Addressing the communication gaps within regulatory set up and balancing safety with new product requirements required to clear the logjam
India’s journey towards agricultural resilience and food security hinges on how well it supports the crop protection industry. A forward-looking, balanced, and dynamic regulatory regime will not only boost farmers' productivity but also position India as a global hub for innovative and sustainable crop protection solutions. It is time for policymakers to act decisively and unlock the true potential of this critical sector.
In this context, experts recently spoke on the topic ‘Supportive Policy, Regulatory Regime for Growth of Crop Protection’ at the first session of second edition of AgroChem Summit 2024 organized by the Indian Chemical News in New Delhi on December 13, 2024.
The session was moderated by Raju Kapoor, Director - Public & Industry Affairs, FMC India. Kapoor outlined the tremendous opportunities as well as challenges. “India could become an integral part of the global value chain. We have a tremendous scientific pool and we are a country which is moving from a trading mindset into an innovation mindset. Our Prime Minister is leading it himself by saying Jay, Vigyan Jay Anusandhan which is very critical. There are a lot of opportunities and the challenges in terms of climate change, biotic & abiotic stress besides the fact that India is operating at 50% of can achieve productivity. For a country with a significant population of small-holding farmers, the crops worth Rs 2 lakh crore are destroyed by pests every year. Therefore, the agriculture sector should be a priority as it is a champion sector.”
Dr. Archana Sinha, Joint Director & Secretary, Central Insecticides Board and Registration Committee, Govt. of India said, “Industry and regulatory bodies have to work in partnership. To realize the goals, the registration committee has finalized the definition of new molecules and it was important to address the problems faced by the farmers. A priority has been created for such new molecules and if the nation feels that there is exigency for a new molecule in a short time, it is being addressed properly.
“The regulatory team has been trying hard to streamline the regulations, address the challenges, and resolve the issues that industry has been facing. Whether it is introducing some new molecules, or trying to bring some new technologies to the country, we are trying our best to take it forward smoothly.
“We are also addressing different Maximum Residue Limit (MRL) problems. The crop grouping report has been deliberated and adopted by the registration committee to address the off label detection of pesticides in some minor crops which has not been found viable by the industry. If we work on some label, expansion or extension is already available, pesticides with some vibrating data gaps. We can also regularly part also so that if a farmer is feeling comfortable and finds good results by using the pesticide, which are already there but not yet approved by the registration committee.
“We would definitely like to invite industry to come forward and adopt some molecules. We are also trying to rationalize the guidelines which are always dynamic in nature with the advent of new molecules and technologies."
S. Ganesan, Vice President – Policy Affairs, UPL Limited said, “After the introduction of online registrations, the number of registrations is about 200 plus. In the first 40 years of the Insecticides Act, we managed to have. Right now we have 300 plus and it is good to see that CIB&RC has achieved it without any additional manpower. There is a perception that new molecules are not entering India. The empirical evidence suggests otherwise. The new molecules entered the country, as per the Ministry’s response in the Parliament during August 2023, said 800 formulations registered with 110 patents.
“India is the only country with a blend of old and new molecules. Comparatively, the EU is often taken as a role model which it is not. In the EU, per hectare use of pesticides way back in 1993 was 2.7 kg and now it is 2.9 kg. So the use per hectare of pesticides in the EU has gone up contrary to popular opinion. In spite of predominant low molecule pesticide. We need the low molecule pesticide along with conventional ones.
“Our farmers use 6,000 tonnes of active ingredients with 567 billion output whereas EU farmers use 3, 21,000 tonnes to give just 300 billion output. Going by this, Indian farmers are the most efficient and the credit goes to the ministry for maintaining the mixed use of traditional and latest molecules. There has to be a healthy combination of so-called new molecules and conventional known and trusted compounds.
“We have to find the low hanging fruits which in my opinion lie under the Patent Act, especially the Section 83 of the Act that is to be introduced. Between 2010 and now, the government has granted the patent to 62 molecules. If introduced on top priority, 36 new molecules will reach the Indian farmers. This requires immediate attention.”
Suresh P. J., Regulatory Policy & Scientific Engagement, Bayer CropScience Limited said, “In terms of data protection, the generation of data depends on the local conditions based on pesticides, human consumption etc. There are strict guidelines which are given and one has to follow them. However, there is a time elapse and cost involved for registration testing, market requirement, farmer’s training and other things otherwise the life cycle of the product is closed. The safety data, especially the bio-efficacy, is based on local conditions.
“We need to have this data generated locally and that's why the government has such a robust system. In terms of regulatory process, it is good that the government started the 3D reforms process. Despite the appreciable efforts of the Agriculture Ministry in streamlining the process, I am not still able to finally get the product launched due to pending approvals from the Health Ministry and FSSAI. There is a gap in understanding between stakeholders and thus it often prevents the launch of the new product.
“Therefore, the governance issue requires intervention at the highest level and there is a need for balancing the safety requirements and need for new molecules. For example, there are many new biological molecules available for use and many countries are taking advantage. Yet we are unable to adopt due to the stringent biodiversity law that says if there is no established safety profile in India, you cannot introduce it because it may lead to bio terrorism. This is despite the fact that these bio based materials are already tested globally.
“On one side we want good safe products but other side we are not allowing the latest biological products with better safety profiles to enter the country. Despite having established regulations, there is still a logjam over the introduction of new products."
AgroChem Summit 2024 themed ‘Capturing Value Through Collaboration, Innovation & Disruption’ was supported by the industry associations including ACFI, BASAI, Croplife India, CCFI and PMFAI. The Gold Partners of the event were Corteva Agriscience and Godrej Agrovet. The Associate Partner was Bayer Limited
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