Minutes of the 302nd meeting of the Registration Committee held on 01-07-2009 at 10.30 A.M. in Krishi Bhawan, New Delhi.
The 302nd meeting of the Registration Committee (RC) was held under the Chairmanship of Dr. N.B. Singh, Agriculture Commissioner on 01-07-2009 in Room No.112, Krishi Bhavan, New Delhi. The quorum was not complete, therefore, the meeting was adjourned for half-an-hour and meeting was reconvened at 11.00 A.M. Dr. P. S. Chandurkar, Plant Protection Adviser to the Government of India, Dte. of P.P.Q.&S., and Dr. Sushil K. Khurana, Secretary, CIB&RC, Dte. of PPQ&S, Faridabad attended the meeting. Shri Madhav Chakraborty, Co-opted Member also attended the meeting. Following Officers from the Secretariat of CIB&RC were also present:-
(i) Dr. S. Kulshrestha, Specialist Grade-I (Pharmacology)
(ii) Dr. Hari Prasad, Joint Director (Chem.)
(iii) Dr. B.S. Phogat, Joint Director (Bio.)
(iv) Dr. A.K. Sinha, Joint Director.(PP)
(v) Dr. R.M. Shukla, Deputy Director (Ento.)
(vi) Shri Vipin Bhatnagar, Deputy Director (Chem.)
(vii) Dr. Subhash Kumar, Assistant Director (WS)
(viii) Dr. Vandana Seth, Assistant Director (Chem.)
(ix) Ms. Kamlesh Miglani, Assistant Director (Chem.)
(x) Sh. S.K. Verma, Section Officer (CIR-II)
(xi) Sh. Niraj Kulshrestha, Assistant (Legal)
At the outset, the Chairman welcomed Dr. Sushil K. Khurana for taking additional charge of Secretary, CIB&RC and thanked the ex-Secretary,CIB&RC, Dr. (Mrs.) S. Kulshrestha for rendering outstanding services for five years, and requested Secretary, CIB&RC, to take up the Agenda for discussion. The following decisions were taken:
Agenda Item No. 1.0 /Confirmation of minutes of the 301st meeting of the Registration Committee.
The Minutes of the 301st 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 301st meeting.
The Committee noted the follow-up actions taken on the decisions of the Registration Committee.
Agenda Item No.2.1 / Applications pending under various sub-sections of the Insecticides Act, 1968.
The Committee noted the pendency of the applications under various sub-sections of the Act.
Agenda Item No.2.2 / Presentation by representative of M/s South India Manufactures Agencies, Chennai on use of Magnesium Phosphide (Degesch) Plates on wood packaging material.
The applicant neither turned up for presentation nor any message received.
Agenda Item No.3.0 / Government Business
Agenda Item No.
3.1 / Presentation on ICMR protocol for evaluation of insecticides to be used in public health with reference to Guidelines for registration of pesticides to be used in public health.
The presentation was made by Dr. R.M. Shukla, Deputy Director (Ento.) regarding protocol for evaluation of insecticides to be used in public health and decided to maintain the status-quo with reference to guidelines for use in public health as under :-
1. Bio-efficacy data generated by Ministry of Health & Family Welfare based on multi-locations for 3 seasons as per their protocol;
2. Data on persistence of the product of the pesticides in different habitats.
The Committee noted that these protocols are for permitting the use of registered pesticides by various public health programs and not for purpose of registration in the country.
Agenda Item No.3.2 / Streamlining of registration of house-hold pesticides
(mosquito coils).
The Committee deliberated the agenda in detail and decided that the following proposed harmonization for mosquito coils of label claims to be put on website to obtain the comments of the stakeholders, if any, within 30 days after displaying the minutes and thereafter, are to be placed in the meeting of the Registration Committee :
S.No. / Weight (g) / Length (cm) / Burning rate (min/cm) / Present nomenclature / Proposed1. / 24(including 25) / 70 / 5.5 / 7±1 hr., 6hr. & 8hr. / 6 hr. min
2. / 29(including 30) / 84 / 6.1 / 9±1 hr., 8hr. & 10hr. / 9 hr. min
3. / 36 / 105 / 6.8 / 12 hr. (11± 1hr. hypothetically) / 12 hr. min
Agenda Item No.
3.3 / Streamlining of label-leaflets of Diazinon in the light of Gazette Notification No. S.O. 45 (E) issued on 08.01.2008.
Approved.
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
Agenda Item No.
4.2.1 / Consideration of an application of M/s Syngenta India Ltd., For indigenous manufacturing of registration of Abamectin 54.2% Technical u/s 9(3) for Export only.
The Committee deliberated the agenda in detail and decided that the applicant may be asked to furnish justification within 30 days for seeking registration for indigenous manufacture for the purpose of export, whereas they are importing the formulation for use in the country.
Agenda Item No.5.0 / 9(3B) Cases
Agenda Item No.
5.1 / Consideration of application of M/s Krishi Vigyan Kendra, Amravati (M.S.) 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.5.2 / Consideration of application of M/s Panacea Agro Bio- tech, Paratwada, Distt. Amrawati 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.5.3 / Consideration of application of M/s Universal Agro Tech, Kolkata 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.5.4 / Consideration of application of M/s Multiplex Bio-tech Pvt. Ltd., Bangalore for grant of registration for indigenous manufacture of Trichoderma harzianum 1% 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 Probitek Biotech, Jalna (MS) 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.5.6 / Consideration of application of M/s Agro Pesticides, Itarsi (M.P.) 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 Fertilizers India, Kerala for grant of registration for indigenous manufacture of Pseudomonas fluorescens 0.5% WP u/s 9(3B).
Approved for a period of two years with commercialization.
Agenda Item No.5.8 / Consideration of application of M/s Surya Bio Products, Eluru (AP) for grant of registration for indigenous manufacture of Bacillus thuringiensis var. kurstaki 0.5% WP (Serotype – 3a 3b 3c; Strain: DOR bt-1) under section 9(3B).
Approved for a period of two years with commercialization.
Agenda Item No.5.9 / Request of M/s Om Agro Organics, Yawatmal (M.S.) for extension of validity period of provisional certificate of registration of Trichoderma viride 1% WP for two year with commercialization u/s 9(3B)
Extension approved for a period of one year [u/s 9(3B)] with commercialization.
Agenda Item No.5.10 / Request for 2nd extension of registration u/s 9(3B) of NPV of Helicoverpa armigera 0.5% AS (1x109 POB/ml minimum) along with enhancement of shelf life from four months to one year of M/s J.R. Bio-Control Laboratories, Yavatmal.
Extension approved for a period of one year [u/s 9(3B)] with commercialization. Also approved for enhancement of shelf life from four months to one year.
Agenda Item No.6.0 / 9(3) Cases - NIL
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 completed from Chemistry angle; and for which MRL are fixed, partially fixed or not required.
Agenda Item No.7.2 / Consideration of application of M/s Shogun Organics Ltd., Mumbai for grant of registration for indigenous manufacture of Allethrin Technical under Section 9(4)
The Committee deliberated the agenda in detail and decided to seek the clarification on the ATR, received from Central Insecticides Laboratory, Faridabad.
Agenda Item No.8.0 / Endorsement Cases
Agenda Item No.
8.1 / Consideration of extension of bioefficacy claims of Flubendiamide 39.35% in Cabbage and Tomato in favour of M/s Bayer Crop Science, Mumbai u/s 9(3).
Approved.
Agenda Item No.8.2 / Consideration of expansion of bioefficacy claims of Bifenthrin 10% EC on Rice in favour of M/s F.M.C. India Ltd., Bangalore
Approved.
Agenda Item No.8.3 / Consideration of extension of bioefficacy claims of Acetamiprid 20% SP in favour of M/s Gharda Chemicals Ltd.,Mumbai .
The Committee deliberated the agenda in detail and decided that ADG (PP), ICAR may be requested to provide the comments by the end of this month as this is a long pending case and may be brought to the forthcoming Registration Committee meeting.
Agenda Item No.8.4 / Endorsement of transfer of Certificates from M/s Mahamaya Life Sciences P. Ltd. to M/s Yogi Crop Science P. Ltd.
The Committee deliberated the agenda in detail and decided not to approve the case.
Agenda Item No.8.5 / Endorsement of change in company name from M/s Jai Chemicals to M/s Jai Chemicals (Prop. Jai farm Chemicals Pvt. Ltd.).
The Committee deliberated the agenda in detail and decided not to approve the case.
Agenda Item No.9.0 / Miscellaneous Items
Agenda Item No.
9.1 / Deferred agenda items of 301st RC meeting.
Agenda Item No.
9.1.1 / Request from M/s Syngenta India Ltd. for label expansion of Metalaxyl-M 35 ES for control of downey mildew on Pearl millet, Sorghum and Sunflower.
The Committee deliberated the agenda in detail and decided to re-examined the data and seek the clarification from the applicant.
Agenda Item No.9.1.2 / Consideration of request of M/s Syngenta India Ltd., Mumbai for approval of modified labels & leaflets in respect of their Certificate of Registration of Emamectin Benzoate 5%SG.
Deferred being the sub-judice.
Agenda Item No.9.1.3 / Appeal of M/s United Phosphorus Ltd., New Delhi regarding registration of Cypermethrin 3%SG for general public use – its outcome.
Noted.
Agenda Item No.9.1.4 / Summary of Joint Inspection Report on verification of Bonafide of M/s Welsuite Glass and Ceramics (P) Ltd., Gavasad, Vadodara.
The Committee was apprised about the bonafide of M/s Welsuit Glass and Ceramics (P) Ltd., Gavasad as per report of the Committee appointed for it. It was decided that a detailed report may be submitted in the forthcoming Registration Committee meeting for reconsideration.
Agenda Item No.9.1.5 / Ex-post facto approval for import permit issued for the period from 01.04.2009 to 28.05.2009.
Approved.
Agenda Item No.9.1.6 / Consideration of application for import permits for Boric acid and other substances for non-insecticidal use.
The Committee deliberated the agenda in detail and approved as per Annexure – A, consisting of Part- I, II and III.
Agenda Item No.9.2 / Consideration of application of M/s Maa Bhagwati Biotech & Chemicals, Wardha for enhancement of shelf-life from four months to one year in respect of the product Verticilium lecanni 1.15% WP.
Approved.
Agenda Item No.9.3 / Consideration of a case of M/s Sumitomo Chemical India Pvt. Ltd., Mumbai for modification in the storage temperature condition of their product, Bacillus thuriengiensis var-israelensis Serotype H 14 (Vectobac 12 AS)
The Committee deliberated the agenda in detail and decided that a presentation should be made by Deputy Director (Chem.) on storage stability studies in the forthcoming meeting of the Registration Committee.
Agenda Item No.9.4 / Request for closure and cancellation of provisional Registration Certificate No. CIR-534/2005(258)-Tricoderma harzianum (WP)-85 for production of “SARDAR ECOGREEN”.
Committee noted that the validity of Certificate is over and therefore, Certificate has automatically stands cancelled.
Agenda Item No.9.5 / Registration of NPV of Helicoverpa armigera 2% AS of M/s Maa Bhagwati Biotech & Chemicals.
Rejected, as the application was not complete. The applicant did not respond in spite of several reminders.
Agenda Item No.9.6 / Generation of bio-efficacy data for registration of biopesticides u/s 9(3) – request from M/s Yash Krishi Takniki Ewam Vigyan Kendra, Allahabad for consideration.
Deferred due to paucity of time.
Agenda Item No.9.7 / Application of M/s Arkin Specialities Pvt. Ltd. on Pyrethrum extract 50% for import from alternate source.
Deferred due to paucity of time.
Agenda Item No.9.8 / Application for registration of Pyrethrin 0.5% + Piperonyl Butoxide 0.5% of M/s Sri Ram Insecticides – issue of certificate regarding.
Deferred due to paucity of time.
Agenda Item No.9.9 / Consideration of a joint representation of M/s Sarup Chemicals Pvt. Ltd., Lucknow; M/s Ambachem Industries, Baroda and M/s Sudama Chem Tech Pvt. Ltd., Baroda regarding supply of non-registered Thiram and other pesticides to Seed processing units of State Seed Processing Corporation in the country.
Deferred due to paucity of time.
Agenda Item No.9.10 / Request from M/s Syngenta India Ltd., New Delhi for import of sample quantity of Abamectin 1.8% EC for Test and Trial purpose.
Approved.
Agenda Item No.9.11 / Ex-post facto approval for import permit issued for the period from 01.06.2009 to 24.06.2009.
Approved.
Agenda Item No.9.12 / Consideration of application for import permit for Boric acid and other substances for non-insecticidal use.
The Committee deliberated the agenda in detail and approved as per Annexure – B, consisting of Part- I, II and III.
Agenda Item No.10.0 / Any Other Item with the permission of Chair
Before concluding the meeting, Chairman, RC inquired about the status of certain number of 9(3) files from Dr. Sushil K. Khurana, Secretary, CIB&RC. He informed that certain number of 9(3) files and few other category files were scrutinized by him as Toxicologist and he had furnished his comments in that capacity. And these files had been marked to Secretary, CIB&RC. He was given the additional charge of Secretary, CIB&RC on 17th June, 2009. Under the circumstances, he found himself unable to review his own comments. That is why these were sent to Dr. Sandhya Kulshrestha (Toxicologist) for peer-review. Registration Committee decided that these may be retrieved back to Secretary, CIB&RC immediately without any review. Said things can be taken care of during making of the agenda-notes.
The meeting ended with a vote of thanks to the Chair.