Consideration of application of M/s Mitsu Ltd., Vapi under Section 9

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Minutes of the 240th Meeting of the Registration Committee held on 4.11.2003
at 2.30 PM. in Committee Room 142, Krishi Bhavan, New Delhi
The 240th meeting of the Registration Committee (RC) was held
under the Chairmanship of Dr. C.D. Mayee, Agriculture Commissioner on
4.11.2003 at 2.30 PM. in Committee Room No. 142, Krishi Bhavan, New Delhi.
Dr. P.S. Chandurkar, PPA to the Govt. of India, Shri P.N. Maji, Joint Industrial
Adviser, Department of Chemicals & Petrochemicals and Shri Y.Tsering
Secretary, CIB & RC, members of the Committee attended the meeting.
The following Officers from the Sectt. of CIB & RC were also present in the
meeting:
1.
2.
3.
4.
6.
7.
8.
9.
Dr. R.B.L. Bhaskar, JD(Bio)
Dr. Brajendra Singh, Ento (I)
Shri Vipin Bhatnagar, JD(Chem.)
Er. S.K. Ghosh, DD (Engg.)
Dr. B.S. Phogat, DD (Weed Science)
Smt. Kanta Arora, A.O. (CIR)
Shri Balbir Singh, SO
Shri Neeraj Kulshrestha, Assistant (Legal)
Agenda Item
No 1.0
Confirmation of the minutes of the
Registration Committee.
239th
meeting of the
While confirming the minutes of the 239th meeting, the Secretary
Registration Committee apprised the contents of the letters No.
P.15023/16/2003-PH (Food) dated16.10.2003 (annexed), received in the
Secretariat of CIB&RC on 27.10.2003 regarding fixation of MRLs for
Hexaconazole 2% EC from Dr. S.R. Gupta, ADG (PFA), Ministry of
Health & Family Welfare, a co-opted member on the Committee. The
Committee was apprised that Hexaconazole technical and Hexaconazole
5% EC were already registered about 10 year back. Hexaconazole 5% EC
is approved for used on apple, rice, groundnut, mango, soybean and tea
crops. Recently Hexaconazole 5% SC has also been approved for use on
mango and rice crops.
2.
The Committee observed that Dr. S.R. Gupta was co-opted on the
Registration Committee on the advice of the Ministry of Health & Family
Welfare since October 2000 to provide input relating to pesticide residues.
Since his co-option, 37 meetings of the Committee have been held. Out of
these, he has attended only 6 meetings and the last meeting which he
attended was 221st. The Committee takes consensus decisions after
taking the views of all the members present. Being co-opted member of
the Committee, it is desirable that he attends the meetings regularly and
provide his input during the deliberations of the Committee. Problems if
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any, can be sorted out during the meetings itself instead sending comments
after decisions have been taken by the Committee
In view of the foregoing, the Committee decided not to take any
cognizance of the letter received from Dr. Gupta and decided that a
suitable communication may be sent to the Secretary, Ministry of Health
& Family Welfare with the request to advise the co-opted member - a
representative of the Ministry for attending the meetings of the RC on
regular basis so to enable the Committee to take balance decisions
Agenda Item
No 2.0
Follow –up action on the decisions taken by the Registration
Committee in its 239th meeting.
The Committee perused the follow-up action taken by the
Secretariat and advised that elaborate action taken may be brought up in
the next meeting of the Registration Committee.
Agenda Item
No 2.1
Applications pending under various Sections of the Insecticides Act,
1968
The Committee noted the pendency under various SubSections of Section 9 of the Act with satisfaction
Agenda Item Government Business
No 3.0
Agenda Item Acceptance of data generated at Institute of Pesticide Formulation
No 3.1
Technology (IPFT) on bio-efficacy parameters.
The Registration Committee deliberated the agenda and decided
that a Committee headed by the Chairman of the Registration Committee
will visit IPFT, Gurgaon together with Dr. P.S. Chandurkar, PPA to the
Government of India, Shri. P.N. Maji, Joint Industrial Adviser,
Department of Chemicals & Petrochemicals and Shri Y, Tsering,
Secretary, CIB&RC to assess the facilities available for generation of data
on bio-efficacy in the Institute.
.
Agenda Item Restriction on use of Monocrotophos.
No 3.2
The Committee deliberated the agenda and decided to defer the
agenda in view of non-availability of input in the discipline of toxicology.
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Agenda Item Clarification on issue of Certificates of Registration in respect of 2,4No 3.3
D Sodium Salt 80% WP
The Committee deliberated the agenda and decided that
Certificates of Registration under Section 9(4) may be issued as per the
existing norms.
Agenda Item Guidelines for permission to liquidate stocks of pesticides and their
No 3.4
formulations and packaging material – Consequent to change of
name of manufacturer / merger of manufacturing companies.
Approved as proposed.
Agenda Item Export cases
No. 4.0
Agenda Item The applicants as per details at Annexure 4.1 have applied for grant
No 4.1
of registration of the already registered technical / formulation
having the same, lower and higher concentration / new concentration
for export under Section 9(3)
Approved.
Agenda Item
No. 5.0
9 (3B) Cases
Agenda Item Consideration of application of /s Ajay Biotech Limited for grant of
No. 5.1
extension of two years of Bacillus thuringiensis vs. Kurstaki 7.5%
WP for data generation for existing registration under Section 9(3B).
The Committee deliberated the agenda and decided to grant
provisional registration which will be valid for one year with
commercialization. The applicant shall be required to submit
application on Form-I alongwith requisite fee.
Agenda Item Consideration of request of M/s BMR, Pune for grant of
No. 5.2
commercialization of their product neem oil based EC containing
Azadirachtin 0.15% min.
The Committee deliberated the agenda and reiterated its earlier
advice given to M/s BMR & Co. while granting provision registration in
its 186th meeting and further extension for one year in its 235th meeting
held on 19.5.2003 that the applicant should generate data on various
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identified parameters and submit the same for consideration of their
application for commercialization.
Agenda Item Action taken report of Agenda item no. 5.1 B(iii) of 239th meeting of
No. 5.3
Registration Committee.
The Committee deliberated the agenda and decided that the
Chairman RC alongith PPA and Secretary CIB&RC shall visit Secretariat
of CIB&RC to examine certain files relating to registration of biopesticides which have been filed on the data dossiers provided by TNAU /
ICAR.
Agenda Item
No. 6.0
9 (3) Cases
Agenda Item Consideration of application of M/s Gharda Chemical Ltd. for grant
No. 6.1
of registration for indigenous manufacture of Fipronil technical
under Section 9(3)
Approved.
Agenda Item Consideration of application of M/s FMC India Pvt. Ltd. for grant of
No. 6.2
registration for import of Bifenthrin technical and indigenous
manufacture of its 10% EC & 10% WP formulations under Section
9(3)
The Committee noted the contents of the letter dated
3.11.2003, addressed to Chairman, R.C. from Dr. S.P. Gupta, ADG
(PFA) (copy enclosed). As per decision of RC taken in its 222nd
meeting, a set of information on prescribed proforma dully filled
up by the applicant has been sent to ADG (PFA), Ministry of
Health & Family Welfare, New Delhi on dated 30.07.2003 for
working out MRL under the PFA Act. After due deliberation the
Committee approved the case. The Committee also decided to
send reply to Dr. Gupta.
Agenda Item Consideration of application of M/s EID Parry for grant of
No. 6.3
registration for import of Benfuracarb technical and of its
formulations viz. 3% Gr. & 40% EC for indigenous manufacture
under Section 9(3)
The Committee noted the contents of the letter dated
3.11.2003, addressed to Chairman, R.C. from Dr. S.P. Gupta, ADG
(PFA) (copy enclosed). As per decision of RC taken in its 222nd
meeting, a set of information on prescribed proforma dully filled
up by the applicant has been sent to ADG (PFA), Ministry of
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Health & Family Welfare, New Delhi on dated 30.07.2003 for
working out MRL under the PFA Act. After due deliberation the
Committee approved the case. The Committee also decided to
send reply to Dr. Gupta.
Agenda Item Consideration of application of M/s BASF India Ltd. for grant of
No. 6.4
registration for import of Dimethomorph technical and indigenous
manufacture of its 50% WP formulation under Section 9(3)
Approved.
Agenda Item Consideration of application of M/s Tagros Chemical Ltd. for grant
No. 6.5
of registration for indigenous manufacture of Deltamethrin technical
under Section 9(3)
Approved.
Agenda Item Applications for registration under Section 9(4)
No. 7.0
Agenda Item A statement showing the cases under Section 9(4) complete from
No. 7.1
chemistry angle may be seen at Annexure 7.1
Approved.
Agenda Item Consideration of application of M/s Tagros India Ltd., Chennai
No. 7.2
under Section 9(4) for grant of registration of Imidacloprid technical
for indigenous manufacture
Approved.
Agenda Item Consideration of application of M/s Mitsu Ltd., Vapi under Section
No. 7.3
9(4) for grant of registration of Imidacloprid technical for indigenous
manufacture
Approved.
Agenda Item Consideration of application of M/s EID Parry (India) Ltd., Chennai
No. 7.4
under Section 9(4) for grant of registration of Alphamethrin
technical for indigenous manufacture
Approved
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Agenda Item Consideration of application of M/s EID Parry India Ltd., Chennai
No. 7.5
under Section 9(4) for grant of registration of Profenophos technical
for indigenous manufacture
Approved.
Agenda Item Miscellaneous items
No. 8.0
Agenda Item A statement showing the endorsement cases which are complete from
No. 8.1
all disciplines may be seen at Annexure 8.1
Approved.
Agenda Item HDPE woven sacks packaging system for transportation of
No. 8.2
Carbendazim 12% + Mancozeb 63% WP from manufacturing plant
to the repacking plants – proposed by M/s Indofil Chemicals
Company, Mumbai
.Approved.
Agenda Item HDPE woven sacks packaging system for transportation of
No. 8.3
Metalaxyl 8% + Mancozeb 64% WP (Matco 8-64 72%) WP from
manufacturing plant to the repacking plants – proposed by M/s
Indofil Chemicals Company, Mumbai
Approved.
Agenda Item Label expansion of Difenoconazole 25% EC for use on chilli for the
No. 8.4
control of die-back and fruit rot diseases and on rice for the control
of sheath blight disease by M/s Syngenta India Ltd., Mumbai.
Approved.
Agenda Item Expansion of label & leaflet claims of Propiconazole 25% EC on
No. 8.5
banana for the control of Sigatoka leaf spot and on coffee for the
control of leaf rust by M/s Syngenta India Ltd., Mumbai.
Approved.
Agenda Item Application of M/s Jaishree Agro Industries Ltd., Delhi for import of
No. 8.6
sample quantity of Abamectin technical for the tests and trials
purpose.
While deliberating the agenda, the Committee observed that M/s
Jayshree Agro Industries Ltd. not only imported technical from non-
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permitted manufacturer but also distributed the material for data
generation Therefore, RC decided that data generated with this material
imported from non-permitted manufacturer will not be valid for
registration purpose. The Committee also decided that the applicant may
submit fresh request on prescribed form for approval of the Committee
for import of sample quantity from specified manufacturer for data
generation.
Agenda Item Enhancement of Shelf Life.
No. 8.7
The Committee deliberated the agenda in detail and endorsed the
enhancement of shelf life of the products as proposed in the agenda.
Any other item
The Committee took note of the representation made by M/s
Willowood Agro Chem Pvt. Ltd., Bikaner for registration of Acetamiprid
technical file no. (i) 18-TI/9(3B)/02, Acetamiprid 3% EC, (ii) file No.
21-F/9(3)/02 and Abamectin 1.9% EC, (iii) file no. 5-FI/9(3B)/03. The
Committee decided that these applications may be scrutinized on priority
and status of the data submission may be put up in the next meeting for
consideration
2.
The Committee decided to hold next meeting of the Committee on
rd
3 December, 2003..
The meeting ended with a Vote of Thanks to the Chair.
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