BIS Quality Control Order for Laboratory Glassware – Single Volume Pipettes

On January 1, 2024, the Ministry of Commerce and Industry, through the Department for Promotion of Industry and Internal Trade (DPIIT), issued the Laboratory Glassware (Quality Control) Order, 2023. This order aims to ensure that all laboratory glassware, particularly Single Volume Pipettes, produced, imported, or sold in India meet strict quality standards, promoting safety and compliance with Indian regulations.

If you are involved in the production, sale, or import of laboratory glassware, this order will directly impact your operations. The government has introduced this regulation in the public interest under the Bureau of Indian Standards (BIS) Act, 2016, after consulting the BIS.

Key Provisions of the Laboratory Glassware (Quality Control) Order, 2023

1. Title and Implementation Timeline

This order is officially titled the Laboratory Glassware (Quality Control) Order, 2023. It will take effect six months after its publication in the Official Gazette.

• Micro enterprises have until twelve months from the publication date to comply (January 1, 2025).

• Small enterprises have a compliance deadline of nine months (October 1, 2024).

• For Large and Medium Scale Enterprises, the order comes into effect after six months (July 1, 2024).

2. Mandatory BIS Certification

All laboratory glassware, specifically Single Volume Pipettes must conform to Indian Standard IS 1117:2018 and must bear the BIS Standard Mark (ISI Mark), which certifies compliance with the required quality and safety standards.

• Manufacturers must obtain a BIS license to use the ISI Mark on their products.

• This rule does not apply to laboratory glassware intended solely for export, or products manufactured for sub-assemblies of exported goods.

3. Exemptions

The order provides certain exemptions:

• Micro and small enterprises, as defined under the Micro, Small, and Medium Enterprises Development Act, 2006, have extended deadlines to comply (12 and 9 months, respectively).

• Goods manufactured solely for export are exempt from this requirement.

4. BIS as Certifying Authority

The Bureau of Indian Standards (BIS) is the designated certifying and enforcement authority. BIS will ensure that manufacturers, importers, and sellers of laboratory glassware comply with the provisions outlined in the order.

5. Penalties for Non-Compliance

Any violation of the provisions of this order will result in penalties as per the Bureau of Indian Standards Act, 2016. This regulation is designed to maintain the high quality of laboratory glassware products, ensuring their safety and compliance with Indian standards.

This order is a significant move towards regulating the quality of Laboratory Glassware – Single Volume Pipettes in India, enhancing public safety, and ensuring that all products adhere to stringent quality control measures.

Stay compliant and prepare your business for these important regulatory changes to continue operating within the guidelines of the industry!

Implementation Dates: Implementation for Medium & Large-Scale Enterprises: 1st July 2024

Date of implementation for Small Enterprises: 1st October 2024.

Date of implementation for Micro Enterprises: 1st January 2025.

Also Read

BIS Certification for Single Volume Pipettes IS 1117: 2018