Category: Services Exports

Gen – AI – IMF report

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Gen-AI: Artificial Intelligence and the Future of Work

The IMF staff discussion note, “Gen-AI: Artificial Intelligence and the Future of Work” provides a comprehensive analysis of the impact of AI on labor markets globally.  Key points of the report are shared below :

Artificial Intelligence (AI) has the potential to reshape the global economy, especially in the realm of labor markets.

Advanced economies will experience the benefits and pitfalls of AI sooner than emerging market and developing economies, largely due to their employment structure focused on cognitive-intensive roles.

There are some consistent patterns concerning AI exposure, with women and college-educated individuals more exposed but also better poised to reap AI benefits, and older workers potentially less able to adapt to the new technology.

Labor income inequality may increase if the complementarity between AI and high-income workers is strong, while capital returns will increase wealth inequality.

However, if productivity gains are sufficiently large, income levels could surge for most workers. In this evolving landscape, advanced economies and more developed emerging markets need to focus on upgrading regulatory frameworks and supporting labor reallocation, while safeguarding those adversely affected. Emerging market and developing economies should prioritize developing digital infrastructure and digital skills

Click here to read the IMF report

AMD – CF schemes for Medical Device Clusters

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Assistance to Medical Device Clusters for Common Facilities (AMD-CF)

The Ministry of Chemicals & Fertilizers Department of Pharmaceuticals has issued the Guidelines for the Scheme for “Assistance to Medical Device Clusters for Common Facilities (AMD-CF)” on May 9 ,2023 with a proposed financial outlay of Rs. 300 crore

About AMD-CF Scheme

AMD-CF Scheme aims to strengthen the existing and new medical device clusters by providing financial assistance for setting up new testing laboratories for medical devices ensuring quality and sustainable growth for the sector

The Scheme further intends to support Central or State Government/s or Institutions or Organization to establish or strengthen the Testing Laboratories for Medical Devices to meet the needs arising due to roll out of the licensing regime of the MDR, 2017 and ensuring availability of more testing facilities for evaluation of Medical Devices on behalf of the manufacturers, as mandated under MDR, 2017 or as per the amendment thereon, from time to time

The Scheme would be implemented in a Public Private Partnership (PPP) mode through one time grant-in-aid for creation of infrastructure and common facilities. A Special Purpose Vehicles (SPVs) will be set up for this purpose. The SPVs will have a minimum of 3 pharma units (including Bulk Drug and Medical Device Units) as its shareholders. There shall be a minimum of five medical device manufacturing units as members of SPV.

The SPV should have representatives from cluster members, financial institutions, state and central government and R&D organisations and the individual manufacturing unit cannot hold more than 40 per cent in the SPV. The Medical Devices enterprises shall hold at least 51 per cent equity of the SPV

The outcomes of the Scheme will be reviewed after 2 years from the date of its initiation.

SIDBI has been appointed as Project Management Agency (PMA) for implementation of Scheme.

Components / Sub schemes of AMD – CF Scheme

There are two components / sub schemes to this AMD – CF scheme :

1. Assistance for Common Facilities (CF) : To strengthen the medical device clusters’ capacity for their sustained growth by creating Common Infrastructure Facilities.
2. Assistance for Testing Facilities (TF) : To strengthen availability of more Medical Device Testing Laboratories in order to boost manufacturing of quality medical devices

Financial outlay of the Schemes :

The sub-schemes are designed to set up 12 common facilities and 12 testing laboratories, under which the common facilities will be supported with a financial assistance of Rs. 240 crore for the common facilities and Rs. 60 crore for the testing facilities

Tenure of the Scheme :

The tenure of the Scheme is from Financial Year 2023-24 to Financial Year 2026-27.

Incentives Under this Scheme :

For Common Infrastructure Facilities (CIF) for the Medical Device (MD) clusters: the limit of support will be 70% of the approved project cost or Rs. 20 cr., whichever is less, as per the approval of SSC (Scheme Steering Committee). In the case of Himalayan States and States in the North East Region, the grant-in-aid would be Rs. 20 Crore per Cluster or 90% of the project cost of the CIF, whichever is less

For Testing Facilities (TF) of Medical Device (MD) products,the limit of support will be 70% of the approved Testing Facilities project cost or Rs. 5 cr., whichever is less, as per the approval of SSC.

In the case of Himalayan States and States in the North East Region, the grant-in-aid would be Rs. 5 Crore per Cluster or 90% of the project cost of the CIF, whichever is less.

Any expenditure above the prescribed limit shall be borne by the elected applicant

Benefits of the Sub Schemes are :

i. Improvement in quality standards of medical devices
ii. Improvement in regulatory compliance specified for medical device
iii.Increased availability of trained personnel for Medical Devices clusters
iv.Increased competitiveness of Medical Devices units in cluster
v. Reduction in the manufacturing cost of Medical Devices

Notice for Invitation of Applications:

The Department has now invited applications from eligible applicants under the Scheme AMDCF.

The eligible applicants may apply through online mode only. The link is https://amdcf.udyamimitra.in/.

The detailed guidelines of the Scheme is available at https://pharmaceuticals.gov.in/schemes.

The last date for filing of the application is 10.02.2024.

Click here to read the AMD-CF Guidelines

NSW portal for Medical Devices

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Launch of NSW Portal for Medical Devices

Central Government has launched a ‘one-stop-shop’ portal NSWS, designed by Invest India through Tata Consultancy Services (TCS) to streamline the import of medical devices in the country. This will be independent of the existing portals – the SUGAM portal or cdscomdonline portal. The existing portals will be disabled by January 15, 2024

The portal facilitates applications for the certificate of registration and licences to manufacture or import medical devices for various purposes such as clinical investigations, tests, evaluations, demonstrations, or training.

From January 1, 2024, the following three activities under the Medical Devices Rules, 2017 will be made live on the NSWS Portal:

i. application for grant of certificate of registration of a notified body- Form MD -01
ii.application for licence to manufacture medical device for clinical investigations, test, evaluation,  examination, demonstration or training- Form MD -12
iii.application for licence to import medical device for clinical investigations, test, evaluation, examination, demonstration or training- Form MD -16

All the stakeholders should submit the application for the above 3 activities, through NSWS portal only

Click the link below to read the detailed guide book on How to apply for CDSCO approval

Guide book on How to apply for CDSCO approval

Source:https://cdsco.gov.in/opencms/opencms/en/Home/

Tamil Nadu Global Investors Meet 2024

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Tamil Nadu Global Investors Meet 2024

Tamil Nadu, with its robust educational system and a strong focus on Science, Technology, Engineering, and Mathematics (STEM), is rapidly emerging as a leader in the Global Capability Centres (GCC) landscape. The state’s journey from skill arbitrage to leadership arbitrage in this domain is a testament to its growing prowess and the trust it has garnered globally.

GCCs, which have been a part of India’s business ecosystem for decades, are witnessing a significant surge in Tamil Nadu. Renowned companies like Cognizant Technology Solutions (CTS), Genpact, and Flipkart are notable examples of businesses that have thrived in this space. Moreover, the state is becoming a hub for startups in the GCC sector, further diversifying and strengthening its position.

As of 2015, India was expected to host over 2025 GCCs, highlighting the sector’s rapid growth. Tamil Nadu, in particular, has been pivotal in this expansion, offering a market potential that ranges from $35 billion to $60 billion. The state’s ability to create a large number of GCC leaders, estimated between 5,000 to 25,000, is also noteworthy. This growth is attributed to the shifting of markets from the West to India, leveraging the country’s strong STEM education.

One of the key strengths of Tamil Nadu in the GCC arena is the close gap between engineering and end-users. Product managers in the state work closely with customers, unlike in the past, where GCCs focused only on building certain parts. This proximity enables the development of trusted relationships and a deeper understanding of end-user needs.

Talent acquisition and retention are other areas where Tamil Nadu excels. The state’s educational institutions, startups, and industries collaborate closely, creating a robust ecosystem that supports the growth and development of GCCs. This synergy is critical in understanding and adapting to consumption patterns in the fast-growing digital economy.

Despite these strengths, GCCs in Tamil Nadu have faced challenges. Initially, driving business transformation and achieving cost efficiencies were significant hurdles. However, these have been largely overcome, and today the focus is on co-innovation, joint IPs, and skill development in collaboration with the government and academia. Cultural gaps and trust-building, once significant challenges, are now areas where best practices have been established.

Opportunities abound in Tamil Nadu, especially in engineering R&D. Cities like Chennai and Coimbatore are recognized for their skilled talent, particularly in Tier 2 cities like Coimbatore. The state offers a comprehensive product portfolio, facilitated by the proximity of engineers, product managers, architects, and customers.

Tamil Nadu is also home to various GCCs from major players in diverse sectors, each contributing uniquely to the ecosystem. For example, Optimum Health focuses on simplifying and scaling healthcare innovation, while Reynold Nissan GCC leverages core automotive technology for local and global markets. Standard Chartered Bank and UPS have also established significant GCC presences in Chennai, tapping into the diverse talent pool and collaborative ecosystem.

In summary, Tamil Nadu’s strengths in education, innovation, and a collaborative ecosystem make it an ideal location for GCCs. The state’s ability to adapt to changing global needs, coupled with its focus on co-innovation and talent development, positions it as a leader in the GCC landscape. With continued investment and growth, Tamil Nadu is set to play an increasingly vital role in the global GCC sector.

Click the link below to watch the TNGIM2024 Day 1 & Day 2 sessions: https://www.tngim2024.com/live-event-listing

Source: https://tngim2024.com/

Electronic Export Documents

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Transition to 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

Sustainability – Mega opportunity

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In sustainability, a mega opportunity for Indian banks

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.

Click here to read the article

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

Centre notifies Green Credit Rules, 2023…

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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.

Click here to read the Notification

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

Announcement – e-commerce exports handbook

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Release of e-commerce exports handbook for MSMEs

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

Click here to read the Handbook

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

Medical Textiles (Quality Control) Order, 2023

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Medical Textiles (Quality Control) Order, 2023

The Union Ministry of Textiles has introduced Quality Control Orders (QCOs) for six medical- textile products that will come into effect from April 1, 2024.

Medical textiles QCO encompass a range of products vital to healthcare and hygiene. The products covered under this QCO include Sanitary Napkins, Medical textiles -Shoe covers, Medical textiles -Dental bib/Napkins, Disposable baby diaper, Reusable sanitary pad/ sanitarynapkin/ period panties andMedical textiles -Bed sheet and pillow cover

In mass consumption items of Medical textiles like Sanitary Pads and baby diapers, self help groups are exempted from QCO while Micro and Small units are given relaxation for 1 year so as facilitate penetration without affecting availability.

The conformity assessment requirements specified in these QCOs are equally applicable to domestic manufacturers as well as foreign manufacturers who intend to export their products to India.

The Bureau of Indian Standards shall be the certifying and enforcing authority. All Medical Textiles shall bear the Standard Mark under a license from the Bureau of Indian Standards

Any person, who contravenes the provisions of this Order, shall be punishable in accordance with the provisions of the Bureau of Indian Standards Act, 2016. Products covered under the order are given below:

For the purposes of the Schedule – A and Schedule – B, it is clarified that the latest version of Indian Standards established and published by the Bureau of Indian Standards from time to time in accordance with the  provisions of clause (17) of section 2 of the Bureau of Indian Standards Act, 2016 (11 of 2016), shall apply from the date of such publication.

Click here to read the Notification

Source – https://texmin.gov.in/quality-control-orders-qco

Notification by UGC

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UGC notifies regulations for Foreign Universities to set up Campuses in India

The University Grants Commission (UGC) on Wednesday notified the regulations for foreign universities to set up and operate their campuses in India.

The Regulations aim to facilitate the entry of Foreign Higher Educational Institutions (FHEIs) into India, in line with the recommendations of the National Education Policy 2020, and to provide an international dimension to higher education in India.

These Regulations outline the conditions and requirements for Foreign Higher Educational Institutions to set up their campuses in India. These Regulations aim to ensure that the education imparted in the campus is at par with that of the main campus in the country of origin and that its operations comply with the applicable laws and Regulations.

Foreign Higher Educational Institutions can offer study programmes leading to the award of certificates, diplomas, degrees, research and other programmes at the undergraduate, postgraduate, doctoral and post-doctoral levels

Eligibility criteria :

The Foreign Higher Educational Institution intending to establish campuses in India shall fulfil any of the following criteria at the time of application, that-

(a) it should have secured a position within the top five hundred in the overall category of global rankings at the time of application, as decided by the Commission from time to time; or
(b) it should have secured a position within the top five hundred in the subject-wise category of global rankings at the time of application or should possess outstanding expertise in a particular area, as decided by the Commission from time to time.

In the case of two or more than two Foreign Higher Educational Institutions intending to collaborate to establish campuses in India, each Foreign Higher Educational Institution should meet the eligibility criteria

Procedure for approval

(1) In case the Foreign Higher Educational Institution intends to set up more than one campus, it shall make a separate application to the Commission under the procedure laid down in these regulations.

(2) Upon fulfilment of the eligibility criteria, the Foreign Higher Educational Institution shall apply online to the Commission along with the non-refundable processing fee, as decided by the Commission from time to time.

(3) The Foreign Higher Educational Institution shall upload the following documents along with the application on the University Grants Commission portal, namely:-

(a) permission by the Governing Body or Board, by whatever name called, for establishing campuses in India;

(b) information on the proposed location, infrastructural facilities, fee structure, academic programmes, courses, curricula, availability of faculty and financial resources for setting up and operations of campuses in India, and any other details that may be sought;

(c) an undertaking to the effect that-

i. the quality of education imparted by it in its Indian campus is similar to that of the main campus in the country of origin; and

ii. the qualifications awarded to the students in the Indian campus shall enjoy the same recognition and status as if they were conducted in its home jurisdiction, that is, they shall be recognized in the country of origin of the Foreign Higher Educational Institution and shall be equivalent to the corresponding qualifications awarded by the Foreign Higher Educational Institution in the main campus located in the country of origin.

(d) the latest Accreditation or Quality Assurance report from a recognized Body; and

(e) any other document as specified in the application portal.

(4)The Commission shall constitute a Standing Committee to examine matters related to the setting up and operation of campuses of Foreign Higher Educational Institutions in India.

(5) The Standing Committee shall assess each application on merit, including the credibility of the educational institutions, the programmes to be offered, their potential to strengthen educational opportunities in India, and the proposed academic infrastructure, and make recommendations thereof.

(6) In case the applicant is a Foreign Higher Educational Institution possessing outstanding expertise in a particular area, the Standing Committee shall consider its strengths, outstanding contribution, research capacities, institutional history, institutional prestige and influence, and professional recognition within the areas, among others.

(7) The recommendations of the Standing Committee shall be placed before the Commission within a period of sixty days from the date of receipt of the application, complete in all respects.

(8) Based on the recommendations of the Standing Committee, the Commission may within a period of sixty days, initially grant in-principle approval and issue a Letter of Intent to the Foreign Higher Educational Institution to set up campuses in India within two years from the date of approval.

(9) The Commission may reserve the right to give an extension, if required, on a case-to- case basis.

(10) The applicant Foreign Higher Educational Institution shall convey its readiness for the commencement of its academic operations to the Commission and the Standing Committee shall examine the readiness of the campus and give its recommendations.

(11) The Commission shall consider the recommendations of the Standing Committee and issue approval to the Foreign Higher Educational Institution, within a period of sixty days, for commencing the operation of a campus in India with or without conditions.

Application Portal to set up Campuses in India by Foreign Higher Educational Institutes (FHEIs) is live now.

Registration link for Eligible FHEIs to Register and apply : http://fhei.ugc.ac.in

Click here to read the UGC Notification
Click here for the Checklist to FHEIs

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