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MINUTES OF THE 243RD MEETING OF THE REGISTRATION COMMITTEE
HELD ON 02.04.2004 AT 2.30 PM IN ROOM NO. 141, KRISHI BHAVAN, NEW
DELHI

The 243rd meeting of the Registration Committee (RC) was held under
the Chairmanship of Dr. C.D. Mayee, Agriculture Commissioner on 02.04.2004 at
2.30 pm. in Room No. 141, 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, members, Dr. R.K. Mahajan, ADG (PFA),
Ministry of Health & Family Welfare co-opted member, Dr. (Miss) P. Kaur,
Principal Scientist (Plant Protection) represented Dr. O.P. Dubey, ADG (PP)
ICAR and Shri Y. Tsering, Member Secretary attended the meeting.

The following Officers from the Sectt. of RC were also present in the meeting:

1. Dr. R.B.L. Bhaskar, JD(Bio)
2. Dr. Brajendra Singh, Ento (I)
3. Dr. (Mrs.) Sandhya Kulshrestha, JD(Medical)
4. Shri Vipin Bhatnagar, JD(Chem.)
5. Er. S.K. Ghosh, DD (Engg.)
6. Dr. B.S. Phogat, DD (Weed Science)
7. Smt. Kanta Arora, A.O. (CIR)
8. Shri Harbhajan Lal Gera, SO
9. Shri Niraj Kulshrestha, Assistant (Legal)

At the outset the Chairman welcomed Dr. R.K. Mahajan, co-opted member
and Dr. (Mrs.) Sandhya Kulshrestha, Joint Director (Medical) in the Sectt. of RC.
.
Agenda Item Confirmation of the minutes of the 242nd meeting of the
No 1.0 Registration Committee.

The minutes of the 242nd meeting of the RC were confirmed
as no comments were received from any of the members.

Agenda Item Follow–up action on the decisions taken by the Registration
No 2.0 Committee in its 242nd meeting

The Committee perused the action taken report by the RC
Secretariat on the decisions taken by the Committee in its 242nd
meeting. With regard to agenda item no. 5.10 regarding grant of
registration of Tricontanol (0.1% EW, 0.05% EC and 0.05% GR)
under Section 9(3B) in favour of the members of Indian
Association of Plant Growth Products (IAPGP), Mumbai, it was
pointed out that the members of the association have not submitted
complete chemical composition on Form-I / labels & leaflets.
Besides they have also not submitted method of analysis,
specification of the product, analytical test report, samples for
testing in CIL, etc. The Committee, therefore, decided that before
issue of Certificates of Registration, the applicants may be asked to
2

make necessary submissions & corrections in Form-I / labels &
leaflets, etc.

As regards further simplification in the guidelines for
registration of bio-pesticides under Any Other Item, the
Committee decided that Dr. (Mrs.) Sandhya Kulshrestha, Joint
Director (Medical) who has joined the Registration Committee
Sectt. be included in place of Dr. D. Kanungo who has since left
the organization. The Committee also decided that the permission
for grant of TA/DA to the members may be obtained from DAC
and meeting may be convened at New Delhi in place of
Bangalore.

Agenda Item Applications pending under various Sub- Sections of the Insecticides
No 2.1 Act, 1968

The Committee noted the pendency under various Sub-
Sections of Section 9 of the Act with satisfaction.

Agenda Item Government Business
No 3.0
Registration of Bio-pesticides - Status.

The Chairman desired to reduce the check list based on
internal discussion among experts to enable receipt of applications
with acceptable / minor deficiencies.

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 Consideration of application of M/s UPL Mumbai for grant of
No 4.2 registration for indigenous manufacture of Bifenthrin 2.5% EC
under Section 9(3) for export only.

Approved.

Agenda Item Consideration of application of M/s P.I. Industries Ltd. for grant of
No 4.3 registration for indigenous manufacture of Terbuphos technical
under Section 9(3) for export only.

Approved.
3

Agenda Item Consideration of application of M/s Parijat Agencies for grant of
No 4.4 registration for indigenous manufacture of Dicamba technical under
Section 9(3) for export only.
Approved.

Agenda Item 9 (3B) Cases
No. 5.0

Agenda Item Consideration of application of M/s Varsha Bio Science and
No. 5.1 Technology, Hyderabad for grant of registration for indigenous
manufacture of Trichoderma viride 1% WP (CFU 2 x 10 6 / gm min.)
under Section 9(3B).

The Committee deliberated the agenda and decided to grant
provisional registration for 2 years with commercialization.

Agenda Item 9 (3) Cases
No. 6.0 NIL

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

The Committee deliberated the agenda and decided to defer the
same in view of several inaccuracies in the list. The Committee decided
that the same may be checked up by DD (Chem) and put up in the next
meeting of the Committee for consideration.

Agenda Item Consideration of application of M/s Gujarat Superphosphate
No. 7.2 Industries (P) Ltd., Ahmedabad under Section 9(4) for grant of
registration of Triazophos Liquid Concentrate for indigenous
manufacture.

Approved subject to correction / verification of chemical
composition by the applicant.

Agenda Item Consideration of application of M/s Meghmani Organics Ltd.,
No. 7.3 Ahmedabad under Section 9(4) for grant of registration of
Lambdacyhalothrin technical for indigenous manufacture.
Approved

Agenda Item Consideration of application of M/s Meghmani Industries Ltd.,
No. 7.4 Ahmedabad under Section 9(4) for grant of registration of
Thiophanate Methyl technical for indigenous manufacture.

Approved
4

Agenda Item Consideration of application of M/s Sudarshan Chemical Industries
No. 7.5 Ltd., Pune under Section 9(4) for grant of registration of
Tricyclazole 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 Endorsement / Alternate / New Packing of 6 & 7 double mosquito
No. 8.2 coils of 25 gm in one pack of Allethrin 0.2% Mosquito Coils –
proposed by M/s BBF Home Care Products Ltd., Ludhiana.

The Committee deliberated the agenda and did not accede the
request of M/s BBF Home Care Products Ltd., Ludhiana for new packing
of 6 & 7 double mosquito coil in one pack.

Agenda Item Application for approval of Trilaminated pouches for packing
No. 8.3 Dodine 65% WP under Section 9(4) – proposed by M/s Indofil
Chemical Company, Mumbai.

Approved.

Agenda Item Application for approval of Tricyclazole 75% WP under Section 9(3)
No. 8.4 – proposed by M/s Indofil Chemical Company, Mumbai.

Approved

Agenda Item Expansion of label claims on Sulphur 80% WP on tea for the control
No. 8.5 of red, pink and purple mites.

Approved.

Addl. Agenda Export Cases.
Item No 4.0

Addl. Agenda The applicants as per details at Annexure 4.1 have applied for grant
Item 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 except the item listed at sr. no. 1 which may be brought
in the next meeting with complete details for consideration.
5

Addl. Agenda 9(3B) Cases.
Item No 5.0

Addl. Agenda Status of application of M/s New Chemi Industries Limited for
Item No 5.2 registration of Pheromone PB-ROPE-L

The Committee deliberated the agenda and decided to grant fresh
provisional registration with commercialization. The certificate will be
valid for one year only.

Addl. Agenda Consideration of application for grant of registration for indigenous
Item No 5.3 manufacture of Trichoderma viride 1% WP (CFU 2 x 106 /gm min.)
of M/s Ecosense Labs. (I)pvt. Ltd., Mumbai under Section 9(3B).

The Committee deliberated the agenda and decided to grant
provisional registration for 2 years with commercialization

Addl. Agenda Consideration of application for grant of registration for indigenous
Item No 5.4 manufacture of Trichoderma viride 1% WP (CFU 2 x 106 /gm min.),
Pseudomonas flourescens 0.5% WP and Trichoderma harzianum 1%
WP (CFU 2 x 106 /gm min.), under Section 9(3B) supported by the
data / dossiers provided by the Tamil Nadu Agricultural University
/ ICAR

The Committee deliberated the agenda and decided to grant
provisional registration with commercialization. The Committee also
decided that the applicants who have submitted data on bio-efficacy
provided by TNAU, may be given similar label claims irrespective of the
label claims submitted by the applicants.

Addl. Agenda Consideration of request of M/s Dhanuka Pesticides Ltd., Gurgaon
Item No 5.5 for extension of provisional registration to import Quizalofop ethyl
5% EC under Section 9(3B) with commercialization.

The Committee deliberated the agenda and decided to grant one
time import of 100 kl of formulated material valid for one year. The
Committee decided that no further extension will be granted in view of
compulsory requirement of MRLs where the pesticides are allowed for
commercialization.

Addl. Agenda Consideration of application of M/s Vestergaard India Pvt. Ltd.,
Item No 5.6 New Delhi for registration for import of Deltamethrin impregnated
Mosquito bed net 5% with commercialization under Section 9(3B)
of the Insecticides Act, 1968

The Committee deliberated the agenda and recalled its earlier
decision taken in its 242nd meeting approving thereby import of 6 million
bed nets (single) or equivalent fabric for commercialization and data
generation in the country. The Committee decided to approve the case
6

subject to submission of sample for testing in CIL, receipt of satisfactory
ATR, specification and correct chemical composition.

Addl. Agenda 9(3) cases
Item No 6.0

Addl. Agenda Consideration of application of M/s Bombay Chemicals Pvt. Ltd.,
Item No 6.1 Mumbai for grant of registration for indigenous manufacture of
Pyrethrum 0.2% Aerosol under Section 9(3)

Approved.

Addl. Agenda Consideration of application of M/s Monsanto India Ltd, Mumbai
Item No 6.2 for grant of registration for indigenous manufacture of IPA Salt of
Glyphosate 54% SL under Section 9(3)

Approved.

Addl. Agenda Consideration of application of M/s Gharda Chemicals Ltd.,
Item No 7.6 Mumbai under Section 9(4) for grant of registration of
Hexaconazole technical for indigenous manufacture.

Approved subject to verification of the name of the applicant in
column 2 of the statement.

Addl. Agenda Miscellaneous items.
Item No 8.0
.
Addl. Agenda A statement showing the endorsement cases which are complete
Item No 8.1 from all disciplines may be seen at Annexure-8.1

Approved. The Committee noted that there are frequent requests
for change of manufacturing sites. The Committee desired that physical
verification of such units by the officers of the Registration Secretariat
may be made in doubtful cases.

Addl. Agenda Lable expansion of Alphacypermethrin 10% EC for Rice – M/s
Item No 8.6 BASF India Ltd., Mumbai.

AND

Addl. Agenda Lable expansion of Fipronil 5% SC for cotton / M/s Gharda
Item No 8.7 Chemicals Ltd., Thane.

The Committee deliberated the agenda items and decided that the
issue may be examined by a Group comprising of Dr. P.S. Chandurkar,
PPA, JD (Bio), JD (Medical), DD (Chemistry) keeping in view the legal
provisions as per the Insecticides Act, technical implications and the past
experience.
7

Addl. Agenda Alternate packing for Aluminium phosphide 15% tablets (12 g) –
Item No 8.8 proposed by M/s United Phosphorous Ltd., Mumbai – justification
regarding.

Approved.

Any other item
As desired, the Secretary, RC submitted the status of the applications of
the following products.

i) Request of M/s Global Agrosystem Pvt. Ltd. for extension of provisional
registration of Chlorpropham 23.4 % HN and Chlorpropham 30% EC
(Gro-stop)

The Committee considered the request of the registrant and decided to
grant extension of provisional registration for the aforesaid product for 6 months.
The Committee decided that no further extension will be granted in view of
compulsory requirement of MRL where pesticides are allowed for
commercialization.

ii) Indigenous manufacture of Dodine technical by M/s Indofil Chemicals
Company, Mumbai under Section 9(3).

On receipt of satisfactory ATR from CIL, the file may be put up to the
Chairman for approval through PPA.

iii) Secretary, R.C placed the minutes of the meeting held under the Chairmanship of
Additional Secretary (AKS), DAC on 31.3.2004 before the Committee regarding
procedure for fixation of maximum residue limits (MRLs) for information ( copy
annexed).

The Secretary, RC apprised the Chairman that he will be away on
election duty as observer with effect from 5.4.2004 to 16.4.2004. Therefore,
minutes prepared by the JD (Bio) will be put up to the Chairman through PPA for
approval.

The meeting ended with a Vote of Thanks to the Chair.
8

ANNEXURE

MINUTES OF THE MEETING HELD ON 31.03.2004 AT 10.30 AM IN CR-142,
KRISHI BHAVAN, NEW DELHI UNDER THE CHAIRMANSHIP OF SHRI A.K.
SINGH, ADDITIONAL SECRETARY (AKS) TO DISCUSS THE PROCEDURE
FOR FIXING MAXIMUM RESIDUE LIMITS FOR PESTICIDES.

A meeting was held on 31.3.2004 at 10.30 AM in CR-142, Krishi Bhavan,
New Delhi under the Chairmanship of Shri A.K. Singh, Additional Secretary
(AKS) to discuss the procedure for fixing maximum residue limits for pesticides.
The list of participants is enclosed.

2. Welcoming the participants, the Chairman desired to know as to whether
the format / checklist containing the list of parameters on which data is required
for fixation of Maximum Residue Limits (MRLs) has been exchanged between
the Secretariat of Registration Committee and the Directorate General of Health
Services. It was informed that the same has been done. The Chairman desired
that the PPA along with the officers of the Registration Committee Secretariat and
the Directorate General of Health Services should sit together and finalize the
final format / checklist immediately and after finalization, same shall be put on
the website of the Secretariat of CIB&RC. The Secretary (CIB&RC) informed
that after finalization of the format / checklist, the same would be require to be put
up before the Registration Committee for approval but assured that the same shall
be done in the next meeting of the Registration Committee, which is scheduled for
2nd April, 2004.

3. Thereafter the entire procedure of Registration of pesticides as also that of
fixation of MRLs was reviewed and discussed. The following decisions were
taken to ensure timely fixation of MRLs for pesticides being registered by the
Registration Committee.

a). that registrants under the Insecticides Act, 1968 shall be asked to submit to
the Registration Committee, the application for registration of a pesticide, along
with the data dossier, in duplicate. The RC Secretariat shall forward one of these
copies, along with the data dossiers, as received, to the Assistant Director General
(PFA), by special messenger, within two working days of its receipt. The
following information should be detailed on the first page of the application by
the RC Sectt. “The application was received on (date of receipt) and sent to
ADG (PFA), Department of Health on (date of dispatch).

b). that the Directorate General of Health Services / Department of Health on
its part, shall examine the application and communicate within ten days,
deficiency / inadequacy of the data / information or inadequacy in the quality of
the data , if any, to the RC Secretariat. The RC Secretariat shall then inform the
applicant, within a period of two weeks of the date of initial receipt of the
application, regarding any inadequacy / deficiency in the data / information
submitted and also inform the applicant that the subject application for
registration will be processed only after the deficiency / inadequacy of data /
information, as required under the checklist, is fulfilled by the applicant.
9

It was further decided that all communication to the applicants, required to
be made by the Directorate General of Health Services / Department of Health,
shall be made only through the Registration Committee.

c). that the Directorate General of Health Services / Department of Health
shall complete all procedures and steps required for fixing of MRLs by them
under the PFA, including examination of the data and clearance by the Sub-
committee on CCFS and the finalization of MRL by the CCFS, within 90 days of
receipt of the complete data. In case fixing of MRL / examination of an
application takes more than 90 days, the same shall be brought to the notice of the
Additional Secretary / Special Secretary, In-charge of Plant Protection Division in
the Department of Agriculture and Cooperation. It was clarified by the Chairman
that such cases should be exceptional but would include those cases where MRLs
can not be fixed within the agreed 90 day period on account of inadequacies in the
quality of data, which are noticed later by the experts or members of the CCFS or
Sub-Committee thereof, and where clarification / additional information is
required after technical evaluation of the data / information supplied by the
applicant.

d). that on its part the Registration Secretariat shall also ensure that deficiency
/ inadequacy of data s against the checklist, shall be communicated to the
applicant within two weeks of the date of initial receipt of the applicant and also
ensure that detailed scrutiny of applications, from various angles as required for
the purpose of registration under the Insecticides Act, 1968, is complete within a
period of 90 days from the date of receipt of complete data, as required and
prescribed in the checklist. In case scrutiny / examination of an application takes
more than the agreed 90 days, the same shall be brought to the notice of the
Additional Secretary / Special Secretary, In-charge of Plant Protection Division in
the Department of Agriculture and Cooperation by the Secretary, R.C. It was
observed by the Chairman that such cases should be exceptional but could include
those cases where the application for registration could not be processed within
the agreed 90 days period on account of inadequacies in the quality of data, which
are noticed later by the experts / members of the RC, and where clarification /
additional information is required after technical evaluation of the data /
information supplied by the applicant.

The Chairman directed that all officers of the Registration Committee
should observe the prescribed time limits set for each stage of registration
process.

It was further decided that after examination of the data has been
completed by the RC Sectt. and once the MRL has been fixed by the Directorate
General of Health Services / Department of Health and communicated to the RC,
the case shall be put up to the Registration Committee for deliberations and
decision within 15 days. It was also decided that the agenda for the meetings of
the Registration Committee should, as a practice, be circulated at least 10 days
prior to the date of the meeting.
10

4. The Chairman desired to know from the representative of the Department
of Health, as to whether there exists a system of inviting objections and
suggestions before notifying the maximum residue limits for pesticides. The Joint
Secretary, Ministry of Health and Family Welfare informed that in case of
notifications under the Prevention of Food Adulteration Act, a draft notification is
issued and normally a period of 90 days is given for inviting objections and
suggestions before the final notification and that this has been the practice in
cases of fixation of MRLs. It was also informed that the final notification for
inviting objections and suggestions.

Therefore, it was decided that the Registration Certificate will be issued
by the RC only after the MRL has been fixed by the Department of Health but
there will be no need to wait for the issual of the final notification of the MRL.
However, it was decided that the following words shall be mentioned as a
footnote / condition on the body of the Registration Certificate:

“This registration is being granted subject to the notification of the
Maximum Residue Limits under the Prevention of Food Adulteration act, 1954.”

5. The Joint Secretary, Ministry of Health and Family Welfare highlighted
that though, initially a registration is granted to a pesticide for specific crops by
the RC, additional crops are added in the registration certificate subsequently and
that this is being done without fixation of MRLs for such crops. She observed
that in such cases, that the entire MRL for pesticide in question needs re-fixation
and requested the Chairman to consider a protocol to be followed by the RC for
such cases so that MRLs could be re-fixed for such cases. The Chairman
observed that before endorsing use of a pesticide on additional crops. MRLs for
the pesticide in respect of all its approved crops must be fixed. It was decided to
follow the protocol detailed at Para 3 above in respect of all such cases where
additional crops are allowed for a particular pesticide by the RC.

6. The Joint Secretary, Ministry of Health and Family Welfare also raised the
question of fixation of MRLs in respect of deemed registered pesticides. The
Joint Secretary, Ministry of Health and Family Welfare also informed that the
deemed registered pesticides which were initially permitted for certain crops,
have later been recommended for other crops also. It was informed by officers of
the RC Secretariat that only in respect of 9 deemed registered pesticides, MRLs
are yet to be fixed. The Chairman directed the RC to put up a detailed note with
reference to such pesticides within 10 days. The Chairman also desired that the
position be reviewed in the next meeting which shall be held after 15 days.

7. The meeting ended with a vote of thanks to the Chair.
11

LIST OF PARTICIPANTS

Sl. No. Name and Organization Department / Organization

1. Shri A.K. Singh, Additional Secretary DAC

2. Ms, Rita Teaotia, Joint Secretary Ministry of Health and
Family Welfare

3. Shri Y. Tsering, Secretary (CIB&RC) Dte. of Plant Protection,
Quarantine and Storage

4. Shri Amand Shah, Deputy Secretary (PP) DAC

5. Dr. P.S. Chandurkar, PPA Dte. of PPQ&S

6. Dr. R.K. Mahajan, Ministry of Health
Assistant Director General and Family Welfare

7. Dr. RBL Bhaskar, Joint Director (Bio) Dte. of PPQ&S

8. Dr. S. Kulshrestha, Joint Director (Med.) Dte. of PPQ&S

9. Mrs. G. Mukherjee, Deputy Director (Chem) Dte, of PPQ&S