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Shardul Nautiyal, Mumbai January 10 , 2025
The Federation of Pharmaceutical and Allied Products Merchant Exporters (FPME) has urged the authorities to address critical issues hampering India's pharmaceutical export ecosystem, highlighting the need for urgent reforms in testing norms, compliance mechanisms, and trade processes.

In the wake of mandatory cough syrup testing introduced after the Gambia incident, FPME has proposed adopting a risk-based testing system. The current blanket testing requirements disproportionately impact small exporters, rendering low-volume shipments commercially unviable despite a 99% compliance rate. A more nuanced system, FPME argues, could ease this burden without compromising safety.

The association also calls for global recognition of the Indian Pharmacopoeia (IP) standard, a move crucial to boosting the credibility and competitiveness of Indian pharma products. Alarmingly, goods marked with the IP standard are often held at ports under the assumption they are meant solely for domestic use. FPME insists such exports must be permitted, as they meet international customer standards.

Addressing long-standing compliance hurdles, FPME is pushing for permanent solutions to implement Track and Trace systems, a measure crucial in combating counterfeit medicines. While implementation has been repeatedly deferred due to practical challenges, the association advocates for global benchmarking and collaborative stakeholder approaches to develop workable solutions.

Additionally, FPME is seeking streamlined import-export processes at airports. By enabling direct transfer facilities for goods imported for re-export, the organization aims to cut costs, enhance efficiency, and promote ease of doing business.

These proposed reforms, FPME emphasizes, are pivotal to strengthening India's position as a global pharmaceutical leader and ensuring the sustainability of its export ecosystem.

Merchant exporters are instrumental in boosting a country's exports and generate the foreign exchange for the Country like normal exports and are mainly engaged in export of goods and not services. Merchant exporters account for around 35 percent of the total exports, helping boost outbound Merchandise Shipments.

FPME since its inception has represented the merchant exporters on various Issues. It has an Advisory Panel to assist members on issues related to the state FDAs, Customs, GST and others. FPME is also represented in Pharmexcil.

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