Delhi High Court

Syngenta India Ltd vs Union Of India on 1 July, 2009

Author: S.Ravindra Bhat

* IN THE HIGH COURT OF DELHI AT NEW DELHI

Judgment reserved on: 17.04.2009
Judgment pronounced on: 01.07.2009

+ W.P. (C) 8123/2008

SYNGENTA INDIA LTD. ..... PETITIONER

Through: Mr. Raju Ramachandran, Sr. Advocate with
Ms. Ruchi Agnihotri Mahajan and Ms. Anushree Tripathi,
Advocates

versus

UNION OF INDIA ..... RESPONDENT

Through: Mr. K. K. Sharma, Advocate for Resp. Nos.1 & 2.
Mr. Laliet Kumar and Mr. Santosh Sharma, Advocates for
Resp. No.3.

CORAM:
HON'BLE MR. JUSTICE S. RAVINDRA BHAT

1. Whether the Reporters of local papers Yes
may be allowed to see the judgment?

2. To be referred to Reporter or not? Yes

3. Whether the judgment should be Yes
reported in the Digest?

Hon'ble Mr. Justice S. Ravindra Bhat

1. The petitioner, in these proceedings, under Article 226 of the Constitution of India,
impugns the decision of the Union Department of Agriculture, dated 5-11-2008, rejecting its
appeal under Section 10 of the Insecticides Act, 1968 ("the Act") against the decision of the
Registration Committee to granting for Emamectin Benzoate 5% SG to the third respondent,
(hereafter "Jaishree") in its 293rd meeting held o 26.09.2008.

2. The facts necessary for deciding the case are that with the Act was brought into
force with express the object of regulating the import, manufacture, sale, transport,
distribution and use of insecticides with a view to prevent risk to human beings or animals,

WP(C) 8123/2008 Page 1
and for matters connected with it. Any prospective manufacturer or importer of any
insecticide/pesticide in India is primarily governed by the regime of this Act. One of the
areas of focus of the Act, is on import of insecticides and formulations, which it strives to
regulate; the concern is enforcement of restrictions on rampant import of chemicals. The
Act delegates the function to scrutinize, examine and analyze insecticides to the
Registration Committee ("the Committee", Respondent No.2 in this case). Section 5 enacts
for the constitution and functions of the committee, for enabling registration of insecticides
on the receipt of applications, after enquiring into the safety and efficacy of the product
(Section 5 (1)). Rule 4 of the Insecticide Rules (hereafter "the Rules") elaborates on the
functions of the Committee. Under Section 5 (5), the committee regulates its procedure and
conduct of business, including the grant of registrations to parties desirous of importing or
manufacturing insecticides, for which purpose it has formulated guidelines. It has
apparently issued a check List specifying the various parameters on which data is required
to be submitted by an applicant along with its Application for Registration.

3. Part B and C of the Checklist prescribe submission of data in respect of "Bio Efficacy
and Residues" and "Toxicity". Form I of Schedule I under Rule 6 of the Rules provides the
necessary contents of an Application seeking Registration of an insecticide. Clause 5 in Form
I requires full disclosure of source of supply of the insecticide/chemical and its chemical
composition, etc. Clauses 7 & 8 prescribe complete submission of data (as per details
specified by RC) on Toxicity (interaction with soil, plant, animals and humans) and bio
efficacy. All these, contends the petitioner, reveal that complete disclosure of information
about an insecticide's source as well as the submission of data are essential pre-requisites to
be fulfilled by an Applicant before its request for registration.

4. Section 9 of the Act, relevant for the purpose of this case, provides for three kinds of
registrations. The first, i.e provisional registration (Section 9 (3-B)) -is granted to an
applicant for a period of two years when an insecticide is introduced for the first time in
India. It can be granted pending an enquiry. It is contended that this provision pre-
supposes insufficiency of examination of the data by the committee; a registration under
Section 9 (3B) is also granted in the event of agricultural exigencies, e.g. outbreak of an
epidemic, etc. that may require taking emergency measures. The second category is regular
registration, under Section 9 (3) - which is - granted only after submission of complete data

WP(C) 8123/2008 Page 2
by an applicant. The committee conducts a full and in-depth study of the data and has to
ensure itself of the efficacy, toxicity and safety (for humans and other animals) of the
insecticide before granting registration. The third category, under Section 9 (4) is popularly
known as a "Me Too" registration; it is on same conditions - and is only granted when there
already exists a registration under S. 9 (3) for a particular Insecticide. In such circumstances,
any second or other person desiring to import or manufacture the insecticide can be
granted registration on exactly the same conditions on which the insecticide was originally
registered under S. 9 (3). The petitioner contends that these "same" conditions necessarily
mean and include the source of import also. It is stated that three kinds of certificates are
granted under Section 9 (3-B), i.e. 'TIT', 'TIM', and 'FIM' categories. The "TIT" signifies a New
source; this and the FIT category applications can be made only under Section 9 (4) and not
under Section 9 (3-B). The registration certificate under 'TIT (New Source)' category can only
be given where there is a prior registration of the Technical i.e. 'active ingredient' in place. It
is contended that the registration for the technical (i.e. active ingredient) of a particular
Formulation granted under Section 9 (3) of the Act brings the data submitted by the
registrant (for the said Insecticide) into the public domain and the Registrant, thereafter,
loses its exclusivity in respect of the said data. It is therefore argued that though
registration is necessary (as no import or manufacturing licence, excise or customs approval,
can be obtained without registration of the insecticide in favour of a party) it also destroys
the exclusive rights which the registrant possesses for the data it has generated.

5. The petitioner alludes, in some detail, about vulnerability resulting from data

disclosure, in the absence of a protection regime, and its utilization by applicants for the

same product, for the purpose of their claim to registration. It is contended that the value in

data protection is that it is the basis for the application (for registration) about the source,

the raw materials, the nature of production of the insecticide, etc. Unless some measure of

protection is afforded, the "data originator" would do all the toil and the "me too" applicant

would reap the rewards. It is claimed that Article 39.3 of the TRIPS mandates protection for

WP(C) 8123/2008 Page 3
the test data submitted by the pharmaceutical and agro-chemical industries for market

approval. It sets the minimum stands in this regard and reads:

"Members, when requiring, as a condition of approving the marketing of
pharmaceutical or of agricultural chemical products which utilize new chemical
entities, the submission of undisclosed test or other data, the origination of which
involves a considerable effort, shall protect such data against unfair commercial use.
In addition, Members shall protect such data against disclosure except where
necessary to protect the public, or unless steps are taken to ensure the data are
protected against unfair commercial use."

6. The petitioner argues that Article 39.3 of TRIPS, clearly recommends that protection
be accorded to the data submitted by an Originator, against unfair commercial use and
disclosure, meaning thereby that a Statutory Authority (in this case the Committee) cannot
rely on the data submitted by the Originator for approving the second and subsequent
applications for the same insecticide. This protection and data exclusivity, however, would
be for a limited period and not in perpetuity. The petitioner also alludes to a "Reddy
Committee" report, dated 31.05.2007 that endorses TRIPS' recommendations concluding
that the Act and the Rules should be amended to ensure that undisclosed test data of the
originator is not put to unfair commercial use by others.

7. It is submitted that the Report's recommendations and due to pressure from the
indigenous lobby, the first Respondent issued a Directive dated 30.10.2007 in respect of
"FIT" (Import of Formulation) registrations. The Directive introduced the concept of
deemed registration of "Technical" i.e. in the category of 'FIT' i.e. where formulation of a
technical was registered and was being imported, the technical for the said Insecticide
would also be deemed to be registered without a separate application for it. It was
reiterated that there would be complete submission of data in respect of the "technical"
even at the time that a registration was sought for the formulation. To grant some measure
of protection to the data originators, the Directive also stated that this registration of
"technical" would come into force and would take effect after three years from the date of
registration of the formulation without a separate application. It is submitted that this
amounted to enforcement of an extremely limited period of data protection as opposed to
the previously unlimited data protection being enjoyed by registrants in the category of FIT
(import of Formulation). The directive, it is submitted, was effectuated through guidelines

WP(C) 8123/2008 Page 4
dated 30.10.2007 framed by the Committee on 13.12.2007. These according to the
petitioner, made amply clear that the data on "Technical" must be complete while
submitting an Application for registration of formulation.

8. In 2003 the petitioner filed application for registration under Section 9 (3) for import
of technical (TIT) sourced from its parent factory in Switzerland, and for indigenous
manufacture of formulation (FIM) for the insecticide, Emamectin Benzoate 5 % Soluble
Granules ("Emamectin 5% SG"). The committee noted that its (the petitioenrs') data was
incomplete on various parameters like toxicity and bio-efficacy, in its meeting held on
2.7.2004. The petitioner, therefore, could not be granted a registration under Section 9 (3).
The petitioner, however, was in the meanwhile, asked by the committee to convert its
application to one under Section 9(3-B), on account of an infestation of cotton crop by
bollworm at the relevant time, as Emamectin is known to be effective in controlling such
infestation Thus, a decision was taken by the Respondent No.2 to grant a provisional
registration under Section 9 (3B) of the Act to the petitioner in the same categories of TIT
(Import of Technical) and FIM (Indigenous Manufacture of Formulation). Accordingly, on
21.7.2004, certificates for provisional registration valid till 20.7.2006 were granted to the
Petitioner in the categories of TIT and FIM under S.9 (3B), for Emamectin 5% SG. This
provisional registration permitted commercialization of the insecticide (since the grant of
provisional registration was only because of the demand expressed by the State
Governments); but was subject to a limit of a total quantity of 5 (five) Metric Tonnes of
Technical Emamectin permitted to the Petitioner during the period of 2 years. It is stated
that from this 5 MT was indigenously manufactured by the Petitioner about 100 MT of
formulation, and used it for commercialization as well as compilation and generation of
exhaustive data.

9. The petitioner states that its provisional registrations in the categories of TIT and FIM
lapsed on 20.07.2006. By that time it claims to have collated and completed its deficient
data. On 11.09.2006, it applied afresh under Section 9 (3) of the Act in the category FIT
(Import of Formulation). On 24.7.2007, the petitioner was granted registration under
Section 9 (3) of the Act in the category of FIT (Import of Formulation). It is claimed that as on
that day, i.e 24.7.2007, there was no registration of the technical Emamectin, since the
previous registration for technical (active ingredient) Emamectin granted on 21.07.04 was

WP(C) 8123/2008 Page 5
not under Section 9(3) but under Section 9(3B) of the Act, was provisional and based on
insufficient data. On 27.07.2007, Jaishree applied for a registration in the categories of "TIT"
(Import of Technical) and "FIM" (Indigenous Manufacture of Formulation) for Emamectin
5% SG under Section 9(3-B) of the Act. The petitioner alleges that the said application
sought a grant of provisional Registration under Section 9(3B) of the Act since Jaishree's
data was incomplete and insufficient for grant of a Section 9(3) of the Act. Reliance is
placed on the minutes of the 278th Meeting of the committee, held on 27.07.2007.

10. It is submitted that the committee directed Jaishree to apply under Section 9(3),
instead of under Section 9(3B) of the Act. On 27.07.2007, itself, Jaishree requested the
Committee to convert its Section 9(3B) Application to one under Section 9(3) of the Act and
grant it registration in the category of "TIT" (New Source) by placing reliance on the data
already submitted by the Petitioner. It is argued that Jaishree also requested for framing
and issuance of necessary guidelines by the committee, to accord propriety to the grant of
such registration in its favour. Jaishree, says the petitioner, intended importation of the
insecticide (technical Emamectin) from a completely new and distinct source i.e. China,
which was different from the Petitioner's source i.e. Switzerland.

11. It is submitted that the Directive dated 30.10.2007 and Guidelines dated 13.12.2007,
could not aid Jaishree's application since the Petitioner's technical Emamectin would only
be deemed be registered with effect from 24.07.2010, after lapse of three years of initial
registration, i.e 24.07.2007. In this background, on 18.2.2008, a Clarification to the directive
dated 30.10.2007, was issued by the first respondent, through an Office Memorandum. This
had the effect of deeming that the Petitioner's registration for technical Emamectin could
be said to have come into effect on 21.07.2007 (3 years from the date of grant of provisional
registration i.e. 21.07.2004). Thus, the registration fo the "technical" of the Petitioner, in
terms of this OM would actually come into effect 3 days prior to the actual grant of
registration to the Petitioner's Formulation (Emamectin Benzoate 5%SG) in the category of
"FIT". It is submitted that this Memorandum, dated 18-2-2008 was considered and acted
upon by the committee, in its 293rd Meeting held on 26.09.08 when it granted registration
to Jaishree under Section 9(3) of the Act.

WP(C) 8123/2008 Page 6
12. The Petitioner opposed the grant of registration to Jaishree, which it (the petitioner)
contends relied on its data, through a written representation. It later appealed under
Section 10 of the Act to the Central Government, i.e the appellate authority highlighting the
irregularity in granting the registration to Jaishree, based on insufficient and truncated data.
The impugned Office Memorandum, dated 18.02.08 was also challenged.

13. The Central Government, by its impugned order dated 5-11-2008, rejected the
petitioner's appeal, and observed that:

"M/s Syngenta India Limited (M/s Syngenta) have appealed against grant of
registration to M/s Jaishree Agro Industries Ltd. (M/s Jaishree). They have
mentioned that the Government had agreed to provide three years freeze on data
submitted by the applicants for formulation import under Section 9(3) of the Act; that
there is no technical Emamectin registered in the country under Section 9(3) as of
how; that in terms of the policy enunciated in 284th meeting of the Registration
Committee, the technical would be deemed to be registered after three years form
the date of formulation import; that as Emamectin Benzoate 5% SG formulation for
import was registered in their favour on 26.07.2007, the technical can be deemed
tobe registered only after 3 years; that the grant of registration for technical to M/s
Jaishree presumes registration of technical prematurely before the expiry of 3 years;
that registration for import of technical from alternate source has been granted to
M/s Jaishree based on truncated data requirement; that as per guidelines for
registration the registrant under section 9(3) is required to submit the complete data
on its own which should be applicable for M/s Jaishree also who have relied on data
furnished by M/s Syngenta instead as implied in their presentation made in the 278th
meeting of the Registration Committee; that policy guidelines should be applicable
prospectively and not retrospectively; that the decision of the Registration Committee
taken in its 293rd meeting is contrary to the decision taken on 284th meeting; that
equating registration under section 9(3) with registration under section 9(3B) for
computing the 3 year period for effecting deemed registration of technical in
contrary to the earlier decision and is arbitrary and illegal; that their provisional
registration for Emamectin Benzoate under section 9(3B) which expired on
20.07.2006 was restricted to import of 5 MT of technical grade material to deal with
exigency of bollworm infestation in cotton at the request of State Governments; that
the impugned decisions taken on 293rd meeting may be stayed till the matter is
decided; that the impugned decision of 293rd meeting (agenda items 6.5 and 3.7) be
quashed. In the hearing held on 04.11.2008, the representatives of M/s Syngenta
elaborated on these points and also asserted that the letter dated 18.02.2008 of the
Government was for formulations for import and not for indigenous manufacture
and therefore the registration issued in 2004 for indigenous manufacture of the
formulation to them did not come under its purview.

The Secretary, CIB&RC, vide letter no.13-29/2008-CIR.I dated 30.10.2008, has
questioned the locus standi of M/s Syngenta in the matter of grant of registration to
another applicant as the matter is between the Registration Committee and another

WP(C) 8123/2008 Page 7
applicant. It has been stated that as per the directive of the Department of
Agriculture & Cooperation dated 18.02.2008, the period of deemed registration is to
be computed from the date of registration with commercialization under section
9(3B), i.e. from 21.07.2004. The registration to M/s Jai shree, who have submitted
requisite data under the relevant guidelines, has been granted as per the policy of the
Government and the guidelines of the Registration Committee. The provisional
registration was granted to M/s Syngenta in 2004 at their own request. In view of
these averments, the appeal is liable to be set aside. These points were further
elaborated by Secretary, CIB&RC in the hearing on 04.11.2008.

Section 10 of the Act provides that "Any person aggrieved by the decision of
the Registration Committee under section 9 may, within a period of 30 days from the
date on which the decision is communicated to him, appeal in the prescribed
manner..." M/s Syngenta, already holding a registration of the insecticide in question,
are an interested party in the matter. It would be too narrow an interpretation if the
scope of section 10 is confined to the applicant/registrant alone. The decision of the
Registration Committee are in public domain and are displayed on the internet. It
would not be fair to deny any person a change to appeal against a decision of the
Registration Committee if he is aggrieved by that decision, provided the person has a
clear interest in the decision.

Coming to the issues raised in the appeal, it is noted that the Government has
been issuing directives from time to time for proper enforcement of the Insecticides
Act, 1968 and the rules made thereunder, and in doing so it has been taking into
account the views of the different sections of the pesticides industry. The letter
dated 30.10.2007, issued in view of the instances where formulation had been
registered for import without registration of technical under section 9(3) thus
blocking registration under section 9(4) and created a monopolistic situation, also
took into account the industry's concern to allow data protection for 3 years till
suitable legislative changes are made. The letter dated 18.02.2008 included the
category of registration under section 9(3B) with commercialization in this
dispensation with a view to remove the perverse tendency to continue with
provisional 9(3B) registration with commercialization, thereby creating monopolistic
situation. The data protection for 3 years is available to his category also. It would
also be disingenuous to make a distinction between registration of formulation for
import and registration of formulation for indigenous manufacture for this purpose
as indefinite protection in either case would have the same consequence, i.e.
existence of a monopolistic situation. Application received for grant of registration
for the same product from any other source thereafter is treated under the category
of new source and the data requirements for that category apply which have been
met by M/s Jaishree. The registration under section 9(3B) with commercialization
was granted to M/s Syngenta at their own request in 2004. The Registration
Committee has taken the decision in question (agenda items 6.5 and 3.7) in its 293 rd
meeting in line with the policy laid down by the Government. As such there is no
reason to interfere with these decisions. The appeal is, therefore, dismissed.

WP(C) 8123/2008 Page 8
14. The petitioner argues that the statutory intention is to ensure that insecticides
approved for registration are safe, non-toxic and efficacious. These parameters can be
verified only upon disclosure of comprehensive materials and data and its review in
accordance with the parameters prescribed by the Committee. Any import or manufacture
of insecticides is preceded by mandatory registration under the Act. In this context, it is
submitted that the three classes of registration under Section 9 presuppose that the
intending manufacturer or importer should disclose most comprehensively the technical
specifications under Section 9 (3). However, such disclosure is unnecessary under Section
9(3B) because it is granted for a limited period and subject to restrictions. The last category
i.e. Section 9 (4) on the other hand rides "piggyback" upon a registered insecticide.

15. It is submitted that insecticides are comprised of active ingredients which are
termed technical that, after additives results in formulations. Whatever be the category in
which a registration is sought i.e. TIT (import of technical); FIT (import of formulation); FIM
(indigenous manufacture of formulation) and TIM (indigenous manufacture of technical),
complete data on the technical or active ingredients of insecticide are submitted. The
petitioner argues that the registration of active ingredients i.e. technical of insecticide
results in the data disclosure in the public domain. This in turn implies that reliance can be
placed upon it by the Committee and other applicants for registration. The registration of
the "technical" resulting led to a demand for protection in accordance with Article 39.2 of
TRIPS. After detailed consideration, a report was prepared and with the object of balancing
the demands of indigenous manufacturers clamoring for registration of technical
immediately on the issuance of the certificate itself. A balance struck by the authorities is
guidelines contained in the directive dated 30.10.2007. This directive stated that the
technical i.e. active ingredients of any insecticide, in the event of registration, would be
deemed registered only three years after the registration of the formulation. Effectively
three years' data exclusivity and protection was granted to those who applied with
complete specifications of the technical as well as formulation and upon registration of their
insecticides under Section 9 (3).

16. It is submitted that the protection afforded by the guidelines dated 30.10.2007
recognized that first application under Section 9 (3) seeking to manufacture insecticide or
more particularly import the insecticide not used in India so far are constrained to make full

WP(C) 8123/2008 Page 9
disclosure. Such data is compiled after investing and expending substantial amounts of
money and resources, as well as time. Unprotected by any regulatory regime, the disclosure
of such data can be exploited by a subsequent applicant, which merely would rely upon it.
Feeling the need to assure applicants seeking registration of insecticide for the first time and
in accordance with the commitment made under Article 39.3 of TRIPS, the directive of
30.10.2007, clarified that once registration is granted, the technical is deemed to be
registered only three years after the first date of registration under Section 9 (3). Having
applied its mind and granted such protection based on a reasonable assessment of all the
circumstances, there was no warrant or necessity to cut down its application by the
subsequent impugned Office Memorandum dated 18.2.2008. In this regard, it is contended
that though termed a clarification, the subsequent impugned order cut down the effect and
virtually took away the benefit granted by the previous Memorandum dated 30.10.2007.

17. It is submitted that having conferred advantage by the guidelines of 30.10.2007
during the currency of the petitioner's registration under Section 9 (3), such substantial
benefit could not be taken away on entirely irrational considerations. Reliance is placed
upon the decisions reported as Narender Kumar Maheshwari v. Union of India 1990 (Supp.)
1 SCC 440; Tata Cellular v. Union of India 1994 (6) SCC 65; Kumari Shrilekha Vidya v. State of
U.P. 1991 (1) SCC 212 and Bannari Amman Sugar Ltd. v. Commercial Tax Officer 2005 (1) SCC
625. It is submitted that a citizen or commercial concern can base their expectations on the
guidelines that confer benefits or advantages to them, which cannot be resiled from by the
state agencies. An unexplained or unjustified departure from such guidelines would violate
such legitimate expectations and would also be deemed arbitrary. It was also contended
that the executive which is a policy maker as well as delegate of statutory power, cannot
depart from the stated policy and adopt different interpretations to achieve the same
objective. It is submitted that this Court should not overlook the Jaishree's express
statements, evident from the record through its letter dated 6.8.2007 and the Minutes of
the 278th Meeting of the Committee dated 27.7.2007 which noted that reliance was placed
upon the petitioner's data. These clearly establish that barring the source of the two
products which are different chemical compositions are the same. It is submitted that the
exception to furnishing of data is enacted only under Section 9 (4). In that situation alone is
an applicant allowed to rely upon the previous registration.

WP(C) 8123/2008 Page 10
18. The petitioner relies upon a decision of this Court in Coromandal v. Union of India 95
(2002) DLT 261. It is contended that the impugned Memorandum dated 18.2.2008 besides
departing substantially and cutting down the protection granted by the previous guidelines
is also unsustainable as it strikes at the root of the policy underlying the Act. The Act
mandates, through the Rules, and guidelines framed by the Committee that toxicity, safety
and efficacy of all substances sought to be registered as insecticides should necessarily be
proved. This being mandated under Section 9 (3), registration without such data under
Section 9 (3B) is for a limited duration and carved out only as an exception. When the latter
class of registration is granted with or without a pending application under Section 9 (3), in
most circumstances, either the data is inadequate or there is no data at all to justify
registration under Section 9 (3). In such circumstances, to deem protection for a data has
commencing from the date of registration under Section 9 (3B) would be arbitrary as it will
amount to affording both kinds of registration the same legal sanctity - which is clearly
impermissible in law.

19. The Central Government in its return resists the Writ Petition and contests the
interpretation of the word "source" given by the petitioner. It is submitted that a source
implies only a manufacturer and does not necessarily mean that the efficacy and safety of
the product has not been established. That being the case, what has to be considered
whether the manufacturer whose product is sourced by an applicant follows the same
process as in the case of an existing applicant or registrant. Even by following different
processes of manufacturing, the same product may be obtained. Similarly, the Central
Government contends that applications under the FIT category can be made under Section 9
(3B) of the Act, for which guidelines were framed by the Committee in its 198 th, 199th and
201st meetings.

20. It is submitted that the petitioner's data in support of its original application was
found to be deficient in regard to toxicity. Consequently, it sought provisional registration
under Section 9 (3B) with commercialization; that request was granted on 2.7.2004.
Consequently, a quantity of 5 MT of the product was allowed to the petitioner for which he
manufactured 100 MT costing about 8 Crores for commercialization. In this context, it is
contended that commercialization signals that the product is safe to the workers in the
manufacturing process and farmers, who use it. It is contended that the chemical

WP(C) 8123/2008 Page 11
composition of the petitioner's product and that of Jaishree are the same. That being the
case and the petitioner having been permitted commercialization under Section 9 (3B)
based on certain data of efficacy and toxicity, the denial of Jaishree's request would be
arbitrary.

21. The Central Government, very crucially asserts as follows in the counter affidavit: -

"To put the record straight, it is stated that the Respondent No.3 had
also applied for grant of registration of this product under Section 9
(3B). However, they were not granted registration because the
Petitioner was granted the registration u/s 9 (3) before respondent
No.3 and the grant of registration under Section 9 (3B) is only for the
introduction of the product for the first time. This fact was intimated
to Respondent No.3 vide Secretariat of Central Insecticides Board &
Registration Committee's letter No.1/TI/9 (3B)/2006-CIR.II dated
24.7.2007. Therefore, they requested that their application may be
considered under Section 9 (3) for import of the product from a new
(alternate) source, which is permissible under already existing
guidelines of the Registration Committee requiring lesser data
package because the efficacy and safety of the product had been
established to the satisfaction of the Registration Committee
(Respondent No.2). Therefore, no separate or special dispensation of
data was made in the process of granting registration to Respondent
No.3. It may also be mentioned that no verification of sources is done
in any case including that of the petitioner. The Registration
Committee verifies the claims of the applicants from the data
submitted to it. It is pertinent to mention here that having attained
some knowledge, the Registration Committee, or any one for that
matter, can further use the knowledge in routine. It is due to this
reason the Registration Committee had framed and adopted the
guidelines for this category with this vision to avoid unnecessary
repetition much before this case. It is more so because the chemical
composition of the product of the Petitioner and that of the
Respondent No.3 are same. If the product of the Petitioner could
prove efficacious and safe on certain minimum data, it is not
understood as to how the product of the Respondent No.3 would not
be efficacious and safe with the same chemical composition. In fact,
the Petitioner is unduly exaggerating the things to mislead this
Hon'ble Court just to buy time to their advantage for business during
the ongoing season for the product. And, it is due to all these reasons
the Appellate Authority upheld the decision of the Respondent No.2 in
the Appeal filed by the petitioner earlier under Section 10 of the Act.
It is, therefore, submitted that Respondent No.2 have not gone
beyond their mandate as given under the Act."

WP(C) 8123/2008 Page 12
22. As far as the question of guidelines is concerned, the Central Government relies
upon the decision making process and refers to the meeting dated 30.3.2000 of the
Committee which had recorded that

"the Committee decided that the proposed guidelines should be harmonized with the
existing guidelines for 9 (3) and 9 (3B). Besides, it was also decided that in import of
formulation the technical grade of the same insecticide should also be registered
simultaneously to the formulation".

It is also submitted that the subsequent meeting of 20.4.2000 and the 201st meeting, of the
Committee, dealt with the same issue and had required simultaneous registration of the
formulation and the "Technical". This decision was in fact in existence and was only
modified after the petitioner was issued with registration on 24.7.2007. Such being the
case, the question of unfairness in the clarification dated 18.2.2008 would not arise. The
Central Government argues that the guidelines dated 30.10.2007 significantly mentions
neither Section 9 (3) nor 9 (3B) and generally deals with the protection of interests of the
applicants introducing new insecticides molecules for certain periods. If all these were kept
in mind, the clarification dated 18.2.2008 is justified and reasonable.

23. Jaishree submits to having applied for registration of Emamectin Benzoate Technical
Import (TIT) and 5% SG (FIM) formulation's indigenous manufacture under Section 9(3B) on
20.02.2006 and also to having furnished complete data reports etc. in accordance with the
prescribed checklist. It denies the petitioner's contention about its placing reliance on the
existing data and technical as incorrect. Had Jaishree relied upon petitioner's data or
technical, there would have been no necessity to submit its details and reports etc. In view
of the grant of registration to the petitioner under Section 9(3), Jaishree requested
consideration of its application under Section 9(3), "TIT New Source", submitting all
requisite data reports etc. Jaishree submits having invested approximately Rs.50 lakhs for
generation of such data and reports.

24. Jaishree makes a comparison of the petitioner's data and its data to say that they
were generated independently from different institutes and laboratories. It is submitted
that the Committee, after detailed scrutiny and verification of the entire materials furnished
by Jaishree with regard to the efficacy and safety, issued the certificate. Jaishree also relies
upon Central Government's return to say that its data was adequate and the insecticide,

WP(C) 8123/2008 Page 13
safe. It argues that the decision of an expert body cannot, save in exceptional situations be
interfered with in judicial review. Reliance is placed on judgment of the Supreme Court
reported as N.D. Jayal v. UOI AIR 2004 SC 867.

25. Jaishree next contends that the source of its products is different from that of the
petitioner, which necessarily meant that the Committee had to adopt a stringent standard
while considering the application under Section 9(3). In this context, it is submitted that
under the Act, what should be examined are the features and characteristics of the
insecticide to ensure its efficacy and safety to human beings and animals. Their source only
signifies the place of their manufacture; it, therefore, does not make any difference if the
chemical composition of the insecticide is the same and as long as the registrant complies
with other conditions provided in the checklist. In this respect, it points to the fact that the
Registration Committee has not made any mention of the source of manufacture in the
petitioner's case itself.

26. Jaishree contends that the question of protection to the "technical" afforded is not
extended by provisions of the Act. They were also not in existence, when the petitioner was
granted registration on 24.07.2007. In these circumstances, there can be no applicability of
the principle of legitimate expectation. It is contended besides that in fact, the legislative
policy, through the provisions of the Act and rules nowhere reflect the intention to confer
data exclusivity or protection of the kind claimed by the petitioner. The guidelines were
issued on 30.10.2007. The authority to do so was with the respondent who had previously
determined that the technical would be deemed registered from the date of registration of
the formulation. The same authorities were, after a consideration of all the circumstances is
of the opinion that clarification was needed and issued it on 18.02.2008.

27. Reliance is placed in this regard on the judgment reported as Kuldeep Singh v. Govt.
of NCT of Delhi AIR 2006 SC 2652 that the executive has right to formulate a policy and at
the same time to vary, amend or rescind it. It is contended that the petitioner has not
sought for quashing of the Office Memorandum dated 18.02.2008. In the absence of such
relief, the decision to grant registration to Jaishree cannot be impugned on the ground of
alleged duty exclusivity.

WP(C) 8123/2008 Page 14
28. It is submitted that the petitioner has already enjoyed monopoly of the products
since 2004 because it applied initially under Section 9(3) in 2003. It was issued with the
Section 9(3B) registration in 2004 without the necessary data generation. It has already
enjoyed exclusive advantages to sell the insecticides, for about five years and earned profits
of approximately Rs.90 crores. Its petition challenging Jaishree's registration conferred on
the basis of independent data and materials furnished by it, should, therefore, not be
entertained.

29. The preceding discussion would show that this Court has to decide on the legality of
the registration granted to Jaishree in the context of the petitioner's submission that
reliance was placed upon its data or technical for which it was afforded protection for a
three year period, ending on 23.07.2010. Though it does not expressly say so, the petitioner
is also asking the Court to ignore the clarificatory guidelines dated 18.02.2008.

30. In the previous sections of the judgment, this Court had recounted the provisions of
the Act, particularly Section 9 and discussed various categories of registration of insecticides
as also the classes, i.e. the importation of formulation and manufacture of formulation and
technical. Before a discussion of the merits of the rival cases, it would be necessary to
extract the two Office Memoranda dated 30.10.2007 and 18.02.2008. The first one, of 30 th
October, 2007, is as follows:

"No.17-2/2006-PP.I
Government of India
Ministry of Agriculture
Department of Agriculture & Cooperation
**************

Krishi Bhavan, New Delhi

Dated the 30th October 2007

To,

The Secretary (CIB&RC) Directorate of PPQ&S NH-IV, Faridabad

Subject:- Procedure for registration of "formulation" for import and its technical grade insecticide

WP(C) 8123/2008 Page 15 Madam,

I am directed to refer to the subject cited above and to convey the approval of the Competent Authority that when a "formulation" is to be registered for import, where its "technical" is not registered, the "technical" shall be deemed to be registered. In such cases, since the evaluation of the "technical" is also done alongwith the "formulation", the "technical" shall get registered automatically, without separate application or evaluation. However, the registration of "technical" in such cases shall come into force only after expiry of 3 years from the date of registration of its "formulation" for import.

It is also decided that Secretary, CIB&RC will formulate the procedure/guidelines in consultation with Registration Committee for treating the "technical" also as deemed registered, after expiry of 3 years from the date of registration of its "formulation" for import. It is further informed that these norms will be applicable to all the "formulation" which are already registered for import, without registering the "technical".

Yours faithfully,

Sd/-

(NEERA SHARMA) Under Secretary to the Government of India"

The second notification, dated 18-2-2008 reads as follows:

"F.No.17-2/2006-PP.I Government of India Ministry of Agriculture Department of Agriculture & Cooperation (PP Division) ***

Krishi Bhawan, New Delhi Dated 18.2.2008

OFFICE MEMORANDUM

Subject :- Procedure for registration of Formulation for import and its technical grade insecticide

***

The undersigned is directed to invite reference to this Department's letter of even number dated 30.10.2007 on the above subject. It is further

WP(C) 8123/2008 Page 16 clarified that the period of three years for effecting the deemed registration of the "Technical", in cases where registration granted for formulations under Section 9(3B) with commercialization, will be computed from the date of issuing registration for formulation under Section 9(3B) with commercialization.

2. Secretary (CIBRC) is directed to take further action.

Sd/-

(Neeru Sharma) Under Secretary to the Govt. of India 23387962

Dr. Sandhya Kulshreshtha, Secretary (CIB&RC), Dte. Of Plant Protection Quarantine & Storage, Faridabad."

31. Section 9, to the extent it is material for deciding this case, reads as follows:

"S. 9(1) Any person desiring to import or manufacture any insecticide may apply to the Registration Committee for the registration of such insecticide and there shall be a separate application for each insecticide :

Provided that any person engaged in the business of import or manufacture of any insecticide immediately before the commencement of this section shall make an application to the Registration Committee within a period of six months from the date of such commencement for the registration of any insecticide which he has been importing or manufacturing before that date.

(2) Every application under sub-section (1) shall be made in such form and contain such particulars as may be prescribed.

(3) On receipt of any such application for the registration of an insecticide, the committee may, after such enquiry as it deems fit and after satisfying itself that the insecticide to which the application relates conforms to the claims made by the importer or by the manufacturer, as the case may be, as regards the efficacy of the insecticide and its safety to human beings and animals, register, on such conditions as may be specified by it and on payment of such fee as may be prescribed, the insecticide, allot a registration number thereto and issue a certificate of registration in token thereof within a period of twelve months from the date of receipt of the application :

WP(C) 8123/2008 Page 17 Provided that the Committee, may, if it is unable within the said period to arrive at a decision on the basis of the materials placed before it, extend the period by a further period not exceeding six months :

Provided further that if the Committee is of opinion that the precautions claimed by the applicant as being sufficient to ensure safety to human beings or animals are not such as can be easily observed or that notwithstanding the observance of such precautions the use of the insecticide involves serious risk to human beings or animals, it may refuse to register the insecticide.

(3A) In the case of applications received by it prior to the 31st March 1975, notwithstanding the expiry of the period specified in sub-section (3) for the disposal of such application, it shall be lawful and shall be deemed always to have been lawful for the Registration Committee to dispose of such application at any time after such expiry but within a period of one year from the commencement of the Insecticides (Amendment) Act, 1977.

Provided that nothing contained in this sub-section shall be deemed to make any contravention before the commencement of the Insecticides (Amendment) Act, 1977, of a condition of a certificate of registration granted before such commencement, an offence punishable under this Act.

(3B) Where the Registration Committee is of the opinion that the insecticide is being introduced for the first time in India, it may, pending any enquiry, register it provisionally for a period of two years on such conditions as may be specified by it.

(3C) The Registration Committee may, having regard to the efficacy of the insecticide and its safety to human beings and animals, vary the conditions subject to which a certificate of registration has been granted and may for that purpose require the certificate holder by notice in writing to deliver up the certificate to it within such time as may be specified in the notice.

(4) Notwithstanding anything contained in this section, where an insecticide has been registered on the application of any person, any other person, desiring to import or manufacture the insecticide or engaged in the business of, import or manufacture thereof shall on application and on payment of prescribed fee be allotted a registration number and granted a certificate of registration in respect thereof on the same conditions on which the insecticide was originally registered."

32. The crucial guidance, under Section 9 is the satisfaction of the committee, that the insecticide "conforms to the claims made by the importer or by the manufacturer, as the case may be, as regards the efficacy of the insecticide and its safety to human beings and

WP(C) 8123/2008 Page 18 animals.." after inquiry into such claims, by applying prescribed parameters. This overbearing concern is underlined by the second proviso to Section 9(3), ie. that:

"...that the precautions claimed by the applicant as being sufficient to ensure safety to human beings or animals are not such as can be easily observed or that notwithstanding the observance of such precautions the use of the insecticide involves serious risk to human beings..."

the committee can, in such circumstances, refuse registration. Section 9(3-B) presupposes that the final opinion formation has not been arrived at; it is an exceptional power, enabling the committee, in the event the insecticide is being introduced for the first time in India, pending an enquiry to grant limited registration, on conditions that may be specified. This power, being an exception, would of course be exercised having regard to the overall policy of the enactment.

33. The facts here are that the petitioner had applied for registration under Section 9(3) in 2003; the data provided by it, was however insufficient, as to toxicity of the substance. This is an important aspect, since one of the non-derogable conditions under the provisions is the safety to human beings and animals; yet, pending supply of such data, its request for provisional registration, for commercialization was permitted, for two years, in 2004. Its application for registration, was finally accepted, under Section 9(3) on 24-7-2007. Significantly, at that point in time, there was no data protection regime of the kind brought in place through the guidelines of 30th October 2007, as effectuated on 13th December 2007.

34. So far as Jaishree is concerned, the application for registration was made for indigenous manufacture, under Section 9(3B) on 20.02.2006. It contends having furnished complete data reports etc. in accordance with the prescribed checklist. It sought to have the application, converted into one under Section 9 (3); later by its letter dated 6-6-2007, it requested the committee to process the application, under section 9(3), stating as follows:

"We have applied for registration of Emamectin benzoate Technical Import and its formulation Indigenous manufacture u/s 9(3b) of Insecticides Act, 1968, in February, 2006. As today, our both the applications are complete from all disciplines as per requirements of 9 (3b).

WP(C) 8123/2008 Page 19 With reference to your above said letter, we are requesting to consider our above applications u/s 9(3) new source. As per the guidelines and requirements of 9(3) our both applications are completed from all disciplines except Toxicity and packaging.

Now we are submitting required information/data in both the disciplines i.e toxicity and packaging as per 9(3) New source.

Please find enclosed additional information for consideration of our applications of Emamectin Benzoate Technical for Technical Import u/s 9(3) New Source and its formulation u/s 9(3).

So far as Emamectin benzoate formulation Indigenous Manufacturer is concern, the CIB & RC has already ensured efficacy and safety to human beings and animals about the insecticide and relevant data is already available with CIB & RC. Therefore, it is not required to submit repeated data on observation in man (Health record of spray operators) and toxicity to Livestock (field trials and observations) or may be submitted later on if required..."

The subsequent letter of 14th August, 2007 by Jaishree to the committee enclosed further information on aspects such as bio-effectiveness, phytotoxicity and residue in plant. The official respondents categorically submit that the petitioner's data was not used by Jaishree; it is also averred that independent testing is not done by the committee, which only goes through the claims, and co-relates with the data furnished to it. Its contention in this regard, inter alia, is that Jaishree

"requested that their application may be considered under Section 9 (3) for import of the product from a new (alternate) source, which is permissible under already existing guidelines of the Registration Committee requiring lesser data package because the efficacy and safety of the product had been established to the satisfaction of the Registration Committee (Respondent No.2). Therefore, no separate or special dispensation of data was made in the process of granting registration to Respondent No.3. It may also be mentioned that no verification of sources is done in any case including that of the petitioner. The Registration Committee verifies the claims of the applicants from the data submitted to it. It is pertinent to mention here that having attained some knowledge, the Registration Committee, or any one for that matter, can further use the knowledge in routine. It is due to this reason the Registration Committee had framed and adopted the guidelines for this category with this vision to avoid unnecessary repetition much before this case. It is more so because the chemical composition of the product of the Petitioner and

WP(C) 8123/2008 Page 20 that of the Respondent No.3 are same. If the product of the Petitioner could prove efficacious and safe on certain minimum data, it is not understood as to how the product of the Respondent No.3 would not be efficacious and safe with the same chemical composition.

(emphasis supplied)

35. It is evident from the above extract, that the committee adopted, on a uniform basis, guidelines which had been evolved earlier that if the efficacy of a product is established, then, in the case of a different source, the authorities would only verify, on application of the prescribed parameters about the safety of such new source, to human beings and animals. The same yardstick was applied to the petitioners and Jaishree.

36. The above discussion should have been sufficient to deal with the petitioners' contention that Jaishree used its data; however, since parties had urged factual contentions, in order to satisfy itself that the committee's approach was correct, the court examined the materials. The petitioner, for bio-efficacy of emamectin benzoate 5% SF conducted six studies on Okra, three at University of Agricultural Sciences Dharwad, during different seasons; two at TN Agricultural University, Coimbatore, 2003-04 and 2006 and one at Punjab Agricultural University, Ludhiana. Jaishree, on the other hand, relied on TN Agricultural University study at Location Allapalayam, Season 2005-06 and location Maampali, season 2006. The four other studies' locales were Malwa Plateau and Nimar Valley, for different seasons, through the Jawaharlal Nehru Krishi Vishwa Vidyalaya, Khargone. The petitioners' cotton studies were from All India Co-ordinated Cotton Improvement Project, Coimbatore ( two studies) and Tamil Nadu Agricultural University, Coimbatore ( three studies). Jaishree's studies, on cotton, on the other hand, were four studies from the Jawaharlal Nehru Krishi Vishwavidyala, during different seasons, two studies from the Indian Agricultural Research Institute, Delhi and two studies of the Tamil Nadu Agricultural University. It would not be necessary to go into greater details, save noticing that the Union's stand is in support of Jaishree, and that the materials on record justify their position that the petitioner's data was not used, in support of Jaishree's claim.

37. The second, and important aspect to be considered is the soundness of petitioner's contention about unfair dilution of data protection afforded by the notification of October, 2007. It would be relevant, at this stage, to notice that:

WP(C) 8123/2008                                                                          Page 21
 (1)    No provision of the Act, or Rules, prescribe or enact data exclusivity, or postpone
registration;


(2)    The petitioner had applied under Section 9(3) much before the notification of
October 2007;


(3)    The petitioner's certificate was granted before the issuance of the notification of
October, 2007.


(4)    The existing regime, through guidelines and the minutes of meeting of 30 th March,

2000 appear to suggest that registration of the formulation and technical, were effective simultaneously.

38. If one keeps in mind the above background of circumstances, what is apparent is that the October 2007 guidelines, directing a data exclusivity regime, was brought into force after the petitioner's registration certificate was issued. No doubt, it conferred a kind of right; perhaps the petitioner can even say that it was led to believe that this state would continue. However, the question is whether the continuation of this non statutory executive regime could be assured to anyone, indefinitely, and also mandated by courts.

39. Whilst there is no challenge to either of the circulars/ memoranda dated 30 th October, 2007 and 18th February, 2008, the court cannot be unmindful of the fact that what is really being sought is a policy mandate. No doubt civil law assures a certain measure of protection to confidential data, and as between two parties, there may be situations where unlawful acquisition of such information by one of another's may be fraught with serious commercial consequences, necessitating equitable remedies, what the court is confronted here is a policy issue. There is no statutory guidance, either in the substantive portion of the enactment, or under the Rules, enabling even the rule making authority to prescribe a period of limitation for "data exclusivity". It has been held Bharat Barrel and Drum Mfg. Co. Ltd. v. ESI Corpn., (1971) 2 SCC 860 that the rule making authorities, in the absence of an enabling power, cannot prescribe periods of limitation. Thus, under our Constitutional framework, prescribing of periods of limitation to do something, or confer a positive right, is an essential legislative function, not exercisable by the courts (Ref. Common Cause -vs-

WP(C) 8123/2008 Page 22 Union of India 2008 (5) SCC 511; P. Ramachandra Rao vs. State of Karnataka 2002 (4) SCC 578). As noted earlier, though neither of the guidelines is in challenge, nevertheless the court cannot depart from these well established principles, while considering the petitioner's claims about unfairness or arbitrariness by the official respondents. Absent a policy clearly discernable under the Act, dealing with data exclusivity, of the kind desired, this court cannot hold that the clarification made through the guidelines of 18 th February, 2008 is illegal. There is no basis, either under the Act, or the rules, in support of such a claim.

40. The next question is whether the clarification or the modification, made through the guidelines of 18th February, 2008 are arbitrary, as taking away something which vested in the petitioner. The jurisdiction under Article 226 concerns the correctness of the decision making process, rather than its merits. The administrative or statutory action of the executive government can be interfered with if it is vitiated by mala fides, illegality, "Wednesbury" unreasonableness, or exercise of power/ refraining from exercise of power, for purposes other than those authorized by law. The scope of such judicial review has been summarized was outlined in Tata Cellular -vs-Union of India 1994 (6) SCC 651. In State of U.P. v. Johri Mal,(2004) 4 SCC 714, the law was re-stated, and the scope of judicial review under Article 226 of the Constitution articulated in the following terms:

"28. The scope and extent of power of the judicial review of the High Court contained in Article 226 of the Constitution of India would vary from case to case, the nature of the order, the relevant statute as also the other relevant factors including the nature of power exercised by the public authorities, namely, whether the power is statutory, quasi-judicial or administrative. The power of judicial review is not intended to assume a supervisory role or don the robes of the omnipresent. The power is not intended either to review governance under the rule of law nor do the courts step into the areas exclusively reserved by the suprema lex to the other organs of the State. Decisions and actions which do not have adjudicative disposition may not strictly fall for consideration before a judicial review court. The limited scope of judicial review, succinctly put, is:

(i) Courts, while exercising the power of judicial review, do not sit in appeal over the decisions of administrative bodies.

(ii) A petition for a judicial review would lie only on certain well-defined grounds.

(iii) An order passed by an administrative authority exercising discretion vested in it, cannot be interfered in judicial review unless it is shown that exercise of discretion itself is perverse or illegal.

WP(C) 8123/2008 Page 23

(iv) A mere wrong decision without anything more is not enough to attract the power of judicial review; the supervisory jurisdiction conferred on a court is limited to seeing that the Tribunal functions within the limits of its authority and that its decisions do not occasion miscarriage of justice.

(v) The courts cannot be called upon to undertake the government duties and functions. The court shall not ordinarily interfere with a policy decision of the State. Social and economic belief of a judge should not be invoked as a substitute for the judgment of the legislative bodies."

41. Judicial authorities, on the issue of whether administrative agencies, exercising powers, under statute can review their decisions, have dealt with the issue often. Talking of the power of "administrative review" the Supreme Court, held, in State of U.P. v. Maharaja Dharmander Prasad Singh, (1989) 2 SCC 505, as follows:

"53. It is erroneous to equate the powers under Sections 14 and 15 of the Act with judicial power which, in the absence of express provisions, could not enable the review of a judicial order after its exercise on the principle of functus officio. In Sardul Singh v. District Food and Supplies Controller, Patiala3 a statutory order, promulgated under Section 3 of the Essential Commodities Act, 1955, contained a provision enabling the cancellation of a "permit" under certain circumstances. The contention was that Section 3 of the parent "Act" itself did not delegate to the subordinate legislative authority to make such a provision for cancellation and, therefore, the provision for cancellation in the subordinate legislature was ultra vires. There was no provision in the Act expressly conferring the power to make a provision for cancellation of the permit. Section 3(2)(d) of the parent Act merely enabled the government to make orders "for regulating by licences, permits or otherwise, the storage, transport, distribution, disposal, acquisition, use or consumption of any essential commodity" and Section 3(2)(j) merely enabled government to make orders for incidental and supplementary matters (emphasis supplied). The question arose whether provisions for cancellation of the permits envisaged in para 10 of the particular statutory order could be said to be relatable to or justified as a matter incidental or supplementary to regulation. This Court held that the power to cancel was an "incidental and supplementary matter."

In R.R. Verma v. Union of India, (1980) 3 SCC 402, the position was formulated as follows:

"We do not think that the principle that the power to review must be conferred by statute either specifically or by necessary implication is applicable to decisions purely of an administrative nature. To extend the

WP(C) 8123/2008 Page 24 principle to pure administrative decisions would indeed lead to untoward and startling results. Surely, any government must be free to alter its policy or its decision in administrative matters. If they are to carry on their daily administration they cannot be hidebound by the rules and restrictions of judicial procedure though of course they are bound to obey all statutory requirements and also observe the principles of natural justice where rights of parties may be affected. Here again, we emphasise that if administrative decisions are reviewed, the decisions taken after review are subject to judicial review on all grounds on which an administrative decision may be questioned in a court."

In M. Satyanandam v. Dy. Secy. to Govt. of A.P., (1987) 3 SCC 574, at page 575, it was held as under:

"learned counsel for the petitioner submits that the order of release was bad because the authorised officer had no power to review the previous order nor he had the power to release the property of the landlady without even giving an opportunity to the petitioner. In the facts of this case as noted by the High Court, we are unable to entertain these contentions. We are unable to accept the contention that the Government cannot review its own order."

42. The correct position therefore, is administrative or statutory powers, in aid of administrative functions, imply flexibility, and the need to review decisions taken. Unlike courts, administrators and administrative bodies have to take decisions on the basis of broad, general policy considerations. Review, as is understood in the functioning of courts, is an entirely different concept; importing elements from such concepts in administrative functioning, would inject an avoidable rigidity in administrative process. The correct position vis-à-vis administrative agencies may be stated as the power to make or change decisions, as the circumstances warrant, having regard to the nature of the power, and the purpose for which it is granted. If, while exercising such power of administrative review, the agency oversteps such limits, or acts illegally, or mala fides, arbitrarily, or its review or modification of a previous order is hit by Wednesbury unreasonableness, or other well established grounds, the court can judicially review it under Article 226 of the Constitution. It may also be noteworthy that Parliament also empowered the executive to vary conditions for registration, having regard to the circumstances, as is evidenced by the power under Section 9 (3C). Thus, even after registration, conditions may be varied, if the committee deems it appropriate, and in accordance with the statutory mandate. In the circumstances, the petitioner's complaint of arbitrariness in the respondents' approach in clarifying the scope

WP(C) 8123/2008 Page 25 of data exclusivity, cannot be accepted. The court discerns that the question of data protection was dealt with in one manner, for the period 2000 to October 2007; it was during that period that the petitioner's registration was granted. The later clarification was made by the respondents; it is by way of a policy review. The petitioner, who does not have any indefeasible or vested right cannot therefore, complain that the policy originally declared in October, 2007, had to apply.

43. Now, the Petitioner's contention regarding arbitrariness on account of not honouring its legitimate expectations. The court's jurisdiction to reach out and cure any legality, in judicial review is no doubt wide. Its exercise is necessarily contextual to the facts and the rights asserted as well is found to be violated. The state is granted, in its legitimate executive sphere, "free play in the joints" to design and fashion policies, which best sub- serve larger public good, having regard to the nature of the activity. While judicial review concerns itself with fairness of procedure in decision-making, legality and regularity of proceedings, legitimately also enabling the courts to enquire whether the decision or decision-making was taken or arrived at in bona fide exercise of powers, it does not extend to arriving at value-judgments on the prudence, desirability or and wisdom of the executive measure complained of. If courts were to examine executive decisions from such standpoints, they would don the mantle of government agencies without the assistance of all those inputs which are vital for arriving at such executive decisions.

44. "Legitimate expectation", an argument put forward by the petitioners to challenge the impugned addendum, is concededly a dimension of fairness, which has to be considered by the decision maker. It is however, not "the key which unlocks the treasury of natural justice and it ought not to unlock the gate that shuts the court out of review on the merits" (Ref. Union of India v. Hindustan Development Corporation 1993 (3) SCC 499). It cannot inhibit the exercise of lawful executive power to make or change polices, in public interest or in furtherance of public policy; courts' interference in such instances, was described by Brennan, J (of the High Court of Australia, in Attorney General for New South Wales v. Quin 1990 [64] Aust LJ 327) as too nebulous to form a basis for invalidating the exercise of state power, setting "the courts adrift on a featureless sea of pragmatism" (quoted in Chanchal Goyal v. State of Assam 2003 (3) SCC 485). There is no statutory or overarching public policy

WP(C) 8123/2008 Page 26 compulsion binding the official respondents to their initial policy of 30 th October 2007, or inhibiting their right to clarify or modify it. The petitioners cannot therefore, fall back on the principle of legitimate expectation as the sole basis for holding the registration granted to Jaishree, or invalidation of the clarificatory guidelines, were framed in a bona fide manner, for valid and relevant considerations.

45. In view of the above discussion and findings, the petition has to fail. The court is of the opinion that this litigation was speculative, as the attempt was clearly to invite the court to make a policy declaration, which could not have been made under any circumstances. The pendency of this proceeding has also resulted in prejudice to the third respondent, who was constrained to give an undertaking not to give effect to its registration; that has subsisted all this while. The petition was heard finally, on five effective dates of hearing. The court is of opinion that the petitioner must bear the third respondents' costs for those hearings, quantified at Rs.75,000/- per hearing. The writ petition is, accordingly dismissed with costs quantified at Rs. 3,75,000/- to be borne by the petitioner, who shall pay it to the third respondent, within four weeks.

CM Nos.15661/2008 & 15824/2008

Dismissed.




                                                                           S. RAVINDRA BHAT, J
JULY 01, 2009
'ajk'




WP(C) 8123/2008                                                                          Page 27