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Minutes of the 261st meeting of the Registration Committee held on 15.02.2006 at 10.00
A.M. in Committee Room No.142, Krishi Bhavan, New Delhi
The 261st meeting of the Registration Committee (RC) was held under the Chairmanship
of Dr. N.B. Singh, Agriculture Commissioner on 15th Feb. 2006 at 1000 hrs. in Krishi Bhavan,
New Delhi. Dr. P.S. Chandurkar, Plant Protection Adviser to the Govt. of India, Dr. P.N.Maji,
Addl. Industrial Adviser, Ministry of Chemicals & Petro Chemicals, Dr. T.P.Rajendran, Assistant
Director General(PP), ICAR and Dr. (Mrs.) S. Kulshrestha, Secretary, CIB&RC attended the
meeting.
Following officers from the Secretariat of CIB&RC were also present:
(i)
Dr.(Mrs.) G. Mukherjee, JD (Chem)
(ii)
Sh.Vipin Bhatnagar, Jt.Dir.(Chem.)
(iii)
Dr. Ravi Prakash, JD (Bio)
(iv)
Dr. R.M. Shukla, DD (Ent.)
(v)
Dr.Mukul Singh, Dy.Dir.(Med.)
(vi)
Dr. Subhash Kumar, Agro (H)
(vii)
Smt. Kanta Arora, AO (CIB&RC)
(viii)
Sh. D.D.Ahuja, SO
(ix)
Sh. Niraj Kulshrestha, Assistant(Legal)
At the outset the Chairman welcomed the participants and requested Secretary,CIB&RC
to take up Agenda for discussion. The following decisions were taken:
Agenda
item No.
1.0
Confirmation of minutes of the 260th
meeting of the Registration Committee
Minutes of the 260th meeting of the Registration Committee (RC were
confirmed, except for S.No.1 of Agenda Item No.4.1, as the application was not
complete from toxicity angle.
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2.0
Follow up action on the decision taken by the Registration Committee in its
260th meeting.
The Committee noted with satisfaction the follow up actions on the
decisions taken in 260th RC meeting.
2.1
Applications pending under various Sub-Sections of the Insecticides Act,
1968.
The Committee noted the receipt, disposal and pendency of applications
for registration under various sub-sections of the Insecticides Act,1968 for the
period from 1.1.06 to 31.1. 06-
2.2
Deferred items of 260th RC meeting
3.1
Revised guidelines for registration under export category.
The Members deliberated the Agenda in detail and in view of the discussions
held in the meeting with the Pesticides Industry Associations decided the following:
(i)
Verification of the import/export activities of the registrant shall be
done at random to ensure that the conditions of registration are met;
(ii)
In the
guideline of category 1, the outline of process of
manufacture shall be submitted by the indigenous manufacturer
under requirement of Chemistry.
(iii)
The import of formulation of 100% export, may be kept under a
separate category (Category 6). The guideline shall be as per
requirement of category I and category II both.
In order to fulfill the International obligations, the Committee decided to
include the following conditions on the Certificates of Registration for export and
also on all 9(3) & 9(4) registration certificates (issued for import/manufacture).
(a)
No export should take place in contravention to the provisions of
the Rotterdam Convention on prior informed consent procedure for certain
hazardous chemicals and pesticides in international trade.
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(b)
If a pesticide is banned or severely restricted in India, before
export ing such pesticide, permission from Designated National Authority
for Pesticide of the Country under Rotterdam Convention may be obtained.
3.2
Guidelines for minimum infrastructural facilities to be created by the
Manufacturers.
The Committee deliberated the Agenda in detail and decided that
the guidelines as suggested by the Expert Group may be enclosed with all
Certificates of Registration of chemical pesticides for guidance to licencing
authorities of the State Departments to issue manufacturing licences.
For Bio-
pesticides, the Committee decided that the guidelines as suggested by All-India
Biotech Association may be discussed by a Group under the Chairmanship of
Dr.T.P.Rajendran, Assistant Director General (PP), ICAR, Krishi Bhawan, New
Delhi
3.3
Guidelines for indigenous manufacture of chemicals figuring in the
Schedule for non-insecticide use.
The Committee deliberated the Agenda in detail and decided that in such
cases, the decision will be taken on case-to-case basis. Further, the Committee
decided that the Applicant, M/s Bombay Chemicals Pvt. Ltd. may be asked to
provide technical information regarding the insecticidal properties, use of PBO as
extender and anti-oxidant etc.
5.1
Consideration of application of M/s Viswa Mithra Bio Agro P. Ltd.,
Guntur for grant of registration for indigenous manufacture of
Beauveria bassiana 1.15% WP under Section 9(3B)
The Committee deliberated the Agenda in detail and approved the grant of
registration for use on rice crop only with commercialization for a period of 2 years.
5.2
Consideration of application of M/s Micoplex (India) for grant of
registration for indigenous manufacture of eauveria bassiana 1.15%
WP under Sec.9(3B).
The Committee deliberated the Agenda in detail and decided to seek the
additional information from the applicant regarding the effectiveness on larval
population in the bio-efficacy data.
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5.4
Consideration of application of M/s Viswa Mithra Bio Agro P. Ltd.,
Guntur for grant of registration for indigenous manufacture of
Verticillium Lecanii (CFU 1x 108 /gm min) (Insecticide) under
Sec.9(3B)
Approved for a period of 2 years with commercialization.
5.5
Consideration of application of M/s Viswa Mithra Bio Agro P. Ltd.,
Guntur
for grant of registration for indigenous manufacture of
Metarhizium Anisopliae (CFU 1x 108 /gm min.) (Insecticide) under
Sec.9(3B)
Approved for a period of 2 years with commercialization.
8.2
Request for endorsement of bigger size packaging of 10 litre, 20
litre capacity Aluminium drums on Certificate of Registration
No.CIR-43088/2003-Propargite (EC) (230)-4 – proposed by M/s P.I.
Industries Ltd., Udaipur.
8.3
Request for endorsement of bulk packing of 5, 10, 20 & 25 Kgs.
Capacity G.I. drums with LDPE liner of thickness not less than
0.062mm, conforming to IS: 2552: 1989 for Sulfosulfuron 75%
WG – proposed by M/s Gharda Chemicals Ltd., Mumbai
8.4
Approval of bulk packing of Monocrotophos, Dichlorvos 76%
and Quinalphos 25% EC – proposed by M/s Cheminova India
Ltd.
Endorsement of 50ml pack size in r/o Alphacypermethrin 10%
EC and Alphacypermethrin 1% + Chlorpyriphos 16% EC of M/s
Gharda Chemicals Ltd.
8.5
8.6
8.7
Request for endorsement of bulk packing of 50ml, 100ml
capacity for export only on Certificate of Registration No.CIR39681/2002-Alphacypermethrin (WP) (222)-400 – proposed byM/s
Gharda Chemicals Ltd.
AND
Request for endorsement of bulk packing of 25, 50, 100 & 200
Litres HMHDPE drums for Imidacloprid 17.8% SL – proposed by
M/s Gharda Chemicals Ltd.
These Agenda Items will be discussed in the presence of the Coopted Member (Packaging) on RC.
8.8
Endorsement of revised shelf life for 24th months in the Certificate
of Registration – request from M/s BASF India Ltd., Mumbai
Approved.
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3.0
Government Business
3.1
Co-option of member in the Registration Committee from Packaging
Discipline.
The Committee noted the nomination of Sh.Madhav Chakraborty, as a
Co-opted Member on the RC and desired that a copy of the Biodata of
Sh.Chakraborty may be obtained.
3.2
Approval of checklist for endorsement of change of name of source of
import of chemicals due to disinvestments.
Approved.
3.3
Proforma for submitting data on residue and toxicity by the applicant for
forwarding to Ministry of Health & Family Welfare for fixation of MRL.
The Committee deliberated the Agenda in detail and deferred its
decision. The Committee decided that the proposal may be discussed in the
presence of ADG(PFA), Ministry of Health & Family Welfare, who is the Co-opted
Member on RC.
3.4
Co-option of member in the Registration Committee from the Department of
Biotechnology.
The Committee deliberated the Agenda in detail and decided that the
representative from the Department of Biotechnology would be invited on need
basis.
3.5
Checklist for preliminary scrutiny of the applications for extension of
provisional registration of pesticides u/s 9(3B) endorsement of bioefficacy
claim on labels/leaflets for registration certificate u/s 9(4), change of name of
source of import, label expansion of household pesticides and revised
checklist of label expansion of pesticides u/s 9(3).
The Committee deliberated the Agenda in detail and decided that this
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Check List may be first examined by Dr.P.S.Chandurkar, PPA,, Sh.P.N.Maji,
Additional Industrial Adviser, Dr.R.M.Shukla, Dy.Director (Bio) and Dr.Subhash
Kumar, Agro(H) and may be put up to RC in its next meeting.
4.0
Export Cases
4.1
List of applications u/s 9(3) Export
Approved.
4.2
Visit to the manufacturing unit of M/s. Mahakrishna Chemical Ltd., Bharauch
for inspection of manufacturing facility, capability and establishment –
Report regarding.
The Committee deliberated the Agenda in detail and decided to issue the
Certificate of Registration for Oryzalin Tech. for indigenous manufacture for export
only after the applicant creates facilities for manufacture of pesticides for which
Certificates of Registration for export have already been issued. The applicant
may be informed accordingly.
5.0
9(3B) Cases
5.1
Consideration of application of M/s. Pest Control India Limited for extension
of provisional registration of NPV of Helicoverpa armigera 0.43%AS
The Committee deliberated the Agenda in detail and decided not to permit
the extension under Sec.9(3B). The applicant may be advised to apply for regular
registration under Sec.9(3).
5.2
Consideration of application of M/s. Pravara Agro Biotech, Ahmednagar for
grant of registration for indigenous manufacture of Pseudomonas
fluorescens 0.5% WP (CFU 2 x 108 gm/min.)
Approved for a period of 2 years with commercialization.
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5.3
Minutes of the meeting of the Expert Group under the Chairmanship of
Dr.Y.K. Gupta to consider the simplification of toxicity data requirements for
registration of Forchlorfenuron (CPPU) in favour of M/s. Omega Fine
Chemicals, Mumbai held on 13th Jan. 2006.
The Committee discussed the recommendations of the Expert Group in
detail and accepted the same.
5.4
Consideration of application of M/s. R.B. Herbal Agro, Caugon Satara, Nasik
for grant of registration for indigenous manufacture of Pseudomonas
fluorescens 0.5% WP (CFU 2 x 108 gm/min.)
Approved for a period of 2 years with commercialization.
5.5
Consideration of application of M/s. Jai Biotech Industries, Satpur, Nasik for
grant of registration for indigenous manufacture of Pseudomonas
fluorescens 0.5% WP (CFU 2 x 108 gm/min.)
Approved for a period of 2 years with commercialization.
5.6
Consideration of application of M/s. Institute of Natural Organic Agriculture,
Pune for grant of registration for indigenous manufacture of Trichoderma
Viride 1% WP.
Approved for a period of 2 years with commercialization.
6.0
9(3) cases
6.1
Consideration of application of M/s. FMC India Pvt. Ltd., Bangalore for grant
of registration for indigenous manufacture of Bifenthrin 2.5%EC, formulation
(Insecticides) for termite control.
The Committee deliberated the Agenda in detail and decided that the
file may be put up to the Chairman,RC for perusal and decision.
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6.2
Consideration of application of M/s. Syngenta India Ltd., Mumbai for grant of
registration for indigenous manufacture of Thiamethoxam 30% FS,
formulation (suspension concentrate for seed treatment) (Insecticides).
Approved.
6.3
Consideration of application of M/s. Gharda Chemical Ltd,, Mumbai for grant
of
registration for indigenous manufacture of Piroxofop – propinyl
(Clodinafop propargyl) technical (Herbicide).
Approved.
6.4
Consideration of application of M/s. Syngenta India Ltd, Mumbai for grant of
registration for import of Metalaxyl – M technical and indigenous
manufacture of its formulation (Metalaxyl M 4% + Mancozeb 64% WP
(Fungicide).
Approved, subject to fixation of tolerance limits by the Ministry of
Health & Family Welfare.
6.5
Presentation by the applicant on application of Tebuconazole 25.9%.
The Committee deliberated the Agenda in detail but did not approve
the registration in absence of enough supportive measures suggested.
6.6
Consideration of application of M/s. Bahar Agro Chem. & Feed Pvt. for grant
of registration for indigenous manufacture of Pyrithiobac Sodium technical
and its formulation of 10% EC (Herbicide)
The Committee deliberated the Agenda in detail and observed that there
are phytotoxicity in all the studies and therefore the applicant may be asked to
provide justifications for safe use of this pesticide w.r.t. to phytotoxicity. Further, it
may be confirmed that the Radiotracer Laboratory in Kerala Agricultural University,
Thrishoor is duly recognized by BARC for undertaking such studies.
6.7
Consideration of application of M/s. Syngenta India Ltd., Mumbai for grant of
registration for indigenous manufacture of Metalaxyl M 31.8% ES
(Fungicide).
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The Committee deliberated the Agenda in detail and decided that the
applicant may be asked to submit data on persistence in water.
6.8
Consideration of application of M/s. Rotam India Ltd, Mumbai for grant of
registration for import of Flumite technical and indigenous manufacture of
its 20% SC formulation.
The Committee deliberated the Agenda in detail and approved
registration of Flumite Tech. And its indigenous manufacture of 20%SC formulation
for use on tea only. Regarding label claims for Brinjal, the Committee was of the
opinion that the waiting period of 10 days prescribed is too long and, therefore, did
not approve.
6.9
Presentation of M/s. United Phosphorus Limited for allowing Cypermethrin
3% Smoke Generator for general use.
The Committee deliberated the Agenda in detail and decided to
maintain the statusquo w.r.t. to use of this pesticide, i.e. its use through Pest
Control Operators (PCOs) only.
7.0
9(4) Cases
7.1
List of applications for registration u/s 9(4)
Approved the applications which were complete and for which MRLs
are fixed, partially fixed or not required.
7.2
Consideration of application of M/s. Punjab Chemicals and Crop Protection
Ltd., Chandigarh for grant of registration of Triazophos Liquid Concentrate
for indigenous manufacture.
Approved.
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7.3
Consideration of application of M/s. Gharda Chemicals Ltd., Mumbai for
grant of registration of Cartap Hydrochloride technical for indigenous
manufacture.
Approved.
7.4
Consideration of application of M/s. Crystal Phosphates Ltd., Delhi for grant
of registration of Sulfosulfuron technical for indigenous manufacture.
Approved.
7.5
Consideration of application of M/s. Artee Graphite Pvt. Ltd., Faridabad for
grant of registration of Imidacloprid technical for indigenous manufacture.
Approved.
7.6
Consideration of application of M/s. Sudama Chem-Tech Pvt. Ltd., Vadodara
for grant of registration of Thiram Technical for indigenous manufacture.
Approved.
8.0
Miscellaneous Items
8.1
Bulk packing for d-trans allethrin Mosquito Coils – Proposed by M/s. Bharat
Box Factory, Ltd. Ludhiana.
AND
8.2
Endorsement of M.S. Drum for bulk packing of 25 lit. & 50 Lit. capacity of
Tirazophos 35 + Deltamethrin 1% EC and Chlorpyrifos 16% +
Alphacypermethrin 1% EC – Proposed by M/s. Gharda Chemicals Limited,
Mumbai.
Deferred, these will be discussed in the presence of Co-opted
Member of Packaging.
8.3
Ex-post-facto approval for import permits issued
Approved.
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8.4
Consideration of Extension of Bioefficacy claim of Imidacloprid 70% WS in
favour of M/s Bayer Crop Science Ltd., Mumbai.
Approved.
8.5
Consideration of request of M/s. Sri Biotech, Hyderabad for endorsement of
Shelf life of 1 year in the CR of their products – Trichoderma viride 1% WP,
Pseudomonas fluorescens 0.5% WP and Beaveria bassiana 1.15% WP.
Approved.
8.6
Import of sample quantity of Abamectin 1.8% by M/s. Cheminova India Ltd.,
Approved.
8.7
Consideration of extension of Bioefficacy claim of Deltamethrin 10% EC
(11% EC w/w ) in favour of M/s. Bayer Crop Science, Mumbai.
Deferred. ADG(PP) may be requested to provide comments within 10
days after the receipt of minutes so that the Agenda could be put up in the next
meeting of RC.
8.8
Issue of import permit for Boric Acid & Other substances for non-insecticidal
use.
The Committee deliberated the Agenda in detail and decided to issue
import permit for 100MT of Boric Acid to M/s Futura Chemicals, Ahmedabad,
subject to the verification of records by the Chairman,RC. Further,the Committee
did not approve the request for import of Boric acid of M/s Zirconia Cera Tech.
Glazes, Mehsna, Gujarat in the absence of recommendations
from the Nodal
Ministry. The Committee approved the issue of import permit of 300MT of Sodium
Cyanide to M/s Hutti Gold Mines, Karnataka. The Committee expressed concern
on the issue of import of boric acid being continued without valid permit by a
number of importers. It was decided to verify the matter from the office of Member,
Customs.
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8.9
Approval of protocol
Approved.
9
Any other item with the permission of the Chair.
As a follow up action on the minutes of 260th RC meeting under Item
No.9(iii), the Committee constituted the following Group:
(i)
Dr. T.P.Rajendran
Asstt. Director General (PP), ICAR
Krishi Bhavan, New Delhi
…
(ii)
Dr.P.S.Chandurkar, PPA
Dte of PPQ&S, Faridabad
(iii)
Dr. Seema Wahab, Adviser ( or its nominee)
Deptt. of Biotechnology, CGO Complex
Lodi Road, New Delhi
(iv)
Dr. Amerika Singh, Director (or its nominee)
National Centre for IPM
Lal Bahadur Shastri Building
IARI, New Delhi-110012
(v)
Dr.(Mrs.) S. Kulshrestha
Secretary,CIB&RC, Dte. of PPQ&S
Faridabad
(vi)
Dr. R.J. Rabindra
Project Director, Project Directorate of
Biological Control, HA FARM PO
Bangalore-560024, Karnataka
(vii)
Dr. T. Marimuthu, Director
Centre for Plant Protection Studies
TNAU, Coimbatore, Tamil Nadu-641003
(viii )
Dr. Subhash Kumar, Agro (H)
Dte. of PPQ&S, Faridabad
Chairman
… Member-Secy.
The Terms of Reference of the Committee are as under:
(a)
To review the guidelines for registration of Biopesticides; and
(b)
Minimum infrastructural facilities for issue of licences
by the State authorities for the Manufacturing Units of
various bio-pesticides.
The meeting ended with a vote of thanks to the Chair.
****
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