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DGFT seeks pharma exporters inputs to expand TRACE list of export compliance charges towards boosting trade
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Shardul Nautiyal, Mumbai
October 01 , 2026
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The Directorate General of Foreign Trade (DGFT) has asked pharma exporters to submit details of product registration, certification, inspection, testing and other statutory compliance charges that are currently not covered under the Trade Regulations, Accreditation & Compliance Enablement (TRACE) framework of the Export Promotion Mission (EPM).
The initiative is aimed at identifying and consolidating export-related compliance costs faced by Indian exporters in overseas markets and considering their inclusion under Annexure-I of the TRACE guidelines. The DGFT/TRACE team has notified a formal process for collecting these requirements through an online form, with Pharmaceuticals Export Promotion Council of India (Pharmexcil). Pharmexcil has advised its member exporters to submit the details on priority.
TRACE, being implemented under the EPM by the DGFT, New Delhi, is intended to facilitate export-related regulatory compliance, testing, certification and other requirements associated with accessing foreign markets. For pharmaceutical exporters, such requirements can include product registration and market-specific certifications, along with inspection and testing charges that may be necessary before products can be exported or registered in a particular country.
According to Pharmexcil director general (DG) Raja Bhanu, exporters should use the opportunity to provide complete details of compliance-related charges that are currently missing from the TRACE Annexure-I list.
The objective is to ensure that relevant statutory compliance expenses incurred by exporters are identified and considered as part of the system. The exercise will also enable the DGFT to consolidate exporter requirements and examine additional categories of charges that may need to be incorporated into the TRACE framework.
Pharmexcil has specifically advised its member exporters to provide details of all relevant inspection charges, testing charges, product registration charges and other certification-related expenses applicable to their export markets. The council has also asked exporters to identify charges that are currently not included in the existing Annexure-I list.
The online submission is expected to provide the DGFT and TRACE team with market-specific information from exporters, particularly in cases where regulatory or certification requirements vary across overseas destinations. The information submitted by exporters will be used for processing and consolidation of the proposed additions to the TRACE list.
The council has urged exporters to submit the information at the earliest so that the DGFT can process the requests and consolidate the requirements efficiently. The exercise is also intended to provide exporters with an avenue to formally flag compliance costs that arise from mandatory overseas regulatory and certification requirements.
For queries or issues relating to inclusion of certification and other compliance charges under TRACE, exporters can contact the TRACE team at trace.epm_dgft@gov.in, epm-dgft@gov.in and tradeconnect-dgft@gov.in, with a copy marked to research@pharmexcil.com.
The initiative comes as export-oriented pharmaceutical companies increasingly have to meet country-specific requirements involving product registration, testing, inspections and certifications before gaining or retaining access to international markets. The collection of these details is therefore intended to give the DGFT a consolidated view of such expenses and facilitate their consideration under the EPM-TRACE framework.
Pharmexcil has urged members to make use of the opportunity and submit their inputs on priority, enabling the authorities to assess and consolidate the requirements for possible inclusion in the TRACE Annexure-I list.
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