Last year, a small engineering unit in Pune waited nearly 60 days for a shipment of imported compressors to clear customs. The reason? No BIS licence under the newly introduced Omnibus Technical Regulations (OTR).
That single delay cost the company ₹15 lakh in idle manpower and warehouse fees.
For thousands of MSMEs making or importing industrial machinery, BIS OTR is no longer optional—it’s the rulebook defining product safety and market access.
What is BIS OTR and why was it introduced?
The Omnibus Technical Regulations (OTR) Order 2024 was notified by the Ministry of Heavy Industries on 28 August 2024. It makes product safety certification mandatory for machinery and equipment used across India’s manufacturing sector. The regulations were formulated under the BIS Act and linked to the Scheme-X conformity assessment system.
Originally slated for enforcement from 28 August 2025, the Ministry’s Amendment Order of 12 June 2025 extended the effective date for machinery to 1 September 2026 so that industry — especially MSMEs — could adapt.
Who needs BIS OTR certification?
Every manufacturer or importer of listed machinery under the First Schedule of the OTR Order must obtain a BIS licence or certificate before manufacturing, importing, selling, or storing such equipment in India.
Key sectors covered under OTR
| Sector | Typical Products Under OTR Scope | Core Indian Standard (Type A/B/C) |
|---|---|---|
| Pumps & Compressors | Industrial pumps, air compressors | IS 16819 / ISO 12100 (Type A) + IS 10431 (Type B) |
| Cranes & Material Handling | Hoists, gantries, conveyors | IS 13367 series + IS 3177 |
| Packaging & Labelling Machinery | FFS machines, shrink wrappers | IS 15560 + safety guards (IS 13792) |
| Textile & Embroidery Machinery | Looms, embroidery machines | IS 667 series + IEC 60204-1 |
| Rubber & Plastics Machinery | Injection moulders, extruders | IS 16819 + ISO 20430 (Type C) |
| Power & Electrical Equipment | Transformers, switchgear, DG sets | IS/IEC 60076, IS 11855 family |
Note: Assemblies, sub-assemblies, and components will follow in later phases as per the June 2025 Amendment Order.
How the BIS OTR process works for MSMEs
The BIS has issued dedicated Guidelines for Grant of Certification under Scheme-X (OTR) (CMD-I/2:17:1, dated 11 July 2025).
Here’s how it unfolds:
Step 1 – Identify applicability
Check if your product’s HS code appears in the First Schedule. If yes, the OTR Order applies. Manufacturers can verify via the BIS Scheme-X portal (Manakonline).
Step 2 – Create a Technical File
Every application requires a Technical File containing:
- Product drawings and safety design justification
- List of applicable IS/IEC standards (Type A, B, C)
- Test reports from BIS-approved labs
- Risk assessment and mitigation plan
- Compliance checklist (EN ISO 12100 alignment)
- User manual and labelling details
Step 3 – Submit online application
Use the BIS OTR portal to submit the Technical File, fee, and Product Compliance Report. MSMEs may self-certify certain documents and upload scanned test reports.
Step 4 – Evaluation and audit
BIS officials review the documents and may conduct a virtual or physical audit of the facility to verify production capability and quality controls.
Step 5 – Grant of Licence or Certificate of Conformity
Depending on the product type, BIS issues either:
- a Standard Mark Licence (for mass-produced items), or
- a Certificate of Conformity (CoC) (for one-off imports or special machines).
OTR timeline at a glance
| Phase | Activity | Average Duration* |
|---|---|---|
| Pre-Application | Product testing & documentation | 2 – 3 weeks |
| BIS Application Review | File examination & query clarification | 2 – 4 weeks |
| Inspection / Audit | Virtual or physical evaluation | 1 – 2 weeks |
| Grant of Licence | Issue of Standard Mark / CoC | Approximately 30 – 45 days |
*Indicative timelines from BIS Scheme-X guidelines and industry practice (2025).
Why OTR matters for MSMEs
1. Simplified compliance path
Before OTR, each machinery segment had its own Quality Control Order (QCO). OTR combines them into a single omnibus framework, reducing overlaps and making it easier for small manufacturers to plan certifications together.
2. Predictable testing and documentation
Under Scheme-X, one Technical File can cover multiple variants of a machine family, saving time and testing costs.
3. Support for domestic testing and Make-in-India
The BIS network of testing labs under OTR allows MSMEs to test locally instead of sending samples abroad.
4. Improved import clearance
Machines certified under OTR face no customs hold-ups for BIS verification, cutting border delays and demurrage.
5. Market trust and export benefit
The BIS mark under OTR aligns with ISO 12100 and EU Machinery Directive concepts—helpful for exporters needing CE-like assurance.
Fees and validity
| Item | Fee (approximate)* | Validity |
|---|---|---|
| Application processing | ₹15,000 – ₹25,000 | — |
| Testing charges | Variable (₹10,000 – ₹2 lakh per sample) | — |
| Licence validity | 2 years (initial) | Renewable with surveillance audit |
*BIS official fee circular to be updated for Scheme-X (2025–26). Consult Green Permits for current schedule.
Penalties for non-compliance
Selling or importing OTR-regulated products without a BIS licence is a statutory offence under the BIS Act (2016). Penalties include:
- Fine up to ₹2 lakh per offence
- Seizure of non-compliant goods
- Possible cancellation of import licences by DGFT for repeat violations
For MSMEs, the bigger risk is business interruption — projects stalled, clients lost, and inventory blocked at customs.
Common MSME mistakes to avoid
- Ignoring HS code mapping — many units assume their machine is exempt when its HS code is actually listed.
- Late testing start — labs have queues months before enforcement.
- Missing Technical File updates — any design change needs a revision submission.
- Skipping renewal — licence renewals should start at least 60 days before expiry.
- Not printing the BIS Mark — use correct marking guidelines to avoid product recall.
Quick Checklist for MSME Compliance
| Step | Action Item |
|---|---|
| 1 | Confirm your product’s coverage in the OTR First Schedule |
| 2 | Identify the applicable IS standards (Type A/B/C) |
| 3 | Prepare Technical File & Product Compliance Report |
| 4 | Conduct testing at BIS-approved labs |
| 5 | Apply for Scheme-X licence on Manakonline |
| 6 | Host virtual/physical audit |
| 7 | Obtain BIS Standard Mark / CoC |
| 8 | Maintain records & renew before expiry |
Conclusion: Simplification with Accountability
The BIS OTR Order marks a major shift from fragmented QCOs to a unified safety framework. For MSMEs, it means clearer rules, predictable processes, and credible market entry.
Failing to act early can delay product launches by months — but starting now with the right documentation and testing plan can secure your supply chain for 2026 and beyond.
Ready to get certified under BIS OTR?
Green Permits helps manufacturers and importers navigate the entire OTR process — from testing and technical file preparation to BIS licence approval.
Phone: +91 78350 06182
Email: wecare@greenpermits.in
Book a Consultation: https://www.greenpermits.in/contact-us/
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FAQs
BIS OTR (Omnibus Technical Regulations) is a new safety rule that makes BIS certification mandatory for many types of industrial machinery and equipment in India. It ensures your products meet Indian safety standards before sale or import.
Any manufacturer or importer dealing with machinery listed in the OTR Order—like pumps, compressors, cranes, packaging, textile, or electrical equipment—must get BIS certification before selling or importing in India.
You prepare a Technical File, get your product tested in a BIS-approved lab, and apply through the BIS online portal. Once reviewed and verified, BIS issues a Licence or Certificate of Conformity valid for two years.
Most applications take around 30–45 days once documents are ready. Fees range from ₹15,000 to ₹25,000 for registration, plus testing charges depending on the product.
Selling or importing without a valid BIS licence can lead to fines, product seizure, and major customs delays. Getting certified early helps you avoid penalties and build customer trust.
