Agrochemical Molecules Agrochemical Molecules Registration: Registration: A Global View A Global View Presentation made at Conference on “Strategies for Globalization & Increasing Competitiveness of the Indian Agrochemical Industry” dated January 13 th , 2006 at Hotel Le Royal Meridien, Mumbai Dr Ajit Kumar Dr Ajit Kumar email: [email protected]email: [email protected]
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Presentation made at Conference on “Strategies for Globalization & Increasing Competitiveness of the Indian Agrochemical Industry” dated January 13th, 2006 at
Nature gave us the raw materials for food but science has improved food production to an incredible extent
A G R O C H E M I C A L S
• Have played a major role in achieving the sustainability
• Since they can cause adverse effects on human health and environment, they are required to be regulated through a process of registration.
A regulatory process of evaluation and acceptance by the statutory authority of the claims made by the applicant in order to:
– Protect the health of people, animals, plants and environment
– Ensure that pests are controlled in a safe and efficient manner
Understanding AgChem Registration
The insecticide Act, 1968
….With a view to prevent risk to Human beings,
Animals and Environment
Import
Use
Manufacture
Distribution
Transport
Sale
The Insecticide Act is enforced through
Legislation Complex
Central
Insecticide Board
(CIB)
Central Insecticide
Laboratory
(CIL)Registration
Committee
(RC)
Types of Registration
• Provisional Registration u/s 9(3b)– For the new molecule introduced first time in
India. Usually granted for a period of 2 years
• Regular Registration u/s 9(3)– Subject to the submission of complete data
• “Me-Too” Registration u/s 9(4)– After 9(3) registration of a molecule, any other
person can apply for registration
Regulatory Provisions Under the Insecticide Act
Registration of agrochemicals is handled at central Government level whereas issues regarding implementation of the Act including manufacturing license is done at the state level.
TOXICITY
PACKAGING
BIOEFFICACY
CHEMISTRY
LEGAL
AgChem Registration is a multi-disciplinary endeavour
5. Central InsecticidesLaboratory (Testing)
2. CIB & RC, Ministry of Agriculture (Registration & Scrutiny)
Detailed Recommendations - Web Based Notification Format
Applicant submits documents to Front office
Office Allots file number and passes documents on to relevant departments
Department scrutinizes papers and uploads date on website for clearance
Applicant views date on website by entering file number and visits CIB & RC on that date for clearance
Enter File Number
1
2
Enter Application Date
Submit
Dear Applicant, your application is ready for
clearance by
<Department Name>
Please come to CIB & RC office Faridabad at <Time>
on <Date>
3 Status Report
<Deparment Name>
<Cleared/On-going/Deficiency>
<Deparment Name>
<Cleared/On-going/Deficiency>
<Deparment Name>
<Cleared/On-going/Deficiency>
<Deparment Name>
<Cleared/On-going/Deficiency>
Issues Impacting Registration Process
• Inclusion in the schedule• Shelf life extension.• Applicability of shelf life extension to all Me-too
registrations• Acceptance of bio-efficacy data generated by GLP
labs• Sub-acute studies on dog• Spray Operator / Live Stock Exposure• Registration for import of formulations only• In-process sampling• ICAR comments• MRLs
Issues ImpactingRegistration Process
Inclusion in the Schedule
• Prerogative of Central Insecticide Board (CIB)
• Generally, CIB meets once in a year
Shelf Life Extension
• Shelf life approval is granted by RC
• Extension is prerogative of CIB
• Unlike all other claims, shelf life extension claim is not automatically passed on to the “Me-Too” registrants
Issues ImpactingRegistration Process
Acceptance of bio-efficacy data generated by GLP labs• Studies generated on chemistry, toxicity,
residue and packaging are accepted
• However, studies on bio-efficacy are accepted only from agricultural universities and ICAR institutes
It is suggested that studies from GLP labs on bio-efficacy should also be accepted
Issues ImpactingRegistration Process
Sub acute study on dog
Suggestions: • Registration committee (RC) should enable
the permission for study or• Regulatory studies to be taken out of the
purview of CPCSEA or • RC should remove this requirement for
registration
Issues ImpactingRegistration Process
CPCSEA (Committee for the Purpose of Control and Supervision of Experiments on Animals) refuses to permit the study
Spray Operator / Live Stock Exposure
The R.C. may accept data on post introduction field surveys (in the same way as factory workers health records) and the applicant may submit the same within a specified time.
Issues ImpactingRegistration Process
• Not needed in other countries
Registration for import of formulations only
• Following can not be ensured– Purity and impurity of technical– Shelf life – Source of technical
• Legal compliance of form-I (S. no. 5 & 7)• Monopoly
Conversely, registration of formulation without registering technical grade should also be allowed for indigenous manufacturing
Issues ImpactingRegistration Process
In-process sampling
• Mandatory for indigenous manufacturer of technical grade – not applicable for imported material
• Breaches confidentiality on the process of manufacture
The above requirement is linked to establishment of chemical equivalence for “Me-Too” products. However, in USA and EU, no such sampling is done. All that is required is five batch analysis as one of the main requirements. Countries like Korea and China do not even require chemical equivalence for grant of a “Me-Too”.
Interestingly, in-process sampling is done even for products u/s 9(3) in India.
Issues ImpactingRegistration Process
ICAR comments
• Applicable on bio-efficacy and residue reports.
• These studies are conducted at SAUs / ICAR centres
Therefore, seeking ICAR comments on their own reports has no logic.
Issues ImpactingRegistration Process
MRL
• Lack of clarity on the issue of fixation of MRL. • Registration Certificates are held up for a long
time for want of MRL fixation.
Suggestions: • Since MRLs are set for trading purposes, it is important for
India to set up these values.
• In absence of sufficient data for MRL fixation, we have one of the following two options :
- Adopt codex MRLs.
- Adopt Limit of Determination (LD) as MRL
Issues ImpactingRegistration Process
Data Harmonization: Why is it needed?
To minimize :• Cost to companies of getting & keeping
registrations (costs passed on to growers)
• Unwarranted use of animals for tox testing purposes