* IN THE HIGH COURT OF DELHI AT NEW DELHI #33 + LPA 367/2009 SYNGENTA INDIA LTD. .... Appellant Through Mr. Mukul Rohatgi, Senior Advocate with Ms. Ruchi Agnihotri Mahajan, Adv. versus UOI THROUGH DEPARTMENT OF AGRICILTURE & CO- OPRATION & Ors. ..... Respondents Through Mr. A.S. Chandhiok, ASG with Mr. Gaurav Duggal, Mr. Ritesh Kumar, Mr. Sandeep Bajaj, Advs. for R-1/UOI. Mr.S. Ganesh and Mr. Sudhir Nandrajog, Senior Advocates with Mr. Laliet Kumar and Mr. Santosh Sharma, Advs. for R-3. CORAM: HON'BLE THE CHIEF JUSTICE HON'BLE MR. JUSTICE MANMOHAN 1.Whether reporters of the local news papers be allowed to see the judgment? 2.To be referred to the Reporter or not ? 3. Whether the judgment should be reported in the Digest ? O R D E R % 11.08.2009 The appellant Syngenta India Ltd. has preferred this appeal against the judgment and order dated 1.7.2009, passed by S. Ravindra Bhat, J. in W.P(C) No. 8123/2008. In the writ petition the appellant impugned the decision of the Department of Agriculture, Government of India, dated 5.11.2008, rejecting its appeal under Section 10 of the Insecticides Act, 1968 (“the Act”) against the decision of the Registration Committee (‘Committee’ for short) for granting registration for Emamectin Benzoate 5% SG to the third respondent – M/s Jaishree Agro Industries Ltd. in its 293rd meeting held on 26.9.2008. The learned Judge came to LPA No.367-09 Page 1 of 18 the conclusion that the 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 and the pendency of this proceeding had 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. Consequently, the learned Judge dismissed the petition with heavy costs. 2. The facts necessary for deciding this appeal are as follows : In 2003 the appellant filed an application for registration under Section 9(3) of the Act 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 (appellants’) data was incomplete on various parameters like toxicity and bio-efficacy, in its meeting held on 2.7.2004. The appellant, therefore, could not be granted a registration under Section 9 (3) of the Act. The appellant, 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 Committee to grant a provisional registration under Section 9 (3B) of the Act to the appellant 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 LPA No.367-09 Page 2 of 18 20.7.2006 were granted to the appellant 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 appellant during the period of 2 years. It is stated that from this 5 MT the appellant indigenously manufactured about 100 MT of formulation, and used it for commercialization as well as compilation and generation of exhaustive data. The provisional registrations granted to the appellant in the categories of TIT and FIM lapsed on 20.07.2006. By that time the appellant claims to have collated and completed its deficient data. On 11.09.2006, the appellant applied afresh under Section 9 (3) of the Act in the category FIT (Import of Formulation). On 24.7.2007, the appellant was granted registration under Section 9 (3) of the Act in the category of FIT (Import of Formulation). 3. On 27.07.2007, the respondent no. 3, 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(3B) of the Act. However, the respondent no. 3, was not granted registration because the appellant was granted the registration under Section 9(3) before respondent No.3 and the grant of registration under Section 9(3B) is only for introduction of the product for the first time. This fact was intimated to the respondent No.3 vide Secretariat of Central LPA No.367-09 Page 3 of 18 Insecticides Board & Registration Committee’s letter No.1/TI/9(3B)/2006-CIR.II dated 24.7.2007. Therefore, the respondent no. 3 requested that its 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 Committee requiring lesser data package because the efficacy and safety of the product had been established to the satisfaction of the Committee. Accordingly, an application was submitted by the respondent no. 3 on 7.8.2007 for registration as TIT(new source) under Section 9(3). Along with the application required information / data was also submitted by the respondent no. 3, as was applicable and required in respect of application under Section 9(3) for TIT (new source). The data submitted comprised more than 4000 pages of detailed technical studies, analysis, reports and other data, including reports of numerous studies conducted by Jawaharlal Nehru Krishi Vishwa Vidyalaya, Indian Agriculture Research Institute, Tamil Nadu Agriculture University etc. which are well known institutions in the field of agriculture. The Committee verified the claims of the respondent no. 3 from the data submitted to it and granted the registration to the respondent no. 3 under Section 9(3) of the Act in its 293rd Meeting held on 26.09.2008. 4. The appeal preferred by the appellant under Section 10 of the Act to the Central Government, i.e the appellate authority, came to be dismissed by order dated 5.11.2008, which interalia reads as follows : LPA No.367-09 Page 4 of 18 “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 to be 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 LPA No.367-09 Page 5 of 18 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 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 LPA No.367-09 Page 6 of 18 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 293rd 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.” 5. After a very elaborate and detailed consideration of the facts and law, the learned single Judge dismissed the writ petition challenging the order of the Central Government passed in appeal under Section 10 of the Act. 6. Mr. Mukul Rohatgi, learned senior counsel appearing for the appellant, inter alia raised the following four submissions before us: (i) that though the respondent no. 3 was effectively LPA No.367-09 Page 7 of 18 seeking registration on parameters / criterion applicable to registrations under Section 9(4) of the Act (“Me Too”) by placing substantial reliance on data of the appellant, the Committee erroneously granted to the respondent No.3 registration under Section 9(3) of the Act; (ii) that in any event the data submitted by the appellant pertained to a technical / active ingredient having a purity of minimum 95% whereas the maximum purity available with the supplier of the respondent no. 3 is 90%. Thus, the data submitted by the appellant was for an entirely different product and there could be no reliance whatsoever on the appellant’s data; (iii) that the order of the Committee granting registration to the respondent no. 3 amounts to unjustified dilution of the data submitted by the appellant which is liable to be protected under the guidelines issued by the Government vide circular dated 30.10.2007; (iv) that Office Memorandum (OM) dated 18.02.2008 purportedly clarifying the circular dated 30.10.2007 is arbitrary and illegal. 7. Before adverting to the submissions made by Mr. Mukul Rohatgi, we may briefly refer to the scheme of the Insecticides Act, 1968 (‘The Act’ for short). The Act was brought into force on 2.9.1968 with 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 connected there with. LPA No.367-09 Page 8 of 18 Any prospective manufacturer or importer of any insecticide / pesticide in India is primarily governed by the regime of this Act. No insecticide can be imported into India / manufactured indigenously, unless the prospective importer / manufacturer has obtained registration under Section 9 of the Act. An insecticide contains an active ingredient or the raw material called the technical and after adding certain additives, these result in formulation. For each activity, there has to be an approved registration of the formulation and/or technical as the case may be. A desirous party can either import the technical of an insecticide and manufacture the formulation indigenously or import the formulation of the insecticide for direct marketing and use in India upon obtaining the approval of the Committee. 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 elaborates on the functions of the Committee. Section 9 of the LPA No.367-09 Page 9 of 18 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 in-depth 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 : LPA No.367-09 Page 10 of 18 (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. 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. LPA No.367-09 Page 11 of 18 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, evidence and data on the basis of which the Committee would take a decision to grant registration under Section 9(3) of the Act. Further, the record of the proceedings before the Committee also makes it clear that the application of respondent no. 3 for registration was only under Section 9(3) and was under the head “Technical import from new source” i.e. TIT (new source). The data submitted by respondent no. 3 comprises more than 4000 pages of detailed technical studies, analysis, reports etc. It is also seen that in the 293rd meeting of the Committee the data was verified by the Committee under Section 9(3) and on satisfaction about the data the registration came to be granted in LPA No.367-09 Page 12 of 18 favour of the respondent No.3 under Section 9(3). The Central Government has also in its counter affidavit filed before the learned single Judge clearly stated that the data submitted by the respondent no. 3 was more than adequate for grant of registration as TIT (new source). It has been further stated in the counter affidavit of the Central Government that chemical composition of the insecticide of the appellant and that of the respondent no. 3 are the same. 13. Learned single Judge has minutely examined the records and has recorded the following findings: “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). 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. LPA No.367-09 Page 13 of 18 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