In India’s compliance landscape, one wrong certification can cost months of delay.
Last year, a Pune-based machinery manufacturer had its shipment held at customs for nearly two months — the reason? The company applied for an ISI Mark license, but its product actually fell under the new BIS OTR (Scheme-X) framework.
This confusion is increasingly common as India transitions toward unified product regulations under the Omnibus Technical Regulation (OTR). Whether you manufacture, import, or sell equipment, understanding the difference between OTR and ISI Mark is crucial to avoid costly mistakes.
Understanding the Basics: BIS, ISI, and OTR (Scheme-X)
What is BIS?
The Bureau of Indian Standards (BIS) is India’s national standards body under the BIS Act, 2016. It ensures that products sold in India meet safety, reliability, and performance benchmarks.
BIS operates several certification schemes:
- Scheme-I (ISI Mark) – for domestically manufactured products under Quality Control Orders (QCOs)
- Scheme-II (CRS) – for electronics and IT goods
- Scheme-III (FMCS) – for foreign manufacturers
- Scheme-X (OTR) – for unified product compliance under Omnibus Technical Regulations
What the ISI Mark Represents
The ISI Mark is the oldest and most recognized product safety symbol in India. It ensures that the product meets the Indian Standard (IS) for its category.
- Applicable to over 350 product categories mandated by the Government through QCOs.
- Covers domestic manufacturing units for goods like cement, steel, home appliances, wires, cables, and industrial components.
- Products are tested, inspected, and licensed directly by BIS under Scheme-I.
In simple terms, ISI certification = mandatory approval for products explicitly listed in government notifications.
What is BIS OTR (Scheme-X)?
The Omnibus Technical Regulation (OTR) is BIS’s latest framework for cross-sector product compliance. Introduced in 2022 and scaled through 2024-25, OTR consolidates scattered safety and quality approvals into a single certification route.
It is designed for:
- Products not already covered under ISI or CRS
- Multi-component or composite systems (e.g., industrial machinery, EV components, renewable-energy devices)
- Both domestic and foreign manufacturers
Under OTR, applicants obtain certification once and can demonstrate compliance with multiple BIS or sectoral standards through a single license.
(Reference: BIS Scheme-X Guidelines 2025, bis.gov.in)
Why India Introduced BIS OTR Certification
Until recently, manufacturers had to navigate several schemes — ISI for certain goods, CRS for electronics, and FMCS for imports. This led to duplication, higher costs, and inconsistent standards.
The BIS OTR framework was introduced to:
- Unify technical regulations across BIS, DPIIT, DGFT, and MoEFCC.
- Support India’s Ease of Doing Business 2025 roadmap.
- Create a single compliance identity for products spanning multiple industrial sectors.
- Simplify export/import clearances and traceability for all regulated products.
According to DPIIT (2024), more than 1,200 product categories are expected to migrate to OTR by FY 2026, replacing multiple scheme-specific registrations.
BIS OTR vs ISI Mark – A Side-by-Side Comparison
| Feature | BIS OTR (Scheme-X) | ISI Mark (Scheme-I) |
|---|---|---|
| Objective | Unified multi-sector compliance under Omnibus Technical Regulations | Mandatory safety and quality assurance for notified products |
| Applicable To | Manufacturers & importers whose products aren’t yet under ISI/CRS | Domestic manufacturers of products under QCOs |
| Testing Process | Type testing + factory evaluation by BIS or accredited labs | In-plant sample testing + BIS surveillance audit |
| Certificate Validity | 2–5 years (renewable) | 1 year initial + renewals up to 5 years |
| Coverage | Industrial machinery, EV components, composite systems | Consumer goods, construction materials, electrical products |
| Foreign Manufacturers | Covered through FMCS-OTR route | Covered under FMCS (Scheme I) |
| Product Marking | OTR Mark / QR code linked to BIS portal | ISI logo with IS number |
| Legal Basis | BIS (Conformity Assessment) Regulations 2018 + Scheme-X Guidelines 2025 | BIS Act 2016 + Quality Control Orders (QCOs) |
Interpretation:
If your product isn’t in a QCO list but is subject to an Indian Standard, the OTR route is usually the right pathway to compliance.
When to Choose OTR vs ISI – Decision Matrix
- Check if your product is in a QCO list.
- If yes, you need an ISI Mark license.
- Examples: cement, domestic wiring cables, pressure cookers, tyres, steel rods.
- If not in a QCO but subject to BIS testing, go for OTR certification.
- Examples: industrial air compressors, EV chargers, hybrid machinery, IoT-based systems.
- If both ISI and OTR overlap, determine your primary regulatory intent:
- Consumer-safety focused → ISI.
- Performance-based, multi-standard or new-technology product → OTR.
Example:
A solar-powered industrial fan combines mechanical and electrical components. Since it spans renewable energy and electrical machinery categories, it qualifies under OTR (Scheme-X) instead of a traditional ISI mark.
Step-by-Step: BIS OTR Certification Process
- Identify the applicable Indian Standard (IS code) for your product.
- Prepare a technical file — design drawings, specifications, raw materials, and safety documentation.
- Apply online through the BIS portal under the Scheme-X / OTR section.
- Submit product samples for type testing at a BIS-approved lab.
- Undergo factory audit or remote inspection to verify manufacturing controls.
- Receive license and mark of conformity upon approval.
- Comply with post-certification obligations, including annual surveillance and renewal after 2–5 years.
Indicative BIS OTR Fee Structure (FY 2025–26)
| Particulars | Fee (₹) | Remarks |
|---|---|---|
| Application processing | 1,000 – 2,000 | Non-refundable |
| Product testing | 20,000 – 50,000 | Depends on product type |
| Annual license fee | 1,000 / product | Payable to BIS |
| Renewal (after 5 yrs) | 2,000 + testing charges | Subject to review |
Source: BIS Fee Circular 2024, Scheme-X Annexure.
Average approval time: 40 – 45 days after submission of complete documents.
Quick Refresher: ISI Mark Certification Process
- Confirm product notification under the relevant QCO.
- Apply through BIS portal with detailed product specifications.
- Submit samples to a BIS-recognized testing laboratory.
- Factory inspection by BIS officials.
- License issuance and permission to affix ISI mark.
- Annual renewal after review and surveillance audit.
For a deeper walkthrough, see Green Permits – ISI Mark Certification Process in India.
Key Differences in Testing and Timelines
- ISI Scheme-I: Single-standard testing, usually within 30–45 days.
- OTR Scheme-X: Cross-disciplinary verification (mechanical + electrical + chemical), 45–60 days average.
- Foreign manufacturers benefit from unified digital filing through the BIS FMCS-OTR portal.
According to BIS internal reports (2024), average OTR approval time is about 45 days, compared with 60–75 days for separate multi-scheme licensing earlier.
Penalties and Non-Compliance Risks
Operating without valid BIS certification—whether ISI or OTR—can invite serious penalties under the BIS Act 2016 and DGFT regulations:
- Fine up to ₹ 2 lakh and seizure of uncertified goods.
- Customs blockage for import consignments lacking BIS license.
- Cancellation of trade license for repeated violations.
- Blacklisting for false or misleading declarations.
Maintaining the correct license also protects brand trust and enables smooth B2B sales to government or PSU buyers.
India’s Future: Unified Product Compliance
The next phase of BIS modernization (2025 – 2027) aims to:
- Integrate OTR with all BIS schemes into one single-window portal.
- Mandate QR-based traceability for every certified product.
- Expand OTR to chemical, mechanical, EV, and renewable sectors.
- Introduce AI-driven conformity monitoring for imported consignments.
By FY 2026, most industrial and hybrid-technology goods will likely be certified under OTR (Scheme-X) instead of individual ISI routes.
Summary Table – Certification Choice at a Glance
| Product Type | Example | Certification Required | Relevant Scheme |
|---|---|---|---|
| Consumer goods under mandatory QCO | Pressure cooker, cable, helmet | ISI Mark | Scheme I |
| Electronic & IT products | Laptop, monitor, printer | CRS | Scheme II |
| Industrial machinery / hybrid systems | Compressor, panel, EV charger | OTR Certification | Scheme X |
| Imported goods for India | Foreign electronics, equipment | FMCS + OTR | Scheme X (FMCS route) |
Business Insight: What Happens if You Choose Wrong
Imagine investing ₹ 20 lakh in product testing under the wrong scheme—only to learn your category moved under OTR.
- You must re-apply, re-test, and pay new fees.
- Customs clearance resets; earlier test reports are void.
- Market launch delays can cost ₹ 5–10 lakh per month in opportunity loss.
That’s why expert pre-screening of your product category saves both time and compliance cost.
Conclusion
In 2025, the question isn’t whether you need BIS certification — it’s which one fits your product.
Choosing the correct path—ISI for mandated goods or OTR for new and composite products—ensures smooth licensing, faster market entry, and full legal protection.
BIS certification is not paperwork — it’s your product’s passport to the Indian market.
Work with Green Permits
Green Permits helps manufacturers, importers, and startups manage every step of BIS compliance — from product classification and lab testing to portal registration and audit support.
📞 +91 78350 06182 | 📧 wecare@greenpermits.in
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FAQs
ISI Mark is mandatory for products under QCO lists, while OTR (Scheme-X) covers all other standardized products not yet notified, especially cross-sector machinery and industrial goods.
Industrial machines, EV components, renewable-energy devices, and composite systems that integrate multiple standards.
Yes. Foreign entities can apply through the FMCS-OTR route, using an authorized Indian representative.
Typically 40–45 days after document submission, depending on testing time.
Up to ₹ 2 lakh fine, product seizure, and trade license cancellation under the BIS Act 2016.
