Let’s first look at what the agrochemical sector in India has achieved since the first Insecticides Act of 1968 was framed even though there are players who have been serving the farmers of our country much before the sector was regulated. Today, India has become the fourth largest producer of agrochemicals in the world and more recently it has surpassed the USA as the second largest exporter after China. 

The agrochemicals along with other inputs has helped India’s agriculture production reach record levels. They have also helped Indian agriculture tackle many national exigencies when the very survival of our major crops like Rice, Cotton and Wheat were threatened by pests and diseases. The industry has taken its responsibility very seriously and is bringing cutting - edge technologies that have reduced the application rates to as low as 4 grams with new chemistries from 3-4 kilograms in the sixties. The sector is also embracing Artificial Intelligence and digitization seamlessly to further make breakthroughs in precision and sustainable agriculture. 

But in spite of this sector spending close to US$ 6 billion in R&D, the perception is as though chemicals are mixed by hand in shady shacks. In spite of the fact that a molecule goes through close to 11 years of research at a cost of US$ 300 million from discovery to commercialization before reaching the farmers, they are subject to arbitrary scrutiny and ban without a scientific basis. In spite of India hardly using on an average 300 grams compared to 11-13 kgs in other countries, there is unsubstantiated criticism from various quarters. 

And most importantly, whenever we talk about reforms of this sector, it is viewed from the lens of MNCs vs. domestic, imports vs. indigenous, patented vs. unpatented, chemicals vs. organic.   

So, what are the policy reforms that need to be taken to take agrochemicals to the next level? And here we need to look at this in the context of the aspiration of India to become a ‘Viksit Bharat’ by 2047. By then, India’s population is also expected to increase to around 1.7 billion from 1.4 billion at present. For feeding the population, India needs to not only increase agriculture production but also the overall productivity to ensure food and more importantly nutritional security of the nation. 

One hectare of land used to feed 2 people in 1950. The same hectare of Land would have to feed 5 people by 2050. The production of food grains has to correspondingly increase by 5 million tonnes annually. 

Climate change is already creating huge disruptions in India’s agriculture landscape. Global warming, caused by the increase in concentration of greenhouse gases (GHGs) in the atmosphere, is emerging as one of the most prominent environmental issues in India. Carbon dioxide (CO2), methane (CH4) and nitrous oxide (N2O) from major crops like Rice and others are causing disruptions. 

India has also lost 668,400 hectares of forest cover in the last 30 years, and the Food and Agriculture Organization (FAO) estimates that the rate of deforestation was 668 square kilometers per year between 2015 and 2020 mainly for agriculture. 

Nearly 147 million ha of land is subjected to soil degradation, including 94 million ha from water erosion, 23 million ha from salinity/alkalinity/acidification, 14 million ha from water-logging/flooding, 9 million ha from wind erosion and 7 million ha from a combination of factors due to different forces. 

Thus, the only way out is to continue to increase productivity per unit of input in the foreseeable future with the least environmental footprint. It will require proper management of soil, water, nutrition, seeds and agri inputs. 

The start has already been made when during Covid pandemic, this sector was identified as one of the 12 champion sectors where India can play a major role. Second and more crucially, we had for the first time nine sectoral and national industry associations coming together to discuss the reforms on the policy and regulatory front that would take the sector to new heights. There were 29 progressive agenda items that were coined 3-D (Discuss, Decide and Deliver) and a three day interaction was organized with key stakeholders from the government. Subsequently, the issues were deliberated under the Chairmanship of the Secretaries of Agriculture and Chemicals. But somewhere down the line the meetings have discontinued. There are decisions taken on certain aspects of the reform agenda, but not in a holistic manner.  The focus has to be brought back to the core reforms outlined in the 3D agenda.  

The only lens through which the issues should be viewed is through the lens of Science and Farmers. The reforms need to be viewed from the perspective of the requirements of the country. An attempt should be made to look at the gaps and a roadmap should be developed.  

However, the more I think about certain policy reforms that would take agrochemicals to the next level, the more I am reminded of the old Hindi movie song “Sau saal pehle”. Probably the new version would be “Dus saal pehle”, it was the same problems, “aaj bhi hai, aur kal bhi rahega” unless there is absolutely a new lens through which this sector is viewed! This is important as because of the dissenting notes from various stakeholders, a whole host of critical reforms are being sidelined. I will outline a few in the following paragraphs. 

The first and foremost big-ticket reform is the reduction in registration timelines for crop protection products so that the farmers are equipped with the latest technologies to combat the various challenges.  

Registration is the most critical process in the product life cycle of agrochemical products. Lengthy registration process in India has long been a bottleneck for introduction of new molecules. 

Moreover, the farmers are not able to reap the benefits of the agro chemical products sooner. There is tremendous scope of improvement with respect to policy changes, process changes and administrative capacity changes thereby reducing timelines and fostering innovative plant protection solutions for Indian farmers. The changes proposed can reduce the time to bring new molecules to the market by almost 3 years, which will be beneficial not only for agro chemical companies but also the farmers of India.  

One of the important policy and process related changes is with respect to introduction of pre-submission dossier consultation. This will minimize the gap between the submitter and the reviewing authority, providing applicants with advanced knowledge of data acceptability. This, in turn, will enable them to generate and provide the required data to the authority in the shortest possible time. 

A cut-off timeline for the completion of the first review by each division should be a maximum of 12 months. Unresolved/recurring queries after two deficiencies can be resolved through face-to-face interactions. MRL setting also takes a lot of time and can be shortened if they can be organized in parallel to registration review / grant. Another important provision that can speed up registration is a mechanism to grant exigency/provisional registration for new molecules. 

As for the Administrative capacity changes are concerned, they can be streamlined in the following lines: 

Thus, the whole process can be shortened to 30-34 months.

Another issue which has been in discussion since 2012 is Minor Changes. Crop protection products generally consist of at least one technical active substance and co-formulants. New scientific and technical knowledge, economic demands, unavailability of supply, improved performance/classification/concerns regarding certain critical co-formulants can make it necessary to change the chemical composition of products with regard to their co-formulants.  

The key objective of Minor changes is to overcome practical concern of significant and non-significant changes of the chemical composition of crop protection products for India. While there is no doubt that at present registration authority are considering minor change proposal for ongoing registration on a case by case basis, this practice is risky as approval criteria is open ended (case-by-case), and in absence of documented criteria, it is limiting Industry to come forward as  the approval is subjective.  

To bring clarity to this matter via written guidelines, a subcommittee needs to be formed with Terms of Reference and stipulated term say 2 months for delivering the guidance/criterion/ data requirement on minor change in formulations.  

The need of this regulation is becoming far more significant as to help to substitute the hazardous constituents with the safer ones and thereby helping compliance at the international level and further improve the image of the agrochemical sector of India.  

In other words, if one is to make such minor changes in the existing chemical composition, it qualifies as a new formulation and requires to be registered with the total data package all over again under the Insecticides Act 1968 and Rules 1971 at present.  

This issue has been deliberated at various registration committee meetings in the last 7-8 years without any conclusion. Provision of Minor changes in formulations will not only benefit the industry but also enhance the overall regulatory framework by imbibing this internationally recognized best practice.  

The third and the most debated issue has been the issue of Regulatory Data Protection. The data submitted by the first time registrant is given protection for a certain number of years the world over. This is given for the registrant to not only stabilize and steward the product in the market but also for recouping the massive investment he incurs in bringing the new product. This issue has been hotly debated from Satwant Committee to various other committees. The industry is divided and a closure to this issue will bring closure to the other 80percent of the issues outlined in the 3-D reform where there is consensus. 

Industry wants to bring the latest technologies to India but the other set of problems related to state licenses, sales permissions, arbitrary bans etc. need to be also streamlined. 

Looking at the road ahead we need to ensure the following to take agrochemicals to the next level: 

•  a predictable, science based policy and regulatory regime for the proper growth of the crop protection sector to make our farmers and Indian agriculture sustainable

•  forward looking progressive regulations which promotes innovation and new product introduction to address the current and future challenges of the farmers

•   encouragement to introduction of cutting edge technologies like Artificial Intelligence, Drones and digitization in service of the farmers

•   Public Private Partnership – we would like to be “Partners in Progress”   

(Views expressed by the author are personal)