BIS OTR Certification

Introduction: India’s Leap Toward a Single Product-Safety Law

India’s manufacturing sector has long navigated a maze of product-specific Quality Control Orders (QCOs).
In 2024, the government took a bold step—launching the Omnibus Technical Regulations (OTR), a unified compliance framework under the Machinery and Electrical Equipment Safety Order, 2024 issued by the Ministry of Heavy Industries.

For the first time, machinery, mechanical, and electrical products fall under one structured compliance route managed by the Bureau of Indian Standards (BIS) through Scheme X.

Manufacturers, importers, and assemblers now have a single certification pathway—BIS OTR Certification—that replaces scattered QCOs and integrates product safety, energy efficiency, and conformity assessment in a single digital ecosystem.

Understanding BIS OTR Certification

What is OTR?

The Omnibus Technical Regulation (OTR) is a harmonised conformity-assessment order that mandates BIS certification for machinery and electrical equipment placed on the Indian market.
It integrates multiple safety standards—mechanical integrity, electrical insulation, EMC compatibility, and human safety—into a single audit and testing regime.

Administered Under

• Implementing Agency: Bureau of Indian Standards (BIS)
• Regulating Ministry: Ministry of Heavy Industries (MHI)
• Legal Basis: Section 14 of the BIS Act 2016 and OTR Order 2024
• Certification Scheme: Scheme X of the BIS (Conformity Assessment) Regulations, 2018

Objectives of OTR

1. Unify Product Safety: Bring multiple industrial sectors under a single technical regulation.
2. Enhance Consumer and Worker Safety: Ensure electrical, mechanical, and operational safety.
3. Enable Ease of Doing Business: Single online portal for domestic and foreign applicants.
4. Boost Export Competitiveness: Indian-certified products gain credibility in global tenders.
5. Facilitate Circular Economy: By linking compliance with EPR and sustainability objectives.

Coverage and Scope: Who Needs BIS OTR Certification

Stakeholder	Applicability	Typical Examples
Manufacturers in India	Must obtain BIS License under Scheme X before sale or distribution.	Machine tools, pumps, compressors, cranes, motors, electrical panels
Importers / Foreign Manufacturers	Require Certificate of Conformity (CoC) for each shipment or a permanent FMCS license.	Imported HVAC units, control gears
Assemblers / OEMs	Must certify if final product carries their brand.	OEMs assembling control panels for clients
E-Commerce Sellers	Responsible for listing only certified products.	Online industrial equipment vendors

Exemptions

• Components already covered under another valid QCO.
• Export-only products clearly marked “Not for sale in India.”
• Equipment used for R&D or field trials under BIS approval.

Products Covered Under OTR (Indicative)

Product Category	Example Products	Governing Indian Standards (IS)
Machinery & Industrial Equipment	Compressors, pumps, valves, gearboxes	IS 8472, IS 5120, IS 2974
Electrical Equipment & Assemblies	Motors, transformers, control panels	IS 12615, IS 13947
Lifting & Handling Equipment	Cranes, hoists, elevators	IS 3177, IS 14665
Thermal & Process Equipment	Boilers, furnaces, heat exchangers	IS 3595, IS 5454
Construction & Agricultural Machinery	Mixers, loaders, tillers, sprayers	IS 9020, IS 4939
Power Tools & Portable Machines	Grinders, drills, cutters	IS 302 Part 2
Automation & Control Systems	PLC panels, switchgear assemblies	IS 8623, IS 5578

(Full list in BIS OTR Schedule I – Machinery & Electrical Equipment Safety Order, 2024.)

Two Paths of Certification Under Scheme X

Type	Applicability	Validity	Marking
Standard Mark License (SML)	Continuous manufacturers	2 – 5 years	Standard Mark + “Scheme X / OTR 2024”
Certificate of Conformity (CoC)	Import / Lot-wise consignments	Per shipment	Accompanies import documents

Detailed Step-by-Step Process

1. Pre-Assessment & Applicability Check

Identify whether your product appears in OTR Schedule I and the corresponding Indian Standard.
A gap assessment helps discover design or testing gaps before formal application.

2. Document Preparation & Technical Construction File (TCF)

The TCF is the heart of the application. It must include:

• Product drawings and bill of materials
• Safety circuit schematics and control logic
• Risk assessment (ISO 12100 / IEC 60204 – 1 basis)
• Routine test plan and internal audit records
• BIS-approved lab test reports
• Installation and user manuals
• Self-declaration of conformity to OTR clauses

3. Online Application on BIS Portal

Login to the BIS OTR portal → Select “Scheme X (OTR)” → Fill manufacturer details and upload documents.
Fees (approx.): ₹15,000 – ₹25,000 per product group.

4. Sample Testing & Evaluation

BIS nominates a laboratory for sample testing. Evaluation includes:

• Type tests as per Indian Standard
• Routine and safety tests
• Energy-efficiency evaluation (if applicable)

Testing time: 4–6 weeks.

5. Factory Audit / Inspection

BIS auditors verify manufacturing process control, quality management (QMS ISO 9001 preferred), and in-process testing equipment.
A Non-Conformity Report (NCR) is issued if gaps exist; corrective action must be submitted within 30 days.

6. License Grant / CoC Issuance

After successful audit and test clearance, BIS issues either:

• Standard Mark License (valid 2–5 years) or
• Certificate of Conformity for imports.

Each certificate contains a unique OTR registration number (e.g., CM/L-XXXXXXX).

7. Post-Certification Compliance

Manufacturers must:

• Maintain records of each batch produced.
• Submit annual returns and renewal documents.
• Allow surveillance audits and market sampling by BIS.

Timeline and Cost Snapshot

Stage	Typical Duration	Cost Estimate (INR)
Documentation & Application	2 – 3 weeks	15 – 25 k
Testing & Evaluation	4 – 6 weeks	30 k – 1.2 lakh
Factory Audit & Report	1 – 2 weeks	25 k + travel
License Issuance	30 – 45 days	5 k license + 5 k annual fee

(Actual charges as per BIS Fee Circular 2025.)

Key Documents Checklist

Category	Examples
Legal Docs	PAN, GST, CIN, CTE/CTO certificates
Technical Docs	Drawings, test reports, manuals, risk assessment
Quality System	QCP, inspection records, internal audit plan
Declarations	Self-declaration of compliance and marking
Additional for Imports	Packing list, invoice, test reports from foreign labs

Post-Certification Obligations

1. Surveillance Audit: Once every 12 months or as decided by BIS.
2. Market Sampling: BIS may pick random samples from market or factory for testing.
3. Renewal: Apply 60 days before expiry with latest test data.
4. Changes / Amendments: For design updates or capacity expansion, submit supplementary documents.

Penalties and Enforcement

Violation	Consequence (Under BIS Act 2016)
Manufacturing without License	Fine up to ₹2 lakh + product seizure
False marking or misuse of logo	License cancellation + criminal action
Repeated non-compliance	Blacklisting for 3 years
Import of un-certified goods	DGFT ban + customs confiscation

Industry Impact of OTR Implementation

For Domestic Manufacturers

• Simplifies multi-category certifications into one scheme.
• Encourages modern testing and documentation discipline.
• Aligns with global IEC/ISO frameworks.

For MSMEs

• Initially cost-intensive but long-term savings by avoiding multiple licenses.
• BIS has announced fee rebates and grouping options for technically similar models.

For Importers and Foreign Brands

• Requires local authorized representatives for applications.
• Greater transparency in traceability and recall procedures.

For Consumers and Industry Buyers

• Assurance that machinery meets essential safety requirements.
• Lower accident risk and energy loss in industrial use.

Common Challenges & Solutions

Challenge	Recommended Action
Complex standards mapping	Use Green Permits’ “Standard Mapping Matrix” to identify correct IS codes.
Testing delays	Plan pre-testing and parallel sample submission.
Documentation errors	Conduct internal mock audits before official inspection.
Lack of awareness in SMEs	Organize training / consulting through BIS-approved advisors like Green Permits.

Mini Case Study: BIS OTR Compliance Success

XYZ Hydraulics (Pune) manufactures hydraulic presses. They approached Green Permits in 2025 to comply under OTR.

• We identified IS specifications (IS 15159 and IS 9000) and prepared the TCF.
• Lab testing and BIS inspection completed within 6 weeks.
• License granted under Scheme X with Standard Mark “BIS/OTR 2024.”
  Outcome: XYZ Hydraulics secured public-sector tenders worth ₹3 crore after OTR certification.

The Bigger Picture: OTR and India’s Sustainability Goals

BIS OTR is not just a technical regulation—it links product safety with sustainability and resource efficiency.
The framework complements India’s EPR policies under Plastic, E-Waste, and Battery Waste Rules, creating a closed-loop compliance ecosystem.

Future phases will include:

• Carbon footprint disclosure for energy-intensive equipment.
• Lifecycle reporting of critical materials used.
• Digital product passports linked to OTR registration numbers.

Green Permits is actively helping clients integrate EPR and BIS compliance to achieve ESG targets.

Conclusion: Compliance as a Business Advantage

OTR signals a turning point for India’s industrial safety regime.
Rather than viewing it as a bureaucratic requirement, forward-looking manufacturers see BIS OTR as a market differentiator—a badge of quality that opens doors to exports, government procurement, and ESG-driven corporate alliances.

BIS OTR Certification is your product’s passport to India’s new industrial economy.

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