Stem Cell Research though young holds lot of promises in terms of new treatment therapies. With new possibilities comes accountability and responsibilities and hence in India in the year 2013 new regulations for stem cell research were laid down to address the complexities and ethical concerns associated with stem cell research. Here we have provided a brief about the new regime and how QAscent Research Solutions Pvt. Ltd. may help you to overcome hurdles associated with stem cell research in India.

1. QAscent Research
Solutions Pvt. Ltd.
Stem Cell Research Capabilities
Quality – Reliability – Satisfaction

2. Who We Are?
Vision
Passion
Determination
Perseverance
Experience
Excellence
Guaranteed satisfaction and
success with QAscent
Adaptation
QAscent Research Solutions Pvt. Ltd. is a full service
CRO. Quality being our forte, Ascent our motto and
Research our passion, we are committed to provide you
with the best possible customized solutions to all your
Clinical Research needs. We are experienced, competent
and confident in handling global to local, pilot to pivotal
projects giving utmost prominence to Quality, Cost and
Clock. We specializes in transforming research into
increased revenue and bottom-line profitability for our
clients.
What does that mean?
In simple terms, you can count on us for any clinical research
related assignments, big or small. Our clients see us as a trusted
advisor and service provider and we’d like to add you to our list of
satisfied partners.

3. Stem Cell Research: Regulatory
Overview
• October 2012, National Apex Committee for Stem Cell Research &
Therapy (NAC-SCRT) Constituted by Department of Health Research,
Ministry of Health & Family Welfare, Govt. of India.
• NAC-SCRT constitution, embarked new regulatory landscape for stem
cell research in India.
• Institutions conducting stem cell research must constitute Institutional
Committee for Stem Cell Research (IC-SCR) or include additional
expertise in the existing IEC with the nomenclature as IC-SCR.
• All Institutions and Investigators, public or private, conducting
research with human stem cells must be registered with NAC-SCRT
“through” IC-SCR.
• National Guideline on Stem Cell Research 2013 formulated by ICMR
and DBT.

4. Stem Cell Research: Regulatory
Overview
• Stem cell research divided into permissible, restricted & prohibited
research.
• SCR, review and approval based on pre-defined algorithm.
• DCGI approval is mandatory for clinical trials involving stem cells
which have undergone more than minimal manipulation.
• Approval of the Drug Controller General of India (DCGI) is
mandatory for stem cell based IND products and application for new
indications (cells for therapies are deemed as drugs) with prior
clearance from IC-SCR and IEC.
• CTRI registration is mandatory for all clinical trials.

5. Stem Cell Research: Review &
Approval Algorithm
IC-SCR & IEC
IC-SCR & IEC
& DCGI
IC-SCR & IEC &
NAC-SCRT & DCGI
Yes
Research Involving Human
Stem Cells or Human Tissues or
Human Foetal Tissues
IC-SCR/NAC-SCRT Review &
Approval Not Required
(DCGI & IEC Approval Required)
No
Embryonic Stem Cells/Induced
Pluripotent Stem Cells
Somatic Stem Cells
Autologous
Allogenic
Minimal
Manipulation
Substantial
Manipulation
IC-SCR & IEC & NAC-SCRT
& DCGI
 IC-SCR = Institutional Committee for Stem
Cell Research
 NAC-SCRT = National Apex Committee for
Stem Cell Research & Therapy
 IEC = Institutional Ethics Committee
 DCGI = Drugs Controller General of India

6. List Of Registered Institutions

7. If You Are Planning To Do Research?
• Step-1: Check for the type of stem-cell.
 If non-human stem cell or tissue no IC-SCR/NAC-SCRT
approval required. Only IEC approval is required.
• Step-2: If human stem cell or tissue refer to the review and approval
algorithm.
• Step-3: If any other form of stem cell research seek clarification from
IC-SCR/NAC-SCRT Secretariat @ nacscrt.secretariat@icmr.org.in

8. How We Can Support Your Research?
We can support you to:
 Formulate the best possible regulatory strategy to place your product
into market taking into consideration quality, cost and clock.
 Make quality regulatory submissions.
 Make quality submissions to IEC(s), IC-SCR(s) & NAC-SCRT.
 Defend your proposal at SEC, IEC & IC-SCR meetings.
 Manage sites by providing trained clinical research coordinators.
 Manage projects by providing project management services.
 File for the marketing application.
 Write manuscripts in leading journals.

9. Contact Us
Subhash Sugathan
Email: subhash@qascentresearch.com
Mobile: +91 9971008625
Dr. Ravi K
Email: ravi@qascentresearch.com
Mobile: +91 9540038430
QASCENT RESEARCH SOLUTIONS PVT. LTD.
Address: Tower 4, Spaze IT Park, Sohna Road, Sector-49, Gurugram,
India