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Minutes of the 246th Meeting of the Registration Committee held on 4th August, 2004 at 1030 hrs. in Krishi Bhavan, New Delhi

The 246th meeting of the Registration Committee (RC) was held under the Chairmanship of Dr. C.D.Mayee, Agriculture Commissioner on 4.8.2004 at 10.30 hours in Committee Room No.142, Krishi Bhavan, New Delhi. Dr. P.S.Chandurkar, Plant Protection Adviser to the Government of India, Shri P.N.Maji, Additional Industrial Adviser, Department of Chemicals & Petrochemicals and Dr. (Mrs.) Sandhya Kulshrestha, Secretary, Central Insecticides Board & Registration Committee (CIB&RC) attended the meeting.

The following officers from the Secretariat of CIB&RC were also present in the meeting:-

1. Dr. R.B.L.Bhaskar, Joint Director (Bioassay)

2. Shri Vipin Bhatnagar, Joint Director (Chemistry)

3. Dr. (Mrs.) G. Mukherjee, Deputy Director (Chemistry)

4. Er. S.K.Ghosh, Deputy Director (Engineering)

5. Dr. R.M.Shukla, Deputy Director (Entomology)

6. Dr. B.S.Phogat, Deputy Director (Weed Science)

7. Dr. Mukul Singh, Deputy Director (Medical)

8. Smt. Kanta Arora, Administrative Officer (CIB&RC)

9. Shri Neeraj Kulshrestha, Assistant (Legal)

At the outset, the Chairman welcomed the participants and requested Secretary (CIB&RC) to take up the agenda.

Before taking up the agenda, Secretary(CIB&RC) informed that the comments of Dr.R.K.Mahajan, Additional Director General (PFA), Ministry of Health & Family Welfare have been received through the Department of Agriculture & Cooperation (DAC) in respect of Agenda item Nos. 5.4 and 6.6 of 244th Registration Committee meeting. The Committee opined that the minutes of the 244th meeting have already been formally confirmed in 245th Registration Committee meeting held on 2.7.04 and decisions have already been acted upon. The Committee also decided that the comments, if any, should be sent within a stipulated time period. Further, the Committee decided that the comments of Additional Director General (PFA), Ministry of Health & Family Welfare received through DAC may be put up to the next Registration Committee meeting along with draft reply to DAC for deliberation and approval.

Agenda item No. 1.0 /

Confirmation of minutes of the 245th meeting of the Registration Committee

The Committee noted that no comments have been received from any of the Members and therefore, the minutes were approved.

Agenda item No 2.0 /

Follow up action on the decision taken by the Registration Committee in its 245th meeting

The Committee noted with satisfaction the follow up action taken on the decisions of 245th meeting of the Registration Committee.
Agenda item No 2.1 /

Applications pending under various Sub-Sections of the Insecticides Act, 1968

The Committee noted the pending applications under various sub-sections of Section 9 of the Insecticides Act.
Agenda item No 3.0 /
Government Business
Agenda item No 3.1 /

Show Cause Notice for ban/restriction on use of Monocrotophos

The members deliberated the issue in detail and decided that, as requested by the manufacturers, they may be called for making presentation in the next meeting of the Registration Committee.
Agenda item No 3.2 /

Application for import of Boric Acid

The members deliberated the agenda in detail. It was informed to the Committee that a large number of applications for import of boric acid for use in glass and ceramics industry etc., have been received. Further, it was informed that importers have requested that the concession of 2 years period has been given for indigenous manufacturers for submission of data by the Registration Committee, the same should also be applicable to importers. Accordingly, the Committee decided that on receipt of application for registration, the importers of boric acid shall also be granted provisional registration for a period of 2 years during which they will be required to generate data as per the guidelines of the Registration Committee for regular registration under Section 9(3) and during this period they will be permitted to import boric acid. For this purpose, all the importers as well as indigenous manufacturers must submit their applications for registration upto 31st December, 2004. Further, the Committee decided to constitute an Expert Group with the following composition to recommend regarding the non-insecticidal as well as non-agricultural/non-public health (insecticide) uses of boric acid:-
1. Shri P.N.Maji, Additional Industrial Adviser - Chairman
Department of Chemicals & Petrochemicals
New Delhi.
2. Dr. (Mrs.) Sandhya Kulshrestha, Secretary (CIB&RC) - Member
Directorate of P.P.Q & S, Faridabad.
3. Dr. R.B.L.Bhaskar, Joint Director (Bioassay) - Member
Directorate of P.P.Q & S, Faridabad.
4. Dr. R.M. Shukla, Deputy Director (Entomology) - Member
Directorate of P.P.Q & S, Faridabad.
5. Er. S.K.Ghosh, Deputy Director (Engineering) - Member
Directorate of P.P.Q & S, Faridabad.
6. Dr. B.S. Phogat, Deputy Director (Weed Science) - Member
Directorate of P.P.Q & S, Faridabad.
7. Representative of Central Glass & Ceramics Research - Member
Institute, Kolkatta
8. Director, Wood Research Institute, - Member
Malleswaram, Bangalore
9. Dr. (Mrs.) G. Mukherjee, Deputy Director (Chemistry) - Member
Directorate of P.P.Q & S, Faridabad. Secretary
The Expert Group can coopt any member and it should submit its report within a period of 20 days. The Committee also decided that the applications mentioned in the agenda are deferred and will be considered after the receipt of the report from the Expert Group. It was also decided to inform the applicants to apply as per the guidelines of the Registration Committee with Form – I, requisite fee as well as data available with them for seeking provisional registration.
Agenda item No 4.0 /

Export Cases

Agenda item No 4.1 /

Applicants applied for grant of registration of the already registered Technical/Formulation having same, lower and higher/new concentration for Export under Section 9(3)

Approved.

Agenda item No 4.2 / Consideration of application of M/s Parijat Agencies, New Delhi for grant of registration for indigenous manufacture of Prometryn technical u/s 9(3) for export only
Approved.
Agenda item No 4.3 / Consideration of application of M/s Atul Limited, Atul (Gujarat) for grant of registration for indigenous manufacture of Difenconazole 15% + Propiconazole 15% EC under Section 9(3) for export only.
Approved.
Agenda item No 5.0 /

9(3B) Cases

Agenda item No 5.1 / Consideration of application of M/s Crop Health Products Ltd. for grant of registration for indigenous manufacture of Trichoderma Viride 1% m/m WP (CFU 2 x 106 min.% gm) under section 9(3B)
Approved with commercialization.
Agenda item No 5.2 /

Application of M/s International Panacea Ltd., New Delhi for extension of validity period of registration certificate for Trichoderma Viride 1% WP under section 9(3B) for 2 years with commercialization

Approved for a period of 2 years with commercialization.
Agenda item No 6.0 / 9(3) Cases
Agenda item No 6.1 / Consideration of application of M/s Wockhardt Life Science Ltd. for grant of registration for indigenous manufacture of Bacillus thuringiensis var. Israelensis WP u/s 9(3)
Approved.
Agenda item No 6.2 / Consideration of application of M/s T. Stanes & Company Ltd. for grant of registration for indigenous manufacture of Beauveria Bassiana 1.15% WP (cfu-1x108/gm. Min.) under section 9(3)
Approved.
Agenda item No 6.3 / Consideration of application of M/s Sumitomo Chemical India Pvt. Ltd., Mumbai for grant of registration for indigenous manufacture of Cyphenothrin 5% EC under Section 9(3)
Approved.
Agenda item No 6.4 / Consideration of M/s Arystra Life Science India Pvt. Ltd. for grant of registration for import of Quizalofop Ethyl 5% EC under Section 9(3)
The Committee deliberated the agenda in detail and noted that quizalofop ethyl is banned for use as pesticide in Norway from 1989. However, the Committee noted that the substance has never been used in the country. Further the Committee noted that the application for this pesticide is for registration for use on soyabean, the crop not grown in Norway and this pesticide is used in other countries like Japan, France, USA etc. After detailed deliberation, the Committee approved the registration under Section 9(3).
Agenda item No 7.0 /

Applications for registration under Section 9(4)

The Committee approved 1291 applications as proposed in the agenda. Further for the products at S.No. 22, 340, 400, 584, 739 & 1110, it was decided to issue the certificate of Registration as streptomycin sulphate + Tetracycline Hydrochloride 90:10 as per the earlier decision of the Registration Committee.
Agenda item No 7.1 / Consideration of application of M/s Gharda Chemicals Ltd., Mumbai u/s 9(4) for grant of registration of Glyphosate Technical for indigenous manufacture
Approved.
Agenda item No 7.2 / Consideration of an application of M/s Intech Pharma Pvt. Ltd., New Delhi u/s 9(4) for grant of registration of Methyl Bromide Technical for indigenous manufacture
Approved.
Agenda item No 7.3 / Consideration of application of M/s Hyderabad Chemical Products Limited, Hyderabad under Section 9(4) for grant of Registration of Triazophos Liquid Concentrate for indigenous manufacture
Approved.
Agenda item No 7.4 / Consideration of application of M/s Sabero Organics (SOGL), Mumbai under Section 9(4) for grant of registration of Dichlorvos Technical for indigenous manufacture.
Approved.
Agenda item No 7.5 /

Consideration of application of M/s Punjab Chemicals & Pharmaceuticals Limited (PC&PL), Chandigarh under Section 9(4) for grant of registration of Cartap Hydrochloride Technical for indigenous manufacture

Approved.
Agenda item No 7.6 /

Consideration of application of M/s Krishi Rasayan (P) Limited, Kolkatta under Section 9(4) for grant of registration of Ethepon Technical for indigenous manufacture.

Rejected, since the in-process sample of the applicant was not comparable with that of the reference standard, the application does not qualify for grant of registration under Section 9(4).
Agenda item No 8.0 /

Miscellaneous Items

Agenda item No 8.1 /

Statement showing the endorsement cases complete from all disciplines

Approved.
Agenda item No 8.2 /

Consideration of application of Central Warehousing Corporation, New Delhi for endorsement of change of source for import of Methyl bromide

Approved.
Agenda item No 8.3 /

Consideration of application of M/s Makhteshim Agan India Pvt. Ltd., Mumbai for endorsement of additional source for import of Propiconazole technical

Approved.
Agenda item No 8.4 /

Consideration of application of M/s UPPER India Tannery (P) Ltd. for grant of registration permit to import the TCMTB for use in industrial purpose or non-agricultural purpose/household

Approved the permission for import of 2 MT of TCMTB 30%
Agenda item No 8.5 /

Consideration of applications for issue of clarification for import of chemicals not included in the Schedule to the Insecticides Act, 1968

The Committee noted that these are not in the schedule and therefore, does not fall under the purview of the Insecticides Act, 1968. Accordingly, a letter may be issued by Secretary (CIB&RC) to such applicants that this chemical is not included in the Schedule to the Insecticides Act, therefore, does not fall under the purview of the Insecticides Act, 1968, as on date. Further, since these have insecticidal activity and therefore may be taken to Central Insecticides Board for inclusion in the Schedule.
Agenda item No 8.6 /

Consideration applications for import of sample quantity for research test & trial purpose

Approved.
Agenda item No 8.7 /

Consideration request of M/s Shreeji Dyestuff Industries, Ahmedabad for issue of NOC for clearance of sample shipment from customs Air Cargo Ahmedabad

The Committee decided as under:-
Sl.No. 1 & 2 : Clarification as indicated in the agenda may be sought from the applicants for
banana plastic bags (neem oil base, ethylene scavenger base);
Sl.No. 3 : Since this is not included into the schedule, they should be informed that at
present it is not included in the schedule and therefore, does not fall under the
purview of the Insecticides Act, 1968. Further, since the chemical has micro-
biocide activity, therefore, details may be sought from the applicant for
inclusion in the schedule.
Sl.No.4 : A quantity of 5 litres as mentioned in the agenda may be permitted for
import.
Sl.No.5 : It is an insecticide, therefore, the applicant may be advised to apply for
registration as per the provisions of the Insecticides Act, 1968.
Agenda item No 8.8 /

Permission to use stocks of M/s Rallis India Ltd. in the old name of M/s Ralchem Ltd. upto their shelf-life period

Deferred, as the Committee noted that huge quantity of stocks are lying and are date expired. Therefore, the Committee decided to seek clarification from the applicant and also the information with respect to the date of change of company’s name.
Agenda item No 8.9 /

Ex-post facto approval for Import permits issued

Approved.
Agenda item No 8.10 /

Permission to use stocks of M/s Biostadt India Limited in the old name of M/s Wockhardt Life Sciences Limited upto their shelf-life period.

Deferred, as the Committee noted that some of stocks are date expired. Therefore, the Committee decided to seek clarification from the applicant and also the information with respect to the date of change of company’s name.
Agenda item No 8.11 /

Endorsement of approval for extension of bioefficacy claims on labels/leaflets of Ethion 50% EC

Approved, except items at Sl.No.6, 10 and 11.
Agenda item No 8.12 / Approval of Protocols
Approved.
Any other item with the permission of the Chair:
It was informed by Secretary (CIB&RC) that as per the communication received from Additional Director General (PFA) on 12th July, 2004, the Maximum Residue Limits (MRL) for Benfuracarb on red gram and rice; Bifenthrin on cotton seeds; and quizalofop ethyl on soya bean have been approved by the Department of Health, Ministry of Health & Family Welfare. They have requested that after the pesticides are granted necessary approval/registration under the Insecticides Act, 1968, a copy of the Registration Certificate and approved labels for those pesticides may be sent to the Department of Health for taking further necessary action i.e for notifying the MRL under Rule 65 of PFA Rule, 1955. Further, they have mentioned that the registration granted by the Registration Committee, will, however, be reckoned as provisional, pending notification for the MRL under PFA Rules, 1955. The copy of the communication received is at Annexure-1. The Secretary also apprised the Committee regarding the communication sent by her to Ministry of Health & Family Welfare. A copy of the communication is at Annexure-2. After perusing, the Committee decided that under the Insecticides Act, 1968 registration under Section 9(3) are regular and cannot be reckoned as provisional.

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