MRA’s – The Indian Experience Anupam Kaul Director Central Marks Department

Bureau of Indian StandardsBureau of Indian Standards

MRA’s – The Indian Experience

Anupam KaulDirector

Central Marks DepartmentBureau of Indian Standards

Bureau of Indian StandardsBureau of Indian StandardsCONFORMITY ASSESSMENT IN INDIA

STANDARDS

BIS(Member ISO/IEC)

Specialist Bodies

Regulatory Bodies

ACCREDITATION

NABCB(QCI)

Member IAF

NABL(DST)

Member APLAC/ILAC

NABAT(QCI)

SystemCertification

Bodies

InspectionBodies

Auditing / Training Personnel

LabAssessment

Personnel

Testing/Calibration

Labs

NPL

Metrology

Bureau of Indian StandardsBureau of Indian StandardsTECHNICAL REGULATIONS in

INDIAThe main Acts/Regulations/Control orders to regulate trade :Prevention of Food Adulteration Act 1954Plant Quarantine (Regulation of Import into India) Order, 2003Meat Food Product Order 1973Milk And Milk Product Order 1992Bureau Of Indian Standards Act, 1986Standards On Weight And Measurement Act 1976Livestock Importation Act 1898AGMARK Act 1937

The Infant Milk Substitutes, Feeding Bottles and Infant Foods Act

Export (Quality Control and Inspection) Act, 1963

Essential commodities Act

Indian Explosives Act

Energy Conservation Act, 2001

Bureau of Indian StandardsBureau of Indian StandardsINDIA – REGULATORY AGENCIES

IMPORTANT AGENCIES INVOLVED IN QUALITY REGULATION

Directorate General of Health Services PFA Ministry of Food Processing Industry FPO Department of Industrial Policy & Promotion BIS & EC Acts Directorate of Marketing and Inspection AGMARK Department of Agriculture & Cooperation Plant Quarantine Department of Animal Husbandry & Dairying MMPO Department of Legal Metrology Weights & Measures Act Bureau of Energy Efficiency Energy Conservation Act Chief Controller of Explosives Indian Explosives Act Directorate General of Mines Safety Coal Mines Regulations Ministry for Road Transport CMVR Central Pollution Control Board


IMPORTS

EXPORTS

EIC

PRODUCT CERTIFICATION - MANDATORY

DOMESTIC

BIS for 109

Products

Bureau of Indian StandardsBureau of Indian StandardsFOREIGN TRADE –

QUALITY REGULATION

FOR IMPORTS:

• Directorate General of Foreign Trade • Relevant Regulatory Agency• BIS for 109 Products

FOR EXPORTS:

Export Inspection Council for about 1000 notified products (Food, footwear, chemicals, engineering, leather, jute etc)


109 Products• Food Colours & Food Additives

• Cement

• Gas Cylinders

• Electrical Appliances

• Infant Milk Products

• Pressure Stoves

• Steel Tubes

• Miners’ Safety Equipment

• Packaged Drinking Water and Natural Mineral Water

• Thermometers

Mandatory BIS Certification


• Product certification Schemes– For Domestic industry– Foreign Manufacturers Certification

Scheme– Indian importers Certification Scheme.

No Accreditation at present

• Management System Certification Schemes– Domestic

Accreditation by RvA

BIS Certification activities


Developed countries apply stricter SPS/TBT measures and control to developing countries

Burden of proof to establish equivalence is on exporting country Controls in developing countries weak and fragmented SPS/TBT requirements incompatible with production and marketing

systems Costs for needed changes act as trade restrictions (resources,

infrastructure constraints) National Standards are not harmonized with ISO / IEC /Codex

Standards in all sectors Accreditation of inspection/certification bodies SPS/TBT Points not effective Information on importing country requirements not available

Developed countries apply stricter SPS/TBT measures and control to developing countries

Burden of proof to establish equivalence is on exporting country Controls in developing countries weak and fragmented SPS/TBT requirements incompatible with production and marketing

systems Costs for needed changes act as trade restrictions (resources,

infrastructure constraints) National Standards are not harmonized with ISO / IEC /Codex

Standards in all sectors Accreditation of inspection/certification bodies SPS/TBT Points not effective Information on importing country requirements not available

FOREIGN TRADE - KEY PROBLEMS

Bureau of Indian StandardsBureau of Indian StandardsPROBLEMS DUE TO MULTIPLE

AGENCIES

• CONFUSION AMONG EXPORTERS FROM OTHER COUNTRIES AS TO WHICH ARE THE ACTUAL NATIONAL STANDARDS

• MULTIPLICITY OF CERTIFICATION PROCEDURES / OPERATIONAL DIFFERENCES

• THE NEED TO NEGOTIATE CONFORMITY ASSESSMENT REQUIREMENTS WITH MULTIPLE AGENCIES

• SEPARATE AGREEMENTS REQUIRED FOR EXPORTS AND IMPORTS

• DIFFERENCES IN APPROACH AMONG AGENCIES INVOLVED

Bureau of Indian StandardsBureau of Indian StandardsMOUs / MRAs : Present Status

BIS• Agreement with Bhutan to extend

Certification Services, 1997• Agreement with Nepal to conduct

inspections for each other, 2004• MOU with Bangladesh (to be signed) for

exchanging information• MRA with Sri Lanka (under negotiation)

for mutual acceptance of results


EIC• Designated Competent Authority by EC for marine

products• Recognised by USFDA for Black Pepper• Recognised by Australian Quarantine & Inspection

Service in December 2002 for marine products• Recognised by Sri Lanka Standards Institution (SLSI)

for 85 products (Agreement signed in December 2002)


Government• Comprehensive Economic Cooperation Agreement between

Governments of India and Singapore which includes mutual acceptance of conformity assessment results based on Guide 65, ISO / IEC 17025 in Sectors such as Food, Electrical & Electronics, Telecom, Agriculture and meat products (likely to finalize in Nov 2004)

• Comprehensive Economic Partnership Agreement between Governments of India and Sri Lanka, includes mutual acceptance of conformity assessment results (areas under regulated sector to be identified)

• Agreement on South Asian Free Trade Area among 7 SARC countries. The Agreement provides for free trade in goods among SAARC member countries. Group MRA as per Guide 68 proposed.


MRA 5 Stage Model

BIS has evolved a 5 Stage MRA model, designed on gradual confidence building among 2 or more MRA partners. This model is under negotiation with SLSI Sri Lanka and will also be proposed to other SAARC countries for mutual acceptance of Product Certification results both in mandatory as well voluntary sectors, where Standards are harmonized.


MRA 5 Stage Model

Phase 1 :Carrying out surveillance inspections and drawal of samples for independent testing on request

Phase 2 : Authorize each other for carrying out pre-certification evaluation of applicant units

Phase 3 : Accept Results of samples tested in each other’s accredited laboratories to importing country’s standards

Phase 4 : Accept Inspection / Test Reports of each other (after harmonization of Standards and practices) for taking certification decisions

Phase 5 : Grant licence based on similar licence granted by MRA partner and continue on same basis


MRA with Singapore

• Framework Agreement between Governments• Each country shall appoint a Designating

Authority for Imports and For Exports• DA shall designate the conformity Assessment

body in relevant fields based on guide 65 accreditation in consultation with counterpart DA

• Importing country to accept Certification granted by Designated CAB

• Certification restricted to territory of specific countries

Bureau of Indian StandardsBureau of Indian Standards RESOLVING ISSUES-INDIAN FOCUS

• Participating in international standardization –systematize, review standards & harmonize

• Harmonization within country – ROLE CLARITY• Regulatory bodies to be trained on Conformity

Assessment Guides and Standards• Strengthening Notification System• Transparency

All standards & CA procedures to be centrally notifiedRequirements of importing countries made available

• Conformity Assessment InfrastructureLabs – identify and strengthen sectorwise & NETWORKProduct Certification bodies to get accredited to Guide 65


MercMercii

DankDanke gute gut

Thank Thank youyou

DhanyavadDhanyavad

Documents

MRA’s – The Indian Experience Anupam Kaul Director Central Marks Department