Observations on the Development of India's Agrochemicals Industry from Product Registration

Date:10-13-2023

According to the latest World Trade Organization (WTO) data, India, ranked sixth globally 10 years ago, has recently surpassed the United States to become the world’s second largest exporter of agrochemical products after China. In terms of export destinations, India currently exports agrochemicals to over 175 countries and regions worldwide. However, the main markets are not economies lacking heavy chemical industries, but traditional chemical powers like the United States, China and Japan.  

 

The Indian government pays high attention to the agrochemical industry, regarding it as one of the ″12 industries where India has the most potential to attain global leadership″. It strives to promote India as a global production and export hub for agrochemical products. Relevant departments predict that with more policy conveniences, quicker approval processes and greater resource inputs, India’s agrochemical exports will sustain a high growth rate of 8-10% before 2025, and is expected to cross the USD 10 billion milestone in the next 3 to 4 years.

 

India’s agrochemical industry is experiencing explosive growth and robust development, garnering high attention. As an industry media, AgroPages is also drawn to developments in India. By tracking and summarizing CIB&RC meeting minutes over the past two years, we can observe the growth trends of India’s agrochemical industry.

 

CIB&RC is an agency under India’s Plant Protection, Quarantine and Storage Bureau responsible for registration, approval and other matters concerning all pesticides in India. CIB&RC holds regular meetings to discuss registration of pesticide products and approval of new compounds in India.

 

New molecule approval

 

The Pesticides Act of 1968 regulates the import, manufacture, sale, transportation, distribution and use of pesticides in India. For a pesticide to be allowed for agricultural use, its active ingredient must first be approved under the 1968 Pesticides Act, followed by the registration of the final pesticide product, before the product can be manufactured.  

 

According to CIB meeting minutes over the past two years (60th to 64th meetings), the Indian government has approved a total of 32 new molecules. Half of these new compounds were approved at the most recent review meeting. These 32 new molecules can be categorized based on their targets into 8 insecticides, 15 fungicides, 8 herbicides and 5 others. A total of 16 companies submitted new molecule applications, with UPL having the most approvals at 10, accounting for 31.25% of the total. The specific approved molecules are shown in table 1.

 

Table 1: New molecules approved by Indian CIB&RC in the past two years

Some of these new molecules deserve attention：

 

Tiafenacil

 

Tiafenacil is a new non-selective uracil herbicide co-developed by Fuam Hannong Co., Ltd., Korea Institute of Chemical Technology and others. It is a new protoporphyrinogen oxidase (PPO) inhibitor type herbicide mainly used in soybean, canola, rice, corn, wheat fields and orchards to control broadleaf weeds and grasses, including those resistant to glyphosate. It can also be used as a defoliant for cotton, fruit trees, etc. It was applied for by PI Industries Ltd.

 

Dichlobentiazox

 

Dichlobentiazox is a benzothiazole fungicide developed by Nippon Combination Chemical Industry Co., Ltd. It has broad spectrum control and long lasting effects. Under different conditions, Dichlobentiazox shows stable control against rice blast and is highly safe to rice seedling growth and germination. Besides rice, it also effectively controls diseases in cucumber, wheat, apple and more. It was applied for by PI Industries Ltd.

 

Dicloromezotiaz

 

Dicloromezotiaz has a novel mode of action compared to conventional insecticides, acting on nAChR receptors. It effectively controls planthoppers, leafhoppers and other rice pests plus diamondback moth, armyworm and peach aphid. It was applied for by PI Industries Ltd.

 

Tebufloquin

 

Tebufloquin is a new product from Meiji Pharmaceutical Co. in Japan, mainly for rice disease control, especially against rice blast strains resistant to other agents. Its unique mode of action inhibits melanin biosynthesis. It was applied for by Hikal Limited.

 

Quinoxyfen

 

Quinoxyfen is a systemic, protective fungicide particularly effective against powdery mildew diseases in cereals, beets, melons, grapes and more. Its vapor activity and mobility provide redistribution in plants. It was applied for by Bharat Rasayan Ltd.

 

Inpyrfluxam

 

Inpyrfluxam is a new broad-spectrum pyrazole carboxamide fungicide from Sumitomo Chemical in Japan for crops like cotton, beets, rice, corn and peanuts. It has excellent efficacy against a range of plant diseases via systemic activity. It was applied for by Sumitomo Chemical India Ltd.

 

Swinglea glutinosa

 

Swinglea glutinosa is a botanical fungicide extracted from Philippine oranges effective against powdery mildew, grey mold, brown rot on crops and ornamentals. Its unique properties make it a key IPM tool. It was applied for by Gowan India Pvt. Ltd.

 

Fenmezodiatiaz

 

Fenmezoditiaz is a novel mesogenic insecticide developed by BASF. It was applied for by BASF India Ltd.

 

Anisiflupurin

 

Anisiflupurin is an adenine-like compound discovered through collaboration between the University of Olomouc (Czech Republic) and Free University of Berlin. As a plant growth regulator, it inhibits stress-induced cytokinin oxidation. Syngenta commercializes it stimulates tobacco callus growth and other benefits. It was applied for by Syngenta India Limited.

 

Based on these data, some noteworthy points emerge.

 

For these newly approved molecules to become commercial products, they still need to go through pesticide registration, which generally takes around 5 years in India. This raises the question - will these new molecules become the next big registrations in the Indian agrochemical market over the next 2-3 years?

 

Among the new molecules, many are patented compounds belonging to Japanese companies. In recent years, Japanese firms have undertaken extensive collaborations with Indian companies, including contract manufacturing of patented compounds, joint factory openings, and co-development of new products. Perhaps these Japanese patented compounds will catalyze a new wave in the Indian market in the coming years.

 

Among the applicants, PI Industries Ltd. has filed for approval of a significant number of new compounds, implying technology and capacity transfer. Will PI be able to capitalize on this opportunity over the next 2-3 years to carve a niche for itself in the global agrochemical industry?

 

New product registration

 

In addition to CIB meetings, CIB&RC meetings are also regularly convened. However, the CIB and CIB&RC meetings differ in level, agenda and content. CIB&RC meetings primarily communicate outcomes on specific company product registration applications, such as approvals, rejections or other actions taken. On the other hand, CIB meetings focus more on reviewing and notifying about broader registration policies and regulations, which provide guidance and legal basis for the CIB&RC meetings. In this way, the CIB and CIB&RC meetings play complementary roles - CIB meetings establish policies and guidelines, while CIB&RC meetings apply those to make decisions on individual product registrations.

 

Product approval status in the past year

 

According to CIB&RC meeting minutes over the past year (442nd to 450th meetings), the Indian government approved a total of 1,309 product agenda items and rejected 206 items. The agenda covers product registrations, changes, and new target crops.

 

Among the approved products, 651 involved original drug substances, accounting for 49.73%, while 603 involved formulations, accounting for 46.07%. The number of registered drug substances exceeding formulations indicates that India's technical manufacturing capabilities are significant.

 

Looking at the 1,309 approved entries, the top six by number of approvals are still leading multinationals. However, many Indian companies like Best Crop Science LLP, Agro Life Science Corporation and Crystal Crop Protection Limited also feature prominently (Figure 1).

Figure 1: Statistics of companies with approved product applications in the past year

Registration status of patented compounds that expired after 2019

 

Among the 651 approved drug substances, 39 have patent expiration dates after 2019, accounting for 5.99% of the total. On average, 4 new compound products are registered per month (Figure 2).

 

 

 

Figure 2: New compounds approved in the past year

These 39 items involve 15 different compounds - 9 insecticides, 4 herbicides and 2 fungicides.

 

The most frequently mentioned are Chlorantraniliprole (18 times), Pinoxaden (4 times) and Pyroxasulfone (3 times), comprising 46.15%, 10.26% and 7.69% respectively. This reflects Chlorantraniliprole's popularity. Aside from patent holder FMC with 2 approvals, Tagros Chemicals India Pvt Ltd also applied for 2 Chlorantraniliprole substances (Figure 3).

Figure 3: Distribution map of 39 new compounds

Analyzing the 39 registration applicants, FMC has the most at 5, followed by UPL with 3. Aside from Deccan Fine Chemicals India Pvt Ltd, the top 9 companies registered Chlorantraniliprole (Figure 4).

Figure 4: Distribution map of companies applying for 39 new compounds

 

FMC, ranking first, also registered 2 Cyantraniliprole and 1 Metamifop. UPL, ranking second, also registered 2 Pyroxasulfone besides Chlorantraniliprole. Adama's portfolio aligns with UPL, also comprising Chlorantraniliprole and Pyroxasulfone.

 

India's agrochemical industry is booming

 

The product registration data reflects the rapid rise of India's agrochemical industry. Its short-term explosive growth relies largely on favorable geostrategy, skilled labor, governance, infrastructure, investment incentives and tax policies.

 

The Crop Protection Federation of India has recommended differentiated import tariffs on agrochemicals - a unified 10% duty on finished products and actives, raised to minimums of 30% and 20% respectively. This 10% gap intends to increase finished product import costs while permitting raw material imports.

 

The Federation also proposed including agrochemicals in the Production-Linked Incentive (PLI) program as the 15th industry, conferring output-based subsidies.

 

Beyond policy incentives, the potential of India's agrochemical market attracts international firms, further enabling explosive industry growth. Factors like India's vast agriculture base and low current product use have drawn major global players to expand via M&A, JVs and partnerships, especially in downstream segments. This establishes India as an export hub while building capacity to meet future domestic demand. Studies predict the industry may attract USD 87 billion in foreign investment over the next decade, evidencing enthusiasm.

 

Another growth driver is India's rapid imitation of off-patent products at low cost, quickly capturing market share domestically and abroad. This imitation capability provides cost advantages to Indian firms. With 26 key active ingredients coming off patent in 2022, representing USD 4.2 billion in sales, major opportunities have opened up.

 

Please contact Annie Feng at AnnieFeng@agropages.com if you would like to know more about pesticide registrations in India.

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This article was initially published in AgroPages' 2023 India Focus magazine.

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