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

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

HOSPEX Healthcare Expo 2023

The “First, Best, and Only Hospital Expo in Kerala” for all your Medical Equipments and Hospital needs.

2nd Edition of HOSPEX Healthcare Expo cum Conferences will be held at Kochi, Kerala from Sep 15th – 17th 2023. This is Kerala’s first B2B Medical Expo which will take place at Zamra International Convention and Exhibition Center, Kochi,  Kerala.

HOSPEX 2023 Expo is the platform to showcase Technology, Products & Innovations to the healthcare fraternity.

Expo cum Conference Theme this year is on :

Future of Healthcare – Device | Digital | Diagnostics

Don’t miss this exclusive opportunity to witness the forefront of medical technology under one roof at the HOSPEX Healthcare Expo.

HOSPEX Expo has a projected walk-in of 10000+ professionals and entrepreneurs from all over South India including doctors, hospital owners, managers, supply & purchase staff, distributors that are all from the medical industry. 

HOSPEX is the Convergence platform where Makers (Medical Device Manufacturers) , Users (Healthcare Establishments) and Innovators (MedTech, HealthTech, Digital Health Innovators, FinTech, Insuretech, CyberTech etc) and Governments , Policy Makers join the connected conversations to strengthen and improve the Healthcare Ecosystem in the country.

For more information about Expo, visit – https://hospex.in/

All Conference details are available at – https://hospex.in/hospex-2023-conference/

Contact :

T S Soumya, Hospex
+91 9080078447
Email – reach@hospex.in

The core focus of HOSPEX Healthcare Expo 2023 is medical knowledge dissemination thereby hosts multitude of conferences focused on the futuristic trends in the medical industry. These conferences provide attendees with the opportunity to learn about new products and technologies, network with other professionals in the field, and stay up-to-date on the recent and futuristic developments in the industry.

SMART Hospitals Conference

Date : Sep 16, 2023

Time : 10 00 am to 6 00 pm

Fee : Rs 500 per delegate

SMART Hospitals Conference focus is to enable Micro and Small Hospitals to Go Digital, use various HealthTech and MedTech Solutions – be it for Clinical Decision Support Solutions, Tech Solutions to help Hospitals to streamline their day to day practices, Tech solutions to improve productivity of healthcare workforce, Technologies that facilitate Quality and Safe Patient Care.

Conference will connect SMART Technologies, Solutions that are needed in healthcare settings as Future of Healthcare will be driven by Practitioners , Healthcare Settings using SMART Devices, Diagnostics and Digital Solutions.

Conference Outline :

  • SMART Medical Technologies help Practitioners to improve service standards
  • SMART Medical Device for Safe Patient care in Clinical Settings , Home Healthcare Setting
  • Testing and Certification of SMART Medical Devices – Global Regulations and Certification Requirements
  • Empowering Practitioners : Virtual Cardiac Care Diagnostic Solutions
  • Telehealth and Telemedicine – NMC Regulations & Clinical Establishments
  • SMART Prescription for Prescribers – EHR Solution
  • SMART Technologies to enable Small Hospitals – Technology Session 
  • SMART HealthTech Ecosystem
  • Digital Health Apps for Enhancing Patient Satisfaction, Loyalty and Referrals
  • Digital Ecosystems: Future of Healthcare – The Value for All: Patients, Healthcare organisations and Innovators, Startups
  • Smart Healthy Aging Tech Solutions

Target Audience :

Medical Professionals, Healthcare Professionals from Hospitals and other Healthcare organisations, HealthTech, MedTech Professionals , Startups, Innovators, Incubation Hubs, Medical Device Industry Representatives, Digital Health Teams, Quality Professionals, Regulatory Affairs Professionals and other stakeholders like Insurers, Governments, Regulators, Corporate Health & Wellness Teams, Corporate Medical Centers, Home Healthcare Service Providers etc

Venue: Zamra Convention Centre, Kochi, Kerala 

Date : September 15, 2023

Time : 2 30 pm – 5 30 pm

Fee – Rs 250 + GST 

Target Audience :

Healthcare Professionals Who are incharge of Procurement Practices in Hospitals and other Healthcare Settings 

Medical Professionals, Promoters, Management Teams, Administrators, Purchase Teams, Biomedical Engineers, Finance Teams, Quality Teams , other functional heads who are interested in understanding more about Quality and Safety related Regulations of Hospital Supply Chain and Vendors .

Workshop shall cover following items that Hospitals Procure with special reference to:

– Biomedical Equipments

– Consumables and Disposables

– Standalone MedTech or Healthtech Software that is used for clinical decision support purpose

Program Objective :

Since Medical Devices, Health Technologies are part of the Value Chain of Hospital Supplies, its imperative for Procurement Teams, Purchase Managers, Finance Teams, Promoters , Quality Teams to learn more about Regulations and Compliances related to their Supply Chain , Value Chain of Hospitals (Suppliers and Vendors)

Hence HOSPEX has designed an Awareness Session covering the following topics for Hospital Teams who are incharge of Procurement :

  • Understanding Medical Device Regulations- Laws of the Land
  • Medical Device Regulations – Role of Bureau of Indian Standards
  • Foreign Regulations , Quality Specification – How its listed in other Key Global Regulations
  • Claims of Voluntary Certifications – How Authentic these claims are ?
  • Materiovigilance Program of India – Regulatory Requirement
  • Post Market Surveillance of Medical Devices
  • Biomedical Engineers Skill Certification Program, Scheme Details, Benefits 

Contact Details :

For more information about Conference, visit – https://hospex.in/hospex-2023-conference/

For more information about Expo, visit – https://hospex.in/

For support in registration, reach out to :

Ms Soumya – 9080078447 

Email – reach@hospex.in

Industry information update – Medical devices

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.

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

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

Industry Information update

Commerce ministry authorises EPCMD to issue registration-cum-membership certificates for exporters

The Commerce Ministry has authorized the newly-established Export Promotion Council for Medical Devices (EPCMD) to issue registration-cum-membership certificates for exporters of specific medical items. These items include bandages, first-aid boxes, hot water bottles, ice bags, gloves, surgical garments, syringes, and stethoscopes.

A Registration-cum-Membership Certificate (RCMC) is required for exporters to avail benefits under the foreign trade policy, as well as customs and excise benefits

Holding the certificate can also help exporters in availing benefits with respect to customs and excise.

These items also include hot water bottles, ice bags, gloves, personal protective garments for surgical/medical use, surgical gowns and drapes, syringes, with or without needles, and stethoscopes.

The directorate general of foreign trade (DGFT) in a public notice stated that the council has been included in FTP for “issuing RCMC for specific items”.

source: https://economictimes.indiatimes.com/news/economy/foreign-trade/commerce-ministry-authorises-epcmd-to-issue-registration-cum-membership-certificates-for-exporters/articleshow/101386747.cms

BSI Launch Event: Antimicrobial Resistance (AMR) certification

BSI Antimicrobial Resistance (AMR) Certification – Launch event on Monday, 26th June 2023 between 15:00 hrs – 16:30hrs (IST)

According to the World Health Organization, antimicrobial resistance (AMR) has been declared a top 10 global public health threat and is expected to get worse unless action is taken. It threatens to undermine the basis of modern medicine by rendering the antibiotics used to treat and prevent infections ineffective.

Resistance can come from many sources – BSI is working with the pharmaceutical industry to focus on the evolution of responsible manufacturing of antibiotics. Manufacturing waste from the production of antibiotics may contribute to the development of AMR in the environment unless emissions from waste streams are effectively controlled

BSI, in collaboration with the AMR Industry Alliance, will launch an industry antibiotic manufacturing certification scheme on 26 June 2023

This independent and impartial certification program is perfectly situated to serve as a mechanism for antibiotic manufacturers to demonstrate evolving best practice and compliance to the Antibiotic Manufacturing Standard. While government regulators have a role to play in promoting responsible manufacturing, the industry has shown its willingness to self-regulate by developing this manufacturing standard and independent certification scheme.

Companies including Centrient, Roche, Pfizer, Teva, Viatris, and Sandoz were participants in the pilot program and have helped provide technical expertise to shape the certification program.

  • Provide independent third-party assurance that your organization is minimizing the risk of waste emissions from manufacturing 
  • Prove that the industry can self-regulate the antimicrobial resistance topic through certification and external third-party independent assessments
  • Differentiate yourselves in healthcare systems tenders by showing your antibiotic products are independently certified by a trusted organization with a recognizable Mark of Trust

Who should attend?

  • Pharmaceutical manufacturers
  • Regulators
  • Government policy makers
  • Trade associations
  • Contract manufacturers
  • Hospital / healthcare systems sustainability procurement

News Letter

Materiovigilance Program of India (MvPI) News Letter

Indian Pharmacopoeia Commission has released its News Letter – Materiovigilance Program of India Volume 5 – Issue 1 recently.

Sharing the same for information

Procedure for submission of cough syrups for Testing

Mandatory Testing of Cough Syrup before ExportProcedure for submission of cough syrups for Testing

Cough syrup exporters will have to undertake testing of their products at specified Government Laboratories and obtain Production of Certificate of Analysis with effect from June 1 before getting permission for the outbound shipments

Ministry of Commerce & Industry has issued a Notification No.06/2023 dated 22nd May 2023 permiting export of cough syrups, subject to the export sample being tested and production of Certificate of Analysis (COA) issued by any of the Central Government Laboratories and any NABL Accredited State Drug Testing Laboratory.

The specified Central Government labs include Indian Pharmacopoeia Commission, Regional Drug Testing Lab (RDTL – Chandigarh), Central Drugs Lab (CDL – Kolkata), Central Drug Testing Lab (CDTL – Chennai Hyderabad, Mumbai), RDTL (Guwahati)] and the NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited drug testing labs of State Governments

In order to facilitate the process of testing of cough syrups at the said laboratories, the following are the pre-requisite requirements for submission of samples :

  1. Covering letter from the Manufacturer / Exporter on Letterhead addressed to concerned Laboratory
  2. Manufacturing License of the product for Export purpose
  3. Export Order
  4. Representative sample from the export consignment
  5. Thrice the quantity required for performing complete analysis of the sample
  6. Qualitative composition of product including excipients
  7. Certificate of analysis by the manufacturer of the particular batch and method of analysis (STP)
  8. Reference / Working standard (with traceability certificate) and placebo as applicable

Source: https://www.dgft.gov.in/CP/?opt=notification