Methods employed by R and D of various companies in screening ideas By Ananda Chakraborty CINE...

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Methods employed by R Methods employed by R and D of various and D of various companies in screening companies in screening ideas ideas By By Ananda Chakraborty Ananda Chakraborty CINE Course- 2006

description

Typical Registration process for Agrochemical

Transcript of Methods employed by R and D of various companies in screening ideas By Ananda Chakraborty CINE...

Page 1: Methods employed by R and D of various companies in screening ideas By Ananda Chakraborty CINE Course-2006.

Methods employed by R and D of Methods employed by R and D of various companies in screening ideasvarious companies in screening ideas

ByByAnanda ChakrabortyAnanda Chakraborty

CINE Course-2006

Page 2: Methods employed by R and D of various companies in screening ideas By Ananda Chakraborty CINE Course-2006.

IntroductionIntroduction

• R and used in two types of roleR and used in two types of role• develop new products, molecules develop new products, molecules • reduce cost or improve product/ service qualityreduce cost or improve product/ service quality

• New Product development: Agrochemical New Product development: Agrochemical

IndustryIndustry• Patent law is an important contention herePatent law is an important contention here

Page 3: Methods employed by R and D of various companies in screening ideas By Ananda Chakraborty CINE Course-2006.

Typical Registration process for Typical Registration process for AgrochemicalAgrochemical

5. Central InsecticidesLaboratory (Testing)

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

1. Applicant AdmnOffice Legal Chemistry Bioefficacy

ToxicologyPackagingRegistration Committee

3. ICAR

For Products Manufactured in India

Inspector 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

5. Central InsecticidesLaboratory (Testing)

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

1. Applicant AdmnOffice Legal Chemistry Bioefficacy

ToxicologyPackagingRegistration Committee

3. ICAR

For Products Manufactured in India

Inspector 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

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Time required for a RegistrationTime required for a Registration

2 months2 monthsRegistration Certificate Issuance

Minimum 6 months

1-2++ months

2-6 months

1-3 months

0.5 month

9(4) – “Me Too”registration

3-12 monthsMRL Fixation (Ministry of Health)

Minimum 12-36 months OVERALL PROCESS

2-6 monthsSample submission, collection & Analysis

6-12 monthsCIB&RC analysis, covering:• Chemistry• Bioefficacy• Toxicology• Packaging

1 monthDocumentation and Form 1 and other documents verification by legal

9(3) and 9(3b) -Fresh Registration

Activity

2 months2 monthsRegistration Certificate Issuance

Minimum 6 months

1-2++ months

2-6 months

1-3 months

0.5 month

9(4) – “Me Too”registration

3-12 monthsMRL Fixation (Ministry of Health)

Minimum 12-36 months OVERALL PROCESS

2-6 monthsSample submission, collection & Analysis

6-12 monthsCIB&RC analysis, covering:• Chemistry• Bioefficacy• Toxicology• Packaging

1 monthDocumentation and Form 1 and other documents verification by legal

9(3) and 9(3b) -Fresh Registration

Activity

Page 5: Methods employed by R and D of various companies in screening ideas By Ananda Chakraborty CINE Course-2006.

Some more facts about Some more facts about Agrochemical industryAgrochemical industry

• For launching one noble chemical in crop For launching one noble chemical in crop protectionprotection

• 140,000 molecules are tested140,000 molecules are tested• $ 210 m ($184 m in 1999) spend$ 210 m ($184 m in 1999) spend• 9.1 years on average from 19.1 years on average from 1stst synthesis to synthesis to

marketingmarketing

Page 6: Methods employed by R and D of various companies in screening ideas By Ananda Chakraborty CINE Course-2006.

R and D process in agrochemicalsR and D process in agrochemicalsNew Lead

Think of a newtarget compound

Synthesisetarget

SCREEN

Evaluateresults

Novel ProductO

MeO2COMe

NN

OCN

Page 7: Methods employed by R and D of various companies in screening ideas By Ananda Chakraborty CINE Course-2006.

Parameters for screeningParameters for screening

The following parameters are used by projecting The following parameters are used by projecting them 10 – 12 years ahead…them 10 – 12 years ahead…

• Activity & Selectivity – 1Activity & Selectivity – 1stst Consideration Consideration (Performance Parameters)(Performance Parameters)

• Properties of the chemical, Residual toxicity and Properties of the chemical, Residual toxicity and Soil toxicity – 2Soil toxicity – 2ndnd Consideration (mainly Consideration (mainly environmental parameters)environmental parameters)

• Patentability, Cost of manufacturing and others – Patentability, Cost of manufacturing and others – 33rdrd Consideration (mainly commercial parameters) Consideration (mainly commercial parameters)

Page 8: Methods employed by R and D of various companies in screening ideas By Ananda Chakraborty CINE Course-2006.

R and D in manufacturing IndustryR and D in manufacturing Industry

• Tata Motors – 3 plantsTata Motors – 3 plants

R and D in Tata Motor

ERC(central level)

In Plant R and D

ProcessImprovement

Product Improvement

Research and Development Structure at Tata motor

Page 9: Methods employed by R and D of various companies in screening ideas By Ananda Chakraborty CINE Course-2006.

• Product improvementProduct improvement• Input from dealersInput from dealers• Input from service personsInput from service persons

• Process ImprovementProcess Improvement• When the process itself needs to be modifiedWhen the process itself needs to be modified• starts working with a major problemstarts working with a major problem • Brainstorming, Exploration of probable causesBrainstorming, Exploration of probable causes• Experimentation and RecommendationExperimentation and Recommendation

Page 10: Methods employed by R and D of various companies in screening ideas By Ananda Chakraborty CINE Course-2006.

Criteria for screeningCriteria for screening

• Effectiveness of the idea on the causeEffectiveness of the idea on the cause • Ease of implementation i.e. the disruption to the Ease of implementation i.e. the disruption to the

manufacturing process should be minimummanufacturing process should be minimum • Cost effectivenessCost effectivenessHere an optimum combination of Here an optimum combination of Effectiveness & Ease Effectiveness & Ease

of implementation is desired first and then cost of implementation is desired first and then cost effectiveness is the distinguishing factor.effectiveness is the distinguishing factor.

Innovative ideas from shop floor employees are also Innovative ideas from shop floor employees are also encouraged and rewardedencouraged and rewarded

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ConclusionConclusion

• Consideration of the marketConsideration of the market • Difference in judging criteriaDifference in judging criteria : : once a once a

process is established, no major changesprocess is established, no major changes • Difference in new product vis-à-vis Difference in new product vis-à-vis

improvement based researchimprovement based research : : aggregate aggregate level business decisionlevel business decision and functional decision and functional decision

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THANK YOUTHANK YOU