Environment p A

8/8/2019 Environment p A

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CHANDRA SHEKHARDeputy Director General

Bureau of Indian Standards

New DelhiINDIA

www.bis.org.in


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REGULATORY REQUIREMENTS IN

INDIA

To safeguard health and safety, Government of IndiaTo safeguard health and safety, Government of Indiapromulgates regulatory requirements for manufacturepromulgates regulatory requirements for manufactureand sale of goods and services, including those importedand sale of goods and services, including those imported

Regulations are stipulated through Various Acts/ Rules &Regulations are stipulated through Various Acts/ Rules &Regulations by different Ministries under Government ofRegulations by different Ministries under Government ofIndiaIndia

Enactment of Acts, Rules & Regulations is done takingEnactment of Acts, Rules & Regulations is done takingcognizance of the relevant WTO Agreementscognizance of the relevant WTO Agreements


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REGULATORY REQUIREMENTSREGULATORY REQUIREMENTS-- KeyKey

ConsiderationsConsiderations

Regulatory measures should be minimum requiredRegulatory measures should be minimum required

Regulatory measures should have minimum complianceRegulatory measures should have minimum compliancecostscosts

Regulatory measures should benefit societyRegulatory measures should benefit society

Regulatory measures should comply with the laws of theRegulatory measures should comply with the laws of thecountrycountry


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REGULATORY REQUIREMENTSREGULATORY REQUIREMENTS-- KeyKey

Considerations (contd)Considerations (contd)

Regulations should be made & enforced in a transparentRegulations should be made & enforced in a transparentmannermanner

Regulations should be fair and treat all equitablyRegulations should be fair and treat all equitably

Regulations should be drafted in clear and simpleRegulations should be drafted in clear and simplelanguage for understanding of alllanguage for understanding of all

Regulatory measures should be flexible for amendments/Regulatory measures should be flexible for amendments/revision , if required due to changed circumstancesrevision , if required due to changed circumstances


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FOREIGN TRADEFOREIGN TRADE

QUALITY REGULATIONS IN INDIAQUALITY REGULATIONS IN INDIA

FOR IMPORTS:FOR IMPORTS:

Directorate General of Foreign TradeDirectorate General of Foreign Trade

Relevant Regulatory AgencyRelevant Regulatory Agency

BIS for 68 ProductsBIS for 68 Products

FOR EXPORTS:FOR EXPORTS:

Export Inspection CouncilExport Inspection Council


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SOME ACTS/ REGULATIONS/SOME ACTS/ REGULATIONS/CONTROL ORDERS TOCONTROL ORDERS TO

REGULATE TRADE IN INDIAREGULATE TRADE IN INDIA

AGENCIES INVOLVEDAGENCIES INVOLVED

Prevention of Food Adulteration ActPrevention of Food Adulteration Act19541954(on the pattern of USFDA)(on the pattern of USFDA)

Directorate General of HealthDirectorate General of HealthServicesServices

Plant Quarantine (Regulation ofPlant Quarantine (Regulation ofImport into India) Order, 2003Import into India) Order, 2003

Department of Agriculture &Department of Agriculture &CooperationCooperation

Insecticides ActInsecticides Act Deptt. Of Agriculture and coDeptt. Of Agriculture and co--operationoperation

Fruit Products Order, 1955Fruit Products Order, 1955 Ministry of Food ProcessingMinistry of Food ProcessingIndustriesIndustries

Meat Food Product Order 1973Meat Food Product Order 1973 Ministry of Food ProcessingMinistry of Food ProcessingIndustriesIndustries

Milk and Milk Product Order 1992Milk and Milk Product Order 1992 Directorate General of HealthDirectorate General of HealthServicesServices

Standards on Weight andStandards on Weight andMeasurement Act 1976Measurement Act 1976

Department of Legal MetrologyDepartment of Legal Metrology

Bureau of Indian Standards act, 1986Bureau of Indian Standards act, 1986 Department of Consumer Affairs,Department of Consumer Affairs,Govt. of IndiaGovt. of India

AGMARK Act 1937AGMARK Act 1937 Directorate of Marketing andDirectorate of Marketing andInspectionInspection


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SOME ACTS/ REGULATIONS/SOME ACTS/ REGULATIONS/CONTROL ORDERS TO REGULATECONTROL ORDERS TO REGULATE

TRADE IN INDIATRADE IN INDIA

AGENCIES INVOLVEDAGENCIES INVOLVED

Drugs & Cosmetics RulesDrugs & Cosmetics Rules Ministry of Health & FamilyMinistry of Health & FamilyWelfareWelfare

Textiles Regulation 1988Textiles Regulation 1988 Ministry of TextilesMinistry of Textiles

Export (Quality Control andExport (Quality Control andInspection) Act, 1963Inspection) Act, 1963

Export Inspection Council ofExport Inspection Council ofIndiaIndia

Indian Explosives Act,1884Indian Explosives Act,1884 Chief Controller of ExplosivesChief Controller of Explosives

Mines ActMines Act Directorate General of MinesDirectorate General of MinesSafetySafety


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ACTS/ REGULATIONS/ CONTROLORDERS

To regulate trade

through Mandatory Certification byBIS

PRODUCTS

Prevention of Food Adulteration Act1954

Infant Milk Products, Packaged

Drinking Water and Natural Mineral

Water

The Infant Milk Substitutes, FeedingBottles and Infant Foods (regulation ofproduction, supply and distribution),Act

Plastic Feeding Bottles

Bureau of Indian Standards Act, 1986 Electrical Wires, Cables, Appliances

and Protection Devices and

Accessories

Indian Explosive Act,1884 Gas Cylinders

Bureau of Indian Standards Act, 1986 Clinical Thermometers

Essential Commodities Act,1955 Pressure stoves, Steel Tubes

Environment (Protection), Act 1986 Compression ignition (diesel)engines

Bureau of Indian Standards Act, 1986 Cement


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BUREAU OF INDIAN STANDARDSBUREAU OF INDIAN STANDARDS

INDIAN STANDARDS INSTITUTION [now known as BUREAU OFINDIANINDIAN STANDARDS INSTITUTION [now known as BUREAU OFINDIANSTANDARDS( BIS)] set up on 6 JANUARY 1947STANDARDS( BIS)] set up on 6 JANUARY 1947

BIS is functioning under MINISTRYOF CONSUMER AFFAIRS, FOOD AND PUBLICBIS is functioning under MINISTRYOF CONSUMER AFFAIRS, FOOD AND PUBLICDISTRIBUTION, GOVT OFINDIA as a statutory body under BIS ACT, 1986 withDISTRIBUTION, GOVT OFINDIA as a statutory body under BIS ACT, 1986 witheffect from 1 APRIL 1987effect from 1 APRIL 1987

NATIONAL STANDARDS BODY ofINDIANATIONAL STANDARDS BODY ofINDIA

OBJECTIVESOBJECTIVES

Harmonious, development of standardization and quality control in national andHarmonious, development of standardization and quality control in national and

international arenainternational arena

Certification schemes for products and systemsCertification schemes for products and systems

Growth and development ofIndian industry, commerce and exportsGrowth and development ofIndian industry, commerce and exports

Consumer protectionConsumer protection


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APPROACH TO STANDARDIZATIONAPPROACH TO STANDARDIZATION

Standards formulated by BIS areStandards formulated by BIS areprimarily, voluntary in natureprimarily, voluntary in nature

Through various Acts/ Regulations, outThrough various Acts/ Regulations, outof the more than 18 000 standardsof the more than 18 000 standardsformulated so far, only 68 standardsformulated so far, only 68 standardsare subject to Mandatory Certificationare subject to Mandatory Certification


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ManufacturersManufacturers

Consumers,Consumers, Government

Departments

Technologists ,Technologists , Regulating

Authorities, Testing

Laboratories, Consultants,

Universities, Other Experts

TECHNICAL COMMITTEESTRUCTURE

(Members From)

ManufacturersManufacturers

Consumers,Consumers,GovernmentDepartments

Technologists , RegulatingAuthorities, TestingLaboratories, Consultants,Universities, Other Experts

BASIC APPROACHBASIC APPROACH

Consensus PrincipleConsensus Principle

BalancedBalancedCommitteeCommitteeStructureStructure


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STANDARDS FORMULATIONSTANDARDS FORMULATION--BASIC STEPSBASIC STEPS

Accepted Code of Good Practice of TBT AgreementAccepted Code of Good Practice of TBT Agreement

International standards/ their relevant parts areInternational standards/ their relevant parts areused in standards settingused in standards setting

However in case of fundamental technical/However in case of fundamental technical/geographical/ climatic problems, standards are setgeographical/ climatic problems, standards are setas per national requirementsas per national requirements

As NSB BIS takes full part in the development ofAs NSB BIS takes full part in the development ofInternational Standards, relevant to the nationalInternational Standards, relevant to the national

needs.needs.


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STANDARDS FORMULATIONSTANDARDS FORMULATION--

CONSENSUS & TRANSPARENCYCONSENSUS & TRANSPARENCY

All standards are widely circulated at draft stageAll standards are widely circulated at draft stage

Period of comments is generally not less than 3Period of comments is generally not less than 3months,months,

For urgent reasons pertaining to safety, health orFor urgent reasons pertaining to safety, health orenvironment, period can be reducedenvironment, period can be reduced

Drafts documents are hosted on BIS website forDrafts documents are hosted on BIS website forpublic commentspublic comments

All comments are duly considered by theAll comments are duly considered by theappropriate authoritiesappropriate authorities

Programme of Work is published and also hosted onProgramme of Work is published and also hosted onBIS website and is periodically updatedBIS website and is periodically updated


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STANDARDS FORMULATEDSTANDARDS FORMULATED

OVERVIEWOVERVIEW INDIAN STANDARDS PUBLISHEDINDIAN STANDARDS PUBLISHED -- 1831518315

CORRESPONDING ISO/IEC STANDARDSCORRESPONDING ISO/IEC STANDARDS -- 58215821

STANDARDS HARMONIZED WITH ISO/IECSTANDARDS HARMONIZED WITH ISO/IECSTANDARDSSTANDARDS(About 76%)(About 76%) -- 44494449

DIVISIONAL COUNCILSDIVISIONAL COUNCILS 1414

TECHNICAL COMMITTEES 301TECHNICAL COMMITTEES 301

TECHNICAL EXPERTSTECHNICAL EXPERTS 1175011750

(Sec. Com+ Sub Com+ Panel)(Sec. Com+ Sub Com+ Panel)


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FIRST

DRAFT

CIRCULATIONTO

COMMITTEE

MEMBERS

P-DRAFT

COMMENTS

CIRCULATION

TO

COMMITTEE

MEMBERS

COMMENTS

PUBLIC

CIRCULATION

COMMENTS

NATIONAL

STANDARD

NEW

WORK

ITEM

MEETINGWC

DRAFT

ADOPTION -- DIVISION

COUNCIL

F-DRAFT

STANDARD

MEETING


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CONFORMITY ASSESSMENTCONFORMITY ASSESSMENT

PRACTICESPRACTICES


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CERTIFICATION ACTIVITIES OF BISCERTIFICATION ACTIVITIES OF BIS

OperatingOperating underunder anan ActAct ofof IndianIndian ParliamentParliament (BIS(BIS ActAct19861986))

OffersOffers thirdthird partyparty assuranceassurance

BasedBased onon wellwell defineddefined schemescheme ofof testingtesting andandinspectioninspection

EnsuringEnsuring adequacyadequacy ofof inin--processprocess qualityquality controlcontrol


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CERTIFICATION ACTIVITIES OF BISCERTIFICATION ACTIVITIES OF BIS

(contd.)(contd.)

Supported by:Supported by:

Testing LaboratoriesTesting Laboratories

BIS LabsBIS Labs

Other LabsOther Labs

Accreditation under National Laboratory AccreditationAccreditation under National Laboratory Accreditation

Scheme according to ISO/IEC 17025Scheme according to ISO/IEC 17025

Traceability to APLAC/ILAC.Traceability to APLAC/ILAC.


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CERTIFICATION SCHEMECERTIFICATION SCHEME

Based on Type 5 of ISO Guide 28 which includes:Based on Type 5 of ISO Guide 28 which includes:

Type testing and assessment of factory quality controlType testing and assessment of factory quality control

and its acceptance followed byand its acceptance followed by

Surveillance that takes into account audit of factorySurveillance that takes into account audit of factoryquality control, andquality control, and

Testing of samples both from factory andTesting of samples both from factory and open marketopen market


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CERTIFICATION SCHEME FORCERTIFICATION SCHEME FORFOREIGN MANUFACTURERSFOREIGN MANUFACTURERS

Scheme for Foreign ManufacturersScheme for Foreign Manufacturers

9393 licenceslicences grantedgranted inin 1616 countriescountries suchsuch asas France,France,UAE,UAE, SouthSouth Korea,Korea, Nepal,Nepal, Switzerland,Switzerland, ThailandThailandBhutan,Bhutan, China,etcChina,etc..

ProductsProducts certifiedcertified includeinclude PackagedPackaged DrinkingDrinking Water,Water,Cement,Cement, WoodWood Products,Products, SteelSteel Products,Products, MilkMilkProducts,Products, ClinicalClinical Thermometers,Thermometers, EnergyEnergy Meters,Meters,ElectricalElectrical AppliancesAppliances && SwitchgearSwitchgear itemsitems etcetc..


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NOTIFICATION PRACTICESNOTIFICATION PRACTICES

Criteria for notification includes assessment of:Criteria for notification includes assessment of:

whether international standard exists or technical contentwhether international standard exists or technical contentdiffers from international standardsdiffers from international standards

impact of regulation on tradeimpact of regulation on trade

whether regulation deals with technical requirements or SPSwhether regulation deals with technical requirements or SPSmeasures for a product/group of products (relevance under themeasures for a product/group of products (relevance under theTBT and SPS Agreements)TBT and SPS Agreements)

Various sources that are consulted:Various sources that are consulted:

TBT Agreement, and relevant Committee recommendations andTBT Agreement, and relevant Committee recommendations anddecisionsdecisions

regulatory agency responsible for the regulationregulatory agency responsible for the regulation


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NOTIFICATION PROCEDURESNOTIFICATION PROCEDURES

PREPARATIONPREPARATION

Initiated by regulator of proposed legislationsInitiated by regulator of proposed legislations

Complete notification format by the Regulatory Body inComplete notification format by the Regulatory Body inconsultation with Ministry of Commerceconsultation with Ministry of Commerce

Clear and descriptive outline of the regulatory proposalClear and descriptive outline of the regulatory proposal

Give adequate time to comment on the proposalGive adequate time to comment on the proposal

Reasonable time for adoption of measureReasonable time for adoption of measure

SUBMISSIONSUBMISSION Prepared notifications are sent to WTO Central Registry ofPrepared notifications are sent to WTO Central Registry of

Notifications (CRN) by National Notification AuthorityNotifications (CRN) by National Notification Authority


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MOUs/ MRAsMOUs/ MRAs-- TOOLS FOR REGULATORYTOOLS FOR REGULATORY

COOPERATIONCOOPERATION

BIS has signed MOUs with 15 countries with a view toBIS has signed MOUs with 15 countries with a view to

Enhance cooperation in standardisation & conformityEnhance cooperation in standardisation & conformityassessmentassessment

Facilitate sharing of expertise and mutual tradeFacilitate sharing of expertise and mutual trade

MRA with SRILANKA :MRA with SRILANKA :

Trade FacilitationTrade Facilitation


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INDO US COOPERATIONINDO US COOPERATION

INITIATIVEINITIATIVEINDO US Portal is a commitment by BIS & ANSI to:INDO US Portal is a commitment by BIS & ANSI to:

Provide common platform for required transparencyProvide common platform for required transparency

Facilitate sharing of information on trade issuesFacilitate sharing of information on trade issues

Provide mutual support at international foraProvide mutual support at international fora

Facilitate harmonisation of Standards & ConformityFacilitate harmonisation of Standards & ConformityAssessment Procedures through increasedAssessment Procedures through increasedtransparencytransparency


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REGIONAL COOPERATIONREGIONAL COOPERATIONINITIATIVESINITIATIVES

Establishment of SARSO (South Asian Regional StandardsEstablishment of SARSO (South Asian Regional StandardsAssociation)Association)

Objectives:Objectives:

Coordination & Cooperation between SAARC countries inCoordination & Cooperation between SAARC countries instandards & Conformity Assessmentstandards & Conformity Assessment

Develop harmonised standardsDevelop harmonised standards

Facilitate intra regional tradeFacilitate intra regional trade

Promote MRAs on conformity assessmentPromote MRAs on conformity assessment


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THANK YOUTHANK YOU

Documents

Environment p A