Registration of pyroxasulfone herbicide: Judgment in favor of UPL Ltd. by the Registration Committee in India

Pyroxasulfone is an important molecule world over and several corporates are in race to register this Pre-emergence herbicide that inhibits weed growth by disrupting the synthesis of very long chain fatty acids VLCFAs. After a well fought out case of corporates where after several petitions and deliberations the RC has given their verdict in the case of M/s. PI Industries Ltd. challenging grant of registration indigenous manufacturer of Pyroxasulfone technical 98.3% w/w (Pyroxasulfone tcchnical) and pyroxasulfone 85% formulation (Pyroxasulfoneformulation) to M/s. UPL Ltd vide agenda item No. 2.4 of its 443th meeting of CIB&RC, the apex body of GOI to grant registration.

UPL had already submitted a detailed presentation in the443rd meeting regarding the safety and efficacy of Pyroxasulfone Technical and Formulation and justified thegrant of relaxation in Bio-efficacy data as per the decision taken by the RC in its 4271h meeting. The registration wasgranted to UPL by the RC only after completely satisfying itself after UPL’s presentation. It was further the submission of the Learned Counsel that TIM Vs. FI-WRT Guidelines, under which Pyroxasulfone Technical hasbeen registered by the RC in the instant case, is itselfbased on the concept of reliance on the data of anunregistered technical embedded in the registered formulation. It was further submitted that the legality and validity of the TIM Vs. FI-WRT Guidelines have already been upheld by the Gujarat High Court was further submitted that the argument taken by PI Industries thatdata of an unregistered technical cannot be relied upon to establish chemical equivalence since the same would amount to treating the unregistered technical as 'deemed registered''.

UPL was represented by learned counsel Mr Ashish kothari along with Mr Ravi Hegde and Dr Anand, the authorised representatives of UPL.

Guidelines

"The data requirement for registration for "Technical for Indigenous Manufacture (TIM)" contained in a 'Formulation registered for Import' (Fl) without registering the "Technical" will be enumerated by the "Registration Committee" (RC) under a new category for registrationcalled "TIM vs Fl". Any applicant desirous of registration of the "Technical for Indigenous Manufacture (IM)" with respect to a registered 'Formulation for Import (Fl)' without registration of its Technical, will be required to submit bridging data on shelf-life and packaging and alsoany other data which the RC may deem fit, and may include data on bio-efficacy and toxicity, based on trial in India and chemical comparison of the Technical grade pesticides″.

ANALYSIS

Before analyzing the arguments advanced by both theparties, it is imperative to note the scope of the present proceedings as directed by the Hon’ble RevisionalAuthority vide its Order dated 24.12.24. By the order RC gave an opinion to determine whether the exemptions provided by the RC for registration of technical vide its decision in its 427th meeting were applicable to the caseof UPL in light of usage of the words "already registeredtechnical" in the said decision.

UPL had applied for registration for indigenous manufacture of Pyroxasulfone technical under TIM Vs.FI-WRT category. It is also an admitted position that UPL had sought exemption from submission of bio-efficacy data by relying upon the second portion of the decision ofthe RC captured in the last Column of the aforesaid table i.e. "However, if application is submitted for technical alone, then chemical equivalence (through live batch analysis) with already registered technical is required toget this exemption."

If the intent was to grant relaxation to certain specific category of applications, the same would have beenspecified by the RC in the decision itself.

The RC cannot lose sight of the fact that if the words ″already registered technical" as contained in thedecision taken by the RC in its 42th meeting are given their literal meaning then the application of the said relaxation would become limited only to applications under TIM Vs. Tl category and would automatically debar applicants under TIM Vs. FI-WRT category from takingadvantage of the relaxation from submitting bio-efficacydata since TIM Vs. FI-WRT Guidelines are applicable only in cases where technical is not registered. This would create a divide/discrimination between technicalregistrants under TIM Vs. TI and TIM Vs. FI-WRT categories even though the two Guidelines arc almost areplica of each other and the only significant difference between these two Guidelines is that under TIM Vs. TI Guidelines, chemical equivalence is established with aregistered technical whereas under TIM Vs. Fl-WRT Guidelines, chemical equivalence is established with an unregistered technical that is embedded in the registered Formulation.

In the view of the discussions and observations all the objections of PI Industries are hereby rejected and the registration granted to UPL qua Pyraxasulfone Technical as well as its Formulation granted in its 443rd RC meeting is upheld.

Dr. Archana Sinha (Secretary, CIB&RC) - RC Member

Dr. JP Singh (Plant Protection Advisor) - RC Member

Dr. Poonam Jasrotia (ADG (PP) ICAR- RC Member

Dr. Praveen Kumar Singh (Agriculture Commissioner) - Chairman RC

Check the original judgment