India: PMFAI Strongly Opposes the Push for Regulatory Data Protection in Agrochemicals
The Pesticides Manufacturers & Formulators Association of India (PMFAI), the national body representing over 220 domestic agrochemical manufacturers since 1967, has strongly opposed the continuous demands raised by multinational companies (MNCs) and importer groups for introducing Regulatory Data Protection (RDP) / Data Exclusivity for agrochemicals in India.
The association has urged the Government of India and the Ministry of Agriculture & Farmers Welfare to reject all requests seeking to incorporate a 5-year Regulatory Data Protection provision into the upcoming Pesticide Management Bill (PMB).
PMFAI highlighted that the issue of Regulatory Data Protection has been rigorously evaluated over the last 16 years by multiple ministries, all of which consistently advised against its introduction. Furthermore, the Parliamentary Standing Committee on Agriculture, Animal Husbandry and Food Processing, in its 36th Report submitted to the 17th Lok Sabha in December 2021, concluded that the existing 20-year patent protection period under India’s TRIPS-compliant patent regime (in effect since January 2005) provides ample time for innovators to recover research and development costs. The committee noted that India’s vast arable land and growing market are inherently attractive enough to bring foreign and domestic innovations without additional data protection.
PMFAI cautioned that the MNC lobby is attempting to mislead authorities by claiming that RDP is essential for introducing new molecules. In reality, any new molecule introduced under India’s patent regime already enjoys 20 years of patent protection — a duration sufficient to recover global investments and earn profits. Western MNCs that failed to commercialize their patented products in India during their patent period are now actively lobbying for RDP to bring older, off-patent molecules to the Indian market with an artificial 5-year market exclusivity.
Over the decades, the Indian agrochemical industry has developed strong capabilities in process chemistry, manufacturing innovation, and cost-efficient production technologies. Following product patent expirations, Indian manufacturers invest significantly in developing alternative manufacturing routes, improved process technologies, higher yields, and environmentally sustainable methods, many of which result in independently patentable innovations. This process innovation ecosystem has made India a globally competitive producer and exporter of crop protection products.
Key Concerns Raised by PMFAI:
- Increased Costs for Smallholder Farmers: Granting post-patent data exclusivity would delay the entry of affordable generic agrochemicals, forcing small and marginal farmers (owning 1–5 acres) to purchase crop protection products at prices 35% to 50% higher, threatening farm profitability and national food security.
- TRIPS-Plus Measure: Extending market exclusivity beyond the statutory 20-year patent term acts as an unjustified “TRIPS-plus” barrier, restricting fair market competition and penalizing domestic generic manufacturing.
- Reward for Past Gains, Not Future Discovery: Most molecules for which MNCs seek RDP are off-patent, commercialized, and registered globally long before reaching India. Granting RDP to off-patent products rewards past international gains rather than stimulating genuine local innovation.
- Undermining Domestic Capability & Exports: India’s leadership in cost-efficient process chemistry and sustainable manufacturing relies on timely access to off-patent molecules. Delaying generic launches will curb domestic manufacturing capabilities and weaken India’s position in international export markets.
“The registration framework should not become a vehicle for securing indirectly what has previously been rejected through the legislative process,” says PMFAI President Pradip Dave. “On behalf of India’s domestic manufacturing sector and millions of farmers, PMFAI appeals to the Government to safeguard national agriculture and the interests of Indian Farmers by not acceding to any demand for inclusion of any provisions for Regulatory Data Protection or Data Exclusivity from the Pesticide Management Bill.”