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In a significant move aimed at streamlining pharmaceutical exports and strengthening regulatory compliance, the Jawaharlal Nehru Custom House (JNCH) has issued revised Standard Operating Procedure (SOP) for the export clearance of drugs and pharmaceutical products through JNPT.
Operating under the Central Board of Indirect Taxes and Customs (CBIC), which functions under the Department of Revenue, Ministry of Finance, Government of India, JNCH has laid down a comprehensive framework that seeks to eliminate procedural ambiguities, reduce repetitive documentation, and facilitate faster export clearances while ensuring adherence to regulatory requirements.
The revised procedures are expected to provide substantial relief to pharmaceutical exporters by simplifying the verification process and clearly distinguishing compliance requirements for manufacturer exporters and merchant exporters. Under the new SOP, once the Assistant Drug Controller (ADC) or the Central Drugs Standard Control Organisation (CDSCO) verifies the prescribed regulatory documents and issues a No Objection Certificate (NOC), Customs authorities will ordinarily not seek the same documents again. This single-window verification mechanism is expected to significantly reduce duplication, minimize delays at ports, and improve the overall efficiency of export processing.
The notification also clearly differentiates the compliance framework for different categories of exporters. Manufacturer exporters will continue to upload the prescribed documents under the Directorate General of Foreign Trade (DGFT) Public Notice 173/2004-09 through the e-Sanchit platform without requiring a separate NOC. Merchant exporters, however, will be required to obtain an ADC/CDSCO NOC by submitting the prescribed documents before undertaking exports, ensuring greater regulatory clarity for non-manufacturing exporters.
Another important feature of the revised SOP is the mandatory requirement for exporters of unapproved, new or banned drugs to obtain a CDSCO NOC through the SUGAM Portal before the State Licensing Authority issues the Manufacturing Licence. The notification also establishes a clearly defined regulatory sequence that requires exporters to first obtain the CDSCO NOC, followed by the manufacturing licence, after which manufacturing can commence before the products are exported. This structured approach is intended to strengthen compliance while ensuring transparency in the export process.
The revised procedures also provide flexibility for exporters in cases where overseas buyers or purchase orders change after manufacturing has been completed. In such situations, exporters can obtain a revised or amended CDSCO NOC before shipment instead of manufacturing the products afresh, thereby reducing unnecessary costs and preventing disruption to export commitments.
To avoid clearance-related issues, the SOP mandates that all Shipping Bill particulars, including product description, brand name, strength, specifications, quantity, weight and country of origin, must exactly match the details mentioned in the ADC/CDSCO NOC. As a one-time facilitation measure, JNCH has also provided interim relief until 30 September 2026, allowing exports in specified cases where the CDSCO NOC was obtained subsequently, provided the exporter possesses the requisite State or Union Territory NOC, Product Permission, Manufacturing Licence and other prescribed approvals. Beyond this transition period, strict adherence to the revised regulatory sequence will become mandatory.
Welcoming the development, the pharma exporters said the notification represents a major step towards improving the ease of doing business for India's pharmaceutical export sector. The Federation of Pharmaceutical and Allied Products Merchant Exporters (FPME) informed that it had recently submitted representations to the Directorate General of Foreign Trade (DGFT), Customs authorities and other government agencies highlighting the practical challenges faced by merchant exporters due to repetitive documentation requirements and procedural delays. FPME stated that the revised SOP addresses several long-standing concerns by introducing a transparent, predictable and export-friendly regulatory framework while reducing unnecessary duplication of document verification and strengthening coordination between Customs and CDSCO.
According to FPME, the revised procedures will not only facilitate smoother exports but also reinforce compliance standards, providing greater certainty for both manufacturer and merchant exporters.
JNCH has urged all pharmaceutical exporters to carefully study the revised notification and ensure that their regulatory, quality assurance, documentation and export teams fully align their processes with the new SOP to ensure seamless compliance and avoid shipment delays.
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