3.158.  Over the review period, the legislation on standardization was substantially amended when the Bureau of Indian Standards (BIS) Act, 2016, came into force in 2017, replacing the BIS Act, 1986. As a result of the introduction of the new BIS Act: (i) multiple conformity assessment schemes, including self-declaration of conformity, became possible; (ii) any agency, in addition to the BIS, may be appointed by the Central Government to assess conformity for mandatory certification; (iii) the Central Government may require any product to be brought under mandatory certification; (iv) mandatory hallmarking for gold and silver was introduced; (v) further measures to protect consumers were introduced; (vi) measures may be taken against retailers (not only manufacturers) and individuals (not only companies) for non-compliance with Indian standards; and (vii) more severe penal provisions were introduced. The 2016 Act covers goods, services, systems, and processes; previously, only goods were covered.[216]

3.159.  The BIS, under the Department of Consumer Affairs, is responsible for standardization. It was officially established as India's national standards body under the BIS Act, 2016

3.160.  The BIS formulates Indian standards in all sectors, except in those stipulated in the Agricultural Produce (Grading and Marking) Act, 1937, and the Drugs and Cosmetics Act, 1940.[217] In this context, the Directorate of Marketing and Inspection (DMI) under the Ministry of Agriculture and Farmers' Welfare, issues grading standards for 164 commodities; and the Central Drugs Standard Control Organization (CDSCO) issues standards for drugs and medical devices.[218] The BIS may recognize other standards-developing organizations (SDOs) in India that develop sector-specific standards; however, this has not yet been done.[219]

3.161.  The procedure to adopt Indian standards has not been substantially revised since 2015 (Chart 3.4). Indian standards are developed by sectional (technical) committees, comprising public and private-sector representatives, and academics. Individuals, industries, and public agencies may submit proposals to formulate standards to the committees. It takes 9 to 24 months to formulate a standard.[220] The use of Indian standards is voluntary, but may become mandatory if it is stipulated in a contract or referred to in a piece of legislation or in a Quality Control Order issued by the Department for Promotion of Industry and Internal Trade (DPIIT).[221] In this case, Indian standards would become technical regulations. The relevant ministry is responsible for deciding which standards should become technical regulations. Standards are reviewed every five years (or earlier).[222] In March 2018 (latest data available), there were 19,294 Indian standards, 27.3% of which were harmonized with international standards.[223] India has a free online catalogue, but standards are not free of charge.[224] a The BIS has 14 Division Councils. Source: Section 22, BIS Rules, 2018; and BIS, Process of Standards Formulation. Viewed at: https://bis.gov.in/?page_id=188

3.162.  Technical regulations are formulated in accordance with the Code of Good Practice of the WTO Agreement on Technical Barriers to Trade and by sectoral legal instruments. In India, the relevant sectoral entities are responsible for formulating and implementing technical regulations.[225] Technical regulations apply to both domestically produced goods and imports

3.163.  The steps to develop technical regulations are broadly common to all sectors, and did not change substantially over the review period (Chart 3.5). In general, draft technical regulations are subject to national and international public consultations. Comments by national stakeholders must be received within 60 days, and WTO Members have at least 60 days to provide comments. Finalizing draft technical regulations takes 6 to 12 months, including approval, vetting, and translation into Hindi. Once technical regulations are finalized as rules, regulations (or Quality Control Orders for those issued by the DPIIT), they are published in the Official Gazette and are simultaneously notified to the WTO. There is no minimum prescribed period of time for a technical regulation to enter into force; a reasonable period of time is given. Technical regulations are amended on an ad hoc basis.[226] India does not have a consolidated online catalogue of draft and approved technical regulations

3.164.  During 2015-20 (end-June), India notified 102 new technical regulations to the WTO, regarding consumer, health and environmental protection. Amendments to nine technical regulations, that had already been notified, were also submitted. During the same period, 24 specific trade concerns were raised in the WTO Committee on Technical Barriers to Trade. The BIS is the national enquiry point for the WTO for all sectors other than telecom. The enquiry point for the telecom sector is the Telecom Engineering Centre (TEC)

3.165.  Conformity assessment with Indian standards is regulated by the BIS (Conformity Assessment) Regulations, 2018, which provide for different types of conformity assessment schemes, including self‑certification.[227] Self‑certification requires the manufacturer to register with the BIS, have samples tested by BIS-recognized laboratories, and complete a self-declaration of conformity.[228]

3.166.  Product certification is voluntary, for both domestic and imported products, except for products that must comply with Indian standards, even if these are not considered technical regulations, for public health and safety and for the protection of the environment. The relevant sectoral entities, in consultation with stakeholders, decide which products require mandatory certification. There are two mandatory certification schemes: Scheme I (mandatory certification) includes 264 products (up from 92 in 2015) which require factory and market surveillance. These include certain types of cement, household electrical devices, food products (e.g. milk powder), and steel and steel products; and Scheme II (mandatory registration) includes 50 electronics and IT products, and solar photovoltaic products, which only require market surveillance.[229]

3.167.  In addition to the two current schemes, the Central Government may introduce others

3.168.  Certified products may use the BIS Standard Mark (ISI symbol). Licences to use this symbol are granted for up to two years and may be renewed for up to five years.[230] Foreign manufacturers must have an authorized representative in India to obtain a licence to use the BIS Standard Mark (ISI symbol). The terms to grant a licence to a foreign manufacturer varies according to the product. The certification process for imports includes an on-site visit. The licence fee amounts to INR 1,000.[231] The BIS also manages the ECO Mark for environmentally friendly products; its use is voluntary

3.169.  The BIS has eight laboratories to perform conformity assessment tests. It also recognizes other laboratories (OSLs) (some 243), which comply with the BIS Laboratory Recognition Scheme, 2018; no overseas OSLs have been recognized.[232] OSL services are used when testing is not viable for the BIS.[233] The accreditation of laboratories is carried out by the National Accreditation Board for Testing and Calibration Laboratories (NABL) and the National Accreditation Board for Certification Bodies (NABCB). Labelling

3.170.  Pre-packaged commodities for retail sale, including imports, must comply with the labelling requirements contained in the Legal Metrology (Packaged Commodities) Rules, 2011 (as amended).[234] Labels should be in either English (preferred) or Hindi. Since 2017, imports must indicate the country of origin or the place of manufacture/assembly.[235] These Rules do not apply to garments, which, since 2017, have been subject to specific labelling requirements.[236]

3.171.  Labelling of pre-packaged/pre-packed food and wholesale food packages must also comply with the requirements contained in the Food Safety and Standards (FSS) (Packaging and Labelling) Regulations, 2011.[237] No changes to the requirements (ingredients, nutritional information, etc.) were introduced over the review period. Imported food must also display the Food Safety and Standard Authority of India (FSSAI) logo, along with the FSSAI licence number. The FSSAI is in the process of reviewing the labelling regulation. In addition to the labelling requirements stipulated in the Regulations, specific labelling requirements apply to alcoholic beverages, food additives, health supplements, and organic food

3.172.  The entities involved in the development and adoption of sanitary and phytosanitary (SPS) measures are the Food Safety Standards Authority of India (FSSAI) for food safety and human health; the Directorate of Plant Protection, Quarantine and Storage, for plant health; and the Department of Animal Husbandry and Dairying, for animal health (Table 3.27). These agencies are also India's national enquiry points under the WTO SPS Agreement

3.173.  According to information provided by the authorities, India's legislative framework for food safety, animal and plant health did not undergo any major changes since 2015. India does not have a single law governing the SPS system (Table 3.28). Over the review period, several regulations to implement the Food Safety and Standards Act, 2006, were adopted; these are related to, inter alia, food or health supplements, the food-recall procedure, imports (e.g. licensing of food importers, clearance, and sampling and analysis)[238], organic food, and packaging

3.174.  The Plant Quarantine (Regulation of Import into India) Order, 2003 (PQ Order 2003) (as amended) and the Destructive Insects and Pests Act, 1914, are the main pieces of legislation that regulate India's National Plant Protection Organization (NPPO). The main objective of this legislation is to prevent the introduction of exotic pests posing a threat to agriculture; thus, they are amended as required by the changing phytosanitary conditions. To prevent the introduction and/or spread of quarantine pests and ensure their control, imports of plants/plant products (for consumption and propagation); germplasm/genetically modified organisms (GMOs)/transgenic plant material for research purposes; deleterious weed species; and live insects/fungi and other microbial cultures/bio‑control agents may be prohibited, restricted or regulated

3.175.  Imports of primary agricultural products require a sanitary-phytosanitary import permit, following the requirements established by PQ Order 2003. Under the Order, plants and plant materials may be imported after an Import (Pest) Risk Analysis (PRA) is conducted, based on scientific principles[239]; thereafter, products are categorized under Schedules IV (prohibited), V (imported on the recommendation of an identified institution with a phytosanitary certificate), VI (import permit and phytosanitary certificate are mandatory), VII (may be imported without an import permit/less risk) and VIII (weeds that require quarantine)

3.176.  To import plants and plant materials other than those listed in the Schedules, importers must file an application to conduct a PRA, to include the agricultural commodities in the relevant Schedule. PRAs involve: an evaluation of the risk of introducing a pest, its establishment, and spread potential; an assessment of the economic and environmental impact of its introduction; and the need to adopt risk-mitigating measures. It may also involve the visit of phytosanitary experts to the production site to carry out pre-shipment inspections and evaluate postharvest treatment technologies and quarantine inspection, and certification facilities. The cost of such a visit is borne by the exporting country. In the event of interception of a quarantine pest in imported consignments, further imports are suspended until the earlier PRA is reviewed and the risk-mitigating measures are evaluated

3.177.  Agricultural commodities are classified into two categories, namely: plants and plant materials for consumption, which may be imported through all the notified ports under PQ Order 2003[240]; and seeds and propagative materials for sowing/propagation, which may be imported only through six major ports: Amritsar, Bengaluru, Chennai, Kolkata, Mumbai and New Delhi. Commodities meant for consumption may be imported through all the notified ports under PQ Order 2003

3.178.  Imports of plants and seeds used for propagation (e.g. cuttings, saplings or bud woods), listed in Schedules V and VI of the PQ Order 2003, may be subject to post-entry quarantine inspection. These plants and seeds must be grown in post-entry quarantine facilities, established by, and at the cost to, the importer, and approved and certified by the inspection authority. The quarantine period is determined based on the type of plant materials and the time taken by them to grow to the stage where symptoms of disease appear

3.179.  Exports of agricultural commodities are checked as per the requirements of importing countries. Export inspections involve sampling and detailed laboratory tests in the case of seeds and planting materials for propagation, whereas visual examination with a hand lens, and washing tests are carried out for plant materials meant for consumption. The export inspections are conducted, in most cases, at the exporters' premises.[241]

3.180.  The Directorate of Marketing and Inspection (DMI) develops quality standards (AGMARK Standards) for any articles scheduled in the Agricultural Produce (Grading and Marketing) Act, 1937. These include fruit, vegetables, cereals, pulses, oilseeds, vegetable oils, ghee, spices, honey, creamery butter, wholemeal wheat flour (wheat atta), and chickpea flour (besan).[242] Standards are developed according to the Food Safety and Standards Act, 2006, and are based on scientific data, Codex Alimentarius and the ISO. The DMI implements a certification scheme for agricultural commodities traded in the domestic and international markets. The scheme is voluntary, except for blended edible vegetable oils and fat spreads.[243]

3.181.  The Department of Animal Husbandry and Dairying (DAHD), previously under the Ministry of Agriculture, currently under the Ministry of Fisheries, Animal Husbandry and Dairying, continues to deal with sanitary issues, related to, inter alia, imports of livestock and livestock products. These imports are also regulated by the Livestock Importation Act, 1898 (as amended)

3.182.  The DAHD is responsible for animal health and veterinary public health. It monitors and controls the production, processing and distribution of animal products, and takes measures to prevent, control and eradicate animal diseases and pests; it also exercises oversight of the safety of products, by-products and derivatives for human or animal consumption. It maintains border quarantine posts and internal control posts to ensure compliance with the sanitary requirements relating to the import or export of animals and animal products and by-products. The DAHD develops and implements central government schemes to prevent, control and contain animal diseases; and also issues guidelines to the states and UTs.[244]

3.183.  Measures taken by the DAHD are based on risk assessment carried out by the Animal Quarantine and Certification (AQC) and Services in the Central Government's official laboratories. Testing of imported livestock/livestock products is done as per health protocols issued by the DAHD. On the basis of the risk assessment, the DAHD classifies pests and diseases. The results of an analysis by official laboratories are a prerequisite for granting or cancelling permits, authorizations or registrations. To prevent and control diseases, the DAHD may inspect and visit premises, and may require that health measures are applied if products pose a threat to veterinary public health or animal health. India recognizes tests carried out by other national or foreign laboratories, authenticated by the official authority of the exporting nation, as a pre-import requirement into the country.[245]

3.184.  With respect to imports, the DAHD carries out the necessary risk assessment to determine the health conditions that regulate the importation or transit of goods, or to demonstrate the safety of products and by-products entering, or marketed in, India. These products must be accompanied by sanitary import permits (SIPs) issued by the DAHD.[246] Permits must be obtained prior to shipping from the country of origin.[247] Permits are valid for 6 or 12 months, depending on the nature of the product, and may be used for multiple consignments. Imports of animals and animal products are only allowed through designated ports, where animal quarantine and certification services are available (Amritsar, Bangalore, Chennai, Delhi, Hyderabad, Kolkata, and Mumbai). Imports of fish products are allowed through the seaport of Vishakhapatnam (Andhra Pradesh), the seaport and airport of Kochi, and the land customs station at Petrapole (only for imports from Bangladesh).[248]

3.185.  In the absence of the required import permits, the DAHD may slaughter the animals, denature the products, or return them to their place of origin. If an animal product or by-product presents a serious threat to health, and/or the sanitary measures taken do not provide a satisfactory level of control, the DAHD may suspend the movement of the product, and apply health measures or establish special conditions for the product to be able to move within India or to be returned or re-exported

3.186.  Imports of poultry and poultry products originating from a region where there was avian influenza were prohibited until 2017.[249] Since 2019, imports are allowed only from areas free of highly pathogenic avian influenza, in accordance with the World Organisation for Animal Health (OIE) Terrestrial Animal Health Code.[250]

3.187.  The main institution involved in the development of SPS measures relating to food is the FSSAI, an autonomous body established under the Ministry of Health and Family Welfare. Enforcement primarily rests with the states and UTs. The FSSAI was established under the Food Safety and Standards Act, 2006, which is a consolidating statute related to food safety regulations

3.188.  The FSSAI specifies the standards for ingredients, additives, contaminants, pesticide residues, and biological hazards. It is responsible for setting standards for food manufactured in India, and it also regulates imports of food products and recalls foodstuffs that are not safe for human consumption. According to the authorities, the standards developed by the FSSAI are based on scientific evidence and on international standards (i.e. Codex), and are duly notified to the WTO before finalization for comments and suggestions, except in case of emergency.[251] At present, there are 18 main regulations concerned with food standards and related regulatory procedures.[252]

3.189.  To establish these standards, the FSSAI establishes panels of independent scientific experts.[253] The panels review the draft standards, and provide their opinions, which are then reviewed by a scientific committee, comprising the chairs of the scientific panels and other experts.[254] Once the draft standard is approved by the Minister of Health and Family Welfare, it is notified for comment to the general public, stakeholders and the WTO. Comments are considered by the scientific committees, and appropriate changes are made to the draft standard. The revised draft standard, validated by the scientific committee and approved by the FSSAI, is sent for legal vetting to the relevant department, to seek consistency with existing legislation and constitutional requirements and, thereafter, it is approved by the Minister of Health and Family Welfare, and published

3.190.  In order to ensure compliance with food safety standards, the FSSAI relies on the National Accreditation Board for Testing and Calibration Laboratories (NABL), and referral laboratories. The FSSAI also has mobile food-testing laboratories, known as Food Safety on Wheels (FSWs), to assess food safety in areas where there are no laboratories

3.191.  Imports of food are sampled and tested, based on risk profiles established on parameters set by the FSSAI.[255] FSSAI officers are present at six entry points (Delhi, Mumbai, Kolkata, Chennai, Cochin and Tuticorin); in other locations, Customs officials may be authorized to act as FSSAI officers. The FSSAI has an online system, the Food Import Clearance System (FICS), to clear bills of entry selected through the risk management system (RMS), through the SWIFT

3.192.  The manufacture, import, research and release of GMOs, and of GMO products, are regulated by the Rules for Manufacture, Use, Import, Export and Storage of Hazardous Micro-Organisms, Genetically Engineered Organisms or Cells, 1989, under the Environment (Protection) Act, 1986. In order to implement the Rules, six competent authorities were created under the Ministry of Environment, Forest and Climate Change (MoEF&CC) (Table 3.29).[256]

3.193.  The Review Committee on Genetic Manipulation (RCGM), in the MoEF&CC's Department of Biotechnology, developed the Guidelines and Standard Operating Procedures (SOPs) that regulate activities involving the use of GMOs in R&D and in industrial and environmental applications, to ensure human health and environmental safety. All projects are reviewed by the RCGM to ensure compliance with the Guidelines and SOPs; subsequently, the production, sale, importation and use of hazardous microorganisms, GMOs or cells may be restricted or prohibited

3.194.  The RCGM issues the clearance letters/import permits for GMOs; however, these must be authorized by the Genetic Engineering Approval Committee (GEAC). The RCGM may also visit the sites where recombinant DNA projects are carried out, to ensure compliance with the Guidelines and SOPs

3.195.  During 2015-20 (June), India notified 155 new SPS measures to the Committee on SPS, most of which were related to food safety. According to the notifications, the SPS measures comply with, or are based on, relevant international standards, and they mostly apply to all Members. India took one emergency measure that applies to all trading partners.[257] During the review period, Members raised seven concerns, of which two were resolved

3.3.3  Sanitary and phytosanitary requirements