{"id":209043,"date":"2009-08-11T00:00:00","date_gmt":"2009-08-10T18:30:00","guid":{"rendered":"https:\/\/www.legalindia.com\/judgments\/syngenta-india-ltd-vs-uoi-through-department-of-on-11-august-2009"},"modified":"2017-05-30T07:18:11","modified_gmt":"2017-05-30T01:48:11","slug":"syngenta-india-ltd-vs-uoi-through-department-of-on-11-august-2009","status":"publish","type":"post","link":"https:\/\/www.legalindia.com\/judgments\/syngenta-india-ltd-vs-uoi-through-department-of-on-11-august-2009","title":{"rendered":"Syngenta India Ltd. vs Uoi Through Department Of … on 11 August, 2009"},"content":{"rendered":"
Delhi High Court<\/div>\n
Syngenta India Ltd. vs Uoi Through Department Of … on 11 August, 2009<\/div>\n
Author: Ajit Prakash Shah<\/div>\n
*      IN THE HIGH COURT OF DELHI AT NEW DELHI\n                                                                     #33\n+      LPA 367\/2009\n\n       SYNGENTA INDIA LTD.                     .... Appellant\n                     Through Mr. Mukul Rohatgi, Senior\n                     Advocate with Ms. Ruchi Agnihotri Mahajan,\n                     Adv.\n\n\n                   versus\n\n\n       UOI THROUGH DEPARTMENT OF AGRICILTURE\n       & CO- OPRATION & Ors.                  ..... Respondents\n                     Through Mr. A.S. Chandhiok, ASG with Mr.\n                     Gaurav Duggal, Mr. Ritesh Kumar, Mr.\n                     Sandeep Bajaj, Advs. for R-1\/UOI.\n                     Mr.S. Ganesh and Mr. Sudhir Nandrajog,\n                     Senior Advocates with Mr. Laliet Kumar and\n                     Mr. Santosh Sharma, Advs. for R-3.\n\n       CORAM:\n       HON'BLE THE CHIEF JUSTICE\n       HON'BLE MR. JUSTICE MANMOHAN\n\n       1.Whether reporters of the local news papers\n          be allowed to see the judgment?\n       2.To be referred to the Reporter or not ?\n       3. Whether the judgment should be reported in the Digest ?\n\n\n                      ORDER\n<\/pre>\n
%                    11.08.2009<\/p>\n
       The appellant Syngenta India Ltd. has preferred this appeal<\/p>\n
against the judgment and order dated 1.7.2009, passed by S.<\/p>\n
Ravindra Bhat, J. in W.P(C) No. 8123\/2008. In the writ petition the<\/p>\n
appellant       impugned    the   decision   of   the   Department      of<\/p>\n
Agriculture, Government of India, dated 5.11.2008, rejecting its<\/p>\n
appeal under Section 10 of the Insecticides Act, 1968 (“the Act”)<\/p>\n
against the decision of the Registration Committee (‘Committee’<\/p>\n
for short) for granting registration for Emamectin Benzoate 5%<\/p>\n
SG to the third respondent – M\/s Jaishree Agro Industries Ltd. in<\/p>\n
its 293rd meeting held on 26.9.2008. The learned Judge came to
\nLPA No.367-09                                                Page 1 of 18<\/span>
\n the conclusion that the litigation was speculative, as the attempt<\/p>\n
was clearly to invite the Court to make a policy declaration, which<\/p>\n
could not have been made under any circumstances and the<\/p>\n
pendency of this proceeding had also resulted in prejudice to the<\/p>\n
third respondent, who was constrained to give an undertaking not<\/p>\n
to give effect to its registration that has subsisted all this while.<\/p>\n
Consequently, the learned Judge dismissed the petition with<\/p>\n
heavy costs.\n<\/p>\n
2.     The facts necessary for deciding this appeal are as follows :<\/p>\n
       In 2003 the appellant filed an application for registration<\/p>\n
under Section 9(3) of the Act for import of technical (TIT) sourced<\/p>\n
from its parent factory in Switzerland, and for indigenous<\/p>\n
manufacture of formulation (FIM) for the insecticide, Emamectin<\/p>\n
Benzoate 5 % Soluble Granules (“Emamectin 5% SG”). The<\/p>\n
Committee noted that its (appellants’) data was incomplete on<\/p>\n
various parameters like toxicity and bio-efficacy, in its meeting<\/p>\n
held on 2.7.2004. The appellant, therefore, could not be granted<\/p>\n
a registration under Section 9 (3) of the Act. The appellant,<\/p>\n
however, was in the meanwhile, asked by the Committee to<\/p>\n
convert its application to one under Section 9(3-B), on account of<\/p>\n
an infestation of cotton crop by bollworm at the relevant time, as<\/p>\n
Emamectin       is   known   to   be   effective   in   controlling   such<\/p>\n
infestation.    Thus, a decision was taken by the Committee to<\/p>\n
grant a provisional registration under Section 9 (3B) of the Act to<\/p>\n
the appellant in the same categories of TIT (Import of Technical)<\/p>\n
and FIM (Indigenous Manufacture of Formulation).             Accordingly,<\/p>\n
on 21.7.2004, certificates for provisional registration valid till<\/p>\n
LPA No.367-09                                                  Page 2 of 18<\/span>
\n 20.7.2006 were granted to the appellant in the categories of TIT<\/p>\n
and FIM under S.9 (3B), for Emamectin 5% SG. This provisional<\/p>\n
registration permitted commercialization of the insecticide (since<\/p>\n
the grant of provisional registration was only because of the<\/p>\n
demand expressed by the State Governments); but was subject<\/p>\n
to a limit of a total quantity of 5 (five) Metric Tonnes of Technical<\/p>\n
Emamectin permitted to the appellant during the period of 2<\/p>\n
years. It is stated that from this 5 MT the appellant indigenously<\/p>\n
manufactured about 100 MT of formulation, and used it for<\/p>\n
commercialization as well as compilation and generation of<\/p>\n
exhaustive data.     The provisional registrations granted to the<\/p>\n
appellant in the categories of TIT and FIM lapsed on 20.07.2006.<\/p>\n
By that time the appellant claims to have collated and completed<\/p>\n
its deficient data. On 11.09.2006, the appellant applied afresh<\/p>\n
under Section 9 (3) of the Act in the category FIT (Import of<\/p>\n
Formulation).   On    24.7.2007,   the   appellant    was      granted<\/p>\n
registration under Section 9 (3) of the Act in the category of FIT<\/p>\n
(Import of Formulation).\n<\/p>\n
3.     On 27.07.2007, the respondent no. 3, applied for a<\/p>\n
registration in the categories of “TIT” (Import of Technical) and<\/p>\n
“FIM” (Indigenous Manufacture of Formulation) for Emamectin 5%<\/p>\n
SG under Section 9(3B) of the Act. However, the respondent no.<\/p>\n
3, was not granted registration because the appellant was<\/p>\n
granted the registration under Section 9(3) before respondent<\/p>\n
No.3 and the grant of registration under Section 9(3B) is only for<\/p>\n
introduction of the product for the first time. This fact was<\/p>\n
intimated to the respondent No.3 vide Secretariat of Central<\/p>\n
LPA No.367-09                                               Page 3 of 18<\/span>
\n Insecticides     Board      &    Registration        Committee’s         letter<\/p>\n
No.1\/TI\/9(3B)\/2006-CIR.II       dated     24.7.2007.      Therefore,        the<\/p>\n
respondent      no.   3   requested     that   its   application    may      be<\/p>\n
considered under Section 9(3) for import of the product from a<\/p>\n
new (alternate) source, which is permissible under already<\/p>\n
existing guidelines of the Committee requiring lesser data<\/p>\n
package because the efficacy and safety of the product had been<\/p>\n
established to the satisfaction of the Committee. Accordingly, an<\/p>\n
application was submitted by the respondent no. 3 on 7.8.2007<\/p>\n
for registration as TIT(new source) under Section 9(3).                  Along<\/p>\n
with the application required information \/ data was also<\/p>\n
submitted by the respondent no. 3, as was applicable and<\/p>\n
required in respect of application under Section 9(3) for TIT (new<\/p>\n
source). The data submitted comprised more than 4000 pages of<\/p>\n
detailed technical studies, analysis, reports and other data,<\/p>\n
including reports of numerous studies conducted by Jawaharlal<\/p>\n
Nehru Krishi Vishwa Vidyalaya, Indian Agriculture Research<\/p>\n
Institute, Tamil Nadu Agriculture University etc. which are well<\/p>\n
known institutions in the field of agriculture.           The Committee<\/p>\n
verified the claims of the respondent no. 3 from the data<\/p>\n
submitted to it and granted the registration to the respondent no.<\/p>\n
3 under Section 9(3) of the Act in its 293rd Meeting held on<\/p>\n
26.09.2008.\n<\/p>\n<\/p>\n
4.     The appeal preferred by the appellant under Section 10 of<\/p>\n
the Act to the Central Government, i.e the appellate authority,<\/p>\n
came to be dismissed by order dated 5.11.2008, which interalia<\/p>\n
reads as follows :\n<\/p>\n
LPA No.367-09                                                      Page 4 of 18<\/span><\/p>\n
                 “M\/s Syngenta India Limited (M\/s Syngenta)
\n                have appealed against grant of registration to
\n                M\/s Jaishree Agro Industries Ltd. (M\/s Jaishree).
\n                They have mentioned that the Government had
\n                agreed to provide three years freeze on data
\n                submitted by the applicants for formulation
\n                import under Section 9(3) of the Act; that there
\n                is no technical Emamectin registered in the
\n                country under Section 9(3) as of how; that in
\n                terms of the policy enunciated in 284th meeting
\n                of the Registration Committee, the technical
\n                would be deemed to be registered after three
\n                years form the date of formulation import; that
\n                as Emamectin Benzoate 5% SG formulation for
\n                import was registered in their favour on
\n                26.07.2007, the technical can be deemed to be
\n                registered only after 3 years; that the grant of
\n                registration for technical to M\/s Jaishree
\n                presumes registration of technical prematurely
\n                before the expiry of 3 years; that registration for
\n                import of technical from alternate source has
\n                been granted to M\/s Jaishree based on truncated
\n                data requirement; that as per guidelines for
\n                registration the registrant under section 9(3) is
\n                required to submit the complete data on its own
\n                which should be applicable for M\/s Jaishree also
\n                who have relied on data furnished by M\/s
\n                Syngenta      instead    as    implied    in   their
\n                presentation made in the 278th meeting of the
\n                Registration Committee; that policy guidelines
\n                should be applicable prospectively and not
\n                retrospectively; that the decision of the
\n                Registration Committee taken in its 293rd
\n                meeting is contrary to the decision taken on
\n                284th meeting; that equating registration under
\n                section 9(3) with registration under section
\n                9(3B) for computing the 3 year period for
\n                effecting deemed registration of technical in
\n                contrary to the earlier decision and is arbitrary
\n                and illegal; that their provisional registration for
\n                Emamectin Benzoate under section 9(3B) which
\n                expired on 20.07.2006 was restricted to import
\n                of 5 MT of technical grade material to deal with
\n                exigency of bollworm infestation in cotton at the
\n                request of State Governments; that the
\n                impugned decisions taken on 293rd meeting
\n                may be stayed till the matter is decided; that
\n                the impugned decision of 293rd meeting
\n                (agenda items 6.5 and 3.7) be quashed. In the
\n                hearing held on 04.11.2008, the representatives
\n                of M\/s Syngenta elaborated on these points and
\n                also asserted that the letter dated 18.02.2008 of
\n                the Government was for formulations for import
\n                and not for indigenous manufacture and
\nLPA No.367-09                                                  Page 5 of 18<\/span>
\n                 therefore the registration issued in 2004 for
\n                indigenous manufacture of the formulation to
\n                them did not come under its purview.<\/p>\n
                The Secretary, CIB&RC, vide letter no.13-
\n                29\/2008-CIR.I dated 30.10.2008, has questioned
\n                the locus standi of M\/s Syngenta in the matter of
\n                grant of registration to another applicant as the
\n                matter is between the Registration Committee
\n                and another applicant. It has been stated that as
\n                per the directive of the Department of
\n                Agriculture & Cooperation dated 18.02.2008, the
\n                period of deemed registration is to be computed
\n                from     the    date     of   registration   with
\n                commercialization under section 9(3B), i.e. from
\n                21.07.2004. The registration to M\/s Jai shree,
\n                who have submitted requisite data under the
\n                relevant guidelines, has been granted as per the
\n                policy of the Government and the guidelines of
\n                the Registration Committee. The provisional
\n                registration was granted to M\/s Syngenta in
\n                2004 at their own request. In view of these
\n                averments, the appeal is liable to be set aside.
\n                These points were further elaborated by
\n                Secretary, CIB&RC in the hearing on 04.11.2008.\n<\/p><\/blockquote>\n
                Section 10 of the Act provides that “Any person
\n                aggrieved by the decision of the Registration
\n                Committee under section 9 may, within a period
\n                of 30 days from the date on which the decision
\n                is communicated to him, appeal in the
\n                prescribed manner…” M\/s Syngenta, already
\n                holding a registration of the insecticide in
\n                question, are an interested party in the matter.
\n                It would be too narrow an interpretation if the
\n                scope of section 10 is confined to the
\n                applicant\/registrant alone. The decision of the
\n                Registration Committee are in public domain
\n                and are displayed on the internet. It would not
\n                be fair to deny any person a change to appeal
\n                against a decision of the Registration Committee
\n                if he is aggrieved by that decision, provided the
\n                person has a clear interest in the decision.\n<\/p><\/blockquote>\n
                Coming to the issues raised in the appeal, it is
\n                noted that the Government has been issuing
\n                directives from time to time for proper
\n                enforcement of the Insecticides Act, 1968 and
\n                the rules made thereunder, and in doing so it
\n                has been taking into account the views of the
\n                different sections of the pesticides industry. The
\n                letter dated 30.10.2007, issued in view of the
\n                instances    where     formulation     had   been
\n                registered for import without registration of
\nLPA No.367-09                                                 Page 6 of 18<\/span>
\n                 technical under section 9(3) thus blocking
\n                registration under section 9(4) and created a
\n                monopolistic situation, also took into account
\n                the industry’s concern to allow data protection
\n                for 3 years till suitable legislative changes are
\n                made. The letter dated 18.02.2008 included the
\n                category of registration under section 9(3B) with
\n                commercialization in this dispensation with a
\n                view to remove the perverse tendency to
\n                continue with provisional 9(3B) registration with
\n                commercialization,         thereby        creating
\n                monopolistic situation. The data protection for 3
\n                years is available to his category also. It would
\n                also be disingenuous to make a distinction
\n                between registration of formulation for import
\n                and registration of formulation for indigenous
\n                manufacture for this purpose as indefinite
\n                protection in either case would have the same
\n                consequence, i.e. existence of a monopolistic
\n                situation. Application received for grant of
\n                registration for the same product from any other
\n                source thereafter is treated under the category
\n                of new source and the data requirements for
\n                that category apply which have been met by M\/s
\n                Jaishree. The registration under section 9(3B)
\n                with commercialization was granted to M\/s
\n                Syngenta at their own request in 2004. The
\n                Registration Committee has taken the decision
\n                in question (agenda items 6.5 and 3.7) in its
\n                293rd meeting in line with the policy laid down
\n                by the Government. As such there is no reason
\n                to interfere with these decisions. The appeal is,
\n                therefore, dismissed.”\n<\/p><\/blockquote>\n
5.     After a very elaborate and detailed consideration of the<\/p>\n
facts and law, the learned single Judge dismissed the writ petition<\/p>\n
challenging the order of the Central Government passed in<\/p>\n
appeal under Section 10 of the Act.\n<\/p>\n<\/p>\n
6.     Mr. Mukul Rohatgi, learned senior counsel appearing for the<\/p>\n
appellant, inter alia raised the following four submissions before<\/p>\n
us:\n<\/p>\n
       (i)      that though the respondent no. 3 was effectively<\/p>\n
LPA No.367-09                                                Page 7 of 18<\/span>
\n                 seeking    registration   on   parameters   \/     criterion<\/p>\n
                applicable to registrations under Section 9(4) of the<\/p>\n
                Act (“Me Too”) by placing substantial reliance on data<\/p>\n
                of the appellant, the Committee erroneously granted<\/p>\n
                to the respondent No.3 registration under Section 9(3)<\/p>\n
                of the Act;\n<\/p><\/blockquote>\n
       (ii)     that in any event the data submitted by the appellant<\/p>\n
                pertained to a technical \/ active ingredient having a<\/p>\n
                purity of minimum 95% whereas the maximum purity<\/p>\n
                available with the supplier of the respondent no. 3 is<\/p>\n
                90%. Thus, the data submitted by the appellant was<\/p>\n
                for an entirely different product and there could be no<\/p>\n
                reliance whatsoever on the appellant’s data;\n<\/p><\/blockquote>\n
       (iii)    that the order of the Committee granting registration<\/p>\n
                to the respondent no. 3 amounts to unjustified dilution<\/p>\n
                of the data submitted by the appellant which is liable<\/p>\n
                to be protected under the guidelines issued by the<\/p>\n
                Government vide circular dated 30.10.2007;\n<\/p><\/blockquote>\n
       (iv)     that Office Memorandum (OM) dated 18.02.2008<\/p>\n
                purportedly clarifying the circular dated 30.10.2007 is<\/p>\n
                arbitrary and illegal.\n<\/p><\/blockquote>\n
7.     Before adverting to the submissions made by Mr. Mukul<\/p>\n
Rohatgi, we may briefly refer to the scheme of the Insecticides<\/p>\n
Act, 1968 (‘The Act’ for short). The Act was brought into force on<\/p>\n
2.9.1968 with the object of regulating the import, manufacture,<\/p>\n
sale, transport, distribution and use of Insecticides with a view to<\/p>\n
prevent risk to human beings or animals connected there with.
\nLPA No.367-09                                                   Page 8 of 18<\/span>
\n Any prospective manufacturer or importer of any insecticide \/<\/p>\n
pesticide in India is primarily governed by the regime of this Act.<\/p>\n
No insecticide can be imported into India \/ manufactured<\/p>\n
indigenously, unless the prospective importer \/ manufacturer has<\/p>\n
obtained registration under Section 9 of the Act. An insecticide<\/p>\n
contains an active ingredient or the raw material called the<\/p>\n
technical and after adding certain additives, these result in<\/p>\n
formulation.    For each activity, there has to be an approved<\/p>\n
registration of the formulation and\/or technical as the case may<\/p>\n
be.    A desirous party can either import the technical of an<\/p>\n
insecticide and manufacture the formulation indigenously or<\/p>\n
import the formulation of the insecticide for direct marketing and<\/p>\n
use in India upon obtaining the approval of the Committee.<\/p>\n
8.     Section 5 of the Act vests the power \/ function to scrutinize,<\/p>\n
examine and analyze insecticides as to their safety and efficacy<\/p>\n
on the Committee. Section 5 makes elaborate provisions for the<\/p>\n
constitution and functions of the Committee, for enabling<\/p>\n
registration of insecticides on the receipt of applications, after<\/p>\n
enquiring into the safety and efficacy of the product.         Under<\/p>\n
Section 5(5), the Committee regulates its procedure and conduct<\/p>\n
of business, including the grant of registrations of parties<\/p>\n
desirous of importing or manufacturing insecticides, for which<\/p>\n
purpose it has formulated guidelines.         It has also issued a<\/p>\n
Checklist specifying the various parameters on which data is<\/p>\n
required to be submitted by an applicant along with its<\/p>\n
application for registration.    Rule 4 of the Insecticides Rules<\/p>\n
elaborates on the functions of the Committee. Section 9 of the
\nLPA No.367-09                                             Page 9 of 18<\/span>
\n Act provides for three kinds of registrations: (i) Section 9(3-B) – a<\/p>\n
provisional registration which is granted to an applicant for a<\/p>\n
period of two years when an insecticide is introduced for the first<\/p>\n
time in India. It can be granted pending an enquiry and also in<\/p>\n
the event of agricultural exigencies.         This section presupposes<\/p>\n
insufficiency of examination of data by the Committee; (ii)<\/p>\n
Section 9(3) – regulation registration – The regular registration is<\/p>\n
granted only after submission of complete data by an applicant.<\/p>\n
The Committee conducts a full and in-depth study of the data and<\/p>\n
has to be ensure itself of the efficacy, toxicity and safety (for<\/p>\n
humans and other animals) of the insecticide before granting<\/p>\n
registration; and (iii) Section 9 (4) provides for what is popularly<\/p>\n
known as a “Me Too” “registration”.             The registration under<\/p>\n
Section 9(4) is granted on same conditions and is only granted<\/p>\n
when there already exists a registration under Section 9 (3) for a<\/p>\n
particular Insecticide. It is obvious that these “same” conditions<\/p>\n
necessarily mean and include the same source of import also.<\/p>\n
9.     At this stage, we may refer to the guidelines framed by the<\/p>\n
Committee for the registration of insecticides and parameters \/<\/p>\n
criterion fixed by it to effectuate verification of the efficacy and<\/p>\n
safety of the insecticides. The Committee has issued a Checklist<\/p>\n
specifying the various parameters on which data is required to be<\/p>\n
submitted       by   an   applicant   along   with   its   application   for<\/p>\n
registration – like Chemistry; Bio-efficacy, toxicity, etc.              The<\/p>\n
Checklist has enumerated categories under which the registration<\/p>\n
of an insecticide can be sought, the relevant categories (for the<\/p>\n
present Appeal) are :\n<\/p>\n
LPA No.367-09                                                   Page 10 of 18<\/span><\/p>\n
        (a)      TIT - import of technical\n\n       (b)      FIM - indigenous manufacture of formulation.\n\n       (c)      FIT - import of formulation.\n\n       (d)      TIT (new source) - import of technical from a different\n\n                \/ new source.\n\n\n<\/pre>\n
10.    The Checklist framed by the Committee is at pages 151 –<\/p>\n
156 of the compilation and the Checklist for TIT (new source),<\/p>\n
which is at page 151, makes it clear that the Committee has laid<\/p>\n
down that in the case of registration of an insecticide which has<\/p>\n
already been permitted by the Committee in the past under<\/p>\n
Section 9(3)of the Act, and which is now proposed to be procured<\/p>\n
from a new source, only the attenuated or reduced data, material<\/p>\n
evidence specified under column no. 12 of the Checklist is<\/p>\n
required to be furnished and if such data is furnished then the<\/p>\n
applicant will be entitled in law to registration under Section 9(3)<\/p>\n
of the Act. We may also mention that the Central Government<\/p>\n
has issued the circular dated 30.10.2007 introducing a concept of<\/p>\n
deemed registration of the technical\/active ingredient of the<\/p>\n
formulation without a separate application being made for the<\/p>\n
same.        The circular also provides for data protection for three<\/p>\n
years from the date of registration of the formulation. By OM<\/p>\n
dated 18.2.2008 the Central Government has clarified that the<\/p>\n
period of three years is to be reckoned not from the date of the<\/p>\n
grant of registration under Section 9(3) of the Act but if<\/p>\n
applicable, from the grant of provisional registration under<\/p>\n
Section       9(3B),   if   previously   granted   with   permission     to<\/p>\n
commercialize.\n<\/p>\n
LPA No.367-09                                                 Page 11 of 18<\/span><\/p>\n
 11.    In the above background of the provisions of the Act, rules<\/p>\n
and the relevant guidelines, we may now proceed to deal with the<\/p>\n
submissions made by the learned senior counsel appearing for<\/p>\n
the appellant.\n<\/p>\n
       Submissions (i) & (ii)<\/p>\n
12.    We have gone through the entire records and it is<\/p>\n
absolutely clear to us that in the present case, the registration<\/p>\n
which was granted to respondent no. 3 was under Section 9(3)<\/p>\n
and not under Section 9(4) of the Act. It is also seen from the<\/p>\n
records that for the purpose of taking the decision to grant<\/p>\n
registration to respondent      no. 3 under Section 9(3), the<\/p>\n
Committee has followed the standard guidelines and criteria<\/p>\n
which are set out in the Checklist framed and issued by the<\/p>\n
Committee, in exercise of its statutory powers under Section 5(5)<\/p>\n
read with Section 9(3) of the Act, under which it is the<\/p>\n
prerogative of the Committee to decide the criteria, material,<\/p>\n
evidence and data on the basis of which the Committee would<\/p>\n
take a decision to grant registration under Section 9(3) of the Act.<\/p>\n
Further, the record of the proceedings before the Committee also<\/p>\n
makes it clear that the application of respondent no. 3 for<\/p>\n
registration was only under Section 9(3) and was under the head<\/p>\n
“Technical import from new source” i.e. TIT (new source).        The<\/p>\n
data submitted by respondent no. 3 comprises more than 4000<\/p>\n
pages of detailed technical studies, analysis, reports etc.      It is<\/p>\n
also seen that in the 293rd meeting of the Committee the data<\/p>\n
was verified by the Committee under Section 9(3) and on<\/p>\n
satisfaction about the data the registration came to be granted in
\nLPA No.367-09                                            Page 12 of 18<\/span>
\n favour of the respondent No.3 under Section 9(3). The Central<\/p>\n
Government has also in its counter affidavit filed before the<\/p>\n
learned single Judge clearly stated that the data submitted by the<\/p>\n
respondent no. 3 was more than adequate for grant of<\/p>\n
registration as TIT (new source). It has been further stated in the<\/p>\n
counter affidavit of the Central Government that chemical<\/p>\n
composition of the insecticide of the appellant and that of the<\/p>\n
respondent no. 3 are the same.\n<\/p>\n
13.    Learned single Judge has minutely examined the records<\/p>\n
and has recorded the following findings:\n<\/p>\n<\/p>\n
                “34. So far as Jaishree is concerned, the
\n                application for registration was made for
\n                indigenous manufacture, under Section 9(3B) on
\n                20.02.2006. It contends having furnished
\n                complete data reports etc. in accordance with
\n                the prescribed checklist. It sought to have the
\n                application, converted into one under Section 9
\n                (3); later by its letter dated 6-6-2007, it
\n                requested the committee to process the
\n                application, under section 9(3), stating as
\n                follows:\n<\/p><\/blockquote>\n
                     “We have applied for registration of
\n                     Emamectin benzoate Technical Import and
\n                     its formulation Indigenous manufacture u\/s
\n                     9(3b) of Insecticides Act, 1968, in February,
\n                     2006. As today, our both the applications
\n                     are complete from all disciplines as per
\n                     requirements of 9 (3b).\n<\/p><\/blockquote>\n
                     With reference to your above said letter, we
\n                     are requesting to consider our above
\n                     applications u\/s 9(3) new source. As per the
\n                     guidelines and requirements of 9(3) our
\n                     both applications are completed from all
\n                     disciplines except Toxicity and packaging.\n<\/p><\/blockquote>\n
                     Now     we    are    submitting    required
\n                     information\/data in both the disciplines i.e
\n                     toxicity and packaging as per 9(3) New
\n                     source.\n<\/p><\/blockquote>\n
LPA No.367-09                                                Page 13 of 18<\/span><\/p>\n
                      Please find enclosed additional information
\n                     for consideration of our applications of
\n                     Emamectin       Benzoate    Technical    for
\n                     Technical Import u\/s 9(3) New Source and
\n                     its formulation u\/s 9(3).\n<\/p><\/blockquote>\n
                     So far as Emamectin benzoate formulation
\n                     Indigenous Manufacturer is concern, the
\n                     CIB & RC has already ensured efficacy and
\n                     safety to human beings and animals about
\n                     the insecticide and relevant data is already
\n                     available with CIB & RC. Therefore, it is not
\n                     required to submit repeated data on
\n                     observation in man (Health record of spray
\n                     operators) and toxicity to Livestock (field
\n                     trials and observations) or may be
\n                     submitted later on if required…”\n<\/p><\/blockquote>\n<\/blockquote>\n
                The subsequent letter of 14th August, 2007 by
\n                Jaishree to the committee enclosed further
\n                information on aspects such as bio-effectiveness,
\n                phytotoxicity and residue in plant. The official
\n                respondents categorically submit that the
\n                petitioner’s data was not used by Jaishree; it is
\n                also averred that independent testing is not done
\n                by the committee, which only goes through the
\n                claims, and co-relates with the data furnished to
\n                it. Its contention in this regard, inter alia, is that
\n                Jaishree<\/p>\n
                     “requested that their application may be
\n                     considered under Section 9 (3) for import of
\n                     the product from a new (alternate) source,
\n                     which is permissible under already existing
\n                     guidelines of the Registration Committee
\n                     requiring lesser data package because the
\n                     efficacy and safety of the product had been
\n                     established to the satisfaction of the
\n                     Registration Committee (Respondent No.2).\n<\/p><\/blockquote>\n
                     Therefore,    no    separate    or     special\n                     dispensation of data was made in the\n                     process    of   granting    registration    to\n<\/pre>\n
                     Respondent No.3. It may also be mentioned
\n                     that no verification of sources is done in
\n                     any case including that of the petitioner.
\n                     The Registration Committee verifies the
\n                     claims of the applicants from the data
\n                     submitted to it. It is pertinent to mention
\n                     here that having attained some knowledge,
\n                     the Registration Committee, or any one for
\n                     that matter, can further use the knowledge
\n                     in routine. It is due to this reason the
\n                     Registration Committee had framed and
\n                     adopted the guidelines for this category
\nLPA No.367-09                                                   Page 14 of 18<\/span>
\n                      with this vision to avoid unnecessary
\n                     repetition much before this case. It is more
\n                     so because the chemical composition of the
\n                     product of the Petitioner and that of the
\n                     Respondent No.3 are same. If the product
\n                     of the Petitioner could prove efficacious and
\n                     safe on certain minimum data, it is not
\n                     understood as to how the product of the
\n                     Respondent No.3 would not be efficacious
\n                     and safe with the same chemical
\n                     composition.\n<\/p><\/blockquote>\n
                                            (emphasis supplied)<\/p>\n<\/blockquote>\n
                35. It is evident from the above extract, that the
\n                committee adopted, on a uniform basis,
\n                guidelines which had been evolved earlier that if
\n                the efficacy of a product is established, then, in
\n                the case of a different source, the authorities
\n                would only verify, on application of the
\n                prescribed parameters about the safety of such
\n                new source, to human beings and animals. The
\n                same yardstick was applied to the petitioners
\n                and Jaishree.\n<\/p><\/blockquote>\n
                36. The above discussion should have been
\n                sufficient to deal with the petitioners’ contention
\n                that Jaishree used its data; however, since
\n                parties had urged factual contentions, in order to
\n                satisfy itself that the committee’s approach was
\n                correct, the court examined the materials. The
\n                petitioner,    for   bio-efficacy  of   emamectin
\n                benzoate 5% SF conducted six studies on Okra,
\n                three at University of Agricultural Sciences
\n                Dharwad, during different seasons; two at TN
\n                Agricultural University, Coimbatore, 2003-04 and
\n                2006 and one at Punjab Agricultural University,
\n                Ludhiana. Jaishree, on the other hand, relied on
\n                TN Agricultural University study at Location
\n                Allapalayam, Season 2005-06 and location
\n                Maampali, season 2006. The four other studies’
\n                locales were Malwa Plateau and Nimar Valley, for
\n                different seasons, through the Jawaharlal Nehru
\n                Krishi    Vishwa     Vidyalaya,   Khargone.     The
\n                petitioners’ cotton studies were from All India Co-\n<\/p><\/blockquote>\n
                ordinated       Cotton     Improvement      Project,
\n                Coimbatore ( two studies) and Tamil Nadu
\n                Agricultural University, Coimbatore ( three
\n                studies). Jaishree’s studies, on cotton, on the
\n                other hand, were four studies from the Jawaharlal
\n                Nehru Krishi Vishwavidyala, during different
\n                seasons, two studies from the Indian Agricultural
\n                Research Institute, Delhi and two studies of the
\n                Tamil Nadu Agricultural University. It would not
\n                be necessary to go into greater details, save
\nLPA No.367-09                                                  Page 15 of 18<\/span>
\n                 noticing that the Union’s stand is in support of
\n                Jaishree, and that the materials on record justify
\n                their position that the petitioner’s data was not
\n                used, in support of Jaishree’s claim.\n<\/p><\/blockquote>\n
14.    In our opinion therefore submissions (i) & (ii) are<\/p>\n
without any merit.\n<\/p>\n
       Submissions (iii) & (iv)<\/p>\n
15.    Insofar as the allegation of dilution of data is concerned it is<\/p>\n
required to be noted that no provision of the Act, or Rules,<\/p>\n
prescribe or enact data exclusivity or protection.           The October<\/p>\n
2007 guidelines, directing a data exclusivity provision, was<\/p>\n
brought into force after the appellant’s registration certificate<\/p>\n
was issued. As per the circular dated 30.10.2007, as amended by<\/p>\n
OM dated 18.2.2008, the exclusivity is only for a period of three<\/p>\n
years from the date of the provisional registration.            Thus the<\/p>\n
period prescribed under the circular had already expired before<\/p>\n
the registration granted to the third respondent.              It is also<\/p>\n
pertinent to note that no challenge has been raised to the OM<\/p>\n
dated 18.2.2008 in the writ petition though submission appears<\/p>\n
to have been raised across the Bar questioning the OM on the<\/p>\n
ground of the arbitrariness.          In any event, we find that the<\/p>\n
submission        regarding   the   data   protection   is    completely<\/p>\n
misconceived.         It is not the case of the appellant that the<\/p>\n
respondent no. 3 in importing its “TIT” has in any way violated<\/p>\n
the confidentiality of appellant’s data. Mr.Ganesh, appearing for<\/p>\n
the respondent No.3, submitted and in our opinion, rightly, that in<\/p>\n
a case of registration of “TIT” (new source) it is not as if the<\/p>\n
applicant is utilizing the materials or the intellectual property of<\/p>\n
the earlier applicant.        The correct position is that since the
\nLPA No.367-09                                                  Page 16 of 18<\/span>
\n Committee has, on an earlier occasion after fully and carefully<\/p>\n
studying all the relevant and applicable materials, approved a<\/p>\n
particular insecticide there is no need thereafter for another<\/p>\n
applicant who wishes to import the same insecticide albeit from a<\/p>\n
different source to reinvent the wheel as it were and to place on<\/p>\n
record the entire mass of material and data which was required<\/p>\n
to register the said insecticide originally. In such a situation that<\/p>\n
the Committee, which is a high powered technical body, has<\/p>\n
considered it appropriate to issue a Checklist providing that when<\/p>\n
a person desires to import the same insecticide, but from a<\/p>\n
different source, the requirement of submission of data are<\/p>\n
appropriately reduced. The respondent no. 3 has fully complied<\/p>\n
with the guidelines of the requirements of the Checklist issued by<\/p>\n
the Committee. In our opinion, therefore there is no illegality in<\/p>\n
the action of the Committee in granting registration in favour of<\/p>\n
the third respondent. In our opinion, the whole object of initiating<\/p>\n
these proceedings is to somehow continue the monopoly of the<\/p>\n
appellant in the product and sale of the insecticide in question. It<\/p>\n
is pertinent to note that now the third respondent is selling the<\/p>\n
same insecticide approximately at the rate of Rs.5,000 per kg.<\/p>\n
which has been all along sold by the appellant at the rate of<\/p>\n
about Rs.9,000\/- per kg.\n<\/p>\n<\/p>\n
16.     We dismiss the appeal with costs of Rs.1 lac, which will be<\/p>\n
paid by the appellant to the respondent nos. 1 and 3 in equal<\/p>\n
proportion.\n<\/p>\n<\/p>\n
                                             CHIEF JUSTICE
\nLPA No.367-09                                             Page 17 of 18<\/span>
\n                   MANMOHAN, J
\nAUGUST 11, 2009
\ndk\/v<\/p>\n
LPA No.367-09             Page 18 of 18<\/span>\n <\/p>\n","protected":false},"excerpt":{"rendered":"
Delhi High Court Syngenta India Ltd. vs Uoi Through Department Of … on 11 August, 2009 Author: Ajit Prakash Shah * IN THE HIGH COURT OF DELHI AT NEW DELHI #33 + LPA 367\/2009 SYNGENTA INDIA LTD. …. Appellant Through Mr. Mukul Rohatgi, Senior Advocate with Ms. Ruchi Agnihotri Mahajan, Adv. versus UOI THROUGH DEPARTMENT […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_lmt_disableupdate":"","_lmt_disable":"","_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[14,8],"tags":[],"class_list":["post-209043","post","type-post","status-publish","format-standard","hentry","category-delhi-high-court","category-high-court"],"yoast_head":"\nSyngenta India Ltd. vs Uoi Through Department Of ... on 11 August, 2009 - Free Judgements of Supreme Court & High Court | Legal India<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.legalindia.com\/judgments\/syngenta-india-ltd-vs-uoi-through-department-of-on-11-august-2009\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Syngenta India Ltd. vs Uoi Through Department Of ... on 11 August, 2009 - 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