The Crop Care Federation of India (CCFI), an association of Indian agrochemical companies, has urged the government not to accept demands for data protection for agrochemical molecules beyond the 20-year patent period. It said such a move could delay the entry of generic products, increase costs for farmers, weaken domestic manufacturing and erode India's export competitiveness.
Speaking to the media, CCFI Chairman Deepak Shah and Vice-Chairman Rajesh Aggarwal said some ‘fellow industrialists’ were seeking additional data protection for molecules whose patents have expired but which have not yet been introduced in India.
According to CCFI, the proposal involves five years of data protection for such molecules, followed by two years for data generation and another two years for regulatory registration. This could mean that some molecules would effectively become available in India nearly 30 years after their original patent issuance.
If another five-year data protection period is subsequently granted, CCFI said, the effective exclusivity period could extend to 35-36 years. Indian companies would then be able to apply for registration only after this period, followed by up to three years for registration. The resulting timeline could approach or exceed the typical 37-40 year commercial lifecycle of an agrochemical molecule.
CCFI argued that such a system would leave Indian manufacturers with little time to commercially exploit generic molecules after obtaining registration. It said this could undermine the competitiveness of India's domestic agrochemical industry and put at risk manufacturing infrastructure estimated at around Rs 45,000 crore.
The federation questioned the rationale for seeking additional protection for molecules that multinational companies have not introduced in India during their patent period.
“When companies invent new molecules they generate data for the whole world, then why do they not register molecules when it is under patent,” CCFI officials asked. They said several patented molecules are currently not registered in India.
Referring to the experience of the earlier data-exclusivity regime, CCFI said that during the 2007 process for registration of technical products, companies did not provide high-purity technical samples and shelf-life data required for registration.
CCFI claimed that since 2010, around six out of every 10 patents granted to Western multinational companies for new pesticide molecules have not resulted in commercial introduction in India. The federation questioned the need to create another layer of exclusivity for molecules that were not made available to Indian farmers during their patent period.
CCFI also sought to put claims about India's limited number of registered agrochemical molecules in perspective. While some industry stakeholders cite around 392 registered molecules in India, CCFI said more than 1,000 molecules are registered globally, while countries such as Brazil have fewer than 300 registered molecules. CCFI Chairman said that the number of molecules registered in India may rise up to 415 in a year or so.
The federation further argued that India, being a major agrochemical manufacturer and the world's third-largest exporter of pesticides, should not become dependent on imported finished formulations.
Imports and domestic manufacturing
CCFI cited industry data to argue that the earlier period of data exclusivity was associated with a sharp rise in agrochemical imports. According to the federation, imports increased 547% during 2007-17, while they grew by only 17% during 2017-24 after the exclusivity period ended.
CCFI said the latter period also saw stronger domestic production and manufacturing capacity, suggesting that the absence of data exclusivity did not prevent India's agrochemical industry from expanding.
The federation also pointed to recent registrations of new pesticide molecules. It said 36 new molecules were registered in India during the past two years, describing this as a record and noting that the number was higher than registrations in several countries that provide data exclusivity, including Malaysia, Brazil and Thailand.
India is currently the world's third-largest agrochemical exporter, according to CCFI, with exports reaching more than 160 countries. The federation also said generic products account for around 90% of the global agrochemical market and that all of the world's 10 top-selling agrochemicals are generics.
Parliamentary panel's concerns
CCFI also cited the findings of parliamentary committees to support its opposition to additional data protection. It referred to the 38th Standing Committee on Chemicals and Fertilizers, which in 2021 questioned whether extending protection beyond the 20-year patent monopoly was appropriate.
According to CCFI, the committee had observed that the existing 20-year patent period was itself a substantial monopoly and that extending protection could encourage the continued use of obsolete technologies.
The federation argued that additional data protection could create further market monopolies and eventually increase agrochemical prices, with direct implications for Indian farmers.