India Must Resist EU, US Pressure on Data Exclusivity in Farm-Chemicals

India is facing increasing pressure from the European Union, the United States and other developed economies to accept stronger intellectual property rules in ongoing trade negotiations, particularly provisions relating to “data exclusivity” for pharmaceuticals and agrochemicals.

While concerns over data exclusivity in pharmaceuticals are widely discussed, its implications for India’s agrochemical industry have received far less attention. Yet the sector is strategically important for India’s exports, manufacturing ecosystem and agricultural economy. 

India has emerged as a major global supplier of affordable pesticides, herbicides and crop-protection chemicals, generating a trade surplus of nearly $14 billion over the past five years. Stricter exclusivity rules could weaken export competitiveness, increase import dependence and raise costs for millions of farmers.

Data exclusivity refers to rules that prevent regulators from relying on safety and field-trial data submitted by an innovator company to approve generic versions of the same product for a fixed period, usually five to 10 years. In practice, this creates an additional monopoly beyond patents. Even if a patent has expired — or does not exist — generic manufacturers may still be unable to enter the market unless they conduct fresh and expensive studies.

The European Union and the United States have been pushing India to adopt such “TRIPS-plus” obligations through free trade agreements. Indian negotiators have historically resisted these demands, arguing that such rules mainly benefit multinational corporations while weakening domestic generic industries.

The issue has become particularly important because India is currently negotiating multiple trade agreements where developed countries are seeking stronger intellectual property commitments extending beyond WTO obligations. Industry groups fear that data exclusivity clauses may also find their way into domestic legislation through the proposed Pesticide Management Bill, for which comments on the draft notification were invited until February 4, 2026. Industry representatives claim multinational corporations are lobbying for explicit exclusivity clauses in the legislation.

The 36th Standing Parliamentary Committee on Agriculture, Animal Husbandry and Food Processing observed in December 2021 that India’s large agrochemical market and vast arable land were sufficient to attract new molecules even without data protection provisions.

Why Data Exclusivity is Outside TRIPS Rules
India’s opposition to data exclusivity dates back to the WTO TRIPS negotiations between 1986 and 1994, when India and several developing countries opposed attempts by the United States and European Community to make such protections mandatory.

Legal experts point to Article 39.3 of the WTO TRIPS Agreement, which requires governments to protect undisclosed test data from unfair commercial use or disclosure. However, the provision does not require countries to grant exclusive rights over the data or prevent regulators from relying on existing data to approve equivalent products.

This means WTO rules do not obligate India to provide data exclusivity. Accepting such provisions through free trade agreements would therefore amount to India voluntarily taking on obligations beyond TRIPS commitments — commonly referred to as “TRIPS-plus” obligations.

India’s generic manufacturing success in medicines, vaccines, biosimilars and agrochemicals has been built partly on preserving this policy flexibility under WTO rules. Accepting TRIPS-plus obligations could fundamentally alter the balance between innovation, affordability and industrial competitiveness.

State of India’s Agrochemical Industry
India’s agrochemical industry has become one of the country’s globally competitive manufacturing sectors. India is now the world’s third-largest exporter of agrochemicals. Exports increased from about $1.7 billion in 2012-13 to $4.4 billion in 2024-25 — a growth of 159%. Indian agrochemicals are exported to more than 150 countries and support thousands of manufacturing jobs, MSMEs, formulation units and rural supply chains.

The industry’s strength is built largely on generic manufacturing. Nearly 90% of the global agrochemical market consists of generic products, and most leading crop-protection chemicals are now off-patent. India has become globally competitive because it can manufacture affordable generic versions at scale.

India’s market size itself acts as a strong incentive for innovation and introduction of new products. India’s Central Insecticides Board and Registration Committee approved 84 new chemical pesticide registrations between January and April 2026 alone, among the highest levels globally. India also registered 36 new pesticide molecules over the previous two years, reportedly more than countries such as Brazil, Malaysia and Thailand, which already provide data exclusivity.

However, concerns remain regarding “non-working” patents held by multinational corporations. Since 2010, six out of every 10 patents granted to Western multinational corporations for new pesticide molecules were reportedly never commercially launched in India despite being introduced abroad. This conflicts with the spirit of Section 83 of India’s Patents Act, which states that patents should be commercially worked in India rather than used to maintain import monopolies.

How Data Exclusivity Could Hurt India’s Interests
If India accepts exclusivity provisions in FTAs, regulators would be restricted from relying on existing field-trial and toxicity data while approving generic herbicides, fungicides and insecticides. Generic manufacturers would either have to wait years for exclusivity periods to end or undertake costly fresh studies, increasing production costs and delaying competition.

This could significantly damage India’s export competitiveness in generic agrochemicals and increase dependence on imports from multinational corporations. It could also raise prices for Indian farmers by delaying the availability of affordable alternatives.

India’s earlier experience with a “de facto” exclusivity regime between 2007 and 2017 is often cited as evidence of these risks. During this period, executive orders issued by the Agriculture Ministry effectively restricted generic approvals for certain agrochemicals. Agrochemical imports reportedly surged by 547%, while India increasingly became a market for older imported pesticides.

Some products banned elsewhere reportedly entered the Indian market during this period, while imported molecules were repackaged and sold at high prices. One frequently cited example is Halosulfuron Methyl 75%, a 25-year-old herbicide imported at around ₹12,000 per kilogram and sold in India at over ₹40,000 per kilogram.

After these restrictions were removed, import growth slowed and domestic production improved. According to GTRI, this demonstrated that exclusivity encouraged imports and monopoly pricing rather than innovation.

Granting data exclusivity on top of existing patents could effectively create a second monopoly layer without corresponding domestic manufacturing or technology transfer.

Wider Industrial Policy and Strategic Concerns
The debate over data exclusivity goes far beyond intellectual property protection. It is fundamentally an industrial policy issue tied to India’s manufacturing strategy, agricultural affordability and trade competitiveness.

India’s success in generic medicines, vaccines, biosimilars and agrochemicals has been built on balancing innovation with affordable access and domestic manufacturing. Accepting TRIPS-plus obligations through FTAs could undermine initiatives such as “Make in India” and “Aatmanirbhar Bharat”, both of which aim to strengthen domestic manufacturing and reduce import dependence.

Western agrochemical companies argue that stronger data protection is necessary to encourage innovation and faster launch of new molecules in India. However, India’s large agricultural market already provides substantial commercial incentives for launching new products, as reflected in the large number of recent registrations.

For India, the final outcome of these negotiations may shape not only future trade agreements, but also the long-term balance between innovation, affordability, farmer welfare and industrial competitiveness in one of the world’s largest agricultural economies.