India CIBRC 427th meeting: Novel AIs entry into Indian agrochemical market is accelerating

The 427th Meeting of the Registration Committee (RC) was held under the Chairmanship of Dr. S. K. Malhotra, Agriculture Commissioner & Chairman, Registration Committee on 25.03.2021 at 10:00 Hrs onwards through NIC video conference.

At the meeting, 12 registration of pesticide technical and 27 formulation products, including 7 herbicides, 7 insecticides/acaricides, 5 fungicides, 1 plant growth regulator and 19 bio-products got approved.

As to the holders, Bayer CropScience got the most 3 registrations, Gujarat Life Sciences，Ichiban Crop Science, Indogulf Cropsciences, M.D. Biocoals and Parijat Industries India got 2. As to the products, Verticillium chlamydosporium 1.0% WP got the most 5 registrations, for indigenous manufacture under section 9(3b).

In view of the recent registrations at CIBRC in India, it reveals that multinational companies (BASF India, ADAMA India, Dow Agrosciences India, Sumitomo Chemical India, FMC India and Syngenta India) have been keen on registrations in Indian. The registrations have involved more and more novel active ingredients, this phenomenon deserves continued attention.

There are four new products being worthy of note: Pyroxasulfone 85% WG, Benzpyrimoxan 93.7% TC, Tetraniliprole 89% TC and Tetraniliprole 18.18% SC, which are respectively analyzed and briefed as follows.

Nihon Nohyaku planning to manufacture brand-new insecticide Benzpyrimoxan 93.7% TC in India

At the 427th meeting of CIBRC, benzpyrimoxan 93.7% TC of Nichino Chemical India was granted registration. Moreover, the company is planning to launch to Japan in May 2021 its Orchestra®flowable and Orchestra®dust formulation, which will be also released to India in 2023. In addition, the company is considering more registrations to be filed for in Southeast Asian countries followed by global promotions using its Orchestra® product line as one of the prime rice field solutions. The company predicts that within 5 years after launch of the above two novel insecticides, the annual peak sales in Japan will reach 1 billion yen and 6 billion yen in India, totaling to roughly 7 billion yen.

Nihon Nohyaku filed for registrations of 2 novel active ingredients-based innovative insecticides Orchestra®flowable and Orchestra®dust formulation in Japan and India. The registration was granted in Japan on September 14th, 2020, which is the first-time registration of benzpyrimoxan in the world. Both products are used to control rice planthopper and leafhopper. Benzpyrimoxan is of novel action mode, being highly insecticidal against those pests which are becoming less sensitive to the existing insecticides. The product is free of cross resistance to existing insecticides, this can be used for resistance management and control of harmful organisms. Nihon Nohyaku is currently developing mixtures of benzpyrimoxan with a variety of insecticides and fungicides. 

Nihon Nohyaku always attaches importance to product research and development. The company spends 10% of its sales on R & D activities, having formulated the goal of “creating at least 1 active ingredient every three years.” Through the launch of new products, the company's business performance is greatly increased, which enables achievement of the objective of annual sales of 100 billion yen. Nihon Nohyaku takes Indian market as one of its most important markets, where direct distributions and production bases have both been set up by the company. In the future, Nihon Nohyaku is prepared to continue strengthening of market development and product development in India so as to consolidate its business operations in India. In the meantime, Nichino Chemical India’s positioning as an overseas production base in relation to patented active ingredients will be reinforced to the benefit of further expansion of overseas business operations of the company.

For many years, the agricultural market of India has been well known as a market to provide high-quality generic products to different part of the world. With Japanese manufacturer’s acquisition of Indian enterprises, the technical strength of Indian enterprises has been enhanced, which play a more and more important role in the global supply chain. In light of the match of demand between Japanese agrochemical enterprises and Indian companies, similar deals are expected to continue in the next few years, and the scope of cooperation may be deepened and ways of cooperation may be more diversified.

Read more information about Japanese companies’ penetration into Indian agrochemical market here:

Indian Market Penetration from “Hidden Champions” -- Japanese Companies: Specializing in Small-scale, High-yielding Cooperation, Looking to Capitalize on Industry Reshuffle

Bayer’s Pyroxasulfone 85% WG granted import registration in India 

At the 427th meeting of CIBRC, Bayer was granted Pyroxasulfone registration in India, which is a registration for import only from Kumiai Chemical.  

Pyroxasulfone (CAS No.447399-55-5) is a novel broad-spectrum and high-active pre-emergence soil treatment herbicide developed by Kumiai Chemical, being an isoxazole herbicide used for pre-emergence sealing treatment. It is primarily used to control gramineae weeds while being also used for control of broad leaves. Pyroxasulfone is safely applicable to a wide range of crops, including corn, cotton, peanut, wheat and sunflower for effective control of gramineae weeds such as green bristlegrass, crab grass and barnyard grass, as well as for control of broad-leaved weeds such as amaranthus, datura, solanum and abutilon. Pyroxasulfone has a lot of superiorities, such as broad spectrum, high activity, low dose and high safety.

Pyroxasulfone’s activity is much higher than chloroacetamide herbicides such as acetochlor and metolachlor, being a potential product to replace acetochlor and metolachlor. In 2016, the global sales of pyroxasulfone was $135million. Its compound annual growth rate from 2011 to 2016 was 166.7%. At present, acetochlor and metolachlor are banned in the EU. In this circumstance, pyroxasulfone may gradually replace the widely-used chloroacetamide herbicides such as acetochlor and metolachlor.

Since the research and development of pyroxasulfone, it has attracted high-degree attentions and is highly regarded among the industry. Kumiai Chemical and lharamic have entered into an agreement with BASF for authorization of the sales for application to crops such as corn, soybean and sunflower in the United States and Canada. In order to further promote the product, Kumiai Chemical has executed agreements with more companies which include FMC, Valet and Bayer. Hence, pyroxasulfone is granted registration in Australia, the United States and Canada covering single agent and mixture products.

Bayer CropScience got new diamide approval – Tetraniliprole 89% TC and 18.18% SC

At the 427th meeting of CIBRC, Bayer’s tetraniliprole (89% TC and 18.18% SC) were both granted registrations, which means an official market release in India. 

Tetraniliprole (CAS No.1229654-66-3) is developed by Bayer and is a patented product of the company, having been granted registration. Tetraniliprole is an anthranilamide (bisamide) insecticide and a newly listed product in IRAC Group 28. 

Compared with commercialized insecticides, the unique structure of the insecticide lies on the trifluoromethyl-containing tetrazolyl introduced into pyrazole 3-site. Its unique chemical structure enables higher effect of control of lepidoptera than chlorantraniliprole, cyantraniliprole and broflanilide. It is used for control of lepidoptera, coleoptera and diptera pests while being also effective on control of spodoptera frugiperda. It is applicable to corn, fruit tree, vegetable, rice, potato and nut tree. It can be also used for leaf surface treatment, soil treatment and seed treatment.

Tetraniliprole is foreseen to replace flubendiamide, and will become a most important bisamide insecticide in Bayer’s pesticide product range. In the years ahead, Bayer will continue its effort on registration and promotion in major countries for application to more than 50 crops covering field crops (rice, corn, soybean, cotton), vegetables (cabbage, solanaceae, bulbs, stem vegetables), fruit trees (nuts, stone fruits, citrus, grapes) for control of more than 40 kinds of targeted pests, which is designated to form a high- efficient, long-lasting and easy-to-use solution to be provided to growers.

So far, tetraniliprole has been granted registration in Canada, Australia, New Zealand, South Korea, Cambodia and Zimbabwe, and will soon be registered in the United States. With the expansion of market, the annual peak sales are expected to reach $350million.

More details are as follows:

Above-mentioned registrations can be taken under two broad categories of registration viz.

• 9(4) Me-too Registration: This is for product and source, which are already registered in India. 9(4) is the easiest method of registration and if all the documents submitted with CIB are in proper order, then registration is issued within 6 months of making the application.

• 9(3) New Registration: This registration is for products or sources, which are not registered in India yet. Any first time registration of a molecule or of a source will be under this category. New registrations can be of:

o 9(3) – TI New Molecule: Technical import registration for a new Molecule, which is never registered in India for Import.

o 9(3) – TI New Source: Technical import registration for technical already registered in India for Import, but a new overseas manufacturer also wants to register itself as an authorized source for exporting the molecule to India.

o 9(3) – FI New molecule: Formulations, which are to be directly imported to India, in finished form.

•  TIM – Technical Indigenous Manufacturing

•  TI – Technical Import

•  FIM – Formulation Indigenous Manufacturing

•  FI – Formulation Import

Download the Minutes here:

Minutes of the 427th Meeting of India Registration Committee