The Pesticides Manufacturers & Formulators Association of India (PMFAI), which represents more than 220 domestic agrochemical manufacturers, has opposed demands by multinational companies (MNCs) and importer groups to introduce Regulatory Data Protection (RDP) or Data Exclusivity for agrochemicals in India. The association urged the government of India and the Ministry of Agriculture & Farmers Welfare to reject proposals seeking to include a five-year RDP provision in the upcoming Pesticide Management Bill (PMB).
PMFAI Cites Previous Government Reviews
According to PMFAI, the issue of Regulatory Data Protection has been examined by multiple government ministries over the past 16 years, with the reviews consistently advising against its introduction. The association also referred to the 36th Report of the Parliamentary Standing Committee on Agriculture, Animal Husbandry and Food Processing, submitted to the 17th Lok Sabha in December 2021.
PMFAI said the committee noted that India’s existing 20-year patent protection period, under its TRIPS-compliant patent regime in effect since January 2005, provides innovators with sufficient time to recover research and development investments. The committee also noted that India’s large arable land base and expanding market provide strong incentives for domestic and international companies to introduce new innovations without additional data protection, according to PMFAI.
PMFAI Questions Need for Additional Data Exclusivity
PMFAI has argued that new molecules introduced under India’s patent system already receive up to 20 years of patent protection. Therefore, the association maintains that an additional five-year data exclusivity period could extend market protection beyond the existing patent framework. The association further claims that many of the molecules for which MNCs are seeking RDP are already off-patent and have been commercialised and registered in international markets before their introduction in India. PMFAI has consequently questioned whether granting additional exclusivity to such products would encourage new research and development in India.
Domestic Industry Highlights Process Innovation
PMFAI has highlighted the capabilities developed by India’s agrochemical manufacturing industry over several decades. According to the association, domestic manufacturers have built expertise in process chemistry, manufacturing innovation and cost-efficient production technologies. Following the expiry of product patents, Indian companies often develop alternative manufacturing routes, improve process efficiency, increase yields and adopt more sustainable production methods. PMFAI said some of these process improvements can also result in independently patentable innovations. The association believes this manufacturing and process-innovation ecosystem has contributed to India’s position as a competitive producer and exporter of crop protection products.
PMFAI Raises Concerns Over Farmer Costs
PMFAI has identified several concerns regarding the proposed five-year RDP provision:
Potential Impact on Agrochemical Costs
The association claims that post-patent data exclusivity could delay the entry of generic agrochemicals into the market. According to PMFAI, this could increase crop protection costs for small and marginal farmers and potentially affect farm profitability.
Additional Market Exclusivity
PMFAI has described the proposed RDP provision as a potential TRIPS-plus measure, arguing that additional market exclusivity could restrict competition beyond the existing patent protection period.
Access to Off-Patent Molecules
The association maintains that many molecules covered by the RDP demand are already off-patent and commercially established in other markets. It therefore argues that additional exclusivity would provide protection for previously developed products rather than directly incentivising new discoveries.
Impact on Domestic Manufacturing and Exports
PMFAI has also expressed concerns that delayed access to off-patent molecules could affect India’s domestic manufacturing capabilities and crop protection exports. The association argues that timely access to such molecules supports process innovation, cost-efficient manufacturing and India’s participation in international markets.
PMFAI Urges Government to Reject RDP Provision
PMFAI has urged the government not to include provisions for Regulatory Data Protection or Data Exclusivity in the Pesticide Management Bill. The association said the registration framework should not be used to introduce protections that, in its view, have previously not received legislative support. As per the press release, PMFAI has called for the government to consider the interests of domestic agrochemical manufacturers and farmers while finalising the proposed pesticide regulatory framework.
