India RegionCrop Protection

The Battle Over Agrochemical Data Protection: How It Impacts Farmers and Industry

26 December 2024, New Delhi: The Pesticides Manufacturers & Formulators Association of India (PMFAI), representing over 220 Indian agrochemical companies, has voiced staunch opposition to the prospect of extending regulatory data protection for agrochemicals beyond the existing 20-year patent period. This move, perceived as a result of intense lobbying by multinational corporations (MNCs) and importers, threatens to undermine the competitiveness of domestic manufacturers and significantly impact India’s farmers. PMFAI’s concerns, articulated in a letter by its President, Mr. Pradip Dave, to the Secretary of the Department of Agriculture and Farmers Welfare, highlight the far-reaching consequences of such a policy shift.

Historical Context and Government Deliberations

The debate surrounding regulatory data protection for agrochemicals is not new. Since 2008, various government bodies, including the Ministry of Agriculture & Farmers Welfare, the Ministry of Chemicals & Fertilizers, the Ministry of Commerce & Industry, and even the Prime Minister’s Office, have deliberated on this issue. Over 16 years of discussions and consultations culminated in a comprehensive analysis by the Parliamentary Standing Committee on Agriculture, Animal Husbandry, and Food Processing. The Committee, after considering inputs from all stakeholders, unequivocally recommended against extending data protection for agrochemicals. This recommendation was incorporated into its Thirty-Sixth Report on the Pesticides Management Bill 2020, presented to Parliament in December 2021.

Mr. Pradip Dave, President, Pesticides Manufacturers & Formulators Association of India (PMFAI)

The Case Against Regulatory Data Protection

PMFAI’s opposition is rooted in the potential repercussions of such a policy on the agrochemical sector and the farming community. First, extending data protection beyond the patent period would effectively prolong monopolies, contravening the World Trade Organization’s (WTO) 20-year patent protection framework. This would stifle competition by delaying the entry of generic products, thereby escalating costs for farmers who rely heavily on affordable agrochemical solutions to protect their crops.

Small and medium enterprises (SMEs), which form the backbone of India’s agrochemical industry, would bear the brunt of this policy. These enterprises, integral to the “Make in India” initiative, would face insurmountable barriers to market entry, curtailing their ability to compete with established MNCs. Such monopolization would result in inflated prices, disproportionately affecting small and marginal farmers who constitute the majority of India’s agricultural workforce.

The Parliamentary Standing Committee’s report underscored that India’s expansive agricultural market does not necessitate additional incentives like regulatory data protection to attract investments in new agrochemical molecules. Instead, the existing patent period provides sufficient protection for inventors to recoup their investments. The Committee further observed that a significant proportion of patented agrochemicals introduced globally are not launched in India. Between 2010 and 2022, only 27 out of 62 patented pesticides were commercially launched in the country. This selective commercialization undermines the socio-economic principles enshrined in Section 83 of the Indian Patents Act, which mandates that patented inventions contribute to national interests.

The demand for extended data protection by MNCs, despite their reluctance to introduce patented products in India, reflects a paradoxical approach. By seeking exclusivity for off-patent pesticides, these corporations effectively hinder the development of generic alternatives, exacerbating economic disparities and compromising the affordability of agrochemicals for Indian farmers.

Impact on the Global and Domestic Agrochemical Markets

Unlike the pharmaceutical industry, where patented products dominate, the global agrochemical market is characterized by the predominance of generic products. Over 80% of the $76 billion global agrochemical market comprises generics. Regulatory data protection would delay the entry of generics into the Indian market, stifling the growth of the domestic agrochemical sector and increasing farmers’ dependency on expensive imported products. This scenario directly contradicts India’s commitment to fostering self-reliance and promoting indigenous manufacturing.

Affordable access to agrochemicals is critical for Indian farmers, particularly those with small landholdings. Pesticides play a pivotal role in safeguarding crops from pests and diseases, directly influencing agricultural productivity and food security. Any policy that jeopardizes the affordability and availability of these inputs would have a cascading effect on the agricultural economy and the livelihoods of millions of farmers.

Call for Rational Policy-Making

PMFAI’s letter serves as a clarion call for rational and balanced policy-making that prioritizes the interests of Indian farmers and the domestic agrochemical industry. The government’s decision to resist extending regulatory data protection aligns with the principles of fair competition and economic inclusivity. Upholding this stance will ensure that agrochemicals remain accessible and affordable, fostering a competitive environment that benefits both manufacturers and farmers.

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