BIS Clarification Regarding Laboratory Glassware

Introduction to the BIS QCO on Laboratory Glassware

The Laboratory Glassware (Quality Control) Order, 2023, that has been issued by the Ministry of Commerce and Industry, mandates compulsory BIS certification for specified laboratory glassware in order to ensure safety, quality, as well as absolute standardisation.

For the purpose of addressing practical challenges that are faced by micro enterprises and R&D-oriented manufacturers, the Ministry has now issued a clarification amendment, introducing specific exemptions from the applicability of the Laboratory Glassware QCO, 2023, under defined conditions.

Key Clarifications & Exemptions Issued in the Notification

1. Exemption for MSME-Registered Enterprises

   Enterprises that are registered on the Udyam Portal under the Ministry of MSME are exempted from the applicability of the QCO for a period of two (2) years from the date of commencement of this clarification, provided:

   1. Investment in plant, machinery, as well as equipment does not exceed ₹25 lakh.
   2. Turnover in the previous financial year does not exceed ₹2 crore.
   3. Supporting certification for investment as well as turnover is provided by a Chartered Accountant.

   During this exemption period, no provisions of the Laboratory Glassware QCO shall apply to such enterprises.

2. Exemption for R&D Imports

   The exemption also applies to manufacturers of laboratory glassware who are importing up to 200 goods or articles per year strictly for research and development purposes, however, with the following conditions:

   1. Imported goods must be used exclusively for research and development purposes.
   2. Such goods must not be sold commercially.
   3. Post-use, the goods shall be disposed of as scrap.
   4. Manufacturers must maintain year-wise records of imported goods.
   5. Records must be furnished to the Central Government whenever required.

What is the Date of Implementation?

• This clarification comes into force from the date of its issue, which is 10th December 2024.
• The two-year exemption period for eligible MSMEs will be calculated from the date of commencement of this clarification.

Benefits to Businesses

• Regulatory relief for small and micro manufacturers.
• Reduced immediate compliance cost for MSMEs.
• Encouragement for R&D activities without certification barriers.
• Time buffer to prepare for BIS certification.
• Improved ease of doing business for laboratory equipment manufacturers.

Now, What Should Businesses Do?

Manufacturers of laboratory glassware should evaluate their MSME status, turnover, as well as investment limits in order to confirm eligibility for exemption. Those importing products for R&D must ensure strict record-keeping as well as non-commercial usage in order to avoid regulatory non-compliance.

With evolving QCO requirements, Brand Liaison supports businesses through simplified documentation, technical assistance, testing support, factory audit assistance, as well as expert BIS consultancy, which is backed by 10+ years of in-depth industry knowledge, ensuring a smooth transition from exemption to full compliance when required.