The Machinery and Electrical Equipment (Omnibus Technical Regulation) Order, 2024 (‘OTR Order’) was issued by the Ministry of Heavy Industries on 28 August 2024. It covers 20 categories of machinery and electrical equipment, along with their assemblies, sub-assemblies, and components, mandating compliance with Indian Standards and compulsory certification from the Bureau of Indian Standards.
Initially, the enforcement of the OTR Order was scheduled in August 2025. However, in response to a multitude of representations filed by various industries impacted by the OTR Order, citing lack of clarity and compliance difficulties, the Ministry of Heavy Industries extended the implementation date of the OTR Order until 1 September 2026 for machines, while the date for implementation of the OTR Order for the assemblies, sub-assemblies and components listed in the Order will be notified separately. This extension also provides time for the Ministry of Heavy Industries to issue guidelines for compliance with the OTR.
Recently, five such guidelines have been issued:
- Guidelines for grant of certification as per the conformity assessment Scheme-X of Schedule-II of BIS (Conformity Assessment) Regulations, 2018, dated 11 July 2025
- Machine Category Specific Guidelines for grant of BIS Certification for Metal Cutting Machines dated 16 July 2025
- Machine Category Specific Guidelines for grant of BIS Certification for Low-Voltage switchgear and control gear assemblies: Part 3 distribution boards intended to be operated by ordinary persons dated 17 July 2025
- Machine Category Specific Guidelines for grant of BIS Certification for Machinery for working Rubber and Plastics dated 22 July 2025
- Machine Category Specific Guidelines for grant of BIS Certification for Semiconductor Converters dated 22 July 2025
Understanding the Guidelines dated 11 July 2025
The Guidelines dated 11 July 2025 have been issued by BIS, Central Marks Department – I. These are guidelines for the grant of certification and are to be read in conjunction with the Bureau of Indian Standards Act, 2016 (‘BIS Act’), and the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018 (‘BIS CA Regulations’).
The OTR Order requires compliance under Scheme-X of the BIS CA Regulations, 2018. Under Scheme X, there are two kinds of product certifications that can be granted:
- License, that is valid for a continuous duration, to use the Standard mark -
- Certificate of conformity that is valid only for a specific prototype or for a particular batch of products.
As per the Guidelines dated 11 July 2025, certification under Scheme-X is to be granted based on successful assessment of the Technical File submitted by the manufacturer, which shall also include a Product Compliance Report. Product Compliance Report is a report on compliance of the product with specified requirements. These requirements are given in the relevant Indian standard applicable for the product. The basic principles for risk assessment and risk reduction have been included in Indian Standard 16819 : 2018 (hereinafter referred to as ‘IS 16819’). This is a Type A standard as per the OTR Order.
The Technical File is assessed vide a review comprising of desk audit and site audit. The Technical File includes documents covering parameters such as the design, manufacture and operation of products, that are necessary to demonstrate compliance of the machinery to the safety standards. The Technical File is required to comprise of the following details:
- Product description with details of variety or grades or type or size, as applicable
- Specified requirements applicable for the product
- Photographs for identification of the product
- Name and address of the manufacturer
- Details for identification and traceability of the product, such as brand name, trademark, date of manufacturing, etc.
- Design of the product including its drawings
- Description of the manufacturing process
- Product Compliance Report including parameters such as risk assessment, safety function diagrams, safety validation reports, and supporting documents for components.
- Details of in-house quality assurance measures including inspection, test plan, etc.
- Instructions for use, maintenance, installation, and safe operation of the product
- Any other requirement specified for the product.
The following categorization is to be used for preparing the Project Compliance Report:
- Engineering design based risk elimination or reduction measures
- Control systems based risk reduction measures
- Instructions, labelling, marking based risk reduction measures.
As per sub-regulation (6) of Regulation 4 of the BIS CA Regulations, 2018, applications can be rejected due to multiple reasons. A few common reasons for rejection include:
- Incomplete documentation: The application is not complete, or there has been failure to respond to the queries raised during audit.
- Non-conformity: Assessment of the technical file establishes that the product does not conform to the specified safety requirements.
- Lack of corrective action: Corrective actions are not taken within the stipulated time.
Apart from these, additional requirements have been laid down for foreign manufacturers. A few important requirements include:
- Applications must be submitted in physical form, and online submission is not accepted
- The appointment of an Authorised Indian Representative (‘AIR’) is mandatory, and the eligibility criteria and responsibilities for the AIR have also been specified
- All costs associated with the grant of certification, such as for inspection, travel, testing, audit logistics etc., must be borne by the applicant.
These guidelines provide a general overview that helps in understanding Scheme-X and the OTR Order.
Understanding Machine Category Specific Guidelines
In order to help understand the certification process of the wide variety of machines included in the ambit of the OTR Order, BIS has issued certain machine category-wise guidelines. So far, four such guidelines have been issued for 1. Metal Cutting Machines, 2. Low-Voltage switchgear and controlgear assemblies, 3. Rubber and Plastics and 4. Semiconductor Converter.
The machine specific guideline outlines:
Technical file
The Technical File is to be submitted for each type of machine, and for each model of the machine, separately.
However, if a specific type of machine has multiple models, then a combined file can be submitted for the same, but one representative model has to be submitted for the purpose of testing.
Checklists for risk evaluation
Risk assessment and conformity checklists have been prepared by BIS to check the requirements specified in the Type A Standard IS 16819, and also for Type B and C Standards. However, these checklists are not exhaustive and are only for guidance.
Each machine category specific guidelines will provide separate checklists as per the Indian Standards relevant for that machine.
- Series/ Grouping guidelines
The manufacturer is required to declare the type of machine intended to be covered by the Certificate of Conformity, along with the date/ month of manufacturing, model name and number, the Lot number/ batch number, and serial number of the machine.
While selecting a representative model for the purpose of testing, the model that poses the highest risk has to be selected, while showcasing the safety features to tackle the same.
Labelling and Marking requirements
Goods ought to be labelled and marked according to Scheme X of the BIS CA Regulations, 2018.
Each machine category specific guideline will provide separate labelling and marking requirements, as per the Indian Standards relevant for that machine.
For example, Metal cutting machines must specifically comply with the labelling and marking requirements laid down in the following Indian Standards:
- IS 17259/ ISO 28881 for Electro-discharge Machine
- IS 17253 (Part 1)/ISO 16090-1 for Machining Centres, Milling Machines, Transfer Machines
- IS 17277 (Part 1)/ISO 16092-1 for Presses
- IS 17258/ISO 23125 for Turning Machines
- IS 17254/ISO 16093 for Sawing Machines for Cold Metal
As more machine specific guidelines are issued, industries will be able to better understand the specific safety requirements impacting their machines.
Conclusion
The OTR Order and the guidelines being framed thereunder aim to become the framework for industrial safety in India. These guidelines provide long-awaited direction and structure to the OTR Order. Once all the machine category specific guidelines are issued, businesses will be able to accurately assess risk and produce high-quality and safe machinery.
[The authors are Partner and Senior Associate, respectively, in BIS practice at Lakshmikumaran & Sridharan Attorneys, Mumbai]
