Minutes of the 275th meeting of the Registration Committee held
on 01st May, 2007 in Room No.142 ,Krishi Bhawan, New Delhi
The 275th meeting of the Registration Committee (RC) was held under
the Chairmanship of Dr. N.B. Singh, Agriculture Commissioner on 1st May, 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, Shri P.N. Maji, Addl. Industrial Advisor, M/o. 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. Hari Prasad, Jt.Dir.(Chem.)
(ii)
Dr. R.M. Shukla, DD (Ent.)
(iii)
Dr.Subhash Kumar, Dy.Dir.(WS)
(iv)
Sh. R.C.Gulati, SO
(v)
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.1.0
Confirmation of minutes of the 274th meeting of the
Registration Committee.
The Minutes of the 274th meeting of the Registration Committee (RC)
were confirmed.
Agenda Item
No.2.0
Follow up action on the decisions taken by the
Registration Committee in its 274th 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 Subsections of the Act.
Agenda Item
No.3.0
Government Business
Agenda Item
No.3.1
Addition to the list of authorities of the
Ministries/Departments of Government of India for
issuance of end-use (No objection) Certificates for
import of Boric Acid.
The Committee noted the directives of DAC and decided to seek
clarification from DAC whether the same is applicable for other multi-use
insecticides which are highly toxic in nature, also subject to approval of DAC.
Further, it has been decided to constitute a Committee to provide the
uniform guidelines to District Industry Centres of State Govt./State Directors of
Industries for providing recommendations for import of such pesticides.
constitution of Committee is as under:1.
Dr.P.S.Chandurkar
-
Chairman
2.
Dr. P.N. Maji
-
Member
3.
Dr. Rajendran
-
Member
4.
Small-Scale Industries(DCSSI)
(To be nominated by M/o.S.S.Industries
5.
Sh. Vipin Bhatnagar
-
Member-Secretary
The Group may submit its report within one month time.
The
Agenda Item
No.3.2
Decision of Department of Agriculture & Cooperation
on the recommendations of the Technical Committee
for Simplification of procedures for registration of
pesticides for export
The Committee noted the recommendations of the DAC (Deptt. of Agri &
Cooperation) regarding simplification of registration of pesticides.
Agenda Item
No.3.3
Guidelines for registration of twin pack of two
registered herbicides and surfactant
The Committee discussed the agenda in detail and approved the
guidelines as annexed. ( Annexure ).
Agenda Item
No.3.4
Directions of DAC on import of Boric Acid for noninsecticidal use
The Committee noted the directives of DAC regarding the reasons of
justifying the grounds for modifying the recommended quantity of the concerned
Ministries/offices/DAC/State Directors of Industries.
Agenda Item
No.4.0
Export Cases
List of applications u/s 9(3) Export
Agenda Item
No.4.1
Approved.
Agenda Item
No.4.2
Consideration of an application of M/s United
Phosphorus Ltd., Mumbai for grant of registration for
indigenous manufacture of Chlorfluazuron Technical
Approved.
Agenda Item
No.4.3
Consideration of an application of M/s japna
Chemicals Pvt. Ltd., for grant of registration for
indigenous manufacture of DEET Technical
Approved.
Agenda Item
No.4.4
Agenda Item
No.4.5
Consideration of an application of M/s Hikal Ltd.,
Mumbai for grant of registration for indigenous
manufacture of Isoxathion Technical
Consideration of an application of M/s Parijat
Industries P. Ltd., for grant of registration for import
of Thidiazuron Technical
The Committee noted that these pesticides are not included in the
schedule and, therefore, decided to inform that get it included in schedule at first
instance.
Agenda Item
No.5.0
9(3B) Cases
Agenda Item
No.5.1
Consideration of an application of M/s Institute of
National Organic Agriculture, Indore for grant of
registration
for
indigenous
manufacture
of
Pseudomonas fluorescens 0.5% WP
Approved for a period of two years with commercialization.
Agenda Item
No.6.0
9(3) Cases
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.7.2
Consideration of an application of M/s Crop Health Products
Ltd., for grant of registration for indigenous manufacture of
Glyphosate Technical
Approved.
Agenda Item
No.7.3
Consideration of an application of M/s Meghmani Organics
Ltd., for grant of registration for indigenous manufacture
of Acetamiprid Technical
Approved.
Agenda Item
No.7.4
Consideration of an application of M/s Magma Industries
Ltd., for grant of registration for indigenous manufacture
of Pendimethalin Technical
Approved.
Agenda Item
No.8.0
Miscellaneous Items
Agenda Item
No.8.1
Additional packaging of 1 tone capacity (jumbo Bag) for
glyphosate Tech. Proposed by M/s Excel Crop Care Ltd.
The agenda was deferred as the Co-Opted Member Packaging was not
present in the Meeting.
Agenda Item
No.8.2
Application for registration of Aluminium Phosphide 77.5%
GR of M/s United Phosphorus Ltd.
The Committee decided to provide an opportunity to the applicant to make
presentation in the next R.C. Meeting regarding the technology, designed,
developed and manufactured by their R&D, for use of Aluminum Phosphide 77.5%
GR.
Agenda Item
No.8.3
Request of M/s United Phosphorus Ltd., Mumbai for
extension of Registration for Open sales of Aluminum
Phosphide 15% w/w 12 gm Tablets
The Committee deliberated the agenda in detail and decided to approve
the open sale of Aluminum Phosphide 15% w/w tablets for a period of one more
year and decided to refer the results of post-marketing surveillance
to the
Expert Group constituted earlier under the Chairmanship of Dr.Y.K. Gupta.
Agenda Item
No.8.4
Data requirements for registration of Bacillus cereus
The Committee decided to refer the matter to the Expert Group constituted
under the Chairmanship of Dr.T.P. Rajendran for review of guidelines for
registration of bio-pesticides.
Agenda Item
No.8.5
Issue of import permit for Boric Acid & other
substances for non-insecticidal use
The Committee decided as per the annexure Part I, II and III.
The meeting ended with a vote of thanks to the Chair.
******
Guidelines for registration of twin pack of two
registered herbicides and surfactant.
Chemistry:
1. Detailed chemical composition
2. Chemical identity of a.i.
3. Physico chemical properties of the combination product and the
surfactant
4. Specifications
5. Method of analysis
6. ATR with and without surfactant.
7. Final chemical composition after mixing with surfactant.
8. Shelf life data (without surfactant)
9. Compatibility of surfactant with the product.
10. Manufacturing process
Bioefficacy:
1. Bioeffectiveness
2. Phytotoxicity
3. Compatibility with other chemicals, if proposed to mix.
4. Persistence in plant
5. Persistence in soil
6. Persistence in water
7. Residues in plant
8. Residues in soil
9. Registration status in foreign countries.
10. MRL proforma in duplicate
Note: Two season data on Bioeffectiveness and phytotoxicity are to
be generated on combination of the two herbicides with &
without surfactant and individual herbicide from minimum
three agro climatic conditions. Rest of the bioefficacy data
are to be generated on the combination of the two herbicides
with surfactant.
Toxicity:
1. Technical product of the individual pesticide should be regularly
registered
2. The toxicity data on final product (Combination product) have to
be generated as per the data prescribed for formulated product
in Gaitonde Committee Report.
3. Data to show that combination is not more toxic than the
individual component of the combination
4. Health monitoring studies in spray applicators, as per the
protocol approved by the RC on the end use of product i.e.
Pesticide X, Pesticide Y, + Surfactant.
Packaging:
1. Manner of packing in detail for formulations and surfactant
separately
2. Suitability of data of content with the container in all the cases.
3. Manner of labeling
4. Labels and leaflets as per the IR 1971.
Annexure
Part-I
Decision of the Registration Committee
on applications for import permit of Boric Acid
Sl.
No.
1
1.
2.
3.
4.
Name of the Applicant (M/s),
Address,
Letter No./Dated
2
Gibraltar Glass & Ceramics Pvt
Ltd, Baroda-Padra Highway Road,
Near Ceramic Nagar, Padra–391
440 (Gujarat)
GGCPL/2007-08
06.04.2007
Approved/ Not approved (Reason)
3
Since RC decided to prepare guidelines for
accepting the recommendations of DAC,
therefore, the final quantity cannot be
decided. However, in order to avoid delay
which may advertently affect the Company,
the R.C. decided to accord permission for
import of 150MT Boric Acid for next three
months, based on the pattern of import of
consumption of the Company in last years.
The matter will be review after R.C.
receives guidelines from the concerned
Expert Group.
Prime Ceramics Pvt Ltd, PadraSince RC decided to prepare guidelines for
Jambusar Road, Gavasad-391 430 accepting the recommendations of DAC,
(Taluka-Padra, Distt Vadodara,
therefore, the final quantity cannot be
Gujarat)
decided. However, in order to avoid delay
PCPL/2007-08
which may advertently affect the Company,
05.04.2007
the R.C. decided to accord permission for
import of 75 MT Boric Acid for next three
months, based on the pattern of import of
consumption of the Company in last years.
The matter will be review after R.C.
receives guidelines from the concerned
Expert Group.
SVM Cera Tea Buil Ltd, 4802/B,
650 MT Boric Acid for next three months.
GIDC, Ankleshwar -393 002, Distt Based on Ministry’s recommendation and
Bharuch (Gujarat)
import during last three-four years.
No. NIL
dated April 16, 2007
Futura Ceramics (P) Ltd,
Since RC decided to prepare guidelines for
A/501, Sapath IV, Opp. Karnavati accepting the recommendations of DAC,
Club,
therefore, the final quantity cannot be
S.G. Highway, Ahmedabad-380
decided. However, in order to avoid delay
051
which may advertently affect the Company,
FCPL/LIC/CIB&RC/200708/09/04
5.
6.
7.
8.
the R.C. decided to accord permission for
import of 100 MT Boric Acid for next three
months, based on the pattern of import of
consumption of the Company in last years.
The matter will be review after R.C.
receives guidelines from the concerned
Expert Group.
Nahar Colours & Coatings
The
Company
has
submitted
Limited, NCCL House, G-1, 90recommendation from the nodal agency of
93, Sukher Industrial Park,
Central Govt. A quantity of 1456.40 MT
Udaipur – 313 004
approved based on the recommendations of
Letter No. NIL
the nodal Ministry and pattern of earlier
dated 09.04.2007
imports.
Orient Glazes Limited, Survey No. The
Company
has
submitted
760, Village Radhu, Khedarecommendation from the nodal agency of
Dholka Road, Distt. Kheda – 387
Central Govt. A quantity of 600 MT per
560
year
approved
based
on
the
Letter No. Nil
recommendations of the nodal Ministry and
Dated April 19, 2007
pattern of earlier imports.
Johnson Matthey Ceramics India
The Company has not applied in prescribed
Pvt Ltd,
format and, therefore, could not be
Plot No. 74 & 75,
approved. The company may resubmit
Sipcot Electronics Complex
application for reconsideration with full
Phase-II, Kumudepali Post, Hosur- information.
635 109
Latter No. Nil
dated 10.04.2007
Karnataka Agro Chemicals,
The
Company
has
submitted
Bangalore
recommendation from the nodal agency of
Central Govt. A quantity of 270 MT
approved based on the recommendations of
the nodal Ministry and pattern of earlier
imports.
Part-II
STATUS OF PENDING APPLICATIONS FOR IMPORT PERMIT OF
DUAL USE INSECTICIDES
(EXCEPT BORIC ACID)
Sl. Name of the Applicant
Approved/Not Approved (Reason)
No
(M/s)
.
1
2
3
1. Tamilnadu
Petro Rejected as the application was not in the prescribed
Products Ltd, Post Box proforma. The company may resubmit the application.
No. 9, Manali Express
Highway,
Manali,
Chennai-600 068
Letter No. TPLOC/BAC
dated 05.03.2007
2.
Gujarat Alkalies and Approved 5113 MT of Barium Carbonate.
Chemicals Limited, P.O.
Petrochemicals – 391
346 (Vadodara, Gujarat)
Letter
No.
MTLP/Imported-BaCO3
/
2007-08 dated 12.4.2007
3.
Isagro
(Asia)
Agrochemicals Pvt Ltd,
101, Solitaire Corporate
Park, 151, M. Vasanji
Road, Chakala, Andheri
(east), Mumbai-400 093.
Latter No. Nil
dated 23.3.2007
Pasupati Acrylon Ltd, M14, Connaught Circus
(Middle Circle), New
Delhi-110 001.
Letter No. PAL:07 dated
16.04.2007
Videocon Industries Ltd,
Videocon Tower, BlockE-1, Jhandewalan
Extension, New Delhi –
110 055.
Letter No. Nil dated
4.
5.
Approved 100 MT of Sodium Cyanide for manufacturing
Technical Grade Synthetic Pyrethroid Pesticides subject to
license issued under the Poison Act by the applicant.
Rejected as application was not in the prescribed proforma.
The company may resubmit application with proper
format.
Agreed to extend the import permit for six months within
the overall quantity approved earlier. The company may
apply in fresh application for any additional quantity.
6.
16.4.2007
Bhagirdha Chemicals &
Industries Ltd, Plot No.
3, Sagar Society, Road
No.2, Banjara Hills,
Hyderabad-500 034.
Letter No. MCF/8018
dated 12.4.2007
Approved 783 MT of Acrylonitrile based on the
recommendation of the Ministry.
Part-III
Representations for issuance of Import permits for Dual Use
Insecticides
Sl. No.
1
1.
Name of the Applicant
Comments
(M/s)
2
3
Nahar Colours & Coating As per the decision of the
Ltd, Udaipur
appellate authority, the RC
considered
their
fresh
application and accorded
quantity as per Part I.
2.
Orient Glazes
Radhu
(Distt
Gujarat).
Limited,
Kheda,
-do-
3.
Navin Fluorine International The application may be
Limited, Mumbai
submitted
in
prescribed
proforma.
Minutes of the 274th meeting of the Registration Committee held
on 21st March, 2007 in Room No.139 ,Krishi Bhawan, New Delhi
The 274th meeting of the Registration Committee (RC) was held under
the Chairmanship of Dr. N.B. Singh, Agriculture Commissioner on 21st March,
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, Shri P.N. Maji, Addl. Industrial Advisor, M/o. Chemicals &
Petrochemicals, Shri Madhab Chakraborthy, Deputy Director, Indian Institute of
Packaging, New Delhi ( Co-opted Member), Dr. P.S. Chopra, ADG(PFA) and
Dr. (Mrs.) S. Kulshrestha, Secretary, CIB&RC attended the meeting.
Following officers from the Secretariat of CIB&RC were also present:
(vi)
Dr. Hari Prasad, Jt.Dir.(Chem.)
(vii)
Dr. R.M. Shukla, DD (Ent.)
(viii)
Dr.Subhash Kumar, Dy.Dir.(WS)
(ix)
Sh. R.C.Gulati, SO
(x)
Sh. Niraj Kulshrestha, Assistant(Legal)
(xi)
Sh. Y.S. Adhana, SSA-III
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.1.0
Confirmation of minutes of the 273rd meeting of the
Registration Committee.
The Minutes of the 273rd meeting of the Registration Committee (RC)
were confirmed.
Agenda Item
No.2.0
Follow up action on the decisions taken by the
Registration Committee in its 273rd 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 Subsections of the Act.
Agenda Item
No.3.0
Government Business
Agenda Item
No.3.1
Registration of Cypermethrin 3% SG for general
public use : Decision of Appellate Authority.
The Committee noted the decision of the appellate authority and decided
to constitute a committee with the following composition to look into the request
of the appellant to permit the use of Cypermethrin 3% SG for general use:
1.
Dr.H.N. Saiyed
-
Chairman
2.
Dr. Usha Gupta
-
Member
3.
Dr. R.M. Shukla
-
Member-Secretary
Agenda Item
No.3.2
Decision in the Appeal of M/s Nahar Colours &
Coating Ltd., Udaipur
The Committee noted the decision of the appellate authority.
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 Atul Ltd., Atul
for grant of registration for indigenous manufacture
of MCPA 315 g/l + 2,4-D 360 g/l Dimethyl Amine Salt
S.L. (Herbicide)
Approved.
Agenda Item
No.4.3
Consideration of an application of M/s United
Phosphorus Ltd., Mumbai for grant of registration for
indigenous manufacture of Picloram Technical
(Herbicide)
Approved.
Agenda Item
No.4.4
Consideration of an application of M/s Godrej Sara
Lee Ltd., Mumbai for grant of registration for import
of Metofluthrin Technical (Insecticide)
Approved.
Agenda Item
No.4.5
Consideration of an application of M/s Godrej Sara
Lee Ltd., Mumbai for grant of registration for
indigenous manufacture of Metofluthrin 7.7% w/w
Paper Emanator (Insecticide)
Approved.
Agenda Item
No.4.6
Consideration of an application of M/s Atul Ltd., Atul
for grant of registration for indigenous manufacture
of Thifensulfuron Methyl Technical (Herbicide)
Approved.
Agenda Item
No.4.7
Consideration of an application of M/s Krishi
Rasayan Export Pvt. Ltd., New Delhi for grant of
registration
for
indigenous
manufacture
of
Epoxiconazole Technical (Fungicide)
Approved.
Agenda Item
No.4.8
Consideration of an application of M/s Krishi
Rasayan Export Pvt. Ltd., New Delhi for grant of
registration
for
indigenous
manufacture
of
Ethofumesate Technical (Herbicide)
Approved.
Agenda Item
No.5.0
9(3B) Cases
Agenda Item
No.5.1
Consideration of application of M/s Directorate of
Oilseed Research (ICAR), Hyderabad for grant of
registration
for
indigenous
manufacture
of
Trichoderma Viride 1.00% WP
Approved for a period of two years with commercialization.
Agenda Item
No.5.2
Consideration of application of M/s Pruthvi Fertilizers
Pvt. Ltd., Anand (Gujarat) for grant of registration for
indigenous
manufacture
of
Psuedomonas
fluorescens 0.5% WP
Approved for a period of two years with commercialization.
Agenda Item
No.5.3
Consideration of application of M/s Pruthvi Fertilizers
Pvt. Ltd., Anand (Gujarat) for grant of registration for
indigenous manufacture of Trichoderma Viride 1.00%
WP
Approved for a period of two years with commercialization.
Agenda Item
No.5.4
Consideration of application of M/s IPM Biocontrols
Labs Pvt. Ltd., Secunderabad
for grant of
registration
for
indigenous
manufacture
of
Psuedomonas fluorescens 0.5% WP
Approved for a period of two years with commercialization.
Agenda Item
No.5.5
Consideration of application of M/s Margo
Biocontrols Pvt. Ltd., Bangalore
for grant of
registration
for
indigenous
manufacture
of
Psuedomonas fluorescens 0.5% WP
Approved for a period of two years with commercialization.
Agenda Item
No.5.6
Consideration of application of M/s Poabs Envirotech
Pvt. Ltd., Kerala
for grant of registration for
indigenous
manufacture
of
Psuedomonas
fluorescens 0.5% WP
Approved for a period of two years with commercialization.
Agenda Item
No.5.7
Consideration of application of M/s Poabs Envirotech
Pvt. Ltd., Kerala
for grant of registration for
indigenous manufacture of Trichoderma Viride 1.00%
WP
Approved for a period of two years with commercialization.
Agenda Item
No.5.8
Consideration of application of M/s Transgene
Biotech Ltd., Andhra Pradesh
for grant of
registration
for
indigenous
manufacture
of
Psuedomonas fluorescens 0.5% WP
Approved for a period of two years with commercialization.
Agenda Item
No.5.9
Consideration of application of M/s Balaji Cropcare
Pvt. Ltd., Rangareddy (AP) for grant of registration
for indigenous manufacture of Trichoderma
harzianum 2.00% WP
Approved for a period of two years with commercialization.
Agenda Item
No.5.10
Consideration of application of M/s IPM Biocontrol
Labs, Secunderabad
for grant of registration for
indigenous manufacture of Trichoderma Viride 1.00%
WP
Approved for a period of two years with commercialization.
Agenda Item
No.5.11
Consideration of application of M/s International
Panacea Ltd. for grant of registration for indigenous
manufacture of Metrahizium anisopliae 1.00% WP
Approved for a period of two years with commercialization.
Agenda Item
No.5.12
Request for extension of validity period of
provisional registration of Deltamethrin Impregnated
Bed net u/s 9(3b) of M/s Vestergaard Frandsen (India)
Pvt. Ltd., New Delhi
The Committee deliberated the agenda in detail and decided to approve
the extension of provisional registration u/s.9(3B) for a period of one year as
commercialization within the already approved quantity of 6 million Impregnated
Bed nets, subject to approval of competent authority DAC.
Agenda Item
No.6.0
9(3) Cases
Agenda Item
No.6.1
Reconsideration of application of M/s Syngenta India
Ltd., Mumbai for grant of registration of Metalaxyl – M
31.8% ES for indigenous manufacture
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.7.2
Consideration of application of M/s Meghmani
Industries Ltd. for grant of registration for indigenous
manufacture of Propiconazole Technical
Approved.
Agenda Item
No.7.3
Consideration of application of M/s Krishi Rasayan
Pvt. Ltd. for grant of registration for indigenous
manufacture of Gibberellic Acid Technical
The Committee deliberated the agenda in detail and in view of the request
of the applicant to exempt the MRL for Gibberellic Acid. It decided to ask the
applicant
and M/s. Sumitomo Chemicals, Mumbai to make presentation for
exemption of MRL in the forthcoming meeting of the R.C.
Agenda Item
No.7.4
Consideration of application of M/s United
Phosphorus Ltd. for grant of registration for
indigenous manufacture of Pretilachlor Technical
Approved.
Agenda Item
No.7.5
Consideration of application of M/s Crop Health
Products Ltd. for grant of registration for indigenous
manufacture of Pretilachlor Technical
Approved.
Agenda Item
No.7.6
Consideration of application of M/s Insecticides India
Ltd. for grant of registration for indigenous
manufacture of Dichlorvos Technical
Approved.
Agenda Item
No.7.7
Consideration of application of M/s Insecticides India
Ltd. for grant of registration for indigenous
manufacture of Alphacypermethrin Technical
Approved.
Agenda Item
No.7.8
Consideration of application of M/s Insecticides India
Ltd. for grant of registration for indigenous
manufacture of Cypermethrin Technical
Approved.
Agenda Item
No.8.0
Miscellaneous Items
Agenda Item
No.8.1
Consideration of application of M/s Rallis India Ltd.,
Bangalore for endorsement of additional source
through their approved supplier in the certificate of
Registration of Dimethoate Technical for import and
change of name of source.
Approved.
Agenda Item
No.8.2
Proposal
of
additional
packing
of
Cartap
Hydrochloride Technical for Import proposed by M/s
Coromandal Fertilizers Ltd., Secunderabad
The Committee deliberated the agenda in detail and decided to refer the
file to Co-opted member for examination of the data/information submitted by the
applicant.
Agenda Item
No.8.3
Consideration of application of M/s Syngenta India
Ltd., Mumbai for label expansion of Metalaxyl M 4% +
Mancozeb 64% WP
Approved, subject to fixation of tolerance limit by M/o. Health & Family
Welfare.
Agenda Item
No.8.4
Proposal of additional pack size of 150 ml cap for
Pretilachlor 50% EC in PET containers proposed by
M/s Syngenta India Ltd., Mumbai
The Committee deliberated the agenda in detail and observed that 50 and
100 ml pack sizes are already approved and 150 ml pack size is not as per the
IS Standards, hence the request of additional pack size of 150 ml was not
approved.
Agenda Item
No.8.5
The
Consideration of request for guidelines for
registration of Rotenone by M/s AS Aquaculture Pvt.
Ltd., Kolkata
Committee decided to constitute an Expert Group to frame the
guidelines for registration of Rotenone for use in pisciculture. The composition of
group is as under:-
i)
Dr. P.S. Chandurkar, Plant Protection Adviser to GOI -, Chairman
ii)
ADG Fisheries, ICAR
iii)
Representative from CIFA, Bhuvaneshwar
iv)
Dr. R.M. Shukla, Member Sec y
Agenda Item
No.8.6
Request of M/s Syngenta India Ltd., Mumbai for
Export of Profenofos in ISO Tank of 16000 to 20000
Ton capacity.
The Committee deliberated the agenda in detail and approved the request
of M/s.Sygenta for export of Profenofos in ISO Tank of 16,000 to 20,000 ton
capacity with the condition to follow the rules and regulations under M/o. Surface
Transport for transportation and IMDG guidelines.
Agenda Item
No.8.7
Request of M/s Bayer Crop Science Ltd., Mumbai for
label expansion of Oxadiargyl 6% EC for controlling
weeds in onion.
The Committee deliberated the agenda in detail and noted that applicant
has not submitted data with respect to the periodic residue study in onion and
green onion and pre-harvest interval in green onion as per earlier decision of the
RC. Hence, did not approve the application.
Agenda Item
No.8.8
Request for change in name of company in respect of
Saga Biotech Pvt. Ltd.
Approved.
Agenda Item
No.8.9
Approval of Protocols
Approved.
Agenda Item
No.8.10
Ex-Post facto approval of export applications
Approved.
Agenda Item
No.8.11
Ex-Post facto approval for import permits issued
Approved.
Agenda Item
No.8.12
Issue of import permit for Boric Acid & Other
substances for non-insecticidal use.
The Committee decided as per the annexure Part I, II and III.
Agenda Item
No.8.13
Incorporation of Customer Care Numbers on Package
The Committee deliberated the agenda in detail and decided that in
view of the Notification No.GSR 425(E), dated 17.7.2006, under Weights &
Measures (for Packed commodities 1977), the pesticides importers and
manufacturers may write the Name, address, telephone Number and E-mail
address of the person who can be or the office which can be contacted, in case
of consumer complaints on labels and leaflets. The letters should be sent to the
Pesticides
Industry Association and State Department of Agriculture in this
regard.
Agenda Item
No.8.14
Request of M/s Syngenta India Ltd., Mumbai for
change of packaging condition for Export of
Pretilachlor Technical and Pretilachlor 50% EC
The Committee deliberated the agenda in detail and decided to
incorporate the following conditions in all the 9(3) and 9(4) Certificate of
Registration issued for manufacture/import for domestic consumption.
In case of export, the packaging shall be as per the requirement of the
importing country and conforming to IMDG guidelines.
Agenda Item
No.8.15
8.1
Deferred Agenda Item of 273rd RC Meeting
8.1
8.9
8.10
Agenda Item No.8.1 of 270th R.C. Meeting
The Committee deliberated agenda in detail and constitute a
Committee under the Chairmanship of Dr. P.M. Maji, Addl.
Industrial Adviser, the other members of the Committee are as
follows:-
i)
Head of Agriculture Division of IARI and Agricultural
Chemistrey, IARI.
ii)
Dr.(Mrs.) G. Mukherjee
iii)
Shri Vipin Bhatnagar, JD(Chemistry)
- Member-Secretary
Agenda item No.8.9 of 270th R.C. Meeting
The Committee deliberated the agenda and decided that file
may be put up to the Co-opted Member, Shri Madhav Chakraborty
for perusal of data/information provided by the applicant.
Agenda item No.8.10 of 270th R.C. Meeting
The Committee deliberated the agenda and decided that file
may be put up to the Co-opted Member, Shri Madhav Chakraborty
for perusal of data/information provided by the applicant.
Agenda Item
No.9.0
Any other item with the permission of the
Chair.
Agenda Item
No.9.1
Correction in the name of product from Trichoderma
Viride 1% WP to Pseudomonas Fluorescens 0.5% WP
in agenda item 5.15 of 270th RC.
Noted.
Agenda Item
No.9.2
Treatment of seeds imported in the country with
unapproved/unknown pesticides
ADG(PP) raised the issue that the seeds imported in the country do not
contain any information regarding the pesticides used for treatment of these
seeds. The Committee decided to request the DAC for taking appropriate action
in this regard.
Agenda Item
No.9.3
Consideration of appliction of M/s. Aura Chem Pvt.
Ltd., Mumbai for grant of registration for indigenous
manufacture of Prallethrin Tech. u/s.9(4) – Agenda
Item 7.2 of 270th RC held on 8.12.2006
The Committee noted that this agenda item was earlier discussed in 270 th
meeting of the RC, wherein, it was decided to refer the matter to PPA to the
Govt. of India for examination and comments in the matter. PPA presented the
comments to the RC, informing, as under:“M/s. Aura Chem Pvt. Ltd., Mumbai vide their letter dated 17.4.2006
informed Shri Murli Dhar, PPO(Chem) about the stage-wise process/synthesis in
the manufacture of Prallethrin Tech. in response to the letter dated 31.3.2006
issued by the PPA for drawal of in-process sample. Accordingly, four steps have
been indicated in this synthesis process requiring total time of 24 hours. This is
for the manufacture of 1 MT Prallethrin. The firm was asked for further details as
to why there is difference in the time required for process when in-process
sample was drawn. The information received from the firm. Accordingly, they
have further clarified that the conditions of manufacture vary depending on the
type of reactor used, size of the reactor, type of stirrer and its speed, speed of
addition of reactants, mass of reaction and conditions set, etc. and that the
difference in the manufacturing conditions prevail depending on the scale of
manufacture. They have further indicated that they have used the same raw
materials and followed the reactions as per earlier registrant to establish
chemical equivalence with the earlier registrants. On further detailed discussion
with the chemist of the firm, it has been indicated that two days’ time is required
for completing one batch of commercial scale manufacture of 5 ton capacity,
whereas 24 hours time is adequate for completing the process of synthesis of
laboratory scale.
The reason for lesser time required for laboratory scale is
merely because of the small quantity of reactants required to be handled and the
products to be washed/separated to reach the end point.
Further, in the
commercial scale manufacturing, the stirring is done at a fixed
speed of
approximately 120 rpm, whereas in the lab scale synthesis the laboratory
magnetic stirrer with variable speed is used, as a result higher rpm could be used
which can enhance the speed of reaction to certain extent.
The chemist of the firm indicated during the discussion that they had
undertaken this kind of lab scale synthesis with this time frame several times in
their lab before the actual demonstration at the time of in-process sampling. The
above explanation given by the applicant is quite logical.
From the above it is clear that the synthesis carried out for the in-process
sampling was complete which resulted in the desired final product with the purity
of 95.26% compared to the minimum requirement of 90% as per earlier
registrants as reported in the Analytical Test Report of CIL. Hence, the sample
confirms to the physico-chemical requirements.”
In view of the above, the Committee approve the above application for
registration.
The meeting ended with a vote of thanks to the Chair.
******
Part-III
Representations for issuance of Import permits for Dual Use
Insecticides
Sl.
No.
1
1.
Name of the
Applicant
(M/s)
2
Nahar Colours &
Coating
Ltd,
Udaipur
2.
Orient
Limited,
(Distt
Gujarat).
Glazes
Radhu
Kheda,
3.
Navin
Fluorine
International
Limited, Mumbai
Minutes of the 274th meeting of the Registration Committee held
on 21st March, 2007 in Room No.139 ,Krishi Bhawan, New Delhi
The 274th meeting of the Registration Committee (RC) was held under
the Chairmanship of Dr. N.B. Singh, Agriculture Commissioner on 21st March,
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, Shri P.N. Maji, Addl. Industrial Advisor, M/o. Chemicals &
Petrochemicals, Shri Madhab Chakraborthy, Deputy Director, Indian Institute of
Packaging, New Delhi ( Co-opted Member), Dr. P.S. Chopra, ADG(PFA) and
Dr. (Mrs.) S. Kulshrestha, Secretary, CIB&RC attended the meeting.
Following officers from the Secretariat of CIB&RC were also present:
(xii)
Dr. Hari Prasad, Jt.Dir.(Chem.)
(xiii)
Dr. R.M. Shukla, DD (Ent.)
(xiv)
Dr.Subhash Kumar, Dy.Dir.(WS)
(xv)
Sh. R.C.Gulati, SO
(xvi)
Sh. Niraj Kulshrestha, Assistant(Legal)
(xvii) Sh. Y.S. Adhana, SSA-III
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.1.0
Confirmation of minutes of the 273rd meeting of the
Registration Committee.
The Minutes of the 273rd meeting of the Registration Committee (RC)
were confirmed.
Agenda Item
No.2.0
Follow up action on the decisions taken by the
Registration Committee in its 273rd 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 Subsections of the Act.
Agenda Item
No.3.0
Government Business
Agenda Item
No.3.1
Registration of Cypermethrin 3% SG for general
public use : Decision of Appellate Authority.
The Committee noted the decision of the appellate authority and decided
to constitute a committee with the following composition to look into the request
of the appellant to permit the use of Cypermethrin 3% SG for general use:
1.
Dr.H.N. Saiyed
-
Chairman
2.
Dr. Usha Gupta
-
Member
3.
Dr. R.M. Shukla
-
Member-Secretary
Agenda Item
No.3.2
Decision in the Appeal of M/s Nahar Colours &
Coating Ltd., Udaipur
The Committee noted the decision of the appellate authority.
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 Atul Ltd., Atul
for grant of registration for indigenous manufacture
of MCPA 315 g/l + 2,4-D 360 g/l Dimethyl Amine Salt
S.L. (Herbicide)
Approved.
Agenda Item
No.4.3
Consideration of an application of M/s United
Phosphorus Ltd., Mumbai for grant of registration for
indigenous manufacture of Picloram Technical
(Herbicide)
Approved.
Agenda Item
No.4.4
Consideration of an application of M/s Godrej Sara
Lee Ltd., Mumbai for grant of registration for import
of Metofluthrin Technical (Insecticide)
Approved.
Agenda Item
No.4.5
Consideration of an application of M/s Godrej Sara
Lee Ltd., Mumbai for grant of registration for
indigenous manufacture of Metofluthrin 7.7% w/w
Paper Emanator (Insecticide)
Approved.
Agenda Item
No.4.6
Consideration of an application of M/s Atul Ltd., Atul
for grant of registration for indigenous manufacture
of Thifensulfuron Methyl Technical (Herbicide)
Approved.
Agenda Item
No.4.7
Consideration of an application of M/s Krishi
Rasayan Export Pvt. Ltd., New Delhi for grant of
registration
for
indigenous
manufacture
of
Epoxiconazole Technical (Fungicide)
Approved.
Agenda Item
No.4.8
Consideration of an application of M/s Krishi
Rasayan Export Pvt. Ltd., New Delhi for grant of
registration
for
indigenous
manufacture
of
Ethofumesate Technical (Herbicide)
Approved.
Agenda Item
No.5.0
9(3B) Cases
Agenda Item
No.5.1
Consideration of application of M/s Directorate of
Oilseed Research (ICAR), Hyderabad for grant of
registration
for
indigenous
manufacture
of
Trichoderma Viride 1.00% WP
Approved for a period of two years with commercialization.
Agenda Item
No.5.2
Consideration of application of M/s Pruthvi Fertilizers
Pvt. Ltd., Anand (Gujarat) for grant of registration for
indigenous
manufacture
of
Psuedomonas
fluorescens 0.5% WP
Approved for a period of two years with commercialization.
Agenda Item
No.5.3
Consideration of application of M/s Pruthvi Fertilizers
Pvt. Ltd., Anand (Gujarat) for grant of registration for
indigenous manufacture of Trichoderma Viride 1.00%
WP
Approved for a period of two years with commercialization.
Agenda Item
No.5.4
Consideration of application of M/s IPM Biocontrols
Labs Pvt. Ltd., Secunderabad
for grant of
registration
for
indigenous
manufacture
of
Psuedomonas fluorescens 0.5% WP
Approved for a period of two years with commercialization.
Agenda Item
No.5.5
Consideration of application of M/s Margo
Biocontrols Pvt. Ltd., Bangalore
for grant of
registration
for
indigenous
manufacture
of
Psuedomonas fluorescens 0.5% WP
Approved for a period of two years with commercialization.
Agenda Item
No.5.6
Consideration of application of M/s Poabs Envirotech
Pvt. Ltd., Kerala
for grant of registration for
indigenous
manufacture
of
Psuedomonas
fluorescens 0.5% WP
Approved for a period of two years with commercialization.
Agenda Item
No.5.7
Consideration of application of M/s Poabs Envirotech
Pvt. Ltd., Kerala
for grant of registration for
indigenous manufacture of Trichoderma Viride 1.00%
WP
Approved for a period of two years with commercialization.
Agenda Item
No.5.8
Consideration of application of M/s Transgene
Biotech Ltd., Andhra Pradesh
for grant of
registration
for
indigenous
manufacture
of
Psuedomonas fluorescens 0.5% WP
Approved for a period of two years with commercialization.
Agenda Item
No.5.9
Consideration of application of M/s Balaji Cropcare
Pvt. Ltd., Rangareddy (AP) for grant of registration
for indigenous manufacture of Trichoderma
harzianum 2.00% WP
Approved for a period of two years with commercialization.
Agenda Item
No.5.10
Consideration of application of M/s IPM Biocontrol
Labs, Secunderabad
for grant of registration for
indigenous manufacture of Trichoderma Viride 1.00%
WP
Approved for a period of two years with commercialization.
Agenda Item
No.5.11
Consideration of application of M/s International
Panacea Ltd. for grant of registration for indigenous
manufacture of Metrahizium anisopliae 1.00% WP
Approved for a period of two years with commercialization.
Agenda Item
No.5.12
Request for extension of validity period of
provisional registration of Deltamethrin Impregnated
Bed net u/s 9(3b) of M/s Vestergaard Frandsen (India)
Pvt. Ltd., New Delhi
The Committee deliberated the agenda in detail and decided to approve
the extension of provisional registration u/s.9(3B) for a period of one year as
commercialization within the already approved quantity of 6 million Impregnated
Bed nets, subject to approval of competent authority DAC.
Agenda Item
No.6.0
9(3) Cases
Agenda Item
No.6.1
Reconsideration of application of M/s Syngenta India
Ltd., Mumbai for grant of registration of Metalaxyl – M
31.8% ES for indigenous manufacture
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.7.2
Consideration of application of M/s Meghmani
Industries Ltd. for grant of registration for indigenous
manufacture of Propiconazole Technical
Approved.
Agenda Item
No.7.3
Consideration of application of M/s Krishi Rasayan
Pvt. Ltd. for grant of registration for indigenous
manufacture of Gibberellic Acid Technical
The Committee deliberated the agenda in detail and in view of the request
of the applicant to exempt the MRL for Gibberellic Acid. It decided to ask the
applicant
and M/s. Sumitomo Chemicals, Mumbai to make presentation for
exemption of MRL in the forthcoming meeting of the R.C.
Agenda Item
No.7.4
Consideration of application of M/s United
Phosphorus Ltd. for grant of registration for
indigenous manufacture of Pretilachlor Technical
Approved.
Agenda Item
No.7.5
Consideration of application of M/s Crop Health
Products Ltd. for grant of registration for indigenous
manufacture of Pretilachlor Technical
Approved.
Agenda Item
No.7.6
Consideration of application of M/s Insecticides India
Ltd. for grant of registration for indigenous
manufacture of Dichlorvos Technical
Approved.
Agenda Item
No.7.7
Consideration of application of M/s Insecticides India
Ltd. for grant of registration for indigenous
manufacture of Alphacypermethrin Technical
Approved.
Agenda Item
No.7.8
Consideration of application of M/s Insecticides India
Ltd. for grant of registration for indigenous
manufacture of Cypermethrin Technical
Approved.
Agenda Item
No.8.0
Miscellaneous Items
Agenda Item
No.8.1
Consideration of application of M/s Rallis India Ltd.,
Bangalore for endorsement of additional source
through their approved supplier in the certificate of
Registration of Dimethoate Technical for import and
change of name of source.
Approved.
Agenda Item
No.8.2
Proposal
of
additional
packing
of
Cartap
Hydrochloride Technical for Import proposed by M/s
Coromandal Fertilizers Ltd., Secunderabad
The Committee deliberated the agenda in detail and decided to refer the
file to Co-opted member for examination of the data/information submitted by the
applicant.
Agenda Item
No.8.3
Consideration of application of M/s Syngenta India
Ltd., Mumbai for label expansion of Metalaxyl M 4% +
Mancozeb 64% WP
Approved, subject to fixation of tolerance limit by M/o. Health & Family
Welfare.
Agenda Item
No.8.4
Proposal of additional pack size of 150 ml cap for
Pretilachlor 50% EC in PET containers proposed by
M/s Syngenta India Ltd., Mumbai
The Committee deliberated the agenda in detail and observed that 50 and
100 ml pack sizes are already approved and 150 ml pack size is not as per the
IS Standards, hence the request of additional pack size of 150 ml was not
approved.
Agenda Item
No.8.5
The
Consideration of request for guidelines for
registration of Rotenone by M/s AS Aquaculture Pvt.
Ltd., Kolkata
Committee decided to constitute an Expert Group to frame the
guidelines for registration of Rotenone for use in pisciculture. The composition of
group is as under:-
i)
Dr. P.S. Chandurkar, Plant Protection Adviser to GOI -, Chairman
ii)
ADG Fisheries, ICAR
iii)
Representative from CIFA, Bhuvaneshwar
iv)
Dr. R.M. Shukla, Member Sec y
Agenda Item
No.8.6
Request of M/s Syngenta India Ltd., Mumbai for
Export of Profenofos in ISO Tank of 16000 to 20000
Ton capacity.
The Committee deliberated the agenda in detail and approved the request
of M/s.Sygenta for export of Profenofos in ISO Tank of 16,000 to 20,000 ton
capacity with the condition to follow the rules and regulations under M/o. Surface
Transport for transportation and IMDG guidelines.
Agenda Item
No.8.7
Request of M/s Bayer Crop Science Ltd., Mumbai for
label expansion of Oxadiargyl 6% EC for controlling
weeds in onion.
The Committee deliberated the agenda in detail and noted that applicant
has not submitted data with respect to the periodic residue study in onion and
green onion and pre-harvest interval in green onion as per earlier decision of the
RC. Hence, did not approve the application.
Agenda Item
No.8.8
Request for change in name of company in respect of
Saga Biotech Pvt. Ltd.
Approved.
Agenda Item
No.8.9
Approval of Protocols
Approved.
Agenda Item
No.8.10
Ex-Post facto approval of export applications
Approved.
Agenda Item
No.8.11
Ex-Post facto approval for import permits issued
Approved.
Agenda Item
No.8.12
Issue of import permit for Boric Acid & Other
substances for non-insecticidal use.
The Committee decided as per the annexure Part I, II and III.
Agenda Item
No.8.13
Incorporation of Customer Care Numbers on Package
The Committee deliberated the agenda in detail and decided that in
view of the Notification No.GSR 425(E), dated 17.7.2006, under Weights &
Measures (for Packed commodities 1977), the pesticides importers and
manufacturers may write the Name, address, telephone Number and E-mail
address of the person who can be or the office which can be contacted, in case
of consumer complaints on labels and leaflets. The letters should be sent to the
Pesticides
Industry Association and State Department of Agriculture in this
regard.
Agenda Item
No.8.14
Request of M/s Syngenta India Ltd., Mumbai for
change of packaging condition for Export of
Pretilachlor Technical and Pretilachlor 50% EC
The Committee deliberated the agenda in detail and decided to
incorporate the following conditions in all the 9(3) and 9(4) Certificate of
Registration issued for manufacture/import for domestic consumption.
In case of export, the packaging shall be as per the requirement of the
importing country and conforming to IMDG guidelines.
Agenda Item
No.8.15
8.2
Deferred Agenda Item of 273rd RC Meeting
8.1
8.9
8.10
Agenda Item No.8.1 of 270th R.C. Meeting
The Committee deliberated agenda in detail and constitute a
Committee under the Chairmanship of Dr. P.M. Maji, Addl.
Industrial Adviser, the other members of the Committee are as
follows:-
ii)
Head of Agriculture Division of IARI and Agricultural
Chemistrey, IARI.
ii)
Dr.(Mrs.) G. Mukherjee
iii)
Shri Vipin Bhatnagar, JD(Chemistry)
- Member-Secretary
Agenda item No.8.9 of 270th R.C. Meeting
The Committee deliberated the agenda and decided that file
may be put up to the Co-opted Member, Shri Madhav Chakraborty
for perusal of data/information provided by the applicant.
Agenda item No.8.10 of 270th R.C. Meeting
The Committee deliberated the agenda and decided that file
may be put up to the Co-opted Member, Shri Madhav Chakraborty
for perusal of data/information provided by the applicant.
Agenda Item
No.9.0
Any other item with the permission of the
Chair.
Agenda Item
No.9.1
Correction in the name of product from Trichoderma
Viride 1% WP to Pseudomonas Fluorescens 0.5% WP
in agenda item 5.15 of 270th RC.
Noted.
Agenda Item
No.9.2
Treatment of seeds imported in the country with
unapproved/unknown pesticides
ADG(PP) raised the issue that the seeds imported in the country do not
contain any information regarding the pesticides used for treatment of these
seeds. The Committee decided to request the DAC for taking appropriate action
in this regard.
Agenda Item
No.9.3
Consideration of appliction of M/s. Aura Chem Pvt.
Ltd., Mumbai for grant of registration for indigenous
manufacture of Prallethrin Tech. u/s.9(4) – Agenda
Item 7.2 of 270th RC held on 8.12.2006
The Committee noted that this agenda item was earlier discussed in 270 th
meeting of the RC, wherein, it was decided to refer the matter to PPA to the
Govt. of India for examination and comments in the matter. PPA presented the
comments to the RC, informing, as under:“M/s. Aura Chem Pvt. Ltd., Mumbai vide their letter dated 17.4.2006
informed Shri Murli Dhar, PPO(Chem) about the stage-wise process/synthesis in
the manufacture of Prallethrin Tech. in response to the letter dated 31.3.2006
issued by the PPA for drawal of in-process sample. Accordingly, four steps have
been indicated in this synthesis process requiring total time of 24 hours. This is
for the manufacture of 1 MT Prallethrin. The firm was asked for further details as
to why there is difference in the time required for process when in-process
sample was drawn. The information received from the firm. Accordingly, they
have further clarified that the conditions of manufacture vary depending on the
type of reactor used, size of the reactor, type of stirrer and its speed, speed of
addition of reactants, mass of reaction and conditions set, etc. and that the
difference in the manufacturing conditions prevail depending on the scale of
manufacture. They have further indicated that they have used the same raw
materials and followed the reactions as per earlier registrant to establish
chemical equivalence with the earlier registrants. On further detailed discussion
with the chemist of the firm, it has been indicated that two days’ time is required
for completing one batch of commercial scale manufacture of 5 ton capacity,
whereas 24 hours time is adequate for completing the process of synthesis of
laboratory scale.
The reason for lesser time required for laboratory scale is
merely because of the small quantity of reactants required to be handled and the
products to be washed/separated to reach the end point.
Further, in the
commercial scale manufacturing, the stirring is done at a fixed
speed of
approximately 120 rpm, whereas in the lab scale synthesis the laboratory
magnetic stirrer with variable speed is used, as a result higher rpm could be used
which can enhance the speed of reaction to certain extent.
The chemist of the firm indicated during the discussion that they had
undertaken this kind of lab scale synthesis with this time frame several times in
their lab before the actual demonstration at the time of in-process sampling. The
above explanation given by the applicant is quite logical.
From the above it is clear that the synthesis carried out for the in-process
sampling was complete which resulted in the desired final product with the purity
of 95.26% compared to the minimum requirement of 90% as per earlier
registrants as reported in the Analytical Test Report of CIL. Hence, the sample
confirms to the physico-chemical requirements.”
In view of the above, the Committee approve the above application for
registration.
The meeting ended with a vote of thanks to the Chair.
******