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With international business expansion, India remains one of the prime targets because it is one of the fastest-growing consumer markets. To guarantee compliance with Indian Standards as well as product safety and quality, it is imperative to get certain foreign products certified according to the BIS standards through the Foreign Manufacturer Certification Scheme (FMCS).
One of the critical features of this scheme is that foreign manufacturers can get a certificate of registration and a BIS (Bureau of Indian Standards) license to use the ISI mark, which signifies that the product meets the requirements for safety and quality set by India.
In this article, we will cover the following topics to help foreign manufacturers understand and navigate the FMCS process effectively:
By the end of this guide, you will have a clear understanding of how to successfully apply for and maintain FMCS certification, ensuring a smooth entry into the Indian market.
The FMCS is a program administered by the Bureau of Indian Standards (BIS) and regulated by the BIS Act of 2016. It enables overseas manufacturers to receive a BIS license enabling them to have an ISI mark on their products, which indicates that their products meet the health and safety requirements of India.
This scheme covers manufacturers located outside of India who operate in a foreign country and wish to sell their products to India. The certification is required for all products under the list of mandatory certifications regulated by the Indian Standards (IS).
The scope of FMCS is wide and covers several categories including but not limited to:
Other categories of products such as Electronics and IT Goods have a different set of regulations. These product categories, such as Electronics and IT Goods, are regulated under a separate framework known as the Compulsory Registration Scheme (CRS) by the Ministry of Electronics and Information Technology (MeitY) and do not fall under FMCS.
This scheme is exclusively applicable to foreign manufacturers that have production facilities outside India. Indian manufacturers are not covered by this scheme and must obtain BIS certification by other means.
To qualify for FMCS, manufacturers must have in-house testing facilities that are self-sufficient and conform to Indian Standards (IS) and the requisite Bureau of Indian Standards (BIS) requirements. These facilities should be capable of conducting all necessary quality and safety tests as specified by BIS.
The applicant must demonstrate a robust quality control and assurance system at the manufacturing unit. Understanding of Indian Standards is necessary while the BIS inspectors determine the degree of adherence to these standards during factory inspections by evaluating production methods, testing equipment, and quality control measures.
Since foreign manufacturers do not have a legal presence in India, they must appoint an Authorized Indian Representative (AIR) to act on their behalf for all regulatory and compliance matters related to FMCS certification.
The authorized AIR must be registered in India. They may include the following:
An AIR is always the point of contact between BIS and the foreign manufacturer. Their most important functions are:
To maximize the FMCS certification process’s efficiency, a competent and skilled AIR is necessary, as he understands the core issues relating to compliance and approvals.
The FMCS certification procedure encompasses various stages, such as submission of documents, plant visits, sample testing, and final approval. These are briefly elaborated below:
Step 1: Application Submission:
The applicant has to apply online via the BIS Manak Online Portal under the FMCS module.
Required Documents:
A non-refundable application fee must be paid at this stage, the amount of which depends on the product category.
Step 2: Factory Inspection by BIS Officials
Once the application is reviewed, BIS officials conduct an on-site inspection of the manufacturing facility. This step is crucial as it verifies whether the production process and in-house testing facilities align with BIS standards. During the inspection, officials also select product samples directly from the production line for further testing. Any inconsistency in manufacturing methods, testing capabilities, or quality assurance measures can result in delays or rejection.
Step 3: Testing Samples in BIS-Approved Laboratories
Once the factory inspection is complete, the selected product samples are sent to BIS-accredited laboratories for rigorous testing. These tests evaluate:
If the samples fail to meet BIS standards, the manufacturer will need to rectify the issues and submit fresh samples, leading to longer approval timelines.
Step 4: BIS Certification
If the sample passes all tests and the factory complies with BIS, the application is approved.
The manufacturer has to pay the license fees and marking fees before receiving certification.
After certification, manufacturers must ensure continuous compliance with BIS regulations, as periodic surveillance audits and market testing are conducted to maintain the validity of the certification.
The cost of obtaining FMCS certification includes multiple components, ranging from application fees to factory inspection and testing charges. Below is a breakdown of the key expenses involved:
Once issued, the FMCS certification is valid for a period of one to two years based on the product category and the regulations of BIS. The manufacturers need to ensure continuing compliance to continue to use the ISI Mark on their products and maintain the certification.
It is renewable for at least one year and maximally up to five years. Manufacturers will have to apply to renew along with compliance documents updated since the last renewal and a renewal fee. For delayed renewal applications, there is an additional INR 5,000 late fee. In the event of failure to renew within the due date, the certification may be suspended temporarily, and the manufacturer will be disallowed from selling the product in India.
BIS carries out routine surveillance audits and random sampling for the testing of certified products against the requirements of the Indian Standards. This includes the following measures:
Market surveillance wherein the BIS selects products from the retail outlets for testing.
Independent laboratory testing to ensure that the product continues to comply with the set standards.
The manufacturer shall correct any violation immediately if the product does not comply.
Non-compliance can lead to suspension, penalties, or revocation of the license. BIS may issue warnings, impose fines, or cancel the certification if serious violations are found. In extreme cases, non-compliant manufacturers may face restrictions on future certification applications.
Manufacturers should regularly audit their production processes, maintain quality control records, and stay updated on any changes in BIS regulations to avoid such issues.
FMCS certification provides foreign manufacturers with several strategic advantages in entering the Indian market. Here are the key benefits:
In summary, FMCS certification not only ensures compliance but also establishes a strong market presence, improves brand perception, and increases business opportunities for foreign manufacturers in India.
Strategizing to have market access is important in India because it serves as a stepping stone before manufacturers make foreign investments in India. The ISI Mark also proves the credibility and veracity of the merchandise and is an indispensable asset in evading trade quotas that could interfere with the sale and distribution of the products.
For foreign manufacturers looking to simplify the financial and operational aspects of expanding into India, services like Karbon can provide seamless cross-border payments and compliance assistance to help manage the complexities of international trade.
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