Aluminium and Aluminium Alloy Products
Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging
Strategic Recommendations for Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging IS 16011:2012
- Engage Early with BIS & Labs
Apply for BIS license and complete foil testing in BIS-approved labs before deadlines. - Partner with Compliance Experts
Take expert guidance for certification, ISI marking, and exemption handling. - Contact ERA Support Team
📧 cs@eraglobal.co.in | 📞 +91 9599296331 | 💬 WhatsApp — for filings, lab coordination, and compliance support. - Track Notifications & Circulars
Subscribe to the ERA Newsletter for real-time updates on QCO 2025, corrigendum, and BIS circulars for any amendments. - Do a Gap Assessment
Check foil grades, packaging lines, and stock for compliance with IS 16011:2012.
| Section | Details |
|---|---|
| Product Name | Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging |
| Applicable Indian Standard (IS) No. | IS 16011:2012 |
| Title of Indian Standard | Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging |
| Quality Control Order | Aluminium and Aluminium Alloy Products (Quality Control) Order, 2025 |
| Notification & Amendments | Notified via S.O. 2021(E), dated 5 May 2025 Corrigendum: S.O. 2682(E), dated 16 June 2025 Corrigendum: S.O. 2683(E), dated 16 June 2025 Supersedes: QCO 2024 (S.O. 4696(E), dated 25 Oct 2024) and QCO 2023 (S.O. 4241(E), dated 27 Sep 2023) |
| Final Enforcement Date | General (other than MSMEs): 1 October 2025 Small Enterprises: 1 January 2026 Micro Enterprises: 1 April 2026 |
| Objective & Scope | To ensure safety, purity, and functional integrity of aluminium foil used for pharmaceutical packaging by mandating BIS certification under IS 16011:2012. |
| Products Covered | Aluminium and aluminium alloy foils intended for blister packs, strip packs, and other pharmaceutical packaging applications. |
| Exemptions | - Products meant exclusively for export. - Imports up to 200 kg per year for R&D (not for sale, must be scrapped after use). |
| Industries Impacted | Pharmaceutical Packaging Industry, Aluminium Foil Manufacturers, Healthcare & Pharma Supply Chain. |
| Mandatory Compliance | BIS certification under Scheme-I of BIS (Conformity Assessment) Regulations, 2018; ISI marking mandatory. |
| Next Steps for Stakeholders | Apply for BIS license, test foils in BIS-recognized labs, update packaging with ISI mark, declare non-marked stock if applicable. |
| Legal Framework Provision & Enforcement | Enforced under BIS Act, 2016. Certification and enforcement by Bureau of Indian Standards (BIS). |
| Penalties for Non-Compliance | Seizure of non-compliant goods, suspension or cancellation of license, fines, and imprisonment up to 2 years, or both. |
| Conclusion | From October 2025, BIS certification is mandatory for pharmaceutical aluminium foil under IS 16011:2012. The 2025 QCO ensures quality and safety in pharma packaging. |
| References / Annexures | QCO 2025: S.O. 2021(E) [5 May 2025] Corrigendum: S.O. 2682(E) [16 June 2025] Corrigendum: S.O. 2683(E) [16 June 2025] Superseded QCO 2024: S.O. 4696(E) [25 Oct 2024] Superseded QCO 2023: S.O. 4241(E) [27 Sep 2023] |
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Notification
 Aluminium and aluminium alloy foil for pharmaceutical packaging (IS 16011:2012) has been notified under the Aluminium and Aluminium Alloy Products (Quality Control) Order, 2025 via S.O. 2021(E) dated 5 May 2025. The Order replaces QCOs of 2023 and 2024. Corrigendum S.O. 2682(E) and Corrigendum S.O. 2683(E), both dated 16 June 2025, corrected IS references and extended MSME timelines.
Enforcement Timeline
- General (large & medium enterprises): 1 October 2025
- Small Enterprises: 1 January 2026
- Micro Enterprises: 1 April 2026
Overview
 IS 16011:2012 specifies the requirements for aluminium and aluminium alloy foils used in pharmaceutical packaging, particularly blister and strip packs. It ensures barrier properties, mechanical integrity, and safety for contact with medicines.
Objective & Scope
 The standard ensures pharmaceutical foils are free from defects, meet barrier requirements against moisture and contamination, and maintain integrity during storage and handling.
Products Covered
 Aluminium and aluminium alloy foils for blister packs, strip packs, and related pharmaceutical packaging.
Exemptions Provided
- Export-only products.
- Imports up to 200 kg annually for R&D purposes, scrapped after use and not sold.
Industries Impacted
- Pharmaceutical Packaging Industry
- Aluminium Foil Producers
- Healthcare & Pharma Distribution
Mandatory Compliance Requirements
All foils must carry ISI marking and comply with IS 16011:2012 under BIS Scheme-I.
Next Steps for Stakeholders
 Manufacturers must apply for BIS certification, complete lab testing, update packaging with ISI mark, and declare pre-certified/non-marked stock.
Legal Provisions, Enforcement & Penalties
 The BIS Act, 2016 governs enforcement, with BIS as the certifying and enforcing authority. Non-compliance attracts penalties including seizure, fines, suspension of license, and imprisonment up to two years.
Conclusion
 From October 2025 (with MSME extensions), aluminium foils for pharmaceutical packaging must comply with IS 16011:2012. The QCO enhances safety and reliability of drug packaging in India.
Ready to start your certification journey?
Let us help you navigate regulatory challenges and achieve certification with ease. Leave us your details, and we’ll get back to you—or request a free consultation today.