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The foil is lightweight, malleable, and has excellent sealing properties, making it ideal for use in blister packs, sachets, and other packaging formats. With its high-performance qualities, aluminium foil ensures that pharmaceutical products remain stable and effective throughout their shelf life.

Introduction

The Ministry of Commerce and Industries (Department for Promotion of Industry & Internal Trade) has issued the Aluminium and Aluminium Alloy Products (Quality Control) Order, 2023, which mandates that manufacturers of aluminium and aluminium alloy foil for pharmaceutical packaging obtain BIS certification (ISI Mark) for their products. This certification is essential to ensure that the foils meet the required standards of quality, safety, and compliance with regulatory requirements. The Indian Standard IS 16011:2012 sets the guidelines for the properties and testing of these foils, ensuring they meet the necessary performance criteria for pharmaceutical packaging. Manufacturers must adhere to these standards to maintain product quality and avoid legal penalties as per the Bureau of Indian Standards Act, 2016.

Why is BIS Certification Necessary for Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging?

BIS certification is crucial for aluminium and aluminium alloy foils used in pharmaceutical packaging to guarantee that the product meets quality standards that ensure the safety and efficacy of packaged medicines. Pharmaceutical packaging materials must provide a reliable barrier to prevent contamination and preserve the potency of the product. Compliance with Indian Standard IS 16011:2012 ensures that the foil meets the required specifications, including strength, flexibility, and resistance to environmental factors. Manufacturers who obtain BIS certification demonstrate their commitment to producing safe, effective, and high-quality products, protecting both consumers and regulatory compliance in the Indian market.

BIS QCO for Aluminium and aluminium alloy foil for pharmaceutical packaging

Overview of Indian Standard IS 16011:2012

IS 16011:2012 establishes the technical requirements and performance standards for aluminium and aluminium alloy foils used in pharmaceutical packaging. This standard specifies the material composition, mechanical properties, and testing procedures to ensure that the foils provide the necessary protection against moisture, light, and other factors that could compromise the safety and quality of pharmaceutical products. The standard also outlines the packaging and handling requirements to ensure that the foil maintains its integrity during storage and transport. BIS certification based on IS 16011:2012 helps manufacturers ensure their products meet these stringent standards and comply with regulatory requirements, thus protecting public health and safety. Non-compliance with this standard could lead to legal consequences under the Bureau of Indian Standards Act, 2016.

Process for BIS Certification

The BIS certification process for Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging involves multiple steps, designed to thoroughly evaluate a product's compliance with the required standards. Here is a general overview of the certification process:

1. Application Submission: Manufacturers must submit an application form along with required documentation to BIS.

2. Documentation Review: BIS reviews the submitted documents to ensure completeness and correctness.

3. Factory Inspection: BIS officials conduct an on-site inspection of the manufacturing facility to assess the production process and quality control measures.

4. Sample Testing: Product samples are taken and tested in BIS-approved laboratories to verify compliance with Indian standards.

5. Certification Grant: Upon successful completion of the inspection and testing, BIS grants certification, allowing the manufacturer to use the BIS mark on their products.

Documents Required for BIS Certification

To apply for BIS certification, manufacturers need to submit the following documents:

●  Application form

●  Manufacturing process details

●  Quality control plan

●  Test reports from BIS-approved laboratories

●  Factory layout and equipment details

●  Proof of business registration

●  Product specifications and technical details

●  Declaration of conformity to Indian standards

Additionally, manufacturers may be required to provide proof of compliance with environmental and safety regulations, depending on the specific type of product being certified.

BIS Documents For Domenstic and Foreign Manufacturer Check

To Know The Process in Detail, Please Visit:

Conclusion

BIS certification for Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging is essential to ensure adherence to quality and safety standards as per IS 16011:2012. By complying with the mentioned Quality control order, certified products provide reliable performance, enhance consumer safety, and reinforce the credibility of manufacturers in the Indian market.

Navigating the BIS certification process can be challenging, especially for small and medium-sized enterprises. EVTL India is a leading consultancy firm dedicated to assisting manufacturers in obtaining BIS certification (ISI Mark) efficiently. With expertise in managing BIS portal submissions, documentation, and regulatory fees, EVTL India ensures a smooth and successful certification process. By choosing EVTL India, manufacturers can enhance their product's marketability both in India and internationally, securing a competitive edge. Additionally, EVTL India provides ongoing support post-certification, helping manufacturers maintain compliance with BIS standards and renew their licenses as needed.