Leading Crop Protection Companies Seek Five-Year Data Protection Framework for New Molecules

Five leading Indian crop protection companies have jointly urged the government to introduce a time-bound framework for Protection of Regulatory Data (PRD) under the proposed Pesticides Management Bill, 2025, arguing that the measure would encourage companies to introduce newer, safer and lower-dose crop protection molecules in India.

Crystal Crop Protection, Rallis India, Dhanuka Agritech, PI Industries and Godrej Agrovet, all members of CropLife India, have proposed a five-year period of regulatory data protection from the first registration of a new molecule or a new use.

The companies said the absence of such protection discourages investment in the registration of new crop protection products, which require years of local studies and significant expenditure before they can be introduced in the Indian market.

According to the companies, bringing a new molecule to India requires an investment of around Rs. 40 crore to Rs. 50 crore and six to eight years of local safety, efficacy and residue studies. However, they argued that subsequent applicants can rely on the regulatory data generated by the original applicant at a much lower cost, estimated at around Rs. 75 lakh.

They said a limited period of data protection would provide an incentive for companies to undertake the investment required to introduce new molecules, while ensuring that the products become available to generic manufacturers and small and medium enterprises once the protection period expires.

Call for Wider Access to Newer Chemistry

The industry group said Indian farmers need access to a wider range of modern crop protection solutions as changing climatic conditions alter pest, weed and disease patterns and resistance to existing products increases.

They argued that newer molecules are generally more targeted, can be applied at lower doses and may offer improved safety profiles compared with older chemistry.

India currently has around 380 registered crop protection molecules, compared with an estimated 1,200 molecules used globally, according to the companies.

Expanding the domestic portfolio, they said, could help improve agricultural productivity while also supporting India's agrochemical manufacturing sector and agricultural exports, particularly as overseas markets tighten residue standards.

India is estimated to lose between 10% and 35% of agricultural output annually to pests, weeds and diseases, with the losses estimated at around Rs. 2 lakh crore, according to the CropLife India-YES BANK Knowledge Report cited in the press release.

Companies Say Generics and SMEs Would Also Benefit

The companies rejected concerns that regulatory data protection would restrict competition, saying the proposed framework would apply only to newly introduced molecules and new uses.

Once the five-year protection period ends, the molecule would become available to generic manufacturers and small and medium enterprises, expanding the range of products they could manufacture and export.

“Evolving pest pressures demand modern crop protection solutions, yet farmers continue to have limited access to the latest innovations,” said Ankur Aggarwal, Chairman of CropLife India and Executive Chairman and Managing Director of Crystal Crop Protection. “A time-bound data protection window brings them newer and safer tools sooner, and every molecule it brings in early belongs to the whole industry once the window closes,” he said.

Dr Gyanendra Shukla, Vice Chairman of CropLife India and Managing Director and CEO of Rallis India, said countries competing with India in the agrochemical export market had already adopted data protection frameworks. “The exporting countries we compete with adopted data protection and grew stronger for it. For India, a modern portfolio keeps our farmers protected and our exports competitive,” he said.

Rahul Dhanuka, Managing Director of Dhanuka Agritech, said rising resistance among pests was increasing the need for newer and lower-dose crop protection solutions.

Global Competitors Provide Data Protection

The companies pointed out that several major agrochemical markets already provide regulatory data protection for new products.

According to the industry group, China provides six years of data protection, while countries including Thailand, Brazil and the United States provide protection for up to 10 years. The European Union provides 10 years of protection, with longer periods available for certain low-risk and biological products.

India currently does not provide a dedicated regulatory data protection period for new crop protection molecules.

The companies also argued that a more balanced registration system could help discourage excessive duplication of registrations and support investment in product quality, stewardship and resistance management. They said the requirement for locally generated safety, efficacy and residue data could also generate more work for Indian laboratories and field research stations.