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BIS Quality Control Order for Aluminium and aluminium alloy foil for pharmaceutical packaging
IS 16011:2012
Issue Order Date: 28th October 2024
Implementation Date: 1st April 2025

Concern Ministry: Ministry of Commerce and Industry

Dear Viewer,

Important update regarding Indian Standard applicable to all existing Licence holders/ New applicants/ manufacturers/ importers/ product sellers for Aluminium and aluminium alloy foil for pharmaceutical packaging.

BIS QCO for Aluminium and aluminium alloy foil for pharmaceutical packaging

Aluminium and Aluminium Alloy Products (Quality Control) Order, 2023 On September 25, 2023, the Ministry of Commerce and Industry, through the Department for Promotion of Industry and Internal Trade (DPIIT), issued the Aluminium and Aluminium Alloy Products (Quality Control) Order, 2023. This regulation, enacted under the Bureau of Indian Standards (BIS) Act, 2016, aims to ensure the quality and safety of Aluminium and aluminium alloy foil for pharmaceutical packaging, aligning with Indian Standards. 

Key Provisions of the Aluminium and Aluminium Alloy Products (Quality Control) Order, 2023

  1. Title and Implementation Timeline 

Officially titled the Aluminium and Aluminium Alloy Products (Quality Control) Order, 2023.

To provide additional time for compliance, the Ministry issued two amendment orders, with the latest titled Products (Quality Control) Order, 2024. This amendment revised the implementation dates, offering a staggered approach for manufacturers based on enterprise size:

  • Medium and large-scale enterprises: Implementation by April 1, 2025.
  • Small enterprises: Implementation by July 1, 2025.
  • Micro enterprises: Implementation by October 1, 2025. 

Mandatory BIS Certification

The regulation mandates that Aluminium and aluminium alloy foil for pharmaceutical packaging conform to Indian Standard IS 16011:2012.

    • BIS license is required for manufacturers to affix the Standard Mark (ISI Mark) on their products.
    • This requirement does not apply to goods manufactured solely for export purposes. 
  1. Certifying and Enforcement Authority
    The Bureau of Indian Standards (BIS) is designated as the certifying and enforcement authority. BIS will oversee the certification process and ensure compliance, restricting the manufacture, import, or sale of non-compliant products.
     
  1. Penalties for Non-Compliance
    Violations of the provisions of this order will attract penalties as specified under the BIS Act, 2016.
     

This regulation underscores the government’s commitment to enhancing the quality and durability of aluminium products in India. By mandating conformity to  IS 16011:2012 and allowing phased implementation, the order supports consumer safety, industry accountability, and ease of compliance for diverse manufacturers.

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

Implementation Dates: Date of implementation for Medium & Large-Scale Enterprises: 1st April 2025

·    Date of implementation for Small Enterprises: 1st July 2025.

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

BIS Certification for Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging IS 16011: 2012

CONCERNED AUTHORITIES

Bureau of Indian Standards Manak Bhawan 9, B.S. Zafar Marg, New Delhi - 110002
Tel: +91-11-23231903
Email : med@bis.org.in
Implementation Dates : 1st April 2025

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