PMFAI Raises Concerns Over Renewed Push for Regulatory Data Protection in Agrochemicals

22 November 2025, Mumbai: The Pesticides Manufacturers & Formulators Association of India (PMFAI), representing 221 Indian pesticide and bio-pesticide manufacturers, has written to the Minister of Agriculture and Farmers Welfare expressing concern over continued lobbying for Regulatory Data Protection (RDP) for agrochemicals beyond the existing patent period.

In a letter addressed to the Ministry, PMFAI stated that proposals for RDP and similar forms of extended exclusivity are being repeatedly raised by multinational companies and importer groups, despite earlier reviews and recommendations against such measures.

Background of the Policy Debate

According to the association, the issue of data protection for agrochemicals has been examined for more than 16 years by multiple ministries, including Agriculture and Farmers Welfare, Chemicals and Fertilizers, Commerce and Industry, and the Prime Minister’s Office.

PMFAI noted that the Parliamentary Standing Committee on Agriculture, Animal Husbandry and Food Processing also evaluated the subject during its review of the Pesticide Management Bill, 2020. The Committee’s final recommendations, presented in December 2021, stated that data protection or exclusivity beyond the 20-year patent period could delay market entry for generic versions of pesticides and affect affordability for farmers.

Key Concerns Highlighted by PMFAI

PMFAI stated that India already provides a 20-year patent period under WTO provisions, and any additional layer of protection through RDP would extend monopoly conditions for agrochemical innovators.

The association argued that extended exclusivity would restrict the growth of domestic manufacturers, particularly MSMEs, and delay the availability of lower-cost generic alternatives. According to PMFAI, such a policy shift could influence input prices for farmers, especially those with small landholdings, where access to cost-effective crop protection products is critical.

The association also referred to the typical life cycle of pesticide molecules, which can extend up to 30–35 years. It expressed concern that implementing RDP could limit the scope for generic entries during this duration, impacting overall market competition.

“We believe that introducing Regulatory Data Protection or extending the patent term for agrochemicals will reduce competition, delay the availability of generic products, and ultimately affect affordability for farmers,” said Pradip Dave, President, PMFAI. “India’s regulatory framework already provides adequate protection for innovators, and any additional layer will impact domestic manufacturers and the farming community.”

Reference to Government Clarification

PMFAI cited an Office Memorandum issued by the Ministry of Agriculture and Farmers Welfare in August 2023. The memorandum referred to Standing Committee observations that RDP or patent term extensions could delay the entry of generic pesticides, create extended monopoly periods, and potentially raise prices for small and marginal farmers.

The association stated that these conclusions remain relevant as discussions around RDP continue.

Appeal to the Ministry

In its submission, PMFAI requested the government not to support the introduction of Regulatory Data Protection or extension of patent terms for agrochemicals. The association reiterated that further protection beyond the existing patent period could limit competition, restrict opportunities for domestic MSMEs, and increase input costs for farmers.

The letter concluded with a request that India maintain its current approach to agrochemical regulation to ensure accessibility and affordability for the farming community.

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