Delhi High Court
Unikil Pvt Ltd vs Union Of India & Anr. on 9 May, 2023
Author: Satish Chandra Sharma
Bench: Chief Justice, Subramonium Prasad
Neutral Citation Number: 2023:DHC:3402-DB
$~
* IN THE HIGH COURT OF DELHI AT NEW DELHI
+ Date of Decision: 09.05.2023
% LPA 530/2022
UNIKIL PESTICIDES PVT. LTD. ..... Appellant
Through: Mr. Aftab Rasheed, Advocate.
versus
UNION OF INDIA & ANR. ..... Respondents
Through: Mr. Kirtiman Singh, CGSC with
Mr.Waize Ali Noor, Ms. Shreya V.
Mehra & Mr. Madhav Bajaj,
Advocates for Respondents No.1/
UOI.
+ LPA 536/2022
UNIKIL PVT LTD ..... Appellant
Through: Mr. Aftab Rasheed, Advocate.
versus
UNION OF INDIA & ANR. ..... Respondents
Through: Mr. Kirtiman Singh, CGSC with
Mr.Waize Ali Noor, Ms. Shreya V.
Mehra & Mr. Madhav Bajaj,
Advocates for Respondents No.1/
UOI.
CORAM:
HON'BLE THE CHIEF JUSTICE
HON'BLE MR. JUSTICE SUBRAMONIUM PRASAD
SATISH CHANDRA SHARMA, CJ. (ORAL)
LPA 530/2022 & 536/2022 Page 1 of 13
Signature Not Verified
Digitaaly Signed
By:BHUPINDER SINGH
ROHELLA
Signing Date:17.05.2023
11:13:54
Neutral Citation Number: 2023:DHC:3402-DB
LPA 530/2022
1. Regard being head to similitude in the controversy involved in both
the LPAs, they were heard together and a common judgment is being
passed. The facts of the LPA 530/2022 are being dealt with as under.
2. The Appellant before this Court has filed this present Appeal under
Clause 10 of Letters Patent being aggrieved by an order dated 10.02.2020
passed by the Learned Single Judge in W.P.(C.) No. 6092/2013 titled Unikil
Pesticides Pvt. Ltd. Vs. Union of India & Anr.
3. The facts of the case reveal that the Writ Petition was preferred under
Article 226 of the Constitution of India by the Appellant herein being
aggrieved by an order dated 10.07.2013 and a prayer was made to issue
Registration Certificate to the Appellant for "Imazathapyr molecule" under
Section 9(4) of the Insecticides Act, 1968 (hereinafter to be referred as
„Insecticides Act‟).
4. The facts of the case further reveal that the Appellant, as stated by
him, is a leading manufacturer/ formulator of pesticides, insecticides,
wedicides and other biocides in the State of Madhya Pradesh having a
factory situated at Industrial Estate Vidisha, Madhya Pradesh.
5. The undisputed facts of the case reveal that the Petitioner preferred an
Application under Section 9(4) of the Insecticides Act for registration of
molecule, which was already registered under Section 9(3) of the
Insecticides Act, and, the claim of the Appellant was rejected.
6. The facts further reveal that the Petitioner (Appellant herein) in the
LPA 530/2022 & 536/2022 Page 2 of 13
Signature Not Verified
Digitaaly Signed
By:BHUPINDER SINGH
ROHELLA
Signing Date:17.05.2023
11:13:54
Neutral Citation Number: 2023:DHC:3402-DB
Writ Petition has stated that there is another Company namely BASF India
Ltd. which has registered the molecule in question under Section 9(3) of the
Insecticides Act, and, in those circumstances, the molecule was already a
registered molecule. The Appellant applied for grant of registration for
importing molecule under Section 9(4) of the Insecticides Act.
The Appellant, thereafter, as stated by him, carried out necessary tests
in respect of the molecule and the same was to be imported from China.
7. The facts further reveal that an order was passed on 02.06.2011
informing the Appellant cancellation of the registration application. The
Appellant, thereafter, submitted a representation on 20.12.2012, and as
nothing was being done, he preferred a Writ Petition before this Court i.e.
W.P.(C.) No. 2319/2013 and the Writ Petition was disposed of by an order
dated 12.04.2013 directing the Respondent to decide the representation of
the Appellant.
8. The Registration Committee has thereafter decided the representation
of the Appellant by an order dated 05.05.2011, and Appellant has again filed
a fresh Writ Petition before this Court i.e. W.P.(C.) No. 6092/2013, and the
Learned Single Judge has dismissed the said Writ Petition.
9. The Appellant‟s contention is that he is importing molecule from
China, and it is already registered under Section 9(3) of the Insecticides Act,
hence the application preferred by the Appellant was rightly preferred under
Section 9(4) of the Insecticides Act, and, therefore, the rejection is bad in
law.
LPA 530/2022 & 536/2022 Page 3 of 13
Signature Not Verified
Digitaaly Signed
By:BHUPINDER SINGH
ROHELLA
Signing Date:17.05.2023
11:13:54
Neutral Citation Number: 2023:DHC:3402-DB
10. The Respondent before this Court had defended the order passed in
the matter, and it was argued before the Learned Single Judge as well as
before this Court that Section 9(4) is applicable only when the import is
from the same source.
11. The Learned Single Judge placing reliance upon a judgment delivered
in the cases of Haryana Pesticides Manufacturers' Association and Ors. V.
Central Insecticides Board & Registration Committee and Ors.,
MANU/PH/0222/2015, and of this Court in Syngenta India Ltd. V. Union
of India (UOI) and Ors., MANU/DE/1955/2009 has dismissed the Writ
Petition.
12. This Court has carefully gone through the order passed by the
Learned Single Judge, and heard Learned Counsel for the Parties at length.
Section 9 of Insecticide Act reads as under.
―9. Registration of insecticides.--(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 such
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 2 [seventeen
months] from the date of such commencement for the
registration of any insecticide which he has been importing or
manufacturing before that date:
[Provided further that where any person referred to in
the preceding proviso fails to make an application under that
proviso within the period specified therein, he may make such
LPA 530/2022 & 536/2022 Page 4 of 13
Signature Not Verified
Digitaaly Signed
By:BHUPINDER SINGH
ROHELLA
Signing Date:17.05.2023
11:13:54
Neutral Citation Number: 2023:DHC:3402-DB
application at any time thereafter on payment of a penalty of
one hundred rupees for every month or part thereof after the
expiry of such period for the registration of each such
insecticide.]
(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 1 [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:
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 day of March, 1975, notwithstanding the expiry of the
period specified in sub-section (3) for the disposal of such
applications, it shall be lawful and shall be deemed always to
have been lawful for the Registration Committee to dispose of
LPA 530/2022 & 536/2022 Page 5 of 13
Signature Not Verified
Digitaaly Signed
By:BHUPINDER SINGH
ROHELLA
Signing Date:17.05.2023
11:13:54
Neutral Citation Number: 2023:DHC:3402-DB
such applications at any time after such expiry but within a
period of one year from the commencement of the Insecticides
(Amendment) Act, 1977 (24 of 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 (24
of 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 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.‖
13. Section 9(3) and 9(4) of the Insecticides Act read together provides
that in case an Application is made for registration of molecule under
Section 9(3), the Committee has to scrutinize the Application and confirm to
the claim made by the importer or by the manufacturer, as the case may be,
as regards to efficacy of the insecticides and its safety to human beings and
LPA 530/2022 & 536/2022 Page 6 of 13
Signature Not Verified
Digitaaly Signed
By:BHUPINDER SINGH
ROHELLA
Signing Date:17.05.2023
11:13:54
Neutral Citation Number: 2023:DHC:3402-DB
animals, and if satisfied, it can be registered. Section 9(4) of the Insecticides
Act, which is a me-too registration, categorically provides that in case the
insecticide is already registered and any other person who wants to import or
manufacture such insecticide, is entitled to apply for grant of certificate of
registration on the same conditions on which the insecticide was originally
registered.
Meaning thereby, if a molecule/ insecticide has to be registered under
Section 9(4), it has to be from the same source as held by Coordinate Bench
of this Court in the case of Syngenta India Ltd. (Supra).
14. The issue involved in the present case is no longer res integra.
15. The Punjab & Haryana High Court in Haryana Pesticides
Manufactures‟ Association and Ors. (supra) on considering the two
provisions, has held as under:
―7. This sub-section, it can be noticed provide for a fast track
where the insecticide has been registered on the application of
a person. It contemplates therefore that a person who applies
for certificate on a 'me-too basis' merely falls in the line to
claim the registration because the insecticide is already
registered on assessment of the formulation, its efficacy and
safety. Though sub-section 4 does not make any reference to the
registered insecticide of a particular technical manufacturer, I
will understand that every registered insecticides is of a
formulation brought through unique process. Same compound
formulations may come through different processes. The
product through different processes may not necessarily have
same safety or efficacy. There may be impurities in one process
which may not be in another registered insecticides brought
through a technical manufacturer tested before registration
under Section 9 (3) ought to be qua the said manufacturer only.
To that extent source of supply becomes very relevant. Another
LPA 530/2022 & 536/2022 Page 7 of 13
Signature Not Verified
Digitaaly Signed
By:BHUPINDER SINGH
ROHELLA
Signing Date:17.05.2023
11:13:54
Neutral Citation Number: 2023:DHC:3402-DB
technical manufacturer having the same formulation may still
have a different efficacy for the product which is brought
through another process. Indian patent law protects not merely
process patent but also product patent. The end product may
enjoy some protection so that the registered insecticide of the
manufacturers shall not be replicated by another manufacturer
even through a different process. Consequently, it is perfectly
tenable to put a 'me-too' application of a technical
manufacturer through a different source is treated as an
application under Section 9 (3) for consideration. The
registration is to the products, namely, of the insecticide in its
particular formulation and not the registration of a product of
the particular manufacturer, who is identified supplier from a
particular source. Consequently, any other person desiring to
import or manufacture insecticide cannot be compelled to show
anything more than he is importing a registered insecticide.‖
16. This Court also in Syngenta India Ltd. (supra), placing reliance on the
Checklist issued by the Committee observed that the same condition as
mentioned in Section 9(4) of the Act would necessarily mean and include
the same source of import also. Relevant findings of the Court are
reproduced hereinbelow:
""8. Section 5 of the Act vests the power / function to scrutinize,
examine and analyze insecticides as to their safety and efficacy
on the Committee. Section 5 makes elaborate provisions 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. Under
Section 5(5), the Committee regulates its procedure and
conduct of business, including the grant of registrations of
parties desirous of importing or manufacturing insecticides, for
which purpose it has formulated guidelines. It has also issued a
Checklist specifying the various parameters on which data is
required to be submitted by an applicant along with its
application for registration. Rule 4 of the Insecticides Rules
LPA 530/2022 & 536/2022 Page 8 of 13
Signature Not Verified
Digitaaly Signed
By:BHUPINDER SINGH
ROHELLA
Signing Date:17.05.2023
11:13:54
Neutral Citation Number: 2023:DHC:3402-DB
elaborates on the functions of the Committee. Section 9 of the
Act provides for three kinds of registrations: (i) Section 9(3-B)
- a provisional registration which 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 and
also in the event of agricultural exigencies. This section
presupposes insufficiency of examination of data by the
Committee; (ii) Section 9(3) - regulation registration - The
regular registration is granted only after submission of
complete data by an applicant. The Committee conducts a full
and indepth study of the data and has to be ensure itself of the
efficacy, toxicity and safety (for humans and other animals) of
the insecticide before granting registration; and (iii) Section 9
(4) provides for what is popularly known as a ―Me Too‖
―registration‖. The registration under Section 9(4) is granted
on same conditions and is only granted when there already
exists a registration under Section 9 (3) for a particular
Insecticide. It is obvious that these ―same‖ conditions
necessarily mean and include the same source of import also.
9. At this stage, we may refer to the guidelines framed by the
Committee for the registration of insecticides and parameters /
criterion fixed by it to effectuate verification of the efficacy and
safety of the insecticides. The Committee has issued a Checklist
specifying the various parameters on which data is required to
be submitted by an applicant along with its application for
registration - like Chemistry; Bio-efficacy, toxicity, etc. The
Checklist has enumerated categories under which the
registration of an insecticide can be sought, the relevant
categories (for the present Appeal) are :
(a) TIT - import of technical
(b) FIM - indigenous manufacture of formulation.
(c) FIT - import of formulation.
(d) TIT (new source) - import of technical from a different /
new source.
LPA 530/2022 & 536/2022 Page 9 of 13
Signature Not Verified
Digitaaly Signed
By:BHUPINDER SINGH
ROHELLA
Signing Date:17.05.2023
11:13:54
Neutral Citation Number: 2023:DHC:3402-DB
10. The Checklist framed by the Committee is at pages 151 -
156 of the compilation and the Checklist for TIT (new source),
which is at page 151, makes it clear that the Committee has laid
down that in the case of registration of an insecticide which has
already been permitted by the Committee in the past under
Section 9(3)of the Act, and which is now proposed to be
procured from a new source, only the attenuated or reduced
data, material evidence specified under column no. 12 of the
Checklist is required to be furnished and if such data is
furnished then the applicant will be entitled in law to
registration under Section 9(3) of the Act. We may also mention
that the Central Government has issued the circular dated
30.10.2007 introducing a concept of deemed registration of the
technical/active ingredient of the formulation without a
separate application being made for the same. The circular
also provides for data protection for three years from the date
of registration of the formulation. By OM dated 18.2.2008 the
Central Government has clarified that the period of three years
is to be reckoned not from the date of the grant of registration
under Section 9(3) of the Act but if applicable, from the grant of
provisional registration under Section 9(3B), if previously
granted with permission to commercialize.
11. In the above background of the provisions of the Act, rules
and the relevant guidelines, we may now proceed to deal with
the submissions made by the learned senior counsel appearing
for the appellant. Submissions (i) & (ii)
12. We have gone through the entire records and it is
absolutely clear to us that in the present case, the registration
which was granted to respondent no. 3 was under Section 9(3)
and not under Section 9(4) of the Act. It is also seen from the
records that for the purpose of taking the decision to grant
registration to respondent no. 3 under Section 9(3), the
Committee has followed the standard guidelines and criteria
which are set out in the Checklist framed and issued by the
Committee, in exercise of its statutory powers under Section
5(5) read with Section 9(3) of the Act, under which it is the
prerogative of the Committee to decide the criteria, material,
LPA 530/2022 & 536/2022 Page 10 of 13
Signature Not Verified
Digitaaly Signed
By:BHUPINDER SINGH
ROHELLA
Signing Date:17.05.2023
11:13:54
Neutral Citation Number: 2023:DHC:3402-DB
evidence and data on the basis of which the Committee would
take a decision to grant registration under Section 9(3) of the
Act.....
xxx
15. Insofar as the allegation of dilution of data is concerned it
is required to be noted that no provision of the Act, or Rules,
prescribe or enact data exclusivity or protection. The October
2007 guidelines, directing a data exclusivity provision, was
brought into force after the appellant's registration certificate
was issued. As per the circular dated 30.10.2007, as amended
by OM dated 18.2.2008, the exclusivity is only for a period of
three years from the date of the provisional registration. Thus
the period prescribed under the circular had already expired
before the registration granted to the third respondent. It is also
pertinent to note that no challenge has been raised to the OM
dated 18.2.2008 in the writ petition though submission appears
to have been raised across the Bar questioning the OM on the
ground of the arbitrariness. In any event, we find that the
submission regarding the data protection is completely
misconceived. It is not the case of the appellant that the
respondent no. 3 in importing its ―TIT‖ has in any way violated
the confidentiality of appellant's data. Mr.Ganesh, appearing
for the respondent No.3, submitted and in our opinion, rightly,
that in a case of registration of ―TIT‖ (new source) it is not as
if the applicant is utilizing the materials or the intellectual
property of the earlier applicant. The correct position is that
since the Committee has, on an earlier occasion after fully and
carefully studying all the relevant and applicable materials,
approved a particular insecticide there is no need thereafter for
another applicant who wishes to import the same insecticide
albeit from a different source to reinvent the wheel as it were
and to place on record the entire mass of material and data
which was required to register the said insecticide originally.
In such a situation that the Committee, which is a high powered
technical body, has considered it appropriate to issue a
Checklist providing that when a person desires to import the
same insecticide, but from a different source, the requirement of
LPA 530/2022 & 536/2022 Page 11 of 13
Signature Not Verified
Digitaaly Signed
By:BHUPINDER SINGH
ROHELLA
Signing Date:17.05.2023
11:13:54
Neutral Citation Number: 2023:DHC:3402-DB
submission of data are appropriately reduced. The respondent
no. 3 has fully complied with the guidelines of the requirements
of the Checklist issued by the Committee. In our opinion,
therefore there is no illegality in the action of the Committee in
granting registration in favour of the third respondent. In our
opinion, the whole object of initiating these proceedings is to
somehow continue the monopoly of the appellant in the product
and sale of the insecticide in question. It is pertinent to note
that now the third respondent is selling the same insecticide
approximately at the rate of Rs.5,000 per kg. which has been all
along sold by the appellant at the rate of about Rs.9,000/- per
kg.‖ (emphasis added)‖
17. In the considered opinion of this Court, the Learned Single Judge was
justified in holding that the Petitioner‟s (Appellant herein) case does not fall
under Section 9(4) of the Insecticides Act as the Petitioner was not
importing the molecule from the same source, and, therefore the
Registration Committee in its 229th Meeting has rightly declined the
Petitioner‟s claim for registration under Section 9(4).
18. The Statutory Provisions governing the field, as contained under
Section 9 of the Insecticides Act, makes it very clear that in case a person
wants a registration of a molecule/ insecticide and the source is changed, the
Application has to be made under Section 9(3) of the Insecticides Act, 1968.
19. This Court does not find any reason to interfere with the order passed
by the Learned Single Judge. Accordingly, the present Appeal i.e. LPA
530/2022 stands dismissed.
LPA 530/2022 & 536/2022 Page 12 of 13
Signature Not Verified
Digitaaly Signed
By:BHUPINDER SINGH
ROHELLA
Signing Date:17.05.2023
11:13:54
Neutral Citation Number: 2023:DHC:3402-DB
LPA 536/2022
In light of the order passed in the LPA 530/2022, this Appeal i.e. LPA
536/2022 which is connected with the said LPA, and also is a case of me-too
registration deserves to be dismissed. Accordingly, this LPA also stands
dismissed.
SATISH CHANDRA SHARMA, CJ
SUBRAMONIUM PRASAD, J.
MAY 09, 2023 aks LPA 530/2022 & 536/2022 Page 13 of 13 Signature Not Verified Digitaaly Signed By:BHUPINDER SINGH ROHELLA Signing Date:17.05.2023 11:13:54