Minutes of the 260th meeting of the Registration Committee held on 17.01.2006 in Committee Room No.142, Krishi Bhavan, New Delhi
The 260th meeting of the Registration Committee (RC) was held under the Chairmanship of Dr. N.B. Singh, Agriculture Commissioner on 17th Jan. 2006 in Krishi Bhavan, New Delhi. Dr. P.S. Chandurkar, Plant Protection Adviser to the Govt. of India, Dr. T.P. Rajendran, ADG (PP), ICAR, Dr P.N. Maji, Addl. Industrial Adviser, Ministry of Chemicals & Petrochemicals 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, Joint Director (Chemistry)
(ii) Sh.Vipin Bhatnagar, Joint Director Chemistry.)
(iii) Dr. Ravi Prakash, Joint Director (Bio)
(iv) Dr.Mukul Singh, Deputy .Director(Medical.)
(v) Dr. Subhash Kumar, Agro (H)
(vi) Smt. Kanta Arora, AO (CIB&RC)
(vii) Sh.R.C. Gulati, Section Officer
(vii) Sh. Niraj Kulshrestha, Assistant (Legal)
At the outset the Chairman welcomed the participants and requested Secretary, CIB&RC to take up Agenda for discussions. The following decisions were taken:
Agenda item No 1.0 /Confirmation of minutes of the 259th meeting of the Registration Committee
The minutes of the 259th meeting of the Registration Committee were confirmed.Agenda item No 2.0 /
Follow up action on the decision taken by the Registration Committee in its 258th & 259th meeting.
The Committee noted with satisfaction the follow up actions on the decisions taken in 258th and 259th Registration Committee Meetings.Agenda item No 2.1 / Applications pending under various Sub-Sections of the Insecticides Act, 1968
The Committee noted the statement regarding applications pending under various Sub-sections.
Agenda item No 3.0 /
Government Business
Agenda item No 3.1 /Revised guidelines for registration under export category
ANDAgenda item No 3.2 / Guidelines for minimum infrastructural facilities to be created by the manufacturers.
AND
Agenda item No 3.3 / Guidelines for indigenous manufacture of chemicals figuring in the Schedule for non-insecticide use
It was decided to defer these policy issues for the next meeting of the RC
Agenda item No 3.4 / Proposals for adoption of alternative test (OECD test guidelines 420, 423 and 425) in place of the classical LD 50 test (401) for acute oral toxicity and review of the toxicity classification under the Insecticides Rules, 1971.
The Committee noted the decision of the Central Insecticides Board. The committee decided that the studies conducted as per the alternative tests of OECD test guidelines 423 and 425 may continued to be accepted. Further, as and when WHO classification of pesticides by hazards is revised, the proposal be put up to CIB to amend the Insecticides Rules with reference to toxicity classification.
Agenda item No 3.5 / Consideration of suggestion made by Additional Secretary & Development Commissioner (SSI) on accepting recommendation of DICs/States regarding quantities for import of Boric Acid for non-insecticidal use.
The members deliberated the agenda in detail and decided that the Registration Committee is following the directives as given by Department of Agriculture & Cooperation, Ministry of Agriculture. As per those directives, the recommendations of nodal Department / Ministry are required to be furnished by the applicants and therefore, the letter may be referred to DAC. In the meanwhile the recommendations of the nodal Department / Ministry will continue to be considered.
Agenda item No 3.6 / Finalization of modalities for drawl of in-process samples, their analysis and submission of Analysis Test Reports (ATRs) for considering applications for grant of registration for indigenous manufacture of Technical Grade Insecticides under Section 9 of the Insecticides Act, 1968.
The Committee decided to constitute a Committee under the Chairmanship of Dr. P.S. Chandurkar, Plant Protection Adviser to the Government of India with the following members to finalise the modalities for drawl of in-process samples:
i) Dr. T.P. Rajendran, ADG(PP), ICAR.
ii) Dr. O.P. Dubey, ADG, ICAR
iii) Shri Vipin Bhatnagar, Joint Director (Chemistry), Sectt. Of CIB&RC.
The Group may be requested to submit its report within a period of one month.
Agenda item No 3.7 / Issue of import permit for Boric Acid & Other substances for non-insecticidal use.
The members deliberated the applications in detail and decided as per enclosed Annexure- I. The Committee also decided that only complete applications as per guidelines till cut off date of agenda be put up to the Registration Committee for consideration. Further, it was decided that in case of deficient applications, deficiencies may be issued twice at an interval of 30 days each, after which the application be rejected and case may be closed.
Agenda item No 3.8 / Submission of Report of the Core Group of Experts constituted by the Registration Committee to examine the total data available with the Secretariat of CIB & RC and the Pesticide Industry in respect of Deemed Registered Pesticide (DRP).
The Committee deliberated the agenda in detail and noted that the draft notification has already been published on the recommendations of the Core Group which were accepted by the Registration Committee and therefore, decided that M/s Indofil Chemical Company, Mumbi may be asked to furnish their request / comments to the Department of Agriculture & Cooperation with respect to the notification.
Agenda item No 4.0 /
Export Cases
Agenda item No 4.1 /Applicants as per details at Annexure 4.1 have applied for grant of registration of the already registered technical / formulation having the same lower and higher concentration / new concentration for export under Section 9(3)
ApprovedAgenda item No 4.2 / Consideration of application of M/s. United Phosphorus Ltd., Gujarat for grant of registration for indigenous manufacture of Oryzalin 48% w/v SC (Herbicide) under Section 9(3) for export only.
Approved
Agenda item No 4.3 / Consideration of application of M/s. United Phosphorus Ltd., Gujarat for grant of registration for under Section 9(3) for export only.
Approved with the following conditions:
“It was decided to put a condition on the certificate of registration that the product is extremely irritant to eyes and therefore provide all necessary protective devices to the workers to ensure their safety during manufacture / handling etc. Also a cautionary statement may be included on the label & leaflet in bold letters indicating that the product is extremely irritant to eyes.”
Agenda item No 4.4 / Consideration of application of M/s. Transchem Limited, Thane (West), Maharashtra for grant of registration for indigenous manufacture of Azamethiophos tech (Insecticides) under Section 9(3) for export only.
The Committee deliberated the agenda in detail and decided to seek additional information on mutagenicity studies and registration / ban / restriction status of the product in other countries.
Agenda item No 4.5 / Consideration of application of M/s. Agrolex (India) Industries, New Delhi for grant of registration for indigenous manufacture of Abameactin tech. (Insecticides) under Section 9(3) for export only.
Approved.
5.0 /
9(3B) Cases
Agenda item No 5.1 / Consideration of application of M/s. Viswa Mithra Bio Agro P. Ltd., Guntur for grant of registration for indigenous manufacture of Beauveria bassiana 1.15% WP under Section 9(3B)The Committee deliberated the agenda in detail and decided that the same may be brought to the Registration Committee in the next meeting with file.
Agenda item No 5.2 / Consideration of application of M/s. Micoplex (India) for grant of registration for indigenous manufacture of Beauveria bassiana 1.15% WP under Section 9(3B).
The Committee deliberated the agenda in detail and decided that the same may be brought to the Registration Committee in the next meeting with file.
Agenda item No 5.3 / Consideration of application of M/s. Micoplex Biotech & Agrochem Pvt. Ltd., Wardha for grant of registration for indigenous manufacture of Trichoderma Viride 1% WP under Section 9(3B).
Approved for 2 years with commercialization.
Agenda item No 5.4 / Consideration of application of M/s. Viswa Mithra Bio Agro Pvt. Ltd., Guntur for grant of registration for indigenous manufacture of Verticillium Lecanii (CFU 1 x 108/gm min) (Insecticide) under Section 9(3B)
The Committee deliberated the agenda in detail and decided that the same may be brought to the Registration Committee in the next meeting with file.
Agenda item No 5.5 / Consideration of application of M/s. Viswa Mithra Bio Agro Pvt. Ltd., Guntur for grant of registration for indigenous manufacture of Metarhizium Anisopliae (CFU 1 x 108/gm min) (Insecticide) under Section 9(3B).
The Committee deliberated the agenda in detail and decided that the same may be brought to the Registration Committee in the next meeting with file.
Agenda item No 5.6 / Consideration of application of M/s. PNP Associates Pvt. Ltd., Faridabad for extension of registration of Forchlorfenuron 0.12% w/w (EC) for import under Section 9(3B) with commercialization.
The Committee deliberated the agenda in detail and did not approved the request of the applicant for extension of provisional registration for import of CPPU because no further data has been submitted despite importing the quantity.
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/rejected/deferred the applications as per Annexure-II
Agenda item No 7.2 / Withdrawal of applications under Section 9(4) by M/s. Insecticide India Ltd.
The Committee deliberated the agenda in detail and agreed to the request of M/s Insecticide India Limited to withdraw the files.
Agenda item No 7.3 / Consideration of an application of M/s. Sudarshan Chemical Industries Ltd., Pune under Section 9(4) for grant of registration of Acetamiprid Tech for indigenous manufacture.
Approved.
Agenda Item No. 8.0 /
Miscellaneous Items
Agenda item No 8.1 / Consideration of request of M/s. BASF India Ltd., Mumbai for change in the name of source of import of Dimethomorph technical – reg.Approved.
Agenda item No 8.2 / Request for endorsement of bigger size packaging of 10 litre, 20 litre capacity Aluminium drums on Certificate of Registration No.CIR-43088/2003-Propargite (EC) (230)-4 – proposed by M/s. P.I. Industries Ltd., Udaipur.
AND
Agenda item No 8.3 / Request for endorsement of bulk packing of 5, 10, 20 & 25 Kgs. capacity G.I. drums with LDPE liner of thickness not less than 0.062mm, conforming to IS: 2552 :1989 for Sulfosulfuron 75% WG – proposed by M/s. Gharda Chemicals Ltd., Mumbai.
AND
Agenda item No 8.4 / Approval of bulk packing of Monocrotophos, Dichlorvos 76% and Quinalphos 25% EC – proposed by M/s. Cheminova India Ltd.
AND
Agenda item No 8.5 / Endorsement of 50ml pack size in respect of Alphacypermethrin 10% EC and Alphacypermethrin 1% + Chlorpyriphos 16% EC of M/s. Gharda Chemicals Ltd.
AND
Agenda item No 8.6 / Request for endorsement of additional packaging of 50ml, 100ml capacity for export only on Certificate of Registration No.CIR-39681/2002-Alphacypermethrin (WP) (222)-400 - proposed by M/s. Gharda Chemicals Ltd.
AND
Agenda item No 8.7 / Request for endorsement of bulk packing of 25, 50, 100, & 200 Litres HMHDPE drums for Imidaclorprid 17.8% SL - proposed by M/s. Gharda Chemicals Ltd.
The Committee decided to discuss these applications in the presence of Packaging Expert which it has decided to co-opt from Indian Institute of Packaging and therefore, decided to defer these applications.
Agenda item No 8.8 / Endorsement of revised shelf life for 24th months in the Certificate of Registration – request from M/s. BASF India Ltd., Mumbai.
Deferred due to paucity of time.
Agenda item No 8.9 / Consideration of Extension of Bioefficacy claim of Imidacloprid 48% FS in favour of M/s. Bayer India Ltd., Mumbai.
The Committee deliberated the agenda in detail and noted the comments of ICAR wherein it has been mentioned that most of the universities / institutes informed that Imidacloprid 48% FS has not been evaluated / tested and therefore, rejected the application. Further, the Committee decided that a show-cause notice may be issued to the applicant to explain the reasons of submission of ingenuine data on bioefficacy.
Agenda item No 8.10. / Ex-post facto approval for import permits issued
Approved.
Agenda item No 8.11 / Consideration of request of M/s. Saraswati Agro Chemicals (India) Pvt. Ltd., Unit No.2, Barhi Brahmna, Jammu for endorsing the shelf life of Triazophos 40% EC (Hostathion) as two years in their Certificate of Registration (CR)
The Committee opined that since this matter falls under the purview of Central Insecticides Board, therefore, may be referred to it.
Agenda Item No. 9 / Any other item with the permission of the Chair.
i) Presentation by M/s Bayer Cropscience on Tebuconazsole 250 EW formulation.
With the prior approval of the Chairman, Registration Committee, representatives of M/s Bayer Cropscience presented their views with reference to non-approval of Tebuconazole 250 EW by the Registration Committee due its being severely irritant to eyes. They have presented worldwide registration overview of the product and risk investigation and management of eye irritation potential, product stewardship measures & programme they propose to undertake if the product is approved for registration.
ii) Presentation by M/s United Phosphorus Ltd. for approval of Cypermethrin 3% Smoke Generator for use by public.
With the prior approval of the Chairman, Registration Committee and as per the request of M/s United Phosphorus Ltd., the presentation was made by Dr. Ajit Kumar of United Phosphorus Ltd. in front of the Registration Committee.
iii) The need for review of data submission / protocol requirement for bio-pesticides.
The Chairman pointed out that the guidelines for registration of bio-pesticides under Section 9(3B) from bio-efficacy are very vague as its require submission of results of some studies. The guidelines should be made more objective. Secretary, CIB&RC pointed out that there is a request from DBT to prepare the guidelines for Myrochecium verucarria. Further the DBT has also requested to relook the limit of contamination and the toxicity data requirement of bio-pesticides. The Committee decided that a Group may be constituted to review the guidelines and composition of the Group may be put up to the next meeting of the RC.
The meeting ended with a Vote of Thanks to the Chair.
8
ANNEXURE-I
(Minutes of 260th RC)
A. Decision on applications for import of Boric Acid for non-insecticidal use (pending from 259th meeting of the RC)