SYNGENTA INDIA LTD Vs. UNION OF INDIA

JUDGEMENT

(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, 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.) 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 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.