Category: Quality News – ISO Standards

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

Awareness and Implementation Webinar

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Awareness and Implementation Webinar on QCOs on Identified Indian Standards under Medical Textiles -20 November 2023 (1430 onwards)

BIS, the National Standards Body of India was established for harmonious development of the activities of standardization, marking and quality certification of goods and for matters connected therewith or incidental thereto. BIS has been providing traceability and tangibility benefits to the national economy in a number of ways, i.e., providing safe reliable quality goods; minimizing health hazards to consumers; promoting exports and imports substitute; control over proliferation of varieties, etc.

The Textiles Department, Bureau of Indian Standards is organizing an “Awareness and Implementation Webinar on QCOs on Identified Indian Standards under Medical Textiles” on Monday, 20 November, 2023  at 1430 hrs onwards. 

The main objective of the webinar is to spread awareness on product standards on Medical Textiles e.g.  Sanitary Pad (Disposable and reusable), Baby Diaper, Bedsheet and Pillow Cover, Shoe Covers, Dental Bib, Coveralls, Facemask etc.

Webinar will not only talk about the salient features and importance of these standards but also disseminate valuable information on BIS conformity assessment/certification process for implementation of standards. 

Through this webinar, it is envisaged to bring the manufacturers/stakeholders of Medical Textiles and BIS to a common platform for discussion on standards which are brought under Quality Control Order(QCO’s)  by Ministry of Textiles (MoT) as well as its implementation related issues. 

Considering the importance of the event we hope that you would make it convenient to participate in the above webinar. It is requested to confirm your participation by return e-mail.

Please note that there is NO REGISTRATION FEE for this webinar.  You can join directly from the following link :-

Webinar Link: https://bismanak.webex.com/bismanak/j.php?MTID=m50648bf361e4ac4891d7924144944c69

Webinar ID: 2516 299 4441
Webinar Password: Txd36@123

Program schedule is given below for your kind reference

Awareness programme

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Awareness programme on
Good Clinical Practice Professional Certification Scheme (GCPPCS)
November 07, 2023 11:00 a.m. to 01:10 p.m. IST

Translational Health Sciences and Technology Institute (THSTI), Department of Biotechnology, Ministry of Science and Technology, Government of India announces the rollout of the Good Clinical Practice Professional Certification Scheme (GCPPCS) awareness webinar series.

This new initiative, believed by us, is the first-in-globe, based on the International ‘Personnel Certification’ standard (ISO 17024:2012). It was launched by the Clinical Development Services Agency (CDSA)- THSTI, , and dedicated to the nation on 75th Independence day by Dr. Renu Swarup, Ex-Secretary, Department of Biotechnology (DBT), Ministry of Science & Technology, Government of India in the presence of Dr. Pramod Garg, Ex-Executive Director, THSTI, DBT.

A series of awareness webinars have been scheduled for the prospective clinical research professionals. The first webinar will be held on November 07, 2023, 11:00 a.m. to 01:10 p.m. IST.

We invite all interested professionals – ethics committee members, clinical researchers or clinical trial team members, investigators involved in clinical research or trial, personnel working in the area of regulatory affairs, pharma, biotech, research institutes, academia, and other personnel working in this area to kindly register.

The registered participants will receive e-Certificates (Certificate of attendance).

There is no fee for attending this webinar. The flyer containing all relevant information is given below. 

last date of registration is 05, November , 2023 Sunday till 17:00 pm IST

The link to register online: https://forms.gle/6P4tvExCMxzMa9CP6

We request you to kindly circulate this information among your friends and colleagues and request them to register. If you need any assistance, please contact gcppcs.cdsa@thsti.res.in

News Letter from IPC

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Medical Device Regulations – Materiovigilance Program of India – News Letter from IPC

News Letter from IPC on Materiovigilance Program is shared below for information.

Since Medical Devices are brought under Full Regulations in the country, one of the mandatory Regulatory Requirement is Market Surveillance by Regulator .

Read the news letter shared below for more information

Click here to read the Newsletter

World Standards Day 2023

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Invitation to All to join WSD 2023 Celebrations

Oct 14th is Celebrated World over as World Standards Day.🎊

CCC(Consultants Consortium of Chennai) and MSCC(Management Systems Consultants Consortium) are organising a webinar on Oct 14th 2023 from 4 pm–5 pm.🗓️

WSD Theme this year : Shared Vision for a better World – Incorporating SDG 3

SDG 3 is all about Good Health and Wellbeing 👩🏻‍⚕️

In alignment with Global Theme,we have scheduled a webinar on the following topic:

Healthcare Quality Assurance – Standards ✅

ISO has released a Healthcare QMS Std – ISO 7101, for the first time globally.🏥
Pharma Sector is witnessing Global MS Standards in Pharma Manufacturing as well💊
Medical Devices Sector is racing towards implementing MDQMS 🩺

Session on Healthcare Quality Assurance is designed to Educate Healthcare Sector – be it Services or Products , and various other stakeholders, about various Healthcare Quality Assurance Standards which are introduced globally to improve the Healthcare Quality Focus across the globe.

Healthcare Services can’t offer Assurance on its Quality when its Supply Chain, Value Chain Quality is not in alignment with its Quality Assurance Framework.

Time to LEARN, UNLEARN and RELEARN 🧑‍🎓

Prog Info :

Date : Oct 14, 2023
Time : 4 pm – 5 pm
Meeting Mode : Zoom Meeting
Fee – No Fee. Free for all 🆓

Registration Link :https://us02web.zoom.us/meeting/register/tZwsd-uhrD8rHdXTn3awk0eCxcSxAzqqSg20

Prior registration is a must. All registered delegates will receive direct mail from ZOOM, CCC Secretariat and also a SMS.

For Prog info, updates, visit – https://ccc-consultants.org/world-standards-day-2023/

For queries , pls mail :

CCC – contact@ccc-consultants.org
MSCC – info@msccglobal.com

World Standards Day (WSD)

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World Standards Day (WSD) -14 October 2023 – Session by QAI

World Standards Day is celebrated globally on Oct 14 every year.

Global Theme for this year is on: Shared vision for better world: Incorporating SDG 3 (Good Health and Well Being)

Quality and Accreditation Institute (QAI) is Celebrating WSD 2023 by organising a one Hour Session based on the Global Theme on 14 October 2023 between 11 AM to 12 PM.

The session will be held in Virtual Mode (Webinar).

Registration Link: https://us02web.zoom.us/meeting/register/tZ0vceGhrzwqHdRVwoCTgdFgh559fLKH8pVN

After registering, you will receive a confirmation email containing information about joining the meeting.

Join hands to celebrate the day.

Training Program – Announcement

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Induction cum Training Program on 13th and 14thJuly 2023 – 2pm to 5 pm – Organised by Indian Pharmacopoea Commission

NCC-MvPI, IPC is organizing 10th Induction-cum-Training Programme from July 13-14, 2023 from 2:00 pm to 5:00 pm via digital/virtual platform to educate/aware Coordinators/Deputy Coordinators of hospitals/clinical establishments those who have submitted the enrolment form under MvPI.

After the completion of the training programme, NCC-MvPI, IPC will provide a time period of 3 months to the hospitals/clinical establishments for actively participating under MvPI.

Based on the active involvement of hospitals/clinical establishments in materiovigilance, NCC-MvPI, IPC will approve the hospitals/clinical establishments as MDMC in forthcoming MvPI partners meeting.

In this connection, all Hospitals / Clinical Establlishments are invited to this training programme in order to strengthen the materiovigilance programme in your organsation. Prior registration is a must.

Click here for Registration

Industry information update – Medical devices

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DoP releases strategy document to fine tune & implement National Medical Devices Policy

In an effort to fine tune and proceed with the implementation of the National Medical Devices Policy, 2023, launched in the month of May, the Department of Pharmaceuticals (DoP) has come out with an elaborate strategy document which emphasises on data security measures, adoption of national nomenclature for medical devices, a strategy to manage e-waste of obsolete medical devices and strengthening of technology transfer capabilities in the sector.

It would also work towards providing awareness to the innovatory community on regulator compliance, early on in the product development cycle through structured programmes using course curriculum, skill training or workshops, it said.

The NMDP, 2023 covers six broad areas of work for the promotion of the medical devices industry including regulatory streamlining, enabling infrastructures, facilitating research and development and innovation, attracting investments in the sector, human resource development and brand positioning and awareness creation.

As part of infrastructure development, the strategy document states, “”In close coordination with the ministry of environment, forest and climate changes, processes will be developed for e-waste management of obsolete medical devices”.

“The Policy strives to create an ecosystem to promote Research and Innovation in the sector under the ambit of the department’s proposed separate ‘Policy to Catalyse R&D and Innovation in the Pharma-MedTech Sector in India’”

Besides, a mechanism will be put in place to hand-hold the innovators and IP holders towards commercialisation of the products

Under the fiscal and non-fiscal measures to attract investments in the sector, it looks at incubation support for start ups in the R&D and innovation, mentorship for entrepreneurs along with skill development, such as business management, market access and commercialisation efforts for the innovation solutions developed, technology transfer mechanism for innovative solutions and relations for start-ups in compliance and regulatory regime.

Under the human resources development strategy, it envisages that since the human resources in the field of design are limited, the National Institutes of Design (NID) and private design schools will be encouraged to teach design centric courses to fill the gap, it added.

Click here to read the Strategy document

Source:https://pharmaceuticals.gov.in/policy/strategy-document-national-medical-devices-policy-2023

Source:http://www.pharmabiz.com/NewsDetails.aspx?aid=160035&sid=1

Carbon Credit Trading Scheme, 2023

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Carbon Credit Trading Scheme, 2023

The Ministry of Power notified the Carbon Credit Trading Scheme, 2023 whereby the governance of Indian Carbon Market and direct oversight of its functioning will be done by the National Steering Committee for Indian Carbon Market

1. The National Steering Committee shall recommend to Bureau the following functions:

  1. for the formulation and finalisation of procedures for institutionalizing the Indian carbon market;
  2. for the formulation and finalisation of the rules and regulations for the functions of Indian carbon market;
  3. for the formulation of specific greenhouse gases emission targets for the obligated entities;
  4. for the formulation and finalisation of guidelines regarding trading of carbon credit certificates outside India;
  5.  to issue carbon credit certificate;
  6. for the development of the process or conditions for crediting period or renewal or expiry of carbon credit certificate;
  7. to monitor the functions of Indian carbon market;
  8.  to constitute any Committee or Working group as required in connection with Indian carbon market; and
  9. any other functions assigned to it by the Central Government.

2. The Chairperson shall call the meeting at least once in a quarter of every year.

The bureau, in its role as administrator, will carry out the following tasks:

 (a) to identify sectors and potential for reduction of greenhouse gases emissions in such sectors and recommend to the Ministry of Power to include such sectors in Indian carbon market;

(b) to develop trajectory and targets for the entities under compliance mechanism;

(c) to issue the carbon credits certificate based on the recommendation of the National Steering Committee for Indian carbon market and subsequent approval of the Central Government;

(d) to develop market stability mechanism for carbon credits;

(e) to develop the procedure for accreditation and functions of accredited carbon verification agency;

(f) to accredit the agencies in accordance with the approved procedure for accredited carbon verification agency;

(g) to determine, the fees and charges payable by the registered entities with the approval of Central Government, for the purposes of meeting the cost and expense towards the implementation of this Scheme;

(h) to develop the process or conditions for crediting period or renewal or expiry of carbon credit certificates;

(i) to develop data submission formats, forms for effective functioning of Indian carbon market;

(j) to undertake capacity building activities for the stakeholders;

(k) to develop and maintain the information technology infrastructure including the user guidance platform required for Indian carbon market;

(l) to maintain secure database with all security protocols as approved by the Central Government;

(m) to constitute any Committee or working group as recommended by the National Steering Committee for Indian carbon market; and

(n) any other functions assigned to it by the Central Government.

The Central Electricity Regulatory Commission as a regulator to Indian Carbon Market shall perform the following functions:

(a) to regulate matters relating to trading of carbon credit certificates;

(b) to safeguard interest of both sellers and buyers;

(c) to regulate frequency of carbon credit certificates trading; and

(d) to provide market oversight and take necessary preventive and corrective actions to prevent fraud or mistrust

The Bureau shall constitute, one or more Technical Committees for different areas as required under compliance mechanism for the purposes of this Scheme

The Bureau with prior approval of the Central Government shall determine the procedure including eligibility criteria for accreditation of any agency to function as accredited carbon verification agency based on the recommendation of the National Steering Committee for Indian carbon market

The sectors and the obligated entities to be covered under the compliance mechanism shall be decided by the Ministry of Power based on recommendations of the Bureau;

The sectors and the obligated entities to be covered under the compliance mechanism shall be decided by the Ministry of Power based on recommendations of the Bureau

The National Steering Committee for Indian carbon market and other authorities shall develop the detailed procedure for operationalising the Indian carbon market, in accordance with this Scheme. The detailed procedure shall contain the following, namely: –

  • criteria for issuance of carbon credit certificates;
  • validity of carbon credit certificates;
  • floor and forbearance price of carbon credit certificates;
  • requirement, format and timeline for submissions;
  • monitoring, reporting and verification; and
  • any other related and incidental matters.

The Bureau may, from time to time, issue such directions and orders to the registered entities, with the approval of the Central Government, as considered appropriate for the implementation of this Scheme.

Click here to read the Notification

New Drugs and Clinical Trial Rules (2023)

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New Drugs and Clinical Trial Rules (2023) 

New Drugs and Clinical Trial Rules (2023) has been passed by the Government of India which aims to replace the use of animals in research, especially in drug testing.

Need for new regulations:

  • Despite increasing investment in the pharmaceutical sector, most drugs that cleared the animal-testing stage fail at the stage of human clinical trials.
  • The limitations of the conventional testing process, beginning with animals, have led an increasing number of researchers to focus on systems that do a better job of capturing the intricacies of human biology and predicting humans’ responses.

Key-highlights of the Amendment:

  • The amendment authorises researchers to instead use non-animal and human-relevant methods, including technologies like 3D organoids, organs-on-chip, and advanced computational methods, to test the safety and efficacy of new drugs.
  • These rules mandate that any CRO conducting a clinical trial or bioavailability/bioequivalence study of new drugs or investigational drugs in human subjects must obtain registration from the Central Licensing Authority before conducting any such studies

Technologies suggested as alternatives:      

To avoid animal use for clinical trials, technologies can be used effectively which includes;

  • Technologies developed using human cells or stem cells: These include millimetre-sized three-dimensional cellular structures that mimic specific organs of the body, called “organoids” or “mini-organs”.
  • ‘Organ-on-a-chip’ Technology: These are AA-battery-sized chips lined with human cells connected to micro channels, to mimic blood flow inside the body.
    • These systems capture several aspects of human physiology, including tissue-tissue interactions and physical and chemical signals inside the body.
  • USING 3D Bioprinter: Bio printers are used to ‘print’ biological tissues using human cells and fluids as ‘bio-ink’.
    • Since they can be built using patient-specific cells, they can also be used to personalise drug-tests.
Click here to read more

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