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Introduction

The DPIIT, under the Ministry of Commerce and Industry, has implemented the Quality Control Order 2023, mandating BIS certification for Gamma Picoline as per IS 16113:2013. From January 1, 2024, manufacturers must obtain BIS certification to market Gamma Picoline in India. This regulation aims to ensure the availability of high-quality Gamma Picoline, critical for industrial applications, aligning with India's goals of promoting safe and standardized chemical production.

Why BIS Certification is Necessary for Gamma Picoline

BIS certification for Gamma Picoline ensures adherence to stringent quality standards, including purity levels, chemical stability, and safety measures. The Quality Control Order, 2023, emphasizes compliance with IS 16113:2013 to maintain consistent quality in industries that rely on Gamma Picoline. Non-compliance may lead to penalties under the Bureau of Indian Standards Act, 2016. Certification provides confidence to manufacturers and users that the product meets safety and performance benchmarks, especially for pharmaceutical and agricultural applications.

Overview of Indian Standard IS 16113:2013

Indian Standard IS 16113:2013 specifies the quality, purity, and safety parameters for Gamma Picoline. These include requirements for chemical composition, physical properties, and manufacturing practices to ensure suitability for industrial applications. BIS certification enforces these standards, fostering uniformity and reliability in the chemical's quality across industries like pharmaceuticals, agrochemicals, and specialty chemicals.

Process for BIS Certification for Gamma Picoline

The BIS certification process for Gamma Picoline involves several steps to ensure product compliance with Indian standards. Here’s an outline:

1. Application Submission: Manufacturers submit a completed application form with supporting documents to BIS.
2. Documentation Review: BIS reviews all submitted documentation to verify compliance with IS 16113:2013.
3. Factory Inspection: BIS officials inspect manufacturing facilities to assess production processes and quality control practices.
4. Sample Testing: Product samples are tested in BIS-approved laboratories to confirm adherence to specified standards.
5. Certification Grant: Upon successful review and testing, BIS grants certification, allowing the manufacturer to use the ISI mark on Gamma Picoline products.

Documents Required for BIS Certification for Gamma Picoline

To apply for BIS certification, manufacturers must provide:

• Application form
• Manufacturing process details
• Quality control plan
• Test reports from BIS-approved laboratories
• Factory layout and equipment specifications
• Business registration documents
• Product specifications and technical data
• Declaration of conformity to IS 16113:2013

Additional documentation related to environmental and safety compliance may be necessary, depending on the product.

BIS Documents For Domenstic and Foreign Manufacturer Check

To Know The Process in Detail, Please Visit:

Conclusion

BIS certification for Gamma Picoline under IS 16113:2013 is critical for ensuring product safety, quality, and compliance in pharmaceutical and agrochemical industries. This certification supports government efforts to standardize chemical production, ensuring reliability and safety in critical applications.

Navigating the BIS certification process can be challenging for manufacturers. EVTL India, a trusted consultancy, provides expert assistance, including managing BIS portal submissions, documentation, and regulatory fees. Partnering with EVTL India simplifies the certification process, ensuring timely approval and ongoing compliance with BIS standards.

For manufacturers seeking to secure BIS certification for Gamma Picoline, EVTL India offers comprehensive support, enabling market access in India and beyond. Contact EVTL India today for seamless certification assistance!