TaxTMI 
TaxTMI 
The Office of the Commissioner of Customs, Nhava Sheva-II, Mumbai Zone-II, has issued Public Notice No. 88/2026 to simplify and standardize export procedures for pharmaceutical consignments. The notification aims to reduce procedural duplication, strengthen regulatory compliance, and enhance the ease of doing business for exporters while ensuring adherence to the provisions of the Drugs and Cosmetics Act, 1940, and the applicable rules.
The Public Notice builds upon earlier guidelines issued by the Jawaharlal Nehru Custom House (JNCH), the Directorate General of Foreign Trade (DGFT), and the Central Drugs Standard Control Organization (CDSCO). It also incorporates changes introduced through the CDSCO Office Order dated 30 April 2024, which significantly altered the approval process for the export of unapproved, new, and banned drugs.
Simplified Procedures for Manufacturer Exporters
For manufacturers exporting approved drugs and pharmaceutical products, the process has been streamlined. Manufacturers are now required to upload the documents prescribed under DGFT Public Notice No. 173 (RE-2008)/2004-2009through the e-Sanchit platform while filing the Shipping Bill. No separate clearance from the Assistant Drugs Controller (ADC) is required for such exports, provided the products are not classified as unapproved, new, or banned drugs.
This measure reduces documentation at the customs stage and facilitates faster export clearance.
Additional Requirements for Merchant Exporters
The Public Notice differentiates between manufacturer exporters and exporters who are not manufacturers. Merchant exporters must continue to submit all prescribed regulatory documents before the Assistant Drugs Controller (ADC) or CDSCO to obtain a No Objection Certificate (NOC).
Once the ADC verifies the documents and issues the NOC, Customs officers will ordinarily rely on that verification and will not request the same documents again. If any clarification is required regarding regulatory compliance, Customs officials are expected to seek confirmation directly from the CDSCO rather than burdening exporters with repeated documentation. This change is intended to minimize duplication and improve coordination between Customs and CDSCO.
Major Regulatory Change for Unapproved, New, and Banned Drugs
One of the most significant aspects of the Public Notice relates to the export of unapproved, new, and banned drugs manufactured exclusively for export.
Following the CDSCO Office Order dated 30 April 2024, the authority previously delegated to State and Union Territory Licensing Authorities to issue export NOCs has been withdrawn with effect from 15 May 2024.
Manufacturers intending to export such products must now:
- Obtain a No Objection Certificate from the appropriate CDSCO Zonal Office through the SUGAM Portal.
- Secure the CDSCO NOC before applying for the Manufacturing Licence from the State Licensing Authority.
- Begin manufacturing only after obtaining the Manufacturing Licence.
- Obtain a revised or amended CDSCO NOC if there is any change in the overseas buyer or purchase order before export.
- Ensure that all particulars declared in the Shipping Bill-including product description, brand, specifications, quantity, weight, and country of origin-match the information contained in the CDSCO NOC.
These requirements establish a clear sequence of regulatory approvals and improve traceability of export consignments.
Transitional Relaxation Until 30 September 2026
Recognizing that exporters may still be transitioning to the revised regulatory framework, Customs has provided a temporary relaxation.
Until 30 September 2026, export clearance may still be permitted in cases where the CDSCO NOC has been obtained after manufacturing, provided the exporter possesses:
- A valid NOC issued by the State or Union Territory Licensing Authority,
- Valid Product Permission,
- A valid Manufacturing Licence, and
- All other prescribed regulatory approvals.
After 30 September 2026, however, compliance with the CDSCO Office Order dated 30 April 2024 will become mandatory, and no such relaxation will be available.
Benefits for Trade and Regulatory Authorities
The Public Notice offers several practical benefits:
- Reduced duplication of document verification between Customs and CDSCO.
- Faster processing of export consignments.
- Greater regulatory certainty for exporters.
- Improved coordination between Customs authorities and CDSCO.
- Enhanced compliance with pharmaceutical export regulations.
- Strengthened transparency and traceability for exports of sensitive pharmaceutical products.
These measures are expected to facilitate legitimate pharmaceutical exports while maintaining India's high regulatory standards.
Conclusion
Public Notice No. 88/2026 represents an important step toward modernizing India's pharmaceutical export procedures. By clearly defining separate processes for manufacturer exporters, merchant exporters, and exporters of unapproved or banned drugs, the notice balances trade facilitation with regulatory oversight.
The emphasis on digital documentation, reliance on CDSCO verification, and elimination of repetitive scrutiny by Customs reflects the Government's broader commitment to improving the ease of doing business. Exporters should carefully review the revised procedures, particularly those dealing with unapproved, new, or banned drugs, and ensure full compliance before the transition period ends on 30 September 2026.
Overall, the Public Notice provides greater clarity, reduces administrative burden, and establishes a more efficient framework for pharmaceutical exports through Jawaharlal Nehru Custom House, Nhava Sheva.
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