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The Pesticides Manufacturers & Formulators Association of India (PMFAI) has urged the Government of India to reject proposals seeking the introduction of Regulatory Data Protection (RDP) or data exclusivity provisions in the proposed Pesticide Management Bill (PMB), arguing that such measures would increase costs for farmers, restrict competition and weaken India’s domestic agrochemical manufacturing ecosystem.
Representing greater than 220 domestic agrochemical manufacturers, PMFAI said the issue has been examined repeatedly by various government ministries over the past 16 years, with recommendations consistently opposing the introduction of data exclusivity provisions. The association also pointed to the Parliamentary Standing Committee on Agriculture, animal life Husbandry and Food Processing, which, in its 2021 report, concluded that India’s existing 20‑year patent protection regime, compliant with the WTO’s TRIPS agreement, already provides sufficient time to innovators to recover research and research (R&D) investments and commercialise new items.
PMFAI contends that multinational agrochemical companies are seeking a further five‑year regulatory exclusivity period to items that have often already enjoyed patent protection globally. According to the association, many of the molecules being discussed are already off‑patent and commercially established in other markets. It argues that granting additional market exclusivity through regulatory channels would efficiently extend protection beyond the statutory patent period and create what it describes as a “TRIPS‑plus” barrier to competition.
The association warned that delaying the entry of generic crop‑protection items could significantly raise input costs to farmers. PMFAI estimates that farmers, particularly small and marginal landholders, could be forced to pay 35-50% higher prices to crop‑protection items if the introduction of generic substitutes is postponed through data exclusivity provisions.
Strong capabilities
PMFAI also said that India’s agrochemical sector has built strong capabilities in process chemistry, manufacturing innovation and cost‑efficient production technologies, enabling domestic companies to develop alternative manufacturing routes and environmentally improved processes once patents expire. The association believes restricting prompt access to off‑patent molecules would undermine these strengths, limit domestic manufacturing opportunities and weaken India’s competitiveness in global agrochemical export markets.
In a statement, PMFAI President Mr. Pradip Dave said the registration framework should not be utilized to secure forms of exclusivity that have previously been rejected through legislative and policy processes. He added that the association is appealing to the government to protect the interests of Indian farmers and domestic manufacturers by excluding any provisions related to regulatory data protection or data exclusivity from the forthcoming legislation.
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