The Delhi High Court has asserted that where registration under Section 9(3) of the Insecticides Act is sought on the strength of data generated from an RTT sample, the Registration Committee must have cogent material establishing that the tested sample is from the same source as the insecticide for which registration is sought. If that source linkage is not reliably demonstrated, the Committee’s satisfaction regarding efficacy and safety is unsupported, and the resulting registration is legally unsustainable.
Emphasising that judicial deference to an expert body does not extend to upholding a decision that lacks material supporting compliance with the statutory precondition under Section 9(3) of the Insecticides Act, the High Court reinforced that regulatory approval under the Insecticides Act cannot rest on unexplained or weakly documented changes in source identity where safety and efficacy data are source-dependent.
Accordingly, the High Court set aside the registration granted to Crystal Crop Protection Ltd. under Section 9(3) of the Insecticides Act, 1968 for import of Halosulfuron Methyl Technical 98% w/w and for indigenous manufacture of Halosulfuron Methyl 75% WG. It held that the Registration Committee could not lawfully grant registration unless it had sufficient material to satisfy itself that the product for which registration was sought was the same as the product on which safety and efficacy data had been generated.
The Division Bench comprising Justice C. Hari Shankar and Justice Om Prakash Shukla emphasised that Section 9(3) requires the Registration Committee to undertake such enquiry as it deems fit and to satisfy itself that the insecticide for which registration is sought conforms to the claims made as to efficacy and safety. Where the applicant relies on data generated from an RTT sample, the Bench held that the issue whether the tested sample and the product proposed to be imported are from the same source becomes fundamental.
On the record before it, the Bench found that there was no reliable material showing that Jiangsu was authorised in 2011 to manufacture Halosulfuron Methyl Technical 98% w/w; rather, the material available showed a 2013 registration for 95% and a later 2018 registration for 98%. Second, in the RTT application, Fertiagro had been disclosed as both manufacturer and supplier, which was inconsistent with the later claim that Jiangsu was the true manufacturer and Fertiagro only the supplier. Third, the Exclusive Service Agreement dated 8 December 2010 itself appeared doubtful because it recited that Jiangsu was manufacturing HSMT 98% even before any supporting registration for that product was shown.
The Bench further noted that the Registration Committee’s minutes did not reveal any cogent reasoning showing how the discrepancy in source had in fact been resolved. The materials referred to in the presentation before the Registration Committee were largely communications and self-serving explanations, without clear documentary proof establishing that the RTT sample and the product covered by the Section 9(3) application were the same. In those circumstances, the Bench held that the statutory satisfaction required under Section 9(3) could not be said to have been validly reached.
Briefly, Dhanuka Agritech Ltd., which already held registration under Section 9(3) for import of Halosulfuron Methyl 75% WG from its Japanese source, challenged the registration later granted to Crystal Crop Protection Ltd., by which Crystal had obtained an RTT permit in 2011 for import of a sample of Halosulfuron Methyl Technical for research, test and trial purposes. It subsequently applied in 2016 under Section 9(3) for registration to import Halosulfuron Methyl Technical 98% min. said to be manufactured by Jiangsu Agrochem Laboratory Co. Ltd., China and supplied through Hebei Bestar Commerce & Trade Co. Ltd., and also for indigenous manufacture of Halosulfuron Methyl 75% WG.
The Registration Committee noticed a discrepancy between the source reflected in the RTT history and the source disclosed in the Section 9(3) application, but ultimately granted registration in its 430th meeting, which was later modified in the 431st meeting.
Dhanuka objected that the data generated by Crystal was based on an RTT sample sourced differently from the product for which import registration was sought, and contended that registration under Section 9(3) of the Insecticides Act had therefore been granted without proper verification of source identity. Its challenge before the revisional authority failed, and the petition before the Single Judge was also dismissed.
