Minimum Viable Product (MVP) Guidance Document

NHA has published a Minimum Viable Product (MVP) Guidance Document for ABDM Compliant HMIS/LMIS Version 4.0

The document outlines the features which are recommended to be included in digital health solutions for a Clinic MIS, Hospital MIS, Lab MIS and Pharmacy MIS

Training Program Announcement

Quality and Accreditation Institute (QAI) is organising a program on Documentation Implementation Verification Elevation (DIVE) Program on ISO 7101:2023 (E) covering Healthcare organization management – Management systems for quality in healthcare organizations – Requirements

Program Details are given below :

Date: 16-17 December 2023
Location: New Delhi (On-Site)
Time: 09:00 AM – 05:00 PM
Rs.10000+18% GST (inaugural offer, std. rate Rs. 15000+18% GST)
Last Date to apply: 30 November 2023

For Registration Form, Pls click here

Your Attractive Heading

Technical Conclave 

Foodchain ID’s 4th Technical Conclave on December 6, 2023 @ Coimbatore

Foodchain ID’s 4th Technical Conclave is scheduled on December 6 2023 at Hotel IBIS,Coimbatore

Program Highlights

– FSSAI regulatory requirements for license and label
– FSSC 22000, version 6 updates and requirements
– Digital tools for international regulations
– Overview of organic certification requirements

Program Details

Date : DECEMBER 6, 2023
Time: 10.00 – 17.00 Hrs
Fee : INR 3000 + TAXES

Registration Link : https://forms.gle/p4gx3amFKUv4y48x7

Certificate of participation shall be given

Global Bio-India 2023

Global Bio-India 2023 would be the largest congregation of biotech startups

Biotechnology sector is recognized as the key driver for contributing to India’s USD 5 Tn economy target. Global Bio-India 2023 would showcase India’s Biotech growth and opportunities to the world.

Department of Biotechnology (DBT), Ministry of Science & Technology, Government of India and it’s Public Sector Undertaking, Biotechnology Industry Research Assistance Council (BIRAC) are organizing Global Bio-India 2023, a mega international congregation of biotechnology stakeholders, including international bodies, regulatory bodies, Central and State Ministries, SMEs, large industries, bioclusters, research institutes, investors, and the startup ecosystem

The event will take place from 4th-6th December’ 2023 at the Bharat Mandapam International Exhibition-Convention Centre (IECC), Hall No. 14, Pragati Maidan, New Delhi

Key Objectives of the program

  • Bio – Partnering, Policy Discussions, CEO’s plans for India & asks from India
  • Showcase and identify key biotechnological innovations, products, services, technologies from national and international companies, start-ups and research institutes
  • Identify funding and collaboration opportunities for biomanufacturing and biotech innovations
  • Explore licensing options for existing products
  • Attract major contract projects from international companies as well as major global venture funding into India
  • Create platforms for new idea evaluation and investments
  • Opportunity for Indian State Governments to attract foreign investment into their respective States
  • Discuss key trends and policy interventions across all sub-sectors including bio-pharma, bio-agriculture, bio-industrial, bio-energy, bio-manufacturing, bio-services etc. and establish takeaways
  • Connect Indian Biotech ecosystem with international ecosystem
  • Learning platform to share experiences of successful companies and geographies.
  • Facilitate interactions of research institutions with the industry

Why Attend this program

Who Should attend :

For registration and Fee details: please refer to the link https://www.globalbioindia.org/registration 

An email confirmation will be sent immediately following the completion of online registration. If you have not received a confirmation, please check your spam or junk mail folder.

Source: https://globalbioindia.org/

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.

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

Notification by UGC

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

Awareness and Implementation Webinar

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

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

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

World Standards Day 2023

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