Industry representatives from CropLife India have requested the central government to incorporate a five-year Protection of Regulatory Data framework into the Draft Pesticides Management Bill, 2025. The move aims to incentivize the introduction of newer, safer molecules and enhance agricultural productivity and export competitiveness.

A group of major crop protection companies in India has formally urged the government to introduce a five-year, time-bound Protection of Regulatory Data (PRD) framework within the Draft Pesticides Management Bill, 2025.

The appeal was issued by members of CropLife India, which include Crystal Crop Protection, Rallis India, Dhanuka Agritech, PI Industries, and Godrej Agrovet. According to the industry stakeholders, a limited and time-bound data protection window acts as a critical incentive to introduce newer, safer, and lower-dose molecules to the domestic farming sector more rapidly.

Data shared by CropLife India and the Yes Bank Knowledge Report indicates that India loses an estimated 10 to 35 percent of agricultural output annually due to pests, weeds, and diseases, amounting to approximately ₹2 lakh crore in losses. These losses tend to increase as global temperatures rise and climate change alters pest and disease patterns.

Currently, bringing a new agrochemical molecule to the Indian market requires an investment of about ₹40 to ₹50 crore and takes between six to eight years of local safety, efficacy, and residue studies. Without a protected period, subsequent applicants can rely on the same registration data within a year at a reduced cost of around ₹75 lakh. Industry representatives note this disparity removes the commercial incentive to introduce innovative molecules to the country.

The proposed PRD framework would apply exclusively to new molecules and new uses, leaving existing market portfolios unaffected. Once the five-year protection window expires, the molecule would become accessible to the broader industry, including the generic sector and small and medium enterprises (SMEs).

Advocates of the framework argue that expanding India's registered portfolio beyond the current 380 molecules out of the 1,200 used globally would strengthen manufacturing competitiveness and help farm exports meet tightening residue limits abroad. Several competing agricultural nations already enforce data protection policies: China provides six years, Thailand, Brazil, and the United States offer up to 10 years, and the European Union provides 10 to 13 years for low-risk and biological products.

Furthermore, industry members highlighted that single-molecule over-registration can lead to severe price drops, potentially causing product misuse and encouraging a market for sub-standard alternatives. A structured protection period is intended to reward genuine research investment, stimulate work within Indian laboratories and field stations, and ensure a more regulated approach to crop protection.

"The debate around regulatory data protection highlights the balance between encouraging local research and supporting the broader generic manufacturing ecosystem. Introducing a defined framework can help attract targeted investments into safer agricultural technologies, while ensuring that small and medium enterprises eventually gain access to a modernized portfolio. For India's agricultural sector to remain competitive globally and address evolving climate challenges, policy frameworks must continue to adapt to support both innovation and broad market access." — Dr. Shishir Gupta, Founder & CEO, StartupLanes

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