Contents 1. Introduction 2. Organization of NCS TCP 3. Comprehensiveness of NCS-TCP 4. Committees of NCS-TCP 5. Appellate Authority (AA) 6. Process of Accreditation/Recognition 7.

Certification of Tissue Culture Plants 8. Standards for Production of Tissue Culture Plants: 9. Standards for Accreditation of Test Laboratories for Virus Diagnosis/Quality Testing of Tissue Cultures of Plants 10. Standards for Recognition of Tissue Culture Production Facilities

Page Number 1 4 5 5 6 6 8 9 9

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11. Status of Accreditation of Test Laboratories and Recognition of Tissue Culture Facilities under NCS-TCP

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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. 2 BCIL

Stakeholders and their major responsibilities Stakeholders Ministry of Agriculture Responsibility 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), the BCIL is of coordinating Accredited the Test various components and monitoring activities Laboratories and Recognized Tissue

Referral Laboratories

Culture Production Units. 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 Division Indian for of Virus Plant

Diagnosis Pathology,

Agriculture

Research Institute (IARI), New Delhi (ii) Referral Centers for Genetic Fidelity Centre and for DNA Fingerprinting Accredited Test Laboratories (ATLs) Diagnostics

(CDFD), Hyderabad. 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. To adopt the NCS-TCP guidelines and Standard Operating Procedures (SOPs) in order to produce quality tissue culture plants.

Recognized Tissue Culture Company

2. Organization Structure of NCS TCP

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NCS TCP is well organized for smooth functioning of the programme. The components of NCS TCP are as under:

Appellate Authority (DBT) Tissue Culture Certification Agency (DBT)

Referral Laboratory Virus Diagnosis - IARI Genetic Fidelity-CDFD

Accreditation Unit (BCIL)

Accreditation Panel

Accreditation Accredited Test Laboratories Certification

Recognition Recognized TC Production Facility

Certification of Tissue Culture Material (Issue of certificate of Quality)

3. Comprehensiveness of NCS-TCP

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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 Laboratories and TCPFs and also suggests improvements in NCS-TCP guidelines/documents. 6 BCIL

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 days from receipt of complete application. In case of non-conformities certificates can be issued within 45 days after formal communication of

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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:

Test Laboratory Application TC Certification Agency

Application Tissue Culture Production Facility

Accreditation Unit

Site visit Accreditation Panel

Site visit

Assessment Report Accreditation Unit Report Positive Accredited Test Laboratories Accreditation /Recognition Recognized TC Production Facility

7. Certification of Tissue Culture Plants:

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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)

Recognized TC Production Facility

Application

Site visit/receipt of sample

Accredited Test Laboratory Testing of Samples Test Report Positive Certificate of Quality (CQ-TCP)

8. Standards for Production of Tissue Culture Material:

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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 Digital top pan/analytical balance pH meter 10 BCIL

Distilled and sterile//millipore water Gas burners Autoclave Laminar flow hoods Incubation chambers Freezer (-20o C) Refrigerator 4o C Vortex mixer micropippettes DNA extraction equipment DNA probes Tissue grinder Centrifuge / Microcentrifuge PCR Horizontal Gel Electrophoresis Gel documentation unit Equipments for DNA fingerprinting Dignostic reagents cDNA probes Polyclonal / monoclonal anti-bodies for diagnostic for commonly Primers

Specific Equipments

(5) Reagents

occurring Viruses (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. 1. Particulars Infrastructure
Lab Facilities

Marks

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

5 5 10 10 5

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2.

Hardening facilities Transfer area, greenhouse, shade area Nursery Technical supervision and monitoring Monitoring of the production process and technical competence of the production staff (operators and supervisory staff) Quality control Selection of clones and maintenance of germplasm Virus indexing Number of multiplication cycles and Clonal uniformity Overall quality of the plants Total

10 5

10

3.

8 10 10 12 100

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 1 Entity Indian Institute of Spices Research (ICAR) National Research Centre for Banana (ICAR) Indian Institute of Horticultural Research (ICAR) Address P.B. 1701, Marikunnu Post, Calicut Kerala673012 Thogamalai road, Thyanapur post, Tiruchirapalli Tamil Nadu-620120 Hessaraghatta Lake P O, Bangalore Karnatka560089 Accredited for Virus indexing and genetic fidelity testing of spices Virus indexing and genetic fidelity testing of banana

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

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7 8

Central Potato Research Institute (IARI) (ICAR) Institute of Himalayan Bioresource Technology, (ICAR) University of Agriculture Science, Banagalore Sugarcane Breeding Institute (ICAR) Agharkar Research Institute, Pune IARI Regional Station, Pune (ICAR) 9 Central Research Institute for Jute and Allied Fibres (ICAR)

Shimla (HP)-171001

Virus indexing and genetic fidelity testing of potato Virus indexing and genetic fidelity testing of TC raised plants

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

Dept. of Plant Pathology Agriculture College, UAS,GKVK Bangalore Karnataka Coimbatore Tamil Nadu-641007 G.G. Agharkar Road, Pune-411004, Maharashtra Agriculture College Estate,Shivajinagar, Pune Maharashtra411005 Barrackpore, Kolkata700120, West Bengal

Virus indexing and genetic fidelity testing of TC raised plants Genetic fidelity and virus indexing of sugarcane Genetic fidelity testing of tissue culture raised banana and sugarcane Virus indexing of tissue culture raised banana and sugarcane 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

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facility. ATLs test the tissue culture plants and generate the test report in 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 1.

States Andhra Pradesh

Recognized Tissue Culture Companies 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. 1.) Devleela Biotechs, Raipur 2.) Aditya Biotech Lab & Research Pvt Ltd., Raipur 1.) Technico Agri Sciences Ltd., Chandigarh 2.) Micropropagation Technology Park (TERI), Gurgaon 3.) Sheel Biotech Ltd., Gurgaon 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

2. 3.

Chhattisgarh Haryana

4.

Gujarat

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5.

Karnataka

1.) Shri Ramco Biotech, Bangalore 2.) Labland Biotech Pvt Ltd., Mysore 3.) Greenearth Biotechnologies Ltd., Bangalore 4.) MSR Biotech Pvt. Ltd., Bangalore 5.) K.F. Biotech Pvt. Ltd., Bangalore 6.) Lakshmi Biotech, Bangalore 1.) L. J. International Ltd. (AVT), Kochi 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 1.) PEPSICO India Holdings Pvt Ltd., Hoshiarpur 1.) Growmore Biotech Ltd., Hosur 2.) SPIC Agro Biotech Centre, Coimbatore 1.) Aryave Biotech Pvt Ltd., Haridwar 1.) Vedic Synergy Biotechnologies Ltd., Durgapur 2.) Elegant Flower Company Pvt Ltd., Kolkata Boinchi Bioplants Pvt Ltd. , Boinchi

6. 7.

Kerala Maharashtra

8. 9. 10. 11.

Punjab Tamil Nadu Uttarakhand West Bengal

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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