Call For Proposal

NBM and BIRAC announces request for expression of interest on ISO 13485:2016 training

Towards strengthening the emerging biotechnology enterprise in India, Department of Biotechnology (DBT) Ministry of Science & Technology has initiated the Mission Program entitled “Industry-Academia Collaborative Mission for Accelerating Discovery Research to Early Development for Biopharmaceuticals - Innovate in India (i3) Empowering biotech entrepreneurs & accelerating inclusive innovation” (“Program”). Biotechnology Industry Research Assistance Council (BIRAC) setup by DBT is the Implementing Agency of i3 Program (Program co-funded by World Bank loan).

The vision of the program is to enable and nurture an ecosystem for preparing India’s technological and product development capabilities in biopharmaceuticals including vaccines, biologics, medical devices and diagnostics to a level that will be globally competitive over the next decade.

The National Biopharma Mission announces a Request for Expression of Interest (REOI) from suitable organizations that have appropriate capability and certification to conduct trainings for ISO 13485:2016 (awareness and certification trainings)

Towards strengthening the emerging biotechnology enterprise in India, Department of Biotechnology (DBT) Ministry of Science & Technology has initiated the Mission Program entitled “Industry-Academia Collaborative Mission for Accelerating Discovery Research to Early Development for Biopharmaceuticals - Innovate in India (i3) Empowering biotech entrepreneurs & accelerating inclusive innovation” (“Program”). Biotechnology Industry Research Assistance Council (BIRAC) setup by DBT is the Implementing Agency of i3 Program (Program co-funded by World Bank loan).

The vision of the program is to enable and nurture an ecosystem for preparing India’s technological and product development capabilities in biopharmaceuticals including vaccines, biologics, medical devices and diagnostics to a level that will be globally competitive over the next decade.

The National Biopharma Mission announces a Request for Expression of Interest (REOI) from suitable organizations that have appropriate capability and certification to conduct trainings for ISO 13485:2016 (awareness and certification trainings)

Under the present call, proposals are invited to conduct ISO 13485:2016 training

NBM plans to organize ISO 13485:2016 training programmes for the capacity building of medical device start-ups and companies. The planned training should be a high value and high impact training programme of an advanced level and shall be aimed at providing guidance and practical experience, promote skill development, optimizing auditing skills, planning, executing, reporting, monitoring the effectiveness and conformity to regulatory guidelines, in order to achieve successful QMS implementation in medical device sector.

 

In view of their importance, NBM plans to organize these trainings for professionals of SMEs/ start-ups who are involved in medical device and diagnostics sector within India. The following types of trainings is planned to be conducted:

 

ISO training

Training/ Workshop

No. of participants

ISO 13485:2016

Awareness Webinars (2 hour each)

1000 (minimum 4 webinars)

ISO 13485:2016

Implementation Training (24 hours trainings)

750

ISO 13485:2016

Internal Auditor Training (16 hours trainings)

250

 

These trainings are proposed to be organized by a certified training agency which fulfil the eligibility criteria (please refer to the published REOI).

Applications are requested from organization certified and competent to impart the course as mentioned above.

  1. The application can be submitted solely by Indian/ International - Company/ Non-profit organizations/ Government entities/ Society/Trusts/ Foundation/ Associations/ Institutes/ R&D Organizations which is a legal entity.
  2. Joint/ collaborative applications will not be accepted.
  3. Application by individuals will not be accepted.
  4. The establishment period as on date of closing of application should be at least five (5) years.
  5. The applicant should not be a Pakistani entity.

 

Criteria Particulars for the Proponent entities:

  • Indian companies – An Indian Company is defined as one which is registered under the Indian Companies Act, 2013 and minimum 51% of the shares of the Company should be held by Indian Citizens holding Indian passport [Indian Citizens do not include Person of Indian Origin (PIO) and Overseas Citizenship of India (OCI) holders].
  • International companies – Incorporated entity established under the specific statute of the respective Country/State.
  • National & International Non-profit organizations/ Government entities/ Institutes/ R&D Organizations – This will include Academic Research Institutes, Universities, Research Foundation, Medical Colleges and Institutes – both public and private who are valid legal entities such as Trust, Society or Corporations established under central or state statute of their respective countries.

View REOI

Proposals are required to be submitted online only. For submission of proposals, applicants need to register with BIRAC through “User Registration”. Additional information on user registration and proposal submission are available online at BIRAC website at www.birac.nic.in.

No Hard Copy to be submitted. Proposals submitted online only would be considered.

For any queries, please contact:

 

Dr. Hardeep Vora, Programme Manager, PMU- National Biopharma Mission

Email: nbm3@birac.nic.in

 

Dr. Divya Wahi, Program Officer, PMU- National Biopharma Mission

Email: nbm-10@birac.nic.in

 

Dr. Pooja Tanwer, Senior Program Officer, PMU-IndCEPI

Email: user-037@birac.nic.in

 

Announcement Date: 22-02-2021
Last Submission Date: 22-03-2021 05:00 PM

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