NABL Training Programs

Training Programs from NABLAnnouncement

Training Programs from NABL

Download the Brochure here :

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Webinar for Med Tech Startups

Webinar with Medical Technology Start-ups on 26 Oct 2021 – Invitation 

Program Announcement from BIS for Med Tech Startups
Webinar with Medical Technology Start-ups on 26 Oct 2021 – Invitation 

Bureau of Indian Standards (BIS), the National Standards body of India, is formulating Indian Standards in various fields. In the field of medical devices and related aspects, BIS has formulated around 1450 standards under its Medical Equipment and Hospital Planning Division Council(MHDC).

With an objective to impart awareness regarding existing Indian Standards on medical devices among the Medtech Start-ups community as well as to explore the feasibility of formulating standards on the novel medical devices developed/being developed by them, the Medical Equipment and Hospital Planning Department (MHD) of BIS is organizing a Webinar with Medical Technology Start-ups on 26 October 2021 from 1400-1700 hrs.

The details of the link for joining the webinar are as follows:

Date26 Oct 2021 (Tuesday)
Time1400 h to 1700 h
Link to joinhttps://bisindia.webex.com/bisindia/j.php?MTID=mec53359b4f7429c481f7ef5c5ec97ebd
Meeting No.2513 899 2572
PasswordBIS@2021

You are cordially invited to participate in the webinar. There is no registration/participation fee. 

Please click on the link below to register :

Contact :
Medical Equipment & Hospital Planning Department
Bureau of Indian Standards
Manak Bhavan
9, Bahadur Shah Zafar Marg
New Delhi – 110 002
Ph : 011-23230910

Indian Clinical Trial & Education Network (INTENT)

EoI Announcement from ICMR

Expression of Interest (EOI) for Participation in “Indian Clinical Trial & Education Network (INTENT)”.

The Indian Council of Medical Research (ICMR) under the Department of Health Research
(DHR), Ministry of Health & Family Welfare,
Government of India, is the apex biomedical
research body in the country for formulation, co-ordination, and promotion of medical research.
The overall goal of ICMR-DHR is to generate evidence to inform policy, program and practices
pertaining to health care in India.

Clinical Studies, Trials and Projection Unit (CSTPU), Indian Council of Medical Research (ICMR),
Department of Health Research (DHR) proposes to launch the Indian Clinical Trial & Education
Network (INTENT), which will serve as a pan-India network of institutes with proven excellence
in clinical research. The network, thus established, will conduct large scale, multi-centric clinical
trials in a timely and well-regulated manner.

Why clinical trial network ?
INTENT envisages to provide evidence-based, cost effective, scientifically sound, and culturally appropriate solutions to diseases and health issues of national and/or regional importance. It will provide a single platform to conduct a range of randomized clinical trials (RCT), that will enable harmonization of trial methods, pooling of results and timely completion of the projects, along with an inclusive representation of the diverse Indian communities. Additionally, this network will be at the forefront for capacity building of a pool of health researchers across the country. The trainees will acquire requisite skills to plan and conduct RCTs and to analyse and disseminate the results that could inform policy and practice.

Structure of INTENT
INTENT will work on a hub and spoke model with a co-ordinating centre located at ICMR-DHR. Hubs will be distributed over the six regions of the country (North, South, East, West, Central and North-east) and will function as nodal point for RCTs in that region. These Advanced Centres for Clinical Trials (ACCT) will include Institutes/Medical Colleges/Hospitals of repute with rich experience and expertise related to RCTs. They will have functional linkages with Multidisciplinary Research Unit (MRU) and/or Model Rural Health Research Unit (MRHRU) under the aegis of ICMR-DHR in the region.

Each regional hub, thus identified, will act as the mentoring body for a region, with the responsibilities of supportive supervision and troubleshooting as required. They will have an inclusive expansion plan so that the newly identified potential partnering agency/institutes/organizations are inducted in the regional network. The identified MRU/MRHRU will act as a Regional Clinical Trial Unit (RCTU), responsible for daily functioning and monitoring of the trials. Each regional hub will select their study sites (spokes) as per the research question to be answered. Funding for human resource, as well as for the mentoring activities at each of these hubs will be provided by ICMR-DHR (Figure 1). The number of regional hubs will be scaled up in a phased manner. Disease-oriented domain specific networks within INTENT will be recognised according to the
domain expertise and subject specific clinical requirements.

Who can apply for Advanced Centre for Clinical Trial?
Govt. Medical Colleges/Institutes
Private Medical Colleges/Institutes
Hospitals with experience of conducting RCTs
ICMR Institutes .

Investigators motivated to lead the regional hubs can apply with institutional approval.

Criteria for selection
Investigator
a. Endorsed by the Head of the Institute/College
b. Experience of initiating/participating in multi-centric RCT
c. Good quality publications on RCTs
d. Subject specialization
e. Preferably a multi-disciplinary team of investigators to be involved, with at least 2 of the team members being mid-level faculty (associate or additional professor, or equivalent experience)

Institute
a. Community outreach programme
b. Access to potential trial participants, both in-patient and outpatients
c. History of collaboration with other institutes/medical colleges/community-based organizations
d. Catchment area catering to various geographical and population groups
e. Presence of requisite infrastructure and space

Trials to be conducted via INTENT
Research priorities of INTENT will reflect the national and/or health priorities of urgent and important nature. Among others, the areas which will be covered by INTENT are reproductive, maternal, neonatal, child and adolescent health (RMNCHA), communicable and noncommunicable diseases, nutrition, mental health, environmental health, health system research, healthcare financing, digital health, occupational health, vulnerable people’s health and oral health.

The clinical trials to be conducted by INTENT partners can be grouped as short, intermediate, and long-term projects. To begin with, the focus of the network will be on short-term projects, where questions relevant to national health needs can be answered within 1-2 years. The projects will be primarily funded by ICMR.

Interested parties should fill the Google form at the following link:
https://docs.google.com/forms/d/e/1FAIpQLSf6yt0HbP0vfJswup8q8nHRt5b1omYX8iQNWt
GEN8aSd3VjaA/viewform?usp=sf_link

The last date of receiving application: 25th October 2021

For further information, please contact:

Dr. Aparna Mukherjee
Scientist E
Clinical Studies Trials & Projection Unit
Epidemiology and Communicable Diseases Division
Indian Council of Medical Research
Email: intent.icmr@gmail.com
Mob: +919968408999

Source : https://main.icmr.nic.in/sites/default/files/upload_documents/EoI_INTENT_v1.pdf

BA BE Centres Regn Process

CDSCO Announcement – BA BE Centres to apply online for Registration Process

CDSCO to move application process for registration of centers for BA/BE studies online from Oct 15 2021

CDSCO has released a notification recently on registration process for BA/ BE Centers.

The National Drug Regulator has switched the applications for registration of bioavailability/bioequivalence (BA/BE) studies from the industry, from physical to digital from the middle of this month – 15th Oct 2021. This is in line with the Central Drugs Standard Control Organisation’s (CDSCO) efforts to implement an e-governance mechanism in the organisation.

The Drugs Controller General (India) Dr V G Somani, in a notice, said that the CDSCO, in collaboration with Centre for Development of Advanced Computing (CDAC), has developed a module for online processing of applications for registration of BA/BE study centres in accordance with New Drugs and Clinical Trial Rules, 2019.

The module is finalised and has been made functional, which can be accessed through the dedicated website of CDSCO. The drug regulatory also requested all concerned stakeholders to avail the facility and welcomed any comments or suggestions to help improve the module.

“Thereafter, the BA/BE centre registration applications processing will be online and physical applications may not be accepted after October 15, 2021, in this regard,” said the notice.

The move comes as CDSCO’s efforts to implement the e-governance mechanism with various online services launched through the Sugam portal on November 14, 2015.

On September 30, the CDSCO has said that the submission of applications on Post Approval Changes in bioavailability (BA)/bioequivalence (BE) study permission and import license for export purpose is functional on online system of Sugam portal, in order to streamline the regulatory submission procedure.

“The facility of offline submission of applications in hard copy or through e-mail may not be available after October 8, 2021, for processing,” said a notice, issued to all stakeholders, State and Union Territory Licensing Authorities and others.

The Sugam e-governance portal has been designed as a single window system for all the stakeholders to access the services provided by the portal, by implementing role based access control and actions. It has consolidated the entire drug regulatory framework at centre and provides a centralised dashboard for monitoring various regulatory clearances all over the country.

The portal is well integrated with the e-Nivesh that is the National portal to provide the project proponent/entrepreneur with all requisite information under one umbrella, which will reduce delays in various regulatory processes. SUGAM enables ease of business by providing the integrated workflow right from making an application for grant of permission/ license, online payment, online review process, query management and grant of permission/license online. Sugam portal internally builds the database of drugs & manufacturers and their current regulatory status (approved/ banned) in India, according to C-DAC, which created the portal.

Source : http://www.pharmabiz.com/NewsDetails.aspx?aid=143001&sid=1

CDSCO Notification

Download the Notification from CDSCO here

QCI – D.L. SHAH Quality Awards

QCI – D.L. SHAH Quality Awards – Announcement from QCI NBQP

About the Award

Applicant organizations, who are QCI members qualify for a 10% relaxation in the application fees.

OBJECTIVE

The QCI-DL Shah Quality Awards were launched in 2007 and are positioned PAN-India as the recognition for successful projects of an organisation that have resulted in continual improvement of processes, products and/or services, better/effective operations and increased customers/stakeholders satisfaction. The awards are given for specific projects which have to be submitted in the form of case studies supported by adequate evidence in the form of documents or video clips.

AWARD CATEGORIES

There are 3 levels of the Award.These levels are:

  1. Level 1 : QCI-D.L. Shah Quality Platinum Award
  2. Level 2 : QCI-D.L. Shah Quality Gold Award
  3. Level 3 : QCI-D.L. Shah Quality Silver Award

Each level has its own distinct rigors and requirements for quality and performance with minimum qualifying marks to be achieved. During the site verification when no suitable project (case study) is found to be eligible under a sector / category, no award shall be given.

ELIGIBILITY CRITERIA

Project(s) can be from any function or department of the organization and is open to all type of organizations/sectors like :

  1. Any Govt Enterprise
  2. PSU
  3. NGO
  4. MSME
  1. Manufacturing
  2. Healthcare
  3. IT/ITes
  4. Finance
  1. Infrastructure
  2. Education
  3. Service
  4. Pharma
  1. Food
  2. Petroleum Oil,Gas
  3. Other

Sectors covered by Gol under Udyog Manthan are encouraged to apply

An organization submitting projects, shall satisfy the following conditions:

  1. The applying unit should be located in India (project(s) implemented at the sites abroad will also be considered on case to case basis).
  2. Projects should have been concluded within the last 3 years from the date of announcement of the award.
  3. Only those Projects which have concluded and have demonstrated benefits for minimum 6 months at least shall be considered.
  4. The organization shall not have been convicted by any Court for any irregularities
  5. Multiple projects applied under the same title from various units shall not be considered by virtue of implementation at other unit/plant in the horizontal deployment process.
  6. Projects applications which have been received in the past but after incorporating substantial continual and break through improvements in the process resulting in outcome(s) demonstrating quantum jumps may be considered after the period of 3 years.
  7. Projects that are entirely sub-contracted are not acceptable, however projects driven through the strategic leadership of the management and implemented with the help of outsourced facilities which are not available in-house would be acceptable (Projects shall be implemented by the applicant under the strategic plan/leadership of the management)
  8. Applications which seem to have negative influence on the human being, Quality of life, environment, Health, Safety, Society etc. will not be considered

Note:

organization can submit a maximum of 3 projects from a particular unit/branch or its regional office.

APPLICATION FEES

Organization TypeApplication Fees*
MSME/Educational/Govt/NGOINR 5000
OthersINR 10,000
Note:-
*G.S.T 18% will be applicable on application fees.
**MSMEs are required to mention their valid UAM registration number while filling up the online application form.
Applicant organizations, who are QCI members qualify for a 10% relaxation in the application fees..

Where to Apply ?

ASSESSMENT CRITERIA

Please click here to see the Detailed Evaluation Criteria

Note

1. Various sectors like large manufacturing, IT/ITes, Finance, Health Care etc. have started applying digital transformation initiatives in their respective areas. In case the organization has took any such initiative, the organization shall provide the information regarding application of new technologies or any

  1. Application of new technologies within the organization or as a part of some project/initiative example any application of Internet of Things (IOT), artificial Intelligence, Robotics etc
  2. Achievements on the Digitalization front through: demonstration through actual achievements – implementation in pipeline or ready for execution as per the roadmap/strategic plan approved by the top management on the aspects mentioned below:
    1. People : Readiness of your organization and its people to accept the changes as a consequences of the transformation including skill upgradation etc.
    2. Product/Services : The impact which digital transformation has or will have on your product(s) and services including the preparedness of the stakeholders.
    3. Process: Impact of the digital transformation on your processes/operations.

2. Such projects for which financial impact cannot be arrived at (e.g. Projects belonging to Government, Education and Social Sector etc.), financial benefits will not be considered as a parameter for evaluation. However, such projects should state the environmental, socio-economic and other benefits with reference to the assessment criteria.

ASSESSMENT PROCESS

a. Online Application

Applicants are required to submit details pertaining to the online application from (available on website)

Guidelines for Preparing project report

b. Preliminary Screening

At this stage, the NBQP Secretariat for completeness and adequacy of the application will scrutinize all the online applications

c. Document Evaluation

  1.  All filtered applications from previous step will undergo document assessment by the Assessment Team
  2. The Assessment Team will examine the case studies on the basis of the assessment criteria
  3.  Incomplete applications or such applications which lack clarity on the enablers, processes or results or are unrelated to any applications of quality tools and techniques will be rejected during this stage.
  4. The decision for cut-off marks and thereafter the selection of projects that will go for the next stage will be taken by NBQP team based on the input/feedback received from the assessment panel.

d. Project Presentation at QCI office

  1.  The aim of the project presentation is to objectively comprehend and seek clarifications from the project team that have actually executed the project. After the presentation, the Assessment Team will finally decide the marks for various criteria through consensus approach. The decision for cut-off marks and thereafter the selection of projects for which site verification are needed will be taken at the end of this phase. Organizations shortlisted after this stage will be informed about the site verification schedule well in advance

Guidelines for preparing the presentation by the Applicant organizations

e. Site Verification

The aim of site visits will be to ensure that the claims made in the project including savings as well as tools employed are verified. The Assessment team will scrutinize the necessary documents as well as interact with Top Management, Project Head & Team personnel of the organization including people involved in the project in order to satisfy that all claims are justified. The CEO/COO/VP along with Project Head shall debrief the Project and answer all the queries put up by the site assessment team.

Note :

  1.  All filtered applications from previous step will undergo document assessment by the Assessment Team
  2. The Site assessment plan will be created by QCI-NBQP with inputs from the assessors and will be informed to the organizations in advance accordingly
  3. Depending on the size of the organization, the physical site visits will be conducted by an assessment team comprising of
    1. a) 2 assessors (including 1 lead assessor) for Large organizations
    2. b) 1 assessor for small organizations
    3. c) Additionally, assessment team may have representation from QCI Team as well
  4.  The terms and conditions w.r.t physical site visit are mentioned in the respective section

f. Report Submission

The assessment team will submit a report of their assessment to NBQP Secretariat for this stage and it will include their inputs regarding their recommendations for the awards.

g. Final Selection

NBQP Secretariat will compile the results based on the cut off set and feedback received from the assessment team and share the recommendation list with the D.L. Shah Trust for the final approval on the winning projects and number of awards

GUIDELINES FOR THE APPLICANTS

Guidelines for the applicants to prepare a project report for project submission
Guidelines for preparing the presentation by the Applicant organizations

Template of application form and How To Apply

AWARD PRESENTATION

The awards will be presented during a special Award Ceremony.

TIMELINES

Application window date starts from 23rd Aug 2021 till 31st Dec 2021

TERMS AND CONDITIONS OF THE AWARDS

  1. 1. Non – disclosure and confidentiality
    1. a) The names of the applicants, evaluation and scoring system developed for the assessment process will be regarded as proprietary and kept confidential. Such information shall be made available only to those individuals who will be directly involved in the assessment and administrative process and shall not be disclosed
    2. b) QCI will not disclose the details about the shortlisted/non-shortlisted candidates at any stage of the assessment. The qualified projects will be notified via e-mail/call by the QCI office directly. 
  2. 2. Any misinterpretation of facts will disqualify the organization from Awards and fees would be non- refundable
  3. 3. Applications will be considered only if the eligibility criteria are satisfied
  4. 4. Incomplete applications or such applications which lack clarity on the enablers, processes or results or are unrelated to any applications of quality tools and techniques will be rejected.
  5. 5. Project Site: only initial site where the project has been implemented will be considered, rest locations will only be considered as a case of replication. Successful applicants will receive the trophy/certificate only for the location against which they submitted the application
  6. 6. No changes in the project application (title, location etc.) will be accepted after the final submission
  7. 7. Application Fees towards submission of the project(s) is non-refundable/ non- adjustable
  8. 8. Any Quality Award applicant and Awardee cannot use the NBQP, QCI and D.L. Shah Trust logo in any way that suggests that QCI is affiliated with, sponsors, approves or endorses them, their organization/websites/products/services etc
  9. 9. QCI and D.L. Shah Trust reserves all the rights to final selection of the Awardee(s). No appeal or protest in this regard would be entertained.
  10. 10. If no outstanding entries have been received, no award will be awarded for the year
  11. 11. In case of Physical Site Visits, following conditions will be applicable

Cost to be borne by the applicant organization 
Besides the requisite application fees for participating in the Award the following costs are to be borne by the applicant organization.

  1. For Presentation round: All costs incurred by the Team Members of various projects who would be making presentation before assessment team members atQuality Council of India office, New Delhi.
  2. For Site verification 
    1. a) All incidental expenses from the residence of the assessment team/Head Office at Delhi will be borne by the applicant organization based on the consolidatedclaim raised by QCI.
    2. b) Airfare charges* (wherever there is air connectivity)/train/AC Sedan car (in case no air/train connectivity exists) 
    3. c) Hotel stay including Food/travel and other miscellaneous expenses.

Note: –

  1. Depending on the size of the organization, the Assessment team members(as stated in section” Assessment Process-Site verification ) and man-days would vary from 1-2 days, so the hotel and travel expenses will vary accordingly
  2. In case the assessment is carried forwarded to the 2nd day, then the stay expenses shall be borne by the applicant organization for the 2nd night as well 

CONTACT POINT

Ms. Shruti Gupta              Administrative Officer|NBQP   Mail at : shruti.nbqp@qcin.org         8800891834

Ms. Priyanka Maithani    Assistant Director|NBQP          Mail at : priyanka.nbqp@qcin.org    8178602471

Source : https://www.qcin.org/nbqp/dsa/home/Home.aspx

Laboratory Excellence Award

Prof. S.K. Joshi Laboratory Excellence Award from QCI NBQP

Prof. S.K. Joshi – Laboratory Excellence Award has been instituted to promote Laboratory Quality and performance improvement in the country. The award has been incepted to ensure the laboratory’s commitment to achieve excellence in providing high precision testing and calibration services in line with the prevalent national/international quality systems legislations including Health, Safety, Environment (HSE).

The Award is to recognize Laboratories (Testing, Medical and Calibration) those have established outstanding achievements in the field of Quality in services and benchmarked in their domain for their best practices

Eligibility:

1.This award is open to all currently operational Laboratories pertaining to Testing, Calibration & Medical including their Proficiency Testing Providers & Reference Material Producers located in India.
2.Participating labs are required to operate the applicable Quality System according to the requirements as stipulated in ISO 17025/ISO 15189/ISO 17043/ISO 17034, regarding its implementation and monitoring.
3. The award require labs to operate with proper HSE measures.
4.The Laboratory should not have been convicted by any Court.
5.A Laboratory once awarded can be considered only after a period of 3 Years

The 5 stages of assessment by Technical Expert Committee (TEC) are as follows:-

Stage 1: Application Document Evaluation
Stage 2: Physical/Virtual Presentation
Stage 3: Site Assessment / verification
Stage 4: Evaluation through Reference check of customer in special case
Stage 5: Inputs to Jury for final evaluation

Assessment Criteria

The assessment of the application submitted by the laboratory is made on the basis of various parameters which have been identified by a team of experts from NBQP/QCI.

Primary Parameters:

  1. Management Commitment – Qualification, Experience, Training & Innovation, Quality Improvement and skill upgradation.
  2. Strategy – Accreditation for entire Laboratory activities (to ensure Sustainability).
  3. Processes – Standard Method (National/International), Validation/Verification, Equipment/Techniques used and Measurement Traceability to SI units.
  4. Infrastructure & Quality Control Resources – Facilities and Environmental Conditions (Innovation for enhancing Good Laboratories Practices) owned by Lab. Use of Certified Reference material, Proficiency Testing Program participation and Inter-Laboratory Comparison and other QC checks.
  5. Customer Complaints, Feedback and Improvement – Diagnosis of the problem (Root Cause Analysis & Quality tools deployed)
  6. Key Results/Satisfaction – Reports, Customer Results, Society Results and Employee Satisfaction. Tangible benefits, intangible benefits or socio economic and environmental benefits

Terms & Conditions Of The Award:

1. Non – disclosure and confidentiality
I. The names of the applicants, evaluation and scoring system developed for the assessment process will be regarded as proprietary and kept confidential. Such information shall be made available only to those individuals who will be directly involved in the assessment and administrative process and shall not be disclosed.
II. QCI will not disclose the details about the shortlisted/non-shortlisted laboratories at any stage of the assessment. The qualified laboratories will be notified via e-mail/call by the QCI office directly.
2. Any misinterpretation of facts will disqualify the laboratories from Awards.
3. Applications received with incomplete data will not qualify.
4. Any Award applicant and Awardee cannot use the NBQP and QCI logo in anyway that suggests that QCI is affiliated with, sponsors, approves or endorses you, your organization, your websites, your products or your services etc.

Application Fees

There is no Application Fees

Award Presenatation

The awards will be presented during a special Award Ceremony

Where to Apply ?

Award Details

check here to know more about various awards and details

When is the Last date for applying ?

Last date for submitting the application form is 16th November 2021

For any queries, contact :

Source – https://labexcellenceaward.qcin.org/Home.aspx

Fee Update from NABL

Revised Fee Structure effective for all applications received on/after 01.10.2021 Posted on 01.10.2021

NABL has released revised Fee Structure for all applications received on or after 1/10/2021 . This is applicable for all Testing and Calibration Labs.

All applicant labs and Accredited, Certified Labs have to make a note of the same.

Download the notification from here .

Medical Device QMS

NABCB Program on MDQMS – Medical Device Quality Management Systems

Program Announcement from NABCB !

NABCB is organising series of webinars on “Medical Devices Quality Management Systems (MDQMS) and Indian Certification for Medical Devices (ICMED) Scheme”

There is no fee for the said Webinar. The Webinar is scheduled on 20 October 2021 at 11:00AM – 01:00 PM (IST)

This webinar would provide an interface wherein you may directly interact with NABCB Officials about NABCB Accreditation system and other requirements, so your participation would make the webinar interesting and fruitful.

Registration link is https://forms.gle/Qg2Z55iYc6oNWKnv7

The flyer is available on link  http://nabcb.qci.org.in/Meeting%20%20flyer%20-%20MDQMS%20%20ICMED-%2020%20October%202021.pdf

Meeting Link shall be provided to all the registered participants a day before the scheduled date.

Contact NABCB Secretariat :
National Accreditation Board for Certification Bodies
Quality Council of India | www.qcin.org
Institution of Engineers Building, 2nd Floor,
2, Bahadur Shah Zafar Marg, New Delhi – 110002, India
Work: +91-11-2337-9321 | Fax: +91-11-2337-8678
Facebook | Linked In Twitter

Notification from CDSCO

Fresh Notification – Voluntary Registration & Labelling Norms from CDSCO for Medical Device Industry

CDSCO has released a fresh notification dated 12th October, 2021 clarifying its stand on Voluntary Registration and Labelling norms to be followed by the Medical Device Industry. CDSCO has called for feedback , suggestion from the industry to the proposed amendments.

Industry and stakeholders are requested to share feedback to CDSCO office, the details are listed in the notification below.

NOTIFICATION – New Delhi, the 12th October, 2021

G.S.R. 729(E).—The following draft of certain rules further to amend the Medical Device Rules, 2017, which the Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and in consultation with the Drugs Technical Advisory Board is hereby published for information of all persons likely to be affected thereby and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of seven days from the date on which copies of the Gazette of India containing these draft rules are made available to public;

Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government;
Objections and suggestions, if any, may be addressed to

The Under Secretary (Drugs Regulation),
Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan,
New Delhi – 110011
or
emailed at – drugsdiv-mohfw@gov.in.

DRAFT RULES

(1) (i) These rules may be called the Medical Devices (……Amendment) Rules, 2021.
(ii) These rules shall, unless specified otherwise, come into force on the date of their final publication in the Official Gazette.

(2) In the Medical Devices Rules, 2017(hereinafter to be referred as said rules), in rule 19B, in subrule(2), in item (iii), at the end, the following Proviso and Explanation thereto shall be inserted, namely:—

“Provided that in case the applicant submits, on or before the 30th November, 2021, an undertaking that applicant shall obtain the ISO 13485 certificate on or before the 31st May, 2022 in lieu of certificate of compliance as referred in clause (iii) of sub-rule (2) of rule 19B, a provisional registration number shall be generated which will remain valid up to the 31st May, 2022 or the date on which the applicant obtained such ISO certificate whichever is earlier. The said generated provisional registration number shall be valid for all purposes.

Explanation.— For the removal of doubt, it is hereby declared that in case of such ISO 13485 certificate not obtained before the 31st May, 2022 as per undertaking referred in the Proviso by the applicant the provisional registration shall be deemed to have been cancelled for all purposes
without any notice.”

(3) In the said rules, in rule 19C, for the words “shall mention the registration number” the following words, letters and figures shall be substituted, namely:—

“may, if so desired, mention the registration number or provisional registration number, as the case may be, for a period up to the 31st May, 2022, thereafter it shall be mandatory for all registration holders”.

(4) In the said rules, in rule 19D, in sub-rule(2), in item (iii), at the end, the following Proviso and Explanation thereto shall be inserted, namely:—

“Provided that in case the applicant submits, on or before the 30th November, 2021, an undertaking that applicant shall obtain the ISO 13485 certificate on or before the 31st May, 2022 in lieu of certificate of compliance as referred in clause (iii) of sub-rule (2) of rule 19D, a provisional registration number shall be generated which will remain valid up to the 31st May, 2022 or the date on which the applicant obtained such ISO certificate whichever is earlier. The said generated provisional registration number shall be valid for all purposes.

Explanation.— For the removal of doubt , it is hereby declared that in case of such ISO 13485 certificate not obtained before the 31st May, 2022 as per undertaking referred in the Proviso by the applicant the provisional registration shall be deemed to have been cancelled for all purposes
without any notice.”

(5) In the said rules, in rule 19E, for the words “shall mention the registration number” the following words, letters and figures shall be substituted, namely:—

“may, if so desired, mention the registration number or provisional registration number, as the case may be, for a period up to the 31st May, 2022, thereafter it shall be mandatory for all registration holders”.

Download the Notification from CDSCO

Source : CDSCO

Good Clinical Practices Training

Awareness Programme For Training Institutions on Good
Clinical Practice Professional Certification Scheme (GCPPCS)

About CDSA

Department of Biotechnology (DBT), Ministry of Science & Technology, Government of India launched CDSA on 28 September 2009 as an extramural unit of Translational Health Science & Technology Institute (THSTI). It was created to facilitate development of affordable healthcare products for public health diseases. Registered as a not-for profit research organization, it aims to develop an eco-system for training and learning and work with public sector institutions, and small and medium enterprises (SME) to translate innovative technologies into medical products for public good.

About GCPPCS

There is an ever-growing demand for trained and certified Good Clinical Practice (GCP) professionals in the clinical research arena both in academia and in industry. Setting up an uniform system to achieve the desired competence standard using internationally accepted best practice for ‘Assessment’ and ‘Certification’ is the key to addressing this unmet need.

To this end, a Certification Scheme for GCP professionals based on the International ‘Personnel Certification’ standard (ISO 17024:2012) has been developed by CDSA-THSTI.

The GCP professional certification scheme has  two aspects – a system of accreditation of Training Institutions to ensure standardised, high-quality GCP training and  GCP Professionals Certification (by Third-Party Certification) to promote certification of professionals both within the country and across the globe.

GCPPCS is owned by the Clinical Development Services Agency (CDSA)-Translational Health Science & Technology Institute (THSTI). THSTI is an autonomous institution under the Department of Biotechnology, Ministry of Science & Technology, Government of India. CDSA-THSTI as Scheme Owner,  has the Steering Committee, Technical Committee and Assessment Committee to draft, review and approve the relevant documents and  effective implementation of the Scheme.  These committees are comprised of multiple stakeholders for example subject and process experts with representatives from ministries, regulator, government agencies, industry, academia, accreditation body, certification body, training institutions and civil society organisations.

Upcoming Program on GCPPCS :

CDSA has successfully completed two webinars for creating awareness and generating interest amongst the Personnel Certification Bodies, Training Institutions and individual GCP professionals for the Good Clinical Practice Professional Certification Scheme (GCPPCS) on September 22 and October 6, 2021.

The next webinar, specifically designed for the Training Institutions, is scheduled for October 20, 2021 from 1400 hrs. Prof Y K Gupta would be delivering the Opening Remarks.

S.NO.DATESPEAKERTOPICRELATED MATERIALREGISTRATION LINK
1October 20,2021Prof. Debjani Roy
Dr. Harish Nadkarni Maheshwari
Dr. Sanish Davis
Dr. Sucheta Banerjee Kurundkar
Mr. S Krishnamurthy
Prof. Y.K Gupta
Awareness Programme For Training Institutions on GCPPCSProgram FlyerRegistration deadline: October 18, 2021

Registration Form

CDSA invites participation from Healthcare Services Sector to explore opportunities to be the Training Partners for this program. Attending this webinar will throw more light about the GCPPCS Program.

For further information, please contact us at gcppcs.cdsa@thsti.res.in 

प्रो. देबजानी रॉय/Prof. Debjani Roy
सदस्य सचिव और कार्यक्रम प्रबंधक, जीसीपीपीसीएस /Member Secretary & Program Manager, GCPPCS – Clinical Development Services Agency Translational Health Science & Technology Institute, 
Department of Biotechnology, Ministry of Science & Technology, Government of India
NCR Biotech Science Cluster, 3rd Milestone, Gurgaon- Faridabad Expressway, Faridabad 121001
क्लिनिकल डेवलोपमेंट सर्विसेस एजेंसी, ट्रांसलेशनल हेल्थ साइंस एंड टेक्नोलॉजी इंस्टिट्यूट,
विज्ञान और प्रौद्योगिकी मंत्रालय, भारत सरकार
Tel: +91-41052296,
Email: debjaniroy.cdsa@thsti.res.ingcppcs.cdsa@thsti.res.in