Minutes of the 235rd Meeting of the Registration Committee held on 19.5.2003
at 3.30 P.M. in Committee Room 139, Krishi Bhavan, New Delhi
The 235rd meeting of the Registration Committee (RC) was held under the
Chairmanship of Dr. C.R. Hazra, Agriculture Commissioner on 19.5.2003 at 3.30 P.M. in
Room No. 139, Krishi Bhavan, New Delhi. Dr. P.S. Chandurkar, PPA to the Govt. of
India, Shri P.N. Maji, Joint Industrial Adviser, Ministry of Chemicals and Fertilizers and
Shri S.S. Prasad, 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.
5.
6.
7.
8..
9.
Dr.D. Kanungo, Consultant
Dr. R.B.L. Bhaskar, JD(Bio)
Dr. Brajendra Singh, Ento(I)
Er. S.K. Ghosh, DD(Engg)
Dr. (Mrs.) G. Mukherjee, DD (Chem-I)
Dr. B.S. Phogat, Agro(H)
Shri Vipin Bhatnagar , DD (Chem-II)
Shri Balbir Singh SO(CIR-I)
Shri Neeraj Kulshrestha, Assistant (Legtal).
At the outset, the Committee welcomed Dr. D. Kanungo, Consultant and Shri
Vipin Bhatnagar, DD (Chem-II) The Committee also placed on record the services
rendered by Dr. (Mrs.) S. Kulshrestha, Joint Director (Medical) and Dr. Hari Prasad, DD
(Chem).
Agenda Item
No 1.0
Confirmation of the minutes of 233rd
Committee
& 234th
meetings of the Registration
The minutes of the 233rd & 234th meetings of the RC were confirmed
as no comments were received from any of the members.
Agenda Item
No 2.0
Follow-up action on the decision taken by the Registration Committee in its
233rd & 234th meetings
The Committee perused the follow-up action taken by the Secretariat
with satisfaction.
Agenda Item
No 2.1
Applications pending under various Sections of the Insecticides Act, 1968
The Committee noted the pendency under various Sub-Sections
Section 9 of the Act.
of
2
Agenda Item
No 3.0
Government Business.
Agenda Item
No 3.1
Verification of generation of data for furnishing to the Registration Committee
for the purpose of Registration of Pesticides under the Insecticides Act 1968
The Committee deliberated the agenda in detail and took the following
decisions:
i)
ii)
iii)
Agenda Item
No 3.2
Prior intimation by the applicants regarding data generation is
withdrawn with immediate effect as per the directives received
from the Office of the Hon’ble Agriculture Minister.
Data on bio-efficacy generated under ICAR / SAU system shall
continue to be accepted.
Data on other parameters generated by the Institutes as per Good
Laboratory Practices (GLPs) shall be accepted. This requirement
will be effective in case of data initiated from 1st July, 2003.
Banning use of Ethion – VIP Reference from Dr. Raghuvansh Prasad Singh,
M.P.
The Committee deliberated the agenda in detail and decided as under:
i)
ii)
Agenda Item
No 3.3
Dr. D. Kanungo, Consultant is to collect details about the reasons
of banning of Ethion in USA through internet.
The case may be put up to the Registration Committee thereafter.
Fixation of maximum residue limits (MRLs) for different pesticides under the
Prevention of Food Adulteration Act, 1954 – suggestions received from
Ministry of Health & Family Welfare
The Committee deliberated the agenda in detail. The decisions taken
by the Committee on the points raised by the Ministry of Health &
Family Welfare are given as under: .
Point Raised by Ministry of Health & Family
Welfare
1
that in the proforma devised by the
Registration Committee in its 222nd
meeting, the applicants seeking registration
are supposed to submit three season residue
data instead of two season data
Decision of RC thereon
The proforma approved by the
Registration Committee in its 222nd
meeting which has been circulated to
pesticide industry as well as Ministry of
Health & Family Welfare envisage
submission of residue data based on
three season trials. In the said meeting,
the Registration Committee has also
approved submission of one season
3
multi-locational data generated at not
less than 4 locations at different agroclimatic zones in case of fungicides and
insecticides. For herbicides and
pesticides which are repeatedly used in
the same locations, requirements of
three seasons / years one location data
shall continue.
2.
that the fruits and vegetable samples may be
taken at different periods viz. 0,1,3,5,10 and
15 days and the applicants may be requested
to provide data in case of fruits and
vegetables in the following format for all
the three season trials
Season Recommended
1
Dose residue
(mg/kg)
Days
R1 R2 R3 AV
Double dose
Residues
(mg/kg)
R1 R2 R3 AV
Samples of agricultural produce are
taken at the time of harvest in case of
cereal, pulses and oil seeds. In case of
fruits and vegetable, the samples are
taken at different intervals depending
upon plucking of the fruits and
vegetables, may be starting from
0,1,3,5,10 and 15 days. The protocol for
this purpose approved by the
Registration Committee already
provides for details as proposed by
Ministry of Health & Family Welfare.
The pesticides are tested at
recommended and double of the
recommended dose
3.
that the registrants of the pesticides are
demonstrating analytical methods for
finding purity at Central Insecticides
Laboratory, Faridabad. Since the MRLs of
the pesticides are implemented by the State
Food and Central Food Laboratories, the
registrants of the new pesticides under
Section ((3) may be requested to
demonstrate residue analysis method and
provide analytical standards to Central Food
Laboratory, Mysore so that the MRLs are
enforced properly in the country. This
representative may be called at the meeting
of the Registration Committee.
Demonstration of residue analysis
method and providing analytical
standards to Central Food Laboratory,
Mysore is agreed. ADG (PFA) is
already a co-opted member of R.C.,
therefore, there is no need to have
another person on the R.C.
4.
that a Committee constituted to analyse the
data on deemed registered pesticides seem
to have completed the work, the residue
data submitted by the registrants may be
sent to Ministry of Health & Family welfare
Analysis of data submitted in respect of
deemed registered pesticides is in
progress. Data on residues as asked by
the Ministry of Health & Family
Welfare would be passed on after
4
so that MRLs of 71 pesticides already fixed consideration
under PFA may be reviewed. Some of the Committee.
pesticides would required to be banned in
the interest of the public health.
5
that the Registration Committee should not
register any pesticides henceforth without
fixing MRLs of pesticides. The views of
Ministry of Health and Family Welfare
should form a separate agenda item for each
meeting of Registration Committee.
Agenda Item
No 3.4
by
the
Registration
Not Agreed upon Fixation of MRL
subsequent to supply of requisite data is
a separate issue and linking this with
registration will unnecessary delay
registration.
Approval of Guidelines for use of Surfactant along with Pesticide
Formulations.
The Committee deliberated the agenda and approved the
guidelines as proposed except the health monitoring study on
spray operators.
Agenda Item
No 3.5
Consideration of an Interim Report of the Core Group of Experts
constituted by the RC on Deemed Registered Pesticides (DRPs)
The RC perused the interim report of the Core Group of Experts
on Deemed Registered Pesticides (DRPs) constituted by the RC
in its 219th meeting held on 6th March 2002 to examine total data
available with the Secretariat of CIB&RC and the pesticide
industry in respect of DRPs on complete chemical profile with
the
identification and quantification of impurities, terminal
residues and waiting periods for crops on which their uses
approved, data on acute, sub-acute and chronic toxicity as per the
decision of Inter-Ministerial Group of DAC which met on
7.4.1998.
Now it was felt by the RC that main purpose of undertaking the
exercise on scrutiny of data on above parameters is to provide
certain data / information to the Ministry of Health & Family
Welfare to facilitate them to prescribe tolerance limits (MRLs) of
pesticides in food commodities under the Prevention of Food
Adulteration (PFA) Act, 1954. Therefore, RC permitted the
Secretariat of CIB&RC to identify the parameters on which the
data / information in respect of DRPs would be required for the
purpose of facilitating the Ministry of Health & Family Welfare
to work out the tolerance limits of these pesticides on food
commodities under the PFA so that Core Group of Experts could
be requested to examine the available data accordingly and
5
submit the final report.
RC also decided to induct Dr. D. Kanungo, Consultant who has
recently joined the Secretariat of CIB&RC, as the member of the
Core Group of Experts on DRPs.
R.C. also decided that status report in this matter be examined in
detail and brought to R.C. with definite recommendations.
Agenda Item
No. 3.6
Review of ban on packaging system for Aluminium phosphide of 3 g
each, comprising of Aluminium tube of capacity of 10 & 20 tables.
Approved as proposed.
Agenda Item
No 4.0
Export Cases
Agenda Item
No 4.1
The applicant as per details at Annexure 4.1 have applied for grant of
registration of the already registered technical / formulation having same
lower and higher concentration / new concentration for export under
Section 9(3)
Approved
Agenda Item
No 4.2
Consideration of application of M/s Isagro (Asia) Agrochem Pvt. Ltd.
for grant of registration for indigenous manufacture of Esfenualerate 5%
EC under Section 9(3) for Export only
Approved.
Agenda Item
No 4.3
Consideration of application of M/s Gharda Chemical Ltd., for grant of
registration for indigenous manufacture of Triclopyr Butotyl ester 32% ..
U/s 9(3) for Export only
Approved.
Agenda Item
No 4.4
Consideration of application of M/s Bhagirdha Chemicals & Ind. Ltd. f
for grant of registration for indigenous manufacture of Triclopyr Butoxy
Ethyl ester technical U/s 9(3) for Export
Approved
6
Agenda Item
No 5.0
9(3B) Cases
Agenda Item
No 5.1
Consideration of application of M/s PNP Associates Pvt. Ltd. for grant of
registration for import of Forchlorfenuron 0.1% EC . U/s 9(3B)
The Committee deliberated the agenda in detail and
approved the same with provision for commercialization
with ceiling of 10 kl. The Committee also decided to
draw the samples from
the first consignment
imported in the country from port for verification. For
this purpose the registrant shall be required to inform
Secretariat of CIB & RC well before the consignment
arrived in the country
Agenda Item
No 5.2
.
Consideration of application of M/BMR Company . for grant of
registration for for indigenous manufacture of need oil based EC
containing Azadirachtin 0.15% under Section 9(3B) for household
purpose.
The Committee deliberated the agenda and granted
extension of provisional registration by one year without
commercialization.
Agenda Item
No. 6.0
9(3) Cases
Agenda Item
No. 6.1
Consideration of application of M/s Godrej Sara Lee Ltd. for grant of
registration for indigenous manufacture of Prallethrin 19% w/w under
Section 9(3)
Approved
Agenda Item
No. 6.2
Consideration of application of Atul Ltd. for grant of registration for
indigenous manufacture of Lambdacyhalothrin technical U/s 9(3)
Approved
Agenda Item
No. 6.3
Consideration of application of M/s Nagarjuna Agrichem Ltd.. . for
grant of registration for indigenous manufacture of Imidacloprid
technical under Section 9(3)
Approved
7
Agenda Item
No. 6.4
Consideration of application of M/s Reckitt Benkiser (I) Ltd. for grant
of registration for indigenous manufacture of D-transallethrin 0.1%
Mosquito coil under Section 9(3)
Approved
Agenda Item
No. 6.5
Consideration of application of M/s Atul Ltd. for grant of registration for
indigenous manufacture of Metsulfuron Methyl technical under Section
9(3)
Approved.
Agenda Item
No. 7.0
Application for registration under Section 9(4)
Agenda Item
No. 7.1
A statement showing the case under section 9(4) may be seen at
Annexure 7.1
The Committee deliberated the agenda in detail and approved. All
the cases in Annexure 7.1 except the cases listed at sr. no. 266,
289, 889. However, before issue of certificate of registration,
requirement of letter of consent needs to be checked, wherever
applicable, by D.D. (Chem.-II)
Agenda Item
No. 7.2
Consideration of application of M/s Heranba Industries Limited, Gujarat
for grant of registration for indigenous manufacture of Deltamethin Tech
. U/s 9(4)
AND
Agenda Item
No. 7.3
Consideration of application of M/s Heranba Industries Limited, Gujarat
for grant of registration for indigenous manufacture of Lasmbda
Cyhalothrin Tech . U/s 9(4)
AND
Agenda Item
No. 7.4
Consideration of application of M/s Sudarshan Chemical Industries Ltd.,
Pune for grant of registration for indigenous manufacture of Imidacloprid
Tech . U/s 9(4)
AND
Agenda Item
No. 7.6
Consideration of application of M/s Epic Enzyme Pharmaceuticals and
Industrial Chemical Ltd, Mumbai for grant of registration for
indigenous manufacture of Ethion Tech . U/s 9(4)
8
AND
Agenda Item
No. 7.7
Consideration of application of M/s Hikal Limited, Mumbai for grant of
registration for indigenous manufacture of Ethion Tech.. U/s 9(4)
Deferred due to want of detailed chemical composition and ATR
received from CIL
Agenda Item
No. 7.5
Consideration of application of M/s Epic Enzyme Pharmaceuticals and
INDS Chemi Ltd, Mumbai for grant of registration for indigenous
manufacture of Chlorpyrifos Tech . U/s 9(4)
Approved.
Agenda Item
No. 8.0
Miscellaneous Items
Agenda Item
No. 8.1
Endorsement Cases for approval as per Annexure 8.1 & 8.1A to 8.1I
Approved all cases except the case at sr. no. 6 details of which
may be put up to the Chairman, RC
Agenda Item
No. 8.2
Consideration of application M./s Rallis India Ltd. for endorsement of
additional source of supply for import of Dimethoate technical on their
CR
Approved.
Agenda Item
No. 8.3
Consideration of application of M/s Rallis India Ltd. for endorsement of
detailed chemical composition on labels & leaflets for the different
formulation of Captan on their CR – reg.
Approved.
Agenda Item
No. 8.4
Approval of direction of use and alternate packaging system of
Metsulfuron methyl 20% WP along with surfactant proposed by M/s
Dupont India Ltd., Gurgaon.
Approved.
Agenda Item
No. 8.5
Consideration of application of M/s Crompton Specialities Asia Pacific
Pte. Ltd. for change in the manufacturing site of the approved source for
import of Carboxin technical Approved.
Approved
9
Agenda Item
No. 8.6
. Consideration of application of M/s Crompton Specialities Asia Pacific
Pte. Ltd. for change in the manufacturing site of the approved source for
import of Propargite technical
Approved.
Agenda Item
No. 8.7
Consideration of application of M/s Crompton Specialities Asia Pacific
Pte. Ltd. for change in the approved source for import of Carboxin
technical
Approved.
Agenda Item
No. 8.8
Consideration of application of M/s Crompton Specialities Asia Pacific
Pte. Ltd. for change in the approved source for import of Carboxin
technical
Approved
Agenda Item
No. 8.9
Consideration of application of M/s BASF India Ltd. for endorsement of
change in the site of import of Flufenoxuron technical on their CR – reg.
Approved
Agenda Item
No. 8.10
Entension of label / claim of Hexaconazole 5% EC on tea for the control
of Blister blight disease.
Approved.
Agenda Item
No.
Approval of Protocols
Approved
The meeting ended with a Vote of Thanks to the Chair.