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.

Chemical & Petrochemicals are also covered under Scheme I: Currently there are 60 chemicals listed under Scheme I whereas more chemicals will be added to the list.  

Please contact us for latest updates including information on updated standards (ISI number) currently in use as well as proposed chemicals that may come to the mandatory BIS certification list.

Authority: The licence is granted by Foreign Manufacturer Certification Department (FMCD) located at BIS Headquarters, New Delhi for FMCS and by Regional and Branch office in case of Domestic manufacturers.

Foreign Manufacturer:

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 1(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 1(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