Key Takeaways

  • The DGFT's changes necessitate clear separation between domestic and export Track and Trace in India obligations.
  • Manufacturers must assess product-specific requirements before upgrading their Track and Trace System in India.
  • Schedule H2 now includes more drugs, with new regulations coming into effect from July 2026 to July 2028.
  • Investing in Track and Trace Aggregation can streamline logistics and support various packaging hierarchies for manufacturers.
  • It's crucial to validate code content and packaging details ahead of upcoming regulatory deadlines.

Sun Teknovation Pvt Ltd. is a leading provider of pharmaceutical serialization and track and trace solutions. After the DGFT policy change, manufacturers face new packaging decisions. Track and Trace in India now requires careful separation of domestic labelling obligations from export-market requirements. The right Track and Trace System in India begins with that distinction.

What Did DGFT Actually Withdraw?

On 31 January 2025, DGFT withdrew paragraph 2.76 of the Handbook of Procedures 2023, which covered track-and-trace procedures for pharmaceutical export consignments. The change aimed to remove overlapping rules while drug authentication remains under health authorities.

The withdrawal did not remove every pharmaceutical identification obligation. Manufacturers must still assess domestic and destination-market requirements. For teams reviewing Track and Trace in India, this is the starting point for a realistic investment plan.

Which Products Have New Schedule H2 Dates?

The June 2026 amendment expanded Schedule H2 coverage beyond the existing top 300 drug brands. Vaccines, anti-cancer drugs, and narcotic and psychotropic drugs covered under the NDPS Act come under the expanded provisions on 1 July 2027. Antimicrobials follow on 1 July 2028.

Covered manufacturers must place a barcode or QR code on primary packaging, or secondary packaging where space is inadequate. QR-code data includes identification, drug and manufacturer details, batch, dates, licence and excipients.

Track and Trace Systems in India should enable reliable product authentication and verification throughout the supply chain. Schedule H2 does not create a universal unit-level serialization or aggregation mandate.

What Should Packaging Teams Check Before Upgrading?

Our integrated online and offline solutions facilitate accurate code inspection while automatically identifying and rejecting non-compliant products. Before investing, check product-specific requirements.

  • Confirm whether the drug falls under existing or expanded Schedule H2 coverage.
  • Check the applicable effective date and packaging level.
  • Verify code content, print placement and scanner readability.
  • Review line speed, carton sizes and rejection handling.
  • Evaluate any additional serialization requirements specified by international markets, importing countries, or individual customers.

For Track and Trace in India, a documented gap assessment is more useful than buying equipment solely around a deadline.

Where Does Aggregation Fit After DGFT Changes?

Track and Trace Aggregation links identified saleable units with cases or pallets through parent-child records. It supports logistics where trading partners use packaging hierarchies.

Aggregation is not compulsory for every Schedule H2 product. Our manual and Multi 2D Aggregation options can support different packaging workflows, including unit-to-case and case-to-pallet relationships.

How Should Manufacturers Choose Their Equipment?

Evaluate line integration, OCR/OCV checks, rejected-pack control and record handling.

Ask Track and Trace System Manufacturers in India to demonstrate using your cartons and production speed. A practical Track and Trace System in India should also allow operators to manage changeovers and retrieve batch records without unnecessary manual work.

What Can Our Track and Trace Portfolio Support?

Sun Teknovation Pvt Ltd. offers online and offline serialization systems with 2D and Data Matrix capabilities, PLC-controlled operation, inspection and automated rejection options. Our portfolio also includes manual and Multi 2D Aggregation, plus eTrack L3 software for plant-level serialization and aggregation management.

We connect Track and Trace Aggregation discussions with line-level verification. Manufacturers comparing Track and Trace System Manufacturers in India can assess these capabilities against their actual domestic and export workflows.

What Should Be Prioritised Between 2026 and 2028?

During 2026, prioritize identifying relevant SKUs and conducting code validation tests to ensure operational readiness. Validate 2027 product labels ahead of July. For antimicrobials, plan testing before July 2028.

Exporters should review foreign rules separately. Track and Trace Aggregation may be helpful for some shipping chains, but should follow verified business requirements. This is also a sensible time to shortlist Track and Trace System Manufacturers in India able to support future packaging changes.

Why Choose Us

At Sun Teknovation Pvt Ltd., we approach pharma packaging projects through the actual line process. Our online and offline Track & Trace equipment combines identifier verification with machine control, while our aggregation options cover manual and Multi 2D workflows. We also offer eTrack L3 for plant-level data coordination. We discuss Track and Trace Aggregation and equipment integration around each market's practical needs.

Conclusion

The DGFT withdrawal changed India’s export procedure, not the need for accurate pharmaceutical identification. The 2026 Schedule H2 expansion now gives manufacturers specific preparations for July 2027 and July 2028. Track and Trace in India should therefore begin with product classification, correct label data and verified line performance. Exporters must separately check destination-market obligations, including serialization or aggregation where applicable. When assessing Track and Trace System Manufacturers in India, focus on verified process needs rather than broad compliance claims. Sun Teknovation Pvt Ltd. can support that planning through our serialization, inspection and aggregation portfolio.

Planning a packaging-line upgrade? Speak with Sun Teknovation Pvt Ltd. about a Track and Trace System in India suited to your products and production workflow.

Call: +91 98982 45695 or Email: connect@sunteknovation.com.

Frequently Asked Questions

The DGFT changes require manufacturers to clearly distinguish domestic labeling obligations from export-market requirements. This means that while some regulations have been withdrawn, the need for accurate pharmaceutical identification remains essential, and manufacturers must adapt to new packaging decisions.
The June 2026 amendment extends Schedule H2 coverage to not only the top 300 drug brands but also includes vaccines, anti-cancer drugs, and narcotic and psychotropic drugs starting July 2027. Antimicrobials will follow suit in July 2028, requiring adequate identification measures.
Manufacturers should confirm whether their products fall under the new Schedule H2 coverage and assess the specific labeling requirements. They must also check the effective date, code content, print placement, and ensure their equipment supports the necessary scanning and rejection processes.
Track and Trace Aggregation connects saleable units with cases or pallets using parent-child records, which aids in logistics management. While it is not mandatory for all Schedule H2 products, it provides significant support for supply chain tracking and management.
When choosing a Track and Trace System Manufacturer, prioritize equipment that provides line integration, effective code verification, and control over rejected packs. It is essential for the system to facilitate easy changeovers and manage batch records to enhance operational efficiency.

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