Bureau of Indian Standards (BIS) and Quality Control Orders
26 Sep 2023
Overview of BIS Certification and Key Updates
The Bureau of Indian Standards (BIS) is the national standards body of India (established under the BIS Act, 2016) which promotes the development of standardization and quality certification of goods. The BIS Product Certification Scheme under the BIS Act, 2016, provides a third-party guarantee of quality, safety, and reliability of products to end consumers located in India.
How are Certifications Granted?
Under the BIS Act 2016, BIS Rules 2018, and BIS (Conformity Assessment) Regulations 2018, there is a provision for Grant of Licence (GoL). The BIS grants a license to both domestic and foreign manufacturers of chemicals based on a successful assessment of manufacturers' infrastructure, production processes, quality controls, and testing capabilities through a visit to the manufacturing premises. The BIS also assesses the product's conformity to relevant Indian Standards (IS) through third‑party laboratory testing or testing in the manufacturing premises, or a combination of both. All products that are certified under the BIS Product Certification Scheme(s) can use the BIS Standard Mark.
What is FMCS?
The BIS has been operating Foreign Manufacturing Certification Scheme (FMCS) certification since the year 2000 under BIS Act, 2016 and the rules and regulations framed thereunder. Under FMCS, the license is issued to a foreign manufacturer to use the BIS Standard Mark on a product that qualifies under the IS. The license is given by the Foreign Manufacturers Certification Department (FMCD). Products that fulfil the necessity of the IS can obtain the license under the mandatory or voluntary certification.
Who Can Apply for the Foreign Manufacturing Certification Scheme?
Manufacturers who have their factory locations outside India can apply for FMCS certification. They must:
- Have all manufacturing facilities or machinery at their factory premises;
- Have competent testing personnel in their lab to test products;
- Ensure conformity of their product to applicable Indian Standard Specifications (ISS);
- Have all arrangements or equipment in their factories for product testing as per ISS;
- Accept the Scheme of Testing and Inspection (SIT) and Marking Fee; and
- Accept the Terms and Conditions of the license.
Mandatory Products Under the Foreign Manufacturing Certification Scheme
Under the FMCS, the following products require FMCS certification:
- Medical equipment
- Aluminium foil
- Batteries
- Food and food-related products
- Kitchen appliance
- Electric motors
- Chemicals and fertilisers
- Cables
- Electric transformers
- Cattle Feeds
- Others
Procedure for Obtaining the FMCS License
- Complete the application form and submit it along with the required documents.
- Pay the necessary fee for the application.
- Conduct a factory inspection to assess the manufacturing and testing infrastructure; during the inspection, a sample of the product will be drawn for independent testing.
- Once the inspection and independent test report confirm compliance with BIS standards, the registration process proceeds.
- Pay the license fee and advance minimum marking fee.
- Sign the Agreement and Indemnity Bond, and provide a $10,000 (USD) Performance Bank Guarantee after the license is granted.
- The FMCS certificate will be issued if the product meets the BIS standards.
Benefits Provided by the FMCS License
- Indian Mark: The license allows foreign manufacturers to use the Indian mark on their products, indicating compliance with IS.
- Conformity: The FMCS ensures that the certified products meet the required IS, enhancing their credibility and reliability in the Indian market.
- Market Access: With the FMCS license, foreign manufacturers gain access to the Indian market, allowing them to expand their reach and cater to the growing consumer base in India.
- Consumer Trust: The use of the Indian mark through FMCS certification builds trust among Indian consumers, as they associate it with quality and conformance to standards.
- BIS Recognition: The FMCS license is granted by the FMCD at BIS Headquarters in New Delhi, providing official recognition by a reputable authority.
Timeline for Processing the Application
Acquiring the BIS registration certificate under Scheme I takes around 5 to 6 months from the date of receipt of the complete application and its recording.
Validity of the Registration Certificate
The registration certificate under Scheme I (for import) is initially valid for 2 years from the date of issuance. After this period, the license needs to be renewed for up to 5 years.
Quality Control Orders Updates under BIS
Change in Effective Date for Certain Quality Control Orders (10 March)
The Ministry of Chemicals and Fertilizers has notified amendment to the effective date of certain Quality Control Orders. The Orders concerning the following products shall come into force on 12 June 2023:
- Acrylonitrile - Butadiene Styrene (ABS)
The Orders concerning the following products shall come into force on 12 March 2024:
- Polycarbonate
- Vinyl Chloride Monomer
- Ethylene Dichloride
Change in Effective Date for Certain Quality Control Orders for Polyurethane and P-xylene (16 March)
The Ministry of Chemicals and Fertilizers has notified that the Quality Control Orders applicable to Polyurethane and p-Xylene shall come into force on 19 March 2024.
Change in Effective Date for Certain Quality Control Orders for Ethylene Glycol (23 March)
The Ministry of Chemicals and Fertilizers has notified that the Quality Control Order applicable to Ethylene Glycol shall come into force on 28 June 2023.
Change in Effective Date for Certain Quality Control Orders (31 March)
The Ministry of Chemicals and Fertilizers has notified amendment to the effective date of certain Quality Control Orders. The Orders concerning the following products shall come into force on 0 3 October 2023:
- Ethylene Vinyl Acetate Copolymers
- Polyethylene Material for Moulding and Extrusion
The Orders concerning the following products shall come into force on 03 July 2023:
- Polyester Continuous Filament Fully Drawn Yarn
- Polyester Partially Oriented Yarn
- Polyester Industrial Yarn
- 100 Percent Polyester Spun Grey and White Yarn
How Intertek Can Help
Our team of regulatory experts supports foreign and domestic chemicals manufacturers with meeting the BIS Product
Certification Scheme requirements. Our services include:
- Verifying product scope according to Indian Standards as per Scheme I.
- Assisting our clients in the preparation of the documentation for the submission of the application.
- Arranging for applications to be submitted to the BIS authority.
- Answering queries raised by the BIS.
- Co-ordinating for the BIS site audit process and providing documentation support.
- Coordinating with the BIS after submission of the application until license is granted.
Please contact chemicals.assuris@intertek.com if you have any questions.
Suyash Kanase,
Regulatory Associate,
Intertek Assuris
Suyash Kanase has over five years of experience in chemical and regulatory compliance. Currently, he supports clients in Central and South Asia and the Middle East in complying with chemical safety and environmental regulations. He has been involved in in various aspects of Indian regulations, including the Bureau of Indian Standards, India REACH, extended producer responsibility (EPR), and Material Safety Data Sheets (MSDS), as well as keeping track of regulatory developments.
His regulatory and chemical compliance experience comes with expertise in risk assessments, sustainability, and science-based assurance services. He believes "regulations force people to do better."