India’s Registration Committee Adopts New Rules for Import and Manufacturing
The Registration Committee considered the governments “Make in India” agenda while deliberating issues and suggesting various changes to the rules governing import and manufacture of pesticides. According to the minutes from the most recent meeting, the RC considered a number of factors – including the possibilities of scarcity of pesticides, non-availability of technical pesticides for the Indian formulators – when making its decisions.
It was also decided that the Department of Agriculture Cooperation & Farmers Welfare (DAC&FW) could consider the opinion from other stake holders before implementing these decisions.
More Stringent Import Guidelines
Pesticides play an important role in increasing of crop production. It is observed that during this decade import of pesticides have increased many folds impacting indigenous manufacturing of pesticides. It is also observed that some of the countries are trying to dump inferior quality pesticides in to Indian market.
The government of India is pushing “Make in India” program to achieve self-reliance and a major thrust has been given to R&D and production of high-quality agrochemicals. The Committee considered the situation alarming and decided to redefine the guidelines for import. The following decision were taken:
- Where the molecule is registered under Indigenous manufacturing category, No Certificate of Registration for such molecules for import shall be granted in any category/section, henceforth.
- All the applications under scrutiny or completed or put up to RC for decision shall be governed under above decision at “a”.
- In view of the above decision TI v/s TIM guidelines stands withdrawn, henceforth. No certificate shall be issued under this category.
- No Certificate shall be issued henceforth u/s 9(4) Technical Import/ Formulation Import, if that molecule/formulation is registered under TIM or FIM.
- It was time again felt that some of the data/information relaxed in case of TI like details of Process of manufacturing of Technical/Formulation, Copy of Certificate of Registration, other authentic documents containing detailed Chemical Composition of the product shall be included in the requirement list, henceforth.
- Five batch samples in case of Technical Import/Formulation Import without Registering Technical have to be drawn from the commercial plant as per FAO guidelines for PRV purposes. All the expenditure on this Item Arrangements System shall be borne by the applicant. A detail proposal may be submitted to DAC&FW for in-principal approval and implementation of this provision.
Import Rule Changes
It was decided that henceforth no certificate shall be issued to any company for import, if the applicant possess the Certificate of Registration of that product under Indigenous Manufacturing. Applicant of TI category has to submit an affidavit that he does not possess the CR of that product in TIM category. All such CR issued shall be stand cancelled and respective states Govt. may be requested for cancelling manufacturing/sell license of those products.
Manufacturing Rule Changes
The existing guidelines relevant to grant of registration for Indigenous Manufacture of pesticides under various categories have to be simplified. The committee decided as under:
- The following studies-Acute oral (Mice), Acute inhalation (Rat), Primary skin irritation, Irritation to mucous membrane in case of TIM category u/s 9(3) shall not be required where chemical equivalence is established, henceforth except in case of first registrant of the molecule.
- Ames test (First tier) shall replace all toxicology data requirement in case of TIM category u/s 9(4).
- All the studies non-adhering to GLP principles conducted by GLP accredited laboratory shall be accepted henceforth for all categories of applications of indigenous category.
- Toxicology studies conducted by Non-GLP laboratories shall also be accepted for two years from the date of approval these minutes to encourage indigenous manufacturing and ease out in the process of registration of TIM/FIM category.
Expired Certificates of Registration Will be Cancelled
It is observed that some sources of import registered in the past have expired, but some of the registrants are continuously importing pesticides from such sources as no verification has been carried out. Therefore it was decided that all Certificate of Registrations, which do not bear validity of duration shall stand cancelled.
All such Certificate of Registration is required to get verified their source of registration and its validity status from the secretary of CIB&RC.
DAC&FW shall be requested to issue a Gazette Notification for cancelling all such Certificates. It was also further decided that all the respective States Govt./UT may also be requested to cancel the manufacturing/repacking license of such products/registrants immediately. After in principle approval of DAC&FW for above, the procedural aspects may be devised by the secretary of CIB&RC and put up to RC.