BIS Certification for Neem Based EC (Azadirachtin) IS 14300

As a result of the extensive agricultural application, BIS certification according to IS 14300 guarantees that Neem Based EC (Azadirachtin) is of quality, purity, safety, stability and performance criteria. Such certification gives farmers, distributors and end users confidence that the product is reliable, effective and safe to use in crop protection, and at the same time the product is environmentally safe. 

An introduction to ISI Mark Certification

Under IS 14300, ISI Mark Certification has ensured that Neem Based EC (Azadirachtin) is of BIS quality to ensure that it is safe, effective and consistent in terms of quality for agricultural use in India.

Certification by ISI encourages manufacturing standardization in the form of frequent factory checks, sampling of products and laboratory testing. To be able to manufacture, import, distribute and sell Neem Based EC (Azadirachtin) lawfully in the Indian market, manufacturers and importers of the product must meet the requirements of BIS. 

Why is ISI Certification necessary?

The reasons why the ISI Certification is necessary in Neem Based EC (Azadirachtin) is important and given as follows:     

1. Quality Assurance : Ensures compliance with Indian Standards for safety, effectiveness, stability, and uniformity.
2. Legal Compliance : The requirement of manufacturing, importation and selling of Neem-based EC is mandatory in India.
3. Consumer Trust : Enhances trust between farmers and the stakeholders as a result of guaranteed performance and quality.
4. Market Acceptance : Increases the possibility of receiving government tenders, institutional purchases, and regulated markets.
5. Brand Credibility : Enhances the reputation of the manufacturer because it shows a desire to maintain quality and respectability in terms of regulations.

Key specifications of IS 14300

The BS 14300 is an Indian Standard awarded by the Bureau of Indian Standards to define the requirements, sampling techniques, test methods, packing, marking, and storage conditions of Neem Based EC (Azadirachtin). This standard guarantees the effectiveness of the product, its safety, and stability of its shelf-life, and consistency during the product usage.

The manufacturers who apply to achieve BIS (ISI Mark) Certification should observe the provisions of IS 14300 strictly. After certification, manufacturers and importers are allowed by law to produce, import, trade and distribute Neem Based EC (Azadirachtin) in India. 

Mandatory Documents 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

Steps to obtain BIS License

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. 

BIS Licensing Approval Timeline 

According to IS 14300, a BIS license for Neem Based EC (Azadirachtin) is expected to take: 

For Simplified Procedure (Indian manufacturers)

Average 40-45 days

For Normal procedure  

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

Why do manufacturers prefer EVTL India?

EVTL India has been a reliable BIS Consultant for Neem Based EC (Azadirachtin) under IS 14300. They offer end-to-end support such as:

• Checking and preparation of technical documentation.
• BIS portal end-to-end management.
• Teaming up with BIS-approved laboratories to conduct tests of products.
• Assistance at the level of inspection and audit in the factories.

EVTL India supports the Indian and international manufacturers in obtaining the BIS certification in an effective cost-saving manner and, at the same time, in accordance with the Indian requirements.  

Conclusion

According to IS 14300, Neem Based EC (Azadirachtin) is not allowed to be marketed in India unless it's certified by the BIS among the manufacturers and importers of the product. The BIS certification guarantees the quality of the product, regulatory conformity, environmental friendliness, and confidence in the farmers, regulators, and other stakeholders in the agricultural sector.

Under the professional advice of EVTL India, manufacturers will be able to streamline the process of BIS certification, ensure the regularity of product quality, and have an easy entry into the Indian biopesticide market, which will promote the growth of the business in the long term and adherence to the regulations. 

Frequently Asked Questions (FAQs)

1. Does neem based EC (Azadirachtin) in India needs BIS Certification?

Yes, to produce, import and market Neem Based EC (Azadirachtin) in India, BIS certification according to IS 14300 is required. 

2. Who is eligible to be certified in BIS under IS 14300?

Indian manufacturers are eligible as well as foreign manufacturers (through an Authorized Indian Representative -AIR).

3. What are the tests needed under IS 14300?

Tests used are Azadirachtin content, stability of formulation during emulsification, moisture content, physical appearance and other laid down chemical and quality parameters. 

4. Will the foreign manufacturers receive ISI Certification of neem based EC (Azadirachtin)?

Yes, the foreign manufacturers are allowed to get the certification by appointing a duly authorized Indian Representative. 

5. Is it mandatory that ISI be marked following the certification of BIS?

Yes, after receiving the BIS certification, ISI marking shall be placed on all goods of Neem Based EC (Azadirachtin) as per the IS 14300.