Introduction — Why OTR Matters for Indian Manufacturers
In August 2025, BIS introduced the Omnibus Technical Regulation (OTR) to standardize product safety compliance across machinery and electrical equipment.
For manufacturers and importers, this marks a shift toward a single framework — BIS Scheme-X — covering multiple product categories under one regime.
Think of OTR as India’s “passport to market entry.” Without it, your machines can’t legally enter domestic commerce after the enforcement date of 1 September 2026.
Last year, an industrial automation supplier in Noida lost two months of sales because its testing reports didn’t align with the new BIS Scheme-X format. A simple process oversight — but a costly delay. Here’s how you can avoid it.
What Is BIS OTR Certification (Scheme-X)?
The Omnibus Technical Regulation is a BIS mechanism that integrates multiple safety standards into a single certification route. Products are certified either as:
- License to Use the Standard Mark (for mass manufacturing) or
- Certificate of Conformity (CoC) (for prototype or lot-based imports).
It operates under Scheme-X — a new BIS scheme covering industrial machinery, electrical systems, automation equipment, and components.
Who Needs OTR Registration in India
You must register if you are a:
- Manufacturer of machinery, electrical or electronic equipment listed under the OTR schedule
- Importer bringing regulated products into India
- Foreign manufacturer supplying to India (via Authorized Indian Representative)
Exemptions apply to: export-only goods, defence equipment, machinery covered under other Quality Control Orders (QCOs), or vehicles regulated by CMVR.
Step-by-Step BIS OTR Process (For Manufacturers & Importers)
1. Determine Applicability & Standard Mapping
Identify if your product falls under the OTR category. Map it to the relevant Indian Standard (e.g., IS 16819 for general safety of machinery) and Type B or C standard for specific machines.
2. Prepare the Technical File
This is the heart of your application. Include:
- Product drawings, BOM, and photographs
- Test reports from BIS-approved labs
- Risk assessment and safety analysis
- Software and control logic details
- Compliance matrix against Essential Requirements
- Quality system manual & production flow chart
3. Submit Application on the BIS OTR Portal
Log into bis.gov.in → Scheme-X Portal. Provide company information, product details, and upload the technical file.
4. Desk Audit by BIS
BIS evaluates documents and test reports. If incomplete, you’ll receive a query within 15–30 days.
5. Site Audit / Factory Inspection
Inspectors verify production process, testing facilities, and compliance with safety standards. Non-conformities must be rectified before approval.
6. Grant of License / Certificate of Conformity
After successful evaluation, BIS issues either:
- License to use Standard Mark (valid for 2 years, renewable), or
- Certificate of Conformity (CoC) for a specific imported lot.
7. Post-Certification Compliance
Licensees must maintain records of testing, marking, and traceability. Renewal applications must be filed at least 90 days before expiry.
BIS OTR Documentation Checklist (2025-26)
| Document | Description |
|---|---|
| Application Form – Scheme X | Filled and digitally signed form on BIS Portal |
| Technical File | Product drawings, safety analysis, testing reports |
| Factory layout and machinery list | Details of production facility and testing equipment |
| ISO 9001 certificate / QMS proof | Demonstrates process control capability |
| Authorized Representative undertaking | Mandatory for foreign manufacturers |
| Test report from BIS recognized lab | Duly signed & valid within 90 days |
| Self-declaration of conformity & CA Certificate | Confirms authentic data and financial validity |
BIS OTR Fees & Timelines (Indicative)
| Stage | Average Time | Fee Range (INR) |
|---|---|---|
| Application processing | 15–30 working days | ₹10,000 – ₹25,000 |
| Site audit / inspection | 20–45 days (post-acceptance) | ₹35,000 – ₹75,000 + travel charges |
| License grant | Within 90 days of complete submission | As per BIS schedule |
| Renewal (after 2 yrs) | 60 days before expiry | ₹10,000 + testing costs |
(Fees may vary by product category and testing requirements.)
Timelines & Process Flow (At a Glance)
Manufacturer → Testing → Portal Application → Desk Audit → Factory Inspection → License Grant → Surveillance Audit / Renewal
Average turnaround time: 60–90 days for a complete submission.
Penalties for Non-Compliance
Under the BIS Act 2016 and DGFT guidelines:
- Sale or import of non-certified products can attract penalties up to ₹2 lakh and seizure of goods.
- DGFT may suspend import licenses for non-BIS-approved machinery.
- Repeat offenders can face prosecution and revocation of licenses.
Common Mistakes to Avoid
- Submitting test reports from non-BIS labs.
- Mismatch between technical file and product label.
- Ignoring OTR applicability for multi-component systems.
- Not budgeting for retesting during renewal.
OTR for Foreign Manufacturers (FMCS Linkage)
Foreign manufacturers must appoint an Authorized Indian Representative (AIR) to liaise with BIS, handle testing coordination, and manage compliance records.
Their certification falls under the Foreign Manufacturer Certification Scheme (FMCS) linked to OTR Scheme-X.
Why Early Preparation Matters
From 2025 to 2026, BIS will phase-in OTR enforcement by sector. If you delay testing or documentation now, your product could miss market entry when the regulation fully applies.
Green Permits helps you navigate BIS Scheme-X filings, coordinate lab testing, and manage documentation end-to-end.
Conclusion & CTA
BIS OTR certification isn’t just a legal step — it’s a strategic move toward quality and market trust. With expert guidance and timely preparation, manufacturers can simplify the entire process from testing to approval.
Green Permits supports Indian and foreign manufacturers through the complete BIS OTR journey — from technical file creation to license renewal.
📞 +91 78350 06182 📧 wecare@greenpermits.in
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FAQs
Scheme-X is the certification scheme created under the Omnibus Technical Regulation for industrial products.
Typically 2 years, renewable subject to surveillance audits and testing.
Yes — if the product is sold in India under the regulated category.
Yes, provided the models share identical safety-critical design and test results.
Yes, testing must be done in BIS-recognized labs in India or through an approved equivalent route under FMCS.
