Minutes of the 280th meeting of the Registration Committee
held on 6th september, 2007 in Room No.218 , Krishi Bhawan, New Delhi.
The 280th meeting of the Registration Committee (RC) was held under the Chairmanship of Dr. N.B. Singh, Agriculture Commissioner on 6th Sep, 2007 at 1030 hrs. in Krishi Bhavan, New Delhi. Dr.P.S. Chandurkar, Plant Protection Adviser to the Govt. of India, Dr. T.P.Rajendran, Assistant Director General(PP), ICAR and Dr. (Mrs.) S. Kulshrestha, Secretary, CIB&RC attended the meeting. Shri P.N. Maji, Ex-Addl. Industrial Advisor, M/o. Chemicals & Petrochemicals attended the meeting as Special Invitee.
Following officers from the Secretariat of CIB&RC were also present:
(i) Dr. S.K. Khurana, Specialist Gr. I
(ii) Dr. B.S. Phogat, Jt.Dir.(Bio.)
(iii) Dr. Ravi Prakash, Jt. Dir(PP)
(iv) Shri Vipin Bhatnagar, Jt.Dir.(Chem)
(v) Shri. A.K. Bandhopadhya, DD (Ent.)
(vi) Dr. Subhash Kumar, Agro(H)
(vii) Sh. R.C. Gulati, SO(CIR-I)
(viii) 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 279th meeting of the Registration Committee
The Minutes of the 279th 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 279th meeting.
The Committee noted the status of follow-up action taken.Agenda item No.2.1 / Applications pending under various Sub-Sections of the Insecticides Act, 1968
The Committee appreciated the efforts of Sectt. of CIB&RC in reducing the pendency of registration applications under various sections of the Act.
Agenda item No.3.0 /
Government Business
Agenda item No 3.1.4 /Guidelines of formulate Star Export Houses
The Committee deliberated the agenda in detail and approved the guidelines for the Star Export House for registration of pesticides for export. Further, the Committee decided that the limit of FOB/FOX export performance may be reviewed after two years.
Agenda item No 3.1.7 /Registration of technical grade of pesticide for import of formulations
The Committee deliberated the agenda in detail and decided that in view of the decision of 198th Meeting of the Registration Committee, wherein the Committee had decided that for import of formulation, technical grade of the same Insecticide should also be registered simultaneously to the formulation, a background paper may be brought to Registration Committee for further deliberation about formulation import guidelines without registering the technical.
Agenda item No 3.1.9 / Guidelines for grant of registration under section 9(3) based on the guidelines for technical import for new sourceThe Committee deliberated the agenda in detail and decided that in case the product is registered for formulation import without registering the technical, then for registering the technical of the same product for import from new source or for l indigenous manufacture u/s.9(3), the same guidelines as exist for TI new source u/s.9(3) and TI versus TIM u/s.9(3) will be applicable for the categories of formulation import versus technical import from new source and technical indigenous manufacture u/s.9(3) respectively.
Agenda item No 3.1.10 / Consideration of request for guidelines for registration of Rotenone by M/s AS Aquaculture Pvt. Ltd., Kolkata
The Committee deliberated the guidelines in detail and approved the same.
Agenda item No 3.1.11 /Exemption of requirement of MRL for Gibberellic Acid
The Members deliberated the agenda in detail and noted that “Gibberallic Acid is already exempted by USEPA, New Zealand, Brazil and Australia from the requirement of tolerance MRL fixation. The reasons being that it is a naturally occurring plant harmone, has non-toxic mode of action, has low toxicity profile and toxicological studies at high dose level(at or above limit doses) identified no toxic endpoints for risk assessment and these substances are naturally occurring in normal human diet” and hence recommended that Gibberalic Acid containing GA3 may be exempted from the fixation of MRL.Agenda item No 3.1.12 / Consideration of guidelines for registration of insecticides for use in aircraft
The Committee deliberated the agenda in detail and approved the same.
Agenda item No 3.1.13 / Revised Guidelines for registration of Bio-pesticides.Deferred.
Agenda item No 3.2 / Quality assurance of toxicity reports generated in Indian Institutions – Submission of analytical report, maintenance of archives etc
The Committee deliberated the agenda in detail and decided that with a view to improve the quality of the data received for assessing safety and efficacy of pesticides for the purpose of registration, the applicant should enclose analytical test report of the batch which has been used for the various pre-clinical toxicity and bio-efficacy and residue studies along with the study reports and no report submitted 1st January, 2008 onwards by the laboratory will be accepted if not accompanied by the analysis report .
Agenda item No 3.3 /
Decision in the Appeal of M/s Navin Fluorine International Ltd., Mumbai against the decision of the Registration Committee
The Committee noted the decision of the appellate authority.
Agenda item No 3.4 /Registration of Prallethrin Tech u/s 9(4) TIM in favour of M/s Aura Chem Pvt. Ltd. and appeal filed by M/s Shogun Organics Pvt. Ltd. – Order of Competent Authority in the DAC u/s 11 of the I.Act, 1968.
The Committee deliberated the agenda in detail and decided that the file of M/s. Aurachem Pvt. Ltd. and of M/s.Shogun be brought to the next meeting of the Registration Committee for fresh consideration of the application as directed by the appellate authority.
Agenda item No 3.5
/Existence of patents in regard of the manufacture of Pyrithiobac Sodium Tech.
The Committee deliberated the agenda in detail and is of the opinion that the registration be granted to the applicant as per the provisions of the Insecticides Act. However, the status of similar cases on patent brought to Registration Committee earlier may also be brought to Committee before taking a final view.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 / Consideration of an application of M/s Nagarjuna Agrichem Ltd., Hyderabad for grant of registration for indigenous manufacture of Flucarbazone Sodium Tech.Approved.
Agenda item No 5.0 / 9(3B) Cases
Agenda item No 5.1 / Consideration of an application of M/s Institute of Natural Organic Agriculture, Pune for grant of registration for indigenous manufacture of Verticillium Lecanii 1.15% WP.
Approved for a period of two year with commercialization.
Agenda item No 5.2 / Consideration of an application of M/s Jai Kisan Agro for grant of registration for indigenous manufacture of Beauveria Bassiana 1.15% WP
Approved for a period of two year with commercialization.
Agenda item No 5.3 / Consideration of an application of M/s Khodke Agro Products Pvt. Ltd for grant of registration for indigenous manufacture of Verticillium Lecannii 1.15% WP
Approved for a period of two year with commercialization.
Agenda item No 5.4 / Consideration of an application of M/s Avishkar Bio-farm Pvt. Ltd. for grant of registration for indigenous manufacture of Beauveria Bassiana 1.15% WP
Approved for a period of two year with commercialization.
Agenda item No 5.5 / Consideration of an application of M/s Khodke Agro Products Pvt. Ltd. for grant of registration for indigenous manufacture of Metrahizium anisopliae 1.15% WP
Approved for a period of two year with commercialization.
Agenda item No 5.6 / Consideration of an application of M/s Khodke Agro Products Pvt. Ltd. for grant of registration for indigenous manufacture of Beauveria Bassiana 1.15% WP
Approved for a period of two year with commercialization.
Agenda item No 5.7 / Consideration of an application of M/s Choudhary Agrotech (I) for grant of registration for indigenous manufacture of Verticillium Lecannii 1.15% WP
Approved for a period of two year with commercialization.
Agenda item No 5.8 / Consideration of an application of M/s Ashwamedh Agritech & Farm Solutions for grant of registration for indigenous manufacture of Trichoderma viride 1.00% WP
Approved for a period of two year with commercialization.
Agenda item No 5.9 / Consideration of an application of M/s Om Agro Organics, Yavatmal for grant of registration for indigenous manufacture of Metrahizium anisopliae 1.15% WP
The Committee deliberated the agenda in detail and decided that the file be sent to ADG(PP) for examination of bio-efficacy data.
Agenda item No 5.10 / Consideration of an application of M/s Kanbiosys Pvt. Ltd., Pune for grant of registration for indigenous manufacture of Verticillium Lecannii 1.15% WP
Approved for a period of two years with commercialization.
Agenda item No 6.0 / 9(3) Cases
Agenda item No 6.1 / Consideration of an application of M/s Pest Control (India) Pvt. Ltd., Bangalore for grant of registration for indigenous manufacture of NPV of Spodoptera litura 0.5% AS
Approved.
Agenda item No 7.0 / 9(4) Cases
Agenda item No 7.1 / List of applications for registration u/s 9(4)
The Committee approved the applications, which are complete from Chemistry angle and for which MRL are fixed, partially fixed or not required.
Agenda item No 8.0 / Miscellaneous Items
Agenda item No 8.1 / Proposal for alternate Transport packaging of 25Kg Capacity proposed by M/s E.I.DuPont India Pvt. Ltd., Guragaon
Deferred as the Co-opted Member, Packaging was not present.
Agenda item No 8.2 / Ex-post facto approval for import permits issued
Approved .
Agenda item No 8.3 / Issue of import permit for Boric Acid & other substances for non-insecticidal use
The committee decided as per Annexure.
Agenda item No 8.4 / Issue of import permit for Boric Acid & other substances for non-insecticidal use – deferred Item of 279th RC Meeting
The Committee deliberated the agenda in detail and decided as per Annexure.
Agenda item No 9.0 / Any other item with the permission of the Chair.
Agenda item No 9.1 Guidelines for Relatively Safer Formulations(RSF)
The report of the group constituted under the Chairmanship of Dr. P.S. Chandurkar, Plant Protection Adviser to the Govt. of India to review guidelines for RSF was presented and deliberated in detail and the following has been decided:-
1) Relatively Safer Formulation category may be dispensed with as there is no definite criteria of safer pesticides. However, existing application for indigenous manufacture under this category may be dealt with as per the existing guidelines.
2) New applications under this category may not be accepted. Even if, RSF is claimed, the same may be classified and considered under new formulation category in view of almost similar data requirement. However, the application already under process will be considered as per previous guidelines.
3) Applicant of existing applications under RSF category shall have to also provide residue data, necessary to fix MRLs, in case the MRLs do not exist for the specified label claim or MRL is required to be fixed.
The meeting ended with a vote of thanks to the Chair.
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ANNEXURE
Decision of the Registration Committee on the applications
for import permits for non-insecticidal use of insecticides
Cases of 280th meeting Agenda
Part-I
Import Permits for Boric Acid
S.No. / Applicant / Decision of the RC---NIL---
Part-IA
Import Permits for Boric Acid
(As per decision of 275th meeting)
S.No. / Applicant / Decision of the RC---NIL---
Part-II
Import Permits other than Boric Acid
S.No. / Applicant / Decision of the RC1. / M/s Artek Surfin Chemicals Limited, Mumbai / Approved issuance of import permit for 88 MT of Copper Sulphate.
2. / M/s Coromandal Fertilizers Limited, Secundrabad / Not approved for want of recommendation of the Nodal Ministry. The same may be submitted by the applicant.
Part-III
Representations
S.No. / Applicant / Decision of the RC1. / M/s Chemi Enterprise, Mumbai / Deferred. DAC may be approached again to reconsider the issue giving full facts.
Decision of the Registration Committee on the applications
for import permits for non-insecticidal use of insecticides
Cases of 279th meeting Agenda
Part-I
Import Permits for Boric Acid
S.No. / Applicant / Decision of the RC1. /
Shri Krishna Industries, Ahmedabad
/ The applicant may be asked to provide the quantity of borax and boric acid consumed during last five years for consideration of their case.2. / MFPL Fuorine Products Ltd., Chennai / The applicant may be asked to give justification for recommendation of higher quantity by DIC than quantity requested.
3. / Zironia Cera Tech Glazes, Palaj Mehsana / The applicants were granted the quantity required. They may be requested to give justification for further requirement.
4. / Dharendera Chemicals Pvt. Ltd., Chennai / Approved issuance of import permit for 100 MT boric acid.
5. / Laser Glass Industries, Morbi / Approved issuance of import permit for 100 MT boric acid.
Part-II
Import Permits other than Boric Acid
S.No. / Applicant / Decision of the RC1. / M/s Gharda Chemicals Ltd., Mumbai / Approved issuance of import permit for 1210 MT of Ethylene Dichloride.
Part-III
Representations
S.No. / Applicant / Decision of the RC1. / M/s Nicomet Industries Ltd., Mumbai / It was decided to renew the import permit for import of the balance quantity of copper sulphate.
2. / M/s Raj Borax Ltd., Mumbai / Approved issuance of import permit for 100 MT boric acid.
3. / M/s Bhansali Chemicals (Madras) Ltd., Chennai / Approved issuance of import permit for 300 MT boric acid. They may also be asked to investigate as to who is issuing advertisement on their behalf for sale of boric acid and intimate the finding to the Registration Committee.
4. / M/s Orient Glazes Ltd., Radhu , Kheda, Gujarat / The details of the application made by the applicant may be brought to the next meeting of the committee.
5. / M/s La Opala Solitaire , Kolkatta / Approved issuance of import permit for 60 MT boric acid and 50 MT barium carbonate.