Aluminium and aluminium alloy foil is commonly used in pharmaceutical packaging because it helps keep medicines safe from moisture, light, air, and other outside contaminants. It is lightweight, strong, and that is main reason for it to protect tablets, capsules, and other medical products so they stay effective for a longer time.
To make sure this foil is safe and good in quality, manufacturers need to follow the Indian standard for this product. Getting BIS Certification for Pharmaceutical Aluminium Foil shows that the foil meets the required quality, safety, and performance standards for use in the pharmaceutical industry.
overview of indian standard is 16011:2012
This is an Indian Standard that focuses on aluminium and aluminium alloy foil used in pharmaceutical packaging applications. It ensures that the foil is:
- Safe for pharmaceutical use
- Free from harmful contaminants
- Strong and durable
- Proper in thickness and quality
- Suitable for protecting medicines from moisture, light, and air
The standard also requires proper testing of the product to check quality and ensure that the foil is safe and suitable for packaging medicines and healthcare products.
testing and inspection requirements
To ensure the quality and reliability of aluminium foils used in pharmaceutical packaging, the standard defines the testing and inspection steps during manufacturing. These checks help make sure that the product is safe, consistent, and suitable for use.
what is r & s ?
- R (Required): Test must be done in the manufacturer’s own lab.
- S (Subcontracting Allowed): Test can be done in an external BIS-approved lab.
raw material tests
- Material Composition (S) – Checks whether the correct aluminium alloy is used. One sample is taken from each consignment and can be tested in an external BIS-approved lab.
physical and quality tests
- Pin Hole Count (R) – Checks for very small holes in the foil. One sample is tested from every fifth finished roll.
- Freedom from Defects (R) – The foil is visually checked to ensure it is free from cracks, holes, or surface defects.
dimensional and thickness tests
- Average Thickness (R) – Ensures the foil thickness is correct. Samples are tested from each control unit.
- Width Tolerance (R) – Checks whether the width of the foil is as per required size.
coating & lamination tests
- Coating/Lamination (R) – Ensures proper coating or lamination is applied on the foil.
strength tests
- Bursting Strength (R) – Checks how much pressure the foil can handle before breaking.
- Peel Strength (R) – Checks how well the layers stick together in laminated foil.
- Sealing Strength (R) – Ensures the foil seals properly for packaging use.
Additional material tests
- Lubricant Test (S) – Checks the quality of lubricants used in manufacturing. One sample is taken from each consignment and can be tested in an external lab.
Importance of These Checks
These tests help ensure the foil is strong, defect-free, properly sized, and safe for pharmaceutical packaging.
bis certification process for pharmaceutical aluminium foil
The BIS certification process ensures that aluminium foils for pharmaceutical packaging meet the required quality and safety standards. The process includes the following simple steps:
- Online Registration: Manufacturers have to register on the BIS Manak portal by submitting company
and product details. Foreign manufacturers must appoint an Authorized Indian
Representative (AIR).
- Testing at BIS-Approved Laboratory: Product samples are tested in BIS-recognized labs to check their quality,
strength, thickness, coating, and overall performance.
- Application Submission: The application is submitted with test reports, technical documents, and KYC
details. Foreign manufacturers must also provide AIR details.
- Factory Inspection: Officials from the Bureau of Indian Standards visit the factory to check
manufacturing process and quality control.
- Grant of BIS License: If all requirements are met, BIS grants the certification license.
- Use of ISI Mark: After approval, manufacturers can use the ISI mark with the CML number,
showing the product is safe and meets the standard.
documents required for bis certification
| Basic Details | - GST Certificate
- Email ID & Contact Number
- Factory & Office Address
- Rent Agreement / Lease Deed (if applicable)
|
| Legal Documents | - Partnership Deed (if partnership firm)
|
| Manufacturing Details | - List of machinery
- Process flow chart
- Layout Plan of Factory
|
| Raw Material Details | - List of Raw Materials
- Supplier Details
- Raw Material Invoices
- Raw Material Test Certificates
|
| Testing & Quality Control | - List of Testing Equipment
- Calibration Certificates
- QC / Lab In-charge Appointment Letter & Qualification
|
| Production Details | - Annual Installed Capacity
- Last Year Production Value
|
| Product & Packaging Details | - Quantity per Package
- Nature of Packing
- Nature of Printing / Marking on Product
|
| Management Details | - Top Management Details
- Concerned Person for BIS Communication
|
| Brand & Certification Documents | - Trademark / Brand Certificate
- Consent Letter from BIS Recognized Laboratory
|
| Additional Documents | - Weekly Off Details
- Hygiene Document (if applicable)
- Relaxation Letter (if applicable)
- Any Other Relevant Document
|
Foreign manufacturers must additionally appoint an Authorized Indian Representative (AIR) to coordinate with the Bureau of Indian Standards (BIS) and manage compliance requirements in India.
Marking Requirements & License Validity
Marking Requirements
When a manufacturer obtains the BIS License, ISI Mark for pharmaceutical aluminium
foil must be applied clearly and permanently on the product or its packaging. In addition
to the ISI Mark, other important details must also be provided on the product or
packaging, as shown in the table below ,this ensures product meets to all quality and
safety standard.
| Requirement | Details |
|---|
| ISI Mark | Indicates that the product is BIS certified and follows to the
standard |
| Standard Number | IS 16011:2012
|
| CML Number | Certification Marks Licence (CML) number issued by BIS |
| Manufacturer Details | Name of manufacturer or registered trademark |
| Alloy Information | Grade or designation of aluminium alloy used |
| Batch / Date | Batch number, heat number, or manufacturing date for traceability |
Note:
Marking is typically applied using durable stamping, tagging, or permanent printing to
ensure clear identification during handling, storage, and transportation, as per BIS
marking requirements.
Validity of BIS Licence for Pharmaceutical Aluminium Foil
After obtaining BIS Certification for the product, the license is valid for a fixed period and
must be maintained by following BIS rules and standards.
| Particulars | Details |
|---|
| Initial Validity | Typically 1 to 2 years, depending on BIS approval conditions |
| Renewal | Must be renewed before expiry by submitting the application along with the prescribed fee and updated documents |
| Surveillance | Includes periodic factory inspections and market sample testing conducted by BIS |
| Compliance | Continuous following to standard and applicable Quality Control Orders (QCOs) is mandatory |
| Risk | Non-compliance or failed sample testing may lead to suspension
or cancellation of the BIS license
|
BIS ISI Mark Certification Costing And Timeline
The cost of BIS certification includes charges for application, inspection, license, testing, and marking. These fees are paid to BIS as per Scheme I guidelines.
cost breakdown
| S. No. | Particular | Amount (INR) | Remarks |
|---|
| 1 | Application Fee | 1000 | To be paid to BIS |
| 2 | Audit / Inspection Fee | 7000 | To be paid to BIS |
| 3 | License Fee | 1000 | To be paid to BIS |
| 4 | Sample Testing Fee | As applicable | Varies by product and lab |
| 5 | Minimum Advance Marking Fee | As applicable | Depends on production and standard |
| 6 | Renewal Fee | 1000 | To be paid to BIS |
| 7 | Inclusion Fee | 5000 | To be paid to BIS |
| 8 | Service Fee | As applicable | Consultant charges (if any) |
Note: Additional costs such as pre-testing or factory pre-inspection may apply. The total cost may vary depending on product type, testing requirements, and current BIS guidelines.
bis marking fee for pharmaceutical aluminium foil
Note: The marking fee is based on reference data from the Manak portal. Actual fees may vary depending on production volume, scale of operation, and current BIS guidelines.
conclusion
BIS certification under IS 16011 ensures that aluminium foils used for pharmaceutical packaging meets the important quality and safety requirements. It also checks that the foil has proper thickness, strength, coating or lamination, and is free from defects so that it can safely protect the medicines. This certification also ensures that the product is manufactured under proper quality control and tested regularly as per the standard.
With the support and guidance of an experienced BIS consultant for pharmaceutical packaging materials ,like EVTL India, manufacturers can complete their certification process smoothly, avoid errors, and get approval within the required time.
