News Brief

On 11 July 2025, Central Marks Department (CMD-I) of Bureau of Indian Standard (BIS) published the guidelines for the grant of certification of OTR (Omnibus Technical Regulation) under Scheme-X to simplify the application procedure.

Scheme-X permits manufacturers (Domestic & Foreign) to continue with their operations in India by offering a license or certificate of conformity. The products' safety and quality are guaranteed by the license or certificate of Conformity. The two main product categories are covered by Scheme-X.

1. Low-voltage control and switch equipment

2. Omnibus Technical Regulation-covered machinery and electrical equipment

This was the much-awaited guidelines for the industries that deal with Heavy Machinery and Equipment and their parts/accessories production, which are covered under the scope of Scheme-X OTR Regulations.

Product Category and HS Codes coverage under the Omnibus Technical Regulation (OTR)

OTR regulations are generally applicable on Chapter 84 and Chapter 85 of HS code classification system. The following mentioned HS code are covered under the OTR regulations of Scheme-X.

Key Standards Listed in OTR of Scheme-X

Three Types of Standards under the OTR regulation

There are three types of standards mentioned under the OTR regulation, which are as follows;

• Type-A standard: (IS 16819:2018/ISO 12100:2010) It is basic safety standard, giving basic concepts, principles for design, and general aspects that can be applied to machinery.

• Type B Standards: These types of standards are known as generic safety standards and deal with one safety aspect or one type of safeguard that can be used across a wide range of Machinery. (Refer third schedule of Scheme-X QCO)

• Type C Standard: These are known as Specific to Machine Safety standards and deal with detailed safety requirements for a particular machine or group of machines.

The guidelines cover the application process, application requirements, and general procedure for testing the sample, auditing process as per BIS Conformity Assessment Regulation, 2018.

Two Types of Certificates

The guidelines cover two types of Certificates as per Scheme-X of BIS, and these are as follows;

1. License: Licence to use Standard Mark having a validity duration on a continuous basis

2. *Certificate of Conformity: Certificate of conformity valid only for specific prototype or for a particular lot or batch of product only.

*Note: As per guidelines, the Certificate of Conformity is waived off for Performance Bank Guarantee submission of 10000 USD by  foreign manufacturer.

Validity of License

Initially license could be granted for at least three years and a maximum of up to six years. In addition, the license could be renewed for a further period, which will be at least three years, and a maximum can go up to six years of validity.

Validity of Certificate of Conformity

The certificate of conformity shall be applicable to a specific product prototype or lot or batch of product only and will not permit manufacturing of similar product on continuous basis.

General Application Documents Check List

• Supportive documents for the Establishment of Firm

• Address Proof of the Factory

• Authorised representative letter, in case the application is signed by a person other than the CEO of the firm.

• #Technical Files (See full details of Technical File in Table 2)

• Brand Details

• Authorised Indian Representative, if applicable

• Declarations/Undertakings (as applicable)

The guidelines clearly state that, the manufacturer needs to submit the technical file during the initial stage of Application to get the License/Certificate of Conformity. The term “Technical file” is a kind of detailed dossier, where the manufacturer needs to submit each and every detail of the manufacturing premises as per guidelines, such as Manufacturing process flow, operation, design, plant layout, testing facilities, testing equipment, etc. Apart from this, the Guidelines also mentioned the Product Compliance Report, which is a key part of the technical file.

Product Compliance Report is very specific to “Test Reports,” which covers various aspects such as

• Identification of Hazards and measures for minimise such Hazards

• Safety function diagrams like stroke limitation, electrical circuit, ground connection, hydraulic circuit, pneumatic circuit

• Safety validation reports with performance level of safety related parts / control systems (SRP/CS)

Test reports could be generated using in-house lab facilities or could be done from BIS Recognised/Empanelled Lab/Accredited Lab.

Table 2. Components of Technical Files

The guidelines clearly indicate the application process flow; the below image is showing the application process which is extracted from the published guidelines.

How to Get the License/Certificate of Conformity

Additional Criteria for Foreign Manufacturers

• Foreign Manufacturer needs to appoint the Authorised Indian Representative (AIR) for submitting the application to BIS department on their behalf. (Detailed requirement for AIR you can access in Annexure-IV of Guidelines.

• The application submission will be in offline mode, and all the relevant documents needs to be submitted to BIS department in hard copies, which should be properly signed and stamped by the legal representative/authorised person of the manufacturing company.

• The applicant must confirm their readiness for the inspection and take all necessary steps—such as paying visit charges, arranging for a visa, and providing any other required support—to ensure that the officer's visit can occur as soon as possible.

• A Performance Bank Guarantee (PBG) of USD 10,000, issued by any bank with a branch in India approved by the Reserve Bank of India, must be provided. The PBG must remain valid for six months beyond the validity period of the licence.

Note: Deposition of PBG not applicable in case of Certificate of Conformity or in case of domestic manufacturer.

 Exemptions under the Omnibus Technical Regulation (OTR) of Scheme-X

• Product/Goods/Articles produced for the export purposes by the Indian Manufacturer will be exempted from these rules.

• These rules also not applicable on Constructive Equipment’s covered under the CMVR Rule 1989 issued by the MoRTH.

Authority Fee

 To gain deeper insights & more updates of the Scheme-X OTR regulation or India BIS compliance, please keep in touch with the REACH24H Team at customer@reach24h.com.