AgroChem Summit 2023: Treat new agrochemical molecule registration at par with pharma, demands industry

AgroChem Summit 2023: Treat new agrochemical molecule registration at par with pharma, demands industry

First session focused on the ease of doing business; enhancing agrochemicals production capacity; simplifying registration process, adopting global best practices; and developing new formulations and molecules

  • By Rahul Koul | March 01, 2023

The first session of AgroChem Summit 2023 titled, ‘Enabling Regulatory Ecosystem for the Growth of Agrochemical Industries’ organized by the Indian Chemical News (ICN) on February 24, 2023 in New Delhi, focused on removing existing bottlenecks within the regulatory ecosystem and improvising the registration process of new chemical molecules. The industry captains discussed the ease of doing business, enhancing agrochemicals production capacity, simplifying registration process, adopting global best practices, and developing new formulations and molecules.

The inaugural edition of the AgroChem Summit 2023 themed as “Making India A Manufacturing Hub” brought together all stakeholders of the agrochemicals sector under one platform to brainstorm on the growth opportunities, safe and judicious use of agrochemicals by farmers, and current issues to draw a roadmap for the future direction of the Indian agrochemicals sector. 

 In his remarks, Dr Samir P. Dave, Secretary, Pesticides Manufacturers & Formulators Association of India listed a couple of issues faced by the industry that require immediate attention.

 “The environment approvals such Environmental Impact Assessment (EIA) which is needed for every unit is a big challenge. As a solution we can have a common set of EIA for all the units collectively rather than going for each of them. Another issue is getting the environmental clearances for old units which is time consuming. It reduces the pesticides productivity as there are so many such units which are not adding any new products and, therefore, don’t require fresh clearances. They don’t get the benefit of product remix regulations. We have taken it up strongly through the Indian Chemical Council. We need to relax the guidelines for submission of data for 40-year old molecules where the information might not be available in Indian context but in global context. Currently we are associated with CSIR for developing non-infringing technologies from off patent generics. The fast-track registration process would help and cooperation is expected from CIB-RC. We need support from the industry bodies to take up all these issues with concerned authorities,” Dr Dave explained.

“It is important to issue guidelines to state governments that they cannot provide the land without proper infrastructure and expect the industry to develop it. The environment department is not taking the pragmatic steps. When the process is same for the pharma and related industries, why different treatment to agrochemicals which is kept in the red category. Green zone is given to certain segments and cleared within three months. Most of the data is copy pasted and might be unnecessary in most of the cases. Also, making the sudden unintentional accidents happening at factories as criminal acts is unfortunate. Penalizing the companies is one option but labeling people criminal is not encouraging. At the same time, it is good to see that the government is seeking inputs from the industry associations. A lot can happen in Indian agriculture if we remove the unnecessary regulations. CIB must help the industry and educate the global regulatory bodies on the quality of Indian agriculture products. It will be helpful in gaining trust globally. Challenges will be there but we have to tackle them together,” said Natubhai Meghjibhai Patel, Managing Director, Meghmani Organics.

“I feel that there is no China plus one strategy today. The concept was developed five years back by multi-national purchasers because there was inconsistent supply by China and they put India as an alternative. However, India has shown that it is here to stay. The kind of phenomenal work which Indian manufacturers did during the Covid-19 ensured that there was no shortage globally. Hence we were contributing to food security globally. Indian companies are now investing into improving quality and meeting global regulatory standards. The generics which are being manufactured here are now exported to Asia Pacific. Earlier these were imported into India and supplied to other nations in the region. In terms of IP rights, India is fully knowledgeable. The American and Japanese multinationals have higher faith in Indian companies than Chinese ones. 70% of new chemistries are coming to India as compared to 30% to China. A lot of contract manufacturing projects are happening here,” said Abhishek Aggarwal, President & COO, Bharat Rasayan & BR Agrotech.

“The 3D policy of the government i.e discuss, decide and deliver resulted in the relaxation in guidelines and few critical policy changes. This relaxation of guidelines happened by CIB & RC and rationalization of the policy for seed treatment, household pesticides, herbicides having surfactants etc. They have allowed waiver of bio efficacy data once there is five batch data. There are many other hurdles that are being removed. There was blanket permission for use of drones for any pesticides and gave us SOP for generating data for use of fungicides. The guidelines have been improved with inputs from associations and are expected to get implemented soon. The biggest improvement they have done in terms of online submission for registration and also track the status. There is still a need for improvements such as fast- tracking the registration of new molecules,” said Vijay Jha, DGM - Regulatory Affairs, Rallis India.

“We require moderate laws and strict regulations. The demand for banning small operators is not prudent. Instead there should be strict compliance for giving the registrations. Competition is necessary for quality and innovation and there shouldn’t be the monopoly of a few.  In terms of hurdles, it takes years to get the consent from the local government to operate and that too without any discrepancy nor the need for any additional paper. It is astonishing that our file with no changes required was kept on hold and investment worth Rs 30 crore lying idle for a year. We request the government to remove such hurdles. Another example is how specific sodium was being manufactured in India and technically was being exported to Japan and formulated there and then imported back into India. The product was earlier sold at Rs 6000 a litre to farmers but is now being sold at Rs 1200, a five times reduction in price. We need course correction,” said S. K. Chaudhary, Founder & Director, Safex Group.

Reacting to the various industry demands, Dr Brijesh Tripathi, Deputy Director – Chemistry, CIB& RC, Ministry of Agriculture & Farmers Welfare said: “We will try to have a facilitative regime for fuel crops. We have made a report and justified that agrochemicals are equal to pharmaceuticals but currently it is under observations. The pesticides bill that was introduced in Rajya Sabha on March 21, 2020 and was later on referred to the Select Committee. Their comments have been received by the department and we have submitted our views that will be presented on the floor of the house. There is a mention of increasing the testing infrastructure and inclusion of private GLP certified labs as the testing labs. In Central Insecticide Laboratory too, the private certified labs could be involved as well for testing. The provisions are there and hopefully will be approved. On the criminalization of misuse part, I must clarify that the strong measures are for wrongdoers who bring a bad name to the industry. The law is not anti-industry but only the implementation part has to be ensured properly besides adoption of global standards.”

Pravin Prashant, Editor, Indian Chemical News who moderated the panel discussion pointed out the need for extending deep sea discharge relaxation for petrochemicals also to the agrochemical industry. He hoped that the industry would benefit from the deliberations at the Summit.

The Summit was supported by Platinum Partner - UPL; Gold Partners - Godrej Agrovet, BASF, FMC, Dassault Systemes Solize, Carbanio, and Auxilife (a unit of GPC); and Associate Partner - Resistotech and Super Scientific Works. The event is supported by Industry Association Partners - PMFAI (Pesticides Manufacturers & Formulators Association of India), Croplife India, ACFI (Agro Chem Federation of India), and CCFI (Crop Care Federation of India).

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