Back
IN THE HIGH COURT OF DELHI
S.RAVINDRA BHAT
SYNGENTA INDIA LTD. - Appellant
Versus
UNION OF INDIA - Respondent
W.P. (C) 8123/2008
Decided On : 01-07-2009
INSECTICIDES ACT, 1968 - REGISTRATION OF INSECTICIDES - DATA PROTECTION - DATA EXCLUSIVITY - LEGITIMATE EXPECTATION - JUDICIAL REVIEW - POLICY DECISION - CLARIFICATION/MODIFICATION OF POLICY - SCOPE OF JUDICIAL REVIEW - FAIRNESS - COSTS.
Fact of the Case:
Petitioner, a manufacturer of insecticide Emamectin Benzoate 5% SG, challenged the decision of the Union Department of Agriculture rejecting its Registration Committee's grant of registration to the third respondent, its competitor, for the same insecticide. The petitioner had applied for registration under Section 9(3) of the Insecticides Act, 1968, but was granted provisional registration under Section 9(3B) due to insufficient data. Later, it was granted registration under Section 9(3). The third respondent applied for registration under Section 9(3B) and later requested conversion to Section 9(3). The Registration Committee granted registration to the third respondent, relying on the data submitted by the petitioner. The petitioner contended that the registration granted to the third respondent was based on its data and violated its data exclusivity rights.
Finding of the Court:
The Court held that there was no statutory provision or enabling power for the Registration Committee to prescribe a data exclusivity regime. The guidelines issued by the Committee in October 2007, providing for data exclusivity, were brought into force after the petitioner had applied for registration. The Court further held that the clarification/modification made through the guidelines of February 2008, which clarified the period of data exclusivity, was not illegal or arbitrary. The Court also held that the petitioner did not have any indefeasible or vested right to data exclusivity and could not complain about the change in policy. The Court dismissed the petition and imposed costs on the petitioner.
Issues: 1. Whether the Registration Committee had the power to prescribe a data exclusivity regime? 2. Whether the guidelines issued by the Committee in October 2007, providing for data exclusivity, were valid? 3. Whether the clarification/modification made through the guidelines of February 2008, which clarified the period of data exclusivity, was illegal or arbitrary? 4. Whether the petitioner had any indefeasible or vested right to data exclusivity?
Ratio Decidendi: 1. The Court held that there was no statutory provision or enabling power for the Registration Committee to prescribe a data exclusivity regime. 2. The Court held that the guidelines issued by the Committee in October 2007, providing for data exclusivity, were brought into force after the petitioner had applied for registration and were not applicable to the petitioner. 3. The Court held that the clarification/modification made through the guidelines of February 2008, which clarified the period of data exclusivity, was not illegal or arbitrary. 4. The Court held that the petitioner did not have any indefeasible or vested right to data exclusivity and could not complain about the change in policy.
Final Decision: The Court dismissed the petition and imposed costs on the petitioner.
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 Registration Committee to granting for Emamectin Benzoate 5% SG to the third respondent, 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 (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 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 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 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 presupposes 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 ?DG_dŽŽ? 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 source; this an
An indispensable Tool for Legal Professionals, Endorsed by Various High Court and Judicial Officers
Please visit our Training & Support
Center or Contact Us for assistance
Scan Me!
India’s Legal research and Law Firm App, Download now!
For Daily Legal Updates, Join us on :
Back to top
