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New Regulatory Regime for 8 Medical Items under Drugs and Cosmetics Act

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Adopting a proactive and sensitive approach to address the needs of the Indian Industry, the Union Ministry of Health & Family Welfare has taken a significant decision for ensuring continued access of eight regulated medical devices today.

The Ministry had earlier notified the following medical items to be regulated under the Drugs and Cosmetics Act which was to come into effect from 1st April, 2021 (as per S.O. 775(E) dated 08th February, 2019 under Medical Devices Rules 2017):

  1. All Implantable Medical Devices;
  2. CT scan equipment;
  3. MRI equipment;
  4. Defibrillators;
  5. PET Equipment;
  6. Dialysis Machine;
  7. X-Ray Machine; and
  8. Bone marrow cell separator.

Accordingly, as per the said order the importers/manufacturers are required to take import/manufacturing licence from Central Licencing Authority or State Licencing Authority, as the case may be, for import/manufacture of above devices, w.e.f. 1st April, 2021.

In order to ensure  supply chain continuity and access to these Medical Devices, while implementing  smooth transition into the new regulatory regime, Union Ministry of Health and Family Welfare hasnow decided that in case an existing importer/manufacturer who is already importing /manufacturing any of these devices, has submitted application to Central Licencing Authority or State Licencing Authority, as the case may be, for grant of import /manufacturing licence in respect of the said device(s) under the provisions of MDR, 2017, the said application shall be deemed valid and the importer/manufacturer can continue to import /manufacture the said device(s) up to 6 months from issue of this order or till the time, the Central Licencing Authority or State Licencing Authority, as the case may be, takes a decision on the said application, whichever is earlier. Order in this regard has been issued by Drugs Controller General (India) on 18th April 2021 through CDSCO website.

Source: PIB

Piyush Goyal says Maharashtra has so far received the highest quantity of Oxygen in India

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Minister of Railways, Commerce & Industry, Consumer Affairs, and Food & Public Distribution, Piyush Goyal today said that Government of India, with all stakeholders, is ensuring maximum Oxygen production in India. In a Tweet, he said that we are currently producing 110% of Oxygen generating capacity and diverting all available Oxygen from industrial use to medical use. Goyal said that Centre is in daily touch with State Governments to assess their needs & help them in best possible manner. He also said that just yesterday, Prime Minister in his review told that Centre & states should work with synergy in this crisis. Expressing sadness over politics being played by the state Government over the issue, Goyal said that Maharashtra has so far received the highest quantity of Oxygen in India.

Source: PIB

PM reviews status of oxygen availability to ensure adequate supply

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PM Narendra Modi took a comprehensive review to ensure adequate medical grade oxygen supply in the country. Inputs from ministries like Health, DPIIT, Steel, Road Transport, etc were also shared with the PM. PM stressed that it is important to ensure synergy across ministries & state governments.

PM Modi also took a detailed review of current situation of oxygen supply and projected use in the coming 15 days across 12 high burden states (Maharashtra, Madhya Pradesh, Gujarat, Uttar Pradesh, Delhi, Chhattisgarh, Karnataka, Kerala, Tamil Nadu, Punjab, Haryana and Rajasthan). An overview of district level situation in these states was presented to the PM.

PM was informed that the Centre and States are in regular contact and estimates for projected demand have been shared with states as on 20th April, 25th April & 30th April. Accordingly, 4,880 MT, 5,619 MT and 6,593 MT have been allocated to these 12 states for meeting their projected demand as on 20th April, 25th April and 30th April, respectively.

PM was briefed about production capacity in the country to meet the rising demand. PM suggested to increase oxygen production as per capacity of each plant. It was discussed that surplus stocks of oxygen supply in steel plants are being offered from medical use.

PM urged officials to ensure seamless and free movement of tankers carrying oxygen throughout the country. The Government has exempted all interstate movement of oxygen tankers from registration of permits to enable easier movement. PM was informed that States and transporters have been asked to ensure tankers move round the clock with drivers working in shifts to ensure faster turnaround and adequate capacity to meet the surge in demand. Cylinder filling plants will also be permitted 24 hour working with necessary safeguards. The Government is allowing Industrial cylinders to be used for medical oxygen after due purging. Similarly nitrogen and argon tankers will be automatically allowed to be converted to oxygen tankers to overcome the potential shortage of tankers.

Officers also briefed the PM about the efforts being made to import medical grade oxygen.

Source: PIB

Union Minister launches “World 1st affordable & long-lasting hygiene product DuroKea Series” developed by IIT Hyderabad

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Union Minister of Education, Ramesh Pokhriyal ‘Nishank’ virtually launched “World 1st affordable and long-lasting hygiene product DuroKea Series”, developed by IIT Hyderabad researchers. Researcher from Indian Institute of Technology Hyderabad led Dr. Jyotsnendu Giri, Associate Professor in Biomedical Engineering and founder EaffoCare Innovation Pvt. Ltd incubating at iTIC, IIT Hyderabad has developed innovative DuroKea long-lasting technologies to combat COVID-19 virus spreading. Chairman, Board of Governors, IIT Hyderabad, B. V. R. Mohan Reddy; Prof. Founder Dean ESIC Medical College and Hospital, Hyderabad, M. Srinivas; Director IIT Hyderabad, Prof. B. S. Murty and other officials from IIT Hyderabad were present on the occasion.

Speaking on the occasion Pokhriyal said that Durokea Product is aligned with the vision of Prime Minister Shri Narendra Modi to attain self reliance. This next generation DuroKea antimicrobial technology starts at Rs. 189, kills 99.99% of germs instantly and leaves behind the long-lasting protective nanoscale coating up to 35 days till next wash, he said.

The Minister informed that the unique property of DuroKea range is to ensure instant killing (within 60 sec) and prolonged protection which is an immense necessity during this current pandemic situation. This revolutionary antimicrobial property of DuroKea products has been tested and certified by Indian Government accredited lab and field-tested at the IIT Hyderabad campus, he added.

He congratulated Durokea Technology team for this attainment and urge the researchers and students of IIT Hyderabad to continue doing great work and bring the name to the country.”

Congratulating the Durokea Team, Director IIT Hyderabad, Prof. B. S. Murty said, “IIT Hyderabad is always at the forefront of the cute-edge research. It has proven time and again, especially during this pandemic time. IITH has delivered many solutions, including low-cost ventilators, effective mask, mobile apps and Fast COVID-19 Test-Kit. Durokea is one such unique invention to come out of IIT Hyderabad to fight against COVID-19. I define IITH as Invent and Innovate in Technology for Humanity and confident that IIT Hyderabad will continue to deliver many such novel innovations.”

Durokea S, DuroKea M, DuroKea H, and DuroKea H Aqua using innovative “Durokea Technology”, is an adhesive Nano formulation. “Durokea Serious products provide instant killing with prolonged protection against wide range of germs including COVID-19 Virus.Each product has been extensively tested through field trial and validated in different Indian Government accredited laboratories. 
Read more about each product in the enclosed document or visit www.keabiotech.com

This is a highly effective and affordable research innovation from IIT Hyderabad, developed by a team led by Dr. Jyotsnendu Giri, Department of Biomedical Engineering, IIT Hyderabad. Dr. Sunil Kumar Yadava, Dr. Qasim M, Meenakshi Chauhan, and Ruby Singh, Suparna Basu, Uzma Hasan, Jayakkumar and Dr. PurandhiRoopmani has a common vision with this innovation.

Source: PIB

Union Health Ministry issues regulatory pathways for foreign produced COVID-19 vaccines

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In a radical reform measure, the Union Government on 13th April 2021 had approved a significant streamlining and fast tracking of regulatory system for COVID-19 vaccines approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL). This decision will facilitate quicker access to such foreign vaccines by India and would encourage imports including import of bulk drug material, optimal utilization of domestic fill and finish capacity etc., which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability within the country.

The Union Government has today issued the Regulatory Pathway in India for COVID-19 Vaccines approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL).

The Central Drugs Standards Control Organization (CDSCO) headed by DCGI has today explained that the following would be the Pathway:

  1. CDSCO shall prepare detailed guidelines specifying regulatory pathway for approval of foreign approved Covid vaccines based on NEGVAC recommendations.
  2. These guidelines have since been prepared and posted by CDSCO on its website. CDSCO will take steps to widely disseminate these guidelines to the concerned stakeholders.
  3. Applicants for grant of approval for Restricted Use in Emergency situation may be submitted to CDSCO.
  4. Application can be made by the foreign manufacturer through its Indian subsidiary or through its authorized agent in India (in case it does not have an Indian subsidiary).
  5. CDSCO will process such applications for Restricted Use in Emergency Situation and DCGI will consider and take a decision within 03 working days from date of submission of complete application by the applicant.
  6. DCGI will issue permission for Restricted Use in Emergency situation with, inter-alia, the following conditions:
  1. Vaccine shall be used as per the guidelines prescribed under National Covid-19 Vaccination Programme.
  2. First 100 beneficiaries of such vaccines shall be assessed for 7 days for safety outcomes before it is rolled out for further Vaccination program.
  3. Applicant shall initiate conduct of post approval bridging clinical trials within 30 days of such approval.
  1. Applications for Restricted Use in Emergency situation for such vaccines maybe accompanied by bridging trial protocol, application for import registration certificate and application for import license.
  2. CDSCO will process applications for Registration Certificate (registration of oversees manufacturing site and product: in this case Covid vaccine) and Import License, within 3 working days from the date of approval of Restricted Use in Emergency Situation.
  3. As per the existing protocol of CDSCO for batch release of vaccines, each batch of the vaccine will be released by Central Drugs Laboratory(CDL), Kasauli before it can be used as per the guidelines prescribed under the National Covid-19 vaccination programme.
  4. The applicant will use Covid vaccine, after receipt of CDL approval, initially only on 100 beneficiaries and submit the safety data to CDSCO.
  5. CDSCO will review the safety data submitted by the applicant, and once found satisfactory, will authorise the applicant to use the vaccine.
  6. CDSCO will approve the protocol for the bridging trial in consultation with Subject Expert Committee (SEC) within 7 days of the receipt of the proposal.
  7. Applicant will conduct the bridging trial within the time lines specified in the approved protocol, and submit data generated in the bridging trial to CDSCO.
  8. After the receipt of the bridging trial results, the DCGI will review the permission granted for Restricted Use in Emergency situation.

Source: PIB

Atal Innovation Mission & Dassault Systemes Fondation to partner for seeding future innovators & entrepreneurs

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Atal Innovation Mission (AIM), NITI Aayog today signed an agreement with Dassault Systemes Fondation to jointly work towards providing a digitally rich ecosystem of Innovation in India and promoting STEM based innovation and entrepreneurship among aspiring young minds across the country.

One of the flagship programs of AIM, the Atal Tinkering Labs (ATLs) has played a pivotal role in fostering creativity and imagination amongst school children. Dassault Systemes Fondation dedicated to transform the future of education and research in India with 3D technologies and virtual universes, is all set to contribute to the ATL program in three broad areas – project based, self-paced learning content, hackathons and challenges and inter-country academia collaborations.

Dassault Systemes Fondation has designed and developed an initiative as part of its CSR objectives, initial set of ‘Ready to use’ well documented self-learning training cum instructional playbook, with appropriate videos for visual understanding which they would be sharing with the ATL students that they can access digitally. This playbook comes with instructional videos for teachers so that it can be implemented with minimal support from experts. This content shall be available for AIM to offer to all schools with ATLs and other schools as well as out of school children in India for use.

Under this SoI, Dassault Systemes Fondation shall design and organise innovative challenges / hackathons for ATLs, promoting problem solving skills, scientific and technology based exploratory learning skills and innovation culture amongst students and teachers.

Speaking during a virtual session of SoI signing today, Mission Director AIM, NITI Aayog R Ramanan said, “We feel privileged to launch the partnership of Atal Innovation Mission with Dassault Systemes Fondation. Dassault Systems are global leaders in design and engineering of large-scale mission critical systems. This would not only enable great interest in scientific research and innovation for our ATL Tinkering Lab students but also stimulate engineering innovation capability making them Future ready innovators and job creators from India accessing world class content available through Dassault.”

Sharing his thoughts about the collaboration with AIM, Chairman of Board of Directors, Sudarshan Mogasale, Dassault Systemes Fondation, India said, “Since the inception of Dassault Systemes Fondation in India, we have been engaged in several activities to imbibe the spirit of innovation, and empowering our next generation students to be Future Ready. The association with Atal Innovation Mission will take this journey to newer heights as we work with Atal Tinkering Labs across the country to augment the spirit of innovation in school children. We are happy to contribute to Atal Innovation Mission’s dream to bring out this transformation in schools in India.”

He further said that as part of the association, “Dassault Systemes Fondation will contribute with project based, activities based and self-paced learning content for Atal Tinkering Labs. The learning content has been created and validated by experienced faculty members from this domain. With AIM, joint hackathons will be hosted, student challenges and inter country academia collaboration programs will be organised for schools to inculcate innovation, product design and a maker’s culture among the school students and seed the interest of being future innovators, entrepreneurs.”

Through this collaboration, AIM and Dassault Systemes Fondation shall jointly encourage inter country collaborations amongst schools and school students for collaborative science / technology learning, skilling and cultural interactions amongst students.

Source: PIB

CCI approves acquisition of 89.6% of equity shareholding of Gangavaram Port Ltd by Adani Ports and Special Economic Zones Ltd

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The Competition Commission of India (CCI) approves acquisition of 89.6% of equity shareholding of Gangavaram Port Limited (“GPL”) by Adani Ports and Special Economic Zones Limited (“APSEZ”) under Section 31(1) of the Competition Act, 2002, on 13th April 2021.

The proposed combination relates to the acquisition of 89.6% of the shareholding in GPL (i.e., the entity operating Gangavaram port) by APSEZ.

APSEZ is an integrated port infrastructure services provider currently present across 11 domestic ports in six maritime states of Gujarat, Goa, Kerala, Andhra Pradesh, Tamil Nadu and Odisha. APSEZ manages the complete logistics chain (i.e., from vessels management to anchorage, pilotage, tug pulling, berthing, goods handling internal transport, storage and handling, processing and final evacuation by road or rail).

GPL is engaged to own, develop and operate the deep-water port at Gangavaram, Andhra Pradesh, pursuant to a concession agreement on Build-Own-Operate-Transfer basis with Government of Andhra Pradesh for a concession period of thirty years from the date of commercial operations and entitled for a further period of 20 years (two periods of 10 years each). Detailed order of the CCI will follow.

Source: PIB

Near 30 lakh doses given on Day 1 of TIKA UTSAV pushes Cumulative Coverage to 10.45 cr

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Today marks Day-2 of the countrywide Tika Utsav. The cumulative number of COVID19 vaccine doses administered in the country has crossed 10.45 Cr today.

Cumulatively, 10,45,28,565 vaccine doses have been administered through 15,56,361 sessions, as per the provisional report till 7 am today. These include 90,13,289 HCWs who have taken the 1st dose and 55,24,344 HCWs who have taken the 2nd dose, 99,96,879 FLWs (1stdose), 47,95,756 FLWs (2nddose), 4,05,30,321 1st dose beneficiaries and 19,42,705 2nd dose beneficiaries more than 60 years old and 3,20,46,911 (1st dose) and 6,78,360 (2nd dose) beneficiaries aged 45 to 60.

HCWsFLWsAge Group 45-60 yearsOver 60 years Total
1st Dose2nd Dose1st Dose2nd Dose1st Dose2nd Dose1st Dose2nd Dose
90,13,28955,24,34499,96,87947,95,7563,20,46,9116,78,3604,05,30,32119,42,70510,45,28,565

Eight states account for 60.13% of the total doses given so far in the country.

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Nearly 30 lakh vaccination doses were administered yesterday, on Day 1 of Tika Utsav.

Day 1 of the countrywide Tika Utsav saw 63,800 Covid Vaccination Centres (CVCs) operational, which is a rise of an average of 18,800 operational CVCs. Most CVCs were operational in the private work places. Additionally, despite being a Sunday, which generally witnesses lower vaccination numbers, the first day of Tika Utsav clocked nearly 30 lakh vaccination doses.

As on Day-86 of the vaccination drive (11th April, 2021), 29,33,418 vaccine doses were given. Out of which, 27,01,439 beneficiaries were vaccinated across 38,398 sessions for 1st dose and 2,31,979 beneficiaries received 2nd dose of vaccine.

Date: 11th April, 2021
HCWsFLWs45 to <60 yearsOver 60 yearsTotal Achievement
1stDose2ndDose1stDose2nd Dose1stDose2nd Dose1stDose2nd Dose1stDose2ndDose
9,22616,05543,26436,54717,70,25836,8788,78,6911,42,49927,01,4392,31,979

In terms of the number of daily doses administered globally, India continues to remain at the top with an average of 40,55,055 doses administered per day. The corresponding figure yesterday was 38,34,574.

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India’s daily new cases continue to rise. 1,68,912 new cases were registered in the last 24 hours.

Ten States including Maharashtra, Uttar Pradesh, Delhi, Chhattisgarh, Karnataka, Kerala, Tamil Nadu, Madhya Pradesh, Gujarat and Rajasthan have shown a rise in the COVID daily new cases. 83.02% of the new cases are reported from these 10 states.

Maharashtra has reported the highest daily new cases at 63,294. It is followed by Uttar Pradesh with 15,276 while Delhi reported 10,774 new cases.

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Sixteen states, as shown under, are displaying an upward trajectory in daily new cases.

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India’s total Active Caseload has reached 12,01,009. It now comprises 8.88% of the country’s total Positive Cases. A net incline of 92,922 cases recorded from the total active caseload in the last 24 hours.

The five states of Maharashtra, Chhattisgarh, Karnataka, Uttar Pradesh and Kerala cumulatively account for 70.16%of India’s total Active Cases. Maharashtra alone accounts for 47.22% of the total active caseload of the country.

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India’s cumulative recoveries stand at 1,21,56,529 today. The National Recovery Rate is 89.86%.

75,086 recoveries were registered in the last 24 hours.

Daily Deaths continue to show an upward trend. 904 deaths were reported in the last 24 hours.

Ten States account for 89.16% of the new deaths. Maharashtra saw the maximum casualties (349). Chhattisgarh follows with 122 daily deaths.

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Nine States/UTs have not reported any COVID19 deaths in the last 24 hours. These are Odisha, Himachal Pradesh, Ladakh (UT), D&D & D&N, Meghalaya, Sikkim, Lakshadweep, A&N Islands and Arunachal Pradesh.

Source: PIB

‘Tika Utsav’ is beginning of second major war against Corona: PM

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Prime Minister Narendra Modi has called the ‘Tika Utsav’, vaccination festival, the beginning of second big war against Corona and has emphasized special focus on social hygiene along with personal hygiene. The Utsav started today on the birth anniversary of Mahatma Jyotiba Phule and will continue till the birth anniversary of Babasaheb Ambedkar on April 14th .

In a message on the occasion, the Prime Minister stressed four points with regard to the drive. First, Each One- Vaccinate  meaning those who can’t go themselves for vaccination, such as illiterate and old people, should be assisted.

Second, Each One- Treat One. This involves helping people in getting Corona treatment, who do not have resources or knowledge to get it.

Third, Each One- Save One, meaning I should wear mask and save myself and others. This should be stressed.

Finally, society and people should lead in creating ‘micro containment zones’. Family members and community members should create ‘micro containment zone’, in case of even a single positive case.  ‘Micro containment zones’ are a key component of fight against Corona in a densely populated country like India, said the Prime Minister.

The Prime Minister emphasized the need for testing and awareness. He asked that every eligible person should get vaccinated. This should be the primary effort of both the society and the administration, he said.

The Prime Minister insisted that we have to move towards zero vaccine wastage. Optimum utilization of vaccination capacity is a way of increasing our capacity, said the Prime Minister

The Prime Minister said our success will be determined by awareness about ‘micro containment zones’, by not moving out of our homes unnecessarily, vaccination of all eligible persons and how we follow covid appropriate behaviour like wearing masks and other protocols.

The Prime Minister asked to make targets at personal, social and administration level for these four days of ‘Tika Utsav’ and diligently make effort to achieve them. He expressed the hope that with people’s participation. Awareness and responsible behaviour we will succeed in containing Corona once again. He ended by reminding – Dawai bhi, kadai bhi.

Source: PIB

MoS Jal Shakti addresses BRICS International Forum webinar; highlights water crisis of the world

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Pic is representational

The Minister of State for Jal Shakti, Rattan Lal Kataria, speaking at a webinar organized by BRICS International Forum, a civil organization, highlighted the role of BRICS Nation in resolving common problems like lack of access to safe drinking water. Shri Kataria cited example of Cape Town, South Africa, which became the first major city to have run out of water in the year 2017-18, to highlight the gravity of water crisis being faced in the world today. He mentioned about Brazil where around 3 million population still lack access to safe drinking water. Russia on the other hand has 1/4th of the world’s fresh surface and ground water resources and provides 248 lpcd water to its residents for domestic use.

Kataria added that the ongoing pandemic has exacerbated the existential global crisis like hunger poverty and water scarcity. He emphasized upon learning from each other’s valuable experience in handling the water crisis as 2.2 billion people across the globe still struggle to have access to safe drinking water (WHO). He termed providing safe drinking water to people as an inescapable duty of any Government and also a Human Right as enshrined in UNGA resolution 64/292.

Kataria informed the esteemed dignitaries that realizing the true importance of providing access to assured and safe drinking water to each rural household, Government of India, under the dynamic leadership of Prime Minister, Narendra Modi, launched an ambitious Scheme to cover all rural households with piped water supply by the year 2024. In August 2019, India launched Jal Jeevan Mission (Water is life) Scheme with a total outlay of Rs 3.60 lakh Crore that is around 48 billion US$.

A Scheme of this scale is unprecedented in the history of this Nation and probably in the world. Kataria informed that in a short span of 1 and a half years, India has provided over 40 million piped water connections to rural households. At this pace, it is expected to meet the ambitious target of covering all rural households well within the time limit.

The MoS Jal Shakti added that the outcome of Jal Jeevan Mission cannot be limited to providing piped water connections to households as it is ushering a Social revolution as each and every household – irrespective of caste, color, creed or religion is getting water at 55 lpcd – following an inclusive approach. It is reducing the drudgery of women who used to travel long distances to get water for their families. In fact, village level committees have been constituted for making plans for augmenting water supply for their respective villages. 50% participation has been ensured for women in such committees. This step shall empower women to take important decisions linked with water management.

The Mission includes a huge investment in water network infrastructure like pipes, taps, water pumps, storage tanks etc. it shall create a huge demand for skilled/semi-skilled workforce like pipe fitters, plumbers, electricians, pump operators etc. Therefore, the Mission includes a component of skill training for the rural youth so that they can earn their living.

Terming JJM as a success story, Kataria mentioned that India is ready to share its experience with other developing Nations. He also called upon the BRICS Nations for sharing the innovative and best practices being followed in water sector both at the Government level as well as amongst the civil organizations. This shall sensitize people towards judicious use of water and to develop efficient water management practices. In the end, he termed BRICS as an association of emerging economies, with considerable regional influence, and built upon the principles of equality, trust, mutual understanding.

The webinar was attended by Prof Prince William Mishiki, Minister of DR Congo, Yulia Berg Co- Founder of The International Business Acceleration Centre, Russia, Purnima Anand President, BRICS International Forum President, International Federation For Indo-Russian Youth Club, Volker Tschapke Consultant for Foreign Trade Federal Association for Economic Development and Foreign Trade Global Economic Trade (Germany) amongst others. It is informed that currently the fifteenth-year anniversary of BRICS missions is being celebrated. India is the chair country of the 13th conference in the BRICS summit and is committed to the common goals uniting the BRICS countries.

Source: PIB

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