Pharma Export: Implementation of Track and Trace system extended

The track and trace system implementation aims at enhancing transparency and accountability in the export of drug formulations

The Health Master

February 3, 2024

267

DGFT Directorate General of Foreign Trade — DGFT

Table of Contents

Last Updated on February 15, 2024 by The Health Master

Track and Trace system

In recent news, the Directorate General of Foreign Trade (DGFT) has made a significant announcement that will have a profound impact on the pharmaceutical sector. The implementation deadline for the track and trace system for the export of pharmaceuticals and drug consignments has been extended.

This move is expected to bring about positive changes in the industry, offering pharmaceutical companies more time to align their operations with the stringent requirements of the track and trace system.

Follow us on WhtasApp Channel

Extension of Implementation Deadline

The primary focus of this announcement is the extension of the implementation deadline.

Initially set for an earlier date, pharmaceutical companies now have until February 01, 2025, to ensure compliance with the tr a ck and trace system.

Download extension notice dated 02-02-2024

Notably, this extension applies to both small scale industries (SSI) and non-SSI manufactured drugs, providing a level playing field for all stakeholders in the pharmaceutical sector.

Objectives of the Initiative

The track and trace system implementation aims at enhancing transparency and accountability in the export of drug formulations.

The emphasis is placed on maintaining the parent-child relationship in the packaging levels and their movement in the supply chain.

This strategic move is expected to bring about a paradigm shift in the way pharmaceutical exports are managed, aligning with international standards.

Click for more articles on DGFT

Stakeholder Communication

Santosh Kumar Sarangi, the director general (DG) of DGFT, has played a pivotal role in communicating the details of this initiative.

Stakeholders are encouraged to reach out for clarifications or assistance via email at dgft@nic.in.

This proactive approach ensures that industry players have access to the necessary support and information during this transitional period.

Download Foreign Trade Policy 2023

Impact on Pharmaceutical Companies

The extended implementation deadline comes as a relief for pharmaceutical manufacturers.

It provides them with additional time to integrate the necessary technological infrastructure, ensuring the seamless implementation of the track and trace system.

This adjustment is crucial, considering the complexities involved in adapting to new standards, especially concerning the parent-child relationship in packaging levels.

Click for Guidance documents for industry

Amendment to Handbook of Procedure

The amendment affecting Para 2.76 (vi) and (vii) of the Handbook of Procedure – 2023 is a key component of this development.

The Public Notice dated February 02, 2024, highlights changes in Para 2.90A of the Handbook of Procedure-2015-20, providing a comprehensive roadmap for the track and trace system.

Significance of Parent-Child Relationship

Sarangi emphasizes that the parent-child relationship in packaging levels is a crucial aspect that demands meticulous attention.

The extended timeline recognizes the complexities involved and allows industry players to navigate the intricacies of the new standards effectively.

Click for more Articles on Pharmaceuticals

Click for more Legal Articles on Pharmaceuticals

DG Sarangi’s Perspective

According to DG Sarangi, the decision to extend the track and trace system implementation deadline is aimed at fostering a robust and compliant pharmaceutical export ecosystem.

This news is likely to be met with appreciation from industry players grappling with the challenges of integrating the required systems and processes.

Industry’s Response

The industry’s response to this development is expected to be positive.

Manufacturers, in particular, will appreciate the additional time granted to align their operations with the track and trace system requirements.

The challenges posed by the implementation of new systems and processes are significant, and this extension offers a much-needed reprieve.

Read or download the following

DGFT dt 02-02-2024 Date extended for Implementation of the Track and Trace system for export of Pharmaceuticals

Handbook on India’s Strategic Trade Control System 2024

DGFT dt 22-05-2023 Amendment in Export Policy of Cough Syrup – Testing laboratories for cough syrups for export

Foreign Trade Policy 2023

Pharmaceutical Sector’s Adaptation

As the pharmaceutical sector adapts to this new timeline, the government’s emphasis on quality control and traceability in drug exports is poised to strengthen India’s position in the global pharmaceutical market.

This shift aligns with international standards and underscores India’s commitment to delivering high-quality pharmaceutical products.

Strengthening India’s Position

The extension of the implementation deadline is not just a reprieve for manufacturers but also a strategic move to bolster India’s position in the global pharmaceutical market.

The government’s commitment to quality control and traceability aligns with international expectations, setting a benchmark for other nations to follow.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

FAQs

Q: Why was the track and trace system implementation deadline extended?
- A: The extension aims to provide pharmaceutical companies with additional time to align their operations with the stringent requirements of the track and trace system.
Q: How does the extension impact small scale pharmaceutical industries?
- A: The extension applies to both small scale industries (SSI) and non-SSI manufactured drugs, ensuring a level playing field for all stakeholders.
Q: What changes were made to the Handbook of Procedure as part of this announcement?
- A: The amendment affects Para 2.76 (vi) and (vii) of Handbook of Procedure – 2023, highlighting changes in Para 2.90A of Handbook of Procedure-2015-20.
Q: How can stakeholders seek clarifications or assistance regarding the track and trace system?
- A: Stakeholders can reach out to Santosh Kumar Sarangi, the director general of DGFT, via email at dgft@nic.in.
Q: How does the extension contribute to India’s position in the global pharmaceutical market?
- A: The extension strengthens India’s position by emphasizing the government’s commitment to quality control and traceability, aligning with international standards.