Delhi High CourtAdministrative and Public LawHealth and Medical Law

Grant of Registration Under Section 9(3) Is Invalid Absent Verified Data Linking RTT Samples to Proposed Sources

Dhanuka Agritech Ltd.v.Union Of India Through The Secretary & Ors.

Grant of Registration Under Section 9(3) Is Invalid Absent Verified Data Linking RTT Samples to Proposed Sources. Dhanuka Agritech Ltd. vs Union Of India Through The Secretary & Ors.. Delhi High Court. LawLens
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In brief

The question

1. Whether the Registration Committee (RC) legally exercised its discretion under Section 9(3) in granting registration to CCPL despite a discrepancy in the source of the insecticide

The court held

The Court allowed the appeal, holding that the RC was not justified in granting the registration as CCPL failed to provide requisite data to establish that the tested RTT sample was identical in source and quality to the insecticide proposed for import

It also directed

The Court quashed and set aside the Section 9(3) registration granted to CCPL for HSMT 98% and HSM 75% WG. Consequently, the judgment of the learned Single Judge was also set aside.

01Facts

The Appellant, Dhanuka Agritech Ltd., holds a Section 9(3) registration under the Insecticides Act, 1968, for importing Halosulfuron Methyl (HSM) 75% WG

¶ 1

In 2011, Respondent No. 4 (CCPL) was granted a Research, Test and Trial (RTT) permit to import a sample of HSMT 98% from Fertiagro, Singapore

¶ 3

In 2016, CCPL applied for registration under Section 9(3) to import HSMT 98% for indigenous manufacture, but declared the manufacturer as Jiangsu (China) and the supplier as Hebei

¶ 4

The Registration Committee (RC), in its 430th and 431st meetings (2021), accepted CCPL’s explanation that the RTT sample originally sourced from Fertiagro was actually manufactured by Jiangsu, despite documents showing Jiangsu only received registration for 95% purity in 2013 and 98% purity in 2018

¶ 8, 11, 48

The Appellant’s revision petition was rejected by the Revisionary Authority

¶ 13

and a subsequent Writ Petition was dismissed by a learned Single Judge

¶ 14

02Issues

i.1. Whether the Registration Committee (RC) legally exercised its discretion under Section 9(3) in granting registration to CCPL despite a discrepancy in the source of the insecticide

¶ 31, 45

ii.2. Whether the data generated from an RTT sample sourced from one entity (Fertiagro) can validly support a Section 9(3) application for a product manufactured by a different source (Jiangsu)

¶ 43, 56

iii.3. Whether the Appellant has the locus standi to challenge the grant of registration to a business rival

¶ 18, 59

03Law Applied

Section 9(3) of the Insecticides Act, 1968, which mandates that the RC must be "satisfied" regarding the efficacy and safety of an insecticide before granting registration

¶ 31

The "Taylor v. Taylor" principle (affirmed in Nazir Ahmed v. King Emperor), which dictates that when the law requires an act to be done in a particular manner, it must be done in that manner or not at all

¶ 30

Section 5(5) and Rule 4(b) regarding the RC's power to regulate its own procedure and the Guidelines for RTT import

¶ 9, 33

Jayaraj v. Commissioner of Excise to allow the challenge in the context of public safety and statutory compliance

¶ 27(ix), 59

Provisions in the judgment · 5 · Linked ones open on LawLens

Insecticides Act, 1968 Section 5Section 9Section 10Section 11Section 36

04Reasoning

The Court found that the RC's "subjective satisfaction" was not based on cogent material. CCPL's Section 9(3) application relied on data from an RTT sample allegedly manufactured by Jiangsu, yet CCPL’s original 2011 RTT application declared Fertiagro as both manufacturer and supplier

¶ 49

The Court noted that Jiangsu did not hold ICAMA registration for 98% purity until 2018, rendering the 2010 Exclusive Service Agreement (ESA) between Jiangsu and Fertiagro highly suspect

¶ 48, 50

The RC's decision in its 430th meeting lacked independent ratiocination, blindly accepting CCPL's self-serving presentation without verifying how a sample from 2011 could be equated to a product whose authorized manufacture only began years later

¶ 53-55

Since Section 9(3) requires strict evidence of safety and efficacy tied to the specific source, the discrepancy meant there was "no evidence" to support the RC’s satisfaction

¶ 43, 56

05Holding

The Court allowed the appeal, holding that the RC was not justified in granting the registration as CCPL failed to provide requisite data to establish that the tested RTT sample was identical in source and quality to the insecticide proposed for import

¶ 57, 58

The Court quashed and set aside the Section 9(3) registration granted to CCPL for HSMT 98% and HSM 75% WG. Consequently, the judgment of the learned Single Judge was also set aside.

¶ 59, 60
Delhi High Court

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Dhanuka Agritech Ltd.vsUnion Of India Through The Secretary & Ors.

Delhi High Court · May 29, 2026

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