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2014 (4) TMI 267

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..... ke international conventions and treaties which provide for the minimum use of pesticides - The pesticides, human health and environment are aspects which are interlinked and there are studies and research which has led to such international conventions - The Food and Agriculture Organization of the United Nations has referred to the fact that 95 countries have agreed to new international convention on dangerous chemicals and pesticides - according to the United Nation's Environmental Programme, there are number of highly toxic chemicals that persist in the environment, accumulate in wild life and people. when the statute like the Act has been intended to have some amount of regulation on use of pesticides or import of pesticides which cannot be altogether avoided, some mechanism has to be provided by which the laws are implemented with more effectiveness and transparency - The Act does not provide for grant of deemed registration and it is by way of guidelines or procedure evolved by the Registration Committee such deemed registration is sought to be granted to the importers like the applicants which are intended to create monopoly in their favour - these aspects are also requi .....

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..... e/material is not scrutinized or tested. It is also contended that by resorting to deemed registration by the Registration Committee, a novel way is found out to create monopoly in favour of the respondents for a period of three years. Further, contentions have also been made referring to the minutes of the 282nd meeting of the Registration Committee dated 22.11.2007, 284 th meeting held on 13.12.2007 and 313th meeting dated 8.11.2010 that in a way the importers who are the respondents, applicants herein, are treated differently than the indigenous manufacturers-original petitioners and therefore there is a discrimination in treatment meted out to the petitioners violating Art. 14 of the Constitution of India, which has led to filing of the petitions and grant of interim relief. 3. Heard learned Advocate General and Sr. Counsel Shri Kamal Trivedi appearing for M/s. Nanavati Associates for some of the applicants. He has referred to the background of the facts and submitted that the ground on which interim relief is granted is not made out and the factual background is totally incorrect. Learned Advocate General Shri Trivedi referred to the grounds and submitted that the fir .....

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..... erred to sec. 9(1) and sec. 9(3) of the Act and submitted that it refers to registration of the insecticides and the procedure which is required to be followed and it takes care and the Committee, which has been constituted would make an inquiry and after satisfying itself with the effect of the pesticide and its safety to human beings and animals, shall register the formulation. He, therefore, submitted that the submissions regarding any exemption are misconceived. He referred to the Minutes of the 313th Meeting (special) of the Registration Committee dated 8.11.2010 produced at Annexure-D and emphasized that it has been specifically provided, The committee deliberated on the merits and demerits of the policy of registration of products i.e. formulation of imports without registering the technical grade and examined the issue purely in the context of the needs of Indian agriculture and environmental safety and recommends that Formulation import without registration of technical be continued for new molecules based on the requirements of the country with regard to the situation of pests, diseases and weeds etc. 6. Learned Advocate General and Sr. Counsel Shri T .....

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..... zed that the procedure as envisaged in the Act read with the Rules are uniformly applicable to the importers as well as the indigenous manufacturers. He submitted that therefore the contention that the importers like the applicants are exempted from necessary test or scrutiny with regard to the effect of the pesticides and its safety to human beings and animals are sufficiently taken care. 9. Learned Sr. Counsel Shri Thakore submitted that, as a matter of fact, indigenous manufacturers get the advantage of Me Too registration as provided in Sec. 9(4) of the Act after the new molecule is permitted to be imported and once the technical grade of the new molecule is registered, the indigenous manufacturers also are entitled for such registration without undergoing the rigours of the procedure for the data and bioefficacy. He therefore submitted that in fact such import is permitted with a view to assist the Indian agriculture and farmers by making available new molecules as well as technical grade. He submitted that as provided in detail in the minutes of meeting of the Registration Committee, new molecules are also specified as to what would be considered or treated as new molecu .....

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..... ilable as during the period when it is used, the data could be generated and therefore it would not be a ground to claim discrimination. He emphasized that there is no discrimination. He also referred to the affidavit of the Government to support his submissions. He has also referred to the guidelines and the Statement of Objects and Reasons of the Act. Learned Sr. Counsel Shri Joshi referred to the judgement of the Hon ble Apex Court in the case of Bajaj Hindustan Limited v. Sir Shadilal Enterprises Limited and anr., reported in (2011) 1 SCC 640, and submitted that as it is a matter of policy decision, normally, the court would not exercise the discretion. 13. Shri Tushar Mehta, learned Addl. Advocate General and Sr. Counsel, appearing with learned advocate Ms. Manisha Lavkumar for respondents Nos. 1-15, the original petitioners, referred to the scheme of the Act and submitted that the issue involved in the present petitions is whether deemed registration , which is sought to be granted, is in conformity with the Act or it is contrary to the provisions of the Act. He referred to the scheme and the background of the facts and submitted that the petitioners are indigenous manufa .....

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..... manufacturer is subjected to such test or verification. 16. Learned Addl. Advocate General and Sr. Counsel Shri Mehta referred to sec. 9(4) of the Act and submitted that it provides for Me Too registration, meaning thereby, when the registration is granted to an importer, the other manufacturers engaged in the business of manufacturing can make an application for grant of registration certificate on the same condition on which the insecticide has been originally registered. However, learned Addl. Advocate General and Sr. Counsel Shri Mehta submitted that the catch is that it would be possible only after the period of 3 years as the guidelines have been devised by the Registration Committee so as to provide that deemed registration is granted to such manufacturers who will be granted registration after 3 years. He submitted that in other words the indigenous manufacturer cannot apply for registration on the basis of the provision of sec. 9(4) during this period of 3 years as the deemed registration is granted in favour of the importer and it will deprive the indigenous manufacturer of the right of registration for a period of 3 years creating a monopoly in favour of such imp .....

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..... criteria have been relaxed. However, he submitted that it was only after the notice was issued by the High Court these aspects have been considered and therefore he emphasized that the sequence of events and the dates may also be relevant. Learned Addl. Advocate General and Sr. Counsel Shri Mehta submitted that there is no provision in the statute providing for deemed registration which is sought to be now evolved by the Registration Committee and therefore it is contrary to law. 19. Again, learned Addl. Advocate General and Sr. Counsel Shri Mehta referred to the Minutes of the 313th Meeting (special) of the Registration Committee dated 8.11.2010 produced at Annexure-D. He also referred to the affidavit-in-reply filed by the respondent Union of India as well as the other respondents and submitted that as stated the policy is to encourage the new molecules. However, it is also required to be considered whether it is genuinely new molecules which are permitted or outdated old molecules which are sought to be imported. He emphasized that the fact that what would be the new molecules has also been considered and it is provided that if it is more than 15 years then it cannot be te .....

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..... est with regard to the technical grade/material inasmuch as it is outside the country and they have no access for inspection of such technical grade/material. He submitted that whatever is stated and produced would be accepted and therefore the quality and safety would be compromised. 22. Learned Asst. Solicitor General of India Shri PS Champaneri appearing for the Union of India referred to the scheme of the Act and referred to the definition of insecticide provided in sec. 3(e) and submitted that it would include both the formulation and the technical grade. He referred to sec. 5 which provides for the Registration Committee and how it is constituted and the board which is appointed. However, he emphasized sec. 5(5) and submitted that the Registration Committee can regulate its own procedure for the registration and it is required to be considered for the purpose of considering the guidelines with regard to deemed registration. Learned Asst. Solicitor General of India Shri PS Champaneri also referred to sec. 36 read with Rule 41 with regard to the power of the Central Government and submitted that the Government is conscious and therefore sec. 17 provides for prohibitio .....

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..... ntroduction of new pesticide molecules in the interest of Indian farmers. He also referred to the affidavit-in-reply filed by Dr. Suresh Kumar, Plant Protection Officer, CIPMC, Vadodara to support his submission. He referred to this affidavit and submitted that the grant of registration for import of formulation without registering its technical is as per the existing law to encourage introduction of new and better pesticide molecules for Indian agriculture. He further referred to para 10 of the affidavit and submitted that as stated, presently for registering a Formulation the applicant is required to provide complete data on the Technical also, which is used for making the Formulation , even if Formulation alone is to be imported. It amounts to providing full set of data required for registering any pesticides under 9(3). However, registering the Technical when any applicant desires to import Formulation alone, may amount to duplication of work in the CIB RC. Since the applicant is any way providing the full data, the procedure is such that the Technical would deem to have been registered along with the Formulation. Protecting the Technical for 3 years from me .....

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..... annot be said to be arbitrary, nor is it contrary to the statutory provisions. 29. In rejoinder, learned Advocate General and Sr. Counsel Shri Kamal Trivedi referred to the papers and submitted that the apprehension about the aspect of safety and quality is required to be protected and he made it clear that at the time of registration of formulation, though it may not be necessary, complete data as well as physical sample of technical grade/material is made available for the purpose of various tests and scrutiny by the laboratory and therefore the submissions made are misconceived. Learned Advocate General and Sr. Counsel Shri Trivedi referred to Annexure-E at p. 47 which provides for the guidelines for registration of pesticides dated 5.10.2011 with complete data in a tabular form and referring to the aspect of chemistry he submitted that various columns are provided for the test and examination of the chemical composition for which Item 1 to 10b are provided. He also referred to other columns of 12a to f. He also referred to col. 16 which provide, The applicant should provide sample along with standards technical sample from the principals/authorized deale .....

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..... made qua the importers when the sample is tested for chemical composition. He submitted that in any case he is ready to make a statement that actual physical sample of the technical grade/material for any such test for the purpose of import of formulation may be made. He also submitted that for every consignment of import which will be accompanied by such physical samples and suitable conditions may be imposed by the authorities which takes care of the apprehension about the safety of human life. He further stated that the same treatment may also be made available to the indigenous manufacturers. 32. In view of the rival submissions, it is required to be considered whether the present civil applications for vacating the interim relief deserve consideration or not. 33. From the rival submissions and the viewpoint as it emerges, it is evident that the focus of both the sides is on the commercial interest. However, when the issue like this is touching upon the aspect of human safety and also the policy of the government as well as the role of the Government or the authority for protecting public interest and the safety of human life, it may require a closer scrutiny for the .....

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..... for 1996. Companies based in Western Europe are currently the world s largest chemical producers. The fastest growing markets are in developing countries, particularly in Latin America and Asia. Africa is increasingly using pesticides on export crops. (emphasis supplied) Thus, according to the United Nation's Environmental Programme, there are number of highly toxic chemicals that persist in the environment, accumulate in wild life and people. 36. It is in this background when, on one hand, there is a move for organic farming or conscious awareness for lesser use of pesticides, it is desirable for a country like ours to have a fresh look at such issues. The Government of India when it is claiming that sufficient care has been taken, as stated in the affidavit, may also have more effective and transparent procedure as well as enactments to protect the soil, environment and human life considering the bioefficacy and the standards of impurities. Therefore, when the statute like the Act has been intended to have some amount of regulation on use of pesticides or import of pesticides which cannot be altogether avoided, some mechanism has to be provided by which the laws are i .....

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..... ct of discrimination that they are not treated on equal footing requires a closer scrutiny. The discrimination which has been claimed has not been made out inasmuch as the indigenous manufacturers are not prohibited or prevented from registering their own technical grade/material on the basis of necessary research and generation of data base. The main focus or complaint has been that when the formulation is imported, its technical grade/material is not required to be registered which may lead to import of such pesticides and chemicals which are spurious/harmful or which may cause harm to the soil and human life is taken care of when learned Advocate General and Sr. Counsel Shri Trivedi appearing for some of the applicants importers have conceded and clarified that the actual physical sample of the technical grade/material is also made available for testing even for import of the formulations. He has further stated that appropriate directions could be issued even if it is not being followed strictly. Learned Sr. Counsel Shri Thakore as well as learned Sr. Counsel Shri Joshi appearing for some of the applicants-importers have also agreed and have no objection. 40. Therefore, wh .....

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..... ion of India or the concerned administrative department to consider the requirements for the imports in India for future and appropriate directions could be issued at the time of final hearing. For example, when it is provided that the molecule one which is registered outside India within 15 years could be treated as new molecule leaves much to be desired as in these days of technology and scientific advancement a span of 15 years could not be a reasonable period and it could be considered for reducing the said period by the respondent Union of India after necessary examination of relevant issues. In fact, prima facie examination of the details as canvassed by learned Addl. Advocate General and Sr. Counsel Shri Mehta that some of the technical grade and formulations have its origin 40 years back and therefore such outdated formulations are sought to be imported to be used in India is a matter of great concern which the respondent Union of India should examine with necessary sensitivity regarding the bioefficacy, Indian agriculture, Indian climatic condtions as well as protection of human life, animals and the environment. Therefore, though sufficient provision is made in the sta .....

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..... ould be the approach which may be considered by the respondent Union of India while considering the commercial interests as well as the interest of human safety and bioefficacy. 46. Therefore, it would be in the fitness of things to leave such larger issues aside for the purpose of deciding the present civil applications for vacating the interim relief. The interim relief may be vacated/modified subject to some of the conditions which takes care of the aspects of safety till fresh guidelines are issued by the Government and the matter is heard and decided finally. This is only as and by way of an interim arrangement pending final hearing and/or a proper mechanism and guidelines by the Union of India with much focus on the aspects of human safety and bioefficacy. The import of such formulations deserves to be allowed as it could not be totally stayed without complete data or the details available which may have a bearing on the agriculture. This has to be considered also while considering the broad aspects for grant of interim relief like prima facie case and comparative hardships, etc. 47. Therefore, the present civil applications deserve to be allowed and accordingly stand a .....

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