Agro Chems > DrAjitKumarFICCIpresentation

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: [email protected]: [email protected]

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>


<Deparment Name>


<Deparment Name>


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


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


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


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.


• 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


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.


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.


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 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

Agro Chems > DrAjitKumarFICCIpresentation

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