Minutes of the 292nd meeting of the Registration Committee
held on 20.08.2008 at 10.30 A.M. in Room No.142, Krishi Bhawan, New Delhi.
The 292nd meeting of the Registration Committee (RC) was held under the Chairmanship of Dr. N.B. Singh, Agriculture Commissioner on 20.08.2008 at 10.30 A.M. in Krishi Bhavan, New Delhi. Dr. P. S. Chandurkar, Plant Protection Adviser to the Govt. of India, Shri A.B. Ramtake, Dy.DCG(I)(represented DCG(I), Dr. T.P. Rajendran, ADG(PP), ICAR(Special Invitee), Dr.P.N.Maji, (Special Invitee) and Dr. (Mrs.) S. Kulshrestha, Secretary, CIB&RC attended the meeting. Following officers from the Secretariat of CIB&RC were also present:
(i) Dr. S.K. Khurana, Specialist Gr. I
(ii) Dr. A.K. Sinha, Jt. Dir(PP)
(iii) Dr.B.S. Phogat, JD(Bio)
(iv) Shri Vipin Bhatnagar, Deputy Director(Chem)
(v) Dr. R.M. Shukla, Deputy Director(Ento.)
(vi) Dr. Subhash Kumar, Agro(H)
(vii) Dr.(Mrs.) Vandana Seth, AD(Chem)
(viii) Miss Kamlesh Miglani, AD(Chem)
(ix) Shri S.C. Verma, SO(CIR-II)
(x) Sh. Niraj Kulshrestha, Assistant(Legal)
At the outset the Chairman welcomed the participants and requested Secretary, CIB&RC to take up Agenda for discussion. The following decisions were taken:
Agenda item No. /Agenda item No.1.0 / Confirmation of minutes of the 292nd meeting of the Registration Committee
The Minutes of the 292nd meeting of the Registration Committee (RC) were confirmed.
Agenda item No.2.0 /
Follow up action on the decision taken by the Registration Committee in its 291st meeting.
The Committee noted with satisfaction the status of follow-up actions taken.Agenda item No.2.1 / Applications pending under various Sub-Sections of the Insecticides Act, 1968
The Committee noted the statement with reference to pending applications.
Agenda item No.2.2 / Presentation by the representative of M/s Syngenta India Ltd.
The Representative of M/s.Syngenta India Ltd. made presentation before the Registration Committee, clarifying the issues with reference to the doses recommended for use of Pirimiphosmethyl 50% E.C.s in polluted water. The Committee deliberated the agenda in detail and noted that the product was recommended in the doses of 12.5 gm/h for the same label claims earlier and, therefore, why it is now being proposed for use in doses of 200gm a.i./h has not been justified . Therefore, the Committee decided to seek the comments of M/o.Health & Family Welfare.
Agenda item No.2.3
/Presentation by the representative of M/s P.I.Industries Ltd., Gurgaon.
The Representative of M/s.P.I. Industries Ltd., presented the replies to the queries as raised by the Members during the presentation made in 291st Meeting of Registration Committee. Further, it was submitted that the product Bispyribac Sodium has low risk to human health and low toxicity to non-target organisms. It has low potential to contaminate ground water/surface water. The product is already registered in USA in 2001 and in Japan, Italy, Brazil and in 46 other countries, including tropical countries Sri Lanka, Thailand, Philippines, Vietnam and Malaysia and, therefore, considering the low toxicity of this herbicide and the fact that it is in use in countries with similar agro-climatic conditions, and that they had already submitted laboratory studies on goat, the applicant requested for waiver of Toxicity to livestock and health monitoring studies in applicators(field trials).
The Committee deliberated the issue in detail and considering the above facts approved the request of the applicant. However, the Committee decided a condition with reference to post-marketing surveillance of 20 volunteers for health monitoring studies to be incorporated on the certificate of Registration of the applicant. The result of this post-marketing surveillance be submitted within a period of two years as per the protocol to be approved by the Registration Committee.Agenda item No.3.0 /
Government Business
Agenda item No.3.1 /Minutes of the meeting with the Associations of Pesticide Industry held on 26.06.2008
The Committee approved the Minutes of the Meeting held on 26.6.2008 with the Associations of Pesticide Industry and decided as follows:-
1. Guidelines for relatively safer formulationThe Registration Committee reexamined the issue regarding guidelines registration of safer formulation indicated and noted that no objective criteria for the relatively safer formulation exists and, therefore, decided to maintain the status-quo.
2. Providing of factory address on label/leaflets:
The Committee deliberated the request of the industry and the problem faced by them in case of many factories wherein it is difficult to provide all factory addresses in short space on label/leaflets. Therefore, the Committee decided that address of the registered corporate office and of the factory where the product is manufactured be given on the label/leaflets.
3. Acceptance of Accelerated Storage stability Studies for shelf-life:
The Committee decided to seek the guidance on the matter from Scientific Advisory Committee on shelf-life of the Central Insecticide Board.
4. Toxicity data requirement for combination product :
The Committee deferred the decision on this issue, as it required detailed discussion and clarification on certain aspects. The Committee decided to discuss this aspect during the next meeting.
5. Review of toxicity data required to bring India in line with International practice:
The Registration Committee decided to constitute a group of Experts from Government and Industry to review and harmonize the toxicity data requirement for registration of pesticides with OECD..
6. Guidelines for the registration of seed treatment:The Committee decided that the comparative statement of the approved guidelines and as proposed by the Industry be brought to the next meeting of the Registration Committee for deliberation.
7. Removal of Consent letter for import of technical in case of 9(4) registration:
The Committee deliberated the issue in detail and decided to maintain the status-quo.
8. Guidelines for endorsement of Supplier’s name in case of technical formulations:
The Committee decided that the sources may supply the material directly for import or through their one or more authorized suppliers. The source for import should clearly indicate all the detail option in the consent letter.
Agenda item No 3.2 /
Clarification on issuance of Certificate of Registration for Technical Grade insecticide in case of import of formulation of insecticides without registering technical
The Committee deliberated and decided that detail proposal be placed in the next meeting of the Registration Committee.
Agenda item No 3.3 /Existence of Patents with respect to Pesticides
The Committee noted claims received by the Sectt.for existence of patent rights and decided to maintain the status-quo till the information is received from the Department of Agriculture & Cooperation.
Agenda item No 4.0 /Export Cases
Agenda item No 4.1 /List of applications u/s.9(3)Export
Approved.
Agenda item No 4.2 / Star Export – Ex-post facto approval u/s.9(3)Agenda item No 4.2.1 / Ex-post-facto approval for issuance of Certificate of Registration to M/s Syngenta India Ltd. for indigenous manufacture of Thiamethoxam 14.10% + Lammbda Cyhalothrin 10.6% u/s 9(3) for export only
Approved.
Agenda item No 4.2.2 / Ex-post-facto approval for issuance of Certificate of Registration to M/s Syngenta India Ltd. for indigenous manufacture of Thiamethoxam 20% + Chlorantraniliprole 10% SC u/s 9(3) for export only
Approved.
Agenda item No 4.2.3 / Ex-post-facto approval for issuance of Certificate of Registration to M/s Syngenta India Ltd. for indigenous manufacture of Difenoconazole 3% u/s 9(3) for export only
Approved.
Agenda item No 4.3 / Consideration of application of M/s Punjab Chemicals & Crop Protection Ltd., Chandigarh for grant of registration for indigenous manufacture of Diflufenican 50%SC under section 9(3) for export only.
The Committee deliberated the agenda in detail and observed that the applicant has submitted the estimated toxicity value of the formulation based on the technical as per the WHO recommended formula and not observed value. The applicant may be asked to submit the information on Diflufenican 50%SC.
Agenda item No 4.4 / Consideration of application of M/s P.I. Drugs & Pharmaceuticals Ltd., Thane for grant to registration of indigeneous manufacture of Azamethiphos 1% GR u/s 9(3) for export only
Approved
Agenda item No 4.5 / Consideration of application of M/s Sujag Fine chemicals Pvt. Ltd., Vadodara for grant to registration of Fluroxypyr 250 g/l (25.4% w/w) u/s 9(3) for export only
The Committee deliberated the agenda in detail and observed that the applicant has submitted the estimated toxicity value of the formulation based on the technical as per the WHO recommended formula and not observed value. The applicant may be asked to submit the information Fluroxypyr 250 g/l (25.4% w/w).
Agenda item No 4.6 / Consideration of application of M/s Sujag Fine chemicals Pvt. Ltd., Vadodara for grant to registration of Fluroxypyr Technical for indigenous manufacture u/s 9(3) for export only
Approved.
Agenda item No 4.7 / Consideration of application of M/s Sujag Fine chemicals Pvt. Ltd., Vadodara for grant to registration for indigenous mmanufacture of Fluroxypyr 180 g/l (18.4% w/w) SL u/s 9(3)for export only
The Committee deliberated the agenda in detail and observed that the applicant has submitted the estimated toxicity value of the formulation based on the technical as per the WHO recommended formula and not observed value. The applicant may be asked to submit the information Fluroxypyr 180 g/l (18.4% w/w) SL.
Agenda item No 4.8 / Consideration of application of M/s Neelagriva Biosciences Pvt. Ltd. for grant of registration for indigenous manufacture of Bacillus Thuringiensis var. kurstaki 0.5% WP under section 9(3) for export only
Approved
Agenda item No 4.9 / Consideration of application of M/s India Pesticides Ltd., Bareilly for grant of registration for indigenous manufacture of Folpet 75% WP under section 9(3) for export only
Approved
Agenda item No 4.10 / Consideration of application of M/s United Phosphorus Ltd., Mumbai for grant of registration for indigenous manufacture of Beta Cypermethrin Technical for export only U/s 9(3).
Approved
Agenda item No 4.11 / Consideration of application of M/s Bayer Crop Science Ltd., Mumbai for grant of registration for indigenous manufacture of Fenamiphos technical for export only U/s 9(3).
Approved
Agenda item No 4.12 / Consideration of application of M/s Parijat Industries (India) Pvt. Ltd., New Delhi i for grant of registration for indigenous manufacture of Bispyribac Sodium 40% SC u/s 9(3) for export only
The Committee deliberated the agenda in detail and observed that the applicant has submitted the estimated toxicity value of the formulation based on the technical as per the WHO recommended formula and not observed value. The applicant may be asked to submit the information Bispyribac Sodium 40% SC u/s 9(3).
Agenda item No 4.13 / Consideration of application of M/s Astec Life Sciences Ltd., Mumbai for grant of registration for indigenous manufacture Prodiamine Technical u/s 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 Biotech International Ltd., New Delhi for grant of registration for indigenous manufacture of Beauveria bassiana 1.5% WP under section 9(3B)
Approved for a period of two years with commercialization.
Agenda item No 5.2 / Consideration of application of M/s Ruchi Biochemicals, Mumbai for grant of registration for indigenous manufacture of Beauveria bassiana 1.15% WP under section 9(3B)
Approved for a period of two years with commercialization.
Agenda item No 5.3 / Consideration of application of Deptt. of Agriculture, Govt. of U.P. (Lucknow) for grant of registration for indigenous manufacture of Beauveria bassiana 1.0% WP under section 9(3B)
Approved for a period of two years with commercialization
Agenda item No 5.4 / Consideration of application of M/s Poshak Fertilizers, Gujarat for grant of registration for indigenous manufacture of Beauveria bassiana 1.15% WP under section 9(3B)
Approved for a period of two years with commercialization.
Agenda item No 5.5 / Consideration of application of M/s Microplex Biotech & Agrochem Pvt. Ltd., Wardha for grant of registration for indigenous manufacture of Bacillus thuringiensis var. Kurstaki 0.5% WP under section 9(3B)
Approved for a period of two years with commercialization.
Agenda item No 5.6 / Consideration of application of M/s Ishwar Agro, Dhule for grant of registration for indigenous manufacture of Trichoderma Viride 1% WP under section 9(3B)
Approved for a period of two years with commercialization.
Agenda item No 5.7 / Consideration of application of M/s Mac Hi-tec Bio Organic Research & Development Centre, Thrissur for grant of registration for indigenous manufacture of Pseudomonas fluorescens 1% WP under Section 9(3B)
Approved for a period of two years with commercialization.
Agenda item No 5.8 / Consideration of application of M/s Ravi Crop Science Ltd., New Delhi for grant of registration for indigenous manufacture of Pseudomonas fluorescens 0.5% WP under section 9(3B)
Approved for a period of two years with commercialization
Agenda item No 5.9 / Consideration of the application of M/s BASF India Ltd., Mumbai for grant registration for import of Long Lasting Nets impregnated with Alpha-cypermethrin 0.667% w/w (200 mg/sq.mt) u/s 9(3B)
The Committee deliberated the agenda in detail and approved the registration for import of Long Lasting Net Impregnated (LLIN) with Alphacypermethrin 0.667% w/w. u/s.9(3b). Further, in view of the request of M/o.Health & Family Welfare, the Committee also decided to permit commercialization for use of these LLINs in public health programme subject to approval of the competent authority in the Department of Agriculture & Cooperation. The applicant should generate complete data for 9(3) registration during this period.
Agenda item No 5.10 / Consideration of the application of M/s Sumitomo Chemical India Pvt. Ltd., Mumbai for grant registration for import of HDPE Long Lasting Nets incorporated with Permethrin 2% w/w u/s 9(3B)
The Committee deliberated the agenda in detail and approved the registration for import of Long Lasting Net Impregnated (LLIN) with Permethrin 2% w/w u/s.9(3). Further, in view of the request of M/o.Health & Family Welfare, the Committee also decided to permit commercialization for use of these LLINs in public health programme subject to approval of the competent authority in the Department of Agriculture & Cooperation. The applicant should generate complete data for 9(3) registration during this period.
Agenda item No 5.11 / Request of M/s. Ecosense Labs (I) Pvt. Ltd., Mumbai for extension of validity period of provisional certificate of registration of Trichoderma viride 1% WP for one year with commercialization
Approved for a period of one year with commercialization.
Agenda item No 5.12 / Request of M/s. Sai Agrotech, Yavatmal for extension of validity period of provisional certificate of registration of Trichoderma viride 1% WP for two year with commercialization