UPL Ltd. secures Pyroxasulfone herbicide registration amid legal challenge

In a significant decision in the agrochemical sector, the Registration Committee (RC) has upheld the registration granted to UPL Ltd. for the indigenous manufacture of Pyroxasulfone Technical (98.3% w/w) and its 85% formulation, following a detailed review process that spanned over a year.

Pyroxasulfone is a globally important pre-emergence herbicide, known for its ability to control weed growth by disrupting the synthesis of very long-chain fatty acids (VLCFAs). With multiple agrochemical players vying for its registration in India, the case involving UPL Ltd. and PI Industries Ltd. drew considerable attention within the industry.

Timeline of the Case

The matter first came up during the 443rd meeting of the Registration Committee held on 22nd December 2022, where UPL had submitted a comprehensive presentation supporting its application. The company sought registration for Pyroxasulfone under the TIM vs. FI-WRT category, which permits applicants to seek registration of a technical based on an already registered formulation without the requirement of a separately registered technical, subject to certain conditions.

UPL justified its application by relying on the RC’s earlier 427th meeting, in which a provision allowed exemption from bio-efficacy data, provided chemical equivalence was established through live batch analysis. UPL argued that the same exemption should apply to its application, even though it was made under the TIM vs. FI-WRT guidelines.

PI Industries challenged the registration, arguing that UPL had relied on an unregistered technical, which they claimed was not permissible under the rules. Following this objection, the matter was escalated to the Joint Secretary, who, acting as the appellate authority, directed the RC to re-evaluate the matter and issue a reasoned order after a technical reassessment.

In compliance with the Joint Secretary’s order, the matter was re-examined in the 461st meeting of the Registration Committee held on 28th January 2025. During this meeting, fresh presentations were made by both parties, and the RC conducted a detailed analysis of the regulatory and legal frameworks governing the case.

Final Decision in Favor of UPL

After reviewing the arguments and the regulatory context, the RC concluded that the exemption granted in the 427th meeting was not limited solely to the TIM vs. TI category and could be extended to applications under the TIM vs. FI-WRT category as well. The committee noted that reading the phrase ″already registered technical″ in a narrow sense would unfairly exclude applicants under the TIM vs. FI-WRT path, even though both registration categories are nearly identical in their purpose and process, differing only in whether the technical is registered or embedded within a registered formulation.

UPL was represented by senior counsel Mr. Ashish Kothari, along with Mr. Ravi Hegde and Dr. Anand, who acted as authorized representatives of the company. Their arguments emphasized that the RC’s own guidelines supported reliance on chemical equivalence with unregistered technicals when part of a registered formulation, as allowed under the TIM vs. FI-WRT category.

The Registration Committee, serving as the Revisional Authority, ultimately rejected all objections raised by PI Industries and upheld the registration granted to UPL for both the technical and the formulation of Pyroxasulfone.