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

CONFORMITY ASSESSMENT IN INDIA BIS (Member ISO/IEC) System Certification Bodies Inspection Bodies NABCB (QCI) Member IAF STANDARDS ACCREDITA TION Specialist Bodies Regulatory Bodies NABL (DST) Member APLAC/ ILAC NABAT (QCI) NPL Testing/ Calibration Labs Lab Assessment Personnel Auditing / Training Personnel Metrology

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

INDIA – 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

PRODUCT CERTIFICATION - MANDATORY IMPORTS EXPORTS Regulatory Bodies BIS for 109 Products EIC DOMESTIC

FOREIGN 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)

Mandatory BIS Certification 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

BIS Certification activities 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

FOREIGN TRADE - KEY PROBLEMS 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

PROBLEMS 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

MOUs / 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

MOUs / MRAs : Present Status 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)

MOUs / MRAs : Present Status 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

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 notified Requirements of importing countries made available Conformity Assessment Infrastructure Labs – identify and strengthen sectorwise & NETWORK Product Certification bodies to get accredited to Guide 65

Danke gut Merci Dhanyavad Thank you