Agrochemical Molecules Registration:

A Global View

Dr Ajit Kumar
email: kumara@uniphos.com

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
Nature gave us the raw materials for
food but science has improved food
production to an incredible extent
 AGROCHEMICALS

• 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.
Understanding AgChem 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
The insecticide Act, 1968
Import ….With a view to prevent risk
to Human beings,
Manufacture Animals and Environment

Transport

Distribution

Sale

Use
The Insecticide Act is enforced through
Legislation Complex

Central Central Insecticide

Insecticide Board Laboratory
(CIB) Registration (CIL)
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.
 AgChem Registration is a multi-
disciplinary endeavour
BIOEFFICACY

TOXICITY CHEMISTRY

LEGAL
PACKAGING
 Overview of the current
Registration Process
2. CIB & RC, Ministry of Agriculture (Registration & Scrutiny)
Submits
application
along with
data

1. Applicant Deficiency
report Admn Office Legal Chemistry Bioefficacy 3. ICAR

Registration Committee Packaging Toxicology

5. Central Insecticides
4. Ministry of Health (MRL Fixation)
Laboratory (Testing)
For Products Manufactured in India
Inspector visits
SCPR CCFS studies site and Sample
Secretariat
studies data SCPR collects the analysis
scrutinizes sample
and recommendatio
residue pro n and approves
recommends
forma MRL For Imported Technicals
the MRL
Submit Sample
samples analysis
 Current Lead Times are
Lengthy and Unpredictable
Activity 9(4) – “Me Too” 9(3) and 9(3b) -
registration Fresh Registration
Documentation and Form 1 0.5 month 1 month
and other documents
verification by legal
CIB&RC analysis, covering: 1-3 months 6-12 months
• Chemistry
• Bioefficacy
• Toxicology
• Packaging
Sample submission, collection 2-6 months 2-6 months
& Analysis
MRL Fixation (Ministry of 1-2++ months 3-12 months
Health)
Registration Certificate 2 months 2 months
Issuance
OVERALL PROCESS Minimum 6 months Minimum 12-36 months
 Speedy Registration
Product Registration = Valuable Business Asset

• More than US $ 184 MM is spend for a

new product development

• There is a cost of every day delay

It’s a Risky Investment

 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
 Proposed registration process
2. CIB & RC, Ministry of Agriculture (Registration & Scrutiny)

Submits
Legal
application Co-
along with ordination Chemistry
data
1. Applicant Cell
Deficiency
report Bioefficacy

Toxicology

Registration
Packaging
Queries Committee
wrt pro
forma
5. Central Insecticides
4. Ministry of Health (MRL Fixation) Laboratory (Testing)
For Products Manufactured in India
Inspector visits
SCPR CCFS studies site and Sample
Secretariat
studies data SCPR collects the analysis
scrutinizes sample
and recommendati
residue pro on and
recommends
forma approves MRL For Imported Technicals
the MRL
Submit Sample
samples analysis
 Proposed Time Line for the Registration Processes
Area Current Norm Expected timelines – Expected timelines
9(3) and 9(3b) – Fresh – 9(4) – ‘Me Too’
Registrations Registrations
Legal Scrutiny 15 days 2 - 5 days 2 - 5 days

Technical Scrutiny (in

case of no deficiencies)
Chemistry No norms 30 - 45 days 15 - 30 days
Bioefficacy 30 - 45 days 15 - 30 days
Toxicology
45 - 60 days N/A
Packaging
15 - 30 days N/A
Sample Drawing &
Inspection 45 - 60 days N/A

Deficiency Clearing No norms Within 30 days Within 30 days

(from the issuance (from the issuance
of notice) of notice)
MRL Fixation No norms 45 – 60 days (in NA
case of no queries)

Registration completion 1yr – 3 yrs (for 6 - 9 months 4 - 6 months

(start to finish) 9(3) cases);
minimum 6
months for 9(4)
 Detailed Recommendations -
Web Based Notification Format
Applicant submits Applicant views date on
Office Allots file number Department scrutinizes
website by entering file
documents to Front and passes documents on papers and uploads date
number and visits CIB & RC
office to relevant departments on website for clearance on that date for clearance

1 Enter File Enter Application

Submit
Number Date

2 Dear Applicant, your on

<Department Name> <Date>
application is ready for
clearance by

Please come to CIB & RC office Faridabad at <Time>

3 Status Report

<Deparment <Cleared/On- <Deparment <Cleared/On-

Name> going/Deficiency> Name> going/Deficiency>

<Deparment <Cleared/On- <Deparment <Cleared/On-

Name> going/Deficiency> Name> 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 Impacting
Registration Process

Inclusion in the Schedule

• Prerogative of Central Insecticide Board

(CIB)

• Generally, CIB meets once in a year

 Issues Impacting
Registration Process

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 Impacting
Registration 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 Impacting
Sub acute study on dog Registration Process

CPCSEA (Committee for the Purpose of

Control and Supervision of Experiments on
Animals) refuses to permit the study

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 Impacting
Registration Process

Spray Operator / Live Stock Exposure

• Not needed in other countries

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 Impacting
Registration Process
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 Impacting
Registration 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 Impacting
Registration 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 Impacting
Registration 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
 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 Registrations : Catch 22 Situation

Export Orders

Export Registrations
 Global Regulatory Regimes
Parameter CIB & RC Plant Safety EPA (USA)
(India) Directorate (UK)
Time lines No Timelines for No timeline,
commitment various parts of only a
at any stage application expeditious
of the Committed for commitment
process their target
timeframes
Transparency & Website Website has Website has
Customer contains extensive relevant extensive
Friendliness limited documentation, relevant
information clear guidelines on documentation,
on technical matters clear guidelines
application along with staff on technical
process contacts etc. matters along
with staff
contacts etc.
 Global Regulatory Regimes
Paramet CIB & RC (India) Plant Safety EPA (USA)
er Directorate (UK)
Data No provision for Business plans Electronic data
Submission electronic or online mention submission is
submission of data implementation of an encouraged,
and no statement of electronic record though not
policy regarding the management, mandatory; pilots
same Digitally signed for online
approvals launched submission are
on
Process No information First level No information
Flow provided administrative provided
process mentioned,
technical processes
not mentioned
Monitoring No plan in place No mention made Detailed 5 steps
“Registration
Review” plan in
place
 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