BIS Compliance in India: Navigating FMCS and Scheme X
Why BIS Compliance Matters
For manufacturers—both local and international—ensuring products meet Indian regulatory standards is essential. The Bureau of Indian Standards (BIS), established under the BIS Act, 2016, plays the critical role of setting these standards and enforcing them through various certification mechanisms such as FMCS and Scheme X.
What Is BIS and Its Importance
BIS certification is essential for several reasons:
BIS certification is essential for several reasons:
BIS is India’s national standard-setting authority responsible for defining norms for products, services, and processes. It issues licenses for items listed under Quality Control Orders (QCOs) and oversees compliance through factory audits, testing, and licensing. Significance of BIS compliance includes:
Consumer protection by ensuring product safety and quality
Fair market practices through equal standards across manufacturers
Legal conformity, lowering risks of penalties and import restrictions
Enhanced trade credibility for global and domestic markets
Cases of delayed imports illustrate how missing FMCS documentation can stall deliveries and attract enforcement action.
Key Certification Schemes
Foreign Manufacturers Certification Scheme (FMCS) / Scheme I
Designed for foreign entities, FMCS allows overseas manufacturers to obtain license to use the ISI mark or CRS Standard Mark, enabling legal access to the Indian market.
Foreign Manufacturers Certification Scheme (FMCS)
The Foreign Manufacturers Certification Scheme (FMCS) is a regulatory mechanism established by Bureau of India (BIS) to govern the quality, safety, and compliance of products imported into India. Since 28th August 2025, the BIS certification scheme has a mandatory character when products, mentioned in Quality Control Orders issued by the government, are brought within the scope of compulsory ISI mark certification. In such cases, foreign manufacturers intending to export these regulated products to India are required to secure a BIS License under the FMCS prior to initiating exports. The absence of such a license renders the import of these products impermissible, with consignments subject to rejection or seizure by Indian customs authorities.
In other words, the scheme operates with a dual framework; it is compulsory for products covered under the mandatory certification regime and remains voluntary for non-regulated products. By extending certification obligations to overseas manufacturers, the FMCS not only strengthens regulatory oversight but also promote the import of products that are consistent with Indian quality standards. It aims at protecting consumers, enhancing market confidence, and ensuring that imported goods comply with established norms of safety and reliability. In essence, the FMCS serves as an important instrument of trade regulations, bridging international manufacturing practices with domestic compliance requirements.
FMCS Certification Process
Appointment of Authorized Indian Representative (AIR): A foreign manufacturer nominates an AIR to act as a legally accountable liaison with BIS [6].
Application Submission: Comprehensive documentation, including technical specifications, corporate credentials, prior testing reports, and compliance history, must be submitted [7].
Factory Inspection: BIS conducts on-site audits to verify production processes and adherence to standards.
Product Testing: Samples undergo rigorous laboratory testing in BIS-accredited facilities [8].
Grant of License: BIS issues a certification license permitting the product to carry the ISI mark legally [9].
Surveillance: Ongoing inspections and testing maintain continuous compliance.
Electrical appliance shipments from certain foreign manufacturers experienced significant delays due to incomplete FMCS documentation, demonstrating the legal necessity of thorough procedural adherence. Non-compliance exposes manufacturers to penalties, shipment holds, import restrictions, and reputational risk [10].
Scheme X
Introduced via the BIS Conformity Assessment Regulations (2018, amended 2022), Scheme X is tailored for high-risk machinery and electrical equipment under the Omnibus Technical Regulation Order (OTR) 2024. Effective from 28 August 2025, it mandates certification for items like switchgear, industrial machinery, earthmoving equipment, and more.
Scheme X Certification Process:
Submit application with detailed technical documentation
Undergo factory inspection by BIS
Conduct testing in BIS-approved labs
Obtain BIS license and ISI marking approval
Remain subject to periodic surveillance audits
Notably, compliance notices have already been issued to non-compliant manufacturers, emphasizing Scheme X’s strict enforcement.
The Bottom Line for Manufacturers
BIS certification is more than regulatory paperwork—it’s a legal necessity that ensures market access, brand credibility, and consumer trust. Whether through FMCS or Scheme X, adherence is vital for business continuity and legal security.
Manufacturers—particularly foreign entities—must incorporate BIS compliance strategies early. This includes understanding applicable schemes, preparing technical documentation, engaging with BIS-accredited labs, and completing audits on time.
By proactively integrating BIS standards into operations, businesses can confidently navigate India’s regulatory landscape and establish long-term compliance resilience.
Conclusion
BIS certification, facilitated through FMCS and Scheme X, serves as a cornerstone of legal compliance and risk mitigation for manufacturers in India. Compliance with BIS standards is more than a procedural requirement; it is a legally enforceable necessity ensuring operational continuity, product safety, and regulatory adherence. Non-compliance may result in fines, license revocation, shipment holds, and reputational harm, while adherence strengthens market credibility, consumer confidence, and lawful access to Indian markets.
For both foreign and domestic manufacturers, integrating BIS standards into business strategy is imperative. FMCS and Scheme X provide clearly defined pathways for compliance, testing, and certification. By diligently following these frameworks, companies can navigate India’s regulatory landscape confidently, mitigate legal and operational risks, and achieve sustainable business growth. Proactive BIS compliance is essential for legal certainty, market access, and long-term operational resilience.
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