Our Support with India BIS (Conformity Assessment) Regulations, 2018

Regulation in Brief: Bureau of Indian Standards (BIS) is a national body in India. The BIS Act, 2016, Rules & Regulations is a means for providing a third-party guarantee of quality, safety, and reliability of products to the customer. Under BIS Act 2016, BIS Rules 2018 and BIS (Conformity Assessment) Regulations 2018, the provision for Grant of Licence (GoL) are addressed. It covers BIS license for both Domestic and Foreign manufactures for chemical products listed in Scheme I.

Foreign Manufacturers Certification Scheme (FMCS) – Under FMCS, licence is granted to a Foreign Manufacturer for use of Standard Mark on a product that conforms to an Indian Standard. Foreign applicant has to nominate an Indian Resident as an Authorized Indian Representative (AIR) while submitting the application. The application goes through manual submission.

Product Certification Scheme for Domestic Manufacturers – Under this scheme, licence is granted to Indian manufacturers for use of Standard Mark on a product that conforms to the Indian standard. The application shall be made in the Form-V as specified in BIS conformity assessment regulations 2018 – Scheme I. Application submission can be done online.

At REACHLaw, we help you secure India BIS Licences for the product categories listed below!

Click on the product category of your interest below to see if your product(s) placed on the Indian market needs an India BIS licence. 

• Chemicals and Textiles

• Iron and Steel

• Aluminium

• Footwear

• Toys

Exporting other products that are not listed above? Click on the link below and check if your product(s) is listed.

https://www.bis.gov.in/product-certification/products-under-compulsory-certification/scheme-i-mark-scheme/

Foreign Manufacturer:

The manufacturers, which have their factory location outside India can apply with filled prescribed Application 

The manufacturers, which have their factory location outside India can apply with filled prescribed Application Form along with necessary documentation.

You need to apply by nominating  an Authorized Indian Representative (AIR) using prescribed Nomination Form. Ensure that application is complete, refer checklist of documents/application under forms & formats.

Submit duly filled-in and complete application along with requisite fees; documentation (in duplicate) and Nomination Form of AIR at FMCD, BIS Headquarters, New Delhi.

BIS will scrutinize the application and queries, if any, will be communicated by email. The BIS designated inspector shall visit the factory to carryout verification of manufacturing & testing infrastructure and draw samples for independent testing in India. Your case would be processed for grant of licence after receipt of satisfactory inspection report & independent test report(s) conforming to applicable Indian Standard(s) in accordance with the product manuals. See steps to obtain BIS Licence:

Timeline: minimum 6 months (180 days) from date of application submission.

Domestic Manufacturer: 

Option 1 – The applicant may apply for grant of licence to the Bureau along with the required documents. A visit will be paid to the factory of the applicant for assessment of the manufacturing infrastructure, production process, quality control and testing capabilities, and the sample(s) will be drawn for testing in third party testing laboratory. The sample(s) may not be drawn in case the grant of licence is to be considered on the basis of factory testing only. Factory testing is permitted for products as listed at Annexure-I (A). For new products coming under certification, as well as for products where there is no third party laboratory, cases may be considered for GoL on factory testing basis.

Timeline: Process of grant of licence is expected to be completed within 90 days, from the date of receipt of the application provided the documentation, assessment of the unit and conformity of the product is established satisfactory at first instance during various stages.

Option 2 – For product listed in Annexure I (C), The applicant may apply for grant of licence to the Bureau along with the required documents and conforming Test Report(s) of the product samples manufactured by the applicant and of raw material(s) (if applicable) issued by a third-party testing laboratory.

A visit will be paid to the factory of the applicant for assessment of the manufacturing infrastructure, production process, quality control and testing capabilities, and draw of samples for testing in the third-party testing laboratory. The test report of the sample(s) drawn during the factory visit will be used for review purposes.

While exercising option 2, the applicant must first register itself on the IT software, wherein he will get a unique code. The applicant will have to submit this code to the third party testing laboratory while submitting the samples for testing and get the receipt for the same. The receipt will be required to be uploaded on IT software after the submission of the sample(s) to the laboratory.

Timeline: Process of grant of licence is expected to be completed within 30 days from the date of receipt of the application if factory visit is satisfactory and conformance of sample to the relevant Indian Standard(s) is established at the first instance.

For Foreign Manufacturer:

1. Authorized Indian Representative
2. Main Application Form V – Download the Form (Basic details of factory & product category)
3. ISI Application Fee – Download the Bank Details(Copy of Remittance / Payment Advice) 
4. Copy of Test Report done within a month by internal laboratory (Indicating conformance of the product to relevant Indian Standard)
5. Address Proof of the Manufacturing Unit (Factory License / Tax Registration copy mentioning the scope as manufacturer)
6. Trade Mark Registration (TM Registration copy)
7. Certificate from concerned regulatory agencies for manufacturing (If there is any)
8. Drawing of the product (As applicable)
9. Present Installed Capacity (Manufacturing)
10. Raw Material Details (Name of component used – name of supplier – quality certification of component) 
11. Details of Machines (Name of machine – make – capacity – number/quantity)
12. Layout plan of factory (Floor & technical) 
13. Details of Manufacturing Process (Process flow chart along with outsourcing details, if any)
14. Nature of packing (Size/quantity of packaging, storage facility) 
15. Details of Test Equipment’s (Name of equipment – Size – Quantity – Calibration Status & Date)
16. Details of QC (Quality Control) Staff (Name of person, qualification, designation, year of experience) 
17. Method of disposal of substandard product (After manufacturing) 
18. Organizational Chart of Factory (Management list with name & designation in chart format) 
19. Location Map of Factory (With indicating the distance from Airport & City Centre)

For Domestic Manufacturer:

1. Application Form V
2. A self-evaluation cum verification report in the proforma, as given in Annexure-II
3. Details of Quality Control Personnel
4. Calibration Certificates of Testing Equipment to be verified during the visit
5. Copies of Test Certificates of Raw Material, as applicable
6. Drawing of sample(s) of the Product and / or Components, as applicable
7. Report of Hygienic Condition, if applicable
8. Plant layout indicating the location of manufacturing area, storage area for raw material and finished product, testing laboratory etc.
9. Location Plan of the factory
10. For the tests which are permitted to be subcontracted and not available with the manufacturer, copy of the agreement or consent letter from the outside laboratory for which arrangement for sub-contracting is made
11. Inspection and Test Plan proposed to be followed, if different from Scheme of Inspection and Testing of the Bureau
12. Undertaking for long duration test as per the template attached as Annexure-III, wherever applicable.
13. In case of option 2, undertaking, as per the template attached as Annexure-IV

At REACHLaw we are happy to support both Indian and Foreign manufacturers to prepare and submit quality applications and obtain BIS license including its maintenance.

REACHLaw Services for India BIS Licence include:

• BIS Licence (FMCS) for Foreign Manufacturer Sites
• Authorized India Representative (AIR) Appointment Support
• BIS Licence for Domestic Manufacture Sites
• BIS Inspector Factory Audit Support
• Indian Standard or Testing Support
• Manak IT Portal Support
• ISI Marking and Labelling Support
• BIS Licence Compliance, Maintenance & Renewal Support
• Indian Authority BIS Consultancy Support
• Training Support
  1. BIS Certificate Online Training Course for Foreign Manufacturers – Please register for course here.
  2. We also provide customized training delivered in person or online by our experts, for quote send your request at

REACHLaw has functioned as a professional chemical regulatory compliance service provider for market access regulations for chemical & allied products since 2008 servicing close to 1000 companies globally for the purpose of chemicals regulatory compliance.

REACHLaw always operates with a high degree of professionalism, regardless of the location of our regional offices, as we have done since the establishment of the company in 2006.

We offer India BIS Licence service using our local subsidiary REACHLaw India Pvt. Ltd. at New Delhi located within 30km from BIS Authority Head Quarters and 25km from Ministry of Chemicals & Fertilizers, Government of India.

For more details please contact us at

1. What is Foreign Manufacturer Certification Scheme (FMCS) or India BIS Licence

This certification scheme is designed for foreign manufacturers seeking BIS (Bureau of Indian Standards) Licence approval. It applies to products other than Electronic and Information Technology (IT) products. For Electronic and IT products, please refer to the Registration Scheme available on this site: https://www.crsbis.in/BIS/about-crs.do.

2. Is BIS Licence Mandatory to access Indian market?

Typically, BIS certification schemes are voluntary. However, certain products specified by the Government of India under Quality Control Orders must bear the Standard Mark and have a valid BIS licence to be imported into India. The list of such products is available here: https://www.bis.gov.in/index.php/product-certification/products-undercompulsory-certification/

3. Is the nomination of AIR mandatory requirement under FMCS?

Yes, the foreign applicant must nominate an Indian Resident as an Authorized Indian Representative (AIR) when submitting the application.

4. Who is eligible to be considered an AIR?

The Authorized Indian Representative (AIR) must be an Indian resident who agrees to assume responsibility for complying with the provisions of the BIS Act, rules, regulations, and terms & conditions specified in the BIS Licence, Agreement, Undertaking, etc. The AIR should be nominated by a senior official of the foreign manufacturer’s branch/office in India. If the manufacturer does not have a branch/office established in India or until such establishment, the foreign manufacturer must nominate an AIR on their firm’s letterhead in the prescribed format.

Each AIR represents only one manufacturing firm and cannot act as the AIR for other foreign manufacturer(s) under the BIS Conformity Assessment schemes. However, this restriction does not apply to foreign manufacturers within the same group of companies and their related importers nominated as AIR.

5. Does the AIR need to be a resident of India?

The AIR should be a resident of India and an Indian national. However, a foreign national may also serve as AIR if employed in any office or branch of the manufacturer in India, provided that individual resides in India.

6. Is it possible for a manufacturer to change its AIR?

Yes, manufacturer has right to change its nominated AIR. BIS should be informed about this change without delay. 

7. Should the payment for FMCS be made in INR or USD?

For SAARC countries, payments can be made in either USD or Indian Rupees (INR) including GST. For all other countries, payments must be made in USD only.

8. Can test reports conforming to standards other than Indian Standards, such as IEC, be accepted?

No, only the test report that complies with the relevant Indian Standard will be accepted.

9. What is the timeline for obtaining the licence?

The average time taken to grant a license is generally six months from the date of receipt of a complete application and its recording. However, this duration may vary due to reasons such as delays in responding to raised queries, organizing inspections, transporting samples, and remitting dues.

10. Can a manufacturer submit a single application for multiple products manufactured at the same factory location?

No, a separate application for each product/Indian Standard Specification (ISS) must be submitted for each factory location.

11. Can a manufacturer submit a single application for the same product manufactured at multiple locations?

No, a separate application must be submitted for each product or Indian Standard Specification (ISS), and for each factory location.

12. As an importer, am I allowed to apply for a license on behalf of the manufacturer?

No, under the FMCS scheme, the application must be made by the foreign manufacturer themselves

13. What is the validity period of the license?

BIS certification under Scheme-I may be initially granted for a period of 1 or 2 years upon payment of the advance minimum marking fee. The license is valid only for the specific varieties mentioned therein. To extend the validity or include additional varieties under the existing license, an application with the necessary fee and documents must be submitted.

14. For BIS licence application does the quantity of any chemical import export matters?

Yes, this will be used to calculate the marking fee paid annually and you need to record volumes for maintenance of license in accordance with the conditions defined under the regulation.

15. Can we use our supplier’s BIS license to import chemicals into India?

If your supplier is a foreign manufacturer who has obtained the BIS license, then you can import chemicals in India only from that specific site mentioned on the license.

16. Does BIS apply to chemical mixtures?

No, it only applies to pure chemicals. Please refer to the scope of product in Indian standard for details.

17. If we choose to discontinue the license, can the bank guarantee be refunded back to us?

Performance Bank Guarantee (PBG) will remain in force and effect during the period licence is valid and it shall continue to be enforceable till all the dues of the Bureau under have been fully paid and its claims satisfied. PBG will be discharged or Refund only once all dues are settled.

18. Can the sample of the product drawn during inspection be tested in any government lab in the country of manufacture?

No, samples drawn during inspection shall only be tested in laboratories accredited by BIS or those recognized by BIS. The samples drawn by BIS shall be sent to a laboratory in India by the applicant firm. The applicant firm is responsible for bearing the actual testing charges.

19. Do I need to submit separate applications for different brands of a product manufactured at the same location?

No, the licence application is specific to a product manufactured at a particular premise. The firm must submit an undertaking for the brand name along with relevant documents.

20. Is there a technical manual available to help applicants understand the requirement for obtaining a BIS License?

Product Manual are available for various Indian Standards under certification.

This guidance documents includes Scheme of Inspection and Testing (SIT), specifying controls and checks to be exercised by the manufacturer. It also covers guidance for product testing, sampling, marking & labelling, test certificate templates etc.

21. What information does the customs officer require at entry point in relation to the chemicals that are in the India BIS list?

A standard Labelling & marking information mentioned in the Indian standard of the product under BIS list will be checked by inspector at entry of port.

22. What is meant by Lab In-charge? For foreign manufacturers what is the process for testing? Does it have to be completed at a local Indian lab?

“Lab in charge” means head person of your lab who is responsible for testing and method development. Testing must be done as per the relevant IS standard at your own premises. The samples will be drawn by the inspector during visit which will be tested in BIS accredited lab at India for conformity. You may also consider comparing results from own premises with an external lab from India to assess compliance with IS.

23. Do foreign manufacturers have to deposit an Indemnity and guarantee fee to BIS?

Yes, foreign manufacturer must sign indemnity and provide a bank guarantee. BIS demands for the

Performance Bank Guarantee of USD 10,000 by foreign manufacturer for the purpose of security against any loss or damage caused to the Bureau by reason of any breach by the said Licensee.

24. IS Mark is required for all the chemicals/products listed before being able to place in India without any volume restrictions or less than 1 tonne does not require it?

Yes, IS mark is required for all chemicals/product listed irrespective of quantities.

25. Can a licence be provided if no manufacturing audit is possible?

Audits/inspection are mandatory for grant of licence. 

26. Can different alike products from the same manufacturing location be combined into 1 application form?

No, separate application for each product & Indian Standard is to be submitted for each factory location.

27. Does BIS assigns a separate licence number per application form?

Yes, separate licence number is assigned per product/IS.

28. What is Mank online? Does foreign manufacturer need to create an account?

It refers to the online platform or electronic system developed by the Bureau of Indian Standards (BIS) for various activities related to standards and certification in India. Yes, a foreign manufacturer after grant of licence needs to create account.   

29. Do we need to report details of each ISI marked consignment anywhere?

Yes, details of each consignment need to be uploaded at Manak online before the estimated date of arrival of shipment.

30. What is market surveillance?

BIS draws sample of ISI marked product from market for testing at BIS recognized lab for conformity.

31. Is it importer’s or manufacturer’s responsibility to submit the sample during market surveillance?

It is importers’ responsibility to provide sample of requested lot to BIS. Manufacturer must coordinate with importer for its timely submission.

32. What is marking fees?

 It is the fees paid towards the use of ISI mark on product after grant of licence. Minimum marking fee is paid in advance during the grant of licence and there after marking fee is paid based on actual export quantities to India.