National Single Window System

National Single Window System (NSWS) is a one-stop-shop portal, and a medium of convenient and efficient online Government-to-Business (G2B) services to the business community, which reduces the complexity in obtaining information and services related to starting businesses in India and deals with various approvals, registrations and permits.

NSWS is a portal wherein investors/ entrepreneurs can identify, apply and obtain regulatory approvals and compliances as under applicable laws in India, for setting up and starting a business unit anywhere in India. However, the final authority of giving approvals lies with the Ministry/ Department/ State authorities and the internal process followed by the respective Ministries/ Departments/ States remains the same.

The Know Your Approvals (KYA) module supports information across 32 Central Departments and 17 States. However, there may be other approvals required that the investors may like to check at their own discretion. Currently, the portal hosts applications for approvals from 21 Central Departments and 14 State Governments

Objectives of NSW:

  1. To establish a single-window mechanism by integrating the services provided by various Central Ministries, Departments, and State Governments
  2. To provide a one-stop-shop for procuring pre-establishment and pre-operation approvals and permits required to establish a business in India
  3. To provide efficient, convenient, transparent, and integrated electronic service to investors, industries, and businesses
  4. To provide a uniform and seamless experience to the business user

Benefits of NSW Portal:

  • All approvals in one place
  • Transparency
  • Cost saving
  • Secure Document repository
  • Fast query management
  • Real time status tracking
  • Easy renewal
  • Integration with Other systems

NSW contribute to economic growth by reducing trade barriers and improving the overall efficiency of trade processes

Services that can be availed through the NSWS

  1. Identification of requisite pre-establishment and pre-operation approval for setting up of a business unit in India 
  2. Application of suggested approvals
  3. Digital repository for storing documents related to approvals
  4. Payment of processing fees to issue any approvals
  5. Post application, tracking and status update on applications submitted
  6. Easy Renewal
  7. Information about approvals such as timelines, fees, documents required etc.

Who can use this Portal?

The users of a National Single Window (NSW) portal typically include a wide range of stakeholders involved in international trade and logistics. The National Single Window System is designed and built for both foreign and domestic investors/ entrepreneurs of any sector, scale and size.

  1. Traders – Importers, exporters, and other businesses engaged in international trade
  2. Government Agencies
  3. Customs Brokers and Agents
  4. Transport and Logistics Providers
  5. Financial Institutions
  6. Certifying Bodies
  7. Trade Associations and Chambers of Commerce
  8. Information providers

How to use the NSWS portal?

An investor/ Business user is required to register on the National Single Window System (NSWS) by clicking on “Sign Up Now” before applying for any service from the portal.  The user requires an email ID and mobile number to register. Once they complete the registration process, they can apply for pre-establishment and pre-operation approvals given by the Ministries/ Departments/ States that are part of the NSWS.

The NSWS does not charge any fee for user registration. However, any fee/ charges required by the Ministry/ Department/ State to process the applications for approvals can be paid through the NSWS portal

For detailed guide on user registration and application submission, please visit https://www.nsws.gov.in/portal/user-guide

On the whole, The National Single Window portal benefits a broad spectrum of stakeholders by promoting efficiency, transparency, compliance, and collaboration in trade processes.

By addressing the diverse needs and interests of traders, government agencies, service providers, consumers, and society at large, an effective NSW system contributes to fostering a more resilient, inclusive, and sustainable trade ecosystem.

Source:https://www.nsws.gov.in/

https://www.investindia.gov.in/

Electronic Export Documents

The U.S. FDA’s Center for Devices and Radiological Health (CDRH) has transitioned from paper to electronic export documents for medical devices.

Starting January 2, 2024, certificates like CFG, COE, and NCR will be electronically issued as downloadable PDFs via CECATS.

Recipients have 45 days to access and print the document.

Verification can be done through the FDA’s FECV system using a QR code, and certificates remain valid for 2 years.

Electronically issued documents include:

  • Certificate to Foreign Government (CFG);
  • Certificate of Exportability (COE) under section 801(e)(1) or 802 of the Food, Drug, and Cosmetic Act (the FD&C Act);
  • Non-Clinical Research Use Only Certificate (NCR);
  • Certificate to Foreign Government for Device Not Exported from the United States (CFG-NE); and
  • Export Permit Letter

Any queries regarding electronic export documents for medical devices, please email to Exportcert@cdrh.fda.gov.

Source: https://www.fda.gov/medical-devices/industry-medical-devices/transition-electronic-export-documents-letter-industry

Announcement from NABH

NABH has released an important notice on January 4,2024 on Fee Remittance by all applicant / Accredited / Certified Health Care Organisations under all programs of NABH

Many Healthcare Organisations associated with NABH are still making direct payment to accounts of Quality Council of India – NABH. Due to this, NABH is facing difficulty in reconciling the amounts received directly as the details of payment are also not updated by the respective HCOs in their online portal.

To avoid unnecessary wastage of time and manpower in tracking the payments, NABH advises its stakeholders to make payments only through the online portal using the Payment Gateway so that the payments are appropriately tracked for convenience of all the parties

To facilitate the Healthcare Organisations to reconcile the fee payment status, NABH has requested all the
HCOs to follow the below steps with immediate effect:

  1. The HCOs are advised to login into their HCO account on the NABH portal for making payments through payment gateway via credit card/debit card/net banking.
  2. In no case HCOs shall deposit cash/cheque/DD directly into any of the accounts of Quality Council of
    India.
  3. In case the HCO has no other option but Bank Transfer (NEFT/RTGS), the payment shall be made
    after seeking approval from NABH secretariat. It shall be the responsibility of HCO to update the
    transaction details like Unique Transaction Reference (UTR) Number, Date of Transaction, Transaction
    Amount, etc on the NABH Portal under the Make Payment category and inform NABH that the Payment
    was done and get the receipts generated for the payments made.
  4. The HCOs are also requested to ensure that the payment details with respect to fee payments of
    current and previous accreditation cycles have been updated on the NABH portal account of the HCO,
    if not done earlier.
  5. Non updation of fee payment details on the portal may result into non-credit of the amounts and
    the HCO may be liable for adverse decision and repayment as per rules.
  6. All HCOs are to ensure that no direct offline payments are made to any account of Quality Council
    of India (QCI)

Notice issued by NABH is given below for reference:

Source:https://nabh.co/

Announcement from NABH

NABH announced that QCI and all its boards are introducing an innovative solution for addressing the queries & concerns promptly and transparently through “Quality Setu”, an integrated QCI portal designed to streamline the NABH helpdesk/complaints redressal process.

Quality Setu is a unified platform for all boards & divisions of QCI that will bridge and synergize the flow of information for its users.

It will also assist users to search for information regarding various schemes, certifications, accreditations, assessments, trainings and other projects, administered or run by the Boards & Divisions of QCI.

Quality Setu will also act as a single-window for all queries & concerns where users can track online, the progress of their engagement with the respective Board and Division, in their personalized section through the app or its portal

The system also has an AI-based Chatbot that guides users in their search and also assist them in resolving their queries and concerns in quick time.

From January 1, 2024, onwards, all queries and concerns pertaining to NABH will be exclusively addressed through the “Quality Setu” portal. This transition is aimed at enhancing efficiency, speedy resolution and ensuring a seamless experience for our stakeholders.

Please access the “Quality Setu” portal using the following website link
Website link: https://qualitysetu.qcin.org

Source: https://nabh.co/

Holistic AI E-book

The year 2022 was pivotal for artificial intelligence (AI), culminating in the emergence of ChatGPT and Microsoft’s subsequent discussions to invest $10 billion in OpenAI. With the AI market projected to grow to $500 billion in 2024, regulatory efforts have intensified in tandem with AI’s rapid adoption.

“The State of Global AI Regulations in 2024,”, a comprehensive guide released by Holistic AI ,sheds light on the following:
a. current state of the global AI landscape,
b. Key developments and anticipating trends in businesses
c. AI governance and its implications

Source:https://www.holisticai.com/papers/the-state-of-ai-regulations-in-2024

Sustainability – Mega opportunity

As India passes the reins of the G20, it has signalled an unwavering dedication to combating global environmental and sustainability challenges. The G20 sustainability working group meetings have spotlighted key pillars: harnessing climate finance, embracing the sustainability development goals (SDGs), and nurturing the financial ecosystem’s capacity.

In parallel, India’s nationally determined contribution commitments to reduce greenhouse gas emissions and the ambitious 2070 net zero emissions target unveil a grand vision of fortifying climate resilience and nurturing sustainable growth.

The big gap: funding the shift to a greener future

Nevertheless, there is a considerable gap between the financial requisites for these ambitions and the current landscape–making for a significant opportunity for India’s banking sector to tap into.

The G20 Leaders declaration underscores the importance of sustainable finance, highlighting needs like for developing countries, blended finance instruments, and reforming multilateral institutions.

Worldwide, banks are increasingly integrating sustainability into their operations. Many have committed substantial funds for sustainability and are transitioning away from fossil fuel financing. They’re also innovating with sustainable finance products like green bonds and leveraging technology for broader customer outreach and lower carbon footprints

While India’s banking sector has begun its ESG journey, it’s still navigating the challenges of balancing sustainability with developmental needs. Drawing from global trends and G20 insights, Indian banks can harness ESG for value creation. By integrating sustainability considerations and technology-driven decision-making, they can champion environmental and social transformation in India’s financial realm.

Indian banks have a pivotal role in driving social change, achieving national objectives, and expanding their lending portfolios.

Their success hinges on accessing global capital, innovating for new segments, and prioritizing digitalization and ESG integration in decision-making.

Achieving these objectives not only promises financial success but also positions Indian banks as leaders in the sustainability transition.

source: https://www.livemint.com/

MedTech Mitra

Union Minister, Health & Family Welfare, Dr. @mansukhmandviya inaugurates “MedTech Mitra,” a groundbreaking initiative by ICMR and CDSCO, supported by NITI Aayog.

This turning point marks a landmark for India’s healthcare landscape, enabling affordable healthcare solutions for all citizens.

ICMR & CDSCO in collaboration with NITI Aayog have launched #MedTechMitra, a game-changer for India’s healthcare. Fostering innovation & strategic support for medical device and diagnostic development. It will strengthen ecosystem, with affordable solutions for all.

MedTech Mitra streamlines MedTech R&D with preclinical & clinical support, collaboration initiatives, & funding opportunities. It is a primary step towards building a robust, self-reliant ecosystem for affordable & accessible healthcare in India.

Source:https://medtechmitra.icmr.org.in/

Centre notifies Green Credit Rules, 2023…

The green credit programme shall incentivise environmental positive actions through market-based mechanism and generate green credit, which shall be tradable and made available for trading on a domestic market platform.

The green credit will arise from taking measures by a person of any environment activities referred to in sub-rule (2) of rule 4.

The green credit programme shall encourage industries, companies and other entities to meet their existing obligations or other obligations under any law for the time being in force, and encourage other persons and entities, to undertake voluntary environmental measures referred to in rule 4 by generating or buying green credit: Provided that the green credit generated or procured to fulfil any obligation in compliance of any law for the time being in force shall not be tradable

The measures that can be taken for the purposes of protection, preservation, or conservation of the environment includes :
a. tree plantation
b. water management
c. sustainable agriculture
d. waste managemen
e. air pollution reduction
f. mangrove conservation and restoration
g. ecomark label development
h. sustainable building and infrastructure

Methodology of generating green credit

The calculation of green credit in respect of any activity undertaken shall be based on equivalence of resource requirement, parity of scale, scope, size and other relevant parameters required to achieve the desired environmental outcome

Procedure for generation of green credit

The Administrator shall develop the website for registration of activities, evaluation and verification of activities undertaken and award of green credit in respect of such verified activities, electronically.

The responsibilities of the Administrator shall include the following, namely:—

(a) develop guidelines, processes and procedures for the implementation of the green credit programme under these rules;
(b) develop methodologies, registration process, guidelines and associated measurement, reporting and verification mechanism;
(c) establish methodologies and processes for issuance of green credit (including issuance of digital green credit), and equivalence of green credit generated from each identified activity;
(d) develop guidelines for the establishment and operation of the Green Credit Registry and trading platform; for self-certification or third-party certification for the registration of an activity for issuance of green credits and its inspection and verification by designated agency, for empanelment of auditors and audit by such auditors;
(e) establish or designate the Green Credit Registry, and trading platform service provider in accordance with the approved guidelines;
(f) develop guidelines for the green credit programme portal, the knowledge and data platform, and for the fees from the registered entities;
(g) develop guidelines for filing of annual returns and progress reports by designated agency, Registry, trading platform and knowledge and data platform

The Central Government shall constitute a Steering Committee & Technical Committee to monitor the implementation of the Green Credit programme under these rules.

The Administrator or designated agency shall establish and maintain a Green Credit Registry for the registration and issuance of each Green Credit.

The Administrator shall establish and maintain a trading platform , which shall perform functions regarding the trading of green credit, in accordance with the guidelines made by the Administrator with the approval of the Central Government.

The Administrator shall develop and maintain a knowledge and data platform, with approval of the Central Government, which may collate key data points generated from the Registry and other information, such as sectoral achievements, best practices, information on capacity building, etc

The Administrator shall appoint a designated agency in accordance with the guidelines approved by the Central Government, who shall conduct verification and submit reports to the Administrator in accordance
with the guidelines

The participation to the Green Credit programme under these rules shall be based on voluntary participation

The activities of the Administrator, designated agency, Registry, trading platform and knowledge and data platform shall be audited within a period of one year at the end of every third financial year by independent auditors to be appointed by the Central Government on the recommendation of the Steering Committee.

Source:https://moef.gov.in/moef/index.html

Announcement – e-commerce exports handbook

The Union Minister of Commerce & Industry Piyush Goyal released a comprehensive “E-Commerce Exports Handbook for MSMEs” prepared by the Directorate General of Foreign Trade (DGFT) in New Delhi on Thursday.

The handbook, a significant initiative supporting the objectives of Foreign Trade Policy 2023, will serve as a definitive guide for MSMEs seeking to harness e-commerce platforms for expanding their exports.

It provides detailed insights into strategies for promoting exports via e-commerce,  facilitating MSMEs to venture into global markets effectively. This is part of the DGFT’s collaboration with different e-Commerce platforms/ enablers to hold training sessions in districts across the country with focus on promoting e-Commerce exports. The e-Commerce exports handbook for MSME will be a key resource for creating awareness e-Commerce exports through these outreach events in the districts.

The handbook, initially released in four languages namely English, Hindi, Gujarati and Kannada, will be translated into all official languages across India, ensuring accessibility and benefitting consumers, entrepreneurs, farmers, and women entrepreneurs looking to contribute significantly to trade and commerce

Source:https://www.dgft.gov.in/

Announcement

Advertising industry’s self-regulatory body ASCI has proposed various guidelines to avoid ‘greenwashing’ by companies.

The Advertising Standards Council of India (ASCI) has come out with a 9-point draft in this regard.

ASCI said the guidelines are aimed to check greenwashing, which it defined as the deceptive practice of making misleading environmental claims.

Proposed guidelines aim to foster a culture of transparency and authenticity in advertising in consumer interest and help them make informed decisions.

Environmental claims can appear in advertisements, marketing material, branding (including business and trading names), on packaging or in other information provided to consumers

The proposed guidelines say any absolute claims like a product has no impact or only a positive impact needs to be supported by a high-level of substantiation.

Comparative claims such as “greener” or “friendlier” can be justified, for example, if the advertised product or service provides a total environmental benefit over that of the advertiser’s previous product or service or competitor products, it has been recommended.

The public consultation on the draft is open till December 31, 2023

Source: https://www.ascionline.in/