India’s pesticide regulatory framework stands at an inflection point. Following public consultations on the Draft Pesticides Management Bill, 2025 (“PMB 2025”), the Ministry of Agriculture and Farmers Welfare is expected to soon introduce legislation in Parliament to replace the nearly six-decade-old Insecticides Act, 1968, and Rules, 1971.
The draft Bill brings several welcome reforms, such as stricter action against spurious products, digitised registration processes and time-bound approvals for generics. Yet, one critical question remains insufficiently addressed – how quickly will Indian farmers gain access to newer crop protection technologies and what incentives exist for innovators to introduce them in India?
This gap is not academic; rather, it has direct consequences for farm productivity, farmer incomes and India’s global competitiveness.
Indian agriculture continues to suffer annual crop losses of 10–35% due to pests and diseases, translating into economic losses exceeding ₹2 lakh crore. Climate variability is further altering pest patterns, increasing their incidence and intensity. These challenges demand faster access to newer, more effective chemistries.
Instead, Indian farmers still rely heavily on molecules introduced three to four decades ago. Overuse of such older chemistries has contributed to rising pest resistance, reducing their effectiveness.
Globally, however, newer molecules which are more targeted and effective at lower dosages are available. Their introduction in India, unfortunately, continues to lag.
Several factors contribute to this delay, including regulatory timelines, capacity constraints, etc. However, one policy lever stands out: the absence of Protection of Regulatory Data (PRD), which directly affects incentives for innovators.
The consequences of delaying a framework for Protection of Regulatory Data extend beyond domestic agriculture into global trade. Lack of PRD not only hurts farmer productivity but also reinforces India’s reliance on older molecules that face increasing regulatory scrutiny abroad. As importing nations adopt stricter residue norms, particularly the EU and UK, India risks losing competitiveness in high-value export markets for a wide gamut of our agricultural products, such as rice, tea, grapes, spices, chillies, among others.
These markets are phasing out older chemistries while lowering permissible residue limits. Recent advisories to Indian rice exporters following stricter EU norms underscore how such shifts can act as non-tariff barriers, affecting exports of key commodities such as basmati rice and tea.
At the heart of the issue lies the economics of innovation. Developing a new molecule typically requires investments of USD 301 million and takes upwards of 12 years for global introduction. Entry into India entails an additional 2–4 years and ₹40–50 crore for local studies on safety, residues, efficacy and environmental impact.
In the absence of PRD, subsequent applicants can rely on this data to secure approvals at a fraction of the original cost. This asymmetry discourages first movers and influences global companies to prioritise markets where regulatory pathways offer more predictable protection from unfair commercial use of their scientific and technical data. As a result, countries such as the United States, China, Brazil and Thailand often gain earlier access to newer chemistries, leaving Indian farmers at a disadvantage.
India is among the world’s largest agri-producers and yet it lags in access to modern chemistries. PMB 2025 is the most significant regulatory overhaul in 60 years, but the current draft PMB 2025 leans decisively toward faster generic entry—consistent with India’s emphasis on affordability and a strong domestic generics industry. However, it does not provide a limited, time-bound mechanism to support the introduction of newer technologies, even where patents may have expired.
Protection of Regulatory Data (PRD) does not confer a monopoly. It simply prevents competitors from relying on the innovator’s safety and efficacy data for a short, defined period. It encourages generic companies to generate their own data, register and enter the market as soon as the original registrants’ regulatory data protection period ends.
This is not a new debate. The Satwant Reddy Committee (2007) recommended limited protection for agrochemical regulatory data. The Committee on Doubling Farmers’ Income later also suggested a calibrated approach to data protection for new molecules. The Parliamentary Standing Committee reviewing the 2020 Bill chose not to incorporate such provisions, prioritising affordability and domestic industry interests.
These concerns are valid. Any PRD framework must be carefully designed to avoid misuse or prolonged exclusivity. However, the equally important question is whether India can afford continued delays in access to safer, more effective crop protection technologies.
Global experience offers useful insights. China’s experience shows that PRD does not impede the generics industry. Despite adopting PRD provisions years ago, China remains the world’s largest exporter of agrochemicals, demonstrating that data protection and a competitive generics ecosystem can co-exist and thrive. In fact, PRD can help refresh the pipeline of molecules that eventually become available for generic production. PRD will only expand—not shrink—domestic manufacturing over time.
Agriculture contributes 16–18% of India’s GDP and supports nearly half its workforce. Delayed access to newer technologies perpetuates reliance on older chemistries, with implications for resistance management, input efficiency and export compliance.
It is recommended that India adopts a specific implementable framework for PRD that is time-bound (5–10 years), applicable only to new molecules and with no extension beyond global norms.
As the government finalises the Bill, the real policy question is not whether to introduce broad or open-ended data protection. It is whether a limited, clearly defined framework can strike the right balance by adopting the global best policies and regulatory practices, accelerating farmer access to new technologies while preserving competition.
The answer to that question will determine how effectively Indian agriculture responds to the combined pressures of pests, climate change and global trade.
The author, Dr Gyanendra Shukla, is MD & CEO, Rallis India (a Tata enterprise), and Vice Chairman, CropLife India. Views expressed are personal.
Media courtesy: CNBC TV18
