IS 16011 BIS Certification for Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging
Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging made, imported or sold in India must be certified against IS 16011 under an ISI mark licence (Scheme-I). What the standard covers, how testing works and how to get the licence.
About IS 16011
| Standard | IS 16011:2012 |
|---|---|
| Title | Aluminium and aluminium alloy foil for pharmaceutical packaging |
| Product covered | Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging |
| Category | Aluminium and Aluminium Alloy Products |
| Scheme | ISI mark licence (Scheme-I) |
| Notified under | Aluminium and Aluminium Alloy Products (Quality Control) Order, 2023, S.O. 4241(E), dated 25th September 2023 · Order PDF |
Editions and amendments of IS 16011
| Edition | Published | Status |
|---|---|---|
| IS 16011:2012 Aluminium and aluminium alloy foil for pharmaceutical packaging - Specification | 30 Nov 2012 | Current, next review 31 Mar 2027 |
No amendments to the current edition are listed by BIS.
Marking fee for IS 16011
BIS charges an annual minimum marking fee for the ISI mark under IS 16011, set by unit size, plus a per-unit rate once production passes the minimum:
| Unit size | Minimum marking fee (per year) |
|---|---|
| Large | ₹1,06,000 |
| Medium | ₹85,000 |
| Small | ₹53,000 |
| Micro | ₹21,200 |
Unit rate: ₹21.5 per mt. Source: BIS marking fee schedule for Scheme-I products, September 2026.
Sampling and key tests for IS 16011
From the BIS product manual for IS 16011, which BIS officers and applicants follow for certification:
Sample quantity:10 pieces/sheets of A 4 size
Tests BIS can carry out in a day during factory inspection:
- All
The full type test covers every clause of IS 16011; the list above is what can be checked on site.
ISI licences under IS 16011
BIS records 30 operative licences (33 including deferred, cancelled or under stop marking). Most licensed factories are in Gujarat (9), Maharashtra (6), West Bengal (3), Telangana (2), Haryana (2).
Testing against IS 16011
BIS inspects the factory and has samples tested to the full Indian Standard at a BIS or BIS-recognised laboratory. After grant, the factory keeps testing production under the Scheme of Inspection and Testing, and BIS draws factory and market samples.
The test report has to cover every clause of IS 16011 that applies to the product, in the edition current on the date of testing. When BIS revises IS 16011 or replaces it with a new edition, existing licence holders move to the new edition by the date BIS sets in its notification.
How to get an ISI mark licence under IS 16011
The licence is granted to the manufacturer for a specific factory and product. Indian factories apply under Scheme-I; overseas factories apply under the Foreign Manufacturers Certification Scheme (FMCS) and must nominate an Authorised Indian Representative.
- Confirm the exact Indian Standard and the varieties to cover
- Get the product tested at a BIS-recognised lab (simplified procedure) or arrange BIS sampling
- Apply on Manak Online with factory, quality-control and test documents
- BIS factory inspection and sample verification
- Grant of licence, then marking with the ISI mark and CM/L number
Timeline. BIS targets 30 days under the simplified procedure (applying with a recent lab test report) and 90 days under the normal procedure. Overseas factories under FMCS typically take around 6 months.
Fees. Application fee ₹1,000 and annual licence fee ₹1,000, inspection charges of ₹7,000 per man-day, testing charges, and an annual minimum marking fee set for each Indian Standard (with concessions for micro and small units).
Mark. Certified products carry the ISI Standard Mark with the IS number and the CM/L-XXXXXXXXXX licence number.
Frequently asked questions
What does IS 16011 cover?
IS 16011:2012: Aluminium and aluminium alloy foil for pharmaceutical packaging. BIS has made certification against it compulsory for aluminium and aluminium alloy foil for pharmaceutical packaging.
Is BIS certification under IS 16011 mandatory?
Yes, for aluminium and aluminium alloy foil for pharmaceutical packaging, under the Aluminium and Aluminium Alloy Products (Quality Control) Order, 2023, S.O. 4241(E). The product needs a valid BIS licence (ISI mark) and must carry the ISI Standard Mark with the IS number and the CM/L-XXXXXXXXXX licence number.
Where is a product tested for IS 16011?
BIS inspects the factory and has samples tested to the full Indian Standard at a BIS or BIS-recognised laboratory. After grant, the factory keeps testing production under the Scheme of Inspection and Testing, and BIS draws factory and market samples.
How long does IS 16011 BIS certification take?
BIS targets 30 days under the simplified procedure (applying with a recent lab test report) and 90 days under the normal procedure. Overseas factories under FMCS typically take around 6 months.
Other standards in Aluminium and Aluminium Alloy Products
- IS 21 Wrought Aluminium and Aluminium Alloys for Manufacture of Utensils
- IS 733 Wrought Aluminium and Aluminium Alloy Bars, Rods and Sections (For General Engineering Purposes)
- IS 734 Wrought Aluminium and Aluminium Alloys, Forging Stock and Forgings for General Engineering Purposes
- IS 736 Wrought Aluminium and Aluminium Alloy Plate for General Engineering Purposes
- IS 737 Wrought Aluminium and Aluminium Alloy Sheet and Strip for General Engineering Purposes
- IS 739 Wrought Aluminium and Aluminium Alloy Wire for General Engineering Purposes
- IS 740 Wrought Aluminium and Aluminium Alloy Rivet Stock for General Engineering Purposes
- IS 1254 Corrugated Aluminium Sheet
- IS 1285 Wrought Aluminium and Aluminium Alloys- Extruded Round Tube and Hollow Sections for General Engineering Purposes
- IS 2067 Wrought Aluminium Wire for Electrical Purposes
Source: BIS lists of products under compulsory certification (Scheme-I, Scheme-II), checked October 2026. See the full BIS product list or all Indian Standards.
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