Overview of BIS FMCS

Foreign Manufacturer Certification Scheme (FMCS) is regulated by the Bureau of Indian Standards (BIS) in compliance with the BIS Act, 2016, and the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018. The certification scheme allows foreign manufacturer to continue their businesses in India after receiving the BIS Licence. The certification scheme is not mandatory till now for all categories of products. However, certain goods can only be imported into India with the Standard Mark and a BIS licence, as announced by the Indian government under Quality Control Orders (QCOs).

QCOs are regulated by various regulatory bodies or ministries in India under the observation of Central Government departments based on their product categories. QCOs are published on the gazette of India with their date of implementation. After the effective date of implementation of QCO, except under a valid Licence or Certificate of Conformity (CoC) from BIS, no person shall manufacture, import, distribute, sell, hire, lease, store, or exhibit for sale any product(s) covered by the QCO without a Standard Mark.

To know the date of commencement and updates of QCOs, please click here.

Competent Authority

Under the Foreign Manufacturers Certification Scheme (FMCS), the Bureau of Indian Standards manages the product certification program for foreign manufacturers.

Obligation

The manufacturers whose companies or premises are located outside of India are required to submit their Foreign Manufacturer Certification Scheme (FMCS) application to get a BIS Licence to ensure the compliance of their products to applicable Indian Standard Specifications.

Authorized Indian Representative (AIR)

In accordance with BIS Rule 16B (4) of 1987, if a foreign applicant wants to get a BIS Licence, first they need to designate an Authorized Indian Representative (AIR). AIR must be an Indian resident and is responsible for ensuring compliance with BIS rules and regulations on behalf of the foreign applicant.

For more info on AIR, please click here.

BIS Mandatory Certification Schemes

BIS offers four types of mandatory certification schemes. For specific chemicals regulations, there are two schemes:

• Scheme-I: Indian Standard Institution Mark Scheme (ISI Mark Scheme)
• Scheme-II: Compulsory Registration Scheme (CRS)

BIS FMCS Certification Process (For ISI Mark Scheme)

Chemicals Regulated under BIS Scheme-I & Scheme-II

Under ISI Mark Scheme (Scheme-I): List of Regulated Chemicals, Fertilizers, Polymers & Textiles

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

Total WTO Notified Chemical QCOs by the Department of Chemical & Petrochemicals in previous year

Under Compulsory Registration Scheme (Scheme-II): List of Regulated Chemicals

General Differences Between Scheme-I and Scheme-II

Major Differences	Scheme-I	Scheme-II
Application Form	Main Application Form-V as specified in BIS (Conformity Assessment) Regulations, 2018 Scheme-I	Main Application Form-I as specified in BIS (Conformity Assessment) Regulations, 2018-Scheme-II
Inspector Audit	BIS grants a licence after conducting an inspection visit to the factory location.	BIS grants a licence to the manufacturer based on self-declaration of conformity of the product.
Forms for AIR Appointment	Foreign Manufacturers need to appoint/nominate an Authorized Indian representative through Form No. VI & VII as specified in BIS (Conformity Assessment) Regulations, 2018, Scheme-I	Foreign manufacturers, required to nominate an Indian representative are specified in Form – IIIA, Form – IIIB, and Form – IV under BIS (Conformity Assessment) Regulations, 2018, Scheme-II
Mode of Application Submission	The process of Application Submission to BIS is available in Manual Mode	In case of Scheme-II, the online portal (CRS is designed) for Application submission.
Timeline for Grant of Licence	The process of granting of licence is expected to be completed within 90 working days provided all the documentation and conformity of the product is established as satisfactory at the first instance.	The process of granting of licence is expected to be completed within 20 working days provided all the documentation and conformity of the product is established as satisfactory at the first instance.
Marking Scheme	After the Grant of Licence, ISI marks shall be used and annual marking to be paid in advance.	After the Grant of Licence, the Standard Mark shall be issued to the manufacturer.
Marking & Labelling	Color Scheme not applicable for the ISI mark as per Scheme-1	The color scheme of the Standard Mark shall be in accordance with Annexure-III, annexed to Scheme-II.
Chemical Listed	Currently, Scheme-1 includes 60 chemicals under the heading of Chemicals, Fertilizers, Polymers & Textiles	Currently, Scheme-II includes three chemicals.

Validity:

The Licence, under Scheme-I, is initially granted for up to 2 years. After which, the licence needs to be renewed for up to 5 years.

Government Fee:

1. Indian Standard Institution Mark Scheme (Scheme-I):

For more info on fees and charges, please click here.

2. Compulsory Registration Scheme (Scheme-II)

 For more info on fees and charges, please click here.

REACH24H’s Services

• Application Preparation and Submission to the BIS
• Authorized Indian Representative (AIR) Appointment
• Inquiries and Communications with Competent Authorities
• Factory Inspection Assistance for ISI Mark Scheme
• Renewal & Change for the Certificates
• Marking and Labelling Support After Licence Granted
• Customized Training

For other services, please visit https://www.reach24h.com/en/industrial-chemicals.

Why Choose REACH24H

• Over 8,000 Satisfied Clients: To date, we have served over 8,000 chemical enterprises, providing them with comprehensive regulatory compliance services that cover a wide range of countries and regions.
• Diverse Expertise and Language Skills: Our team of experts has diverse professional backgrounds and comprehensive language skills to provide efficient, diverse, and high-quality regulatory compliance services.
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• Specialized Industrial Chemical Division: Our Industrial Chemical Division comprises specialized departments for REACH regulatory affairs, GHS and EHS compliance, AP chemical registration, Japan business, and technical services.

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