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TMI Blog2014 (4) TMI 267X X X X Extracts X X X X X X X X Extracts X X X X ..... the petitioners that the technical material is not registered or evaluated for import of formulation is factually incorrect. It is contended that a wrong impression is sought to be created that registration of the technical grade/material is given a go-bye while importing the formulation and hence exemption has been given to the respondents herein by the Registration Committee. It is also contended that in this manner compromise is made to the safety and needs of human life as well as agriculture as the technical grade/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, 284th 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 vio ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ivedi pointedly referred to the prayer clause and submitted that there is a catch by which the registration of the applicants-original respondents is sought for the technical grade on the basis of which persons like the original petitioners who are indigenous manufacturers can claim the benefit of registration of technical grade/material on the basis of the provisions of the Act, particularly sec. 9(4) which is considered as "Me Too" registration. 5. Learned Advocate General and Sr. Counsel Shri Trivedi referred 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, &nb ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... tific manner with appropriate material, and if there is any difference, a clarification could be sought from the applicants. He therefore submitted that the submissions made by the original petitioners with regard to any exemption or the fact that the importers like the applicants are permitted to import the formulations without any technical grade verification and are granted exemption, whereas the indigenous manufactures are required to undergo rigorous test for the purpose of formulations as well as the technical grade is misconceived. He emphasized 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... igenous manufacturers are not treated on equal footing and the importers are having the benefit of the guidelines which are made to favour them. However, he submitted that the procedure provided which has been referred to is the same. He emphasized the definition of 'insecticide' as provided in sec. 3(e) of the Act and submitted that it provides for both the formulation as well as the technical grade. Therefore, learned Sr. Counsel Shri Joshi submitted that most of the data is provided even for technical grade and the use test may not be available 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ould be registered. 15. Learned Addl. Advocate General and Sr. Counsel Shri Mehta further referred to the scheme of the Act and submitted that sec. 9(3) refers to the registration of insecticides and it provides for the examination of efficacy of insecticides and safety of human being and animals which is verified only on the basis of papers submitted by the importer as the technical grade could be at the premises or the factory located outside the country and therefore there will not be any test or examination, whereas the indigenous 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ndian farmers. He emphasized that it should not be confined to a limited issue but should be considered on a broader perspective for the interests of the Indian manufacturers and Indian farmers. He pointedly referred to sec. 9(3), 9(3B) and 9(4) of the Act. He also referred to the guidelines of the Registration Committee framed earlier in the year 2007 in its 284th Meeting dated 13.2.2007. He also referred to the subsequent meeting of the Registration Committee, i.e., 313th Meeting (special) dated 8.11.2010 and submitted that the 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 produc ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... in connivance with the multinationals a guideline or a device is made to grant them a monopoly at the cost of the Indian farmers and agriculture. 21. He again referred to Annexure-G which is a representation dated 11.7.2006 made to the Ministry of Agriculture, Govt. of India, with much detailed focus on such aspects and submitted that it was followed by another representation dated 3.10.2006 which has not been considered. He also referred to Annexure-J and submitted that the authorities will not have a chance to have any test 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... onsider that the efficacy and safety is not compromised. He submitted that the guidelines which provide for registration of a formulation without registering the technical grade/material cannot be said to be erroneous. Similarly, he submitted that the policy providing for "deemed registration" of a technical after three years cannot be said to be contrary to the provision of law. He submitted that the practice of registration of a formulation and making the technical grade a deemed registration is to encourage introduction 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 makin ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... e local manufacturers as they are not required to generate new data. 28. Learned Asst. Solicitor General Shri Champaneri also referred to the statement of objects and reasons as well as the amendment Act No. 24 of 1977, Amendment Act No. 23 of 2000 and submitted that it is in public interest the steps are taken to protect human life and also providing for scope for new molecules which could be used advantageously by Indian agriculture. He, therefore, submitted that the guidelines as well as the policy cannot 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... enous manufacturers such a test or verification is required, whereas for the importers it is not required. He also submitted that as could be seen from the data that some of the formulations are 50 years old and therefore there are loopholes and catches which may not be feasible, but in fact they are intended to benefit the importers and multinationals at the cost of indigenous manufacturers. 31. Learned Advocate General and Sr. Counsel Shri Kamal Trivedi for the purpose of clarification referred to the papers and submitted that the test of carcinogenicity is also to be 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 th ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ew international convention on dangerous chemicals and pesticides. It records, "The aim of the Convention is to enable importing countries to decide what chemicals they want to receive and to keep out the ones they cannot manage safely." Maria de Rodrigues, Chairperson of the Conference said, "it is expected that the trade can be better controlled and that the risks of these dangerous chemicals can be reduced to benefit people and the environment." It is also recorded, "the global market for pesticides continues to grow and is estimated at $30 billion 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... and bioefficacy, and (b) discrimination are required to be considered. Again, as stated above, the aspect of safety, bioefficacy, etc. are issues which the respondent Union of India has to come out with more effective guideline or mechanism. The emphasis about compulsory registration of the technical according to the applicants importers, is intended only for commercial interests of the petitioners is required to be considered. 39. The emphasis of learned Addl. Advocate General and Sr. Counsel Shri Mehta that this aspect coupled with the aspect 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 Ad ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... rest of justice to continue the interim relief and the court could examine the issues in detail at the time of final hearing. 42. Therefore, at this stage, for the purpose of deciding the present civil applications for vacating the interim relief, it has to be considered for such limited aspects on the prima facie material and examination or scrutiny of rival submissions in order to maintain a balance of the rival claims and the aspects of safety of human and animal life or the environment. Further, it would be for the respondent-Union 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 canva ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ith reference to the international conventions or treaties which provide for lesser use of such harmful pesticides and also where it has been stated that organic farming is better than indiscriminate use of such pesticides. The court may consider the rival claims or balance the rival claims that in spite of such limitations, to what extent it is necessary to import permitting the use thereof for agriculture. Again, it will require research and study to have complete data for the pros and cons of use of such pesticides and what should 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 m ..... X X X X Extracts X X X X X X X X Extracts X X X X
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