Agro Chems > DrAjitKumarFICCIpresentation
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Agrochemical Molecules Registration:Agrochemical Molecules Registration:
A Global ViewA Global View
Presentation made at Conference on “Strategies for Globalization & Increasing Competitiveness of the Indian Agrochemical Industry” dated January 13th, 2006 at
Hotel Le Royal Meridien, Mumbai
Dr Ajit KumarDr Ajit Kumar
email: kumara@uniphos.comemail: kumara@uniphos.com
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)
Overview of the current Registration Process
1. ApplicantAdmn Office Legal Chemistry Bioefficacy
ToxicologyPackagingRegistration Committee
3. ICAR
For Products Manufactured in IndiaInspector visits
site and collects the
sample
Sample analysis
For Imported Technicals
Submit samples
Sample analysis
4. Ministry of Health (MRL Fixation)
Secretariat scrutinizes residue pro
forma
SCPR studies data
and recommends
the MRL
CCFS studies SCPR
recommendation and approves
MRL
Submits application along with
data
Deficiency report
Activity 9(4) – “Me Too” registration
9(3) and 9(3b) - Fresh Registration
Documentation and Form 1 and other documents verification by legal
0.5 month 1 month
CIB&RC analysis, covering:• Chemistry• Bioefficacy• Toxicology• Packaging
1-3 months 6-12 months
Sample submission, collection & Analysis
2-6 months 2-6 months
MRL Fixation (Ministry of Health)
1-2++ months 3-12 months
Registration Certificate Issuance
2 months 2 months
OVERALL PROCESS Minimum 6 months Minimum 12-36 months
Current Lead Times are Lengthy and Unpredictable
Speedy Registration
Product Registration = Valuable Business Asset
It’s a Risky Investment
• More than US $ 184 MM is spend for a new product development
• There is a cost of every day delay
Speedy Registration Approvals
• Serve as a catalyst for economic development and corporate transformation
• Serve as incentive on R&D investment
• Are stimulus to creativity and innovations
World over there is an intense interaction with Regulators and the Industry Associations on various issues which impact the registration process.
India is No Exception
5. Central InsecticidesLaboratory (Testing)
2. CIB & RC, Ministry of Agriculture (Registration & Scrutiny)
Proposed registration process
1. Applicant
Co-ordination
CellChemistry
Toxicology
PackagingRegistration Committee
4. Ministry of Health (MRL Fixation)
Submits application along with
data
Deficiency report
For Products Manufactured in IndiaInspector visits
site and collects the
sample
Sample analysis
For Imported Technicals
Submit samples
Sample analysis
Secretariat scrutinizes residue pro
forma
SCPR studies data
and recommends
the MRL
CCFS studies SCPR
recommendation and
approves MRL
Bioefficacy
Legal
Queries wrt pro forma
Proposed Time Line for the Registration ProcessesArea Current Norm Expected timelines –
9(3) and 9(3b) – Fresh Registrations
Expected timelines – 9(4) – ‘Me Too’ Registrations
Legal Scrutiny 15 days 2 - 5 days 2 - 5 days
Technical Scrutiny (in case of no deficiencies)
Chemistry
Bioefficacy
Toxicology
Packaging
Sample Drawing & Inspection
No norms 30 - 45 days
30 - 45 days
45 - 60 days
15 - 30 days
45 - 60 days
15 - 30 days
15 - 30 days
N/A
N/A
N/A
Deficiency Clearing No norms Within 30 days (from the issuance of notice)
Within 30 days (from the issuance of notice)
MRL Fixation No norms 45 – 60 days (in case of no queries)
N A
Registration completion (start to finish)
1yr – 3 yrs (for 9(3) cases); minimum 6 months for 9(4)
6 - 9 months 4 - 6 months
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
• Timeline to registration
Data Harmonization:India vs. OECD
– Primary skin irritation : 4 hours (OECD) vs 24 hours (India)
– Sub acute inhalation study – Reversal segment - sub acute studies – Acute oral – GCR Vs. OECD test guidelines
420, 423 and 425 – Labeling based on formulations : A potent
barrier in international trade.
Above discrepancies often lead to conduction of repeat study and many a times the studies can not be repeated because of animal welfare groups
Export Orders
Export Registrations
Export Registrations : Catch 22 Situation
Global Regulatory RegimesParameter CIB & RC
(India)Plant Safety Directorate (UK)
EPA (USA)
Time lines No commitment at any stage of the process
Timelines for various parts of application
Committed for their target timeframes
No timeline, only a expeditious commitment
Transparency & Customer Friendliness
Website contains limited information on application process
Website has extensive relevant documentation, clear guidelines on technical matters along with staff contacts etc.
Website has extensive relevant documentation, clear guidelines on technical matters along with staff contacts etc.
Parameter
CIB & RC (India) Plant Safety Directorate (UK)
EPA (USA)
Data Submission
No provision for electronic or online submission of data and no statement of policy regarding the same
Business plans mention implementation of an electronic record management, Digitally signed approvals launched
Electronic data submission is encouraged, though not mandatory; pilots for online submission are on
Process Flow
No information provided
First level administrative process mentioned, technical processes not mentioned
No information provided
Monitoring No plan in place No mention made Detailed 5 steps “Registration Review” plan in place
Global Regulatory Regimes
Going Global : Weapons in our Arsenal
• Technological and manpower resources
• Raw material
• Infrastructure
• English as a language
Registration approval should be seen as a tool for national development and wealth creation.
Global Headquarters of 100 leading Generic Pesticide Manufacturers
• China – 31• India – 22• Eastern & Western Europe – 19• East Asia – 11• USA – 5• Latin America – 5• Turkey – 4• Israel – 2• Australia - 1
Data reveal that generic manufacturers are consolidating in western world but proliferating in developing world particularly in India and China.
Professional Development
training the staff professionally, will help in streamlining the registration system in line with global competitiveness :
– Government (both central and state)
– Companies
– R & D Institutes
– Central and State Agricultural Universities
– NGOs
– Consultants
– Industry and Trade Associations
China - An Example
China effectively utilizes the registration system to develop its economy and to become leader in Agrochemical supply to the world.
Public Dealing : Registration Unit U.K. Experience
The agency deals with pesticide industry, other government departments etc. and considers industry’s need to be a priority.
“…We aim always to be courteous, helpful and accurate in all our contact with you…”
“…we aim to ensure that all our clients receive the same high level of service…”
– Our standards of service– Courtesy and helpfulness
With Patent Regime in force now, and data protection law at the threshold, the whole world is looking at us.
There is going to be influx of many registration applications in India.
Are we prepared to take up the challenge ?
Wind of Change
Face it… or Phase Out !
Thank You
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