MINUTES of 320Th MEETING of REGISTRATION COMMITTEE HELD on 30.06.2011 at 10.30 A.M. IN

MINUTES OF 320th MEETING OF REGISTRATION COMMITTEE HELD ON 30.06.2011 AT 10.30 A.M. IN COMMITTEE ROOM NO-139, AT KRISHI BHAVAN, NEW DELHI.

The 320th meeting of Registration Committee (RC) was held under the Chairmanship of Dr. Gurbachan Singh, Agriculture Commissioner on 30.6.2011 in Committee Room No. 139, Krishi Bhavan, New Delhi. Dr. V.K. Yadava, Plant Protection Adviser to the Government of India;Dr. T.P. Rajendran, ADG (PP), ICAR; Dr. D. Kanungo, Addl. DG, MOH&FW, New Delhi, and Dr. A.K. Sinha,Addl. Plant Protection Adviser (CIB&RC) attended the meeting. Dr. (Mrs.) Sandhya Kulshrestha, Consultant, MOH&FW also attended the meeting. Following Officers from the Secretariat of CIB&RC were also present:-

(i)Dr. B.S. Phogat, Joint Director (WS)

(ii)Dr. B. Tripathi, Deputy Director (WS).

(iii)Dr. Arnab Das Gupta, DD (PP)

(iv)Shri B.N. Jha, DD (C)

(v)Dr. Subhash Kumar, Assistant Director (WS)

(vi)Shri Dipankar Bhattacharya, Assistant Director (Chem.)

(vii)Dr. Vandana Seth, Assistant Director (Chem.)

(viii)Ms. Kamlesh Miglani, Assistant Director (Chem.)

(ix)Shri D.S. Sehrawat, PPO (Pack.)

(x)Shri S.K. Verma, SO (CIR-II)

(xi)Sh. Niraj Kulshrestha, Assistant (Legal)

At the outset, the Chairman welcomed the members and experts of Registration Committee and requested APPA (CIB&RC) to take up the agenda, item-wise for discussions and the following decisions were taken by the RC:-

Agenda item No. /

Particulars of Agenda

1.0 /

Confirmation of minutes of the 319th meeting of the Registration Committee.

While discussing about the confirmation of the minutes Dr. D. Kanungo, Member, RC pointed out to the recording of the minutes of the foregoing agenda item

(i)The following may be inserted in the introductory para of minutes of 319th RC.
“At the outset, the Chairman welcomed the members and experts of Registration Committee and informed the Committee that the sub-committee constituted under the chairmanship of Dr. D. Kanungo, Additional DG, Ministry of Health and FW “to harmonize the Toxcicological Data requirement for registration of pesticides with OECD and EU data requirement” has submitted its report. The chairman showed the copy of the report i.e. “Kanungo Committee Report” to all present in the meeting and the RC appreciated the efforts made by Dr. D. Kanungo and members of the sub-committee as the report was submitted in a remarkable shortest possible time.
(ii) Agenda item No. 6.3 – It was clarified in the meeting that as per the guidelines and checklist in 315th and 317th Meeting of Registration Committee, no data other than required to ascertain the chemical equivalence,on any of the parameters viz; Chemistry, Bio-efficacy, Toxicity and Packaging is required in case of identical chemical composition for the same label claims under FIM Vs. FIT category.Hence, there is no need to change the decision of RC and the case stands approved.
(iii) A meeting of Dr. (Mrs.) Sandhya Kulshreshtha, Consultant (Pharma)alongwith applicant and scientist of DRDO be fixed up for clarification on the toxicity issue and the complete case be brought in the next RC Meeting.
1.2 /

Report of the Committee on reply of Show Cause Notice Submitted by M/s Biotech International Ltd., New Delhi, in respect of registration of Bacillus thuringiensis var. israelensis (Bti) technical and formulation.

The committee deliberated the agenda in detail and accepted the report submitted by the Fact Finding Committee. The Committee took a view that the applicant has provided the required data and information, as reply to the Show-cause Notice. Further, it was decided that the 9 (3) registration of Bacillus thuringiensis var. israelensis (Bti) technical and formulation is valid as per the information on the Certificate and label leaflet. It was, however, decided that the user agencies and the concerned state governments may ensure potency of the formulation(s) and regularly evaluate that in reputed and ICMR accredited/designated laboratories, before being used in public health to bring in the desired suppression of vector mosquitoes.
2.0 /

Follow up action on the decision taken by the Registration Committee in its 319th meeting.

Noted with satisfaction.

2.1 / Applications pending under various sub-sections of the Insecticides Act, 1968.
Noted with satisfaction. As the inflow of applications and outflow of Registration Certificates are almost same therefore, it is very difficult to reduce the pendency. However, the committee decided that extra effort be made for reducing the pendency in the Sectt. of CIB&RC.
2.2 / Presentation of M/s Vestergaard Frandsen (I) Pvt. Ltd., New Delhi for the guidelines of Insecticide in corporate wall lining – Zero Vector Durable Lining – reg.
RC decided that materials presented in the meeting be examined by the Secretariat for a view to be taken.
2.3 / Presentation of M/s M.B. Sales Corporation, Mumbai for the import permit for chemicals for non-insecticidal use regarding.
RC decided that materials provided in the meeting be examined by the Secretariat for a view to be taken in the next meeting.
2.4 / Presentation of M/s Shreeji Impex, Mumbai for the Import Permit for Chemicals for non-insecticidal use regarding.
RC decided that materials provided in the meeting be examined by the Secretariat for a view to be taken in the next meeting.
3.0 / Government Business
3.1 /

Decision of Appellant Authority on Appeal No. 1 of 2011 M/s Crystal Phosphates Ltd., (CPL) regarding registration of Abamectin Technical and formulation.

As per Decision of the Appellate Authority, the RC decided to constitute a committee for the purpose and directed to submit the report in the next RC meeting:-

(i)Dr. B.S. Phogat, JD (WS)
(ii) Dr. R.M. Shukla, JD (E)
(iii) Dr. B.N. Jha, DD (Chem.)
(iv)Shri Niraj Kulshreshtha, LA (by C.A)
3.2 / Consideration of the decision of the Appellate Authority Appeal No. 6 of 2010, filed by M/s Global Exim, Mumbai
Noted.
3.3 / Regulation of manufacture and import of multi-use insecticides.
The issue was deliberated in detail. The committee was of the view that since no applicant for Boric Acid Indegenous Manufacture are coming forward for the grant of registration and also not providing information for the quantity being manufactured annually so as to explore the possibility of regulating them. It was therefore, decided that a detailed policy paper may be sent to DAC to take up the issue with the committee of Secretaries by referring the earlier correspondence on the issue. Sectt. of CIB&RC has also made several efforts with Department of Chemicals and Petro Chemicals, Ministry of Chemicals and Fertilizers, Shastri Bhavan, New Delhi on this issue but no concrete information has been provided by them as there is no restriction on sale of Boric Acid for non-insecticidal use from the Ministry.
3.4 / Checklist for submission of application for RTT extension of shelf-life u/s 9(3B)/9(3), endorsement of extension of validity of Registration Certificate(s) u/s 9(4) and duplicate C.R. – Follow-up action of 319th RC meeting.
Approved as at Annexure-I.
3.5 / Guidelines for import of technical grade pesticides from New Source for export.
The agenda was deliberated in detail and committee noted that applicant has not submitted any new facts which was deliberated in 291st Meeting of RC. Hence, committee decided not to amend the existing guidelines for export or addition of new condition.
3.6 / WP(C) No. 2071 of 2011 in the matter of M/s Crystal Phosphate Limited Vs. Union of India & Other in the High Court of Delhi.
The issue was deliberated in detail. The RC took the note of the decision of the Hon’ble High Court. In view of the directives of the Hon’ble High Court of Delhi for thoroughly examining the complaints with regards to source of import. The RC decided to constitute a committee comprising of
Dr. A.K. Sinha, APPA (CIB&RC) - Chairman
Dr. V.T. Gajbhiye, Head, Division of Agricultural Chemical, IARI
Shri Vipin Bhatnagar, JD (Chem), CIL
Dr. (Mrs) Vandana Seth, AD (Chem.), CIR, Member Secretary
Shri Niraj Kulshreshtha, LA, CIR
The committee should submit its report before one week of the next RC meeting positively.
3.7 / Continuation of Chairmanship of sub-committee (s) of RC after superannuation of Dr. D. Kanungo- reg.
The committee deliberated the agenda in detail and decided that Dr. D. Kanungo may continue as a Chairman of the Sub-Committee (S) and Expert Committee constituted by the RC Committee. However, Committee further decided that administrative opinion on the issue may be obtained from DAC.
4.0 / Export Cases
4.1 / List under section 9(3) Export of applications
5.0 / 9(3B) Cases
5.1 / Consideration of application of M/s Bio-Control Laboratory, Varanasi for grant of registration for indigenous manufacture of Bacilliusthuringiensisvar kurstaki (Secrotype 3a3b3c) 0.5% WP (Strain: DOR Bt – I) under Section 9(3B).
Approved with commercialization for a period of two years subject to submission of registration code number with respect to deposition of microbial strain in the formulation in National Repository as per decision of 314th meeting of RC.
5.2 / Consideration of application of M/s Bio-Control Laboratory, Meerut for grant registration for indigenous manufacture of NPV of Helicoverpa armigera 2% AS under section 9(3B)
Approved with commercialization for a period of two years subject to submission of registration code number with respect to deposition of microbial strain in the formulation in National Repository as per decision of 314th meeting of RC.
5.3 / Consideration of application of Deptt. of Agriculture (Plant Protection), Lucknow for the grant of registration for indigenous manufacture of NPV of Helicoverpa armigera 2.0% AS under section 9(3).
This is the 9(3) case,inadvertently appeared in 9(3B). Decision on this agenda is available at 6.2 u/s. 9(3).
5.4 / Consideration of application of M/s Agri Life, Medak Dist., (A.P.) for grant of registration for indigenous manufacture of Paecilomyces lilacinus 1.0% WP u/s 9(3B).
Approved with commercialization for a period of two years subject to submission of registration code number with respect to deposition of microbial strain in the formulation in National Repository as per decision of 314th meeting of RC.
5.5 / Consideration of application of M/s Jyothiraditya Bio Solutions Ltd., Mysore for grant of registration for indigenous manufacture of Paecilomyces lilacinus 1.0% WP u/s 9(3B).
Approved with commercialization for a period of two years subject to submission of registration code number with respect to deposition of microbial strain in the formulation in National Repository as per decision of 314th meeting of RC.
5.6 / Consideration of application of M/s Viswa Mithra Bio Agro (P) Ltd., Guntur Dist., (AP) for grant of registration for indigenous manufacture of Paecilomyces lilacinus 1.0% WP u/s 9(3B).
Approved with commercialization for a period of two years subject to submission of registration code number with respect to deposition of microbial strain in the formulation in National Repository as per decision of 314th meeting of RC.
5.7 / Consideration of application of M/s Srikar Biotech Pvt. Ltd., Hyderabad for grant of registration for indigenous manufacture of Verticillium lecanii 1.15% WP u/s 9(3B).
Approved with commercialization for a period of two years subject to submission of registration code number with respect to deposition of microbial strain in the formulation in National Repository as per decision of 314th meeting of RC.
5.8 / Consideration of application of M/s Poshak Bio research (P) Ltd., Gujarat for grant of registration for indigenous manufacture of Bacillius thuringiensis var kurstaki (Secrotype 3a3b3c) 0.5% WP (Strain: DOR Bt-1) under section 9(3B).
Approved with commercialization for a period of two years subject to submission of registration code number with respect to deposition of microbial strain in the formulation in National Repository as per decision of 314th meeting of RC.
5.9 / Consideration of application of M/s Agro Biotech Research Centre, Kottoyam for grant of registration for indigenous manufacture of Bacillius thuringiensis var kurstaki (Secrotype 3a3b3c) 0.5% WP (Strain: DOR Bt-1) under section 9(3B).
Approved with commercialization for a period of two years subject to submission of registration code number with respect to deposition of microbial strain in the formulation in National Repository as per decision of 314th meeting of RC.
5.10 / Consideration of application of M/s Ruchi Biochemicals, Goregaon, Mumbai for grant of registration for indigenous manufacture of Bacillius thuringiensis sarovar kurstaki (Secrotype 3a3b3c) 0.5% WP (Strain: DOR Bt-1) under section 9(3B).
Approved with commercialization for a period of two years subject to submission of registration code number with respect to deposition of microbial strain in the formulation in National Repository as per decision of 314th meeting of RC.
5.11 / Consideration of application of M/s Hindustan Bioenergy Ltd., Lucknow for grant of registration for indigenous manufacture of Bacillus thuringiensis var kustaki (Secrotype 3a3b3c) 0.5% WP (Strain: DOR Bt-1) under section 9(3B).
Approved with commercialization for a period of two years subject to submission of registration code number with respect to deposition of microbial strain in the formulation in National Repository as per decision of 314th meeting of RC.
5.12 / Consideration of application of M/s Nitapol Industries, Kolkatta for grant of registration for indigenous manufacture of Bacillus thuringensis var kurstaki (Secrotype 3a3b3c) 0.5% WP (Strain: DOR Bt-1) under section 9(3B).
Approved with commercialization for a period of two years subject to submission of registration code number with respect to deposition of microbial strain in the formulation in National Repository as per decision of 314th meeting of RC.
5.13 / Consideration of application of M/s Excel crop Care Ltd., Mumbai for grant of registration for indigenous manufacture of Verticillium Chlamydosporium 1.0% WP u/s 9(3B).
Approved with commercialization for a period of two years subject to submission of registration code number with respect to deposition of microbial strain in the formulation in National Repository as per decision of 314th meeting of RC.
5.14 / Consideration of application of M/s Biosys Agrotech Pvt. Ltd., Mamdsaur for grant of registration for indigenous manufacture of Pseudomonas fluorescens 0.5% WP u/s 9(3B).
Approved with commercialization for a period of two years subject to submission of registration code number with respect to deposition of microbial strain in the formulation in National Repository as per decision of 314th meeting of RC.
5.15 / Consideration of application of M/s Unique Bio-tech Ltd., Hyderabad for grant of registration for indigenous manufacture of Trichoderma viride 1% WP u/s 9(3B).
Approved with commercialization for a period of two years subject to submission of registration code number with respect to deposition of microbial strain in the formulation in National Repository as per decision of 314th meeting of RC.
5.16 / Consideration of application of M/s Esvin Advanced Technologies Ltd., Chennai for grant of registration for indigenous manufacture of Psedudomonas fluorescens 0.5% WP u/s 9(3B).
Approved with commercialization for a period of two years subject to submission of registration code number with respect to deposition of microbial strain in the formulation in National Repository as per decision of 314th meeting of RC.
5.17 / Consideration of application of M/s Romvijay Biootech Pvt. Ltd., Pondichery for grant of registration for indigenous manufacture of Pseudomonas fluorescens 1.0% WP u/s 9(3B).
Approved with commercialization for a period of two years subject to submission of registration code number with respect to deposition of microbial strain in the formulation in National Repository as per decision of 314th meeting of RC.
5.18 / Consideration of application of M/s Aviral Bio-tech & Fertilizer Pvt. Ltd., Bhopal for grant registration for indigenous manufacture of Pseudomonas fluorescens 0.5% WP u/s 9(3B).
Approved with commercialization for a period of two years subject to submission of registration code number with respect to deposition of microbial strain in the formulation in National Repository as per decision of 314th meeting of RC.
5.19 / Consideration of application of M/s Roshan Bio & Naturals, Delhi for grant of registration for indigenous manufacture of Beauveria bassiana 1.15% WP under section 9(3B).
Approved with commercialization for a period of two years subject to submission of registration code number with respect to deposition of microbial strain in the formulation in National Repository as per decision of 314th meeting of RC.
5.20 / Consideration of application of M/s Romvijay Biootech (P) Ltd., Pondicherry for grant of registration for indigenous manufacture of Trichoderma harzianum 1.0% WP 9(3B).
Approved with commercialization for a period of two years subject to submission of registration code number with respect to deposition of microbial strain in the formulation in National Repository as per decision of 314th meeting of RC.
5.21 / Consideration of application of M/s Bharat Biocon Pvt. Ltd., New Delhi for grant of registration for indigenous manufacture of Verticillium Lecanii 1.15% WP u/s 9(3B).
Approved with commercialization for a period of two years subject to submission of registration code number with respect to deposition of microbial strain in the formulation in National Repository as per decision of 314th meeting of RC.
5.22 / Consideration of application of M/s Bharat Biocon Pvt. Ltd., New Delhi for grant of registration for indigenous manufacture of Pseudomonas fluorescens 0.5% WP u/s 9(3B).
Approved with commercialization for a period of two years subject to submission of registration code number with respect to deposition of microbial strain in the formulation in National Repository as per decision of 314th meeting of RC.
5.23 / Consideration of application of M/s Jayco Chemicals India Ltd., Hapur for grant of registration for indigenous manufacture of Trichoderma viride 1.0% WP u/s 9(3B).
Approved with commercialization for a period of two years subject to submission of registration code number with respect to deposition of microbial strain in the formulation in National Repository as per decision of 314th meeting of RC.
5.24 / Consideration of application of M/s Excel Crop Care Ltd., Mumbai for grant of registration for indigenous manufacture of Paecilomyces lilacinus 1.0% WP u/s 9(3B).
Approved with commercialization for a period of two years subject to submission of registration code number with respect to deposition of microbial strain in the formulation in National Repository as per decision of 314th meeting of RC.
5.25 / Consideration of application of M/s Bharat Biocon Pvt. Ltd., New Delhi for grant of registration for indigenous manufacture of Beauveria bassiana 1.15% WP under section 9(3B).
Approved with commercialization for a period of two years subject to submission of registration code number with respect to deposition of microbial strain in the formulation in National Repository as per decision of 314th meeting of RC.
5.26 / Consideration of application of M/s Bharat Biocon Pvt. Ltd., New Delhi for grant of registration for indigenous manufacture of Bacillus thuringiensis sarovar kurstaki (Secrotype 3a3b3c) 0.5% WP (Strain: DOR Bt-1) under section 9(3B).
Approved with commercialization for a period of two years subject to submission of registration code number with respect to deposition of microbial strain in the formulation in National Repository as per decision of 314th meeting of RC.
5.27 / Consideration of application of M/s Bharat Biocon Pvt. Ltd., New Delhi for grant of registration for indigenous manufacture of Paecilomyces lilacinus 1.0% WP u/s 9(3B).
Approved with commercialization for a period of two years subject to submission of registration code number with respect to deposition of microbial strain in the formulation in National Repository as per decision of 314th meeting of RC.
5.28 / Consideration of application of M/s Sun Agro Biosystem Pvt. Ltd., Chennai for grant of registration for indigenous manufacture of Trichoderma harzianum 1.0% WP under section 9(3B).
Approved with commercialization for a period of two years subject to submission of registration code number with respect to deposition of microbial strain in the formulation in National Repository as per decision of 314th meeting of RC.
5.29 / Consideration of application of M/s Nico Orgo Manure, Dakor (Gujarat) for 1st extension of provisional registration of Paecilomyces lilacinus 1.0% WP u/s 9(3B) for controlling various nematodes in different crops.
Extension is granted for the period of one year with commercialization from the date of issue of letter for extension.
5.30 / Request of M/s Sujay Biotech Pvt. LTd., Vijaywada (A.P.) for 1st time extension of validity period of provisional Certificate of Registration of Trichoderma viride 1% WP for one year with commercialization.
Extension is granted for the period of one year with commercialization from the date of issue of letter for extension.