Contents Page Number

1. Introduction 1

2. Organization of NCS TCP 4

3. Comprehensiveness of NCS-TCP 5

4. Committees of NCS-TCP 5

5. Appellate Authority (AA) 6

6. Process of Accreditation/Recognition 6

7. Certification of Tissue Culture Plants 8

8. Standards for Production of Tissue Culture Plants: 9

9. Standards for Accreditation of Test 9

Laboratories for Virus Diagnosis/Quality Testing of

Tissue Cultures of Plants

10. Standards for Recognition of Tissue Culture 11

Production Facilities

11. Status of Accreditation of Test Laboratories and Recognition 12

of Tissue Culture Facilities under NCS-TCP

BCIL

1. Introduction

Department of Biotechnology (DBT), Government of India authorized as the

Certification Agency by Ministry of Agriculture vide the Gazette of India

Notification dated 10th March 2006 under section 8 of the Seeds Act, 1966.

Accordingly, DBT has established National Certification System for Tissue

Culture Raised Plants (NCS TCP) to facilitate certification of the tissue culture

raised plants upto laboratory level.

NCS-TCP is the unique quality management system for tissue culture industry.

This is a very comprehensive system closely associated with all the stakeholders

namely Tissue Culture Certification Agency (DBT), Accreditation Unit (AU) and

Project Management Unit (PMU) at Biotech Consortium India Limited (BCIL),

Referral Centres, Accredited Test Laboratories (ATLs), Recognized Tissue

Culture Production Facilities and State Agriculture/Horticulture Departments to

ensure production and distribution of quality tissue culture plants.

Test Laboratories have been accredited by DBT for testing and certification of

tissue culture raised plants. Tissue culture production facilities have been

recognized based on infrastructure, technical competency and package &

practice of production of tissue culture plants. Accredited Test laboratories

(ATLs) test and certify the tissue culture plants produced by recognized tissue

culture production facilities.

Biotech Consortium India Limited (BCIL) has been identified as the

Accreditation Unit (AU) under the NCS-TCP to assist DBT in Accreditation of

Test Laboratories and Recognition of Tissue Culture Production Facilities. BCIL

has also been identified as Project Management Unit (PMU) under NCS-TCP.

As the PMU, BCIL coordinates among the various components and facilitates

monitoring the activities of Accredited Test Laboratories and Recognized Tissue

culture Production Facilities.

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Stakeholders and their major responsibilities

Stakeholders Responsibility

Ministry of Agriculture Authorized Department of

Biotechnology for implementation of

NCS TCP under Section 8 of the

Seeds Act 1966

Department of

Biotechnology

Ensuring successful implementation of

NCS TCP as the Tissue Culture

Certification Agency

Biotech Consortium India

Limited As the Accreditation Unit, BCIL is

assisting DBT in Accreditation of Test

Laboratories and Recognition of

Tissue Culture Production Facilities

and as Project Management Unit

(PMU), BCIL is coordinating the

various components and monitoring

the activities of Accredited Test

Laboratories and Recognized Tissue

Culture Production Units.

Referral Laboratories Responsible for developing protocols

and providing technical guidance to

Accredited Test Laboratories. Referral

Laboratory will also perform

conformity test in case of dispute on

result of the test conducted.

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There are two Referral laboratories

(i) Referral Center for Virus

Diagnosis – Division of Plant

Pathology, Indian Agriculture

Research Institute (IARI), New

Delhi

(ii) Referral Centers for Genetic

Fidelity - Centre for DNA

Fingerprinting and Diagnostics

(CDFD), Hyderabad.

Accredited Test

Laboratories (ATLs)

To test and certify tissue culture plants

of recognized tissue culture

production facilites. Based on the Test

Report, each Accredited Test

Laboratories are authorized to issue

the “Certificate of Quality” for the

tissue culture raised plants (CQ-TCP)

on behalf of the Certification Agency.

Recognized Tissue Culture

Company

To adopt the NCS-TCP guidelines and

Standard Operating Procedures

(SOPs) in order to produce quality

tissue culture plants.

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2. Organization Structure of NCS TCP

NCS TCP is well organized for smooth functioning of the programme.

The components of NCS TCP are as under:

Accreditation Recognition

Certification

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Appellate Authority(DBT)

Accreditation Unit (BCIL)

Accreditation Panel

Accredited Test Laboratories Recognized TC

Production Facility

Referral LaboratoryVirus Diagnosis - IARIGenetic Fidelity-CDFD

Tissue Culture Certification Agency

(DBT)

Certification of Tissue Culture Material

(Issue of certificate of Quality)

3. Comprehensiveness of NCS-TCP

1. Guidelines of NCS-TCP is continuous evolving based on experience

gained during the course of its implementation

2. Standard criteria has been approved and adopted for Accreditation of Test

Laboratories (TL) and Recognition of Tissue Culture Production Facilities

(TCPFs)

3. Standard Operating Procedures (SOPs) for ATLs and TCPFs were

developed and adopted for ensuring Quality Management System (QMS)

4. Training programmes for technical personnel of ATLs are being organized

time to time.

5. Technical auditing is undertaken to ATLs and Recognized TCPFs to

ensure effective implementation and continuous improvement

6. Standards for production of economical crops such as potato, banana,

apples, bamboo, black peeper, citrus, sugarcane, and vanilla were

approved.

7. Awareness programmes are organized to popularize the system and

creates widespread awareness on NCS-TCP and its recent advancements

among the stakeholders.

4. Committees of NCS-TCP

Apex Committee: This is a top-level committee, which approves the

guidelines, documents and various policy related issues

Project Monitoring and Evaluation Committee (PMEC): This approves

the recommendations of Accreditation Panel following site visits for Test

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Laboratories and TCPFs and also suggests improvements in NCS-TCP

guidelines/documents.

Accreditation Panel: This is a group of experts and subcommittee

derived from the panel undertakes site visits to Test Laboratory and

Tissue Culture Production Facilities and prepares detailed assessment

report.

5. Appellate Authority (AA)

An Appellate Authority under the Chairpersonship of Secretary, DBT has

been established to review the decision taken with regard to Accreditation

of Test laboratories, Recognition of Tissue Culture production facilities and

also for Certification of tissue culture materials. The Nodal Officer

designated by the Certification Agency will act as Member Secretary.

The constitution of the Appellate Authority and guidelines on redressal of

grievances is available at NCS-TCP website (http://www.dbtncstcp.nic.in)

6. Process of Accreditation/Recognition

Duly filled application form complete in all respect along with prescribe fee

is registered for further consideration. Fees (which include registration,

inspection and certification) are required only for recognition of tissue

culture production facilities. Accreditation Unit established at BCIL, New

Delhi evaluates the application and self assessment reports under the

guidance of experts of Accreditation Panel. Site visit is organized to

assess the compliance with NCS-TCP guidelines. Detailed assessment

report is prepared covering the status of compliance, noncompliance,

need for corrective actions and various suggestions for better quality

management. Based on compliance certificate is issued within 45 working

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days from receipt of complete application. In case of non-conformities

certificates can be issued within 45 days after formal communication of

their corrective actions. Criteria for evaluation of Test Laboratory and

Tissue Culture Production Facilities, application forms and fee structure

are available at NCS-TCP website (www.dbtncstcp.nic.in )

Process for Accreditation/Recognition:

Application Application

Site visit Site visit

Assessment Report

Report Positive

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Test Laboratory

TC Certification Agency

Tissue Culture

Production

Facility

Accreditation Unit

Accreditation Panel

Recognized TC Production Facility

Accredited TestLaboratories

Accreditation /Recognition

Accreditation Unit

7. Certification of Tissue Culture Plants:

The Tissue Culture Production Facility may register its application for

Certification of Tissue Culture material with the nearest ATL. Only Recognized

Production facilities will be eligible to register for certification of plant

tissue culture raised material. The ATL examines the application and if found

complete in all respect it will intimate the applicant within two working days,

regarding requirements for sending the samples. The ATL will arrange for site

inspection, receipt of samples, testing etc as per prescribed format. The fees for

certification will be deposited along with the sample at the ATL. The ATL will

provide the Test Report within the 6 working days from the receipt of samples.

Based on the test report the Certificate of quality will be issued. The information

on fee charged by ATLs and application form (NCS-TCP Form 3) are available at

NCS-TCP website (http://www.dbtncstcp.nic.in)

Application Site visit/receipt of sample

Positive

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Recognized TC Production Facility

Accredited Test Laboratory

Testing of Samples

Test Report Certificate of Quality (CQ-TCP)

8. Standards for Production of Tissue Culture Material:

The Accredited Test Laboratories will issue the certificates only if Tissue Culture

material is produced in conformity with tissue culture standards. The Guidelines

for Potato, Banana, Sugarcane, Apple, Citrus, Vanilla, Bamboo and Black pepper

have already been approved by Ministry of Agriculture. Standards/Guidelines for

production of Tissue Culture material of remaining plant species are currently

being prepared for different species of plant as per requirements, by DBT in

consultation with scientists/institutes working in respective area. Approved crop

specifics standards can be downloaded from NCS-TCP website

(http://www.dbtncstcp.nic.in)

9. Standards for Accreditation of Test Laboratories for Virus

Diagnosis/Quality Testing of Tissue Cultures of Plants

(1) Public Sector, Govt. funded Institute/University having adequate

capacities in both virology and molecular biology, which is not engaged in

commercial tissue culture activity

(2) Laboratory should be headed by trained virologist with experience in

molecular diagnostics / molecular biologist working on molecular marker

related technologies

(3) Laboratory should have at least one trained Scientist and one Technical

Assistant having expertise in the area of virology/molecular markers and

have experience with regard to the latest techniques/tools to be adopted

for the test procedures.

(4) Minimum infrastructure required for basic virology / molecular marker

laboratory

General Equipments:

Common laboratory glassware and instruments

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Digital top pan/analytical balance

pH meter

Distilled and sterile//millipore water

Gas burners

Autoclave

Laminar flow hoods

Incubation chambers

Freezer (-20o C)

Refrigerator 4o C

Vortex mixer

micropippettes

Specific Equipments

DNA extraction equipment

DNA probes

Tissue grinder

Centrifuge / Microcentrifuge

PCR

Horizontal Gel Electrophoresis

Gel documentation unit

Equipments for DNA fingerprinting

(5) Reagents

Dignostic reagents

cDNA probes

Polyclonal / monoclonal anti-bodies for diagnostic for commonly

occurring Viruses

Primers

(6) Applicable test methods as per prescribed norms

(7) ISO-17025 Certification would be preferred

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10. STANDARDS FOR RECOGNITION OF TISSUE CULTURE PRODUCTION UNITS UNDER NATIONAL CERTIFICATION SYSTEM FOR TISSUE CULTURE RAISED PLANTS (NCS-TCP)

The standard parameters which need to be complied with for recognition of

the Tissue Culture Production Facilities have been categorized into critical

and non critical parameters. The conformity with the standards is assessed by

the subcommittee of Accreditation Panel (AP) through a site visit. The

recommendation for recognition is based on conformity with all the critical and

non critical parameters. In case of non conformity, the subcommittee of

Accreditation Panel advises for the corrective actions. On completion of

corrective actions, depending upon the nature of non conformity either a site

visit is made to ascertain compliance or the documented evidence is

accepted.

Eligibility for applying for Recognition of Tissue Culture Production facilities under NCS-TCP:

Any tissue culture production facility (Public sector, Private sector, NGO and

others) engaged in production of Tissue Culture Plant with minimum

production capacity of 0.5 million plants can apply for Recognition under

NCS-TCP. The application form (NCS-TCP Form 2) can be downloaded from

NCS-TCP website and the duly filled application form in 5 sets along with

demand draft of Rs. 1000/- (Rupees: One Thousand Only) towards

registration can be send to Biotech Consortium India Ltd.

Score Card for Assessing TC Units:

S. No. Particulars Marks1. Infrastructure

Lab Facilities Washing room Media Preparation room Inoculation room, Growth room Power back up

5510105

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Hardening facilities Transfer area, greenhouse, shade area Nursery

105

2. Technical supervision and monitoringMonitoring of the production process and technical competence of the production staff (operators and supervisory staff)

10

3. Quality control Selection of clones and maintenance of

germplasm Virus indexing Number of multiplication cycles and Clonal

uniformity Overall quality of the plants

81010

12Total 100

11. Status of Accreditation of Test Laboratories and Recognition of Tissue

Culture Companies under NCS-TCP

A. Status of Accreditation of Test Laboratories

Nine Test Laboratories have been accredited to test and certify various tissue

culture raised plant species. List of Accredited Test Laboratories is as follows:

S.No

Entity Address Accredited for

1 Indian Institute of Spices Research (ICAR)

P.B. 1701, Marikunnu Post, Calicut Kerala-673012

Virus indexing and genetic fidelity testing of spices

2 National Research Centre for Banana (ICAR)

Thogamalai road, Thyanapur post, Tiruchirapalli Tamil Nadu-620120

Virus indexing and genetic fidelity testing of banana

3 Indian Institute of Horticultural Research (ICAR)

Hessaraghatta Lake P O, Bangalore Karnatka-560089

Virus indexing of ornamentals and genetic fidelity testing of anthurium and gerbera

4 Central Potato Research

Shimla (HP)-171001 Virus indexing and genetic fidelity testing of potato

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Institute (IARI) (ICAR)

5 Institute of Himalayan Bioresource Technology, (ICAR)

P.O. Box 6, Palampur (H.P)-176061

Virus indexing and genetic fidelity testing of TC raised plants

6 University of Agriculture Science, Banagalore

Dept. of Plant Pathology Agriculture College, UAS,GKVK Bangalore Karnataka

Virus indexing and genetic fidelity testing of TC raised plants

7 Sugarcane Breeding Institute (ICAR)

Coimbatore Tamil Nadu-641007

Genetic fidelity and virus indexing of sugarcane

8 Agharkar Research Institute, Pune

G.G. Agharkar Road, Pune-411004, Maharashtra

Genetic fidelity testing of tissue culture raised banana and sugarcane

  IARI Regional Station, Pune (ICAR)

Agriculture College Estate,Shivajinagar, Pune Maharashtra-411005

Virus indexing of tissue culture raised banana and sugarcane

9 Central Research Institute for Jute and Allied Fibres (ICAR)

Barrackpore, Kolkata-700120, West Bengal

Virus indexing and genetic fidelity testing of banana, potato, orchids, bamboo and other crops as per requirement

The profiles of Accredited Test Laboratories (ATLs) are available at NCS-TCP

website (www.dbtncstcp.nic.in)

B. Operation of ATLs

Standard Operating Procedures (SOPs) had been developed and circulated to all

the ATLs under this system. Frequent monitoring of the ATLs has been carried

out by the Project Management Unit at BCIL to facilitate compliance with the

SOPs.

An Accredited Test Laboratory receives application for virus/quality (genetic

fidelity) along with the prescribed fees in the prescribe format given in the SOPs

for testing of tissue culture plants from a Recognized tissue culture production

facility. ATLs test the tissue culture plants and generate the test report in

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prescribed format given in the SOPs. Based on the test report, ATLs issue

Certificate of Quality and Certification labels for the tissue culture raised plants to

the Recognized tissue culture production facilities as per the formats given in the

SOPs. The SOPs for the ATLs can be downloaded from NCS-TCP website

(http://www.dbtncstcp.nic.in).

C. Status of Recognition of tissue culture companies under NCS-TCP

Forty five tissue culture companies have been recognized as on October 6, 2010.

Their state wise distribution is given below:

S.no States Recognized Tissue Culture Companies

1. Andhra Pradesh 1.) A.G. Bioteck Laboratories (India) Ltd., Hyderabad

2.) Anantha Biotechnologies, Ananthapur 

3.) BrookFileds Biotech Pvt. Ltd., Kadapa

4.) ACE Agro Technologies, Secunderabad

5.) Agri Vitro Tech Laboratories, Secunderabad

6.) S & S Agro Biotech Pvt. Ltd., Secunderabad

7.) Godrej Agrovet Ltd. (Plant Biotech Division), R.R. Dist

8.) Sai Lara Biotechnologies, Hyderabad

9.) Phytica Biotech Pvt. Ltd., Medak Dist.

2. Chhattisgarh 1.) Devleela Biotechs, Raipur

2.) Aditya Biotech Lab & Research Pvt Ltd., Raipur

3. Haryana 1.) Technico Agri Sciences Ltd., Chandigarh2.) Micropropagation Technology Park (TERI), Gurgaon3.) Sheel Biotech Ltd., Gurgaon

4. Gujarat 1.) Shaili Biotech (P) Ltd., Ahmedabad

2.) Cadila Pharmaceuticals Ltd (Agro Division), Ahmedabad

3.) Arcadia Agro, Mogar Anand

4.) Sarjan Biotech Pvt. Ltd., Bhuj Kutch

5.) Neesa Agritech Pvt. Ltd., Ahmedabad

5. Karnataka 1.) Shri Ramco Biotech, Bangalore

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2.) Labland Biotech Pvt Ltd., Mysore3.) Greenearth Biotechnologies Ltd., Bangalore4.) MSR Biotech Pvt. Ltd., Bangalore5.) K.F. Biotech Pvt. Ltd., Bangalore6.) Lakshmi Biotech, Bangalore

6. Kerala 1.) L. J. International Ltd. (AVT), Kochi

7. Maharashtra 1.) K.F. Bioplants Pvt. Ltd., Pune

2.) Reliance Life Sciences Pvt. Ltd., Mumbai

3.) H.U Gugle Agro Biotech Co., Ahmadnagar

4.) Ajeet Seeds Ltd., Aurangabad

5.) Nirmeeti Biotech, Pune

6.) Jain Irrigation Systems Ltd., Jalgaon

7.) Gargi Biotek Pvt Ltd., Pune

8.) Rise N Shine Biotech Pvt. Ltd, Pune

9.) Seema Biotech, Kolhapur

10.) Vasantdada Sugar Institute, Pune

11.) Futura Bioplants Pvt Ltd., Pune

8. Punjab 1.) PEPSICO India Holdings Pvt Ltd., Hoshiarpur

9. Tamil Nadu 1.) Growmore Biotech Ltd., Hosur

2.) SPIC Agro Biotech Centre, Coimbatore

10. Uttarakhand 1.) Aryave Biotech Pvt Ltd., Haridwar

11. West Bengal 1.) Vedic Synergy Biotechnologies Ltd., Durgapur

2.) Elegant Flower Company Pvt Ltd., Kolkata

3.) Boinchi Bioplants Pvt Ltd. , Boinchi

12. Uttar Pradesh 1.) Tissue Culture Facility, Biotech Park, Lucknow

The profiles of Recognized Tissue Culture Production facilities are available at

NCS-TCP website (www.dbtncstcp.nic.in)

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