BIS Certification for Bromadiolone CB IS 12913

Only products containing Bromadiolone CB which meet the requirements of specifications of active ingredient concentration, moisture content, stability, package, and labelling are eligible for registration under BIS. Under BIS Certification for Bromadiolone CB, the manufacturers are now free to manufacture, distribute, and sell their products in India. 

Understanding BIS License

The standards of Bromadiolone CB, including points such as the concentration of the active ingredient, physical stability, moisture content, packaging and labelling, and long-term storage conditions, are determined by IS 12913.

Bromadiolone CB that is accredited according to IS 12913 should be of high quality, performance, safety, and compliance. Manufacturers who satisfy these requirements are allowed to display ISI mark on their products which is a guarantee to the end-user of reliability, performance, and safety. 

Why BIS License matters on products

Bromadiolone CB has several advantages over getting a BIS License mentioned as follows:

1. Increased Quality : Assures adherence to the IS 12913 standards and reduction in flawed or unsafe products.
2. Regulatory Compliance : Legalizes the production and sale in India; fines or bans uncertified products.
3. Market Credibility : ISI-certified Bromadiolone CB has buyers, distributors, and government agencies that have confidence in it.
4. Competitive Advantage : Certified products have a preference in tenders, institutional procurement, and export markets.
5. Performance Reliability : Active ingredient and packaging consistency minimizes operational risks and makes it effective. 

Key specifications of Indian Standard IS 12913

The Indian Standard IS 12913 gives the quality and safety standards of Bromadiolone CB as a rodenticide. It establishes specifications on active ingredient concentration, pharmacy stability, and water content to be effective and have a shelf life.

Packaging requirements are also included in the standard to avoid leakage and contamination. The safe handling and regulation are provided through mandatory labelling and marking norms. In order to receive BIS Certification and ISI Mark, compliance with IS 12913 is mandatory. 

Complete document list for BIS Registration

The following documents are necessary for Domestic Manufacturers:

1. List of raw material
2. Layout plan of the factory premises
3. List of testing equipment as per the Indian standard
4. Quality Control (QC) Personnel Details (Education degree and Aadhaar card)
5. GST
6. Authorized Person Aadhar & Pan Card
7. MSME
8. Electricity Bill
9. Email Address & Permanent Contact Number
10. Office Address
11. Factory Address
12. Copy of Partnership Deed / MOA (for Private Limited Co.)
13. Premises document / Rent Agreement
14. List of Manufacturing Machinery  

The following documents are necessary for Foreign Manufacturers:

1. Checklist for Application
2. Copy of Swift Remittance
3. Duly Filled Application Form
4. Copy of Business License
5. List of Machinery
6. List of Raw Material
7. Test certificate of Raw Material
8. List of Testing Equipment
9. Calibration certificate of Test Equipment
10. Process Flowchart
11. Layout Plan
12. Location Plan (Route Map)
13. Details of Technical Personnel
14. Qualification of QC
15. Copy of Certification of Product and/ System
16. Factory Test Report  
17. Agreement with AIR
18. Aadhar Card of AIR
19. AIR Nomination Form
20. Educational Degree of AIR
21. Undertakings
22. Scope of License

Standard Procedure for BIS Licensing

There are two key procedures to get your BIS license: Simplified and Normal.

Simplified Procedure

The steps involved in the simplified procedure are:

1. Document Collection : All the necessary KYC and technical documents are collected in order to start the BIS application without problems.
2. BIS Portal Registration : The license application is processed by the manufacturer being registered on the official portal of BIS.
3. Pre-Testing of Samples : Before submission, product samples are tested in a BIS authorized laboratory.
4. In-House Lab Requirement : Depending on the product, an internal laboratory facility might be necessary according to the BIS requirements.
5. BIS Review & Clarifications : BIS examines the submissions of documents and test reports and may request clarification.
6. BIS Audit at Factory : The audit of the product samples carried out by the BIS inspectors is done at the factory    . 
7. Timely Audit Completion : The audit, inspection and sample collection are conducted within 17 days of the application submission along with the EVTL India engineer.
8. EVTL India Engineer- Factory Inspection : The BIS auditor and an engineer at EVTL India undertake a proper inspection at the factory.
9. Independent Collection of Samples : The BIS auditor draws samples to be tested by the post-audit.
10. Sample Testing at BIS Lab : BIS sealed samples are sent to BIS laboratories, and the BIS department pays the price of testing.
11. Grant of BIS License : Upon satisfactory document inspection, testing and audit, ISI license is issued. 

Normal Procedure

The steps involved in the normal procedure are:

1. Submit Documents : Firstly, it is required to submit all the KYC and technical documentation to start the BIS application.
2.  Plan In-House Laboratory and Technical Proposal : Prepare an internal lab in case necessary and prepare all technical documentation.
3. Ready Factory Test Report (FTR) : Carry out in-house tests and document the FTR to demonstrate that the product is to the standards.
4. Submit Application & Fees : Includes your BIS application and the amount of fees necessary by the government.
5. BIS Audit : An audit of documents and processes at a BIS takes place within 3 weeks.
6. EVTL India Engineer Factory Inspection : BIS auditor inspects the factory with an EVTL India engineer to make sure that everything is in order. 
7. Sample Collection & Sealing : The BIS auditor picks samples randomly, puts them into a sealed sample and forward the sample to a BIS authorized lab to be tested.
8. License Approval : After the lab tests of the sample are passed-on, BIS issues the ISI license, and your product is certified and market-ready. 

Duration of BIS Approval process

According to IS 12913, the approximate schedule of BIS License for Bromadiolone CB is: 

For Simplified Procedure (Indian manufacturers)

Average 40-45 days

For Normal procedure  

• For Indian Manufacturers : 50-60 days
• For International Manufacturers : Approximately 180 days  

How does EVTL India assist manufacturers in BIS Certification?

EVTL India supports the manufacturers in the entire process of BIS Certification by giving them professional advice on which standards to adopt and the necessities to comply with. Being a BIS Consultant for Bromadiolone CB, the team helps the company with the correct documentation and arranges the testing of the product at the BIS-approved labs.

EVTL India also trains the manufacturers on the BIS factory audits and inspections to prevent delays. EVTL India is a BIS Agent for Bromadiolone CB that is the Authorized Indian Representative (AIR) to foreign manufacturers. This support will be end-to-end so that the approvals will be achieved faster and the BIS certification process will be smooth. 

Conclusion

Bromadiolone CB manufacturers have to follow IS 12913 and acquire BIS Certification to guarantee the safety of their products, their effectiveness, and adherence to the regulations.

Through the direction of EVTL India, approvals are made in time, product credibility is boosted, and entry into regulated markets becomes smooth. Partnering with EVTL India ensures a faster, transparent, and hassle-free BIS certification journey.

Frequently Asked Questions (FAQs)

1. Do the bromadiolone CB products need to be BIS certified?

Yes, BIS certification in accordance with IS 12913 is required in India. 

2. Who is eligible to certify under BIS ?

Indian and foreign manufacturers but foreign manufacturers must have an Authorized Indian Representative (AIR). 

3. What is the importance of BIS Certification to bromadiolone CB?

It ensures legal sale, reliability of a product, and acceptance in the market.

4. What are the tests provided in IS 12913?

Tests mentioned in IS 12913 are concentration of the active ingredient, stability, moisture content, packaging, and marking compliance. 

5. Is it possible to get foreign manufacturer BIS Certified?

Yes, by an Authorized Indian Representative (AIR).