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FPME raises critical areas of delay in export consignments of medicines at ports
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Shardul Nautiyal, Mumbai
January 27 , 2026
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In order to enhance ease of doing business and solidify India’s reputation as the ‘Pharmacy of the World’, the Federation of Pharmaceutical and Allied Products Merchant Exporters (FPME) has identified critical areas of delay in export consignments of various kinds of medicines at ports.
Documentation which is beyond the jurisdiction of the port authorities are demanded such as manufacturing license with text "for export only", Certificates of Analysis (CoA) and WHO-GMP certificates for product that are freely consumed by patients in India but access curtailed to Indian origin and other nations patients outside India.
“It has been observed that goods marked as Indian Pharmacopoeia (IP) are being stopped by the port authority under the pretext that these are meant for domestic sales only. These goods, which are in medium and small quantities, should be allowed to be exported as these are acceptable to the foreign customers,” according to an official.
FPME emphasizes promoting the IP standard globally to enhance the credibility and marketability of Indian pharma products. This aligns with India's goal to strengthen its position as a global pharma leader.
This issue, often exacerbated by new officer appointments, delays shipments unnecessarily. FPME urges the Pharmaceuticals Export Promotion Council of India (Pharmexcil) to liaise with the Central Board of Indirect Taxes and Customs (CBIC), Directorate General of Foreign Trade (DGFT) to issue clear guidelines that products which have been providing relief and treatment to millions of patients till now have no reason to be curtailed.
Besides this, labelling restrictions are also impacting exports. The Central Drugs Standard Control Organization (CDSCO)’s internal memo restricting "For sale in India only" labelled products has negatively impacted small exporters. It has also harmed India's global image as a leading pharma exporter, benefiting competitors. FPME has also submitted detailed representations to address this concern.
Another festering issue and pending demand is of exemption from Section 43(B) for MSME payments. Section 43(B) of the Indian Income Tax Act mandates payments to MSMEs within 45 days, posing challenges for exporters due to fluctuating cash flows and currency issues. FPME plans to take this issue to the Union ministry of commerce, advocating for exemptions for exporters.
Exporters face inconsistent and exorbitant banking charges, which vary significantly across banks. FPME recommends the standardization of charges to support exporters and improve competitiveness.
It is also pushing for permanent solutions for track and trace compliance. The deferred implementation of Track and Trace systems due to practical challenges needs a long-term resolution. FPME advocates for stakeholder collaboration and global benchmarking to develop feasible solutions to combat counterfeit medicines.
The association is also asking to streamline import-export processes at airports. FPME proposes direct transfer facilities for imported goods destined for export to minimize costs and improve efficiency, boosting ease of doing business.
FPME officials further highlighted the industry’s contributions and potential, stating, "We are deeply concerned about these issues and their impact on our industry. With over USD 25 billion exports of which 30% stems from the merchant exporters, we have the capacity to double our growth annually, if these challenges are addressed. India can reinforce its global position as the Pharmacy to the World. The federation remains committed to addressing the challenges of its 300+ member base, ensuring sustainable growth for the industry."
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