MINUTES of 322Nd MEETING of REGISTRATION COMMITTEE HELD on 26.08.2011 at 10.30 A.M. IN
MINUTES OF 322nd MEETING OF REGISTRATION COMMITTEE HELD ON 26.08.2011 AT 10.30 A.M. IN COMMITTEE ROOM NO-142, AT KRISHI BHAVAN, NEW DELHI.
The 322nd meeting of Registration Committee (RC) was held under the Chairmanship of Dr. Gurbachan Singh, Agriculture Commissioner on 26.08.2011 in Committee Room No. 142, Krishi Bhavan, New Delhi. Dr. V.K. Yadava, Plant Protection Adviser to the Government of India; Dr. B.S. Phogat, Addl. Plant Protection Adviser (CIB&RC) and Shri Madhav Chakraborty, Co-opted Member attended the meeting. Dr. T.P. Rajendran, Assistant Director General (Plant Protection), ICAR sought leave of absence from Chairman due to preoccupation. Following Officers from the Secretariat of CIB&RC were also present:-
(i)Dr. Sushil K. Khurana, Consultant
(ii)Dr. (Mrs.) Sandhya Kulshrestha, Consultant
(iii)Dr. Sarita Bhalla, Spl. Gr. I
(iv)Dr. R.M. Shukla, JD (E)
(v)Dr. B. Tripathi, Deputy Director (WS).
(vi)Dr. Arnab Das Gupta, DD (PP)
(vii)Sh. D. Bhattacharya, AD(Chem.)
(viii)Dr. Subhash Kumar, Assistant Director (WS)
(ix)Dr. Vandana Seth, Assistant Director (Chem.)
(x)Ms. Kamlesh Miglani, Assistant Director (Chem.)
(xi)Sh. S.K. Ghosh, Consultant & Former Dy. Director (Packaging)
(xii)Sh. K.V. Singh, PPO (Pack.)
(xiii)Sh. Niraj Kulshreshtha, Legal Asstt.
(xiv)Sh. Sher Singh, SO (CIR-II)
Since the quorum was not complete, therefore the meeting was adjourned for half an hour and reconvened at 11.00 AM.At the outset, the Chairman welcomed the members and experts of CIB&RC 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 321th meeting of the Registration Committee.
Minutes of the 321st Meeting of Registration Committee held on 28.7.2011 are confirmed.
2.0 /Follow up action on the decision taken by the Registration Committee in its 321th meeting.
The committee noted the follow-up action with satisfaction.
2.1 / Applications pending under various sub-sections of the Insecticides Act, 1968.Noted.
3.0 / Government Business
3.1 /
Recommendation of the Workshop on MRLs in Commodity / Food & Consumer Safety held on 26-28th October, 2010-reg. (Deferred case 321th RC)
The committee deliberated the Agenda in detail and decisions are at Annexure-I.3.2 / Representation form Maharashtra Biocontrol Manufactures Association regarding deposition of Microbial Strain in the National repository.(Deferred case 321th RC)
RC deliberated the Agenda in detail and decided that the applicant should comply with the earlier decision of RC, in this regard, in order to safeguard and align to all relevant national regulations and international agreement and conventions in regard to handling of microorganisms.
3.3 / Request from M/s Crop Life India, New Delhi for approval for additional manufacturing site of an already approved source (company) for Import of pesticides (technical/formulation)-regarding.
The agenda was deliberated in detail and decided to constitute a committee under the chairmanship of Dr. V.K.Yadava, PPA alongwith members Dr.(Mrs.) Sandhya Kulshreshtha, Consultant (Pharma.) and Sh. Vipin Bhatnagar, Joint Director (Chemistry) as a Member Secretary. The committee will submit its report within one month.
4.0 / Export Cases
4.1 /
Applications for registration for Export of technical and formulations of pesticides already registered for the use in the country.
Approved as per list (Annexure 4.1.1 of Agenda) except at S.No. 8, 25 and 27 for which detailed agenda may be put up in the next RC. Further, product at S.No. 12 is sub-judice and at S.No. 19 not approved.4.2 / Consideration of an application of M/s P.I. Industries Ltd., for grant of registration of import of Orysastrobin Technical u/s 9(3) for Export only.
Approved subject to verification of registration status in other countries.
4.3 / Consideration of an application of M/s Deccan Fine Chemicals (India) Ltd, for grant of registration for indigenous manufacture of Clethodim Technical u/s 9(3) for Export only.
Approved.
5.0 / 9(3B) Cases
5.1 / Request of M/s Ganesh Biocontrol Systems, Rajkot for extension of validity period of provisional certificate of registration of Trichoderma viride 1% WP for one year with commercialization.
Extension is granted for a period of one year with commercialization from the date of issue of letter of extension.
5.2 / Request of M/s Gujarat Eco Microbial Tech Pvt. Ltd., Vododara (Gujarat) for extension of validity period of provisional certificate of registration of Trichoderma viride 1% WP for one year with commercialization.
Extension is granted for a period of one year with commercialization from the date of issue of letter of extension.
5.3 / Request of M/s Nico Orgo Manures, Dakor (Gujarat) for extension of validity period of provisional certificate of Trichoderma viride 1% WP for one year with commercialization.
Extension is granted for a period of one year with commercialization from the date of issue of letter of extension.
5.4 / Request of M/s Gujarat Eco Microbial Technologies Pvt. Ltd., Vadodara for extension of validity period of plrovisional certificate of registration of Pseudomonas fluorescens 0.5% for two years with commercialization.
Extension is granted for a period of one year with commercialization from the date of issue of letter of extension.
5.5 / Request of M/s Western Organics, Indore for extension of validity period of provisional certificate of registration of Pseudomonas fluorescens 1.0% WP for two years with commercialization.
Extension is granted for a period of one year with commercialization from the date of issue of letter of extension.
5.6 / Request of M/s IPM Biocontrol Labs (Pvt) Ltd., Secunderabad for extension of validity period of provisional certificate of registration of Pseudomonas fluorescens 0.5% WP for one year with commercialization.
Extension is granted for a period of one year with commercialization from the date of issue of letter of extension.
5.7 / Request of M/s Gujarat Eco Microbial Technologies Pvt.Ltd, Vadodara for extension of validity period of provisional certificate of registration of Trichoderma Harzianum 1.0% WP for two years with commercialization.
Extension is granted for a period of one year with commercialization from the date of issue of letter of extension.
5.8 / Request of M/s Biotech International Ltd., New Delhi for extension of validity period of provisional certificate of registration of Trichoderma Harzianum 1.0% WP for two years with commercialization.
Extension is granted for a period of one year with commercialization from the date of issue of letter of extension.
5.9 / Request of M/s Sri Aurobindo Institute of Rural development, KVK, Gaddipally, Nalgonda for extension of validity period of provisional certificate of registration of Trichoderma viride 1% WP for one year with commercialization.
Extension is granted for a period of one year with commercialization from the date of issue of letter of extension.
5.10 / Request of M/s Western Organics, Indore for extension of validity period of provisional certificate of registration of Trichoderma Harzianum 1.0% WP for two years with commercialization.
Extension is granted for a period of one year with commercialization from the date of issue of letter of extension.
5.11 / Consideration of application of M/s Indore Biotech Inputs & Research Pvt. Ltd., Indore, M.P. for 2nd extension of provisional registration of Bacillus thuringiensis var Kurstaki 0.5% WP u/s 9(3B) for controlling of Castor Semilooper of Castor crop.-
Extension is granted for a period of one year with commercialization from the date of issue of letter of extension.
5.12 / Consideration of application M/s International –Panacea Ltd., New Delhi for 3rd extension of pro-visional registration of Matarhizium Anisopliae 1.0% WP u/s 9(3B) for controlling Shoot & Fruit Borer on Brinjal crop.
Extension is granted for a period of one year with commercialization from the date of issue of letter of extension.
5.13. / Consideration of application M/s Biotech International Ltd., New Delhi for 3rd extension of provisional registration of Matarhizium Anisopliae 1.5% WP u/s 9(3B) for controlling of Aphid & Rhionoceros Beetle in Cotton and Coconut corp.
Extension is granted for a period of one year with commercialization from the date of issue of letter of extension.
5.14 / Consideration of application M/s Biotech International Ltd., New Delhi for 1st extension of provisional registration of Paecilomyces Lilacinus 1.0% WP u/s 9(3B) for controlling of Nematodes in various crops.
Extension is granted for a period of one year with commercialization from the date of issue of letter of extension.
5.15 / Consideration of application M/s Western Organics, Indore, M.P. for 2nd extension of provisional registration of Verticillium Chlamyolosporium 1.0% WP u/s 9(3B) for controlling of Nematodes in various crops.
Extension is granted for a period of one year with commercialization from the date of issue of letter of extension.
5.16 / Consideration of application M/s Juna Life Science Pvt. Ltd., Kukpally, Hyderabad (A.P.) for 2nd extension of provisional registration of Beauveria bassiana 1.15% WP u/s 9(3B) for controlling Rice Leaf Folder in Rice crop.
Extension is granted for a period of one year with commercialization from the date of issue of letter of extension.
5.17 / Consideration of application M/s Indore Biotech Inputs & Research (P) Ltd., Indore, M.P. for 2nd extension of provisional registration of Verticillium Lecanii 1.15% WP u/s 9(3B) for controlling of White backed plant hopper in rice crop.
Extension is granted for a period of one year with commercialization from the date of issue of letter of extension.
5.18. / Consideration of application M/s Khodke, Agro Product Pvt. Ltd., Amravati for 2nd extension of provisional registration of Verticillium Lecanii 1.15% WP u/s 9(3B) for controlling of Mealy bug & Scale Insect in Citrus.
Extension is granted for a period of one year with commercialization from the date of issue of letter of extension.
5.19. / Consideration of application M/s Gujarat Life Science Pvt. Ltd., Vadodara, Gujarat for 1st extension of provisional registration of Beauveria bassiana 1.15% WP u/s 9(3B) for controlling of Rice leaf folder in Rice Crop.
Extension is granted for a period of one year with commercialization from the date of issue of letter of extension.
5.20 / Consideration of application M/s Indore Biotech Inputs & Research (P) Ltd., Indore, M.P. for 2nd extension of provisional registration of Beauveria bassiana 1.15% WP u/s 9(3B) for controlling of Rice leaf folder in Rice Crop.
Extension is granted for a period of one year with commercialization from the date of issue of letter of extension.
5.21 / Consideration of application M/s Khodke, Agro Product Pvt. Ltd., Amravati for 2nd extension of provisional registration of Beauveria bassiana 1.15% WP u/s 9(3B) for controlling of Rice Leaf Folder in Rice Crop.
Extension is granted for a period of one year with commercialization from the date of issue of letter of extension.
5.22 / Consideration of application M/s Shri Ram Solvent Extractions Pvt. Ltd., Uttarakhand, for 2nd extension of provisional registration of Beauveria bassiana 1.5% WP u/s 9(3B) for controlling of Rice Leaf Folder in Rice Crop.
Extension is granted for a period of one year with commercialization from the date of issue of letter of extension.
5.23 / Application of the Energy and Resources Institute New Delhi for Eucalyptus leaf extract/concentrate & Eucalyptus leaf extract 30% EC – status regarding.
Approved with commercialisation for a period of two years. Further, it has been decided to put condition on registration certificate with respect to toxicity data which has not been found satisfactory.
5.24 / Consideration of application of M/s Institute of Plant Biotechnology, Nasik (MS) for grant of registration for indigenous manufacture of Verticillium Lecanil 1.15% u/s 9(3B).
Approved with commercialisation 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.
9 (3) Cases
6.1 / Consideration of application of M/s Isagro (Asia) Agrochemicals Pvt.Ltd, Mumbai for grant of registration of Orthosulfamuron 50% WG Formulation for import.
Approved subject to fixation of MRL.
6.2 / Consideration of application of M/s Sumitomo Chemical India Pvt. Ltd., Mumbai for grant of registration for import of Metofluthrin technical, Metofluthrin 5% EC and Metofluthrin 0.005% Mosquito Coil under section 9(3).
Committee deliberated the agenda in detail and decided that a detailed analysis of the toxicological aspects is to be prepared by Dr. S.K. Khurana, Consultant (Path) for discussion in next R.C.
Committee further decided that a clarification from Ministry of Health and Family Welfare is to be sought whether guidelines for registration of a chemical under drugs and cosmetic category will also be applicable when the same chemical is registered as pesticide.
6.3 / Consideration of an application of M/s Godrej Sara Lee Ltd, Mumbai for grant of registration for formulation indigenous manufacturing of Transfluthrin 0.03% MC under section 9(3).
Approved.
6.4 / Consideration of an application of M/s Chemtura Chemicals India Pvt. Ltd., Mumbai for grant of registration for formulation indigenous manufacturing of Thiram 40% FS (Seed dressing fungicide ) u/s 9(3).
Approved.
7.0 / 9(4) Cases
7.1 / List of applications for regn. u/s 9(4)
The committee deliberated the agenda in detail and approved the applications which are complete as per revised guidelines approved in 315th RC, complete from chemistry angle and for which MRL is fixed, partially fixed or not required. Reference list on page 195 to 197 of Agenda.
7.2 / Consideration of application of M/s Insecticides India Ltd., for grant of registration for indigenous manufacture of Clodinafop Propargyl technical u/s 9(4).
Approved.
8.0 / Endorsement Cases
8.1 / Request of M/s Bayer Crop Science Ltd., Mumbai for Label expansion of Fenoxaprop-p-ethyl 9.3% EC for use in black gram.
Approved.
8.2 / Approval of Laminated pouch of 20 gm capacity as an additional packing – proposed by M/s Syngenta India Ltd., New Delhi.
Approved.
8.3 / Request from M/s Syngenta Crop Protection Pvt. Ltd, Mumbai for the endorsement of Bulk packaging of Paclobutrazole 23% SC & Repack in country.
Approved.
9.0 / Miscellaneous Items
9.1 / Consideration of application for import permits for Boric acid other substances for non-insecticidal use.
Approved as per Annexure-II. (Part I, II & III)
9.2 / Consideration of application for Enhancement of Shelf-Life under Section 9(4) of the Insecticides Act, 1968.
Approved as per Annexure No. 9.2.1 of Agenda except Sr. No . 20.
10.0 /
Online filing of application for registration under different categories:-
10.1 / Summary of disposal of cases including cases being taken up for the approval of Registration Committee.The committee deliberated the agenda in detail and approved the applications under section 9(4) which are complete from chemistry angle and for which MRL are fixed, partially fixed or not fixed. Reference agenda on page 211 to 220.
11.0 / Any other item with the Permission of Chair.11.1 / Status of application of M/s. B.M.R. & Co. Pune registration of Neem Oil based formulation containing 0.15% Azadirachtin EC for control of Mosquito larvae u/s 9(3) of the Insecticides Act, 1968
The RC discussed the agenda in view of its decisions taken earlier in its 319th meeting held on 26.5.2011 and decided to issue registration certificate to the applicant with the provisional shelf life of one year with the condition for submission of shelf-life data as per RC requirements.
11.2 / Status of application of M/s. PNP and associates Pvt. Ltd., Faridabad for registration of Paclobutrazol 23% SC w/w (25% w/v) new source u/s 9(3) without registration of technical.
Members deliberated the agenda in detail and observed that the application is not complete from toxicity discipline even as per TIT/FIT new source guidelines which was communicated to the applicant at first instance. Hence, the applicant may be asked to fulfill the deficiencies in toxicity as per the old guidelines. The Committee further observed that the case is complete from chemistry, bio-efficacy except corrections in label & leaflets (as per data submitted) and clarification about high residues in one of the studies as well as about packaging conditions. Registration Committee also decided that new guidelines for formulations import from new source approved in 307th RC are not applicable in this case.
11.3 / Nomination of Dr. D. Kanungo, Retired ADG, DGHS, MOH&FW as Medical Toxicologist as Member in the Registration Committee Meeting.
As per the directives of DAC, RC decided to co-opt Dr. Kanungo, retired Additional Director General, DGHS, MOH&FW as an expert of Medical Toxicology under section 5(4) of the Insecticides Act, 1968 till fresh nomination is received from Ministry of Health & Family Welfare. RC further decided that he will continue to Chair the expert committees/sub-committees communicated by the Registration Committee. However, he will not be entitled for TA/DA from this department.
Annexure I
SNo. / Recommendations / Comments. / RC Decisions1. / Respective MRLs of the Deemed registered pesticides being used for IPM in crops and in public health need to be urgently put in place. / The data made available by the Pesticide Industry on DRP products has already been submitted to Min. of Health & Family Welfare. No additional data is available with the Sectt. on these products. A request has already been made to Pesticide Industry for this purpose. / RC agreed with the comments of the Sectt. of CIB&RC and further decided that ICAR may be requested to submit the data available with them/ being generated by them on residues of Deemed Registered Pesticides (DRP) and same may be forwarded to Food Standard and Safety Authority of India (FSSAI), Ministry of Health & Family Welfare.
2. / Review the MRLs of 71 products which have been registered prior to 2004 and where data available were not fully supportive. / Data/information available in the Sectt. of CIB&RC has already been sent to Min. of Health & Family Welfare. No additional data is available. However, request has already been made to Pesticide Industry for this purpose. / Agreed with the comments of the Sectt. of CIB&RC
3. / Pesticide mixing in spray tanks by farmers is frequent and hence Crop Life recommends faster registration on scientifically tested combination/ready mix products for desired benefits of GAP. / The combination products are already being considered for registration on the basis of efficacy and safety. / Agreed with the comments of the Sectt. of CIB&RC
4. / We may create revolving research fund for the agrochemical R&D just as we have a ‘Pharma fund’ to encourage new and innovative research for chemical in the country. / Administrative decision may be considered by DAC. / Agreed with the comments of the Sectt. of CIB&RC
5. / Harmonized protocol document that is under consideration of CIB&RC may be recommended as a national guideline document for bio-efficacy and residue data generation. (to be developed in consultation with stakeholders). / RC has already constituted a committee under the chairmanship of Dr. T.P. Rajendran for harmonization of protocol for bioefficacy and residue data generation. / Agreed with the comments of the Sectt. of CIB&RC and further decided that the Committee should submit report by next RC
6. / Break up number of bio-efficacy/residue trials for the temperate, tropical and subtropical countries. Use that for supplementing Indian data requirement. / Keeping in view various agro-climatic conditions existing in the country, multi-location data for bioefficacy has been suggested to improve the efficacy/production. Data generated in other countries may not be of much help. / Agreed with the comments of the Sectt. of CIB&RC
7. / Develop modern analytical techniques and utilize GLP accredited labs for joint collaborative research on issues of risk assessment. Coalition of scientific expertise is the call of the workshop. / Research is not the objective of the Sectt./RF. However, the data generated in GLP labs utilizing modern analytical techniques is being considered for risk analysis and the available scientific expertise is always a component of the Expert Committees constituted by the Registration Committee for specific toxicological problems. / Agreed with the comments of the Sectt. of CIB&RC. However, till such facilities are not upgraded, existing system may continue.