Pyridine is a heterocyclic basic organic compound having a strong and distinctive odour,
extensively used as a solvent and intermediate in industrial chemical manufacturing. It is a
transparent and flammable liquid that is useful in the manufacture of drugs, agrochemicals, dyes
and many other chemical products. BIS certification of Pyridine is required to guarantee its
compliance in terms of purity, chemical characteristics, safety, etc. Even small differences in the
composition of pyridine will influence the reaction rates and other factors that determine the
efficacy of the chemical process.
IS 8058:2018 sets very specific requirements regarding solubility behaviour, relative density,
boiling range, pyridine content, residue on evaporation, chlorides, moisture content and colour.
All these attributes form the basis for determining the chemical stability and appropriateness of
pyridine in industrial use.
Quality Parameters under IS 8058:2018
IS 8058: 2018 is the Indian Standard for Pyridine used in pharmaceuticals, agrochemicals,
laboratories, and chemical synthesis industries. It outlines the quality specifications and testing
methods to ensure reliable industrial performance and product safety. As per the BIS (Bureau of
Indian Standards), Pyridine is:
- Evaluated for moisture content
- Checked for distillation properties
- Assessed for color
- Tested for chemical composition
Eligibility Criteria for applying BIS Certification in India
BIS authorisation under IS 8058:2018 is required for businesses involved in manufacturing, importing, or supplying Pyridine (Chemical Grade) in India.
Applicable to:
- Manufacturers (India) - Must get BIS approval if the products are covered under QCO.
- Foreign Manufacturers - Need certification to export the Pyridine to India.
- Importers/Brand Owners - Must ensure that the products are BIS-certified before sale. S
- ellers/Distributors - Should only sell certified Pyridine Chemical.
Testing and Inspection Requirements
To ensure consistent quality performance of Pyridine used in pharmaceuticals, agrochemicals, laboratories and chemical synthesis industries, the Bureau of Indian Standards outlines the minimum requirements under IS 8058:2018. This certification ensures that manufacturers supply Pyridine with controlled purity, stable chemical behaviour and reliable performance across industrial and scientific applications.
The BIS testing parameters and quality checks for the Pyridine are listed below:
IS 8058:2018 Pyridine BIS Approval Process Explained
The BIS Authorisation process ensures that the chemical meets the required safety standards. This process is set by the Bureau of Indian Standards (BIS) and includes the following steps:
- Online Registration: Manufacturers register on the BIS Manak portal by submitting company, factory, and product details. Foreign manufacturers must appoint an Authorized Indian Representative (AIR).
- Testing at BIS-Approved Laboratory: Product samples are tested in BIS-approved laboratories for purity, identity, relative density, boiling range and residue on evaporation.
- Application Submission: The application is submitted along with test reports, technical documents, and factory details. Foreign manufacturers must also submit AIR-related documents.
- Factory Inspection: BIS officials visit the manufacturing facility to evaluate production processes, safety measures, and the quality control system.
- Grant of BIS License: After meeting all the necessary conditions, BIS grants the certification license under Scheme-I.
- Use of ISI Mark: Once the license is granted, ISI mark can be used for marking the product along with a CM/L number.
Required Documents for IS 8058:2018 Approval
| Document Category | Documents Required |
|---|
| Basic Details | GST Certificate, Email ID & Contact Number, Factory & Office Address, Rent Agreement / Lease Deed (if applicable),Partnership Deed (if applicable for partnership firms) |
| Manufacturing Details | List of Machinery, Process Flow Chart, Factory Layout Plan |
| 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, Product Printing / Marking Details |
| Management Details | Top Management Details, BIS Communication Contact Person |
| 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 Manufacturer Requirement | Appointment of Authorized Indian Representative (AIR) for BIS coordination and compliance in India |
The Foreign manufacturers must designate an Authorized Indian Representative (AIR) in India.
The representative is the local point of contact for the Bureau of Indian Standards (BIS) and
manages all compliance and regulatory requirements in India.
Marking Requirements & License Validity
Marking Requirements
After the manufacturer obtains a BIS license, the ISI Mark for Pyridine Chemical must be written
clearly and permanently either on its packaging or on the product. Additional details are
provided below:
| Requirement | Details |
|---|
| ISI Mark | Indicates that the product is BIS certified and conforms to standards |
| Standard Number | IS 8058:2018 |
| CML Number | Certification Marks License (CML) number issued by BIS |
| Manufacturer Details | Name of manufacturer or registered trademark |
| 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.
renewal &Validity of BIS License for pyridine chemical
| 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 |
| Surveillane | BIS may inspect factories and test samples periodically |
| Annual Fees | Annual license fee must be paid regularly |
| Compliance | Continuous compliance with BIS requirements is necessary |
| License Format | BIS is shifting towards a 10-digit license number format |
| Non-Compliance Risk | May lead to suspension or cancellation of license |
is 8058:2018 pyridine BIS license fee details
The cost of BIS Approval for Industrial Pyridine includes charges for application, inspection,
license, testing, and marking. These fees are paid to BIS as per Scheme I guidelines.
| Charge Type | Indian Manufacturers | Foreign Manufacturers |
|---|
| Application Fee | INR 1,000 | USD 15 |
| Audit Charges | INR 7,000 | USD 3,200 – 5,900 |
| License Fee | INR 1,000 | USD 15 |
| Marking Fee | As applicable | As applicable |
| Testing Charges | As applicable | As applicable |
| EVTL India Consultancy Fee | As per actual | As per actual |
Note:
- Application fee for foreign manufacturers is payable via SWIFT (SAARC countries may pay in INR with applicable GST).
- Audit charges for foreign manufacturers vary based on country/location.
- The marking fee is determined based on the product category and production volume (MSME benefits may apply).
- Testing charges are to be paid directly to BIS-recognised laboratories.
- Consultancy fees can vary depending on product type and factory location.
Conclusion
A failure to adhere to the IS 8058:2018 guidelines for pyridine may pose various production
challenges to the manufacturer. As the chemical plays a crucial role in various industries,
adherence to the regulations becomes an important issue in order to avoid any negative
consequences.
BIS Certification of Pyridine enhances the reputation of manufacturers since it assures the
quality of each batch of their product according to the standard specifications. Expert assistance
helps to ensure proper documentation procedures, laboratory communication, and audit
readiness. EVTL India makes it easy for the manufacturers to obtain the BIS Certification for
Pyridine.
