One of the most discussed but still unresolved issues in the crop protection sector is the need for Regulatory Data Protection (RDP) for first-time registrants of agrochemical molecules in India.
What is RDP and why is it Important for agrochemicals?
Regulatory Data Protection (RDP) ensures that data submitted by the first registrant of a crop protection product is safeguarded from unfair commercial use. This data includes detailed studies on safety, bio-efficacy, toxicology, packaging, shelf life, and transportation, which are required to prove the safety and efficacy of the molecule. The process can involve up to 5,000 pages of regulatory data.
The cost of discovering a new molecule now exceeds $300-350 million (₹2,400-2,800 crore), often spread over 11 years, and only a few molecules make it to commercialisation due to the high costs involved. This financial burden is a primary reason that the Trade-Related Aspects of Intellectual Property Rights (TRIPS), under the General Agreement on Tariffs and Trade (GATT), mandates that such regulatory data be treated as a trade secret under Article 39.3, which reads, “…the submission of enclosed test or other data, the origination of which involves a considerable effort shall protect such data against unfair commercial use…”
For India, the cost to register a new molecule — whether patented or not — can reach around ₹40-50 crore, covering the various tests required for registration. Once a molecule is registered, additional costs are incurred for product extension, stewardship, and sales and marketing. However, “me-too” registrations, which are based on the original data, can be granted at a fraction of this cost—around ₹20 lakh.
Why is RDP critical?
Without RDP, the first registrant bears the full cost of research, development, and registration, while competitors can submit their own registration based on the same data, significantly reducing their investment. This creates an unfair situation, where the first registrant is unable to recoup their investment.
RDP also encourages the introduction of new molecules. While India has registered only about 300 out of 1,250 agrochemical molecules globally, 40 per cent of these have been in use for over 50 years. If India aspires to be a hub for agrochemical innovation, it must create an environment that protects the interests of innovators and supports the introduction of new technologies.
The misconception about patent expiry
Some argue that since patented products have enjoyed exclusivity for 20 years, RDP is unnecessary. However, RDP serves a different purpose. A patent provides protection for the invention of the molecule itself, while RDP protects the data submitted for its registration. Even patented products cannot be registered in India without submitting comprehensive regulatory data. The long development process — sometimes extending beyond the 20 years of patent protection—means that RDP is essential for ensuring that the innovator has the opportunity to recover their investment.
Industry opposition to RDP
Opponents of RDP, mostly from within the industry, argue that it would lead to higher prices for farmers. However, this argument fails to consider the broader impact. RDP does not prevent the registration of generics; it only protects the original data submitted for registration. In fact, countries with RDP policies have seen increased competition in the market, ultimately benefiting farmers by providing access to a wider range of products.
Moreover, once a product is registered and commercialised, it often leads to local manufacturing and export opportunities. Denying RDP would hinder the potential for local production of new molecules and limit export opportunities, especially in light of the current geopolitical situation, which favors “China Plus One” strategies.
Government committee recommendations
In light of the ongoing debate, the Indian government appointed a committee led by Ms. Satwant Reddy, then Secretary of Chemicals, to thoroughly examine the issue. After consultations with experts and industry representatives, the committee recommended a 3-year RDP period, which was agreed upon by the industry. This recommendation was incorporated into the Pesticide Management Bill, 2008, which later proposed a 5-year RDP period.
The way forward
To make agriculture more resilient and sustainable, India must ensure the steady introduction of newer, safer products. RDP provides the necessary environment for innovation, offering protection to those who invest significant resources into developing new molecules. Without it, India risks falling behind in the global agrochemical market and loses out on opportunities for domestic production and exports.
Given the long development timelines and high costs, many countries like the Philippines, Indonesia, Brazil, Chile, the US, Japan, and even China, have recognised the importance of RDP, with protection periods ranging from 5 to 7 years or longer foster innovation. India needs to follow suit if it wants to become a base for agrochemical breakthroughs and remain competitive in the global market.
In conclusion, the issue of RDP should be resolved to encourage innovation, improve market competition, and ensure that farmers have access to the best and safest crop protection products. It is crucial that India creates a policy environment that incentivises the development and introduction of new agrochemical technologies.
(Salil Singhal is Chairman Emeritus, PI Industries, and Dr. K C Ravi is Chief Executive Officer, Syngenta India Pvt. Limited. Views expressed are personal)
