Minutes of the 254th meeting of the Registration Committee held on 30th
June,2005 in Committee Room No.139, Krishi Bhavan, New Delhi
The 254th meeting of the Registration Committee (RC) was held under the
Chairmanship of Dr. N.B. Singh, Agriculture Commissioner on 30th June,2005 at 1030 hrs. in
Krishi Bhavan, New Delhi. Dr. P.S. Chandurkar, Plant Protection Adviser to the Govt. of
India, Dr. O.P. Dubey, Assistant Director General, ICAR, 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,Jt.Dir.(Chem.)
(ii)
Sh.Vipin Bhatnagar, Jt.Dir.(Chem.)
(iii)
Dr. Ravi Prakash, JD (Bio)
(iv)
Dr. R.M. Shukla, DD (Ent.)
(v)
Dr. (Mrs.) Mukul Singh, DD (Med.)
(vi)
Dr. Subhash Kumar, Agro (H)
(vii)
Smt. Kanta Arora, AO (CIB&RC)
(viii)
Sh. Rajmant Singh, Section officer
(ix)
Sh. Niraj Kulshrestha, Assistant Legal
Since the quorum was not complete, therefore, the meeting was adjourned
for half an hour and reconvened at 1100 hrs. to transact the business.
At the outset, the Chair welcomed the participants and requested
Secretary,CIB&RC to take up the Agenda for discussion. Following decisions were
taken:
Agenda
Item
No.1.0
Confirmation of minutes of the 253rd meeting of the Registration
Committee.
The minutes of the 253rd meeting of the Registration Committee
(RC) were confirmed.
Agenda
Item
No.2.0
Follow-up action on the decisions taken by the Registration
Committee in its 253rd meeting.
The Committee noted the follow up actions on the decisions of the
RC with satisfaction. Secy.,CIB&RC apprised that as per the decision
taken during 253rd meeting under Agenda Item No.8.2, the applicant
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has been called to make presentation to justify change in the weight of
the chalk Accordingly, presentation was made by the applicant who
informed that since the chemical composition will remain the same and,
therefore, alternate packaging will not alter the efficacy or toxicity.
However, by doing so they intend to provide more quantity at
reasonable price and also protection from duplication,
as a special
mode has to be developed for the same. The Committee after detailed
deliberations approved the applicant’s request for endorsement of
change in length and weight of the chalk upto 9.5cm. and 20gm.,
respectively.
Agenda
Item
No.2.1
Application pending under various Sub-sections of the
Insecticides Act,1968.
The Committee appreciated the efforts of the Secretariat of
CIB&RC in clearing the pendency of registration applications.
Agenda
Item
No3.0
Government Business
Agenda
Item
No3.1
Review of various pesticides which are banned in other countries but
are being used in India.
The Committee approved the Terms & Reference of the Expert Group
as per Agenda.
Agenda
Item
No3.2
Recommendation of expert group for fixing guidelines for the
minimum inftrastructural facilities to be created by the manufacturer
of pesticides and their formulations to meet the requirements for
issue of licence by respective State Govt.(Licencing Authority)
The Committee was apprised that the comments of the All India
Biotech Association has been received informing that the suggested
parameters are not applicable for biopesticides.
In view of this, the
Committee approved the guidelines for minimum infrastructural facilities for
chemical pesticides and desired that the Association may be asked to
submit the minimum infrastructural facilities required for the manufacture of
biopesticides for deliberation by the RC.
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Agenda
Item
No3.3
Revised guidelines for registration under export category –
recommendation of the Group constituted by Registration Committee
to review the guidelines for registration of pesticides and its
formulations for export purpose.
Approved. (Agenda Item No.4.6 is Item No.3.3 of the Minutes).
Agenda
Item
No.4.0
Export Cases
Agenda
Item
No.4.1
Applications u/s 9(3) for export only as per details given in Annexure4.1
Approved.
Agenda
Item
No.4.2
Application of M/s United Phosphosrus Ltd, Vapi for grant of
registration for indigenous manufacture of Metamitron 70% WDG
(Herbicide)
Approved.
Agenda
Item
No.4.3
Application of M/s Gujarat Agrochem Ltd, Panoli for grant of
registration for indigenous manufacture of Metamitron 70% WDG
(Herbicide)
The applicant may be asked to provide the details of the internet source
for toxicity.
Agenda
Item
No.4.4
Application of M/s Punjab Chemicals & Pharmaceuticals Ltd, Vapi for
grant of registration for indigenous manufacture of Ametryn Technical
and its 80% WP formulation (Herbiocide)
Approved under Sec.9(3B) for a period of 2 years.
Agenda
Item
No.4.5
Application of M/s Bharat Rasayan Ltd, for grant of registration of
Oryzalin Technical
The Committee deliberated the Agenda in detail and deferred in view
of the information on carcinogenicity. The Committee decidedto seek the
registration status of
Oryzalin in other countries and also to put up
information to the Committee if any registration of this product for export is
permitted earlier along with the information submitted by the applicant on
carcinogenicity.
Agenda
Item
No.4.6
Transferred to Item No. 3.3
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Agenda
Item
No.4.7
Application of M/s Aimco Pesticides Ltd, Mumbai for grant of
registration for indigenous manufacture of Triclopyr Butoxy Ethyl
Ester 32% EC (Herbicide) u/s 9(3) for export only.
Approved.
Agenda
Item
No.4.8
Application of M/s Sumitomo Chemical India Pvt. Ltd, Mumbai for
grant of registration for import of Fenitrothion 20% CS (Micro
encapsulated suspension) (Insecticide) u/s 9(3) for export only.
Approved.
Agenda
Item
No.4.9
Consideration of application of M/s Aimco Pesticides Ltd., Mumbai
for grant of registration for indigenous manufacture of Fluroxypyr
Meptyl Ester 26.2% EC (Herbicide) under Section 9(3) for export only.
Approved.
Agenda
Item
No.4.10
Application of M/s United Phosphosrus Ltd, Vapi for grant of
registration for indigenous manufacture of Sodium Acifluorfen
Techncial (Herbicide) u/s 9(3) for export only.
The application was deliberated in detail and deferred in view of the
information on mucous membrane irritation and carcinogenicity submitted
by the applicant, the Committee did not approve the application due to its
toxicity of mucous membrane and carcinogenicity.
Agenda
Item
No.4.11
Application of M/s Atul Ltd, Gujarat for grant of registration for
indigenous manufacture of Tribenuron Methyl Techncial (Herbicide)
u/s 9(3) for export only.
Approved.
Agenda
Item
No.4.12
Chemicals Ltd, for grant of registration for indigenous manufacture of
Triclopyr Butotyl Ester 600 g/ 1 EC (Herbicide) u/s 9(3) for export only.
Approved.
Agenda
Item
No.5.0
9(3B) Cases
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Agenda
Item
No.5.1
Application of M/s Sheer Agro Bio-Fertilizer Creative Organization,
Purba Medinipur (WB) for grant of registration for indigenous
manufacture of Tricoderma Viridi 1% WP u/s 9(3b)
Approved for a period of 2 years with commercialization.
Agenda
Item
No.5.2
Application of M/s Central Bio Tech, Nagpur for grant of registration
for indigenous manufacture of Tricoderma Viridi 1% WP u/s 9(3b).
Approved for a period of 2 years with commercialization
Agenda
Item
No.5.3
Application of M/s Indore Biotech Inputs & Research (P) Ltd, Indore
for extension of validity of Registration Certificate for provisional
registration of Tricoderma Viridi WP
Approved for a period of 2 years with commercialization.
Agenda
Item
No.5.4
Application of M/s Yash Krishi Takniki Ewam Vigyan Kendra,
Allahabad for grant of registration for indigenous manufacture of
Trichoderma Viride 1% WP u/s 9(3b).
Approved for a period of 2 years with commercialization.
Agenda
Item
No.5.5.
Consideration of application of M/s K.N. Bio Tech Pvt Ltd., Hyderabad
for grant of registration for indigenous manufacture of Trichoderma
Viride 1% WP under Section 9(3B)
Approved for a period of 2 years with commercialization.
Agenda
Item
No.5.6
Application of M/s Modern Biotech, Jalgaon (MS) for grant of
registration for indigenous manufacture of Trichoderma Viride 1% WP
u/s 9(3b).
Approved for a period of 2 years with commercialization.
Agenda
Item
No.5.7
Application of M/s Amit Bio Tech. Kolkata for grant of registration for
indigenous manufacture of Trichoderma Viride 1% WP u/s 9(3b)
Approved for a period of 2 years with commercialization.
Agenda
Item
No.6.0
9(3) Cases
NIL
Agenda
Item
No.7.0
9(4) cases
Agenda
Item
No.7.1
Applications for registration under Section 9(4)
The Committee approved the applications for which MRL is fixed, not
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required or partially fixed.
Agenda
Item
No.7.2
Application of M/s Bhagiradha Chemicals and Industries
Ltd,
Hyderabad u/s 9(4) for grant of registration for indigenous
manufacture of Lambdacyhalothrin Technical.
Approved.
Agenda
Item
No.7.3
Application of M/s Punjab Chemicals & Pharmaceuticals Ltd,
Chandigarh for grant of registration for indigenous manufacture of
Metribuzin Technical
Approved.
Agenda
Item
No.7.4
Application of M/s Bhagiradha Chemicals and Industries
Ltd,
Hyderabad u/s 9(4) for grant of registration for indigenous
manufacture of Acetamiprid Technical
Approved.
Agenda
Item
No.7.5
Application of M/s United Chemicals, Hyderabad u/s 9(4) for grant of
registration for indigenous manufacture of Ethephon Technical
Approved.
Agenda
Item
No.7.6
Application of M/s India Pesticides Ltd, Lucknow u/s 9(4) for grant of
registration for indigenous manufacture of Chlorpyriphos Technical
Approved.
Agenda
Item
No.7.7
Application of M/s Acme Organics P. Ltd. For registration of
Cyphenothrin 5% EC u/s 9(4)
Approved.
Agenda
Item
No.7.8
Application
of
M/s
Insecticides
India
Ltd,
Delhi u/s 9(4) for grant of registration for indigenous manufacture of
Acetamiprid Technical
Approved.
Agenda
Item
No.7.9
Application of M/s Parijat Agencies, New Delhi u/s 9(4) for grant of
registration for indigenous manufacture of Thiamethoxam Technical.
Approved.
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Agenda
Item
No.7.10
Application
of
M/s
Khard
Soaps
Private
Ltd,
Jhansi u/s 9(4) for grant of registration for indigenous manufacture of
Pyrethrum 2% Extract.
Approved.
Agenda
Item
No.7.11
Application
of
M/s
Insecticides
India
Ltd,
Delhi u/s 9(4) for grant of registration for indigenous manufacture of
Imidacloprid Technical.
Approved.
Agenda
Item
No.8.0
Miscellaneous Items
Agenda
Item
No.8.1
List of endorsement cases
Agenda
Item
No.8.2
Application of M/s Syngenta Crop Protection P. Ltd for endorsement
of new packaging system (HDPE-Portapac) for Paraquat dichloride
24% SL
Approved.
While deliberating the agenda in detail, Secy.,CIB&RC informed that
the applicant has requested to permit them to make presentation to the
Members of the Committee about the benefits of new packaging system.
The Committee decided to call the applicant to make presentation in the
next meeting.
Agenda
Item
No.8.3
Approval of bulk packaging of Monocrotophos 36% SL, Dichlorovos
76% EC and Quinalphos 25% EC – Proposed by M/s Cheminova India
Ltd., Mumbai
Deferred.
The applicant may be asked to submit the relevant rules
under Central Motor Transport Act,1989 for bulk transportation for
hazardous chemicals.
Agenda
Item
No.8.4
Alternate packing of Carbendazim 12% + Mancozeb 63% WP –
Proposed by M/s United Phosphorus Ltd, Mumbai.
Deferred.
The Committee decided to obtain the comments on the
feasibility of the proposed packaging of the product by the Indian Institute
of Packaging.
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Agenda
Item
No.8.5
Alternate packaging system for packing Alphacypermethrin 10% EC –
Proposed by M/s HIL, New Delhi
Approved.
Agenda
Item
No.8.6
Alternate packaging of Propoxur 0.5% + Cyfluthrin 0.025% WW spray
– Proposed by M/s Aero Industries, Mumbai
Approved
Agenda
Item
No.8.7
. Alternate packaging system for packing of Imidaclorprid 17.8 SL Proposed by M/s Insecticides Ltd., New Delhi.
Approved.
Agenda
Item
No.8.8
Additional packaging for prallethrin 1% Liquid Vaporiser proposed by
M/s Icon Household Products P. Ltd.
Approved.
Agenda
Item
No.8.9
Ex-post facto approval for import permits issued
Agenda
Item
No.8.10
Permission to use stocks of M/s Dow Agro Science India Pvt. Ltd. In
the old name of M/s De-Nocil Crop Protection Pvt. Ltd.
Approved.
Approved.
Agenda
Item
No.8.11
Consideration of extension of Bioefficacy claim of Acetamiprid 20%
SP in favour of M/s De-Nocil Crop Protection, Mumbai
The Committee deliberated the Agenda in detail and in view of the
recommended harvesting interval of 7-10 days on Okra which in the
opinion of the Committee is not feasible to be observed and rejected the
extension of claim on Okra crop.
Regarding Cabbage, the Committee
decided to re-examine the data with reference to the time of application of
pesticide and put up to the Committee for consideration.
Agenda
Item
No.8.12
Application of M/s Balaji Pest Control, Delhi for endorsement of
additional manufacturing unit (Lian Yun Gang Dead Sea Bromine
Compounds Co. Ltd., China for import of Methyl Bromide Technical.
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Approved.
Agenda
Item
No.8.13
Approval of Protocols
Approved.
Agenda Item
No 9
Any other item with the permission of the Chair.
1. Protocol regarding toxicity to livestock
(field
Hexaconazole 0.2% dust of M/s Rallis India Limited.
trials)
for
The Committee noted the submission of the applicant that the
parameters as suggested by the Committee regarding glucose
estimation will be performed by the applicant. However, it may not be
possible to assess the respiratory parameters (FEVI, FVC ration, PEFR,
etc. in cattle in field conditions. Accordingly, the Committee approved
their
request
for
deleting
the
respiratory
parameters
for
observation/investigation in cattle.
2. Label expansion under Section (4)
The Committee was apprised that in its 243rd RC meeting held on 2nd
April, 2004, a Group was constituted under the Chairmanship of Dr. P. S.
Chandurkar, Plant Protection Adviser to the Govt. of India for considering
the label expansion for 9(4) registrants. The Group met on 29 th June,
2005 and after taking into consideration the technical implications and
legal provisions of the Insecticides Act,1968, recommended to permit label
claim expansion to 9(4) registrants, if requisite data as per the guidelines
to prove the efficacy and residue, whe4rever applicable is submitted by the
applicant. This would not violate any provision of the Act as the
registration under Sec.9(4) was issued to the applicant on the basis of
same terms & conditions as in case of 9(3) registrants. Moreover, it would
be in the interest of the farming community to grant such expansion as it
would increase the options available for use of pesticides to the farmers.
The Committee approved the recommendations of the Group to permit the
label claim expansion for the first time by 9(4) registrants on submission of
requisite data.
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3. Reconsideration of the application of M/s BMR Co. Ltd., Pune for
grant of registration of Neem-oil containing Azadirachtin 0.15%EC
A Sub-Committee was constituted under the Chairmanship of Dr. C.D.
Mayee, Chairman, ASRB to examine the application of M/s BMR Co. Ltd.,
Pune for grant of registration of Neem-oil based formulation containing
Azadirachtin 0.15% EC.
Secretary, CIB&RC apprised that
the Sub-
Committee met on 29th June,2005 and recommended as follows:
“The Committee felt that since this is the first product of Neem useful
for household purposes, the registration can be granted under Sec.9(3B)
with commercialization specifically for the Neem Oil based formulation
containing Azadirachtin 0.15% w/w (Min.) for larvaecide under household
situation where they can use this product specifically for Mosquito control in
household conditions like desert coolers, flowerpots and water bodies within
the house, stagnated water in home gardens and places where larvae of
mosquito multiply. The Committee felt that the dose calculated by them is
on higher side, therefore, it is suggested that they should reduce the dose in
consultation with Dr.Mukherjee of NCL who has helped the Company in the
development of the product and provided the data for registration.”
In view of the above, the Committee decided to grant registration
under section 9(3B) for two years permitting commercialization of Neem oil
based formulation containing Azadirachtin 0.15% w/w minimum for control
of mosquito larval control in stagnant water bodies in household conditions
with dose 12ppm (8ml/Litre) and to call back the certificate of registration of
the applicant granted under Sec.9(3B)
to amend and incorporate the
conditions accordingly.
4. Applications for endorsement – disposal at the level of the Sectt. of
CIB&RC – reg.
The Committee was apprised of the decision taken in the meeting held on
26th May,2005 with the Associations of the Pesticides Industry under the
Chairmanship of Dr.N.B.Singh, Agriculture Commissioner & Chairman,RC,
wherein it was decided to issue the endorsement w.r.t. change of factory
address, transfer of certificate of registration, endorsement of second factory
address, endorsement of already approved source for import of pesticides,
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label claims, packaging etc. at the level of Secretary,CIB&RC. However,
applications for endorsement pertaining to new approvals for label claims,
packaging system, source for import
be brought to the Registration
Committee for approval. The Committee approved the above decision taken
in the said meeting.
5. PPA informed that there is an application for the endorsement of address
of second Manufacturing Unit on the Certificate of Registration of M/s
Maharasthra Insecticides Ltd., Mumbai.
Since it is a subsidiary
Company of MAIDC, therefore, they have not submitted the NOC from
the State Department of agriculture. The Committee decided that this
requirement cannot be waived and they may be requested to submit the
same for getting the second factory address endorsed on their Certificate
of Registration.
6. The Committee was apprised that there is a request from M/s Omega to
waive off toxicity data for registration of CPPU Tech. For indigenous
manufacture under Section (3) of the Act. The Committee decided to put
up the status of application for its consideration in the next meeting.
The meeting ended with a vote of thanks to the Chair.
*******