India ranks number 1 in the world, with highest cultivated land of around 1,891,761 square kilometers. But in terms of total value of food produced, India is at the fourth spot. One of the major reasons behind this disparity is the low agrochemical consumption. In terms of total agrochemical consumption, India is at 10th place, with annual consumption of around 40 million Kgs, which compared to China’s 1,806 million Kgs, is minimal.
To increase the farm production Indian government is trying to increase farmer’s awareness about proper usage of agrochemicals. Indian government is also trying to root out unregulated and spurious pesticides in market, to ensure availability of good quality products at right price. Keeping this in mind, government through its regulatory body Central Insecticides board & Registration Committee, introduced new registration guidelines in 2017. The guidelines are to ensure proper registration of agrochemicals from genuine source; in order to encourage big companies with quality products to enter the market and to have better regulation on imported AI and prevent illegal import of agrochemicals in the market.
Overview of the Registration Process
With new registration guidelines coming into effect, import registrations have become more difficult. But it’s an opportunity for genuine suppliers, as the entry of spurious manufacturers gets more difficult. Under the new guidelines, following registrations certificates (RCs) are valid for sale of agrochemicals in India;
• TIM – Technical Indigenous Manufacturing
• TI – Technical Import
• FIM – Formulation Indigenous Manufacturing
• FI – Formulation Import
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.
Registration Process 9(3) – TI New Source
For any technical already registered in India, TI New Source 9(3) is the best way for entering in the Indian market for any manufacturer willing to get registered as alternative source and directly export the molecule to India. The registration process will need minimum of two companies. An Indian company, principle applicant for import registration & second will be source, who is the manufacturer and will be registered as a source in the registration, and will be the future supplier of product to the Indian company. Under the new guidelines manufacturer/source, should have a valid registration in the source country (e.g. ICAMA in China) and manufacturing license, without which CIB will not process the registration application.
Total time taken to complete TI New Source is around 45 – 54 months. The complete registration process can be distributed in following stages, with tentative timelines for the same.
1. Application of Sample Import Permit (RTT): The first step will be to get Sample Import Permit (RTT) to import sample quantities of technical in order to start data generation in India. Letter of authorization and ICAMA, both legalized from Indian embassy in China will be required for making the application. It will take around 2 – 4 months to get the RTT.
2. Data generation: After getting RTT and importing the samples field trials on all registered crops will begin for 2 season. It will take around 24-30 months to get all the bio-efficacy reports after the start of trials. Also the shelf life data will need 32 months to complete, so the total time taken for generation of all data and completion of studies will take 32 months approximate. In the meantime other chemistry and tox studies will be completed. GLP data from any lab across the world is acceptable for TI registration. However field trial, efficacy and chemistry data has to be generated in India, after getting the RTT.
3. Evaluation of application and submission of deficiencies (if any): After the application for TI has been made with all the required data, CIB will assess it and check the registration dossier. In case some deficiencies are there in the data, they will need to be completed. Normally this whole process takes around 12-18 months (depending upon data deficiency, if any). Once all deficiencies have been complete, the TI is approved in the registration committee meeting.
The new guidelines are not much different from the old ones; except for more data is now required for registration. Moreover both Indian importer and overseas exporter need to keep in mind certain important points, before finalizing any contract for registration and making the application.
• Indian company can’t have both TIM and TI registration for the same molecule. If the company already has both, then TI registration stands cancelled. If the company gets a TIM after getting TI, then also TI will be cancelled.
• Source should have valid registration in the source country (eg. ICAMA in China) and manufacturing license.
• Earlier there was no validity of TI registration once issued. But now the validity of TI registration is similar to validity of ICAMA. Once the ICAMA is renewed, new ICAMA is to be submitted with CIB in order to renew the validity of TI registration.
• Any data generated in India, by Indian importer or Chinese source, before obtaining RTT and proper import of samples there after, will not be acceptable by CIB in registration process. However, GLP data generated outside India will be acceptable in the registration dossier.
No doubt, new registration guidelines make TI registration process more expensive and lengthy. But the new guidelines are well defined and reduce confusion about Indian registration process. However, there are still areas of improvement and CIB is already working in making registration process more transparent and smooth. For companies, planning to enter India and invest money in registrations, this is the right time to do so. With transparency and clear requirements, it has become easier for genuine sources to get TI registration, and with stringent guidelines it has become more difficult for illegitimate sources to register new products or renew old registrations.
P.S. The draft registration guidelines, earlier suggested to stop the import of products in India, which are registered under TIM. But that proposal was dropped from the final policy. Any product whether or not available under TIM in India, can be applied for TI registration and be imported for sale in India.