January 2025
With reference of Policy Circular No. 6/2023-24 dated 19.10.2023, DGFT’s import authorisation/ Import License under HSN 8471, which includes laptops and tablets has been extended till 31st Dec 2024.
Along with the extension, DGFT has come up with an announcement that importers under HSN 8471 are required to secure fresh approvals starting from January 1, 2025. The government will soon release detailed guidelines for this process.
This step aligns with the government’s effort to encourage domestic manufacturing in the laptop and tablet sector.
Official notification can be assessed here.
BIS-CRS
MEITY Proposed Essential Requirement for Pouch Cells and their Batteries
Meity deliberating on mandating the performance of Pouch cells and batteries under CRO 2021. On September 10, 2024, MeitY organised a meeting to discuss the essential requirements (ERs), prepared by MeitY for Li-ion pouch cells and batteries. MeitY has taken this step based on the complaints received about sub-standard Li-ion cells being imported and sold in the Indian market.
The Ministry has requested BIS to formulate a standard on pouch cell performances since standard development is a time-consuming process so taking consumer safety of priority MeitY has taken the initiative and formulated ERs for Li-ion Cell pouch cell only taking reference from IS 16047 (part 3) with some changes on ambient temperature and cycles for charging and discharging suitable to Indian environment. The proposed ER may be notified of BIS-CRS compliance shortly.
BIS proposed MEITY to align the requirements of ER as per IS 16047-3 which is harmonized with global standards. However, BIS and MEITY pondering on the technical parameters and scope of ER as of date. Later when technical requirements are finalized the series guidelines of existing Rechargeable cells and batteries may be reviewed.
Industry associations like TEMA, FICCI, and ICEA supported this change with limited performance parameters, and sufficient time to be given for compliance.
Meity has asked for the comments from industry on the ER scope, and harmonization of ER with IS 16047-3 by the end of September. Based on the comments received MEITY will convene the next meetings in the first week of October.
STQC
The Ministry of Electronics and IT (MeitY) has announced mandating Essential security requirements (ER) for CCTV cameras on 09th April 2024 under CRO 2021. As per the notification it was expected to implement it on 09th Oct 2024. to review the readiness of its implementation a meeting held at MEITY on 10th Sep 2024 with stakeholders.
However, most of the industry representative seems not to be ready fully for compliance with said ER due to supply chain delay, changes in design and components, lack of testing infrastructure, delay from BIS for implementation guidelines etc. considering this industry expects a minimum 3–6 months extension in this order.
STQC has been advised to seek recognition from BIS for ER testing to support the industry and resolve duplication of testing by STQC and BIS Labs. BIS clarified that as of date test reports of BIS-recognized labs will be accepted. The testing done by STQC, under PPO, would be acceptable for only those models that would be submitted to STQC for testing post their BIS recognition. Industry requested to reconsider this fact.
However, STQC committed that for PPO (public procurement order) they can test CCTV in 45 days. To implement earliest at BIS take the below steps:
- Preparing UTRF (Unified test report format)
- Recognizing Pvt. Labs for ER testing.
- Preparing Implementation Guidelines.
Guidelines for Implementation of Revised IS/IEC 60669-2-1: 2021
The Bureau of Indian Standards (BIS) has revised the IS/IEC 60669-2-1: 2008 standard, which governs switches for households and similar installations. Below are the key points:
- The Indian Standard IS/IEC 60669-2-1: 2008 has been revised to IS/IEC 60669-2-1: 2021.
- The last date of concurrent running Indian standard has been extended to 12 October 2024 after which IS/IEC 60669-2-1: 2008 shall stand withdrawn.
Steps for Existing Licensees as per IS/IEC 60669-2-1: 2008
- All existing licensees shall switch over to the IS/IEC 60669-2-1: 2021 by 12 October 2024.
- Existing licensees shall submit conformance to IS/IEC 60669-2-1:2021 through complete test report(s) issued by BIS recognized lab for all lead model(s) from the existing scope of license.
- The licensees shall provide an undertaking stating that the requirement of IS/IEC 60669-2-1: 2021 has been implemented in all other existing series models (s)
- If the licensee fails to complete all actions by 12 October 2024, cancellation of the license/deletion of the model from the scope of the license is to be initiated
Steps for New Applicants:
- No new applications are to be accepted as per existing IS/IEC 60669-2-1: 2008 after 12 October 2024
- Applications that are recorded shall be permitted only up to 12 October 2024 and for such cases applicants shall give a declaration that they will implement the revised Indian standard.
- The application is under process as per old Indian standards they have to submit an undertaking that they shall change to the revised standard before 12 October 2024.
- If the application fails to complete all actions by 12 October 2024, the application may be processed for cancellation.
Voice Compliance
As we know, the Telecom Regulatory Authority of India (TRAI) has been diligently striving to safeguard consumers from fraudulent practices for over a year now. The same was highlighted as one of the priorities in the list of agendas for this financial year of our new telecom minister. Following this within the past 3 months several directives have been issued by TRAI. In light of the recent directions, TRAI has mandated Access Providers to strictly comply with the established guidelines and take appropriate actions regarding the mandatory requirements.
Now, TRAI has come up with the consultation paper dated 28th August 2024 on the Review of the Telecom Commercial Communications Customer Preference Regulations, 2018. This consultation paper is aimed at resolving and streamlining appropriate processes/strategies for the issues/ complexities being faced while implementing the TCCCPR 2018 regulations in today’s time.
The official extract of the consultation paper can be accessed from here.
ISI
Potable Water Bottles (Quality Control) Amendment Order
The Ministry of Commerce and Industry has issued the Potable Water Bottles (Quality Control) Amendment Order, 2024. This order will be recognized by this name and will take effect from the date it is published in the Official Gazette i.e. 29th August 2024.
According to this order, potable water bottles must comply with the standards specified in Indian Standard IS 17803:2022 for potable water bottles made of copper, stainless steel, or aluminium. These bottles must display the Standard Mark and be licensed by the Bureau of Indian Standards, per Scheme-1 of Schedule-II of the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018.
BIS Draft Quality Control Order For Electric Fence Energizers
The Ministry of Commerce and Industry issued a draft Quality Control Order, titled Electric Fence Energizers (Quality Control) Order, 2024. It shall come into force on the date of its publication in the Official Gazette.
Electric Fence Energizers must comply with the Indian Standard IS 302-2 76:1999 titled “Safety of household and similar electrical appliances Part 2 particular requirements Sec 76 electric fence energizers.
These goods must have the Standard Mark, which is issued by the Bureau of Indian Standards (BIS) under a license, according to Scheme-I of Schedule-II of the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018.
Additionally, this Order does not apply to goods or articles that are manufactured domestically for export.
The implementation dates are as follows:
- General Enterprises (excluding Micro and Small Enterprises): Six months from the date of publication of this order in e-gazette.
- Small Enterprises: Six months from the date of publication of this order in e-gazette.
- Micro Enterprises: Twelve months from the date of publication of this order in e-gazette.
BIS Quality Control Order for Upholstered Composites used for Non-Domestic Furniture
The Ministry of Textiles has issued the Protective Textiles Quality Control (Upholstered Composites Used for Non-Domestic Furniture) Amendment Order, 2024, which will come into effect on the date of its publication in the Official Gazette i.e. 12th September 2024.
This Order applies to:
- Upholstered composites used in non-domestic furniture, excluding those intended for export.
- Upholstered composites or fabrics sold as raw materials, in rolls, or utilized in the assembly of non-domestic furniture.
All upholstered composites used for non-domestic furniture must comply with Indian Standard IS 15768:2008 (Textiles – Resistance to Ignition of Upholstered Composites Used for Non-Domestic Furniture – Specification) and must carry the Standard Mark, issued under a license from the Bureau of Indian Standards (BIS).
This certification will be by Scheme-I of Schedule-II of the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018.
Polycarbonate (Quality Control) Amendment Order
The Ministry of Chemicals and Fertilizers has introduced the Polycarbonate (Quality Control) Amendment Order, 2024, which shall come into force on March 12, 2025.
This order requires that all polycarbonate goods or articles comply with Indian Standard 14434:1998. These products must display the Standard Mark under a license from the Bureau of Indian Standards, under Scheme-I of Schedule-II of the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018.
Styrene-Butadiene Rubber Latex (Quality Control) Amendment Order
The Ministry of Chemicals and Fertilizers has introduced the Styrene-Butadiene Rubber Latex (Quality Control) Amendment Order, 2024, which shall come into force on the date of its publication in the Official Gazette i.e. 18th September 2024.
This order requires that Styrene-Butadiene Rubber Latex must comply with Indian Standard 11356:2020. exempts carboxylated SBR latex from the order for the manufacture of automotive lithium-ion batteries. The standard (11356:2020) applies to a variety of uses, including adhesives, carpet backings, and upholstery.
The product must display the Standard Mark under a license from the Bureau of Indian Standards, under Scheme-I of Schedule-II of the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018.
BIS Quality Control Order for Safety of Household, Commercial and Similar Electrical Appliances
This Order may be called the Safety of Household, Commercial and Similar Electrical Appliances (Quality Control) Order, 2024. It shall apply to all electrical appliances intended for household, commercial or similar applications with a rated voltage not exceeding 250V single-phase alternating current or 415V three-phase alternating current.
All appliances mentioned must comply with IS 302 (Part 1): 2008 (Safety of Household and Similar Electrical Appliances: General Requirements) and must display the Standard Mark, authorized by a license from the Bureau of Indian Standards, under Scheme-1 of Schedule-II of the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018.
The Order does not apply to goods manufactured domestically for export.
Date of implementation:
- For general- 17th March 2025
- For small enterprises- 17th June 2025
- For micro enterprises- 17th September 2025
BIS Quality Control Order for Cross-Recessed Screws
The Ministry of Commerce and Industry notified Cross Recessed Screws (Quality Control) Order, 2024.
This Order may be called the Cross Recessed Screws (Quality Control) Order, 2024. It shall come into force on the date of its publication in the Official Gazette i.e. 17th September 2024.
All goods or articles mentioned in the order must comply with their respective Indian standard and must display the Standard Mark, authorized by a license from the Bureau of Indian Standards, under Scheme-1 of Schedule-II of the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018.
The Order does not apply to goods manufactured domestically for export.
Date of implementation:
- For general- 17th March 2025
- For small enterprises- 17th June 2025
- For micro enterprises- 17th September 2025
BIS Quality Control Order for Hand Tools
The Ministry of Commerce and Industry notified Hand Tools (Quality Control) Order, 2024.
This Order may be called the Hand Tools (Quality Control) Order, 2024. It shall come into force on the date of its publication in the Official Gazette i.e. 17th September 2024.
All goods or articles mentioned in the order must comply with their respective Indian standard and must display the Standard Mark, authorized by a license from the Bureau of Indian Standards, by Scheme-1 of Schedule-II of the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018.
The Order does not apply to goods manufactured domestically for export.
Date of implementation:
- General- 17th March 2025
- Small enterprises- 17th June 2025
- Micro enterprises- 17th September 2025
Flame- Producing Lighters (Quality Control) Amendment Order
The Ministry of Commerce and Industry has introduced the Flame-Producing Lighters (Quality Control) Amendment Order, 2024, which shall come into force on 20th September 2024.
This order requires that Flame-Producing Lighters must comply with Indian Standard IS/ISO 9994: 2018. The products must display the Standard Mark under a license from the Bureau of Indian Standards, under Scheme-I of Schedule-II of the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018.
Waste Management
Draft – Green Hydrogen Certification Scheme of India
The Ministry of New and Renewable Energy has issued the Draft Green Hydrogen Certification Scheme of India for Stakeholder Consultation.
The objectives of the scheme are as follows:
a) To detail the governance structure of the certification scheme and, thus, further outline the roles and responsibilities of different stakeholders involved in the certification process.
b) To elaborate on the scope of the certification and system boundaries necessary to be followed in the Green Hydrogen certification procedure.
c) Clear and transparent guidelines for the calculation of the GHG emission intensity on each occasion of Green Hydrogen production.
d) Establish the monitoring needs within Green Hydrogen production so that assessment and continuous improvement can be carried out, further stating parameters and methodologies to be followed in continuous monitoring to hold the process transparent and compliant with the standards of Green Hydrogen.
e) Provide a suitable verification mechanism for the Green Hydrogen projects and identify the Bureau of Energy Efficiency as the nodal agency for the accreditation of Verification Agencies and issue certification about Green Hydrogen in consonance with the standard notified by the Government.
f) Design the reporting scheme for Green Hydrogen production and introduce a system of ongoing data tracking, a chain of custody that ensures Green Hydrogen production is transparent and accountable, from its origin and production to its end use.
g) The Green Hydrogen Certification process should be established as a Guarantee of Origin to ensure the Green Hydrogen originating and production process is transparent and authentic.
BEE
Notification for QR Code Implementation in LED Bulbs
In continuation of their last advisory w.r.t QR code implementation in BEE-certified products, BEE notification dated 25th September 2024 has announced that the implementation of QR code in LED bulbs will be mandatory from 1st January 2025.
For the manufacturers interested in the process of generating the QR code, BEE will set up a trial process for such manufacturers starting from 1st October 2024.
The official notification can be accessed through the link: Link
Revised Labelling Fees for Voluntary Appliance/Equipment of BEE Under the S&L Program
In a recent notification, BEE has published a revised labelling fee for the appliance covered under the voluntary regime of BEE.
For the manufacturers/permittees of those appliances with increased labelling fees, the difference will be shown as an outstanding balance in the portal. And the same must be paid along with other applicable fees in the portal.
The revised labelling fees are under effect from April 1st 2024.
The official notification can be accessed through the link
The revised labelling fees for the appliances are mentioned in the below table:
Extension of Star Rating Table Validity Ceiling Fan
The Bureau of Energy Efficiency (BEE) has extended the validity of the existing star rating table of Ceiling fans from January 17th, 2024 to December 31st, 2025 (extended for a year).
To maintain the active registration of your model with BEE, it is essential to complete the Model Continuation process by December 31, 2024.
The Official notification can be accessed with the below link.
CDSCO
On September 19, 2024, the notification issued by the Ministry of Health and Family Welfare outlines amendments to the New Drugs and Clinical Trials Rules, 2019, under the Drugs and Cosmetics Act, 1940. The amendments primarily focus on the introduction of a new regulatory framework for Clinical Research Organisations (CROs) involved in clinical trials, bioavailability, and bioequivalence studies.
Key points include:
Registration Requirement:
- CROs must be registered with the Central Licencing Authority to conduct clinical trials or bioavailability/bioequivalence studies of new or investigational drugs in human subjects.
- Application for registration is to be submitted in Form CT-07B, with the required fee and documents.
Grant of Registration:
- The Central Licencing Authority will scrutinize the application and either grant or reject registration within 45 working days.
- If deficiencies are found, they must be rectified, and registration may be reconsidered within 90 days.
Validity and Renewal:
- The registration is valid for 5 years, and renewal applications must be submitted before the expiry date. Until the renewal is granted or rejected, the registration remains valid.
Inspection and Compliance:
- Registered CROs can be inspected by authorised officials without prior notice, and failure to comply may result in warnings, suspension, or cancellation of registration.
These amendments are set to come into force on April 1, 2025, and establish a comprehensive regulatory framework to ensure CROs meet stringent standards in clinical trials.
Official notice can be accessed here
Compliance Case Studies
Vincular Understood My Actual Problem! Importer comments on our Expertise
A leading importer of wireless equipment was denied wireless equipment import despite having ETA-SD approval leading to daily penalties and shipment delays.
Read about this case study to know how we effectively solved this case.
Li-Ion Battery Certification Success Story!
A global leader in power storage and management faced challenges entering the Indian market with their Lithium-ion batteries used for Solar applications because the existing standard was not applicable for lithium batteries.
Read about this case study to know what we did to help the global leader enter the Indian market.
From the Founder’s Desk
The unheard story of VINCULAR – our beginning
I worked in corporate India for over 15 years, with 8 of those years focused on managing product compliance for a global networking brand. During this time, I recognized a growing need for compliance solutions, which led me to study the market more closely.
My research revealed that each product had unique compliance requirements, causing global brands to face numerous regulatory challenges when entering the Indian market. This confirmed my idea of launching a consultancy. Continue reading…
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