Learn how to get BIS ISI certification for aluminium and aluminium alloy foil for pharmaceutical packaging as per IS 16011:2012. Standphill India offers expert consultancy for fast and hassle-free BIS compliance.

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

In the pharmaceutical industry, packaging integrity is critical. Aluminium and aluminium alloy foils play a vital role in protecting medicines against moisture, oxygen, light, and microbial contamination. To maintain consistent quality and ensure consumer safety, the Government of India has mandated BIS ISI certification for these products under IS 16011:2012.

This article outlines the BIS certification process for pharmaceutical-grade aluminium foils and explains how Standphill India can support manufacturers and suppliers in achieving compliance efficiently.

About IS 16011:2012

IS 16011:2012 sets the technical standards for bare, coated, and laminated aluminium foils used in pharmaceutical packaging?. Key specifications include:

Thickness: 20–40 micrometers

Barrier properties: Protection against moisture, oxygen, and light

Mechanical strength: High bursting and peel strength to resist tearing

Surface quality: Free from defects such as splits, slivers, wrinkles, or stains

Low pinhole count: Ensures optimal barrier performance

Coating quality: Uniform lacquer coating for effective heat sealing

By conforming to this standard, manufacturers ensure their products meet the rigorous demands of the pharmaceutical industry, safeguarding drug efficacy and extending shelf life.

Regulatory Requirement

The Ministry of Commerce and Industry, through the Aluminium and Aluminium Alloy Products (Quality Control) Order, 2024, has made BIS certification mandatory for aluminium foils used in pharmaceutical packaging?.

Key Compliance Dates:

Enterprise Category	Effective Date
General Manufacturers	1st April 2025
Micro Enterprises	1st October 2025
Small Enterprises	1st July 2025

Failure to comply will attract penalties under the Bureau of Indian Standards Act, 2016.

BIS Certification Process: A Step-by-Step Overview

1. Product Testing

Manufacturers must submit samples to a BIS-recognized laboratory. Testing focuses on physical, mechanical, and chemical properties, ensuring full compliance with IS 16011:2012.

2. Application Filing

Companies must register on the BIS Manakonline portal and submit all necessary documentation, including test reports, factory details, quality management plans, and technical specifications.

3. Factory Inspection

BIS officers conduct an on-site audit to verify production processes, quality control measures, and infrastructure readiness. Sample collection for cross-testing may occur.

4. Grant of ISI License

Upon satisfactory audit and test approval, BIS grants permission to use the ISI mark bearing the standard number IS 16011:2012.

5. Post-Certification Compliance

Manufacturers must maintain robust quality assurance systems and comply with ongoing BIS surveillance, including regular factory audits and market sampling.

Why Partner with Standphill India?

Navigating the BIS certification process can be complex and time-consuming. At Standphill India, we specialize in providing end-to-end BIS certification consultancy services for aluminium and aluminium alloy products.

Our Services Include:

Comprehensive documentation and application support

Coordination with BIS-recognized laboratories for timely testing

Factory audit preparation and compliance gap analysis

Objection handling and follow-up with BIS officials

Post-certification management and license renewals

Why Choose Us:

Deep domain expertise in aluminium and pharmaceutical-grade standards

Strong industry relationships with BIS labs and certification bodies

A proven track record of quick and successful certifications

Dedicated project management for each client

At Standphill India, we ensure a seamless, accurate, and faster certification journey, minimizing disruption to your production and market timelines.

Conclusion

Obtaining BIS ISI certification under IS 16011:2012 is now essential for manufacturers and suppliers of pharmaceutical-grade aluminium foils. Early preparation and professional guidance are key to ensuring compliance, avoiding penalties, and maintaining market credibility.

For More Blogs Click Here.

• BIS Certification for Solar Water Heating Systems in India
• BIS Certification for Hand Tools - Process, Documents, Fees
• BIS Certification Guide for Hydrogenated Rice Bran Fatty Acids: Process, Documents & Fees
• BIS Certification for HDPE/PP Woven Sacks for Packaging of 50 kg Cement IS 11652
• BIS Certification for HDPE/PP Laminated Woven Sacks for Mail Sorting, Storage, Transportation and Distribution IS 17399
• BIS Certification for PP Woven Laminated Block Bottom Valve Sacks for 50 kg Cement Packaging IS 16709
• BIS Certification for Semiconductor Motor Controller & Soft Starter - IS/IEC 60947-4-2
• BIS Certification for Semiconductor Controllers & Contactors for Non-Motor Loads - IS/IEC 60947-4-3
• BIS ISI Mark Certification for Proximity Switches – IS/IEC 60947-5-2 | ISI Mark Guide
• BIS Certification for Polycarbonate
• BIS Certification for Electric Sieving Machines
• BIS CRS Certification for Amplifiers