Minutes of 400th meeting of the india registration committee

5.18 Request for 2nd time extension of validity period of provisional certificate of registration of Trichoderma viride 1.5% WP for one year with commercialization M/s Antecedent Pabul

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MINUTES OF 400th MEETING OF REGISTRATION COMMITTEE HELD

ON 23.04.2019 IN THE CHAMBER OF DR S K MALHOTRA, ROOM

NO 231, KRISHI BHAWAN, NEW DELHI

The 400thMeeting of Registration Committee (RC) was held under the

Chairmanship of Dr S K Malhotra, Agriculture Commissioner on 23.04.2019 at

10:00 AM in Room No 231 Krishi Bhawan, New Delhi Sh Rajesh Malik, Plant

Protection Advisor, Dte of PPQ&S, Faridabad; Dr P K Chakarbarty, Member

ASRB, (Special invite), New Delhi; Dr K K Sharma, Project Coordinator, IARI,

Pusa, New Delhi and Dr Sushil K Khurana, Secretary, CIB&RC, attended the

meeting The quorum was not complete as the Secretary CIB&RC was at Hon’ble

Supreme Court to attend the hearing in an important matter, therefore, it was

postponed for twohours and again convened Following officers from the Secretariat

of CIB&RC also attended the meeting to present their agendas and advises as and

when required/or volunteered to provide the information during the deliberations

1 Dr Sandhya Kulshrestha, Consultant (Pharma)

2 Dr Sarita Bhalla, Consultant (Pharma)

3 Dr Archana Sinha, JD (Chem.)

4 Ms Kamlesh Miglani, JD (Chem.)

5 Sh Hariom Miglani, Sr Law Officer

At the outset, Chairman welcomed the members & experts and asked Secretary, CIB&RC

to take up the agenda for deliberations The decisions taken by the RC are as under: -

Agenda

item No

Particulars of Agenda

1.0 Confirmation of minutes of the 399thmeeting of the Registration Committee

Committee deliberated the minutes of 399th meeting of registration Committee and confirmed with the following modifications: -

1 Agenda item No 7.4 is approved

2 Item No 10.1.1, deferred in 398thRC:

A) Total No of applications may be read as 3659, instead of 3664 B) Satisfactory :2687 may read as 2695

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a) Serial No 3655 available at S.No.3608 b) Serial No 3656 available at S.No.3609 c) Serial No 3657 available at S.No.3616 d) Serial No 3658 available at S.No.3636 e) Serial No 3659 available at S.No.3649 f) Serial No 3660 available at S.No.3650 g) Serial No 3661 available at S.No.3653 h) Serial No 3662 available at S.No.3656

4 The following applications reflected in the minutes of the 399th (deferred 398th) meeting were not included in the agenda note of 398th RC meeting

i) Serial No 3660, 3661, 3662, 3663, 3664

5 Agenda Item No 9.26 annexure 9.26.1 S No 11 Approved of 1500 MT of Sodium Cyanide for import for one calendar year in view of the decision taken by RC (for manufacturing of Glufosinate Technical)

1.1 Follow-up actions and related presentations

The Committee noted with satisfaction follow-up actions taken by the Secretariat of CIB&RC

NIL

3.1 Challenges before the Regulators regarding- deferred agenda of 399th RC

1 On the issue of the drawl of in process sample w.r.t 9(4) TIM applications RC decided that hence forth the procedure of in process drawl of sample followed for 9(4) TIM applications shall be replaced with submission of samples by the applicant for pre-registration verification and the same shall be tested/analyzed at CIL and the results thereof shall be conclusive However, as and when felt expedient by the Sectt of CIB&RC scientific experts may be deputed for verification of the samples Furthermore, the applicant shall submit an affidavit in

this regard along with the sample as per the format given atAnnexure 3.1.1

2 RC also took cognizance on the issue of non adherence to the crucial aspects of examining the NMR report at the time of issuance of Certificate of Registrations

At first stage, the RCdesired that the complete list of all such applications under TIM and TI u/s 9(3) and 9(4) shall be prepared and placed before theRC for which the Certificate of Registrations had been issued, wherein the condition for “subject

to confirmatory NMR” has been incorporated in the CRs

3 RC observed and appreciated the fact, that there are technical difficulties felt by Secretariat of CIB&RC in examining the online applications especially where certain scientific comparison are required from the old files which are difficult to trace Keeping in view the maintenance of transparency and ease of doing business above concerns have been taken up with NIC officials from time to time including upgradation of the CROP system, verification and uploading of digitized data,

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dedicated manpower has not been provided extention of services which is leading

to day to day hardship hampering the routine work RC directed that NIC officials may again berequested/informed to resolve the above difficulties as expeditiously

as possible preferably within a period of one month from the date of hoisting of the minutes DAC&FW may be apprised accordingly

4 RC also took cognizance of the fact that there may be certain molecules in which the resistance could have been developed whereby the efficacy of the product becomes questionable which may defeat the very purpose of the Insecticides Act,

1968 Therefore, keeping in view the importance and urgency in the matter, RC decided that ICAR may be requested to examine the above issues on a larger canvass and submit its report to the RC for further deliberations and arriving at an appropriate decision in the larger public interest

5 No comments are received w.r.t Bio-efficacy data generation of Technical compounds from ICAR hence the issue needs further deliberation

3.2 Extraneous influencing factors in execution of time line for scrutiny of single

application (by individual expert) up to issuance of certificate (in working days)

Registration Committee deliberated the agenda and decided for each factors as under:

(i) Submission of deficient files by the applicant at the initial stage

Registration Committee observed that in some cases an applicant does not submit all data/documents as per guidelines and checklist approved by the Registration Committee, at the time of submission of application for a particular category This type of incomplete submission increases the period

of technical scrutiny and consideration by RC thereof This increases the overall pendency on the part of CIB&RC Secretariat for a fault on the part of the applicant Therefore, RC decided that hence forth if an incomplete application is received from the applicant and comes to notice at the preliminary scrutiny/technical scrutiny stage, the processing of the same may

be stopped by the CIB&RC Secretariat and brought to the notice of RC for rejection or otherwise in its immediate next meeting

(ii) Six months time for submission of deficiency reply by the applicant in all

categories except export where deficiency reply can be submitted by applicant in 90 days

Registration Committee observed that if an applicant submits, all data/documents as per guidelines and checklist approved by the Registration Committee, at the time of submission of application for a particular category, then not much time is required to submit reply of a deficiency where only clarification would be required Further, RC noted that now a days deficiencies are conveyed and received through online/e-mail Therefore, RC reduced the timeline for submission of deficiency reply by the applicant from 6 months/90 days to 60 days from the date of issue of deficiency letter, in general

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henceforth However, the category wise timeline has been decided in agenda item no 3.3

(iii) Verification of Consent letter from the technical supplier [in the case of 9(4)

FIM applications]

Registration Committee observed that no timeline is fixed for submission of reply of verification e-mail sent to the Technical supplier [in the case of 9(4) FIM case] Therefore, RC fixed the timeline of 30 days from the date of issue

of letter henceforth.If reply is not received in the Secretariat of CIB&RC within the prescribed timeline, the relevant file shall be closed at the Secretariat level on the very first day of expiry of the prescribed timeline and list of such closed files shall be brought before the Registration Committee for rejection or otherwise in its immediate next meeting

(iv) Fixation of MRL for new molecule/label expansion of already registered

formulation products

Registration Committee decided that the letter may be issued to FSSAI preferably within 15 days after display of the minutes of the RC meeting The applicant may also take pro-active approach and submit all related documents well in time to avoid delay in issuance of letter to FSSAI

(v) Designated National Authority(DNA) verification from country of import

On completion of the file by the expert (at the level of Secretariat) the DNA shall be communicated within fifteen days by mail for verification of the source If no response is received by the respective DNA, first reminder will

be sent thereafter And still if no response is received within seven days a second reminder will be sent thereafter requesting to provide the requisite information within 10 days In case still if no response is received from DNA within 30 days and the applicant will be informed accordingly to follow up the matter within 30 days from the non receipt of the information and thereafter case will be treated as closed

(vi) Analysis Test Report by CIL

Registration Committee fixed the timeline for Central Insecticide Laboratory (CIL) to provide a copy of the Analysis Test Report (ATR) within 60 days from the receipt of the sample so as to enable the RC to arrive at an appropriate decision

(vii) Readiness for sample drawl by the applicant in the cases of 9(4) TIM

On the issue of the drawl of in process sample w.r.t 9(4) TIM applications RC decided that hence forth the procedure of in process drawl of sample followed for 9(4) TIM applications shall be replaced with submission of samples by the

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applicant for pre-registration verification and the same shall be tested/analyzed

at CIL and the results thereof shall be conclusive However, as and when felt expedient by the Sectt of CIB&RC scientific experts may be deputed for verification of the samples Furthermore, the applicant shall submit an affidavit

in this regard along with the sample as per the format given at Annexure 3.1.1

(viii) ICAR comments

Registration Committee noted that 30 days time is already prescribed for submission of comments by ICAR RC directed that ICAR may be informed

about the timeline

(ix) The report from NBAIM, Mau Nath Bhanjan, (UP) w.r.t Biopesticides Strains

Registration Committee considered and decided that the applicant may submit the request to NBAIM 30 days prior to submission of application to Secretariat of CIB&RC for grant of registration of Bio-pesticides henceforth

(x) Ex-facto approval of shelf life by Central Insecticides Board(CIB)

Registration Committee noted the proposal

3.3 Fixation of timeline for submission of consent letter by the Technical supplier (in the

case of 9(4) FIM case) and deficiency reply by the applicant in other categories.- deferred agenda of 399th RC

Registration Committee considered and fixed the revised timeline category for submission of deficiency reply by the applicant and submission of reply of verification e-mail sent to the Technical supplier [in the case of 9(4) FIM case]

henceforth as per Annexure 3.3.1 Registration Committee further decided that if

consent letter by the Technical supplier [in the case of 9(4) FIM case] and deficiency reply by the applicant in other categories is not received in the Secretariat of CIB&RC within the above prescribed timeline, the relevant file shall

be closed at the Secretariat level on the very first day of expiry of the prescribed timeline and list of such closed files shall be brought before the Registration Committee for rejection or otherwise in its immediate next meeting

3.4 Transfer of Certificate of Registration (CR) of one person/undertaking in the name

of another person/undertaking

Committee deliberated the agenda and decided to constitute a committee comprising of the following experts:

1 Dr Sandhya Kulshrestha, Consultant (Pharma) – Chairman

2 Sh Hariom Miglani, Sr Law Officer – Member

3 Sh Niraj Kulshrestha, Law Officer – Member Secretary The committee shall examine the issue of the transfer of certificate from one registrant to another company /person keeping in view the earlier decisions of the RC and shall submit appropriate recommendations In view of the correct interpretation of Rule 6(B) of the

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expeditiously preferably within one month and placed its recommendations before the RC

RC further decided that still the recommendations are placed by the committee and are deliberated by the RC, no application of endorsement for transfer of certificates shall be processed

3.5 Issues pertaining to exemption of laboratories for the purpose of importing

insecticides or pesticides for R &D activities and data generation for registration

RC noted that only 12 GLP accredited laboratories have replied to the information sought

by Sectt of CIB&RC regarding previous years expenditure on Research and Development activities and registration related data generation RC also noted that DAC&FW has sought clarification on its decision taken in the matter in the 393rd RC meeting Accordingly, RC directed that the expert committee constituted for this purpose in the 391st

RC meeting shall examine the entire issue including clarification sought by DAC&FW

and submit the report in its next RC meeting

3.6 Draft CR and Label/Leaflets (wherever applicable) be made part of agenda for

consideration of the Registration Committee

The committee was apprised that the system of receipt of application in hard copy is in the process of phase out and now most of the applications are received online Hence, with the present software it is not possible to generate draft CR before agenda is placed for consideration and approved by the RC However, it is possible only for some of applications received in hard copy and are processed manually Therefore, NIC will be requested to modify the software to bring the DCR along with the Agenda stage Till such time the Draft Certificate of Registration (DCR) which also include Label & Leaflet for hard copy files may be prepared and submitted along with the agenda and explore for the inclusion from the files which has been submitted in soft copy

3.7 Classification of Pesticides based on their Toxicity under the Insecticides Rules, 1971

–reg

The Committee noted the information Also noted that the matter will be discussed in forthcoming Central Insecticides Board Meeting

3.8 Committee constituted by the Registration Committee for examining the proposal of

Fall Army Warm (FAW)

Members deliberated the information as provided in the agenda and noted that a number

of proposals were received for consideration of management of suspected incidence of Fall Army Worm (FAW) on maize in the country The committee also noted that many of the proposals indicated that the formulation was effective against FAW, however, no data on efficacy and/or residue were submitted by the industries Only few proposals were accompanied with one season bio-efficacy and/or residue data The committee further noted that the pesticides permitted for the management of FAW during 391st RC meeting should have necessary trials for label expansion developed as per CIB&RC guidelines within three years by pesticide industries The committee did not receive any data for these pesticides so far, though it might have been generated for at least one season

Looking into the invasive nature and spread potential of this exotic pest, it was decided that the available multi-location data on bio-efficacy and/or residue (even for one season) for potential pesticides generated for FAW on maize under Indian conditions may be submitted by the Pesticide Associations/ industries to the Secretariat of CIB&RC within a week of upload of the minutes on the website for consideration by the RC The RC constituted the following committee to examine the data received and make recommendations for ad-hoc permission to deal with the exigency if arise

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1 Dr P.K Chakrabarty, Former ADG (PP&B), ICAR and Member, ASRB- Chairman

2 Dr K.K Sharma, Network Coordinator, AINP on Pesticide Residues, ICAR-IARI, New Delhi- Member

3 Dr J C Sekhar, Principal Scientist & In-charge, WNC ICAR-IIMR, Hyderabad- Member

4 Dr S Vennila, Principal Scientist, ICAR- NCIPM, New Delhi-Member

5 Dr Vandana Tripathy, Senior Scientist, AINP on Pesticide Residues, ICAR-IARI, New Delhi-Member

6 Dr K W Deshkar, Deputy Director (E), CIB&RC- Member Secretary

3.9 Display of Bharat Kosh Portal for public use to make payment of balance amount the

firm in view of decision taken by the Registration Committee in its 397th meeting held

on 30.01.2019 and 04.02.2019 (vide agenda item no 3.13) and 398th meeting held on 25.03.2019 (vide agenda item no 3.4) regarding the proposed fees structure of addition, deletion or alternation of the certificate of registration including label and leaflet as per Rule 6 (B) of the Insecticides Rules, 1971

RC noted and directed to place the information Annexure 3.9.1 on the website for the use

by the stakeholders and DAC &FW should be informed

4.1 List under section 9(3) Export applications

The Agenda was deliberated in detail & approved the cases as per Annexure 4.1.1, 4.1.2, 4.1.3, 4.1.4 and 4.1.4 except the product at S No 12, 13, 14 & 15 in Annexure – 4.1.1 and

at serial No 1 in Annexure 4.1.2 The Committee further decided that the applicants of these bio-pesticides products shall be invited for presentation why they want to export the Bio-pesticide products and all the other products covered under the Gazette Notification

SO 3951 (E) dated 08.08.2018 published on 09.08.2018 The Committee further decided that the applications of import for export category shall be subjected to the decision taken

by the Committee in its 357thmeeting It was also directed to recheck cases and should strictly follow Gazette Notification SO 3951 (E) dated 08.08.2018 published on 09.08.2018 of Ministry of Agriculture, Cooperation and Farmers Welfare while issuing

approvals

4.2 Consideration of application of M/s Sajjan India Ltd., for grant of registration of

Tolpyralate Technical 96% w/w min for manufacture for export only under section

9(3) export

Committee deliberated the agenda and approved the case

4.3 Consideration of application of Meghmani Organics Ltd., grant of registration of

Tetramethrin Technical 95% w/w min for manufacture for export only under section

9(3)

Committee deliberated the agenda and approved the case

5.1 Consideration of application of M/s CNG Agrocare Pvt Ltd Kolkata for grant of

registration for indigenous Bio-pesticide manufacturing of Trichoderma harzianum

1.0% WP under section 9(3b) (Strain Designation: IIHR Th-2 Strain Accession

No.ITCC-6888)

Committee deliberated the agenda and approved for grant of registration for indigenous

manufacture of Trichoderma harzianum 1.0% WP

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5.2 Consideration of application of M/s Choudhari Agro-tech (I) Pvlt Ltd Nagpur for

grant of registration for indigenous Bio-pesticide manufacturing of Bacillus

thuringiensis Var kurstaki 0.5% WP (Serotype s 3a, 3b & 3c) under section 9(3b),

(Strain Designation: DOR Bt-1 Accession No NAIMCC-B-01118)

Committee deliberated the agenda and decided to ask for details on analytical test report for pre registration verification of the sample from CIL, Faridabad as further result for LC50 and potency value have not been reported in the ATR submitted by CIL and details

on test report for molecular identification of microbial culture from NBAIM, Maunath

Bhanjan, Uttar Pradesh as the species reported by NBAIM is nearest match to Bacillus

thuringiensis instead of the application for the species Bacillus thuringiensis Var kurstaki

5.3 Consideration of application of M/s SRT Agro Science Pvt Ltd Durg (Chhatisgarh)

for grant of registration for indigenous Bio-pesticide manufacturing of Bacillus

thuringiensis var kurstaki 0.5% WP (Serotype serotype 3a, 3b & 3c H-14) under

section 9(3b), (Strain Designation: DOR Bt-1 Accession No.NAITCC-B01118)

on test report for molecular identification of microbial culture from NBAIM, Maunath

Bhanjan, Uttar Pradesh as the species reported by NBAIM is nearest match to Bacillus

thuringiensis instead of the application for the species Bacillus thuringiensis Var kurstaki

5.4 Request for 1st time extension of validity period of provisional certificate of

registration of Trichoderma harzianum 1.0% WP for one year with commercialization

M/s Uttam Chemicals Industries

Committee deliberated the agenda and approved the 1st Extension from 05/12/2018 for further one year with same label claims RC also decided that a condition may be incorporated on the extension letter that for further extension if required, the applicant shall submit the proof of progress in data generation from the head of concerned institute/university or Director of research

registration of Trichoderma viride 1.5% WP for one year with commercialization M/s

Biopesticide and Biofertilizer Unit

Akash Laboratories

registration of Pseudomonas fluorescens 1.0% WP for one year with

commercialization M/s Parle Bio Care LLP

Committee deliberated the agenda and approved 1st Extension from 22/12/2018 for further one year with same label claims RC also decided that a condition may be incorporated

on the extension letter that for further extension if required, the applicant shall submit the

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proof of progress in data generation from the head of concerned institute/university or Director of research

commercialization M/s Lotus Biotech

on the extension letter that for further extension if required, the applicant shall submit the proof of progress in data generation from the head of concerned institute/university or Director of research

commercialization M/s Director Research Services

5.10 Request for 3rd time extension of validity period of provisional certificate of

commercialization M/s Prathibha Biotech Pvt Ltd

Committee deliberated the agenda and approved 3rd Extension from 02/01/2019 for further one year with same label claims No further extension shall be granted

5.11 Request for 2nd time extension of validity period of provisional certificate of

Gokulam Enterprises

Committee deliberated the agenda and approved 2nd Extension from 04/01/2019 for further one year with same label claims RC also decided that a condition may be incorporated on the extension letter that for further extension if required, the applicant shall submit the proof of progress in data generation from the head of concerned institute/university or Director of research

Kavery Organic Agri Inputs Pvt Ltd

Committee deliberated the agenda and approved 2nd Extension from 02/01/2019 for further one year with same label claims RC also decided that a condition may be incorporated on the extension letter that for further extension if required, the applicant shall submit the proof of progress in data generation from the head of concerned institute/university or Director of research

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Committee deliberated the agenda and approved 2nd Extension from 04/01/2019 for further one year with same label claims RC also decided that a condition may be incorporated

commercialization M/s Criyagen Agri & Biotech Pvt Ltd

Gujarat Life Sciences (P) Ltd

Antecedent Pabulum INC

Benzer Crop Science

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commercialization M/s Sowbhagya Biotech P Ltd

commercialization M/s Benzer Crop Science

commercialization M/s Crop Health Biotech

commercialization M/s Pratik Industries

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commercialization M/s Growtech Agri Science and Research Pvt Ltd

M/s Growtech Agri Science and Research Pvt Ltd

Growtech Agri Science and Research Pvt Ltd

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M/s Crop Health Biotech

commercialization M/s Allwin Industries

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registration of Pseudomonas fluorescens 1.5% AS for one year with

commercialization M/s R.B Herbal Agro

commercialization M/s Cadila Pharmaceuticals Ltd

Committee deliberated the agenda and Approved with same label claims RC also decided that a condition may be incorporated on the extension letter that for further extension if required, the applicant shall submit the proof of progress in data generation from the head

of concerned institute/university or Director of research RC deliberated that the extension letter will be issued from the date of expiry date of PRC that is 24.08.2019

5.41 Request for 2nd time extension of validity period of provisional certificate of

commercialization M/s Patanjali Bio Research Institute Pvt Ltd

Patanjali Bio Research Institute Pvt Ltd

Som Phytopharma (India) Ltd

Agri Bio Care

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5.46 Request for 2nd time extension of validity period of provisional certificate of registration

of Trichoderma viride 1.5% WP for one year with commercialization M/s Krishi Vigyan

commercialization M/s Amar Biotech

Arya Biotech and Research Laboratories

Advance Crop Care India Pvt Ltd

commercialization M/s Anshul Agro Chemicals

Anshul Agro Chemicals

Committee deliberated the agenda and approved 2nd Extension from 12/03/2019 for further

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Criyagen Agri & Biotech Pvt Ltd

M/s Krishi Biosys

commercialization M/s Krishi Biosys

commercialization M/s Gujarat Eco Microbial Technology Pvt Ltd

Gujarat Eco Microbial Technology Pvt Ltd

commercialization M/s Poabs Biotech Pvt Ltd

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Tagros Chemicals India Ltd

Kaveri Seed Company Ltd

commercialization M/s Tari Bio-tech

Chhattisgarh Agro Biotech Lab

on the extension letter that for further extension if required, the applicant shall submit the proof of progress in data generation from the head of concerned institute/university or

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M/s New Swadeshi Sugar Mills

New Swadeshi Sugar Mills

commercialization M/s Viswa Mithra Bio Agro (P) Ltd

commercialization M/s Agro Bio-tech Research Centre Ltd

Agro Bio-tech Research Centre Ltd

Bio pesticides Laboratory, Department of Entomology

commercialization M/s ShreeSamarth Agro Tech

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Bio Pest Control Industries

commercialization M/s Peptech Biosciences Ltd

Committee deliberated the agenda and deferred for want of the comments from the toxicity expert

commercialization M/s Jhass Agro Industries

Jhass Agro Industries

Krishi Vikas Sahakari Samiti Ltd

Committee deliberated the agenda and approved 1st Extension from 20/04/2019 for further

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M/s Central Insecticides & Fertilizers

Central Insecticides & Fertilizers

M/s Gujarat Metals and Chemicals Company

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ShreeSamarth Agro Tech

Director Research Services, Indira Gandhi Krishi Vishwa Vidyalaya

Complete agenda may be presented before the RC in its next meeting

registration of NPV of Helicoverpa armigera 2.0% AS for one year with

commercialization M/s Ruchi Oyster Mushroom

Lotus Biotech, Bangalore

Parle Bio Care LLP

registration of Verticillium clamydosporium (WP) for one year with commercialization M/s P.J Margao Pvt.Ltd

commercialization M/s Subway agribiotech and research foundation

registration of Beauveria bassiana (WP) for one year with commercialization M/s

Subway agribiotech and research foundation

registration of Metarhizium anisopliae 1.15% WP for one year with commercialization

M/s Shri Ram Solvent Extraction Pvt.Ltd

registration of Verticillium clamydosporium 1.0% (WP) for one year with

commercialization M/s Patanjali Bio Research Institute Pvt Ltd

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registration of Beauveria bassiana (WP) for one year with commercialization M/s

Arya Bio Tech & Research Laboratories

commercialization M/s Arya Bio Tech & Research Laboratories

registration of Verticillium clamydosporium 1.0% (WP) for one year with

commercialization M/s Krishi Biosays Bangalore

registration of Bacillus thuriengiensis var kurstaki 0.5% WP for one year with

commercialization M/s Som Phytopharma (India) Ltd

6.1 Consideration of an application of M/s GSP Crop Science Pvt Ltd., for grant of

registration for Indigenous manufacturer of the product Chlorpyriphos 20% w/w CS

under section 9(3)

Committee deliberated the agenda and Approved for grant of registration for indigenous

manufacture of Chlorpyriphos 20% w/w CS and waiting period/pre-harvest interval for

control of Brown plant hopper, Green Leaf hopper & White backed plant hopper on Paddy

A cautionary statement may be incorporated on the label and leaflet that “Product is highly toxic to fish and aquatic organisms and thus the product containing the molecules may be avoided mixing with nearby aquaculture; Chlorpyriphos is toxic to fish therefore it should not be used pisci-culture / aquaculture / waterbodies; it is toxic to honey bees spray application should be avoided during the foraging period of bees

6.2 Consideration of application of M/s Aaria Bio-Life sciences Research Pvt Ltd Pune

for grant of registration for indigenous manufacture of Pseudomonas fluorescens

1.0% WP u/s 9(3) (Strain: IIHR, PF-2, Accession No.ITCC No.B0034)

Committee deliberated the agenda and rejected as the sample tested in the CIL has been found non satisfactory w.r.t the parameter tested in CIL and the molecular identity test

report from ICAR – NBAIM, Mau Nath Bhanjan found for the species Pseudomonas fragi instead to Pseudomonas fluorescens

6.3 Consideration of application of M/s Yashwantrao Mohite Krishna Sahakari Sakhar

Karkhana Ltd Satara for grant of registration for indigenous Biopesticide

manufacture of Trichoderma viride 1.0% WP u/s 9(3) (Strain Designation:

TNAU-TV-1, Strain Accession No.ITCC -6914)

Committee deliberated the agenda and approved for grant of registration of indigenous manufacture of Trichoderma viride 1.0% WP The labels claims are to be mentioned

6.4 Consideration of application of M/s Manshya Enviro Biotech Pvt Ltd Pune for grant

of registration for indigenous manufacture of Beauveria bassiana 1.15% WP

formulation under section 9(3)

Committee deliberated the agenda (F No 9886-B/F/9(3)/2018) and rejected as the sample tested in the CIL has been found non-satisfactory w.r.t the parameter tested in CIL and

observed that application for the product Beauveria bassiana 1.15% WP has already been

deliberated by the RC in its 398th meeting held 25.03.2019 Vide File No

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9347-B/F/9(3)/2018 and was rejected on the same ground Therefore RC decided no such application shall be entertained in future and applicant have to submit an undertaking that they have not applied earlier under section 9(3b) or 9(3) for the product

6.5 Consideration of application of M/s Manshya Enviro-biotech Pvt Ltd., Pune for

grant of registration for indigenous manufacture of Verticillium lecanii 1.15% WP

under section 9(3) (Strain Designation As-MEGH-VL ACC.No.MCC 1028)

Committee deliberated the agenda (F No 9887-B/F/9(3)/2018) and rejected as the sample tested in the CIL has been found non-satisfactory w.r.t the parameter tested in CIL and

observed that application for the product Verticillium lecanii 1.15% WPhas already been

deliberated by the RC in its 398th meeting held 25.03.2019 Vide File No B/F/9(3)/2018 and was rejected on the same ground Therefore, RC decided no such application shall be entertained in future and applicant have to submit an undertaking that they have not applied earlier under section 9(3b) or 9(3) for the product

9348-6.6 Consideration of application of M/s Mansya Enviro-Biotech Pvt Ltd., Pune for grant

of registration for indigenous manufacture of Pseudomonas fluorescens 1.0% WP

under section 9(3) (Strain: IIHR, PF-2, Accession No.ITCC No.B0034)

Committee deliberated the agenda and rejected as the sample tested in the CIL has been found non satisfactory w.r.t CFU count and other microbial contaminant

6.7 Consideration of application of M/s Microbac (India) Ltd Yashwantrao Mohite

Krishna Sahakari Sakhar Karkhana Ltd Satara for grant of registration for

indigenous Bio-pesticide manufacturing of Trichoderma viride 1.5% WP under section

9(3) (Strain Designation: IIHR-TVG-5, Strain Accession No.ITCC-6889)

a) Committee deliberated issue and earlier minutesof agenda 11.2 of 393th RC held

on 24.09.2018 and observed that no information with respect to notification of Insecticides Analysts (as per section 19 of in the Insecticide Act), has been provided however only the information w.r.t authorization of official/s for analysing the sample of bio-pesticides for pre-registration is given RC, further observed that Mahatma Phule Krishi Vidyapeeth (MPKV- College of Agriculture) themselves are involved in manufacturing activities of bio-pesticides and are also testing the samples of bio-pesticides for pre-registration verification as well as against the provisions of section 19 of the Act This has been viewed seriously by the RC and therefore decided that analytical test reports for pre-registration verification of bio-pesticides shall not be considered from the above said institute b) In view of the above RC also directed that Secretariat of CIB&RC send a communication to this effect to the applicant informing them again to submit fresh sample for testing in the CIL Faridabad and the MPKV- College of Agriculture not

to entertain the analysis of such samples

6.8 Consideration of application of M/s S & S Biotech Nagpur for grant of registration

for indigenous Bio-pesticide manufacturing of Trichoderma viride 1.0% WP under

section 9(3) (Strain Designation: TNAU-TV-1, strain Accession No.ITCC-6914)

Committee deliberated the agenda and approved for grant of registration of indigenous

manufacture of Trichoderma viride 1.0% WP

6.9 Consideration of application of M/s Shiv Paramount organics & fertilizers Pvt Ltd

Meerut for grant of registration for indigenous manufacture of Pseudomonas

fluorescens 1.0% WP under section 9(3) (Strain : IIHR, PF-2, Accession No.ITCC

No.B0034)

Committee deliberated the agenda and rejected as the sample tested in the CIL has been

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report from ICAR – NBAIM, Mau Nath Bhanjan found for the species Pseudomonas fragi instead to Pseudomonas fluorescens

6.10 Consideration of application of M/s Curative Microbes Pvt Ltd, Junagardh

(Gujarat) for grant of registration for indigenous manufacture of Pseudomonas

fluorescenc 1.0% WP under section 9(3) (Strain: IIHR, PF-2, Accession No.ITCC

6.11 Consideration of application of M/s Arghos International, Kolkatat for grant of

registration for indigenous Bio-pesticide manufacturing of Bacillus thuringieniss var

isralensis 5% AS serotype H14 Strain VCRC B17 Accession No MTCC-5596)

of test report for molecular identification of microbial culture from NBAIM, Maunath

Bhanjan, Uttar Pradesh as the species reported by NBAIM is nearest match to Bacillus thuringiensis instead of the application for the species Bacillus thuringiensis Var

isralensis

6.12 Consideration of application of M/s Aaria Bio-Lifesciences Research Pvt Ltd Pune

for grant of registration for indigenous manufacture of Verticillium lecanii 1.15% WP

under section 9(3) (Stratin Designation AS-MEGH-VL ACC No.MCC 1028)

Committee deliberated the agenda and rejected as the sample tested in the CIL has been found non satisfactory w.r.t the parameter tested in CIL and the molecular identity test

report from ICAR – NBAIM, Mau Nath Bhanjan found for the species Lecaniicillum (Verticillium) fusisporum instead to Verticillium lecanii

6.13 Consideration of application of M/s Microbax (India) Ltd Hyderabad for grant of

registration for indigenous manufacture of Pseudomonas fluorescens 1.0% WP under

section 9(3) (Strain: IIHR, PF-2, Accession No.ITCC No.B0034)

a) Committee deliberated issue and earlier minutes of agenda 11.2 of 393th RC held

on 24.09.2018 and observed that no information with respect to notification of Insecticides Analysts (as per section 19 of in the Insecticide Act), has been provided however only the information w.r.t authorization of official/s for analysing the sample of bio-pesticides for pre-registration is given RC, further observed that Mahatma Phule Krishi Vidyapeeth (MPKV- College of Agriculture) themselves are involved in manufacturing activities of bio-pesticides and are also testing the samples of bio-pesticides for pre-registration verification as well as against the provisions of section 19 of the Act This has been viewed seriously by the RC and therefore decided that analytical test reports for pre-registration verification of bio-pesticides shall not be considered from the above said institute b) In view of the above RC also directed that Secretariat of CIB&RC send a communication to this effect to the applicant informing them again to submit fresh sample for testing in the CIL Faridabad and the MPKV- College of Agriculture not

to entertain the analysis of such samples

6.14 Consideration of application of M/s Aaria Bio-Lifesciences Research Pvt Ltd., Pune

for grant of registration for indigenous manufacture of Beauveria bassiana 1.15% WP

formulation under section 9(3)

Committee deliberated the agenda and rejected as the sample tested in the CIL has been found non satisfactory w.r.t CFU count and other microbial contaminant

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6.15 Consideration of an application of M/s Excel Crop Care Ltd., for grant of registration

for indigenous manufacture of the product Paclobutrazole 40% w/w SC under section

9(3)

Committee deliberated the agenda and Approved for grant of registration for indigenous

manufacture of Paclobutrazole 40% w/w SC and waiting period/pre-harvest interval on

Pigeon Pea (as Plant Growth Regulator) subject to fixation of MRL A cautionary statement may be incorporated on the label and leaflet that “Product may be toxic to aquatic organisms its use may be avoided mixing with nearby aquaculture/water bodies and higher concentration may be detrimental to plants normal development”

6.16 Consideration of an application of M/s Crystal Crop Protection Pvt Ltd., for grant

of registration for import of Metribuzin Technical 95% w/w min (TI vs TIM) under

section 9(3)

Committee deliberated the agenda and observed that applicant has not submitted information on packing condition/material in which sample was stored during shelf life studies and performance of the container (change in weight, visible cracks/change in shape) during shelf life has not been submitted in the test report of shelf life data Therefore, applicant may be asked to submit the same and the case may be presented to

RC with complete facts

7.1 Consideration of an application of M/s Godavari Farm Chemical Industires Ltd., for

indigenous manufacture of Deltamethirn Technical 98% w/w min under section 9(4)

TIM

The file is closed for the want of clarification to the deficiency raised on 02.08.2017

8.1 Consideration of the request from M/s Bayer Crop Science Ltd., for endorsement of

Label extension of Imidacloprid 21% w/w + Beta Cyfluthrin 10.5% w/w SC

The RC deliberated agenda and approved the label claim Imidacloprid 21% w/w + Beta

Cyfluthrin 10.5% w/w SC for bed bug (Cimex lectularius) for house hold purpose

8.2 Consideration of the request from M/s Jai Kisan Agro, Indore for endorsement of

third time extension of validity period of Metarhizium anisopliae 1.15% WP

The RC deliberated agenda and observed that the validity period for one year has already been expired on 22.06.2018 Therefore, no further extension of validity period shall be granted

8.3 Consideration of the request from M/s Mircoplex Biotech & Agrochem Pvt Ltd for

endorsement of third time extension of validity period of NPV of Helicoverpa

armigera (AS)-30

The RC deliberated agenda and deferred due to incomplete scrutiny from other section

8.4 Consideration of the request from M/s Apex Bio-Sciences for endorsement of third

time extension of validity period of Trichoderma viride -1.5% WP

The RC deliberated agenda and approved the validity period for 1st time from 02.12.2018 for further one year

8.5 Consideration of the request from M/s Anupam Rasayan India Ltd., for endorsement

of additional factory addresses on the 25 Certificate of Registration

Committee deliberated the agenda and approved the same subject to the deposit of the balance amount of Rs 100/- per certificate of registration in Bharat Kosh vide the decision

of the RC taken in the present meeting vide agenda item no 3.9

8.6 Consideration of the request from M/s Arcon Crop Science (I) Pvt Ltd for

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Viramagam Road, Iyava, Ta Sanadand, Dist Ahmedabad (Gujarat) to 20, Uma Estate, Nr Bhagyoday Hotel, Sanand Virmagam Road, Vasna, Ta Sanand, Dist Ahmedabad (Gujarat) in respect of 23 Certificate of registration

8.7 Consideration of the request from M/s KPR Agrochem Ltd for endorsement of

additional factory addresses on the 22 Certificate of registration

8.8 Consideration of the request from M/s Sinochem India Company Pvt Ltd for the

endorsement of change of office address from Unit 4B, IVth Floor, M-6 Plaza, Jasola, District Centre Jasola, New Delhi-110025 to Unit 4H & 4J, IVth Floor, M-I Plaza, Jasola District Centre, Jasola, New Delhi-110025 in respect of 5 registration certificate

8.9 Consideration of the request from M/s Hyderabad Chemicals Pvt Ltd for

endorsement of change of name of the company name from M/s Hyderabad Chemicals Pvt Ltd to M/s Nichino India Pvt Ltd in respect of 5 registration certificate

8.10 Consideration of the request form M/s VJ Crop Science Pvt Ltd for change of office

and factory address in respect of 31 Certificate of registration

8.11 Consideration of the request from M/s HPM Tapasya Agriproduct Pvt Ltd., to M/s

Kunzite Crop Sciences Pvt Ltd regarding

Committee deliberated the agenda and approved

8.12 Consideration of the request from M/s S.S Crop Care Pvt Ltd regarding change of

name from S.S Crop Care Ltd., in respect of 14 certificate of registration

8.13 Consideration of request for change of name of firm from Rahul Organics Ltd., to

M/s Croprise Agrochem Ltd., in respect of 123 certificate of registration

Committee deliberated the agenda and approved the same except the products Triazophos, Deltamethin – Triazophos and Dichlorvos which are banned/phased out/restricted etc subject to the deposit of the balance amount of Rs 100/- per certificate of registration in Bharat Kosh vide the decision of the RC taken in the present meeting vide agenda item no 3.9 Further, the RC took a serious view as to why the applicant had applied for the above products However, the RC sternly warns the applicant not to repeat this in future

8.14 Consideration of the request from M/s Life Agro Chemical for endorsement of

change of factory address from Plot No 16-17, Somnath Industrial Area, Opp Railway Fatak, Gondal Road, Lothariya Rajkot, Gujarat -360022 to Plot No.20,

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Survey No.40/1, P1 Golden Industrial Estate-D, B/h Sharpar Village, Virva, Ta Lodhika Dist Rajkot-360311 in the certificate of 40 registrations of registration

Committee deliberated the agenda and approved the same except the products Dichlorvos which are banned/phased out/restricted etc subject to the deposit of the balance amount

of Rs 100/- per certificate of registration in Bharat Kosh vide the decision of the RC taken

in the present meeting vide agenda item no 3.9 Further, the RC took a serious view as

to why the applicant had applied for the above products However, the RC sternly warns the applicant not to repeat this in future

8.15 Consideration of the request from M/s Sumitomo Chemical India Pvt Ltd., for grant

of permission to use stocks having old company name i.e M/s Sumitomo Chemical India Pvt Ltd with old registered office address on label and leaflets

Committee deliberated the agenda and observed that the applicant has not mentioned the batch number, date of manufacturing, date of expiry and the quantity of the stocks for which the present request is being made Further, the RC took a serious view as to why the applicant had applied for the above products Triazophos and Phorate which are banned/phased out/restricted etc However, the RC sternly warns the applicant not to repeat this in future The applicant is required to submit a complete list of the stocks excluding the banned products with the details mentioned above

8.16 Consideration of the request from M/s Mahindra Agri Solutions for change of name

of company subsequent to the business transfer agreement between M/s Mahindra Agri Soluation Ltd., and Mahindra Summit Agri Science Ltd in respect of 147 certificate of registration

Committee deliberated the agenda and in view of the clarification submitted the RC approved the same except the products Triazophos which are banned/phased out/restricted etc subject to the deposit of the balance amount of Rs 100/- per certificate of registration

in Bharat Kosh vide the decision of the RC taken in the present meeting vide agenda item

no 3.9 Further, the RC took a serious view as to why the applicant had applied for the above products However, the RC sternly warns the applicant not to repeat this in future

8.17 Consideration of the request from M/s FMC India Pvt Ltd for endorsement of

additional factory address in the Certificate of registration Bifenthrin 10% EC with

registration No CIR-236/2003(240) –Bifenthrin(EC) -02

8.18 Consideration of the request form M/s Crop Life Science Ltd., for endorsement of

factory address in the Plot No D-2 CH/357, Dahej-II, Industrial Estate, Ta Vagra, Dist Bharuch, Gujarat

Committee deliberated the agenda and approved subject to the deposit of the balance amount of Rs 100/- per certificate of registration in Bharat Kosh vide the decision of the

RC taken in the present meeting vide agenda item no 3.9

8.19 Consideration of the request from M/s Rallis India Ltd., for endorsement of

additional factory address on the 30 Certificate of registration

Committee deliberated the agenda and approved subject to the deposit of the balance amount of Rs 100/- per certificate of registration in Bharat Kosh vide the decision of the

RC taken in the present meeting vide agenda item no 3.9

8.20 Consideration of the request from M/s FMG Agri Granules India Pvt Ltd., for

change of name of company from M/s FMG Agri Granules India Pvt Ltd., to Alchem

Agri Tech India Pvt Ltd., in respect of Acephate 75% WP vide registration

No.CIR-110354/2013-Acephate (WP) (343)-29

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Agri Tech India Pvt Ltd., in respect of Neem oil based EC containing Azadrichtin

0.03% (300 ppm) min Vide registration No.CIR-61516/2008-Azadrichtin (EC)

(294)-1259

Agri Tech India Pvt Ltd., in respect of Neem seed kernel based EC containing

Azadrichtin 0.15% (1500 ppm) min Vide registration

No.CIR-61514/2008-Azadrichtin (EC) (294)-1257

Agri Tech India Pvt Ltd., in respect of Neem extract concentrate containing

Azadrichtin 5% w/w min Vide registration No.CIR-61515/2008-Azadrichtin

(294)-1298

Agri Tech India Pvt Ltd., in respect of Bifenthrin 10% EC Vide registration

No.CIR-61344/2010-Bifenthrin (EC) (309)-90

Agri Tech India Pvt Ltd., in respect of Buprofezin 25% EC Vide registration

No.CIR-110355/2013-Buprofezin (EC) (343)-34

Agri Tech India Pvt Ltd., in respect of Cartap hydrochloride 50% SP Vide

registration No.CIR-110356/2013-Cartap hydrochloride (SP) (343)-32

Agri Tech India Pvt Ltd., in respect of Emamectin benzoate 5% SG Vide registration

No.CIR-65352/2010-Emamectin benzoate (SG) (310)-57

Agri Tech India Pvt Ltd., in respect of Ethephon 39% SL Vide registration

No.CIR-110357/2013- Ethephon (SL) (343)-9

Agri Tech India Pvt Ltd., in respect of Glyphosate 41% SL Vide registration

No.CIR-64343/2010-Glyphosate (SL) (309)-655

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Agri Tech India Pvt Ltd., in respect of Hexaconazole 5% EC Vide registration

No.CIR-110361/2013- Hexaconazole (EC) (343)-38

Agri Tech India Pvt Ltd., in respect of Imidacloprid 17.8% SL Vide registration

No.CIR-66656/2011- Imidacloprid (SL) (319)-1530

Agri Tech India Pvt Ltd., in respect of Lambda cyhalothrin 25% EC Vide registration

No.CIR-110359/2013- Lambda cyhalothrin (EC) (343)-10

Agri Tech India Pvt Ltd., in respect of Paraqueat dichloride 24% SL Vide

registration No.CIR-110363/2013- Paraquat dichloride (SL) (343)-26

Agri Tech India Pvt Ltd., in respect of Profenophos 50% EC Vide registration

No.CIR-110362/2013- Profenophos (EC) (343)-531

Agri Tech India Pvt Ltd., in respect of Thiamethoxam 25% WG Vide registration

No.CIR-110360/2013- Thiamethoxam (GR) (343)-28

Agri Tech India Pvt Ltd., in respect of Tricontanol EW 0.1% min Vide registration

No.CIR-65684/2011-Tricontanol (EW) (314)-566

Agri Tech India Pvt Ltd., in respect of Cartap hydrochloride 4% GR Vide registration

No.CIR-115173/2014- Cartap hydrochloride (GR (350)-121

Agri Tech India Pvt Ltd., in respect of Carbendazim 12% + Mancozeb 63% WP Vide

registration No.CIR-115181/2014- Carbendazim + Mancozeb (WP) (350)-198

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change of name of company from M/s FMG Agri Granules India Pvt Ltd., to Alchem Agri Tech India Pvt Ltd., in respect of Chlorpyriphos 20% EC Vide registration No.CIR-115172/2014-Chlorpyriphos (EC) (350) -177

Agri Tech India Pvt Ltd., in respect of Copper Oxychloride 50% WP Vide registration

No.CIR-115178/2014-Copper Oxychloride (WP) (350) -152

Agri Tech India Pvt Ltd., in respect of Cypermethrin 10% EC Vide registration

No.CIR-115175/2014-Cypermethrin (EC) (350)-133

Agri Tech India Pvt Ltd., in respect of Cypermethrin 25% EC Vide registration

No.CIR-115176/2014-Cypermethrin (EC) (35)-134

Agri Tech India Pvt Ltd., in respect of Mancozeb 75% WP Vide registration

No.CIR-115174/2014-Mancozeb (WP) (350)-107

Agri Tech India Pvt Ltd., in respect of Profenophos 40% + Cypermethrin 4% EC

Vide registration No.CIR-115180/2014-Profenophos + Cypermethrin (EC) (35)-124

Agri Tech India Pvt Ltd., in respect of Tricyclazole 75% WP Vide registration

No.CIR-115179/2014-Tricyclazole (WP) (35)-65

Agri Tech India Pvt Ltd., in respect of Neem extract concentrate containing

Azadrichtin 10% w/w min Vide registration No.CIR61517/2008Azadrichtin (294)

-1260

Agri Tech India Pvt Ltd., in respect of Acetamiprid 25% SP Vide registration

No.CIR-100443/2011-Acetamiprid (SP) (316)-5

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Agri Tech India Pvt Ltd., in respect of Tricontanol GR 0.05% min Vide registration

No.CIR-65683/2011-Tricontanol (GR) (314)-565

8.49 Consideration of the request from M/s Sumitomo Chemical India Ltd., for change of

name of company from M/s Sumitomo Chemical India Pvt Ltd to Sumitomo Chemical India Ltd in respect of 207 certificate of registration

Committee deliberated the agenda and approved the same except the products Triazophos, Dichlorovos and Phorate which are banned/phased out/restricted etc subject to the deposit

of the balance amount of Rs 100/- per certificate of registration in Bharat Kosh vide the decision of the RC taken in the present meeting vide agenda item no 3.9 Further, the

RC took a serious view as to why the applicant had applied for the above products However, the RC sternly warns the applicant not to repeat this in future

8.50 Closer of the case with respect to Endorsement of inclusion of additional already

approved source of import of Cartap Hydrochloride Technical 98% w/w min (for

Guidance of RC) M/s Krishi Rasayan Export Pvt Ltd

RC deliberated the agenda and approved for closure of the application

8.51 Closer of the case with respect to Endorsement of change of name of source of import

of Thiamethoxam Technical 97% w/w (for Guidance of RC) M/s Syngenta India Ltd

8.52 Closer of the case with respect to Endorsement of change of address of source of

import of Triazophos Technical 60% w/w min (for Guidance of RC) M/s SDS

Ramcides Crop Science Pvt Ltd

of Thiram Technical 95% w/w (for Guidance of RC) M/s Chemtura Chemicals India

Pvt Ltd

of Carbafuron Technical 75% w/w (for Guidance of RC) M/s Hyderabad Chemical

Ltd

8.55 Endorsement of change of name of source of import of Propineb Technical 85% w/w

min (for Guidance of RC) M/s Willowood Chemicals

RC deliberated the agenda and decided that the applicant may be asked to submit fresh application under category new source

8.56 Endorsement of change of name and address of source of import of Hexythiazox

Technical 97% w/w min (for Guidance of RC) M/s Crystal Crop Protection

RC deliberated the agenda and decided that the applicant may be asked to submit fresh application under category new source / toll manufacturing

8.57 Endorsement of application of Bio-efficacy study u/s9(3) of Buprofezin 20 + Acephate

50% WP M/s Rallis India Ltd.,

RC deliberated the agenda and approved for label claim of Buprofezin 20 + Acephate 50%

WP for thrips, jassids amd mealy bugs in cotton with cautionary statement as Buprofezin

is WHO class IV – unlikely hazardous pesticides and insect growth regulator Even though relatively safe, use of insecticides for mealy bug should be avoided to the extent possible

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Coccinellid predators Injudicious use of pesticides disturbs the eco-balance by killing

friendly insects while cotton mealy bug may not be easily affected due to presence of waxy coat enveloping the body, Acephate is toxic to fish and aquatic invertebrates and thus the product containing the molecules may be avoided near aquaculture

8.58 Application of M/s Indofil industries ltd for endorsement of retention of previous

packaging in 20 g, 100 g, 250 g, 500 g & 1 Kg Trilaminated pouches made of (12 u PET/9 u Aluminum foil /80 u polyethylene) The pouches shall be mechanically heat sealed from top bottom and vertical individual pouch shall be further packed in 3 ply E-fluted cartons as a secondary pack; whereas 5 ply CFB boxes of capacity 10 kg max shall be used as a transport pack for Mancozeb 75% WG

8.59 Application of M/s Krishi Rasayan Exports Pvt Ltd for Endorsement of additional

packing in 30gm in HDPE container which shall be further packed in 5 ply corrugated box of specification IS 2771 (Part-1) -1990 of capacity 3 kg for Dimethomorph 12% + Pyraclosrobin 6.7% WG

8.60 Application of M/s Arysta Life Science India Ltd for Endorsement for LDPE liner

of capacity 100g, 250g and 500g as primary which shall be further packed in HDPE container of same capacity as secondary packing Secondary packing shall be further packed in 5 ply CFB boxes as per IS 2771 (pt-1) 1989 as transport packing for Diflubensuron 2% Granules

8.61 Application of M/s Syngenta India Ltd for Endorsement for bulk packing of 50 kg

capacity in HDPE drum for Triasulfuron 20% WG

8.62 Application of M/s Krishi Rasayan Exports Pvt Ltd for Endorsement for alternate

packing of capacity 1 g, 5g 10 g in HDPE bottle as per IS 9754-1981 which shall be further packed in 5 ply CFB Box as per IS 2771 (part-1) -1990 for Gebberellic Acid Technical (90% w/w min)

Committee deliberated the agenda and approved subject to outcome of the findings at Agenda Item No 9.26

8.63 Application of M/s Godrej Consumers Products Ltd for Endorsement for additional

packing of refill (25 ml) in PET bottle 120 units of secondary pack cartons will be packed in 5 ply corrugated box of specification IS 2771 (part-1 ) -1990 for Transfluthrin 1.6% LV

8.64 Application of M/s Godrej Consumers Products Ltd for Endorsement for additional

packing of 1refill (25 ml) + 1 machine, 48 units of secondary pack cartons will be packed in 5 ply corrugated box of specification IS 2771 (Part-1) – 1990 as transport packing for Transfluthrin 1.6% LV

8.65 Application of M/s Godrej Consumers Products Ltd for Endorsement Alternate

packing of single tray refill in flow wrap pouches The gel mat tray is sealed on top

by vapor permeable membrane and individually packed in pouches made of (12micron PET/52 micron LDPE) 96 such pouches shall be packed in CFB boxes as per IS 2771 (pt-1) 1990 for Tansfluthrin 20% w/w MV Gel

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8.66 Application of M/s UPL ltd for Endorsement for primary packing in 25g, 250g, 500g

and 1 kg capacity in Trilaminated pouch (PET 12u/MET PET 12u/LDPE 100u) which shall be packed in CFB boxes of capacity 10kg (conforming to IS 2771(part-1) -1990 for Carbendazim 12% + Mancozeb 63% WS

8.67 Application of M/s P I Industries Ltd for Endorsement for alternate packing in

PET bottle of capacity 2000 ml conforming to IS:13123-2000 which shall be further packed in CFB boxes of capacity 10litres for Pendimethalin 30% EC

8.68 Application of M/s P.I Industries Ltd for Endorsement for alternate packaging in

PET bottle of capacity 5000 ml conforming to IS:131123-2000 which shall be further packed in CFB boxes of capacity 10 liter as per IS 2771 (pt-1) 1990 for Pendimethalin 30% EC

8.69 Application of M/s Excel Crop Care Ltd for Endorsement for additional primary

packing in 6gm trilaminated (100u-LDPE/9u aluminum foil/12u PET) pouch as primary pack such 50 pouches are packed in inner duplex carton weighting up to 300g as secondary packing such 12 inner cartons are further packed in CFB boxes of

5 ply as a transport packaging up to 3.6 kg for Fipronil 40% + Imidcaloprid 40%

WG

8.70 Application of M/s Hikal Ltd for Endorsement for alternate packaging in LDPE

liner having minimum thickness 100 micron as primary packing which shall be further packed in jumbo bag (FIBC) (polypropylene) of capacity 500 kg as secondary/transport packaging for Diuron Technical 98% min

8.71 Application of M/s BASF India Ltd for endorsement of additional pack size of 4.0

liters in HDPE container which shall be packed in CFB box of capacity 8 liters as transport packing as per IS 2771(pt-1)1990 for Bentazone 480 g/l SL

8.72 Consideration of application for endorsement of M/s Phalada Agro Research

Foundation, Bangalore for the 1st time extension of validity period of provisional

registration of Bacillus thuringensisvar var kurstaki 0.5% WP with commercialization

Sh K W Deshkar, DD (E) informed that this has already been approved earlier

8.73 Consideration of application for endorsement of M/s Subway agribiotech and

research foundation, Maharashtra for the third time extension of validity period of

provisional registration for Beauveria bassiana 1.15% WP with commercialization

This agenda has been withdrawn and it has already been deferred vide agenda item no 5.93 for the want of complete information from all the experts This is to be brought before the next RC meeting

8.74 Consideration of application for endorsement of M/s Subway agribiotech and

research foundation, Maharashtra for the third time extension of validity period of

provisional registration for N.P.V of Helicoverpa armigera 0.5% AS with

commercialization

This agenda has been withdrawn and it has already been deferred vide agenda item no 5.92 for the want of complete information from all the experts This is to be brought before

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8.75 Consideration of application for endorsement of M/s Ruchi Oyster Mushroom

Gondia (MS) for the first time extension of validity period of provisional registration

for N.P.V of Helicoverpa armigera 2.0% AS with commercialization

8.76 Consideration of application for endorsement of M/s Parle Bio Care LLP, Bahraich

(UP) for the first time extension of validity period of provisional registration for

Trichoderma viride 1.5% WP with commercialization

8.77 Consideration of application for endorsement of M/s Lotus Biotech, Bangalore for

the first time extension of validity period of provisional registration for Trichoderma

viride 1.5% WP with commercialization

the next RC meeting

8.78 Consideration of application for endorsement of M/s Director Research Services,

Indira Gandhi Krishi Vishwa Vidyalaya, Krishak Naar, Chhattisgarh for the first

time extension of validity period of provisional registration for Trichoderma viride

1.5% WP with commercialization

the next RC meeting

8.79 Consideration of request of M/s Indogulf Crop Science Ltd., for the endorsement of

Imidacloprid 17.8% SL

RC deliberated the agenda and approved for tomato

8.80 Consideration of request of M/s Meghmani Organics Ltd., for the endorsement of

RC deliberated the agenda and approved for stem borer, leaf folder and green leaf hopper

in rice and termite in sugar cane

8.82 List of online under section 9(4) endorsement file pending with

bio-efficacy(entomology) unit for want of updating of L/L from data bank

The RC noted and directed Secretariat to update the data bank with reference to approved

label claims of all registered pesticides at Annexure 8.82.1

8.83 Pending for want of data bank by NIC + MRL issue (scrutinized list) (PP division)

label claims of all registered pesticides at Annexure 8.83.1

8.84 Online endorsement files for approval

RC deliberated and decided to approve the endorsement applications as per Annexure 8.84.1 Except Sr.19

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8.85 Consideration of an application of M/s PI Industries Ltd., for grant of registration

for formulation indigenous manufacture of the product Bispyribac Sodium 10% w/v

(9.5% w/w) SC under section 9(3)

Committee deliberated the agenda and approved for grant of registration for formulation indigenous manufacture of Bispyribac sodium 10% w/w SC However, RC noticed that the instant application though received under Endorsement category cannot be granted endorsement as the application falls under the FIM vs FI category of registration u/s 9(3)

9.1 Revival of pending file of M/s Adama India Pvt Ltd of Clofentezine 42% w/w SC for

deficiency reply from applicant for more than six months

Committee deliberated the agenda and agreed to process the application

9.2 A part agenda is prepared for the file No.6128-TI/9(3)/2015-CIR-II of Clomazone

Technical (TI New Source) of M/s FMC India Pvt Ltd and File

No.6164-TI/9(3)/2015-CIR-II of Glyphosate Technical (TI New Source) of M/s Excel Crop Care

Ltd for which the deficiency replies were received after more than six months of deficiencies communicated to the applicant

Committee deliberated the agenda and agreed for further process of application as mentioned below –

S.No File

No

Applicant Name

Product Name

Date of Deficiency communicat

ed

Deficie ncy reply receive

d

Time taken

1 TI/9(3) /2015- CIR-II

6128-M/S FMC India Pvt

Ltd

Clomazone Technical(Ne

6164-M/S Excel Crop Care Ltd

Glyphosate Technical 95% Min

20-07-2017

10-05-2018

9 months

20 days

9.3 Closure of file for pending deficiency reply more than six months M/s Bayer Crop

Science for label expansion of Betacyfluthrin w/w + Imidacloprid 19.8% w/w OD

RC was apprised that no response was received even after more than 2 years of the communication of deficiency hence RC adhering to its earlier decision in 381st RC meeting

vide Agenda item 1.3 decided to reject the application

9.4 Consideration of file under category of Technical Import (New Source) – violation

CIB&RC guidelines M/s FMC India Pvt Ltd of Carbosulfan Technical 92% w/w min

RC deliberated the agenda and decided that applicant needs to submit the data as per CIB&RC guidelines for TI(New Source) if the application is not submitted within the stipulated time period from issue of RTT permit

9.5 Consideration of application for Enhancement of Shelf life under section 9(4) of the

insecticides Act, 1968

Committee deliberated the agenda and approved as per Annexure 9.5.1

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9.6 Consideration of application for import permits for multiuse insecticides (other than

Boric Acid) for non-insecticidal use

9.7 List of Endorsement files (Hard copies) pending long time for closure

Committee deliberated the agenda and agreed for closer the file as per Annexure 9.7.1 9.8 Problems being faced at the Secretariat level in execution of the decision taken by the

Registration Committee vide Agenda item No 9.21 in its 397th Meeting held on 30.01.2019 and 04.02.2019

RC directed that the matter may be setteled at Sectt level

9.9 Application for the import of sample quantity of 20 kg of F9600 Technical 96% min

coded herbicide from the overseas manufacture M/s FMC corporation

Committee deliberated the agenda and approved for import of 15 kg for RTT purpose from M/s FMC Corporation, Stine Research Centre, 1090, Elkton Road, Newark, DE19711, USA

9.10 Status of pending application (hard copy) of Paecilomyces lilacinus 1.15% WP under

section 9(3b) and 9(3) (follow up action.)

The agenda was deliberated by RC and it was decided that all the cases as detailed in the

Annexure 9.10.1are to be processed as per the guidelines approved by RC

9.11 List of online file under section 9(4) Endorsement pending with Weed Science unit of

CIB&RC for want of updating labels and leaflets from data bank

label claims of all registered pesticidesAnnexure 9.11.1

9.12 Application detailed submitted by Toxicity for closure of application of

Fenoxaprop-p-ethyl Technical 88% w/w min M/s Excel Phosphates Pvt, Ltd

RC was apprised that no response was received even after more than 1 ½ year of the communication of deficiency hence RC adhering to its earlier decision in 381st RC meeting vide Agenda item 1.3 decided to reject the application

9.13 Application detailed submitted by Toxicity for closure of application of Diafenthiuron

Technical 96% w/w min M/s Atul Ltd

9.14 Application detailed submitted by Toxicity for closure of application of Clodinafop

propargyl Technical 95% w/w min M/s Godavari Farm Chemicals Industries Ltd

9.15 Application detailed submitted by Toxicity for closure of application of Cypermethrin

Technical 95% w/w min M/s Excel Phosphates Pvt, Ltd

RC was apprised that no response was received even after more than six months of the communication of deficiency hence RC adhering to its earlier decision in 381st RC meeting vide Agenda item 1.3 decided to reject the application

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9.16 Application detailed submitted by Toxicity for closure of application of Bifenthrin

Technical 92% w/w min M/s AIMCO Pesticides, Ltd

RC was apprised that no response was received even after almost 2 years of the communication of deficiency hence RC adhering to its earlier decision in 381st RC meeting vide Agenda item 1.3 decided to reject the application

9.17 Status of application of M/s Dow Agrocsiences India Pvt Ltd Mumbai Maharashtra

for grant of registration of Methoxyfenozide Technical 96% w/w min

RC deliberated the agenda and noted that the molecule is already registered for use in the country under formulation import category The instant application is for registering Methoxyfenozide Technical 96% min w/w under section 9(3) Technical import category

RC also noted that the product is registered @ 97% w/w purity with the validity up to 31.07.2019 Therefore, applicant may be asked to make a presentation on the status of the product in the source country

9.18 Status of application of M/s Sulphur Mills Ltd of Fipronil 0.8% WG for registration

under section 9(3) formulation indigenous manufacturer as per insecticides act 1968

Committee deliberated the agenda and noted that many formulations of Sulphur are registered for use in the country containing Sulphur as active ingredient ranging from 40%

to 85% w/w In the instant application Sulphur is being used @ 90% w/w with the claim

as inert ingredient RC also deliberated that inert ingredient are expected to lack usual or anticipated biological action In view of this RC did not approve the scrutiny of file for grant of registration u/s 9(3)

9.19 List of pending online endorsement certificates of draft stage approved at the level of

Secretariat of CIB&RC

RC recalled its decision taken in its 397th meeting and observed that all the cases pertaining to the endorsement of any category shall be placed before the RC for an appropriate decision In view of above RC decided that the enclosed list of the endorsement files on the above subject shall be placed before the RC in its next meeting

vide agenda at Annexure 9.19.1

9.20 Endorsement of New /Alternate/additional packaging under section 9(4) already

approved by RC

9.21 Agenda for list of pending files online endorsement certificate as draft stage without

RC

Committee deliberated the agenda and approved as per Annexure 9.21.1 except serial No

46 & 50 for which MRL is not fixed

9.22 Report of team on verification of end use of imported boric acid by M/s Welsuit glass

& Ceramic Pvt Ltd

RC noted the report submitted by the team and approved 750 MT of Boric acid

9.23 Report of the committee for 9(4) FIM case which are pending since the formulations

are not in list of pesticides and formulations registered for use in the country under the insecticides act, 1968 updated on 31.12.2018

RC deliberated and accepted the recommendations of the report submitted by the committee RC further decided to recall the certificate of registration granted for 2,4-D

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sodium salt 80% WP issued u/s 9(4) FIM category as the product is required to be considered under 9(4) TIM category

9.24 Consideration of an application of M/s ADAMA India Pvt Ltd., for grant of

endorsement of shelf life extension for Propaquizafop Technical 91% w/w min under

section 9(3)

Committee deliberated the agenda and approved shelf life of two years for the formulation

Propaquizafop Technical 91% w/w min under section 9(3)

9.25 Consideration of an application of M/s Parijat Industries Pvt Ltd., for grant

endorsement of shelf life extension for formulation Fipronil 4% + Thiamethoxam 4%

SC under section 9(3)

Committee deliberated the agenda and approved shelf life of two years for the formulation

Fipronil 4% + Thiamethoxam 4% SC under section 9(3)

9.26 Complaint received from M/s Jiangxi New Reyphon Biochemical Co Ltd., regarding

export of Gibberellic acid Technical from China

Committee deliberated the agenda and directed Secretriat of CIB&RC to sent communication to ICAMA to verify the registration status of M/s Hunan Biological Medicine Factory, China to manufacture and export Gibberellic acid Technical

9.27 List of RTT files Ex-post facto approval

The RC noted and granted ex-post facto approval for the RTT permits issued by the Secretariat

9.28 List of bio-pesticide old files hard copy for closure

The RC noted and approved for rejectection of file at Annexure 9.28.1

10.0 Online filling of application for registration under different categories

10.1 Consideration of application u/s 9(4) FIM category received only by complete

On-line system

The Agenda was deliberated in detail & all the complete cases were approved as proposed

in Annexure – 10.1.1 of the agenda except the products covered under the Gazette Notification SO 3951 (E) dated 08.08.2018 published on 09.08.2018 RC directed the Secretariat of CIB&RC that all the cases under section 9(4) must be issued after confirming the fixation of MRL for the product It was also directed to recheck cases and should strictly follow Gazette Notification SO 3951 (E) dated 08.08.2018 published on 09.08.2018 of Ministry of Agriculture, Cooperation and Farmers Welfare while issuing

approvals

11.0 Any other item with the Permission of Chair

11.1 Issuing of the certificate of registration to M/s Crystal Crop Protection Pvt Ltd –

reg

The RC was apprised by Secretariat regarding the approval of the grant of registration of Thiamethoxam 0.9% + Fibronil 0.2% GR to the above applicant vide decision taken by the RC in its 393rd meeting held on 24.09.2018 vide agenda item No 6.2 The Certificate

of Registration is under the process of authentication Meanwhile the applicant has request

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for application for change in name and registered office address simultaneously the applicant has also submitted an application online while Computer S.No 126844 on 16.04.2019 RC desired to bring complete case regarding change of name and address before the RC in its next meeting

11.2 Consideration of applications of 9(4)FIM which are kept pending for decision /

issuance of CR in view of agenda item No 3.6 of 398th RC meeting

The pending applications under section 9(4) FIM under agenda item no 10.1.1 of earlier

RC meetings shall be considered for issue of Certificate of Registration for the formulations listed in Agenda Item No 3.6 of 398th RCmeeting as per the recommendations of the committee constituted

11.3 Requirements for extension of validity period of provisional certificate of registration

11.4 Follow up action with DGFT, The Ministry of Commerce and Industry on regulation

of multi/dual use insecticides underthe provision of Insecticides Act, 1968 and Rules

While deliberating the agenda on the judgment dated 10.09.2018 passed by Hon’ble High Court of Kerala at Ernakulam in W.A 1745 of 2018 and 1579 of 2018 it was apprised to the RC that the officers from CIB&RC visited the office of Joint D.G in Udyog Bhawan

on 18.04.2019 &22.04.2019 for the purpose of discussion and collection of information for regulating multi / dual use substances in the schedule to the Insecticides Act 1968 and Rules through notification by the DGFT being implementing authority for the Foreign Trade Policy/Import Policy under Foreign Trade Dev & Reg Act 1992 It was decided that a detailed communication in this regard be sent by the Secretariat of CIB&RC to concerned Authority in the DGFT

11.5 Suggestions of the stakeholders regarding report of the sub-committee in

implementation of crop grouping principles for extending label claims in tabular form

Committee deliberated the agenda and directed the sub-committee constituted for crop grouping under the Chairmanship of Dr K.K.Sharma for submitting revised crop grouping after reviewing the comments received from different stakeholders RC also nominated Shri.A.K.Reddy, DD(WS) as member secretary in place of Dr.Subash Kumar DD(WS)

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11.6 Suggestions of the stakeholders regarding report of the sub-committee on field

persistence studies in plant and their analytical test studies in plant samples in tabular form

Committee deliberated the agenda and directed the sub-committee already constituted for field persistence studies in plant and their analytical test studies in plant samples under the Chairmanship of Dr K.K.Sharma for submitting revised report after reviewing the comments received from different stakeholders RC also nominated Shri.A.K.Reddy, DD(WS) as member secretary in place of Dr.Subash Kumar DD(WS)

Annexure – 3.1.1

AFFIDAVIT (PROFORMA)

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