In the chemicals industry, the BIS Certification of Gamma Picoline is one of the most important
regulations that ensures that the chemical substance satisfies all the necessary standards.
Gamma Picoline is a chemical intermediate which is widely used in manufacturing Active
Pharmaceutical Ingredients (APIs), dyes, and agrochemical products. It is known for helping to
carry out reactions and increase yield within industrial chemical reactions.
According to IS 16113:2013, the compliance criteria include aspects like relative density,
distillation range, evaporation residues, water content, chloride content, ammonium content,
sulphate content, etc. These criteria ensure chemical stability and make the compound worthy
of use during industrial reactions.
What is IS 16113:2013 for Gamma Picoline
This is the Indian Standard that specifies the quality requirements and testing parameters for
Gamma Picoline used in pharmaceutical intermediates, agrochemicals, etc. It ensures that the
chemical maintains the required purity, composition consistency, and industrial performance for
safe commercial use. As per the BIS (Bureau of Indian Standards), Gamma Picoline is:
- Evaluated for impurity levels
- Verified for compliance with industrial quality standards
- Assessed for chemical consistency
- Tested for purity
Who Can Apply for Gamma Picoline BIS Approval
BIS authorisation under IS 16113:2013 is required for businesses involved in manufacturing,
importing, or supplying Methylpyridine in India.
Applicable to:
- Manufacturers (India) - Must get BIS approval if their products are covered under QCO.
- Foreign Manufacturers - Need certification to export the chemical to India.
- Importers/Brand Owners - Must ensure that the products are BIS-certified before sale.
- Sellers/Distributors - Should only sell certified Gamma Picoline.
Testing and Inspection Requirements
To maintain uniform chemical quality of Gamma Picoline used in pharmaceutical intermediates
and agrochemicals, BIS prescribes specific compliance requirements under IS 16113:2013. The
standard ensures that the product meets defined standards related to purity, composition,
stability and controlled impurity levels.
The major BIS testing requirements and quality evaluation parameters for Gamma Picoline are
outlined below:
Step-by-Step BIS Approval Process Under IS 16113:2013
Gamma Picoline undergoes the BIS Authorisation process to meet the quality and safety
requirements needed for its effective industrial use. 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 chemical composition, silica content, moisture content, fineness, compressive strength, and other physical performance parameters.
- 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: The Bureau of Indian Standards officials inspect the manufacturing units to verify the production process, safety measures, and quality control system.
- Grant of BIS License: Upon successful verification of all requirements, BIS grants the certification license under Scheme-I.
- Use of ISI Mark: Once approved, the manufacturer can use the ISI mark on the product with a CM/L number, confirming that the product meets BIS standards.
Documentation checklist for bis license
| 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 are required to appoint an Authorized Indian Representative (AIR) in India. The representative is the local point of contact for the Bureau of Indian Standards (BIS) and takes care of all rules and compliance work in India.
Marking Requirements & License Validity
Marking Requirements
When the maker gets the BIS license, the ISI Mark for 4-Methylpyridine should be written in a
clear and permanent manner on the package or product itself. Additional details are provided
below:
| Requirement | Details |
|---|
| ISI Mark | Indicates that the product is BIS certified and conforms to standards |
| Standard Number | IS 16113:2013 |
| 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.
BIS License Validity requirements
| 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 |
complete BIS Certification Cost Breakdown for IS 16113
The cost of BIS Approval for 4-Picoline 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
Non-compliance with the requirements of IS 16113:2013 for gamma picoline may create many
problems for industries such as variation in yield from reactions, stability of the produced
material, etc., and even rejection during the manufacturing process. Gamma picoline is often
used as an intermediate chemical and any deviation in purity or amount of impurities may cause
complications in the formulation process.
The BIS Certification for Gamma Picoline guarantees that all batches meet certain quality
standards tested in laboratories and through inspection systems. This not only helps improve
the reliability of the product but also increases the trust level of buyers. EVTL India provides all
necessary assistance in obtaining BIS Certification.
