Free Consultation
info@elitasrcs.com | ➀ +91-9076611766 ➁ +91-9076611767
BIS QCOs | Government Guidelines
Mandatory

BIS Certification for
Aluminium Foil for Pharmaceutical Packaging IS 16011

BIS Certification for Aluminium Foil for Pharmaceutical Packaging in India
Home BIS Certification Aluminium Foil for Pharmaceutical Packaging IS 16011
IS 16011:2012 is the Indian Standard that defines the manufacturing, chemical, and physical requirements for aluminium and aluminium alloy foil used in pharmaceutical packaging. It is published by the Bureau of Indian Standards (BIS) and covers products including blister pack foils, strip pack foils, and pharma laminates. Raw material compliance: The aluminium material must conform to grades 19000, 19500, 19600, 31000, or 40800 as specified in IS 737.
 

Is IS 16011 Certification Mandatory?

Yes, and penalties for non-compliance are severe. Under Section 14 of the Bureau of Indian Standards Act, 1986, the Ministry of Commerce and Industry (Department for Promotion of Industry and Internal Trade) has issued a Quality Control Order requiring all manufacturers of aluminium and aluminium alloy foil for pharmaceutical packaging to obtain ISI Mark certification before placing their product in the Indian market.


Consequences of non-compliance:

  • Product seizure by enforcement authorities
  • Significant monetary fines
  • Suspension from pharmaceutical supply chains

 

Product Types Covered Under IS 16011          

“Licence is granted to use Standard Mark on Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging as per IS 16011:2012”.

Types / Scope of license

Type / Variety - Bare Blister Pack Foil/Coated Blister Pack Foil/Bare Pharma Strip Pack Foil/Pharma Laminate

Nominal Thickness– From …… up to and including …… mm or µm

Width(to be given type-wise) – Up to and including ……. mm

Delivery Condition - As rolled/Fully Annealed etc.

Coating/Lamination (to be given type-wise for each side) - e.g. Pharma Laminate with one side laminated with 35 gsm LDPE and non laminated side with primer coating with shellac
 

Procedure to obtain BIS Certification of Aluminium and Aluminium Alloy Foil

BIS Certification India for Indian Manufacturers (Standard Timeframe – 30 days)
BIS FMCS Certification for Foreign Manufacturers (Standard Timeframe – 180 days)

 

Quality Parameters Tested Under IS 16011

Your product must pass testing on all nine mandatory parameters before a BIS licence is granted:

  • Pin hole count:  Measures foil integrity; pinholes compromise barrier protection
  • Average thickness of bare foil — Ensures dimensional consistency across production
  • Freedom from defects: Visual and structural inspection for surface anomalies
  • Coating / Lamination: Verifies adhesion and composition of applied layers
  • Width: Dimensional accuracy as specified type-wise in the licence
  • Bursting strength: Pressure resistance of the foil under mechanical stress
  • Peel strength: Bond integrity of lamination layers
  • Sealing strength: Durability of heat-sealed pack closures
  • Lubricants: Composition and quantity compliance

 

Requirements to Obtain a BIS Licence

Before applying, manufacturers must have the following in place:

Operational requirements:

  • Raw material conforming to IS 737 grades
  • In-house testing laboratory equipped for all mandatory tests
  • Qualified Quality Control personnel

Documentation requirements (4 categories):

  • Administrative details
  • Technical details
  • Quality Control personnel details
  • Commercial details


Note: ERCS Pvt. Ltd. will audit your readiness against all requirements before your BIS application is filed, eliminating the risk of rejection or costly re-inspections.

 

Cost of IS 16011 BIS Certification

Expenses involved in obtaining BIS certificate for Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging as per IS 16011 under the Product Certification (Scheme-I) of BIS :

S No.

Particular

Amount (INR)

Remarks

1.

Application Fee

1000 

To be paid directly to BIS 

2.

Audit Fee

7000

To be paid directly to BIS 

3.

License Fee

1000

To be paid directly to BIS 

4.

Sample Testing Fee

As Applicable

To be paid directly to BIS (Testing charges vary from product to product and lab to lab.)

5.

Minimum Advance Marking Fee

As per actual

To be paid directly to BIS (Marking fee varies as per Indian Standard)

6.

Renewal Fee

1000

To be paid directly to BIS 

7.

Inclusion Fee

5000

To be paid directly to BIS 

8.

ERCS Pvt Ltd Service Fee

Please contact info@elitasrcs.com
 

Remarks

Including all the taxes
 
  • In the certification process, product testing is the most important stage as it determines whether the quality of the product meets Indian standards.
  • For the same purpose, investments in testing facilities are required to install test equipment for internal factory test laboratories.
  • Apart from charges mentioned above in the table, we may ask you to pay/reimbursement for a Pre-Visit at your Factory Premises to ensure the conformity of your product as per the relevant Indian Standard & BIS guidelines for its BIS certification.
 

How ERCS Pvt. Ltd. Supports Your Certification

To get BIS certification and produce a standard quality product, the manufacturer must ensure that their product must follow the specified Indian Standard Specifications (ISS) which we directly interpret to you from the BIS officials as per the Indian Standards.
 
ECRS Private Limited will be your friend, philosopher and guide in the whole process of getting your product certified by the concerned authorities/ departments.
 

What we do for you:

a.     Ensuring the conformity of your product as per IS 16011:
ERCS Pvt. Ltd. has developed a vast network within the Aluminium & Aluminum Alloy Industry various BIS departments to assist for ensuring conformity of the product Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging according to IS 16011.
 
b.     Effective documentation with the awareness of the BIS guidelines:
In order to facilitate the manufacturing industry in obtaining BIS certifications, guidelines have been developed. Our team has the experience of completing over 450 projects and technically competent acquaintances in various Industries.
 
We are familiar with the Indian Standard Specifications & BIS guidelines and deliver the most suitable interpretation to the Quality Control Personnel so we can do a reliable and effective documentation of your product in accordance with the BIS guidelines.
 
c.      A pre-visit can be paid at your factory premises:
In the process of getting BIS certification, the officer from BIS authority visits the factory for inspection. In order to get good results, the BIS inspection should go smoothly without any Non-Conformity. By keeping this goal in mind, our team will organize a pre-visit to your factory premises so that the required changes can be adapted so as to remove the elements of fallibility.
 
d.     Assistance for BIS audits:
We will explain the whole procedure of conducting a BIS inspection and make you aware of the things which need to be prepared and readily available at the time of inspection.
 

Benefits of Getting ISI Mark Certification

  • The term “ISI mark" means, that a certain product conforms to the quality standards set up by the government.
  • It is compulsory for Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging to obtain the ISI Mark and the violators are penalized with the material seize and a significant sum as fine.
  • Getting certification improves the probability of your product to survive and compete in the market.
  • Customers have the tendency of buying ISI certified products as it ensured safety and standard quality. Hence, with the certified products you can win the confidence and trust of the buyer.
  • With the word of mouth of such client list, you can establish your credibility in the market.
  • Hence with the renowned brand, you can raise the standard and benchmark the market value of the product.
Need Compliance Help?

Fill out the form below and one of our regulatory experts will contact you shortly.