Navigating pesticide and fertilizer regulations: A comprehensive guide to registration and licensing procedures in India

Introduction

India stands out as a global agricultural leader, not only catering to the sustenance needs of its massive population but also playing a pivotal role in ensuring global food security. About 45.76 percent of the total workforce is engaged in agriculture and allied sectors during 2022-23, highlighting the sector's indispensable role in the Indian economy (MoSPI, 2023). The Gross Value Added (GVA) from agriculture and allied sectors was 18.2 percent contributing significantly to the nation's economic output (MoSPI, 2024). In 2021-22, the net sown area covered a large area of 1,410 lakh hectares, accompanied by a gross cropped area of 2,191 lakh hectares, showcasing the country's immense scale of agricultural activities (MoSPI, 2023). India with only 4 percent of the world's water resources and 2.4 percent of the world's land, India supports 17.8 percent of the world's population and 15 percent of the livestock population (IMPRI, 2024), so agriculture plays a vital role in ensuring food security for its vast population. However, pests and diseases pose a serious threat to crop yields, leading to considerable losses. To address this challenge, farmers have increasingly turned to agrochemicals, which help enhance yields by providing essential nutrients, protecting crops from pests and diseases, and optimizing growth conditions. Agrochemicals are chemical formulations that protect crops from pests, diseases, and weeds. They also help farmers yield more crops per acre of land for a longer period. Agrochemicals are comprised of fertilizers, plant-protection chemicals or pesticides, soil conditioners, liming and acidifying agents, and chemicals used in animal husbandry, such as antibiotics and hormones. (Vedantu, 2024) [4] .

The Indian agrochemicals market reached approximately USD 6.51 billion in 2023 (Expert Market Research, 2024) [5] , with pesticide exports showing a notable surge from 2017-18 to 2021-22, reaching 32664 crore rupees. This growth trajectory highlights a widening gap between export and import values, indicating a flourishing trade surplus in the pesticide sector (Department of Chemicals and Petrochemicals, 2022) [6] . It signifies a strong domestic production capacity and rising competitiveness in global pesticide markets. Governments oversee pesticides for several reasons. Their primary aim is safeguarding human health and the environment from potential risks linked with pesticide application. This encompasses protecting pesticide users, consumers, crops, animals, wildlife, water sources, and various other aspects. Additional goals involve guaranteeing that pesticide products work effectively for their intended purposes and maintaining a fair marketplace for those involved in manufacturing, importing, and distributing these products. The legislation serves as one means by which nations work towards these goals, governing various aspects like manufacturing, registration, importation, transportation, storage, sale, use, and disposal of pesticides. (FAO and WHO, 2020) [7] Understanding the details of registration and licensing procedures is crucial for individuals operating within the pesticides and fertilizers industry. It ensures compliance with regulatory standards, facilitates the smooth registration process for new products, and enables effective management of manufacturing, distribution, and sale operations. By gaining insight into these procedures, industry professionals can navigate the regulatory landscape more effectively, minimize legal risks, and contribute to the safe and responsible use of pesticides and fertilizers in India.

Research Methodology

In the formulation of the licensing procedures, primary reliance was placed upon the acquisition of secondary data. The main sources for this data encompassed governmental acts, rules, and guidelines established by relevant administrative bodies. Furthermore, important information was gathered from trustworthy sources such as government-maintained databases, official websites of regulatory departments, as well as reputable private institutions. This approach ensured that the licensing framework was carefully developed based on a thorough understanding of the regulatory landscape as outlined by official mandates and industry standards.

Results and Discussion

The Insecticide Act of 1968 and the Insecticide Rule, of 1971 facilitate the registration process, use, distribution, sale, import, and export of pesticides. In India, these rules are overseen by two authorities: The Central Insecticides Board and Registration Committee (CIBRC) and the Food Safety and Standards Authority of India (FSSAI). The CIBRC provides guidance to governments on matters concerning the manufacture, application, and safety of pesticides. Additionally, it offers recommendations regarding how pesticides work, their toxicity levels, and how long they can be stored before expiring. Another important component of the CIBRC is the registration committee, tasked with registering pesticides after evaluating laboratory test results such as toxicity, efficacy, shelf-life, Etc. FSSAI plays a crucial role in ensuring food safety standards are upheld across India. Before newly created pesticides can be sold, they must undergo a registration process administered by the Central Insecticide Board and Registration Committee. (Koranga et al., 2021) [11] . With the implementation of updated registration standards, obtaining import registrations has become more challenging, presenting an advantage for genuine suppliers, as the entry of spurious manufacturers gets more difficult. The following registration certificates (RCs) are valid for the sale of agrochemicals in India; 1. TIM (Technical Indigenous Manufacturing): This refers to the manufacturing of technical-grade pesticides within India using indigenous (domestic) resources and processes. "Technical grade" pesticides are the pure active ingredients of pesticides before they are formulated into end products for use. 2. TI (Technical Import): TI refers to the importation of technical-grade pesticides from other countries. These pesticides are not formulated products ready for use but rather pure active ingredients. Importing technical-grade pesticides allows Indian companies to access specific active ingredients that may not be locally produced.

FIM (Formulation Indigenous Manufacturing): FIM

involves the formulation of pesticides within India using indigenous resources and processes. Formulation involves blending the active ingredient(s) with other substances (called inert ingredients) to create the final pesticide product ready for use by farmers. 4. FI (Formulation Import): FI refers to the importation of formulated pesticide products from other countries. These products are already formulated and ready to be used by farmers. Importing formulated pesticides can provide access to a wider range of products or formulations that may not be available domestically.

The above-mentioned registrations can be taken under two broad categories of registration viz. 9(4) Me-too Registration: This is for products and sources 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 not registered in India yet. Any first-time molecule or source registration will be under this category.

Registration Process for Pesticide Step 1: Application Form Submission and Payment of Fees

The first step to register any pesticide is to fill out application Form I. Within this form, the signature of the applicant holds significant importance. For an individual, they sign it themselves or someone they've authorized can sign on their behalf. In the case of Hindu Undivided Families, the head of the family (called the Karta) or someone authorized by them can sign. For partnership firms, the managing director has to sign the form, while for companies, anyone authorized by the Board of Directors can sign the form I. In instances other than these, the person who is responsible for the business has to sign it. If any changes occur, they need to inform the Secretary of the Central Insecticides Board and Registration Committee and the Licensing Officer about these changes promptly. The application should include details regarding the chemical composition, stability in storage, toxicity assessment, bioefficacy data, specific instructions for storage and use, proposed specifications, analytical test reports, characterization of active ingredients, 7 copies of proposed labels and leaflets, and manner of packing. After completion of the application form, include a bank draft made out to the Accounts Officer, Directorate of Plant Protection, Quarantine & Storage, Faridabad, covering the registration fee. The registration fee varies depending on the application type. For applications under Sections 9(3) or 9(3B) of the Insecticides Act, 1968, the fee is Rs. 5,000 each, while for Section 9(4) applications, it is Rs. 2,500. Payment has to be made via a demand draft drawn on the State Bank of India, Faridabad, payable to the Accounts Officer, Directorate of Plant Protection, Quarantine and Storage, Faridabad, Haryana. Following this, send the filled application form along with the bank draft to the Secretary, Registration Committee, Directorate of Plant Protection, Quarantine & Storage, NH-IV, Faridabad-121001, Haryana.

Step 2: Site Inspection After receiving the application, the regulatory authority conducts a physical inspection of the manufacturing premises to ensure compliance with safety and quality standards as per the Insecticide Rules, 1971.

Step 3: Technical Evaluation

The CIBRC or State Licensing Authority evaluates the technical data provided in the application to determine if the proposed insecticide meets the safety and efficacy standards specified in the Insecticide Rules, 1971.

Step 4: Certificate of Registration Upon approval of the application, a certificate of registration will be issued, either in Form II or Form II-A, depending on the specifics of the application.

Licenses to Manufacture Insecticides

Individuals must acquire a license from the designated state Licensing Officer to engage in the manufacturing, distribution, sale, exhibit for sale, stocking of pesticides, or undertaking pest control operations. Obtaining the license within the stipulated timeframe is mandatory after receiving a pesticide registration certificate; otherwise, the certificate will be revoked. The manufacturing of insecticides requires the submission of a license application using Form III or Form IV, along with the requisite fee. The fee is Rs. 2000 per insecticide, with a maximum of Rs. 20,000 for all insecticides applied. In cases where manufacturing is intended across multiple sites, separate applications and licenses are mandatory for each location. In the event of loss, damage, or defacement of the original license, applicants must pay a fee of Rs. 100 for the issuance of a duplicate license

Conditions of License

The license issued must be kept at the approved premises and presented for inspection upon request. Any changes to the expert staff listed in the license require prompt reporting to the relevant authorities. Additionally, for the manufacture of additional insecticides within the licensed period, prior approval and compliance with fee requirements are essential. Compliance with Act and rules, obtaining ISI Mark Certificate, and selling insecticides only with ISI Mark Certification are mandatory.

Registration process for ISI Mark

The normal BIS Certification process involves several steps: First, the applicant must meet BIS Certificate requirements and submit the necessary documents. Then, BIS officials inspect the products and the factory/industry. After inspection, samples are sent to BIS-approved labs for testing. If the product passes all tests, BIS issues the certificate within 60 to 65 days from application submission. In contrast, the Simplified Procedure is faster in that applicants submit reports of samples already tested and approved by BIS, along with an online registration application and required documents. BIS officials inspect products and factories during document scrutiny. Samples are sent for testing at BIS-approved labs. If verified and approved, the certificate is granted within 35 to 40 days of application.

License for Sale, Etc., of Insecticides

Individuals are required to duly fill out either Form VI or Form VII and submit it, along with the requisite fees as specified, to the licensing officer to apply for or renew a license for the sale, stock, or display of insecticides. The fee for each insecticide applied for is ₹500, up to a maximum of ₹7500. If an insecticide is sold or stocked at more than one location, a separate fee is required for each place. However, for insecticides commonly used in households and registered as such, the maximum fee is ₹7500 per place. Additionally, if the sale location is in rural areas, the fee is reduced to one-fifth of the specified amount. If an insecticide is to be sold or stocked at multiple places, separate applications and licenses are necessary for each location. When applying for a license to operate, sell, stock, or distribute insecticides, the applicant is required to provide a certificate from their principal company. This certificate, referred to as Form VI-D, and should be addressed to the licensing officer and contain detailed information about the principal company, including registration and manufacturing license numbers. Additionally, it should entail the applicant's complete name, address, and the specific types of insecticides they intend to handle. The license to sell, stock, or exhibit for sale or distribute insecticides will be issued in Form VIII.

Duration & Renewal of Licenses

Licenses issued or renewed remain valid for two years unless earlier suspended or canceled. Licenses for the manufacturing of insecticides under provisional registration expire at the same time as the provisional registration period ends. To ensure proper compliance, applications for license renewal must be submitted before the expiry date. However, late applications submitted within three months following the expiration incur late fees. Late fees vary based on the type of license. For manufacturing or pest control, late fees start from ₹500 and increase for each subsequent month. For other licenses, late fees begin at ₹100. But in a rural area, late fees are only one-fifth of the regular late fee.

Packing and Labelling

Insecticides cannot be sold, distributed, or transported unless they are properly packed and labeled according to regulations. This ensures that consumers receive products that meet safety standards and are clearly identified. Each package containing insecticides must adhere to specifications approved by the Registration Committee. Before packaging, every batch of insecticide undergoes analysis to ensure it meets manufacturing standards. Once packaged, insecticides are considered suitable for sale, distribution, or use, even if further steps are required for marketability. Each package must include a leaflet with detailed instructions on how to use the insecticide safely and effectively. This leaflet also provides information on potential hazards to humans, animals, and the environment, along with instructions for storage and disposal. Approved leaflets, signed by the Registration Committee Secretary, are provided to the manufacturer and state licensing officer to ensure compliance with regulations.

Manner of Labeling

The following details must be printed or written in permanent ink on the label of the innermost container of any insecticide and on the outer covering in which the container is packaged. The label on insecticide containers should be firmly attached to prevent easy removal. It should feature a square shape, placed diagonally, taking up at least one-sixteenth of the label's total area. This square is divided into two equal triangles: the top one displays symbols and warning words, while the bottom one shows a specific color. These labels are crucial for ensuring safety and providing clear warnings to users about the potential risks associated with the insecticides. By prominently displaying symbols, words, and colors on the labels, users can quickly identify the toxicity level of the product and take appropriate precautions during handling and storage. The regulations help protect both users and the environment from potential harm caused by misuse or mishandling of insecticides. In addition to the safety measures mentioned before, labels on highly flammable insecticides should warn against open flames or heat. Labels and leaflets on insecticide packages should be in Hindi, English, and one or two local languages. Labels should not make false claims about safety, like "SAFE" or "NON-POISONOUS", to avoid misleading users.

Source: Slideshare

Source: Agronational

Entry points for Import

Insecticides can only be imported into India through specific entry points, which include:

• Ferozepore Cantonment and Amritsar railway stations for imports by rail from West Pakistan.

• Ranaghat, Bongaon, and Mahiassan railway stations for imports by rail from East Pakistan.

• Madras, Calcutta, Bombay, Cochin, and Kandla for imports by sea.

• Madras, Calcutta, Bombay, Delhi, and Ahmedabad for imports by air.

Fertilizer Registration Process

Fertilizer Control Order, 1985 (Amendment in 2021) facilitate the registration process, use, distribution, sale, import, and export of fertilizers.

Certificate of Registration

Each individual or entity, whether they are a manufacturer, importer, pool handling agency, wholesaler, or retail dealer, who plans to sell or engage in the sale of fertilizers, must submit a Memorandum of Intimation to the Notified Authority. This memorandum, filled out using Form A1 and duplicated, must be accompanied by the prescribed fee and a Certificate of Source in Form O. If fertilizers are acquired for sale from multiple origins, a Certificate of Source must be provided for each of these origins using Form O. Upon receiving a fully completed Memorandum of Intimation, the Notified Authority will issue an acknowledgment of receipt using Form A2. This acknowledgment serves as an authorization letter, granting the concerned person the status of an authorized dealer for the purposes specified in this Order. The notified authority for the certificate of registration is Directorate of Agriculture, Sector -10 A, CH Road, Krishi Bhavan, Gandhinagar. To sell fertilizers as Industrial Dealer, one must obtain a registration certificate. This process involves filling out an application using Form A, and paying the required fee along with a Certificate of Source in Form O.

Time period

The Controller will issue a registration certificate within thirty days of receiving an application from any individual who applies for it under clause 8.

Period of validity

Each registration certificate provided according to clause 9 and every authorization letter issued in accordance with clause 8 will remain valid for five years from the date of issuance, unless renewed, suspended, or revoked.

Renewal of certificate of registration and authorisation letter Application for Renewal

Each holder of a certificate of registration or an authorization letter, granted under the respective clauses, who wishes to renew it must submit an application. This application, made before the expiration date of the certificate or letter, should be addressed to the Controller for registration certificates and to the Notified Authority for authorization letters. The application should be submitted in duplicate, accompanied by the prescribed renewal fee and a certificate of source as stipulated, using Form C for registration certificates and Form A1 for authorization letters.

Submission to the Controller or Notified Authority

Upon receipt of the renewal application, along with the requisite fee and certificate of source, the Controller or the Notified Authority, depending on the type of document being renewed, will proceed with the renewal process.

Renewal Processing

The Controller or the Notified Authority will thoroughly review the renewal application to ensure compliance with all regulatory requirements. If the application is deemed complete and in accordance with the provisions, the renewal process will be initiated.

Issuance of Acknowledgment

Following the successful processing of the renewal application, the Controller or the Notified Authority will issue an acknowledgment receipt in Form A2. This acknowledgment serves as confirmation that the certificate of registration or authorization letter has been renewed.

Certificate for Manufacture of Mixtures of Fertilizers

Individuals or entities interested in preparing mixtures of fertilizers or special blends must obtain a certificate of manufacture under clauses 15 or 16. This ensures compliance with regulations and adherence to specified terms and conditions. Manufacturers are required to ensure that their fertilizer mixtures, whether solid or liquid, meet the standards set by both the Central and State Governments as published in the Official Gazette.

To obtain a certificate allowing the preparation of fertilizer mixtures, individuals must meet certain qualifications specified by the State Government or employ someone who meets these qualifications.

• Additionally, they must possess minimum laboratory facilities as outlined in clause 21A of the regulation. • The application process involves submitting Form D, along with the required fee, to the registering authority. • For those seeking certification for standard fertilizer mixtures, the application form D should be duplicated together with the fees prescribed. • Those applying for special mixtures should also include an attested copy of the purchaser's requisition with the application form D should be duplicated together with the fees prescribed. • This formal process ensures that those preparing fertilizer mixtures have the necessary qualifications and facilities, contributing to the quality and safety of agricultural inputs.

The registering authority is obligated to issue a certificate of manufacture. This certificate, presented in Form F, signifies approval for the production of standard fertilizer mixtures. Similarly, if an application for a certificate of manufacture for a special mixture satisfies the requirements and is not declined then the registering authority is mandated to grant a certificate of manufacture. This certificate, provided in Form G, signifies authorization for the production of specialized fertilizer blends The registering authority is obliged to provide the applicant with a copy of this order within forty-five days from the date of receiving the application.

Period of validity

Certificates of manufacture for special fertilizer mixtures remain valid for six months from the date of issuance. Conversely, certificates of manufacture for standard fertilizer mixtures are valid for three years from the date of issuance, provided they are not suspended or revoked.

Renewal of certificates of manufacture for fertilizer mixtures

Holders of certificates seeking renewal must submit an application to the registering authority using Form D before the expiration date of their current certificate. This application should be duplicated and accompanied by the prescribed renewal fee. Upon receiving the renewal application, the registering authority assesses factors such as the applicant's performance and relevant circumstances. Based on this assessment, the authority may choose to renew the certificate of manufacture by endorsing Form F. If the certificate of registration is not renewed, the registering authority must provide written reasons for this decision.

If an application for renewal is not submitted before the certificate of manufacture expires but is made within one month of its expiration, the certificate may still be renewed. However, an additional fee, as prescribed by the State Government, must be paid for this purpose.

Packing and Marking Requirements

Containers holding fertilizers must prominently display the word "FERTILISER" and include only the particulars specified by the Controller. For containers weighing 5 kg or less, this information can be provided on a securely affixed label instead of directly on the container. Containers holding Biofertilizer, Organic fertilizer, or nonedible de-oiled cake fertilizer must prominently display the appropriate term ("BIOFERTILISER/ ORGANIC FERTILISER OR NON-EDIBLE DE-OILED CAKE FERTILISER") and include only the particulars specified by the Controller. All containers must be securely packed and sealed to prevent tampering with the contents. Bags containing Indianmanufactured fertilizers must also bear lead seals to ensure the integrity of the contents until use. Fertilizer bags get cut, torn, or damaged while being transported or handled during loading or unloading, the manufacturer can, after informing both the State and Central Governments, either repack the fertilizer in new bags or adjust the quantity to match the declared weight.

Conclusion

The Insecticide Act of 1968 and the Insecticide Rule of 1971 provide a framework for regulating the registration, distribution, and use of pesticides in India. Oversight of these regulations falls under the purview of the Central Insecticides Board and Registration Committee (CIBRC) and the Food Safety and Standards Authority of India (FSSAI). With stringent registration standards, the entry of spurious manufacturers is deterred, benefiting genuine suppliers. Importantly, compliance with regulations, including obtaining ISI Mark Certification, is mandatory for selling insecticides. Furthermore, the fertilizer registration process, governed by the Fertilizer Control Order of 1985, involves submitting memoranda and certificates to the Notified Authority, ensuring adherence to quality and safety standards. Licenses for manufacturing insecticides and fertilizers necessitate compliance with various regulatory requirements, including documentation, fees, and renewal procedures, to ensure product safety and efficacy.

References

1. Ministry of Statistics and Programme Implementation. Percentage share in economic activity in GVA for 2022-23 (first revised estimates) at current prices (base 2011-12). New Delhi: Government of India; 2023.
2. Department of Chemicals and Petrochemicals. Chemical and petrochemical statistics at a glance. New Delhi: Government of India; 2022.
3. FAO, WHO. International code of conduct on pesticide management: guidance on pesticide legislation. 2nd ed. Rome: FAO; 2020.
4. Koranga R, Mehta V, Bhandari D. Pesticide usage in India as compared to the world. In: Raju SVS, Sharma KR, editors. Recent trends in insect pest management. 5th ed. New Delhi: AkiNik Publications; 2021. p. 1-16.
5. Directorate of Plant Protection, Quarantine and Storage. Insecticides Rules, 1971. Faridabad: Government of India.
6. Directorate of Agriculture. Fertilizer Control Order, 1985. Gujarat: Government of Gujarat.